Methods and devices for cutting and collecting soft tissue

• US 20040006338A1
• Filed: 10/16/2002
• Published: 01/08/2004
• Est. Priority Date: 07/03/2002
• Status: Active Grant

• 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
• Granted Patent: US 7,044,956 B2
• Time in Patent Office: Days
• US Class Current: 606/45
• 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 method of cutting breast tissue using RF energy, comprising the steps of:

providing a device having an elongate RF cutting element, the elongate RF cutting element having a cutting side, the elongate cutting element being movable between a bowed position and a straightened position;

introducing the device into a patient'"'"'s breast with the RF cutting element in the straightened position;

activating the RF cutting element;

moving the RF cutting element to the bowed position;

retracting tissue away from the RF cutting element while the RF element is in the bowed position; and

rotating the device to cut a portion of breast tissue with the cutting side of the RF cutting element.

2. The method of claim 1, wherein:

the retracting step is carried out with the device having a thickened portion which trails the cutting side, the thickened portion retracting tissue away from the cutting element.

3. The method of claim 2, wherein:

the retracting step is carried out with the thickened portion being at least two times larger than a cutting element thickness.

4. The method of claim 2, wherein:

the retracting step is carried out with the thickened portion being at least three times larger than a cutting element thickness.

5. The method of claim 2, wherein:

the retracting step is carried out with the thickened portion being spaced from the cutting side by a distance of less than 0.25 inch.

6. The method of claim 2, wherein:

the retracting step is carried out with the device including a tissue collection element which trails the cutting element.

7. The method of claim 2, wherein:

the retracting step is carried out with the thickened portion retracting tissue away from a radially inner surface of the cutting element when the cutting element is in the bowed position.

8. The method of claim 2, wherein:

the retracting step is carried out with the thickened portion retracting tissue away from a radially outer surface of the RF cutting element.

9. The method of claim 7, wherein:

the retracting step is carried out with the thickened portion retracting tissue away from a radially outer surface of the RF cutting element.

10. The method of claim 2, wherein:

the retracting step is carried out with the thickened portion not transmitting energy for cutting the tissue.

11. The method of claim 2, wherein:

the retracting step is carried out with a side of the cutting element opposite the cutting side being electrically insulated so that RF energy is not delivered to the tissue from the side of the cutting element opposite the cutting side.

12. The method of claim 1, wherein:

the retracting step is carried out with a separate element which is independently movable relative to the cutting element.

13. The method of claim 12, wherein:

the retracting step is carried out with the separate element being movable between bowed and retracted positions.

14. The method of claim 12, wherein:

the retracting step is carried out with the separate element including a tissue collection element which collects tissue cut by the cutting element.

15. A device for cutting breast tissue using RF energy, comprising:

a shaft;

an elongate RF cutting element coupled to the shaft, the elongate RF cutting element having a cutting side, the elongate cutting element being movable between a bowed position and a straightened position; and

a tissue retractor which is also movable between a bowed position and straightened position, the tissue retractor having a thickened portion positioned to retract tissue away from the cutting element when the cutting element and tissue retractor are in the bowed positions.

16. The device of claim 15, wherein:

the shaft has a longitudinal axis, wherein rotation of the shaft about the longitudinal axis moves the cutting element through the tissue.

17. The device of claim 15, wherein:

the tissue retractor includes a tissue collection element which collects tissue cut by the cutting element.

18. The device of claim 15, wherein:

the tissue retractor is positioned adjacent a radially inner side of the cutting element when the tissue retractor and cutting element are in the bowed positions.

19. The device of claim 15, wherein:

the tissue retractor includes a membrane, whereby the membrane provides the thickened portion when in a collapsed configuration.

20. The device of claim 15, wherein:

the thickened portion is at least two times larger than a cutting element thickness.

21. The device of claim 15, wherein:

the thickened portion is at least three times larger than a cutting element thickness.

22. The device of claim 15, wherein:

the thickened portion is spaced from the cutting side by a distance of less than 0.25 inch.

23. The device of claim 15, further comprising:

a tissue collection element which trails the cutting element to collect tissue cut by the cutting element.

24. The device of claim 15, wherein:

the thickened portion is formed at least in part by an electrical insulation which covers part of the cutting element.

25. The device of claim 15, wherein:

a side of the RF cutting element opposite the cutting side is insulated so that RF energy is not delivered to the tissue from the side opposite the cutting side.

26. The device of claim 15, wherein:

the thickened portion retracts tissue away from a radially inner surface of the cutting element when the cutting element is in the bowed position.

27. The device of claim 15, wherein:

the thickened portion retracts tissue away from a radially outer surface of the cutting element when the cutting element is in the bowed position.

28. The device of claim 15, wherein:

the thickened portion retracts tissue away from both a radially inner surface and a radially outer surface of the cutting element when the cutting element is in the bowed position.

29. A method of removing breast tissue, comprising the steps of:

providing a tissue cutting device having an elongate cutting element coupled to a shaft, the cutting element being movable between a bowed position and a retracted position, wherein a deployed part of the cutting element lies outside the shaft when in the bowed position, the deployed part of the cutting element having a cutting side which penetrates the tissue as the shaft is rotated;

introducing the tissue cutting device into a breast;

coupling a power source to the elongate cutting element;

moving the elongate cutting element to the bowed position so that the deployed part of the cutting element lies outside the shaft;

preventing energy from being transmitted from a portion of the deployed part of the cutting element for cutting to the tissue while the elongate cutting element is in the bowed position; and

rotating the cutting device so that the cutting side of the bowed cutting element penetrates the breast tissue to cut the breast tissue for removal.

30. The method of claim 29, wherein:

the preventing step is carried out by preventing energy from being transmitted from a radially inner portion of the cutting element to the tissue.

31. The method of claim 29, wherein:

the preventing step is carried out by partially covering the deployed part of the cutting element.

32. The method of claim 31, wherein:

the preventing step is carried out by partially covering the deployed part of the cutting element with insulation which prevents transmission of energy to the tissue.

33. The method of claim 29, wherein:

the preventing step is carried out by covering the deployed part of the cutting element with an element which is also movable between bowed and retracted positions.

34. The method of claim 33, wherein:

the preventing step is carried out with the element positioned adjacent a radially inner side of the cutting element.

35. The method of claim 33, wherein:

the preventing step is carried out with a tissue collection element preventing contact between the tissue and the portion of the cutting element; and

the rotating step is carried out to sever tissue which is collected by the tissue collection element.

36. The method of claim 29, wherein:

the preventing step is carried out with the portion of the cutting element not transmitting energy being primarily on a trailing side of the cutting element.

37. A device for removing tissue, comprising:

a shaft;

a cutting element coupled to the shaft, the cutting element being movable between a bowed position and a retracted position, wherein a deployed part of the cutting element lies outside the shaft when in the bowed position, the deployed part of the cutting element having a cutting side which penetrates the tissue as the shaft is rotated, the cutting element having means for preventing energy for cutting tissue from being transmitted from a portion of the deployed part of the bowed cutting element to the tissue.

38. The device of claim 37, wherein:

the preventing means prevents energy from being transmitted from a radially inner portion of the cutting element to the tissue.

39. The device of claim 37, wherein:

the preventing means partially covers the deployed part of the cutting element.

40. The device of claim 37, wherein:

the preventing means includes insulation which partially covers the deployed part of the cutting element.

41. The device of claim 37, wherein:

the preventing means covers the deployed part of the cutting element with an element which is also movable between bowed and retracted positions.

42. The device of claim 37, wherein:

the preventing means includes an element positioned adjacent a radially inner side of the cutting element.

43. The device of claim 37, wherein:

the preventing means includes a tissue collection element which prevents contact between the tissue being cut and the portion of the cutting element, the tissue collection element collecting the tissue being cut by the cutting element.

44. The device of claim 37, wherein:

the preventing step means prevents transmission of energy to the tissue primarily from a trailing side of the cutting element which is opposite the cutting side.

45. A device for removing breast tissue, comprising:

a shaft;

a cutting element mounted to the shaft, the cutting element being movable between a bowed position and a straightened position, the cutting element bowing outward away from the shaft when in the bowed position, the cutting element having an elongate cutting side which cuts tissue when the shaft is rotated, the cutting element having a length which is at least 25 times larger than a width of the cutting element.

46. The device of claim 45, wherein:

the cutting element has an exposed surface area for transmitting energy to the tissue being cut, the exposed surface area including a radially inner part and a radially outer part, the radially outer part being larger than the radially inner part.

47. The device of claim 45, wherein:

only one cutting element is mounted to the shaft.

48. The device of claim 45, wherein:

the cutting element has a rectangular cross-sectional shape.

49. The device of claim 45, further comprising:

a tissue collection element coupled to at least one of the cutting element and the shaft, the tissue, collection element collecting tissue which is severed by the cutting element.

50. The device of claim 45, wherein:

the length of the cutting element is at least 40 times larger than the width of the cutting element.

51. The device of claim 45, wherein:

the length of the cutting element is at least 100 times larger than the width of the cutting element.

52. The device of claim 45, wherein;

the cutting element has an effective width that is less than the width of the cutting element, the effective width being a width which is exposed for contact with the tissue being cut to transmit cutting energy to the tissue.

53. The device of claim 52, wherein:

the length of the cutting element is at least 25 times larger than the effective width.

54. The device of claim 52, wherein:

the length of the cutting element is at least 40 times larger than the effective width.

55. The device of claim 52, wherein:

the length of the cutting element is at least 100 times larger than the effective width.

56. A method of cutting breast tissue for removal, comprising the steps of:

providing a tissue cutting device having an elongate cutting element, the cutting element being movable between a bowed position and a retracted position, the cutting element having a radially outer side and a radially inner side;

introducing the tissue cutting device into a breast;

moving the elongate cutting element to the bowed position;

coupling a power source to the elongate cutting element; and

rotating the cutting element after the moving step so that the cutting element cuts the breast tissue, wherein the radially outer side has a larger surface area for transmitting energy to cut the tissue than the radially inner side.

57. The method of claim 56, wherein:

the rotating step is carried out with the radially outer side having an exposed part for transmitting energy to the tissue which is at least 20% larger than an exposed part of radially inner side for transmitting energy to the tissue.

58. The method of claim 56, wherein:

the rotating step is carried out with the radially outer side having an exposed part for transmitting energy to the tissue which is at least 35% larger than an exposed part of radially inner side for transmitting energy to the tissue.

59. The method of claim 56, wherein:

the rotating step is carried out while partially covering at least part of the radially inner side of the cutting element.

60. The method of claim 56, wherein:

the rotating step is carried out with a cover positioned adjacent the cutting element, the cover also being movable between bowed and retracted positions.

61. The method of claim 60, wherein:

the preventing step is carried out with the cover positioned adjacent a radially inner side of the cutting element.

62. The method of claim 56, wherein:

the preventing step is carried out with the portion of the cutting element not transmitting energy to the tissue being primarily on a trailing side of the cutting element.

63. The method of claim 56, wherein:

the preventing step is carried out with a tissue collection element preventing contact between the tissue and the portion of the cutting element; and

the rotating step is carried out to sever tissue which is collected by the tissue collection element.

64. The method of claim 56, wherein:

the preventing step is carried out by insulating part of the deployed part of the cutting element to prevent transmission of energy to the tissue.

65. A device for cutting breast tissue for removal, comprising:

a shaft; and

an elongate cutting element mounted to the shaft, the cutting element being movable between a bowed position and a retracted position, the cutting element having a radially outer side and a radially inner side, wherein the radially outer side has a larger surface area for transmitting energy to cut the tissue than the radially inner side.

66. The device of claim 65, wherein:

the radially outer side has an exposed part for transmitting energy to the tissue which is at least 20% larger than an exposed part of radially inner side for transmitting energy to the tissue.

67. The device of claim 65, wherein:

the radially outer side has an exposed part for transmitting energy to the tissue which is at least 35% larger than an exposed part of radially inner side for transmitting energy to the tissue.

68. The device of claim 65, wherein:

the radially inner side of the cutting element is partially covered.

69. The device of claim 65, wherein:

the radially inner side is covered by a cover positioned adjacent the cutting element, the cover also being movable between bowed and retracted positions.

70. The device of claim 65, wherein:

the partially covered portion of the cutting element is on a trailing side of the cutting element.

71. The device of claim 65, further comprising:

a tissue collection element for collecting tissue severed by the cutting element.

72. The device of claim 65, wherein:

the cutting element has a deployed part lying outside the shaft in the bowed position, wherein at least part of the cutting element is covered with insulation.

73. 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.

73-1. 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.

74. 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.

75. A 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.

76. 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.