Methods and devices for collection of soft tissue

• US 5,810,806 A
• Filed: 08/29/1996
• Issued: 09/22/1998
• Est. Priority Date: 08/29/1996
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Tran, Minh, Burbank, Fred H., Ritchart, Mark A., Cole, Mark
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/705,622
• Time in Patent Office: 754 Days
• Field of Search: 606/41, 606/42, 606/45-50, 604/21, 604/22
• US Class Current: 606/45
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue

Abstract

This invention provides an inventive tissue sampling probe which offers many advantages over probes available in the prior art. Unexpectedly superior results are obtained in connection with the retrieval of intact tissue specimens, because of a unique combination of cutting features, including, for example, the employment of an electrosurgical cutting element and a vacuum assist in one preferred embodiment. A particularly important feature of the invention is the ability to manipulate the electrosurgical cutting element to cleanly sever the distal end of the tissue specimen. In certain embodiments, this is accomplished without any cutting impact on surrounding tissue. The versatility of the invention permits its use in many applications, including, for example, breast biopsies, laparoscopic surgery, and lymphadenectomy procedures.

Claims

1. A tissue sampling apparatus, comprising:

a tubular body having a primary lumen for receiving a tissue sample, the tubular body having a distal end, a proximal end, and a longitudinal axis; and

an electrosurgical cutting element disposed at the distal end of the tubular body, said cutting element being movable, relative to said tubular body, in a direction transverse to said axis, across a cross-sectional area defined by the distal end of said tubular body, in order to sever a distal end of an intact tissue sample core captured within said primary lumen.

2. The tissue sampling apparatus as recited in claim 1, wherein the electrosurgical cutting element comprises a wire disposed distally of the distal end of the tubular body.

3. The tissue sampling apparatus as recited in claim 2, wherein said wire comprises a single substantially circular wire which is pivotable from side-to-side to sever a distal end of the tissue sample, thereby completely severing the tissue sample from surrounding tissue.

4. The tissue sampling apparatus as recited in claim 2, wherein the wire comprises a pair of wires which together are actuatable from a rest position to a severing position, the pair of wires together forming a substantially circular cutting element disposed circumferentially along a distal edge of the tubular body in said rest position, and the pair of wires being drawn together across the cross-sectional area in order to sever a distal end of the tissue sample, thereby completely severing the tissue sample from surrounding tissue.

5. The tissue sampling apparatus as recited in claim 2, wherein the wire comprises a single wire which is actuatable from a rest position to a severing position, the wire forming a substantially circular cutting element disposed circumferentially about a distal edge of the tubular body in the rest position, and the wire being drawn across the cross-sectional area of the distal end of the tubular body while being electrically energized in the severing position, the drawing motion of the wire across the cross-sectional area functioning to sever a distal end of the tissue sample, thereby completely severing the tissue sample from surrounding tissue.

6. The tissue sampling apparatus as recited in claim 2, wherein the wire comprises a single wire which is actuatable from a rest position to a severing position, the wire forming a semicircular cutting element disposed circumferentially along a portion of a distal edge of the tubular body in the rest position, and the wire being drawn across the cross-sectional area of the distal end of the tubular body while being electrically energized in the severing position, the drawing motion of the wire across the cross-sectional area functioning to sever a portion of the distal end of the tissue sample.

7. The tissue sampling apparatus as recited in claim 2, wherein the distal end of the tubular body comprises a second electrosurgical cutting element, the tubular body being constructed of an electrically conductive material and being further surrounded by an insulative jacket along its entire length except at its distal cutting end, the second electrosurgical cutting element being adapted to cut tissue, creating a tissue sample core, as the apparatus is advanced into a patient'"'"'s body, and the electrosurgical cutting wire being adapted to sever a distal end of said tissue sample core.

8. The tissue sampling apparatus as recited in claim 2, and further comprising a support stem attached to said wire and disposed proximally thereof for supporting and controlling said wire, and a secondary lumen for receiving said support stem.

9. The tissue sampling apparatus as recited in claim 8, wherein the support stem is movable proximally to retract the wire cutting element in a proximal direction, and is movable distally to extend the wire cutting element in a distal direction.

10. The tissue sampling apparatus as recited in claim 9, wherein the support stem is preformed to allow movement of the wire cutting element in a non-linear direction as it is extended distally.

11. The tissue sampling apparatus as recited in claim 8, and further comprising a mechanical actuator for moving said support stem to thereby actuate said wire.

12. The tissue sampling apparatus as recited in claim 1, wherein the electrosurgical cutting element is also movable axially relative to said tubular body.

13. The tissue sampling apparatus as recited in claim 1, wherein the tissue sample core has a diameter substantially equal to an inside diameter of said tubular body.

14. The tissue sampling apparatus as recited in claim 1, and further comprising means for drawing tissue to be sampled into the primary lumen.

15. The tissue sampling apparatus as recited in claim 14, wherein said means for drawing tissue comprises a mechanical grasper having openable jaws which are adapted to extend through the primary lumen of said tubular body.

16. The tissue sampling apparatus as recited in claim 14, wherein said means for drawing tissue comprises a source of vacuum pressure for drawing a vacuum through the primary lumen.

17. The tissue sampling apparatus as recited in claim 16, and further comprising:

a support stem attached to said wire and disposed proximally thereof for supporting and controlling said wire;

a secondary lumen for receiving said support stem; and

an annular space surrounding said support stem within said secondary lumen, said annular space functioning as a vent port, drawing air at ambient pressure distally therethrough to repressurize regions in said primary lumen distal to the tissue sample being drawn proximally through said primary lumen, said repressurization functioning to assist transport of said sample proximally through the primary lumen.

18. The tissue sampling apparatus as recited in claim 16, wherein said body lumen is adapted to accommodate a plurality of tissue samples, said apparatus further comprising a movable stop plunger disposed at the proximal end of the tubular body lumen, said movable stop plunger preventing the tissue samples from being drawn proximally to the vacuum pressure source, and being movable in a proximal direction as additional tissue samples are captured in order to expand the lumen space available to accommodate the tissue samples.

19. The tissue sampling apparatus as recited in claim 16, wherein said apparatus further comprises a housing portion, the housing portion comprising a first switch for simultaneously activating the source of vacuum pressure and an electrocautery generator for providing electrical current to said electrosurgical cutting element, a second switch for activating only the source of vacuum pressure, and a third switch for activating only the electrocautery generator.

20. The tissue sampling apparatus as recited in claim 16, and further comprising a tissue reservoir disposed proximally of said tubular body.

21. The tissue sampling apparatus as recited in claim 20, wherein said tissue reservoir is disposed in a vacuum pressure line between the tubular body and the source of vacuum pressure.

22. The tissue sampling apparatus as recited in claim 16, and further comprising a vacuum override switch for selectively cutting off the source of vacuum pressure.

23. The tissue sampling apparatus as recited in claim 1, wherein the tubular body is comprised of a non-electrically conductive material.

24. The tissue sampling apparatus as recited in claim 1, wherein said tubular body lumen is adapted to accommodate a plurality of tissue samples.

25. The tissue sampling apparatus as recited in claim 1, wherein said apparatus is adapted to enter solid tissue, thereby creating a blind hole as it is advanced into said tissue.

26. The tissue sampling apparatus as recited in claim 1, wherein the tubular body is flexible and steerable in order to obtain tissue samples from any desired location on the wall of a tissue cavity, and the apparatus is adapted for delivery to a desired tissue location percutaneously.

27. The tissue sampling apparatus as recited in claim 26, and further comprising a percutaneous biopsy instrument having a hollow outer piercing needle which is adapted for entry into a patient'"'"'s body, the hollow outer piercing needle including a lumen extending along its length, wherein the flexible tubular body is adapted for insertion into the patient'"'"'s body through said hollow outer piercing needle lumen.

28. The tissue sampling apparatus as recited in claim 1, and further comprising a coating on the interior surface of the tubular body to facilitate transport of tissue samples therethrough.

29. The tissue sampling apparatus as recited in claim 1, and further comprising depth marks on said tubular body to facilitate positioning of the apparatus in a patient'"'"'s body.

30. The tissue sampling apparatus as recited in claim 1, wherein said tubular body is adapted to accommodate insertion of a sensing probe through the primary lumen thereof.

31. The tissue sampling apparatus as recited in claim 30, wherein said sensing probe comprises a radiation detecting probe.

32. The tissue sampling apparatus as recited in claim 30, wherein said sensing probe comprises an ultrasound probe.

33. The tissue sampling apparatus as recited in claim 30, wherein said sensing probe comprises a multivision probe.

34. The tissue sampling apparatus as recited in claim 30, wherein said apparatus is adapted to accommodate a scissors through the primary lumen after the sensing probe has been removed therefrom, said scissors functioning to dissect distally to a position just proximal to a lesion of interest.

35. A tissue sampling apparatus, comprising:

a tubular body having a primary lumen for receiving a tissue sample, the tubular body having a distal end, a proximal end, and a longitudinal axis;

an electrosurgical wire disposed at the distal end of the tubular body, said wire comprising a single wire loop which is actuatable from a rest position to a severing position, the wire loop forming a semicircular cutting element disposed along a circumferential portion of the distal end of the tubular body in the rest position, and the wire being movable across a cross-sectional area of the distal end of the tubular body while being electrically energized, from the rest position to the severing position, wherein said wire lies along a circumferential portion of the distal end of the tubular body which is opposed to the circumferential portion along which the wire is disposed in the rest position, the wire having a pair of ends which are each fixedly attached to opposing sides of the tubular body distal end, the transverse movement of the wire across said cross-sectional area of the distal end of the tube from the rest position to the severing position functioning to sever a distal end of the tissue sample.

36. A tissue sampling apparatus, comprising:

a tubular body having a primary lumen for receiving a tissue sample, the tubular body having a wall, distal end, a proximal end, and a longitudinal axis;

a slit extending part of the way through the thickness of the tube wall, the slit creating a flexible band of material between the slit and the distal end of the tubular body, the flexible band of material being predisposed to rest in a partially collapsed position across the cross-sectional area of the tubular body;

an inner coaxial tube insertable into the lumen of the tubular body to thereby push the material band into a circumferential configuration substantially coincident with the remainder of the tubular body, the tubular body being electrically conductive to conduct electrical energy from an electrocautery generator to the flexible band of material;

said flexible band of material comprising an electrosurgical element, wherein when the inner coaxial tube is removed from the tubular body lumen, the electrically energized flexible band of material collapses to its rest position across the cross-sectional area of the tubular body, the collapsing motion of the band of material functioning to sever the distal end of a tissue sample.

37. A method of capturing a body tissue sample using a tissue sampling apparatus comprising a tubular body having a lumen extending therethrough, a distal end, at least one electrosurgical cutting element disposed distally of the distal end of the tubular body, an actuator for moving the at least one cutting element, and an electrocautery generator, the method comprising:

activating the electrocautery generator to energize the at least one electrosurgical cutting element;

advancing the tubular body through a solid tissue portion a desired distance so that one of the at least one energized electrosurgical cutting elements cuts a tissue sample core as the tissue sample enters the lumen, the cutting process creating a blind hole in said solid tissue portion; and

actuating one of the at least one electrosurgical cutting elements so that it moves across at least a portion of a cross-sectional area of the tissue sample core at its distal end, thereby severing the distal end to capture the tissue sample core in a substantially intact condition within the tubular body lumen.

38. The method of capturing a body tissue sample as recited in claim 37, wherein the tissue sample core has a diameter substantially equal to an inner diameter of the tubular body.

39. The method of capturing a body tissue sample as recited in claim 37, wherein the at least one electrosurgical cutting element comprises only a single electrosurgical cutting element.

40. The method of capturing a body tissue sample as recited in claim 37, wherein the at least one electrosurgical cutting element comprises first and second electrosurgical cutting elements, the first electrosurgical cutting element cut ting said tissue sample core during the advancing step, and the second electrosurgical cutting element severing a distal end of the tissue sample core during the actuating step.