Excisional devices having selective cutting and atraumatic configurations and methods of using same

• US 20040087872A1
• Filed: 11/06/2002
• Published: 05/06/2004
• Est. Priority Date: 11/06/2002
• 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, Daniel M.
• Granted Patent: US 7,029,451 B2
• Time in Patent Office: Days
• US Class Current: 600/564
• CPC Class Codes: A61B 10/0266 means for severing sample

Abstract

Surgical devices include a selectively cutting and atraumatic distal tip that is configured to assume a first configuration in which cutting surface or surfaces thereof are effective to cut tissue and a second configuration in which the cutting surface or surfaces thereof are ineffective to cut tissue.

Claims

1. A method of retrieving a specimen from a mass of tissue, comprising:

providing a device having a proximal and a distal end and including, near the distal end, a tissue cutter adapted to cut the specimen from the mass of tissue and a specimen collector adapted to collect the cut specimen, the device further including a tip disposed at the distal end thereof, the tip being configured to selectably assume a first configuration that is effective to cut tissue and a second configuration that is ineffective to cut tissue;

causing the tip to assume the first configuration;

inserting the device into the mass of tissue with the tip in the first configuration;

causing the tip to assume the second configuration;

moving the tissue cutter to cut the specimen from the mass of tissue;

moving the tissue collector to collect the cut specimen, and retracting the device from the mass of tissue while the tip remains in the second configuration.

2. The method of claim 1, wherein the method further includes the step of advancing the device within the mass of tissue over a distance substantially equal to a length of the tip after the causing step.

3. The method of claim 1, wherein the tip is biased to assume the second configuration and wherein the inserting step causes the tip to assume the first configuration.

4. The method of claim 1, wherein the tip is spring-mounted and wherein the second causing step is carried out by stopping a forward movement imposed upon the device in the inserting step.

5. The method of claim 1, wherein the tissue collector moving step draws a thin flexible sheath over the cut specimen.

6. The method of claim 1, wherein the tissue collector moving step includes collecting the specimen and isolating the collected specimen from contact with the surrounding tissue.

7. The method of claim 1, wherein the tip includes a cutting surface that extends away from the distal tip of the device in the first configuration and wherein the second causing step includes at least partially retracting the cutting surface within the tip.

8. The method of claim 1, wherein the tip includes a cutting surface that is exposed to the mass of tissue in the first configuration and not exposed to the mass of tissue in the second configuration.

9. The method of claim 1, wherein the tip includes a cutting surface that is uncovered and exposed to the mass of tissue in the first configuration and wherein the second causing step includes covering the cutting surface such that the cutting surface is not exposed to the mass of tissue.

10. The method of claim 1, wherein the tissue cutter and the tissue collector are integrated and wherein the moving steps are carried out simultaneously.

11. The method of claim 1, wherein the first and second causing steps include steps of inflating and deflating a bladder, respectively.

12. The method of claim 1, wherein the first and second causing steps include steps of deflating and inflating a bladder, respectively.

13. A method of retrieving a specimen from a mass of tissue, comprising:

advancing an excisional device through the mass of tissue and creating a dissection path, the device including a radially extendible tissue cut and collect assembly and a selectively atraumatic and cutting distal tip, the tip being in a first configuration that is effective to cut tissue;

causing the tip to assume a second configuration that is ineffective to cut tissue;

operating the cut and collect assembly to cut and collect the specimen from the mass of tissue;

removing the excisional device and the collected specimen from the mass of tissue with the tip in the second configuration.

14. The method of claim 13, further including a step of further advancing the excisional device along the dissection path after the tip assumes the second configuration.

15. The method of claim 14, wherein the further advancing step advances the excisional device along the dissection path a distance that is less than or equal to a length of the tip that is exposed to the mass of tissue when the tip is in the first configuration.

16. A device to cut and collect a specimen from a mass of tissue, comprising:

a shaft defining a proximal and a distal end;

a cut and collect assembly on the shaft near the distal end, the cut and collect assembly being configured to cut the specimen from the mass of tissue and to collect the cut specimen; and

a selectively atraumatic and cutting tip disposed at the distal end of the shaft, the tip including a tissue cutting surface or edge that is configured to selectably assume a first configuration that is effective to cut tissue and a second configuration that is ineffective to cut tissue.

17. The device of claim 16, wherein the cutting surface extends beyond the distal end of the shaft when the tip is in the first configuration and wherein the cutting surface is at least partially retracted within the shaft when the tip is in the second configuration.

18. The device of claim 16, wherein the cutting surface extends beyond the distal end of the shaft when the tip is in the first configuration and wherein the cutting surface is at least partially covered when the tip is in the second configuration.

19. The device of claim 16, the tip is configured to pivot between the first and second configurations.

20. The device of claim 16, wherein the tip includes a resilient member that exerts a biasing force that biases the cutting surface to assume the second configuration.

21. The device of claim 20, wherein the tip is configured such that when the device is advanced into the mass of tissue, a force exerted by the mass of tissue against the tip overcomes the biasing force and causes the tip to assume the first configuration.

22. The device of claim 16, wherein the tip further includes a selectively inflatable bladder that is configured to cause the cutting surface to assume the first configuration when inflated and the second configuration when deflated.

23. The device of claim 16, wherein the tip further includes a selectively inflatable bladder that is configured to cause the cutting surface to assume the first configuration when deflated and the second configuration when inflated.

24. The device of claim 16, wherein the tissue cutting surface is resiliently deformable and is configured to extend away from the shaft in the first configuration and is configured to retract within the shaft in the second configuration.

25. The device of claim 16, wherein the tip includes a guard that is configured to slide on the shaft to selectively expose and cover the tissue cutting surface.

26. The device of claim 16, wherein the tissue cutting surface is a distal extension of the cut and collect assembly.

27. The device of claim 26, wherein the tissue cutting surface is configured to assume the second configuration when the cut and collect assembly is operative to cut and collect tissue.

28. A surgical device for acting upon biological tissue, comprising:

a shaft defining a proximal end and a distal end;

a work assembly adapted to act upon the tissue, the work assembly being disposed near the distal end of the shaft and including a sheath that is configured to at least partially trail the distal end of the shaft as the device is removed from the tissue, and

a distal tip, the distal tip including a cutting surface that is adapted to cut the tissue, the distal tip being configured such that the cutting surface does not damage the sheath as the device is removed from the tissue.

29. The surgical device of claim 28, wherein the cutting surface is adapted to be energized by an RF energy source.

30. The surgical device of claim 28, wherein the cutting surface is effective to dissect the tissue when the device is inserted into the tissue.

31. The surgical device of claim 28, wherein the sheath includes a thin flexible membrane.

32. The surgical device of claim 28, wherein the work assembly includes a tissue cutter and wherein the sheath is configured to collect the tissue cut by the tissue cutter.

33. The surgical device of claim 32, wherein the sheath is attached to the tissue cutter.

34. The surgical device of claim 32, wherein the sheath is configured to isolate the cut tissue from surrounding tissue.

35. The surgical device of claim 28, wherein the cutting surface is formed of a shape memory material.

36. The surgical device of claim 28, wherein the cutting surface is configured to assume a first configuration that is effective to cut tissue when subjected to a first temperature range and to assume a second configuration that is ineffective to cut tissue when subjected to a second temperature range.

37. The surgical device of claim 28, wherein the distal tip includes a selectively inflatable bladder that is configured to selectively cover and uncover the cutting surface.

38. The surgical device of claim 28, wherein the distal tip includes a selectively inflatable bladder that is configured to expose the cutting surface to surrounding tissue when inflated and to move the cutting surface away from the surrounding tissue when deflated.

39. The surgical device of claim 28, wherein the cutting surface is coupled to the work element such that when the work element is in an inoperative configuration, the cutting surface is effective to cut tissue and when the work element is in an operative position, the cutting surface is ineffective to cut tissue.

40. The surgical device of claim 28, wherein the cutting is configured to pivot between a first configuration in which it is effective to cut tissue and a second configuration in which is ineffective to cut tissue.

41. A surgical device, comprising:

a shaft defining a proximal and a distal end,

an actuator attached near the proximal end of the shaft

a work element configured to act upon tissue, the work element being coupled to the actuator and disposed near the distal end of the shaft;

a distal tip fitted to the distal end of the shaft, the distal tip being configured to assume a first configuration in which the distal tip extends a first distance from the distal end of the shaft and is effective to cut tissue and a second configuration in which the distal tip extends a second distance from the distal end of the shaft and is ineffective to cut tissue, the second distance being less than the first distance.

42. The surgical instrument of claim 41, wherein the distal tip is coupled to the actuator.

43. The surgical instrument of claim 41, wherein the distal tip is configured to be operated independently of the work element.

44. The surgical instrument of claim 41, wherein the distal tip includes an inflatable bladder and wherein the bladder is inflated when the distal tip is in the first configuration and at least partially deflated when the distal tip is in the second configuration.

45. The surgical instrument of claim 41, wherein the distal tip includes a resiliently deformable cutting surface that is adapted to cut tissue.

46. The surgical instrument of claim 41, wherein the distal tip is coupled to the work element such that when the work element is in an inoperative configuration, the distal tip is in the first configuration and when the work element is in an operative position, the distal tip is in the second configuration.

47. The surgical instrument of claim 41, the distal tip is configured to assume the first configuration when subjected to a temperature that is above a predetermined threshold temperature and to assume the second configuration when subjected to a temperature that is below the predetermined threshold temperature.

48. The surgical instrument of claim 41, wherein the distal tip is biased to assume the second configuration.

49. The surgical instrument of claim 48, wherein the distal tip is coupled to a resilient member that imposes a biasing force on the distal tip, the biasing force causing the distal tip to assume the second configuration until a mechanical force is imposed upon the distal tip that overcomes the biasing force.