Prosthetic cardiac valve and method for making same

• US 20040236411A1
• Filed: 06/29/2004
• Published: 11/25/2004
• Est. Priority Date: 07/19/2001
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Sarac, Timur Paul, Smedira, Nicholas G.
• Granted Patent: US 7,377,938 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

Abstract

A prosthetic valve for replacing a cardiac valve includes an expandable support member and at least two valve leaflets made of a first layer of biological material selected from peritoneal tissue, pleural tissue or pericardial tissue. A second layer of biological material is attached to the support member. The second layer is also made from peritoneal tissue, pleural tissue or pericardial tissue. The second layer includes a radially inwardly facing surface that defines a conduit for directing blood flow. The valve leaflets extend across the conduit to permit unidirectional flow of blood through the conduit. Methods for making and implanting the prosthetic valve are also provided.

Claims

1. A prosthetic valve for replacing a cardiac valve, said prosthetic valve comprising:

an expandable support member;

at least two valve leaflets made of a first layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

a second layer of biological material attached to said support member, said second layer being selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow; and

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit.

2. The prosthetic valve of claim 1 wherein said support member comprises a stent having inner and outer surfaces, said second layer being attached to said inner surface.

3. The prosthetic valve of claim 2 wherein said support means further comprises a strut member located at each of at least two commissural sides formed by the junctions of adjoining portions of said at least two valve leaflets.

4. The prosthetic valve of claim 2 wherein said second layer extends along a portion of the length of said stent to form an enclosed section of said stent that is lined with said second layer and at least one bare section of said stent that is not lined with said second layer.

5. The prosthetic valve of claim 2 wherein said stent has oppositely disposed proximal and distal end sections and a center section disposed between said end sections, said at least two valve leaflets extending within said center section.

6. The prosthetic valve of claim 5 wherein said second layer extends along said center section of said stent.

7. The prosthetic valve of claim 6 wherein said second layer includes at least two radial openings in said center section.

8. The prosthetic valve of claim 6 wherein said second layer further extends along said proximal end section of said stent.

9. The prosthetic valve of claim 6 wherein said proximal and distal end sections of said stent are bare and said center section of said stent is lined with said second layer.

10. The prosthetic valve of claim 5 wherein said second layer extends along said proximal end section of said stent.

11. The prosthetic valve of claim 5 wherein said center section of said stent has a convex shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.

12. The prosthetic valve of claim 11 wherein said distal end section of said stent has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.

13. The prosthetic valve of claim 5 wherein said distal end section of said stent has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.

14. The prosthetic valve of claim 5 wherein at least one of said proximal, distal, and center sections of said stent is balloon-expanded.

15. The prosthetic valve of claim 14 wherein at least one of said proximal, distal, and center sections of said stent is self-expanding.

16. The prosthetic valve of claim 15 wherein said proximal section of said stent is balloon-expanded and said distal and center sections are self-expanding.

17. The prosthetic valve of claim 1 wherein said second layer of biological material comprises a serous membrane.

18. The prosthetic valve of claim 17 wherein said first layer of biological material comprises a serous membrane.

19. The prosthetic valve of claim 17 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

20. The prosthetic valve of claim 1 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

21. The prosthetic valve of claim 1 wherein said first layer of biological material comprises a serous membrane.

22. The prosthetic valve of claim 1 wherein each of said at least two valve leaflets has an oppositely disposed pair of lateral sides spaced apart by a free edge, said lateral sides of each of said at least two valve leaflets adjoining each other and being attached to each other to form at least two commissural sides that are separated by said free edges, said free edges being coaptable to permit unidirectional flow of blood through said conduit.

23. The prosthetic valve of claim 22 wherein said support means comprises at least one strut member positioned at each of said commissural sides formed at the junction of said lateral sides of said at least two valve leaflets.

24. A prosthetic valve for replacing an aortic valve, said prosthetic valve comprising:

an expandable stent having inner and outer surfaces;

at least two valve leaflets made of a first layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

a second layer of biological material attached to said inner surface of said stent, said second layer being selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow; and

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit.

25. The prosthetic valve of claim 24 further comprising a strut member located at each of at least two commissural sides formed by the junctions of adjoining portions of said at least two valve leaflets.

26. The prosthetic valve of claim 24 wherein said second layer extends along a portion of the length of said stent to form an enclosed section of said stent that is lined with said second layer and at least one bare section of said stent that is not lined with said second layer.

27. The prosthetic valve of claim 24 wherein said stent has oppositely disposed proximal and distal end sections and a center section disposed between said end sections, said at least two valve leaflets extending within said center section.

28. The prosthetic valve of claim 27 wherein said second layer extends along said center section of said stent.

29. The prosthetic valve of claim 28 wherein said second layer includes at least two radial openings in said center section.

30. The prosthetic valve of claim 28 wherein said second layer further extends along said proximal end section of said stent.

31. The prosthetic valve of claim 28 wherein said proximal and distal end sections of said stent are bare and said center section of said stent is lined with said second layer.

32. The prosthetic valve of claim 27 wherein said second layer extends along said proximal end section of said stent.

33. The prosthetic valve of claim 27 wherein said center section of said stent has a convex shape in the axial direction for conforming to the shape of the cardiac wall downstream of the aortic valve.

34. The prosthetic valve of claim 33 wherein said distal end section of said stent has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the aortic valve.

35. The prosthetic valve of claim 27 wherein said distal end section of said stent has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the aortic valve.

36. The prosthetic valve of claim 27 wherein at least one of said proximal, distal, and center sections of said stent is balloon-expanded.

37. The prosthetic valve of claim 36 wherein at least one of said proximal, distal, and center sections of said stent is self-expanding.

38. The prosthetic valve of claim 37 wherein said proximal section of said stent is balloon-expanded and said distal and center sections are self-expanding.

39. The prosthetic valve of claim 24 wherein said second layer of biological material comprises a serous membrane.

40. The prosthetic valve of claim 39 wherein said first layer of biological material comprises a serous membrane.

41. The prosthetic valve of claim 39 wherein said first layer of biological material comprises an inner lining of serous membrane and an outer lining of fascia.

42. The prosthetic valve of claim 24 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

43. The prosthetic valve of claim 24 wherein said first layer of biological material comprises a serous membrane.

44. The prosthetic valve of claim 24 wherein each of said at least two valve leaflets has an oppositely disposed pair of lateral sides spaced apart by a free edge, said lateral sides of each of said at least two valve leaflets adjoining each other and being attached to each other to form at least two commissural sides that are separated by said free edges, said free edges being coaptable to permit unidirectional flow of blood through said conduit.

45. The prosthetic valve of claim 44 further comprising at least one strut member positioned at each of said commissural sides formed at the junction of said lateral sides of said at least two valve leaflets.

46. A method for producing a prosthetic valve, said method comprising the steps of:

harvesting a first layer of biological material comprising a single sheet of material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

trimming the sheet of biological material to form at least two valve leaflets, each of the at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by a free edge;

placing the lateral sides of each of the at least two valve leaflets adjacent each other and attaching them to each other to form an oppositely disposed pair of commissural sides separated by the free edges that are coaptable to permit unidirectional flow of blood;

attaching support means to the sheet of biological material to provide structural support for the at least two valve leaflets, the support means comprising an expandable stent;

harvesting a second layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue; and

attaching the second layer of biological material to an inner surface of the stent.

47. The method of claim 46 wherein the support means further comprises at least two strut members, said method further comprising the step of positioning one of the at least two strut members at each of the at least two commissural sides.

48. The method of claim 46 wherein the second layer of biological material includes a radially inwardly facing surface that defines a conduit for directing blood flow, said method further comprising the step of attaching the at least two valve leaflets to the stent and the second layer of biological material so that the at least two valve leaflets extend across the conduit.

49. The method of claim 46 wherein said step of harvesting the second layer of biological material comprises harvesting a serous membrane of peritoneal, pleural or pericardial tissue.

50. The method of claim 49 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal, pleural or pericardial tissue.

51. The method of claim 49 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of serous membrane and an outer lining of fascia.

52. The method of claim 46 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of serous membrane and an outer lining of fascia.

53. The method of claim 46 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal, pleural or pericardial tissue.

54. The method of claim 46 wherein said step of attaching the second layer of biological material to the inner surface of the stent comprises attaching the second layer along a portion of the length of the stent to form a first section of said stent that is lined with the second layer and a second section of the stent that is bare.

55. The method of claim 46 wherein the stent has oppositely disposed proximal and distal end sections and a center section disposed between the end sections, said step of attaching the sheet of biological material to the stent comprises attaching the at least two valve leaflets to the center section of the stent.

56. The method of claim 55 wherein said step of attaching the second layer of biological material to the inner surface of the stent includes the step of attaching the second layer along the inner surface in the center section of the stent.

57. The method of claim 56 further comprising the step of forming at least two radial openings in the second layer in the center section.

58. The method of claim 56 wherein said step of attaching the second layer of biological material to the inner surface of the stent includes the step of attaching the second layer along the inner surface in the proximal end section of the stent.

59. The method of claim 55 wherein said step of attaching the second layer of biological material to the inner surface of the stent includes the step of attaching the second layer along the inner surface in the proximal end section of the stent.

60. A method for replacing a cardiac valve with a prosthetic valve, said method comprising the steps of:

harvesting a first layer of biological material comprising a single sheet of material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

trimming the sheet of biological material to form at least two valve leaflets, each of the at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by a free edge;

placing the lateral sides of each of the at least two valve leaflets adjacent each other and attaching them to each other to form an oppositely disposed pair of commissural sides separated by the free edges that are coaptable to permit unidirectional flow of blood;

attaching support means to the sheet of biological material to provide structural support for the at least two valve leaflets, the support means comprising an expandable stent having oppositely disposed proximal and distal end sections and a center section disposed between the end sections, the at least two valve leaflets being attached to the center section of the stent;

harvesting a second layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;

attaching the second layer of biological material to an inner surface of the stent to complete the process of forming the prosthetic valve;

collapsing the stent of the prosthetic valve to a radially compressed condition;

inserting the prosthetic valve into the heart to the annulus of the cardiac valve in the compressed condition; and

expanding the stent of the prosthetic valve into engagement with the annulus.

61. The method of claim 60 wherein said step of expanding the stent comprises expanding at least one of the proximal, distal, and center sections of the stent with an inflatable balloon.

62. The method of claim 61 wherein said step of expanding the stent further comprises releasing a constraining wire so that at least one of the proximal, distal, and center sections of the stent self-expands.

63. The method of claim 62 wherein the proximal section of the stent is expanded by the balloon and the distal and center sections are self-expanding.

64. The method of claim 60 wherein said step of expanding the stent further comprises releasing a constraining wire so that at least one of the proximal, distal, and center sections of the stent self-expands.

65. The method of claim 60 wherein said step of attaching the second layer of biological material to the inner surface of the stent includes the step of attaching the second layer along the inner surface in the center section of the stent.

66. The method of claim 65 further comprising the step of forming at least two radial openings in the second layer in the center section.

67. The method of claim 65 wherein said step of attaching the second layer of biological material to the inner surface of the stent includes the step of attaching the second layer along the inner surface in the proximal end section of the stent.

68. The method of claim 64 wherein said step of attaching the second layer of biological material to the inner surface of the stent includes the step of attaching the second layer along the inner surface in the proximal end section of the stent.