Tri-composite, full root, stentless valve

• US 20020116053A1
• Filed: 01/18/2002
• Published: 08/22/2002
• Est. Priority Date: 01/27/1999
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc), Carbomedics Inc. (Snia SpA)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: OʼConnor, Lisa G., McIIroy, Brian K., Simpson, Charles L., Westaby, Stephen, Casagrande, Ivan
• Granted Patent: US 6,797,000 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/91 Heart

Abstract

A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Claims

1. A prosthetic heart valve, comprising three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets.

2. The prosthetic heart valve of claim 1, wherein the valve leaflets are selected from the group comprising xenographs and homographs.

3. The prosthetic heart valve of claim 2, wherein at least one of the valve leaflets is a xenograph comprising a porcine valve leaflet.

4. The prosthetic heart valve of claim 1, wherein at least one of the valve leaflets is aortic.

5. The prosthetic heart valve of claim 1, wherein at least one of the valve leaflets is pulmonary.

6. The prosthetic heart valve of claim 1, wherein at least one of the valve leaflets is a non-coronary, xenograph valve leaflet.

7. The prosthetic heart valve of claim 1, wherein at least one of the valve leaflets has been trimmed to exclude extraneous muscle tissue.

8. The prosthetic heart valve of claim 7, wherein the void resulting from muscle trimming is filled by the adjacent leaflet.

9. The prosthetic heart valve of claim 1, wherein the full root length of tissue for the at least one valve extends 1-3 cm from below an annulus defined by the valve leaflets in the fluid flow passage to 1-3 cm above the sinotubular junction of the aorta.

10. The prosthetic heart valve of claim 1, further comprising a pericardial covering on at least one of the inflow end and the outflow end thereof.

11. The prosthetic heart valve of claim 10, wherein the pericardium covering comprises a mammalian pericardium.

12. The prosthetic heart valve of claim 11, wherein the pericardium covering is sutured to the valve using hidden stitching.

13. The prosthetic heart valve of claim 11, wherein the pericardium covering is sutured to the valve using locking stitching.

14. The prosthetic heart valve of claim 11, wherein the pericardium covering extends 1-15 cm the length of the valve.

15. The prosthetic heart valve of claim 11, wherein the pericardium covering contains a stitch which facilitates surgeon suture placement by indicating where sutures can be placed without damaging the leaflets.

16. The prosthetic heart valve of claim 1, wherein at least one of the valve leaflets is fixed using a technique selected from the group comprising gluteraldehyde fixation and photofixation.

17. The prosthetic heart valve of claim 1, wherein the valve leaflets are affixed using a technique selected from the group comprising adhesion, fusion, and stitching.

18. The prosthetic heart valve of claim 1, wherein the valve leaflets are affixed using a locking stitch.

19. The prosthetic heart valve of claim 17, wherein the valve leaflets are affixed using a suture that will not unravel.

20. The prosthetic heart valve of claim 1, further comprising a trimming guide.

21. The prosthetic heart valve of claim 20, wherein the trimming guide includes a marking indicating the location of at least one of the valve leaflets.

22. The prosthetic heart valve of claim 21, wherein the marking comprises at least one of a suture, a marking, a drawn marking.

23. The prosthetic heart valve of claim 22, wherein the marking is a suture selected from the group comprising a biodegradable suture, a dissolvable suture, a resorbable suture, a hidden suture, and a locking suture.

24. The prosthetic heart valve of claim 1, wherein the hidden and locking stitching sutures two valve leaflets together.

25. The prosthetic heart valve of claim 24, wherein the stitching includes thread of a first color indicating a trimming area and thread of a second color indicating a non-trimming area.

26. The prosthetic heart valve of claim 24, wherein the hidden stitching indicates an area that may not be trimmed.

27. The prosthetic heart valve of claim 24, wherein the hidden stitching includes a suture that will not unravel when cut.

28. The prosthetic heart valve of claim 24, wherein the locking stitching indicates an area that may be trimmed.

29. The prosthetic heart valve of claim 24, wherein the locking stitching includes a suture that will not unravel when cut.

30. The prosthetic heart valve of claim 24, wherein the locking suture is also a hidden stitch.

31. A prosthetic heart valve, comprising a plurality of assembled parts, wherein the assembled parts are sutured together by hidden stitching and locking stitching.

32. The prosthetic heart valve of claim 31, wherein the valve leaflets are selected from the group comprising xenographs and homographs.

33. The prosthetic heart valve of claim 32, wherein at least one of the valve leaflets is a xenograph comprising a porcine valve leaflet.

34. The prosthetic heart valve of claim 31, wherein at least one of the valve leaflets is aortic.

35. The prosthetic heart valve of claim 31, wherein at least one of the valve leaflets is pulmonary.

36. The prosthetic heart valve of claim 31, wherein at least one of the valve leaflets is a non-coronary, xenograph valve leaflet.

37. The prosthetic heart valve of claim 31, wherein at least one of the valve leaflets has been trimmed to exclude extraneous muscle tissue.

38. The prosthetic heart valve of claim 37, wherein the void resulting from muscle trimming is filled by the adjacent leaflet.

39. The prosthetic heart valve of claim 31, wherein the full root length of tissue for at least one valve extends 1-3 cm from below an annulus defined by the valve leaflets in the fluid flow passage to 1-3 cm above the sinotubular junction of the aorta.

40. The prosthetic heart valve of claim 31, further comprising a pericardial covering on at least one of the inflow end and the outflow end thereof.

41. The prosthetic heart valve of claim 40, wherein the pericardium covering comprises a mammalian pericardium.

42. The prosthetic heart valve of claim 41, wherein the pericardium covering is sutured to the valve using hidden stitching.

43. The prosthetic heart valve of claim 41, wherein the pericardium covering is sutured to the valve using locking stitching.

44. The prosthetic heart valve of claim 41, wherein the pericardium covering extends 1-5 cm the length of the valve.

45. The prosthetic heart valve of claim 41, wherein the pericardium covering contains a stitch which facilitates surgeon suture placement by indicating where sutures can be placed without damaging the leaflets.

46. The prosthetic heart valve of claim 31, wherein at least one of the valve leaflets is fixed using a technique selected from the group comprising gluteraldehyde fixation and photofixation.

47. The prosthetic heart valve of claim 31, wherein the valve leaflets are affixed using a technique selected from the group comprising adhesion, fusion, and stitching.

48. The prosthetic heart valve of claim 31, wherein the valve leaflets are affixed using a locking stitch.

49. The prosthetic heart valve of claim 47, wherein the valve leaflets are affixed using a suture that will not unravel.

50. The prosthetic heart valve of claim 31, further comprising a trimming guide.

51. The prosthetic heart valve of claim 50, wherein the trimming guide includes a marking indicating the location of at least one of the valve leaflets.

52. The prosthetic heart valve of claim 51, wherein the marking comprises at least one of a suture, a marking, a drawn marking.

53. The prosthetic heart valve of claim 52, wherein the marking is a suture selected from the group comprising a biodegradable suture, a dissolvable suture, a resorbable suture, a hidden suture, and a locking suture.

54. The prosthetic heart valve of claim 31, wherein the hidden and locking stitching sutures two valve leaflets together.

55. The prosthetic heart valve of claim 54, wherein the stitching includes thread of a first color indicating a trimming area and thread of a second color indicating a non-trimming area.

56. The prosthetic heart valve of claim 54, wherein the hidden stitching indicates an area that may not be trimmed.

57. The prosthetic heart valve of claim 54, wherein the hidden stitching includes a suture that will not unravel when cut.

58. The prosthetic heart valve of claim 54, wherein the locking stitching indicates an area that may be trimmed.

59. The prosthetic heart valve of claim 54, wherein the locking stitching includes a suture that will not unravel when cut.

60. The prosthetic heart valve of claim 54, wherein the locking suture is also a hidden stitch.

61. A tri-composite, full root, stentless heart valve wherein leaflet sections that are attached to form the tri-composite have been treated by photochemical fixation prior to assembly.

62. The valve of claim 61 wherein sutures are used to attach the sections wherein the sutures are sewn such that they do not unravel when cut.

63. The valve of claim 61 including a pericardial sewing ring attached to a posterior end of the valve.

64. The valve of claim 61 wherein the leaflet sections comprise porcine or bovine tissue.

65. The valve of claim 61 wherein the valve is made of porcine tissue.

66. A prosthetic heart valve comprising a tri-composite, full root, stentless valve, which has been made by suturing together three pieces of animal tissue that each includes a heart valve leaflet to form a tubular structure having an external surface, an inner surface, an posterior end, a anterior end, and in which the three leaflets have cusps and edges, with the adjacent edges of the valve leaflets meeting to form commissures, wherein the pieces have been treated by photochemical fixation prior to suturing.

67. The valve of claim 66 wherein sutures are used to attach the sections wherein the sutures are sewn such that they do not unravel when cut.

68. The valve of claim 66 including a pericardial sewing ring attached to a posterior end of the valve.

69. The valve of claim 66 wherein the leaflet sections are made of porcine or bovine tissue.

70. The valve of claim 66 wherein the valve is made of porcine tissue.

71. A process for the manufacture of a prosthetic heart valve, comprising:

providing mammalian sections contain heart valve leaflets;

treating the sections using photofixation;

attaching three sections to define a tubular structure wherein the leaflets match to form commissures at adjacent edges of the leaflets;

attaching a sewing ring at a posterior end of the tubular structure;

thereby forming a full root, tri-composite, stentless heart valve.

72. The process of claim 71 wherein sutures are used to attach the sections wherein the sutures are sewn such that they do not unravel when cut.

73. The process of claim 71 wherein the leaflet sections are made of porcine or bovine tissue.

74. The process of claim 71 wherein the valve is made of porcine tissue.

75. A process for the replacement of a heart valve in a human, comprising:

removing an existing heart valve from the human and implanting a tri-composite, full root, stentless heart valve wherein leaflet sections that are sutured together to form the tri-composite have been treated by photochemical fixation prior to assembly in place of the existing heart valve.

76. The process of claim 75 wherein sutures are used to attach the sections wherein the sutures are sewn such that they do not unravel when cut.

77. The process of claim 75 wherein the leaflet sections are made of porcine or bovine tissue.

78. The process of claim 75 wherein the valve is made of porcine tissue.