Expandable ring percutaneous tissue removal device

• US 6,036,698 A
• Filed: 11/02/1998
• Issued: 03/14/2000
• Est. Priority Date: 10/30/1998
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Vivant Medical, Inc. (Johnson Controls International plc)
• Inventors: Hermann, George D., Sutton, Douglas S., Howell, Thomas A., Sirimanne, D. Laksen, Fawzi, Natalie V.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Priddy, Michael B
• Application Number:
  US09/184,766
• Time in Patent Office: 498 Days
• Field of Search: 606/114, 600/562, 600/564, 600/566, 600/567
• US Class Current: 606/114
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive 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 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2017/346 with wings
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

This is a device for percutaneous tissue sampling or excision. In particular, it uses an expandable ring cutter which produces an accurately located, discrete tissue mass that is removable through a comparatively much smaller access member. The tissue mass is easily reconstructed to its original form and orientation once taken from the body for further study.

Claims

1. A tissue removal assembly, comprising:

a cutting member, moveable between a collapsed first position and an expanded second position, the cutting member having a first end, a second end, and at least one cutting surface;

a first access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the first end of the cutting member; and

a second access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the second end of the cutting member;

the second access member axially rotatable about the longitudinal axis so that axial rotation of the second access member will move the cutting member between the collapsed first position and the expanded second position.

2. The tissue removal assembly of claim 1 additionally comprising:

a tubular tissue removal member having a proximal end, a distal end, an interior surface, an exterior surface, a longitudinal axis, an open, distally located tissue entry opening;

a relatively more proximal, tissue exit port, and a tissue removal passageway extending between the proximal and distal ends.

3. The tissue removal assembly of claim 2 where the tissue removal member is configured to accommodate the cutting member and the first and second access members in the axial passageway when the cutting member is in the collapsed first position, and where the cutting member is extendible through the tissue entry opening.

4. The tissue removal assembly of claim 1 where the cutting surface is configured to cut a substantially cylindrical path through discrete tissue mass.

5. The tissue removal assembly of claim 2 where the cutting member is manually manipulatable from the proximal end of the tubular tissue removal member.

6. The tissue removal assembly of claim 1 where the cutting member is at least partially radio-opaque.

7. The tissue removal assembly of claim 1 where the cutting member is a wire cutting member.

8. The tissue removal assembly of claim 7 where the cutting surface is serrated.

9. The tissue removal assembly of claim 1 where the cutting member is a ribbon cutting member having a leading edge, a trailing edge, and a ribbon surface.

10. The tissue removal assembly of claim 9 where the cutting surface of the ribbon cutting member is the leading edge.

11. The tissue removal assembly of claim 10 where the leading edge is serrated.

12. The tissue removal assembly of claim 10 further comprising a second cutting surface on the ribbon surface.

13. The tissue removal assembly of claim 12 where the second cutting surface is serrated.

14. The tissue removal assembly of claim 1 where the cutting member comprises a material selected from the group consisting of titanium, nickel, stainless steel, cobalt, tantalum, tungsten, and alloys thereof.

15. The tissue removal assembly of claim 1 where the cutting member comprises titanium and nickel.

16. The tissue removal assembly of claim 1 where the cutting member is a radio frequency cutter utilizing radio frequency energy to cut discrete tissue mass.

17. The tissue removal assembly of claim 16 further comprising a radio frequency source connected to the cutting member, the radio frequency source being suitable for cutting discrete tissue mass.

18. The tissue removal assembly of claim 1 where the cutting member is a mechanical blade.

19. The tissue removal member of claim 18 further comprising a mechanical energy source connected to the cutting member, the mechanical energy source being suitable for cutting discrete tissue mass.

20. The tissue removal member of claim 18 where the mechanical blade cutting member is mechanically vibrated to cut discrete tissue mass.

21. The tissue removal member of claim 18 where the mechanical blade cutting member is rotated to cut discrete tissue mass.

22. The tissue removal assembly of claim 1 where the cutting member is a radio frequency cutting member having a sharp mechanical cutting surface.

23. The tissue removal assembly of claim 1 where the cutting member is an ultrasound cutter utilizing high frequency audio energy to cut discrete tissue mass.

24. The tissue removal assembly of claim 23 further comprising an ultrasound source connected to the cutting member which is suitable for cutting the discrete tissue mass.

25. The tissue removal assembly of claim 2 further comprising a localization wire sized to fit within the tissue removal passageway and is extendable through the tissue entry opening located in the tubular tissue removal member.

26. The tissue removal assembly of claim 25 where the localization wire is at least partially radiopaque.

27. The tissue removal assembly of claim 25 where the localization wire comprises a material selected from the group consisting of titanium, nickel, stainless steel, cobalt, tantalum, tungsten, and alloys thereof.

28. The tissue removal assembly of claim 25 where the localization wire comprises titanium and nickel.

29. The tissue removal assembly of claim 2 further comprising a sheath removably affixed to the exterior surface of the tubular tissue removal member, the sheath having a distal end, a proximal end, and a longitudinal axis.

30. The tissue removal assembly of claim 29 where the sheath is perforated in a direction parallel to the sheath longitudinal axis.

31. The tissue removal assembly of claim 30 additionally comprising a handle near the proximal end of the sheath to facilitate opening the sheath along the perforation.

32. The tissue removal assembly of claim 2 where the tubular tissue removal member further includes a shaft passageway exterior to the tissue removal passageway and generally parallel to the tubular tissue removal member longitudinal axis;

and

the cutting member, first access member, and second access members are slideable within and rotatable within the shaft passageway to advance the cutting surface.

33. The tissue removal assembly of claim 2 where the tubular tissue removal member further includes a shaft passageway interior to the tissue removal passageway and generally parallel to the tubular tissue removal member longitudinal axis;

and

the cutting member, first access member, and second access members are slideable within and rotatable within the shaft passageway to advance the cutting surface.

34. The tissue removal assembly of claim 2 where the cutting member is attachable to the distal end of the tubular tissue removal member.

35. The tissue removal assembly of claim 34 where the first and second access members are attachable to the tubular tissue removal member.

36. The tissue removal assembly of claim 35 where the tubular tissue removal member defines a longitudinal aperture, the aperture extending from the tubular tissue removal member distal end towards the tissue removal member proximal end;

the aperture defining first and second tubular tissue removal member longitudinal edges.

37. The tissue removal assembly of claim 36 where the first and second access members are attachable to the tubular tissue removal member along at least a portion of the first and second tubular tissue removal member longitudinal edges.

38. The tissue removal assembly of claim 2 where the tubular tissue removal member defines a longitudinal aperture, the aperture extending from the tubular tissue removal member distal end towards the tissue removal member proximal end;

the aperture defining first and second tubular tissue removal member longitudinal edges; and

further comprising;

a cutting member support ring attachable to the distal end of the tubular tissue removal member, the support ring moveable between a collapsed first position and an expanded second position and having a first end, a second end, and a surface adapted for connecting to the cutting member;

a first support rod having a longitudinal axis, a proximal end, and a distal end attachable to both the first end of the support ring and the distal end of the tubular tissue removal member, the first support rod longitudinal axis attachable to the tubular tissue removal member along at least a portion of the first tubular tissue removal member longitudinal edge; and

a second support rod having a longitudinal axis, a proximal end, a distal end attachable to both the first end of the support ring and the distal end of the tubular tissue removal member, the second support rod longitudinal axis attachable to the tubular tissue removal member along at least a portion of the second tubular tissue removal member longitudinal edge, the second support rod axially rotatable about the longitudinal axis so that axial rotation of the second support rod will move the support ring between the collapsed first position and the expanded second position.

39. The tissue removal assembly of claim 2 further comprising a tissue manipulation device locatable within the tissue removal passageway, said tissue manipulation device configured for removing excised discrete tissue mass.

40. The tissue removal assembly of claim 2 further comprising a manipulatable grasping tool locatable within the tissue removal passageway, said grasping tool configured for removing excised discrete tissue mass.

41. The tissue removal assembly of claim 40 where the manipulatable grasping tool comprises a pair of opposing jaws suitable for grasping excised discrete tissue mass.

42. The tissue removal assembly of claim 40 where the manipulatable grasping tool comprises a grasping braid suitable for grasping excised discrete tissue mass.

43. The tissue removal assembly of claim 2 further comprising a manipulatable suction tool locatable within the tissue removal passageway, said suction tool configured for removing excised discrete tissue mass.

44. The tissue removal assembly of claim 2 further comprising a trocar having an exterior surface, a distal section, a proximal section, and a longitudinal axis, the trocar sized to fit within the tissue removal passageway.

45. The trocar of claim 44 where the trocar defines a longitudinal aperture substantially extending along the trocar longitudinal axis.

46. The trocar of claim 44 further comprising at least one longitudinal groove extending along the surface of the trocar, the groove having a distal end and a proximal end.

47. The trocar of claim 46 further comprising at least one indentation located distally of the distal end of the groove.

48. The trocar of claim 44 where the distal section of the trocar comprises a material selected from the group consisting of titanium, nickel, stainless steel, cobalt, tantalum, tungsten, and alloys thereof, and where the proximal section comprises a biologically inert plastic.

49. The trocar of claim 44 where the distal end further comprises at least one retractable cutting surface biased to assume an extended first position and movable to a retracted second position.

50. The tissue removal assembly of claim 2 where the tissue removal member is at least partially radiopaque.

51. The tissue removal assembly of claim 2 where the tissue removal member is expandable.

52. The tissue removal assembly of claim 51 where the tissue removal member is braided.

53. The tissue removal assembly of claim 51 further comprising an extensible tissue separating member attachable to the distal end of the tubular tissue removal member.

54. The tissue removal assembly of claim 53 where the extensible tissue separating member is connected to a radio frequency source.

55. The tissue removal assembly of claim 54 where the extensible tissue separating member is connected to at least one of the first or second access members.

56. The tissue removal assembly of claim 54 where the extensible tissue separating member has a sharp cutting surface.

57. The tissue removal assembly of claim 53 where the extensible tissue separating member is a mechanical blade.

58. The tissue removal assembly of claim 2 additionally comprising a tissue collection chamber having a proximal end and a distal end for collecting excised discrete tissue mass.

59. The tissue removal assembly of claim 58 where the tissue collection chamber contains an external label for indicating information.

60. The tissue removal assembly of claim 58 where the tissue collection chamber contains markings on at least one of the distal or proximal ends for indicating the orientation of the excised discrete tissue mass.

61. The tissue removal assembly of claim 58 where at least one of the distal or proximal ends of the tissue collection chamber additionally defines a port;

the port and tissue collection chamber each configured to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument.

62. The tissue removal assembly of claim 61 further comprising a tissue retrieval chamber assembly attachable to the tubular tissue removal member proximal end;

the tissue collection chamber assembly having at least one port to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument;

the tissue collection chamber assembly adapted to at least partially contain the tissue collection chamber.

63. The tissue removal assembly of claim 62 where the tissue collection chamber and tissue collection chamber assembly each are transparent to x-ray energy.

106. The tissue removal assembly of claim 51 where the tissue removal member is coated with a coating material.

107. The tissue removal assembly of claim 1 further comprising an extensible tissue separating member attachable to the distal end of the first access member and the distal end of the second access member.

108. The tissue removal assembly of claim 53 where the extensible tissue separating member is serrated.

64. A radio frequency-assisted tissue removal assembly, comprising:

a cutting member, moveable between a collapsed first position and an expanded second position, the cutting member having a first end, a second end, and at least one cutting surface;

a first access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the first end of the cutting member;

a second access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the second end of the cutting member;

the second access member axially rotatable about the longitudinal axis so that axial rotation of the second access member will move the cutting member between the collapsed first position and the expanded second position;

an expandable tubular tissue removal member having a proximal end, a distal end, an interior surface, an exterior surface, a longitudinal axis, an open, distally located tissue entry opening;

a relatively more proximal, tissue exit port, and a tissue removal passageway extending between the proximal and distal ends; and

a radio frequency energy source attachable to the cutting member.

65. The radio frequency-assisted tissue removal assembly of claim 64 further comprising a localization wire moveable through the tissue removal passageway.

66. The radio frequency-assisted tissue removal assembly of claim 64 further comprising a tissue collection chamber having a proximal end and a distal end;

and

where at least one of the distal or proximal ends of the tissue collection chamber additionally defines a port;

the port and tissue collection chamber each configured to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument.

67. The radio frequency-assisted tissue removal assembly of claim 66 further comprising a tissue collection chamber assembly attachable to the tubular tissue removal member proximal end;

the tissue collection chamber assembly having at least one port to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument;

the tissue collection chamber assembly adapted to at least partially contain the tissue collection chamber.

68. The radio frequency-assisted tissue removal assembly of claim 64 further comprising a trocar moveable through the tissue removal passageway.

69. The radio frequency-assisted tissue removal assembly of claim 64 further comprising a tissue retrieval member moveable through the tissue removal passageway.

70. A tissue removal assembly, comprising:

a cutting member, moveable between a collapsed first position and an expanded second position, the cutting member having a first end, a second end, and at least one cutting surface, the cutting surface capable of mechanically cutting discrete tissue mass;

a first access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the first end of the cutting member;

a second access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the second end of the cutting member;

the second access member axially rotatable about the longitudinal axis so that axial rotation of the second access member will move the cutting member between the collapsed first position and the expanded second position; and

an expandable tubular tissue removal member having a proximal end, a distal end, an interior surface, an exterior surface, a longitudinal axis, an open, distally located tissue entry opening;

a relatively more proximal, tissue exit port, and a tissue removal passageway extending between the proximal and distal ends.

71. The tissue removal assembly of claim 70 further comprising a localization wire moveable through the tissue removal passageway.

72. The tissue removal assembly of claim 70 further comprising a tissue collection chamber having a proximal end and a distal end;

and

where at least one of the distal or proximal ends of the tissue collection chamber additionally defines a port;

the port and tissue collection chamber each configured to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument.

73. The tissue removal assembly of claim 72 further comprising a tissue retrieval chamber assembly attachable to the tubular tissue removal member proximal end;

the tissue collection chamber assembly having at least one port to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument;

the tissue collection chamber assembly adapted to at least partially contain the tissue collection chamber.

74. The tissue removal assembly of claim 70 further comprising a trocar moveable through the tissue removal passageway.

75. The tissue removal assembly of claim 70 further comprising a tissue retrieval member moveable through the tissue removal passageway.

76. A tissue removal assembly, comprising:

a cutting member, moveable between a collapsed first position and an expanded second position, the cutting member having a first end, a second end, and at least one cutting surface;

a first access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the first end of the cutting member;

a second access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the second end of the cutting member;

the second access member axially rotatable about the longitudinal axis so that axial rotation of the second access member will move the cutting member between the collapsed first position and the expanded second position;

an expandable tubular tissue removal member having a proximal end, a distal end, an interior surface, an exterior surface, a longitudinal axis, an open, distally located tissue entry opening;

a relatively more proximal, tissue exit port, and a tissue removal passageway extending between the proximal and distal ends; and

where the cutting member is attachable to the distal end of the expandable tubular tissue removal member.

77. The tissue removal assembly of claim 76 further comprising a localization wire moveable through the tissue removal passageway.

78. The tissue removal assembly of claim 76 further comprising a tissue collection chamber having a proximal end and a distal end;

and

where at least one of the distal or proximal ends of the tissue collection chamber additionally defines a port;

the port and tissue collection chamber each configured to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument.

79. The tissue removal assembly of claim 78 further comprising a tissue collection chamber assembly attachable to the tubular tissue removal member proximal end;

the tissue collection chamber assembly having at least one port to accommodate the cutting member, first access member, second access member, and a tissue retrieval instrument;

the tissue collection chamber assembly adapted to at least partially contain the tissue collection chamber.

80. The tissue removal assembly of claim 76 further comprising a trocar moveable through the tissue removal passageway.

81. The tissue removal assembly of claim 76 further comprising a tissue retrieval member moveable through the tissue removal passageway.

82. A procedure for removing tissue from a selected internal tissue region, comprising the steps of:

a) introducing, to a position adjacent the selected internal tissue region, a tissue removal member, said member comprising;

a cutting member moveable between a collapsed first position and an expanded second position, the cutting member having a first end, a second end, and at least one cutting surface;

a first access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the first end of the cutting member; and

a second access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the second end of the cutting member;

the second access member axially rotatable about the longitudinal axis so that axial rotation of the second access member will move the cutting member between the collapsed first position and the expanded second position,

b) moving and advancing the cutting member to cut a discrete tissue mass in the selected internal tissue region having a diameter generally greater than the tissue removal member, and

c) removing the discrete tissue mass through the tissue removal member.

83. The procedure of claim 82 where the cutting member is a radio frequency cutter.

84. The procedure of claim 83 where the radio frequency cutter further comprises a mechanical blade.

85. The procedure of claim 82 where the cutting member is a mechanical blade.

86. The procedure of claim 85 further including the step of vibrating the mechanical blade cutting member.

87. The procedure of claim 85 further including the step of rotating the mechanical blade cutting member.

88. The procedure of claim 82 where the cutting member is an ultrasound cutter.

89. The procedure of claim 82 where the tissue removal member is a braided, expandable tubular member.

90. The procedure of claim 82 further including the step of placing the discrete tissue mass in a tissue collection chamber.

91. The procedure of claim 88 further including the step of delivering the tissue collection chamber containing the discrete tissue mass to a laboratory.

92. The procedure of claim 82 further including the step of further cutting the discrete tissue mass into one or more smaller pieces.

94. The procedure of claim 92 where the enclosing sheath is partially removed.

95. The procedure of claim 92 where the enclosing sheath is completely removed.

96. The procedure of claim 92 where the cutting member is a radio frequency cutter.

97. The procedure of claim 95 where the radio frequency cutter further comprises a mechanical blade.

98. The procedure of claim 92 where the cutting member is a mechanical blade.

99. The procedure of claim 97 further including the step of vibrating the mechanical blade cutting member.

100. The procedure of claim 97 further including the step of rotating the mechanical blade cutting member.

93. A procedure for removing tissue from a selected internal tissue region, comprising the steps of:

a) making an incision in a skin region,

b) introducing to a position adjacent a selected internal tissue region, a trocar, a localization wire, a cutting member moveable between a collapsed first position and an expanded second position, the cutting member having a first end, a second end, and at least one cutting surface, a first access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the first end of the cutting member, a second access member having a longitudinal axis, a proximal end and a distal end, the distal end of which is fixed to the second end of the cutting member;

the second access member axially rotatable about the longitudinal axis so that axial rotation of the second access member will move the cutting member between the collapsed first position and the expanded second position,

an expandable tissue removal member having an enclosing sheath removably affixed to the exterior surface of the tissue removal member,

c) inserting the localization wire through the selected internal tissue region,

d) withdrawing the trocar from the position adjacent the selected internal tissue region,

e) removing the enclosing sheath from the tissue removal member,

f) moving and advancing the cutting member to cut a discrete tissue mass in the selected internal tissue region having a diameter generally greater than the expandable tissue removal member, and

g) removing the discrete tissue mass through the tissue removal member.

101. The procedure of claim 93 where the cutting member is an ultrasound cutter.

102. The procedure of claim 93 where the tissue removal member is a braided, expandable tubular member.

103. The procedure of claim 93 further including the step of placing the discrete tissue mass in a tissue collection chamber.

104. The procedure of claim 103 further including the step of delivering the tissue collection chamber containing the discrete tissue mass to a laboratory for analysis.

105. The procedure of claim 93 further including the step of further cutting the discrete tissue mass into one or more smaller pieces.