Medical valve leaflet structures with peripheral region receptive to tissue ingrowth

• US 20060253188A1
• Filed: 03/03/2006
• Published: 11/09/2006
• Est. Priority Date: 03/03/2005
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Case, Brian C.
• Granted Patent: US 8,303,647 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
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

Composite leaflets and prosthetic valves incorporating the same are disclosed. An illustrative composite leaflet includes a flexible inner region, which is formed with a synthetic polymeric material, and a flexible peripheral region, which is formed with a remodelable material effective to promote tissue ingrowth. The peripheral region extends from at least a portion of the flexible inner region and is configured to contact a wall of a tubular body passage and thereby promote tissue ingrowth into the peripheral region from the wall of the tubular body passage.

Claims

1. A medical valve prosthesis for implantation within a bodily passage, the valve prosthesis comprising at least one leaflet including a first region configured to extend into a lumen of the bodily passage and a second region configured for contact with a wall of the bodily passage, said second region having greater capacity for tissue ingrowth than said first region.

2. The medical valve prosthesis of claim 1, also including a frame attached to said at least one leaflet.

3. The medical valve prosthesis of claim 1 having at least two of said leaflets.

4. The medical valve prosthesis of claim 1 wherein said second region comprises a remodelable material.

5. The medical valve prosthesis of claim 4, wherein said second region comprises a remodelable extracellular matrix material.

6. The medical valve prosthesis of claim 5 wherein said remodelable extracellular matrix material comprises submucosa.

7. The medical valve prosthesis of claim 6, wherein said remodelable extracellular matrix material comprises porcine submucosa.

8. The valve prosthesis of claim 7, wherein said porcine submucosa comprises small intestine submucosa, urinary bladder submucosa, or stomach submucosa.

9. A medical valve leaflet for implantation within a tubular body passage, the medical valve leaflet comprising:

a flexible inner region comprising a synthetic polymeric material; and

a flexible peripheral region extending from at least a portion of said flexible inner region, said flexible peripheral region comprising a remodelable material effective to promote tissue ingrowth;

said peripheral region configured to contact a wall of the tubular body passage and thereby promote tissue ingrowth into said peripheral region from the wall of the tubular body passage.

10. The medical valve leaflet of claim 9, wherein said remodelable material comprises a remodelable extracellular matrix material.

11. The medical valve leaflet of claim 9, wherein said inner region is attached to said peripheral region with sutures.

12. The medical valve leaflet of claim 9, wherein said inner region is attached to said peripheral region with an adhesive.

13. The medical valve leaflet of claim 9, which is configured for implantation in a vascular vessel.

14. The medical valve leaflet of claim 13, which is configured for implantation in a venous vessel.

15. The medical valve leaflet of claim 10, wherein said remodelable extracellular matrix material comprises submucosa.

16. The medical valve leaflet of claim 15, wherein said remodelable extracellular matrix material comprises porcine submucosa.

17. A medical valve leaflet, comprising:

a first segment, said first segment having a first segment boundary portion; and

a second segment, said second segment having a second segment boundary portion,

wherein said first segment boundary portion is attached to said second segment boundary portion.

18. The medical valve leaflet of claim 17, wherein said first segment is flexible.

19. The medical valve leaflet of claim 17, wherein said first segment is formed with a synthetic polymeric material.

20. The medical valve leaflet of claim 17, wherein said second segment is flexible.

21. The medical valve leaflet of claim 17, wherein said second segment is configured to contact a wall of a tubular body passage and is receptive to tissue ingrowth into said second segment from the wall of the tubular body passage.

22. The medical valve leaflet of claim 17, wherein said second segment is resorbable.

23. The medical valve leaflet of claim 17, wherein said second segment is collagenous.

24. The medical valve leaflet of claim 17, wherein said second segment comprises an extracellular matrix material.

25. The medical valve leaflet of claim 24, wherein said extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

26. A method of manufacturing a medical valve leaflet, comprising:

providing a first segment of material, said first segment having a first segment boundary portion;

providing a second segment, said first segment having a second segment boundary portion; and

attaching at least a portion of said first segment boundary portion to at least a portion of said second segment boundary portion.

27. The method of claim 26, wherein said first segment is attached to said second segment with sutures.

28. The method of claim 26, wherein said first segment is attached to said second segment with an adhesive.

29. The method of claim 26, wherein said second segment comprises a single layer of material.

30. The method of claim 29, wherein said second segment sandwiches at least a portion of said first segment boundary portion.

31. The method of claim 26, wherein said second segment comprises two layers of material.

32. A valve prosthesis, comprising:

a frame; and

one or more leaflets attached to said frame, said one or more leaflets comprising a first segment having a first segment boundary portion and a second segment having a second segment boundary portion, wherein said first segment boundary portion is attached to said second segment boundary portion.

33. The valve prosthesis of claim 32 having a total of two leaflets.

34. The valve prosthesis of claim 32 having a total of three leaflets.

35. The valve prosthesis of claim 32, wherein said first segment is formed with a flexible polymeric material.

36. The valve prosthesis of claim 32, wherein said second segment is configured to contact a wall of a tubular body passage and is receptive to tissue ingrowth into said second segment from the wall of the tubular body passage.

37. The valve prosthesis of claim 32, wherein said second segment is formed with a flexible remodelable material.

38. The valve prosthesis of claim 32, wherein said second segment is effective to promote tissue ingrowth from the wall of the tubular body passage.

39. The valve prosthesis of claim 32, wherein said one or more leaflets are sutured to said frame.

40. The valve prosthesis of claim 32, wherein said one or more leaflets are vacuum pressed to said frame.

41. The valve prosthesis of claim 32, wherein said second segment boundary portion overlaps a portion of said first segment boundary portion.

42. The valve prosthesis of claim 32, wherein a portion of said second segment is wrapped around said frame.

43. A method of treating a patient, comprising:

providing at least one valve leaflet comprising a first segment and a second segment extending from at least a portion of said first segment,

implanting said valve leaflet in a bodily passageway of the patient.

44. The method of claim 43, wherein said first segment is formed with a synthetic polymer.

45. The method of claim 43, wherein said second segment is configured to contact a wall of a tubular body passage and thereby promote tissue ingrowth into said second segment from the wall of the tubular body passage.

46. The method of claim 43, wherein said second segment comprises an extracellular matrix material.

47. The method of claim 46, wherein said extracellular matrix material comprises submucosa.

48. The method of claim 43, comprising implanting at least two of said leaflets in a bodily passageway of the patient.

49. The method of claim 43, wherein said bodily passageway is a vascular vessel.

50. A medical valve leaflet for implantation within a tubular body passage, the medical valve leaflet comprising:

a flexible inner region comprising a non-remodelable material; and

a flexible peripheral region extending from at least a portion of said flexible inner region, said flexible peripheral region comprising a remodelable material;

said peripheral region configured to contact a wall of the tubular body passage and promote tissue ingrowth into said peripheral region from the wall of the tubular body passage.

51. A prosthetic medical valve device for implantation within a tubular body passage, the medical valve comprising:

a flexible inner region comprising a synthetic polymeric material; and

a flexible peripheral region attached to said flexible inner region, said flexible peripheral region receptive to tissue ingrowth.