Implantable valve

• US 20070050014A1
• Filed: 08/31/2006
• Published: 03/01/2007
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Johnson, Chad
• Granted Patent: US 8,470,022 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

Described are implantable prosthetic valve devices comprising isolated granulation tissue. Also described are methods of treatment that include implanting at least one of these valves within a body passageway of a patient, for example, within a vein to treat venous insufficiency.

Claims

1. An implantable valve for modifying fluid flow in a body passageway, said valve comprising isolated granulation tissue.

2. The valve of claim 1, wherein said isolated granulation tissue includes mesothelial cells.

3. The valve of claim 1, wherein said isolated granulation tissue includes myofibroblasts.

4. The valve of claim 1, wherein said isolated granulation tissue is decellularized.

5. The valve of claim 1, wherein said isolated granulation tissue is formed in a body cavity.

6. The valve of claim 5, wherein said body cavity is in a human.

7. The valve of claim 5, wherein said body cavity is in a human patient to receive said implantable valve.

8. The valve of claim 1 which is a monocusp valve.

9. The valve of claim 1 which is a multicuspid valve.

10. The valve of claim 1 which is a bicuspid valve.

11. The valve of claim 1 which is a tricuspid valve.

12. The valve of claim 1 configured for implantation as a vascular valve.

13. The valve of claim 1 configured for implantation as a heart valve.

14. The valve of claim 1 configured for implantation as a venous valve.

15. The valve of claim 1, wherein said valve is frameless.

16. The valve of claim 1 in combination with at least one frame element.

17. The valve of claim 16, wherein said at least one frame element is collapsible.

18. The valve of claim 16, wherein said at least one frame element is bioresorbable.

19. The valve of claim 16, wherein said at least one frame element comprises a metallic material.

20. The valve of claim 1, wherein said valve includes adaptations to attach said valve to walls of said body passageway.

21. A method of forming an implantable valve cusp for modifying fluid flow in a body passageway, comprising:

inserting a cusp-forming device into a body cavity;

removing the cusp-forming device from the body cavity after tissue has formed thereon.

22. The method of claim 21, wherein said cusp-forming device comprises a three-dimensional body.

23. The method of claim 21, wherein at least a portion of said cusp-forming device is non-planar.

24. The method of claim 21, wherein said cusp-forming device comprises a synthetic polymer.

25. The method of claim 21, wherein said cusp-forming device comprises a mesh material.

26. The method of claim 21, wherein said cusp-forming device comprises a metallic material.

27. The method of claim 21, wherein said cusp-forming device comprises at least one frame element.

28. The method of claim 21, wherein said body cavity is that of a vertebrate.

29. The method of claim 21, wherein said body cavity is that of a human.

30. The method of claim 21, wherein said body cavity is that of a bovine, equine, ovine, or porcine.

31. The method of claim 21, wherein said body cavity is a peritoneal cavity.

32. The method of claim 21, wherein the cusp-forming device is removed from and/or inserted into the body cavity laparoscopically.

33. The method of claim 21, wherein said tissue includes granulation tissue.

34. The method of claim 21, wherein said tissue comprises mesothelial cells.

35. The method of claim 21, wherein said tissue comprises myofibroblasts.

36. The method of claim 21, wherein the cusp-forming device is removed from the body cavity at least 15 days after being inserted therein.

37. The method of claim 21, wherein the cusp-forming device is removed from the body cavity no later than 45 days after being inserted therein.

38. The method of claim 21, further comprising manipulating said cusp-forming device and/or said tissue after removing said device and said tissue from said body cavity.

39. The method of claim 38, wherein said manipulating comprises separating at least a portion of said tissue from said cusp-forming device.

40. The method of claim 38, wherein said manipulating comprises associating said cusp-forming device and/or said tissue with at least one frame element.

41. The method of claim 38, wherein said manipulating comprises associating said cusp-forming device and/or said tissue with at least one adaptation for attaching said valve to walls of said body passageway.

42. The method of claim 38, wherein said manipulating comprises decellularizing said tissue.

43. A medical product, comprising:

at least one implantable valve for modifying fluid flow in a body passageway, said at least one valve comprising isolated granulation tissue; and

a sealed package containing said at least one valve.

44. The medical product of claim 43, wherein said at least one implantable valve is configured as a venous valve.

45. The medical product of claim 43, wherein said at least one implantable valve is configured as a heart valve.

46. The medical product of claim 43, wherein said package is configured to maintain said at least one implantable valve in a sterile condition when sterilely packaged therein.

47. A method of treatment comprising implanting at least one valve within a body passageway of a patient, the at least one valve comprising isolated granulation tissue.

48. The method of claim 47, wherein the at least one valve is implanted within a vascular vessel to treat a condition of the vascular system.

49. The method of claim 47, wherein the at least one valve is implanted within a vein to treat venous insufficiency.

50. The method of claim 47, wherein the at least one valve is implanted percutaneously.