Prosthetic valve and method for making same

• US 20040260390A1
• Filed: 06/29/2004
• Published: 12/23/2004
• 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 7,547,322 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• 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 placement within a body passage includes at least two valve leaflets made from a first layer of either peritoneal fascia tissue or pleural tissue. Support structure is attached to the first layer to provide structural support for the valve leaflets. A method for producing the prosthetic valve is also provided.

Claims

1. A prosthetic valve for placement within a body passage, said prosthetic valve comprising:

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

support means attached to said first layer to provide structural support for said at least two valve leaflets.

2. The prosthetic valve of claim 1 wherein said support means 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.

3. The prosthetic valve of claim 2 wherein said support means further comprises an expandable stent having inner and outer surfaces.

4. The prosthetic valve of claim 3 further comprising 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 fascia tissue and pleural tissue.

5. The prosthetic valve of claim 4 wherein said second layer of biological material includes a radially inwardly facing surface that defines a conduit for directing blood flow, said at least two valve leaflets extending across said conduit.

6. The prosthetic valve of claim 4 further comprising a third layer of biological material attached to said outer surface of said stent, said third layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

7. The prosthetic valve of claim 4 wherein said second layer of biological material comprises a serous membrane.

8. The prosthetic valve of claim 7 wherein said first layer of biological material comprises a serous membrane.

9. The prosthetic valve of claim 7 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

10. 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.

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

12. The prosthetic valve of claim 1 wherein said support means comprises an expandable stent.

13. The prosthetic valve of claim 12 further comprising a second layer of biological material attached to said stent, said second layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

14. The prosthetic valve of claim 13 wherein said second layer of biological material comprises a serous membrane.

15. The prosthetic valve of claim 14 wherein said first layer of biological material comprises a serous membrane.

16. The prosthetic valve of claim 14 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

17. The prosthetic valve of claim 13 wherein said second layer extends along the entire length of said stent and forms a tubular conduit inside said stent.

18. 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 the body passage.

19. The prosthetic valve of claim 18 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.

20. The prosthetic valve of claim 1 further comprising an anchoring ring for placement in the body passage, said anchoring ring being connectable with said support means.

21. A prosthetic valve for placement within a body passage to permit unidirectional flow of blood through the body passage, 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 fascia tissue and pleural tissue; and

a second layer of biological material attached to said support member, said second layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue, said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow;

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

22. The prosthetic valve of claim 21 wherein said support means 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.

23. The prosthetic valve of claim 22 wherein said support member has cylindrical inner and outer surfaces, said second layer being attached to said inner surface.

24. The prosthetic valve of claim 23 further comprising a third layer of biological material attached to said outer surface of said support member, said third layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

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

26. The prosthetic valve of claim 25 wherein said first layer of biological material comprises a serous membrane.

27. The prosthetic valve of claim 25 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

28. The prosthetic valve of claim 21 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

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

30. The prosthetic valve of claim 21 wherein said second layer extends along the entire length of said support member.

31. The prosthetic valve of claim 21 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 the body passage.

32. The prosthetic valve of claim 31 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.

33. The prosthetic valve of claim 21 further comprising an anchoring ring for placement in the body passage, said anchoring ring being connectable with said support means.

40. The prosthetic valve of claim 32 wherein said second layer of biological material comprises a serous membrane.

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

42. The prosthetic valve of claim 40 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

34. A prosthetic valve for placement within a body passage, said prosthetic valve comprising:

a single sheet of biological material selected from a group consisting of peritoneal fascia tissue and pleural tissue, said sheet being trimmed to form at least two valve leaflets, each of said at least two valve leaflets having 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 an oppositely disposed pair of commissural sides separated by said free edges that are coaptable to permit unidirectional flow of blood through the body passage; and

support means attached to said sheet to provide structural support for said at least two valve leaflets.

35. The prosthetic valve of claim 34 wherein said support means 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.

36. The prosthetic valve of claim 35 wherein said support means further comprises an expandable stent having inner and outer surfaces.

37. The prosthetic valve of claim 36 further comprising 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 fascia tissue and pleural tissue.

38. The prosthetic valve of claim 37 wherein said second layer of biological material includes a radially inwardly facing surface that defines a conduit for directing blood flow, said at least two valve leaflets extending across said conduit.

39. The prosthetic valve of claim 38 further comprising a third layer of biological material attached to said outer surface of said stent, said third layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

43. The prosthetic valve of claim 34 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

44. The prosthetic valve of claim 34 wherein said first layer of biological material comprises a serous membrane.

45. The prosthetic valve of claim 34 wherein said support means comprises an expandable stent.

46. The prosthetic valve of claim 45 further comprising a second layer of biological material attached to said stent, said second layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

47. The prosthetic valve of claim 46 wherein said second layer of biological material comprises a serous membrane.

48. The prosthetic valve of claim 47 wherein said first layer of biological material comprises a serous membrane.

49. The prosthetic valve of claim 47 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

50. The prosthetic valve of claim 46 wherein said second layer extends along the entire length of said stent and forms a tubular conduit inside said stent.

51. The prosthetic valve of claim 34 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.

52. The prosthetic valve of claim 34 further comprising an anchoring ring for placement in the body passage, said anchoring ring being connectable with said support means.

53. A method for making a prosthetic valve for placement within a body passage, said method comprising the steps of:

harvesting a first layer of biological material selected from a group consisting of peritoneal fascia tissue and pleural tissue;

forming the first layer of biological material into at least two valve leaflets;

providing a support member; and

attaching the first layer of biological material to the support member.

54. The method of claim 53 wherein the support means comprises at least two strut members, said method further comprising the steps of:

forming at least two commissural sides for the prosthetic valve at the junctions of adjoining portions of the at least two valve leaflets; and

positioning one of the at least two strut members at each of the at least two commissural sides.

55. The method of claim 54 wherein the support means further comprises an expandable stent having inner and outer surfaces, said method further comprising the steps of:

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

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

56. The method of claim 55 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.

57. The method of claim 56 further comprising the step of attaching a third layer of biological material to the outer surface of the stent, the third layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

58. The method of claim 55 wherein said step of harvesting the second layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

59. The method of claim 58 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

60. The method of claim 58 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of a serous membrane and an outer lining of fascia.

61. The method of claim 53 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of a serous membrane and an outer lining of fascia.

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

63. The method of claim 53 wherein the support means comprises an expandable stent having inner and outer surfaces, said method further comprising the steps of:

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

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

64. The method of claim 63 wherein said step of harvesting the second layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

65. The method of claim 64 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

66. The method of claim 64 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of a serous membrane and an outer lining of fascia.

67. The method of claim 63 wherein said step of attaching the second layer of biological material to the inner surface of the stent comprises attaching the second layer along the entire length of the stent so that the second layer forms a tubular conduit inside the stent.

68. The method of claim 63 wherein said support means further comprises at least two strut members, said method further comprising the steps of:

forming at least two commissural sides for the prosthetic valve at the junctions of adjoining portions of the at least two valve leaflets; and

positioning one of the at least two strut members at each of the at least two commissural sides.

69. The method of claim 53 wherein said step of forming the first layer of biological material into at least two valve leaflets further comprises the steps of:

trimming the first layer to form a plurality of segments that extend radially outward from the at least two valve leaflets;

rolling each of the segments in a radially inward direction to form a ring of circumferentially spaced buttresses that extend around the periphery of the at least two valve leaflets; and

securing each of the buttresses in their rolled condition to strengthen the ring formed by the buttresses and provide support for the at least two valve leaflets.

70. The method of claim 53 wherein said step of forming the first layer of biological material into at least two valve leaflets further comprises the steps of:

trimming the first layer into an elliptical shape;

cutting the elliptical shape along its minor axis into at least two pieces, wherein the edge of each piece that is cut forms the free edge of each of the at least valve leaflets;

rolling the peripheral edge of each of the at least two pieces in a radially inward direction to form a continuous ring that extends around the periphery of each of the at least two valve leaflets; and

securing the ring in its rolled condition to strengthen the ring and provide support for the at least two valve leaflets.

71. A method for producing a prosthetic valve for placement within a body passage, 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 fascia tissue and pleural 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 through the body passage; and

attaching support means to the sheet of biological material to provide structural support for the at least two valve leaflets.

72. The method of claim 71 wherein the support means 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.

73. The method of claim 72 wherein the support means further comprises an expandable stent having inner and outer surfaces, said method further comprising the steps of:

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

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

74. The method of claim 73 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.

75. The method of claim 74 further comprising the step of attaching a third layer of biological material to the outer surface of the stent, the third layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

76. The method of claim 73 wherein said step of harvesting the second layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

77. The method of claim 76 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

78. The method of claim 76 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of a serous membrane and an outer lining of fascia.

79. The method of claim 71 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of a serous membrane and an outer lining of fascia.

80. The method of claim 71 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

81. The method of claim 77 wherein the support means further comprises an expandable stent having inner and outer surfaces, said method further comprising the steps of:

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

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

82. The method of claim 81 wherein said step of harvesting the second layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

83. The method of claim 82 wherein said step of harvesting the first layer of biological material comprises harvesting a serous membrane of peritoneal fascia or pleural tissue.

84. The method of claim 82 wherein said step of harvesting the first layer of biological material comprises harvesting an inner lining of a serous membrane and an outer lining of fascia.

85. The method of claim 81 wherein said step of attaching the second layer of biological material to the inner surface of the stent comprises attaching the second layer along the entire length of the stent so that the second layer forms a tubular conduit inside the stent.

86. The method of claim 85 wherein said support means further comprises at least two strut members, said method further comprising the steps of:

forming at least two commissural sides for the prosthetic valve at the junctions of adjoining portions of the at least two valve leaflets; and

positioning one of the at least two strut members at each of the at least two commissural sides.

87. The method of claim 71 wherein said step of forming the first layer of biological material into at least two valve leaflets further comprises the steps of:

trimming the first layer to form a plurality of segments that extend radially outward from the at least two valve leaflets;

rolling each of the segments in a radially inward direction to form a ring of circumferentially spaced buttresses that extend around the periphery of the at least two valve leaflets; and

securing each of the buttresses in their rolled condition to strengthen the ring formed by the buttresses and provide support for the at least two valve leaflets.

88. The method of claim 71 wherein said step of forming the first layer of biological material into at least two valve leaflets further comprises the steps of:

trimming the first layer into an elliptical shape;

cutting the elliptical shape along its minor axis into at least two pieces, wherein the edge of each piece that is cut forms the free edge of each of the at least valve leaflets;

rolling the peripheral edge of each of the at least two pieces in a radially inward direction to form a continuous ring that extends around the periphery of each of the at least two valve leaflets; and

securing the ring in its rolled condition to strengthen the ring and provide support for the at least two valve leaflets.