US20160000437A1 - Surgical instrument with wireless communication between control unit and remote sensor - Google Patents
Surgical instrument with wireless communication between control unit and remote sensor Download PDFInfo
- Publication number
- US20160000437A1 US20160000437A1 US14/848,557 US201514848557A US2016000437A1 US 20160000437 A1 US20160000437 A1 US 20160000437A1 US 201514848557 A US201514848557 A US 201514848557A US 2016000437 A1 US2016000437 A1 US 2016000437A1
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- US
- United States
- Prior art keywords
- sensor
- end effector
- control unit
- instrument
- shaft
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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- JLRPDHMKEGSPOP-UHFFFAOYSA-N CC[NH+](C(C)OCC)[O-] Chemical compound CC[NH+](C(C)OCC)[O-] JLRPDHMKEGSPOP-UHFFFAOYSA-N 0.000 description 1
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Definitions
- Patent Application Publication No. 2014/0171966 which is a continuation application claiming priority under 35 U.S.C. ⁇ 120 to U.S. patent application Ser. No. 13/118,259, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN A CONTROL UNIT OF A ROBOTIC SYSTEM AND REMOTE SENSOR, filed May 27, 2011, which issued on Apr. 1, 2014 as U.S. Pat. No. 8,684,253, which is a continuation-in-part application claiming priority under 35 U.S.C. ⁇ 120 to U.S. patent application Ser. No.
- Known surgical staplers include an end effector that simultaneously makes a longitudinal incision in tissue and applies lines of staples on opposing sides of the incision.
- the end effector includes a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway.
- One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples.
- the other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge.
- the instrument includes a plurality of reciprocating wedges which, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil.
- FIGS. 1 and 2 are perspective views of a surgical instrument according to various embodiments of the present invention.
- FIGS. 3-5 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention.
- FIG. 6 is a side view of the end effector according to various embodiments of the present invention.
- FIG. 7 is an exploded view of the handle of the instrument according to various embodiments of the present invention.
- FIGS. 8 and 9 are partial perspective views of the handle according to various embodiments of the present invention.
- FIG. 10 is a side view of the handle according to various embodiments of the present invention.
- FIGS. 11 , 13 - 14 , 16 , and 22 are perspective views of a surgical instrument according to various embodiments of the present invention.
- FIGS. 12 and 19 are block diagrams of a control unit according to various embodiments of the present invention.
- FIG. 15 is a side view of an end effector including a sensor transponder according to various embodiments of the present invention.
- FIGS. 17 and 18 show the instrument in a sterile container according to various embodiments of the present invention.
- FIG. 20 is a block diagram of the remote programming device according to various embodiments of the present invention.
- FIG. 21 is a diagram of a packaged instrument according to various embodiments of the present invention.
- FIGS. 23 and 24 are perspective views of a surgical instrument according to various embodiments of the present invention.
- FIGS. 25-27 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention.
- FIG. 28 is a side view of the end effector according to various embodiments of the present invention.
- FIG. 29 is an exploded view of the handle of the instrument according to various embodiments of the present invention.
- FIGS. 30 and 31 are partial perspective views of the handle according to various embodiments of the present invention.
- FIG. 32 is a side view of the handle according to various embodiments of the present invention.
- FIG. 33 is a schematic block diagram of one embodiment of a control unit for a surgical instrument according to various embodiments of the present invention.
- FIG. 34 is a schematic diagram illustrating the operation of one embodiment of the control unit in conjunction with first and second sensor elements for a surgical instrument according to various embodiments of the present invention
- FIG. 35 illustrates one embodiment of a surgical instrument comprising a first element located in a free rotating joint portion of a shaft of the surgical instrument;
- FIG. 36 illustrates one embodiment of a surgical instrument comprising sensor elements disposed at various locations on a shaft of the surgical instrument
- FIG. 37 illustrates one embodiment of a surgical instrument where a shaft of the surgical instrument serves as part of an antenna for a control unit;
- FIGS. 38 and 39 are perspective views of a surgical instrument according to various embodiments of the present invention.
- FIG. 40A is an exploded view of the end effector according to various embodiments of the present invention.
- FIG. 40B is a perspective view of the cutting instrument of FIG. 40A ;
- FIGS. 41 and 42 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention.
- FIG. 43 is a side view of the end effector according to various embodiments of the present invention.
- FIG. 44 is an exploded view of the handle of the instrument according to various embodiments of the present invention.
- FIGS. 45 and 46 are partial perspective views of the handle according to various embodiments of the present invention.
- FIG. 47 is a side view of the handle according to various embodiments of the present invention.
- FIGS. 48 and 49 illustrate a proportional sensor that may be used according to various embodiments of the present invention.
- FIG. 50 is a block diagram of a control unit according to various embodiments of the present invention.
- FIGS. 51-53 and FIG. 63 are perspective views of a surgical instrument according to various embodiments of the present invention.
- FIG. 54 is a bottom view of a portion of a staple cartridge according to various embodiments.
- FIGS. 55 and 57 are circuit diagrams of a transponder according to various embodiments.
- FIG. 56 is a bottom view of a portion of a staple cartridge according to various embodiments.
- FIG. 58 is a perspective view of a staple cartridge tray according to various embodiments.
- FIGS. 59 and 60 are circuit diagrams of a transponder according to various embodiments.
- FIG. 61 is a flow diagram of a method of preventing reuse of a staple cartridge in surgical instrument according to various embodiments
- FIG. 62 is a block diagram of a circuit for preventing operation of the motor according to various embodiments.
- FIGS. 64 and 65 are perspective views of a surgical cutting and fastening instrument according to various embodiments of the present invention.
- FIG. 66A is an exploded view of the end effector according to various embodiments of the present invention.
- FIG. 66B is a perspective view of the cutting instrument of FIG. 66A ;
- FIGS. 67 and 68 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention.
- FIG. 69 is a side view of the end effector according to various embodiments of the present invention.
- FIG. 70 is an exploded view of the handle of the instrument according to various embodiments of the present invention.
- FIGS. 71 and 72 are partial perspective views of the handle according to various embodiments of the present invention.
- FIG. 73 is a side view of the handle according to various embodiments of the present invention.
- FIGS. 74-75 illustrate a proportional sensor that may be used according to various embodiments of the present invention.
- FIGS. 76-90 illustrate mechanical blocking mechanisms and the sequential operation of each according to various embodiments of the present invention.
- FIGS. 91-92 illustrate schematic diagrams of circuits used in the instrument according to various embodiments of the present invention.
- FIG. 93 is a flow diagram of a process implemented by the microcontroller of FIG. 92 according to various embodiments of the present invention.
- FIG. 94 is a flow diagram of a process implemented by an interlock according to various embodiments of the present invention.
- Various embodiments of the present invention are directed generally to a surgical instrument having at least one remote sensor transponder and means for communicating power and/or data signals to the transponder(s) from a control unit.
- the present invention may be used with any type of surgical instrument comprising at least one sensor transponder, such as endoscopic or laparoscopic surgical instruments, but is particularly useful for surgical instruments where some feature of the instrument, such as a free rotating joint, prevents or otherwise inhibits the use of a wired connection to the sensor(s).
- an endoscopic stapling and cutting instrument i.e., an endocutter
- FIGS. 1 and 2 depict an endoscopic surgical instrument 10 that comprises a handle 6 , a shaft 8 , and an articulating end effector 12 pivotally connected to the shaft 8 at an articulation pivot 14 .
- Correct placement and orientation of the end effector 12 may be facilitated by controls on the hand 6 , including (1) a rotation knob 28 for rotating the closure tube (described in more detail below in connection with FIGS. 4-5 ) at a free rotating joint 29 of the shaft 8 to thereby rotate the end effector 12 and (2) an articulation control 16 to effect rotational articulation of the end effector 12 about the articulation pivot 14 .
- the end effector 12 is configured to act as an endocutter for clamping, severing and stapling tissue, although in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical instruments, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc.
- the handle 6 of the instrument 10 may include a closure trigger 18 and a firing trigger 20 for actuating the end effector 12 .
- the end effector 12 is shown separated from the handle 6 by the preferably elongate shaft 8 .
- a clinician or operator of the instrument 10 may articulate the end effector 12 relative to the shaft 8 by utilizing the articulation control 16 , as described in more detail in U.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference.
- the end effector 12 includes in this example, among other things, a staple channel 22 and a pivotally translatable clamping member, such as an anvil 24 , which are maintained at a spacing that assures effective stapling and severing of tissue clamped in the end effector 12 .
- the handle 6 includes a pistol grip 26 towards which a closure trigger 18 is pivotally drawn by the clinician to cause clamping or closing of the anvil 24 toward the staple channel 22 of the end effector 12 to thereby clamp tissue positioned between the anvil 24 and channel 22 .
- the firing trigger 20 is farther outboard of the closure trigger 18 . Once the closure trigger 18 is locked in the closure position, the firing trigger 20 may rotate slightly toward the pistol grip 26 so that it can be reached by the operator using one hand.
- proximal and distal are used herein with reference to a clinician gripping the handle 6 of an instrument 10 .
- end effector 12 is distal with respect to the more proximal handle 6 .
- spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings.
- surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
- the closure trigger 18 may be actuated first. Once the clinician is satisfied with the positioning of the end effector 12 , the clinician may draw back the closure trigger 18 to its fully closed, locked position proximate to the pistol grip 26 . The firing trigger 20 may then be actuated. The firing trigger 20 returns to the open position (shown in FIGS. 1 and 2 ) when the clinician removes pressure. A release button 30 on the handle 6 , and in this example, on the pistol grip 26 of the handle, when depressed may release the locked closure trigger 18 .
- FIG. 3 is an exploded view of the end effector 12 according to various embodiments.
- the end effector 12 may include, in addition to the previously-mentioned channel 22 and anvil 24 , a cutting instrument 32 , a sled 33 , a staple cartridge 34 that is removably seated in the channel 22 , and a helical screw shaft 36 .
- the cutting instrument 32 may be, for example, a knife.
- the anvil 24 may be pivotably opened and closed at a pivot point 25 connected to the proximate end of the channel 22 .
- the anvil 24 may also include a tab 27 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close the anvil 24 .
- the anvil 24 may pivot about the pivot point 25 into the clamped or closed position. If clamping of the end effector 12 is satisfactory, the operator may actuate the firing trigger 20 , which, as explained in more detail below, causes the knife 32 and sled 33 to travel longitudinally along the channel 22 , thereby cutting tissue clamped within the end effector 12 . The movement of the sled 33 along the channel 22 causes the staples of the staple cartridge 34 to be driven through the severed tissue and against the closed anvil 24 , which turns the staples to fasten the severed tissue.
- the sled 33 may be part of the cartridge 34 , such that when the knife 32 retracts following the cutting operation, the sled 33 does not retract.
- the channel 22 and the anvil 24 may be made of an electrically conductive material (such as metal) so that they may serve as part of the antenna that communicates with the sensor(s) in the end effector, as described further below.
- the cartridge 34 could be made of a nonconductive material (such as plastic) and the sensor may be connected to or disposed in the cartridge 34 , as described further below.
- FIGS. 4 and 5 are exploded views and FIG. 6 is a side view of the end effector 12 and shaft 8 according to various embodiments.
- the shaft 8 may include a proximate closure tube 40 and a distal closure tube 42 pivotably linked by a pivot links 44 .
- the distal closure tube 42 includes an opening 45 into which the tab 27 on the anvil 24 is inserted in order to open and close the anvil 24 .
- Disposed inside the closure tubes 40 , 42 may be a proximate spine tube 46 .
- Disposed inside the proximate spine tube 46 may be a main rotational (or proximate) drive shaft 48 that communicates with a secondary (or distal) drive shaft 50 via a bevel gear assembly 52 .
- the secondary drive shaft 50 is connected to a drive gear 54 that engages a proximate drive gear 56 of the helical screw shaft 36 .
- the vertical bevel gear 52 b may sit and pivot in an opening 57 in the distal end of the proximate spine tube 46 .
- a distal spine tube 58 may be used to enclose the secondary drive shaft 50 and the drive gears 54 , 56 .
- the main drive shaft 48 , the secondary drive shaft 50 , and the articulation assembly are sometimes referred to herein as the “main drive shaft assembly.”
- the closure tubes 40 , 42 may be made of electrically conductive material (such as metal) so that they may serve as part of the antenna, as described further below.
- Components of the main drive shaft assembly e.g., the drive shafts 48 , 50
- a bearing 38 positioned at a distal end of the staple channel 22 , receives the helical drive screw 36 , allowing the helical drive screw 36 to freely rotate with respect to the channel 22 .
- the helical screw shaft 36 may interface a threaded opening (not shown) of the knife 32 such that rotation of the shaft 36 causes the knife 32 to translate distally or proximately (depending on the direction of the rotation) through the staple channel 22 .
- the bevel gear assembly 52 a - c causes the secondary drive shaft 50 to rotate, which in turn, because of the engagement of the drive gears 54 , 56 , causes the helical screw shaft 36 to rotate, which causes the knife 32 to travel longitudinally along the channel 22 to cut any tissue clamped within the end effector.
- the sled 33 may be made of, for example, plastic, and may have a sloped distal surface. As the sled 33 traverses the channel 22 , the sloped forward surface may push up or drive the staples in the staple cartridge 34 through the clamped tissue and against the anvil 24 . The anvil 24 turns the staples, thereby stapling the severed tissue. When the knife 32 is retracted, the knife 32 and sled 33 may become disengaged, thereby leaving the sled 33 at the distal end of the channel 22 .
- the surgical instrument may include a battery 64 in the handle 6 .
- the illustrated embodiment provides user-feedback regarding the deployment and loading force of the cutting instrument in the end effector 12 .
- the embodiment may use power provided by the user in retracting the firing trigger 18 to power the instrument 10 (a so-called “power assist” mode).
- the handle 6 includes exterior lower side pieces 59 , 60 and exterior upper side pieces 61 , 62 that fit together to form, in general, the exterior of the handle 6 .
- the handle pieces 59 - 62 may be made of an electrically nonconductive material, such as plastic.
- a battery 64 may be provided in the pistol grip portion 26 of the handle 6 .
- the battery 64 powers a motor 65 disposed in an upper portion of the pistol grip portion 26 of the handle 6 .
- the battery 64 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO 2 or LiNiO 2 , a Nickel Metal Hydride chemistry, etc.
- the motor 65 may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 RPM to 100,000 RPM.
- the motor 64 may drive a 90° bevel gear assembly 66 comprising a first bevel gear 68 and a second bevel gear 70 .
- the bevel gear assembly 66 may drive a planetary gear assembly 72 .
- the planetary gear assembly 72 may include a pinion gear 74 connected to a drive shaft 76 .
- the pinion gear 74 may drive a mating ring gear 78 that drives a helical gear drum 80 via a drive shaft 82 .
- a ring 84 may be threaded on the helical gear drum 80 .
- the handle 6 may also include a run motor sensor 110 in communication with the firing trigger 20 to detect when the firing trigger 20 has been drawn in (or “closed”) toward the pistol grip portion 26 of the handle 6 by the operator to thereby actuate the cutting/stapling operation by the end effector 12 .
- the sensor 110 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firing trigger 20 is drawn in, the sensor 110 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to the motor 65 . When the sensor 110 is a variable resistor or the like, the rotation of the motor 65 may be generally proportional to the amount of movement of the firing trigger 20 .
- the control unit may output a PWM control signal to the motor 65 based on the input from the sensor 110 in order to control the motor 65 .
- the handle 6 may include a middle handle piece 104 adjacent to the upper portion of the firing trigger 20 .
- the handle 6 also may comprise a bias spring 112 connected between posts on the middle handle piece 104 and the firing trigger 20 .
- the bias spring 112 may bias the firing trigger 20 to its fully open position. In that way, when the operator releases the firing trigger 20 , the bias spring 112 will pull the firing trigger 20 to its open position, thereby removing actuation of the sensor 110 , thereby stopping rotation of the motor 65 .
- the bias spring 112 any time a user closes the firing trigger 20 , the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by the motor 65 .
- the operator could stop retracting the firing trigger 20 to thereby remove force from the sensor 100 , to thereby stop the motor 65 .
- the user may stop the deployment of the end effector 12 , thereby providing a measure of control of the cutting/fastening operation to the operator.
- the distal end of the helical gear drum 80 includes a distal drive shaft 120 that drives a ring gear 122 , which mates with a pinion gear 124 .
- the pinion gear 124 is connected to the main drive shaft 48 of the main drive shaft assembly. In that way, rotation of the motor 65 causes the main drive shaft assembly to rotate, which causes actuation of the end effector 12 , as described above.
- the ring 84 threaded on the helical gear drum 80 may include a post 86 that is disposed within a slot 88 of a slotted arm 90 .
- the slotted arm 90 has an opening 92 at its opposite end 94 that receives a pivot pin 96 that is connected between the handle exterior side pieces 59 , 60 .
- the pivot pin 96 is also disposed through an opening 100 in the firing trigger 20 and an opening 102 in the middle handle piece 104 .
- the handle 6 may include a reverse motor (or end-of-stroke sensor) 130 and a stop motor (or beginning-of-stroke) sensor 142 .
- the reverse motor sensor 130 may be a limit switch located at the distal end of the helical gear drum 80 such that the ring 84 threaded on the helical gear drum 80 contacts and trips the reverse motor sensor 130 when the ring 84 reaches the distal end of the helical gear drum 80 .
- the reverse motor sensor 130 when activated, sends a signal to the control unit which sends a signal to the motor 65 to reverse its rotation direction, thereby withdrawing the knife 32 of the end effector 12 following the cutting operation.
- the stop motor sensor 142 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of the helical gear drum 80 so that the ring 84 trips the switch 142 when the ring 84 reaches the proximate end of the helical gear drum 80 .
- the sensor 110 detects the deployment of the firing trigger 20 and sends a signal to the control unit which sends a signal to the motor 65 to cause forward rotation of the motor 65 at, for example, a rate proportional to how hard the operator pulls back the firing trigger 20 .
- the forward rotation of the motor 65 in turn causes the ring gear 78 at the distal end of the planetary gear assembly 72 to rotate, thereby causing the helical gear drum 80 to rotate, causing the ring 84 threaded on the helical gear drum 80 to travel distally along the helical gear drum 80 .
- the rotation of the helical gear drum 80 also drives the main drive shaft assembly as described above, which in turn causes deployment of the knife 32 in the end effector 12 . That is, the knife 32 and sled 33 are caused to traverse the channel 22 longitudinally, thereby cutting tissue clamped in the end effector 12 . Also, the stapling operation of the end effector 12 is caused to happen in embodiments where a stapling-type end effector is used.
- the ring 84 on the helical gear drum 80 will have reached the distal end of the helical gear drum 80 , thereby causing the reverse motor sensor 130 to be tripped, which sends a signal to the control unit which sends a signal to the motor 65 to cause the motor 65 to reverse its rotation.
- This causes the knife 32 to retract, and also causes the ring 84 on the helical gear drum 80 to move back to the proximate end of the helical gear drum 80 .
- the middle handle piece 104 includes a backside shoulder 106 that engages the slotted arm 90 as best shown in FIGS. 8 and 9 .
- the middle handle piece 104 also has a forward motion stop 107 that engages the firing trigger 20 .
- the movement of the slotted arm 90 is controlled, as explained above, by rotation of the motor 65 .
- the middle handle piece 104 will be free to rotate CCW.
- the firing trigger 20 will engage the forward motion stop 107 of the middle handle piece 104 , causing the middle handle piece 104 to rotate CCW.
- the middle handle piece 104 will only be able to rotate CCW as far as the slotted arm 90 permits. In that way, if the motor 65 should stop rotating for some reason, the slotted arm 90 will stop rotating, and the user will not be able to further draw in the firing trigger 20 because the middle handle piece 104 will not be free to rotate CCW due to the slotted arm 90 .
- the closure system includes a yoke 250 connected to the closure trigger 18 by a pin 251 that is inserted through aligned openings in both the closure trigger 18 and the yoke 250 .
- a pivot pin 252 about which the closure trigger 18 pivots, is inserted through another opening in the closure trigger 18 which is offset from where the pin 251 is inserted through the closure trigger 18 .
- the distal end of the yoke 250 is connected, via a pin 254 , to a first closure bracket 256 .
- the first closure bracket 256 connects to a second closure bracket 258 .
- the closure brackets 256 , 258 define an opening in which the proximate end of the proximate closure tube 40 (see FIG. 4 ) is seated and held such that longitudinal movement of the closure brackets 256 , 258 causes longitudinal motion by the proximate closure tube 40 .
- the instrument 10 also includes a closure rod 260 disposed inside the proximate closure tube 40 .
- the closure rod 260 may include a window 261 into which a post 263 on one of the handle exterior pieces, such as exterior lower side piece 59 in the illustrated embodiment, is disposed to fixedly connect the closure rod 260 to the handle 6 . In that way, the proximate closure tube 40 is capable of moving longitudinally relative to the closure rod 260 .
- the closure rod 260 may also include a distal collar 267 that fits into a cavity 269 in proximate spine tube 46 and is retained therein by a cap 271 (see FIG. 4 ).
- the closure brackets 256 , 258 cause the proximate closure tube 40 to move distally (i.e., away from the handle end of the instrument 10 ), which causes the distal closure tube 42 to move distally, which causes the anvil 24 to rotate about the pivot point 25 into the clamped or closed position.
- the proximate closure tube 40 is caused to slide proximately, which causes the distal closure tube 42 to slide proximately, which, by virtue of the tab 27 being inserted in the window 45 of the distal closure tube 42 , causes the anvil 24 to pivot about the pivot point 25 into the open or unclamped position.
- an operator may clamp tissue between the anvil 24 and channel 22 , and may unclamp the tissue following the cutting/stapling operation by unlocking the closure trigger 18 from the locked position.
- the control unit may receive the outputs from end-of-stroke and beginning-of-stroke sensors 130 , 142 and the run-motor sensor 110 , and may control the motor 65 based on the inputs. For example, when an operator initially pulls the firing trigger 20 after locking the closure trigger 18 , the run-motor sensor 110 is actuated. If the staple cartridge 34 is present in the end effector 12 , a cartridge lockout sensor (not shown) may be closed, in which case the control unit may output a control signal to the motor 65 to cause the motor 65 to rotate in the forward direction. When the end effector 12 reaches the end of its stroke, the reverse motor sensor 130 will be activated. The control unit may receive this output from the reverse motor sensor 130 and cause the motor 65 to reverse its rotational direction. When the knife 32 is fully retracted, the stop motor sensor switch 142 is activated, causing the control unit to stop the motor 65 .
- an on-off type sensor could be used.
- the rate of rotation of the motor 65 would not be proportional to the force applied by the operator. Rather, the motor 65 would generally rotate at a constant rate. But the operator would still experience force feedback because the firing trigger 20 is geared into the gear drive train.
- the instrument 10 may include a number of sensor transponders in the end effector 12 for sensing various conditions related to the end effector 12 , such as sensor transponders for determining the status of the staple cartridge 34 (or other type of cartridge depending on the type of surgical instrument), the progress of the stapler during closure and firing, etc.
- the sensor transponders may be passively powered by inductive signals, as described further below, although in other embodiments the transponders could be powered by a remote power source, such as a battery in the end effector 12 , for example.
- the sensor transponder(s) could include magnetoresistive, optical, electromechanical, RFID, MEMS, motion or pressure sensors, for example. These sensor transponders may be in communication with a control unit 300 , which may be housed in the handle 6 of the instrument 10 , for example, as shown in FIG. 11 .
- the control unit 300 may comprise a processor 306 and one or more memory units 308 .
- the processor 306 may control various components of the instrument 10 , such as the motor 65 or a user display (not shown), based on inputs received from the various end effector sensor transponders and other sensor(s) (such as the run-motor sensor 110 , the end-of-stroke sensor 130 , and the beginning-of-stroke sensor 142 , for example).
- the control unit 300 may be powered by the battery 64 during surgical use of instrument 10 .
- the control unit 300 may comprise an inductive element 302 (e.g., a coil or antenna) to pick up wireless signals from the sensor transponders, as described in more detail below.
- Input signals received by the inductive element 302 acting as a receiving antenna may be demodulated by a demodulator 310 and decoded by a decoder 312 .
- the input signals may comprise data from the sensor transponders in the end effector 12 , which the processor 306 may use to control various aspects of the instrument 10 .
- the control unit 300 may comprise an encoder 316 for encoding the signals and a modulator 318 for modulating the signals according to the modulation scheme.
- the inductive element 302 may act as the transmitting antenna.
- the control unit 300 may communicate with the sensor transponders using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band). Also, the control unit 300 may transmit signals at a different frequency range than the frequency range of the received signals from the sensor transponders. Also, although only one antenna (inductive element 302 ) is shown in FIG. 12 , in other embodiments the control unit 300 may have separate receiving and transmitting antennas.
- control unit 300 may comprise a microcontroller, a microprocessor, a field programmable gate array (FPGA), one or more other types of integrated circuits (e.g., RF receivers and PWM controllers), and/or discrete passive components.
- the control units may also be embodied as system-on-chip (SoC) or a system-in-package (SIP), for example.
- SoC system-on-chip
- SIP system-in-package
- the control unit 300 may be housed in the handle 6 of the instrument 10 and one or more of the sensor transponders 368 for the instrument 10 may be located in the end effector 12 .
- the inductive element 302 of the control unit 300 may be inductively coupled to a secondary inductive element (e.g., a coil) 320 positioned in the shaft 8 distally from the rotation joint 29 .
- the secondary inductive element 320 is preferably electrically insulated from the conductive shaft 8 .
- the secondary inductive element 320 may be connected by an electrically conductive, insulated wire 322 to a distal inductive element (e.g., a coil) 324 located near the end effector 12 , and preferably distally relative to the articulation pivot 14 .
- the wire 322 may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass though the articulation pivot 14 and not be damaged by articulation.
- the distal inductive element 324 may be inductively coupled to the sensor transponder 368 in, for example, the cartridge 34 of the end effector 12 .
- the transponder 368 as described in more detail below, may include an antenna (or coil) for inductive coupling to the distal coil 324 , a sensor and integrated control electronics for receiving and transmitting wireless communication signals.
- the transponder 368 may use a portion of the power of the inductive signal received from the distal inductive element 326 to passively power the transponder 368 . Once sufficiently powered by the inductive signals, the transponder 368 may receive and transmit data to the control unit 300 in the handle 6 via (i) the inductive coupling between the transponder 368 and the distal inductive element 324 , (ii) the wire 322 , and (iii) the inductive coupling between the secondary inductive element 320 and the control unit 300 .
- control unit 300 may communicate with the transponder 368 in the end effector 12 without a direct wired connection through complex mechanical joints like the rotating joint 29 and/or without a direct wired connection from the shaft 8 to the end effector 12 , places where it may be difficult to maintain such a wired connection.
- the distances between the inductive elements e.g., the spacing between (i) the transponder 368 and the distal inductive element 324 , and (ii) the secondary inductive element 320 and the control unit 300
- the couplings could be optimized for inductive transfer of energy.
- the distances could be relatively short so that relatively low power signals could be used to thereby minimize interference with other systems in the use environment of the instrument 10 .
- the inductive element 302 of the control unit 300 is located relatively near to the control unit 300 .
- the inductive element 302 of the control unit 300 may be positioned closer to the rotating joint 29 to that it is closer to the secondary inductive element 320 , thereby reducing the distance of the inductive coupling in such an embodiment.
- the control unit 300 (and hence the inductive element 302 ) could be positioned closer to the secondary inductive element 320 to reduce the spacing.
- the surgical instrument 10 may use a single inductive coupling between the control unit 300 in the handle 6 and the transponder 368 in the end effector 12 , thereby eliminating the inductive elements 320 , 324 and the wire 322 .
- a stronger signal may be required due to the greater distance between the control unit 300 in the handle 6 and the transponder 368 in the end effector 12 .
- more than two inductive couplings could be used. For example, if the surgical instrument 10 had numerous complex mechanical joints where it would be difficult to maintain a direct wired connection, inductive couplings could be used to span each such joint.
- inductive couplers could be used on both sides of the rotary joint 29 and both sides of the articulation pivot 14 , with the inductive element 321 on the distal side of the rotary joint 29 connected by a wire 322 to the inductive element 324 of the proximate side of the articulation pivot, and a wire 323 connecting the inductive elements 325 , 326 on the distal side of the articulation pivot 14 as shown in FIG. 14 .
- the inductive element 326 may communicate with the sensor transponder 368 .
- the transponder 368 may include a number of different sensors. For example, it may include an array of sensors. Further, the end effector 12 could include a number of sensor transponders 368 in communication with the distal inductive element 324 (and hence the control unit 300 ). Also, the inductive elements 320 , 324 may or may not include ferrite cores. As mentioned before, they are also preferably insulated from the electrically conductive outer shaft (or frame) of the instrument 10 (e.g., the closure tubes 40 , 42 ), and the wire 322 is also preferably insulated from the outer shaft 8 .
- FIG. 15 is a diagram of an end effector 12 including a transponder 368 held or embedded in the cartridge 34 at the distal end of the channel 22 .
- the transponder 368 may be connected to the cartridge 34 by a suitable bonding material, such as epoxy.
- the transponder 368 includes a magnetoresistive sensor.
- the anvil 24 also includes a permanent magnet 369 at its distal end and generally facing the transponder 368 .
- the end effector 12 also includes a permanent magnet 370 connected to the sled 33 in this example embodiment.
- transponder 368 This allows the transponder 368 to detect both opening/closing of the end effector 12 (due to the permanent magnet 369 moving further or closer to the transponder as the anvil 24 opens and closes) and completion of the stapling/cutting operation (due to the permanent magnet 370 moving toward the transponder 368 as the sled 33 traverses the channel 22 as part of the cutting operation).
- FIG. 15 also shows the staples 380 and the staple drivers 382 of the staple cartridge 34 .
- the sled 33 drives the staple drivers 382 which drive the staples 380 into the severed tissue held in the end effector 12 , the staples 380 being formed against the anvil 24 .
- a surgical cutting and fastening instrument is but one type of surgical instrument in which the present invention may be advantageously employed.
- Various embodiments of the present invention may be used in any type of surgical instrument having one or more sensor transponders.
- the battery 64 powers (at least partially) the firing operation of the instrument 10 .
- the instrument may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described in the '573 application, which is incorporated herein. It should be recognized, however, that the instrument 10 need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention.
- the instrument 10 may include a user display (such as a LCD or LED display) that is powered by the battery 64 and controlled by the control unit 300 . Data from the sensor transponders 368 in the end effector 12 may be displayed on such a display.
- the shaft 8 of the instrument 10 may collectively serve as part of an antenna for the control unit 300 by radiating signals to the sensor transponder 368 and receiving radiated signals from the sensor transponder 368 . That way, signals to and from the remote sensor in the end effector 12 may be transmitted via the shaft 8 of the instrument 10 .
- the proximate closure tube 40 may be grounded at its proximate end by the exterior lower and upper side pieces 59 - 62 , which may be made of a nonelectrically conductive material, such as plastic.
- the drive shaft assembly components (including the main drive shaft 48 and secondary drive shaft 50 ) inside the proximate and distal closure tubes 40 , 42 may also be made of a nonelectrically conductive material, such as plastic.
- components of end effector 12 (such as the anvil 24 and the channel 22 ) may be electrically coupled to (or in direct or indirect electrical contact with) the distal closure tube 42 such that they may also serve as part of the antenna.
- the sensor transponder 368 could be positioned such that it is electrically insulated from the components of the shaft 8 and end effector 12 serving as the antenna.
- the sensor transponder 368 may be positioned in the cartridge 34 , which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft 8 (such as the distal end of the distal closure tube 42 ) and the portions of the end effector 12 serving as the antenna may be relatively close in distance to the sensor 368 , the power for the transmitted signals may be held at low levels, thereby minimizing or reducing interference with other systems in the use environment of the instrument 10 .
- the control unit 300 may be electrically coupled to the shaft 8 of the instrument 10 , such as to the proximate closure tube 40 , by a conductive link 400 (e.g., a wire). Portions of the outer shaft 8 , such as the closure tubes 40 , 42 , may therefore act as part of an antenna for the control unit 300 by radiating signals to the sensor 368 and receiving radiated signals from the sensor 368 .
- Input signals received by the control unit 300 may be demodulated by the demodulator 310 and decoded by the decoder 312 (see FIG. 12 ).
- the input signals may comprise data from the sensors 368 in the end effector 12 , which the processor 306 may use to control various aspects of the instrument 10 , such as the motor 65 or a user display.
- the link 400 may connect the control unit 300 to components of the shaft 8 of the instrument 10 , such as the proximate closure tube 40 , which may be electrically connected to the distal closure tube 42 .
- the distal closure tube 42 is preferably electrically insulated from the remote sensor 368 , which may be positioned in the plastic cartridge 34 (see FIG. 3 ).
- components of the end effector 12 such as the channel 22 and the anvil 24 (see FIG. 3 ), may be conductive and in electrical contact with the distal closure tube 42 such that they, too, may serve as part of the antenna.
- the control unit 300 can communicate with the sensor 368 in the end effector 12 without a direct wired connection.
- the sensor 368 may include communication circuitry for radiating signals to the control unit 300 and for receiving signals from the control unit 300 , as described above.
- the communication circuitry may be integrated with the sensor 368 .
- the components of the shaft 8 and/or the end effector 12 may serve as an antenna for the remote sensor 368 .
- the remote sensor 368 is electrically connected to the shaft (such as to distal closure tube 42 , which may be electrically connected to the proximate closure tube 40 ) and the control unit 300 is insulated from the shaft 8 .
- the sensor 368 could be connected to a conductive component of the end effector 12 (such as the channel 22 ), which in turn may be connected to conductive components of the shaft (e.g., the closure tubes 40 , 42 ).
- the end effector 12 may include a wire (not shown) that connects the remote sensor 368 the distal closure tube 42 .
- surgical instruments such as the instrument 10
- the instrument 10 is placed in a closed and sealed container 280 , such as a plastic or TYVEK container or bag, as shown in FIGS. 17 and 18 .
- the container and the instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
- the radiation kills bacteria on the instrument 10 and in the container 280 .
- the sterilized instrument 10 can then be stored in the sterile container 280 .
- the sealed, sterile container 280 keeps the instrument 10 sterile until it is opened in a medical facility or some other use environment.
- other means of sterilizing the instrument 10 may be used, such as ethylene oxide or steam.
- control unit 300 When radiation, such as gamma radiation, is used to sterilize the instrument 10 , components of the control unit 300 , particularly the memory 308 and the processor 306 , may be damaged and become unstable. Thus, according to various embodiments of the present invention, the control unit 300 may be programmed after packaging and sterilization of the instrument 10 .
- a remote programming device 320 which may be a handheld device, may be brought into wireless communication with the control unit 300 .
- the remote programming device 320 may emit wireless signals that are received by the control unit 300 to program the control unit 300 and to power the control unit 300 during the programming operation. That way, the battery 64 does not need to power the control unit 300 during the programming operation.
- the programming code downloaded to the control unit 300 could be of relatively small size, such as 1 MB or less, so that a communications protocol with a relatively low data transmission rate could be used if desired.
- the remote programming unit 320 could be brought into close physical proximity with the surgical instrument 10 so that a low power signal could be used.
- control unit 300 may comprise an inductive coil 402 to pick up wireless signals from a remote programming device 320 .
- a portion of the received signal may be used by a power circuit 404 to power the control unit 300 when it is not being powered by the battery 64 .
- Input signals received by the coil 402 acting as a receiving antenna may be demodulated by a demodulator 410 and decoded by a decoder 412 .
- the input signals may comprise programming instructions (e.g., code), which may be stored in a non-volatile memory portion of the memory 308 .
- the processor 306 may execute the code when the instrument 10 is in operation. For example, the code may cause the processor 306 to output control signals to various sub-systems of the instrument 10 , such as the motor 65 , based on data received from the sensors 368 .
- the control unit 300 may also comprise a non-volatile memory unit 414 that comprises boot sequence code for execution by the processor 306 .
- the processor 306 may first execute the boot sequence code (“boot loader”) 414 , which may load the processor 306 with an operating system.
- the control unit 300 may also send signals back to the remote programming unit 320 , such as acknowledgement and handshake signals, for example.
- the control unit 300 may comprise an encoder 416 for encoding the signals to then be sent to the programming device 320 and a modulator 418 for modulating the signals according to the modulation scheme.
- the coil 402 may act as the transmitting antenna.
- the control unit 300 and the remote programming device 320 may communicate using any suitable wireless communication protocol (e.g., Bluetooth) and any suitable frequency (e.g., an ISM band). Also, the control unit 300 may transmit signals at a different frequency range than the frequency range of the received signals from the remote programming unit 320 .
- FIG. 20 is a simplified diagram of the remote programming device 320 according to various embodiments of the present invention.
- the remote programming unit 320 may comprise a main control board 230 and a boosted antenna board 232 .
- the main control board 230 may comprise a controller 234 , a power module 236 , and a memory 238 .
- the memory 238 may stored the operating instructions for the controller 234 as well as the programming instructions to be transmitted to the control unit 300 of the surgical instrument 10 .
- the power module 236 may provide a stable DC voltage for the components of the remote programming device 320 from an internal battery (not shown) or an external AC or DC power source (not shown).
- the boosted antenna board 232 may comprise a coupler circuit 240 that is in communication with the controller 234 via an I 2 C bus, for example.
- the coupler circuit 240 may communicate with the control unit 300 of the surgical instrument via an antenna 244 .
- the coupler circuit 240 may handle the modulating/demodulating and encoding/decoding operations for transmissions with the control unit.
- the remote programming device 320 could have a discrete modulator, demodulator, encoder and decoder.
- the boost antenna board 232 may also comprise a transmitting power amp 246 , a matching circuit 248 for the antenna 244 , and a filter/amplifier 249 for receiving signals.
- the remote programming device could be in communication with a computer device 460 , such as a PC or a laptop, via a USB and/or RS232 interface, for example.
- a memory of the computing device 460 may store the programming instructions to be transmitted to the control unit 300 .
- the computing device 460 could be configured with a wireless transmission system to transmit the programming instructions to the control unit 300 .
- control unit 300 could have a plate instead of a coil, as could the remote programming unit 320 .
- FIG. 21 is a diagram of a packaged instrument 10 according to such an embodiment.
- the handle 6 of the instrument 10 may include an external connection interface 470 .
- the container 280 may further comprise a connection interface 472 that mates with the external connection interface 470 of the instrument 10 when the instrument 10 is packaged in the container 280 .
- the programming device 320 may include an external connection interface (not shown) that may connect to the connection interface 472 at the exterior of the container 280 to thereby provide a wired connection between the programming device 320 and the external connection interface 470 of the instrument 10 .
- the present invention is directed to a surgical instrument, such as an endoscopic or laparoscopic instrument.
- the surgical instrument may comprise a shaft having a distal end connected to an end effector and a handle connected to a proximate end of the shaft.
- the handle may comprise a control unit (e.g., a microcontroller) that is in communication with a first sensor element.
- the surgical instrument may comprise a rotational joint for rotating the shaft.
- the surgical instrument may comprise the first element located in the shaft distally from the rotational joint.
- the first element may be coupled to the control unit either by a wired or wireless electrical connection.
- a second element may be located in the end effector and may be coupled to the first element by a wireless electrical connection.
- the first and second elements may be connected and/or coupled by a wired or a wireless electrical connection.
- the control unit may communicate with the second sensor element in the end effector without a direct wired electrical connection through complex mechanical joints like a rotating joint or articulating pivot where it may be difficult to maintain such a wired electrical connection.
- the distances between the inductive elements may be fixed and known, the couplings between the first and second sensor elements may be optimized for inductive and/or electromagnetic transfer of energy. Also, the distances may be relatively short so that relatively low power signals may be used to minimize interference with other systems in the use environment of the instrument.
- the electrically conductive shaft of the surgical instrument may serve as an antenna for the control unit to wirelessly communicate signals to and from one or more sensor elements.
- one or more sensor elements may be located on or disposed in a nonconductive component of the end effector, such as a plastic cartridge, thereby insulating the sensor element from conductive components of the end effector and the shaft.
- the control unit in the handle may be electrically coupled to the shaft.
- the shaft and/or the end effector may serve as an antenna for the control unit to radiate signals from the control unit to the one or more sensor elements and/or receive radiated echo response signals from the one or more sensor elements.
- Such a design is particularly useful in surgical instruments having complex mechanical joints (such as rotary joints) and articulating pivots, which make it difficult to use a direct wired electrical connection between the sensor elements and the control unit for communicating electrical signals therebetween.
- Various embodiments of the present invention are directed generally to a surgical instrument comprising one or more sensor elements to sense the location, type, presence and/or status of various components of interest disposed on the surgical instrument.
- the present invention is directed generally to a surgical instrument having one or more sensor elements to sense the location, type, presence and/or status of various components of interest disposed in an end effector portion of the surgical instrument.
- These components of interest may comprise, for example, a sled, a staple cartridge, a cutting instrument or any other component that may be disposed on the surgical instrument and more particularly disposed in the end effector portion thereof.
- the present invention may be used with any type of surgical instrument such as endoscopic or laparoscopic surgical instruments, it is particularly useful for surgical instruments comprising one or more free rotating joints or an articulation pivots that make it difficult to use wired electrical connections to the one or more passive and/or active sensor elements.
- the one or more sensor elements may be passive or active sensor elements adapted to communicate with a control unit in any suitable manner. In various embodiments, some of the sensor elements may not be supplied power over a wired electrical connection and as described herein, neither the passive nor the active sensor elements may comprise an internal power supply.
- the sensor elements may operate using the power provided by the minute electrical current induced in the sensor element itself or an antenna coupled to the sensor element by an incoming radio frequency (RF) interrogation signal transmitted by the control unit. This means that the antenna and/or the sensor element itself may be designed to collect power from the incoming interrogation signal and also to transmit an outbound backscatter signal in response thereto.
- RF radio frequency
- RF interrogation signals may be received by the passive sensor element wirelessly over a predetermined channel.
- the incident electromagnetic radiation associated with the RF interrogation signals is then scattered or reflected back to the interrogating source such as the control unit.
- the passive sensor element signals by backscattering the carrier of the RF interrogation signal from the control unit.
- just enough power may be received from the RF interrogation signals to cause the active sensor element to power up and transmit an analog or digital signal back to the control unit in response in response to the RF interrogation signal.
- the control unit may be referred to as a reader, interrogator or the like.
- the status of a component located in the end effector portion of the surgical instrument may be determined through the use of a system comprising passive and/or active sensor elements coupled to a control unit.
- the passive sensor elements may be formed of or comprise passive hardware elements such as resistive, inductive and/or capacitive elements or any combination thereof.
- the active sensor elements may be formed of or comprise active hardware elements. These active hardware elements may be integrated and/or discrete circuit elements or any combination thereof. Examples of integrated and/or discrete hardware elements are described herein below.
- the system may comprise a control unit coupled to a primary sensor element (primary element) disposed at a distal end of a shaft of the surgical instrument prior to an articulation pivot (as described below) and a secondary sensor element (secondary element) disposed on a component of interest in an end effector portion of the surgical instrument located subsequent to the articulation pivot (e.g., on a sled as described below).
- primary element wirelessly interrogates or illuminates the secondary element by transmitting an electromagnetic pulse signal over a channel at a predetermined frequency, duration and repetition rate.
- the secondary element When the interrogation pulse signal is incident upon, i.e., strikes or illuminates, the secondary element, it generated an echo response signal.
- the echo response signal is a reflection of the electromagnetic energy incident upon the secondary element.
- the primary element listens for the echo response signal reflected from the secondary element and couples the echo response signal to the control unit in a suitable form for subsequent processing.
- the echo response signal may be of the same frequency as the interrogation pulse or some harmonic frequency thereof.
- the amount of reflected energy in the echo response signal depends upon the material, shape and size of the secondary element. The amount of reflected energy in the echo response signal also depends upon the distance between the primary element and the secondary element.
- the material, shape and size of the secondary element as well as the relative distance between the primary and secondary elements may be selected to generate a unique echo response signal that is indicative of a desired measurement associated with the component of interest coupled to the secondary element.
- unique echo response signals may indicate the location, type, presence and/or status of various components and sub-components disposed in the surgical instrument.
- the various components and sub-components disposed in the end effector portion of the surgical instrument subsequent to a freely rotating joint or articulation pivot that may make it difficult or impractical to provide a wired electrical connection between the primary and the secondary elements.
- the echo response signals also may be used to determine the distance between the primary and secondary elements.
- the secondary element may be made integral with or may be attached to a component of interest and the echo response signal may provide information associated with the component of interest.
- This arrangement may eliminate the need to transmit or provide power to the secondary element over a wired connection and may be a cost effective solution to providing various additional passive and/or active sensor elements in the surgical instrument.
- an endoscopic stapling and cutting instrument i.e., an endocutter
- FIGS. 23 and 24 depict an endoscopic surgical instrument 2010 that comprises a handle 2006 , a shaft 2008 , and an articulating end effector 2012 pivotally connected to the shaft 2008 at an articulation pivot 2014 .
- Correct placement and orientation of the end effector 2012 may be facilitated by controls on the hand 2006 , including (1) a rotation knob 2028 for rotating the closure tube (described in more detail below in connection with FIGS. 26-27 ) at a free rotating joint 2029 of the shaft 2008 to thereby rotate the end effector 2012 and (2) an articulation control 2016 to effect rotational articulation of the end effector 2012 about the articulation pivot 2014 .
- the end effector 2012 is configured to act as an endocutter for clamping, severing and stapling tissue, although in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical instruments, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc.
- the handle 2006 of the instrument 2010 may include a closure trigger 2018 and a firing trigger 2020 for actuating the end effector 2012 . It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector 2012 .
- the end effector 2012 is shown separated from the handle 2006 by the preferably elongate shaft 2008 .
- the handle may comprise a control unit 2300 (described below) in communication with a first element 2021 by way of an electrical connection 2023 .
- the electrical connection 2023 may be a wired electrical connection such as an electrically conductive insulated wire or may be a wireless electrical connection.
- the electrically conductive insulated wire may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass through the articulation control 2016 , the rotation knob 2028 , the free rotating joint 2029 and other components in the handle 2006 of the instrument 2010 without being damaged by rotation.
- the first element 2021 may be disposed at a distal end of the shaft 2008 prior to the articulation pivot 2014 .
- a second element 2035 (shown in FIG. 25 below) may be disposed in the articulating end effector 2012 and is in wireless communication with the first element 2021 . The operation of the first and second elements 2021 , 2023 and the control unit 2300 is described below.
- a clinician or operator of the instrument 2010 may articulate the end effector 2012 relative to the shaft 2008 by utilizing the articulation control 2016 , as described in more detail in U.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference.
- the end effector 2012 includes in this example, among other things, a staple channel 2022 and a pivotally translatable clamping member, such as an anvil 2024 , which are maintained at a spacing that assures effective stapling and severing of tissue clamped in the end effector 2012 .
- the handle 2006 includes a pistol grip 2026 towards which a closure trigger 2018 is pivotally drawn by the clinician to cause clamping or closing of the anvil 2024 toward the staple channel 2022 of the end effector 2012 to thereby clamp tissue positioned between the anvil 2024 and channel 2022 .
- the firing trigger 2020 is farther outboard of the closure trigger 2018 .
- the firing trigger 2020 may rotate slightly toward the pistol grip 2026 so that it can be reached by the operator using one hand. Then the operator may pivotally draw the firing trigger 2020 toward the pistol grip 2026 to cause the stapling and severing of clamped tissue in the end effector 2012 .
- the '573 application describes various configurations for locking and unlocking the closure trigger 2018 .
- different types of clamping members besides the anvil 2024 could be used, such as, for example, an opposing jaw, etc.
- proximal and distal are used herein with reference to a clinician gripping the handle 2006 of the instrument 2010 .
- end effector 2012 is distal with respect to the more proximal handle 2006 .
- spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings.
- surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
- the closure trigger 2018 may be actuated first. Once the clinician is satisfied with the positioning of the end effector 2012 , the clinician may draw back the closure trigger 2018 to its fully closed, locked position proximate to the pistol grip 2026 . The firing trigger 2020 may then be actuated. When the clinician removes pressure from the firing trigger 2020 , it returns to the open position (shown in FIGS. 23 and 24 ). A release button 2030 on the handle 2006 , and in this example, on the pistol grip 2026 of the handle, when depressed may release the locked closure trigger 2018 .
- FIG. 25 is an exploded view of the end effector 2012 according to various embodiments.
- the end effector 2012 may include, in addition to the previously-mentioned channel 2022 and anvil 2024 , a cutting instrument 2032 , a sled 2033 , a staple cartridge 2034 that is removably seated in the channel 2022 , and a helical screw shaft 2036 .
- the second element 2035 may be coupled or formed integrally with a component of interest.
- the cutting instrument 2032 may be, for example, a knife.
- the anvil 2024 may be pivotably opened and closed at a pivot point 2025 connected to the proximate end of the channel 2022 .
- the anvil 2024 may also include a tab 2027 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close the anvil 2024 .
- the closure trigger 2018 When the closure trigger 2018 is actuated, that is, drawn in by a user of the instrument 2010 , the anvil 2024 may pivot about the pivot point 2025 into the clamped or closed position. If clamping of the end effector 2012 is satisfactory, the operator may actuate the firing trigger 2020 , which, as explained in more detail below, causes the knife 2032 and sled 2033 to travel longitudinally along the channel 2022 , thereby cutting tissue clamped within the end effector 2012 .
- the movement of the sled 2033 along the channel 2022 causes the staples of the staple cartridge 2034 to be driven through the severed tissue and against the closed anvil 2024 , which turns the staples to fasten the severed tissue.
- U.S. Pat. No. 6,978,921 entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments.
- the sled 2033 which may comprise the second element 2035 , may be part of the cartridge 2034 , such that when the knife 2032 retracts following the cutting operation, the sled 2033 and the second element 2035 do not retract.
- the cartridge 2034 could be made of a nonconductive material (such as plastic).
- the second element 2035 may be connected to or disposed in the cartridge 2034 , for example.
- the second element 2035 may be attached to the sled 2033 in any suitable manner and on any suitable portion thereof.
- the second element 2035 may be embedded in the sled 2033 or otherwise integrally formed (e.g., co-molded) with the sled 2033 . Accordingly, the location of the sled 2033 may be determined by detecting the location of the second element 2035 .
- the second element 2035 may be formed of various materials in various sizes and shapes and may be located at certain predetermined distances from the first element 2021 to enable the control unit 2300 to ascertain the type, presence and status of the staple cartridge 2034 .
- FIGS. 26 and 27 are exploded views and FIG. 28 is a side view of the end effector 2012 and shaft 2008 according to various embodiments.
- the shaft 2008 may include a proximate closure tube 2040 and a distal closure tube 2042 pivotably linked by a pivot links 2044 .
- the distal closure tube 2042 includes an opening 2045 into which the tab 2027 on the anvil 2024 is inserted in order to open and close the anvil 2024 .
- Disposed inside the closure tubes 2040 , 2042 may be a proximate spine tube 2046 .
- the first element 2021 may be a coil disposed about the proximate spine tube 2046 (e.g., as shown in FIGS. 26 and 27 ).
- the first element 2021 may be connected to the control unit 2300 by way of the wired electrical connection 2023 , which may comprise lengths of wire forming the coil. The lengths of wire may be provided along the proximate spine tube 2046 to connect to the control unit 2300 .
- the first element 2021 may be contained within the proximate spine tube 2046 (e.g., as shown in FIG. 28 ). In either case, the first element 2021 is electrically isolated from the proximate spine tube 2046 .
- the secondary drive shaft 2050 is connected to a drive gear 2054 that engages a proximate drive gear 2056 of the helical screw shaft 2036 .
- the vertical bevel gear 2052 b may sit and pivot in an opening 2057 in the distal end of the proximate spine tube 2046 .
- a distal spine tube 2058 may be used to enclose the secondary drive shaft 2050 and the drive gears 2054 , 2056 .
- main drive shaft 2048 the secondary drive shaft 2050 , and the articulation assembly (e.g., the bevel gear assembly 2052 a - c ), are sometimes referred to herein as the “main drive shaft assembly.”
- Components of the main drive shaft assembly e.g., the drive shafts 2048 , 2050
- a bearing 2038 positioned at a distal end of the staple channel 2022 , receives the helical drive screw 2036 , allowing the helical drive screw 2036 to freely rotate with respect to the channel 2022 .
- the helical screw shaft 2036 may interface a threaded opening (not shown) of the knife 2032 such that rotation of the shaft 2036 causes the knife 2032 to translate distally or proximately (depending on the direction of the rotation) through the staple channel 2022 .
- the bevel gear assembly 2052 a - c causes the secondary drive shaft 2050 to rotate, which in turn, because of the engagement of the drive gears 2054 , 2056 , causes the helical screw shaft 2036 to rotate, which causes the knife 2032 to travel longitudinally along the channel 2022 to cut any tissue clamped within the end effector.
- the sled 2033 may be made of, for example, plastic, and may have a sloped distal surface.
- the second element 2035 may be attached to the sled 2033 in any suitable manner to determine the status, location and type of the sled 2033 and/or the staple cartridge 2034 .
- the sloped forward surface may push up or drive the staples in the staple cartridge 2034 through the clamped tissue and against the anvil 2024 .
- the anvil 2024 turns the staples, thereby stapling the severed tissue.
- the knife 2032 and sled 2033 may become disengaged, thereby leaving the sled 2033 at the distal end of the channel 2022 .
- the surgical instrument may include a battery 2064 in the handle 2006 .
- the illustrated embodiment provides user-feedback regarding the deployment and loading force of the cutting instrument in the end effector 2012 .
- the embodiment may use power provided by the user in retracting the firing trigger 2018 to power the instrument 2010 (a so-called “power assist” mode).
- the handle 2006 includes exterior lower side pieces 2059 , 2060 and exterior upper side pieces 2061 , 2062 that fit together to form, in general, the exterior of the handle 2006 .
- the handle pieces 2059 - 2062 may be made of an electrically nonconductive material, such as plastic.
- a battery 2064 may be provided in the pistol grip portion 2026 of the handle 2006 .
- the battery 2064 powers a motor 2065 disposed in an upper portion of the pistol grip portion 2026 of the handle 2006 .
- the battery 2064 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO 2 or LiNiO 2 , a Nickel Metal Hydride chemistry, etc.
- the motor 2065 may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 to 100,000 RPM.
- the motor 2065 may drive a 90° bevel gear assembly 2066 comprising a first bevel gear 2068 and a second bevel gear 2070 .
- the bevel gear assembly 2066 may drive a planetary gear assembly 2072 .
- the planetary gear assembly 2072 may include a pinion gear 2074 connected to a drive shaft 2076 .
- the pinion gear 2074 may drive a mating ring gear 2078 that drives a helical gear drum 2080 via a drive shaft 20082 .
- a ring 2084 may be threaded on the helical gear drum 2080 .
- the handle 2006 may also include a run motor sensor 2110 in communication with the firing trigger 2020 to detect when the firing trigger 2020 has been drawn in (or “closed”) toward the pistol grip portion 2026 of the handle 2006 by the operator to thereby actuate the cutting/stapling operation by the end effector 2012 .
- the sensor 2110 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firing trigger 2020 is drawn in, the sensor 2110 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to the motor 2065 . When the sensor 2110 is a variable resistor or the like, the rotation of the motor 2065 may be generally proportional to the amount of movement of the firing trigger 2020 .
- the rotation of the motor 2065 is relatively low.
- the rotation of the motor 2065 is at its maximum. In other words, the harder the user pulls on the firing trigger 2020 , the more voltage is applied to the motor 2065 , causing greater rates of rotation.
- the handle 2006 may include a middle handle piece 2104 adjacent to the upper portion of the firing trigger 2020 .
- the handle 2006 also may comprise a bias spring 2112 connected between posts on the middle handle piece 2104 and the firing trigger 2020 .
- the bias spring 2112 may bias the firing trigger 2020 to its fully open position. In that way, when the operator releases the firing trigger 2020 , the bias spring 2112 will pull the firing trigger 2020 to its open position, thereby removing actuation of the sensor 2110 , thereby stopping rotation of the motor 2065 .
- the bias spring 2112 any time a user closes the firing trigger 2020 , the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by the motor 2065 .
- the operator could stop retracting the firing trigger 2020 to thereby remove force from the sensor 2110 , to thereby stop the motor 2065 .
- the user may stop the deployment of the end effector 2012 , thereby providing a measure of control of the cutting/fastening operation to the operator.
- the distal end of the helical gear drum 2080 includes a distal drive shaft 2120 that drives a ring gear 2122 , which mates with a pinion gear 2124 .
- the pinion gear 2124 is connected to the main drive shaft 2048 of the main drive shaft assembly. In that way, rotation of the motor 2065 causes the main drive shaft assembly to rotate, which causes actuation of the end effector 2012 , as described above.
- the ring 2084 threaded on the helical gear drum 2080 may include a post 2086 that is disposed within a slot 2088 of a slotted arm 2090 .
- the slotted arm 2090 has an opening 2092 at its opposite end 2094 that receives a pivot pin 2096 that is connected between the handle exterior side pieces 2059 , 2060 .
- the pivot pin 2096 is also disposed through an opening 2100 in the firing trigger 2020 and an opening 2102 in the middle handle piece 2104 .
- the handle 2006 may include a reverse motor (or end-of-stroke sensor) 2130 and a stop motor (or beginning-of-stroke) sensor 2142 .
- the reverse motor sensor 2130 may be a limit switch located at the distal end of the helical gear drum 2080 such that the ring 2084 threaded on the helical gear drum 2080 contacts and trips the reverse motor sensor 2130 when the ring 2084 reaches the distal end of the helical gear drum 2080 .
- the reverse motor sensor 2130 when activated, sends a signal to the control unit which sends a signal to the motor 2065 to reverse its rotation direction, thereby withdrawing the knife 2032 of the end effector 2012 following the cutting operation.
- the stop motor sensor 2142 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of the helical gear drum 2080 so that the ring 2084 trips the switch 2142 when the ring 2084 reaches the proximate end of the helical gear drum 2080 .
- the handle 2006 also may comprise the control unit 2300 .
- the control unit 2300 may be powered through the battery 2064 with the addition of a conditioning circuit (not shown).
- the control unit 2300 is coupled to the first element 2021 by an electrical connection 2023 .
- the electrical connection 2023 may be a wired electrical connection or a wireless electrical connection.
- the sensor 2110 detects the deployment of the firing trigger 2020 and sends a signal to the control unit which sends a signal to the motor 2065 to cause forward rotation of the motor 2065 at, for example, a rate proportional to how hard the operator pulls back the firing trigger 2020 .
- the forward rotation of the motor 2065 in turn causes the ring gear 2078 at the distal end of the planetary gear assembly 2072 to rotate, thereby causing the helical gear drum 2080 to rotate, causing the ring 2084 threaded on the helical gear drum 2080 to travel distally along the helical gear drum 2080 .
- the rotation of the helical gear drum 2080 also drives the main drive shaft assembly as described above, which in turn causes deployment of the knife 2032 in the end effector 2012 . That is, the knife 2032 and the sled 2033 are caused to traverse the channel 2022 longitudinally, thereby cutting tissue clamped in the end effector 2012 . Also, the stapling operation of the end effector 2012 is caused to happen in embodiments where a stapling-type end effector is used.
- the ring 2084 on the helical gear drum 2080 will have reached the distal end of the helical gear drum 2080 , thereby causing the reverse motor sensor 2130 to be tripped, which sends a signal to the control unit which sends a signal to the motor 2065 to cause the motor 2065 to reverse its rotation.
- This causes the knife 2032 to retract, and also causes the ring 2084 on the helical gear drum 2080 to move back to the proximate end of the helical gear drum 2080 .
- the middle handle piece 2104 includes a backside shoulder 2106 that engages the slotted arm 2090 as best shown in FIGS. 30 and 31 .
- the middle handle piece 2104 also has a forward motion stop 2107 that engages the firing trigger 2020 .
- the movement of the slotted arm 2090 is controlled, as explained above, by rotation of the motor 2065 .
- the middle handle piece 2104 will be free to rotate CCW.
- the firing trigger 2020 will engage the forward motion stop 2107 of the middle handle piece 2104 , causing the middle handle piece 2104 to rotate CCW.
- the middle handle piece 2104 will only be able to rotate CCW as far as the slotted arm 2090 permits. In that way, if the motor 2065 should stop rotating for some reason, the slotted arm 2090 will stop rotating, and the user will not be able to further draw in the firing trigger 2020 because the middle handle piece 2104 will not be free to rotate CCW due to the slotted arm 2090 .
- the closure system includes a yoke 2250 connected to the closure trigger 2018 by a pin 2251 that is inserted through aligned openings in both the closure trigger 2018 and the yoke 2250 .
- a pivot pin 2252 about which the closure trigger 2018 pivots, is inserted through another opening in the closure trigger 2018 which is offset from where the pin 2251 is inserted through the closure trigger 2018 .
- retraction of the closure trigger 2018 causes the upper part of the closure trigger 2018 , to which the yoke 2250 is attached via the pin 2251 , to rotate CCW.
- the distal end of the yoke 2250 is connected, via a pin 2254 , to a first closure bracket 2256 .
- the first closure bracket 2256 connects to a second closure bracket 2258 .
- the closure brackets 2256 , 2258 define an opening in which the proximate end of the proximate closure tube 2040 ( FIG. 26 ) is seated and held such that longitudinal movement of the closure brackets 2256 , 2258 causes longitudinal motion by the proximate closure tube 2040 .
- the instrument 2010 also includes a closure rod 2260 disposed inside the proximate closure tube 2040 .
- the closure rod 2260 may include a window 2261 into which a post 2263 on one of the handle exterior pieces, such as exterior lower side piece 2059 in the illustrated embodiment, is disposed to fixedly connect the closure rod 2260 to the handle 2006 . In that way, the proximate closure tube 2040 is capable of moving longitudinally relative to the closure rod 2260 .
- the closure rod 2260 may also include a distal collar 2267 that fits into a cavity 2269 in proximate spine tube 2046 and is retained therein by a cap 2271 ( FIG. 26 ).
- the closure brackets 2256 , 2258 cause the proximate closure tube 2040 to move distally (i.e., away from the handle end of the instrument 2010 ), which causes the distal closure tube 2042 to move distally, which causes the anvil 2024 to rotate about the pivot point 2025 into the clamped or closed position.
- the proximate closure tube 2040 is caused to slide proximately, which causes the distal closure tube 2042 to slide proximately, which, by virtue of the tab 2027 being inserted in the window 2045 of the distal closure tube 2042 , causes the anvil 2024 to pivot about the pivot point 2025 into the open or unclamped position.
- an operator may clamp tissue between the anvil 2024 and channel 2022 , and may unclamp the tissue following the cutting/stapling operation by unlocking the closure trigger 2018 from the locked position.
- the control unit 2300 may receive the outputs from end-of-stroke and beginning-of-stroke sensors 2130 , 2142 and the run-motor sensor 2110 , and may control the motor 2065 based on the inputs. For example, when an operator initially pulls the firing trigger 2020 after locking the closure trigger 2018 , the run-motor sensor 2110 is actuated. If the staple cartridge 2034 is present in the end effector 2012 , a cartridge lockout sensor (not shown) may be closed, in which case the control unit may output a control signal to the motor 2065 to cause the motor 2065 to rotate in the forward direction. When the end effector 2012 reaches the end of its stroke, the reverse motor sensor 2130 will be activated. The control unit may receive this output from the reverse motor sensor 2130 and cause the motor 2065 to reverse its rotational direction. When the knife 2032 is fully retracted, the stop motor sensor switch 2142 is activated, causing the control unit to stop the motor 2065 .
- an on-off type sensor may be used.
- the rate of rotation of the motor 2065 would not be proportional to the force applied by the operator. Rather, the motor 2065 would generally rotate at a constant rate. But the operator would still experience force feedback because the firing trigger 2020 is geared into the gear drive train.
- the instrument 2010 may include a number of sensor elements in the end effector 2012 for sensing various conditions related to the end effector 2012 , such as sensor elements for determining the status of the staple cartridge 2034 (or other type of cartridge depending on the type of surgical instrument), the progress of the stapler during closure and firing, etc.
- the sensor elements may be passively powered by inductively coupled signals, as described in commonly assigned U.S. patent application Ser. No. 11/651,715, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS, now U.S. Pat. No. 8,652,120, which is incorporated herein by reference.
- the sensor elements reflect or scatter incident electromagnetic energy or power up in response to the interrogation signal and transmit echo response pulses or signals that may be coupled back to the control unit 2300 for processing.
- the sensor elements may be powered by the minute electrical current induced in the sensor element itself or an antenna coupled to the sensor element by the incoming incident electromagnetic energy (e.g., the RF carrier of the interrogation signal) transmitted by the control unit 2300 .
- These sensor elements may comprise any arrangement of electrical conductors to transmit, receive, amplify, encode, scatter and/or reflect electromagnetic energy waves of any suitable predetermined frequency (e.g., wavelength [ ⁇ ]), having a suitable predetermined pulse width that may be transmitted over a suitable predetermined time period.
- the passive sensor elements may comprise any suitable arrangement of resistive, inductive, and/or capacitive elements.
- the active sensor elements may comprise semiconductors such as transistors, integrated circuits, processors, amplifiers and/or any combination of these active elements. For succinctness the passive and/or active sensor elements are referred to hereinafter as the first element 2021 and the second element 2035 .
- the first element 2021 may be in wired or wireless communication with the control unit 2300 , which, as previously discussed, may be housed in the handle 2006 of the instrument 2010 , for example, as shown below in FIG. 33 .
- the first element 2021 is in wireless communication with the second element 2035 .
- FIG. 33 illustrates a schematic block diagram of one embodiment of the control unit 2300 .
- the control unit 2300 may comprise a processor 2306 and one or more memory units 2308 .
- the processor 2306 may control various components of the instrument 2010 , such as the motor 2065 or a user display (not shown), based on inputs received from the one or more end effector sensor element(s) and/or other sensor elements located throughout the instrument 2010 (such as the run-motor sensor 2110 , the end-of-stroke sensor 2130 , and the beginning-of-stroke sensor 2142 , for example).
- the control unit 2300 may be powered by the battery 2064 during surgical use of the instrument 2010 .
- the control unit 2300 may be coupled to the first element 2021 over the electrical connection 2023 and may communicate with the second element 2035 , as described in more detail below.
- the control unit 2300 may comprise a transmitter 2320 and a receiver 2322 .
- the first element 2021 may be coupled to the transmitter 2320 to transmit an output interrogation signal or may be coupled to the receiver 2322 to receive an echo response signal in accordance with the operation of a switch 2324 .
- the switch 2324 may operate under the control of the processor 2306 , the transmitter 2320 or the receiver 2322 or any combination thereof to place the control unit 2300 either in transmitter or receiver mode.
- the switch 2324 couples the first element 2021 to the transmitter 2320 and thus the first element 2021 acts as a transmitting antenna.
- An encoder 2316 encodes the output interrogation signal to be transmitted, which is then modulated by a modulator 2318 .
- An oscillator 2326 coupled to the modulator 2318 sets the operating frequency for the output signal to be transmitted.
- the switch 2324 couples the first element 2021 to the receiver 2322 . Accordingly, the first element 2021 acts as a receiving antenna and receives input signals from the other sensor elements (e.g., the second element 2035 ).
- the received input signals may be demodulated by a demodulator 2310 and decoded by a decoder 2312 .
- the input signals may comprise echo response signals from one or more of the sensor elements (e.g., the second element 2035 ).
- the echo response signals may comprise information associated with the location, type, presence and/or status of various components located in the end effector 2012 or in other location in the instrument 2010 .
- the echo signals may comprise signals reflected by the second element 2035 , which may be attached to the sled 2033 , the staple cartridge 2034 or any other component located in the end effector 2012 or may be located on any component of interest on any portion of the instrument 2010 .
- the echo signal data reflected from the second element 2035 may be used by the processor 2306 to control various aspects of the instrument 2010 .
- the control unit 2300 may employ the encoder 2316 for encoding the output signals and the modulator 2318 for modulating the output signals according to a predetermined modulation scheme.
- the first element 2021 is coupled to the transmitter 2320 through the switch 2324 and acts as a transmitting antenna.
- the encoder 2316 may comprise a timing unit to generate timing pulses at a predetermined suitable pulse repetition frequency. These timing pulses may be applied to the modulator 2318 to trigger the transmitter at precise and regularly occurring instants of time.
- the modulator 2318 may produce rectangular pulses of known pulse duration to switch the oscillator 2326 on and off.
- the oscillator 2326 produces short duration pulses of a predetermined power and frequency (or wavelength ⁇ ) set by the oscillator 2326 .
- the pulse repetition frequency may be determined by the encoder 2312 and the pulse duration may be determined by the modulator 2318 .
- the switch 2324 under control of the control unit 2300 automatically connects the transmitter 2320 to the first element 2021 for the duration of each output pulse.
- the first element 2021 radiates the transmitter 2320 output pulse signal and picks up or detects the reflected echo signals for application to the receiver 2322 .
- the switch 2324 connects the first element 2021 to the receiver 2322 for the intervals between transmission pulses.
- the receiver 2322 receives echo signals of the transmitted pulse output signals that may be reflected from one or more sensor elements located on the instrument such as the second element 2035 attached to the sled 2033 .
- the receiver 2322 amplifies the echo signals and presents them to the demodulator 2310 in suitable form.
- the demodulated echo signals are provided to the decoder 2312 where they are correlated with the transmitted output pulse signals to determine the location, type, presence and/or status of various components located in the end effector 2012 .
- the distance between the first and second elements 2021 , 2035 may be determined
- the control unit 2300 may communicate with the first element 2021 using any suitable wired or wireless communication protocol and any suitable frequency (e.g., an ISM band).
- the control unit 2300 may transmit output pulse signals in various frequency ranges.
- the control unit 2300 may comprise separate receiving and transmitting elements, for example.
- control unit 2300 may be implemented using integrated and/or discrete hardware elements, software elements, or a combination of both.
- integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate arrays (FPGA), logic gates, registers, semiconductor devices, chips, microchips, chip sets, microcontroller, system-on-chip (SoC) or system-in-package (SIP).
- discrete hardware elements may include circuits, circuit elements (e.g., logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, relay and so forth).
- control unit 2300 may be embodied as a hybrid circuit comprising discrete and integrated circuit elements or components on one or more substrates.
- control unit 2300 may provide a digital (e.g., on/off, high/low) output and/or an analog output to a motor control unit.
- the motor control unit also may be embodied using elements and/or components similar to the control unit 2300 .
- the motor control unit may be used to control the motor 2065 in response to the radiated echo response signals from the one or more passive and/or active sensor elements.
- the first element 2021 may be an inductive element (e.g., a first coil) coupled to the control unit 2300 by the wired electrical connection 2023 .
- the wired electrical connection 2023 may be an electrically conductive insulated wire.
- the second element 2035 also may be an inductive element (e.g., a second coil) embedded, integrally formed with or otherwise attached to the sled 2033 .
- the second element 2035 is wirelessly coupled to the first element 2021 .
- the first element 2021 is preferably electrically insulated from the conductive shaft 2008 .
- the second element 2035 is preferably electrically insulated from the sled 2033 and other components located in the staple cartridge 2034 and/or the staple channel 2022 .
- the second element 2035 receives the output pulse signal transmitted by the first element 2021 and reflects or scatters the electromagnetic energy in the form of an echo signal.
- the control unit 2300 can determine the location, type, presence and/or status of various components located in the end effector 2012 by decoding the echo signals reflected therefrom.
- FIG. 34 is a schematic diagram 2400 illustrating the operation of one embodiment of the control unit 2300 in conjunction with the first and second elements 2021 , 2035 .
- the following description also references FIG. 33 .
- the first element 2021 is coupled to the control unit 2300 by a channel, e.g., the electrical connection 2023 .
- the electrical connection 2023 may be a wired or wireless channel.
- the first element 2021 wirelessly interrogates or illuminates the second element 2035 by transmitting an interrogation signal in the form of one or more interrogation pulses 2402 .
- the interrogation pulses 2402 may be of a suitable predetermined frequencyf as may be determined by the oscillator 2326 .
- the interrogation pulses 2402 may have a predetermined pulse width PW as may be determined by the modulator 2318 and may be transmitted at a pulse repetition rate T as may be determined by the encoder 2316 .
- the transmitted interrogation pulses 2402 that are incident upon (e.g., strike or illuminate) the second element 2035 is reflected or scattered by the second element 2035 in the form of echo response pulses 2404 .
- the echo response pulses 2404 are electromagnetic energy reflections of the interrogation pulses 2402 incident upon the second element 2021 , but much weaker in signal strength.
- the first element 2021 listens for the echo response pulses 2404 and couples the echo response pulses 2402 to the control unit 2300 in a suitable form.
- the demodulator 2310 receives the weak echo response pulses 2404 and amplifies and demodulates them.
- the decoder 2312 and the processor 2306 process the received echo response pulses 2404 to extract information therefrom.
- the processor 2306 (or other logic) may be programmed to ascertain various properties associated with the end effector 2012 and components in accordance with the received echo response pulses 2404 .
- the frequency f, PW and T of the echo response pulses 2404 may be the same as the interrogation pulses 2402 . In various embodiments, the frequency f, PW and T of the echo response pulses 2404 may be different than the interrogation pulses 2402 . In one embodiment, the frequency f, for example, of the echo response pulses 2404 may be a harmonic frequency of the interrogation pulse 2402 frequency.
- the amount of reflected electromagnetic energy in the echo response pulses 2404 depends upon the material, shape and size of the second element 2035 . The amount of reflected electromagnetic energy in the echo response pulses 2404 also depends upon the distance D between the first element 2021 and the second element 2035 .
- the material that the second element 2035 is formed of may determine the amount of reflected energy. For example, a metal object will reflect more energy than an object of the same size and shape made of wood, plastic, etc. In general, the better the electrical conductive properties of the material the greater is the reflection.
- the shape of the second element 2035 also may determine how the energy is reflected or scattered. For example, if the second element 2035 has a flat side facing the first element 2021 , the second element 2035 may reflect more energy back towards the first element 2021 .
- a circular object may reflect or scatter the energy in the various directions normal to the surface struck by the incident electromagnetic energy and an object with irregularities will scatter the incident electromagnetic energy more randomly.
- the size of the second element 2021 also may determine the amount of reflected energy.
- a larger second element 2035 will reflect more energy than a smaller second element 2035 of the same material and shape and at the same distance D from the first element 2021 .
- the second element 2035 should have a certain minimum size relative to the wavelength ( ⁇ ) of the radiated electromagnetic energy of the interrogation pulses 2402 to produce practical reflected echo response pulses 2404 .
- the size of the second element 2035 may be equal to or greater than about a quarter of the wavelength ( ⁇ /4) of the electromagnetic energy of the interrogation pulses 2402 .
- any suitable predetermined frequency f may be selected to accommodate the size of the second element 2035 to be detected. Accordingly, the size of the second element 2035 may be selected to be greater than or equal to ⁇ /4 (or c/4f), for example, once the interrogation pulse 2402 frequency is determined. As previously discussed, the amount of energy reflected by the second element 2035 also depends on the distance D between the first element 2021 and the second element 2035 .
- the material, shape and size of the second element 2035 and the relative distance D between it and the first element 2021 may be selected to generate unique echo response pulses 2404 that may be indicative of a desired measurement associated with the second element 2035 .
- unique echo response pulses 2404 may indicate the location, type, presence and/or status of various components and/or sub-components disposed on the surgical instrument 2010 . Especially the various components and sub-components disposed in the end effector 2012 portion of the surgical instrument 2010 subsequent to the articulation pivot 2014 .
- the echo response pulses 2404 also may be used to determine the distance D between the first element 2021 and the second element 2035 .
- the echo response pulses 2404 may be processed by the control unit 2300 to extract and provide information associated with the component of interest, such as the location, type, presence and/or status of the sled 2033 , the staple cartridge 2034 , and so on.
- This arrangement may eliminate the need to transmit or provide power over a wired connection to the second element 2035 and may be a cost effective solution to providing various sensor elements on the surgical instrument 2010 .
- the first element 2021 wirelessly interrogates or illuminates the second element 2035 by transmitting an interrogation signal in the form of one or more interrogation pulses 2402 .
- the electromagnetic energy in the interrogation pulses 2402 are coupled by the sensor element 2035 and serve to power-up the sensor element 2035 . Once powered-up, the sensor element 2035 transmits the echo response pulses 2404 back to the control unit 2300 .
- the status of the staple cartridge 2034 and the location of the sled 2033 may be determined by transmitting the interrogation pulse 2402 and listening for an echo response pulse 2404 .
- the first and second elements 2021 , 2035 may be passive sensors or electromagnetic elements (which may comprise resistive, inductive and capacitive elements or any combination thereof).
- the first element 2021 may be an inductance in the form of a primary coil located at the distal end of the shaft 2008 (as shown in FIGS. 23 , 24 , 26 - 28 ).
- the second element 2035 may be an inductive element in the form of a secondary coil located in the sled 2033 (as shown in FIGS. 25 , 27 , 28 ).
- the first element 2021 “pings” or transmits interrogation pulses 2402 .
- the echo response pulses 2404 reflected by the second element 2035 may be indicative of the presence of the sled 2033 in the staple channel 2022 , its distance from the first element 2021 or its location longitudinally along the staple channel 2022 .
- the instrument 2010 can determine the presence or status of the staple cartridge 2034 or the sled 2033 in the end effector 2012 or the longitudinal location of the sled 2033 along the staple channel 2022 . This information may be used to determine the loaded status of the staple cartridge 2034 , for example.
- the second element 2035 may be formed of different materials, in different shapes or sizes to produce a unique echo response pulse 2404 that is indicative of the instrument 2010 type or presence of the staple cartridge 2034 within the end effector 2012 . This eliminates the need to include any powered memory or sensor elements in the end effector 2012 to electronically determine the type, presence or status of the staple cartridge 2034 in the end effector 2012 .
- the second element 2035 may be attached to the sled 2033 and the echo response pulse 2404 may be used to determine whether the sled 2033 is located in a first position at the proximal end of the staple channel 2022 or a second position at the distal end of the staple channel 2022 or in any intermediate positions therebetween.
- the control unit 2300 may be determine the position of the sled 2033 based on the elapsed time between transmitting the interrogation pulse 2402 and receiving the echo response pulse 2404 . If the sled 2033 is in the first position the echo response pulse 2404 is received sooner than if the sled 2033 was located at the second position or any position therebetween.
- the control unit 2300 may use this information to determine the intermediate location of the sled 2033 in the channel 2022 and provide some measure of control of the cutting/fastening operation, such as inhibiting the cutting/fastening operation if the sled 2033 , or other component, is not in a predetermined location.
- control unit 2300 may provide some measure of control of the cutting/fastening operation based on whether or not an echo response pulse 2404 is received within a predetermined time period. For example, if an echo response pulse 2404 is received within the predetermined period, the control unit 2300 determines that the sled 2033 in located in the proximate end on the staple channel 2022 . In contrast, if the no echo response pulse 2404 is received within the predetermined period, the control unit 2300 determines that the sled 2033 has moved away from the proximate end to the distal end of the staple channel 2022 (e.g., the instrument has been fired).
- control unit 2300 may determine either that the staple cartridge 2034 has been fired and, therefore, the sled 2033 has moved away longitudinally from the proximate end of the staple channel 2022 or that there is no staple cartridge 2034 loaded and, therefore, prevents the instrument 2010 (e.g., a surgical stapler) from firing.
- instrument 2010 e.g., a surgical stapler
- first element 2021 is shown disposed at one end of the elongate shaft 2008 near the articulation pivot 2014 , the first element 2021 may be disposed anywhere along the elongate shaft 2008 and/or in the handle 2006 in suitable wireless or wired communication with the second element 2035 .
- FIG. 35 illustrates one embodiment of the surgical instrument 2010 comprising the first element 2021 located in the free rotating joint 2029 portion of the shaft 2008 .
- the following description also references FIGS. 25 , 27 , 28 and 34 .
- the first element 2021 is coupled to the control unit 2300 via the electrical connection 2023 .
- Additional elements may be employed, for example, when the surgical instrument 2010 has numerous complex mechanical joints and where it would be difficult to maintain a direct wired connection. In such cases, inductive couplings may be used to span each such joint.
- inductive couplers may be used on both sides of the rotary joint 2029 and both sides of the articulation pivot 2014 , with an inductive element on the distal side of the rotary joint 2029 connected by an electrical connection to another inductive element on the proximate side of the articulation pivot 2014 .
- a third element 2328 and a fourth element 2330 may be disposed on the shaft 2008 .
- These elements 2328 , 2330 may disposed anywhere along the shaft 2008 .
- the third element 2328 may be disposed on the proximal end of the shaft 2008 just prior to the articulation control 2016 .
- the fourth element 2330 may be disposed on the distal end of the shaft 2008 just prior to the articulation pivot 2014 .
- the third and fourth elements 2328 , 2330 may be coupled by an electrical connection 2332 , which may be a wired or a wireless electrical connection.
- the second element 2035 is disposed or attached to a component of interest in the end effector 2012 .
- the third element 2328 is wirelessly coupled to the first element 2021 and receives interrogation pulses 2402 therefrom.
- the third element 2328 transmits the interrogation pulse 2402 along the electrical connection 2332 to the fourth element 2330 .
- the fourth element 2330 wirelessly couples the interrogation pulse 2402 to the second element 2035 .
- the echo response pulses 2404 are transmitted back to the first element 2021 in reverse order.
- the echo response pulse 2404 is wirelessly coupled to the fourth element 2330 , is relayed to the third element 2328 via the electrical connection 2332 and is then wirelessly coupled to the first element 2021 .
- the third and fourth elements 2328 , 2330 may be formed of passive and/or active sensor elements (e.g., resistive, inductance, capacitive and/or semiconductor elements).
- the third and fourth elements 2328 , 2330 may be passive coils formed of various materials and in various shapes and sizes or may comprise semiconductor elements such as transistors to operate in active mode.
- FIG. 36 illustrates one embodiment of the surgical instrument 2010 comprising sensor elements disposed at various locations on the shaft.
- the first element 2021 may be disposed on the proximate end of the shaft 2008 just prior to the articulation control 2016 .
- the first element 2021 is wirelessly coupled to the control unit 2300 via wireless electrical connection 2023 .
- the third element 2328 and the fourth element 2330 are disposed along the shaft 2008 subsequent to the articulation control 2016 and prior to the articulation pivot 2014 .
- the third element 2328 may be disposed on the proximate end of the shaft 2008 subsequent to the articulation control 2016 and the fourth element 2330 may be disposed on the distal end of the elongate shaft 2008 prior to the articulation pivot 2014 .
- the third and fourth elements 2328 , 2330 are coupled by the electrical connection 2332 , which may be a wired or a wireless electrical connection.
- the second element 2035 may be disposed on a component of interest located in the end effector 2012 .
- the third element 2328 is wirelessly coupled to the first element 2021 and receives the interrogation pulses 2402 therefrom.
- the third element 2328 transmits the interrogation pulse 2402 along the electrical connection 2332 to the fourth element 2330 .
- the fourth element 2330 wirelessly couples the interrogation pulse 2402 to the second element 2035 .
- the echo response pulses 2404 are transmitted back to the first element 2021 in reverse order.
- the echo response pulse 2404 is wirelessly coupled to the fourth element 2330 , is relayed to the third element 2328 via the electrical connection 2332 and is wirelessly coupled to the first element 2021 thereafter.
- FIG. 37 illustrates one embodiment of the instrument 2010 where the shaft serves as part of the antenna for the control unit 2300 .
- the shaft 2008 of the instrument 2010 including for example, the proximate closure tube 2040 and the distal closure tube 2042 , may collectively serve as part of an antenna for the control unit 2300 by radiating the interrogation pulses 2402 to the second element 2035 and receiving the echo response pulses 2404 reflected from the second element 2035 . That way, signals to and from the control unit 2300 and the second element 2035 disposed in the end effector 2012 may be transmitted via the shaft 2008 of the instrument 2010 .
- the proximate closure tube 2040 may be grounded at its proximate end by the exterior lower and upper side pieces 2059 - 2062 , which may be made of a nonelectrically conductive material, such as plastic.
- the drive shaft assembly components (including the main drive shaft 2048 and secondary drive shaft 2050 ) inside the proximate and distal closure tubes 2040 , 2042 may also be made of a nonelectrically conductive material, such as plastic.
- components of the end effector 2012 (such as the anvil 2024 and the channel 2022 ) may be electrically coupled to (or in direct or indirect electrical contact with) the distal closure tube 2042 such that they may also serve as part of the antenna.
- the second element 2035 may be positioned such that it is electrically insulated from the components of the shaft 2008 and the end effector 2012 serving as the antenna.
- the second element 2035 may be positioned in the cartridge 2034 , which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft 2008 (such as the distal end of the distal closure tube 2042 ) and the portions of the end effector 2012 serving as the antenna may be relatively close in distance to the second element 2035 , the power for the transmitted signals may be held at low levels, thereby minimizing or reducing interference with other systems in the use environment of the instrument 2010 .
- control unit 2300 may be electrically coupled to the shaft 2008 of the instrument 2010 , such as to the proximate closure tube 2040 , by an electrically conductive connection 2410 (e.g., a wire). Portions of the outer shaft 2008 , such as the closure tubes 2040 , 2042 , may therefore act as part of an antenna for the control unit 2300 by radiating signals in the form of interrogation pulses 2402 to the second element 2035 and receiving radiated signals in the form of echo response pulses 2404 from the second element 2035 .
- the echo response pulses 2404 received by the control unit 2300 may be demodulated by the demodulator 2310 and decoded by the decoder 2312 as previously discussed.
- the echo response pulses 2404 may comprise information from the second element 2035 such as, the location, type, presence and/or status of various components disposed on the end effector 2012 portion of the instrument 2010 , which the processor 2306 may use to control various aspects of the instrument 2010 , such as the motor 2065 or a user display.
- the electrical connection 2410 may connect the control unit 2300 to components of the shaft 2008 of the instrument 2010 , such as the proximate closure tube 2040 , which may be electrically connected to the distal closure tube 2042 .
- the distal closure tube 2042 is preferably electrically insulated from the remote sensor 2368 , which may be positioned in the plastic cartridge 2034 .
- components of the end effector 2012 such as the channel 2022 and the anvil 2024 , may be conductive and in electrical contact with the distal closure tube 2042 such that they, too, may serve as part of the antenna.
- the control unit 2300 can communicate with the second element 2035 in the end effector 2012 without a direct wired connection.
- the power levels could be optimized for low levels to thereby minimize interference with other systems in the use environment of the instrument 2010 .
- the second element 2035 is shown disposed in the articulating end effector 2012 , the second element 2035 may be disposed in any suitable location on the instruments 2010 while maintaining wireless communication with the first element 2021 (and/or the shaft 2008 ) at least on one portion of the transmission or reception cycle.
- the second element 2035 also may be coupled to any component within the staple cartridge 2034 .
- the control unit 2300 may communicate with any of the first 2021 , second 2035 , third 2328 and fourth 2330 elements and additional elements through complex mechanical joints like the rotating joint 2029 without a direct wired connection, but rather through a wireless connection where it may be difficult to maintain a wired connection.
- the distances between the first, second, third, fourth 2021 , 2035 , 2328 , 2330 elements, and any additional elements and/or any combination thereof may be fixed and known the couplings between these elements 2021 , 2035 , 2328 , 2330 may be optimized for efficient inductive transfer of electromagnetic energy. Also, these distances may be relatively short so that relatively low power signals may be used and minimize interference with other systems in the use environment of the instrument 2010 .
- more or fewer sensor elements may be inductively, electromagnetically and/or otherwise coupled.
- the control unit 2300 may comprise the first element 2021 formed integrally therewith.
- the first element 2021 in the handle 2006 and the second element 2035 in the end effector 2012 can communicate directly without the third and fourth elements 2328 , 2330 .
- a stronger signal may be required due to the greater distance between the control unit 2300 in the handle 2006 and the second element 2035 in the end effector 2012 .
- the battery 2064 powers (at least partially) the firing operation of the instrument 2010 .
- the instrument 2010 may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described in the '573 application, which is incorporated herein by reference. It should be recognized, however, that the instrument 2010 need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention.
- the instrument 2010 may include a user display (such as a LCD or LED display) that is powered by the battery 2064 and controlled by the control unit 2300 . Data from the sensor transponders 2368 in the end effector 2012 may be displayed on such a display.
- FIGS. 38 and 39 depict a surgical cutting and fastening instrument 3010 according to various embodiments of the present invention.
- the illustrated embodiment is an endoscopic instrument and, in general, the embodiments of the instrument 3010 described herein are endoscopic surgical cutting and fastening instruments. It should be noted, however, that according to other embodiments of the present invention, the instrument may be a non-endoscopic surgical cutting and fastening instrument, such as a laparoscopic instrument.
- the surgical instrument 3010 depicted in FIGS. 38 and 39 comprises a handle 3012 , a shaft 3014 , and an articulating end effector 3016 pivotally connected to the shaft 3014 at an articulation pivot 3018 .
- Correct placement and orientation of the end effector 3016 may be facilitated by controls on the handle 3012 , including (1) a rotation knob 3017 for rotating the closure tube (described in more detail below in connection with FIGS. 41-42 ) at a free rotating joint 3019 of the shaft 3014 to thereby rotate the end effector 3016 and (2) an articulation control 3020 to effect rotational articulation of the end effector 3016 about the articulation pivot 3018 .
- the end effector 3016 is configured to act as an endocutter for clamping, severing and stapling tissue, although, in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc.
- the handle 3012 of the instrument 3010 may include a closure trigger 3022 and a firing trigger 3024 for actuating the end effector 3016 .
- the end effector 3016 is shown separated from the handle 3012 by a preferably elongate shaft 3014 .
- a clinician or operator of the instrument 3010 may articulate the end effector 3016 relative to the shaft 3014 by utilizing the articulation control 3020 as described in more detail in U.S. patent application Ser. No. 11/329,020 entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference.
- the end effector 3016 includes in this example, among other things, a staple channel 3026 and a pivotally translatable clamping member, such as an anvil 3028 , which are maintained at a spacing that assures effective stapling and severing of tissue clamped in the end effector 3016 .
- the handle 3012 includes a pistol grip 3030 towards which a closure trigger 3022 is pivotally drawn by the clinician to cause clamping or closing of the anvil 3028 toward the staple channel 3026 of the end effector 3016 to thereby clamp tissue positioned between the anvil 3028 and the channel 3026 .
- the firing trigger 3024 is farther outboard of the closure trigger 3022 .
- the firing trigger 3024 may rotate slightly toward the pistol grip 3030 so that it can be reached by the operator using one hand. The operator may then pivotally draw the firing trigger 3024 toward the pistol grip 3030 to cause the stapling and severing of clamped tissue in the end effector 3016 .
- different types of clamping members besides the anvil 3028 may be used, such as, for example, an opposing jaw, etc.
- proximal and distal are used herein with reference to a clinician gripping the handle 3012 of an instrument 3010 .
- the end effector 3016 is distal with respect to the more proximal handle 3012 .
- spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings.
- surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
- the closure trigger 3022 may be actuated first. Once the clinician is satisfied with the positioning of the end effector 3016 , the clinician may draw back the closure trigger 3022 to its fully closed, locked position proximate to the pistol grip 3030 . The firing trigger 3024 may then be actuated. The firing trigger 3024 returns to the open position (shown in FIGS. 38 and 39 ) when the clinician removes pressure, as described more fully below. A release button 3032 on the handle 3012 , when depressed, may release the locked closure trigger 3022 . Various configurations for locking and unlocking the closure trigger 3022 using the release button 3032 are described in U.S.
- FIG. 40A is an exploded view of the end effector 3016 according to various embodiments
- FIG. 40B is a perspective view of the cutting instrument of FIG. 40A
- the end effector 3016 may include, in addition to the previously-mentioned channel 3026 and anvil 3028 , a cutting instrument 3034 , a staple cartridge 3038 that is removably seated (e.g., installed) in the channel 3026 , a sled 3036 disposed within the staple cartridge 3038 , and a helical screw shaft 3040 .
- the anvil 3028 may be pivotably opened and closed at a pivot point 3042 connected to the proximate end of the channel 3026 .
- the anvil 3028 may also include a tab 3044 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close the anvil 3028 .
- the closure trigger 3022 When the closure trigger 3022 is actuated, that is, drawn in by an operator of the instrument 3010 , the anvil 3028 may pivot about the pivot point 3042 into the clamped or closed position. If clamping of the end effector 3016 is satisfactory, the operator may actuate the firing trigger 3024 , which, as explained in more detail below, causes the cutting instrument 3034 to travel longitudinally along the channel 3026 .
- the cutting instrument 3034 includes upper guide pins 3046 that enter an anvil slot 3048 in the anvil 3028 to verify and assist in maintaining the anvil 3028 in a closed state during staple formation and severing. Spacing between the channel 3026 and anvil 3028 is further maintained by the cutting instrument 3034 by having middle pins 3050 slide along the top surface of the channel 3026 while a bottom foot 3052 opposingly slides along the undersurface of the channel 3026 , guided by a longitudinal opening 3054 in the channel 3026 .
- the staple cartridge 3038 is in an unfired, or unspent, state.
- the staple cartridge 3038 is in a fired, or spent, state.
- Actuation of the staple cartridge 3038 causes staple drivers 3060 to cam upwardly, driving staples 3062 out of upwardly open staple holes 3064 formed in the staple cartridge 3038 .
- the staples 3062 are subsequently formed against a staple forming undersurface 66 of the anvil 3028 .
- a staple cartridge tray 3068 encompasses from the bottom the other components of the staple cartridge 3038 to hold them in place.
- the staple cartridge tray 3068 includes a rearwardly open slot 3070 that overlies the longitudinal opening 3054 in the channel 3026 .
- a lower surface of the staple cartridge 3038 and an upward surface of the channel 3026 form a firing drive slot 3200 ( FIG. 43 ) through which the middle pins 3050 pass during distal and proximal movement of the cutting instrument 3034 .
- the sled 3036 may be an integral component of the staple cartridge 3038 such that when the cutting instrument 3034 retracts following the cutting operation, the sled 3036 does not retract.
- U.S. Pat. No. 6,978,921 entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments.
- FIGS. 41 and 42 are exploded views and FIG. 43 is a side view of the end effector 3016 and shaft 3014 according to various embodiments.
- the shaft 3014 may include a proximate closure tube 3072 and a distal closure tube 3074 pivotably linked by a pivot links 3076 .
- the distal closure tube 3074 includes an opening 3078 into which the tab 3044 on the anvil 3028 is inserted in order to open and close the anvil 3028 , as further described below.
- Disposed inside the closure tubes 3072 , 3074 may be a proximate spine tube 3079 .
- a main rotational (or proximate) drive shaft 3080 that communicates with a secondary (or distal) drive shaft 3082 via a bevel gear assembly 3084 .
- the secondary drive shaft 3082 is connected to a drive gear 3086 that engages a proximate drive gear 3088 of the helical screw shaft 3040 .
- the vertical bevel gear 3084 b may sit and pivot in an opening 3090 in the distal end of the proximate spine tube 3079 .
- a distal spine tube 3092 may be used to enclose the secondary drive shaft 3082 and the drive gears 3086 , 3088 .
- a bearing 3094 positioned at a distal end of the staple channel 3026 , receives the helical drive screw 3040 , allowing the helical drive screw 3040 to freely rotate with respect to the channel 3026 .
- the helical screw shaft 3040 may interface a threaded opening (not shown) of the cutting instrument 3034 such that rotation of the shaft 3040 causes the cutting instrument 3034 to translate distally or proximately (depending on the direction of the rotation) through the staple channel 3026 .
- the bevel gear assembly 3084 a - c causes the secondary drive shaft 3082 to rotate, which in turn, because of the engagement of the drive gears 3086 , 3088 , causes the helical screw shaft 3040 to rotate, which causes the cutting instrument 3034 to travel longitudinally along the channel 3026 to cut any tissue clamped within the end effector 3016 .
- the sled 3036 may be made of, for example, plastic, and may have a sloped distal surface.
- the sloped distal surface may cam the staple drivers 3060 upward, which in turn push up or drive the staples 3062 in the staple cartridge 3038 through the clamped tissue and against the staple forming undersurface 3066 of the anvil 3028 , thereby stapling the severed tissue.
- the cutting instrument 3034 When the cutting instrument 3034 is retracted, the cutting instrument 3034 and the sled 3036 may become disengaged, thereby leaving the sled 3036 at the distal end of the channel 3026 .
- FIGS. 44-47 illustrate an exemplary embodiment of a motor-driven endocutter, and in particular the handle 3012 thereof, that provides operator-feedback regarding the deployment and loading force of the cutting instrument 3034 in the end effector 3016 .
- the embodiment may use power provided by the operator in retracting the firing trigger 3024 to power the device (a so-called “power assist” mode).
- the handle 3012 includes exterior lower side pieces 3096 , 3098 and exterior upper side pieces 3100 , 3102 that fit together to form, in general, the exterior of the handle 3012 .
- a battery 3104 may be provided in the pistol grip portion 3030 of the handle 3012 .
- the battery 3104 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO 2 or LiNiO 2 , a Nickel Metal Hydride chemistry, etc.
- the battery 3104 powers a motor 3106 disposed in an upper portion of the pistol grip portion 3030 of the handle 3012 .
- the motor 3106 may be a DC brushed driving motor having a maximum rotation of approximately 5000 to 100,000 RPM.
- the motor 3106 may drive a 90-degree bevel gear assembly 3108 comprising a first bevel gear 3110 and a second bevel gear 3112 .
- the bevel gear assembly 3108 may drive a planetary gear assembly 3114 .
- the planetary gear assembly 3114 may include a pinion gear 3116 connected to a drive shaft 3118 .
- the pinion gear 3116 may drive a mating ring gear 3120 that drives a helical gear drum 3122 via a drive shaft 3124 .
- a ring 3126 may be threaded on the helical gear drum 3122 .
- the handle 3012 may also include a run motor sensor 3128 in communication with the firing trigger 3024 to detect when the firing trigger 3024 has been drawn in (or “closed”) toward the pistol grip portion 3030 of the handle 3012 by the operator to thereby actuate the cutting/stapling operation by the end effector 3016 .
- the sensor 3128 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firing trigger 3024 is drawn in, the sensor 3128 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to the motor 3106 . When the sensor 3128 is a variable resistor or the like, the rotation of the motor 3106 may be generally proportional to the amount of movement of the firing trigger 3024 .
- the control unit may output a PWM control signal to the motor 3106 based on the input from the sensor 3128 in order to control the motor 3106 .
- the handle 3012 may include a middle handle piece 3130 adjacent to the upper portion of the firing trigger 3024 .
- the handle 3012 also may comprise a bias spring 3132 connected between posts on the middle handle piece 3130 and the firing trigger 3024 .
- the bias spring 3132 may bias the firing trigger 3024 to its fully open position. In that way, when the operator releases the firing trigger 3024 , the bias spring 3132 will pull the firing trigger 3024 to its open position, thereby removing actuation of the sensor 3128 , thereby stopping rotation of the motor 3106 .
- the bias spring 3132 any time an operator closes the firing trigger 3024 , the operator will experience resistance to the closing operation, thereby providing the operator with feedback as to the amount of rotation exerted by the motor 3106 .
- the operator could stop retracting the firing trigger 3024 to thereby remove force from the sensor 3128 , to thereby stop the motor 3106 .
- the operator may stop the deployment of the end effector 3016 , thereby providing a measure of control of the cutting/fastening operation to the operator.
- the distal end of the helical gear drum 3122 includes a distal drive shaft 3134 that drives a ring gear 3136 , which mates with a pinion gear 3138 .
- the pinion gear 3138 is connected to the main drive shaft 3080 of the main drive shaft assembly. In that way, rotation of the motor 3106 causes the main drive shaft assembly to rotate, which causes actuation of the end effector 3016 , as described above.
- the ring 3126 threaded on the helical gear drum 3122 may include a post 3140 that is disposed within a slot 3142 of a slotted arm 3144 .
- the slotted arm 3144 has an opening 3146 its opposite end 3148 that receives a pivot pin 3150 that is connected between the handle exterior side pieces 3096 , 3098 .
- the pivot pin 3150 is also disposed through an opening 3152 in the firing trigger 3024 and an opening 3154 in the middle handle piece 3130 .
- the handle 3012 may include a reverse motor (or end-of-stroke) sensor 3156 and a stop motor (or beginning-of-stroke) sensor 3158 .
- the reverse motor sensor 3156 may be a normally-open limit switch located at the distal end of the helical gear drum 3122 such that the ring 3126 threaded on the helical gear drum 3122 contacts and closes the reverse motor sensor 3156 when the ring 3126 reaches the distal end of the helical gear drum 3122 .
- the reverse motor sensor 3156 when closed, sends a signal to the control unit which sends a signal to the motor 3106 to reverse its rotation direction, thereby withdrawing the cutting instrument of the end effector 3016 following the cutting operation.
- the stop motor sensor 3158 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of the helical gear drum 3122 so that the ring 3126 opens the switch 3158 when the ring 3126 reaches the proximate end of the helical gear drum 3122 .
- the sensor 3128 detects the deployment of the firing trigger 3024 and sends a signal to the control unit which sends a signal to the motor 3106 to cause forward rotation of the motor 3106 at, for example, a rate proportional to how hard the operator pulls back the firing trigger 3024 .
- the forward rotation of the motor 3106 in turn causes the ring gear 3120 at the distal end of the planetary gear assembly 3114 to rotate, thereby causing the helical gear drum 3122 to rotate, causing the ring 3126 threaded on the helical gear drum 3122 to travel distally along the helical gear drum 3122 .
- the rotation of the helical gear drum 3122 also drives the main drive shaft assembly as described above, which in turn causes deployment of the cutting instrument 3034 in the end effector 3016 . That is, the cutting instrument 3034 and sled 3036 are caused to traverse the channel 3026 longitudinally, thereby cutting tissue clamped in the end effector 3016 . Also, the stapling operation of the end effector 3016 is caused to happen in embodiments where a stapling-type end effector is used.
- the ring 3126 on the helical gear drum 3122 will have reached the distal end of the helical gear drum 3122 , thereby causing the reverse motor sensor 3156 to be actuated, which sends a signal to the control unit which sends a signal to the motor 3106 to cause the motor 3106 to reverse its rotation.
- This causes the cutting instrument 3034 to retract, and also causes the ring 3126 on the helical gear drum 3122 to move back to the proximate end of the helical gear drum 3122 .
- the middle handle piece 3130 includes a backside shoulder 3160 that engages the slotted arm 3144 as best shown in FIGS. 45 and 46 .
- the middle handle piece 3130 also has a forward motion stop 3162 that engages the firing trigger 3024 .
- the movement of the slotted arm 3144 is controlled, as explained above, by rotation of the motor 3106 .
- the middle handle piece 3130 will be free to rotate CCW.
- the firing trigger 3024 will engage the forward motion stop 3162 of the middle handle piece 3130 , causing the middle handle piece 3130 to rotate CCW.
- the middle handle piece 3130 will only be able to rotate CCW as far as the slotted arm 3144 permits. In that way, if the motor 3106 should stop rotating for some reason, the slotted arm 3144 will stop rotating, and the operator will not be able to further draw in the firing trigger 3024 because the middle handle piece 3130 will not be free to rotate CCW due to the slotted arm 3144 .
- FIGS. 48 and 49 illustrate two states of a variable sensor that may be used as the run motor sensor 3128 according to various embodiments of the present invention.
- the sensor 3128 may include a face portion 3164 , a first electrode (A) 3166 , a second electrode (B) 3168 , and a compressible dielectric material 3170 (e.g., EAP) between the electrodes 3166 , 3168 .
- the sensor 3128 may be positioned such that the face portion 3164 contacts the firing trigger 3024 when retracted. Accordingly, when the firing trigger 3024 is retracted, the dielectric material 3170 is compressed, as shown in FIG. 49 , such that the electrodes 3166 , 3168 are closer together.
- the distance “b” between the electrodes 3166 , 3168 is directly related to the impedance between the electrodes 3166 , 3168 , the greater the distance the more impedance, and the closer the distance the less impedance. In that way, the amount that the dielectric material 3170 is compressed due to retraction of the firing trigger 3024 (denoted as force “F” in FIG. 49 ) is proportional to the impedance between the electrodes 3166 , 3168 .
- This impedance provided by the sensor 3128 may be used with suitable signal conditioning circuitry to proportionally control the speed of the motor 3106 , for example.
- FIGS. 44-47 Components of an exemplary closure system for closing (or clamping) the anvil 3028 of the end effector 3016 by retracting the closure trigger 3022 are also shown in FIGS. 44-47 .
- the closure system includes a yoke 3172 connected to the closure trigger 3022 by a pin 3174 that is inserted through aligned openings in both the closure trigger 3022 and the yoke 3172 .
- a pivot pin 3176 about which the closure trigger 3022 pivots, is inserted through another opening in the closure trigger 3022 which is offset from where the pin 3174 is inserted through the closure trigger 3022 .
- closure brackets 3180 , 3182 define an opening in which the proximal end of the proximate closure tube 3072 (see FIG. 41 ) is seated and held such that longitudinal movement of the closure brackets 3180 , 3182 causes longitudinal motion by the proximate closure tube 3072 .
- the instrument 3010 also includes a closure rod 3184 disposed inside the proximate closure tube 3072 .
- the closure rod 3184 may include a window 3186 into which a post 3188 on one of the handle exterior pieces, such as exterior lower side piece 3096 in the illustrated embodiment, is disposed to fixedly connect the closure rod 3184 to the handle 3012 .
- the proximate closure tube 3072 is capable of moving longitudinally relative to the closure rod 3184 .
- the closure rod 3184 may also include a distal collar 3190 that fits into a cavity 3192 in proximate spine tube 3079 and is retained therein by a cap 3194 (see FIG. 41 ).
- the closure brackets 3180 , 3182 cause the proximate closure tube 3072 to move distally (i.e., away from the handle 3012 of the instrument 3010 ), which causes the distal closure tube 3074 to move distally, which causes the anvil 3028 to rotate about the pivot point 3042 into the clamped or closed position.
- the proximate closure tube 3072 is caused to slide proximally, which causes the distal closure tube 3074 to slide proximally, which, by virtue of the tab 3044 being inserted in the opening 3078 of the distal closure tube 3074 , causes the anvil 3028 to pivot about the pivot point 3042 into the open or unclamped position.
- an operator may clamp tissue between the anvil 3028 and channel 3026 , and may unclamp the tissue following the cutting/stapling operation by unlocking the closure trigger 3022 from the locked position.
- the control unit may receive the outputs from end-of-stroke and beginning-of-stroke sensors 3156 , 3158 and the run-motor sensor 3128 , and may control the motor 3106 based on the inputs. For example, when an operator initially pulls the firing trigger 3024 after locking the closure trigger 3022 , the run-motor sensor 3128 is actuated. If the control unit determines that an unspent staple cartridge 3038 is present in the end effector 3016 , as described further below, the control unit may output a control signal to the motor 3106 to cause the motor 3106 to rotate in the forward direction. When the end effector 3016 reaches the end of its stroke, the reverse motor sensor 3156 will be activated. The control unit may receive this output from the reverse motor sensor 3156 and cause the motor 3106 to reverse its rotational direction. When the cutting instrument 3034 is fully retracted, the stop motor sensor switch 3158 is activated, causing the control unit to stop the motor 3106 .
- the instrument 3010 may include a transponder in the end effector 3016 .
- the transponder may generally be any device suitable for transmitting a wireless signal(s) indicating one or more conditions of the end effector 3016 .
- wireless signals may be transmitted by the transponder to the control unit responsive to wireless signals received from the control unit.
- the wireless signals transmitted by the control unit and the transponder are referred to as “interrogation” and “reply” signals, respectively.
- the transponder may be in communication with one or more types of sensors (e.g., position sensors, displacement sensors, pressure/load sensors, proximity sensors, etc.) located in the end effector 3016 for transducing various end effector conditions such as, for example, a state of the staple cartridge 3038 (e.g., fired or unfired) and the respective positions of the anvil 3028 (e.g., open or closed) and the sled 3036 (e.g., proximal or distal).
- the transponder may be a passive device such that its operating power is derived from wireless signals (e.g., interrogation signals).
- the transponder may be an active device powered by a self-contained power source (e.g., a battery) disposed within the end effector 3016 .
- the transponder and the control circuit may be configured to communicate using any suitable type of wireless signal.
- the transponder and the control circuit may transmit and receive wireless signals using magnetic fields generated by inductive effects.
- the transponder and the control circuit may instead transmit and receive wireless signals using electromagnetic fields (e.g., RF signals, optical signals), or using electric fields generated by capacitive effects, for example.
- the end effector 3016 may include additional transponders, with each transponder having one more dedicated sensors for inputting data thereto.
- FIG. 50 illustrates a block diagram of the control unit 3196 according to various embodiments.
- the control unit 3196 may comprise a processor 3198 and one or more memory units 3200 .
- the control unit 3196 may be powered by the battery 3104 or other suitable power source contained within the instrument 3010 .
- the control unit 3196 may further comprise an inductive element 3202 (e.g., a coil or antenna) to transmit and receive wireless signals (e.g., interrogation and reply signals) from the transponder via magnetic fields. Signals received by the inductive element 3202 may be demodulated by a demodulator 3204 and decoded by a decoder 3206 .
- an inductive element 3202 e.g., a coil or antenna
- the processor 3198 may control various components of the instrument 3010 , such as the motor 3106 and a user display (not shown), based on inputs of the end effector sensors (as indicated by the decoded signals) and inputs received from other various sensor(s) (such as the run-motor sensor 3128 , the end-of-stroke and beginning-of-stroke sensors 3156 , 3158 , for example).
- Wireless signals output by the control unit 3196 may be in the form of alternating magnetic fields emitted by the inductive element 3202 .
- the control unit 3196 may comprise an encoder 3208 for encoding data to be transmitted to the transponder and a modulator 3210 for modulating the magnetic field based on the encoded data using a suitable modulation scheme.
- the control unit 3196 may communicate with the transponder using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band or other RF band). Also, the control unit 3196 may transmit signals at a different frequency range than the frequency range of the reply signals received from the transponder. Additionally, although only one antenna (inductive element 3202 ) is shown in FIG. 50 , in other embodiments the control unit 3196 may have separate receiving and transmitting antennas.
- control unit 3196 may comprise a microcontroller, a microprocessor, a field programmable gate array (FPGA), one or more other types of integrated circuits (e.g., RF receivers and PWM controllers), and/or discrete passive components.
- the control unit 3196 may also be embodied as system-on-chip (SoC) or a system-in-package (SIP), for example.
- SoC system-on-chip
- SIP system-in-package
- the control unit 3196 may be housed in the handle 3012 of the instrument 3010 and the transponder 3212 may be located in the end effector 3016 .
- the inductive element 3202 of the control unit 3196 may be inductively coupled to a secondary inductive element (e.g., a coil) 3214 positioned in the shaft 3014 distally from the rotation joint 3019 .
- the secondary inductive element 3214 is preferably electrically insulated from the conductive shaft 3014 .
- the secondary inductive element 3214 may be connected by an electrically conductive, insulated wire 3216 to a distal inductive element (e.g., a coil) 3218 located near the end effector 3016 , and preferably distally located relative to the articulation pivot 3018 .
- the wire 3216 may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass though the articulation pivot 3018 and not be damaged by articulation.
- the distal inductive element 3218 may be inductively coupled to the transponder 3212 in, for example, the staple cartridge 3038 of the end effector 3016 .
- the transponder 3212 as described in more detail below, may include an antenna (or coil) for inductively coupling to the distal coil 3218 , as well as associated circuitry for transmitting and receiving wireless signals.
- the transponder 3212 may be passively powered by magnetic fields emitted by the distal inductive element 3218 . Once sufficiently powered, the transponder 3212 may transmit and/or receive data (e.g., by modulating the magnetic fields) to the control unit 3196 in the handle 3012 via (i) the inductive coupling between the transponder 3212 and the distal inductive element 3218 , (ii) the wire 3216 , and (iii) the inductive coupling between the secondary inductive element 3214 and the control unit 3196 .
- the control unit 3196 may thus communicate with the transponder 3212 in the end effector 3016 without a hardwired connection through complex mechanical joints like the rotating joint 3019 and/or without a hardwired connection from the shaft 3014 to the end effector 3016 , places where it may be difficult to maintain such connections.
- the distances between the inductive elements e.g., the spacing between (i) the transponder 3212 and the distal inductive element 3218 , and (ii) the secondary inductive element 3214 and the control unit 3196
- the couplings could be optimized for inductive energy transfer.
- the distances could be relatively short so that relatively low power signals could be used to thereby minimize interference with other systems in the use environment of the instrument 3010 .
- the inductive element 3202 of the control unit 3196 is located relatively near to the control unit 3196 .
- the inductive element 3202 of the control unit 3196 may be positioned closer to the rotating joint 3019 to that it is closer to the secondary inductive element 3214 , thereby reducing the distance of the inductive coupling in such an embodiment.
- the control unit 3196 (and hence the inductive element 3202 ) could be positioned closer to the secondary inductive element 3214 to reduce the spacing.
- the surgical instrument 3010 may use a single inductive coupling between the control unit 3196 in the handle 3012 and the transponder 3212 in the end effector 3016 , thereby eliminating the inductive elements 3214 , 3218 and the wire 3216 .
- stronger signals may be required due to the greater distance between the control unit 3196 in the handle 3012 and the transponder 3212 in the end effector 3016 .
- more than two inductive couplings could be used. For example, if the surgical instrument 3010 had numerous complex mechanical joints where it would be difficult to maintain a hardwired connection, inductive couplings could be used to span each such joint.
- inductive couplings could be used on both sides of the rotary joint 3019 and both sides of the articulation pivot 3018 , with an inductive element 3220 on the distal side of the rotary joint 3019 connected by the wire 3216 to the inductive element 3218 of the proximate side of the articulation pivot, and a wire 3222 connecting inductive elements 3224 , 3226 on the distal side of the articulation pivot 3018 as shown in FIG. 53 .
- the inductive element 3226 may communicate with the transponder 3212 .
- each of the inductive elements 3202 , 3214 , 3218 , 3224 , 3226 may or may not include ferrite cores. Additionally, the inductive elements 3214 , 3218 , 3224 , 3226 are also preferably insulated from the electrically conductive outer shaft (or frame) of the instrument 3010 (e.g., the closure tubes 3072 , 3074 ), and the wires 3216 , 3222 are also preferably insulated from the outer shaft 3014 .
- FIG. 54 is a bottom view of a portion of the staple cartridge 3038 including the transponder 3212 according to various embodiments. As shown, the transponder 3212 may be held or embedded in the staple cartridge 3038 at its distal end using a suitable bonding material, such as epoxy.
- FIG. 55 illustrates a circuit diagram of the transponder 3212 according to various embodiments.
- the transponder 3212 may include a resonant circuit 3249 comprising an inductive element 3250 (e.g., a coil or antenna) and a capacitor 3252 .
- the transponder 3212 may further include a microchip 3254 coupled to the resonant circuit 3249 .
- the microchip 3254 may be, for example, an RFID device containing circuitry for enabling communication with the control unit 3196 via the inductive element 3250 of the resonant circuit 3249 .
- the microchip 3254 may include at least one data input for receiving data in the form of discrete or analog signals from the sensors 3235 disposed in the end effector 3016 .
- the sensors 3235 may include, for example, position sensors, displacement sensors, pressure/load sensors, proximity sensors for sensing various end effector conditions.
- the microchip 3254 also may include one or more dynamic memory devices 3255 (e.g., flash memory devices) for storing data transmitted from, for example, the control unit 3196 .
- the microchip 3254 may further include one or more non-dynamic memory devices 3257 (e.g., write-once memory devices) for storing static data, such as, for example, a staple cartridge identification number, manufacturer information, and information pertaining to physical characteristics of the staple cartridge 3038 .
- the resonant circuit 3249 of the transponder 3212 is caused to resonate, thereby causing an alternating input voltage to be applied to the microchip 3254 .
- the resonant circuit 3249 may have a resonant frequency given by
- L 1 is the inductance value of the inductive element 3250 and C 1 is the capacitance value of the capacitor 3252 .
- the values of L 1 and C 1 may be selected such that the resonant frequency of the circuit 3249 is equal or nearly equal to the frequency of magnetic field transmitted by the distal inductive element 3218 .
- the circuitry of the microchip 3254 may include a rectifying circuitry (not shown) for rectifying and conditioning the alternating input voltage to provide a DC voltage sufficient to power the microchip 3254 .
- the microchip 3254 may selectively load the inductive element 3250 based on data received from the sensors 3235 and the data stored in the memory devices 3255 , 3257 , thus modulating the magnetic fields coupling the distal inductive element 3218 and the inductive element 3250 .
- the modulation of the magnetic field modulates the voltage across the distal inductive element 3218 , which in turn modulates the voltage across the inductive element 3202 of the control unit 3196 .
- the control unit 3196 may demodulate and decode the voltage signal across the inductive element 3202 to extract data communicated by the microchip 3254 .
- the control unit 3196 may process the data to verify, among other things, that the staple cartridge 3038 is compatible with the instrument 3010 and that end effector conditions are suitable for conducting a firing operation. Subsequent to verification of the data, the control unit 3196 may enable a firing operation.
- the resonant circuit 3249 may further include a fuse 3256 connected in series with the inductive element 3250 .
- the fuse 3256 is closed (e.g., conductive)
- the inductive element 3250 is electrically coupled to the resonant circuit 3249 , thus enabling the transponder 3212 to function as described above in response to an alternating magnetic field emitted by the distal inductive element 3218 .
- the closed state of the fuse 3256 thus corresponds to an enabled state of the transponder 3212 .
- the inductive element 3250 When the fuse 3256 is opened (e.g., non-conductive), the inductive element 3250 is electrically disconnected from the resonant circuit 3249 , thus preventing the resonant circuit 3249 from generating the voltage necessary to operate the microchip 3254 .
- the open state of the fuse 3256 thus corresponds to a disabled state of the transponder 3212 .
- the placement of the fuse 3256 in FIG. 55 is shown by way of example only, and it will be appreciated that the fuse 3256 may be connected in any manner such that the transponder 3212 is disabled when the fuse 3256 is opened.
- the fuse 3256 may be actuated (e.g., transitioned from closed to opened) substantially simultaneously with a firing operation of the instrument 3010 .
- the fuse 3256 may be actuated immediately before, during, or immediately after a firing operation. Actuation of the fuse 3256 thus transitions the transponder 3212 from the enabled state to the disabled state. Accordingly, if an attempt is made to reuse the staple cartridge 3038 , the transponder 3212 will be unable to communicate data in response to a wireless signal transmitted by the distal inductive element 3218 .
- control unit 3196 may determine that the transponder 3212 is in a disabled state indicative of the fired state of the staple cartridge 3038 and prevent a firing operation from being enabled. Thus, actuation of the fuse 3256 prevents reuse of a staple cartridge 3038 when the staple cartridge 3038 is in the fired state.
- the fuse 3256 may be a mechanically-actuated fuse that is opened in response to movement of the cutting instrument 3034 when actuated, for example.
- the fuse 3256 may include a section of wire extending transversely across a longitudinal slot 3258 of the staple cartridge 3038 through which the cutting instrument 3034 passes during a firing operation.
- the distal movement of the cutting instrument 3034 severs the fuse 3256 , thus transitioning the transponder 3212 to the disabled state so that it cannot be reused.
- the fuse 3256 may be an electrically-actuated fuse.
- the control unit 3196 may transmit a wireless signal to the transponder 3212 such that the resulting current flow through fuse 3256 is sufficient to cause the fuse 3256 to open.
- the strength of the wireless signal needed to open the fuse 3256 may be different in amplitude, frequency, and duration than that used to communicate with the transponder 3212 .
- other electrically-actuated components may be used instead of an electrically-actuated fuse to disable the transponder 3212 .
- the control unit 3196 may transmit a wireless signal to the transponder 3212 such that resulting voltage developed across the resonant circuit 3256 sufficiently exceeds the voltage rating of the capacitor 3252 and/or circuitry of the microchip 3254 to cause their destruction.
- the fuse 3256 may instead be a thermally-actuated fuse (e.g., a thermal cutoff fuse) that is caused to open in response to heat generated by the flow of excessive current therethrough.
- a thermally-actuated fuse e.g., a thermal cutoff fuse
- FIG. 57 illustrates a circuit diagram of the transponder 3212 according to various embodiments for enabling wireless communication with the control unit 3196 when the staple cartridge 3038 is in the fired state.
- the resonant circuit 3249 of the transponder 3212 may include a second capacitor 3260 in parallel with the capacitor 3252 .
- the fuse 3256 may be connected in series with the second capacitor 3260 such that the resonant frequency of the resonant circuit 3249 is determined by the open/closed state of the fuse 3256 . In particular, when the fuse 3256 is closed, the resonant frequency is given by
- me open state or me ruse 3256 thus corresponds to a second resonant state of the transponder 3212 .
- the fuse 3256 may be mechanically, electrically or thermally actuated substantially simultaneously with a firing operation.
- the control unit 3196 may be configured to determine the resonant state of the transponder 3212 (and thus the unfired/fired state of the staple cartridge 3038 ) by discriminating between the two resonant frequencies.
- the control unit 3196 may continue to receive data from the transponder 3212 .
- the placement of the fuse 3256 and use of the second capacitor 3260 to alter the resonant frequency is provided by way of example only.
- the fuse 3256 may be connected such that the inductive value of the inductive element 3250 is changed when the fuse 3256 is opened (e.g., by connecting the fuse 3256 such that a portion of the inductive element 3250 is short-circuited when the fuse 3256 is closed).
- a switch may be used as an alternative to the fuse 3256 for effecting the transition between transponder states.
- the staple cartridge tray 3068 of the staple cartridge 3038 may include a switch 3262 (e.g., a normally-open limit switch) located at its proximal end.
- the switch 3262 may be mounted such that when the sled 3036 is present in the unfired position, the sled 3036 maintains the switch 3262 in a closed (e.g., conductive) state.
- the switch 3262 transitions to an open (e.g., non-conductive state), thus effecting a transition in the state of the transponder 3212 as described above.
- the switch 3262 may be a normally-closed switch mounted at the distal end of the staple cartridge tray 3068 such that the switch 3262 is caused to open when the sled 3036 is present in the fired position.
- the switch 3262 may be located at the proximal or distal ends of the staple cartridge 3038 and mounted such that it may be suitably actuated by the sled 3036 when present in the unfired and fired positions, respectively.
- these components may instead be connected to data inputs of the microchip 3254 .
- the open/closed states of the mechanically-actuated fuse 3256 or the switch 3262 may be transmitted to the control unit 3196 in the same manner as the data corresponding to other end effector conditions.
- embodiments of the present invention may instead utilize alterable data values in a dynamic memory device 3255 of the transponder 3212 .
- the dynamic memory device 3255 may store a first data value (e.g., a data bit having a value of 1) corresponding to a first data state of the transponder 3212 .
- the first data value may be written to the dynamic memory device 3255 during the manufacture of the staple cartridge 3038 , for example.
- the first data state may thus be indicative of the unfired state of the staple cartridge 3038 .
- the control unit 3196 may enable operation of the instrument 3010 if the end effector conditions are otherwise suitable for conducting a firing operation. Substantially simultaneously with the firing operation, the control unit 3196 may transmit a wireless signal to the transponder 3212 containing a second data value (e.g., a data bit having a value of 0).
- the second data value may be stored to the dynamic memory device 3255 such that the first data value is overwritten, thus transitioning the transponder 3212 from the first data state to a second data state.
- the second data state may thus be indicative of the fired state of the staple cartridge 3038 . If an attempt is made to reuse the staple cartridge 3038 , the control unit 3196 may determine that the transponder 3212 is in the second data state and prevent a firing operation from being enabled.
- the transponders 3212 in the above-described embodiments includes a microchip 3254 for wirelessly communicating data stored in memory devices 3235 , 3237 and data input from the sensors 3235
- the transponder may not include a microchip 3254 .
- FIG. 59 illustrates a “chipless” transponder 3264 in the form of a resonant circuit having components similar to those of the resonant circuit 3249 , such as an inductive element 3250 , a capacitor 3252 , and a fuse 3256 .
- the transponder 3264 may include one or more sensors 3235 connected in series with the components 3250 , 3252 , 3256 .
- each sensor 3235 may be a limit switch (e.g., a normally open or a normally closed limit switch) mounted in the end effector 3016 for sensing a corresponding end effector condition (e.g., a position of the anvil 3028 , a position of the sled 3036 , etc.).
- each limit switch 3235 may be in a closed (e.g., conductive) state when its sensed condition is compatible with a firing operation, thus establishing electrical continuity through the resonant circuit.
- the resonant circuit When each switch 3235 and the fuse 3256 is in the closed state, the resonant circuit will be caused to resonate at a frequency f r responsive to a magnetic field emitted by the distal inductive element 3218 .
- the closed states of the fuse 3256 and the switches 3235 thus correspond to an enabled state of the transponder 3264 that is indicative of, among other things, the unfired state of the staple cartridge 3038 .
- the control unit 3196 may sense the resonance (e.g., by sensing magnetic field loading caused by the resonant circuit) to determine the enabled state, at which time the control unit 3196 may enable operation of the instrument 3010 .
- the fuse 3256 may be mechanically, electronically or thermally actuated as described above, thus transitioning the transponder 3264 to a disabled state indicative of the fired state of the staple cartridge 3038 . If a subsequent firing operation is attempted without replacing the staple cartridge 3038 , the control unit 3196 may determine the disabled state based on the absence of a sensed resonance in response to an emitted magnetic field, in which case the control unit 3196 prevents the firing operation from being performed.
- FIG. 60 illustrates another embodiment of a chipless transponder 3264 in the form of a resonant circuit including an inductive element 3250 , a first capacitor 3252 , a second capacitor 3260 , and a fuse 3256 connected in series with the second capacitor 3260 .
- the fuse 3256 may be mechanically, electronically or thermally actuated substantially simultaneously with a firing operation, as in above-described embodiments.
- the transponder 3264 may additionally include one or more sensors 3235 (e.g., limit switches) connected in series with a third capacitor 3266 of the resonant circuit. Accordingly, when each switch 3235 and the fuse 3256 are in the closed state, the resonant circuit will be caused to resonate at a frequency
- the closed states of the fuse 3256 and the switches 3235 correspond to a first resonant state (e.g., resonant frequency f r1 ) of the transponder 3264
- the open state of the fuse 3256 corresponds to a second resonant state (e.g., either of resonant frequencies f r3 or f r4 ).
- the capacitance values C 1 , C 2 and C 3 may be selected such that the resonant frequencies f r1 , f r2 , f r3 and f r4 are different.
- the control unit 3196 may be configured to discriminate between resonant frequencies to determine the first or second state of the transponder 3266 (and thus the unfired or fired state of the staple cartridge 3038 ), and to enable or prevent operation of the instrument 3010 accordingly.
- the control unit 3196 may further be configured to determine a third state of the transponder 3264 corresponding the closed state of the fuse 3256 and an open state of any of the switches 3235 . In this case, the control unit 3196 may operate to prevent a firing operation until the end effector condition(s) causing the open switch(es) 3235 is resolved.
- FIG. 61 is a flow diagram of a method of preventing reuse of a staple cartridge in surgical instrument that may be performed in conjunction with embodiments of the instrument 3010 described above.
- a first wireless signal is transmitted to the transponder 3212 , 3264 and at step 3305 a second wireless signal is received from the transponder 3212 , 3264 such that one of a first electronic state and a second electronic state of the transponder 3212 , 3264 may be determined based on the second wireless signal.
- the wireless signals may be magnetic signals generated by inductive effects, although electric fields and electromagnetic fields may alternatively be employed.
- States of the transponder 3212 , 3264 are indicative of states of the staple cartridge 3038 .
- the first and second transponder states may indicate the unfired and fired states of the staple cartridge 3038 , respectively.
- the cutting instrument 3034 may be enabled at step 3315 . After the instrument 3010 is enabled, the operator may initiate a firing operation when ready.
- the transponder 3212 , 3264 may be transitioned from the first electronic state to the second electronic state substantially simultaneously with an actuation of the cutting instrument 3034 . Accordingly, if an attempt is made to reuse the staple cartridge 3038 at step 3300 , the second electronic state of the transponder 3212 , 3264 (indicative of the fired staple cartridge state) may be determined at step 3310 and a firing operation consequently prevented, as shown at step 3325 .
- a limit on the number of firing operations may be implemented by the control unit 3196 using, for example, a counter (not shown) contained within the processor 3198 .
- the counter may be incremented once for each firing operation indicated by one or more sensor inputs received by the control unit 3196 (e.g., inputs received from the end-of-stroke and beginning-of-stroke sensors 3156 , 3158 and the run-motor sensor 3128 ).
- the processor 3198 may compare the counter contents to a predetermined number.
- the predetermined number may be stored in the memory 3200 of the processor 3198 during instrument manufacture, for example, and represent the maximum number of firing operations performable by the instrument 3010 .
- the predetermined number may be determined based upon, among other things, operational lifetimes of the various instrument components and/or the expected requirements of a medical procedure for which the instrument 3010 is to be used.
- the control unit 3196 may be configured to prevent additional firing operations by the instrument 3010 .
- instruction code stored in the memory 3200 may cause the processor 3198 to prevent further output of power and/or control signals necessary for motor operation.
- control unit 3196 may prevent firing operations in excess of the predetermined number by disabling electronic components necessary for motor operation.
- the control unit 3196 may be connected to the motor 3106 via conductive leads 3268 , one of which includes an electronically-actuated fuse 3270 .
- the control unit 3196 may cause increased current to be applied to the motor 3106 such that the fuse 3270 is opened (e.g., rendered non-conductive), thus preventing further motor operation.
- the placement of the fuse 3270 is shown by way of example only, and that the fuse 3270 may be connected in other ways to effect the same result.
- the fuse 3270 may be connected between the battery 3104 and the electrical components of the instrument 3010 .
- the control unit 3196 may short circuit the fuse 3270 such that it is caused to open, thus removing power from the electrical components.
- control unit 3196 may be configured to electronically disable one or more components necessary for motor operation (e.g., capacitors, transistors, etc.) other than a fuse by applying excessive voltages and/or currents thereto. Such components may be internal or external to the control unit 3196 .
- a counter within the processor 3198
- other embodiments may utilize an electro-mechanical counter having a mechanical input suitably coupled to a component of the instrument 3010 (e.g., the firing trigger 3024 ) such that the counter is incremented once for each firing operation.
- the counter may include a set of electrical contacts that close (or open) when the counted number of firing operations exceeds a predetermined number stored within the counter.
- the contacts may serve as an input to the control unit 3196 , and the processor 3198 may be programmed to enable or disable instrument operation based on the state of the contacts.
- the contacts may be connected to other components of the instrument (e.g., the battery 3104 or the motor 3106 ) such that power to the motor 3106 is interrupted when the predetermined number of counts is exceeded.
- the battery 3104 powers (at least partially) the firing operation of the instrument 3010 .
- the instrument may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described are described in U.S. patent application Ser. No. 11/343,573 referenced above, now U.S. Pat. No. 7,416,101, which is incorporated herein. It should be recognized, however, that the instrument 3010 need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention.
- the instrument 3010 may include a user display (such as a LCD or LED display) that is powered by the battery 3104 and controlled by the control unit 3196 .
- a user display such as a LCD or LED display
- Data from the transponder 3212 , 3264 in the end effector 3016 may be displayed on such a display.
- the shaft 3014 of the instrument 3010 may collectively serve as part of an antenna for the control unit 3196 by radiating signals to the transponder 3212 , 3264 and receiving radiated signals from the transponder 3212 , 3264 . That way, signals to and from the transponder 3212 , 3264 in the end effector 3016 may be transmitted via the shaft 3014 of the instrument 3010 .
- the proximate closure tube 3072 may be grounded at its proximate end by the exterior lower and upper side pieces 3096 , 3098 , which may be made of a nonelectrically conductive material, such as plastic.
- the drive shaft assembly components (including the main drive shaft 3080 and secondary drive shaft 3082 ) inside the proximate and distal closure tubes 3072 , 3074 may also be made of a nonelectrically conductive material, such as plastic.
- components of end effector 3016 (such as the anvil 3028 and the channel 3026 ) may be electrically coupled to (or in direct or indirect electrical contact with) the distal closure tube 3074 such that they may also serve as part of the antenna.
- the transponder 3212 , 3264 could be positioned such that it is electrically insulated from the components of the shaft 3014 and end effector 3016 serving as the antenna.
- the transponder 3212 , 3264 may be positioned in the staple cartridge 3038 , which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft 3014 (such as the distal end of the distal closure tube 3074 ) and the portions of the end effector 3016 serving as the antenna may be relatively close in distance to the transponder 3212 , 3264 , the power for the transmitted signals may be controlled such that interference with other systems in the use environment of the instrument 3010 is reduced or minimized
- the control unit 3196 may be electrically coupled to the shaft 3014 of the instrument 3010 , such as to the proximate closure tube 3072 , by a conductive link 3272 (e.g., a wire). Portions of the outer shaft 3014 , such as the closure tubes 3072 , 3074 , may therefore act as part of an antenna for the control unit 3196 by transmitting signals to the transponder 3212 , 3264 and receiving signals transmitted by the transponder 3212 , 3264 . Signals received by the control unit 3196 may be demodulated by the demodulator 3204 and decoded by the decoder 3206 , as described above.
- a conductive link 3272 e.g., a wire
- the link 3272 may connect the control unit 3196 to components of the shaft 3014 of the instrument 3010 , such as the proximate closure tube 3072 , which may be electrically connected to the distal closure tube 3074 .
- the distal closure tube 3074 is preferably electrically insulated from the transponder 3212 , 3264 , which may be positioned in the plastic staple cartridge 3038 .
- components of the end effector 3016 such as the channel 3026 and the anvil 3028 , may be conductive and in electrical contact with the distal closure tube 3074 such that they, too, may serve as part of the antenna.
- the control unit 3196 can communicate with the transponder 3212 , 3264 in the end effector 3016 without a hardwired connection.
- the power levels could be optimized to thereby minimize interference with other systems in the use environment of the instrument 3010 .
- the components of the shaft 3014 and/or the end effector 3016 may serve as an antenna for the transponder 3212 , 3264 .
- the transponder 3212 , 3264 is electrically connected to the shaft 3014 (such as to distal closure tube 3074 , which may be electrically connected to the proximate closure tube 3072 ) and the control unit 3196 is insulated from the shaft 3014 .
- the transponder 3212 , 3264 could be connected to a conductive component of the end effector 3016 (such as the channel 3026 ), which in turn may be connected to conductive components of the shaft (e.g., the closure tubes 3072 , 3074 ).
- the end effector 3016 may include a wire (not shown) that connects the transponder 3212 , 3264 the distal closure tube 3074 .
- FIGS. 64 and 65 depict a surgical cutting and fastening instrument 4010 according to various embodiments of the present invention.
- the illustrated embodiment is an endoscopic instrument and, in general, the embodiments of the instrument 4010 described herein are endoscopic surgical cutting and fastening instruments. It should be noted, however, that according to other embodiments of the present invention, the instrument may be a non-endoscopic surgical cutting and fastening instrument, such as a laparoscopic instrument.
- the surgical instrument 4010 depicted in FIGS. 64 and 65 comprises a handle 4012 , a shaft 4014 , and an articulating end effector 4016 pivotally connected to the shaft 4014 at an articulation pivot 4018 .
- An articulation control 4020 may be provided adjacent to the handle 4012 to effect rotation of the end effector 4016 about the articulation pivot 4018 .
- the end effector 4016 is configured to act as an endocutter for clamping, severing and stapling tissue, although, in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc.
- the handle 4012 of the instrument 4010 may include a closure trigger 4022 and a firing trigger 4024 for actuating the end effector 4016 .
- the end effector 4016 is shown separated from the handle 4012 by a preferably elongate shaft 4014 .
- an operator of the instrument 4010 may articulate the end effector 4016 relative to the shaft 4014 by utilizing the articulation control 4020 as described in more detail in U.S. patent application Ser. No. 11/329,020 entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference.
- the end effector 4016 includes in this example, among other things, a staple channel 4026 and a pivotally translatable clamping member, such as an anvil 4028 , which are maintained at a spacing that assures effective stapling and severing of tissue clamped in the end effector 4016 .
- the handle 4012 includes a pistol grip 4030 towards which a closure trigger 4022 is pivotally drawn by the operator to cause clamping or closing of the anvil 4028 toward the staple channel 4026 of the end effector 4016 to thereby clamp tissue positioned between the anvil 4028 and the channel 4026 .
- the firing trigger 4024 is farther outboard of the closure trigger 4022 .
- the firing trigger 4024 may rotate slightly toward the pistol grip 4030 so that it can be reached by the operator using one hand. The operator may then pivotally draw the firing trigger 4024 toward the pistol grip 4030 to cause the stapling and severing of clamped tissue in the end effector 4016 .
- different types of clamping members besides the anvil 4028 may be used, such as, for example, an opposing jaw, etc.
- proximal and distal are used herein with reference to an operator gripping the handle 4012 of an instrument 4010 .
- the end effector 4016 is distal with respect to the more proximal handle 4012 .
- spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings.
- surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
- the closure trigger 4022 may be actuated first. Once the operator is satisfied with the positioning of the end effector 4016 , the operator may draw back the closure trigger 4022 to its fully closed, locked position proximate to the pistol grip 4030 . The firing trigger 4024 may then be actuated. The firing trigger 4024 returns to the open position (shown in FIGS. 64 and 65 ) when the operator removes pressure, as described more fully below. A release button 4032 on the handle 4012 , when depressed, may release the locked closure trigger 4022 . Various configurations for locking and unlocking the closure trigger 4022 using the release button 4032 are described in U.S.
- FIG. 66A is an exploded view of the end effector 4016 according to various embodiments.
- the end effector 4016 may include, in addition to the previously-mentioned channel 4026 and anvil 4028 , a cutting instrument 4034 , a sled 4036 , a staple cartridge 4038 that is removably seated (e.g., installed) in the channel 4026 , and a helical screw shaft 4040
- FIG. 66B is a perspective view of the cutting instrument of FIG. 66A .
- the anvil 4028 may be pivotably opened and closed at a pivot point 4042 connected to the proximate end of the channel 4026 .
- the anvil 4028 may also include a tab 4044 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close the anvil 4028 .
- the closure trigger 4022 When the closure trigger 4022 is actuated, that is, drawn in by an operator of the instrument 4010 , the anvil 4028 may pivot about the pivot point 4042 into the clamped or closed position. If clamping of the end effector 4016 is satisfactory, the operator may actuate the firing trigger 4024 , which, as explained in more detail below, causes the cutting instrument 4034 to travel longitudinally along the channel 4026 .
- the cutting instrument 4034 includes upper guide pins 4046 that enter an anvil slot 4048 in the anvil 4028 to verify and assist in maintaining the anvil 4028 in a closed state during staple formation and severing. Spacing between the channel 4026 and anvil 4028 is further maintained by the cutting instrument 4034 by having middle pins 4050 slide along the top surface of the channel 4026 while a bottom foot 4052 opposingly slides along the undersurface of the channel 4026 , guided by a longitudinal opening 4054 in the channel 4026 .
- a staple cartridge tray 4068 encompasses from the bottom the other components of the staple cartridge 4038 to hold them in place.
- the staple cartridge tray 4068 includes a rearwardly open slot 4070 that overlies the longitudinal opening 4054 in the channel 4026 .
- a lower surface of the staple cartridge 4038 and an upward surface of the channel 4026 form a firing drive slot 4200 ( FIG. 69 ) through which the middle pins 4050 pass during distal and proximal movement of the cutting instrument 4034 .
- the sled 4036 may be an integral component of the staple cartridge 4038 such that when the cutting instrument 4034 retracts following the cutting operation, the sled 4036 does not retract.
- U.S. Pat. No. 6,978,921 entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments.
- FIGS. 67 and 68 are exploded views and FIG. 69 is a side view of the end effector 4016 and shaft 4014 according to various embodiments.
- the shaft 4014 may include a proximate closure tube 4072 and a distal closure tube 4074 pivotably linked by a pivot links 4076 .
- the distal closure tube 4074 includes an opening 4078 into which the tab 4044 on the anvil 4028 is inserted in order to open and close the anvil 4028 , as further described below.
- Disposed inside the closure tubes 4072 , 4074 may be a proximate spine tube 4079 .
- a main rotational (or proximate) drive shaft 4080 that communicates with a secondary (or distal) drive shaft 4082 via a bevel gear assembly 4084 .
- the secondary drive shaft 4082 is connected to a drive gear 4086 that engages a proximate drive gear 4088 of the helical screw shaft 4040 .
- the vertical bevel gear 4084 b may sit and pivot in an opening 4090 in the distal end of the proximate spine tube 4079 .
- a distal spine tube 4092 may be used to enclose the secondary drive shaft 4082 and the drive gears 4086 , 4088 .
- a bearing 4094 ( FIG. 69 ) positioned at a distal end of the staple channel 4026 receives the helical screw shaft 4040 , allowing the helical screw shaft 4040 to freely rotate with respect to the channel 4026 .
- the helical screw shaft 4040 may interface a threaded opening (not shown) of the cutting instrument 4034 such that rotation of the helical screw shaft 4040 causes the cutting instrument 4034 to translate distally or proximately (depending on the direction of the rotation) through the staple channel 4026 .
- the bevel gear assembly 4084 a - c causes the secondary drive shaft 4082 to rotate, which in turn, because of the engagement of the drive gears 4086 , 4088 , causes the helical screw shaft 4040 to rotate, which causes the cutting instrument 4034 to travel longitudinally along the channel 4026 to cut any tissue clamped within the end effector 4016 .
- the sled 4036 may be made of, for example, plastic, and may have a sloped distal surface.
- the sloped distal surface may cam the staple drivers 4060 upward, which in turn push up or drive the staples 4062 in the staple cartridge 4038 through the clamped tissue and against the staple forming undersurface 4066 of the anvil 4028 , thereby stapling the severed tissue.
- the cutting instrument 4034 When the cutting instrument 4034 is retracted, the cutting instrument 4034 and the sled 4036 may become disengaged, thereby leaving the sled 4036 at the distal end of the channel 4026 .
- FIGS. 70-73 illustrate an exemplary embodiment of a motor-driven endocutter, and in particular the handle 4012 thereof, that provides operator-feedback regarding the deployment and loading force of the cutting instrument 4034 in the end effector 4016 .
- the embodiment may use power provided by the operator in retracting the firing trigger 4024 to power the device (a so-called “power assist” mode).
- the handle 4012 includes exterior lower side pieces 4096 , 4098 and exterior upper side pieces 4100 , 4102 that fit together to form, in general, the exterior of the handle 4012 .
- a battery 4104 may be provided in the pistol grip portion 4030 of the handle 4012 .
- the battery 4104 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO 2 or LiNiO 2 , a Nickel Metal Hydride chemistry, etc.
- the battery 4104 powers a motor 4106 disposed in an upper portion of the pistol grip portion 4030 of the handle 4012 .
- the motor 4106 may be a DC brushed driving motor having a maximum rotation of approximately 5000 to 100,000 RPM.
- the motor 4106 may drive a 90-degree bevel gear assembly 4108 comprising a first bevel gear 4110 and a second bevel gear 4112 .
- the bevel gear assembly 4108 may drive a planetary gear assembly 4114 .
- the planetary gear assembly 4114 may include a pinion gear 4116 connected to a drive shaft 4118 .
- the pinion gear 4116 may drive a mating ring gear 4120 that drives a helical gear drum 4122 via a drive shaft 4124 .
- a ring 4126 may be threaded on the helical gear drum 4122 .
- the handle 4012 may also include a run motor sensor 4128 in communication with the firing trigger 4024 to detect when the firing trigger 4024 has been drawn in (or “closed”) toward the pistol grip portion 4030 of the handle 4012 by the operator to thereby actuate the cutting/stapling operation by the end effector 4016 .
- the sensor 4128 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firing trigger 4024 is drawn in, the sensor 4128 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to the motor 4106 . When the sensor 4128 is a variable resistor or the like, the rotation of the motor 4106 may be generally proportional to the amount of movement of the firing trigger 4024 .
- a microcontroller may output a PWM control signal to the motor 4106 based on the input from the sensor 4128 in order to control the motor 4106 .
- the handle 4012 may include a middle handle piece 4130 adjacent to the upper portion of the firing trigger 4024 .
- the handle 4012 also may comprise a bias spring 4132 connected between posts on the middle handle piece 4130 and the firing trigger 4024 .
- the bias spring 4132 may bias the firing trigger 4024 to its fully open position. In that way, when the operator releases the firing trigger 4024 , the bias spring 4132 will pull the firing trigger 4024 to its open position, thereby removing actuation of the sensor 4128 , thereby stopping rotation of the motor 4106 .
- the bias spring 4132 any time an operator closes the firing trigger 4024 , the operator will experience resistance to the closing operation, thereby providing the operator with feedback as to the amount of rotation exerted by the motor 4106 .
- the operator could stop retracting the firing trigger 4024 to thereby remove force from the sensor 4128 , to thereby stop the motor 4106 .
- the operator may stop the deployment of the end effector 4016 , thereby providing a measure of control of the cutting/fastening operation to the operator.
- the distal end of the helical gear drum 4122 includes a distal drive shaft 4134 that drives a ring gear 4136 , which mates with a pinion gear 4138 .
- the pinion gear 4138 is connected to the main drive shaft 4080 of the main drive shaft assembly. In that way, rotation of the motor 4106 causes the main drive shaft assembly to rotate, which causes actuation of the end effector 4016 , as described above.
- the ring 4126 threaded on the helical gear drum 4122 may include a post 4140 that is disposed within a slot 4142 of a slotted arm 4144 .
- the slotted arm 4144 has an opening 4146 its opposite end 4148 that receives a pivot pin 4150 that is connected between the handle exterior side pieces 4096 , 4098 .
- the pivot pin 4150 is also disposed through an opening 4152 in the firing trigger 4024 and an opening 4154 in the middle handle piece 4130 .
- the handle 4012 may include a reverse motor (or end-of-stroke) sensor 4156 and a stop motor (or beginning-of-stroke) sensor 4158 .
- the reverse motor sensor 4156 may be a normally-open limit switch located at the distal end of the helical gear drum 4122 such that the ring 4126 threaded on the helical gear drum 4122 contacts and closes the reverse motor sensor 4156 when the ring 4126 reaches the distal end of the helical gear drum 4122 .
- the reverse motor sensor 4156 when closed, sends a signal to the motor 4106 to reverse its rotation direction, thereby retracting the cutting instrument 4034 of the end effector 4016 following a cutting operation.
- the stop motor sensor 4158 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of the helical gear drum 4122 so that the ring 4126 opens the switch 4158 when the ring 4126 reaches the proximate end of the helical gear drum 4122 .
- the sensor 4128 detects the deployment of the firing trigger 4024 and sends a signal to the motor 4106 to cause forward rotation of the motor 4106 at, for example, a rate proportional to how hard the operator pulls back the firing trigger 4024 .
- the forward rotation of the motor 4106 in turn causes the ring gear 4120 at the distal end of the planetary gear assembly 4114 to rotate, thereby causing the helical gear drum 4122 to rotate, causing the ring 4126 threaded on the helical gear drum 4122 to travel distally along the helical gear drum 4122 .
- the rotation of the helical gear drum 4122 also drives the main drive shaft assembly as described above, which in turn causes deployment of the cutting instrument 4034 in the end effector 4016 . That is, the cutting instrument 4034 and sled 4036 are caused to traverse the channel 4026 longitudinally, thereby cutting tissue clamped in the end effector 4016 . Also, the stapling operation of the end effector 4016 is caused to happen in embodiments where a stapling-type end effector is used.
- the ring 4126 on the helical gear drum 4122 will have reached the distal end of the helical gear drum 4122 , thereby causing the reverse motor sensor 4156 to be actuated, which sends a signal to the motor 4106 to cause the motor 4106 to reverse its rotation.
- This causes the cutting instrument 4034 to retract, and also causes the ring 4126 on the helical gear drum 4122 to move back to the proximate end of the helical gear drum 4122 .
- the middle handle piece 4130 includes a backside shoulder 4160 that engages the slotted arm 4144 as best shown in FIGS. 71 and 72 .
- the middle handle piece 4130 also has a forward motion stop 4162 that engages the firing trigger 4024 .
- the movement of the slotted arm 4144 is controlled, as explained above, by rotation of the motor 4106 .
- the middle handle piece 4130 will be free to rotate CCW.
- the firing trigger 4024 will engage the forward motion stop 4162 of the middle handle piece 4130 , causing the middle handle piece 4130 to rotate CCW.
- the middle handle piece 4130 will only be able to rotate CCW as far as the slotted arm 4144 permits. In that way, if the motor 4106 should stop rotating for some reason, the slotted arm 4144 will stop rotating, and the operator will not be able to further draw in the firing trigger 4024 because the middle handle piece 4130 will not be free to rotate CCW due to the slotted arm 4144 .
- FIGS. 74 and 75 illustrate two states of a variable sensor that may be used as the run motor sensor 4128 according to various embodiments of the present invention.
- the sensor 4128 may include a face portion 4164 , a first electrode (A) 4166 , a second electrode (B) 4168 , and a compressible dielectric material 4170 (e.g., EAP) between the electrodes 4166 , 4168 .
- the sensor 4128 may be positioned such that the face portion 4164 contacts the firing trigger 4024 when retracted. Accordingly, when the firing trigger 4024 is retracted, the dielectric material 4170 is compressed, as shown in FIG. 75 , such that the electrodes 4166 , 4168 are closer together.
- the distance “b” between the electrodes 4166 , 4168 is directly related to the impedance between the electrodes 4166 , 4168 , the greater the distance the more impedance, and the closer the distance the less impedance. In that way, the amount that the dielectric material 4170 is compressed due to retraction of the firing trigger 4024 (denoted as force “F” in FIG. 75 ) is proportional to the impedance between the electrodes 4166 , 4168 , which can be used to proportionally control the motor 4106 .
- FIGS. 70-73 Components of an exemplary closure system for closing (or clamping) the anvil 4028 of the end effector 4016 by retracting the closure trigger 4022 are also shown in FIGS. 70-73 .
- the closure system includes a yoke 4172 connected to the closure trigger 4022 by a pin 4174 that is inserted through aligned openings in both the closure trigger 4022 and the yoke 4172 .
- a pivot pin 4176 about which the closure trigger 4022 pivots, is inserted through another opening in the closure trigger 4022 which is offset from where the pin 4174 is inserted through the closure trigger 4022 .
- closure brackets 4180 , 4182 define an opening in which the proximal end of the proximate closure tube 4072 (see FIG. 67 ) is seated and held such that longitudinal movement of the closure brackets 4180 , 4182 causes longitudinal motion by the proximate closure tube 4072 .
- the instrument 4010 also includes a closure rod 4184 disposed inside the proximate closure tube 4072 .
- the closure rod 4184 may include a window 4186 into which a post 4188 on one of the handle exterior pieces, such as exterior lower side piece 4096 in the illustrated embodiment, is disposed to fixedly connect the closure rod 4184 to the handle 4012 .
- the proximate closure tube 4072 is capable of moving longitudinally relative to the closure rod 4184 .
- the closure rod 4184 may also include a distal collar 4190 that fits into a cavity 4192 in proximate spine tube 4079 and is retained therein by a cap 4194 (see FIG. 67 ).
- the closure brackets 4180 , 4182 cause the proximate closure tube 4072 to move distally (i.e., away from the handle 4012 of the instrument 4010 ), which causes the distal closure tube 4074 to move distally, which causes the anvil 4028 to rotate about the pivot point 4042 into the clamped or closed position.
- the proximate closure tube 4072 is caused to slide proximally, which causes the distal closure tube 4074 to slide proximally, which, by virtue of the tab 4044 being inserted in the opening 4078 of the distal closure tube 4074 , causes the anvil 4028 to pivot about the pivot point 4042 into the open or unclamped position.
- an operator may clamp tissue between the anvil 4028 and channel 4026 , and may unclamp the tissue following the cutting/stapling operation by unlocking the closure trigger 4022 from the locked position.
- the instrument 4010 may include an interlock for preventing instrument 4010 operation when the staple cartridge 4038 is not installed in the channel 4026 , or when the staple cartridge 4038 is installed in the channel 4026 but spent. Operation of the interlock is twofold. First, in the absence of an unspent staple cartridge 4038 within the channel 4026 , the interlock operates to mechanically block distal advancement of the cutting instrument 4034 through the channel 4026 in response to actuation of the firing trigger 4024 . Using suitable electronics disposed within the handle 4012 , the interlock next detects the increase in current through the motor 4106 resulting from the immobilized cutting instrument 4034 and consequently interrupts current to the motor 4106 .
- the interlock eliminates the need for electronic sensors in the end effector 4016 , thus simplifying instrument design. Moreover, because the magnitude and duration of mechanical blocking force needed to produce the detected increase in motor current is significantly less than that which would be exerted if only a conventional mechanical interlock was used, physical stresses experienced by instrument components are reduced.
- the interlock may include (1) a blocking mechanism to prevent actuation of the cutting instrument 4034 by the motor 4106 when an unspent staple cartridge 4038 is not installed in the channel 4026 , and (2) a lockout circuit to detect the current through the motor 4106 and to interrupt the current through the motor 4106 based on the sensed current.
- FIG. 94 is a flow diagram of the process implemented by the interlock according to various embodiments.
- the actuation of the cutting instrument 4034 by the motor 4106 is mechanically blocked by the blocking mechanism in the absence of an unspent staple cartridge 4038 within the channel 4026 .
- the blocking mechanism may include components or features of conventional mechanical interlocks.
- the current through the motor 4106 resulting from the blocked actuation of the cutting instrument 4034 is detected by the lockout circuit.
- detection of the current may include, for example, the steps of sensing the motor current, generating a signal representative of the sensed motor current, and comparing the generated signal to a threshold signal.
- Interrupting the current may include, for example, interrupting the current when the result of the comparison at step 4266 indicates that the generated signal exceeds the threshold signal. Interrupting the current through the motor 4106 may further include interrupting the current based on a position of the cutting instrument 4034 .
- the blocking mechanism of the interlock may include features similar or identical to those of conventional mechanical interlocks for physically blocking advancement of the cutting instrument 4034 in the absence of an unspent staple cartridge 4038 within the channel 4026 .
- FIG. 76 illustrates a blocking mechanism 4196 according to one embodiment.
- the blocking mechanism 4196 may comprise a pair of spring fingers 4198 positioned in the channel 4026 .
- the spring fingers 4196 may raise up to block the middle pins 4050 of the cutting instrument 4034 when the sled 4036 (not shown in FIG. 76 ) is not present in an unfired position at the proximal end of the channel 4026 , such as when the staple cartridge 4038 is not installed or when the staple cartridge 4038 is installed but spent.
- two spring fingers 4198 are shown, it will be appreciated that more or fewer spring fingers 4198 may be used instead.
- FIGS. 77-80 depict the operation of the spring fingers 4198 sequentially as the instrument 4010 is fired.
- an unspent staple cartridge 4038 has been inserted into the channel 4026 .
- the presence of the sled 4036 in its unfired position depresses the spring fingers 4198 such that the firing drive slot 4200 through which the middle pins 4050 will pass is unimpeded.
- firing of the staple cartridge 4038 has commenced, with the sled 4036 and the middle pins 4050 of the cutting instrument 4034 having distally traversed off of the spring fingers 4198 , which then spring up into the firing drive slot 4200 .
- the staple cartridge 4038 is now spent with the sled 4036 fully driven distally and no longer depicted.
- the cutting instrument 4034 is being retracted proximally. Since the spring fingers 4198 pivot from a more distal point, the middle pins 4050 of the cutting instrument 4034 are able to ride up onto the spring fingers 4198 during retraction, causing them to be depressed out of the firing drive slot 4200 .
- the cutting instrument 4034 is fully retracted and now confronts the non-depressed pair of spring fingers 4198 to prevent distal movement.
- the blocking mechanism 4196 thereby remains activated until an unspent staple cartridge 4038 is installed in the channel 4026 .
- FIG. 81 depicts a blocking mechanism 4202 according to another embodiment.
- the blocking mechanism 4202 which is disclosed in U.S. Pat. No. 7,044,352 referenced above, includes a pair of hooks 4204 having ramped ends 4206 distally placed with regard to attachment devices 4208 .
- the attachment devices 4208 are inserted through apertures 4210 in the channel 4026 , thereby springedly attaching the hooks 4204 to the channel 4026 .
- the ramped ends 4206 lie above a hook recess 4212 defined in the channel 4026 .
- the ramped ends 4206 are depressed into the hook recess 4212 , thereby clearing the way for the middle pins 4050 of the cutting instrument 4034 to move distally through the firing drive slot 4200 so that the staple cartridge 4038 may be actuated.
- a thin shaft 4214 coupling the attachment devices 4208 respectively to the ramped end 4206 of each hook 4204 resiliently responds to absence of the sled 4036 , as depicted, wherein the ramped ends 4206 return to impede the firing drive slot 4200 to block the retracted middle pins 4050 of the cutting instrument 4034 .
- two hooks 4204 are shown, it will be appreciated that more or fewer hooks 4204 may be used instead.
- FIGS. 82-85 depict the sequence of operation of the hooks 4204 .
- the staple cartridge 4038 is unspent so that the distally positioned sled 4036 depresses the ramped ends 4206 into the hook recess 4212 , allowing the middle pins 4050 of the cutting instrument 4034 to move distally through the firing drive slot 4200 during firing, as depicted in FIG. 83 .
- the ramped ends 4206 resiliently raise out of the hook recess 4212 to occupy the firing drive slot 4200 .
- the cutting instrument 4034 is being retracted to the point of contacting the ramped ends 4206 of the hooks 4204 . Since the distal end of the ramped ends 4206 is lower than the proximal part of the ramped ends 4206 , the middle pins 4050 of the cutting instrument 4034 ride over the ramped ends 4206 , forcing them down into the hook recess 4212 until the middle pins 4050 are past the ramped ends 4206 , as depicted in FIG. 85 , wherein the ramped ends 4206 resiliently spring back up to block the middle pins 4050 . Thus, the cutting instrument 4034 is prevented from distal movement until an unspent staple cartridge 4038 is installed in the channel 4026 .
- FIG. 86 depicts a blocking mechanism 4216 according to yet another embodiment.
- the blocking mechanism 4216 is integrally formed with the staple cartridge 4038 and includes proximally projecting blocking members 4218 resiliently positioned above the sled 4036 (not shown in FIG. 86 ).
- the blocking members 4218 each reside within a downward and proximally opening cavity 4220 .
- Each blocking member 4218 includes a leaf spring end 4222 that is held within the cavity 4220 .
- the cavities 4220 are vertically aligned and spaced and parallel about a proximally presented vertical slot 4224 in the staple cartridge 4038 through which the cutting surface 4056 (not shown in FIG. 86 ) passes.
- the staple cartridge 4038 also includes slots 4226 that longitudinally pass through the staple cartridge 4038 , being open from a portion of a proximal and underside of the staple cartridge 4038 to receive the sled 4036 .
- Each blocking member 4218 has a deflectable end 4228 having a ramped distal side 4227 and blocking proximal side 4229 .
- the blocking members 4218 are shaped to reside within their respective cavities 4220 when depressed and to impede the distally moving middle pins 4050 of the cutting instrument 4034 when released.
- FIGS. 87-90 depict the blocking mechanism 4216 sequentially as the instrument 4010 is fired.
- an unspent staple cartridge 4038 has been inserted into the channel 4026 with the sled 4036 depressing upward the deflectable ends 4228 so that the firing drive slot 4200 is unimpeded.
- firing of the staple cartridge 4038 has commenced, with the sled 4036 and the middle pins 4050 of the cutting instrument 4034 having distally traversed past the deflectable ends 4228 , which then spring down into the firing drive slot 4200 .
- the staple cartridge 4038 is now spent with the sled 4036 fully driven distally and no longer depicted.
- the cutting instrument 4034 is being retracted proximally. Since the deflectable ends 4228 pivot from a more distal point, the middle pins 4050 of the cutting instrument 4034 are able to ride under the ramped distal sides 4227 of the deflectable ends 4228 during retraction, causing them to be depressed up, out of the firing drive slot 4200 .
- the cutting instrument 4034 is fully retracted and the middle pints 4050 now confront the blocking proximal sides 4229 of the non-depressed (released) pair of deflectable ends 4228 to prevent distal movement.
- the blocking mechanism 4216 thereby remains activated until an unspent staple cartridge 4038 is installed in the channel 4026 .
- the blocking mechanisms 4196 , 4202 , 4216 of the above-discussed embodiments are provided by way of example only. It will be appreciated that other suitable blocking mechanisms may be used instead.
- FIG. 91 is a schematic diagram of an electrical circuit 4231 of the instrument 4010 according to various embodiments of the present invention.
- the circuit 4231 may be housed within the handle 4012 .
- the circuit 4231 may include a single-pole double-throw relay 4230 , a single-pole single-throw relay 4232 , a double-pole double-throw relay 4234 , a current sensor 4236 , a position sensor 4238 , and a current detection module 4240 .
- Relay 4232 , the current sensor 4236 , the position sensor 4238 , and the current detection module 4240 collectively form a lockout circuit 4241 .
- the lockout circuit 4241 operates to sense the current through the motor 4106 and to interrupt the current based upon the sensed current, thus “locking out” the instrument 4010 by disabling its operation.
- sensor 4128 is activated when an operator pulls in the firing trigger 4024 after locking the closure trigger 4022 .
- switch 4156 is open (indicating that the cutting/stapling operation of the end effector 4016 is not yet complete)
- coil 4242 of relay 4230 is de-energized, thus forming a conductive path between the battery 4104 and relay 4232 via a normally-closed contact of relay 4230 .
- Coil 4244 of relay 4232 is controlled by the current detection module 4240 and the position sensor 4238 as described below. When coil 4244 is de-energized and coil 4242 is de-energized, a conductive path between the battery 4104 and a normally-closed contact of relay 4234 is formed.
- Relay 4234 controls the rotational direction of the motor 4106 based on the states of switches 4156 , 4158 .
- switch 4156 is open and switch 4158 is closed (indicating that the cutting instrument 4034 has not yet fully deployed distally)
- coil 4246 of relay 4234 is de-energized. Accordingly, when coils 4242 , 4244 , 4246 are collectively de-energized, current from the battery 4104 flows through the motor 4106 via the normally-closed contacts of relay 4234 and causes the forward rotation of the motor 4106 , which in turn causes distal deployment of the cutting instrument 4034 as described above.
- coil 4242 of relay 4230 When switch 4156 is closed (indicating that the cutting instrument 4034 has fully deployed distally), coil 4242 of relay 4230 is energized, and coil 4246 of relay 4234 is energized via a normally-open contact of relay 4230 . Accordingly, current now flows to the motor 4106 via normally-open contacts of relays 4230 , 4234 , thus causing reverse rotation of the motor 4106 which in turn causes the cutting instrument 4034 to retract from its distal position and switch 4156 to open. Coil 4242 of relay 4230 remains energized until limit switch 4158 is opened, indicating the complete retraction of the cutting instrument 4034 .
- the magnitude of current through the motor 4106 during its forward rotation is indicative of forces exerted upon the cutting instrument 4034 during its deployment.
- the absence of an unspent staple cartridge 4038 in the channel 4026 e.g., the presence of a spent staple cartridge 4038 or the absence of a staple cartridge 4038 altogether
- the resistive force exerted by the blocking mechanism 4196 , 4202 , 4216 against the cutting instrument 4034 causes an increase in motor torque, thus causing motor current to increase to a level that is measurably greater than that present during a cutting and stapling operation.
- the lockout circuit 4241 may differentiate between deployment of the cutting instrument 4034 when an unspent cartridge 4038 is installed in the channel 4026 versus deployment of the cutting instrument 4034 when an unspent cartridge 4038 is absent from the channel 4026 .
- the current sensor 4236 may be coupled to a path of the circuit 4231 that conducts current to the motor 4106 during its forward rotation.
- the current sensor 4236 may be any current sensing device (e.g., a shunt resistor, a Hall effect current transducer, etc.) suitable for generating a signal (e.g., a voltage signal) representative of sensed motor current.
- the generated signal may be input to the current detection module 4240 for processing therein, as described below.
- the current detection module 4240 may be configured for comparing the signal generated by the current sensor 4236 to a threshold signal (e.g., a threshold voltage signal) to determine if the blocking mechanism 4196 , 4202 , 4216 has been activated.
- a suitable value of the threshold signal may be empirically determined a priori by, for example, measuring the peak signal generated by the current sensor 4236 when the cutting instrument 4034 is initially deployed (e.g., over the first 0.06 inches of its distal movement) during a cutting and stapling operation, and when the cutting instrument 4034 is deployed and encounters the activated blocking mechanism 4196 , 4202 , 4216 .
- the threshold signal value may be selected to be less than the peak signal measured when the blocking mechanism 4196 , 4202 , 4216 is activated, but larger than the peak signal measured during a cutting and stapling operation.
- the current detection module 4240 may comprise a comparator circuit 4248 for receiving the threshold and current sensor 4236 signals and generating a discrete output based on a comparison of the received signals.
- the comparator circuit 4248 may generate a 5 VDC output when the threshold signal is exceeded and a 0VDC output when the threshold signal is not exceeded.
- the threshold signal may be generated, for example, using a suitable signal reference circuit (e.g., a voltage reference circuit) (not shown).
- a suitable signal reference circuit e.g., a voltage reference circuit
- the result of the threshold and current sensor 4236 signal comparison is primarily of interest during the initial deployment (e.g., during the first 0.06 inches of distal movement) of the cutting instrument 4034 . Accordingly, the current detection module 4240 may limit the comparison based on the distal position of the cutting instrument 4034 as indicated by the position sensor 4238 .
- the position sensor 4238 may be any type of position sensing device suitable for generating a signal indicative of a distal position of the cutting instrument 4034 . In one embodiment and as shown in FIG. 91 , for example, the position sensor 4238 may be a normally-open Hall effect position switch 4238 that is actuated based on its proximity to a magnet mounted on the ring 4126 .
- the position switch 4238 may mounted within the handle 4012 and operate such that when the distal position of the cutting instrument 4034 (as indicated by the position of ring 4126 ) is within a pre-determined distance (e.g., distal position ⁇ 0.06 inches) of its proximal-most position, the position switch 4238 is closed. Conversely, when the distal position of the cutting instrument 4034 exceeds the predetermined distance (e.g., distal position >0.06 inches), the position switch 4238 is opened.
- the position switch 4238 may be connected in series with the output of the comparator circuit 4248 to limit the comparison based on the position of the cutting instrument 4034 .
- the output of the position switch 4238 will remain at 0VDC (according to the example presented above), regardless of the result of the comparison.
- position sensors 4238 e.g., mechanically-actuated limit switches, rotary potentiometers, etc.
- auxiliary contacts (not shown) of switch 4158 may be used as an alternative to a separate position sensor 4238 .
- the position sensor 4238 does not include a switched output (e.g., when the position sensor 4238 is a potentiometer or other analog-based position sensor)
- additional processing of the position sensor 4236 output using, for example, a second comparator circuit may be necessary.
- the output of the position switch 4238 may be connected to coil 4244 of relay 4232 .
- Driver circuitry (not shown) between the position switch 4238 and the coil 4244 may be provided if necessary. Accordingly, if the signal generated by the current sensor 4236 exceeds the threshold signal (indicating activation of the blocking mechanism 4196 , 4202 , 4216 due to the absence of an unspent staple cartridge 4038 ), and the cutting instrument 4034 is within the predetermined distance of its proximal-most position, coil 4244 will be energized.
- FIG. 92 is a schematic diagram of an electrical circuit 4249 of the instrument 4010 according to another other embodiment of the present invention in which a processor-based microcontroller 4250 is used to implement functionality of the lockout circuit 4241 described above.
- the microcontroller 4250 may include components well known in the microcontroller art such as, for example, a processor, a random access memory (RAM) unit, an erasable programmable read-only memory (EPROM) unit, an interrupt controller unit, timer units, analog-to-digital conversion (ADC) and digital-to-analog conversion (DAC) units, and a number of general input/output (I/O) ports for receiving and transmitting digital and analog signals.
- RAM random access memory
- EPROM erasable programmable read-only memory
- I/O general input/output
- the current sensor 4236 and the position sensor 4238 may be connected to analog and digital inputs, respectively, of the microcontroller 4250 , and the coil 4244 of relay 4232 may be connected to a digital output of the microcontroller 4250 . It will be appreciated that in embodiments in which the output of the position sensor 4238 is an analog signal, the position sensor 4238 may be connected to an analog input instead.
- the circuit 4249 of FIG. 92 includes relays 4230 , 4232 , 4234 , it will be appreciated that in other embodiments the relay switching functionality may be replicated using solid state switching devices, software, and combinations thereof.
- instructions stored and executed in the microcontroller 4250 may be used to control solid state switched outputs of the microcontroller 4250 .
- switches 4156 , 4158 may be connected to digital inputs of the microcontroller 4250 .
- FIG. 93 is a flow diagram of a process implemented by the microcontroller 4250 according to various embodiments.
- the microcontroller 4250 receives the signal generated by the current sensor 4236 via an analog input and converts the received signal into a corresponding digital current sensor signal.
- values of the digital current sensor signal are compared to a digital threshold value stored within the microcontroller 4250 .
- the digital threshold value may be, for example, a digitized representation of the threshold signal discussed above in connection with FIG. 91 . If all values of the digital current sensor signal are less than the digital threshold value, the process terminates at step 4256 . If a value of the digital current sensor signal exceeds the digital threshold value, the process proceeds to step 4258 .
- step 4258 the position sensor 4238 input is processed to determine if the cutting instrument 4034 is within the predetermined distance of its proximal-most position. If the cutting instrument 4034 is not within the predetermined distance, the process is terminates at step 4260 . If the cutting instrument 4034 is within the predetermined distance, the process proceeds to step 4262 .
- step 4262 the digital output to corresponding to coil 4244 is energized, thus causing the normally closed contacts of relay 4232 to open, which in turn interrupts the current flow to the motor 4106 .
- the current detection module 4240 or the microcontroller 4250 may be configured to determine derivative and/or integral characteristics of the current sensor signal for comparison to corresponding thresholds signals or values.
- the current sensor signal may be processed prior to its analysis using, for example, signal conditioners and/or filters implementing one or more filter response functions (e.g., infinite impulse response functions).
- the inventive surgical instrument disclosed herein need not be a cutting-type surgical instrument, but rather could be used in any type of surgical instrument including remote sensor transponders.
- it could be a non-cutting endoscopic instrument, a grasper, a stapler, a clip applier, an access device, a drug/gene therapy delivery device, an energy device using ultrasound, RF, laser, etc.
- the present invention may be in laparoscopic instruments, for example.
- the present invention also has application in conventional endoscopic and open surgical instrumentation as well as robotic-assisted surgery.
- the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
- reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
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Abstract
Description
- The present application is a continuation application claiming priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 14/559,224, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND REMOTE SENSOR, filed Dec. 3, 2014, now U.S. Patent Application Publication No. 2015/0090762, which is a continuation application claiming priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 14/176,671, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN A CONTROL UNIT OF A ROBOTIC SYSTEM AND REMOTE SENSOR, filed Feb. 10, 2014, now U.S. Patent Application Publication No. 2014/0171966, which is a continuation application claiming priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 13/118,259, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN A CONTROL UNIT OF A ROBOTIC SYSTEM AND REMOTE SENSOR, filed May 27, 2011, which issued on Apr. 1, 2014 as U.S. Pat. No. 8,684,253, which is a continuation-in-part application claiming priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 11/651,807, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND REMOTE SENSOR, filed Jan. 10, 2007, which issued on Jun. 11, 2013 as U.S. Pat. No. 8,459,520, the entire disclosures of which are hereby incorporated by reference herein.
- The above listed application are related to the following U.S. patent applications, filed Jan. 10, 2007, which are also incorporated herein by reference in their respective entireties:
- (1) U.S. patent application Ser. No. 11/651,715, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS, now U.S. Pat. No. 8,652,120;
- (2) U.S. patent application Ser. No. 11/651,806, entitled SURGICAL INSTRUMENT WITH ELEMENTS TO COMMUNICATE BETWEEN CONTROL UNIT AND END EFFECTOR, now U.S. Pat. No. 7,954,682;
- (3) U.S. patent application Ser. No. 11/651,768, entitled PREVENTION OF CARTRIDGE REUSE IN A SURGICAL INSTRUMENT, now U.S. Pat. No. 7,721,931;
- (4) U.S. patent application Ser. No. 11/651,771, entitled POST-STERILIZATION PROGRAMMING OF SURGICAL INSTRUMENTS, now U.S. Pat. No. 7,738,971;
- (5) U.S. patent application Ser. No. 11/651,788, entitled INTERLOCK AND SURGICAL INSTRUMENT INCLUDING SAME, now U.S. Pat. No. 7,721,936; and
- (6) U.S. patent application Ser. No. 11/651,785, entitled SURGICAL INSTRUMENT WITH ENHANCED BATTERY PERFORMANCE, now U.S. Pat. No. 7,900,805.
- Known surgical staplers include an end effector that simultaneously makes a longitudinal incision in tissue and applies lines of staples on opposing sides of the incision. The end effector includes a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocating wedges which, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil.
- Various embodiments of the present invention are described herein by way of example in conjunction with the following figures wherein:
-
FIGS. 1 and 2 are perspective views of a surgical instrument according to various embodiments of the present invention; -
FIGS. 3-5 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention; -
FIG. 6 is a side view of the end effector according to various embodiments of the present invention; -
FIG. 7 is an exploded view of the handle of the instrument according to various embodiments of the present invention; -
FIGS. 8 and 9 are partial perspective views of the handle according to various embodiments of the present invention; -
FIG. 10 is a side view of the handle according to various embodiments of the present invention; -
FIGS. 11 , 13-14, 16, and 22 are perspective views of a surgical instrument according to various embodiments of the present invention; -
FIGS. 12 and 19 are block diagrams of a control unit according to various embodiments of the present invention; -
FIG. 15 is a side view of an end effector including a sensor transponder according to various embodiments of the present invention; -
FIGS. 17 and 18 show the instrument in a sterile container according to various embodiments of the present invention; -
FIG. 20 is a block diagram of the remote programming device according to various embodiments of the present invention; -
FIG. 21 is a diagram of a packaged instrument according to various embodiments of the present invention; -
FIGS. 23 and 24 are perspective views of a surgical instrument according to various embodiments of the present invention; -
FIGS. 25-27 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention; -
FIG. 28 is a side view of the end effector according to various embodiments of the present invention; -
FIG. 29 is an exploded view of the handle of the instrument according to various embodiments of the present invention; -
FIGS. 30 and 31 are partial perspective views of the handle according to various embodiments of the present invention; -
FIG. 32 is a side view of the handle according to various embodiments of the present invention; -
FIG. 33 is a schematic block diagram of one embodiment of a control unit for a surgical instrument according to various embodiments of the present invention; -
FIG. 34 is a schematic diagram illustrating the operation of one embodiment of the control unit in conjunction with first and second sensor elements for a surgical instrument according to various embodiments of the present invention; -
FIG. 35 illustrates one embodiment of a surgical instrument comprising a first element located in a free rotating joint portion of a shaft of the surgical instrument; -
FIG. 36 illustrates one embodiment of a surgical instrument comprising sensor elements disposed at various locations on a shaft of the surgical instrument; -
FIG. 37 illustrates one embodiment of a surgical instrument where a shaft of the surgical instrument serves as part of an antenna for a control unit; -
FIGS. 38 and 39 are perspective views of a surgical instrument according to various embodiments of the present invention; -
FIG. 40A is an exploded view of the end effector according to various embodiments of the present invention; -
FIG. 40B is a perspective view of the cutting instrument ofFIG. 40A ; -
FIGS. 41 and 42 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention; -
FIG. 43 is a side view of the end effector according to various embodiments of the present invention; -
FIG. 44 is an exploded view of the handle of the instrument according to various embodiments of the present invention; -
FIGS. 45 and 46 are partial perspective views of the handle according to various embodiments of the present invention; -
FIG. 47 is a side view of the handle according to various embodiments of the present invention; -
FIGS. 48 and 49 illustrate a proportional sensor that may be used according to various embodiments of the present invention; -
FIG. 50 is a block diagram of a control unit according to various embodiments of the present invention; -
FIGS. 51-53 andFIG. 63 are perspective views of a surgical instrument according to various embodiments of the present invention; -
FIG. 54 is a bottom view of a portion of a staple cartridge according to various embodiments; -
FIGS. 55 and 57 are circuit diagrams of a transponder according to various embodiments; -
FIG. 56 is a bottom view of a portion of a staple cartridge according to various embodiments; -
FIG. 58 is a perspective view of a staple cartridge tray according to various embodiments; -
FIGS. 59 and 60 are circuit diagrams of a transponder according to various embodiments; -
FIG. 61 is a flow diagram of a method of preventing reuse of a staple cartridge in surgical instrument according to various embodiments; -
FIG. 62 is a block diagram of a circuit for preventing operation of the motor according to various embodiments; -
FIGS. 64 and 65 are perspective views of a surgical cutting and fastening instrument according to various embodiments of the present invention; -
FIG. 66A is an exploded view of the end effector according to various embodiments of the present invention; -
FIG. 66B is a perspective view of the cutting instrument ofFIG. 66A ; -
FIGS. 67 and 68 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention; -
FIG. 69 is a side view of the end effector according to various embodiments of the present invention; -
FIG. 70 is an exploded view of the handle of the instrument according to various embodiments of the present invention; -
FIGS. 71 and 72 are partial perspective views of the handle according to various embodiments of the present invention; -
FIG. 73 is a side view of the handle according to various embodiments of the present invention; -
FIGS. 74-75 illustrate a proportional sensor that may be used according to various embodiments of the present invention; -
FIGS. 76-90 illustrate mechanical blocking mechanisms and the sequential operation of each according to various embodiments of the present invention; -
FIGS. 91-92 illustrate schematic diagrams of circuits used in the instrument according to various embodiments of the present invention; -
FIG. 93 is a flow diagram of a process implemented by the microcontroller ofFIG. 92 according to various embodiments of the present invention; and -
FIG. 94 is a flow diagram of a process implemented by an interlock according to various embodiments of the present invention. - Various embodiments of the present invention are directed generally to a surgical instrument having at least one remote sensor transponder and means for communicating power and/or data signals to the transponder(s) from a control unit. The present invention may be used with any type of surgical instrument comprising at least one sensor transponder, such as endoscopic or laparoscopic surgical instruments, but is particularly useful for surgical instruments where some feature of the instrument, such as a free rotating joint, prevents or otherwise inhibits the use of a wired connection to the sensor(s). Before describing aspects of the system, one type of surgical instrument in which embodiments of the present invention may be used—an endoscopic stapling and cutting instrument (i.e., an endocutter)—is first described by way of illustration.
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FIGS. 1 and 2 depict an endoscopicsurgical instrument 10 that comprises ahandle 6, ashaft 8, and an articulatingend effector 12 pivotally connected to theshaft 8 at anarticulation pivot 14. Correct placement and orientation of theend effector 12 may be facilitated by controls on thehand 6, including (1) a rotation knob 28 for rotating the closure tube (described in more detail below in connection withFIGS. 4-5 ) at a free rotating joint 29 of theshaft 8 to thereby rotate theend effector 12 and (2) anarticulation control 16 to effect rotational articulation of theend effector 12 about thearticulation pivot 14. In the illustrated embodiment, theend effector 12 is configured to act as an endocutter for clamping, severing and stapling tissue, although in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical instruments, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc. - The
handle 6 of theinstrument 10 may include aclosure trigger 18 and a firingtrigger 20 for actuating theend effector 12. It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating theend effector 12. Theend effector 12 is shown separated from thehandle 6 by the preferably elongateshaft 8. In one embodiment, a clinician or operator of theinstrument 10 may articulate theend effector 12 relative to theshaft 8 by utilizing thearticulation control 16, as described in more detail in U.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference. - The
end effector 12 includes in this example, among other things, astaple channel 22 and a pivotally translatable clamping member, such as ananvil 24, which are maintained at a spacing that assures effective stapling and severing of tissue clamped in theend effector 12. Thehandle 6 includes apistol grip 26 towards which aclosure trigger 18 is pivotally drawn by the clinician to cause clamping or closing of theanvil 24 toward thestaple channel 22 of theend effector 12 to thereby clamp tissue positioned between theanvil 24 andchannel 22. The firingtrigger 20 is farther outboard of theclosure trigger 18. Once theclosure trigger 18 is locked in the closure position, the firingtrigger 20 may rotate slightly toward thepistol grip 26 so that it can be reached by the operator using one hand. Then the operator may pivotally draw the firingtrigger 20 toward thepistol grip 12 to cause the stapling and severing of clamped tissue in theend effector 12. U.S. patent application Ser. No. 11/343,573, filed Jan. 31, 2006, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK, now U.S. Pat. No. 7,416,101, (the '573 application) which is incorporated herein by reference, describes various configurations for locking and unlocking theclosure trigger 18. In other embodiments, different types of clamping members besides theanvil 24 could be used, such as, for example, an opposing jaw, etc. - It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping the
handle 6 of aninstrument 10. Thus, theend effector 12 is distal with respect to the moreproximal handle 6. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. - The
closure trigger 18 may be actuated first. Once the clinician is satisfied with the positioning of theend effector 12, the clinician may draw back theclosure trigger 18 to its fully closed, locked position proximate to thepistol grip 26. The firingtrigger 20 may then be actuated. The firingtrigger 20 returns to the open position (shown inFIGS. 1 and 2 ) when the clinician removes pressure. A release button 30 on thehandle 6, and in this example, on thepistol grip 26 of the handle, when depressed may release the lockedclosure trigger 18. -
FIG. 3 is an exploded view of theend effector 12 according to various embodiments. As shown in the illustrated embodiment, theend effector 12 may include, in addition to the previously-mentionedchannel 22 andanvil 24, a cuttinginstrument 32, asled 33, astaple cartridge 34 that is removably seated in thechannel 22, and ahelical screw shaft 36. The cuttinginstrument 32 may be, for example, a knife. Theanvil 24 may be pivotably opened and closed at apivot point 25 connected to the proximate end of thechannel 22. Theanvil 24 may also include atab 27 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close theanvil 24. When theclosure trigger 18 is actuated, that is, drawn in by a user of theinstrument 10, theanvil 24 may pivot about thepivot point 25 into the clamped or closed position. If clamping of theend effector 12 is satisfactory, the operator may actuate the firingtrigger 20, which, as explained in more detail below, causes theknife 32 andsled 33 to travel longitudinally along thechannel 22, thereby cutting tissue clamped within theend effector 12. The movement of thesled 33 along thechannel 22 causes the staples of thestaple cartridge 34 to be driven through the severed tissue and against theclosed anvil 24, which turns the staples to fasten the severed tissue. U.S. Pat. No. 6,978,921, entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments. Thesled 33 may be part of thecartridge 34, such that when theknife 32 retracts following the cutting operation, thesled 33 does not retract. Thechannel 22 and theanvil 24 may be made of an electrically conductive material (such as metal) so that they may serve as part of the antenna that communicates with the sensor(s) in the end effector, as described further below. Thecartridge 34 could be made of a nonconductive material (such as plastic) and the sensor may be connected to or disposed in thecartridge 34, as described further below. - It should be noted that although the embodiments of the
instrument 10 described herein employ anend effector 12 that staples the severed tissue, in other embodiments different techniques for fastening or sealing the severed tissue may be used. For example, end effectors that use RF energy or adhesives to fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680, entitled ELECTROSURGICAL HEMOSTATIC DEVICE, and U.S. Pat. No. 5,688,270, entitled ELECTROSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OR OFFSET ELECTRODES, which are incorporated herein by reference, discloses cutting instruments that use RF energy to fasten the severed tissue. U.S. patent application Ser. No. 11/267,811, now U.S. Pat. No. 7,673,783 and U.S. patent application Ser. No. 11/267,383, now U.S. Pat. No. 7,607,557, which are also incorporated herein by reference, disclose cutting instruments that use adhesives to fasten the severed tissue. Accordingly, although the description herein refers to cutting/stapling operations and the like, it should be recognized that this is an exemplary embodiment and is not meant to be limiting. Other tissue-fastening techniques may also be used. -
FIGS. 4 and 5 are exploded views andFIG. 6 is a side view of theend effector 12 andshaft 8 according to various embodiments. As shown in the illustrated embodiment, theshaft 8 may include aproximate closure tube 40 and adistal closure tube 42 pivotably linked by a pivot links 44. Thedistal closure tube 42 includes anopening 45 into which thetab 27 on theanvil 24 is inserted in order to open and close theanvil 24. Disposed inside theclosure tubes proximate spine tube 46. Disposed inside theproximate spine tube 46 may be a main rotational (or proximate) driveshaft 48 that communicates with a secondary (or distal) driveshaft 50 via a bevel gear assembly 52. Thesecondary drive shaft 50 is connected to adrive gear 54 that engages aproximate drive gear 56 of thehelical screw shaft 36. Thevertical bevel gear 52 b may sit and pivot in an opening 57 in the distal end of theproximate spine tube 46. Adistal spine tube 58 may be used to enclose thesecondary drive shaft 50 and the drive gears 54, 56. Collectively, themain drive shaft 48, thesecondary drive shaft 50, and the articulation assembly (e.g., the bevel gear assembly 52 a-c), are sometimes referred to herein as the “main drive shaft assembly.” Theclosure tubes drive shafts 48, 50) may be made of a nonconductive material (such as plastic). - A
bearing 38, positioned at a distal end of thestaple channel 22, receives thehelical drive screw 36, allowing thehelical drive screw 36 to freely rotate with respect to thechannel 22. Thehelical screw shaft 36 may interface a threaded opening (not shown) of theknife 32 such that rotation of theshaft 36 causes theknife 32 to translate distally or proximately (depending on the direction of the rotation) through thestaple channel 22. Accordingly, when themain drive shaft 48 is caused to rotate by actuation of the firing trigger 20 (as explained in more detail below), the bevel gear assembly 52 a-c causes thesecondary drive shaft 50 to rotate, which in turn, because of the engagement of the drive gears 54, 56, causes thehelical screw shaft 36 to rotate, which causes theknife 32 to travel longitudinally along thechannel 22 to cut any tissue clamped within the end effector. Thesled 33 may be made of, for example, plastic, and may have a sloped distal surface. As thesled 33 traverses thechannel 22, the sloped forward surface may push up or drive the staples in thestaple cartridge 34 through the clamped tissue and against theanvil 24. Theanvil 24 turns the staples, thereby stapling the severed tissue. When theknife 32 is retracted, theknife 32 andsled 33 may become disengaged, thereby leaving thesled 33 at the distal end of thechannel 22. - According to various embodiments, as shown
FIGS. 7-10 , the surgical instrument may include abattery 64 in thehandle 6. The illustrated embodiment provides user-feedback regarding the deployment and loading force of the cutting instrument in theend effector 12. In addition, the embodiment may use power provided by the user in retracting the firingtrigger 18 to power the instrument 10 (a so-called “power assist” mode). As shown in the illustrated embodiment, thehandle 6 includes exteriorlower side pieces upper side pieces handle 6. The handle pieces 59-62 may be made of an electrically nonconductive material, such as plastic. Abattery 64 may be provided in thepistol grip portion 26 of thehandle 6. Thebattery 64 powers amotor 65 disposed in an upper portion of thepistol grip portion 26 of thehandle 6. Thebattery 64 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO2 or LiNiO2, a Nickel Metal Hydride chemistry, etc. According to various embodiments, themotor 65 may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 RPM to 100,000 RPM. Themotor 64 may drive a 90°bevel gear assembly 66 comprising afirst bevel gear 68 and asecond bevel gear 70. Thebevel gear assembly 66 may drive aplanetary gear assembly 72. Theplanetary gear assembly 72 may include apinion gear 74 connected to adrive shaft 76. Thepinion gear 74 may drive amating ring gear 78 that drives ahelical gear drum 80 via adrive shaft 82. Aring 84 may be threaded on thehelical gear drum 80. Thus, when themotor 65 rotates, thering 84 is caused to travel along thehelical gear drum 80 by means of the interposedbevel gear assembly 66,planetary gear assembly 72 andring gear 78. - The
handle 6 may also include arun motor sensor 110 in communication with the firingtrigger 20 to detect when the firingtrigger 20 has been drawn in (or “closed”) toward thepistol grip portion 26 of thehandle 6 by the operator to thereby actuate the cutting/stapling operation by theend effector 12. Thesensor 110 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firingtrigger 20 is drawn in, thesensor 110 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to themotor 65. When thesensor 110 is a variable resistor or the like, the rotation of themotor 65 may be generally proportional to the amount of movement of the firingtrigger 20. That is, if the operator only draws or closes the firingtrigger 20 in a little bit, the rotation of themotor 65 is relatively low. When the firingtrigger 20 is fully drawn in (or in the fully closed position), the rotation of themotor 65 is at its maximum. In other words, the harder the user pulls on the firingtrigger 20, the more voltage is applied to themotor 65, causing greater rates of rotation. In another embodiment, for example, the control unit (described further below) may output a PWM control signal to themotor 65 based on the input from thesensor 110 in order to control themotor 65. - The
handle 6 may include amiddle handle piece 104 adjacent to the upper portion of the firingtrigger 20. Thehandle 6 also may comprise abias spring 112 connected between posts on themiddle handle piece 104 and the firingtrigger 20. Thebias spring 112 may bias the firingtrigger 20 to its fully open position. In that way, when the operator releases the firingtrigger 20, thebias spring 112 will pull the firingtrigger 20 to its open position, thereby removing actuation of thesensor 110, thereby stopping rotation of themotor 65. Moreover, by virtue of thebias spring 112, any time a user closes the firingtrigger 20, the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by themotor 65. Further, the operator could stop retracting the firingtrigger 20 to thereby remove force from thesensor 100, to thereby stop themotor 65. As such, the user may stop the deployment of theend effector 12, thereby providing a measure of control of the cutting/fastening operation to the operator. - The distal end of the
helical gear drum 80 includes adistal drive shaft 120 that drives aring gear 122, which mates with apinion gear 124. Thepinion gear 124 is connected to themain drive shaft 48 of the main drive shaft assembly. In that way, rotation of themotor 65 causes the main drive shaft assembly to rotate, which causes actuation of theend effector 12, as described above. - The
ring 84 threaded on thehelical gear drum 80 may include apost 86 that is disposed within aslot 88 of a slottedarm 90. The slottedarm 90 has anopening 92 at itsopposite end 94 that receives apivot pin 96 that is connected between the handleexterior side pieces pivot pin 96 is also disposed through anopening 100 in the firingtrigger 20 and anopening 102 in themiddle handle piece 104. - In addition, the
handle 6 may include a reverse motor (or end-of-stroke sensor) 130 and a stop motor (or beginning-of-stroke)sensor 142. In various embodiments, thereverse motor sensor 130 may be a limit switch located at the distal end of thehelical gear drum 80 such that thering 84 threaded on thehelical gear drum 80 contacts and trips thereverse motor sensor 130 when thering 84 reaches the distal end of thehelical gear drum 80. Thereverse motor sensor 130, when activated, sends a signal to the control unit which sends a signal to themotor 65 to reverse its rotation direction, thereby withdrawing theknife 32 of theend effector 12 following the cutting operation. - The
stop motor sensor 142 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of thehelical gear drum 80 so that thering 84 trips theswitch 142 when thering 84 reaches the proximate end of thehelical gear drum 80. - In operation, when an operator of the
instrument 10 pulls back the firingtrigger 20, thesensor 110 detects the deployment of the firingtrigger 20 and sends a signal to the control unit which sends a signal to themotor 65 to cause forward rotation of themotor 65 at, for example, a rate proportional to how hard the operator pulls back the firingtrigger 20. The forward rotation of themotor 65 in turn causes thering gear 78 at the distal end of theplanetary gear assembly 72 to rotate, thereby causing thehelical gear drum 80 to rotate, causing thering 84 threaded on thehelical gear drum 80 to travel distally along thehelical gear drum 80. The rotation of thehelical gear drum 80 also drives the main drive shaft assembly as described above, which in turn causes deployment of theknife 32 in theend effector 12. That is, theknife 32 andsled 33 are caused to traverse thechannel 22 longitudinally, thereby cutting tissue clamped in theend effector 12. Also, the stapling operation of theend effector 12 is caused to happen in embodiments where a stapling-type end effector is used. - By the time the cutting/stapling operation of the
end effector 12 is complete, thering 84 on thehelical gear drum 80 will have reached the distal end of thehelical gear drum 80, thereby causing thereverse motor sensor 130 to be tripped, which sends a signal to the control unit which sends a signal to themotor 65 to cause themotor 65 to reverse its rotation. This in turn causes theknife 32 to retract, and also causes thering 84 on thehelical gear drum 80 to move back to the proximate end of thehelical gear drum 80. - The
middle handle piece 104 includes a backside shoulder 106 that engages the slottedarm 90 as best shown inFIGS. 8 and 9 . Themiddle handle piece 104 also has a forward motion stop 107 that engages the firingtrigger 20. The movement of the slottedarm 90 is controlled, as explained above, by rotation of themotor 65. When the slottedarm 90 rotates CCW as thering 84 travels from the proximate end of thehelical gear drum 80 to the distal end, themiddle handle piece 104 will be free to rotate CCW. Thus, as the user draws in the firingtrigger 20, the firingtrigger 20 will engage the forward motion stop 107 of themiddle handle piece 104, causing themiddle handle piece 104 to rotate CCW. Due to the backside shoulder 106 engaging the slottedarm 90, however, themiddle handle piece 104 will only be able to rotate CCW as far as the slottedarm 90 permits. In that way, if themotor 65 should stop rotating for some reason, the slottedarm 90 will stop rotating, and the user will not be able to further draw in the firingtrigger 20 because themiddle handle piece 104 will not be free to rotate CCW due to the slottedarm 90. - Components of an exemplary closure system for closing (or clamping) the
anvil 24 of theend effector 12 by retracting theclosure trigger 18 are also shown inFIGS. 7-10 . In the illustrated embodiment, the closure system includes ayoke 250 connected to theclosure trigger 18 by a pin 251 that is inserted through aligned openings in both theclosure trigger 18 and theyoke 250. Apivot pin 252, about which theclosure trigger 18 pivots, is inserted through another opening in theclosure trigger 18 which is offset from where the pin 251 is inserted through theclosure trigger 18. Thus, retraction of theclosure trigger 18 causes the upper part of theclosure trigger 18, to which theyoke 250 is attached via the pin 251, to rotate CCW. The distal end of theyoke 250 is connected, via apin 254, to afirst closure bracket 256. Thefirst closure bracket 256 connects to asecond closure bracket 258. Collectively, theclosure brackets FIG. 4 ) is seated and held such that longitudinal movement of theclosure brackets proximate closure tube 40. Theinstrument 10 also includes aclosure rod 260 disposed inside theproximate closure tube 40. Theclosure rod 260 may include a window 261 into which apost 263 on one of the handle exterior pieces, such as exteriorlower side piece 59 in the illustrated embodiment, is disposed to fixedly connect theclosure rod 260 to thehandle 6. In that way, theproximate closure tube 40 is capable of moving longitudinally relative to theclosure rod 260. Theclosure rod 260 may also include adistal collar 267 that fits into acavity 269 inproximate spine tube 46 and is retained therein by a cap 271 (seeFIG. 4 ). - In operation, when the
yoke 250 rotates due to retraction of theclosure trigger 18, theclosure brackets proximate closure tube 40 to move distally (i.e., away from the handle end of the instrument 10), which causes thedistal closure tube 42 to move distally, which causes theanvil 24 to rotate about thepivot point 25 into the clamped or closed position. When theclosure trigger 18 is unlocked from the locked position, theproximate closure tube 40 is caused to slide proximately, which causes thedistal closure tube 42 to slide proximately, which, by virtue of thetab 27 being inserted in thewindow 45 of thedistal closure tube 42, causes theanvil 24 to pivot about thepivot point 25 into the open or unclamped position. In that way, by retracting and locking theclosure trigger 18, an operator may clamp tissue between theanvil 24 andchannel 22, and may unclamp the tissue following the cutting/stapling operation by unlocking theclosure trigger 18 from the locked position. - The control unit (described further below) may receive the outputs from end-of-stroke and beginning-of-
stroke sensors motor sensor 110, and may control themotor 65 based on the inputs. For example, when an operator initially pulls the firingtrigger 20 after locking theclosure trigger 18, the run-motor sensor 110 is actuated. If thestaple cartridge 34 is present in theend effector 12, a cartridge lockout sensor (not shown) may be closed, in which case the control unit may output a control signal to themotor 65 to cause themotor 65 to rotate in the forward direction. When theend effector 12 reaches the end of its stroke, thereverse motor sensor 130 will be activated. The control unit may receive this output from thereverse motor sensor 130 and cause themotor 65 to reverse its rotational direction. When theknife 32 is fully retracted, the stopmotor sensor switch 142 is activated, causing the control unit to stop themotor 65. - In other embodiments, rather than a proportional-
type sensor 110, an on-off type sensor could be used. In such embodiments, the rate of rotation of themotor 65 would not be proportional to the force applied by the operator. Rather, themotor 65 would generally rotate at a constant rate. But the operator would still experience force feedback because the firingtrigger 20 is geared into the gear drive train. - The
instrument 10 may include a number of sensor transponders in theend effector 12 for sensing various conditions related to theend effector 12, such as sensor transponders for determining the status of the staple cartridge 34 (or other type of cartridge depending on the type of surgical instrument), the progress of the stapler during closure and firing, etc. The sensor transponders may be passively powered by inductive signals, as described further below, although in other embodiments the transponders could be powered by a remote power source, such as a battery in theend effector 12, for example. The sensor transponder(s) could include magnetoresistive, optical, electromechanical, RFID, MEMS, motion or pressure sensors, for example. These sensor transponders may be in communication with acontrol unit 300, which may be housed in thehandle 6 of theinstrument 10, for example, as shown inFIG. 11 . - As shown in
FIG. 12 , according to various embodiments thecontrol unit 300 may comprise aprocessor 306 and one ormore memory units 308. By executing instruction code stored in thememory 308, theprocessor 306 may control various components of theinstrument 10, such as themotor 65 or a user display (not shown), based on inputs received from the various end effector sensor transponders and other sensor(s) (such as the run-motor sensor 110, the end-of-stroke sensor 130, and the beginning-of-stroke sensor 142, for example). Thecontrol unit 300 may be powered by thebattery 64 during surgical use ofinstrument 10. Thecontrol unit 300 may comprise an inductive element 302 (e.g., a coil or antenna) to pick up wireless signals from the sensor transponders, as described in more detail below. Input signals received by theinductive element 302 acting as a receiving antenna may be demodulated by ademodulator 310 and decoded by adecoder 312. The input signals may comprise data from the sensor transponders in theend effector 12, which theprocessor 306 may use to control various aspects of theinstrument 10. - To transmit signals to the sensor transponders, the
control unit 300 may comprise anencoder 316 for encoding the signals and amodulator 318 for modulating the signals according to the modulation scheme. Theinductive element 302 may act as the transmitting antenna. Thecontrol unit 300 may communicate with the sensor transponders using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band). Also, thecontrol unit 300 may transmit signals at a different frequency range than the frequency range of the received signals from the sensor transponders. Also, although only one antenna (inductive element 302) is shown inFIG. 12 , in other embodiments thecontrol unit 300 may have separate receiving and transmitting antennas. - According to various embodiments, the
control unit 300 may comprise a microcontroller, a microprocessor, a field programmable gate array (FPGA), one or more other types of integrated circuits (e.g., RF receivers and PWM controllers), and/or discrete passive components. The control units may also be embodied as system-on-chip (SoC) or a system-in-package (SIP), for example. - As shown in
FIG. 11 , thecontrol unit 300 may be housed in thehandle 6 of theinstrument 10 and one or more of thesensor transponders 368 for theinstrument 10 may be located in theend effector 12. To deliver power and/or transmit data to or from thesensor transponders 368 in theend effector 12, theinductive element 302 of thecontrol unit 300 may be inductively coupled to a secondary inductive element (e.g., a coil) 320 positioned in theshaft 8 distally from the rotation joint 29. The secondaryinductive element 320 is preferably electrically insulated from theconductive shaft 8. - The secondary
inductive element 320 may be connected by an electrically conductive,insulated wire 322 to a distal inductive element (e.g., a coil) 324 located near theend effector 12, and preferably distally relative to thearticulation pivot 14. Thewire 322 may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass though thearticulation pivot 14 and not be damaged by articulation. The distalinductive element 324 may be inductively coupled to thesensor transponder 368 in, for example, thecartridge 34 of theend effector 12. Thetransponder 368, as described in more detail below, may include an antenna (or coil) for inductive coupling to thedistal coil 324, a sensor and integrated control electronics for receiving and transmitting wireless communication signals. - The
transponder 368 may use a portion of the power of the inductive signal received from the distalinductive element 326 to passively power thetransponder 368. Once sufficiently powered by the inductive signals, thetransponder 368 may receive and transmit data to thecontrol unit 300 in thehandle 6 via (i) the inductive coupling between thetransponder 368 and the distalinductive element 324, (ii) thewire 322, and (iii) the inductive coupling between the secondaryinductive element 320 and thecontrol unit 300. That way, thecontrol unit 300 may communicate with thetransponder 368 in theend effector 12 without a direct wired connection through complex mechanical joints like the rotating joint 29 and/or without a direct wired connection from theshaft 8 to theend effector 12, places where it may be difficult to maintain such a wired connection. In addition, because the distances between the inductive elements (e.g., the spacing between (i) thetransponder 368 and the distalinductive element 324, and (ii) the secondaryinductive element 320 and the control unit 300) and fixed and known, the couplings could be optimized for inductive transfer of energy. Also, the distances could be relatively short so that relatively low power signals could be used to thereby minimize interference with other systems in the use environment of theinstrument 10. - In the embodiment of
FIG. 12 , theinductive element 302 of thecontrol unit 300 is located relatively near to thecontrol unit 300. According to other embodiments, as shown inFIG. 13 , theinductive element 302 of thecontrol unit 300 may be positioned closer to the rotating joint 29 to that it is closer to the secondaryinductive element 320, thereby reducing the distance of the inductive coupling in such an embodiment. Alternatively, the control unit 300 (and hence the inductive element 302) could be positioned closer to the secondaryinductive element 320 to reduce the spacing. - In other embodiments, more or fewer than two inductive couplings may be used. For example, in some embodiments, the
surgical instrument 10 may use a single inductive coupling between thecontrol unit 300 in thehandle 6 and thetransponder 368 in theend effector 12, thereby eliminating theinductive elements wire 322. Of course, in such an embodiment, a stronger signal may be required due to the greater distance between thecontrol unit 300 in thehandle 6 and thetransponder 368 in theend effector 12. Also, more than two inductive couplings could be used. For example, if thesurgical instrument 10 had numerous complex mechanical joints where it would be difficult to maintain a direct wired connection, inductive couplings could be used to span each such joint. For example, inductive couplers could be used on both sides of the rotary joint 29 and both sides of thearticulation pivot 14, with theinductive element 321 on the distal side of the rotary joint 29 connected by awire 322 to theinductive element 324 of the proximate side of the articulation pivot, and awire 323 connecting theinductive elements articulation pivot 14 as shown inFIG. 14 . In this embodiment, theinductive element 326 may communicate with thesensor transponder 368. - In addition, the
transponder 368 may include a number of different sensors. For example, it may include an array of sensors. Further, theend effector 12 could include a number ofsensor transponders 368 in communication with the distal inductive element 324 (and hence the control unit 300). Also, theinductive elements closure tubes 40, 42), and thewire 322 is also preferably insulated from theouter shaft 8. -
FIG. 15 is a diagram of anend effector 12 including atransponder 368 held or embedded in thecartridge 34 at the distal end of thechannel 22. Thetransponder 368 may be connected to thecartridge 34 by a suitable bonding material, such as epoxy. In this embodiment, thetransponder 368 includes a magnetoresistive sensor. Theanvil 24 also includes apermanent magnet 369 at its distal end and generally facing thetransponder 368. Theend effector 12 also includes apermanent magnet 370 connected to thesled 33 in this example embodiment. This allows thetransponder 368 to detect both opening/closing of the end effector 12 (due to thepermanent magnet 369 moving further or closer to the transponder as theanvil 24 opens and closes) and completion of the stapling/cutting operation (due to thepermanent magnet 370 moving toward thetransponder 368 as thesled 33 traverses thechannel 22 as part of the cutting operation). -
FIG. 15 also shows thestaples 380 and thestaple drivers 382 of thestaple cartridge 34. As explained previously, according to various embodiments, when thesled 33 traverses thechannel 22, thesled 33 drives thestaple drivers 382 which drive thestaples 380 into the severed tissue held in theend effector 12, thestaples 380 being formed against theanvil 24. As noted above, such a surgical cutting and fastening instrument is but one type of surgical instrument in which the present invention may be advantageously employed. Various embodiments of the present invention may be used in any type of surgical instrument having one or more sensor transponders. - In the embodiments described above, the
battery 64 powers (at least partially) the firing operation of theinstrument 10. As such, the instrument may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described in the '573 application, which is incorporated herein. It should be recognized, however, that theinstrument 10 need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention. For example, theinstrument 10 may include a user display (such as a LCD or LED display) that is powered by thebattery 64 and controlled by thecontrol unit 300. Data from thesensor transponders 368 in theend effector 12 may be displayed on such a display. - In another embodiment, the
shaft 8 of theinstrument 10, including for example, theproximate closure tube 40 and thedistal closure tube 42, may collectively serve as part of an antenna for thecontrol unit 300 by radiating signals to thesensor transponder 368 and receiving radiated signals from thesensor transponder 368. That way, signals to and from the remote sensor in theend effector 12 may be transmitted via theshaft 8 of theinstrument 10. - The
proximate closure tube 40 may be grounded at its proximate end by the exterior lower and upper side pieces 59-62, which may be made of a nonelectrically conductive material, such as plastic. The drive shaft assembly components (including themain drive shaft 48 and secondary drive shaft 50) inside the proximate anddistal closure tubes anvil 24 and the channel 22) may be electrically coupled to (or in direct or indirect electrical contact with) thedistal closure tube 42 such that they may also serve as part of the antenna. Further, thesensor transponder 368 could be positioned such that it is electrically insulated from the components of theshaft 8 and endeffector 12 serving as the antenna. For example, thesensor transponder 368 may be positioned in thecartridge 34, which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft 8 (such as the distal end of the distal closure tube 42) and the portions of theend effector 12 serving as the antenna may be relatively close in distance to thesensor 368, the power for the transmitted signals may be held at low levels, thereby minimizing or reducing interference with other systems in the use environment of theinstrument 10. - In such an embodiment, as shown in
FIG. 16 , thecontrol unit 300 may be electrically coupled to theshaft 8 of theinstrument 10, such as to theproximate closure tube 40, by a conductive link 400 (e.g., a wire). Portions of theouter shaft 8, such as theclosure tubes control unit 300 by radiating signals to thesensor 368 and receiving radiated signals from thesensor 368. Input signals received by thecontrol unit 300 may be demodulated by thedemodulator 310 and decoded by the decoder 312 (seeFIG. 12 ). The input signals may comprise data from thesensors 368 in theend effector 12, which theprocessor 306 may use to control various aspects of theinstrument 10, such as themotor 65 or a user display. - To transmit data signals to or from the
sensors 368 in theend effector 12, thelink 400 may connect thecontrol unit 300 to components of theshaft 8 of theinstrument 10, such as theproximate closure tube 40, which may be electrically connected to thedistal closure tube 42. Thedistal closure tube 42 is preferably electrically insulated from theremote sensor 368, which may be positioned in the plastic cartridge 34 (seeFIG. 3 ). As mentioned before, components of theend effector 12, such as thechannel 22 and the anvil 24 (seeFIG. 3 ), may be conductive and in electrical contact with thedistal closure tube 42 such that they, too, may serve as part of the antenna. - With the
shaft 8 acting as the antenna for thecontrol unit 300, thecontrol unit 300 can communicate with thesensor 368 in theend effector 12 without a direct wired connection. In addition, because the distances betweenshaft 8 and theremote sensor 368 is fixed and known, the power levels could be optimized for low levels to thereby minimize interference with other systems in the use environment of theinstrument 10. Thesensor 368 may include communication circuitry for radiating signals to thecontrol unit 300 and for receiving signals from thecontrol unit 300, as described above. The communication circuitry may be integrated with thesensor 368. - In another embodiment, the components of the
shaft 8 and/or theend effector 12 may serve as an antenna for theremote sensor 368. In such an embodiment, theremote sensor 368 is electrically connected to the shaft (such as todistal closure tube 42, which may be electrically connected to the proximate closure tube 40) and thecontrol unit 300 is insulated from theshaft 8. For example, thesensor 368 could be connected to a conductive component of the end effector 12 (such as the channel 22), which in turn may be connected to conductive components of the shaft (e.g., theclosure tubes 40, 42). Alternatively, theend effector 12 may include a wire (not shown) that connects theremote sensor 368 thedistal closure tube 42. - Typically, surgical instruments, such as the
instrument 10, are cleaned and sterilized prior to use. In one sterilization technique, theinstrument 10 is placed in a closed and sealedcontainer 280, such as a plastic or TYVEK container or bag, as shown inFIGS. 17 and 18 . The container and the instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on theinstrument 10 and in thecontainer 280. The sterilizedinstrument 10 can then be stored in thesterile container 280. The sealed,sterile container 280 keeps theinstrument 10 sterile until it is opened in a medical facility or some other use environment. Instead of radiation, other means of sterilizing theinstrument 10 may be used, such as ethylene oxide or steam. - When radiation, such as gamma radiation, is used to sterilize the
instrument 10, components of thecontrol unit 300, particularly thememory 308 and theprocessor 306, may be damaged and become unstable. Thus, according to various embodiments of the present invention, thecontrol unit 300 may be programmed after packaging and sterilization of theinstrument 10. - As shown in
FIG. 17 , aremote programming device 320, which may be a handheld device, may be brought into wireless communication with thecontrol unit 300. Theremote programming device 320 may emit wireless signals that are received by thecontrol unit 300 to program thecontrol unit 300 and to power thecontrol unit 300 during the programming operation. That way, thebattery 64 does not need to power thecontrol unit 300 during the programming operation. According to various embodiments, the programming code downloaded to thecontrol unit 300 could be of relatively small size, such as 1 MB or less, so that a communications protocol with a relatively low data transmission rate could be used if desired. Also, theremote programming unit 320 could be brought into close physical proximity with thesurgical instrument 10 so that a low power signal could be used. - Referring back to
FIG. 19 , thecontrol unit 300 may comprise aninductive coil 402 to pick up wireless signals from aremote programming device 320. A portion of the received signal may be used by apower circuit 404 to power thecontrol unit 300 when it is not being powered by thebattery 64. - Input signals received by the
coil 402 acting as a receiving antenna may be demodulated by ademodulator 410 and decoded by adecoder 412. The input signals may comprise programming instructions (e.g., code), which may be stored in a non-volatile memory portion of thememory 308. Theprocessor 306 may execute the code when theinstrument 10 is in operation. For example, the code may cause theprocessor 306 to output control signals to various sub-systems of theinstrument 10, such as themotor 65, based on data received from thesensors 368. - The
control unit 300 may also comprise anon-volatile memory unit 414 that comprises boot sequence code for execution by theprocessor 306. When thecontrol unit 300 receives enough power from the signals from theremote control unit 320 during the post-sterilization programming operation, theprocessor 306 may first execute the boot sequence code (“boot loader”) 414, which may load theprocessor 306 with an operating system. - The
control unit 300 may also send signals back to theremote programming unit 320, such as acknowledgement and handshake signals, for example. Thecontrol unit 300 may comprise anencoder 416 for encoding the signals to then be sent to theprogramming device 320 and amodulator 418 for modulating the signals according to the modulation scheme. Thecoil 402 may act as the transmitting antenna. Thecontrol unit 300 and theremote programming device 320 may communicate using any suitable wireless communication protocol (e.g., Bluetooth) and any suitable frequency (e.g., an ISM band). Also, thecontrol unit 300 may transmit signals at a different frequency range than the frequency range of the received signals from theremote programming unit 320. -
FIG. 20 is a simplified diagram of theremote programming device 320 according to various embodiments of the present invention. As shown inFIG. 20 , theremote programming unit 320 may comprise amain control board 230 and a boostedantenna board 232. Themain control board 230 may comprise acontroller 234, apower module 236, and amemory 238. Thememory 238 may stored the operating instructions for thecontroller 234 as well as the programming instructions to be transmitted to thecontrol unit 300 of thesurgical instrument 10. Thepower module 236 may provide a stable DC voltage for the components of theremote programming device 320 from an internal battery (not shown) or an external AC or DC power source (not shown). - The boosted
antenna board 232 may comprise acoupler circuit 240 that is in communication with thecontroller 234 via an I2C bus, for example. Thecoupler circuit 240 may communicate with thecontrol unit 300 of the surgical instrument via anantenna 244. Thecoupler circuit 240 may handle the modulating/demodulating and encoding/decoding operations for transmissions with the control unit. According to other embodiments, theremote programming device 320 could have a discrete modulator, demodulator, encoder and decoder. As shown inFIG. 20 , theboost antenna board 232 may also comprise a transmittingpower amp 246, a matching circuit 248 for theantenna 244, and a filter/amplifier 249 for receiving signals. - According to other embodiments, as shown in
FIG. 20 , the remote programming device could be in communication with acomputer device 460, such as a PC or a laptop, via a USB and/or RS232 interface, for example. In such a configuration, a memory of thecomputing device 460 may store the programming instructions to be transmitted to thecontrol unit 300. In another embodiment, thecomputing device 460 could be configured with a wireless transmission system to transmit the programming instructions to thecontrol unit 300. - In addition, according to other embodiments, rather than using inductive coupling between the
control unit 300 and theremote programming device 320, capacitively coupling could be used. In such an embodiment, thecontrol unit 300 could have a plate instead of a coil, as could theremote programming unit 320. - In another embodiment, rather than using a wireless communication link between the
control unit 300 and theremote programming device 320, theprogramming device 320 may be physically connected to thecontrol unit 300 while theinstrument 10 is in itssterile container 280 in such a way that theinstrument 10 remains sterilized.FIG. 21 is a diagram of a packagedinstrument 10 according to such an embodiment. As shown inFIG. 22 , thehandle 6 of theinstrument 10 may include anexternal connection interface 470. Thecontainer 280 may further comprise aconnection interface 472 that mates with theexternal connection interface 470 of theinstrument 10 when theinstrument 10 is packaged in thecontainer 280. Theprogramming device 320 may include an external connection interface (not shown) that may connect to theconnection interface 472 at the exterior of thecontainer 280 to thereby provide a wired connection between theprogramming device 320 and theexternal connection interface 470 of theinstrument 10. - In one embodiment, the present invention is directed to a surgical instrument, such as an endoscopic or laparoscopic instrument. The surgical instrument may comprise a shaft having a distal end connected to an end effector and a handle connected to a proximate end of the shaft. The handle may comprise a control unit (e.g., a microcontroller) that is in communication with a first sensor element. Further, the surgical instrument may comprise a rotational joint for rotating the shaft. In such a case, the surgical instrument may comprise the first element located in the shaft distally from the rotational joint. The first element may be coupled to the control unit either by a wired or wireless electrical connection. A second element may be located in the end effector and may be coupled to the first element by a wireless electrical connection. The first and second elements may be connected and/or coupled by a wired or a wireless electrical connection.
- The control unit may communicate with the second sensor element in the end effector without a direct wired electrical connection through complex mechanical joints like a rotating joint or articulating pivot where it may be difficult to maintain such a wired electrical connection. In addition, because the distances between the inductive elements may be fixed and known, the couplings between the first and second sensor elements may be optimized for inductive and/or electromagnetic transfer of energy. Also, the distances may be relatively short so that relatively low power signals may be used to minimize interference with other systems in the use environment of the instrument.
- In another embodiment of the present invention, the electrically conductive shaft of the surgical instrument may serve as an antenna for the control unit to wirelessly communicate signals to and from one or more sensor elements. For example, one or more sensor elements may be located on or disposed in a nonconductive component of the end effector, such as a plastic cartridge, thereby insulating the sensor element from conductive components of the end effector and the shaft. In addition, the control unit in the handle may be electrically coupled to the shaft. In that way, the shaft and/or the end effector may serve as an antenna for the control unit to radiate signals from the control unit to the one or more sensor elements and/or receive radiated echo response signals from the one or more sensor elements. Such a design is particularly useful in surgical instruments having complex mechanical joints (such as rotary joints) and articulating pivots, which make it difficult to use a direct wired electrical connection between the sensor elements and the control unit for communicating electrical signals therebetween.
- Various embodiments of the present invention are directed generally to a surgical instrument comprising one or more sensor elements to sense the location, type, presence and/or status of various components of interest disposed on the surgical instrument. In one embodiment, the present invention is directed generally to a surgical instrument having one or more sensor elements to sense the location, type, presence and/or status of various components of interest disposed in an end effector portion of the surgical instrument. These components of interest may comprise, for example, a sled, a staple cartridge, a cutting instrument or any other component that may be disposed on the surgical instrument and more particularly disposed in the end effector portion thereof. Although the present invention may be used with any type of surgical instrument such as endoscopic or laparoscopic surgical instruments, it is particularly useful for surgical instruments comprising one or more free rotating joints or an articulation pivots that make it difficult to use wired electrical connections to the one or more passive and/or active sensor elements.
- The one or more sensor elements may be passive or active sensor elements adapted to communicate with a control unit in any suitable manner. In various embodiments, some of the sensor elements may not be supplied power over a wired electrical connection and as described herein, neither the passive nor the active sensor elements may comprise an internal power supply. The sensor elements may operate using the power provided by the minute electrical current induced in the sensor element itself or an antenna coupled to the sensor element by an incoming radio frequency (RF) interrogation signal transmitted by the control unit. This means that the antenna and/or the sensor element itself may be designed to collect power from the incoming interrogation signal and also to transmit an outbound backscatter signal in response thereto. The lack of an onboard power supply means that the sensor elements may have a relatively small form factor. In embodiments comprising a passive sensor element RF interrogation signals may be received by the passive sensor element wirelessly over a predetermined channel. The incident electromagnetic radiation associated with the RF interrogation signals is then scattered or reflected back to the interrogating source such as the control unit. Thus, the passive sensor element signals by backscattering the carrier of the RF interrogation signal from the control unit. In embodiments comprising an active sensor element, on the other hand, just enough power may be received from the RF interrogation signals to cause the active sensor element to power up and transmit an analog or digital signal back to the control unit in response in response to the RF interrogation signal. The control unit may be referred to as a reader, interrogator or the like.
- In one embodiment, the status of a component (e.g., sled, staple cartridge, cutting instrument) located in the end effector portion of the surgical instrument may be determined through the use of a system comprising passive and/or active sensor elements coupled to a control unit. The passive sensor elements may be formed of or comprise passive hardware elements such as resistive, inductive and/or capacitive elements or any combination thereof. The active sensor elements may be formed of or comprise active hardware elements. These active hardware elements may be integrated and/or discrete circuit elements or any combination thereof. Examples of integrated and/or discrete hardware elements are described herein below.
- In one embodiment, the system may comprise a control unit coupled to a primary sensor element (primary element) disposed at a distal end of a shaft of the surgical instrument prior to an articulation pivot (as described below) and a secondary sensor element (secondary element) disposed on a component of interest in an end effector portion of the surgical instrument located subsequent to the articulation pivot (e.g., on a sled as described below). Rather than transmitting continuous power to the secondary element over a wired electrical connection, the primary element wirelessly interrogates or illuminates the secondary element by transmitting an electromagnetic pulse signal over a channel at a predetermined frequency, duration and repetition rate. When the interrogation pulse signal is incident upon, i.e., strikes or illuminates, the secondary element, it generated an echo response signal. The echo response signal is a reflection of the electromagnetic energy incident upon the secondary element. After transmitting the interrogation signal, the primary element listens for the echo response signal reflected from the secondary element and couples the echo response signal to the control unit in a suitable form for subsequent processing. The echo response signal may be of the same frequency as the interrogation pulse or some harmonic frequency thereof. The amount of reflected energy in the echo response signal depends upon the material, shape and size of the secondary element. The amount of reflected energy in the echo response signal also depends upon the distance between the primary element and the secondary element. Therefore, the material, shape and size of the secondary element as well as the relative distance between the primary and secondary elements may be selected to generate a unique echo response signal that is indicative of a desired measurement associated with the component of interest coupled to the secondary element. For example, unique echo response signals may indicate the location, type, presence and/or status of various components and sub-components disposed in the surgical instrument. Especially, the various components and sub-components disposed in the end effector portion of the surgical instrument subsequent to a freely rotating joint or articulation pivot that may make it difficult or impractical to provide a wired electrical connection between the primary and the secondary elements. The echo response signals also may be used to determine the distance between the primary and secondary elements. In this manner, the secondary element may be made integral with or may be attached to a component of interest and the echo response signal may provide information associated with the component of interest. This arrangement may eliminate the need to transmit or provide power to the secondary element over a wired connection and may be a cost effective solution to providing various additional passive and/or active sensor elements in the surgical instrument. Before describing aspects of the system, one type of surgical instrument in which embodiments of the present invention may be used—an endoscopic stapling and cutting instrument (i.e., an endocutter)—is first described by way of illustration.
-
FIGS. 23 and 24 depict an endoscopicsurgical instrument 2010 that comprises ahandle 2006, ashaft 2008, and an articulatingend effector 2012 pivotally connected to theshaft 2008 at anarticulation pivot 2014. Correct placement and orientation of theend effector 2012 may be facilitated by controls on thehand 2006, including (1) arotation knob 2028 for rotating the closure tube (described in more detail below in connection withFIGS. 26-27 ) at a free rotating joint 2029 of theshaft 2008 to thereby rotate theend effector 2012 and (2) anarticulation control 2016 to effect rotational articulation of theend effector 2012 about thearticulation pivot 2014. In the illustrated embodiment, theend effector 2012 is configured to act as an endocutter for clamping, severing and stapling tissue, although in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical instruments, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc. - The
handle 2006 of theinstrument 2010 may include aclosure trigger 2018 and afiring trigger 2020 for actuating theend effector 2012. It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating theend effector 2012. Theend effector 2012 is shown separated from thehandle 2006 by the preferably elongateshaft 2008. The handle may comprise a control unit 2300 (described below) in communication with afirst element 2021 by way of anelectrical connection 2023. Theelectrical connection 2023 may be a wired electrical connection such as an electrically conductive insulated wire or may be a wireless electrical connection. The electrically conductive insulated wire may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass through thearticulation control 2016, therotation knob 2028, the free rotating joint 2029 and other components in thehandle 2006 of theinstrument 2010 without being damaged by rotation. Thefirst element 2021 may be disposed at a distal end of theshaft 2008 prior to thearticulation pivot 2014. A second element 2035 (shown inFIG. 25 below) may be disposed in the articulatingend effector 2012 and is in wireless communication with thefirst element 2021. The operation of the first andsecond elements control unit 2300 is described below. In one embodiment, a clinician or operator of theinstrument 2010 may articulate theend effector 2012 relative to theshaft 2008 by utilizing thearticulation control 2016, as described in more detail in U.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference. - The
end effector 2012 includes in this example, among other things, astaple channel 2022 and a pivotally translatable clamping member, such as ananvil 2024, which are maintained at a spacing that assures effective stapling and severing of tissue clamped in theend effector 2012. Thehandle 2006 includes apistol grip 2026 towards which aclosure trigger 2018 is pivotally drawn by the clinician to cause clamping or closing of theanvil 2024 toward thestaple channel 2022 of theend effector 2012 to thereby clamp tissue positioned between theanvil 2024 andchannel 2022. Thefiring trigger 2020 is farther outboard of theclosure trigger 2018. Once theclosure trigger 2018 is locked in the closure position, thefiring trigger 2020 may rotate slightly toward thepistol grip 2026 so that it can be reached by the operator using one hand. Then the operator may pivotally draw thefiring trigger 2020 toward thepistol grip 2026 to cause the stapling and severing of clamped tissue in theend effector 2012. The '573 application describes various configurations for locking and unlocking theclosure trigger 2018. In other embodiments, different types of clamping members besides theanvil 2024 could be used, such as, for example, an opposing jaw, etc. - It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping the
handle 2006 of theinstrument 2010. Thus, theend effector 2012 is distal with respect to the moreproximal handle 2006. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. - The
closure trigger 2018 may be actuated first. Once the clinician is satisfied with the positioning of theend effector 2012, the clinician may draw back theclosure trigger 2018 to its fully closed, locked position proximate to thepistol grip 2026. Thefiring trigger 2020 may then be actuated. When the clinician removes pressure from thefiring trigger 2020, it returns to the open position (shown inFIGS. 23 and 24 ). Arelease button 2030 on thehandle 2006, and in this example, on thepistol grip 2026 of the handle, when depressed may release the lockedclosure trigger 2018. -
FIG. 25 is an exploded view of theend effector 2012 according to various embodiments. As shown in the illustrated embodiment, theend effector 2012 may include, in addition to the previously-mentionedchannel 2022 andanvil 2024, acutting instrument 2032, asled 2033, astaple cartridge 2034 that is removably seated in thechannel 2022, and ahelical screw shaft 2036. Thesecond element 2035 may be coupled or formed integrally with a component of interest. Thecutting instrument 2032 may be, for example, a knife. Theanvil 2024 may be pivotably opened and closed at apivot point 2025 connected to the proximate end of thechannel 2022. Theanvil 2024 may also include atab 2027 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close theanvil 2024. When theclosure trigger 2018 is actuated, that is, drawn in by a user of theinstrument 2010, theanvil 2024 may pivot about thepivot point 2025 into the clamped or closed position. If clamping of theend effector 2012 is satisfactory, the operator may actuate thefiring trigger 2020, which, as explained in more detail below, causes theknife 2032 andsled 2033 to travel longitudinally along thechannel 2022, thereby cutting tissue clamped within theend effector 2012. The movement of thesled 2033 along thechannel 2022 causes the staples of thestaple cartridge 2034 to be driven through the severed tissue and against theclosed anvil 2024, which turns the staples to fasten the severed tissue. U.S. Pat. No. 6,978,921, entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments. Thesled 2033, which may comprise thesecond element 2035, may be part of thecartridge 2034, such that when theknife 2032 retracts following the cutting operation, thesled 2033 and thesecond element 2035 do not retract. Thecartridge 2034 could be made of a nonconductive material (such as plastic). In one embodiment, thesecond element 2035 may be connected to or disposed in thecartridge 2034, for example. In the illustrated embodiment, thesecond element 2035 may be attached to thesled 2033 in any suitable manner and on any suitable portion thereof. In other embodiments, thesecond element 2035 may be embedded in thesled 2033 or otherwise integrally formed (e.g., co-molded) with thesled 2033. Accordingly, the location of thesled 2033 may be determined by detecting the location of thesecond element 2035. Thesecond element 2035 may be formed of various materials in various sizes and shapes and may be located at certain predetermined distances from thefirst element 2021 to enable thecontrol unit 2300 to ascertain the type, presence and status of thestaple cartridge 2034. - It should be noted that although the embodiments of the
instrument 2010 described herein employ anend effector 2012 that staples the severed tissue, in other embodiments different techniques for fastening or sealing the severed tissue may be used. For example, end effectors that use RF energy or adhesives to fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680, entitled ELECTROSURGICAL HEMOSTATIC DEVICE, and U.S. Pat. No. 5,688,270, entitled ELECTROSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OR OFFSET ELECTRODES, which are incorporated herein by reference, discloses cutting instruments that use RF energy to fasten the severed tissue. U.S. patent application Ser. No. 11/267,811, now U.S. Pat. No. 7,673,783 and U.S. patent application Ser. No. 11/267,383, now U.S. Pat. No. 7,607,557, which are also incorporated herein by reference, disclose cutting instruments that use adhesives to fasten the severed tissue. Accordingly, although the description herein refers to cutting/stapling operations and the like, it should be recognized that this is an exemplary embodiment and is not meant to be limiting. Other tissue-fastening techniques may also be used. -
FIGS. 26 and 27 are exploded views andFIG. 28 is a side view of theend effector 2012 andshaft 2008 according to various embodiments. As shown in the illustrated embodiment, theshaft 2008 may include aproximate closure tube 2040 and adistal closure tube 2042 pivotably linked by apivot links 2044. Thedistal closure tube 2042 includes anopening 2045 into which thetab 2027 on theanvil 2024 is inserted in order to open and close theanvil 2024. Disposed inside theclosure tubes proximate spine tube 2046. Disposed inside theproximate spine tube 2046 may be a main rotational (or proximate)drive shaft 2048 that communicates with a secondary (or distal)drive shaft 2050 via a bevel gear assembly 2052. In the illustrated embodiment, thefirst element 2021 may be a coil disposed about the proximate spine tube 2046 (e.g., as shown inFIGS. 26 and 27 ). In a wired electrical connection configuration, thefirst element 2021 may be connected to thecontrol unit 2300 by way of the wiredelectrical connection 2023, which may comprise lengths of wire forming the coil. The lengths of wire may be provided along theproximate spine tube 2046 to connect to thecontrol unit 2300. In a wireless electrical connection configuration, a wire is not necessary and theelectrical connection 2023 to thecontrol unit 2300 is a wireless electrical connection. In one embodiment, thefirst element 2021 may be contained within the proximate spine tube 2046 (e.g., as shown inFIG. 28 ). In either case, thefirst element 2021 is electrically isolated from theproximate spine tube 2046. - The
secondary drive shaft 2050 is connected to adrive gear 2054 that engages aproximate drive gear 2056 of thehelical screw shaft 2036. Thevertical bevel gear 2052 b may sit and pivot in an opening 2057 in the distal end of theproximate spine tube 2046. Adistal spine tube 2058 may be used to enclose thesecondary drive shaft 2050 and the drive gears 2054, 2056. Collectively, themain drive shaft 2048, thesecondary drive shaft 2050, and the articulation assembly (e.g., the bevel gear assembly 2052 a-c), are sometimes referred to herein as the “main drive shaft assembly.” Components of the main drive shaft assembly (e.g., thedrive shafts 2048, 2050) may be made of a nonconductive material (such as plastic). - A
bearing 2038, positioned at a distal end of thestaple channel 2022, receives thehelical drive screw 2036, allowing thehelical drive screw 2036 to freely rotate with respect to thechannel 2022. Thehelical screw shaft 2036 may interface a threaded opening (not shown) of theknife 2032 such that rotation of theshaft 2036 causes theknife 2032 to translate distally or proximately (depending on the direction of the rotation) through thestaple channel 2022. Accordingly, when themain drive shaft 2048 is caused to rotate by actuation of the firing trigger 2020 (as explained in more detail below), the bevel gear assembly 2052 a-c causes thesecondary drive shaft 2050 to rotate, which in turn, because of the engagement of the drive gears 2054, 2056, causes thehelical screw shaft 2036 to rotate, which causes theknife 2032 to travel longitudinally along thechannel 2022 to cut any tissue clamped within the end effector. Thesled 2033 may be made of, for example, plastic, and may have a sloped distal surface. As previously discussed, thesecond element 2035 may be attached to thesled 2033 in any suitable manner to determine the status, location and type of thesled 2033 and/or thestaple cartridge 2034. As thesled 2033 traverses thechannel 2022, the sloped forward surface may push up or drive the staples in thestaple cartridge 2034 through the clamped tissue and against theanvil 2024. Theanvil 2024 turns the staples, thereby stapling the severed tissue. When theknife 2032 is retracted, theknife 2032 andsled 2033 may become disengaged, thereby leaving thesled 2033 at the distal end of thechannel 2022. - According to various embodiments, as shown
FIGS. 29-32 , the surgical instrument may include abattery 2064 in thehandle 2006. The illustrated embodiment provides user-feedback regarding the deployment and loading force of the cutting instrument in theend effector 2012. In addition, the embodiment may use power provided by the user in retracting thefiring trigger 2018 to power the instrument 2010 (a so-called “power assist” mode). As shown in the illustrated embodiment, thehandle 2006 includes exteriorlower side pieces upper side pieces handle 2006. The handle pieces 2059-2062 may be made of an electrically nonconductive material, such as plastic. Abattery 2064 may be provided in thepistol grip portion 2026 of thehandle 2006. Thebattery 2064 powers amotor 2065 disposed in an upper portion of thepistol grip portion 2026 of thehandle 2006. Thebattery 2064 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO2 or LiNiO2, a Nickel Metal Hydride chemistry, etc. According to various embodiments, themotor 2065 may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 to 100,000 RPM. Themotor 2065 may drive a 90°bevel gear assembly 2066 comprising afirst bevel gear 2068 and asecond bevel gear 2070. Thebevel gear assembly 2066 may drive aplanetary gear assembly 2072. Theplanetary gear assembly 2072 may include apinion gear 2074 connected to a drive shaft 2076. Thepinion gear 2074 may drive amating ring gear 2078 that drives ahelical gear drum 2080 via a drive shaft 20082. Aring 2084 may be threaded on thehelical gear drum 2080. Thus, when themotor 2065 rotates, thering 2084 is caused to travel along thehelical gear drum 2080 by means of the interposedbevel gear assembly 2066,planetary gear assembly 2072 andring gear 2078. - The
handle 2006 may also include arun motor sensor 2110 in communication with thefiring trigger 2020 to detect when thefiring trigger 2020 has been drawn in (or “closed”) toward thepistol grip portion 2026 of thehandle 2006 by the operator to thereby actuate the cutting/stapling operation by theend effector 2012. Thesensor 2110 may be a proportional sensor such as, for example, a rheostat or variable resistor. When thefiring trigger 2020 is drawn in, thesensor 2110 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to themotor 2065. When thesensor 2110 is a variable resistor or the like, the rotation of themotor 2065 may be generally proportional to the amount of movement of thefiring trigger 2020. That is, if the operator only draws or closes thefiring trigger 2020 in a little bit, the rotation of themotor 2065 is relatively low. When thefiring trigger 2020 is fully drawn in (or in the fully closed position), the rotation of themotor 2065 is at its maximum. In other words, the harder the user pulls on thefiring trigger 2020, the more voltage is applied to themotor 2065, causing greater rates of rotation. - The
handle 2006 may include amiddle handle piece 2104 adjacent to the upper portion of thefiring trigger 2020. Thehandle 2006 also may comprise abias spring 2112 connected between posts on themiddle handle piece 2104 and thefiring trigger 2020. Thebias spring 2112 may bias thefiring trigger 2020 to its fully open position. In that way, when the operator releases thefiring trigger 2020, thebias spring 2112 will pull thefiring trigger 2020 to its open position, thereby removing actuation of thesensor 2110, thereby stopping rotation of themotor 2065. Moreover, by virtue of thebias spring 2112, any time a user closes thefiring trigger 2020, the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by themotor 2065. Further, the operator could stop retracting thefiring trigger 2020 to thereby remove force from thesensor 2110, to thereby stop themotor 2065. As such, the user may stop the deployment of theend effector 2012, thereby providing a measure of control of the cutting/fastening operation to the operator. - The distal end of the
helical gear drum 2080 includes adistal drive shaft 2120 that drives aring gear 2122, which mates with apinion gear 2124. Thepinion gear 2124 is connected to themain drive shaft 2048 of the main drive shaft assembly. In that way, rotation of themotor 2065 causes the main drive shaft assembly to rotate, which causes actuation of theend effector 2012, as described above. - The
ring 2084 threaded on thehelical gear drum 2080 may include apost 2086 that is disposed within aslot 2088 of a slottedarm 2090. The slottedarm 2090 has anopening 2092 at itsopposite end 2094 that receives apivot pin 2096 that is connected between the handleexterior side pieces pivot pin 2096 is also disposed through anopening 2100 in thefiring trigger 2020 and anopening 2102 in themiddle handle piece 2104. - In addition, the
handle 2006 may include a reverse motor (or end-of-stroke sensor) 2130 and a stop motor (or beginning-of-stroke)sensor 2142. In various embodiments, thereverse motor sensor 2130 may be a limit switch located at the distal end of thehelical gear drum 2080 such that thering 2084 threaded on thehelical gear drum 2080 contacts and trips thereverse motor sensor 2130 when thering 2084 reaches the distal end of thehelical gear drum 2080. Thereverse motor sensor 2130, when activated, sends a signal to the control unit which sends a signal to themotor 2065 to reverse its rotation direction, thereby withdrawing theknife 2032 of theend effector 2012 following the cutting operation. - The
stop motor sensor 2142 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of thehelical gear drum 2080 so that thering 2084 trips theswitch 2142 when thering 2084 reaches the proximate end of thehelical gear drum 2080. - The
handle 2006 also may comprise thecontrol unit 2300. Thecontrol unit 2300 may be powered through thebattery 2064 with the addition of a conditioning circuit (not shown). Thecontrol unit 2300 is coupled to thefirst element 2021 by anelectrical connection 2023. As previously discussed, theelectrical connection 2023 may be a wired electrical connection or a wireless electrical connection. - In operation, when an operator of the
instrument 2010 pulls back thefiring trigger 2020, thesensor 2110 detects the deployment of thefiring trigger 2020 and sends a signal to the control unit which sends a signal to themotor 2065 to cause forward rotation of themotor 2065 at, for example, a rate proportional to how hard the operator pulls back thefiring trigger 2020. The forward rotation of themotor 2065 in turn causes thering gear 2078 at the distal end of theplanetary gear assembly 2072 to rotate, thereby causing thehelical gear drum 2080 to rotate, causing thering 2084 threaded on thehelical gear drum 2080 to travel distally along thehelical gear drum 2080. The rotation of thehelical gear drum 2080 also drives the main drive shaft assembly as described above, which in turn causes deployment of theknife 2032 in theend effector 2012. That is, theknife 2032 and thesled 2033 are caused to traverse thechannel 2022 longitudinally, thereby cutting tissue clamped in theend effector 2012. Also, the stapling operation of theend effector 2012 is caused to happen in embodiments where a stapling-type end effector is used. - By the time the cutting/stapling operation of the
end effector 2012 is complete, thering 2084 on thehelical gear drum 2080 will have reached the distal end of thehelical gear drum 2080, thereby causing thereverse motor sensor 2130 to be tripped, which sends a signal to the control unit which sends a signal to themotor 2065 to cause themotor 2065 to reverse its rotation. This in turn causes theknife 2032 to retract, and also causes thering 2084 on thehelical gear drum 2080 to move back to the proximate end of thehelical gear drum 2080. - The
middle handle piece 2104 includes abackside shoulder 2106 that engages the slottedarm 2090 as best shown inFIGS. 30 and 31 . Themiddle handle piece 2104 also has aforward motion stop 2107 that engages thefiring trigger 2020. The movement of the slottedarm 2090 is controlled, as explained above, by rotation of themotor 2065. When the slottedarm 2090 rotates CCW as thering 2084 travels from the proximate end of thehelical gear drum 2080 to the distal end, themiddle handle piece 2104 will be free to rotate CCW. Thus, as the user draws in thefiring trigger 2020, thefiring trigger 2020 will engage theforward motion stop 2107 of themiddle handle piece 2104, causing themiddle handle piece 2104 to rotate CCW. Due to thebackside shoulder 2106 engaging the slottedarm 2090, however, themiddle handle piece 2104 will only be able to rotate CCW as far as the slottedarm 2090 permits. In that way, if themotor 2065 should stop rotating for some reason, the slottedarm 2090 will stop rotating, and the user will not be able to further draw in thefiring trigger 2020 because themiddle handle piece 2104 will not be free to rotate CCW due to the slottedarm 2090. - Components of an exemplary closure system for closing (or clamping) the
anvil 2024 of theend effector 2012 by retracting theclosure trigger 2018 are also shown inFIGS. 29-32 . In the illustrated embodiment, the closure system includes ayoke 2250 connected to theclosure trigger 2018 by a pin 2251 that is inserted through aligned openings in both theclosure trigger 2018 and theyoke 2250. Apivot pin 2252, about which theclosure trigger 2018 pivots, is inserted through another opening in theclosure trigger 2018 which is offset from where the pin 2251 is inserted through theclosure trigger 2018. Thus, retraction of theclosure trigger 2018 causes the upper part of theclosure trigger 2018, to which theyoke 2250 is attached via the pin 2251, to rotate CCW. The distal end of theyoke 2250 is connected, via apin 2254, to afirst closure bracket 2256. Thefirst closure bracket 2256 connects to asecond closure bracket 2258. Collectively, theclosure brackets FIG. 26 ) is seated and held such that longitudinal movement of theclosure brackets proximate closure tube 2040. Theinstrument 2010 also includes aclosure rod 2260 disposed inside theproximate closure tube 2040. Theclosure rod 2260 may include a window 2261 into which apost 2263 on one of the handle exterior pieces, such as exteriorlower side piece 2059 in the illustrated embodiment, is disposed to fixedly connect theclosure rod 2260 to thehandle 2006. In that way, theproximate closure tube 2040 is capable of moving longitudinally relative to theclosure rod 2260. Theclosure rod 2260 may also include adistal collar 2267 that fits into acavity 2269 inproximate spine tube 2046 and is retained therein by a cap 2271 (FIG. 26 ). - In operation, when the
yoke 2250 rotates due to retraction of theclosure trigger 2018, theclosure brackets proximate closure tube 2040 to move distally (i.e., away from the handle end of the instrument 2010), which causes thedistal closure tube 2042 to move distally, which causes theanvil 2024 to rotate about thepivot point 2025 into the clamped or closed position. When theclosure trigger 2018 is unlocked from the locked position, theproximate closure tube 2040 is caused to slide proximately, which causes thedistal closure tube 2042 to slide proximately, which, by virtue of thetab 2027 being inserted in thewindow 2045 of thedistal closure tube 2042, causes theanvil 2024 to pivot about thepivot point 2025 into the open or unclamped position. In that way, by retracting and locking theclosure trigger 2018, an operator may clamp tissue between theanvil 2024 andchannel 2022, and may unclamp the tissue following the cutting/stapling operation by unlocking theclosure trigger 2018 from the locked position. - The control unit 2300 (described further below) may receive the outputs from end-of-stroke and beginning-of-
stroke sensors motor sensor 2110, and may control themotor 2065 based on the inputs. For example, when an operator initially pulls thefiring trigger 2020 after locking theclosure trigger 2018, the run-motor sensor 2110 is actuated. If thestaple cartridge 2034 is present in theend effector 2012, a cartridge lockout sensor (not shown) may be closed, in which case the control unit may output a control signal to themotor 2065 to cause themotor 2065 to rotate in the forward direction. When theend effector 2012 reaches the end of its stroke, thereverse motor sensor 2130 will be activated. The control unit may receive this output from thereverse motor sensor 2130 and cause themotor 2065 to reverse its rotational direction. When theknife 2032 is fully retracted, the stopmotor sensor switch 2142 is activated, causing the control unit to stop themotor 2065. - In other embodiments, rather than a proportional-
type sensor 2110, an on-off type sensor may be used. In such embodiments, the rate of rotation of themotor 2065 would not be proportional to the force applied by the operator. Rather, themotor 2065 would generally rotate at a constant rate. But the operator would still experience force feedback because thefiring trigger 2020 is geared into the gear drive train. - The
instrument 2010 may include a number of sensor elements in theend effector 2012 for sensing various conditions related to theend effector 2012, such as sensor elements for determining the status of the staple cartridge 2034 (or other type of cartridge depending on the type of surgical instrument), the progress of the stapler during closure and firing, etc. The sensor elements may be passively powered by inductively coupled signals, as described in commonly assigned U.S. patent application Ser. No. 11/651,715, entitled SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS, now U.S. Pat. No. 8,652,120, which is incorporated herein by reference. In other embodiments, the sensor elements reflect or scatter incident electromagnetic energy or power up in response to the interrogation signal and transmit echo response pulses or signals that may be coupled back to thecontrol unit 2300 for processing. In other embodiments, the sensor elements may be powered by the minute electrical current induced in the sensor element itself or an antenna coupled to the sensor element by the incoming incident electromagnetic energy (e.g., the RF carrier of the interrogation signal) transmitted by thecontrol unit 2300. These sensor elements may comprise any arrangement of electrical conductors to transmit, receive, amplify, encode, scatter and/or reflect electromagnetic energy waves of any suitable predetermined frequency (e.g., wavelength [λ]), having a suitable predetermined pulse width that may be transmitted over a suitable predetermined time period. The passive sensor elements may comprise any suitable arrangement of resistive, inductive, and/or capacitive elements. The active sensor elements may comprise semiconductors such as transistors, integrated circuits, processors, amplifiers and/or any combination of these active elements. For succinctness the passive and/or active sensor elements are referred to hereinafter as thefirst element 2021 and thesecond element 2035. Thefirst element 2021 may be in wired or wireless communication with thecontrol unit 2300, which, as previously discussed, may be housed in thehandle 2006 of theinstrument 2010, for example, as shown below inFIG. 33 . Thefirst element 2021 is in wireless communication with thesecond element 2035. -
FIG. 33 illustrates a schematic block diagram of one embodiment of thecontrol unit 2300. According to various embodiments, thecontrol unit 2300 may comprise aprocessor 2306 and one ormore memory units 2308. By executing instruction code stored in thememory 2308, theprocessor 2306 may control various components of theinstrument 2010, such as themotor 2065 or a user display (not shown), based on inputs received from the one or more end effector sensor element(s) and/or other sensor elements located throughout the instrument 2010 (such as the run-motor sensor 2110, the end-of-stroke sensor 2130, and the beginning-of-stroke sensor 2142, for example). Thecontrol unit 2300 may be powered by thebattery 2064 during surgical use of theinstrument 2010. Thecontrol unit 2300 may be coupled to thefirst element 2021 over theelectrical connection 2023 and may communicate with thesecond element 2035, as described in more detail below. Thecontrol unit 2300 may comprise a transmitter 2320 and areceiver 2322. Thefirst element 2021 may be coupled to the transmitter 2320 to transmit an output interrogation signal or may be coupled to thereceiver 2322 to receive an echo response signal in accordance with the operation of aswitch 2324. - The
switch 2324 may operate under the control of theprocessor 2306, the transmitter 2320 or thereceiver 2322 or any combination thereof to place thecontrol unit 2300 either in transmitter or receiver mode. In transmitter mode, theswitch 2324 couples thefirst element 2021 to the transmitter 2320 and thus thefirst element 2021 acts as a transmitting antenna. An encoder 2316 encodes the output interrogation signal to be transmitted, which is then modulated by amodulator 2318. Anoscillator 2326 coupled to themodulator 2318 sets the operating frequency for the output signal to be transmitted. In receiver mode, theswitch 2324 couples thefirst element 2021 to thereceiver 2322. Accordingly, thefirst element 2021 acts as a receiving antenna and receives input signals from the other sensor elements (e.g., the second element 2035). The received input signals may be demodulated by ademodulator 2310 and decoded by a decoder 2312. The input signals may comprise echo response signals from one or more of the sensor elements (e.g., the second element 2035). The echo response signals may comprise information associated with the location, type, presence and/or status of various components located in theend effector 2012 or in other location in theinstrument 2010. The echo signals, for example, may comprise signals reflected by thesecond element 2035, which may be attached to thesled 2033, thestaple cartridge 2034 or any other component located in theend effector 2012 or may be located on any component of interest on any portion of theinstrument 2010. The echo signal data reflected from thesecond element 2035 may be used by theprocessor 2306 to control various aspects of theinstrument 2010. - To transmit an output signal from the
first element 2021 to thesecond element 2035, thecontrol unit 2300 may employ the encoder 2316 for encoding the output signals and themodulator 2318 for modulating the output signals according to a predetermined modulation scheme. As previously discussed, in transmitter mode, thefirst element 2021 is coupled to the transmitter 2320 through theswitch 2324 and acts as a transmitting antenna. The encoder 2316 may comprise a timing unit to generate timing pulses at a predetermined suitable pulse repetition frequency. These timing pulses may be applied to themodulator 2318 to trigger the transmitter at precise and regularly occurring instants of time. Thus, in one embodiment, themodulator 2318 may produce rectangular pulses of known pulse duration to switch theoscillator 2326 on and off. In accordance with the modulation scheme, theoscillator 2326 produces short duration pulses of a predetermined power and frequency (or wavelength λ) set by theoscillator 2326. The pulse repetition frequency may be determined by the encoder 2312 and the pulse duration may be determined by themodulator 2318. Theswitch 2324 under control of thecontrol unit 2300 automatically connects the transmitter 2320 to thefirst element 2021 for the duration of each output pulse. In transmission mode, thefirst element 2021 radiates the transmitter 2320 output pulse signal and picks up or detects the reflected echo signals for application to thereceiver 2322. In receiver mode, theswitch 2324 connects thefirst element 2021 to thereceiver 2322 for the intervals between transmission pulses. Thereceiver 2322 receives echo signals of the transmitted pulse output signals that may be reflected from one or more sensor elements located on the instrument such as thesecond element 2035 attached to thesled 2033. Thereceiver 2322 amplifies the echo signals and presents them to thedemodulator 2310 in suitable form. Subsequently, the demodulated echo signals are provided to the decoder 2312 where they are correlated with the transmitted output pulse signals to determine the location, type, presence and/or status of various components located in theend effector 2012. In addition, the distance between the first andsecond elements - The
control unit 2300 may communicate with thefirst element 2021 using any suitable wired or wireless communication protocol and any suitable frequency (e.g., an ISM band). Thecontrol unit 2300 may transmit output pulse signals in various frequency ranges. Although in the illustrated embodiment, only thefirst element 2021 is shown to perform the transmission and reception functions, in other embodiments thecontrol unit 2300 may comprise separate receiving and transmitting elements, for example. - According to various embodiments, the
control unit 2300 may be implemented using integrated and/or discrete hardware elements, software elements, or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate arrays (FPGA), logic gates, registers, semiconductor devices, chips, microchips, chip sets, microcontroller, system-on-chip (SoC) or system-in-package (SIP). Examples of discrete hardware elements may include circuits, circuit elements (e.g., logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, relay and so forth). In other embodiments, thecontrol unit 2300 may be embodied as a hybrid circuit comprising discrete and integrated circuit elements or components on one or more substrates. In various embodiments, thecontrol unit 2300 may provide a digital (e.g., on/off, high/low) output and/or an analog output to a motor control unit. The motor control unit also may be embodied using elements and/or components similar to thecontrol unit 2300. The motor control unit may be used to control themotor 2065 in response to the radiated echo response signals from the one or more passive and/or active sensor elements. - Referring back to
FIGS. 23-28 , in one embodiment, thefirst element 2021 may be an inductive element (e.g., a first coil) coupled to thecontrol unit 2300 by the wiredelectrical connection 2023. The wiredelectrical connection 2023 may be an electrically conductive insulated wire. Thesecond element 2035 also may be an inductive element (e.g., a second coil) embedded, integrally formed with or otherwise attached to thesled 2033. Thesecond element 2035 is wirelessly coupled to thefirst element 2021. Thefirst element 2021 is preferably electrically insulated from theconductive shaft 2008. Thesecond element 2035 is preferably electrically insulated from thesled 2033 and other components located in thestaple cartridge 2034 and/or thestaple channel 2022. Thesecond element 2035 receives the output pulse signal transmitted by thefirst element 2021 and reflects or scatters the electromagnetic energy in the form of an echo signal. By varying the material, size, shape and location of thesecond element 2035 relative to thefirst element 2021, thecontrol unit 2300 can determine the location, type, presence and/or status of various components located in theend effector 2012 by decoding the echo signals reflected therefrom. -
FIG. 34 is a schematic diagram 2400 illustrating the operation of one embodiment of thecontrol unit 2300 in conjunction with the first andsecond elements FIG. 33 . Thefirst element 2021 is coupled to thecontrol unit 2300 by a channel, e.g., theelectrical connection 2023. Theelectrical connection 2023 may be a wired or wireless channel. As previously discussed, thefirst element 2021 wirelessly interrogates or illuminates thesecond element 2035 by transmitting an interrogation signal in the form of one or more interrogation pulses 2402. The interrogation pulses 2402 may be of a suitable predetermined frequencyf as may be determined by theoscillator 2326. The interrogation pulses 2402 may have a predetermined pulse width PW as may be determined by themodulator 2318 and may be transmitted at a pulse repetition rate T as may be determined by the encoder 2316. The transmitted interrogation pulses 2402 that are incident upon (e.g., strike or illuminate) thesecond element 2035 is reflected or scattered by thesecond element 2035 in the form of echo response pulses 2404. The echo response pulses 2404 are electromagnetic energy reflections of the interrogation pulses 2402 incident upon thesecond element 2021, but much weaker in signal strength. After transmitting the interrogation pulses 2402, thefirst element 2021 listens for the echo response pulses 2404 and couples the echo response pulses 2402 to thecontrol unit 2300 in a suitable form. Thedemodulator 2310 receives the weak echo response pulses 2404 and amplifies and demodulates them. The decoder 2312 and theprocessor 2306 process the received echo response pulses 2404 to extract information therefrom. The processor 2306 (or other logic) may be programmed to ascertain various properties associated with theend effector 2012 and components in accordance with the received echo response pulses 2404. - The frequency f, PW and T of the echo response pulses 2404 may be the same as the interrogation pulses 2402. In various embodiments, the frequency f, PW and T of the echo response pulses 2404 may be different than the interrogation pulses 2402. In one embodiment, the frequency f, for example, of the echo response pulses 2404 may be a harmonic frequency of the interrogation pulse 2402 frequency. The amount of reflected electromagnetic energy in the echo response pulses 2404 depends upon the material, shape and size of the
second element 2035. The amount of reflected electromagnetic energy in the echo response pulses 2404 also depends upon the distance D between thefirst element 2021 and thesecond element 2035. - The material that the
second element 2035 is formed of may determine the amount of reflected energy. For example, a metal object will reflect more energy than an object of the same size and shape made of wood, plastic, etc. In general, the better the electrical conductive properties of the material the greater is the reflection. The shape of thesecond element 2035 also may determine how the energy is reflected or scattered. For example, if thesecond element 2035 has a flat side facing thefirst element 2021, thesecond element 2035 may reflect more energy back towards thefirst element 2021. A circular object may reflect or scatter the energy in the various directions normal to the surface struck by the incident electromagnetic energy and an object with irregularities will scatter the incident electromagnetic energy more randomly. The size of thesecond element 2021 also may determine the amount of reflected energy. For example, a largersecond element 2035 will reflect more energy than a smallersecond element 2035 of the same material and shape and at the same distance D from thefirst element 2021. It will be appreciated that thesecond element 2035 should have a certain minimum size relative to the wavelength (λ) of the radiated electromagnetic energy of the interrogation pulses 2402 to produce practical reflected echo response pulses 2404. For example, the size of thesecond element 2035 may be equal to or greater than about a quarter of the wavelength (λ/4) of the electromagnetic energy of the interrogation pulses 2402. The wavelength λ of the transmitted interrogation pulses 2402 is related to the frequency f in accordance with the equation: λ=c/J; where c is the speed of light and f is the signal frequency. Therefore, to detect small objects the wavelength λ must be small and thus the frequency f must be high. Any suitable predetermined frequency f may be selected to accommodate the size of thesecond element 2035 to be detected. Accordingly, the size of thesecond element 2035 may be selected to be greater than or equal to λ/4 (or c/4f), for example, once the interrogation pulse 2402 frequency is determined. As previously discussed, the amount of energy reflected by thesecond element 2035 also depends on the distance D between thefirst element 2021 and thesecond element 2035. - Accordingly, the material, shape and size of the
second element 2035 and the relative distance D between it and thefirst element 2021 may be selected to generate unique echo response pulses 2404 that may be indicative of a desired measurement associated with thesecond element 2035. For example, unique echo response pulses 2404 may indicate the location, type, presence and/or status of various components and/or sub-components disposed on thesurgical instrument 2010. Especially the various components and sub-components disposed in theend effector 2012 portion of thesurgical instrument 2010 subsequent to thearticulation pivot 2014. The echo response pulses 2404 also may be used to determine the distance D between thefirst element 2021 and thesecond element 2035. In this manner, by integrating thesecond element 2035 or attaching it to a components of interest, such as thesled 2033, the echo response pulses 2404 may be processed by thecontrol unit 2300 to extract and provide information associated with the component of interest, such as the location, type, presence and/or status of thesled 2033, thestaple cartridge 2034, and so on. This arrangement may eliminate the need to transmit or provide power over a wired connection to thesecond element 2035 and may be a cost effective solution to providing various sensor elements on thesurgical instrument 2010. - In one embodiment, where the
second element 2035 is an active sensor element, as previously discussed, thefirst element 2021 wirelessly interrogates or illuminates thesecond element 2035 by transmitting an interrogation signal in the form of one or more interrogation pulses 2402. The electromagnetic energy in the interrogation pulses 2402 are coupled by thesensor element 2035 and serve to power-up thesensor element 2035. Once powered-up, thesensor element 2035 transmits the echo response pulses 2404 back to thecontrol unit 2300. - In one embodiment, the status of the
staple cartridge 2034 and the location of thesled 2033 may be determined by transmitting the interrogation pulse 2402 and listening for an echo response pulse 2404. As previously discussed, the first andsecond elements first element 2021 may be an inductance in the form of a primary coil located at the distal end of the shaft 2008 (as shown inFIGS. 23 , 24, 26-28). Thesecond element 2035 may be an inductive element in the form of a secondary coil located in the sled 2033 (as shown inFIGS. 25 , 27, 28). Thefirst element 2021 “pings” or transmits interrogation pulses 2402. The echo response pulses 2404 reflected by thesecond element 2035 may be indicative of the presence of thesled 2033 in thestaple channel 2022, its distance from thefirst element 2021 or its location longitudinally along thestaple channel 2022. In this manner, theinstrument 2010 can determine the presence or status of thestaple cartridge 2034 or thesled 2033 in theend effector 2012 or the longitudinal location of thesled 2033 along thestaple channel 2022. This information may be used to determine the loaded status of thestaple cartridge 2034, for example. Further thesecond element 2035 may be formed of different materials, in different shapes or sizes to produce a unique echo response pulse 2404 that is indicative of theinstrument 2010 type or presence of thestaple cartridge 2034 within theend effector 2012. This eliminates the need to include any powered memory or sensor elements in theend effector 2012 to electronically determine the type, presence or status of thestaple cartridge 2034 in theend effector 2012. - In another embodiment, the
second element 2035 may be attached to thesled 2033 and the echo response pulse 2404 may be used to determine whether thesled 2033 is located in a first position at the proximal end of thestaple channel 2022 or a second position at the distal end of thestaple channel 2022 or in any intermediate positions therebetween. Thecontrol unit 2300 may be determine the position of thesled 2033 based on the elapsed time between transmitting the interrogation pulse 2402 and receiving the echo response pulse 2404. If thesled 2033 is in the first position the echo response pulse 2404 is received sooner than if thesled 2033 was located at the second position or any position therebetween. For example, as thesled 2033 moves longitudinally along thestaple channel 2022 the response time of the received echo response pulse 2404 relative to the transmitted interrogation pulse 2402 increases. This information may be used by thecontrol unit 2300 to determine the intermediate location of thesled 2033 in thechannel 2022 and provide some measure of control of the cutting/fastening operation, such as inhibiting the cutting/fastening operation if thesled 2033, or other component, is not in a predetermined location. - In yet another embodiment, the
control unit 2300 may provide some measure of control of the cutting/fastening operation based on whether or not an echo response pulse 2404 is received within a predetermined time period. For example, if an echo response pulse 2404 is received within the predetermined period, thecontrol unit 2300 determines that thesled 2033 in located in the proximate end on thestaple channel 2022. In contrast, if the no echo response pulse 2404 is received within the predetermined period, thecontrol unit 2300 determines that thesled 2033 has moved away from the proximate end to the distal end of the staple channel 2022 (e.g., the instrument has been fired). In this manner, if no echo response pulse 2404 is received, thecontrol unit 2300 may determine either that thestaple cartridge 2034 has been fired and, therefore, thesled 2033 has moved away longitudinally from the proximate end of thestaple channel 2022 or that there is nostaple cartridge 2034 loaded and, therefore, prevents the instrument 2010 (e.g., a surgical stapler) from firing. - Although the
first element 2021 is shown disposed at one end of theelongate shaft 2008 near thearticulation pivot 2014, thefirst element 2021 may be disposed anywhere along theelongate shaft 2008 and/or in thehandle 2006 in suitable wireless or wired communication with thesecond element 2035. -
FIG. 35 illustrates one embodiment of thesurgical instrument 2010 comprising thefirst element 2021 located in the free rotating joint 2029 portion of theshaft 2008. The following description also referencesFIGS. 25 , 27, 28 and 34. Thefirst element 2021 is coupled to thecontrol unit 2300 via theelectrical connection 2023. Additional elements may be employed, for example, when thesurgical instrument 2010 has numerous complex mechanical joints and where it would be difficult to maintain a direct wired connection. In such cases, inductive couplings may be used to span each such joint. For example, inductive couplers may be used on both sides of the rotary joint 2029 and both sides of thearticulation pivot 2014, with an inductive element on the distal side of the rotary joint 2029 connected by an electrical connection to another inductive element on the proximate side of thearticulation pivot 2014. Accordingly, athird element 2328 and afourth element 2330 may be disposed on theshaft 2008. Theseelements shaft 2008. Thethird element 2328 may be disposed on the proximal end of theshaft 2008 just prior to thearticulation control 2016. Thefourth element 2330 may be disposed on the distal end of theshaft 2008 just prior to thearticulation pivot 2014. The third andfourth elements second element 2035 is disposed or attached to a component of interest in theend effector 2012. Thethird element 2328 is wirelessly coupled to thefirst element 2021 and receives interrogation pulses 2402 therefrom. Thethird element 2328 transmits the interrogation pulse 2402 along the electrical connection 2332 to thefourth element 2330. Thefourth element 2330 wirelessly couples the interrogation pulse 2402 to thesecond element 2035. The echo response pulses 2404 are transmitted back to thefirst element 2021 in reverse order. For example, the echo response pulse 2404 is wirelessly coupled to thefourth element 2330, is relayed to thethird element 2328 via the electrical connection 2332 and is then wirelessly coupled to thefirst element 2021. Similarly to the first andsecond elements fourth elements fourth elements -
FIG. 36 illustrates one embodiment of thesurgical instrument 2010 comprising sensor elements disposed at various locations on the shaft. For example, thefirst element 2021 may be disposed on the proximate end of theshaft 2008 just prior to thearticulation control 2016. Thefirst element 2021 is wirelessly coupled to thecontrol unit 2300 via wirelesselectrical connection 2023. Thethird element 2328 and thefourth element 2330 are disposed along theshaft 2008 subsequent to thearticulation control 2016 and prior to thearticulation pivot 2014. Thethird element 2328 may be disposed on the proximate end of theshaft 2008 subsequent to thearticulation control 2016 and thefourth element 2330 may be disposed on the distal end of theelongate shaft 2008 prior to thearticulation pivot 2014. The third andfourth elements second element 2035 may be disposed on a component of interest located in theend effector 2012. Thethird element 2328 is wirelessly coupled to thefirst element 2021 and receives the interrogation pulses 2402 therefrom. Thethird element 2328 transmits the interrogation pulse 2402 along the electrical connection 2332 to thefourth element 2330. Thefourth element 2330 wirelessly couples the interrogation pulse 2402 to thesecond element 2035. The echo response pulses 2404 are transmitted back to thefirst element 2021 in reverse order. For example, the echo response pulse 2404 is wirelessly coupled to thefourth element 2330, is relayed to thethird element 2328 via the electrical connection 2332 and is wirelessly coupled to thefirst element 2021 thereafter. -
FIG. 37 illustrates one embodiment of theinstrument 2010 where the shaft serves as part of the antenna for thecontrol unit 2300. Accordingly, theshaft 2008 of theinstrument 2010, including for example, theproximate closure tube 2040 and thedistal closure tube 2042, may collectively serve as part of an antenna for thecontrol unit 2300 by radiating the interrogation pulses 2402 to thesecond element 2035 and receiving the echo response pulses 2404 reflected from thesecond element 2035. That way, signals to and from thecontrol unit 2300 and thesecond element 2035 disposed in theend effector 2012 may be transmitted via theshaft 2008 of theinstrument 2010. - The
proximate closure tube 2040 may be grounded at its proximate end by the exterior lower and upper side pieces 2059-2062, which may be made of a nonelectrically conductive material, such as plastic. The drive shaft assembly components (including themain drive shaft 2048 and secondary drive shaft 2050) inside the proximate anddistal closure tubes anvil 2024 and the channel 2022) may be electrically coupled to (or in direct or indirect electrical contact with) thedistal closure tube 2042 such that they may also serve as part of the antenna. Further, thesecond element 2035 may be positioned such that it is electrically insulated from the components of theshaft 2008 and theend effector 2012 serving as the antenna. For example, thesecond element 2035 may be positioned in thecartridge 2034, which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft 2008 (such as the distal end of the distal closure tube 2042) and the portions of theend effector 2012 serving as the antenna may be relatively close in distance to thesecond element 2035, the power for the transmitted signals may be held at low levels, thereby minimizing or reducing interference with other systems in the use environment of theinstrument 2010. - In such an embodiment, the
control unit 2300 may be electrically coupled to theshaft 2008 of theinstrument 2010, such as to theproximate closure tube 2040, by an electrically conductive connection 2410 (e.g., a wire). Portions of theouter shaft 2008, such as theclosure tubes control unit 2300 by radiating signals in the form of interrogation pulses 2402 to thesecond element 2035 and receiving radiated signals in the form of echo response pulses 2404 from thesecond element 2035. The echo response pulses 2404 received by thecontrol unit 2300 may be demodulated by thedemodulator 2310 and decoded by the decoder 2312 as previously discussed. The echo response pulses 2404 may comprise information from thesecond element 2035 such as, the location, type, presence and/or status of various components disposed on theend effector 2012 portion of theinstrument 2010, which theprocessor 2306 may use to control various aspects of theinstrument 2010, such as themotor 2065 or a user display. - To transmit data signals to or from the
second element 2035 in theend effector 2012, theelectrical connection 2410 may connect thecontrol unit 2300 to components of theshaft 2008 of theinstrument 2010, such as theproximate closure tube 2040, which may be electrically connected to thedistal closure tube 2042. Thedistal closure tube 2042 is preferably electrically insulated from theremote sensor 2368, which may be positioned in theplastic cartridge 2034. As mentioned before, components of theend effector 2012, such as thechannel 2022 and theanvil 2024, may be conductive and in electrical contact with thedistal closure tube 2042 such that they, too, may serve as part of the antenna. - With the
shaft 2008 acting as the antenna for thecontrol unit 2300, thecontrol unit 2300 can communicate with thesecond element 2035 in theend effector 2012 without a direct wired connection. In addition, because the distances betweenshaft 2008 and thesecond element 2035 is fixed and known, the power levels could be optimized for low levels to thereby minimize interference with other systems in the use environment of theinstrument 2010. - Although throughout this description, the
second element 2035 is shown disposed in the articulatingend effector 2012, thesecond element 2035 may be disposed in any suitable location on theinstruments 2010 while maintaining wireless communication with the first element 2021 (and/or the shaft 2008) at least on one portion of the transmission or reception cycle. Thesecond element 2035 also may be coupled to any component within thestaple cartridge 2034. - The
control unit 2300 may communicate with any of the first 2021, second 2035, third 2328 and fourth 2330 elements and additional elements through complex mechanical joints like the rotating joint 2029 without a direct wired connection, but rather through a wireless connection where it may be difficult to maintain a wired connection. In addition, because the distances between the first, second, third, fourth 2021, 2035, 2328, 2330 elements, and any additional elements and/or any combination thereof, may be fixed and known the couplings between theseelements instrument 2010. - In other embodiments, more or fewer sensor elements may be inductively, electromagnetically and/or otherwise coupled. For example, in some embodiments, the
control unit 2300 may comprise thefirst element 2021 formed integrally therewith. Thefirst element 2021 in thehandle 2006 and thesecond element 2035 in theend effector 2012 can communicate directly without the third andfourth elements control unit 2300 in thehandle 2006 and thesecond element 2035 in theend effector 2012. - In the embodiments described above, the battery 2064 (
FIG. 29 ) powers (at least partially) the firing operation of theinstrument 2010. As such, theinstrument 2010 may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described in the '573 application, which is incorporated herein by reference. It should be recognized, however, that theinstrument 2010 need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention. For example, theinstrument 2010 may include a user display (such as a LCD or LED display) that is powered by thebattery 2064 and controlled by thecontrol unit 2300. Data from thesensor transponders 2368 in theend effector 2012 may be displayed on such a display. -
FIGS. 38 and 39 depict a surgical cutting andfastening instrument 3010 according to various embodiments of the present invention. The illustrated embodiment is an endoscopic instrument and, in general, the embodiments of theinstrument 3010 described herein are endoscopic surgical cutting and fastening instruments. It should be noted, however, that according to other embodiments of the present invention, the instrument may be a non-endoscopic surgical cutting and fastening instrument, such as a laparoscopic instrument. - The
surgical instrument 3010 depicted inFIGS. 38 and 39 comprises ahandle 3012, ashaft 3014, and an articulatingend effector 3016 pivotally connected to theshaft 3014 at anarticulation pivot 3018. Correct placement and orientation of theend effector 3016 may be facilitated by controls on thehandle 3012, including (1) a rotation knob 3017 for rotating the closure tube (described in more detail below in connection withFIGS. 41-42 ) at a free rotating joint 3019 of theshaft 3014 to thereby rotate theend effector 3016 and (2) anarticulation control 3020 to effect rotational articulation of theend effector 3016 about thearticulation pivot 3018. In the illustrated embodiment, theend effector 3016 is configured to act as an endocutter for clamping, severing and stapling tissue, although, in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc. - The
handle 3012 of theinstrument 3010 may include aclosure trigger 3022 and afiring trigger 3024 for actuating theend effector 3016. It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating theend effector 3016. Theend effector 3016 is shown separated from thehandle 3012 by a preferablyelongate shaft 3014. In one embodiment, a clinician or operator of theinstrument 3010 may articulate theend effector 3016 relative to theshaft 3014 by utilizing thearticulation control 3020 as described in more detail in U.S. patent application Ser. No. 11/329,020 entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference. - The
end effector 3016 includes in this example, among other things, astaple channel 3026 and a pivotally translatable clamping member, such as ananvil 3028, which are maintained at a spacing that assures effective stapling and severing of tissue clamped in theend effector 3016. Thehandle 3012 includes apistol grip 3030 towards which aclosure trigger 3022 is pivotally drawn by the clinician to cause clamping or closing of theanvil 3028 toward thestaple channel 3026 of theend effector 3016 to thereby clamp tissue positioned between theanvil 3028 and thechannel 3026. Thefiring trigger 3024 is farther outboard of theclosure trigger 3022. Once theclosure trigger 3022 is locked in the closure position as further described below, thefiring trigger 3024 may rotate slightly toward thepistol grip 3030 so that it can be reached by the operator using one hand. The operator may then pivotally draw thefiring trigger 3024 toward thepistol grip 3030 to cause the stapling and severing of clamped tissue in theend effector 3016. In other embodiments, different types of clamping members besides theanvil 3028 may be used, such as, for example, an opposing jaw, etc. - It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping the
handle 3012 of aninstrument 3010. Thus, theend effector 3016 is distal with respect to the moreproximal handle 3012. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. - The
closure trigger 3022 may be actuated first. Once the clinician is satisfied with the positioning of theend effector 3016, the clinician may draw back theclosure trigger 3022 to its fully closed, locked position proximate to thepistol grip 3030. Thefiring trigger 3024 may then be actuated. Thefiring trigger 3024 returns to the open position (shown inFIGS. 38 and 39 ) when the clinician removes pressure, as described more fully below. Arelease button 3032 on thehandle 3012, when depressed, may release the lockedclosure trigger 3022. Various configurations for locking and unlocking theclosure trigger 3022 using therelease button 3032 are described in U.S. patent application Ser. No. 11/343,573 entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK, now U.S. Pat. No. 7,416,101, which is incorporated herein by reference. -
FIG. 40A is an exploded view of theend effector 3016 according to various embodiments, andFIG. 40B is a perspective view of the cutting instrument ofFIG. 40A . As shown in the illustrated embodiment, theend effector 3016 may include, in addition to the previously-mentionedchannel 3026 andanvil 3028, acutting instrument 3034, astaple cartridge 3038 that is removably seated (e.g., installed) in thechannel 3026, asled 3036 disposed within thestaple cartridge 3038, and ahelical screw shaft 3040. - The
anvil 3028 may be pivotably opened and closed at apivot point 3042 connected to the proximate end of thechannel 3026. Theanvil 3028 may also include atab 3044 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close theanvil 3028. When theclosure trigger 3022 is actuated, that is, drawn in by an operator of theinstrument 3010, theanvil 3028 may pivot about thepivot point 3042 into the clamped or closed position. If clamping of theend effector 3016 is satisfactory, the operator may actuate thefiring trigger 3024, which, as explained in more detail below, causes thecutting instrument 3034 to travel longitudinally along thechannel 3026. - As shown, the
cutting instrument 3034 includes upper guide pins 3046 that enter ananvil slot 3048 in theanvil 3028 to verify and assist in maintaining theanvil 3028 in a closed state during staple formation and severing. Spacing between thechannel 3026 andanvil 3028 is further maintained by thecutting instrument 3034 by havingmiddle pins 3050 slide along the top surface of thechannel 3026 while abottom foot 3052 opposingly slides along the undersurface of thechannel 3026, guided by alongitudinal opening 3054 in thechannel 3026. A distally presented cuttingsurface 3056 between the upper guide pins 3046 andmiddle pins 3050 severs clamped tissue while distally-presentedsurface 3058 actuates thestaple cartridge 3038 by engaging and progressively driving thesled 3036 through thestaple cartridge 3038 from an unfired position located at a proximal end of thestaple cartridge 3038 to a fired position located at a distal end of thestaple cartridge 3038. When thesled 3036 is in the unfired position, thestaple cartridge 3038 is in an unfired, or unspent, state. When thesled 3036 is in the fired position, thestaple cartridge 3038 is in a fired, or spent, state. Actuation of thestaple cartridge 3038 causesstaple drivers 3060 to cam upwardly, drivingstaples 3062 out of upwardly openstaple holes 3064 formed in thestaple cartridge 3038. Thestaples 3062 are subsequently formed against astaple forming undersurface 66 of theanvil 3028. Astaple cartridge tray 3068 encompasses from the bottom the other components of thestaple cartridge 3038 to hold them in place. Thestaple cartridge tray 3068 includes a rearwardlyopen slot 3070 that overlies thelongitudinal opening 3054 in thechannel 3026. A lower surface of thestaple cartridge 3038 and an upward surface of thechannel 3026 form a firing drive slot 3200 (FIG. 43 ) through which themiddle pins 3050 pass during distal and proximal movement of thecutting instrument 3034. Thesled 3036 may be an integral component of thestaple cartridge 3038 such that when thecutting instrument 3034 retracts following the cutting operation, thesled 3036 does not retract. U.S. Pat. No. 6,978,921, entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments. - It should be noted that although the embodiments of the
instrument 3010 described herein employ anend effector 3016 that staples the severed tissue, in other embodiments different techniques for fastening or sealing the severed tissue may be used. For example, end effectors that use RF energy or adhesives to fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680 entitled ELECTROSURGICAL HEMOSTATIC DEVICE, and U.S. Pat. No. 5,688,270 entitled ELECTROSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OR OFFSET ELECTRODES, both of which are incorporated herein by reference, disclose cutting instruments that uses RF energy to fasten the severed tissue. U.S. patent application Ser. No. 11/267,811 entitled SURGICAL STAPLING INSTRUMENTS STRUCTURED FOR DELIVERY OF MEDICAL AGENTS, now U.S. Pat. No. 7,673,783, and U.S. patent application Ser. No. 11/267,383 entitled SURGICAL STAPLING INSTRUMENTS STRUCTURED FOR PUMP-ASSISTED DELIVERY OF MEDICAL AGENTS, now U.S. Pat. No. 7,607,557, both of which are also incorporated herein by reference, disclose cutting instruments that uses adhesives to fasten the severed tissue. Accordingly, although the description herein refers to cutting/stapling operations and the like, it should be recognized that this is an exemplary embodiment and is not meant to be limiting. Other tissue-fastening techniques may also be used. -
FIGS. 41 and 42 are exploded views andFIG. 43 is a side view of theend effector 3016 andshaft 3014 according to various embodiments. As shown in the illustrated embodiment, theshaft 3014 may include aproximate closure tube 3072 and adistal closure tube 3074 pivotably linked by apivot links 3076. Thedistal closure tube 3074 includes anopening 3078 into which thetab 3044 on theanvil 3028 is inserted in order to open and close theanvil 3028, as further described below. Disposed inside theclosure tubes proximate spine tube 3079. Disposed inside theproximate spine tube 3079 may be a main rotational (or proximate)drive shaft 3080 that communicates with a secondary (or distal)drive shaft 3082 via abevel gear assembly 3084. Thesecondary drive shaft 3082 is connected to adrive gear 3086 that engages aproximate drive gear 3088 of thehelical screw shaft 3040. Thevertical bevel gear 3084 b may sit and pivot in anopening 3090 in the distal end of theproximate spine tube 3079. Adistal spine tube 3092 may be used to enclose thesecondary drive shaft 3082 and the drive gears 3086, 3088. Collectively, themain drive shaft 3080, thesecondary drive shaft 3082, and the articulation assembly (e.g., thebevel gear assembly 3084 a-c) are sometimes referred to herein as the “main drive shaft assembly.” - A
bearing 3094, positioned at a distal end of thestaple channel 3026, receives thehelical drive screw 3040, allowing thehelical drive screw 3040 to freely rotate with respect to thechannel 3026. Thehelical screw shaft 3040 may interface a threaded opening (not shown) of thecutting instrument 3034 such that rotation of theshaft 3040 causes thecutting instrument 3034 to translate distally or proximately (depending on the direction of the rotation) through thestaple channel 3026. Accordingly, when themain drive shaft 3080 is caused to rotate by actuation of the firing trigger 3024 (as explained in further detail below), thebevel gear assembly 3084 a-c causes thesecondary drive shaft 3082 to rotate, which in turn, because of the engagement of the drive gears 3086, 3088, causes thehelical screw shaft 3040 to rotate, which causes thecutting instrument 3034 to travel longitudinally along thechannel 3026 to cut any tissue clamped within theend effector 3016. Thesled 3036 may be made of, for example, plastic, and may have a sloped distal surface. As thesled 3036 traverses thechannel 3026, the sloped distal surface may cam thestaple drivers 3060 upward, which in turn push up or drive thestaples 3062 in thestaple cartridge 3038 through the clamped tissue and against the staple forming undersurface 3066 of theanvil 3028, thereby stapling the severed tissue. When thecutting instrument 3034 is retracted, thecutting instrument 3034 and thesled 3036 may become disengaged, thereby leaving thesled 3036 at the distal end of thechannel 3026. -
FIGS. 44-47 illustrate an exemplary embodiment of a motor-driven endocutter, and in particular thehandle 3012 thereof, that provides operator-feedback regarding the deployment and loading force of thecutting instrument 3034 in theend effector 3016. In addition, the embodiment may use power provided by the operator in retracting thefiring trigger 3024 to power the device (a so-called “power assist” mode). As shown in the illustrated embodiment, thehandle 3012 includes exteriorlower side pieces upper side pieces 3100, 3102 that fit together to form, in general, the exterior of thehandle 3012. Abattery 3104 may be provided in thepistol grip portion 3030 of thehandle 3012. Thebattery 3104 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO2 or LiNiO2, a Nickel Metal Hydride chemistry, etc. Thebattery 3104 powers amotor 3106 disposed in an upper portion of thepistol grip portion 3030 of thehandle 3012. According to various embodiments, themotor 3106 may be a DC brushed driving motor having a maximum rotation of approximately 5000 to 100,000 RPM. Themotor 3106 may drive a 90-degreebevel gear assembly 3108 comprising afirst bevel gear 3110 and asecond bevel gear 3112. Thebevel gear assembly 3108 may drive aplanetary gear assembly 3114. Theplanetary gear assembly 3114 may include apinion gear 3116 connected to adrive shaft 3118. Thepinion gear 3116 may drive amating ring gear 3120 that drives ahelical gear drum 3122 via adrive shaft 3124. Aring 3126 may be threaded on thehelical gear drum 3122. Thus, when themotor 3106 rotates, thering 3126 is caused to travel along thehelical gear drum 3122 by means of the interposedbevel gear assembly 3108,planetary gear assembly 3114 andring gear 3120. - The
handle 3012 may also include arun motor sensor 3128 in communication with thefiring trigger 3024 to detect when thefiring trigger 3024 has been drawn in (or “closed”) toward thepistol grip portion 3030 of thehandle 3012 by the operator to thereby actuate the cutting/stapling operation by theend effector 3016. Thesensor 3128 may be a proportional sensor such as, for example, a rheostat or variable resistor. When thefiring trigger 3024 is drawn in, thesensor 3128 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to themotor 3106. When thesensor 3128 is a variable resistor or the like, the rotation of themotor 3106 may be generally proportional to the amount of movement of thefiring trigger 3024. That is, if the operator only draws or closes thefiring trigger 3024 in a little bit, the rotation of themotor 3106 is relatively low. When thefiring trigger 3024 is fully drawn in (or in the fully closed position), the rotation of themotor 3106 is at its maximum. In other words, the harder the operator pulls on thefiring trigger 3024, the more voltage is applied to themotor 3106, causing a greater rate of rotation. In another embodiment, for example, the control unit (described further below) may output a PWM control signal to themotor 3106 based on the input from thesensor 3128 in order to control themotor 3106. - The
handle 3012 may include amiddle handle piece 3130 adjacent to the upper portion of thefiring trigger 3024. Thehandle 3012 also may comprise abias spring 3132 connected between posts on themiddle handle piece 3130 and thefiring trigger 3024. Thebias spring 3132 may bias thefiring trigger 3024 to its fully open position. In that way, when the operator releases thefiring trigger 3024, thebias spring 3132 will pull thefiring trigger 3024 to its open position, thereby removing actuation of thesensor 3128, thereby stopping rotation of themotor 3106. Moreover, by virtue of thebias spring 3132, any time an operator closes thefiring trigger 3024, the operator will experience resistance to the closing operation, thereby providing the operator with feedback as to the amount of rotation exerted by themotor 3106. Further, the operator could stop retracting thefiring trigger 3024 to thereby remove force from thesensor 3128, to thereby stop themotor 3106. As such, the operator may stop the deployment of theend effector 3016, thereby providing a measure of control of the cutting/fastening operation to the operator. - The distal end of the
helical gear drum 3122 includes adistal drive shaft 3134 that drives aring gear 3136, which mates with apinion gear 3138. Thepinion gear 3138 is connected to themain drive shaft 3080 of the main drive shaft assembly. In that way, rotation of themotor 3106 causes the main drive shaft assembly to rotate, which causes actuation of theend effector 3016, as described above. - The
ring 3126 threaded on thehelical gear drum 3122 may include apost 3140 that is disposed within aslot 3142 of a slottedarm 3144. The slottedarm 3144 has anopening 3146 itsopposite end 3148 that receives apivot pin 3150 that is connected between the handleexterior side pieces pivot pin 3150 is also disposed through anopening 3152 in thefiring trigger 3024 and anopening 3154 in themiddle handle piece 3130. - In addition, the
handle 3012 may include a reverse motor (or end-of-stroke)sensor 3156 and a stop motor (or beginning-of-stroke)sensor 3158. In various embodiments, thereverse motor sensor 3156 may be a normally-open limit switch located at the distal end of thehelical gear drum 3122 such that thering 3126 threaded on thehelical gear drum 3122 contacts and closes thereverse motor sensor 3156 when thering 3126 reaches the distal end of thehelical gear drum 3122. Thereverse motor sensor 3156, when closed, sends a signal to the control unit which sends a signal to themotor 3106 to reverse its rotation direction, thereby withdrawing the cutting instrument of theend effector 3016 following the cutting operation. - The
stop motor sensor 3158 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of thehelical gear drum 3122 so that thering 3126 opens theswitch 3158 when thering 3126 reaches the proximate end of thehelical gear drum 3122. - In operation, when an operator of the
instrument 3010 pulls back thefiring trigger 3024, thesensor 3128 detects the deployment of thefiring trigger 3024 and sends a signal to the control unit which sends a signal to themotor 3106 to cause forward rotation of themotor 3106 at, for example, a rate proportional to how hard the operator pulls back thefiring trigger 3024. The forward rotation of themotor 3106 in turn causes thering gear 3120 at the distal end of theplanetary gear assembly 3114 to rotate, thereby causing thehelical gear drum 3122 to rotate, causing thering 3126 threaded on thehelical gear drum 3122 to travel distally along thehelical gear drum 3122. The rotation of thehelical gear drum 3122 also drives the main drive shaft assembly as described above, which in turn causes deployment of thecutting instrument 3034 in theend effector 3016. That is, thecutting instrument 3034 andsled 3036 are caused to traverse thechannel 3026 longitudinally, thereby cutting tissue clamped in theend effector 3016. Also, the stapling operation of theend effector 3016 is caused to happen in embodiments where a stapling-type end effector is used. - By the time the cutting/stapling operation of the
end effector 3016 is complete, thering 3126 on thehelical gear drum 3122 will have reached the distal end of thehelical gear drum 3122, thereby causing thereverse motor sensor 3156 to be actuated, which sends a signal to the control unit which sends a signal to themotor 3106 to cause themotor 3106 to reverse its rotation. This in turn causes thecutting instrument 3034 to retract, and also causes thering 3126 on thehelical gear drum 3122 to move back to the proximate end of thehelical gear drum 3122. - The
middle handle piece 3130 includes abackside shoulder 3160 that engages the slottedarm 3144 as best shown inFIGS. 45 and 46 . Themiddle handle piece 3130 also has aforward motion stop 3162 that engages thefiring trigger 3024. The movement of the slottedarm 3144 is controlled, as explained above, by rotation of themotor 3106. When the slottedarm 3144 rotates CCW as thering 3126 travels from the proximate end of thehelical gear drum 3122 to the distal end, themiddle handle piece 3130 will be free to rotate CCW. Thus, as the operator draws in thefiring trigger 3024, thefiring trigger 3024 will engage theforward motion stop 3162 of themiddle handle piece 3130, causing themiddle handle piece 3130 to rotate CCW. Due to thebackside shoulder 3160 engaging the slottedarm 3144, however, themiddle handle piece 3130 will only be able to rotate CCW as far as the slottedarm 3144 permits. In that way, if themotor 3106 should stop rotating for some reason, the slottedarm 3144 will stop rotating, and the operator will not be able to further draw in thefiring trigger 3024 because themiddle handle piece 3130 will not be free to rotate CCW due to the slottedarm 3144. -
FIGS. 48 and 49 illustrate two states of a variable sensor that may be used as therun motor sensor 3128 according to various embodiments of the present invention. Thesensor 3128 may include aface portion 3164, a first electrode (A) 3166, a second electrode (B) 3168, and a compressible dielectric material 3170 (e.g., EAP) between theelectrodes sensor 3128 may be positioned such that theface portion 3164 contacts thefiring trigger 3024 when retracted. Accordingly, when thefiring trigger 3024 is retracted, thedielectric material 3170 is compressed, as shown inFIG. 49 , such that theelectrodes electrodes electrodes dielectric material 3170 is compressed due to retraction of the firing trigger 3024 (denoted as force “F” inFIG. 49 ) is proportional to the impedance between theelectrodes sensor 3128 may be used with suitable signal conditioning circuitry to proportionally control the speed of themotor 3106, for example. - Components of an exemplary closure system for closing (or clamping) the
anvil 3028 of theend effector 3016 by retracting theclosure trigger 3022 are also shown inFIGS. 44-47 . In the illustrated embodiment, the closure system includes ayoke 3172 connected to theclosure trigger 3022 by apin 3174 that is inserted through aligned openings in both theclosure trigger 3022 and theyoke 3172. Apivot pin 3176, about which theclosure trigger 3022 pivots, is inserted through another opening in theclosure trigger 3022 which is offset from where thepin 3174 is inserted through theclosure trigger 3022. Thus, retraction of theclosure trigger 3022 causes the upper part of theclosure trigger 3022, to which theyoke 3172 is attached via thepin 3174, to rotate CCW. The distal end of theyoke 3172 is connected, via apin 3178, to afirst closure bracket 3180. Thefirst closure bracket 3180 connects to asecond closure bracket 3182. Collectively, theclosure brackets FIG. 41 ) is seated and held such that longitudinal movement of theclosure brackets proximate closure tube 3072. Theinstrument 3010 also includes aclosure rod 3184 disposed inside theproximate closure tube 3072. Theclosure rod 3184 may include a window 3186 into which apost 3188 on one of the handle exterior pieces, such as exteriorlower side piece 3096 in the illustrated embodiment, is disposed to fixedly connect theclosure rod 3184 to thehandle 3012. In that way, theproximate closure tube 3072 is capable of moving longitudinally relative to theclosure rod 3184. Theclosure rod 3184 may also include adistal collar 3190 that fits into acavity 3192 inproximate spine tube 3079 and is retained therein by a cap 3194 (seeFIG. 41 ). - In operation, when the
yoke 3172 rotates due to retraction of theclosure trigger 3022, theclosure brackets proximate closure tube 3072 to move distally (i.e., away from thehandle 3012 of the instrument 3010), which causes thedistal closure tube 3074 to move distally, which causes theanvil 3028 to rotate about thepivot point 3042 into the clamped or closed position. When theclosure trigger 3022 is unlocked from the locked position, theproximate closure tube 3072 is caused to slide proximally, which causes thedistal closure tube 3074 to slide proximally, which, by virtue of thetab 3044 being inserted in theopening 3078 of thedistal closure tube 3074, causes theanvil 3028 to pivot about thepivot point 3042 into the open or unclamped position. In that way, by retracting and locking theclosure trigger 3022, an operator may clamp tissue between theanvil 3028 andchannel 3026, and may unclamp the tissue following the cutting/stapling operation by unlocking theclosure trigger 3022 from the locked position. - The control unit (described further below) may receive the outputs from end-of-stroke and beginning-of-
stroke sensors motor sensor 3128, and may control themotor 3106 based on the inputs. For example, when an operator initially pulls thefiring trigger 3024 after locking theclosure trigger 3022, the run-motor sensor 3128 is actuated. If the control unit determines that anunspent staple cartridge 3038 is present in theend effector 3016, as described further below, the control unit may output a control signal to themotor 3106 to cause themotor 3106 to rotate in the forward direction. When theend effector 3016 reaches the end of its stroke, thereverse motor sensor 3156 will be activated. The control unit may receive this output from thereverse motor sensor 3156 and cause themotor 3106 to reverse its rotational direction. When thecutting instrument 3034 is fully retracted, the stopmotor sensor switch 3158 is activated, causing the control unit to stop themotor 3106. - According to various embodiments, the
instrument 3010 may include a transponder in theend effector 3016. The transponder may generally be any device suitable for transmitting a wireless signal(s) indicating one or more conditions of theend effector 3016. In certain embodiments, for example, wireless signals may be transmitted by the transponder to the control unit responsive to wireless signals received from the control unit. In such embodiments, the wireless signals transmitted by the control unit and the transponder are referred to as “interrogation” and “reply” signals, respectively. The transponder may be in communication with one or more types of sensors (e.g., position sensors, displacement sensors, pressure/load sensors, proximity sensors, etc.) located in theend effector 3016 for transducing various end effector conditions such as, for example, a state of the staple cartridge 3038 (e.g., fired or unfired) and the respective positions of the anvil 3028 (e.g., open or closed) and the sled 3036 (e.g., proximal or distal). According to various embodiments and as discussed below, the transponder may be a passive device such that its operating power is derived from wireless signals (e.g., interrogation signals). In other embodiments, the transponder may be an active device powered by a self-contained power source (e.g., a battery) disposed within theend effector 3016. The transponder and the control circuit may be configured to communicate using any suitable type of wireless signal. According to various embodiments and as discussed below, for example, the transponder and the control circuit may transmit and receive wireless signals using magnetic fields generated by inductive effects. It will be appreciated that the transponder and the control circuit may instead transmit and receive wireless signals using electromagnetic fields (e.g., RF signals, optical signals), or using electric fields generated by capacitive effects, for example. It will further be appreciated that theend effector 3016 may include additional transponders, with each transponder having one more dedicated sensors for inputting data thereto. -
FIG. 50 illustrates a block diagram of thecontrol unit 3196 according to various embodiments. As shown, thecontrol unit 3196 may comprise aprocessor 3198 and one ormore memory units 3200. Thecontrol unit 3196 may be powered by thebattery 3104 or other suitable power source contained within theinstrument 3010. In certain embodiments, thecontrol unit 3196 may further comprise an inductive element 3202 (e.g., a coil or antenna) to transmit and receive wireless signals (e.g., interrogation and reply signals) from the transponder via magnetic fields. Signals received by theinductive element 3202 may be demodulated by ademodulator 3204 and decoded by adecoder 3206. By executing instruction code stored in thememory 3200, theprocessor 3198 may control various components of theinstrument 3010, such as themotor 3106 and a user display (not shown), based on inputs of the end effector sensors (as indicated by the decoded signals) and inputs received from other various sensor(s) (such as the run-motor sensor 3128, the end-of-stroke and beginning-of-stroke sensors - Wireless signals output by the
control unit 3196 may be in the form of alternating magnetic fields emitted by theinductive element 3202. Thecontrol unit 3196 may comprise anencoder 3208 for encoding data to be transmitted to the transponder and amodulator 3210 for modulating the magnetic field based on the encoded data using a suitable modulation scheme. Thecontrol unit 3196 may communicate with the transponder using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band or other RF band). Also, thecontrol unit 3196 may transmit signals at a different frequency range than the frequency range of the reply signals received from the transponder. Additionally, although only one antenna (inductive element 3202) is shown inFIG. 50 , in other embodiments thecontrol unit 3196 may have separate receiving and transmitting antennas. - According to various embodiments, the
control unit 3196 may comprise a microcontroller, a microprocessor, a field programmable gate array (FPGA), one or more other types of integrated circuits (e.g., RF receivers and PWM controllers), and/or discrete passive components. Thecontrol unit 3196 may also be embodied as system-on-chip (SoC) or a system-in-package (SIP), for example. - As shown in
FIG. 51 , thecontrol unit 3196 may be housed in thehandle 3012 of theinstrument 3010 and thetransponder 3212 may be located in theend effector 3016. To transmit signals to thetransponder 3212 and receive signals therefrom, theinductive element 3202 of thecontrol unit 3196 may be inductively coupled to a secondary inductive element (e.g., a coil) 3214 positioned in theshaft 3014 distally from the rotation joint 3019. The secondaryinductive element 3214 is preferably electrically insulated from theconductive shaft 3014. - The secondary
inductive element 3214 may be connected by an electrically conductive,insulated wire 3216 to a distal inductive element (e.g., a coil) 3218 located near theend effector 3016, and preferably distally located relative to thearticulation pivot 3018. Thewire 3216 may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass though thearticulation pivot 3018 and not be damaged by articulation. The distalinductive element 3218 may be inductively coupled to thetransponder 3212 in, for example, thestaple cartridge 3038 of theend effector 3016. Thetransponder 3212, as described in more detail below, may include an antenna (or coil) for inductively coupling to thedistal coil 3218, as well as associated circuitry for transmitting and receiving wireless signals. - In certain embodiments, the
transponder 3212 may be passively powered by magnetic fields emitted by the distalinductive element 3218. Once sufficiently powered, thetransponder 3212 may transmit and/or receive data (e.g., by modulating the magnetic fields) to thecontrol unit 3196 in thehandle 3012 via (i) the inductive coupling between thetransponder 3212 and the distalinductive element 3218, (ii) thewire 3216, and (iii) the inductive coupling between the secondaryinductive element 3214 and thecontrol unit 3196. Thecontrol unit 3196 may thus communicate with thetransponder 3212 in theend effector 3016 without a hardwired connection through complex mechanical joints like the rotating joint 3019 and/or without a hardwired connection from theshaft 3014 to theend effector 3016, places where it may be difficult to maintain such connections. In addition, because the distances between the inductive elements (e.g., the spacing between (i) thetransponder 3212 and the distalinductive element 3218, and (ii) the secondaryinductive element 3214 and the control unit 3196) are fixed and known, the couplings could be optimized for inductive energy transfer. Also, the distances could be relatively short so that relatively low power signals could be used to thereby minimize interference with other systems in the use environment of theinstrument 3010. - In the embodiment of
FIG. 51 , theinductive element 3202 of thecontrol unit 3196 is located relatively near to thecontrol unit 3196. According to other embodiments, as shown inFIG. 52 , theinductive element 3202 of thecontrol unit 3196 may be positioned closer to the rotating joint 3019 to that it is closer to the secondaryinductive element 3214, thereby reducing the distance of the inductive coupling in such an embodiment. Alternatively, the control unit 3196 (and hence the inductive element 3202) could be positioned closer to the secondaryinductive element 3214 to reduce the spacing. - In other embodiments, more or fewer than two inductive couplings may be used. For example, in some embodiments, the
surgical instrument 3010 may use a single inductive coupling between thecontrol unit 3196 in thehandle 3012 and thetransponder 3212 in theend effector 3016, thereby eliminating theinductive elements wire 3216. Of course, in such an embodiment, stronger signals may be required due to the greater distance between thecontrol unit 3196 in thehandle 3012 and thetransponder 3212 in theend effector 3016. Also, more than two inductive couplings could be used. For example, if thesurgical instrument 3010 had numerous complex mechanical joints where it would be difficult to maintain a hardwired connection, inductive couplings could be used to span each such joint. For example, inductive couplings could be used on both sides of the rotary joint 3019 and both sides of thearticulation pivot 3018, with aninductive element 3220 on the distal side of the rotary joint 3019 connected by thewire 3216 to theinductive element 3218 of the proximate side of the articulation pivot, and awire 3222 connectinginductive elements articulation pivot 3018 as shown inFIG. 53 . In this embodiment, theinductive element 3226 may communicate with thetransponder 3212. - In the above-described embodiments, each of the
inductive elements inductive elements closure tubes 3072, 3074), and thewires outer shaft 3014. -
FIG. 54 is a bottom view of a portion of thestaple cartridge 3038 including thetransponder 3212 according to various embodiments. As shown, thetransponder 3212 may be held or embedded in thestaple cartridge 3038 at its distal end using a suitable bonding material, such as epoxy. -
FIG. 55 illustrates a circuit diagram of thetransponder 3212 according to various embodiments. As shown, thetransponder 3212 may include aresonant circuit 3249 comprising an inductive element 3250 (e.g., a coil or antenna) and acapacitor 3252. Thetransponder 3212 may further include amicrochip 3254 coupled to theresonant circuit 3249. In certain embodiments, themicrochip 3254 may be, for example, an RFID device containing circuitry for enabling communication with thecontrol unit 3196 via theinductive element 3250 of theresonant circuit 3249. Themicrochip 3254 may include at least one data input for receiving data in the form of discrete or analog signals from thesensors 3235 disposed in theend effector 3016. As discussed above, thesensors 3235 may include, for example, position sensors, displacement sensors, pressure/load sensors, proximity sensors for sensing various end effector conditions. Themicrochip 3254 also may include one or more dynamic memory devices 3255 (e.g., flash memory devices) for storing data transmitted from, for example, thecontrol unit 3196. Themicrochip 3254 may further include one or more non-dynamic memory devices 3257 (e.g., write-once memory devices) for storing static data, such as, for example, a staple cartridge identification number, manufacturer information, and information pertaining to physical characteristics of thestaple cartridge 3038. - In response to alternating magnetic fields emitted by the distal
inductive element 3218, theresonant circuit 3249 of thetransponder 3212 is caused to resonate, thereby causing an alternating input voltage to be applied to themicrochip 3254. Theresonant circuit 3249 may have a resonant frequency given by -
- where L1 is the inductance value of the
inductive element 3250 and C1 is the capacitance value of thecapacitor 3252. The values of L1 and C1 may be selected such that the resonant frequency of thecircuit 3249 is equal or nearly equal to the frequency of magnetic field transmitted by the distalinductive element 3218. The circuitry of themicrochip 3254 may include a rectifying circuitry (not shown) for rectifying and conditioning the alternating input voltage to provide a DC voltage sufficient to power themicrochip 3254. Once powered, themicrochip 3254 may selectively load theinductive element 3250 based on data received from thesensors 3235 and the data stored in thememory devices inductive element 3218 and theinductive element 3250. The modulation of the magnetic field modulates the voltage across the distalinductive element 3218, which in turn modulates the voltage across theinductive element 3202 of thecontrol unit 3196. Thecontrol unit 3196 may demodulate and decode the voltage signal across theinductive element 3202 to extract data communicated by themicrochip 3254. Thecontrol unit 3196 may process the data to verify, among other things, that thestaple cartridge 3038 is compatible with theinstrument 3010 and that end effector conditions are suitable for conducting a firing operation. Subsequent to verification of the data, thecontrol unit 3196 may enable a firing operation. - According to various embodiments, the
resonant circuit 3249 may further include afuse 3256 connected in series with theinductive element 3250. When thefuse 3256 is closed (e.g., conductive), theinductive element 3250 is electrically coupled to theresonant circuit 3249, thus enabling thetransponder 3212 to function as described above in response to an alternating magnetic field emitted by the distalinductive element 3218. The closed state of thefuse 3256 thus corresponds to an enabled state of thetransponder 3212. When thefuse 3256 is opened (e.g., non-conductive), theinductive element 3250 is electrically disconnected from theresonant circuit 3249, thus preventing theresonant circuit 3249 from generating the voltage necessary to operate themicrochip 3254. The open state of thefuse 3256 thus corresponds to a disabled state of thetransponder 3212. The placement of thefuse 3256 inFIG. 55 is shown by way of example only, and it will be appreciated that thefuse 3256 may be connected in any manner such that thetransponder 3212 is disabled when thefuse 3256 is opened. - According to various embodiments, the
fuse 3256 may be actuated (e.g., transitioned from closed to opened) substantially simultaneously with a firing operation of theinstrument 3010. For example, thefuse 3256 may be actuated immediately before, during, or immediately after a firing operation. Actuation of thefuse 3256 thus transitions thetransponder 3212 from the enabled state to the disabled state. Accordingly, if an attempt is made to reuse thestaple cartridge 3038, thetransponder 3212 will be unable to communicate data in response to a wireless signal transmitted by the distalinductive element 3218. Based upon the absence of this data, thecontrol unit 3196 may determine that thetransponder 3212 is in a disabled state indicative of the fired state of thestaple cartridge 3038 and prevent a firing operation from being enabled. Thus, actuation of thefuse 3256 prevents reuse of astaple cartridge 3038 when thestaple cartridge 3038 is in the fired state. - In certain embodiments, the
fuse 3256 may be a mechanically-actuated fuse that is opened in response to movement of thecutting instrument 3034 when actuated, for example. As shown inFIG. 56 , for example, thefuse 3256 may include a section of wire extending transversely across alongitudinal slot 3258 of thestaple cartridge 3038 through which thecutting instrument 3034 passes during a firing operation. When theinstrument 3010 is fired, the distal movement of thecutting instrument 3034 severs thefuse 3256, thus transitioning thetransponder 3212 to the disabled state so that it cannot be reused. - According to other embodiments, the
fuse 3256 may be an electrically-actuated fuse. For example, subsequent to receiving data from thetransponder 3212 and verifying that theend effector 3016 is in a condition to be fired, thecontrol unit 3196 may transmit a wireless signal to thetransponder 3212 such that the resulting current flow throughfuse 3256 is sufficient to cause thefuse 3256 to open. It will be appreciated that the strength of the wireless signal needed to open thefuse 3256 may be different in amplitude, frequency, and duration than that used to communicate with thetransponder 3212. Additionally, it will be appreciated that other electrically-actuated components may be used instead of an electrically-actuated fuse to disable thetransponder 3212. For example, thecontrol unit 3196 may transmit a wireless signal to thetransponder 3212 such that resulting voltage developed across theresonant circuit 3256 sufficiently exceeds the voltage rating of thecapacitor 3252 and/or circuitry of themicrochip 3254 to cause their destruction. - As an alternative to using an electrically-actuated fuse, the
fuse 3256 may instead be a thermally-actuated fuse (e.g., a thermal cutoff fuse) that is caused to open in response to heat generated by the flow of excessive current therethrough. - In certain cases, it may be desirable to communicate with the
transponder 3212 when thestaple cartridge 3038 is in the fired state. In such cases, it is not possible to entirely disable thetransponder 3212 as described in the embodiments above.FIG. 57 illustrates a circuit diagram of thetransponder 3212 according to various embodiments for enabling wireless communication with thecontrol unit 3196 when thestaple cartridge 3038 is in the fired state. As shown, theresonant circuit 3249 of thetransponder 3212 may include asecond capacitor 3260 in parallel with thecapacitor 3252. Thefuse 3256 may be connected in series with thesecond capacitor 3260 such that the resonant frequency of theresonant circuit 3249 is determined by the open/closed state of thefuse 3256. In particular, when thefuse 3256 is closed, the resonant frequency is given by -
- where C2 is we capacitance value of the
second capacitor 3260. The closed state of thefuse 3256 thus corresponds to a first resonant state of thetransponder 3212. When thefuse 3256 is opened, the resonant frequency is given by -
- me open state or me
ruse 3256 thus corresponds to a second resonant state of thetransponder 3212. As described in the above embodiments, thefuse 3256 may be mechanically, electrically or thermally actuated substantially simultaneously with a firing operation. Thecontrol unit 3196 may be configured to determine the resonant state of the transponder 3212 (and thus the unfired/fired state of the staple cartridge 3038) by discriminating between the two resonant frequencies. Advantageously, because the resonant circuit 3256 (and thus the microchip 3254) continue to operate after thefuse 3256 is opened, thecontrol unit 3196 may continue to receive data from thetransponder 3212. It will be appreciated that the placement of thefuse 3256 and use of thesecond capacitor 3260 to alter the resonant frequency is provided by way of example only. In other embodiments, for example, thefuse 3256 may be connected such that the inductive value of theinductive element 3250 is changed when thefuse 3256 is opened (e.g., by connecting thefuse 3256 such that a portion of theinductive element 3250 is short-circuited when thefuse 3256 is closed). - According to various embodiments, a switch may be used as an alternative to the
fuse 3256 for effecting the transition between transponder states. For example, as shown inFIG. 58 , thestaple cartridge tray 3068 of thestaple cartridge 3038 may include a switch 3262 (e.g., a normally-open limit switch) located at its proximal end. Theswitch 3262 may be mounted such that when thesled 3036 is present in the unfired position, thesled 3036 maintains theswitch 3262 in a closed (e.g., conductive) state. When thesled 3036 is driven from the unfired position to the fired position during a firing operation, theswitch 3262 transitions to an open (e.g., non-conductive state), thus effecting a transition in the state of thetransponder 3212 as described above. It will be appreciated that in other embodiments theswitch 3262 may be a normally-closed switch mounted at the distal end of thestaple cartridge tray 3068 such that theswitch 3262 is caused to open when thesled 3036 is present in the fired position. It will further be appreciated that theswitch 3262 may be located at the proximal or distal ends of thestaple cartridge 3038 and mounted such that it may be suitably actuated by thesled 3036 when present in the unfired and fired positions, respectively. - As an alternative to connecting the mechanically-actuated
fuse 3256 or theswitch 3262 to disable/alter theresonant circuit 3249, these components may instead be connected to data inputs of themicrochip 3254. In this way, the open/closed states of the mechanically-actuatedfuse 3256 or theswitch 3262 may be transmitted to thecontrol unit 3196 in the same manner as the data corresponding to other end effector conditions. - As an alternative to the
fuse 3256 and theswitch 3262, embodiments of the present invention may instead utilize alterable data values in adynamic memory device 3255 of thetransponder 3212. For example, thedynamic memory device 3255 may store a first data value (e.g., a data bit having a value of 1) corresponding to a first data state of thetransponder 3212. The first data value may be written to thedynamic memory device 3255 during the manufacture of thestaple cartridge 3038, for example. The first data state may thus be indicative of the unfired state of thestaple cartridge 3038. Based on a determination of the first data state of thetransponder 3212, thecontrol unit 3196 may enable operation of theinstrument 3010 if the end effector conditions are otherwise suitable for conducting a firing operation. Substantially simultaneously with the firing operation, thecontrol unit 3196 may transmit a wireless signal to thetransponder 3212 containing a second data value (e.g., a data bit having a value of 0). The second data value may be stored to thedynamic memory device 3255 such that the first data value is overwritten, thus transitioning thetransponder 3212 from the first data state to a second data state. The second data state may thus be indicative of the fired state of thestaple cartridge 3038. If an attempt is made to reuse thestaple cartridge 3038, thecontrol unit 3196 may determine that thetransponder 3212 is in the second data state and prevent a firing operation from being enabled. - Although the
transponders 3212 in the above-described embodiments includes amicrochip 3254 for wirelessly communicating data stored inmemory devices 3235, 3237 and data input from thesensors 3235, in other embodiments the transponder may not include amicrochip 3254. For example,FIG. 59 illustrates a “chipless”transponder 3264 in the form of a resonant circuit having components similar to those of theresonant circuit 3249, such as aninductive element 3250, acapacitor 3252, and afuse 3256. Additionally, thetransponder 3264 may include one ormore sensors 3235 connected in series with thecomponents sensor 3235 may be a limit switch (e.g., a normally open or a normally closed limit switch) mounted in theend effector 3016 for sensing a corresponding end effector condition (e.g., a position of theanvil 3028, a position of thesled 3036, etc.). In such embodiments, eachlimit switch 3235 may be in a closed (e.g., conductive) state when its sensed condition is compatible with a firing operation, thus establishing electrical continuity through the resonant circuit. - When each
switch 3235 and thefuse 3256 is in the closed state, the resonant circuit will be caused to resonate at a frequency fr responsive to a magnetic field emitted by the distalinductive element 3218. The closed states of thefuse 3256 and theswitches 3235 thus correspond to an enabled state of thetransponder 3264 that is indicative of, among other things, the unfired state of thestaple cartridge 3038. Thecontrol unit 3196 may sense the resonance (e.g., by sensing magnetic field loading caused by the resonant circuit) to determine the enabled state, at which time thecontrol unit 3196 may enable operation of theinstrument 3010. Substantially simultaneously with the actuation of thecutting instrument 3034, thefuse 3256 may be mechanically, electronically or thermally actuated as described above, thus transitioning thetransponder 3264 to a disabled state indicative of the fired state of thestaple cartridge 3038. If a subsequent firing operation is attempted without replacing thestaple cartridge 3038, thecontrol unit 3196 may determine the disabled state based on the absence of a sensed resonance in response to an emitted magnetic field, in which case thecontrol unit 3196 prevents the firing operation from being performed. -
FIG. 60 illustrates another embodiment of achipless transponder 3264 in the form of a resonant circuit including aninductive element 3250, afirst capacitor 3252, asecond capacitor 3260, and afuse 3256 connected in series with thesecond capacitor 3260. Thefuse 3256 may be mechanically, electronically or thermally actuated substantially simultaneously with a firing operation, as in above-described embodiments. Thetransponder 3264 may additionally include one or more sensors 3235 (e.g., limit switches) connected in series with athird capacitor 3266 of the resonant circuit. Accordingly, when eachswitch 3235 and thefuse 3256 are in the closed state, the resonant circuit will be caused to resonate at a frequency -
- responsive to a magnetic field emitted by the distal
inductive element 3218. When one of theswitches 3235 is opened and thefuse 3256 is closed, the resonant frequency will be -
- and when each of the
switches 3235 is closed and thefuse 3256 is opened, the resonant frequency will be -
- When the
switches 3235 and thefuse 3256 are opened, the resonant frequency will be -
- The closed states of the
fuse 3256 and theswitches 3235 correspond to a first resonant state (e.g., resonant frequency fr1) of thetransponder 3264, and the open state of thefuse 3256 corresponds to a second resonant state (e.g., either of resonant frequencies fr3 or fr4). The capacitance values C1, C2 and C3 may be selected such that the resonant frequencies fr1, fr2, fr3 and fr4 are different. Thecontrol unit 3196 may be configured to discriminate between resonant frequencies to determine the first or second state of the transponder 3266 (and thus the unfired or fired state of the staple cartridge 3038), and to enable or prevent operation of theinstrument 3010 accordingly. Thecontrol unit 3196 may further be configured to determine a third state of thetransponder 3264 corresponding the closed state of thefuse 3256 and an open state of any of theswitches 3235. In this case, thecontrol unit 3196 may operate to prevent a firing operation until the end effector condition(s) causing the open switch(es) 3235 is resolved. -
FIG. 61 is a flow diagram of a method of preventing reuse of a staple cartridge in surgical instrument that may be performed in conjunction with embodiments of theinstrument 3010 described above. Atstep 3300, a first wireless signal is transmitted to thetransponder transponder transponder transponder staple cartridge 3038. In certain embodiments, for example, the first and second transponder states may indicate the unfired and fired states of thestaple cartridge 3038, respectively. - At
step 3310, if the first electronic state (indicative of an unfired staple cartridge state) is determined, thecutting instrument 3034 may be enabled atstep 3315. After theinstrument 3010 is enabled, the operator may initiate a firing operation when ready. - At
step 3320, thetransponder cutting instrument 3034. Accordingly, if an attempt is made to reuse thestaple cartridge 3038 atstep 3300, the second electronic state of thetransponder 3212, 3264 (indicative of the fired staple cartridge state) may be determined atstep 3310 and a firing operation consequently prevented, as shown atstep 3325. - Above-described embodiments advantageously prevent operation of the
instrument 3010 when a spent staple cartridge 3038 (or no staple cartridge 3038) is present in theend effector 3016, thus preventing cutting of tissue without simultaneous stapling. In addition to preventing operation of theinstrument 3010 under such circumstances, it may further be desirable to prevent operation of theinstrument 3010 after it has been used to perform a predetermined number of firing operations. Limiting the number of firing operations may be necessary, for example, so that use of theinstrument 3010 does not cause operational lifetimes of its various components (e.g., thecutting instrument 3034, thebattery 3104, etc.) to be exceeded. - According to various embodiments, a limit on the number of firing operations may be implemented by the
control unit 3196 using, for example, a counter (not shown) contained within theprocessor 3198. The counter may be incremented once for each firing operation indicated by one or more sensor inputs received by the control unit 3196 (e.g., inputs received from the end-of-stroke and beginning-of-stroke sensors processor 3198 may compare the counter contents to a predetermined number. The predetermined number may be stored in thememory 3200 of theprocessor 3198 during instrument manufacture, for example, and represent the maximum number of firing operations performable by theinstrument 3010. The predetermined number may be determined based upon, among other things, operational lifetimes of the various instrument components and/or the expected requirements of a medical procedure for which theinstrument 3010 is to be used. When the counted number of firing operations is equal to the predetermined number, thecontrol unit 3196 may be configured to prevent additional firing operations by theinstrument 3010. In embodiments in which thecontrol unit 3196 directly or indirectly controls rotation of the motor 3106 (e.g., via a PWM signal output in response to an input from the run-motor sensor 3128), instruction code stored in thememory 3200 may cause theprocessor 3198 to prevent further output of power and/or control signals necessary for motor operation. - In other embodiments, the
control unit 3196 may prevent firing operations in excess of the predetermined number by disabling electronic components necessary for motor operation. For example, as shown inFIG. 62 , thecontrol unit 3196 may be connected to themotor 3106 via conductive leads 3268, one of which includes an electronically-actuatedfuse 3270. Subsequent to the retraction of thecutting instrument 3034 after the final firing operation (e.g., when the number of firing operations is equal to the predetermined number), thecontrol unit 3196 may cause increased current to be applied to themotor 3106 such that thefuse 3270 is opened (e.g., rendered non-conductive), thus preventing further motor operation. It will be appreciated that the placement of thefuse 3270 is shown by way of example only, and that thefuse 3270 may be connected in other ways to effect the same result. For example, thefuse 3270 may be connected between thebattery 3104 and the electrical components of theinstrument 3010. In such embodiments, when the number of firing operations equals the predetermined number, thecontrol unit 3196 may short circuit thefuse 3270 such that it is caused to open, thus removing power from the electrical components. - As an alternative to the
fuse 3270, it will be appreciated that a switch (e.g., a relay contact) controllable by a discrete output of thecontrol unit 3196 may be used instead. Additionally, it will be appreciated thecontrol unit 3196 may be configured to electronically disable one or more components necessary for motor operation (e.g., capacitors, transistors, etc.) other than a fuse by applying excessive voltages and/or currents thereto. Such components may be internal or external to thecontrol unit 3196. - Although above-described embodiments for limiting instrument use utilize a counter within the
processor 3198, it will be appreciated that other embodiments may utilize an electro-mechanical counter having a mechanical input suitably coupled to a component of the instrument 3010 (e.g., the firing trigger 3024) such that the counter is incremented once for each firing operation. The counter may include a set of electrical contacts that close (or open) when the counted number of firing operations exceeds a predetermined number stored within the counter. The contacts may serve as an input to thecontrol unit 3196, and theprocessor 3198 may be programmed to enable or disable instrument operation based on the state of the contacts. Alternatively, the contacts may be connected to other components of the instrument (e.g., thebattery 3104 or the motor 3106) such that power to themotor 3106 is interrupted when the predetermined number of counts is exceeded. - In the embodiments described above, the
battery 3104 powers (at least partially) the firing operation of theinstrument 3010. As such, the instrument may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described are described in U.S. patent application Ser. No. 11/343,573 referenced above, now U.S. Pat. No. 7,416,101, which is incorporated herein. It should be recognized, however, that theinstrument 3010 need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention. For example, theinstrument 3010 may include a user display (such as a LCD or LED display) that is powered by thebattery 3104 and controlled by thecontrol unit 3196. Data from thetransponder end effector 3016 may be displayed on such a display. - In another embodiment, the
shaft 3014 of theinstrument 3010, including for example, theproximate closure tube 3072 and thedistal closure tube 3074, may collectively serve as part of an antenna for thecontrol unit 3196 by radiating signals to thetransponder transponder transponder end effector 3016 may be transmitted via theshaft 3014 of theinstrument 3010. - The
proximate closure tube 3072 may be grounded at its proximate end by the exterior lower andupper side pieces main drive shaft 3080 and secondary drive shaft 3082) inside the proximate anddistal closure tubes anvil 3028 and the channel 3026) may be electrically coupled to (or in direct or indirect electrical contact with) thedistal closure tube 3074 such that they may also serve as part of the antenna. Further, thetransponder shaft 3014 andend effector 3016 serving as the antenna. For example, as discussed above, thetransponder staple cartridge 3038, which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft 3014 (such as the distal end of the distal closure tube 3074) and the portions of theend effector 3016 serving as the antenna may be relatively close in distance to thetransponder instrument 3010 is reduced or minimized - In such an embodiment, as shown in
FIG. 59 , thecontrol unit 3196 may be electrically coupled to theshaft 3014 of theinstrument 3010, such as to theproximate closure tube 3072, by a conductive link 3272 (e.g., a wire). Portions of theouter shaft 3014, such as theclosure tubes control unit 3196 by transmitting signals to thetransponder transponder control unit 3196 may be demodulated by thedemodulator 3204 and decoded by thedecoder 3206, as described above. - To transmit data signals to or from the
transponder end effector 3016, thelink 3272 may connect thecontrol unit 3196 to components of theshaft 3014 of theinstrument 3010, such as theproximate closure tube 3072, which may be electrically connected to thedistal closure tube 3074. Thedistal closure tube 3074 is preferably electrically insulated from thetransponder plastic staple cartridge 3038. As mentioned before, components of theend effector 3016, such as thechannel 3026 and theanvil 3028, may be conductive and in electrical contact with thedistal closure tube 3074 such that they, too, may serve as part of the antenna. - With the
shaft 3014 acting as the antenna for thecontrol unit 3196, thecontrol unit 3196 can communicate with thetransponder end effector 3016 without a hardwired connection. In addition, because the distance betweenshaft 3014 and thetransponder instrument 3010. - In another embodiment, the components of the
shaft 3014 and/or theend effector 3016 may serve as an antenna for thetransponder transponder distal closure tube 3074, which may be electrically connected to the proximate closure tube 3072) and thecontrol unit 3196 is insulated from theshaft 3014. For example, thetransponder closure tubes 3072, 3074). Alternatively, theend effector 3016 may include a wire (not shown) that connects thetransponder distal closure tube 3074. -
FIGS. 64 and 65 depict a surgical cutting andfastening instrument 4010 according to various embodiments of the present invention. The illustrated embodiment is an endoscopic instrument and, in general, the embodiments of theinstrument 4010 described herein are endoscopic surgical cutting and fastening instruments. It should be noted, however, that according to other embodiments of the present invention, the instrument may be a non-endoscopic surgical cutting and fastening instrument, such as a laparoscopic instrument. - The
surgical instrument 4010 depicted inFIGS. 64 and 65 comprises ahandle 4012, ashaft 4014, and an articulatingend effector 4016 pivotally connected to theshaft 4014 at anarticulation pivot 4018. Anarticulation control 4020 may be provided adjacent to thehandle 4012 to effect rotation of theend effector 4016 about thearticulation pivot 4018. In the illustrated embodiment, theend effector 4016 is configured to act as an endocutter for clamping, severing and stapling tissue, although, in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc. - The
handle 4012 of theinstrument 4010 may include aclosure trigger 4022 and afiring trigger 4024 for actuating theend effector 4016. It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating theend effector 4016. Theend effector 4016 is shown separated from thehandle 4012 by a preferablyelongate shaft 4014. In one embodiment, an operator of theinstrument 4010 may articulate theend effector 4016 relative to theshaft 4014 by utilizing thearticulation control 4020 as described in more detail in U.S. patent application Ser. No. 11/329,020 entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No. 7,670,334, which is incorporated herein by reference. - The
end effector 4016 includes in this example, among other things, astaple channel 4026 and a pivotally translatable clamping member, such as ananvil 4028, which are maintained at a spacing that assures effective stapling and severing of tissue clamped in theend effector 4016. Thehandle 4012 includes apistol grip 4030 towards which aclosure trigger 4022 is pivotally drawn by the operator to cause clamping or closing of theanvil 4028 toward thestaple channel 4026 of theend effector 4016 to thereby clamp tissue positioned between theanvil 4028 and thechannel 4026. Thefiring trigger 4024 is farther outboard of theclosure trigger 4022. Once theclosure trigger 4022 is locked in the closure position as further described below, thefiring trigger 4024 may rotate slightly toward thepistol grip 4030 so that it can be reached by the operator using one hand. The operator may then pivotally draw thefiring trigger 4024 toward thepistol grip 4030 to cause the stapling and severing of clamped tissue in theend effector 4016. In other embodiments, different types of clamping members besides theanvil 4028 may be used, such as, for example, an opposing jaw, etc. - It will be appreciated that the terms “proximal” and “distal” are used herein with reference to an operator gripping the
handle 4012 of aninstrument 4010. Thus, theend effector 4016 is distal with respect to the moreproximal handle 4012. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. - The
closure trigger 4022 may be actuated first. Once the operator is satisfied with the positioning of theend effector 4016, the operator may draw back theclosure trigger 4022 to its fully closed, locked position proximate to thepistol grip 4030. Thefiring trigger 4024 may then be actuated. Thefiring trigger 4024 returns to the open position (shown inFIGS. 64 and 65 ) when the operator removes pressure, as described more fully below. Arelease button 4032 on thehandle 4012, when depressed, may release the lockedclosure trigger 4022. Various configurations for locking and unlocking theclosure trigger 4022 using therelease button 4032 are described in U.S. patent application Ser. No. 11/343,573 entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK, now U.S. Pat. No. 7,416,101, which is incorporated herein by reference. -
FIG. 66A is an exploded view of theend effector 4016 according to various embodiments. As shown in the illustrated embodiment, theend effector 4016 may include, in addition to the previously-mentionedchannel 4026 andanvil 4028, acutting instrument 4034, asled 4036, astaple cartridge 4038 that is removably seated (e.g., installed) in thechannel 4026, and ahelical screw shaft 4040, andFIG. 66B is a perspective view of the cutting instrument ofFIG. 66A . - The
anvil 4028 may be pivotably opened and closed at apivot point 4042 connected to the proximate end of thechannel 4026. Theanvil 4028 may also include atab 4044 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close theanvil 4028. When theclosure trigger 4022 is actuated, that is, drawn in by an operator of theinstrument 4010, theanvil 4028 may pivot about thepivot point 4042 into the clamped or closed position. If clamping of theend effector 4016 is satisfactory, the operator may actuate thefiring trigger 4024, which, as explained in more detail below, causes thecutting instrument 4034 to travel longitudinally along thechannel 4026. - As shown, the
cutting instrument 4034 includes upper guide pins 4046 that enter ananvil slot 4048 in theanvil 4028 to verify and assist in maintaining theanvil 4028 in a closed state during staple formation and severing. Spacing between thechannel 4026 andanvil 4028 is further maintained by thecutting instrument 4034 by havingmiddle pins 4050 slide along the top surface of thechannel 4026 while abottom foot 4052 opposingly slides along the undersurface of thechannel 4026, guided by alongitudinal opening 4054 in thechannel 4026. A distally presented cuttingsurface 4056 between the upper guide pins 4046 andmiddle pins 4050 severs clamped tissue while distally-presentedsurface 4058 actuates thestaple cartridge 4038 by progressively driving thesled 4036 from an unfired position to a fired position. Actuation of thestaple cartridge 4038 causesstaple drivers 4060 to cam upwardly, drivingstaples 4062 out of upwardly openstaple holes 4064 formed in thestaple cartridge 4038. Thestaples 4062 are subsequently formed against a staple forming undersurface 4066 of theanvil 4028. Astaple cartridge tray 4068 encompasses from the bottom the other components of thestaple cartridge 4038 to hold them in place. Thestaple cartridge tray 4068 includes a rearwardlyopen slot 4070 that overlies thelongitudinal opening 4054 in thechannel 4026. A lower surface of thestaple cartridge 4038 and an upward surface of thechannel 4026 form a firing drive slot 4200 (FIG. 69 ) through which themiddle pins 4050 pass during distal and proximal movement of thecutting instrument 4034. Thesled 4036 may be an integral component of thestaple cartridge 4038 such that when thecutting instrument 4034 retracts following the cutting operation, thesled 4036 does not retract. U.S. Pat. No. 6,978,921, entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments. - It should be noted that although the embodiments of the
instrument 4010 described herein employ anend effector 4016 that staples the severed tissue, in other embodiments different techniques for fastening or sealing the severed tissue may be used. For example, end effectors that use RF energy or adhesives to fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680 entitled ELECTROSURGICAL HEMOSTATIC DEVICE, and U.S. Pat. No. 5,688,270 entitled ELECTROSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OR OFFSET ELECTRODES, both of which are incorporated herein by reference, disclose cutting instruments that uses RF energy to fasten the severed tissue. U.S. patent application Ser. No. 11/267,811 entitled SURGICAL STAPLING INSTRUMENTS STRUCTURED FOR DELIVERY OF MEDICAL AGENTS, now U.S. Pat. No. 7,673,783, and U.S. patent application Ser. No. 11/267,383 entitled SURGICAL STAPLING INSTRUMENTS STRUCTURED FOR PUMP-ASSISTED DELIVERY OF MEDICAL AGENTS, now U.S. Pat. No. 7,607,557, both of which are also incorporated herein by reference, disclose cutting instruments that uses adhesives to fasten the severed tissue. Accordingly, although the description herein refers to cutting/stapling operations and the like, it should be recognized that this is an exemplary embodiment and is not meant to be limiting. Other tissue-fastening techniques may also be used. -
FIGS. 67 and 68 are exploded views andFIG. 69 is a side view of theend effector 4016 andshaft 4014 according to various embodiments. As shown in the illustrated embodiment, theshaft 4014 may include aproximate closure tube 4072 and adistal closure tube 4074 pivotably linked by apivot links 4076. Thedistal closure tube 4074 includes anopening 4078 into which thetab 4044 on theanvil 4028 is inserted in order to open and close theanvil 4028, as further described below. Disposed inside theclosure tubes proximate spine tube 4079. Disposed inside theproximate spine tube 4079 may be a main rotational (or proximate)drive shaft 4080 that communicates with a secondary (or distal)drive shaft 4082 via abevel gear assembly 4084. Thesecondary drive shaft 4082 is connected to adrive gear 4086 that engages aproximate drive gear 4088 of thehelical screw shaft 4040. Thevertical bevel gear 4084 b may sit and pivot in anopening 4090 in the distal end of theproximate spine tube 4079. Adistal spine tube 4092 may be used to enclose thesecondary drive shaft 4082 and the drive gears 4086, 4088. Collectively, themain drive shaft 4080, thesecondary drive shaft 4082, and the articulation assembly (e.g., thebevel gear assembly 4084 a-c) are sometimes referred to herein as the “main drive shaft assembly.” - A bearing 4094 (
FIG. 69 ) positioned at a distal end of thestaple channel 4026 receives thehelical screw shaft 4040, allowing thehelical screw shaft 4040 to freely rotate with respect to thechannel 4026. Thehelical screw shaft 4040 may interface a threaded opening (not shown) of thecutting instrument 4034 such that rotation of thehelical screw shaft 4040 causes thecutting instrument 4034 to translate distally or proximately (depending on the direction of the rotation) through thestaple channel 4026. Accordingly, when themain drive shaft 4080 is caused to rotate by actuation of the firing trigger 4024 (as explained in further detail below), thebevel gear assembly 4084 a-c causes thesecondary drive shaft 4082 to rotate, which in turn, because of the engagement of the drive gears 4086, 4088, causes thehelical screw shaft 4040 to rotate, which causes thecutting instrument 4034 to travel longitudinally along thechannel 4026 to cut any tissue clamped within theend effector 4016. Thesled 4036 may be made of, for example, plastic, and may have a sloped distal surface. As thesled 4036 traverses thechannel 4026, the sloped distal surface may cam thestaple drivers 4060 upward, which in turn push up or drive thestaples 4062 in thestaple cartridge 4038 through the clamped tissue and against the staple forming undersurface 4066 of theanvil 4028, thereby stapling the severed tissue. When thecutting instrument 4034 is retracted, thecutting instrument 4034 and thesled 4036 may become disengaged, thereby leaving thesled 4036 at the distal end of thechannel 4026. -
FIGS. 70-73 illustrate an exemplary embodiment of a motor-driven endocutter, and in particular thehandle 4012 thereof, that provides operator-feedback regarding the deployment and loading force of thecutting instrument 4034 in theend effector 4016. In addition, the embodiment may use power provided by the operator in retracting thefiring trigger 4024 to power the device (a so-called “power assist” mode). As shown in the illustrated embodiment, thehandle 4012 includes exteriorlower side pieces upper side pieces 4100, 4102 that fit together to form, in general, the exterior of thehandle 4012. Abattery 4104 may be provided in thepistol grip portion 4030 of thehandle 4012. Thebattery 4104 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO2 or LiNiO2, a Nickel Metal Hydride chemistry, etc. Thebattery 4104 powers amotor 4106 disposed in an upper portion of thepistol grip portion 4030 of thehandle 4012. According to various embodiments, themotor 4106 may be a DC brushed driving motor having a maximum rotation of approximately 5000 to 100,000 RPM. Themotor 4106 may drive a 90-degreebevel gear assembly 4108 comprising afirst bevel gear 4110 and asecond bevel gear 4112. Thebevel gear assembly 4108 may drive aplanetary gear assembly 4114. Theplanetary gear assembly 4114 may include apinion gear 4116 connected to adrive shaft 4118. Thepinion gear 4116 may drive amating ring gear 4120 that drives ahelical gear drum 4122 via adrive shaft 4124. Aring 4126 may be threaded on thehelical gear drum 4122. Thus, when themotor 4106 rotates, thering 4126 is caused to travel along thehelical gear drum 4122 by means of the interposedbevel gear assembly 4108,planetary gear assembly 4114 andring gear 4120. - The
handle 4012 may also include arun motor sensor 4128 in communication with thefiring trigger 4024 to detect when thefiring trigger 4024 has been drawn in (or “closed”) toward thepistol grip portion 4030 of thehandle 4012 by the operator to thereby actuate the cutting/stapling operation by theend effector 4016. Thesensor 4128 may be a proportional sensor such as, for example, a rheostat or variable resistor. When thefiring trigger 4024 is drawn in, thesensor 4128 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to themotor 4106. When thesensor 4128 is a variable resistor or the like, the rotation of themotor 4106 may be generally proportional to the amount of movement of thefiring trigger 4024. That is, if the operator only draws or closes thefiring trigger 4024 in a little bit, the rotation of themotor 4106 is relatively low. When thefiring trigger 4024 is fully drawn in (or in the fully closed position), the rotation of themotor 4106 is at its maximum. In other words, the harder the operator pulls on thefiring trigger 4024, the more voltage is applied to themotor 4106, causing a greater rate of rotation. In another embodiment, for example, a microcontroller (e.g., themicrocontroller 4250 ofFIG. 92 ) may output a PWM control signal to themotor 4106 based on the input from thesensor 4128 in order to control themotor 4106. - The
handle 4012 may include amiddle handle piece 4130 adjacent to the upper portion of thefiring trigger 4024. Thehandle 4012 also may comprise abias spring 4132 connected between posts on themiddle handle piece 4130 and thefiring trigger 4024. Thebias spring 4132 may bias thefiring trigger 4024 to its fully open position. In that way, when the operator releases thefiring trigger 4024, thebias spring 4132 will pull thefiring trigger 4024 to its open position, thereby removing actuation of thesensor 4128, thereby stopping rotation of themotor 4106. Moreover, by virtue of thebias spring 4132, any time an operator closes thefiring trigger 4024, the operator will experience resistance to the closing operation, thereby providing the operator with feedback as to the amount of rotation exerted by themotor 4106. Further, the operator could stop retracting thefiring trigger 4024 to thereby remove force from thesensor 4128, to thereby stop themotor 4106. As such, the operator may stop the deployment of theend effector 4016, thereby providing a measure of control of the cutting/fastening operation to the operator. - The distal end of the
helical gear drum 4122 includes adistal drive shaft 4134 that drives aring gear 4136, which mates with apinion gear 4138. Thepinion gear 4138 is connected to themain drive shaft 4080 of the main drive shaft assembly. In that way, rotation of themotor 4106 causes the main drive shaft assembly to rotate, which causes actuation of theend effector 4016, as described above. - The
ring 4126 threaded on thehelical gear drum 4122 may include apost 4140 that is disposed within aslot 4142 of a slottedarm 4144. The slottedarm 4144 has anopening 4146 itsopposite end 4148 that receives apivot pin 4150 that is connected between the handleexterior side pieces pivot pin 4150 is also disposed through anopening 4152 in thefiring trigger 4024 and anopening 4154 in themiddle handle piece 4130. - In addition, the
handle 4012 may include a reverse motor (or end-of-stroke)sensor 4156 and a stop motor (or beginning-of-stroke)sensor 4158. In various embodiments, thereverse motor sensor 4156 may be a normally-open limit switch located at the distal end of thehelical gear drum 4122 such that thering 4126 threaded on thehelical gear drum 4122 contacts and closes thereverse motor sensor 4156 when thering 4126 reaches the distal end of thehelical gear drum 4122. Thereverse motor sensor 4156, when closed, sends a signal to themotor 4106 to reverse its rotation direction, thereby retracting thecutting instrument 4034 of theend effector 4016 following a cutting operation. - The
stop motor sensor 4158 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of thehelical gear drum 4122 so that thering 4126 opens theswitch 4158 when thering 4126 reaches the proximate end of thehelical gear drum 4122. - In operation, when an operator of the
instrument 4010 pulls back thefiring trigger 4024, thesensor 4128 detects the deployment of thefiring trigger 4024 and sends a signal to themotor 4106 to cause forward rotation of themotor 4106 at, for example, a rate proportional to how hard the operator pulls back thefiring trigger 4024. The forward rotation of themotor 4106 in turn causes thering gear 4120 at the distal end of theplanetary gear assembly 4114 to rotate, thereby causing thehelical gear drum 4122 to rotate, causing thering 4126 threaded on thehelical gear drum 4122 to travel distally along thehelical gear drum 4122. The rotation of thehelical gear drum 4122 also drives the main drive shaft assembly as described above, which in turn causes deployment of thecutting instrument 4034 in theend effector 4016. That is, thecutting instrument 4034 andsled 4036 are caused to traverse thechannel 4026 longitudinally, thereby cutting tissue clamped in theend effector 4016. Also, the stapling operation of theend effector 4016 is caused to happen in embodiments where a stapling-type end effector is used. - By the time the cutting/stapling operation of the
end effector 4016 is complete, thering 4126 on thehelical gear drum 4122 will have reached the distal end of thehelical gear drum 4122, thereby causing thereverse motor sensor 4156 to be actuated, which sends a signal to themotor 4106 to cause themotor 4106 to reverse its rotation. This in turn causes thecutting instrument 4034 to retract, and also causes thering 4126 on thehelical gear drum 4122 to move back to the proximate end of thehelical gear drum 4122. - The
middle handle piece 4130 includes abackside shoulder 4160 that engages the slottedarm 4144 as best shown inFIGS. 71 and 72 . Themiddle handle piece 4130 also has aforward motion stop 4162 that engages thefiring trigger 4024. The movement of the slottedarm 4144 is controlled, as explained above, by rotation of themotor 4106. When the slottedarm 4144 rotates CCW as thering 4126 travels from the proximate end of thehelical gear drum 4122 to the distal end, themiddle handle piece 4130 will be free to rotate CCW. Thus, as the operator draws in thefiring trigger 4024, thefiring trigger 4024 will engage theforward motion stop 4162 of themiddle handle piece 4130, causing themiddle handle piece 4130 to rotate CCW. Due to thebackside shoulder 4160 engaging the slottedarm 4144, however, themiddle handle piece 4130 will only be able to rotate CCW as far as the slottedarm 4144 permits. In that way, if themotor 4106 should stop rotating for some reason, the slottedarm 4144 will stop rotating, and the operator will not be able to further draw in thefiring trigger 4024 because themiddle handle piece 4130 will not be free to rotate CCW due to the slottedarm 4144. -
FIGS. 74 and 75 illustrate two states of a variable sensor that may be used as therun motor sensor 4128 according to various embodiments of the present invention. Thesensor 4128 may include aface portion 4164, a first electrode (A) 4166, a second electrode (B) 4168, and a compressible dielectric material 4170 (e.g., EAP) between theelectrodes sensor 4128 may be positioned such that theface portion 4164 contacts thefiring trigger 4024 when retracted. Accordingly, when thefiring trigger 4024 is retracted, thedielectric material 4170 is compressed, as shown inFIG. 75 , such that theelectrodes electrodes electrodes dielectric material 4170 is compressed due to retraction of the firing trigger 4024 (denoted as force “F” inFIG. 75 ) is proportional to the impedance between theelectrodes motor 4106. - Components of an exemplary closure system for closing (or clamping) the
anvil 4028 of theend effector 4016 by retracting theclosure trigger 4022 are also shown inFIGS. 70-73 . In the illustrated embodiment, the closure system includes ayoke 4172 connected to theclosure trigger 4022 by apin 4174 that is inserted through aligned openings in both theclosure trigger 4022 and theyoke 4172. Apivot pin 4176, about which theclosure trigger 4022 pivots, is inserted through another opening in theclosure trigger 4022 which is offset from where thepin 4174 is inserted through theclosure trigger 4022. Thus, retraction of theclosure trigger 4022 causes the upper part of theclosure trigger 4022, to which theyoke 4172 is attached via thepin 4174, to rotate CCW. The distal end of theyoke 4172 is connected, via apin 4178, to afirst closure bracket 4180. Thefirst closure bracket 4180 connects to asecond closure bracket 4182. Collectively, theclosure brackets FIG. 67 ) is seated and held such that longitudinal movement of theclosure brackets proximate closure tube 4072. Theinstrument 4010 also includes aclosure rod 4184 disposed inside theproximate closure tube 4072. Theclosure rod 4184 may include awindow 4186 into which apost 4188 on one of the handle exterior pieces, such as exteriorlower side piece 4096 in the illustrated embodiment, is disposed to fixedly connect theclosure rod 4184 to thehandle 4012. In that way, theproximate closure tube 4072 is capable of moving longitudinally relative to theclosure rod 4184. Theclosure rod 4184 may also include adistal collar 4190 that fits into acavity 4192 inproximate spine tube 4079 and is retained therein by a cap 4194 (seeFIG. 67 ). - In operation, when the
yoke 4172 rotates due to retraction of theclosure trigger 4022, theclosure brackets proximate closure tube 4072 to move distally (i.e., away from thehandle 4012 of the instrument 4010), which causes thedistal closure tube 4074 to move distally, which causes theanvil 4028 to rotate about thepivot point 4042 into the clamped or closed position. When theclosure trigger 4022 is unlocked from the locked position, theproximate closure tube 4072 is caused to slide proximally, which causes thedistal closure tube 4074 to slide proximally, which, by virtue of thetab 4044 being inserted in theopening 4078 of thedistal closure tube 4074, causes theanvil 4028 to pivot about thepivot point 4042 into the open or unclamped position. In that way, by retracting and locking theclosure trigger 4022, an operator may clamp tissue between theanvil 4028 andchannel 4026, and may unclamp the tissue following the cutting/stapling operation by unlocking theclosure trigger 4022 from the locked position. - According to various embodiments, the
instrument 4010 may include an interlock for preventinginstrument 4010 operation when thestaple cartridge 4038 is not installed in thechannel 4026, or when thestaple cartridge 4038 is installed in thechannel 4026 but spent. Operation of the interlock is twofold. First, in the absence of anunspent staple cartridge 4038 within thechannel 4026, the interlock operates to mechanically block distal advancement of thecutting instrument 4034 through thechannel 4026 in response to actuation of thefiring trigger 4024. Using suitable electronics disposed within thehandle 4012, the interlock next detects the increase in current through themotor 4106 resulting from the immobilized cuttinginstrument 4034 and consequently interrupts current to themotor 4106. Advantageously, the interlock eliminates the need for electronic sensors in theend effector 4016, thus simplifying instrument design. Moreover, because the magnitude and duration of mechanical blocking force needed to produce the detected increase in motor current is significantly less than that which would be exerted if only a conventional mechanical interlock was used, physical stresses experienced by instrument components are reduced. - According to various embodiments, the interlock may include (1) a blocking mechanism to prevent actuation of the
cutting instrument 4034 by themotor 4106 when anunspent staple cartridge 4038 is not installed in thechannel 4026, and (2) a lockout circuit to detect the current through themotor 4106 and to interrupt the current through themotor 4106 based on the sensed current. -
FIG. 94 is a flow diagram of the process implemented by the interlock according to various embodiments. Atstep 4264, the actuation of thecutting instrument 4034 by themotor 4106 is mechanically blocked by the blocking mechanism in the absence of anunspent staple cartridge 4038 within thechannel 4026. As discussed below, the blocking mechanism may include components or features of conventional mechanical interlocks. - At
step 4266, the current through themotor 4106 resulting from the blocked actuation of thecutting instrument 4034 is detected by the lockout circuit. As discussed below, detection of the current may include, for example, the steps of sensing the motor current, generating a signal representative of the sensed motor current, and comparing the generated signal to a threshold signal. - At
step 4268, the current through themotor 4106 is interrupted based on the detected current. Interrupting the current may include, for example, interrupting the current when the result of the comparison atstep 4266 indicates that the generated signal exceeds the threshold signal. Interrupting the current through themotor 4106 may further include interrupting the current based on a position of thecutting instrument 4034. - According to various embodiments, the blocking mechanism of the interlock may include features similar or identical to those of conventional mechanical interlocks for physically blocking advancement of the
cutting instrument 4034 in the absence of anunspent staple cartridge 4038 within thechannel 4026.FIG. 76 illustrates ablocking mechanism 4196 according to one embodiment. As shown, theblocking mechanism 4196 may comprise a pair ofspring fingers 4198 positioned in thechannel 4026. In particular, thespring fingers 4196 may raise up to block themiddle pins 4050 of thecutting instrument 4034 when the sled 4036 (not shown inFIG. 76 ) is not present in an unfired position at the proximal end of thechannel 4026, such as when thestaple cartridge 4038 is not installed or when thestaple cartridge 4038 is installed but spent. Although twospring fingers 4198 are shown, it will be appreciated that more orfewer spring fingers 4198 may be used instead. -
FIGS. 77-80 depict the operation of thespring fingers 4198 sequentially as theinstrument 4010 is fired. InFIG. 77 , anunspent staple cartridge 4038 has been inserted into thechannel 4026. The presence of thesled 4036 in its unfired position depresses thespring fingers 4198 such that the firingdrive slot 4200 through which themiddle pins 4050 will pass is unimpeded. - In
FIG. 78 , firing of thestaple cartridge 4038 has commenced, with thesled 4036 and themiddle pins 4050 of thecutting instrument 4034 having distally traversed off of thespring fingers 4198, which then spring up into thefiring drive slot 4200. - In
FIG. 79 , thestaple cartridge 4038 is now spent with thesled 4036 fully driven distally and no longer depicted. Thecutting instrument 4034 is being retracted proximally. Since thespring fingers 4198 pivot from a more distal point, themiddle pins 4050 of thecutting instrument 4034 are able to ride up onto thespring fingers 4198 during retraction, causing them to be depressed out of thefiring drive slot 4200. - In
FIG. 80 , thecutting instrument 4034 is fully retracted and now confronts the non-depressed pair ofspring fingers 4198 to prevent distal movement. Theblocking mechanism 4196 thereby remains activated until anunspent staple cartridge 4038 is installed in thechannel 4026. -
FIG. 81 depicts ablocking mechanism 4202 according to another embodiment. Theblocking mechanism 4202, which is disclosed in U.S. Pat. No. 7,044,352 referenced above, includes a pair ofhooks 4204 having ramped ends 4206 distally placed with regard toattachment devices 4208. Theattachment devices 4208 are inserted throughapertures 4210 in thechannel 4026, thereby springedly attaching thehooks 4204 to thechannel 4026. The ramped ends 4206 lie above ahook recess 4212 defined in thechannel 4026. Thus, when each rampedend 4206 is contacted by thesled 4036 of an unspent staple cartridge 4038 (not shown inFIG. 81 ), the ramped ends 4206 are depressed into thehook recess 4212, thereby clearing the way for themiddle pins 4050 of thecutting instrument 4034 to move distally through the firingdrive slot 4200 so that thestaple cartridge 4038 may be actuated. Athin shaft 4214 coupling theattachment devices 4208 respectively to the rampedend 4206 of eachhook 4204 resiliently responds to absence of thesled 4036, as depicted, wherein the ramped ends 4206 return to impede thefiring drive slot 4200 to block the retractedmiddle pins 4050 of thecutting instrument 4034. Although twohooks 4204 are shown, it will be appreciated that more orfewer hooks 4204 may be used instead. -
FIGS. 82-85 depict the sequence of operation of thehooks 4204. InFIG. 82 , thestaple cartridge 4038 is unspent so that the distally positionedsled 4036 depresses the ramped ends 4206 into thehook recess 4212, allowing themiddle pins 4050 of thecutting instrument 4034 to move distally through the firingdrive slot 4200 during firing, as depicted inFIG. 83 . With thesled 4036 andmiddle pins 4050 distally removed with respect to theblocking mechanism 4202, the ramped ends 4206 resiliently raise out of thehook recess 4212 to occupy thefiring drive slot 4200. - In
FIG. 84 , thecutting instrument 4034 is being retracted to the point of contacting the ramped ends 4206 of thehooks 4204. Since the distal end of the ramped ends 4206 is lower than the proximal part of the ramped ends 4206, themiddle pins 4050 of thecutting instrument 4034 ride over the ramped ends 4206, forcing them down into thehook recess 4212 until themiddle pins 4050 are past the ramped ends 4206, as depicted inFIG. 85 , wherein the ramped ends 4206 resiliently spring back up to block the middle pins 4050. Thus, thecutting instrument 4034 is prevented from distal movement until anunspent staple cartridge 4038 is installed in thechannel 4026. -
FIG. 86 depicts ablocking mechanism 4216 according to yet another embodiment. Theblocking mechanism 4216 is integrally formed with thestaple cartridge 4038 and includes proximally projecting blockingmembers 4218 resiliently positioned above the sled 4036 (not shown inFIG. 86 ). In particular, the blockingmembers 4218 each reside within a downward andproximally opening cavity 4220. Each blockingmember 4218 includes aleaf spring end 4222 that is held within thecavity 4220. - The
cavities 4220 are vertically aligned and spaced and parallel about a proximally presentedvertical slot 4224 in thestaple cartridge 4038 through which the cutting surface 4056 (not shown inFIG. 86 ) passes. Thestaple cartridge 4038 also includesslots 4226 that longitudinally pass through thestaple cartridge 4038, being open from a portion of a proximal and underside of thestaple cartridge 4038 to receive thesled 4036. - Each blocking
member 4218 has adeflectable end 4228 having a rampeddistal side 4227 and blockingproximal side 4229. The blockingmembers 4218 are shaped to reside within theirrespective cavities 4220 when depressed and to impede the distally movingmiddle pins 4050 of thecutting instrument 4034 when released. -
FIGS. 87-90 depict theblocking mechanism 4216 sequentially as theinstrument 4010 is fired. InFIG. 87 , anunspent staple cartridge 4038 has been inserted into thechannel 4026 with thesled 4036 depressing upward the deflectable ends 4228 so that the firingdrive slot 4200 is unimpeded. - In
FIG. 88 , firing of thestaple cartridge 4038 has commenced, with thesled 4036 and themiddle pins 4050 of thecutting instrument 4034 having distally traversed past the deflectable ends 4228, which then spring down into thefiring drive slot 4200. - In
FIG. 89 , thestaple cartridge 4038 is now spent with thesled 4036 fully driven distally and no longer depicted. Thecutting instrument 4034 is being retracted proximally. Since the deflectable ends 4228 pivot from a more distal point, themiddle pins 4050 of thecutting instrument 4034 are able to ride under the rampeddistal sides 4227 of the deflectable ends 4228 during retraction, causing them to be depressed up, out of thefiring drive slot 4200. - In
FIG. 90 , thecutting instrument 4034 is fully retracted and themiddle pints 4050 now confront the blockingproximal sides 4229 of the non-depressed (released) pair of deflectable ends 4228 to prevent distal movement. Theblocking mechanism 4216 thereby remains activated until anunspent staple cartridge 4038 is installed in thechannel 4026. - The blocking
mechanisms -
FIG. 91 is a schematic diagram of anelectrical circuit 4231 of theinstrument 4010 according to various embodiments of the present invention. In certain embodiments, thecircuit 4231 may be housed within thehandle 4012. In addition to thesensor 4128,sensors 4156, 4158 (depicted as a normally-open limit switch and a normally-closed limit switch, respectively), thebattery 4104, and themotor 4106, thecircuit 4231 may include a single-pole double-throw relay 4230, a single-pole single-throw relay 4232, a double-pole double-throw relay 4234, acurrent sensor 4236, aposition sensor 4238, and acurrent detection module 4240.Relay 4232, thecurrent sensor 4236, theposition sensor 4238, and thecurrent detection module 4240 collectively form alockout circuit 4241. As described below, thelockout circuit 4241 operates to sense the current through themotor 4106 and to interrupt the current based upon the sensed current, thus “locking out” theinstrument 4010 by disabling its operation. - As described above,
sensor 4128 is activated when an operator pulls in thefiring trigger 4024 after locking theclosure trigger 4022. Whenswitch 4156 is open (indicating that the cutting/stapling operation of theend effector 4016 is not yet complete),coil 4242 ofrelay 4230 is de-energized, thus forming a conductive path between thebattery 4104 andrelay 4232 via a normally-closed contact ofrelay 4230.Coil 4244 ofrelay 4232 is controlled by thecurrent detection module 4240 and theposition sensor 4238 as described below. Whencoil 4244 is de-energized andcoil 4242 is de-energized, a conductive path between thebattery 4104 and a normally-closed contact ofrelay 4234 is formed.Relay 4234 controls the rotational direction of themotor 4106 based on the states ofswitches switch 4156 is open andswitch 4158 is closed (indicating that thecutting instrument 4034 has not yet fully deployed distally),coil 4246 ofrelay 4234 is de-energized. Accordingly, when coils 4242, 4244, 4246 are collectively de-energized, current from thebattery 4104 flows through themotor 4106 via the normally-closed contacts ofrelay 4234 and causes the forward rotation of themotor 4106, which in turn causes distal deployment of thecutting instrument 4034 as described above. - When
switch 4156 is closed (indicating that thecutting instrument 4034 has fully deployed distally),coil 4242 ofrelay 4230 is energized, andcoil 4246 ofrelay 4234 is energized via a normally-open contact ofrelay 4230. Accordingly, current now flows to themotor 4106 via normally-open contacts ofrelays motor 4106 which in turn causes thecutting instrument 4034 to retract from its distal position andswitch 4156 to open.Coil 4242 ofrelay 4230 remains energized untillimit switch 4158 is opened, indicating the complete retraction of thecutting instrument 4034. - The magnitude of current through the
motor 4106 during its forward rotation is indicative of forces exerted upon thecutting instrument 4034 during its deployment. As described above, the absence of anunspent staple cartridge 4038 in the channel 4026 (e.g., the presence of a spentstaple cartridge 4038 or the absence of astaple cartridge 4038 altogether) results in activation of theblocking mechanism cutting instrument 4034 is prevented. The resistive force exerted by theblocking mechanism instrument 4034 causes an increase in motor torque, thus causing motor current to increase to a level that is measurably greater than that present during a cutting and stapling operation. Accordingly, by sensing the current through themotor 4106, thelockout circuit 4241 may differentiate between deployment of thecutting instrument 4034 when anunspent cartridge 4038 is installed in thechannel 4026 versus deployment of thecutting instrument 4034 when anunspent cartridge 4038 is absent from thechannel 4026. - The
current sensor 4236 may be coupled to a path of thecircuit 4231 that conducts current to themotor 4106 during its forward rotation. Thecurrent sensor 4236 may be any current sensing device (e.g., a shunt resistor, a Hall effect current transducer, etc.) suitable for generating a signal (e.g., a voltage signal) representative of sensed motor current. The generated signal may be input to thecurrent detection module 4240 for processing therein, as described below. - According to various embodiments, the
current detection module 4240 may be configured for comparing the signal generated by thecurrent sensor 4236 to a threshold signal (e.g., a threshold voltage signal) to determine if theblocking mechanism instrument 4010, a suitable value of the threshold signal may be empirically determined a priori by, for example, measuring the peak signal generated by thecurrent sensor 4236 when thecutting instrument 4034 is initially deployed (e.g., over the first 0.06 inches of its distal movement) during a cutting and stapling operation, and when thecutting instrument 4034 is deployed and encounters the activatedblocking mechanism blocking mechanism - In certain embodiments and as shown in
FIG. 91 , thecurrent detection module 4240 may comprise acomparator circuit 4248 for receiving the threshold andcurrent sensor 4236 signals and generating a discrete output based on a comparison of the received signals. For example, thecomparator circuit 4248 may generate a 5 VDC output when the threshold signal is exceeded and a 0VDC output when the threshold signal is not exceeded. The threshold signal may be generated, for example, using a suitable signal reference circuit (e.g., a voltage reference circuit) (not shown). The design and operation of thecomparator circuit 4248 and signal reference circuit are well known in the art and are not described further herein. - The result of the threshold and
current sensor 4236 signal comparison is primarily of interest during the initial deployment (e.g., during the first 0.06 inches of distal movement) of thecutting instrument 4034. Accordingly, thecurrent detection module 4240 may limit the comparison based on the distal position of thecutting instrument 4034 as indicated by theposition sensor 4238. Theposition sensor 4238 may be any type of position sensing device suitable for generating a signal indicative of a distal position of thecutting instrument 4034. In one embodiment and as shown inFIG. 91 , for example, theposition sensor 4238 may be a normally-open Halleffect position switch 4238 that is actuated based on its proximity to a magnet mounted on thering 4126. Theposition switch 4238 may mounted within thehandle 4012 and operate such that when the distal position of the cutting instrument 4034 (as indicated by the position of ring 4126) is within a pre-determined distance (e.g., distal position <0.06 inches) of its proximal-most position, theposition switch 4238 is closed. Conversely, when the distal position of thecutting instrument 4034 exceeds the predetermined distance (e.g., distal position >0.06 inches), theposition switch 4238 is opened. Theposition switch 4238 may be connected in series with the output of thecomparator circuit 4248 to limit the comparison based on the position of thecutting instrument 4034. In this way, if the threshold signal is exceeded when the distal position of thecutting instrument 4034 is greater than pre-determined distance, the output of theposition switch 4238 will remain at 0VDC (according to the example presented above), regardless of the result of the comparison. It will be appreciated that other types of position sensors 4238 (e.g., mechanically-actuated limit switches, rotary potentiometers, etc.) may be used instead as an alternative to the Halleffect position switch 4238 described above. Additionally, it will be appreciated that auxiliary contacts (not shown) ofswitch 4158 may be used as an alternative to aseparate position sensor 4238. In embodiments in which theposition sensor 4238 does not include a switched output (e.g., when theposition sensor 4238 is a potentiometer or other analog-based position sensor), additional processing of theposition sensor 4236 output using, for example, a second comparator circuit, may be necessary. - As shown in
FIG. 91 , the output of theposition switch 4238 may be connected tocoil 4244 ofrelay 4232. Driver circuitry (not shown) between theposition switch 4238 and thecoil 4244 may be provided if necessary. Accordingly, if the signal generated by thecurrent sensor 4236 exceeds the threshold signal (indicating activation of theblocking mechanism cutting instrument 4034 is within the predetermined distance of its proximal-most position,coil 4244 will be energized. This causes normally-closed switch ofrelay 4232 to open, thereby interrupting current flow to themotor 4106 and removing the resistive force exerted by theblocking mechanism cutting instrument 4034. Importantly, because theblocking mechanism blocking mechanism end effector 4016, instrument design is simplified. -
FIG. 92 is a schematic diagram of anelectrical circuit 4249 of theinstrument 4010 according to another other embodiment of the present invention in which a processor-basedmicrocontroller 4250 is used to implement functionality of thelockout circuit 4241 described above. Although not shown for purposes of clarity, themicrocontroller 4250 may include components well known in the microcontroller art such as, for example, a processor, a random access memory (RAM) unit, an erasable programmable read-only memory (EPROM) unit, an interrupt controller unit, timer units, analog-to-digital conversion (ADC) and digital-to-analog conversion (DAC) units, and a number of general input/output (I/O) ports for receiving and transmitting digital and analog signals. Thecurrent sensor 4236 and theposition sensor 4238 may be connected to analog and digital inputs, respectively, of themicrocontroller 4250, and thecoil 4244 ofrelay 4232 may be connected to a digital output of themicrocontroller 4250. It will be appreciated that in embodiments in which the output of theposition sensor 4238 is an analog signal, theposition sensor 4238 may be connected to an analog input instead. Additionally, although thecircuit 4249 ofFIG. 92 includesrelays microcontroller 4250 may be used to control solid state switched outputs of themicrocontroller 4250. In such embodiments,switches microcontroller 4250. -
FIG. 93 is a flow diagram of a process implemented by themicrocontroller 4250 according to various embodiments. Atstep 4252, themicrocontroller 4250 receives the signal generated by thecurrent sensor 4236 via an analog input and converts the received signal into a corresponding digital current sensor signal. - At
step 4254, values of the digital current sensor signal are compared to a digital threshold value stored within themicrocontroller 4250. The digital threshold value may be, for example, a digitized representation of the threshold signal discussed above in connection withFIG. 91 . If all values of the digital current sensor signal are less than the digital threshold value, the process terminates atstep 4256. If a value of the digital current sensor signal exceeds the digital threshold value, the process proceeds to step 4258. - At
step 4258, theposition sensor 4238 input is processed to determine if thecutting instrument 4034 is within the predetermined distance of its proximal-most position. If thecutting instrument 4034 is not within the predetermined distance, the process is terminates atstep 4260. If thecutting instrument 4034 is within the predetermined distance, the process proceeds to step 4262. - At
step 4262, the digital output to corresponding tocoil 4244 is energized, thus causing the normally closed contacts ofrelay 4232 to open, which in turn interrupts the current flow to themotor 4106. - Although embodiments described above compare the magnitude of the current sensor signal (or a digitized version thereof) to a threshold signal or value, it will be appreciated that other metrics for analyzing the current sensor signal may additionally or alternatively be used to differentiate between deployment of the
cutting instrument 4034 when anunspent cartridge 4038 is installed in thechannel 4026 versus deployment of thecutting instrument 4034 when anunspent cartridge 4038 is absent from thechannel 4026. For example, thecurrent detection module 4240 or themicrocontroller 4250 may be configured to determine derivative and/or integral characteristics of the current sensor signal for comparison to corresponding thresholds signals or values. Additionally, in certain embodiments the current sensor signal may be processed prior to its analysis using, for example, signal conditioners and/or filters implementing one or more filter response functions (e.g., infinite impulse response functions). - The various embodiments of the present invention have been described above in connection with cutting-type surgical instruments. It should be noted, however, that in other embodiments, the inventive surgical instrument disclosed herein need not be a cutting-type surgical instrument, but rather could be used in any type of surgical instrument including remote sensor transponders. For example, it could be a non-cutting endoscopic instrument, a grasper, a stapler, a clip applier, an access device, a drug/gene therapy delivery device, an energy device using ultrasound, RF, laser, etc. In addition, the present invention may be in laparoscopic instruments, for example. The present invention also has application in conventional endoscopic and open surgical instrumentation as well as robotic-assisted surgery.
- The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
- Although the present invention has been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. For example, different types of end effectors may be employed. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modification and variations.
- Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Claims (21)
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US9358005B2 (en) | 2010-09-30 | 2016-06-07 | Ethicon Endo-Surgery, Llc | End effector layer including holding features |
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2011
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