US20050113716A1 - Biopsy device having endoscope - Google Patents

Abstract

A biopsy device having an endoscope comprises a biopsy instrument, suitable for collecting at least one tissue sample from a body lumen, such as a mammary duct, and a cutter introducer sized for receiving the biopsy instrument and introducing the biopsy instrument into a mammary duct to retrieve a tissue sample therefrom.

Description

RELATED APPLICATION
• This application is a continuation-in-part of application Ser. No. 10/422,381, filed on Apr. 24, 2003.
TECHNICAL FIELD OF THE INVENTION
• The invention generally relates to a device for obtaining mammary duct tissue samples for analysis. More specifically, the invention relates to a biopsy device having an endoscope and an introducer therefor.
BACKGROUND OF THE INVENTION
• Breast cancer is one of the health threats most feared by women, and is indeed the most common form of cancer in women. A key to treatment is early detection. For example, an annual mammogram is a method that has been used in hopes of early detection of breast cancer. One problem with mammography is that such an imaging technique can only find breast cancer once it has taken form. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. While breast cancer is most common among women, in rare instances the human male may also have occurrences of breast cancer.
• Other methods of detecting breast cancer are based on the fact that in a vast majority of instances breast cancer begins in the lining of mammary ducts. Studies have shown that fluid within the mammary duct contains high levels of breast cancer markers, and that an estimated 80%-90% of all breast cancers occur within the intraductal epithelium of the mammary glands. Fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Likewise, mammary fluid typically contains cells and cellular debris or products that can also be used in cytological or immunological assays. As such, techniques such as ductal lavage, collection of mammary duct discharge, and brushing biopsies have been utilized to obtain such samples for diagnostic purposes.
• If suspicious tissue is located, a biopsy of the tissue may then be taken. One biopsy device that has been utilized is the Mammotome® biopsy system available from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. After mapping an area to be biopsied, the Mammotome® probe, a needle-like device with a hollow passage therethrough, is introduced through an incision cut into the breast and inserted further until the desired biopsy region is accessed. When the probe is positioned at the region of concern, tissue is received into a window in the probe with vacuum assist. A cutter then cuts and removes tissue samples for examination. The samples are passed through the hollow passage of the probe into a collection chamber. Because the Mammotome® probe is directional, multiple specimens can be collected without having to remove and reinsert the device. The Mammotome® probe is removed after the samples have been collected, and the incision is closed.
• Such a system significantly decreases the invasiveness of the biopsy procedure by only requiring a small incision and puncture, which may be done under local anesthetic. However, in certain situations, such as where the tissue to be biopsied is in a mammary duct, the incision and probe insertion required with the Mammotome® is unnecessarily invasive and undesirable.
• What is needed is a biopsy device for conducting a minimally invasive biopsy procedure without the need for an incision. It is also desirable that the physician be able to take multiple tissue samples from a single biopsy site. It is further desirable for the physician to be able to identify and record the location of each sample of tissue extracted. The present invention meets the foregoing desires and provides an improved device for taking a biopsy within a mammary duct, as well as a device that facilitates memorializing in the patient's records the location of the tissue sampled.
SUMMARY OF THE INVENTION
• A biopsy device embodying the present invention comprises a biopsy instrument provided with a tissue cutter suitable for collecting at least one tissue sample from a body lumen, such as a mammary duct, and a cutter introducer sized for receiving the tissue cutter and guiding the tissue cutter into a mammary duct.
• The biopsy instrument includes a holster, a housing reciprocably mounted in the holster, and an elongated hollow cutter that extends from the housing and is driven by a cutter drive motor situated within the housing. A power connector, operably connected to a power source, is associated with the cutter drive motor. The hollow cutter rotates about a longitudinal axis thereof upon energization of the motor by activating a switch operably associated with the motor. The hollow cutter also extends distally relative to the holster when the housing is urged into the holster. An ejector assembly is removably mounted to the housing and received within the cutter. The ejector assembly includes an endoscope which is slidably received within the hollow cutter and may be extended therethrough. The endoscope serves the dual purpose of viewing the area to be biopsied, as well as serving as a piston for urging or expelling biopsied material from the cutter. A coupling mount for removably receiving the cutter introducer, such as a boss terminating in a distal, radially outwardly extending flange, is also provided on the biopsy cutter.
• Preferably included within the housing is a power source, such as a battery, which can be a primary battery, i.e., single use, or a secondary battery, i.e., rechargeable. Alternatively, the power source may be external to the housing and the holster therefor, but operatively connected to the power connector. The housing and holster are preferably formed of a lightweight rigid plastic. The cutter is preferably formed of a lightweight metal such as stainless or surgical steel, or the like.
• The other component of the biopsy device is the cutter introducer, which is comprised of a hollow handle, and an elongated sheath having open opposite ends, i.e., a distal end and a proximal end, mounted to the handle and adapted to receive the cutter element therewithin. A window cut-out or aperture is provided at a distal end portion of the sheath. The window or aperture preferably includes a hook portion for grasping and pulling the target tissue through the window and into the sheath. A proximal end portion of the sheath is fixed within the handle. The hollow handle further defines an axial passage leading to the sheath.
• The handle of the cutter introducer preferably includes an integral azimuth indicator, which may be unitary with the handle. The azimuth indicator can also be a pair of azimuth indices that can be aligned vis-a-vis one another, and the like. The handle can also include a socket for receiving the coupling mount of the biopsy instrument. For example, the coupling socket on the handle may be an annular cavity which can receive the boss of the holster provided with a radially outwardly extending flange. The handle is also preferably formed of a lightweight rigid plastic. A tissue anchor extendable through the introducer is desirable in some cases. The tissue anchor can comprise a hollow hub and flexible outwardly biased tines that extend from the hub and an optional retriever rod. The tissue anchor is slidably and rotatably mounted within the sheath at the distal end portion thereof. The tines of the anchor are extendable from the open distal end of the sheath and spread radially outwardly when so extended. A distal end portion of the retriever rod, which retracts the anchor and the tines within the sheath, is configured to engage the anchor.
• In order to obtain a tissue sample with the biopsy device from a mammary duct the cutter introducer is first inserted into a nipple orifice at the nipple surface and then advanced into the mammary duct. The endoscope may be utilized within the introducer to locate and view the biopsy site, if desired. When a tissue mass of interest is located, and the distal end portion of the sheath positioned as desired, the tines of the anchor are extended beyond the open distal end by urging the hub of the tissue anchor to slide towards the distal end. The tines are pushed through the open distal end, and because they are outwardly biased, spread out radially to contact the walls of the mammary duct and immobilize the introducer.
• The biopsy instrument, in particular the cutter, is inserted into the introducer and extended towards the distal end portion thereof. A tissue mass from the biopsy site is received within the introducer sheath through an aperture or cut-out at the distal end portion of the introducer sheath. The motor for driving the cutter element is energized and rotates the cutter element. As the distal end of the cutter travels across the aperture, that portion of the tissue mass received within the introducer sheath is severed. The biopsy instrument is withdrawn from the introducer sheath after the desired tissue samples have been taken. The hollow cutter element receives the tissue mass within its interior, and the severed tissue is later ejected from the hollow cutter by the ejector assembly for analysis.
• When it is desired to remove the introducer, a retriever rod may be extended through the introducer sheath to engage the hub of the tissue anchor. The retriever rod is then retracted and draws the anchor back into the sheath, thereby disengaging the tines from the mammary duct. The introducer can then be withdrawn from the mammary duct. Alternatively, the anchor can be urged past the distal end of the introducer and left in the mammary duct as a biopsy site marker or indicator.
BRIEF DESCRIPTION OF THE DRAWINGS
• In the drawings,
• FIG. 1 is a perspective view of an embodiment of a biopsy device;
• FIG. 2 is a partial cross sectional side view of the biopsy instrument;
• FIG. 3 is a partial cross sectional top view of the biopsy instrument ofFIG. 2;
• FIG. 4 is a cross sectional side view, partially broken, of the cutter introducer;
• FIG. 5 is an enlarged cross sectional view of the distal end portion of the cutter introducer and the tissue anchor in a retracted position;
• FIG. 6 is an enlarged cross sectional side view of the distal end portion of the cutter introducer with the tissue anchor in an extended position;
• FIG. 7 is an enlarged cross sectional side view of the distal end portion of the biopsy introducer with the tissue anchor in an extended position and a retriever rod engaged with a tissue anchor latch;
• FIG. 8 is an enlarged cross sectional side view of the distal end portion of the cutter introducer with the tissue anchor extended and engaged with a mammary duct, and a cutter within the introducer;
• FIG. 9 is an enlarged cross sectional side view of the distal end portion of the biopsy introducer with an alternate embodiment of the tissue anchor in an extended position and equipped with a retriever rod suitable for engaging the tissue anchor;
• FIG. 10 is a schematic of a human breast having the biopsy device inserted therein, and an azimuth marker circumscribing a breast nipple;
• FIG. 11 is a cross sectional side view of another embodiment of a biopsy device with an ejector assembly comprising an endoscope which is shown in an extended state;
• FIG. 12 is a cross section side view of the biopsy device ofFIG. 11 with the endoscope in a retracted state;
• FIG. 13 is a perspective view of another embodiment of a biopsy device having an endoscope;
• FIG. 14 is an enlarged cross sectional view of the distal end portion of an embodiment of the biopsy device having a hooked window portion; and
• FIG. 15 is an enlarged cross sectional view of the distal end portion of an embodiment of the biopsy device taking a core tissue sample.
DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION
• The invention disclosed herein is susceptible of embodiment in many different forms. Shown in the drawings and described hereinbelow in detail are preferred embodiments of the invention. It is to be understood, however, that the present disclosure is an exemplification of the principles of the invention and does not limit the invention to the illustrated embodiments.
• A preferred embodiment of a biopsy device is shown inFIG. 1.Biopsy device10 is comprised of abiopsy instrument12 and acutter introducer14 removably carried by thebiopsy instrument12 and having hollow elongatedsheath26 mounted to handle24. Thebiopsy instrument12 comprises aholster16, ahousing18 that is slidably and reciprocably received inholster16, and a hollow elongated cutter42 (FIG. 2), slidably received withinelongated sheath26 ofcutter introducer14. Theelongated cutter42 is driven by cutter motor38 (FIG. 3) withinhousing18. Anend cap22, removable to access various components within thehousing18, seals the proximal end ofhousing18. An on-off switch, such asbutton switch45 for energizingcutter motor38 extends from thecap22.Elongated sheath26 has open opposite ends, i.e., adistal end28 and a proximal end that is mounted to handle24. A cut-out oraperture30 is provided at adistal end portion32 of thesheath26.Depth indicators35, axially spaced from one another can also be provided onsheath26, if desired.Handle24 is adapted for rotatable as well as removable mounting tohousing18, and includes a pair of integrally formed azimuth indicators, in particular,distal indicator34 andproximal indicator36, that are axially aligned with one another.
• The cutter orblade42 is configured for sliding travel through thehandle24 andsheath26 of theintroducer14. Specifically, the outer diameter of thecutter42 is smaller than the inner diameter of thesheath26. Thecutter42 is also sufficiently long to extend to thedistal end portion32 of the sheath, and preferably such that when fully extended, the cutter element projects beyond theaperture30.
• As can be seen inFIGS. 2 and 3, a power connector, such aslead40 forcutter drive motor38 is also included in thehousing18 and is operably associated with thecutter drive motor38 which driveshollow cutter42 by rotating it about the longitudinal axis of thecutter introducer14. In particular,motor38 drives spurgear39, which in turn is engaged withspur gear43 secured to the proximal end portion ofcutter42. Themotor38 can be energized by any switching mechanism available in the art. For example, a two-position switch45 can be operatively connected in a circuit between a power source and themotor38, preferably biased in the OFF-position. Alternatively, the switch may also be formed by abattery38 that serves as the power source and aconductive post71 surrounded by insulatedspring68. As the housing is moved axially into the holster,battery38 contacts post71 to complete an electrical circuit between the motor and the battery. Thus,power lead67, in cooperation withconductive post71,spring68 andpower lead40, form an electrical circuit between thecutter drive motor38 and thebattery54. As yet another alternative, the switch and power supply can be operably connected to the motor, but situated external to the housing. For example, a foot-operated switch can be utilized in such instances.
• Positioned between the distal end ofholster16 and distal end ofhousing18 is a return spring, such ascoil spring56. Theholster16 further defines agroove58 through whichdorsal post60 is positioned and extends therethrough from housing18 (FIG. 2). Theventral post60 within thegroove58 serves as a stop to limit the longitudinal movement of thehousing18 relative to theholster16, as well as to prevent rotational movement of thehousing18 relative to theholster16.
• Coil spring56 is axially aligned with thecutter42 inholster16, through whichcutter42 is extended for axial reciprocation withinelongated sheath26. A hollow support or bearing70 may also be provided within theholster16, through whichcutter42 passes. Also provided by theholster16 is acoupling mount48 for removably attaching thebiopsy instrument12 tocutter introducer14. Thecoupling mount48 is preferably aboss49 terminating in a distal, radially outwardly extending flange. Couplingmount48 may also include an o-ring seal51 that circumscribesboss49.
• Apusher rod assembly46 includes elongatedpiston rod62 and anactuator handle63, and is removably mounted within thehousing18. Thepiston rod62 is slidably received within thehollow cutter42. Thepusher rod assembly46 is slidably positioned withinhousing18, and actuator handle63 is accessible from outside the housing for manual actuation. Further disposed withinhousing18 is a pusherrod coil spring66 biased against forward axial movement of thepusher rod assembly46.Piston rod62 extends from actuator handle63 into and throughcutter42.Piston rod62 has an outer diameter that is smaller than the inner diameter of thehollow cutter42 such that any material within thecutter42 is pushed out bypiston rod62 when extended. In particular, whenpusher rod assembly46 is pushed forward,piston rod62 projects past the distal end72 (FIG. 8) of thecutter42, thereby clearing thehollow cutter42 of any contents therein, such as tissue samples.Housing18 further includes pusher stop65 which limits the extent to which thepusher rod assembly46 can be moved distally. The pusher rod assembly is guided by at least a holster track, defined byguide rail75 and guide rail77 (FIG. 1).
• The other major component of the biopsy device is a cutter introducer removably mounted to holster16. A cross section of a preferred embodiment of thebiopsy introducer14 is shown inFIG. 4. As discussed above, thecutter introducer14 comprises a number of components, includinghollow handle24 andelongated sheath26 having anaperture30 formed at adistal end portion32 of thesheath26. Thedistal end28 ofsheath26 preferably terminates in an atraumatic tip, such as a circumferential bevel. Aproximal end portion33 of thesheath26 is fixed within thehandle24. Anaxial passage25 is further defined by thehollow handle24 and leads tosheath26. Preferably thehandle passage25 is tapered so as to permit easier introduction of thecutter42 or other instrument into thesheath26. Thehandle24 also defines anannular coupling socket37 for rotatable mounting tocoupling mount48 of thebiopsy instrument12. In this embodiment, thesocket37 is configured to receivecoupling mount48 on holster16 (FIGS. 2 and 3).
• Also shown within thedistal end portion32 ofsheath26 thereof istissue anchor76.Tissue anchor76 is optional and aids the operator in maintaining penetration control as indicated bydepth marker35. An externally applied nipple clamp (not shown) may be optionally employed to clamp or retainintroducer sheath26 within the nipple duct sphincter muscle, thereby also aiding in penetration control.
• An enlarged view of thedistal end portion32 of the introducer is shown inFIGS. 5 and 6.Tissue anchor76 comprises ahollow hub78, flexible, outwardlybiased tines80 that extend from thehub78, and alatch82 which extends from the hub axially. Thetissue anchor76 is slidably and rotatably mounted within thedistal end portion32 of thesheath26. Alternatively,tissue anchor76 may be extended through thesheath26 after an endoscopic viewing procedure has located the biopsy site. Theanchor76 can be partially or fully extendable through the opendistal end28 of thesheath26, as desired.Latch82 is configured to engage a distal end portion86 of a retriever rod, which is discussed in further detail below.
• Referring toFIG. 5, thetissue anchor76 is shown in a retracted position. Thetissue anchor76 can be pushed partially throughdistal end28 to extend thetines80 untilannular step88 abuts beveleddetent90. Thetissue anchor76 may be pushed by any appropriate device, such as by an endoscope viewing assembly, push rod, or other instrument that is extendable through thesheath26 to engagehub78.
• Referring toFIG. 6, the extent to whichtissue anchor76 can be extended throughdistal end28 may be limited byhub78 which includes anannular step88, in cooperation withbeveled detent90 formed about thedistal end portion32. As thetines80 are extended past thedistal end28, their outward bias causes thetines80 to spread radially and engage the interior of the mammary duct (not shown). As such, the axial position of thesheath26 within the mammary duct is secured. Thehub78, however, is sized to rotate relative tosheath26. As such, thesheath26 may be rotated abouthub78 within the mammary duct to reposition the circumferential orientation ofaperture30 even after thetissue anchor76 has been engaged by manipulation of the handle24 (FIG. 1). As will be discussed in further detail below, rotatable repositioning theaperture30 permits collection of multiple tissue samples from the same region of a mammary duct.
• Preferably, theannular step88 and beveleddetent90 are contoured so that by application of additional force, thetissue anchor76 can be urged past thedistal end28 of thesheath26 and left in place as a marker for the biopsy site. Tactile feedback is provided to the operator by increased resistance from the interaction ofannular step88 anddetent90 when theanchor76 is extended, but still within thesheath26. Alternatively,tissue anchor76 can be disengaged fromsheath26 by gently withdrawingsheath26 from the biopsy site such thattissue anchor76 is left behind still engaged with the mammary duct wall.
• If it is desired to remove theanchor76, preferably it is disengaged from the mammary duct by retraction into thesheath26. In order to retract theanchor76, aretriever rod84 is introduced through thesheath26. Theretriever rod84 includes adetent85 for engaging thelatch82 extending from thehub78 as shown inFIG. 7. Theretriever rod84 is then retracted from theintroducer14, thereby also retracting theanchor76.
• In order to obtain a tissue sample with the biopsy device10 (FIG. 1), thecutter introducer14 is first inserted into a mammary duct via a nipple orifice. The desired nipple orifice is first located through use of any means such as an illuminated nipple cup (not shown). A nipple orifice dilator or catheter (not shown) may be used to dilate the nipple orifice, if desired, to permit easier insertion of the introducer. An endoscope may be extended within the introducer to enable viewing of the biopsy site. When a desired mass of tissue is located, theanchor76 is extended as described above, and as shown inFIG. 8. Thehollow cutter42 of the biopsy instrument is guided through thecutter introducer14 and pushed towards thedistal end portion32 and theaperture30. A tissue mass is received within thesheath26 through the aperture or cut-out30 at thedistal end portion32. The tissue mass can be urged into theaperture30 by external pressure applied to the breast or alternatively with the aid of a vacuum, or by pressing the aperture against the desired biopsy area. Thecutter motor38 for driving thecutter42 of the biopsy instrument can then be energized. Driven bymotor38,cutter42 rotates and severs the portion of the tissue mass received within thesheath26 as thedistal end72 of thecutter42 travels acrossaperture30. Preferably, thehollow cutter42 receives the tissue mass within its interior. Thebiopsy instrument12 is removed from theintroducer14 after the desired tissue sample is obtained, and the tissue sample is later expelled from thecutter42 bypiston rod62 of the pusher rod assembly extending therethrough. Alternatively, thehollow cutter42 may be operatively connected to a vacuum source for removal of the severed tissue sample through a central passageway defined by thehollow cutter42.
• An alternate embodiment of the tissue anchor and retriever rod are shown inFIG. 9.Anchor91 has a configuration similar to the anchor discussed above, but includes a base92 defining a threadedhole93.Retriever rod94 has a threadeddistal end95 that is threadably engageable with threadedhole93.Anchor91 can thereby extended to a desired degree and retracted by threadedly engagingretriever rod94 withanchor91 and extending or retracting theretriever rod94.
• To obtain multiple tissue samples from a biopsy site, and to discern the relative original locations of the tissue samples as part of the tissue analysis an azimuth marker is provided. To that end, and as illustrated inFIG. 10, anazimuth marker98 having a plurality ofcircumferential marks100, is provided and can be as part of a biopsy kit.Azimuth marker98 is removably secured about anipple102, such as with a physiologically compatible pressure sensitive adhesive. The clinician notes howazimuthal indicators34 and36 align withcircumferential marks100 while the microendoscope is still positioned withinintroducer14. The cooperation of theazimuthal indicators34 and36 anddepth markers35 establishes the location of the target tissue so that the microendoscope can be removed and thebiopsy instrument12 inserted. Utilizing the procedure discussed above, a tissue sample is obtained. As part of the procedure, the practitioner aligns the distalazimuthal indicator34 and proximalazimuthal indicator36 with a mark on theazimuth marker98 and notes the indicator position. After a tissue sample is excised by thecutter42, thebiopsy instrument12 is disengaged from thebiopsy introducer14. The practitioner extends thepusher rod assembly46 by forwardly movingpush rod handle63, and thereby causing piston rod62 (FIG. 8) to pass beyond the distal end ofcutter42 and eject the severed tissue sample. The tissue sample or samples may be collected on a collection tray having multiple recesses or numbered slots for tracking the source of the tissue sample. Thebiopsy instrument12 can then be reinserted into theintroducer14, which is still held in place at the biopsy site by thetissue anchor76, and rotated such thatdistal indicator34 andproximal indicator36 are aligned with a circumferential mark onazimuthal marker98 different than that for prior tissue samples. In so doing, the aperture at the distal end portion of the introducer is repositioned to accept a tissue mass from a position adjacent to or near the previously excised tissue mass. The cutter then excises and retains a portion of this particular tissue. This sampling process is repeated as desired. For example, the practitioner can obtain tissue samples by aligning thedistal indicator34 andproximal indicator36 with successive circumferential markers in a clockwise direction. Alternatively, multiple tissue samples can be obtained without retracting thebiopsy instrument12 from theintroducer14. In this case, the aperture30 (FIG. 8) is positioned and thecutter42 is rotated by thecutter drive motor38 and passed across theaperture30, which is then rotatably repositioned and the cutter is again rotated and passed across the newly positionedaperture30. In so doing, multiple tissue samples are held within thehollow cutter42. Thecutter42 is then removed and the multiple tissue samples ejected by the pusher rod assembly. As discussed, after the desired tissue samples are obtained, a retriever rod can be used to retract the anchor, and thereby, permit retraction of the introducer. If desired, the rod64 of the pusher rod assembly may also serve as the retriever rod.
• Another preferred embodiment of a biopsy device is shown inFIG. 11.Biopsy device210 is comprised of abiopsy instrument212 and acutter introducer214 removably carried by thebiopsy instrument212 and having hollow elongatedsheath226 mounted to handle224. Thecutter introducer214 is essentially the same as described in the previous embodiment.
• Thebiopsy instrument212 comprises aholster216, ahousing218 that is slidably and reciprocably received inholster216, and a hollowelongated cutter242, slidably received withinelongated sheath226 ofcutter introducer214. Anejector assembly261 is further provided, which comprises a rocker arm, such asejector handle member263, ahinge member267, and abarrel member269. Thebarrel member269 further defines apassageway271 including acollar portion272. Theejector assembly261 further comprises anendoscope262 having an adapter, such as a Tuohy fitting276, that removably secures the endoscope to thecollar portion272 of thepassageway271. Also provided is an ejectorassembly coil spring266, which is biased against distal movement of theejector assembly261 towards thecutter introducer214. Since theendoscope262 is secured within the ejector assembly, its movement corresponds to the movement ofejector assembly261. Operatively connected to thepassageway271 is aremovable port member273, through which solution, such as irrigation liquids may be introduced.Port member273 is also suitable for providing a conduit for a suctioning device. A return spring, such ascoil spring256 is also provided between thehousing218 and theholster216. Also, an on-off switch, such asbutton switch245 is provided, which when actuated causes a motor to rotatecutter242 such as described above.
• As shown, the ejector assembly handle263 is engaged withend cap222, when theejector assembly261 is in a forward position thereby acting as a detent member. Theendoscope262 is also positioned such that itsdistal end275 is extended proximate to or beyond thedistal end277 of thecutter242. By positioning theendoscope262 proximate thedistal end277 of thecutter242, the practitioner is able to view the biopsy site in real time up to the time the cutting operation takes place.
• When the practitioner is ready to begin cutting, tissue is urged through thewindow230 by manipulating the patient's breast. In order to provide acollection reservoir279, theendoscope262 is first retracted as shown inFIG. 12. In this embodiment, the ejector assembly handle263 is disengaged from theend cap222 such that the ejectorassembly coil spring266 urges rearward movement of theejector assembly261. Accordingly, theendoscope262 is retracted such thatreservoir279 is created in the distal end portion of thecutter242. As discussed above, excised tissue may be collected in thisreservoir279. One benefit of the present configuration is that a practitioner can retract theendoscope262 by fingertip control by releasing the ejector handle263 as described.
• Shown inFIG. 13 is another embodiment of a biopsy device having an endoscope. In many respects,biopsy device310 is similar to the biopsy device ofFIGS. 11 and 12. For example,biopsy device310 comprises anintroducer314 and aninstrument312 having an ejector assembly (not shown) comprising anendoscope362. One difference is the detent member used for positioning the ejector assembly andendoscope362. In this embodiment, arotatable hub380 having anarm member382 is provided withend cap322.Hub380 further defines apassage384 through whichendoscope362 is passed. As before,endoscope362 is removably secured with the ejector assembly. As shown, thearm member382 is positioned such that the ejector assembly handle363 is pushed up against thearm member382 by the internal ejector assembly coil spring (not shown). With thearm member382 so positioned, the ejector assembly and itsendoscope262 are held in the desired position within theintroducer314. Also, thehousing318 is prevented from being moved relative to theholster316. When the practitioner is ready to begin the cutting operation, thehub380 andarm member382 are rotated such that the ejector assembly coil spring causes the ejector assembly to retract the endoscope such as described with the previous embodiment.
• Referring toFIG. 14, another optional feature of the present invention is to provide ahook431 inwindow430. Since the practitioner is able, withendoscope462 to view the desired tissue passed throughwindow430, the practitioner is also able to secure the tissue withhook431. Thehook431 better enables the practitioner to maintain the position of the desired tissue within thesheath426 during the cutting process by thecutter442 since the hook grasps the desired tissue as shown. In addition,hook431 is utilized to pull tissue throughwindow430 intosheath426. This is accomplished by engaging tissue with thehook431 and pulling on the tissue, which urges the tissue into thesheath426. It is preferred that in a 0.039 inch (0.09906 centimeter) diameter stainless tube having a wall thickness of 0.0025 inches (0.00635 centimeter) that the hook have a depth of between one-third and one-half the tube diameter, or in this example, 0.13 to 0.185 inches (0.3302 to 0.4699 centimeters). It is most desired that the hook depth be about one-half the tube diameter. Thehook431 readily grasps the soft duct wall and pulls tissue into thecutter window430 and supports the tissue such that its position within thewindow430 is maintained as thecutter442 is advanced. As pressure is increased, thehook431 either pierces the tissue and thereafter begins tearing it off or the tissue slips off thehook431. Since the practitioner is able to view the biopsy site in real time with theendoscope462, the practitioner is able to best determine the amount of pulling force to exert without tearing the tissue, and to see when to advance thecutter442. The viewing capability of the endoscope with the cutter in position to be activated for the cutting procedure also provides the practitioner with great flexibility in the size of the sample taken. For example, if the practitioner wishes to take a relatively small sample, thehook431 is merely utilized to grasp tissue. On the other hand, if a larger tissue sample is desired, additional pressure is utilized so the hook pulls more tissue within thewindow430. Given the relatively small difference between the amount of pressure being exerted in these two situations, as discussed above, the real time visual inspection through theendoscope462 allows such a procedure to take place.
• While it has been found that a deeper hook depth is generally more advantageous, various factor constrain the hook depth, including the marginal strength of the material forming the introducer, the wall thickness, and the outside diameter of the tube. This is because the hooking process causes a shaft deflection which may cause the advancing cutter to catch the hook causing damage thereto. Therefore, as little shaft deflection as possible is desired, and the dimensions described above provide satisfactory results.
• It is also preferred that thewindow430 be relatively long. In the example being discussed of a 0.039 inch (0.09906 centimeter) diameter stainless tube having a wall thickness of 0.0025 inches (0.00635 centimeter), and hook depth of 0.13 to 0.185 inches (0.3302 to 0.4699 centimeters), it is preferred that the window have a length of greater than 0.197 inches (0.5 centimeter). Thelonger window430 allows a desired amount of tissue to be pulled therein byhook431.
• Yet another type of sampling that is possible with the present biopsy device is shown inFIG. 15. In addition to the sampling by urging tissue through a window and excising this tissue as discussed thus far, the biopsy device may in some embodiments also act as a core type cutter. For example, thedistal end577 ofcutter542 can be urged beyond thedistal end portion532 of thesheath526 to cut core samples of tissue. As shown, endoscope562 can be utilized by the practitioner to view the coring procedure.
• Preferably, thedistal end577 of thecutter542 has an inner diameter that is 90% to 95% of inner diameter of the rest of thecutter542. It has been found that a fully parallel cutter sometimes results in a core sample that remains attached to the patient. The reduced diameterdistal end542 creates a packing feature, which will tend to pull the tissue and tear away from the uncut end. In other words, after the cutter has cut tissue, the endoscope is advanced to slightly compact the tissue against the distal end within the cutter to aid in sample removal. Another alternative method is to insert a sharpened forward moving pin into the cutter after the core is cut by removing the endoscope. The moving pin acts to wedge the tissue sample within the cutter to aid in sample removal.
• The foregoing descriptions are to be taken as illustrative, but not limiting. Still other variants within the spirit and scope of the present invention will readily present themselves to those skilled in the art.

Claims (22)

1. A biopsy device suitable for collection of a tissue sample from a biopsy site in a body lumen, the biopsy device comprising:

a cutter introducer comprising an elongated, hollow sheath, the sheath rotatable about a longitudinal axis having a distal end portion and a proximal end portion, wherein the distal end portion defines an aperture for receiving a tissue mass, and a hollow handle about the proximal end portion of the sheath;

a biopsy instrument comprising an elongated cutter for severing the tissue sample, received through the aperture, the cutter element being sized for removable insertion in the cutter introducer; and

an endoscope, the endoscope being sized for removable insertion in the elongated cutter and having a distal end portion movably positionable proximate the aperture.

2. The biopsy device ofclaim 1, wherein the cutter is motor driven and the motor is actuated by a switch.

3. The biopsy device ofclaim 1, further comprising an ejector assembly, the ejector assembly including the endoscope which is suitable for ejecting the tissue sample from the cutter.

4. The biopsy device ofclaim 3, wherein the ejector assembly further comprises a detent member to restrict axial movement of the ejector assembly relative to the biopsy instrument.

5. The biopsy device ofclaim 4, wherein the detent member comprises a rotatable hub.

6. The biopsy device ofclaim 4, wherein the detent member comprises a rocker arm.

7. The biopsy device ofclaim 1, wherein the sheath further includes spaced depth indicators thereon.

8. The biopsy device ofclaim 1, further comprising a port member suitable for permitting the introduction of a solution to the biopsy site.

9. The biopsy device ofclaim 1, wherein the aperture comprises a hook portion.

10. The biopsy device ofclaim 9, wherein sheath has an inner diameter and the hook portion has a hook depth in a range of ⅓ to ½ the inner diameter.

11. The biopsy device ofclaim 9, wherein the aperture has a length greater than 0.197 inches (0.5 centimeter).

12. A biopsy device suitable for collection of at least one tissue sample from a biopsy site in a lumen, the biopsy device comprising:

a holster;

a housing reciprocably mounted with the holster;

a cutter drive motor in the housing;

a power source operably associated with the cutter drive motor;

a switch operably associated with the motor and the power source for energizing the cutter drive motor;

a hollow cutter driven by the cutter drive motor and rotatably mounted in the housing;

an endoscope removably mounted to the housing and slidably receivable within the hollow cutter; and

a coupling mount on the holster for removably receiving a biopsy introducer, the introducer comprising an elongated, apertured hollow sheath having a distal end portion and a proximal end portion, wherein the distal end portion defines an aperture for receiving the tissue sample.

13. The biopsy device ofclaim 12, wherein the power source is situated within the housing.

14. The biopsy device ofclaim 13, wherein the power source is a battery.

15. The biopsy device ofclaim 12, wherein the coupling mount is a boss terminating in an distal, radially outwardly extending flange.

16. The biopsy device ofclaim 12, further comprising an ejector assembly, the ejector assembly including the endoscope which is suitable for ejecting the tissue sample from the cutter.

17. The biopsy device ofclaim 16, wherein the ejector assembly comprises a detent member to restrict axial movement of the ejector assembly relative to the housing.

18. The biopsy device ofclaim 17, wherein the detent member comprises a rotatable hub.

19. The biopsy device ofclaim 17, wherein the detent member comprises a rocker arm.

20. A biopsy device suitable for collection of at least one tissue sample from a biopsy site in a lumen, the biopsy device comprising an introducer and an instrument:

the instrument further comprising:

a holster and a housing reciprocably mounted to the holster;

a cutter drive motor in the housing;

a power source operably associated with the cutter drive motor, the cutter drive motor and power source being operatively connected to a switch for energizing the cutter drive motor;

an elongated hollow cutter driven by the cutter drive motor and rotatably mounted in the housing;

an ejector assembly suitable for ejecting the tissue sample from the cutter, the ejector assembly including an endoscope piston removably mounted with the housing and slidably receivable within the hollow cutter; and

a coupling mount on the holster for removably receiving the introducer;

the introducer further comprising an elongated, hollow sheath having a distal end portion and a proximal end portion, wherein the distal end portion defines an aperture for receiving the tissue sample, the aperture comprising a hook portion, the sheath suitable for removably receiving the cutter therein.

21. The biopsy device ofclaim 20, wherein sheath has an inner diameter and the hook portion has a hook depth in a range of ⅓ to ½ the inner diameter.

22. The biopsy device ofclaim 20, wherein the aperture has a length greater than 0.197 inches (0.5 centimeter).

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