Apparatus for attachment and reinforcement of tissue, apparatus for reinforcement of tissue, methods of attaching and reinforcing tissue, and methods of reinforcing tissue

• US 7,945,332 B2
• Filed: 05/20/2008
• Issued: 05/17/2011
• Est. Priority Date: 05/22/2007
• Status: Active Grant

• Current Assignee: David A. Schechter
• Original Assignee: VitruMed, Inc.
• Inventors: Schechter, David A.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US12/123,808
• Publication Number:
  US 20080294222A1
• Time in Patent Office: 1,092 Days
• Field of Search: 607/1, 607/2, 607/3, 607/50, 606/32, 606/51
• US Class Current: 607/50
• 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 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/1412 Blade
• CPC Class Codes: A61B 2018/1455 having a moving blade for cutting tissue grasped by the jaws
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

There are disclosed methods and apparatus for attachment and reinforcement of tissue, and methods and apparatus for reinforcement of tissue. In an embodiment, the apparatus includes an energy applicator configured to apply energy to generate heat within a target tissue to evaporate water to create dried tissue, and denature at least one of collagen and elastin to attach portions together, and a biopolymer applicator configured for to receive the heat generated to allow biopolymer material to change from solid to molten, and to allow the biopolymer to fill dried tissue to reinforce portions of the target tissue and provide a hermetic seal.

In another embodiment, the method includes applying energy to tissue surfaces with an energy applicator, and applying a biopolymer material into the tissue surfaces with a biopolymer applicator disposed on a housing in connection with the energy applicator. Other embodiments are also disclosed.

Claims

1. Apparatus for attachment and reinforcement of tissue, the apparatus comprising:

an energy applicator positioned adjacent a first tissue contacting surface, the energy applicator configured to apply an amount of energy to generate heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue, and denature at least one of collagen and elastin within the target tissue to attach portions of the target tissue together; and

a biopolymer applicator disposed at a second tissue contacting surface, the biopolymer applicator configured for housing a biopolymer material at a location adjacent to the target tissue to receive the heat generated by the energy applied to the target tissue so as to allow the biopolymer material to change phase from a solid state to a molten state, and to allow the biopolymer to fill the dried tissue so as to reinforce the portions of the target tissue attached to one another and provide a hermetic seal once the biopolymer cools and returns to the solid state.

2. Apparatus in accordance with claim 1, wherein the energy applicator is a radio-frequency applicator.

3. Apparatus in accordance with claim 1, wherein the energy applicator is a ultrasonic applicator.

4. Apparatus in accordance with claim 1, wherein the energy applicator is a laser applicator.

5. Apparatus in accordance with claim 1, wherein the energy applicator is a microwave applicator.

6. Apparatus in accordance with claim 1, wherein the biopolymer applicator includes a porous plate.

7. Apparatus in accordance with claim 1, wherein the porous plate is thermally stable up to a temperature above 200°

C.

8. Apparatus in accordance with claim 1, wherein the porous plate is a high temperature thermoplastic.

9. Apparatus in accordance with claim 8, wherein the high temperature thermoplastic is polytetrafluoroethylene (PTFE).

10. Apparatus in accordance with claim 1, wherein the porous plate is a porous ceramic.

11. Apparatus in accordance with claim 1, wherein the porous plate is a porous metal.

12. Apparatus in accordance with claim 11, wherein the porous plate is an electrode for the energy applicator using radio-frequency energy.

13. Apparatus in accordance with claim 6, wherein the porous plate includes a metal surface, and the porous plate is an electrode for the energy applicator using radio-frequency energy.

14. Apparatus in accordance with claim 6, wherein the biopolymer applicator includes the biopolymer material embedded within the porous plate.

15. Apparatus in accordance with claim 6, wherein the biopolymer applicator includes a reservoir adjacent to the biopolymer material embedded within the porous plate, and the reservoir containing an additional amount of the biopolymer material.

16. Apparatus in accordance with claim 15, wherein the reservoir includes a thermal regulator to control the change phase of the biopolymer material from the solid state to the molten state.

17. Apparatus in accordance with claim 16, wherein the thermal regulator includes a resistive element to directly heat the biopolymer material so as to control the change phase of the biopolymer material from the solid state to the molten state.

18. Apparatus in accordance with claim 16, wherein the thermal regulator includes at least one of a gas heat exchange system and a liquid heat exchange system to thermally regulate the biopolymer material so as to control the change phase of the biopolymer material from the solid state to the molten state.

19. Apparatus in accordance with claim 16, wherein the thermal regulator includes a thermoelectric cooling system to thermally regulate the biopolymer material so as to control the change phase of the biopolymer material from the solid state to the molten state.

20. Apparatus in accordance with claim 16, wherein the thermal regulator includes a direct cooling system to thermally regulate the biopolymer material so as to control the change phase of the biopolymer material from the solid state to the molten state.

21. Apparatus in accordance with claim 20, wherein the direct cooling system includes a saline infusion to thermally regulate the biopolymer material so as to control the change phase of the biopolymer material from the solid state to the molten state.

22. Apparatus in accordance with claim 15, wherein the reservoir includes a tube along a length of an endoscopic shaft in connection to the biopolymer applicator.

23. Apparatus in accordance with claim 15, wherein the reservoir is configured to actively pump the biopolymer material across the porous plate.

24. Apparatus in accordance with claim 15, further comprising biopolymer cartridges providing the biopolymer material, and wherein the reservoir is configured to receive the biopolymer cartridges to provide the biopolymer material to the biopolymer applicator.

25. Apparatus in accordance with claim 14, wherein the porous plate is configured to allow the biopolymer to passively wick into the target tissue.

26. Apparatus in accordance with claim 1, wherein the biopolymer material is electrically non-conductive.

27. Apparatus in accordance with claim 1, wherein the biopolymer material is polycaprolactone (PCL).

28. Apparatus in accordance with claim 1, wherein the biopolymer material is a polycaprolactone (PCL) copolymer.

29. Apparatus in accordance with claim 1, wherein the biopolymer material has a molecular weight less than 3000 MW, a melt temperature between about 37°

C. and 200°

C., and a melt viscosity less than about 1000 cps.

30. Apparatus in accordance with claim 1, wherein the biopolymer material has a glass transition temperature of about 60°

C.

31. Apparatus in accordance with claim 1, wherein the biopolymer material has a bioabsorbable dye in order to provide visible feedback that the biopolymer material has been absorbed into the target tissue.

32. Apparatus in accordance with claim 31, wherein the bioabsorbable dye is methylene blue.

33. Apparatus in accordance with claim 1, wherein the first tissue contact surface and the second tissue contacting surface are adjacent to one another.

34. Apparatus in accordance with claim 1, wherein the first tissue contact surface and the second tissue contacting surface are remotely located from one another.

35. Apparatus in accordance with claim 1, wherein the first tissue contacting surface of the energy applicator is positioned on a set of jaws, and wherein the second tissue contacting surface of the biopolymer applicator is positioned on a set of jaws.

36. Apparatus in accordance with claim 35, wherein the first tissue contact surface and the second tissue contacting surface are adjacent to one another on one jaw of the set of jaws.

37. Apparatus in accordance with claim 35, wherein the first tissue contact surface and the second tissue contacting surface are remotely located from one another on opposed jaws of the set of jaws.

38. Apparatus in accordance with claim 35, wherein the biopolymer applicator includes a third tissue contacting surface, and wherein the second tissue contacting surface includes a first porous plate and the third tissue contacting surface includes a second porous plate.

39. Apparatus in accordance with claim 38, wherein the second tissue contacting surface and the third tissue contacting surface are remotely located from one another on opposed jaws of the set of jaws.

40. Apparatus in accordance with claim 35, further comprising a pressure controller in operable connection with the set of jaws, wherein the pressure controller has a low pressure setting and a high pressure setting, wherein the low pressure setting is configured to allow the jaws to apply a low amount of pressure so as to grasp and approximate tissue without excessive damage to the tissue, and wherein the high pressure setting is configured to allow the jaws to apply a high amount of pressure so as to clamp the tissue for welding with the energy applicator and the biopolymer applicator.

41. Apparatus in accordance with claim 40, wherein the pressure controller at the high pressure setting has an initial set-point during initial activation of the energy applicator, and the pressure controller has an escalating pressure up to a maximum set-point subsequent to initial activation of the energy applicator.

42. Apparatus in accordance with claim 35, further comprising a knife for division of the target tissue.

43. Apparatus in accordance with claim 42, further comprising at least one of the jaws forming a knife channel therein containing the knife, wherein the knife extends from the knife channel.

44. Apparatus in accordance with claim 42, wherein the knife is attached to a deployable electrode portion of a radio-frequency applicator of the energy applicator.

45. Apparatus in accordance with claim 35, wherein the energy applicator is a radio-frequency applicator, and electrodes are configured to cause current to flow in a lateral direction between the jaws.

46. Apparatus in accordance with claim 1, wherein the energy applicator and the biopolymer applicator are configured for lung resection.

47. Apparatus in accordance with claim 1, wherein the energy applicator and the biopolymer applicator are configured as a biopsy device to remove a tissue sample, and the biopolymer applicator is configured to reinforce the tissue sample with biopolymer.

48. Apparatus in accordance with claim 1, wherein the energy applicator and the biopolymer applicator are configured as a urinary incontinence treatment device.

49. Apparatus in accordance with claim 1, wherein the energy applicator and the biopolymer applicator are configured as a somnoplasty device.

50. Apparatus for reinforcement of tissue, the apparatus comprising:

an energy applicator positioned adjacent a first tissue contacting surface, the energy applicator configured to apply an amount of energy to generate heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue; and

a biopolymer applicator disposed at a second tissue contacting surface, the biopolymer applicator configured for housing a biopolymer material at a location adjacent to the target tissue to receive the heat generated by the energy applied to the target tissue so as to allow the biopolymer material to change phase from a solid state to a molten state, and to allow the biopolymer to fill the dried tissue so as to provide a hemostatic barrier once the biopolymer cools and returns to the solid state.

51. A method of attaching and reinforcing tissue, the method comprising:

applying energy adjacent to tissue surfaces with an energy applicator, wherein the application of the energy is configured to generate an amount of heat within the tissue surfaces so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue, and denature at least one of collagen and elastin within the tissue surfaces to attach portions of the tissue surfaces to one another; and

applying a biopolymer material into the tissue surfaces with a biopolymer applicator disposed on a housing in connection with the energy applicator, wherein the application of the biopolymer material includes housing the biopolymer material at a location adjacent to the tissue surfaces to receive the heat generated by the energy applied to the target tissue so as to allow the biopolymer material to change phase from a solid state to a molten state, and to allow the biopolymer to fill the dried tissue so as to reinforce the portions of the target tissue attached to one another and provide a hermetic seal once the biopolymer cools and returns to the solid state.

52. A method of reinforcing tissue, the method comprising:

applying energy adjacent a tissue surface with an energy applicator, wherein the application of the energy is configured to generate an amount of heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue; and

applying a biopolymer material into the target tissue with a biopolymer applicator disposed on a housing in connection with the energy applicator, wherein the application of the biopolymer includes housing the biopolymer material at a location adjacent to the target tissue to receive the heat generated by the energy applied to the target tissue so as to allow the biopolymer material to change phase from a solid state to a molten state, and to allow the biopolymer to fill the dried tissue so as to provide a hemostatic barrier once the biopolymer cools and returns to the solid state.