US20070161925A1 - Biopsy device with inner cutter - Google Patents

Abstract

The invention is directed to devices and methods for accessing a desired target site within a patient's body and for separating and collecting a tissue specimen from the target site. The device includes a probe member or cannula with a penetrating distal tip, and a tissue cutting member which is disposed within the probe member to cut a tissue specimen from supporting tissue at the biopsy site. This probe is releasably secured to a housing to provide a plurality of discrete orientations of the probe about its longitudinal axis. Vacuum may be provided to the inner lumen of the cutting member to transport tissue through the inner lumen thereof. Rotation (and optionally longitudinal reciprocation) of the tissue cutter is effective to separate a tissue specimen from surrounding tissue at the target site. Vacuum or fluid pressure may be used to move the specimen cut from the target site proximally within the inner lumen defined at least in part by the cutting member for collection. An elongated accessing cannula having an tissue receiving aperture communicating with an inner lumen of the accessing cannula, may be provided with the device and is preferably concentrically disposed within the probe member and about the tissue cutter. The tissue cutting surface of the tissue cutter preferably is longitudinally oriented and may be at an angle with respect to the longitudinal axis of the tissue cutter.

Description

FIELD OF THE INVENTION
• The present invention relates generally to the field of biopsy devices and the methods of using such devices. More specifically, it relates to a device and method for accessing and removing pathologically suspect tissue from within a patient's body.
BACKGROUND OF THE INVENTION
• In diagnosing and treating certain medical conditions, such as potentially cancerous tumors, it is usually desirable to perform a biopsy, in which a specimen of the suspicious tissue is removed for pathological examination and analysis. In many instances, the suspicious tissue is located in a subcutaneous site, such as inside a human breast. To minimize surgical intrusion into the patient's body, it is desirable to be able to insert a small instrument into the patient's body to access the targeted site and to extract the biopsy specimen therefrom.
• Electrosurgical techniques have been used in a variety of biopsy procedures. In electrosurgery, high frequency electrical energy is typically applied to patient tissue through an active electrode, the electrical circuit being completed by a return electrode in contact with the patent's tissue. Electrical energy flowing through the tissue from the active electrode is effective to ablate tissue near the active electrode, forming an opening in the tissue and so allowing insertion of the instrument into a patient's body. A return electrode may be placed on the exterior of the patient's body or may be intracorporeally disposed. The return electrode is typically attached to the patient at a point remote from where the primary or active electrode contacts the tissue. However, in the case of a bipolar electrode for example, the return electrode may be disposed near to the active electrode. An electrosurgical biopsy instrument is disclosed and claimed in U.S. patent application Ser. No. 09/159,467 for “Electrosurgical Biopsy Device and Method,” now U.S. Pat. No. 6,261,241, assigned to the assignee of the subject application, and which is hereby incorporated by reference in its entirety.
SUMMARY OF THE INVENTION
• This invention is directed to biopsy devices and methods for accessing and collecting a tissue specimen that provides access to a targeted biopsy site and provides for the separation of the tissue from supporting tissue at the targeted biopsy site and the capture of the separated tissue specimen.
• An elongated tissue biopsy device having features of the invention includes an elongated probe with an outer member having a tissue penetrating distal tip, a proximal tubular portion, an inner lumen extending within the tubular portion and an opened section in a distal portion which provides access to tissue at the targeted biopsy site. The probe includes an elongated tissue-cutting member which is slidably disposed within the inner lumen of the outer member and is provided with a tissue cutting surface which is configured to sever tissue extending into the probe through an aperture. The cutting surface on the tissue cutting member may be a longitudinally oriented cutting surface which is rotationally or rotationally and longitudinally moved to cut a tissue specimen or the cutting surface may be circumferentially oriented on the distal end of the cutting member which is rotationally and longitudinally moved to sever specimen tissue from supporting tissue at the targeted biopsy site. The cutting member may be configured to provide longitudinal reciprocation in addition to rotation in the case of longitudinally oriented cutting surfaces and rotational reciprocation in addition to longitudinal motion in the case of circumferentially oriented cutting surfaces.
• The cutting member has an inner lumen extending to the proximal end thereof for tissue specimen removal. Mechanical withdrawal of the tissue specimen may be employed or the proximal end of the cutting member may be configured to be in fluid communication with a vacuum source to aspirate the severed tissue specimen through the inner lumen of the cutter member to a tissue collection station. A fluid directing conduit may be provided in the inner lumen of the cutting member with a discharge port that is distal to the tissue specimen to deliver pressurized fluid distal to a severed tissue specimen to aid in transporting the specimen proximally through the inner lumen of the cutting member to the tissue collection station. In this manner, the mechanical withdrawal and/or the vacuum on the proximal end of the specimen and a positive pressure on the distal end of the specimen move the specimen through the inner lumen of the cutting member to a specimen collection station.
• The probe is secured, preferably releasably secured, to a drive housing provided with at least one drive unit. The tissue cutter is operatively connected to the at least one drive unit to provide the desired cutting motion. The proximal end of the outer cannula is releasably secured to the drive housing so that the orientation of the outer cannula with respect to the housing can be selected before the probe is inserted into the patient.
• The probe may be provided with a tubular tissue accessing cannula which is concentrically disposed between the outer member and the tissue cutting member and a distal portion of the accessing cannula is provided with a tissue accessing aperture. The tissue accessing cannula is connected by its proximal end to a drive unit within the housing to rotate the cannula to adjust the orientation of the tissue receiving aperture about the longitudinal axis of the accessing cannula. A proximal extremity of the cutting member is connected to a second drive unit or units to effect the rotation and any longitudinal motion desired for cutting the tissue specimen
• A method of cutting and collecting a biopsy tissue specimen from a targeted biopsy site of a patient includes
• • a) advancing an elongated tissue biopsy device having features of the invention at least partially into tissue at a desired site within the patient's body with the tissue penetrating distal tip of the outer cannula distal to the tissue to be separated from the target site;
  • b) exposing the inner lumen of the accessing cannula to tissue through the accessing aperture;
  • c) applying a vacuum to the inner lumen of the accessing cannula to draw tissue into the inner lumen thereof; and
  • d) separating a tissue specimen from the target site by rotating (or rotating and longitudinally reciprocating) the tissue-cutting member to cut a tissue specimen from supporting tissue at the biopsy site which extends into the inner lumen. Vacuum may be applied to the inner lumen of the cutting member, to pull or aspirate the tissue sample proximally. In addition, or alternatively, fluid pressure may be applied to a distal portion of the inner lumen distal to the specimen to push the tissue specimen proximally or the specimen may be mechanically withdrawn. Fluid pressure may include pressure from a liquid delivered into the interior of the device, such as a physiological saline solution, and may include a gas, such as pressurized carbon dioxide, nitrogen or air, delivered into the interior of the device. The tissue specimen may then be withdrawn from the patient for subsequent pathological examination.
• After acquisition of a tissue specimen or specimens, the biopsy device may be withdrawn from the patient and the specimen removed. However, vacuum and/or fluid pressure or mechanical devices may be sufficient to remove the tissue specimen from the patient without removal of the device from the patient's body.
• The outer member of the probe provides the support for the probe to enable precise location of the accessing port to the desired location at the target site with its longitudinal orientation being preset before the device is introduced into the patient. If an accessing cannula is provided with the biopsy device, the accessing cannula is rotated to further position the tissue accessing aperture to the desired specimen tissue and also to relocate the accessing aperture for taking further specimens. The cutting member quickly and cleanly severs the tissue specimen from the supporting tissue to provide a better tissue specimen for pathological examination.
• These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an elevational view, partially in section, of an elongated tissue biopsy device having features of the invention.
• FIG. 2 is a perspective view of the distal portion of the outer member or cannula of the biopsy device shown in theFIG. 1.
• FIG. 3 is a transverse view, partially in section, of the proximal end of the distal tip of the outer member shown inFIG. 2 taken along the lines3-3.
• FIG. 4 is a perspective view of the distal portion of the tissue accessing cannula of a biopsy device shown inFIG. 1.
• FIG. 5 is a transverse cross-sectional view of the tissue accessing cannula shownFIG. 4 taken along the lines5-5.
• FIG. 6 is a perspective view of the distal portion of the tissue cutter of the biopsy device shown inFIG. 1.
• FIG. 7 is a transverse cross-sectional view of the tissue cutter shown inFIG. 6 taken along the lines7-7.
• FIG. 8 is a perspective view of the proximal end of the biopsy device illustrating the releasable connection between the proximal end of the probe and the housing.
• FIGS. 9A and 9B are schematic transverse cross-sectional views of the probe shown inFIG. 1 in open and closed configurations respectively with the aperture of the tissue accessing device opening to the left.
• FIGS. 10A and 10B are schematic transverse cross-sectional views of the probe shown inFIG. 1 in open and closed configurations respectively with the aperture of the tissue accessing device opening upwardly.
• FIGS. 11A and 11B are schematic transverse cross-sectional views of the probe shown inFIG. 1 in open and closed configurations respectively with the aperture of the tissue accessing device opening to the right.
• FIGS. 12A and 12B are schematic transverse cross-sectional views of the probe shown inFIG. 1 in open and closed configurations respectively with the aperture of the tissue accessing device opening downwardly.
• FIG. 13 is a perspective view of the distal portion of an alternative design for the probe embodying features of the invention in a closed condition.
• FIG. 14 is a top plan view of the tissue cutter of the probe shown inFIG. 13.
• FIG. 15 is a perspective view of the probe shown inFIG. 13 partially open.
• FIG. 16 is a perspective view of the probe shown inFIG. 13 with the leading distal cutting edge depicted.
• FIG. 17 is a perspective view of the probe shown inFIG. 13 further rotated from that shown inFIG. 16.
• FIG. 18 is a perspective view of the probe shown inFIG. 13 with the aperture of the outer member almost closed.
• FIG. 19 is a perspective view of the distal portion of an alternative tissue cutting cannula suitable for use in the biopsy device shown inFIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
• FIGS. 1-7 illustrate asystem10 which includes abiopsy device11 embodying features of the invention. Thebiopsy device11 generally includes an elongated shaft or probe12 having an outer member orcannula13 with atissue penetrating tip14 on the distal end thereof, atissue accessing cannula15 with atissue receiving aperture16 and a tissue-cuttingmember17 with atissue cutting surface18. The proximal end of theouter member13 is releasably secured to adrive housing20 to provide a plurality of discrete orientations to theouter member13. Thehousing20 is provided with a drive unit (not shown) configured to provide motion to thetissue accessing cannula15 and thetissue cutter17. A tissuespecimen collection station21 is connected in a fluid flow relationship with thetissue cutter17 throughconduit22 and is connected to a vacuum source (not shown) throughconduit23.
• As shown in more detail inFIG. 2 theouter member13 has an elongatedtubular body24 with aninner lumen25 which is configured to receive and support the accessingcannula15. The distal end ofinner lumen25 opens to the tissue accessing space between the distal end of thetubular body24 and the proximal end oftissue penetrating tip14. A connecting strut orwall portion26 extends between the tissue penetratingdistal tip14 and thetubular body24 of theouter member13. As shown inFIG. 3, theproximal end27 of the penetratingtip14 is provided with a firstcircular groove28 which is configured to receive the distal end of the accessingcannula15 as shown inFIGS. 1 and 3 and a secondcircular groove29 which is configured to receive the distal end oftissue cutter17. The penetratingdistal tip14 may have a variety of tip shapes in addition to the conical shape shown and may have an arcuate RF electrode such as disclosed in U.S. Pat. No. 6,261,241, and co-pending application Ser. No. 09/477,255, filed on Jan. 4, 2000, both assigned to the present assignee. The width and length of thestrut26 preferably is sufficient to provide required support to thedistal tip14. A stiffening rib may be provided to the underside of the strut for structural stiffness. Multiple struts may be used, provided that a large enough opening is available for tissue access to theaperture16 of the accessingcannula15.
• As best shown inFIGS. 4 and 5, the accessingcannula15 has atubular body30 which defines at least in part thetissue receiving aperture16. Thetubular body30 has aninner lumen31 which is configured to slidably receive thetissue cutter17. Theaperture16 is configured to receive tissue for the specimen of suitable size. The arcuate length of the side edges32 and33 forming theaperture16. Thecannula15 is configured at its proximal end to be operatively connected to a drive unit (not shown) to rotate thetubular body30 aboutlongitudinal axis34 to provide a desired orientation to theaperture16.
• Thetissue cutter17, as depicted inFIGS. 6 and 7, is formed oftubular member35 which has aninner lumen36 and which has anarcuate wall portion37 formingside cutting surface18. Thetissue cutting surface18 may be a sharpened edge of thearcuate wall portion37 or it may be a blade (not shown) secured to the edge. The cuttingsurface18 should be longer than the length of the aperture to ensure complete severance of the tissue specimen from the supporting tissue at the target site upon rotation of the cuttingsurface18. Thetissue cutter17 is rotated to effect tissue cutting by cuttingsurface18, but the member may also be provided with reciprocating longitudinal movement in addition to the rotational movement thereof to provide a cleaner tissue cut. Both edges of thearcuate wall portion37 may be sharpened or provided with blades to be cutting surfaces.
• FIGS. 1 and 8 illustrate the releasable connection between theouter member13 and thehousing20 to allow for a plurality of discrete orientations of the tissue receiving space of the outer member. As shown, the proximal end of thetubular portion24 ofouter member13 is provided with a plurality of longitudinally extendingupstanding ribs38 spaced about the periphery of thetubular portion24. A corresponding number of recessedpassageways39 are disposed about theopening40 in thedistal face41 ofhousing20 designed to receive theribs38.Arcuate ridges42 are provided between theribs38 to receivetooth43 ofreleasable locking mechanism44 provided in the interior ofhousing20. Themechanism44 for releasably locking the proximal end of theouter member13 may take a variety of configurations. Theparticular mechanism44 shown inFIG. 8 is preferably manually operated by the fingers of the operating physician. Theoperator45 is pivotally connected within thehousing20 at an intermediate location so that downward pressure onbutton46 in the top portion of thehousing20 connected toelongated member47 presses the proximal end ofoperator45 raising the distal end and thetooth43 to release thetooth43 from theridge42 to allow for movement of the proximal end oftubular portion24 ofouter member13 with respect to thehousing20. The distal end of themechanism44 is biased upwardly byspring48 so that when the proximal end of theouter member13 is inserted into opening40 thetooth43 rides up rampingsurface49 on the proximal end of theridge42 and seats and is locked on the front face ofridge42.
• Thedrive housing20 and attachedprobe11 allows the entire unit to be disposable. The drive units within the housing control the motion of the accessingcannula15 to orient theaperture16 and the motion of the cuttingmember17 which may be rotation or rotation and longitudinal reciprocation. Other means (not shown) may provide mechanical and electrical power, vacuum, and control to the probe device. Examples of replaceable snap-in type drive units are disclosed in Burbank et al., U.S. patent application Ser. No. 10/179,933, “Apparatus and methods for Accessing a Body Site” hereby incorporated by reference in its entirety. Drive units such as that described in WO 02/069808 (which corresponds to co-pending U.S. application Ser. No. 09/707,022, filed Nov. 6, 2000 and U.S. application Ser. No. 09/864,021, filed May 23, 2001), which are incorporated herein by reference, may be readily modified by those skilled in the art to accommodate the movement of the accessingcannula15 and the cuttingmember17.
• FIGS. 9A and 9B,10A and11B and11A and11B schematically illustrate the operation of thedevice11 and the rotation of theprobe12 to discrete orientations. This series of sketches depict the sequencing of taking tissue specimens from below or the bottom side of a target site. InFIG. 9A theaperture16 is open to the left with thearcuate wall portion40 in a non cutting position. A vacuum is applied to theinner lumen31 of thetissue cutter17 and tissue50 (shown in phantom) from the target site is pulled into the interior of the accessingcannula15 through theaperture16. InFIG. 9B thearcuate portion37 oftissue cutter17 is rotated to sever the aspiratedtissue50 from the supporting tissue at the target site with the cuttingsurface18. The vacuum within theinner lumen31 of thetissue cutter17 pulls the tissue specimen through the inner lumen and into thecollection station21 shown inFIG. 1. The accessingcannula15 is then rotated so that theaperture16 is facing upwardly as shown inFIG. 10A and as shown inFIG. 10B the procedure for cutting the tissue specimen is repeated. InFIG. 11A and 11B theaperture16 is open to the right and the procedure is again repeated for additional specimens. Other intermediate positions for theaperture16 are possible. When the target site is accessed from the upper portion thereof, theprobe device11 is released from thehousing20 and then is inverted or turned through 180° so that thestrut26 is on top as shown inFIGS. 12A and 12B with theaperture16 open downwardly. Thehousing20, not shown in these drawings, may remain in the same orientation. The same motion for the accessingcannula15 as described above may be used to obtain a similar series of tissue specimens from the top of the target site. If the target site is large enough, the probe may pass through the site and accessing may occur from within the interior of the target site in the same or similar manner as that discussed above for accessing the tissue from the top or bottom of the tissue site.
• FIGS. 13-18 illustrate aprobe60 for a biopsy device embodying features of the invention. Inprobe60 the outer member orcannula61 has atissue receiving aperture62 for receiving tissue from the target site. Theouter member61 has a sharpdistal tip63 shown in phantom which is configured to easily penetrate through tissue to the target site.Tissue cutter64 is rotatably disposed withinouter member61 and has a proximal end (not shown) operatively connected to one or more drive units within housing (not shown) for imparting cutting motion thereto such as previously described .herein. Theinner lumen65 oftissue cutter64 is configured for fluid communication with a vacuum source (not shown) to urge a tissue specimen through theinner lumen65. Thetissue cutter64 has anaperture67 as shown inFIG. 14 defined in part by cuttingedge68 andnon-cutting edge69. The cutting surface is longitudinally oriented at an angle with respect to the longitudinal axis of thetissue cutter64. The cutting surface oredge68 has a distal leadingcutting edge portion70 and a proximal trailingcutting edge portion71. This tissue cutter structure provides better application of vacuum to tissue at the target site and as a result provides better control of the tissue cutting. The cutting action is shown in the sequence shown inFIGS. 13 and 15-18. InFIG. 13, theaperture62 of theouter member61 is closed by thearcuate wall portion73 oftissue cutter64. Thenon-cutting edge69 oftissue cutter64 first appears at the distal end ofaperture67 as shown inFIG. 15. Application of vacuum begins to pull tissue from the target site into the interior of the tissue cutter at the distal location. As thetissue cutter64 rotates (as shown inFIGS. 16-18) thenon-cutting edge69 first appears to allow tissue to be pulled into theinner lumen65 of the tissue cutter and thecutting edge68 of the tissue cutter follows, cutting off tissue pulled into the interior of the cutter from the supporting tissue at the target site starting from the leadingcutting edge portion70 to the trailing proximalcutting edge portion71 along the length of theaperture67.
• FIG. 19 illustrates analternative cutting member80 which is formed oftubular member81 and which has a sharpeneddistal end82. The cuttingmember80 may be advanced distally to sever tissue which has been pulled into the accessingcannula15 through theaperture16. The cuttingmember80 may also be rotated continuously in one direction or be provided with reciprocating rotary motion in addition to the longitudinal motion to facilitate tissue cutting as shown by thearrows83 and84.
• The elongated shaft or probe of the biopsy device has a length of about 3 to about 15 cm, preferably, about 5 to about 13 cm, and more specifically, about 8 to about 9 cm for breast biopsy use. To assist in properly locating the probe of the device during advancement thereof into a patient's body, (as described below), the distal extremity of the various members may be provided with markers at desirable locations that provide enhanced visualization by eye, by ultrasound, by X-ray, or other imaging or visualization means. An echogenic polymer coating that increases contrast resolution in ultrasound imaging devices (such as ECHOCOAT™ by STS Biopolymers, of Henrietta, N.Y.) is suitable for ultrasonic visualization. Radiopaque markers may be made with, for example, stainless steel, platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals, alloys and oxides of these metals. In addition, the surfaces of the device in contact with tissue or other components of the device may be provided with a suitable lubricious coating such as a hydrophilic material or a fluoropolymer.
• The outer member or cannula, the accessing cannula and the tissue cutter are preferably formed of stainless steel. However, other high strength materials such as MP35N, other cobalt-chromium alloys, NiTi alloys, ceramics, glasses, and high strength polymeric materials or combinations thereof may be suitable.
• A patient's skin usually must be breached in order to gain access to a body site where a tissue specimen is to be obtained. A scalpel or other surgical instrument may be used to make an initial incision in the skin. After the specimens have been taken, the biopsy device may be removed from the patient. The entire device may be removed; however, in preferred embodiments, the outer member may remain within a patient's body to aid, for example, in the acquisition of further tissue specimens and in the placement of markers at the site from which a tissue sample was taken. In addition, it will be readily appreciated that other types of instruments may be inserted into the tissue site through the fixed outer cannula or accessing cannula in addition to or in place of the instruments described above.
• While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention to be defined by the scope of the appended claims as broadly as the prior art will permit.
• Terms such a “element”, “member”, “device”, “sections”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the terms “means” or “step” followed by a particular function without specific structure or action. All patents and patent applications referred to above are hereby incorporated by reference in their entirety. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Claims (27)

1-40. (canceled)

41. A tissue biopsy device for accessing and collecting a tissue specimen from a target site within a patient, comprising:

a. a housing having at least one drive unit;

b. an outer elongated tubular probe member which has an inner lumen extending therein, which has a tissue penetrating distal tip, and which has a tissue receiving aperture proximal to the penetrating distal tip in fluid communication. with the inner lumen and which has a proximal end configured to be secured to the drive housing and which has a plurality of orientations about the longitudinal axis; and

c. an elongated tissue cutter which is formed at least in part of a tubular member, which is rotatably disposed within the inner lumen of the elongated tubular probe member, which has a longitudinal axis, which has a longitudinal tissue cutting surface, which has an inner lumen extending therein for receiving tissue cut by the tissue cutting surface and which is configured for rotation within the inner lumen of the outer member to cut tissue pulled into the inner lumen of the tissue cutter.

42. The probe ofclaim 41 wherein the tissue cutter has a non-cutting surface which defines a tissue receiving aperture along with the tissue cutting surface.

43. The probe ofclaim 42 wherein the non-cutting surface of the tissue cutter is parallel with the cutting surface thereof.

44. The probe ofclaim 41 wherein the cutting surface of the tissue cutter has a leading distal cutting edge portion and a trailing proximal cutting edge portion.

45. An tissue biopsy device for accessing and collecting a tissue specimen from a target site within a patient, comprising:

a. a housing having at least one drive unit;

b. an elongated probe member which has a longitudinal axis, which has an inner lumen extending therein, which has a tissue penetrating distal tip, which has an open section proximal to the tissue penetrating distal tip configured to receive tissue from the target site and which has a proximal end configured to be rotatably secured to the drive housing to provide a plurality of orientations of the open section about the longitudinal axis; and

c. an elongated tissue cutter which is slidably disposed within the elongated probe member, which has a tissue cutting surface, which defines at least in part an inner lumen extending therein for receiving a tissue specimen, which is operably connected to at least one drive unit of the housing to move the tissue cutter to cut a tissue specimen from tissue extending into the open tissue receiving section of the elongated member.

46. The biopsy device ofclaim 45, wherein the cutting surface of the tissue cutter is longitudinally oriented.

47. The biopsy device ofclaim 45, wherein the cutting surface of the tissue cutter is defined at least in part by an arcuate wall section of the tissue cutter.

48. The biopsy device ofclaim 47 wherein the arcuate wall section of the tissue cutter has a longer arc length than the arc length of the aperture.

49. The biopsy device ofclaim 47, wherein the cutting surface of the tissue cutter is longer than the aperture of the elongated probe member.

50. The biopsy device ofclaim 45 wherein the inner lumen defined at least in part by the tissue cutter is configured to access a vacuum source to transport a tissue specimen through the inner lumen thereof to a tissue collector in fluid communication with the inner lumen.

51. The biopsy device ofclaim 45, wherein the tissue cutter is configured for rotational movement about a longitudinal axis.

52. The biopsy device ofclaim 51, wherein the tissue cutting member is also configured for reciprocating longitudinal movement.

53. The biopsy device ofclaim 52, wherein the tissue cutter is configured for reciprocating longitudinal movement of between about 0.01 inch and about 0.1 inch.

54. The biopsy device ofclaim 47, wherein the arcuate wall section of the tissue cutter has longitudinally oriented cutting surfaces along both edges.

55. The biopsy device ofclaim 45 wherein the cutting surface of the tissue cutter is longitudinally oriented at an angle with respect to the longitudinal axis of the tissue cutter.

56. The biopsy device ofclaim 47 wherein the cutting surface of the tissue cutter has a leading distal cutting edge portion and a trailing proximal cutting edge portion.

57. The biopsy device ofclaim 47 wherein the tissue cutter has a non-cutting surface which extends parallel with the cutting surface.

58. The biopsy device ofclaim 57 wherein the cutting and non-cutting surfaces of the tissue cutter define in part a tissue receiving aperture.

59. The biopsy device ofclaim 45, wherein the tissue cutter is configured for longitudinal movement along a longitudinal axis.

60. The biopsy device ofclaim 59, wherein the tissue cutting member is also configured for reciprocating rotational movement.

61. The biopsy device ofclaim 45 wherein the drive housing which has a plurality of drive units.

62. The biopsy device ofclaim 45 wherein the elongated probe member is releasably secured to the drive housing

63. A method of separating a biopsy tissue specimen from supporting tissue at a target site within a patient's body, comprising:

a. providing a biopsy device comprising:

i. a drive housing having at least one drive member;

ii. an elongated probe member which is rotatably secured to the drive housing, which has an inner lumen extending therein, which has a tissue penetrating distal tip, which has an open section proximal to the tissue penetrating distal tip; and

iii. an elongated tissue cutting member which is formed at least in part of a tubular member, which is slidably disposed within the inner lumen of the elongated probe member, which has at least one tissue cutting surface, which has an inner lumen extending therein for receiving tissue cut by the tissue cutting surface, and which is connected to a drive unit of the elongated probe member to move the tissue cutter within the inner lumen of the elongated probe member;

b. advancing the elongated probe member at least partially into or adjacent to tissue at the target site;

c. exposing the tissue receiving aperture of the elongated probe member to tissue at the tissue site;

d. applying a vacuum to the inner lumen of the tissue cutting member to draw tissue from the tissue site into the inner lumen of the elongated probe member;

e. moving the tissue cutting member within the inner lumen of the elongated probe member by operating the drive member within the elongated probe member to cut tissue drawn into the inner lumen from supporting tissue at the tissue site; and

f. transporting cut tissue through the inner lumen of the tissue cutter.

64. The method ofclaim 63, wherein the tissue cutting member is moved longitudinally and rotated to cut tissue.

65. The method ofclaim 64, wherein the longitudinal movement of the tissue cutting member is reciprocating movement.

66. The method ofclaim 63, wherein pressurized fluid is provided within the inner lumen of the tissue cutting member distal to a tissue specimen therein to transport the tissue specimen proximally within the inner lumen of the tissue cutting member.

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