WO2011007351A1

WO2011007351A1 - Surgical stapler assembly

Info

Publication number: WO2011007351A1
Application number: PCT/IL2010/000561
Authority: WO
Inventors: Noam Hassidov; Eran Brauner; Sigalit Portnoy
Original assignee: Fund For Medical Research - Rambam Medical Center
Priority date: 2009-07-13
Filing date: 2010-07-13
Publication date: 2011-01-20

Abstract

A surgical stapler having a mechanical drive cable assembly for the stapler mechanism separated spatially from the lockable joint used to align and grasp the stapler in its desired position. This enables the lockable joint to be constructed in a form which provides it with much greater freedom of motion than prior art joints. One implementation has a laterally attached drive cord assembly. In such a stapler, the length of the stapler is not compromised by the additional length of a cord bundle issuing axially from its end, as in prior art staplers, which limit maneuvering ability within the confines of a body cavity. The drive cord assembly can be attached to the stapler by means of a pivot, such that the stapler can be inserted into a body cavity with the drive cord assembly deployed collinearly, and once within the body cavity, rotated to its lateral position.

Description

SURGICAL STAPLER ASSEMBLY

FIELD OF THE INVENTION

The present invention relates to the field of surgical staplers, especially for use in the confined spaces typical of laparoscopic surgery, or of open surgery in confined locations such as in thoracic or rectal surgery.

BACKGROUND OF THE INVENTION

The use of staplers in laparoscopic and open surgery in modern medicine started more then three decades ago initially with the round stapler and later the straight stapler, each with its unique benefits and modes of operation.

The round stapler, used to create a circular anastomosis, comprises two parts: a round anvil with an outer diameter of 10-25 mm, and the stapling house that is generally connected via a flexible cable or ridged rod to an external handle. The handle enables the physician to (a) connect the anvil to the stapling house (b) retract and close the anvil onto the stapling house (c) fire the stapler. The following patent documents are believed to be representative of this type of prior art stapler WO 2006/079261, WO 2004/110285, US 6,119,913, US 5,467,911, US 4,485,817, US 4,473,077, US 2005/187576, US 4,488,523, US 4,576,167.

The straight stapler generally fires at least two lines of staples in a straight line, followed by a knife that cuts the tissue apart between the lines of staples. The stapling house is generally connected via a rod to an external handle. The rod might have joints or a flexible neck. The stapling housing and the rod are generally limited to an outer diameter of 12mm, which enables the insertion of the tool into the abdominal cavity via a standard 12mm laparoscopic port. The following patent documents are believed to be representative of this type of stapler: Straight stapler US 2008/308604, US2007/295780, US2007/084898; Straight stapler with one joint US2008/029575, US2005/006431; Straight stapler with two joints US2006/11 1209; Straight stapler with flexible neck US 4,610,383.

The straight stapler with a 90 degree deflector functions in the same manner as the straight stapler but with one main advantage, the stapling house is deflected through a 90 degree angle which enables the physician easy access to remote locations such as the rectum. The main disadvantage when using this stapler is that the physician can not introduce this tool via a standard 12mm laparoscopic port, and a long incision is required in the abdominal wall. The following patent documents are believed to be representative of this type of stapler: Straight stapler with 90 deg deflector without a flexible neck US5,465,894, US 4,728,020, US 2009/020584, US2007/278277, US2007/221702, US2007/215670, US2006/273135; Straight stapler with 90 deg deflector with a flexible neck US 5,452,836, US 5,405,073, US2005/113821, US2006/163312.

US7,404,508, US2008/0048002, US2007/0027469 and US2007/0073341, to K. W. Smith et al, describe stapler and cutting devices having a passive articulation joint that can be unlocked for alignment within the body cavity, and locked for rigidity during use.

The hand-held straight stapler functions in the same way as the straight stapler but for use in open surgery. The following patent documents are believed to be representative of this type of stapler: EP 2018826, US 2009/001122, WO 2008/057281, US 2005/230453, GB 1082821

The skin stapler is another member of the stapler family, used to close external wounds, and the clip applier is used to clip blood vessels in laparoscopic surgery.

The disclosures of each of the publications mentioned in this section and in other sections of the specification, are hereby incorporated by reference, each in its entirety.

SUMMARY OF THE INVENTION

The present disclosure describes new surgical staplers constructed such that they can be inserted through an incision or opening in a body cavity, having a limited cross section, such as a laparoscopic port, and yet are able to operate over a wide angular and spatial range within the limited confines of a surgical site within the body cavity. A first exemplary one of such staplers has a laterally attached drive cord assembly, such that the length of the stapler is not compromised by the additional length of the cord bundle issuing axially from its end, which would limit its maneuvering abilities within the body cavity. These advantages are also apparent for use in open surgery in confined spaces, such as in thoracic surgery. Since a laterally protruding cable bundle would impede the entry of the stapler through a standard laparoscopic port, according to another exemplary implementation of the presently claimed invention, the drive cord assembly can be attached to the stapler by means of a pivot, such that the stapler can be inserted into a body cavity with the drive cord assembly deployed collinearly with it, and once within the body cavity, the drive cord assembly can be rotated to its lateral position, so as not to impede the motion envelope of the stapler. In general, prior art surgical tools such as staplers, are inserted to their intended position at the surgical site by means of a rigid or partially jointed gripping rod, which then also transmits the activating commands to the tool to perform its intended action. In such an arrangement, the positioning mechanism of the tool and the activating mechanism of the tool are incorporated into the same handle-like element. The generally long dimensions of the handle-like element may then limit the maneuverability of the tool and the accessibility of the tool to tight locations, especially within the limited confines of the body cavity where the operation is being performed. A number of exemplary stapler systems are described, being typical of such mechanically actuated surgical tools, in which this maneuverability and accessibility limitation is removed by separating the holding mechanism and the actuating mechanism into disparate elements. A number of different approaches are presented using this concept.

One exemplary implementation is of a stapler with a spherical joint at its extremity, by which it can be held. This joint could advantageously be a spherical ball connected to the stapler, such that the spherical ball can be held by the forceps of a conventional surgical grasper tool, or a tool specifically designed for that purpose. This arrangement of a spherical ball held by the forceps enables the stapler to be readily held by the grasper in different orientations, with a change in orientation, if required, being simply achievable by relaxing the grip on the spherical ball and re-gripping it when the new orientation has been aligned. The use of such a spherical ball grip should enable it to be oriented and positioned with six degrees of freedom, since the spherical ball is free to rotate in any direction within the forceps. The provision of a rotary joint to enable the grasper shaft to rotate provides one axis of rotation which can be achieved without the need to release the grip on the spherical ball. The functional operation of the stapler may be provided by means of an actuating mechanism provided distinctly from the grasper rod defining the position and orientation of the stapler, as will now be expounded.

A possible method of use of the above-described staplers with a pivoted cable driving inlet and spherical joint grasping for insertion and maneuvering in a laparoscopic surgical procedure may be proposed using two or three laparoscopic ports. The stapler housing itself may be inserted through a first laparoscopic port using a flexible cable bundle attached by means of a pivoted connection to the stapler. A second laparoscopic port can be used for inserting into the body cavity a grasper tool, which can be used to orientate the stapler in a desired orientation, such as by gripping a spherical ball on the end of the stapler housing. A third laparoscopic port can optionally be used for inserting into the body cavity a grasper tool for manipulating the tissue to be operated on into the jaws of the stapler. By this means a versatile laparoscopic procedure can be performed enabling access for the surgeon to the point of operation even within surgical sites having limited lateral dimensions.

As an adaption of the above-mentioned system, an insertion tool is described by use of which the stapler can be inserted into the body cavity by means of a rigid insertion arm. This implementation uses an insertion tool with a hollow bore, attached to the stapler housing using a detachable connector. The drive cable bundle is passed from its actuating handle to the stapler through this insertion tool and its hollow bore. Once the stapler has been inserted through the laparoscopic port using this insertion tool, the detectable connector can be unmated and the rigid insertion grasping arm can be withdrawn over the cable bundle, leaving the stapler deployed within the body cavity with its flexible drive cable bundle deployed behind it, yet without the encumbrance of the rigid arm needed for inserting the stapler. Once the stapler is deployed freely within the body cavity, a second grasper can be inserted through a second laparoscopic port to align the stapler to its desired position, and optionally, a third grasper can be inserted through a third laparoscopic port to align the tissue within the stapler jaws.

Another exemplary stapler system described in this disclosure provides a solution by which two generally competing design constraints can be fulfilled. In order to operate within bodily cavities having limited internal dimensions, there is need for a stapler having a short length, such that its movement envelope will not be limited by the closeness of the walls of the body cavity. On the other hand, in order to provide drive motion to the stapling device and its cutting knife, electric motors or hydraulic cylinders are generally used. Such drives means are generally located in a lengthened housing connected to the end of the stapler housing itself. This increased length is in contradiction to the requirement of a short stapler assembly. Furthermore, if the drive motors or hydraulic cylinders are installed alongside the stapler such that its length is not increased, the increased diameter of the stapler assembly would not permit it to pass through the limited inside diameter of the laparoscopic port. In order to comply with these contrasting constraints, a stapler is described which has a geometrical shape capable of being changed by folding of the stapler housing. In the unfolded configuration, it has the form of a straight comparatively thin tube for insertion through the laparoscopic port. Once inserted, the stapler can be folded to a second configuration, in the form of a "U" shape, which though of larger lateral dimensions than the first configuration, is considerably shorter, such that it can be readily used in a limited volume body cavity. This foldable configuration thus enables the stapler to fulfill both of the above-mentioned competing functions of small overall diameter with short length.

One of the important features of the various implementations described hereinabove is that the drive cable assembly for the stapler operating mechanism is separated spatially from the lockable joint used to align and then grasp the stapler in its desired position. This enables the lockable joint to be constructed in a form which provides it with much greater freedom of motion than prior art joints, which are constructed with the drive cable assembly running through the grasping joint. This feature makes the staplers of the present disclosure substantially more useful and versatile, especially for operation within confined body cavities. According to various different exemplary implementations, such lockable joints can be constructed of interlocking tubular shapes, tightened against each other by means of a tensioning cord, or various alternative forms of universal joints, also locked by the use of tensioning cords.

Although the various implementations of the devices in this application have been described as relating to a surgical stapler assembly, it is to be understood that the invention is not intended to be limited just to stapler assemblies, but that the various configurations can equally well be applied for use in other mechanically actuated surgical tools, such as surgical scissors, or grasper tools, or a surgical distractor tool, or the like. In any such a tool in which the longitudinal dimensions or the position of attachment of the drive cable assembly may limit its maneuverability within a limited size body cavity, the various improvements and novel configurations described in this disclosure with respect to the stapler assemblies, may also be advantageously applied to other such surgical tools.

Furthermore, although the various implementations of the devices in this disclosure have generally been described with respect to their use for insertion though a laparoscopic port, it is to be understood that the invention is not intended to be limited for use just in laparoscopic surgery, but that the various configurations can equally well be applied for use in conventional surgery in cavities having limited dimensions, or through access incisions or openings having limited accessibility.

Amongst the exemplary implementations of the devices described in this disclosure, there is provided a surgical stapler assembly comprising:

(i) a stapler head comprising a staple housing and an anvil for gripping tissue to be stapled, (ii) a grasper arm adapted to grip the stapler head at a lockable joint, and (iii)at least one mechanically driven drive cable assembly for actuating the stapler head, the at least one drive cable assembly entering the stapler head at a location spatially separated from the lockable joint, such that the drive cable assembly does not traverse the lockable joint,

wherein the absence of a drive cable assembly traversing the lockable joint endows it with greater freedom of motion than that of a similar joint having a drive cable assembly traversing it.

In such a surgical stapler assembly, the lockable joint may take a number of alternative forms - a serial array of interlocking segments, threaded on a cable for locking them, or a universal joint, or a double universal joint. If the joint is a single or double universal joint, at least one axis of the crosspiece of the lockable joint may be equipped with a splined journal adapted to rotate within a splined bearing, such that lateral motion of the journal relative to the bearing locks that axis of the lockable joint. Alternatively, at least one axis of the crosspiece of the lockable joint may be equipped with a journal adapted to rotate freely within a bearing, such that application of a lateral force on the journal at an angle essentially perpendicular to its axis binds the journal to its bearing, thereby locking that axis of the lockable joint.

Any of the above described implementations may further comprise a steering assembly for aiming the surgical stapler head in a desired direction.

Additionally, alternative implementations of any of the above-described systems may further involve a surgical stapler assembly comprising:

(i) a staple housing,

(ii) an anvil for gripping tissue to be stapled, and

(iii) at least one mechanically driven drive cable assembly for actuating at least one of the anvil, a staple firing mechanism, and a cutting blade,

wherein the drive cable assembly is attached to the surgical stapler assembly at an orientation substantially different from the direction of the axis of the stapler assembly, such that the effective length of the stapler assembly is not increased by the presence of the drive cable assembly.

Such a surgical stapler assembly, may further comprise a pulley for rotating a longitudinal drive shaft in the stapler, the drive shaft actuating either of the staple firing mechanism and a cutting blade,

wherein the mechanically driven drive cable assembly comprises a pair of drive cables entering the surgical stapler assembly at an orientation substantially different from that of the axis of the stapler assembly, and wound around the pulley, such that mutually opposite motion of the pair of drive cables causes either of the staple firing mechanism and the cutting blade to operate.

According to another exemplary implementation, the surgical stapler assembly may further comprise a pulley attached to the anvil such that rotation of the pulley opens the anvil,

wherein the mechanically driven drive cable assembly comprises a pair of drive cables entering the surgical stapler assembly at an orientation substantially different from that of the axis of the stapler assembly, and wound around the pulley, such that mutually opposite motion of the pair of drive cables causes operation of the anvil.

In any of these surgical stapler assemblies incorporating a drive cable assembly, the orientation of the drive cable assembly is advantageously essentially perpendicular to the axis of the stapler assembly. Furthermore, the drive cable assembly may be attached by means of a pivot such that it can be aligned co-linearly with the stapler assembly for passage through an opening of limited cross section into a body cavity. In the latter case, the surgical stapler assembly may advantageously be of such a diameter that it can be inserted through a standard laparoscopic port when the drive cable assembly is aligned co- linearly with the stapler assembly.

Another exemplary implementation involves a surgical stapler assembly comprising:

(i) a stapler head having at least one protrusion jutting from its body, and

(ii) a surgical grasper whose forceps are adapted to grip the stapler by the protrusion, (iii) wherein the protrusion and the forceps are shaped such that the stapler can be gripped in any one of a plurality of directions when the grasper is closed on the protrusion.

In such a surgical stapler assembly, the at least one protrusion may be an essentially spherical ball, and the forceps are adapted to fit around the ball, or it may be in the form of at least one fin attached to the stapler head . Additionally, the at least one protrusion may be located on an extremity of the stapler head. The surgical grasper may advantageously comprise a rigid rod for directing the surgical grasper at its grasping target.

Furthermore, such surgical stapler assemblies may comprise:

(i) a stapling tool driven by means of a cable bundle connected to a staple activating handle, and (ii) a stapling tool handle attached demountably to the stapling tool by means of a hollow rigid arm, the cable bundle from the staple activating handle to the stapling tool passing through the hollow rigid arm,

wherein the hollow rigid arm is configured to enable insertion of the stapling tool through an opening of limited cross section into a body cavity, and wherein demounting of the stapling tool from the stapling tool handle enables the stapling tool to be oriented as desired in the bodily cavity unencumbered by the hollow rigid arm.

The stapling tool may advantageously be of such a diameter that it can be inserted through a standard laparoscopic port.

Still other example implementations involve a surgical stapler assembly comprising:

(i) a stapling head, and

(ii) a housing incorporating a motor assembly for actuating the stapler head, the housing being connected pivotably to the stapling head,

wherein the housing and the stapling head can be aligned essentially co-linearly when the assembly is to be inserted through an opening of limited cross section into a body cavity, and the housing can be rotated such that it is folded against the stapling head when the assembly is deployed within the body cavity.

The motor assembly may alternatively transfer its drive to actuate the stapler head either by means of at least one flexible drive cable, or through at least a pair of gear wheels, one of the gear wheels being located in the housing and one of the gear wheels being located in the stapler head, and wherein the pair of gear wheels are positioned such that they mesh when the housing is rotated such that it is folded against the stapling head.

The surgical stapler may advantageously be of such a diameter when folded that it can be inserted through a standard laparoscopic port.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully from the following detailed description of some exemplary implementations, taken in conjunction with the drawings in which:

Fig. IA illustrates schematically a general overview of an exemplary surgical stapler having a laterally connected cable driving inlet; Figs. IB- IG illustrate schematically a mode of operation of the stapler head, detailing the opening and closing cycle of the anvil and the staple firing cycle; Figs. IH- IJ illustrate schematically an exemplary cutting cycle using the staplers illustrated in Figs. IA- IG; and

Fig. IK shows a lateral cross section of the staplers of Figs. IA-I J;

Figs. 2A-2C illustrate schematically other mechanically driven surgical tools using the laterally connected cable driving inlet described in the previous Figs, where Figs. 2A-2B illustrate a surgical grasper, while Fig. 2C illustrates a pair of scissors;

Figs. 3A-3D illustrate schematically an exemplary stapler, such as those shown above, with a spherical joint by which it can be held;

Figs. 4A-4I schematically illustrate a stapler with a spherical joint of the type shown in

Figs. 3A-3D, and its grasping handle in several poses and in different modes of operation;

Figs. 5 A-5B illustrate schematically a stapler with a pivotal cable driving inlet;

Figs. 6A-6C present schematically a method of use of the above-described staplers with pivotal cable driving inlet and spherical joint grasping for insertion and maneuvering in a laparoscopic surgical procedure;

Figs. 7A-7E illustrate schematically a dual phase stapler with its actuating handles;

Figs. 8A-8B show a stapler having docking fins built into the body;

Figs. 9A-9B illustrates schematically a semi disposable stapler design, in which the only disposable part of the system is the stapler head;

Fig. 10 illustrates a stapler with a flexible neck augmented with a locking mechanism;

Figs. 1 IA-I IB illustrate a geometrical shape-changing stapler with a cable drive mechanism;

Figs. 12A-12B illustrate a geometrical shape-changing stapler with a cable drive mechanism;

Figs. 13A- 13 C illustrate schematically a stapler head connected to the operating handle by means of a lockable joint comprising a series of interlocking shapes;

Figs. 14A-14C illustrate schematically another exemplary rotary joint for use with the staplers of the present disclosure, incorporating a universal joint;

Figs. 15A-15C illustrate schematically another exemplary rotary joint, similar to that shown in Figs. 14A to 14 C but incorporating a double Cardan joint;

Figs. 16A-16D illustrate schematically an example of a splined pin locking mechanism for use with joints such as those of Figs 14A to 14C or 15A to 15C;

Figs. 17A-17C illustrate schematically an example of a smooth journal pin locking mechanism for use with joints such as those of Figs 14A to 14C or 15A to 15C; and Figs. 18A-18B illustrate schematically a mechanism for steering the stapler heads previously described in the previous figures.

DETAILED DESCRIPTION

Reference is now made to Fig. IA, which illustrates schematically a general overview of an exemplary stapler having a laterally connected cable driving inlet. Such an arrangement enables the stapler to operate in more restricted spaces than a prior art stapler having an axially end-connected operating cable. The stapler head 2 is connected laterally with a cable bundle 1 to the actuating handle A. The handle has levers designed to open and close the stapler head and to shoot the staples into the tissue. The actuating handle A could be replaced with a foot paddle or with electrical motors incorporated into a workstation.

Fig. IB-I G illustrate a mode of operation of the stapler head, detailing the opening and closing cycle of the anvil 11 and the staple firing cycle. Fig. IB illustrates a cut-away view of the stapler head, with the staple housing 10 and the anvil 11 closed. The actuating mechanism comprises a pair of driving cables 3 that pass through the cable bundle 1 to the handle A (Fig. IA) that supplies the power to move the cables linearly. The drive cables are wound around a drive pulley or wheel 16, such that application of linear motion to the cable 3 causes the drive wheel 16 to rotate on it main axis 16A. An eccentric connecting rod 14 is used as the actuating arm of the anvil, attached to the drive wheel by means of a pin 15 and to the anvil by pin 13. Rotation of the drive wheel 16 causes the connecting rod 14 to move upwards pivoting on its pin 15, forcing the anvil 11 to rotate around the anvil pin 12 and to open the stapler, as shown in Fig. 1C. The tissue 9 is inserted into the gap between the anvil 1 1 and the staple housing 10 and the stapler is closed in a reversed cycle, by pulling on the opposite end of the drive cable 3 such that the drive wheel rotates in the other direction.

According to another exemplary implementation, the open/close mechanism of the above-described staplers can be fitted with an internal locking mechanism as shown in the magnified view of the operating mechanism of the stapler in Fig. ID. The pin 15 of the connecting rod 14 is located, relative to the line 17 joining the anvil pin 17 with the axis 16A of the drive pulley 16, on the opposite side of the line 17 to the body of the stapler 10, 11, such that when the anvil is closed, forces exerted by the tissue to attempt to raise the anvil, such as due to tissue flexibility or due to the firing of the staples cycle, will not succeed in opening the anvil and freeing the tissue. This position is kept without the need to apply any forces via the cable 3. In Fig. ID, the pin 15 is shown to the right of the joining line 17.

Reference is now made to Figs. IE- IG illustrating the firing cycle of the staples. A second pair of drive cables 4 is wrapped around a pulley wheel 26, rotation of which causes rotation of the threaded rod 24 attached to the pulley 26. The threaded rod is used for actuating the staple firing mechanism. The threaded rod is held by bearings 25 at each of its ends. A staple firing hammer 20 is mounted on the threaded rod 24, like a nut. When the rod 24 rotates, the hammer moves along it forcing up pistons 21 that are limited to an upward sliding motion only. The pistons then push the staples 22 against a hollow 23 in the anvil 11, as a result of which, the staple edges close by changing their shape from a U shape as presented on Fig. IE to a C shape as presented on Fig. IF. As the staples 21 are driven upwards, they pierce the tissue or body part 9 and close when they encounter the hollows 23. Fig. IG shows the tissue completely stapled shut with the hammer 20 at its final position.

In Figs. IE- IG, the rotary sign at the right hand side of the axis of the threaded rod illustrates how the drive is transmitted to the threaded rod in prior art staplers, which use axial end drive mechanisms to operate the staple firing procedure. The anvil opening and closing mechanism may also be operated by such an end drive.

Reference is now made to Figs. IH-U, which schematically illustrates an exemplary cutting cycle using the staplers illustrated in Figs. 1A-1G. Fig. IH illustrates a stapler with lateral cable driving inlet and a cross sectional view of the knife 27, which may be contained within the hammer 20, and may be held stowed by means of the protrusion 28, until the hammer is moved from its home position. When the hammer is moved to commence the stapling cycle, as shown in Fig. II, the knife pops up, such as by means of being spring loaded 27A, through an elongate window in the stapler housing 29, enabling the knife to cut the tissue 9 following the staple firing action. Fig. U shows the knife at the end of its travel, after the tissue has been completely stapled and the cut completed. Fig. IK shows a schematic end view of the stapler, showing the firing/cutting drive cable 4 mounted around the firing pulley 26 rotating on its axis 24.

Reference is now made to Figs. 2A-2C, which illustrate schematically other examples of mechanically driven surgical tools using the laterally connected cable driving inlet described in the above Figures. Figs. 2A-2B illustrate a surgical grasping tool, with the opening and closing of the jaws 1OA, 1 IA activated by pulling on one or the other sides of the cable 3 A. The movable jaw HA of the grasper pivots around pin 12A. Fig. 2A shows the jaws open, while Fig. 2B shows the jaws locked shut. The opening and closing mechanisms shown are similar to those described for the staplers of Figs. 1A-1D. If a distractor tool is to be implemented, then the gripping profile should be disposed on the outer edges of the jaws, to grip the distracted tissue or bone as the jaws are opened.

Reference is now made to Fig. 2C, which illustrates schematically a pair of surgical scissors, constructed and operative in a similar manner to the grasper shown in Figs. 2A- 2B, but using scissor blades 1OB, 1 IB instead of jaws.

Reference is now made to Figs. 3A-3D, which illustrate schematically an exemplary stapler, such as those shown hereinabove, with a spherical joint by which it can be held. Fig. 3A illustrates a spherical ball 5 connected to the stapler. The spherical ball can be held by the forceps 6 of a grasper tool 7, and Figs. 3B-3D illustrate how this arrangement enables the stapler to be held in different orientations with the spherical forceps 6 closed on the spherical ball 5. The ball may be dimpled or roughened or have flats formed on its surfaces to ensure a slip-free grip. In order to change orientation, it is evident that there is need only to relax the tight grip on the ball, before regripping it in the new orientation, and there is no need to release the ball completely and thus to lose the spatial contact between tool and ball. A simple implementation of this grasping procedure could be achieved by use of two clamping positions, one of which firmly clamps the ball, and the other of which releases the grip sufficiently for the ball to be rotated. Though a ball shaped protrusion, being angularly isotropic, provides the most versatile means of gripping the stapler, it is to be understood that any other suitable protrusion which can be gripped may also be used, as will be expounded hereinbelow.

Reference is now made to Fig. 4A-4I which illustrate a stapler with such a spherical joint and its grasping handle in several poses and in different modes of operation. Fig. 4A shows an actuating handle A that opens and closes the stapler on the selected tissue, and fires the staples, generally with the concomitant cutting action. The rod 7 of the grasping tool is connected to another actuating handle B, which enables the rod to be rotated around its axis using the rotary bearing 30. The spherical forceps 6 may be actuated using a lever pivoted at pin 31. The lever can be locked in a closed condition once the stapler grasping position has been achieved. The second actuating handle B, acts as a grasper tool to locate and move the stapler spatially to its desired position and orientation. If Fig.4A, the actuating handles A, B, are shown as separate entities, though they could equally well be combined into a single tool. In Figs. 4B-4C, the spherical forceps 6 is shown grasping the spherical ball 5 such that the actuating handle and the stapler are co-linear. In Figs. 4D-4E, the stapler is shown held at an angle to the grasping tool to illustrate the lateral angular adjustment possible using this method of grasping. In Figs. 4F-4G the grasping tool is shown rotated about its axis 7, and in Figs. 4H-4I, all of the possible modes of rotation are shown, providing essentially 6 degrees of freedom to the stapler. The multiple degrees of freedom are achieved by combination of a rotation 34 about the rod, a rotation 35 around the spherical ball, and a rotation 36 of the stapler around its own longitudinal axis.

Reference is now made to Figs. 5A-5B which illustrates a stapler with pivotal cable driving inlet. The lateral drive cable entry stapler shown in the above examples has very versatile orientation capabilities within the bodily cavity in which it is functioning. However, the limited diameter of a standard laparoscopic entry port 8 would prevent it from being inserted into that body cavity. In order to overcome this limitation, the lateral cable driving inlet as shown in Fig. IA can be replaced with a pivotal cable driving inlet as shown in the exemplary stapler of Fig 5A. The cable bundle 1 is connected to a rotary housing 40 that can pivot about the axis of rotation. After the stapler has been inserted in to the body cavity with the cable bundle deployed co-linearly with the stapler, it can be rotated to the lateral entry position, as shown in Fig. 5B, to enable the stapler freer movement within the body cavity.

Reference is now made to Figs. 6A-6C which present schematically a possible method of use of the above-described staplers with pivotal cable driving inlet and spherical joint grasping for insertion and maneuvering in a laparoscopic surgical procedure. In Fig 6A, the stapler 2, operated by actuating handle A, is inserted manually through the laparoscopic port 8 with the cable bundle deployed co-linearly with the stapler body, and is then free to wander within the body cavity. The object of the procedure is to operate on the tissue 9 within that body cavity. Then as shown in Fig. 6B, a grasping tool operated by actuating handle B is inserted via a second laparoscopic port, to grasp the spherical ball 5 of the stapler body with the spherical forceps 6. Additionally, the cable bundle can now be swung into its lateral position. Then, as shown in Fig. 6C, with the help of a standard laparoscopic grasping tool C, the tissue 9 can optionally be maneuvered into the open stapler, and the operation on the tissue performed. Such a scenario may need to be operated using 2 operating personnel. If the hand operated handle A were to be replaced with a foot paddle, the procedure could easily be operated by a single physician.

Furthermore, the tool B used to grasp the spherical ball could be augmented with a rotation mechanism, as described in Figs. 4A-4I, thus enabling the physician more detailed movements. The tool B could be fabricated of flexible and bendable material, or it could have one or more elbow joints in the rod 7.

Reference is now made to Figs. 7A-7E, which illustrate a dual phase stapler with its actuating handles. This exemplary implementation is different from the procedures used with prior art rigid-arm staplers, in that the stapler described in Figs. 7A-7E incorporates two functional operations in one system. In the first phase, the tool is inserted in a rigid configuration in the same way as prior art staplers, but once the stapler is within the body cavity, it is converted to its second phase in which its drive cables become flexible such that the stapler can be readily maneuvered within the body cavity by use of the tools and method shown in Figs. 6A-6C. This system is now shown in detail in Figs. 7A-7E.

In Fig. 7A, there is shown schematically a holding tool D which grips the stapler 2 using a special connector 50, 51, whose function will be explained further in connection with Fig. 7D. The connector can be disconnected using a lever 55 in the tool's handle. The tool has a hollow rigid tube 52 through which is threaded the cable bundle 1 for activating the stapler by means of the stapler's own actuating handle A. In Fig. 7A, the situation is shown before insertion of the stapler head 2 into the body cavity. The rigid tool, with its rotary actuator 53 is used to position the stapler spatially and rotationally as best as is possible with its rigid arm, in order to grasp the tissue to be operated on.

In Fig. 7B, the system is shown with the tool D introduced via the laparoscopic port 8 into the body cavity, and with the stapler opened by means of the lever 56 on tool A, in order to grasp the tissue part 9. The physician then closes the stapler using the tool A, as shown in Fig. 7C, and as described hereinabove. However, using such a rigid arm tool may result in the tissue part being held in an unfavorable or unwieldy position for the treatment, and the tissue and the stapler head may not be optimally positioned for the planned stapling operation.

Reference is therefore made to Fig. 7D which illustrates how the system of the present disclosure enables these disadvantages to be overcome by use of the two part stapler holder, with its two separate functions. In Fig. 7D, the parts 50 and 51 of the special connector have been separated by actuation of the lever 55 in the tool actuating handle D. The connector 50, 51, may be any suitable demountable connector, such as a mechanical, a friction-based, a magnetic, an electro-magnetic or any other connector pair. The actuating handle D can then be pulled back, and the hollow tube 52 attached to handle D withdrawn from the laparoscopic port 8 with the flexible cable bundle 1 sliding through the hollow tube and remaining as the connection to the stapler within the body cavity from the stapler actuating handle A. In order to manipulate the stapler to the correct position and angle, a grasper tool can then be inserted through a second laparoscopic port, as shown above in the implementation of Fig. 6B. This is shown schematically in Fig. 7E, where one grasper tool C is shown inserted through the second port 8A to manipulate the stapler into position, and a second grasper tool C may be inserted through a third port 8B to manipulate the tissue 9 to guide it into position relative to the stapler. Once the tissue and stapler are optimally positioned and aligned relative to each other, the stapling and cutting (if applicable) action can be performed by use of the actuating handle A of the system.

Reference is now made to Figs. 8A-8B, which illustrate an alternative method to the use of spherical ball joint, by which the stapler may be grasped by means of the grasping tool. As presented in Fig. 7E, the grasping tool may be used to grasp the head of the stapler. Since the stapler head is generally fabricated of stainless steel and may have a round shape, it may be problematic to grasp using standard laparoscopic grasper tools. Figs. 8A-8B show a stapler having docking fins 60 built into the body. This enables an easy grip to be achieved when using the standard grasping tools 61 that are commonly used in the Operating Room. The fins could be fabricated from flexible materials to enable easy accesses via the laparoscopic port, or non-flexible fins could be attached to the stapler using rotary hinges, thus enabling the deployment of the fins after the stapler has been introduced in to the body through the laparoscopic port.

In prior art stapler systems, both the stapler head and the operating handle are generally disposable, which is wasteful of resources since the only part of the system which needs to be disposable is the stapler head itself 2. Reference is now made to Figs. 9A-9B, which illustrates a semi disposable stapler design in which the only disposable part of the system is the stapler head 2. The stapler head is attached by means of a connector 70, 71 to the cable bundle 1 and the actuating handle A, both of which are non-disposable and can be sterilized between surgeries and reused. The disposable element comprises the connector 70 connected to the stapler housing, while the mating part of the connector 71 is attached to the cable bundle 1 and is reusable.

Reference is now made to Fig. 10 which illustrates a stapler with flexible neck 75 augmented with a locking mechanism 76. The neck 75 is of the segmented type that can revert from flexible to non-flexible by turning the knob 76. This could be preformed mechanically or electronically. One exemplary implementation is the use of a series of metal tubular segments connected to each other with spherical joints at their ends. The cable bundle passes through the segmented tube. One end of the cable is connected to the stapler head 2 and the other end to the actuating knob 76. When the cable is loose, the metal tube segments and the spherical joints can move and rotate but when the knob is turned, the cable is tightened and the spherical joints lock, transforming the flexible neck into a stiff neck, while nevertheless keeping its curved shape. Further details of how this locking mechanism operates are shown in the implementation of Figs. 13A-13C. This implementation has the advantage over prior art stapler systems in that it can be inserted and maneuvered in a flexible configuration, but when needed, it can be locked in a rigid configuration for firmly positioning the stapler for operating on the subject tissue.

References now made to Figs. 1 IA-I IB and 12A-12B which illustrate staplers having characteristics that allow them to change their geometric profile. These stapler examples fulfill two generally competing design constraints: firstly, the stapler should be capable of being introduced via a laparoscopic port with limited diameter; secondly, the stapler should be able to fit into small anatomical cavities with limited space and to be maneuvered therein. One such example is the lower part of the pelvis where the rectum connects to the sigmoid colon. In order to comply with these constraints, a stapler with a geometrical shape capable of being changed is described. The stapler is constructed such that it has two different geometrical configurations. In Fig. 1 IA, there is shown the stapler in an unfolded configuration, in the form of a straight tube ready for insertion through the laparoscopic port. In Fig. 1 IB, there is shown the stapler in its folded configuration, in the form of a "U" shape such that it can be readily used in limited volume cavities. This foldable configuration thus enables the stapler to fulfill both of the above-mentioned competing functions of small overall diameter with short length.

Figs. 1 IA-I IB illustrate such a geometrical shape-changing stapler with a cable drive mechanism. In Fig. HA, an exemplary method of constructing such a foldable stapler is shown. The threaded staple firing drive rod 24 is connected by a flexible cable 90 having a sliding joint 91 such as a splined joint, to gear wheels 92, and is driven by an electrical motor 93 powered through electrical cables 94. The close/open mechanism of the anvil may be is driven by a helical gear 95 connected in a similar manner to a second electrical motor. The motor housing 81 and the stapler housing 80 are not rigidly connected, but rather may be hinged at a hinge joint 82, with the ensuing gap being covered by a flexible sheet of material 96 or a bellows. Fig. HB illustrates the stapler when in its closed configuration.

Figs. 12A-12B illustrate a similar geometrical shape-changing stapler with a gear driven mechanism. In this exemplary construction, the threaded staple firing drive rod 24 is connected to a cogwheel 100 and the motor 103 is connected via gear train 102 to another cogwheel 101. When the device is folded, such that the stapler housing 80 and the motor housing 81 are disposed side by side, as shown in Fig. 12B, the cogwheels 100,101, mesh since their spatial position has been designed accordingly, and power can be transferred from the motor 103 to the threaded rod 24, and the stapler operated. A locking mechanism may be provided to ensure that the motor housing and the stapler head maintain their mutual position. A similar mechanism can be used for transferring power from the second motor 104 through its geared driveshaft 105 to the opening and closing mechanism of the stapler jaw, using a helical gear (as shown above in Figs. 1 IA and 1 IB) or a 45° bevel gear in order to rotate the motion through 90° for actuating the anvil operating wheel.

The folding configurations shown in Figs. 11 A-12B may also be used to implement compact surgical grasper or distraction tools or surgical scissors, but in these cases only a single motor would be required to open or close the jaws of the tool.

According to further exemplary implementations, the stapler could be hydraulically operated through cylinders.

One of the features of the various above implementations described in this disclosure is that the drive cable assembly for the stapler operating mechanism is separated spatially from the lockable joint used to grasp the stapler. This enables the lockable joint to be constructed in a form which provides it with much greater freedom of motion than prior art joints, which are constructed with the drive cable assembly running through them. This feature makes the staplers of the present disclosure substantially more user-friendly, especially for operation within confined body cavities. A number of exemplary implementations of such lockable joints are now provided.

Reference is now made the Figs. 13 A to 13* C, which illustrate schematically a stapler head including the staple housing 10 and the anvil 11, connected to the operating handle by means of a lockable joint comprising a series of interlocking tubular shapes 130, loosely assembled on a tensioning cord 132. The shapes may advantageously have spherical ends so that they can rotate in all directions relative to each other. The tensioning cord 132 is shown in these drawings as terminated in a spherical ball 135, fitted into the innermost interlocking spherical shape 134, which is attached to the stapler body. As shown in Fig. 13 A, the stapler drive cable assembly 1 enters the stapler body in a location other than through the lockable joint. In Fig. 13 B, the lockable joint is shown adjusted to a suitable angle selected by the surgeon during the procedure. In Fig. 13B, the tensioning cord 132 is still slack, such that the interlocking spherical shapes are still separate and loosely threaded on the tensioning cord, enabling the angle of the lockable joint to be adjusted. In Fig. 13C, the tensioning cord 132 has been pulled tight, and since the most distal spherical ball 135 is trapped within the innermost spherical shape 134, the tension on the cord causes the interlocking shapes to lock together, thereby locking the joint in the position selected. The surface texture of the interlocking shapes must provide sufficient friction between adjacent elements that with an acceptable tension applied to the tensioning cord 132, the interlocked shapes provide the locking power required by the stapling application. This joint, and any of those described elsewhere in this disclosure, could be covered by a flexible membrane, in order to keep body fluids away from the operating mechanism, thus enabling smooth operation of the joint.

Reference is now made to Figs. 14A to 14C, which illustrate schematically another exemplary rotary joint for use with the staplers of the present disclosure. This joint is a double axis, universal joint 142, in which the grasping handle 140 is attached by means of two perpendicularly disposed journal pins 144, 146, rotating within the bearing surfaces of the universal joint. Figs. 14A and 14B show two perpendicular views of the universal jointj one from the side and one from the top, while Fig. 14C shows a side view with the stapler aligned at a large acute angle to the grasping handle. An example of a locking mechanism for use with such a joint will be shown in Figs 16A to 16D or in Figs. 17A to 17C hereinbelow.

Reference is now made to Figs. 15A to 15C, which illustrate schematically another exemplary rotary joint, similar to that shown in Figs. 14A to 14 C but with the grasping rod 150 attached to the stapler by means of a serial pair of twin axis, universal joints 152, in order to increase the flexibility of the joint. This joint is also known as a double Cardan joint. Such a double universal joint is capable of much larger angular orientations than the single universal joint shown in Figs. 14A to 14C. Figs. 15A and 15B show two perpendicular views of the pair of universal joints, one from the side and one from the top, while Fig. 15C shows a side view with the stapler aligned at a large obtuse angle to the grasping handle

Reference is now made to Figs. 16A to 16D, which illustrate schematically an example of a locking mechanism for use with joints such as those of Figs 14A to 14C or 15A to 15C. In Fig. 16A, there is shown a close-up view of universal joint shown in Fig. 14 A. The grasping arm 160 is attached to a yoke 163 rigidly connected to the stapler housing, by means of the universal joint. As shown in Fig 16D, the crosspiece 168 of the joint has splined journal pins 164, which fit into splined holes 166 in the grasping rod 160 and the attachment yoke 163 respectively. A tensioning cord 162 runs down the grasping rod 160 and is attached rigidly to the stapler housing. As shown in Fig. 16B, since the splined bearing hole 166 is larger than the diameter of the splined journal pin 164, so long as the tensioning cord is slack, the grasping rod 160 can rotate freely around the axis of the crosspiece journal pin 164. Likewise the other axis of the universal joint can rotate freely in the perpendicular direction. However as shown in Fig. 16C, as soon as the tensioning cord 162 is tightened, the stapler housing is pulled to the right in the drawing, and with it the attachment yoke 163 and the cross piece journal pins 164, such that the splines in the journal pins 164 lock against the splined inner surface of the hole 166 in the grasping rod 160. The same action takes place in the perpendicular direction, thereby locking the joint.

Reference is now made to Figs. 17A to 17C, which illustrate schematically another example of a locking mechanism, similar to that in Figs. 16A to 16D, but in which the crosspiece 178 has smooth journal pins 174, which rotate within bearing housings 176 in the attachment yoke 173. When the tensioning cord 172 is tightened, the journal pins 174 are tightened against the internal surfaces of the bearing housings 176, and lock the joint.

Reference is now made to Figs. 18A and 18B, which illustrate schematically one suggested method by which the stapler heads previously described can be steered by the surgeon, so that they are aimed along the direction desired by the surgeon. The example illustrated in Figs. 18A and 18B is that of a stapler having a universal joint, such as that shown in Figs. 14A to 14C, though it is to be understood that the method is applicable to any of the joints used for aligning such staplers.

The steering assembly 184 comprises in the case shown in Figs 18A, 18B, cords or wires 189A, 189B attached 185 to the yoke 182 which is rigidly connected to the stapler housing. Although only two cords are shown in Figs. 18A, 18B, it is to be understood that in general four cords will be needed, arranged orthogonally in pairs, in order to provide steering freedom in all directions. The cords may be maintained in their desired circumferential position around the grasping arm 183 by containing them within thin tubes 188A and 188B, which may be fixed to the grasping arm by means of a support ring 187. Fig. 18A shows the stapler housing lined up axially with the grasping arm 183. In Fig. 18B, cord 189A has been put under tension, and cord 189B released, such that the stapler housing makes an angle with the grasping arm with the cord 189 A on the inside of the angle of turning. A convenient way of generating the turning motion could be by having pairs of cords arranged as a closed loop around an external pulley, such that by rotating the pulley, the stapler turns in the desired direction. By co-ordinated manipulation of the relevant pairs of the four cords, it is possible to direct the stapler head in the direction desired by the surgeon.

It is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.

Claims

1. A surgical stapler assembly comprising:

a stapler head comprising a staple housing and an anvil for gripping tissue to be stapled;

a grasper arm adapted to grip said stapler head at a lockable joint; and at least one mechanically driven drive cable assembly for actuating said stapler head, said at least one drive cable assembly entering said stapler head at a location spatially separated from said lockable joint, such that said drive cable assembly does not traverse said lockable joint,

wherein said absence of a drive cable assembly traversing said lockable joint endows it with greater freedom of motion than that of a similar joint having a drive cable assembly traversing it.

2. A surgical stapler assembly according to claim 1, wherein said lockable joint is a serial array of interlocking segments, threaded on a cable for locking them.

3. A surgical stapler assembly according to claim 1, wherein said lockable joint is a universal joint.

4 A surgical stapler assembly according to claim 1, wherein said lockable joint is a double universal joint.

5 A surgical stapler assembly according to either of claims 3 and 4, wherein at least one axis of the crosspiece of said lockable joint has a splined journal adapted to rotate within a splined bearing, such that lateral motion of said journal relative to said bearing locks said at least one axis of said lockable joint.

6 A surgical stapler assembly according to either of claims 3 and 4, wherein at least one axis of the crosspiece of said lockable joint has ajournal adapted to rotate freely within a bearing, such that application of a lateral force on said journal at an angle essentially perpendicular to its axis binds said journal to its bearing, thereby locking said at least one axis of said lockable joint.

7. A surgical stapler assembly according to any of the previous claims, further comprising a steering assembly for aiming said surgical stapler head in a desired direction.

8. A surgical stapler assembly comprising:

a staple housing;

an anvil for gripping tissue to be stapled; and

at least one mechanically driven drive cable assembly for actuating at least one of said anvil, a staple firing mechanism, and a cutting blade,

wherein said drive cable assembly is attached to said surgical stapler assembly at an orientation substantially different from the direction of the axis of said stapler assembly, such that the effective length of said stapler assembly is not increased by the presence of said drive cable assembly.

9. A surgical stapler assembly according to claim 8, further comprising a pulley for rotating a longitudinal drive shaft in said stapler, said drive shaft actuating one of said staple firing mechanism and a cutting blade,

wherein said mechanically driven drive cable assembly comprises a pair of drive cables entering said surgical stapler assembly at an orientation substantially different from that of the axis of said stapler assembly, and wound around said pulley, such that mutually opposite motion of said pair of drive cables causes either of said staple firing mechanism and said cutting blade to operate.

10. A surgical stapler assembly according to claim 8, further comprising a pulley attached to said anvil such that rotation of said pulley opens said anvil,

wherein said mechanically driven drive cable assembly comprises a pair of drive cables entering said surgical stapler assembly at an orientation substantially different from that of the axis of said stapler assembly, and wound around said pulley, such that mutually opposite motion of said pair of drive cables causes operation of said anvil.

11. A surgical stapler assembly according to any of claims 8 to 10 wherein said orientation of said drive cable assembly is essentially perpendicular to the axis of said stapler assembly.

12. A surgical stapler assembly according to any of claims 8 to 10 wherein said drive cable assembly is attached by means of a pivot such that it can be aligned co-linearly with said stapler assembly for passage through an opening of limited cross section into a body cavity.

13. A surgical stapler assembly according to claim 12 wherein said surgical stapler assembly is of such a diameter that it can be inserted through a standard laparoscopic port when said drive cable assembly is aligned co-linearly with said stapler assembly.

14. A surgical stapler assembly comprising:

a stapler head having at least one protrusion jutting from its body; and a surgical grasper whose forceps are adapted to grip said stapler by said protrusion,

wherein said protrusion and said forceps are shaped such that said stapler can be gripped in any one of a plurality of directions when said grasper is closed on said protrusion.

15. A surgical stapler assembly according to claim 14, wherein said at least one protrusion is an essentially spherical ball, and said forceps are adapted to fit around said ball.

16. A surgical stapler assembly according to claim 14, wherein said at least one protrusion is located on an extremity of said stapler head.

17. A surgical stapler assembly according to claim 14, wherein said at least one protrusion is in the form of at least one fin attached to said stapler head.

18. A surgical stapler assembly according to claim 14, wherein said surgical grasper comprises a rigid rod for directing said surgical grasper at its grasping target.

19. A surgical stapler assembly comprising:

a stapling tool driven by means of a cable bundle connected to a staple activating handle; and a stapling tool handle attached demountably to said stapling tool by means of a hollow rigid arm, said cable bundle from said staple activating handle to said stapling tool passing through said hollow rigid arm,

wherein said hollow rigid arm is configured to enable insertion of said stapling tool through an opening of limited cross section into a body cavity, and wherein demounting of said stapling tool from said stapling tool handle enables said stapling tool to be oriented as desired in said bodily cavity unencumbered by said hollow rigid arm.

20. A surgical stapler assembly according to claim 19, wherein said stapling tool is of such a diameter that it can be inserted through a standard laparoscopic port.

21. A surgical stapler assembly comprising:

a stapling head; and

a housing incorporating a motor assembly for actuating said stapler head, said housing being connected pivotably to said stapling head;

wherein said housing and said stapling head can be aligned essentially co-linearly when said assembly is to be inserted through an opening of limited cross section into a body cavity, and said housing can be rotated such that it is folded against said stapling head when said assembly is deployed within said body cavity.

22. A surgical stapler assembly according to claim 21 wherein said motor assembly transfers its drive to actuate said stapler head by means of at least one flexible drive cable.

23. A surgical stapler assembly according to claim 21 wherein said motor assembly transfers its drive to actuate said stapler head through at least a pair of gear wheels, one of said gear wheels being located in said housing and one of said gear wheels being located in said stapler head, and wherein said pair of gear wheels are positioned such that they mesh when said housing is rotated such that it is folded against said stapling head.

24. A surgical stapler assembly according to claim 21, wherein said surgical stapler is of such a diameter when folded that it can be inserted through a standard laparoscopic port.¹