Methods and devices for cutting and collecting soft tissue

• US 20040006355A1
• Filed: 07/03/2002
• Published: 01/08/2004
• Est. Priority Date: 07/03/2002
• Status: Abandoned Application

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Vetter, James W., Chernomorsky, Ary S., Anderson, Scott C., Clifford, Mark J., Brounstein, Dan
• Application Number:
  US10/189,277
• Publication Number:
  US 20040006355A1
• Time in Patent Office: Days
• US Class Current: 606/167
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/008 Removal of tumors
• CPC Class Codes: A61B 2018/1407 Loop

Abstract

Devices and methods for cutting and collecting a specimen from a mass of tissue. The device may include an integrated cut and collect assembly. The integrated cut and collect assembly includes a cutting portion and a collection portion that includes a flexible membrane. The collection portion of the assembly is attached to the cutting portion thereof. The cutting portion is configured to cut the specimen from the mass of tissue and the collection portion is configured to collect the cut specimen and to encapsulate and isolate the cut specimen within the membrane to enable its safe retraction from the mass of tissue.

Claims

1. A device for cutting and collecting a specimen from a mass of tissue, comprising:

an integrated cut and collect assembly, the integrated cut and collect assembly including a cutting portion and a collection portion that includes a flexible membrane, the collection portion being attached to the cutting portion, the cutting portion being configured to cut the specimen from the mass of tissue and the collection portion being configured to collect the cut specimen and to isolate the cut specimen within the membrane.

2. The device of claim 1, further comprising:

a shaft, and

an actuator, the integrated cut and collect assembly being coupled to the shaft, the assembly being coupled to the actuator such that operation of the actuator causes a deployment of the integrated assembly from a retracted position at least partially within the shaft to a selectable expanded position away from the shaft.

3. The device of claim 2, wherein the integrated cut and collect assembly assumes a bowed shape in the expanded position.

4. The device of claim 1, wherein the thin flexible membrane is configured to at least partially encapsulate the cut specimen.

5. The device of claim 1, wherein the thin flexible membrane is configured to encapsulate at least 40% of the specimen.

6. The device of claim 1, wherein the cutting portion defines a cutting edge and a trailing edge and wherein the collection portion of the integrated cut and collect assembly extends from the trailing edge to the shaft.

7. The device of claim 1, wherein the thin flexible membrane portion includes a polymeric material.

8. The device of claim 7, wherein the polymeric material includes one of an organic, inorganic and organic-inorganic polymer.

9. The device of claim 7, wherein the polymeric material includes a silicone or silicone-containing elastomer.

10. The device of claim 1, wherein the integrated cut and collect assembly includes an RF cutting portion.

11. The device of claim 1, wherein the cutting portion is configured to be energized by an RF energy source.

12. The device of claim 1, wherein the flexible membrane is substantially non-conductive in tissue and includes an RF resistant material.

13. The device of claim 1, wherein the flexible membrane includes a teraphthalate, a tetrafluoroethylene, a polytetrafluoroethylene, a polyimid, a polyester, Kevlar®

and M5®

.

14. The device of claim 1, wherein the flexible membrane has a laminar structure that includes a reinforcing layer.

15. The device of claim 14, wherein the reinforcing layer includes at least one of polyester, polyurethane and polyimid.

16. The device of claim 14, wherein a layer of silicone or silicone-containing elastomer is disposed between the reinforcing layer and a point of contact with the tissue cutting portion.

17. The device of claim 1, wherein the flexible membrane is shaped like a bag.

18. The device of claim 1, wherein the flexible membrane is fluid-tight.

19. The device of claim 2, wherein the actuator is effective to simultaneously operate the cutting and the collection portions of the integrated cut and collect assembly.

20. The device of claim 2, wherein expansion of the cutting portion causes an expansion of the collection portion of the integrated cut and collect assembly.

21. The device of claim 1, wherein the integrated cut and collect assembly is configured as a single loop that expands and retracts upon operation of the actuator.

22. The device of claim 1, wherein the cutting portion includes a braided leading edge.

23. The device of claim 22, wherein the cutting portion defines a braided metallic tube.

24. The device of claim 23, wherein the collection portion is attached to the braided metallic tube.

25. The device of claim 1, wherein the cutting portion includes a metallic braided cutter disposed around a mandrel that supports the collection portion of the integrated cut and collect assembly.

26. The device of claim 1, wherein the collection portion defines a flexible membrane that includes a locally thicker portion around which the cutting portion is crimped.

27. The device of claim 1, wherein the cutting portion includes first and second metallic ribbons disposed so as to sandwich a portion of the flexible membrane therebetween.

28. The device of claim 27, wherein the first metallic ribbon is attached to the second metallic ribbon through at least one of a rivet, a weld and a pin.

29. The device of claim 1, wherein the cutting portion includes a metallic ribbon and wherein the flexible membrane is sewn onto the metallic ribbon.

30. The device of claim 1, wherein the cutting portion includes a flat flexible metallic ribbon that defines a plurality of windows defining a centerline, and wherein the flat metallic ribbon is bent at the centerline around a portion of the collection portion.

31. The device of claim 1, wherein the cutting portion includes a first ribbon and wherein the thin flexible membrane is attached to a second ribbon, both the first and second ribbon being mechanically coupled to one another and to the actuator.

32. The device of claim 31, wherein the second ribbon is coupled to an RF energy source.

33. The device of claim 31, wherein the second ribbon is disposed so as to at least partially overlap the first ribbon.

34. The device of claim 31, further including a mechanical coupling between the first and second ribbons.

35. The device of claim 1, wherein the cutting portion has a generally cylindrical shape that defines an internal lumen in which a first part of the collection portion is secured, a remaining part of the collection portion emerging from a slot defined in the cutting portion and being attached to the shaft.

36. The device of claim 35, further including a flexible mandrel disposed within the internal lumen of the cutting portion, the first part of the flexible membrane being wrapped around the mandrel, a length of the mandrel being larger than a length of the slot.

37. The device of claim 2, further including an inflatable balloon disposed on the shaft.

38. The device of claim 2, wherein the inflatable balloon is configured to be inflated by one of a gas and a fluid.

39. The device of claim 2, wherein the balloon is configured to massage the mass of tissue by pulsating the inflation of the balloon.

40. The device of claim 2, wherein the inflatable balloon is configured as a cooling sleeve.

41. The device of claim 2, wherein the inflatable balloon is configured as a tissue expander.

42. The device of claim 2, wherein the inflatable balloon is configured to stabilize the device when inserted in tissue.

43. The device of claim 2, wherein the inflatable balloon is configured to at least one of seal an incision through which the device is inserted and to provide hemostatis.

44. The device of claim 2, wherein the inflatable balloon is configured to reduce capacitive coupling to reduce tissue heating.

45. The device of claim 1, wherein the integrated cut and collect assembly is single use and disposable.

46. The device of claim 2, wherein the shaft and the integrated cut and collect assembly are single use and disposable.

47. The device of claim 1, wherein the device is single use and disposable.

48. The device of claim 1, wherein the membrane of the collection portion configured so as to enable the collected and isolated specimen to at least partially trail behind the device as the device is retracted from the mass of tissue.

49. The device of claim 1, wherein the cutting portion includes a first ribbon and wherein the collecting portion includes a second ribbon and a tube encircling at least a portion of the second ribbon, the thin flexible membrane being attached to the tube and to an exterior surface of the device, both the first and second ribbon being mechanically coupled to one another and to the actuator.

50. The device of claim 1, wherein the flexible membrane is attached to the collection portion by an adhesive.

51. The device of claim 50, wherein the adhesive includes a cyanoacrylate.

52. The device of claim 2, wherein the shaft defines a trough in which the integrated cut and collect assembly may at least partially retract.

53. The device of claim 52, wherein the trough includes a ledge portion that is configured to accommodate the membrane when the integrated cut and collect assembly is in the retracted position.

54. The device of claim 2, wherein the shaft defines a trough that is configured to separate the integrated cut and collect assembly from the mass of tissue when the integrated assembly is in the retracted position.

55. The device of claim 2, wherein the cutting portion of the integrated cut and collect assembly is configured to be energized by RF energy and wherein the shaft defines a 20 trough that is configured to enable the cutting portion to become fully energized before coming into contact with the tissue to be cut.

56. The device of claim 2, wherein the cutting portion of the integrated cut and collect assembly of the integrated cut and collect assembly is configured to be energized by RF energy and wherein the shaft defines a trough that is configured to reduce thermal damage to the tissue to be cut while the cutting portion is energizing in the trough.

57. The device of claim 2, wherein the shaft defines a trough and wherein the membrane is disposed over the trough and attached to the shaft, the cut and collect assembly being configured so as to stretch the membrane open and closed as the cut and collect assembly is expanded and retracted, respectively.

58. The device of claim 2, wherein the cut and collect assembly includes a single ribbon that is split into a cutting portion and a collecting portion, the membrane being attached to the collecting portion and to the shaft.

59. A method of cutting and isolating a specimen from a mass of tissue, comprising the steps of:

inserting an instrument that includes an integrated cut and collect assembly into the mass of tissue, the integrated cut and collect assembly including a cutting portion and a collection portion that includes, a thin flexible membrane, the collection portion being attached to the cutting portion, the cutting portion being configured to cut the specimen from the mass of tissue and the collection portion being configured to collect the cut specimen from the mass of tissue and to isolate the cut specimen from the mass of tissue within the membrane,

isolating the specimen from surrounding tissue by cutting the specimen from the mass of tissue with the cutting portion and collecting the cut specimen within the flexible membrane of the collecting portion.

60. The method of claim 59, wherein isolating step includes a step of drawing the flexible membrane around the cut specimen.

61. The method of claim 59, wherein the flexible membrane in the inserting and isolating steps includes a polymeric material.

62. The method of claim 59, wherein the flexible membrane includes a silicone or silicone containing elastomer.

63. The method of claim 59, wherein the flexible membrane in the inserting and isolating steps includes at least one of a teraphthalate, a tetrafluoroethylene, a polytetrafluoroethylene, a polyimid, a polyester, Kevlar®

and M5®

.

64. The method of claim 59, wherein the flexible membrane in the inserting and isolating steps is shaped like a bag.

65. The method of claim 59, wherein the flexible membrane in the inserting and isolating steps is fluid tight.

66. The method of claim 59, wherein the isolating step includes a step of energizing the cutting portion using an RF energy source.

67. The method of claim 59, wherein the isolating step includes cutting a margin of healthy tissue around the specimen.

68. The method of claim 59, wherein the isolating step preserves a tissue architecture of the cut and collected specimen.

69. The method of claim 59, wherein the instrument defines a longitudinal axis and wherein the isolating step is carried out while rotating the instrument about the longitudinal axis.

70. The method of claim 59, wherein the isolating step is carried out to physically isolate the specimen from surrounding tissue so that the cut and collected specimen does not contact the surrounding tissue from which the specimen is cut.

71. The method of claim 59, wherein the isolating step is carried out with the collection portion of the integrated cut and collect assembly expanding to a size at least as large as a size of the specimen.

72. The method of claim 59, wherein the instrument defines a longitudinal axis and wherein the inserting step includes positioning the instrument such that the specimen to be cut is adjacent the cutting portion and wherein the isolating step is carried out by rotating the instrument about the longitudinal axis so that the cutting portion cuts the specimen and the isolating step collects and isolates the cut specimen within the flexible membrane.

73. The method claim 59, wherein the instrument further includes a shaft and an actuator, the integrated cut and collect assembly being coupled to the shaft, the assembly being coupled to the actuator such that operation of the actuator causes a deployment of the integrated assembly from a retracted position at least partially within the shaft to a selectable expanded position away from the shaft.

74. The method of claim 73, wherein the isolating step is initiated by acting upon the actuator to cause a simultaneous deployment of both the cutting and collecting portions of the integrated cut and collect assembly.

75. The method of claim 73, wherein the instrument further includes an inflatable balloon disposed on the shaft and wherein the method further includes inflating the balloon.

76. The method of claim 75, wherein the inflating step is carried after the inserting step.

77. The method of claim 75, wherein the inflating step inflates the balloon by one of a gas and a fluid.

78. The method of claim 75, further including the step of massaging the mass of tissue by pulsating the inflation of the balloon.

79. The method of claim 75, further comprising the step of cooling the inflatable balloon by inflating the balloon with cooled gas or fluid.

80. The method of claim 75, further comprising the step of expanding the tissue by inflating the balloon.

81. The method of claim 75, further comprising the step of stabilizing the device by inflating the balloon.

82. The method of claim 75, further comprising at least one of a step of sealing an incision through the instrument is inserted and providing hemostatis by inflating the balloon.

83. The method of claim 75, further comprising the step of reducing tissue heating by reducing capacitive coupling through inflation of the balloon.

84. A device for cutting and collecting a specimen from a mass of tissue, comprising:

a shaft defining a proximal and a distal end;

a work assembly near the distal end of the shaft, the work assembly being configured to cut the specimen from the mass of soft tissue and to isolate the cut specimen from surrounding tissue;

a single actuator near the proximal end of the shaft, the single actuator being mechanically coupled to the work assembly such that rotation of the device and operation of the single actuator is effective to cut, collect and isolate the specimen from the mass of tissue as the device is rotated.

85. The device of claim 84, wherein the device defines a longitudinal axis and wherein the actuator is configured to selectively slide along the longitudinal axis to selectively deploy and retract the work assembly.

86. The device of claim 84, wherein the work assembly is configured to be energized by an RF energy source.

87. The device of claim 85, wherein sliding the actuator toward the distal end deploys the work assembly and wherein sliding the actuator in the proximal position retracts the work assembly.

88. The device of claim 87, wherein the work assembly is configured so that the collected specimen is isolated from the mass of tissue when the actuator is slid in the proximal position and the work element is retracted.

89. Method of collecting a tissue specimen from a mass of tissue, comprising the steps of:

inserting a surgical instrument into the mass of tissue to a target location within the mass of tissue, the instrument including a shaft and a work assembly near a distal end of the shaft, the work assembly being configured to controllably cut the specimen from the mass of soft tissue and to isolate the cut specimen from the mass of tissue within a tissue isolator;

controlling the work assembly of the surgical instrument to cut and isolate the specimen, and

retracting the instrument from the mass of tissue while the specimen is isolated within the tissue isolator and at least partially trails the distal end of the shaft.

90. The method of claim 89, further including a step of making an incision into the mass of tissue prior to the inserting step, the instrument creating an insertion path defined between the incision and the target location and wherein the isolated specimen trails the distal end of the shaft within the insertion path during the retracting step.

91. The method of claim 89, further including a step of making an incision into the mass of tissue prior to the inserting step, the incision making step making an incision that is only as large as needed to enable insertion of the distal end of the shaft into the mass of tissue and wherein the retracting step retracts the isolated specimen from the tissue mass without substantially enlarging the incision.

92. A surgical instrument for retrieving a tissue specimen from a mass of tissue, comprising:

a shaft defining a proximal and a distal end, and

a work assembly coupled to the shaft near the distal end thereof, the work assembly including;

a tissue cutting portion configured to cut the tissue specimen from the mass of tissue;

a tissue collection portion that includes a membrane, the membrane being configured to encapsulate and isolate the cut specimen from the mass of tissue and being adapted to stretch to enable the encapsulated specimen to at least partially trail the distal end of the shaft as the surgical instrument is retracted from the mass of tissue.

93. The instrument of claim 92, wherein the tissue cutting portion is configured to be energized with RF energy and wherein the membrane includes an RF resistant material.

94. The instrument of claim 92, wherein the membrane includes a polymeric material.

95. The instrument of claim 92, wherein the membrane includes at least one of an organic, inorganic and organic-inorganic polymer.

96. The instrument of claim 92, wherein the membrane includes a silicone or silicone-containing elastomer.

97. The instrument of claim 92, wherein the membrane includes at least one of a teraphthalate, a tetrafluoroethylene, a polytetrafluoroethylene, a polyimid, a polyester, Kevlar®

and M5®

.

98. The instrument of claim 92, wherein the tissue collection portion is selectably expandable and retractable in a radial direction relative to the shaft.

99. The instrument of claim 92, wherein the tissue cutting portion is selectably expandable and retractable in a radial direction relative to the shaft.

100. The instrument of claim 92, wherein the membrane has a laminar structure that includes a reinforcing layer.

101. The instrument of claim 100, wherein the reinforcing layer includes at least one of polyester, polyurethane and polyimid.

102. The instrument of claim 100, wherein a layer of silicone or silicone-containing elastomer is disposed between the reinforcing layer and a point of contact with the tissue cutting portion.

103. The instrument of claim 92, wherein the membrane is shaped like a bag.

104. The instrument of claim 92, wherein the membrane is fluid-tight.

105. The instrument of claim 92, wherein the membrane is semi-porous.

106. The instrument of claim 92, wherein the collection portion is mechanically coupled to the cutting portion.

107. The instrument of claim 92, wherein the membrane has includes a woven and coated layer.