Undamaged tissue collection assembly and method

• US 20040030263A1
• Filed: 08/28/2002
• Published: 02/12/2004
• Est. Priority Date: 08/29/2001
• Status: Abandoned Application

• Current Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Original Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Inventors: Hird, Barbara A., Smith, Jeffrey A., Scholl, John A., Dubrul, William R., Buehlmann, Eric L.
• Application Number:
  US10/229,900
• Publication Number:
  US 20040030263A1
• Time in Patent Office: Days
• US Class Current: 600/565
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• 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 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/322 Skin grafting apparatus
• CPC Class Codes: A61B 2017/008 Removal of tumors
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: G01N 1/04 in the solid state, e.g. by cutting
• CPC Class Codes: G01N 1/06 providing a thin slice, e.g. microtome

Abstract

A tissue sample collection assembly collects undamaged cells from a tissue specimen comprising a damaged tissue layer at a margin thereof. The assembly includes a tissue-severing device used to separate at least a portion of the damaged tissue layer. The tissue-severing device may have a tissue-adhesive surface so that undamaged cells may contact and adhere to the tissue-adhesive surface for subsequent analysis. The assembly may comprise an apertured device comprising inner and outer surfaces with apertures passing therebetween. The apertures may be sized and shaped so that when the inner surface of the apertured device is pressed against a tissue specimen, portions of an undamaged tissue layer of the tissue specimen pass through the apertures and past the outer surface so that the tissue-severing device can sever the undamaged tissue layer portions from the remainder of the tissue specimen. Exposed undamaged tissue may adhere to a tissue-adhesive surface of the tissue-severing device.

Claims

1. A tissue sample collection assembly, for collecting undamaged cells from a tissue specimen, comprising:

a reference surface placeable against a tissue specimen, the tissue specimen comprising a damaged tissue layer at a margin of the tissue specimen, the damaged tissue layer having a first, expected thickness; and

a tissue-severing device spaced apart from the reference surface by a second distance, said second distance being at most about 40% greater than the first thickness;

whereby said tissue-severing device may be used to separate at least a portion of the damaged tissue layer of the tissue specimen so that undamaged cells may be analyzed.

2. The assembly according to claim 1 wherein said tissue-severing device has a tissue-adhesive surface facing the reference surface so that undamaged cells may contact and adhere to the tissue-adhesive surface.

3. The assembly according to claim 1 wherein said second distance is at most about 20% greater than the first thickness.

4. The assembly according to claim 1 wherein said second distance is at most about 10% greater than the first thickness.

5. The assembly according to claim 1 wherein the tissue-severing device is non-removably mounted to the reference surface.

6. The assembly according to claim 1 wherein the tissue-severing device and the reference surface are fixed relative to one another.

7. The assembly according to claim 1 wherein the tissue-severing device and the reference surface are movable relative to one another.

8. The assembly according to claim 1 further comprising a vacuum source coupleable to the reference surface.

9. The assembly according to claim 8 wherein the tissue-severing device is movable from a first position laterally offset from the reference surface to a second position laterally aligned with the reference surface so to separate said portion of the damaged tissue layer during such movement.

10. The assembly according to claim 1 wherein the tissue-severing device comprises a flat, solid blade.

11. The assembly according to claim 1 wherein the tissue-severing device comprises a translucent or transparent portion, said translucent or transparent portion comprising said tissue-adhesive surface.

12. The assembly according to claim 1 wherein the tissue-adhesive surface comprises a removable, double-adhesive-sided tape.

13. A tissue sample collection assembly, for collecting undamaged cells from a tissue specimen, comprising:

a reference surface placeable against a tissue specimen, the tissue specimen comprising a damaged tissue layer at a margin of the tissue specimen, the damaged tissue layer having a first, expected thickness;

a tissue-severing device spaced apart from the reference surface by a second distance, said second distance being at least as great as the first thickness; and

said tissue-severing device having a tissue-adhesive surface facing the reference surface;

whereby said tissue-severing device may be used to separate at least a portion of the ii damaged tissue layer of the tissue specimen so that undamaged cells may contact and adhere to the tissue-adhesive surface.

14. The assembly according to claim 13 wherein the tissue-severing device is non-removably mounted to the reference surface.

15. The assembly according to claim 13 wherein the tissue-severing device and the reference surface are fixed relative to one another.

16. The assembly according to claim 13 wherein the tissue-severing device and the reference surface are movable relative to one another.

17. The assembly according to claim 13 further comprising a vacuum source coupleable to the reference surface.

18. The assembly according to claim 17 wherein the tissue-severing device is movable from a first position laterally offset from the reference surface to a second position laterally aligned with the reference surface so to separate said portion of the damaged tissue layer during such movement.

19. The assembly according to claim 13 wherein the tissue-severing device comprises a flat, solid blade.

20. The assembly according to claim 13 wherein the tissue-severing device comprises a translucent or transparent portion, said translucent or transparent portion comprising said tissue-adhesive surface.

21. The assembly according to claim 13 wherein the tissue-adhesive surface comprises a removable, double-adhesive-sided tape.

22. A tissue sample collection assembly, for collecting undamaged cells from beneath a damaged tissue layer at a margin of a tissue specimen, the damaged tissue layer having a first thickness, comprising:

an apertured device comprising inner and outer surfaces with apertures passing therebetween;

a tissue-severing device having a tissue-adhesive surface placeable adjacent to the outer surface; and

said apertures sized and shaped so that when the inner surface of the apertured device is pressed against a tissue specimen, portions of an undamaged tissue layer of the tissue specimen pass through the apertures and past the outer surface so that the tissue-severing device can sever the undamaged tissue layer portions from the remainder of the tissue specimen, whereby exposed undamaged tissue may adhere to the tissue-adhesive surface of the tissue-severing device.

23. The assembly according to claim 22 wherein the apertured device comprises a generally tubular braided device.

24. The assembly according to claim 23 wherein the tissue-severing device comprises a curved cutting edge.

25. The assembly according to claim 24 wherein the tissue-severing device is generally tubular.

26. The assembly according to claim 24 wherein the tissue-severing device comprises a resilient, coiled, generally tubular blade.

27. The assembly according to claim 23 wherein the generally tubular braided device contracts radially when placed in tension longitudinally.

28. The assembly according to claim 23 further comprising a tissue-impervious, removable protective layer surrounding the apertured device to help prevent seeding of tissue cells from the tissue specimen when the tissue specimen is removed from a patient along a tissue track of the patient.

29. The assembly according to claim 28 wherein the protective layer comprises a second generally tubular braided device.

30. A method for analyzing undamaged tissue from a margin of a tissue specimen of a type in which the margin comprises a damaged tissue layer overlying undamaged tissue, said damaged tissue layer comprising damaged tissue, said damaged tissue having been damaged during a tissue specimen removal procedure, the method comprising:

determining an expected thickness of damaged tissue;

selecting a chosen thickness of damaged tissue to be removed, said chosen thickness being greater than said expected thickness;

removing at least a portion of the damaged tissue layer to expose a region of the undamaged tissue, said portion of the damaged tissue layer having an inner surface;

analyzing tissue from at least a chosen one of the undamaged tissue region and said inner surface of said portion of the damaged tissue region; and

the selecting step comprising minimizing said chosen thickness to help ensure that the tissue analyzed is close to the margin of the tissue specimen to help with the determination of whether there is tissue of interest at the margin.

31. The method according to claim 30 wherein the removing step comprises incremental removal of layers of damaged tissue to expose said region of undamaged tissue.

32. The method according to claim 30 wherein the removing step comprises:

pressing an apertured device, comprising at least one aperture, and the damaged tissue layer against one another causing damaged tissue to protrude through said aperture; and

separating at least some of the protruding damaged tissue from the remainder of the tissue specimen to expose said region of underlying undamaged tissue.

33. The method according to claim 32 wherein the pressing step is carried out using an apertured device comprising outer and inner surfaces, the separating step comprising pressing the outer surface against the tissue specimen and passing a blade over the inner surface.

34. The method according to claim 33 wherein the blade passing step comprises rotating the blade over the inner surface.

35. The method according to claim 32 wherein the pressing step is carried out using an apertured device comprising a stiff member having a plurality of said apertures.

36. The method according to claim 32 wherein the pressing step is carried out using an apertured device comprising a mesh.

37. The method according to claim 32 wherein the pressing step is carried out using an apertured device comprising a generally tubular braided device.

38. The method according to claim 37 and wherein the pressing step comprises placing the tissue specimen within the generally tubular braided device and applying tension on the generally tubular braided device thereby contracting the generally tubular braided device onto the tissue specimen.

39. The method according to claim 38 wherein the separating step comprises passing a curved blade edge over the braided device.

40. The method according to claim 39 wherein the passing step is carried out using an at least substantially continuous loop, curved blade edge.

41. The method according to claim 39 further comprising adjusting a transverse dimension of the curved blade edge.

42. The method according to claim 41 wherein the transverse dimension adjusting step is carried out using a resilient coiled blade.

43. The method according to claim 32 wherein the pressing step is carried out using an apertured device comprising first and second, generally tubular, braided devices, the first braided device comprising a plurality of said apertures, said second braided device having a tissue-impervious surface to prevent tissue from passing therethrough, said first braided device at least partially housed within the second braided device.

44. The method according to claim 43 wherein the pressing step comprises placing the tissue specimen within the first braided device.

45. The method according to claim 44 wherein the pressing step comprises applying tension on the first braided device thereby contracting the first braided device onto the tissue specimen.

46. The method according to claim 45 further comprising withdrawing the first braided device, and the tissue specimen therein, from within the second braided device.

47. The method according to claim 46 wherein the withdrawing step takes place after the applying tension step.

48. The method according to claim 30 wherein the removing step comprises abrading the damaged tissue layer.

49. The method according to claim 30 wherein the removing step comprises passing a tissue-separating tool over the damaged tissue layer.

50. The method according to claim 49 further comprising selecting a tissue-separating tool according to the expected thickness of the damaged tissue layer.

51. The method according to claim 49 wherein the passing step is carried out using a tissue-separating tool having a plurality of individual tissue-severing edges.

52. The method according to claim 49 wherein the passing step is carried out using a tissue-separating tool having one tissue-severing edge.

53. The method according to claim 49 wherein the passing step is carried out using a vacuum-assisted tissue-separating tool comprising a vacuum surface and a tissue-severing element associated with the vacuum surface.

54. The method according to claim 53 wherein the passing step is carried out using a tissue-separating the tool having a tissue-contacting surface and having said vacuum surface set back from said tissue-contacting surface.

55. The method according to claim 49 wherein the tissue-separating tool passing step comprises adhering tissue from the undamaged tissue region to a tissue sample region of the tissue-separating tool.

56. The method according to claim 55 wherein the adhering step is carried out using an adhesive surface at the tissue sample region.

57. The method according to claim 55 wherein the adhering step is carried out using a removable adhesive surface device at the tissue sample region.

58. The method according to claim 55 wherein the adhering step is carried out using a removable adhesive tape at the tissue sample region.

59. The method according to claim 55 wherein the tissue analyzing step is carried out on the tissue adhering to the tissue sample region.

60. The method according to claim 30 wherein the analyzing step comprises removing a tissue sample from the undamaged tissue region.

61. The method according to claim 60 further comprising:

placing the tissue sample into a liquid to create a tissue sample cell/liquid mixture;

removing liquid from the tissue sample cell/liquid mixture to leave tissue sample cells; and

analyzing the tissue sample cells.

62. The method according to claim 30 wherein the analyzing step comprises at least one of the following:

optical reflectivity of the tissue, radiographic analysis, histological analysis, pathologic analysis, MRI analysis, electrical analysis, resistive analysis, impedance analysis, refractive analysis, cell analysis, ultrasound analysis, fine needle aspiration analysis.

63. The method according to claim 30 wherein the removing step comprises:

placing the tissue sample within an open-ended container, said container having an inner wall with a chosen cross-sectional shape, with the tissue specimen adjacent to the inner wall; and

passing a cutting device into the container, said cutting device having a cutting edge positionable a chosen distance inwardly of the inner wall.

64. The method according to claim 63 wherein the tissue specimen placing step is carried out using a container having a cylindrical inner wall.

65. The method according to claim 64 wherein a cutting device passing step is carried out using a cutting device having a circular edge.

66. A method for analyzing undamaged tissue from a margin of a tissue specimen of a type in which the margin comprises a damaged tissue layer overlying undamaged tissue, said damaged tissue layer comprising damaged tissue, said damaged tissue having been damaged during a tissue specimen removal procedure, the method comprising:

removing a tissue sample from the margin of the tissue specimen, the tissue sample comprising damaged tissue and undamaged tissue;

selecting an analysis technique that differentiates between damaged tissue and undamaged tissue in a tissue sample; and

analyzing undamaged tissue from the tissue sample.

67. The method according to claim 66 wherein the analyzing step is carried out using at least one of MRI, US, PET, CT, X-ray, photo-spectral analysis and electron microscopic analysis.

68. A method for analyzing undamaged tissue from a margin of a tissue specimen of a type in which the margin comprises a damaged tissue layer overlying undamaged tissue, said damaged tissue layer comprising damaged tissue, said damaged tissue having been damaged during a tissue specimen removal procedure, the method comprising:

inserting a tissue sampling device into the damaged tissue layer and through damaged tissue to access undamaged tissue;

capturing an undamaged tissue sample using the tissue sampling device;

removing the undamaged tissue sample from the tissue specimen; and

analyzing the undamaged tissue sample.

69. A method for analyzing undamaged tissue from a margin of a tissue specimen of a type in which the margin comprises a damaged tissue layer overlying undamaged tissue, said damaged tissue layer comprising damaged tissue, said damaged tissue having been damaged during a tissue specimen removal procedure, the method comprising:

inserting a tissue characteristic analysis probe into the damaged tissue layer and through damaged tissue to access undamaged tissue; and

analyzing the undamaged tissue for said tissue characteristic using the tissue characteristic analysis probe.

70. The method according to claim 69 wherein the inserting step is carried out by inserting a plurality of analysis probes at spaced-apart positions.

71. The method according to claim 69 wherein the inserting step is carried out by inserting analysis probes at positions on opposite sides of the tissue specimen.

72. A method for obtaining a tissue analysis sample following removal of a tissue specimen through an access track of a patient, the access track opening into a tissue specimen excision void of the patient, comprising:

selecting a sample retrieval structure, movable between a collapsed state an expanded state, the sample retrieval structure having a tissue-adhesive surface;

inserting the sample retrieval structure in a first collapsed state along an access track and into an excision void of a patient;

expanding the sample retrieval structure to an expanded state;

pressing the tissue-adhesive surface against a wall defining the excision void thereby causing tissue from said wall to adhere to the tissue-adhesive surface;

collapsing the sample retrieval structure to a second collapsed state; and

removing the sample retrieval structure, together with tissue adhering to the tissue-adhesive surface, from the patient, whereby said tissue adhering to the tissue-adhesive surface may be analyzed.

73. The method according to claim 72 further comprising removing a layer of tissue from at least a portion of the wall defining the excision void prior to the inserting step so to remove damaged tissue and expose undamaged tissue.

74. The method according to claim 72 wherein the selecting step comprises selecting an inflatable sample retrieval structure having an external surface.

75. The method according to claim 74 wherein the selecting step is carried out with the tissue-adhesive surface covering at least a portion of the external surface.

76. The method according to claim 74 wherein the expanding step is carried out by inflating the sample retrieval structure.

77. The method according to claim 74 wherein the selecting step comprises selecting a compliant, substantially non-elastic balloon as the inflatable sample retrieval structure.