WO2002069808A9 - Biopsy apparatus - Google Patents

Biopsy apparatus

Info

Publication number
WO2002069808A9
WO2002069808A9 PCT/US2001/051235 US0151235W WO02069808A9 WO 2002069808 A9 WO2002069808 A9 WO 2002069808A9 US 0151235 W US0151235 W US 0151235W WO 02069808 A9 WO02069808 A9 WO 02069808A9
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
cannula
cutting device
distal end
lumen
Prior art date
Application number
PCT/US2001/051235
Other languages
French (fr)
Other versions
WO2002069808A3 (en
WO2002069808A2 (en
Inventor
Michael E Miller
Joseph L Mark
Charles Butcher
John Phillip Hancock
Original Assignee
Suros Surgical Systems Inc
Michael E Miller
Joseph L Mark
Charles Butcher
John Phillip Hancock
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27107810&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2002069808(A9) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US09/707,022 external-priority patent/US6758824B1/en
Application filed by Suros Surgical Systems Inc, Michael E Miller, Joseph L Mark, Charles Butcher, John Phillip Hancock filed Critical Suros Surgical Systems Inc
Priority to GB0215654A priority Critical patent/GB2376633B/en
Priority to JP2002568992A priority patent/JP4064243B2/en
Publication of WO2002069808A2 publication Critical patent/WO2002069808A2/en
Publication of WO2002069808A3 publication Critical patent/WO2002069808A3/en
Publication of WO2002069808A9 publication Critical patent/WO2002069808A9/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/025Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0283Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0208Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00973Surgical instruments, devices or methods, e.g. tourniquets pedal-operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/007Auxiliary appliance with irrigation system

Definitions

  • This invention relates to biopsy instruments and methods for taking a biopsy. More specifically, this invention relates to disposable biopsy devices for removing several tissue samples using a single insertion.
  • a biopsy can be performed by either an open procedure or a percutaneous method. The open surgical biopsy procedure first requires localization ofthe lesion by insertion of a wire loop, while using visualization technique, such as X-ray or ultrasound.
  • Percutaneous biopsies have been performed using either Fine Needle Aspiration or core biopsy in conjunction with real-time visualization techniques, such as ultrasound or mamniography (X-ray).
  • Fine Needle Aspiration involves the removal of a small number of cells using an aspiration needle. A smear ofthe cells is then analyzed using cytology techniques. Although Fine Needle Aspiration is less intrusive, only a small amount of cells are available for analysis. In addition, this method does not provide for a pathological assessment ofthe tissue, which can provide a more complete assessment ofthe stage ofthe cancer, if found. In contrast, in core biopsy a larger fragment of tissue can be removed without destroying the structure ofthe tissue.
  • core biopsy samples can be analyzed using a more comprehensive histology technique, which indicates the stage ofthe cancer.
  • the entire mass may be removed using the core biopsy method.
  • core biopsy is preferred, and there has been a trend towards the core biopsy method, so that a more detailed picture can be constructed by pathology of the disease ' s progress and type.
  • the first core biopsy devices were ofthe spring advanced, "Tru-Cut” style consisting of a hollow tube with a sharpened edge that was inserted into the breast to obtain a plug of tissue.
  • This device presented several disadvantages. First, the device would sometimes fail to remove a sample, therefore, requiring additional insertions. This was generally due to tissue failing to prolapse into the sampling notch. Secondly, the device had to be inserted and withdrawn to obtain each sample, therefore, requiring several insertions in order to acquire sufficient tissue for pathology.
  • the biopsy apparatus disclosed in U.S. Patent No. 5,526,822 to Burbank, et al was designed in an attempt to solve many of these disadvantages.
  • the Burbank apparatus is a biopsy device that requires only a single insertion into the biopsy site to remove multiple tissue samples.
  • the device incorporates a tube within a tube design that includes an outer piercing needle having a sharpened distal end for piercing the tissue.
  • the outer needle has a lateral opening forming a tissue receiving port.
  • the device has an inner cannula slidingly disposed within the outer cannula, and which serves to cut tissue that has prolapsed into the tissue receiving port. Additionally, a vacuum is used to draw the tissue into the tissue receiving port.
  • Vacuum assisted core biopsy devices such as the Burbank apparatus, are available in handheld (for use with ultrasound) and stereotactic (for use with X-ray) versions.
  • Stereotactic devices are mounted to a stereotactic unit that locates the lesion and positions the needle for insertion.
  • the patient lies face down on a table, and the breast protrudes from an opening in the table.
  • the breast is then compressed and immobilized by two mamniography plates.
  • the mamniography plates create images that are communicated in real-time to the stereotactic unit.
  • the stereotactic unit then signals the biopsy device and positions the device for insertion into the lesion by the operator.
  • the breast is not immobilized. Rather the patient lies on her back and the doctor uses an ultrasound device to locate the lesion. The doctor must then simultaneously operate the handheld biopsy device and the ultrasound device.
  • the Burbank device presents an advancement in the field of biopsy devices, several disadvantages remain and further improvements are needed.
  • the inner cutter must be advanced manually, meaning the surgeon manually moves the cutter back and forth by lateral movement of a knob mounted on the outside ofthe instrument or by one ofthe three pedals at the footswitch.
  • the vacuum source that draws the tissue into the receiving port is typically supplied via a vacuum chamber attached to the outer cannula.
  • the vacuum chamber defines at least one, usually multiple, communicating holes between the chamber and the outer cannula. These small holes often become clogged with blood and bodily fluids. The fluids occlude the holes and prevent the aspiration from drawing the tissue into the receiving port.
  • many ofthe components ofthe current biopsy devices are reusable, such as the driver portions, which control the outer and inner needles. This poses several notable disadvantages.
  • the reusable portion must be cleaned and/or sterilized. This increases the time necessary to wrap up the procedure, which ultimately affects the cost ofthe procedure.
  • the required clean-up and/or sterilization of reusable parts increases the staffs' potential exposure to body tissues and fluids.
  • the reusable handle is heavy, large and cumbersome for handheld use.
  • a further disadvantage is that current biopsy devices comprise an open system where the tissue discharge port is simply an open area ofthe device.
  • a surgical assistant must remove the tissue from the open compartment using forceps and place the tissue on a sample plate. This ritual must be followed for every sample and, therefore, multiple operators are required.
  • the open system increases the exposure to potentially infectious materials, and requires increased handling ofthe sample. As a practical matter, the open system also substantially increases the cleanup time and exposure, because a significant amount of blood and bodily fluid leaks from the device onto the floor and underlying equipment.
  • the inner cutter often fails to completely sever the tissue.
  • no tissue sample is present (dry tap), and therefore, reinsertion is required.
  • the failure to completely sever the tissue after the first advancement ofthe inner cutter results in a necessary second advancement of the inner cutter.
  • the procedure is prolonged, which is significant because the amount of trauma to the tissue and, ultimately, to the patient is greatly affected by the length ofthe procedure. Therefore, it is in the patient's best interest to minimize the length ofthe procedure by making each and every attempt at cutting the tissue a successful and complete cut.
  • the inner cutter when using the "tube within a tube” type biopsy device, the inner cutter can lift up into the tissue receiving opening during cutting. This lifting causes the inner cutter to catch on the edge ofthe tissue receiving opening, which ultimately results in an incomplete cut and dulling ofthe blade, rendering the blade useless. Also, prior devices often produce small tissue samples. As the inner cutter advances, the cutting edge not only starts to sever the tissue, it also pushes the tissue in front ofthe cutter. This results in a tissue sample that is smaller than the amount of tissue drawn into the tissue receiving opening.
  • a need remains for a tissue removal device that reliably applies a vacuum without becoming plugged with blood and bodily fluids.
  • a need also remains for a tissue removal device that is entirely disposable so that both exposure to bio-hazard and clean-up time are significantly minimized, while convenience is maximized.
  • a further need remains for a tissue removal device that completely severs the maximum amount of tissue without requiring numerous attempts at cutting the tissue.
  • a need also remains for a tissue removal device that is MRI compatible.
  • a need remains for a biopsy tissue removal device that is completely automated, therefore making the handheld biopsy device a more efficient and attractive option.
  • the present invention fulfills the aforementioned needs by providing a disposable tissue removal device comprising a cutting element mounted to a handpiece.
  • the cutting element includes an outer cannula defining a tissue-receiving opening and an inner cannula concentrically disposed within the outer cannula.
  • the outer cannula has a trocar tip at its distal end and a cutting board snugly disposed within the outer cannula.
  • the inner cannula defines an inner lumen that extends the length ofthe inner cannula, and which provides an avenue for aspiration.
  • the inner cannula terminates in an inwardly beveled, razor-sharp cutting edge and is driven by, both a rotary motor, and a reciprocating motor. As the inner cannula moves past the tissue-receiving opening, the inwardly beveled edge helps to eliminate the risk of catching the edge on the tissue-receiving opening. At the end of its stroke, the inner cannula makes contact with the cutting board to completely sever the tissue.
  • the cutting board is made of a material that is mechanically softer than the cutting edge yet hard enough to withstand the force ofthe inner cannula.
  • both the rotary motor and the reciprocating motors are hydraulic motors. Because hydraulic motors do not require any electrical components, this feature allows all ofthe components to be fabricated of MRI compatible materials.
  • the tissue-receiving opening is formed by opposite longitudinal edges that form a number of teeth.
  • the teeth face away from the cutting board at the distal end ofthe outer cannula. The teeth help prevent the forward motion ofthe tissue in the opening as the inner cannula moves forward toward the cutting board. This feature maximizes the length and overall size ofthe core, ultimately resulting in a more efficient lesion removal.
  • the outer cannula incorporates a stiffening element opposite the tissue-receiving opening. This stiffening element aids in maintaining the longitudinal integrity ofthe outer cannula as it is advanced through the tissue.
  • one embodiment incorporates additional features to prevent the inner cannula from rising up into the tissue-receiving opening.
  • a bead of stiffening material may be affixed to the inner wall ofthe outer cannula, or a dimple may be formed in the inner wall ofthe outer cannula. The bead, or dimple urges the inner cannula away from the tissue- receiving opening and prevents the inner cannula from catching on the opening.
  • FIG. 1 is a top perspective view of a tissue biopsy apparatus in accordance with one embodiment ofthe present invention.
  • FIG. 2 is a top elevational view ofthe tissue biopsy apparatus shown in FIG. 1.
  • FIG. 3 A and FIG. 3B are side cross-sectional views ofthe tissue biopsy apparatus depicted in FIGS. 1 and 2, with the tissue cutting inner cannula shown in its retracted and extended positions.
  • FIG. 4 is a perspective view of a cover for the tissue biopsy apparatus as shown FIG. 1.
  • FIG. 5 is an enlarged side cross-sectional view ofthe operating end ofthe tissue biopsy apparatus depicted in FIGS. 1 and 2.
  • FIG. 6 is a side partial cross-sectional view of working end of a tissue biopsy apparatus in accordance with an alternative embodiment.
  • FIG. 7 is an end cross-sectional view ofthe apparatus depicted in FIG. 6, taken along line 7-7 as viewed in the direction ofthe arrows.
  • FIG. 8 is an end cross-sectional view similar to FIG. 7 showing a modified configuration for a stiffening member.
  • FIG. 8(a) is an end cross-sectional view similar to FIG. 7 showing a modified configuration for another stiffening member.
  • FIG. 9 is an enlarged side cross-sectional view of a fluid introduction port at the hub connecting the outer cannula to the handpiece for a tissue biopsy apparatus as depicted in FIG. 1.
  • FIG. 10 is a schematic drawing ofthe hydraulic control system for the operation ofthe tissue biopsy apparatus shown in FIG. 1.
  • FIG. 11 is a schematic drawing of a control system for an electric rotary motor for use with the apparatus ofthe present invention.
  • Fig. 12 is a top elevational view of a tissue biopsy apparatus according to a further embodiment ofthe present invention.
  • Fig. 13 is a side cross-sectional view ofthe biopsy apparatus shown in Fig.
  • Fig. 14 is a side cross-sectional view of a motor assembly incorporated into the biopsy apparatus shown in Fig. 12.
  • Fig. 15 is an end elevational view from the left end ofthe assembly depicted in Fig. 14.
  • Fig. 16 is an end elevational view ofthe right end ofthe assembly depicted in Fig. 14.
  • Fig. 17 is a top elevational view of a rotary motor assembly in accordance with one specific embodiment ofthe invention.
  • Fig. 18 is a side elevational view of a cannula hub for engagement with the assembly depicted in Fig. 14.
  • Fig. 19 is a rear elevational view ofthe cannula hub shown in Fig. 18.
  • Fig. 20 is a side cross-sectional view ofthe cannula hub shown in Fig. 18.
  • Fig. 21 is a top perspective view of an upper housing component ofthe biopsy apparatus depicted in Fig. 12.
  • Fig. 22 is an end cross-sectional view ofthe upper housing shown in Fig. 21, taken along line 22-22 as viewed in the direction ofthe arrows.
  • Fig. 23 is a top perspective view of a lower housing for use with the biopsy apparatus shown in Fig. 12.
  • Fig. 24 is a top elevational view ofthe lower housing shown in Fig. 23.
  • FIGS. 1-10 A tissue biopsy apparatus 10 in accordance with one embodiment ofthe present invention is shown in FIGS.
  • the apparatus 10 includes a cutting element 11 mounted to a handpiece 12.
  • the cutting element 11 is sized for introduction into a human body.
  • the present invention concerns an apparatus for excising breast tissue samples.
  • the cutting element 11 and the overall biopsy apparatus 10 are configured for ease of use in this surgical environment.
  • the biopsy apparatus 10 is configured as a hand-held device.
  • the same inventive principles can be employed in a tissue biopsy apparatus that is used stereotatically in which the apparatus is mounted on a support fixture that is used to position the cutting element 11 relative to the tissue to be sampled. Nevertheless, for the purposes of understanding the present invention, the tissue biopsy apparatus will be described as a hand-held device.
  • the cutting element 11 is configured as "tube-within-a-tube" cutting device. More specifically, the cutting element 11 includes an outer cannula 15 terminating in a tip 16. Preferably, the tip is a trocar tip that can be used to penetrate the patient's skin. Alternatively, the tip 16 can simply operate as a closure for the open end ofthe cannula 15. In this instance, a separate introducer would be required.
  • the cutting element 11 further includes an inner cannula 17 that fits concentrically within the outer lumen 27 (FIG. 5) ofthe outer cannula 15.
  • both a rotary motor 20 (FIG. 1) and a reciprocating motor 22 drive the inner cannula 17. Both motors are supported witl ⁇ n the handpiece 12.
  • the rotary motor 20 and reciprocating motor 22 are configured for simultaneous operation to translate the inner cannula 17 axially within the outer cannula 15, while rotating the inner cannula 17 about its longitudinal axis.
  • FIG. 5 One specific configuration ofthe working end ofthe cutting element 11 is depicted in FIG. 5.
  • the outer cannula 15 defines a tissue-receiving opening 25, which communicates with the outer lumen 27.
  • a pair of opposite longitudinal edges 26 (FIGS. 1 and 2) define the tissue-receiving opening 25.
  • the outer cannula 15 is open at its distal end 28 with the trocar tip 16 engaged therein.
  • the trocar tip 16 forms an engagement hub 30 that fits tightly within the distal end 28 ofthe outer cannula 15.
  • the hub 30 can be secured by welding, press-fit, adhesive or other means suitable for a surgical biopsy instrument.
  • the working end ofthe cutting element 11 further includes a cutting board 31 that is at least snugly disposed within the outer lumen 27 at the distal end 28 ofthe outer cannula 15. Most preferably, the cutting board 31 is in direct contact with the engagement hub 30 ofthe trocar tip 16. The cutting board 31 can be permanently affixed within the outer cannula 15 and/or against the engagement hub 30 ofthe trocar tip.
  • the inner cannula 17 defines an inner lumen 34 that is hollow along the entire length ofthe cannula to provide for aspiration ofthe biopsy sample.
  • the inner cannula 17 terminates in a cutting edge 35.
  • the cutting edge 35 is formed by an inwardly beveled surface 36 to provide a razor-sharp edge.
  • the inwardly beveled surface helps eliminate the risk of catching the edge 35 on the tissue- receiving opening 25 ofthe outer cannula.
  • the beveled surface 36 helps avoid pinching the biopsy material between the inner and outer cannulas during a cutting stroke.
  • both the outer cannula 15 and the inner cannula 17 are formed of a surgical grade metal.
  • the two cannulae are formed of stainless steel.
  • the cannulae can be formed of Inconel, Titanium or other materials with similar magnetic characteristics.
  • the trocar tip 16 is most preferably formed of stainless steel honed to a sharp tip.
  • the trocar tip 16 can be suitably bonded to the outer cannula 15, such as by welding or the use of an appropriate adhesive, hi some embodiments, the inner and outer cannulae can be formed of a non-metallic material of appropriate strength and stiffness.
  • the cutting board 31 is formed of a material that is configured to reduce the friction between the cutting edge 35 ofthe inner cannula 17 and the cutting board 31.
  • the cutting edge 35 necessarily bears against the cutting board 31 when the inner cannula 17 is at the end of its stroke while severing a tissue sample. Since the inner cannula is also rotating, the cutting edge necessarily bears directly against the cutting board 31, particularly after the tissue sample has been cleanly severed.
  • the impact-cutting surface has been formed ofthe same material as the cutting element. This leads to significant wear or erosion ofthe cutting edge. When numerous cutting cycles are to be performed, the constant wear on the cutting edge eventually renders it incapable of cleanly severing a tissue sample.
  • the present invention contemplates forming the cutting board 31 of a material that reduces this frictional wear.
  • the cutting board 31 is formed of a material that is mechanically softer than the material of the cutting edge 35.
  • the cutting board 31 cannot be so soft that the cutting edge 35 forms a pronounced circular groove in the cutting board, which significantly reduces the cutting efficiency ofthe inner cannula.
  • the cutting board 31 is formed of a plastic material, such as polycarbonate, ABS or DELRIN ® .
  • the rotary motor 20 includes a motor housing 39 that is sized to reciprocate within the handpiece 12.
  • the housing 39 defines a pilot port 40 that is connected to the hydraulic control system 150 (see FIG. 10) by appropriate tubing.
  • the motor 20 can be a number of hydrauhcally powered rotating components.
  • the motor 20 is an air motor driven by pressured air.
  • the motor 20 includes a vaned rotor 42 that is mounted on a hollow tubular axle 43 extending through the motor housing 39.
  • the axle 43 is supported on bearings 44 at opposite ends ofthe housing so that the rotor 42 freely rotates within the motor housing 39 under pneumatic pressure.
  • tubular axle 43 is connected to the proximal end 37 ofthe inner cannula 17 by way of a coupler 46.
  • the ends ofthe two tubes are mounted within the coupler 46 and held in place by corresponding set screws 47.
  • the coupler 46 is formed of a plastic material that provides a generally airtight seal around the joint between the inner cannula 17 and the tubular axle 43. It is important that the coupler 46 provide a solid connection ofthe inner cannula 17 to the rotating components ofthe motor 20 so that the inner cannula 17 does not experience any torrential slip during the cutting operation.
  • the invention further contemplates an aspiration tube 50 that mates with the tubular axle 43.
  • the tissue aspiration path from the working end ofthe cutting element 11 is along the inner lumen 34 ofthe inner cannula 17, through the tubular axle 43 ofthe rotary motor 20, and through the aspiration tube 50 to a tissue collection location in the form of a collection trap 55.
  • the aspiration tube 50 In order to maintain the vacuum or aspiration pressure within this aspiration path, the aspiration tube 50 must be fluidly sealed against the tubular axle 43.
  • the motor housing 39 defines a mounting hub 51 into which the aspiration tube 50 is engaged.
  • the position ofthe aspiration tube 50 is fixed by way of a set screw 52 passing through the mounting hub 51.
  • the joint between the aspiration tube 50 and the tubular axle 43 allows relative rotational between the two components.
  • the tubular axle 43 rotates with the rotor 42.
  • the aspiration tube 50 need not rotate for use with the biopsy apparatus ofthe present invention.
  • the mounting hub 51 can include an arrangement of seal rings (not shown) at the joint between the aspiration tube 50 and the tubular axle 43 to further seal the aspiration system.
  • the aspiration tube 50 communicates with a collection trap 55 that is removably mounted to the handpiece 12.
  • the collection trap 55 includes a pilot port 107 that is connected by appropriate tubing to the hydraulic control system 150, as described in more detail herein.
  • a vacuum or aspiration pressure is drawn through the pilot port 107 and the collection trap 55. This vacuum then draws a tissue sample excised at the working end ofthe cutting element 11, all the way through the inner cannula 17, tubular axle 43 and aspiration tube 50 until it is deposited within the trap. Details ofthe collection trap 55 will be discussed herein.
  • the present invention contemplates an inner cannula 17 that performs its cutting operation by both rotary and reciprocating motion.
  • the handpiece 12 supports a reciprocating motor 22.
  • both motors 20 and 22 are hydrauhcally powered, most preferably pneumatically.
  • This feature allows the motors to be formed of plastic, since no electrical components are required.
  • every component ofthe biopsy apparatus 10 in accordance with the present invention can be formed of a non-metallic material, most preferably a medical grade plastic.
  • the biopsy apparatus 10 is eminently compatible with surgical imaging systems that may be used during the biopsy procedure.
  • MRI Magnetic Resonance Imaging
  • the entire apparatus can be disposable.
  • the elimination of substantially all metal components reduces the overall weight ofthe handpiece 12, making it very easily manipulated by the surgeon.
  • the reciprocating motor 22 includes a pneumatic cylinder 60.
  • the cylinder 60 includes a pilot port 61 that connects the cylinder to the hydraulic control system 150 through appropriate tubing.
  • the motor 22 includes a piston 63 that reciprocates within the cylinder 60 in response to hydraulic fluid pressure provided at the pilot port 61.
  • the piston 63 includes a central bore 64 for mounting the piston 63 to the aspiration tube 50.
  • the aspiration tube 50 is press-fit within the bore 64.
  • the engagement between the aspiration tube 50 and the piston 63 can be enhanced by use of a set screw (not shown) or an adhesive or epoxy. At any rate, it is essential that the aspiration tube 50 and piston 63 move together, since the motor 22 must eventually drive the inner cannula 17 axially within the outer cannula.
  • the piston 63 also reciprocates the rotary motor 20, which is essentially mounted to the reciprocating aspiration conduit. This movement is depicted by comparing the position ofthe rotary motor 20 between FIG. 3A and FIG. 3B. More specifically, the motor 20 as well as the aspiration conduit, including the inner cannula 17, moves within the handpiece 12.
  • the handpiece housing 70 is provided with openings 73 (FIG. 3B) at its opposite ends for slidably supporting the aspiration tube 50 and inner cannula 17. Since the distal housing 70 is preferably formed of a plastic material, no thrust bearings or rotary bearings are necessary to accommodate low friction axial movement ofthe cannula through the housing openings 73.
  • the biopsy apparatus 10 includes a handpiece 12 that carries all ofthe operating components and supports the outer and inner cannulas.
  • the handpiece 12 includes a distal housing 70 within which is disposed the rotary motor 20.
  • the distal end 71 ofthe housing 70 is configured into a fitting 72.
  • This fitting 72 engages a mating flange 77 on an outer cannula hub 75.
  • the hub 75 supports the outer cannula 15 witlrin an engagement bore 76 (see FIG. 3B).
  • the engagement between the outer cannula hub 75 and the distal end 71 ofthe housing 70 need not be airtight.
  • the mating components ofthe fitting between the two parts need not be capable of generating a fluid-tight seal.
  • the engagement between the hub 75 and the housing 70 for supporting the outer cannula 15 provides a leak path through the outer lumen 27 to the atmosphere.
  • tissue biopsy apparatus 10 providing aspiration through the inner lumen 34 ofthe inner cutting cannula 17 will draw tissue through the inner lumen.
  • a vacuum can be created behind the advancing tissue.
  • the tissue will stop advancing along the length ofthe inner lumen because the vacuum behind the tissue sample equals the vacuum in front ofthe tissue sample that is attempting to draw the sample to the collection trap 55.
  • the leak path through the outer lumen 27 allows atmospheric air to fall in behind the tissue sample when the inner cutter is retracted from the cutting board.
  • the atmospheric air helps to relieve the vacuum behind the advancing tissue and aids in drawing the tissue down the length ofthe aspiration channel to the collection trap 55.
  • the atmospheric air leak path is not essential.
  • the fitting 72 and the mating flange 77 can be engaged by simple twisting motion, most preferably via Luer-type fittings.
  • the cannula hub 75 is mounted on the handpiece 12, thereby supporting the outer cannula 15.
  • the handpiece can then be used to project the outer cannula into the body adjacent the sample site.
  • the outer cannula 15 can be used to introduce an anesthetic.
  • the outer cannula can be used to guide a radio-opaque marker to mark the location the removed material.
  • the housing defines an inner cavity 79 that is open through an access opening 81.
  • the access opening 81 is preferably provided to facilitate assembly ofthe tissue biopsy apparatus 10.
  • the distal end 71 ofthe housing 70 can be provided with a pair of distal braces 80 that add stiffness to the distal end 71 while the apparatus is in use.
  • the braces 80 allow the distal housing 70 to be formed as a thin-walled plastic housing. Similar braces can be provided at the opposite end ofthe distal housing as necessary to add stiffness to the housing.
  • the distal housing is configured to support the reciprocating motor 22 and in particular the cylinder 60.
  • the proximal end 83 ofthe distal housing 70 defines a pressure fitting 84. It is understood that this pressure fitting 84 provides a tight leak-proof engagement between the distal end 88 ofthe cylinder 60 and the proximal end 83 ofthe housing.
  • the pressure fitting 84 forms a spring cavity 85 within which a portion ofthe return spring 66 rests.
  • the pressure fitting 84 defines distal piston stop 86. The piston 63 contacts these stops at the end of its stroke. The location ofthe piston stop 86 is calibrated to allow the cutting edge 35 to contact the cutting board 31 at the working end ofthe cutting element 11 to allow the cutting edge to cleanly sever the biopsy tissue.
  • the cylinder 60 is initially provided in the form of an open-ended cup.
  • the open end corresponding to distal end 88, fastens to the pressure fitting 84.
  • the pressure fitting can include a threaded engagement, a press-fit or an adhesive arrangement.
  • the cylinder cup thus includes a closed proximal end 89.
  • This proximal end defines the pilot port 61, as well as a central opening 62 (FIG. 3B) through which the aspiration tube 50 extends.
  • the proximal end 89 ofthe cylinder 60 is configured to provide a substantially airtight seal against the aspiration tube 50 even as it reciprocates within the cylinder due to movement ofthe piston 63.
  • the proximal end 89 ofthe cylinder 60 defines a proximal piston stop 90, which can either be adjacent the outer cylinder walls or at the center portion ofthe proximal end. This proximal piston stop 90 limits the reverse travel ofthe piston 63 under action ofthe return spring 66 when pressure within the cylinder has been reduced.
  • the collection trap 55 is mounted to the handpiece 12 by way of a support housing 93.
  • the handpiece 12 can be limited to the previously described components, hi this instance, the collection trap 55 can be situated separate and apart from the handpiece, preferably close to the source of vacuum or aspiration pressure.
  • the proximal end ofthe aspiration tube 50 would be connected to the collection trap by a length of tubing.
  • the aspiration tube 50 would reciprocate away from and toward the proximal end ofthe cylinder 60, so that it is preferable that the handpiece includes a cover configured to conceal the reciprocating end ofthe aspiration tube.
  • the collection trap 55 is removably mounted to the handpiece 12.
  • the support housing 93 includes a distal end fitting 96 that engages the proximal end 89 of cylinder 60.
  • a variety of engagements are contemplated, preferably in which the connection between the two components is generally airtight.
  • the proximal end 97 ofthe support housing 93 forms a cylindrical mounting hub 98.
  • the mounting hub 98 surrounds a proximal end ofthe collection trap 55.
  • the hub forms a bayonet-type mounting groove 99 that receives pins 103 attached to the housing 102 ofthe trap 55.
  • a pair of diametrically opposite wings 104 can be provided on the housing 102 to facilitate the twisting motion needed to engage the bayonet mount between the collection trap 55 and the support housing 93. While the preferred embodiment contemplates a bayonet mount, other arrangements for removably connecting the collection trap 55 to the support housing 93 are contemplated. To be consistent with one ofthe features ofthe invention, it is preferable that this engagement mechanism be capable of being formed in plastic.
  • the support housing 93 is provided with an aspiration passageway 100 that spans between the proximal and distal ends ofthe housing. Since the aspiration tube 50 reciprocates, it preferably does not extend into the collection trap 55.
  • the collection trap 55 includes a housing 102, as previously explained.
  • the housing forms a pilot port 107, which is connectable to a vacuum generator.
  • appropriate tubing to the hydraulic control system 150 connects the pilot port 107.
  • the trap 55 includes a filter element 110 mounted within the trap, hi the preferred embodiment, the filter element is a mesh filter than allows ready passage of air, blood and other fluids, while retaining excised biopsy tissue samples, and even morcellized tissue.
  • the filter element 110 is preferably constructed so that vacuum or aspiration pressure can be drawn not only at the bottom end ofthe filter element, but also circumferentially around at least a proximal portion ofthe element 110. In this way, even as material is drawn toward the proximal end of the filter, a vacuum can still be drawn through other portions ofthe filter, thereby maintaining the aspiration circuit.
  • the handpiece 12 can include individual covers for closing the access opening 81 in the distal housing 70 and the access openings 95 in the support housing 93. Those covers can support tubing for engagement with the pilot ports 40 and 61. Alternatively and most preferably, a single cover 13 as depicted in FIG. 4, is provided for completely enclosing the entire handpiece.
  • the distal end 71 ofthe housing 70 can define a number of engagement notches 115 equally spaced around the perimeter ofthe distal end.
  • the handpiece cover 13 can then include a like number of equally distributed tangs 117 projecting inwardly from the inner surface from the 118. These tangs are adapted to snap into the engagement notches 115 to hold the cover 113 in position over the handpiece 12.
  • the cover can be attached by sliding axially over the handpiece 12.
  • the cover 13 can include fittings for fluid engagement with the two pilot ports 40 and 61.
  • the cover can be formed with openings for insertion of engagement tubing to mate with the respective pilot ports to provide hydraulic fluid to the rotary motor 20 and the reciprocating motor 22.
  • the cover 13 extends from the distal end 71 of the distal housing 70 to the proximal end 97 ofthe support housing 93. The cover can thus terminate short ofthe bayonet mounting feature between the support housing and the collection trap 55.
  • the proximal end 97 ofthe support housing 93 can be configured to include a similar array of engagement notches with a corresponding array of mating tangs formed at the proximal end ofthe cover 13. It can be appreciated from the foregoing discussion that the biopsy apparatus
  • the biopsy apparatus 10 ofthe present invention provides a complete "closed" tissue excision and recovery system.
  • the apparatus 10 is fluid tight so that no bodily fluids can escape. Biopsy procedures with many prior devices involves significant blood splatter due to the nature in which the tissue samples are extracted and recovered.
  • the biopsy apparatus 10 provides a closed path from the tissue receiving opening 25 to the collection trap 55, while still maintaining the highly efficient reciprocating and rotating cutting operation.
  • an outer cannula 125 includes a tissue-receiving opening 126.
  • the opening is formed by opposite longitudinal edges 127.
  • a number of teeth 129 are formed at each longitudinal edge 127.
  • the teeth are proximally facing — i.e., away from the cutting board 31 (not shown) at the distal end ofthe outer cannula. With this orientation, the teeth 129 help prevent forward motion of tissue drawn into the opening 126 as the inner cannula 17 moves forward toward the cutting board.
  • the cutting edge not only starts to sever the tissue, it also pushes tissue in front ofthe inner cannula.
  • the ultimate length ofthe biopsy sample retrieved with the cut is smaller than the amount of tissue drawn into the tissue-receiving opening ofthe outer cannula.
  • the tissue sample removed through the inner cannula 17 is substantially the same length as the tissue-receiving opening 126.
  • each ofthe teeth 129 tends to hold the tissue in place as the cutting edge 35 severs the tissue adjacent the outer cannula wall.
  • each "bite” is substantially as large as possible so that a large tissue mass can be removed with much fewer "bites” and in a shorter period of time.
  • the teeth can also cut into the tissue to prevent it from retracting out ofthe opemng as the inner cutting cannula 17 advances.
  • the outer cannula 125 depicted in FIG. 6 can also incorporate a stiffening element 131 opposite the tissue-receiving opemng 126.
  • the stiffening element 131 adds bending stiffness to the outer cannula 125 at the distal end in order to maintain the longitudinal integrity ofthe outer cannula 125 as it is advanced into a tissue mass.
  • the working end ofthe cutting device is compromised as it bends slightly upward or downward as the outer cannula passes into the body. This bending can either close or expand the tissue- receiving opening, which leads to difficulties in excising and retrieving a tissue sample.
  • the cutting mechanism ofthe present invention relies upon full, flush contact between the cutting edge ofthe inner cannula 17 and the cutting board 31. If the end ofthe outer cannula 125 is slightly askew, this contact cannot be maintained, resulting in an incomplete slice ofthe tissue sample. As depicted in the cross-sectional view ofthe FIG. 7, the stiffening element
  • 131 in one embodiment is a crimp extending longitudinally in the outer wall ofthe cannula substantially coincident with the tissue-receiving opening 126.
  • the outer cannula 125' depicted in FIG. 8 shows two additional versions of a stiffening element. In both cases, a bead of stiffening material is affixed to the outer cannula. Thus in one specific embodiment, a bead 131' is adhered to the inner wall ofthe outer cannula. In a second specific embodiment, a bead 131" is affixed to the outside of the outer cannula.
  • the beads can be formed of a like material with the outer cannula, and in both cases, the beads provide the requisite additional bending stiffness.
  • Another version of a stiffening element is shown if FIG. 8(a). In this case, a layer 131'" of additional stainless steel is bonded to the outer wall ofthe outer cannula 125".
  • a further feature that can be integrated into the outer cannula 125 is the dimple 135.
  • One problem frequently experienced by tube-within- a-tube cutters is that the inner reciprocating cutter blade contacts or catches on the outer cannula at the distal edge ofthe tissue-receiving opening.
  • the dimple 135 urges the inner cannula 17 away from the tissue-receiving opening 126. In this way, the dimple prevents the cutting edge ofthe inner cannula 17 from catching on the outer cannula as it traverses the tissue-receiving opening.
  • the dimple 135 is in the form of a slight crimp in the outer cannula 125.
  • the dimple 135 can be formed by a protrusion affixed or adhered to the inner surface ofthe outer cannula.
  • the dimple 135 is situated immediately proximal to the tissue-receiving opening to help maintain the distance between the cutting edge and the tissue-receiving opening.
  • the outer cannula 15 is supported by a hub 75 mounted to the distal end ofthe handpiece.
  • the outer cannula hub 140 provides a mean for introducing fluids into the outer lumen 27 ofthe outer cannula.
  • the hub 140 includes an engagement bore 141 within which the outer cannula 15 is engaged.
  • the hub also defines a flange 142 configured for mating with the fitting 72 at the distal end 71 ofthe housing 70.
  • the outer cannula hub 140 is similar to the hub 75 described above. With this embodiment, however, an irrigation fitting 145 is provided.
  • the fitting defines an irrigation lumen 146 that communicates with the engagement bore 141.
  • this irrigation lumen is in fluid commumcation with the outer lumen 27 ofthe outer cannula 15.
  • the irrigation fitting 145 can be configured for engagement with a fluid-providing device, such as a syringe.
  • the hub 140 thus provides a mechanism for introducing specific fluids to the biopsy site. In certain procedures, it may be necessary to introduce additional anesthetic to the sampling site, which can be readily accommodated by the irrigation fitting 145.
  • the preferred embodiment ofthe tissue biopsy apparatus 10 relies upon hydraulics or pneumatics for the cutting action.
  • the apparatus includes a hydraulic rotary motor 20 and a hydraulic reciprocating motor 22. While the apparatus 10 can be adapted for taking a single biopsy slice, the preferred use is to completely remove a tissue mass through successive cutting slices.
  • the cutting element 11 is positioned directly beneath a tissue mass, while an imaging device is disposed above the mass.
  • the imaging device such as an ultra-sound imager, provides a real-time view ofthe tissue mass as the tissue biopsy apparatus 10 operates to successively remove slices ofthe mass. Tissue is continuously being drawn into the cutting element 11 by the aspiration pressure or vacuum drawn through the inner cannula 17. Successive reciprocation ofthe inner cannula 17 removes large slices ofthe mass until it is completely eliminated.
  • the present invention contemplates a hydraulic control system 150, as illustrated in the diagram of FIG. 10.
  • the bulk ofthe control system is housed within a central console.
  • the console is connected to a pressurized fluid source 152.
  • the fluid source provides a regulated supply of filtered air to the control system 150.
  • pressurized fluid from the source as provided at the several locations 152 throughout the control system. More specifically, pressurized fluid is provided to five valves that form the basis ofthe control system.
  • pressurized fluid 152 passes through a pressure regulator 154 and gauge 155.
  • the gauge 155 is preferably mounted on the console for viewing by the surgeon or medical technician.
  • the pressure regulator 154 is manually adjustable to control the pressurized fluid provided from the source 152 to the two-position hydraulic valve 158.
  • the valve 158 can be shifted between a flow path 158a and a flow path 158b.
  • a return spring 159 biases the hydraulic valve to its normal position 158a.
  • valve 158 In the normally biased position of flow path 158a, the valve 158 comiects cylinder pressure line 161 to the fluid source 152.
  • This pressure line 161 passes through an adjustable flow control valve 162 that can be used to adjust the fluid flow rate through the pressure line 161.
  • the adjustable flow control valve 162 can be mounted on a console for manipulation during the surgical procedure.
  • the pressure line 161 is connected to the pilot port 61 ofthe reciprocating motor 22.
  • the initial position ofthe hydraulic valve 158 is such that the reciprocating motor and inner cannula are driven toward the distal end ofthe cutting element.
  • the inner cannula 17 covers the tissue-receiving opening 25 ofthe outer cannula 15.
  • Pressurized fluid along cylinder pressure 161 is also fed to a pressure switch 165.
  • the pressure switch has two positions providing flow paths 165a and 165b.
  • an adjustable return spring 166 biases this switch to its normal position at which fluid from the pressure source 152 terminates within the valve.
  • the pressure switch 165 moves to its flow path 165b in which the fluid source 152 is hydrauhcally connected to the pressure input line 168.
  • This pressure input line 168 feeds an oscillating hydraulic valve 170. It is this valve that principally operates to oscillate the reciprocating motor 22 by alternately pressurizing and releasing the two-position hydraulic valve 158.
  • the pressure switch 165 is calibrated to sense an increase in pressure within the cylinder pressure line 161 or in the reciprocating motor cylinder 60 that occurs when the piston 66 has reached the end of its stroke. More specifically, the piston reaches the end of its stroke when the inner cannula 17 contacts the cutting board 31. At this point, the hydraulic pressure behind the piston increases, which increase is sensed by the pressure valve 165 to stroke the valve to the flow path 165b.
  • the oscillating hydraulic valve 170 has two positions providing flow paths 170a and 170b. In position 170a, input line 179 is fed to oscillating pressure output line 172. With flow path 170b, the input line 179 is fed to a blocked line 171. Thus, with fluid pressure provided from pressure switch 165 (through flow path 165b), the oscillating valve 170 opens flow path 170a which completes a fluid circuit along output line 172 to the input ofthe hydraulic valve 158.
  • Fluid pressure to output line 172 occurs only when there is fluid pressure within input line 179.
  • This input line is fed by valve 176, which is operated by foot pedal 175.
  • the valve 176 is biased by a return spring 177 to the initial position of flow path 176a.
  • the valve 176 is moved against the force ofthe spring to flow path 176b. In this position, pressurized fluid from the source 152 is connected to the foot pedal input line 179.
  • pressurized fluid then flows through input line 179 to output line 172 and ultimately to the hydraulic valve 158.
  • the fluid pressure in the output line 172 shifts the valve 158 to the flow path 158b. In this position, the fluid pressure behind the piston 63 is relieved so that the return spring 66 forces the piston toward the proximal end. More specifically, the return spring retracts the inner cannula 17 from the tissue cutting opening 25.
  • the relief of the fluid pressure in line 161 also causes the pressure switch 165 to return to its initial neutral position of flow path 165a, due to the action ofthe return spring 166.
  • the pressure input line 168 is no longer connected to the fluid source 152, so no pressurized fluid is provided to the oscillating hydraulic valve 170. Since this valve is not spring biased to any particular state, its position does not necessarily change, except under conditions described herein.
  • the hydraulic control system 150 starts and finishes the tissue biopsy apparatus 10 with the tissue-receiving opening closed. It is important to have the opening closed once the procedure is complete so that no additional tissue may be trapped or pinched within the cutting element 11 as the apparatus is removed from the patient.
  • the system 150 also controls the operation ofthe rotary motor 20.
  • the motor 20 is an air motor.
  • This air motor is controlled by another hydraulic valve 182.
  • the initial position ofthe valve provides a flow path 182a in which the fluid source 152 is connected to blocked line 183.
  • the hydraulic valve 182 is pressurized, it moves to flow path 182b in which the fluid source 152 is connected to the pilot port 140 ofthe air motor. In this position, pressurized fluid continuously drives the air motor 20, thereby rotating the inner cannula 17.
  • a muffler M can be provided on the air motor to reduce noise.
  • the rotary motor hydraulic valve 182 is controlled by fluid pressure on pressure activation line 180.
  • This activation line 180 branches from the foot pedal input line 179 and is connected to the foot pedal switch 176.
  • the switch moves to its flow path 176b.
  • the pressure activation line 180 is connected to the fluid source 152 so fluid pressure is provided directly to the rotary motor hydraulic valve 182.
  • the valve 182 includes a biasing spring 184 that must be overcome by the fluid pressure at the input to the valve.
  • the fluid control for the rotary motor 20 is not fed through the oscillating hydraulic valve 170, the motor operates continuously as long as the foot pedal 175 is depressed.
  • the speed ofthe rotary motor 20 is not adjustable in the illustrated embodiment. Since the motor 20 is connected directly to the fluid source 152, which is preferably regulated at a fixed pressure, the air motor actually operates at one speed.
  • the reciprocating motor 22 is supplied through a pressure regulator 154 and a flow control valve 162. Thus, the speed of reciprocation ofthe cutting blade 35 is subject to control by the surgeon or medical technician.
  • the reciprocation ofthe cutting element 11 can be a function ofthe tissue being sampled, the size ofthe tissue biopsy sample to be taken, and other factors specific to the particular patient. These same factors generally do not affect the slicing characteristic ofthe cutting edge 35 achieved by rotating the inner cannula.
  • the hydraulic control system 150 also regulates the aspiration pressure or vacuum applied through the aspiration conduit, which includes the inner cannula 17.
  • the pressure activation line 180 branches to feed an aspiration valve 185.
  • the valve is movable from its initial flow path 185a to a second flow path 185b.
  • the fluid source 152 is connected to a blocked line 186.
  • the valve 185 shifts against the biasing spring 187 to the flow path 185b.
  • the venturi element 190 is connected to the fluid source. This venturi element thus generates a vacuum in a vacuum control line 193 and in aspiration line 191.
  • the venturi element 190 can include a muffler M to reduce noise within the handpiece.
  • the venturi element 190 can include a muffler M to reduce noise within the handpiece.
  • the vacuum pressure can be calibrated by a selection of an appropriate venturi component 190.
  • the vacuum drawn on control line 193 operates on vacuum switch 194.
  • a variable biasing spring 195 initially maintains the vacuum switch 194 at its flow path 194a. In this flow path, the vacuum input line 196 is not connected to any other line. However, at a predetermined vacuum in control line 193, the valve moves to flow path 194b. In this position, the vacuum input line 196 is connected to pressure line 192.
  • the vacuum switch 194 operates in the form of a "go-nogo" switch - in other words, when the aspiration vacuum reaches a predetermined operating threshold, the vacuum switch is activated. When the vacuum switch 184 is initially activated, it remains activated as long as the foot pedal is depressed. Thus vacuum input line 196 is continuously connected to pressure line 192 as long as the foot pedal 175 is depressed.
  • valve 158 the fluid pressure in line 192, and ultimately in vacuum input line 196, is determined by the state of valve 158.
  • the pressure line 192 is dead.
  • pressure line 192 is connected to the regulated fluid source. Pressurized fluid then flows from pressure line 192, through vacuum switch flow path 194b, through vacuum input line 196 to the left side of oscillating valve
  • valve 158 allows pressurized fluid to again flow to the reciprocating motor 22 causing it to move through the next cutting stroke.
  • pressurized fluid passes from line 192, through vacuum input line 196, and through an adjustable flow control valve 197 to a second input for the oscillating hydraulic valve 170.
  • Pressure on the vacuum input line 196 shifts the oscillating valve 170 to its second position for flow path 170b.
  • pressurized fluid passing through the foot pedal valve 176 terminates within valve 170.
  • the pressure in output line 172 drops which allows the hydraulic valve 158 shift back to its original position 158a under operation ofthe return spring 159. In this position, fluid pressure is again supplied to the reciprocating motor 22 to cause the piston 66 to move through its cutting stroke.
  • the oscillating valve 170 is influenced by fluid pressure on lines 168 and 196, and that these lines will not be fully pressurized at the same time.
  • pressure from source 152 is automatically supplied to reciprocating motor 22 and pressure valve 165, causing the valve to move to flow path 165b.
  • line 168 is pressurized which shifts oscillating valve 170 to the left to state 170a.
  • the oscillating valve will remain in that state until line 196 is pressurized, regardless ofthe position of pressure switch 165.
  • the fluid pressure on line 196 does not increase to operating levels until the foot pedal 175 has been depressed and the aspiration circuit has reached its operating vacuum.
  • the vacuum switch 194 can be calibrated to sense fine changes in vacuum.
  • the completion of this return stroke can be determined by the state ofthe vacuum switch 194.
  • the vacuum switch 194 can operate as an indicator that a tissue sample has been drawn completely through the aspiration conduit into the collection trap 55. More specifically, when the vacuum sensed by vacuum switch 194 has one value when the inner cannula is open to atmospheric pressure. This vacuum pressure changes when a tissue sample is drawn into the inner cannula 17. The vacuum pressure changes again when the tissue is dislodged so that the inner cannula is again open to atmospheric pressure. At this point, the inner cannula 17 is clear and free to resume a cutting stroke to excise another tissue sample.
  • the vacuum switch 194 can stroke to its flow path 194b to provide fluid pressure to the left side ofthe oscillating valve 170, causing the valve to stroke to flow path 170b .
  • the hydraulic control system 150 provides a complete system for continuously reciprocating the axial motor 22.
  • the system provides constant continuous pressure to both the rotary motor 20 and the aspiration line 191, so long as the foot pedal 175 is depressed. Once the foot pedal is released, fluid pressure in activation line 180 drops which causes the air motor control valve 182 and the aspiration control valve 185 to shift to their original or normal positions in which fluid pressure is terminated to those respective components.
  • pressure is maintained to the reciprocating motor 22 because the motor is fed through valve 158, which is connected directly to the fluid source 152.
  • the hydraulic control system 150 in the illustrated embodiment incorporates five controllable elements.
  • the fluid pressure provided to activate the reciprocating motor 22 is controlled through the regulator 154.
  • the fluid flow rate to the piston 66 is controlled via the adjustable control valve 162.
  • the pressure at which the pressure switch 165 is activated is determined by an adjustable return spring 166.
  • the aspiration pressure vacuum at which the vacuum switch 194 is activated is controlled by an adjustable return spring 195.
  • the adjustable flow control valve 197 controls the fluid flow from the vacuum switch 194 to the oscillating hydraulic valve 170.
  • Each of these adjustable elements controls the rate and duration of oscillation ofthe reciprocating motor 22.
  • the pressure switch 165 essentially operates as an "end of stroke" indicators.
  • the pressure switch 165 changes dramatically. It is this change that causes the pressure switch 165 to change states.
  • This state change causes the oscillating valve 170 to shift valve 158 to terminate fluid pressure to the motor 22, causing it to stop its cutting stroke and commence its return stroke.
  • the excised tissue sample is gradually drawn along the aspiration conduit.
  • fluid pressure bleeds from pressure line 161 and pressure switch 165 and ultimately from line 168 feeding oscillating valve 170.
  • the hydrauhcally controlled reciprocation ofthe inner cutting cannula provides a cleaner and better-controlled cut of biopsy tissue. Since the reciprocating motor 22 is fed from a substantially constant source of pressurized fluid, the pressure behind the motor piston 63 remains substantially constant throughout the cutting stroke. This substantially constant pressure allows the inner cutting cannula to advance through the biopsy tissue at a rate determined by the tissue itself.
  • the rate of advancement of the motor piston 63 and therefor the inner cannula 17 decreases proportionately.
  • This feature allows the cutting edge to slice cleanly through the tissue without the risk of simply pushing the tissue.
  • the rotation ofthe cutting edge can facilitate this slicing action.
  • the constant pressure behind the piston 63 allows the cutting edge to advance more quickly through the tissue.
  • the rotary motor 20 can consist of an electric motor, rather than a pneumatic motor. As depicted in FIG. 11, the pressure activation line 180 can be fed to an on-off pressure switch 198 that is governed by an adjustable bias spring 199.
  • the switch 198 establishes a connection between an electric reciprocating motor 20 and a battery pack 200.
  • the battery pack 200 is mounted within the handpiece 12, but can instead be wired to an external battery contained within the console.
  • the tissue biopsy apparatus 10 depicted in FIG. 1 has an overall length of under sixteen inches (16") and an outer diameter less than one and one quarter inches (1.25").
  • the outer cannula and therefore the cutting element 11 have a length measured from the handpiece 12 of approximately five inches (5").
  • the outer cannula preferably has a nominal outer diameter of 0.148" and a nominal inner diameter of 0.136".
  • the inner cannula most preferably has a nominal outer diameter of 0.126" so that it can reciprocate freely within the outer cannula without catching on the tissue cutting opening.
  • the inner cannula has a nominal wall thickness of .010", which yields a nominal inner lumen diameter of about .106.”
  • the length ofthe tissue-receiving opening determines the length of biopsy sample extracted per each oscillation ofthe reciprocating motor 22.
  • the opening has a length of about 0.7", which means that a 0.7" long tissue sample can be extracted with each cutting cycle.
  • the collection trap can have a length of about 2.5" and a diameter of about .05".
  • the interior volume ofthe collection trap can vary depending upon the size of each biopsy slug and the amount of material to be collected.
  • the filter disposed within the collection trap 55 manufactured by Performance Systematix, Inc. of Callondoni, MI.
  • the cutting stroke for the inner cannula is about 0.905".
  • the return spring 66 within the reciprocating motor 22 is preferably a conical spring to reduce the compressed height ofthe spring, thereby allow a reduction in the overall length ofthe hydraulic cylinder 60.
  • the return spring 66 can be calibrated so that the return stroke occurs in less than about 0.3 seconds.
  • the inwardly beveled surface 36 of cutting edge 35 is oriented at an approximately 30° angle.
  • the aspiration pressure vacuum is nominally set at 27 in.Hg. during the cutting stroke. When the cannula is retracted and the outer lumen 27 is open, the vacuum pressure is reduced to 25 in.Hg.
  • This aspiration pressure normally allows aspiration of a tissue sample in less than about 1 second and in most cases in about 0.3 second.
  • the hydraulic control system 150 preferably is calibrated so that the inner cannula dwells at its retracted position for about 0.3 seconds to allow complete aspiration ofthe tissue sample. Adjusting the return spring 195 ofthe vacuum switch 194 can control this dwell rate.
  • the inner cannula 17 can advance through the cutting stroke in about two seconds. This stroke speed can be accomplished with a regulated pressure at source 152 of about 20 p.s.i. When the inner cannula reaches the end of its cutting stroke, the pressure can increase at about five p.s.i. per second.
  • the return spring 166 ofthe pressure switch 165 is set so that the end of cutting stroke is sensed within about 0.5 seconds.
  • a tissue biopsy apparatus 300 is configured as depicted in FIGS. 12-24. As with the biopsy apparatus 10 ofthe prior figures, the apparatus 300 includes a cutting element 302 mounted to a user manipulable handpiece 305.
  • the handpiece includes an upper housing 310, and a lower housing 311 (see Fig. 13).
  • a cannula hub 312 is mounted to the handpiece 305 to support the outer cannula 303 ofthe cutting element 302 in a fashion similar to that described above.
  • the biopsy apparatus 300 further includes a filter canister 315 that is removably mounted to the handpiece 305, again in a manner similar to that described above.
  • the biopsy apparatus 300 incorporates a secondary lumen
  • the upper housing 310 preferably includes a channel 322 defined along its entire length. The channel is configured to receive the secondary lumen 320 therein with the lumen recessed within the housing so as to not interfere with the ability ofthe surgeon to comfortably grip the biopsy apparatus 300.
  • the biopsy apparatus 300 includes a reciprocating motor assembly 330 and a rotary motor assembly motor 332. Each of these assemblies is constructed similar to the like assemblies described above.
  • the reciprocating motor assembly 330 includes a housing 340 that is contained within the upper and lower housing 310, 311 that define the handpiece 305.
  • the reciprocating motor 334 is similar to the motor described above.
  • the motor includes a tube fitting 335 for receiving a hollow tube 337 (see Fig. 13).
  • the tube 337 is connected to the hydraulic control system 150 depicted in Fig. 10 to provide an alternating supply of pressurized air to the reciprocating motor 334 in a manner described above.
  • the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in Fig. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in FIG. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in FIG. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in Fig. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in Fig. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in FIG. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332.
  • the rotary motor 332 includes opposite anti-rotation wings 355 that ride along the rails 341 as the motor 332 is reciprocated, and at the same time resist rotation of the rotary motor 332 during its operation.
  • the rotary motor 332 further includes a tube fitting 357 that is arranged to engage a hollow tube 358 (see Fig. 13) which, like the tube 337, provides a connection to the hydraulic control system 150.
  • the housing 340 forms a Luer fitting 345 at its distal end 342, as illustrated in FIG. 16.
  • the Luer fitting includes a circumferential recess 347 and a number of spaced flanges 348. Preferably, four such flanges spaced at 90° intervals are incorporated into the Luer fitting 345.
  • the recess 347 defines an enlarged gap 349 between one pair of flanges.
  • a number of retention dimples 350 are defined at the base ofthe circumferential recess 347, as depicted in FIGS. 14 and 15.
  • the Luer fitting 345 is configured to mate with the cannula hub 312. As shown in Fig.
  • the cannula hub 312 includes a number of Luer wings 370 corresponding in number to the plurality of flanges 348.
  • Each ofthe wings 370 is configured to fit within the recess the 347 between flanges 348.
  • One ofthe wings 370 includes an enlargement 371 that prevents the cannula 312 from being improperly oriented, or more specifically assures a pre-determined orientation ofthe tissue receiving opening ofthe cannula 312.
  • the enlargement 371 is preferably configured to fit within the enlarged gap 349 ofthe Luer fitting 345 to insure an upward orientation ofthe cutting element 302, as depicted in Figs. 12 and 13.
  • the bottom surface ofthe cannula hub 312 defines a number of protuberances 372.
  • Each ofthe protuberances is sized to fit within one ofthe retention dimples 350 ofthe Luer fitting 345.
  • each ofthe protuberances 372 engages within a corresponding dimples to hold the cannula hub 312 in place.
  • the cannula hub 312 includes a central bore 376 extending through the hub. One portion 377 ofthe bore is sized to tightly receive the outer cannula 303 ofthe cutting element 302 as described with respect to outer cannula 15. Preferably, the outer cannula 303 is engaged in a substantially fluid tight fit.
  • the hub 312 is configured for removable engagement with the Luer fitting 345 ofthe handpiece 305 so the entire handpiece can be removed from the hub 312 while the outer cannula 303 is still in place within the patient.
  • the inner cutting element 304 is withdrawn from the lumen 306 ofthe outer cannula, since the inner cutting element is connected to the reciprocating motor assembly 334 as described above.
  • the cannula hub 312 and outer cannula 302 remain at the surgical site to permit introduction of medical treatments or other instruments through the bore 376 and lumen 306.
  • a local anaesthetic, drug or treatment material such as a radioactive pellet
  • other surgical instruments such as a visualization scope, can be guided to the biopsy site through the hub 312 and cannula 302.
  • the cannula hub 312 also includes a tube fitting 375.
  • the Tube fitting 375 mates with the secondary lumen 320 that traverses the outer length ofthe handpiece 305.
  • the fitting 375 can be of any suitable configuration for providing a fluid-tight engagement between the fitting and a tube. Referring to back to Fig. 14, the reciprocating motor assembly motor housing
  • the proximal end ofthe housing 340 defines a circumferential flange 363 that is sealed against the ends ofthe upper and lower housings 310, 311 ofthe handpiece 305.
  • a pair of tube cutouts 365 are formed at the perimeter ofthe flange 363 to provide a passageway for the hydraulic tubes 337 and 358 supplying pressurized fluid to the reciprocating and rotary motors.
  • the upper and lower housings 310 and 311 can be configured as shown in Figs. 21-24.
  • the upper housing 310 includes an interior channel 380 that passes substantially along the entire length ofthe interior ofthe upper housing 310. This interior channel is aligned with one ofthe tube cutouts 365 in the flange 363 ofthe housing 340. This interior channel can provide a pathway for the tube 358 feeding pressurized fluid to the rotary motor assembly 332.
  • the upper housing 310 further defines a number of interior support walls 382. These walls project into the interior space and serve as a bulkhead for supporting the various working components ofthe handpiece 305.
  • the lower housing 311 includes a number of interior support walls
  • the lower housing 311 can include a longitudinal support rib 387 that preferably is arranged to support the reciprocating motor 334. At least some ofthe interior support wall 385 ofthe lower housing 311 can define tube cutouts 389 to receive the tube 337 feeding pressurized fluid to the reciprocating motor 334.
  • the lower housing 311 can include a number of mounting holes 395. These mounting holes can be arranged to permit mounting ofthe tissue biopsy apparatus 300 on an existing biopsy table, hi the preferred embodiment ofthe invention, the biopsy apparatus 300 can be mounted on a slideable carriage that can be separately driven to project the cutting element 302 into the patient. Support beds of this type are well known and the mounting feature 395 ofthe handpiece 305 can be specifically configured to accommodate any particular support bed.
  • the upper and lower housings 310, 311 include interlocking mating edges 397, 398, respectively. In a most preferred embodiment, the edges include press-fit male/female interfaces.
  • the upper and lower housings 310, 311 can be sandwiched about the housing 340, with the mating edges 397 and 398 in engagement.
  • the engagement can simply be a removable snap-fit, while in other embodiments, the engagement can be permanent, such as by the use of an adhesive.
  • the tissue biopsy apparatus 300 can be connected to the hydraulic control system 150 described above. Each ofthe components can operate in a manner similar to that described above.
  • the cannula hub 312 provides a fluid interface for the external secondary lumen 320 which can be used to introduce a fluid, such as a saline solution, to the surgical site.
  • a saline flush can be contained in a hermetically sealed bag, such as bag 400 depicted in FIG. 12.
  • a pinch valve 402 can engage the secondary lumen, preferably adjacent the saline bag 400.
  • the pinch valve can be opened at the moment that the cutting blade starts to retract from the cutting opening.
  • the pinch valve 402 can be controlled to remain open for a pre-determined period of time, but is preferably closed before the cutting blade advances forward to make the next biopsy cut.
  • the amount of time that the pinch valve remains open to allow the saline flush to enter the cutting element 302 can be calibrated based upon a pre- detennined volume of fluid desired at the surgical site, hi some procedures, the pinch valve 402 remains open for 1-2 seconds, although in certain applications, a shorter time in the range of 0.5 seconds may be preferred.
  • the valve operation can be calibrated to achieve a specific fluid volume, such as about 1 cc of saline.
  • the hydraulic confrol system 150 depicted in FIG. 10 can be modified to incorporate a fluid line branching from the line 192.
  • the line 192 is pressurized when the reciprocating motor starts its return stroke. Pressure in the branch fluid line can be used to open the pinch valve 402, while a drop in pressure can operate to close the valve.
  • the pinch valve can be electrically controlled, again in response to fluid pressure in line 192 which signals the beginning ofthe motor return sfroke.
  • the closure ofthe pinch valve 402 can be dictated by a drop in pressure in line 192 or by an increase in pressure in line 161, which arises as the reciprocating motor begins its cutting stroke. It is understood that wlrier a pinch valve is described, other on-off type fluid valves can be utilized to control the timing of fluid flow through the lumen 320 and cannula hub 312.
  • the saline flush can keep the cutting element clean of blood and tissue that might otherwise clot or j am the advancement of the inner cutting member.
  • a further benefit is that the saline can facilitate drawing tissue into the cutting opening during the cutting cycle.
  • the saline flush can help propel the excised tissue toward the collection canister.
  • the secondary lumen 320 can be used to introduce a puff of air into the cutting element 302.
  • the puff of air like the saline can be used to keep the interior channel ofthe cutting element clean. If properly pressurized, the introduction of air can prevent blood from flowing into the cutting element 302 as the cutting member and excise tissue sample is retracted.
  • the saline bag 400 can be replaced with a source of pressurized air.
  • the air source can provide air pressurized to 3-5 p.s.i.g.
  • the secondary lumen 320 can be closed as the cutting blade advances to remove a tissue sample, and opened as the blade starts to refract. The pressurized air will pass around the outside ofthe inner cutting blade toward the opening at the end ofthe cutting element 302. The pressure of this puff of air can be calibrated as necessary to counteract the blood pressure at the surgical site and keep the blood from flowing into the cutting element 302.
  • the tissue biopsy apparatus 10 or 300 described above provides significant advantages over prior biopsy devices.
  • One significant benefit is that the apparatus of the present invention is completely closed. This feature means that no fluid, such as blood, can escape or leak from the biopsy apparatus 10 or 300.
  • the each extracted tissue sample is drawn into a removable opening that is open to the ahnosphere.
  • the present invention does not include any component that is open to the ahnosphere, with the exception ofthe secondary lumen 320 which is confroUably open to atmosphere to keep the aspiration passageway open and clean.
  • the present invention provides a system for repeatably and precisely withdrawing uniformly sized biopsy samples. With each stroke ofthe cutting blade, a uniformly dimension biopsy sample is withdrawn and pulled into the collection canister at the proximal end ofthe apparatus.
  • the biopsy apparatus 10 and 300 ofthe present invention can readily remove an entire lesion or region of suspect tissue. This is a significant improvement over prior devices that are only capable of extracting a limited quantity of tissue for biopsy evaluation only.
  • biopsies were performed upon patients after obtaining informed consent and preparing the patients according to standard biopsy procedures. In each case, biopsies were performed according to the following procedure. The patient was positioned on her back on the surgical table, and the lesion was located using ultrasound. A small incision was made in the breast. While viewing the lesion using ultrasound, an early embodiment ofthe present invention was inserted into the breast with the tissue receiving opening adjacent the lesion. The cutter was engaged to sample and/or remove the lesion. The lesions varied in size from 6 - 22 mm. The surgeon's comments are provided in Table 1. TABLE 1
  • Table 1 illustrates the success ofthe present invention in its early stage of development. A majority ofthe trials, trials 1-6,8,1-12, and 14-18, resulted in a successful removal ofthe lesion with little to no problems. Lesions were removed quickly and, in some cases, only a few cores were required (see trials 1, 4, and 6). In trial number 8 it was noted that the cores were up to 25mm in length.
  • the surgeon experienced difficulties removing the lesion because the inner cutting blade would ride up and catch on the tissue receiving opening (see trials 5, and 9,).
  • this problem has been resolved in the present invention by integrating a crimp in the outer cannula.
  • the crimp forms a dimple that protrudes from the inner surface ofthe cannula and into the outer lumen. As the inner cannula passes the dimple, the dimple forces the inner cannula away from the tissue- receiving opening and prevents the inner cannula from riding up into the opening.
  • the cutting edge ofthe inner cannula is inwardly beveled.
  • This inwardly beveled surface also helps eliminate risk of catching by guiding the inner cannula back into the hollow outer cannula.
  • a stiffening element is provided on the outer cannula opposite the tissue-receiving opening.
  • the biopsy devices of this invention reliably, quickly and efficiently sample and remove lesions in tissue.

Abstract

A disposable tissue removal device (10) comprises a 'tube within a tube' cutting element (11) mounted to a handpiece (10). The inner cannula (17) of the cutting element (11) defines an inner lumen (34) and terminates in an inwardly beveled, razor-sharp cutting edge (35). The inner cannula (17) is driven by both a rotary motor (20) and a reciprocating motor (22). At the end of its stroke, the inner cannula (17) makes contact with a cutting board (31) to completely sever the tissue. An aspiration vacuum is applied to the inner lumen (34) to aspirate excised tissue through the inner cannula (17) and to into a collection trap (55) that is removably mounted to the handpiece (10). The rotary and reciprocating motors (20, 22) are hydraulically powered through a foot pedal (175) operated hydraulic circuit (150). The entire tissue removal or biopsy device (10) is configured to the disposable. In one embodiment, the cutting element (11) includes a cannula hub (75) that can be connected to a fluid source, such as a valve-controlled saline bag (400).

Description

BIOPSY APPARATUS
FIELD OF THE INVENTION
This invention relates to biopsy instruments and methods for taking a biopsy. More specifically, this invention relates to disposable biopsy devices for removing several tissue samples using a single insertion.
BACKGROUND OF THE INVENTION
In the diagnosis and treatment of breast cancer, it is often necessary to remove multiple tissue samples from a suspicious mass. The suspicious mass is typically discovered during a preliminary examination involving visual examination, palpitation, X-ray, MRI, ultrasound imaging or other detection means. When this preliminary examination reveals a suspicious mass, the mass must be evaluated by taking a biopsy in order to determine whether the mass is malignant or benign. Early diagnosis of breast cancer, as well as other forms of cancer, can prevent the spread of cancerous cells to other parts ofthe body and ultimately prevent fatal results. A biopsy can be performed by either an open procedure or a percutaneous method. The open surgical biopsy procedure first requires localization ofthe lesion by insertion of a wire loop, while using visualization technique, such as X-ray or ultrasound. Next, the patient is taken to a surgical room where a large incision is made in the breast, and the tissue surrounding the wire loop is removed. This procedure causes significant trauma to the breast tissue, often leaving disfiguring results and requiring considerable recovery time for the patient. This is often a deterrent to patients receiving the medical care they require. The open technique, as compared to the percutaneous method, presents increased risk of infection and bleeding at the sample site. Due to these disadvantages, percutaneous methods are often preferred.
Percutaneous biopsies have been performed using either Fine Needle Aspiration or core biopsy in conjunction with real-time visualization techniques, such as ultrasound or mamniography (X-ray). Fine Needle Aspiration involves the removal of a small number of cells using an aspiration needle. A smear ofthe cells is then analyzed using cytology techniques. Although Fine Needle Aspiration is less intrusive, only a small amount of cells are available for analysis. In addition, this method does not provide for a pathological assessment ofthe tissue, which can provide a more complete assessment ofthe stage ofthe cancer, if found. In contrast, in core biopsy a larger fragment of tissue can be removed without destroying the structure ofthe tissue. Consequently, core biopsy samples can be analyzed using a more comprehensive histology technique, which indicates the stage ofthe cancer. In the case of small lesions, the entire mass may be removed using the core biopsy method. For these reasons core biopsy is preferred, and there has been a trend towards the core biopsy method, so that a more detailed picture can be constructed by pathology of the disease ' s progress and type.
The first core biopsy devices were ofthe spring advanced, "Tru-Cut" style consisting of a hollow tube with a sharpened edge that was inserted into the breast to obtain a plug of tissue. This device presented several disadvantages. First, the device would sometimes fail to remove a sample, therefore, requiring additional insertions. This was generally due to tissue failing to prolapse into the sampling notch. Secondly, the device had to be inserted and withdrawn to obtain each sample, therefore, requiring several insertions in order to acquire sufficient tissue for pathology.
The biopsy apparatus disclosed in U.S. Patent No. 5,526,822 to Burbank, et al was designed in an attempt to solve many of these disadvantages. The Burbank apparatus is a biopsy device that requires only a single insertion into the biopsy site to remove multiple tissue samples. The device incorporates a tube within a tube design that includes an outer piercing needle having a sharpened distal end for piercing the tissue. The outer needle has a lateral opening forming a tissue receiving port. The device has an inner cannula slidingly disposed within the outer cannula, and which serves to cut tissue that has prolapsed into the tissue receiving port. Additionally, a vacuum is used to draw the tissue into the tissue receiving port.
Vacuum assisted core biopsy devices, such as the Burbank apparatus, are available in handheld (for use with ultrasound) and stereotactic (for use with X-ray) versions. Stereotactic devices are mounted to a stereotactic unit that locates the lesion and positions the needle for insertion. In preparation for a biopsy using a stereotactic device, the patient lies face down on a table, and the breast protrudes from an opening in the table. The breast is then compressed and immobilized by two mamniography plates. The mamniography plates create images that are communicated in real-time to the stereotactic unit. The stereotactic unit then signals the biopsy device and positions the device for insertion into the lesion by the operator.
In contrast, when using the handheld model, the breast is not immobilized. Rather the patient lies on her back and the doctor uses an ultrasound device to locate the lesion. The doctor must then simultaneously operate the handheld biopsy device and the ultrasound device.
Although the Burbank device presents an advancement in the field of biopsy devices, several disadvantages remain and further improvements are needed. For example, the inner cutter must be advanced manually, meaning the surgeon manually moves the cutter back and forth by lateral movement of a knob mounted on the outside ofthe instrument or by one ofthe three pedals at the footswitch. Also, the vacuum source that draws the tissue into the receiving port is typically supplied via a vacuum chamber attached to the outer cannula. The vacuum chamber defines at least one, usually multiple, communicating holes between the chamber and the outer cannula. These small holes often become clogged with blood and bodily fluids. The fluids occlude the holes and prevent the aspiration from drawing the tissue into the receiving port. This ultimately prevents a core from being obtained, a condition called a "dry tap." In addition, many ofthe components ofthe current biopsy devices are reusable, such as the driver portions, which control the outer and inner needles. This poses several notable disadvantages. First, the reusable portion must be cleaned and/or sterilized. This increases the time necessary to wrap up the procedure, which ultimately affects the cost ofthe procedure. In addition, the required clean-up and/or sterilization of reusable parts increases the staffs' potential exposure to body tissues and fluids. Finally, the reusable handle is heavy, large and cumbersome for handheld use.
A further disadvantage is that current biopsy devices comprise an open system where the tissue discharge port is simply an open area ofthe device. A surgical assistant must remove the tissue from the open compartment using forceps and place the tissue on a sample plate. This ritual must be followed for every sample and, therefore, multiple operators are required. In addition, the open system increases the exposure to potentially infectious materials, and requires increased handling ofthe sample. As a practical matter, the open system also substantially increases the cleanup time and exposure, because a significant amount of blood and bodily fluid leaks from the device onto the floor and underlying equipment.
Additionally, when using the current biopsy devices, physicians have encountered significant difficulties severing the tissue. For instance, the inner cutter often fails to completely sever the tissue. When the inner cutting needle is withdrawn, no tissue sample is present (dry tap), and therefore, reinsertion is required. In the case ofthe Burbank apparatus, the failure to completely sever the tissue after the first advancement ofthe inner cutter results in a necessary second advancement of the inner cutter. In this event, the procedure is prolonged, which is significant because the amount of trauma to the tissue and, ultimately, to the patient is greatly affected by the length ofthe procedure. Therefore, it is in the patient's best interest to minimize the length ofthe procedure by making each and every attempt at cutting the tissue a successful and complete cut. Additionally, when using the "tube within a tube" type biopsy device, the inner cutter can lift up into the tissue receiving opening during cutting. This lifting causes the inner cutter to catch on the edge ofthe tissue receiving opening, which ultimately results in an incomplete cut and dulling ofthe blade, rendering the blade useless. Also, prior devices often produce small tissue samples. As the inner cutter advances, the cutting edge not only starts to sever the tissue, it also pushes the tissue in front ofthe cutter. This results in a tissue sample that is smaller than the amount of tissue drawn into the tissue receiving opening.
An additional disadvantage ofthe prior devices is presented by the complexity ofthe three-pedal footswitch. Prior devices utilized a three-pedal footswitch; one pedal for advancing the inner cannula, another pedal for retracting the inner cannula, and a third pedal for tuπring on the aspiration. Operation ofthe three pedals is difficult and awkward.
These disadvantages become even more significant when using the handheld biopsy device. For instance, the physician must operate the biopsy device and the ultrasound probe simultaneously making it particularly difficult to manually advance ofthe inner cutter. In addition, when an assistant is required to remove each sample from the open discharge port, use ofthe handheld device becomes even more awkward. Due to these disadvantages, many physicians have declined to use the handheld models.
This is unfortunate because, some lesions that can signify the possible presence of cancer cannot be seen using the stereotactic unit. In these cases, the doctor must resort to either the handheld device or open surgical biopsy. Due to the difficulties associated with the handheld device, doctors often choose the open surgical biopsy, which is particularly unfortunate because a majority ofthe lesions that cannot be seen using the stereotactic unit turn out to be benign. This means that the patient has unnecessarily endured a significant amount of pain and discomfort; not to mention extended recovery time and disfiguring results. In addition, the patient has likely incurred a greater financial expense because the open surgical technique is more difficult, time consuming and costly, especially for those patient without health insurance.
The disadvantages ofthe open surgical technique coupled with the odds that the lesion is benign present a disincentive for the patient to consent to the biopsy.
The added discomfort alone is enough to cause many patients to take the risk that the lesion is benign. The acceptance of this risk can prove to be fatal for the minority of cases where the lesion is malignant.
Finally, current vacuum assisted biopsy devices are not capable of being used in conjunction with MRI. This is due to the fact that many ofthe components are made of magnetic components that interfere with the operation ofthe MRI. It would be desirable to perform biopsies in conjunction with MRI because it currently is the only non-invasive visualization modality capable of defining the margins ofthe tumor. In light ofthe foregoing disadvantages, a need remains for a tissue removal device that reliably applies a vacuum without becoming plugged with blood and bodily fluids. A need also remains for a tissue removal device that is entirely disposable so that both exposure to bio-hazard and clean-up time are significantly minimized, while convenience is maximized. A further need remains for a tissue removal device that completely severs the maximum amount of tissue without requiring numerous attempts at cutting the tissue. A need also remains for a tissue removal device that is MRI compatible. Finally, a need remains for a biopsy tissue removal device that is completely automated, therefore making the handheld biopsy device a more efficient and attractive option.
SUMMARY OF THE INVENTION
The present invention fulfills the aforementioned needs by providing a disposable tissue removal device comprising a cutting element mounted to a handpiece. The cutting element includes an outer cannula defining a tissue-receiving opening and an inner cannula concentrically disposed within the outer cannula.
The outer cannula has a trocar tip at its distal end and a cutting board snugly disposed within the outer cannula. The inner cannula defines an inner lumen that extends the length ofthe inner cannula, and which provides an avenue for aspiration. The inner cannula terminates in an inwardly beveled, razor-sharp cutting edge and is driven by, both a rotary motor, and a reciprocating motor. As the inner cannula moves past the tissue-receiving opening, the inwardly beveled edge helps to eliminate the risk of catching the edge on the tissue-receiving opening. At the end of its stroke, the inner cannula makes contact with the cutting board to completely sever the tissue. The cutting board is made of a material that is mechanically softer than the cutting edge yet hard enough to withstand the force ofthe inner cannula.
An aspiration is applied to the inner lumen through an aspiration tube. The aspiration tube communicates with a collection trap that is removably mounted to the handpiece. The aspiration draws the sample into the tissue-receiving opening and after the tissue is cut, draws the tissue through the inner cannula to a collection trap. In a specific embodiment, both the rotary motor and the reciprocating motors are hydraulic motors. Because hydraulic motors do not require any electrical components, this feature allows all ofthe components to be fabricated of MRI compatible materials.
In another embodiment, the tissue-receiving opening is formed by opposite longitudinal edges that form a number of teeth. The teeth face away from the cutting board at the distal end ofthe outer cannula. The teeth help prevent the forward motion ofthe tissue in the opening as the inner cannula moves forward toward the cutting board. This feature maximizes the length and overall size ofthe core, ultimately resulting in a more efficient lesion removal. In another embodiment, the outer cannula incorporates a stiffening element opposite the tissue-receiving opening. This stiffening element aids in maintaining the longitudinal integrity ofthe outer cannula as it is advanced through the tissue.
In addition to the inwardly beveled edge ofthe inner cannula, one embodiment incorporates additional features to prevent the inner cannula from rising up into the tissue-receiving opening. A bead of stiffening material may be affixed to the inner wall ofthe outer cannula, or a dimple may be formed in the inner wall ofthe outer cannula. The bead, or dimple urges the inner cannula away from the tissue- receiving opening and prevents the inner cannula from catching on the opening.
DESCRIPTION OF THE FIGURES
FIG. 1 is a top perspective view of a tissue biopsy apparatus in accordance with one embodiment ofthe present invention.
FIG. 2 is a top elevational view ofthe tissue biopsy apparatus shown in FIG. 1. FIG. 3 A and FIG. 3B are side cross-sectional views ofthe tissue biopsy apparatus depicted in FIGS. 1 and 2, with the tissue cutting inner cannula shown in its retracted and extended positions.
FIG. 4 is a perspective view of a cover for the tissue biopsy apparatus as shown FIG. 1. FIG. 5 is an enlarged side cross-sectional view ofthe operating end ofthe tissue biopsy apparatus depicted in FIGS. 1 and 2.
FIG. 6 is a side partial cross-sectional view of working end of a tissue biopsy apparatus in accordance with an alternative embodiment.
FIG. 7 is an end cross-sectional view ofthe apparatus depicted in FIG. 6, taken along line 7-7 as viewed in the direction ofthe arrows.
FIG. 8 is an end cross-sectional view similar to FIG. 7 showing a modified configuration for a stiffening member.
FIG. 8(a) is an end cross-sectional view similar to FIG. 7 showing a modified configuration for another stiffening member. FIG. 9 is an enlarged side cross-sectional view of a fluid introduction port at the hub connecting the outer cannula to the handpiece for a tissue biopsy apparatus as depicted in FIG. 1.
FIG. 10 is a schematic drawing ofthe hydraulic control system for the operation ofthe tissue biopsy apparatus shown in FIG. 1.
FIG. 11 is a schematic drawing of a control system for an electric rotary motor for use with the apparatus ofthe present invention.
Fig. 12 is a top elevational view of a tissue biopsy apparatus according to a further embodiment ofthe present invention. Fig. 13 is a side cross-sectional view ofthe biopsy apparatus shown in Fig.
12, taken along line 13-13 as viewed in the direction ofthe arrows.
Fig. 14 is a side cross-sectional view of a motor assembly incorporated into the biopsy apparatus shown in Fig. 12.
Fig. 15 is an end elevational view from the left end ofthe assembly depicted in Fig. 14.
Fig. 16 is an end elevational view ofthe right end ofthe assembly depicted in Fig. 14.
Fig. 17 is a top elevational view of a rotary motor assembly in accordance with one specific embodiment ofthe invention. Fig. 18 is a side elevational view of a cannula hub for engagement with the assembly depicted in Fig. 14.
Fig. 19 is a rear elevational view ofthe cannula hub shown in Fig. 18.
Fig. 20 is a side cross-sectional view ofthe cannula hub shown in Fig. 18.
Fig. 21 is a top perspective view of an upper housing component ofthe biopsy apparatus depicted in Fig. 12.
Fig. 22 is an end cross-sectional view ofthe upper housing shown in Fig. 21, taken along line 22-22 as viewed in the direction ofthe arrows.
Fig. 23 is a top perspective view of a lower housing for use with the biopsy apparatus shown in Fig. 12. Fig. 24 is a top elevational view ofthe lower housing shown in Fig. 23.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of promoting an understanding ofthe principles ofthe invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation ofthe scope ofthe invention is thereby intended. The invention includes any alterations and further modifications in the illustrated devices and described methods and further applications ofthe principles ofthe invention which would normally occur to one skilled in the art to which the invention relates. A tissue biopsy apparatus 10 in accordance with one embodiment ofthe present invention is shown in FIGS.
The apparatus 10 includes a cutting element 11 mounted to a handpiece 12. The cutting element 11 is sized for introduction into a human body. Most particularly, the present invention concerns an apparatus for excising breast tissue samples. Thus, the cutting element 11 and the overall biopsy apparatus 10 are configured for ease of use in this surgical environment. In the illustrated embodiment, the biopsy apparatus 10 is configured as a hand-held device. However, the same inventive principles can be employed in a tissue biopsy apparatus that is used stereotatically in which the apparatus is mounted on a support fixture that is used to position the cutting element 11 relative to the tissue to be sampled. Nevertheless, for the purposes of understanding the present invention, the tissue biopsy apparatus will be described as a hand-held device.
The cutting element 11 is configured as "tube-within-a-tube" cutting device. More specifically, the cutting element 11 includes an outer cannula 15 terminating in a tip 16. Preferably, the tip is a trocar tip that can be used to penetrate the patient's skin. Alternatively, the tip 16 can simply operate as a closure for the open end ofthe cannula 15. In this instance, a separate introducer would be required.
The cutting element 11 further includes an inner cannula 17 that fits concentrically within the outer lumen 27 (FIG. 5) ofthe outer cannula 15. In the most preferred embodiment, both a rotary motor 20 (FIG. 1) and a reciprocating motor 22 drive the inner cannula 17. Both motors are supported witlύn the handpiece 12. Again, in accordance with the preferred embodiment the rotary motor 20 and reciprocating motor 22 are configured for simultaneous operation to translate the inner cannula 17 axially within the outer cannula 15, while rotating the inner cannula 17 about its longitudinal axis. One specific configuration ofthe working end ofthe cutting element 11 is depicted in FIG. 5. The outer cannula 15 defines a tissue-receiving opening 25, which communicates with the outer lumen 27. A pair of opposite longitudinal edges 26 (FIGS. 1 and 2) define the tissue-receiving opening 25. The outer cannula 15 is open at its distal end 28 with the trocar tip 16 engaged therein. Preferably, the trocar tip 16 forms an engagement hub 30 that fits tightly within the distal end 28 ofthe outer cannula 15. The hub 30 can be secured by welding, press-fit, adhesive or other means suitable for a surgical biopsy instrument.
The working end ofthe cutting element 11 further includes a cutting board 31 that is at least snugly disposed within the outer lumen 27 at the distal end 28 ofthe outer cannula 15. Most preferably, the cutting board 31 is in direct contact with the engagement hub 30 ofthe trocar tip 16. The cutting board 31 can be permanently affixed within the outer cannula 15 and/or against the engagement hub 30 ofthe trocar tip.
The inner cannula 17 defines an inner lumen 34 that is hollow along the entire length ofthe cannula to provide for aspiration ofthe biopsy sample. The inner cannula 17 terminates in a cutting edge 35. Preferably the cutting edge 35 is formed by an inwardly beveled surface 36 to provide a razor-sharp edge. The inwardly beveled surface helps eliminate the risk of catching the edge 35 on the tissue- receiving opening 25 ofthe outer cannula. In addition, the beveled surface 36 helps avoid pinching the biopsy material between the inner and outer cannulas during a cutting stroke.
In a specific embodiment, both the outer cannula 15 and the inner cannula 17 are formed of a surgical grade metal. Most preferably, the two cannulae are formed of stainless steel. In the case of an MRI compatible device, the cannulae can be formed of Inconel, Titanium or other materials with similar magnetic characteristics. Likewise, the trocar tip 16 is most preferably formed of stainless steel honed to a sharp tip. The trocar tip 16 can be suitably bonded to the outer cannula 15, such as by welding or the use of an appropriate adhesive, hi some embodiments, the inner and outer cannulae can be formed of a non-metallic material of appropriate strength and stiffness.
The cutting board 31 is formed of a material that is configured to reduce the friction between the cutting edge 35 ofthe inner cannula 17 and the cutting board 31. The cutting edge 35 necessarily bears against the cutting board 31 when the inner cannula 17 is at the end of its stroke while severing a tissue sample. Since the inner cannula is also rotating, the cutting edge necessarily bears directly against the cutting board 31, particularly after the tissue sample has been cleanly severed. In prior devices, the impact-cutting surface has been formed ofthe same material as the cutting element. This leads to significant wear or erosion ofthe cutting edge. When numerous cutting cycles are to be performed, the constant wear on the cutting edge eventually renders it incapable of cleanly severing a tissue sample.
Thus, the present invention contemplates forming the cutting board 31 of a material that reduces this frictional wear. In one embodiment, the cutting board 31 is formed of a material that is mechanically softer than the material of the cutting edge 35. However, the cutting board 31 cannot be so soft that the cutting edge 35 forms a pronounced circular groove in the cutting board, which significantly reduces the cutting efficiency ofthe inner cannula. In a most preferred embodiment ofthe invention, the cutting board 31 is formed of a plastic material, such as polycarbonate, ABS or DELRIN®.
Returning again to FIGS. 1, 2 and 3 A - 3B, the rotary motor 20 includes a motor housing 39 that is sized to reciprocate within the handpiece 12. The housing 39 defines a pilot port 40 that is connected to the hydraulic control system 150 (see FIG. 10) by appropriate tubing. The present invention contemplates that the motor 20 can be a number of hydrauhcally powered rotating components. Most preferably, the motor 20 is an air motor driven by pressured air. Thus, the motor 20 includes a vaned rotor 42 that is mounted on a hollow tubular axle 43 extending through the motor housing 39. The axle 43 is supported on bearings 44 at opposite ends ofthe housing so that the rotor 42 freely rotates within the motor housing 39 under pneumatic pressure.
In the illustrated embodiment, tubular axle 43 is connected to the proximal end 37 ofthe inner cannula 17 by way of a coupler 46. The ends ofthe two tubes are mounted within the coupler 46 and held in place by corresponding set screws 47. Preferably the coupler 46 is formed of a plastic material that provides a generally airtight seal around the joint between the inner cannula 17 and the tubular axle 43. It is important that the coupler 46 provide a solid connection ofthe inner cannula 17 to the rotating components ofthe motor 20 so that the inner cannula 17 does not experience any torrential slip during the cutting operation.
Since the inner cannula 17 provides an avenue for aspiration ofthe biopsy sample, the invention further contemplates an aspiration tube 50 that mates with the tubular axle 43. Thus, the tissue aspiration path from the working end ofthe cutting element 11 is along the inner lumen 34 ofthe inner cannula 17, through the tubular axle 43 ofthe rotary motor 20, and through the aspiration tube 50 to a tissue collection location in the form of a collection trap 55. In order to maintain the vacuum or aspiration pressure within this aspiration path, the aspiration tube 50 must be fluidly sealed against the tubular axle 43. Thus, the motor housing 39 defines a mounting hub 51 into which the aspiration tube 50 is engaged. The position ofthe aspiration tube 50 is fixed by way of a set screw 52 passing through the mounting hub 51. In contrast to the joint between the inner cannula 17 and the tubular axle 43, the joint between the aspiration tube 50 and the tubular axle 43 allows relative rotational between the two components. The tubular axle 43, of course, rotates with the rotor 42. However, the aspiration tube 50 need not rotate for use with the biopsy apparatus ofthe present invention. The mounting hub 51 can include an arrangement of seal rings (not shown) at the joint between the aspiration tube 50 and the tubular axle 43 to further seal the aspiration system.
The aspiration tube 50 communicates with a collection trap 55 that is removably mounted to the handpiece 12. The collection trap 55 includes a pilot port 107 that is connected by appropriate tubing to the hydraulic control system 150, as described in more detail herein. For the present purposes, it is understood that a vacuum or aspiration pressure is drawn through the pilot port 107 and the collection trap 55. This vacuum then draws a tissue sample excised at the working end ofthe cutting element 11, all the way through the inner cannula 17, tubular axle 43 and aspiration tube 50 until it is deposited within the trap. Details ofthe collection trap 55 will be discussed herein.
As explained above, the present invention contemplates an inner cannula 17 that performs its cutting operation by both rotary and reciprocating motion. Thus, the handpiece 12 supports a reciprocating motor 22. In one aspect ofthe invention, both motors 20 and 22 are hydrauhcally powered, most preferably pneumatically. This feature allows the motors to be formed of plastic, since no electrical components are required. In fact, with the exception ofthe outer cannula 15, trocar tip 16 and inner cannula 17, every component ofthe biopsy apparatus 10 in accordance with the present invention can be formed of a non-metallic material, most preferably a medical grade plastic. Thus, the biopsy apparatus 10 is eminently compatible with surgical imaging systems that may be used during the biopsy procedure. The compatibility of the apparatus 10 with Magnetic Resonance Imaging (MRI) is important because MRI is currently the only non-invasive visualization modality capable of defining the margins ofthe tumor. In addition, since the biopsy apparatus is formed of a relatively inexpensive plastic (as opposed to a more expensive metal), the entire apparatus can be disposable. Moreover, the elimination of substantially all metal components reduces the overall weight ofthe handpiece 12, making it very easily manipulated by the surgeon.
Referring most specifically to FIGS. 3A and 3B, the reciprocating motor 22 includes a pneumatic cylinder 60. The cylinder 60 includes a pilot port 61 that connects the cylinder to the hydraulic control system 150 through appropriate tubing. The motor 22 includes a piston 63 that reciprocates within the cylinder 60 in response to hydraulic fluid pressure provided at the pilot port 61. The piston 63 includes a central bore 64 for mounting the piston 63 to the aspiration tube 50. In one embodiment, the aspiration tube 50 is press-fit within the bore 64. The engagement between the aspiration tube 50 and the piston 63 can be enhanced by use of a set screw (not shown) or an adhesive or epoxy. At any rate, it is essential that the aspiration tube 50 and piston 63 move together, since the motor 22 must eventually drive the inner cannula 17 axially within the outer cannula.
It should be understood that in addition to powering the inner cannula, the piston 63 also reciprocates the rotary motor 20, which is essentially mounted to the reciprocating aspiration conduit. This movement is depicted by comparing the position ofthe rotary motor 20 between FIG. 3A and FIG. 3B. More specifically, the motor 20 as well as the aspiration conduit, including the inner cannula 17, moves within the handpiece 12. Preferably, the handpiece housing 70 is provided with openings 73 (FIG. 3B) at its opposite ends for slidably supporting the aspiration tube 50 and inner cannula 17. Since the distal housing 70 is preferably formed of a plastic material, no thrust bearings or rotary bearings are necessary to accommodate low friction axial movement ofthe cannula through the housing openings 73.
The biopsy apparatus 10 includes a handpiece 12 that carries all ofthe operating components and supports the outer and inner cannulas. The handpiece 12 includes a distal housing 70 within which is disposed the rotary motor 20. The distal end 71 ofthe housing 70 is configured into a fitting 72. This fitting 72 engages a mating flange 77 on an outer cannula hub 75. The hub 75 supports the outer cannula 15 witlrin an engagement bore 76 (see FIG. 3B). In accordance with one aspect ofthe present invention, the engagement between the outer cannula hub 75 and the distal end 71 ofthe housing 70 need not be airtight. In other words, the mating components ofthe fitting between the two parts need not be capable of generating a fluid-tight seal. In accordance with one embodiment ofthe invention, the engagement between the hub 75 and the housing 70 for supporting the outer cannula 15 provides a leak path through the outer lumen 27 to the atmosphere. In the use ofthe tissue biopsy apparatus 10, providing aspiration through the inner lumen 34 ofthe inner cutting cannula 17 will draw tissue through the inner lumen. As the tissue advances farther along the lumen, in some instances a vacuum can be created behind the advancing tissue. At some point in these instances, the tissue will stop advancing along the length ofthe inner lumen because the vacuum behind the tissue sample equals the vacuum in front ofthe tissue sample that is attempting to draw the sample to the collection trap 55. Thus, the leak path through the outer lumen 27 allows atmospheric air to fall in behind the tissue sample when the inner cutter is retracted from the cutting board. The atmospheric air helps to relieve the vacuum behind the advancing tissue and aids in drawing the tissue down the length ofthe aspiration channel to the collection trap 55. However, in some applications, particularly where smaller "bites" ofthe target tissue are taken, the atmospheric air leak path is not essential.
Preferably the fitting 72 and the mating flange 77 can be engaged by simple twisting motion, most preferably via Luer-type fittings. In use, the cannula hub 75 is mounted on the handpiece 12, thereby supporting the outer cannula 15. The handpiece can then be used to project the outer cannula into the body adjacent the sample site. In certain uses ofthe biopsy apparatus 10, it is desirable to remove the handpiece 12 from the cannula hub 75 leaving the outer cannula 15 within the patient. For example, the outer cannula 15 can be used to introduce an anesthetic. In other applications, once the target tissue has been completely excised, the outer cannula can be used to guide a radio-opaque marker to mark the location the removed material. Returning again to the description ofthe housing 70, the housing defines an inner cavity 79 that is open through an access opening 81. The access opening 81 is preferably provided to facilitate assembly ofthe tissue biopsy apparatus 10. The distal end 71 ofthe housing 70 can be provided with a pair of distal braces 80 that add stiffness to the distal end 71 while the apparatus is in use. The braces 80 allow the distal housing 70 to be formed as a thin-walled plastic housing. Similar braces can be provided at the opposite end ofthe distal housing as necessary to add stiffness to the housing.
The distal housing is configured to support the reciprocating motor 22 and in particular the cylinder 60. Thus, in one embodiment ofthe invention, the proximal end 83 ofthe distal housing 70 defines a pressure fitting 84. It is understood that this pressure fitting 84 provides a tight leak-proof engagement between the distal end 88 ofthe cylinder 60 and the proximal end 83 ofthe housing. In one specific embodiment, the pressure fitting 84 forms a spring cavity 85 within which a portion ofthe return spring 66 rests. In addition, in a specific embodiment, the pressure fitting 84 defines distal piston stop 86. The piston 63 contacts these stops at the end of its stroke. The location ofthe piston stop 86 is calibrated to allow the cutting edge 35 to contact the cutting board 31 at the working end ofthe cutting element 11 to allow the cutting edge to cleanly sever the biopsy tissue.
In the illustrated embodiment, the cylinder 60 is initially provided in the form of an open-ended cup. The open end, corresponding to distal end 88, fastens to the pressure fitting 84. In specific embodiments, the pressure fitting can include a threaded engagement, a press-fit or an adhesive arrangement.
The cylinder cup thus includes a closed proximal end 89. This proximal end defines the pilot port 61, as well as a central opening 62 (FIG. 3B) through which the aspiration tube 50 extends. Preferably, the proximal end 89 ofthe cylinder 60 is configured to provide a substantially airtight seal against the aspiration tube 50 even as it reciprocates within the cylinder due to movement ofthe piston 63. The proximal end 89 ofthe cylinder 60 defines a proximal piston stop 90, which can either be adjacent the outer cylinder walls or at the center portion ofthe proximal end. This proximal piston stop 90 limits the reverse travel ofthe piston 63 under action ofthe return spring 66 when pressure within the cylinder has been reduced.
In a further aspect ofthe invention, the collection trap 55 is mounted to the handpiece 12 by way of a support housing 93. It should be understood that in certain embodiments, the handpiece 12 can be limited to the previously described components, hi this instance, the collection trap 55 can be situated separate and apart from the handpiece, preferably close to the source of vacuum or aspiration pressure. In this case, the proximal end ofthe aspiration tube 50 would be connected to the collection trap by a length of tubing. In the absence ofthe collection trap 55, the aspiration tube 50 would reciprocate away from and toward the proximal end ofthe cylinder 60, so that it is preferable that the handpiece includes a cover configured to conceal the reciprocating end ofthe aspiration tube.
However, in accordance with the most preferred embodiment, the collection trap 55 is removably mounted to the handpiece 12. A pair of longitudinally extending arms 94, that define an access opening 95 therebetween, forms the support housing 93. The support housing 93 includes a distal end fitting 96 that engages the proximal end 89 of cylinder 60. A variety of engagements are contemplated, preferably in which the connection between the two components is generally airtight. The proximal end 97 ofthe support housing 93 forms a cylindrical mounting hub 98. As best shown in FIG. 1, the mounting hub 98 surrounds a proximal end ofthe collection trap 55. The hub forms a bayonet-type mounting groove 99 that receives pins 103 attached to the housing 102 ofthe trap 55. A pair of diametrically opposite wings 104 can be provided on the housing 102 to facilitate the twisting motion needed to engage the bayonet mount between the collection trap 55 and the support housing 93. While the preferred embodiment contemplates a bayonet mount, other arrangements for removably connecting the collection trap 55 to the support housing 93 are contemplated. To be consistent with one ofthe features ofthe invention, it is preferable that this engagement mechanism be capable of being formed in plastic. hi order to accommodate the reciprocating aspiration tube, the support housing 93 is provided with an aspiration passageway 100 that spans between the proximal and distal ends ofthe housing. Since the aspiration tube 50 reciprocates, it preferably does not extend into the collection trap 55. As excised tissue is drawn into the trap 55, a reciprocating aspiration tube 50 can contact the biopsy material retained within the trap. This movement ofthe tube can force tissue into the end ofthe tube, clogging the tube. Moreover, the reciprocation ofthe aspiration tube can compress tissue into the end ofthe trap, thereby halting the aspiration function. The collection trap 55 includes a housing 102, as previously explained. The housing forms a pilot port 107, which is connectable to a vacuum generator. Preferably in accordance with the present invention, appropriate tubing to the hydraulic control system 150 connects the pilot port 107. The trap 55 includes a filter element 110 mounted within the trap, hi the preferred embodiment, the filter element is a mesh filter than allows ready passage of air, blood and other fluids, while retaining excised biopsy tissue samples, and even morcellized tissue. In addition, the filter element 110 is preferably constructed so that vacuum or aspiration pressure can be drawn not only at the bottom end ofthe filter element, but also circumferentially around at least a proximal portion ofthe element 110. In this way, even as material is drawn toward the proximal end of the filter, a vacuum can still be drawn through other portions ofthe filter, thereby maintaining the aspiration circuit.
The handpiece 12 can include individual covers for closing the access opening 81 in the distal housing 70 and the access openings 95 in the support housing 93. Those covers can support tubing for engagement with the pilot ports 40 and 61. Alternatively and most preferably, a single cover 13 as depicted in FIG. 4, is provided for completely enclosing the entire handpiece. The distal end 71 ofthe housing 70 can define a number of engagement notches 115 equally spaced around the perimeter ofthe distal end. The handpiece cover 13 can then include a like number of equally distributed tangs 117 projecting inwardly from the inner surface from the 118. These tangs are adapted to snap into the engagement notches 115 to hold the cover 113 in position over the handpiece 12. The cover can be attached by sliding axially over the handpiece 12. The cover 13 can include fittings for fluid engagement with the two pilot ports 40 and 61. Alternatively, the cover can be formed with openings for insertion of engagement tubing to mate with the respective pilot ports to provide hydraulic fluid to the rotary motor 20 and the reciprocating motor 22. In a specific embodiment, the cover 13 extends from the distal end 71 of the distal housing 70 to the proximal end 97 ofthe support housing 93. The cover can thus terminate short ofthe bayonet mounting feature between the support housing and the collection trap 55. Although not shown in the figures, the proximal end 97 ofthe support housing 93 can be configured to include a similar array of engagement notches with a corresponding array of mating tangs formed at the proximal end ofthe cover 13. It can be appreciated from the foregoing discussion that the biopsy apparatus
10 ofthe present invention provides a complete "closed" tissue excision and recovery system. In other words, unlike prior biopsy devices, the apparatus 10 is fluid tight so that no bodily fluids can escape. Biopsy procedures with many prior devices involves significant blood splatter due to the nature in which the tissue samples are extracted and recovered. With the present invention, the biopsy apparatus 10 provides a closed path from the tissue receiving opening 25 to the collection trap 55, while still maintaining the highly efficient reciprocating and rotating cutting operation.
Referring now to FIGS. 6-8, alternative embodiments ofthe outer cannula are depicted. As shown in FIG. 6 an outer cannula 125 includes a tissue-receiving opening 126. The opening is formed by opposite longitudinal edges 127. In one specific embodiment, a number of teeth 129 are formed at each longitudinal edge 127. As depicted in the figure, the teeth are proximally facing — i.e., away from the cutting board 31 (not shown) at the distal end ofthe outer cannula. With this orientation, the teeth 129 help prevent forward motion of tissue drawn into the opening 126 as the inner cannula 17 moves forward toward the cutting board. In prior devices, as the reciprocating cutting element advances through the outer cannula, the cutting edge not only starts to sever the tissue, it also pushes tissue in front ofthe inner cannula. Thus, with these prior devices, the ultimate length ofthe biopsy sample retrieved with the cut is smaller than the amount of tissue drawn into the tissue-receiving opening ofthe outer cannula. With the teeth 129 ofthe outer cannula 125 of this embodiment ofthe invention, the tissue sample removed through the inner cannula 17 is substantially the same length as the tissue-receiving opening 126. As the inner cannula 17 advances into the tissue, each ofthe teeth 129 tends to hold the tissue in place as the cutting edge 35 severs the tissue adjacent the outer cannula wall. With this feature, each "bite" is substantially as large as possible so that a large tissue mass can be removed with much fewer "bites" and in a shorter period of time. In addition to supporting the subject tissue as the inner cannula advances, the teeth can also cut into the tissue to prevent it from retracting out ofthe opemng as the inner cutting cannula 17 advances.
The outer cannula 125 depicted in FIG. 6 can also incorporate a stiffening element 131 opposite the tissue-receiving opemng 126. The stiffening element 131 adds bending stiffness to the outer cannula 125 at the distal end in order to maintain the longitudinal integrity ofthe outer cannula 125 as it is advanced into a tissue mass. In some prior devices that lack such a stiffening element, the working end ofthe cutting device is compromised as it bends slightly upward or downward as the outer cannula passes into the body. This bending can either close or expand the tissue- receiving opening, which leads to difficulties in excising and retrieving a tissue sample. The cutting mechanism ofthe present invention relies upon full, flush contact between the cutting edge ofthe inner cannula 17 and the cutting board 31. If the end ofthe outer cannula 125 is slightly askew, this contact cannot be maintained, resulting in an incomplete slice ofthe tissue sample. As depicted in the cross-sectional view ofthe FIG. 7, the stiffening element
131 in one embodiment is a crimp extending longitudinally in the outer wall ofthe cannula substantially coincident with the tissue-receiving opening 126. The outer cannula 125' depicted in FIG. 8 shows two additional versions of a stiffening element. In both cases, a bead of stiffening material is affixed to the outer cannula. Thus in one specific embodiment, a bead 131' is adhered to the inner wall ofthe outer cannula. In a second specific embodiment, a bead 131" is affixed to the outside of the outer cannula. In either case, the beads can be formed of a like material with the outer cannula, and in both cases, the beads provide the requisite additional bending stiffness. Another version of a stiffening element is shown if FIG. 8(a). In this case, a layer 131'" of additional stainless steel is bonded to the outer wall ofthe outer cannula 125".
Returning to FIG. 6, a further feature that can be integrated into the outer cannula 125 is the dimple 135. One problem frequently experienced by tube-within- a-tube cutters is that the inner reciprocating cutter blade contacts or catches on the outer cannula at the distal edge ofthe tissue-receiving opening. With the present invention, the dimple 135 urges the inner cannula 17 away from the tissue-receiving opening 126. In this way, the dimple prevents the cutting edge ofthe inner cannula 17 from catching on the outer cannula as it traverses the tissue-receiving opening. In the illustrated embodiment of FIG. 6, the dimple 135 is in the form of a slight crimp in the outer cannula 125. Alternatively, as with the different embodiments ofthe stiffening element, the dimple 135 can be formed by a protrusion affixed or adhered to the inner surface ofthe outer cannula. Preferably, the dimple 135 is situated immediately proximal to the tissue-receiving opening to help maintain the distance between the cutting edge and the tissue-receiving opening.
As previously described, the outer cannula 15 is supported by a hub 75 mounted to the distal end ofthe handpiece. In an alternative embodiment depicted in FIG. 9, the outer cannula hub 140 provides a mean for introducing fluids into the outer lumen 27 ofthe outer cannula. Thus, the hub 140 includes an engagement bore 141 within which the outer cannula 15 is engaged. The hub also defines a flange 142 configured for mating with the fitting 72 at the distal end 71 ofthe housing 70. Thus, the outer cannula hub 140 is similar to the hub 75 described above. With this embodiment, however, an irrigation fitting 145 is provided. The fitting defines an irrigation lumen 146 that communicates with the engagement bore 141.
Ultimately, this irrigation lumen is in fluid commumcation with the outer lumen 27 ofthe outer cannula 15. The irrigation fitting 145 can be configured for engagement with a fluid-providing device, such as a syringe. The hub 140 thus provides a mechanism for introducing specific fluids to the biopsy site. In certain procedures, it may be necessary to introduce additional anesthetic to the sampling site, which can be readily accommodated by the irrigation fitting 145.
As discussed above, the preferred embodiment ofthe tissue biopsy apparatus 10 according to the present invention relies upon hydraulics or pneumatics for the cutting action. Specifically, the apparatus includes a hydraulic rotary motor 20 and a hydraulic reciprocating motor 22. While the apparatus 10 can be adapted for taking a single biopsy slice, the preferred use is to completely remove a tissue mass through successive cutting slices. In one typical procedure, the cutting element 11 is positioned directly beneath a tissue mass, while an imaging device is disposed above the mass. The imaging device, such as an ultra-sound imager, provides a real-time view ofthe tissue mass as the tissue biopsy apparatus 10 operates to successively remove slices ofthe mass. Tissue is continuously being drawn into the cutting element 11 by the aspiration pressure or vacuum drawn through the inner cannula 17. Successive reciprocation ofthe inner cannula 17 removes large slices ofthe mass until it is completely eliminated.
In order to achieve this continuous cutting feature, the present invention contemplates a hydraulic control system 150, as illustrated in the diagram of FIG. 10. Preferably the bulk ofthe control system is housed within a central console. The console is connected to a pressurized fluid source 152. Preferably the fluid source provides a regulated supply of filtered air to the control system 150.
As depicted in this diagram of FIG. 10, pressurized fluid from the source as provided at the several locations 152 throughout the control system. More specifically, pressurized fluid is provided to five valves that form the basis ofthe control system.
At the left center ofthe diagram of FIG. 10, pressurized fluid 152 passes through a pressure regulator 154 and gauge 155. The gauge 155 is preferably mounted on the console for viewing by the surgeon or medical technician. The pressure regulator 154 is manually adjustable to control the pressurized fluid provided from the source 152 to the two-position hydraulic valve 158. The valve 158 can be shifted between a flow path 158a and a flow path 158b. A return spring 159 biases the hydraulic valve to its normal position 158a.
In the normally biased position of flow path 158a, the valve 158 comiects cylinder pressure line 161 to the fluid source 152. This pressure line 161 passes through an adjustable flow control valve 162 that can be used to adjust the fluid flow rate through the pressure line 161. Like the pressure gauge 155 and pressure regulator 154, the adjustable flow control valve 162 can be mounted on a console for manipulation during the surgical procedure. The pressure line 161 is connected to the pilot port 61 ofthe reciprocating motor 22. Thus, in the normal or initial position ofthe hydraulic control system 150, fluid pressure is provided to the cylinder 60 to drive the piston 63 against the biasing force ofthe return spring 66. More specifically with reference to FIG. 3B, the initial position ofthe hydraulic valve 158 is such that the reciprocating motor and inner cannula are driven toward the distal end ofthe cutting element. In this configuration, the inner cannula 17 covers the tissue-receiving opening 25 ofthe outer cannula 15. With the inner cannula so positioned, the outer cannula can be introduced into the patient without risk of tissue filling the tissue-receiving opening 25 prematurely. Pressurized fluid along cylinder pressure 161 is also fed to a pressure switch 165. The pressure switch has two positions providing flow paths 165a and 165b. In addition, an adjustable return spring 166 biases this switch to its normal position at which fluid from the pressure source 152 terminates within the valve. However, when pressurized fluid is provided through cylinder pressure line 161, the pressure switch 165 moves to its flow path 165b in which the fluid source 152 is hydrauhcally connected to the pressure input line 168. This pressure input line 168 feeds an oscillating hydraulic valve 170. It is this valve that principally operates to oscillate the reciprocating motor 22 by alternately pressurizing and releasing the two-position hydraulic valve 158. The pressure switch 165 is calibrated to sense an increase in pressure within the cylinder pressure line 161 or in the reciprocating motor cylinder 60 that occurs when the piston 66 has reached the end of its stroke. More specifically, the piston reaches the end of its stroke when the inner cannula 17 contacts the cutting board 31. At this point, the hydraulic pressure behind the piston increases, which increase is sensed by the pressure valve 165 to stroke the valve to the flow path 165b.
The oscillating hydraulic valve 170 has two positions providing flow paths 170a and 170b. In position 170a, input line 179 is fed to oscillating pressure output line 172. With flow path 170b, the input line 179 is fed to a blocked line 171. Thus, with fluid pressure provided from pressure switch 165 (through flow path 165b), the oscillating valve 170 opens flow path 170a which completes a fluid circuit along output line 172 to the input ofthe hydraulic valve 158.
Fluid pressure to output line 172 occurs only when there is fluid pressure within input line 179. This input line is fed by valve 176, which is operated by foot pedal 175. The valve 176 is biased by a return spring 177 to the initial position of flow path 176a. However, when the foot pedal 175 is depressed, the valve 176 is moved against the force ofthe spring to flow path 176b. In this position, pressurized fluid from the source 152 is connected to the foot pedal input line 179. When the oscillating hydraulic valve 170 is in its initial position flow path 170a, pressurized fluid then flows through input line 179 to output line 172 and ultimately to the hydraulic valve 158.
The fluid pressure in the output line 172 shifts the valve 158 to the flow path 158b. In this position, the fluid pressure behind the piston 63 is relieved so that the return spring 66 forces the piston toward the proximal end. More specifically, the return spring retracts the inner cannula 17 from the tissue cutting opening 25. The relief of the fluid pressure in line 161 also causes the pressure switch 165 to return to its initial neutral position of flow path 165a, due to the action ofthe return spring 166. In turn, with the flow path 165a, the pressure input line 168 is no longer connected to the fluid source 152, so no pressurized fluid is provided to the oscillating hydraulic valve 170. Since this valve is not spring biased to any particular state, its position does not necessarily change, except under conditions described herein.
Returning to the foot pedal 175 and valve 176, once the foot pedal is released, the biasing spring 177 forces the valve 176 from its flow path 176b to its normal initial flow path 176a. In this position the foot pedal input line 179 is no longer connected to the fluid source 152. When the oscillating valve 170 is at flow path 170a, the fluid pressure through output line 172 is eliminated. In response to this reduction in fluid pressure, hydraulic valve 158 is shifted to its original flow path 158a by operation ofthe return spring 159. In this position, the cylinder pressure line 161 is again connected to the fluid source 152, which causes the reciprocating motor 22 to extend the inner cannula 17 to its position blocking the tissue-receiving opening 25. Thus, in accordance with the present invention, the hydraulic control system 150 starts and finishes the tissue biopsy apparatus 10 with the tissue-receiving opening closed. It is important to have the opening closed once the procedure is complete so that no additional tissue may be trapped or pinched within the cutting element 11 as the apparatus is removed from the patient.
Thus far the portion ofthe hydraulic control system 150 that controls the operation ofthe reciprocating motor 22 has been described. The system 150 also controls the operation ofthe rotary motor 20. Again, in the most preferred embodiment, the motor 20 is an air motor. This air motor is controlled by another hydraulic valve 182. As shown in FIG. 10, the initial position ofthe valve provides a flow path 182a in which the fluid source 152 is connected to blocked line 183. However, when the hydraulic valve 182 is pressurized, it moves to flow path 182b in which the fluid source 152 is connected to the pilot port 140 ofthe air motor. In this position, pressurized fluid continuously drives the air motor 20, thereby rotating the inner cannula 17. It can be noted parenthetically that a muffler M can be provided on the air motor to reduce noise. The rotary motor hydraulic valve 182 is controlled by fluid pressure on pressure activation line 180. This activation line 180 branches from the foot pedal input line 179 and is connected to the foot pedal switch 176. When the foot pedal 175 is depressed, the switch moves to its flow path 176b. In this position the pressure activation line 180 is connected to the fluid source 152 so fluid pressure is provided directly to the rotary motor hydraulic valve 182. As with the other hydraulic valves, the valve 182 includes a biasing spring 184 that must be overcome by the fluid pressure at the input to the valve.
It should be understood that since the fluid control for the rotary motor 20 is not fed through the oscillating hydraulic valve 170, the motor operates continuously as long as the foot pedal 175 is depressed. In addition, it should also be apparent that the speed ofthe rotary motor 20 is not adjustable in the illustrated embodiment. Since the motor 20 is connected directly to the fluid source 152, which is preferably regulated at a fixed pressure, the air motor actually operates at one speed. On the other hand, as discussed above, the reciprocating motor 22 is supplied through a pressure regulator 154 and a flow control valve 162. Thus, the speed of reciprocation ofthe cutting blade 35 is subject to control by the surgeon or medical technician. The reciprocation ofthe cutting element 11 can be a function ofthe tissue being sampled, the size ofthe tissue biopsy sample to be taken, and other factors specific to the particular patient. These same factors generally do not affect the slicing characteristic ofthe cutting edge 35 achieved by rotating the inner cannula.
The hydraulic control system 150 also regulates the aspiration pressure or vacuum applied through the aspiration conduit, which includes the inner cannula 17. In the illustrated embodiment, the pressure activation line 180 branches to feed an aspiration valve 185. The valve is movable from its initial flow path 185a to a second flow path 185b. In the initial flow path, the fluid source 152 is connected to a blocked line 186. However, when fluid pressure is applied on line 180, the valve 185 shifts against the biasing spring 187 to the flow path 185b. In this path, the venturi element 190 is connected to the fluid source. This venturi element thus generates a vacuum in a vacuum control line 193 and in aspiration line 191. Again, as with the air motor, the venturi element 190 can include a muffler M to reduce noise within the handpiece. As long as the foot pedal 175 is depressed and the valve 176 is in its flow path 176b, fluid pressure is continuously applied to the aspiration hydraulic valve 195 and the venturi element 190 generates a continuous vacuum or negative aspiration pressure. As with the operation ofthe rotary motor, this vacuum is not regulated in the most preferred embodiment. However, the vacuum pressure can be calibrated by a selection of an appropriate venturi component 190.
When the venturi component 190 is operating, the vacuum drawn on control line 193 operates on vacuum switch 194. A variable biasing spring 195 initially maintains the vacuum switch 194 at its flow path 194a. In this flow path, the vacuum input line 196 is not connected to any other line. However, at a predetermined vacuum in control line 193, the valve moves to flow path 194b. In this position, the vacuum input line 196 is connected to pressure line 192. In the preferred embodiment, the vacuum switch 194 operates in the form of a "go-nogo" switch - in other words, when the aspiration vacuum reaches a predetermined operating threshold, the vacuum switch is activated. When the vacuum switch 184 is initially activated, it remains activated as long as the foot pedal is depressed. Thus vacuum input line 196 is continuously connected to pressure line 192 as long as the foot pedal 175 is depressed.
Looking back to the hydraulic valve 158, the fluid pressure in line 192, and ultimately in vacuum input line 196, is determined by the state of valve 158. When the valve 158 is in its flow path 158a in which regulated fluid pressure is provided to the reciprocating motor 22, the pressure line 192 is dead. However, when the valve 158 moves to flow path 158b, pressure line 192 is connected to the regulated fluid source. Pressurized fluid then flows from pressure line 192, through vacuum switch flow path 194b, through vacuum input line 196 to the left side of oscillating valve
170, causing the valve to stroke to flow path 170b. When the oscillating valve 170 is in this flow path, output line 172 is dead, which allows valve 158 to move to its flow path 158a under the effect ofthe return spring 159. In this state, valve 158 allows pressurized fluid to again flow to the reciprocating motor 22 causing it to move through the next cutting stroke.
Thus, when both the valve 158 and the vacuum switch 194 are moved to their alternate states, pressurized fluid passes from line 192, through vacuum input line 196, and through an adjustable flow control valve 197 to a second input for the oscillating hydraulic valve 170. Pressure on the vacuum input line 196 shifts the oscillating valve 170 to its second position for flow path 170b. In this position, pressurized fluid passing through the foot pedal valve 176 terminates within valve 170. As a consequence, the pressure in output line 172 drops which allows the hydraulic valve 158 shift back to its original position 158a under operation ofthe return spring 159. In this position, fluid pressure is again supplied to the reciprocating motor 22 to cause the piston 66 to move through its cutting stroke.
It should be appreciated that the oscillating valve 170 is influenced by fluid pressure on lines 168 and 196, and that these lines will not be fully pressurized at the same time. When the system is imtially energized, pressure from source 152 is automatically supplied to reciprocating motor 22 and pressure valve 165, causing the valve to move to flow path 165b. In this state, line 168 is pressurized which shifts oscillating valve 170 to the left to state 170a. The oscillating valve will remain in that state until line 196 is pressurized, regardless ofthe position of pressure switch 165. It can also be appreciated that in the preferred embodiment, the fluid pressure on line 196 does not increase to operating levels until the foot pedal 175 has been depressed and the aspiration circuit has reached its operating vacuum.
In an alternative embodiment, the vacuum switch 194 can be calibrated to sense fine changes in vacuum. In this alternative embodiment, the completion of this return stroke can be determined by the state ofthe vacuum switch 194. The vacuum switch 194 can operate as an indicator that a tissue sample has been drawn completely through the aspiration conduit into the collection trap 55. More specifically, when the vacuum sensed by vacuum switch 194 has one value when the inner cannula is open to atmospheric pressure. This vacuum pressure changes when a tissue sample is drawn into the inner cannula 17. The vacuum pressure changes again when the tissue is dislodged so that the inner cannula is again open to atmospheric pressure. At this point, the inner cannula 17 is clear and free to resume a cutting stroke to excise another tissue sample. Thus, the vacuum switch 194 can stroke to its flow path 194b to provide fluid pressure to the left side ofthe oscillating valve 170, causing the valve to stroke to flow path 170b .
It can be appreciated from this detail explanation that the hydraulic control system 150 provides a complete system for continuously reciprocating the axial motor 22. In addition, the system provides constant continuous pressure to both the rotary motor 20 and the aspiration line 191, so long as the foot pedal 175 is depressed. Once the foot pedal is released, fluid pressure in activation line 180 drops which causes the air motor control valve 182 and the aspiration control valve 185 to shift to their original or normal positions in which fluid pressure is terminated to those respective components. However, in the preferred embodiment, pressure is maintained to the reciprocating motor 22 because the motor is fed through valve 158, which is connected directly to the fluid source 152.
The hydraulic control system 150 in the illustrated embodiment incorporates five controllable elements. First, the fluid pressure provided to activate the reciprocating motor 22 is controlled through the regulator 154. In addition, the fluid flow rate to the piston 66 is controlled via the adjustable control valve 162. The pressure at which the pressure switch 165 is activated is determined by an adjustable return spring 166. Likewise, the aspiration pressure vacuum at which the vacuum switch 194 is activated is controlled by an adjustable return spring 195. Finally the adjustable flow control valve 197 controls the fluid flow from the vacuum switch 194 to the oscillating hydraulic valve 170. Each of these adjustable elements controls the rate and duration of oscillation ofthe reciprocating motor 22.
In the preferred embodiment, the pressure switch 165 essentially operates as an "end of stroke" indicators. In other words, when the inner cannula 17 reaches the end of its forward or cutting stroke, it contacts the cutting board 31. When it contacts the cutting board, the pressure in the cylinder pressure line 161 changes dramatically. It is this change that causes the pressure switch 165 to change states. This state change causes the oscillating valve 170 to shift valve 158 to terminate fluid pressure to the motor 22, causing it to stop its cutting stroke and commence its return stroke. During this return stroke, the excised tissue sample is gradually drawn along the aspiration conduit. Also during the return stroke, fluid pressure bleeds from pressure line 161 and pressure switch 165 and ultimately from line 168 feeding oscillating valve 170. When this valve strokes, fluid pressure bleeds from valve 158 allowing the valve to return to state 158a to pressurize the motor 22 for a new cutting stroke. The operation of each of these hydraulic valves introduces an inherent time delay so that by the time the pressure to the reciprocating motor 22 has been restored the aspiration vacuum has pulled the tissue sample through the entire aspiration conduit and into the collection trap 55. The use of a hydrauhcally controlled inner cutting cannula provides significant advantages over prior tissue cutting devices. The use of hydraulics allows most ofthe operating components to be formed of inexpensive and light-weight non- metallic materials, such as medical-grade plastics. The hydraulic system ofthe present invention eliminates the need for electrical components, which means that electrical insulation is unnecessary to protect the patient.
Perhaps most significantly, the hydrauhcally controlled reciprocation ofthe inner cutting cannula provides a cleaner and better-controlled cut of biopsy tissue. Since the reciprocating motor 22 is fed from a substantially constant source of pressurized fluid, the pressure behind the motor piston 63 remains substantially constant throughout the cutting stroke. This substantially constant pressure allows the inner cutting cannula to advance through the biopsy tissue at a rate determined by the tissue itself.
In other words, when the cutting edge 35 encounters harder tissue during a cutting stroke, the rate of advancement of the motor piston 63 and therefor the inner cannula 17 decreases proportionately. This feature allows the cutting edge to slice cleanly through the tissue without the risk of simply pushing the tissue. The rotation ofthe cutting edge can facilitate this slicing action. When the inner cannula encounters less dense tissue, the constant pressure behind the piston 63 allows the cutting edge to advance more quickly through the tissue. hi alternative embodiment, the rotary motor 20 can consist of an electric motor, rather than a pneumatic motor. As depicted in FIG. 11, the pressure activation line 180 can be fed to an on-off pressure switch 198 that is governed by an adjustable bias spring 199. When the activation line 180 is pressurized the switch 198 establishes a connection between an electric reciprocating motor 20 and a battery pack 200. Preferably, the battery pack 200 is mounted within the handpiece 12, but can instead be wired to an external battery contained within the console.
In the preferred embodiment, the tissue biopsy apparatus 10 depicted in FIG. 1 has an overall length of under sixteen inches (16") and an outer diameter less than one and one quarter inches (1.25"). The outer cannula and therefore the cutting element 11 have a length measured from the handpiece 12 of approximately five inches (5"). The outer cannula preferably has a nominal outer diameter of 0.148" and a nominal inner diameter of 0.136". The inner cannula most preferably has a nominal outer diameter of 0.126" so that it can reciprocate freely within the outer cannula without catching on the tissue cutting opening. The inner cannula has a nominal wall thickness of .010", which yields a nominal inner lumen diameter of about .106." The length ofthe tissue-receiving opening determines the length of biopsy sample extracted per each oscillation ofthe reciprocating motor 22. In one specific embodiment, the opening has a length of about 0.7", which means that a 0.7" long tissue sample can be extracted with each cutting cycle. In order to accommodate a large number of these biopsy tissue slugs, the collection trap can have a length of about 2.5" and a diameter of about .05". Of course, the interior volume ofthe collection trap can vary depending upon the size of each biopsy slug and the amount of material to be collected. In a specific embodiment, the filter disposed within the collection trap 55 manufactured by Performance Systematix, Inc. of Callondoni, MI.
In accordance with a specific embodiment, the cutting stroke for the inner cannula is about 0.905". The return spring 66 within the reciprocating motor 22 is preferably a conical spring to reduce the compressed height ofthe spring, thereby allow a reduction in the overall length ofthe hydraulic cylinder 60. In addition, the return spring 66 can be calibrated so that the return stroke occurs in less than about 0.3 seconds. Preferably, the inwardly beveled surface 36 of cutting edge 35 is oriented at an approximately 30° angle. The aspiration pressure vacuum is nominally set at 27 in.Hg. during the cutting stroke. When the cannula is retracted and the outer lumen 27 is open, the vacuum pressure is reduced to 25 in.Hg. This aspiration pressure normally allows aspiration of a tissue sample in less than about 1 second and in most cases in about 0.3 second. In accordance with a most preferred embodiment, the hydraulic control system 150 preferably is calibrated so that the inner cannula dwells at its retracted position for about 0.3 seconds to allow complete aspiration ofthe tissue sample. Adjusting the return spring 195 ofthe vacuum switch 194 can control this dwell rate.
In a preferred embodiment, the inner cannula 17 can advance through the cutting stroke in about two seconds. This stroke speed can be accomplished with a regulated pressure at source 152 of about 20 p.s.i. When the inner cannula reaches the end of its cutting stroke, the pressure can increase at about five p.s.i. per second. Preferably, the return spring 166 ofthe pressure switch 165 is set so that the end of cutting stroke is sensed within about 0.5 seconds. In a modification ofthe present invention, a tissue biopsy apparatus 300 is configured as depicted in FIGS. 12-24. As with the biopsy apparatus 10 ofthe prior figures, the apparatus 300 includes a cutting element 302 mounted to a user manipulable handpiece 305. The handpiece includes an upper housing 310, and a lower housing 311 (see Fig. 13). A cannula hub 312 is mounted to the handpiece 305 to support the outer cannula 303 ofthe cutting element 302 in a fashion similar to that described above. The biopsy apparatus 300 further includes a filter canister 315 that is removably mounted to the handpiece 305, again in a manner similar to that described above. In this embodiment, the biopsy apparatus 300 incorporates a secondary lumen
320 that engages the cannula hub 312. The secondary lumen 320 can be used to supply a quantity of irrigation fluid or a measured quantity of air to the cutting element, in a manner described below. In the illustrated embodiment, the upper housing 310 preferably includes a channel 322 defined along its entire length. The channel is configured to receive the secondary lumen 320 therein with the lumen recessed within the housing so as to not interfere with the ability ofthe surgeon to comfortably grip the biopsy apparatus 300.
Referring now to Fig. 13, it can be seen that the biopsy apparatus 300 includes a reciprocating motor assembly 330 and a rotary motor assembly motor 332. Each of these assemblies is constructed similar to the like assemblies described above. In the present embodiment, the reciprocating motor assembly 330 includes a housing 340 that is contained within the upper and lower housing 310, 311 that define the handpiece 305.
The reciprocating motor 334 is similar to the motor described above. The motor includes a tube fitting 335 for receiving a hollow tube 337 (see Fig. 13). The tube 337 is connected to the hydraulic control system 150 depicted in Fig. 10 to provide an alternating supply of pressurized air to the reciprocating motor 334 in a manner described above.
As shown in Fig. 13 and 14, the housing 340 includes a pair of opposite rails 341, which serve as guides for reciprocation ofthe rotary motor 332. As shown in
Fig. 17, the rotary motor 332 includes opposite anti-rotation wings 355 that ride along the rails 341 as the motor 332 is reciprocated, and at the same time resist rotation of the rotary motor 332 during its operation. The rotary motor 332 further includes a tube fitting 357 that is arranged to engage a hollow tube 358 (see Fig. 13) which, like the tube 337, provides a connection to the hydraulic control system 150.
The housing 340 forms a Luer fitting 345 at its distal end 342, as illustrated in FIG. 16. The Luer fitting includes a circumferential recess 347 and a number of spaced flanges 348. Preferably, four such flanges spaced at 90° intervals are incorporated into the Luer fitting 345. The recess 347 defines an enlarged gap 349 between one pair of flanges. Moreover, a number of retention dimples 350 are defined at the base ofthe circumferential recess 347, as depicted in FIGS. 14 and 15. The Luer fitting 345 is configured to mate with the cannula hub 312. As shown in Fig. 18-20, the cannula hub 312 includes a number of Luer wings 370 corresponding in number to the plurality of flanges 348. Each ofthe wings 370 is configured to fit within the recess the 347 between flanges 348. One ofthe wings 370 includes an enlargement 371 that prevents the cannula 312 from being improperly oriented, or more specifically assures a pre-determined orientation ofthe tissue receiving opening ofthe cannula 312. The enlargement 371 is preferably configured to fit within the enlarged gap 349 ofthe Luer fitting 345 to insure an upward orientation ofthe cutting element 302, as depicted in Figs. 12 and 13.
The bottom surface ofthe cannula hub 312 defines a number of protuberances 372. Each ofthe protuberances is sized to fit within one ofthe retention dimples 350 ofthe Luer fitting 345. Thus, when the hub is pushed into the recess 347 and rotated, each ofthe protuberances 372 engages within a corresponding dimples to hold the cannula hub 312 in place.
The cannula hub 312 includes a central bore 376 extending through the hub. One portion 377 ofthe bore is sized to tightly receive the outer cannula 303 ofthe cutting element 302 as described with respect to outer cannula 15. Preferably, the outer cannula 303 is engaged in a substantially fluid tight fit. The hub 312 is configured for removable engagement with the Luer fitting 345 ofthe handpiece 305 so the entire handpiece can be removed from the hub 312 while the outer cannula 303 is still in place within the patient. When the handpiece is removed, the inner cutting element 304 is withdrawn from the lumen 306 ofthe outer cannula, since the inner cutting element is connected to the reciprocating motor assembly 334 as described above. Thus, the cannula hub 312 and outer cannula 302 remain at the surgical site to permit introduction of medical treatments or other instruments through the bore 376 and lumen 306. For instance, a local anaesthetic, drug or treatment material, such as a radioactive pellet, can be introduced in this manner, before, during or after the biopsy procedure. Moreover, other surgical instruments, such as a visualization scope, can be guided to the biopsy site through the hub 312 and cannula 302.
The cannula hub 312 also includes a tube fitting 375. The Tube fitting 375 mates with the secondary lumen 320 that traverses the outer length ofthe handpiece 305. The fitting 375 can be of any suitable configuration for providing a fluid-tight engagement between the fitting and a tube. Referring to back to Fig. 14, the reciprocating motor assembly motor housing
340 also includes a proximal end 360 that defines a mounting hub 361. The mounting hub is similar to the hub 98 described above, and is particularly configured to engage the filter canister 315. As indicated above, the hub and canister interface can be in the form of a bayonet mount to provide a fluid tight quick release engagement. The proximal end ofthe housing 340 defines a circumferential flange 363 that is sealed against the ends ofthe upper and lower housings 310, 311 ofthe handpiece 305. A pair of tube cutouts 365 are formed at the perimeter ofthe flange 363 to provide a passageway for the hydraulic tubes 337 and 358 supplying pressurized fluid to the reciprocating and rotary motors. In order to accommodate the tubes, as well as to firmly support the working components ofthe handpiece 305, the upper and lower housings 310 and 311 can be configured as shown in Figs. 21-24. In a specific embodiment, the upper housing 310 includes an interior channel 380 that passes substantially along the entire length ofthe interior ofthe upper housing 310. This interior channel is aligned with one ofthe tube cutouts 365 in the flange 363 ofthe housing 340. This interior channel can provide a pathway for the tube 358 feeding pressurized fluid to the rotary motor assembly 332. The upper housing 310 further defines a number of interior support walls 382. These walls project into the interior space and serve as a bulkhead for supporting the various working components ofthe handpiece 305. Likewise, the lower housing 311 includes a number of interior support walls
385. In addition, near the proximal end 360, the lower housing 311 can include a longitudinal support rib 387 that preferably is arranged to support the reciprocating motor 334. At least some ofthe interior support wall 385 ofthe lower housing 311 can define tube cutouts 389 to receive the tube 337 feeding pressurized fluid to the reciprocating motor 334.
In addition, the lower housing 311 can include a number of mounting holes 395. These mounting holes can be arranged to permit mounting ofthe tissue biopsy apparatus 300 on an existing biopsy table, hi the preferred embodiment ofthe invention, the biopsy apparatus 300 can be mounted on a slideable carriage that can be separately driven to project the cutting element 302 into the patient. Support beds of this type are well known and the mounting feature 395 ofthe handpiece 305 can be specifically configured to accommodate any particular support bed. Preferably, the upper and lower housings 310, 311 include interlocking mating edges 397, 398, respectively. In a most preferred embodiment, the edges include press-fit male/female interfaces. When all the components are assembled within the housing 340, the upper and lower housings 310, 311 can be sandwiched about the housing 340, with the mating edges 397 and 398 in engagement. In one specific embodiment, the engagement can simply be a removable snap-fit, while in other embodiments, the engagement can be permanent, such as by the use of an adhesive.
The tissue biopsy apparatus 300 can be connected to the hydraulic control system 150 described above. Each ofthe components can operate in a manner similar to that described above. The cannula hub 312 provides a fluid interface for the external secondary lumen 320 which can be used to introduce a fluid, such as a saline solution, to the surgical site. In this embodiment, a saline flush can be contained in a hermetically sealed bag, such as bag 400 depicted in FIG. 12.
In one preferred embodiment, a pinch valve 402 can engage the secondary lumen, preferably adjacent the saline bag 400. The pinch valve can be opened at the moment that the cutting blade starts to retract from the cutting opening. The pinch valve 402 can be controlled to remain open for a pre-determined period of time, but is preferably closed before the cutting blade advances forward to make the next biopsy cut. Likewise, the amount of time that the pinch valve remains open to allow the saline flush to enter the cutting element 302 can be calibrated based upon a pre- detennined volume of fluid desired at the surgical site, hi some procedures, the pinch valve 402 remains open for 1-2 seconds, although in certain applications, a shorter time in the range of 0.5 seconds may be preferred. The valve operation can be calibrated to achieve a specific fluid volume, such as about 1 cc of saline. In one particular embodiment, the hydraulic confrol system 150 depicted in FIG. 10 can be modified to incorporate a fluid line branching from the line 192. As described above, the line 192 is pressurized when the reciprocating motor starts its return stroke. Pressure in the branch fluid line can be used to open the pinch valve 402, while a drop in pressure can operate to close the valve. Alternatively, the pinch valve can be electrically controlled, again in response to fluid pressure in line 192 which signals the beginning ofthe motor return sfroke. The closure ofthe pinch valve 402 can be dictated by a drop in pressure in line 192 or by an increase in pressure in line 161, which arises as the reciprocating motor begins its cutting stroke. It is understood that wliile a pinch valve is described, other on-off type fluid valves can be utilized to control the timing of fluid flow through the lumen 320 and cannula hub 312.
Several benefits arise by providing the saline flush. One primary benefit is that the saline flush can keep the cutting element clean of blood and tissue that might otherwise clot or j am the advancement of the inner cutting member. A further benefit is that the saline can facilitate drawing tissue into the cutting opening during the cutting cycle. Moreover, the saline flush can help propel the excised tissue toward the collection canister.
As an alternative, or an adjunct, the secondary lumen 320 can be used to introduce a puff of air into the cutting element 302. The puff of air, like the saline can be used to keep the interior channel ofthe cutting element clean. If properly pressurized, the introduction of air can prevent blood from flowing into the cutting element 302 as the cutting member and excise tissue sample is retracted. Thus, the saline bag 400 can be replaced with a source of pressurized air. In certain applications, the air source can provide air pressurized to 3-5 p.s.i.g. As with the saline flush, the secondary lumen 320 can be closed as the cutting blade advances to remove a tissue sample, and opened as the blade starts to refract. The pressurized air will pass around the outside ofthe inner cutting blade toward the opening at the end ofthe cutting element 302. The pressure of this puff of air can be calibrated as necessary to counteract the blood pressure at the surgical site and keep the blood from flowing into the cutting element 302.
The tissue biopsy apparatus 10 or 300 described above provides significant advantages over prior biopsy devices. One significant benefit is that the apparatus of the present invention is completely closed. This feature means that no fluid, such as blood, can escape or leak from the biopsy apparatus 10 or 300. In prior devices, the each extracted tissue sample is drawn into a removable opening that is open to the ahnosphere. The present invention does not include any component that is open to the ahnosphere, with the exception ofthe secondary lumen 320 which is confroUably open to atmosphere to keep the aspiration passageway open and clean. The present invention provides a system for repeatably and precisely withdrawing uniformly sized biopsy samples. With each stroke ofthe cutting blade, a uniformly dimension biopsy sample is withdrawn and pulled into the collection canister at the proximal end ofthe apparatus. Thus, the biopsy apparatus 10 and 300 ofthe present invention can readily remove an entire lesion or region of suspect tissue. This is a significant improvement over prior devices that are only capable of extracting a limited quantity of tissue for biopsy evaluation only.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. It should be understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit ofthe invention are desired to be protected.
EXAMPLES
EXAMPLE 1
Eighteen trial biopsies were performed upon patients after obtaining informed consent and preparing the patients according to standard biopsy procedures. In each case, biopsies were performed according to the following procedure. The patient was positioned on her back on the surgical table, and the lesion was located using ultrasound. A small incision was made in the breast. While viewing the lesion using ultrasound, an early embodiment ofthe present invention was inserted into the breast with the tissue receiving opening adjacent the lesion. The cutter was engaged to sample and/or remove the lesion. The lesions varied in size from 6 - 22 mm. The surgeon's comments are provided in Table 1. TABLE 1
Surgeon's Comments Regarding the Use of Early Embodiments ofthe Present
Biopsy Device
Figure imgf000038_0001
Figure imgf000039_0001
Table 1 illustrates the success ofthe present invention in its early stage of development. A majority ofthe trials, trials 1-6,8,1-12, and 14-18, resulted in a successful removal ofthe lesion with little to no problems. Lesions were removed quickly and, in some cases, only a few cores were required (see trials 1, 4, and 6). In trial number 8 it was noted that the cores were up to 25mm in length.
In some trials, the surgeon experienced difficulties removing the lesion because the inner cutting blade would ride up and catch on the tissue receiving opening (see trials 5, and 9,). However, this problem has been resolved in the present invention by integrating a crimp in the outer cannula. The crimp forms a dimple that protrudes from the inner surface ofthe cannula and into the outer lumen. As the inner cannula passes the dimple, the dimple forces the inner cannula away from the tissue- receiving opening and prevents the inner cannula from riding up into the opening. In a further embodiment, the cutting edge ofthe inner cannula is inwardly beveled. This inwardly beveled surface also helps eliminate risk of catching by guiding the inner cannula back into the hollow outer cannula. In addition, to prevent the deflection of the tip downward, as noted in trial 13, a stiffening element is provided on the outer cannula opposite the tissue-receiving opening.
EXAMPLE 2
Surgeons performing biopsies using the device of this invention and a device having the features of U.S. Patent No. 5,526,822 to Burbank provided feedback as to the efficiency of each device. The surgeons' input was used to calculate the amount of time and the number of strokes necessary to remove a lesion. Table 2 compares the amount of time and the number of strokes necessary to remove comparable lesions using each device.
TABLE 2 Comparison of Removal Times and Number of Strokes ofthe Present Biopsy Device with the Prior Art Device
Figure imgf000041_0001
This data demonstrates that the present tissue biopsy apparatus consistently removes a lesion with fewer strokes and in less time than the prior cutter. The present tissue biopsy device performs 80% faster than the prior cutter, which ultimately results in reduced trauma to the tissue.
CONCLUSION
The biopsy devices of this invention reliably, quickly and efficiently sample and remove lesions in tissue.

Claims

What is claimed:
1. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defining an outer lumen (27, 306) and a tissue-receiving opening (25, 126) adjacent a distal end (28) of said outer cannula communicating with said outer lumen; an inner cannula (17, 304) slidably disposed within said outer lumen (27, 306) and defining an inner lumen (34) from an open distal end to an open opposite proximal end, said inner cannula defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); a first hydraulic rotary motor (20, 332) operably coupled to said inner cannula
(17, 304) to rotate said inner cannula within said outer cannula (15, 125); a second hydraulic reciprocating motor (22, 334) operably coupled to said inner cannula (17, 304) to translate said inner cannula within said outer cannula (15, 125, 303) while said inner cannula rotates; and a hydraulic system (150) connecting said first (20, 332) and second (22, 334) hydraulic motors to a source of pressurized fluid (152).
2. The tissue cutting device (10, 300) of claim 1 further comprising a cutting board (31) disposed at said distal end (28) of said outer cannula (15, 125, 303).
3. The tissue cutting device (10, 300) of claim 2 wherein said cutting board (31) is formed of a resilient plastic material having a hardness less than a hardness of said inner cannula (17, 304) at said cutting edge (35), but sufficient to substantially prevent permanent deformation of said cutting board under pressure from said cutting edge as said inner cannula rotates and reciprocates against said cutting board.
4. The tissue cutting device (10, 300) of claim 1 wherein said cutting edge (35) is an inwardly beveled surface.
5. The tissue cutting device (10, 300) of claim 4 further comprising a dimple (135) in an inner surface of said outer cannula (125) immediately proximal to said tissue-receiving opening (126), said dimple sized to fit between said inner cannula (17, 304) and said outer cannula.
6. The tissue cutting device (10, 300) of claim 1 further comprising a handpiece (12) removably engageable to said outer cannula (15, 125, 303) and supporting said inner cannula (17, 304), said first hydraulic rotary motor (20, 332), and said second hydraulic reciprocating motor (22, 334).
7. The tissue cutting device (10, 300) of claim 6 further comprising a collection trap (55, 315) removably mountable to said handpiece (12) and in communication with said proximal end of said inner lumen (17, 304).
8. The tissue cutting device (10, 300) of claim 7 wherein said collection trap (55, 315) includes a filter element (110) disposed within said collection frap.
9. The tissue cutting device (10, 300) of claim 7 further comprising a vacuum source in fluid communication with said collection trap (55, 315) to aspirate tissue through said inner lumen (17, 304) into said collection trap (55, 315).
10. The tissue cutting device (10, 300) of claim 6 further comprising a cover (13) removably engageable to and enclosing said handpiece (12).
11. The tissue cutting device (10, 300) of claim 10 wherein said cover includes: at least one tang (117) projecting inwardly from an inner surface (118) thereof; and said handpiece (12) defines at least one engagement notch (115) configured for receiving a corresponding one of said at least one tang (117) for engaging said cover (13) to said handpiece.
12. The tissue cutting device (10, 300) of claim 1 wherein said outer cannula (15, 125, 303) further includes a stiffening element (131) along a length thereof for increasing the bending resistance of said outer cannula.
13. The tissue cutting device (10, 300) of claim 12 wherein said stiffening element (131) includes a longitudinally extending rib (131) defined in an outer surface of said outer cannula (125).
14. The tissue cutting device (10, 300) of claim 13 wherein said rib (131) includes a bead adhered to a surface of said outer cannula (125).
15. The tissue cutting device (10, 300) of claim 13 wherein said rib (131) includes a crimp in said outer cannula (125).
16. The tissue cutting device (10, 300) of claim 12 wherein said stiffening element (131) is substantially diametrically opposite the tissue-receiving opening (25, 126).
17. The tissue cutting device (10, 300) of claim 12 wherein said stiffening element (131) includes a layer of rigid material bonded to a surface of said outer cannula (125).
18. The tissue cutting device (10, 300) of claim 17 wherein said material is stainless steel.
19. The tissue cutting device (10, 300) of claim 1 further comprising a vacuum source in fluid communication with said inner lumen (34) at said proximal end of said inner cannula (17, 304) to aspirate tissue through said inner lumen.
20. The tissue cutting device (10, 300) of claim 1 further comprising: an irrigation lumen (146, 320) in fluid communication with said outer lumen
(27, 306); and a source of irrigation fluid in communication with said irrigation lumen (146, 320).
21. The tissue cutting device (10, 300) of claim 20 wherein said source of fluid includes an anesthetic fluid.
22. The tissue cutting device (10, 300) of claim 1 further comprising a dimple (135) in an inner surface of said outer cannula (125) immediately proximal to said tissue receiving opening (126), said dimple sized to fit between said inner cannula (17, 304) and said outer cannula.
23. The tissue cutting device (10, 300) of claim 1 wherein said tissue- receiving opening (126) includes a pair of opposite sides (127) extending longitudinally along said outer cannula (125), at least one of said opposite sides defining at least one tooth (129) arranged to engage tissue drawn into said opening when said cannula is inserted into a body.
24. The tissue cutting device (10, 300) of claim 23 wherein at least one of said opposite sides (127) defines a plurality of teeth (129), said teeth angled proximally away from said distal end of said outer cannula (125).
25. The tissue cutting device (10, 300) of claim 23 wherein each of said opposite sides (127) defines a plurality of teeth (129), said teeth angled proximally away from said distal end of said outer cannula (125).
26. The tissue cutting device (10, 300) of claim 1 further comprising a trocar tip (16) having an engagement hub (30) configured to fit tightly within said distal end (28) of said outer cannula (15, 125, 303).
27. The tissue cutting device (10, 300) of claim 26 further comprising a cutting board (31) disposed within said outer lumen (27, 306) affixed to said engagement hub (30).
28. The tissue cutting device (10, 300) of claim 1 further comprising: a tubular axle (43) having a distal end and a proximal end; and a coupler (46) connecting said distal end of said tubular axle (43) to said proximal end of said inner cannula (17, 304), wherein said first hydraulic rotary motor (20, 332) is coupled to said tubular axle (43) to rotate said axle and said inner cannula (17, 304) therewith.
29. The tissue cutting device (10, 300) of claim 28 wherein said rotary motor (20, 332) includes: a motor housing (39) having opposite ends and defining a pilot port (40) in fluid communication with said hydraulic system (150) to receive said pressurized fluid; a rotor rotatably disposed within said housing (39) and connected to said axle (43) extending through said housing; and bearing surfaces (44) at said opposite ends of said housing (39) for rotatably supporting said axle (43).
30. The tissue cutting device (10, 300) of claim 29 wherein said second hydraulic reciprocating motor (22, 334) includes: a hydraulic cylinder having a second pilot port (61) in fluid connection with said hydraulic system (150) to receive said pressurized fluid; a piston (63) slidably disposed within said cylinder; and a hollow tube (50) in fluid communication with said proximal end of said hollow axle (43), said tube (50) engaged to said piston (63) and operably coupled to said first motor (20, 332) to move said first motor as said piston slides within said cylinder.
31. The tissue cutting device (10, 300) of claim 30 wherein said second hydraulic motor (22, 334) further includes: a return spring (66) disposed within said cylinder and biased against said piston (63) to move said piston, said housing and said inner camiula (17, 304) in a direction away from distal end (28) of said outer cannula (15, 125, 303).
32. The tissue cutting device (10, 300) of claim 31 further comprising: a collection frap (55) in fluid communication with said hollow tube (50); and a vacuum source in fluid communication with said collection trap (55) to aspirate tissue through said inner lumen (27, 306), said hollow axle (43) and said tube (50) into said collection frap.
33. The tissue cutting device (10, 300) of claim 1 wherein said second hydraulic reciprocating motor (20, 332) includes: a hydraulic cylinder having a pilot port (61) in fluid connection with said hydraulic system (150) to receive said pressurized fluid; a piston (63) disposed within said cylinder and operably coupled to said inner cannula (17, 304) to move said inner cannula within said outer cannula (15, 125) toward said distal end (28) of said outer cannula; a return spring (66) disposed within said cylinder and biased against said piston (63) to move said piston and said inner cannula (17, 304) within said outer cannula (15, 125, 303) in a direction away from distal end (28) of said outer cannula.
34. The tissue cutting device (10, 300) of claim 1, wherein said hydraulic system (150) includes: a manual switch (176) disposed between an output line (180) and said source of pressurized fluid (152), said manual switch operable in a first position to connect said output line to said source, and in a second position to disconnect said output line from said source; a first pressure actuated switch (182) disposed between said source of pressurized fluid (152) and said first motor (20, 332), said first switch operable in response to fluid pressure in said output line (180) to connect or disconnect said first motor to/from said source; and a second pressure actuated switch (158) disposed between said source of pressurized fluid (152) and said second motor (22, 334), said second switch operable in response to fluid pressure in said output line (180) to connect or disconnect said second motor to/from said source.
35. The tissue cutting device (10, 300) of claim 34, wherein said hydraulic system (150) includes a vacuum source.
36. The tissue cutting device (10, 300) of claim 35, wherein: said vacuum source includes a venturi device (190); and said hydraulic system (150) includes a third pressure actuated switch (185) disposed between said source of pressurized fluid (152) and said venturi device (190), said third switch operable in response to fluid pressure in said output line (180) to connect or disconnect said venturi device to/from said source.
37. The tissue cutting device (10, 300) of claim 34, wherein: said second hydraulic motor (22, 334) includes a hydraulic cylinder having a piston (63) operably coupled to said inner cannula (17, 304), a hydraulic input (61) connected to said second pressure actuated switch (158) and a return spring (66) disposed within said cylinder and operating on said piston (63) against fluid pressure at said hydraulic input; and said hydraulic system (150) further includes an oscillating switch (170) disposed between said output line (180) and said second pressure actuated switch (158), said oscillating switch operable in response to fluid pressure in said hydraulic cylinder to connect or disconnect said hydraulic input (61) to/from said second pressure actuated switch.
38. A tissue cutting device (10, 300) comprising : an outer cannula (15, 125, 303) defining a tissue-receiving opening (25, 126) adjacent a distal end (28) thereof; an inner cannula (17, 304) slidably disposed within said outer cannula (15, 125, 303) and defining a lumen (34) from an open distal end to an open opposite proximal end, said inner cannula further defining a cutting edge (35) at said open distal end; a motor assembly operably coupled to said inner cannula (17, 304) for rotationally and reciprocatingly driving said inner cannula within said outer cannula (15, 125, 303); and a cutting board (31) disposed at said distal end (28) of said outer cannula (15, 125, 303), said cutting board formed of a resilient plastic material having a hardness less than a hardness of said inner camiula at said cutting edge (35) but sufficient to substantially prevent permanent deformation of said cutting board under pressure from said cutting edge as said inner cannula (17, 304) rotates and reciprocates against said cutting board.
39. The tissue cutting device (10, 300) of claim 38 wherein said cutting edge (35) is an inwardly beveled surface.
40. The tissue cutting device (10, 300) of claim 38 further comprising a trocar tip (16), said trocar tip having an engagement hub (30) configured to fit tightly within said distal end (28) of said outer cannula (15, 125).
41. The tissue cutting device (10, 300) of claim 40 wherein said cutting board (31) is affixed to said engagement hub (30) of said trocar tip (16).
42. h a cannula (125) sized for insertion in a human body, the cannula having a distal end and a proximal end and a substantially cylindrical outer wall defining a lumen along a longitudinal axis thereof, in which the lumen is sized to receive a movable cutting member (17) therethrough, the improvement comprising an opening (126) defined adjacent the distal end through the outer wall communicating with the lumen, said opening having opposite edges (127) extending along the longitudinal axis, at least one of said edges defining at least one tooth (129) arranged to engage tissue drawn into said opening when the cannula is inserted into a body.
43. The improvement in a cannula according to claim 42 wherein said tooth is angled proximally away from said distal end of said cannula.
44. The improvement in a cannula (125) according to claim 42 wherein each of said edges (127) defines at least one tooth (129), said tooth angled proximally away from said distal end of cannula.
45. The improvement in a cannula (125) according to claim 42 wherein each of said edges (127) defines a plurality of teeth (129), said teeth proximally angled away from said distal end of cannula.
46. In a cannula (15, 125, 303) sized for insertion in a human body, the cannula having a substantially cylindrical outer wall defining a lumen (27, 306) along a longitudinal axis thereof, in which the lumen is sized to receive a movable cutting member (17, 304) therethrough, the outer wall defining a lateral opening (25, 126) therethrough communicating with the lumen, the improvement comprising a stiffening member (131) associated with the outer wall adjacent the lateral opening.
47. The improvement in a cannula (15, 125, 303) according to claim 46, wherein said stiffening member (131) includes a longitudinally extending rib defined in the outer wall.
48. The improvement in a cannula (15, 125, 303) according to claim 47, wherein said rib is defined substantially diametrically opposite the lateral opening (25, 126) in the outer wall.
49. The improvement of claim 47 wherein said rib (131) includes a crimp defined in said outer cannula (125).
50. The improvement of claim 47 wherein said rib (131) includes abead adhered to a said outer cannula (125).
51. The improvement of claim 46 wherein said stiffening member (131) is a layer of rigid material bonded to a surface of said outer cannula (125).
52. In a cannula (15, 125, 303) sized for insertion in a human body, the cannula having a substantially cylindrical outer wall defining a lumen (27, 306) along a longitudinal axis thereof, in which the lumen is sized to receive a movable cutting member (17, 304) therethrough, the outer wall defining a lateral opening (25, 126) therethrough communicating with the lumen, the improvement comprising a dimple (135) associated with the outer wall and projecting into the lumen adjacent the lateral opening, said dimple sized to fit between the cutting member and the outer wall when the cutting member is within the lumen.
53. The improvement in a cannula (15, 125, 303) according to claim 52, wherein said dimple (135) is formed by a crimp in the outer wall ofthe cannula.
54. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defining an outer lumen (27, 306) and a tissue-receiving opening (25, 126) adjacent a distal end of said outer cannula communicating with said outer lumen; an inner cannula (17, 304) slidably disposed within said outer lumen and defining an inner lumen (34) from an open distal end to an open opposite proximal end, said inner cannula defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); a first motor (20, 332) operably coupled to said inner cannula (17, 304) to move said inner cannula in a first direction within said outer lumen (27, 306); means for supporting (39) said first motor (20, 332) for movement with said inner cannula (17, 304) in a second direction different from said first direction; and a second motor (22, 334) operably coupled to said means for supporting (39) to move said first motor (20, 332), and thereby said inner cannula (17, 304), in said second direction while said first motor moves said inner cannula in said first direction.
55. The tissue cutting device (10, 300) of claim 54 wherein said means for supporting (39) said first motor (20, 332) includes: a tubular axle (43) extending through and supporting said first motor (20, 332), having a distal end operably connected to said proximal end of said inner cannula (17, 304), and a proximal end operably coupled to said second motor (22, 334) to move said axle and thereby said first motor and said inner cannula in said second direction.
56. The tissue cutting device (10, 300) of claim 54 wherein said first motor (20, 332) is a hydraulic motor.
57. The tissue cutting device (10, 300) of claim 54 wherein said first motor (20, 332) is a rotary motor and said first direction is rotational.
58. The tissue cutting device (10, 300) of claim 54 wherein said second motor (22, 334) is a linear motor and said second direction is reciprocation toward and away from said distal end of said outer cannula (15, 125, 303).
59. The tissue cutting device (10, 300) of claim 58 wherein said second motor (22, 334) is a hydraulic motor.
60. The tissue cutting device (10, 300) of claim 59 wherein said second motor (22, 334) includes: a hydraulic cylinder having a pilot port (61) in fluid connection with a hydraulic system (150) to receive a pressurized fluid; a piston (63) disposed within said cylinder and operably coupled to said inner cannula (17, 304) to move said inner cannula within said outer cannula (15, 125) toward said distal end (28) of said outer cannula; a return spring (66) disposed with said cylinder and biased against said piston (63) to move said piston and said inner cannula (17, 304) within said outer cannula (15, 125) away from distal end (28) of said outer cannula.
61. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defining an outer lumen (27, 306) between a distal end and an opposite proximal end, and further defining a tissue-receiving opening (25, 126) adjacent said distal end communicating with said lumen; a cutting member (17, 304) slidably disposed within said outer lumen (27, 306), said cutting member defining an inner lumen (34) therethrough between a distal end and an opposite proximal end, and further defining a cutting edge (35) at said distal end of said cutting member; a handpiece (12, 305) supporting a drive mechanism operably coupled to said cutting member (17, 304) to move said cutting edge (35) across said tissue-receiving opening (25, 126) to sever tissue projecting therethrough; a vacuum source in fluid communication with said proximal end of said cutting member (17, 304); and a hub (75, 140, 312) having a distal end attached to said proximal end of said outer cannula (15, 125, 303), and a proximal end detachably mounted to said handpiece (12, 305) to permit separation of said outer cannula from said handpiece and said cutting member (17, 304).
62. The tissue cutting device (10, 300) of claim 61 wherein: said proximal end of said hub (75, 140, 312) defines a mating flange (77, 142, 348); and said handpiece (12, 305) defines a fitting (72, 345) configured for removable engagement with said mating flange (77, 142, 348).
63. The tissue cutting device (10, 300) of claim 61 further comprising a radio-opaque marker disposed within said outer cannula (15, 125, 303).
64. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defining an outer lumen (34) between a distal end and an opposite proximal end, and further defining a tissue-receiving opening (25, 126) adjacent said distal end communicating with said lumen; a cutting member (17, 304) slidably disposed within said outer lumen (27, 306), said cutting member defining an inner lumen (34) therethrough between a distal end and an opposite proximal end, and further defining a cutting edge (35) at said distal end of said cutting member; a handpiece (12, 305) supporting a drive mechanism operably coupled to said cutting member (17, 304) to move said cutting edge (35) past said tissue-receiving opening (25, 126) to sever tissue projecting therethrough; a vacuum source in fluid communication with said inner lumen (34) at said proximal end of said cutting member (17, 304); and a hub (75, 140, 312) having a distal end attached to said proximal end of said outer cannula (15, 125, 303), and a proximal end mounted to said handpiece (12, 305), said hub defining a leak path between said outer lumen (27, 306) of said outer cannula and atmospheric air when said distal end of said outer cannula is disposed within a body and said hub is disposed outside the body.
65. The tissue cutting device (10, 300) of claim 64 wherein: said handpiece (12, 305) includes a housing (70, 340) having a distal end (71) defining a fitting (77, 142, 348); and said hub (75, 140, 312) defines a mating flange (77, 142, 348) at said proximal end, said mating flange engageable to said fitting (72, 345) to connect said handpiece (12, 305) to said hub.
66. The tissue cutting device (10, 300) of claim 65 wherein said leak path is defined between said housing (70, 340) and said hub (75, 140, 312).
67. A tissue cutting system (9) comprising: an outer cannula (15, 125, 303) defining a tissue-receiving opening (25, 126) adjacent a distal end thereof; an inner cannula (17, 304) slidably disposed within said outer cannula (15,
125, 303) and defining a lumen (34) from an open distal end to an open opposite proximal end, said inner cannula defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); a cutting board (31) disposed at said distal end of said outer cannula (15, 125, 303) distal from said tissue-receiving opening (25, 126), said cutting board configured to conform to said cutting edge (36) for impact cutting of tissue between said cutting edge and said cutting board; a piston (63) disposed within a hydraulic cylinder (22, 330) and operably coupled to said inner cannula (17, 304) to move said inner cannula within said outer cannula (15, 125, 303) toward said cutting board (31); a return spring (66) disposed within said cylinder (22) and operable against said piston (63) to move said piston in a direction away from said cutting board (31); a source of pressurized fluid (152) connected to said hydraulic cylinder (22, 330) having a first state providing pressurized fluid to said cylinder and a second state permitting fluid to bleed from said cylinder; and a pressure switch (165) coupled to said source of pressurized fluid (152) to switch said source between said first state and said second state as a function ofthe magnitude ofthe fluid pressure within said cylinder.
68. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defimng a tissue-receiving opening (25, 126) adjacent a distal end (28) thereof; an inner cannula (17, 304) slidably disposed within said outer cannula (15, 125, 303) and defining a lumen (34) from an open distal end to an open opposite proximal end, said inner cannula defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); a cutting board (31) disposed at said distal end of said outer cannula (15, 125, 303) and cooperating with said cutting edge (35) of said inner cannula (17, 304) to sever tissue under pressure from said cutting edge against said cutting board; a hydraulic reciprocating motor (22, 334) operably coupled to said inner cannula (17, 304) to advance said inner cannula within said outer cannula (15, 125, 303) against said cutting board (31); and a hydraulic system (150) connecting said hydraulic motor (22) to a source of pressurized fluid (152) to provide a substantially constant fluid pressure to said motor as said motor advances said inner cannula (17, 304).
69. The tissue cutting device (10, 300) of claim 68 further comprising a pressure switch (165) coupled to said source of pressurized fluid (152) to switch from providing pressurized fluid to said motor to permitting fluid to bleed from said motor.
70. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defining an outer lumen (27) and a tissue- receiving opening (25, 126) adjacent a distal end (28) of said outer cannula communicating with said outer lumen; an inner cannula (17,- 304) slidably disposed within said outer lumen (15, 125, 303) and defining an inner lumen (34) from an open distal end to an open opposite proximal end, said inner cannula defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); and a drive mechanism operably coupled to said inner cannula (17, 304) to move said inner cannula relative to said tissue-receiving opening (25, 126) in said outer cannula (15, 125, 303), wherein said drive mechanism is substantially composed of a non-metallic material.
71. The tissue cutting device (10, 300) of claim 70, wherein said drive mechanism includes: a first motor (20, 332) operable to rotate said inner cannula (17, 304); and a second motor (22, 334) operable to translate said inner cannula (17, 304).
72. The tissue cutting device of claim 71 , wherein said first (20, 332) and second (22, 334) motors are hydraulic motors.
73. The tissue cutting device (10, 300) of claim 70, wherein said non- metallic material is a plastic.
74. The tissue cutting device (10, 300) of claim 70, further comprising a handpiece (12, 305) supporting said drive mechanism and said outer cannula (15,
125, 303).
75. The tissue cutting device (10, 300) of claim 74, wherein said handpiece (12, 305) is substantially composed of anon-metallic material.
76. The tissue cutting device (10, 300) of claim 75, wherein said handpiece (12, 305) is substantially composed of a plastic material.
77. A tissue cutting device (300) comprising: an elongated handpiece (305) defining an elongated channel (322) on an outer surface of said handpiece; a cannula hub (312) mounted to said handpiece (305) and having a fluid port (375); a tube (320) connected at one end to said fluid port (375) and having an opposite end connectable to a fluid source, said tube disposed within said elongated channel and sized to be recessed within said channel relative to said outer surface; an outer cannula (303) supported at a proximal end by said cannula hub (312) and defining a tissue-receiving opening (126) adjacent a distal end thereof, and a lumen (306) between said proximal and distal ends in fluid commumcation with said fluid port (375) of said cannula hub (312); and an inner cutting member (304) slidably disposed within said lumen (306) of said outer cannula (303) and defining a cutting edge at said distal end operable to sever tissue proj ecting through said tissue-receiving opening (126).
78. The tissue cutting device (10, 300) of claim 77, further comprising a fluid source connected to said opposite end of said tube (320), said fluid source including: a container (400) holding a supply of a fluid; and a valve (402) between said container (400) and said fluid port and operable to confrol the flow of fluid from said container through said tube (320).
79. The tissue cutting device (300) of claim 78, wherein said valve (402) is a pinch valve engaged about said tube.
80. A method for performing a tissue biopsy at a sample site within a patient comprising the steps of: introducing an outer cannula (15, 125, 303) into the patient with a tissue receiving opening (25, 126) adjacent the sample site; providing a medical treatment through the outer cannula (15, 125, 303) at the sample site; connecting the outer cannula (15, 125, 303) to a tissue biopsy handpiece (12, 305) having a motor-driven tissue cutting cannula (17, 304) with the tissue cutting cannula extending into the outer cannula; operating the tissue biopsy handpiece (12, 305) to excise tissue through the tissue receiving opening (25, 126); and storing the excised tissue for subsequent examination.
81. A tissue cutting device (10, 300) for removing tissue from a patient comprising: an outer cannula (15, 125, 303) configured for introduction into the patient and defining a tissue-receiving opening (25, 126) adjacent a distal end thereof; an inner cannula (17, 304) slidably disposed within said outer cannula (15, 125, 303) and defining a lumen (27, 306) from an open distal end to an open opposite end, said inner cannula further defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); a motor assembly operably coupled to said inner cannula (17, 304) to rotate and reciprocate said inner cannula (17, 304) within said outer cannula (15, 125, 303); a vacuum source fluidly coupled to said inner cannula (17, 304) for generating a vacuum in said lumen (34) of said inner cannula to draw severed tissue therethrough; and a tissue collection chamber (55) interposed between said vacuum source and said open opposite end of said inner cannula to receive severed tissue drawn into said chamber by the vacuum.
82. The tissue cutting device of claim 81 , wherein said tissue collection chamber (55) includes a filter permitting passage of fluid therethrough while retaining the severed tissue within said chamber.
83. A tissue cutting device (10, 300) comprising: an outer cannula (15, 125, 303) defining a tissue-receiving opening (25, 126) adjacent a distal end thereof; an inner cannula (17, 304) slidably disposed within said outer cannula (15, 125, 303) and defining a lumen (34) from an open distal end to an open opposite proximal end, said inner cannula defining a cutting edge (35) at said open distal end operable to sever tissue projecting through said tissue-receiving opening (25, 126); a rotary motor (20, 332) operably coupled to said inner cannula (17, 304) to rotate said inner cannula within said outer cannula (15, 125, 303); a reciprocating motor (22, 334) operably coupled to said rotary motor (20, 332) to franslate said rotary motor and thereby translate said inner camiula (17, 304) within said outer cannula (15, 125, 303) while said inner cannula rotates; and a handpiece (12, 305) supporting said rotary motor (20, 332) and said reciprocating motor (22, 334), said handpiece including a pair of opposite rails (341), wherein said rotary motor (20, 332) includes a pair of opposite outwardly projecting wings configured to be slidably supported on said opposite rails (341) to resist rotation of said rotary motor while permitting said rotary motor to franslate relative to said rails.
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US7883476B2 (en) 2011-02-08
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