Mechanical heart valve

• US 6,395,024 B1
• Filed: 06/01/1999
• Issued: 05/28/2002
• Est. Priority Date: 05/20/1997
• Status: Expired due to Term

• Current Assignee: Tri Flo Medical Inc.
• Original Assignee: Tri Flo Medical Inc.
• Inventors: Lapeyre, Didier, Steinseifer, Ulrich
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/323,402
• Time in Patent Office: 1,092 Days
• Field of Search: 623/2.1,2.2,2.22,2.23,2.25,2.28,2.29,2.33,2.42
• US Class Current: 623/2.22
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

An improved trileaflet mechanical heart valve 100 can include an improved leaflet 110. The valve 100 and leaflet 110 provide improved flow characteristics, minimize blood clotting behind the leaflets, and provide more natural opening and closing times. The valve can include a valve housing 105 which contains pivot/hinge mechanism (130, 200, and 300) for allowing rotation of and retention of the leaflets 110. The valve housing 105 can also include windows or openings 125 which allows for complete washing of the pivot/hinge mechanism (130, 200, and 300) as well as the leaflets 110. The novel leaflets 110 are airfoil-like having a complex S-shaped curvature on their outer surface. This novel geometry, when combined with the location of the leaflet'"'"'s pivot axis, causes a tendency for the leaflets 110 to rotate towards the closed position. Thus, the leaflets 110 begin to close much earlier than a conventional leaflet and are substantially closed before the flow reverses, similar to the function of a natural valve.

Claims

1. A rotatable leaflet for a prosthetic heart valve comprising:

a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces, wherein the inner surface generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface; and

first and second winglet portions situated on opposite ends of the leaflet to facilitate rotation of the leaflet.

2. The rotatable leaflet of claim 1, wherein the inner surface has a convex curvature from the first winglet portion to the second winglet portion.

3. The rotatable leaflet of claim 1, wherein the outer surface has a concave curvature from the first winglet portion to the second winglet portion.

4. The rotatable leaflet of claim 1, 2, or 3, wherein the distance between the inner and outer surfaces is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the leaflet has an airfoil-like cross section.

5. The rotatable leaflet of claim 4, wherein the leaflet is formed from pyrolytic carbon.

6. The rotatable leaflet of claim 1, wherein the leaflet is formed from pyrolytic carbon.

7. The rotatable leaflet of claim 1, wherein each winglet portion is attached to the inner and outer surfaces and the leading and trailing edge surfaces.

8. A rotatable leaflet for an early-closing prosthetic heart valve comprising:

a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces;

first and second winglet portions situated on opposite ends of the leaflet to facilitate rotation of the leaflet; and

closure means for causing the leaflet to rotate toward a closed position prior to substantial backwards flow of blood through the heart valve.

9. The rotatable leaflet of claim 8, wherein the closure means causes the leaflet to begin to rotate toward a closed position about when a maximum flow rate has been achieved through the valve.

10. The rotatable leaflet of claim 8, wherein the closure means comprises a configuration wherein the inner surface has a convex curvature from the leading edge surface to the trailing edge surface and the outer surface has a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface.

11. The rotatable leaflet of claim 10, wherein the closure means further comprises a configuration wherein the distance between the inner and outer surfaces is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the leaflet has an airfoil-like cross section.

12. The rotatable leaflet of claim 10, wherein the inner surface has a convex curvature from the first winglet portion to the second winglet portion.

13. The rotatable leaflet of claim 12, wherein the outer surface has a concave curvature from the first winglet portion to the second winglet portion.

14. The rotatable leaflet of claim 8 or 11, wherein the leaflet is formed from pyrolytic carbon.

15. A mechanical prosthetic heart valve, the valve comprising:

an annular housing having an inner circumferential surface; and

at least one leaflet disposed adjacent to the inner circumferential surface and capable of rotation between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve, the leaflet comprising;

a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces, wherein the inner surface generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface; and

first and second winglet portions situated on opposite ends of the leaflet to facilitate rotation of the leaflet.

16. The mechanical prosthetic heart valve of claim 15, wherein the annular housing comprises a nozzle shape along the inner circumferential surface.

17. The mechanical prosthetic heart valve of claim 15, wherein the inner circumferential surface includes inflow projections to receive the leaflet.

18. The mechanical prosthetic heart valve of claim 15, wherein the inner surface of the at least one leaflet has a convex curvature from the first winglet portion to the second winglet portion.

19. The mechanical prosthetic heart valve of claim 18, wherein the outer surface of the at least one leaflet has a concave curvature from the first winglet portion to the second winglet portion.

20. The mechanical prosthetic heart valve of claim 15, 18 or 19, wherein the distance between the inner and outer surfaces of the at least one leaflet is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the at least one leaflet has an airfoil-like cross section.

21. The mechanical prosthetic heart valve of claim 15, further comprising at least two leaflets.

22. The mechanical prosthetic heart valve of claim 21, further comprising at least three leaflets.

23. The mechanical prosthetic heart valve of claim 15, wherein the valve housing is formed from a metallic material.

24. The mechanical prosthetic heart valve of claim 15, wherein the at least one leaflet is formed from pyrolytic carbon.

25. A mechanical early-closing prosthetic heart valve, the valve comprising:

an annular housing having an inner circumferential surface; and

at least one leaflet disposed adjacent to the inner circumferential surface and capable of rotation between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve, the leaflet comprising closure means for causing the leaflet to rotate toward a closed position prior to substantial back flow of blood through the heart valve.

26. The mechanical early-closing prosthetic heart valve of claim 25, wherein the closure means causes the leaflet to begin to rotate toward a closed position about when a maximum flow rate has been achieved through the valve.

27. The mechanical early-closing prosthetic heart valve of claim 25, wherein the at least one leaflet comprises:

a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces; and

first and second winglet portions situated on opposite ends of the at least one leaflet to facilitate rotation of the leaflet.

28. The mechanical early-closing prosthetic heart valve of claim 27, wherein the closure means comprises a configuration wherein the inner surface generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface.

29. The mechanical early-closing prosthetic heart valve of claim 28, wherein the closure means further comprises a configuration wherein the distance between the inner and outer surfaces of the at least one leaflet is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the leaflet has an airfoil-like cross section.

30. A mechanical prosthetic heart valve comprising:

an annular housing having an inner circumferential surface; and

at least one leaflet disposed adjacent to the inner circumferential surface and capable of rotation between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve, the at least one leaflet comprising a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces, and first and second winglet portions situated on opposite ends of the at least one leaflet to facilitate rotation of the at least one leaflet; and

first and second leaflet pivot structures adapted to cooperate with the first and second winglets, respectively, to facilitate rotation of the at least one leaflet between the open and closed positions, each of the first and second leaflet pivot structures comprising;

an inflow projection extending from the inner circumferential surface of the housing and adapted to contact one of the winglet portions in one of the open and closed positions; and

a closing projection extending from the inner circumferential surface of the housing and adapted to contact one of the winglet portions in the closed position, wherein the closing projection and the inflow projection are configured and spaced from one another to increase flow velocity proximate the one of the winglet portions.

31. The mechanical prosthetic heart valve of claim 30, wherein each inflow projection has a first width proximate the inner surface of the annular housing, and a second width distal from the inner surface of the valve housing less than the first width.

32. The mechanical prosthetic heart valve of claim 30, wherein each closing projection has a first width proximate the inner surface of the annular housing, and a second width distal from the inner surface of the valve housing less than the first width.

33. The mechanical prosthetic heart valve of claim 30, wherein the annular housing defines at least one opening therethrough proximate the inflow and closing projections.

34. The mechanical prosthetic heart valve of claim 33, wherein the distance between the inflow projection and the closing projection decreases in the blood flow direction to direct at least a portion of the blood flow through the at least one opening when the at least one leaflet is in the open position.

35. The mechanical prosthetic heart valve of claim 30, wherein the inner surface of the at least one leaflet generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface of the at least one leaflet generally defines a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface.

36. The mechanical prosthetic heart valve of claim 35, wherein the distance between the inner and outer surfaces is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the at least one leaflet has an airfoil-like cross section.

37. A mechanical prosthetic heart valve comprising:

an annular housing having an inner circumferential surface and defining at least one opening through the circumferential surface; and

at least one leaflet disposed adjacent to the inner circumferential surface and capable of rotation between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve, the at least one leaflet comprising a main portion and first and second winglet portions situated on opposite ends of the leaflet to facilitate rotation of the leaflet, wherein no portion of the at least one leaflet is received within the at least one opening during rotation between the open and the closed position to provide for increased blood flow proximate to one of the winglet portions.

38. The mechanical prosthetic heart valve of claim 37, wherein the annular housing includes first and second leaflet pivot structures adapted to cooperate with the first and second winglet portions, respectively, to facilitate rotation of the at least one leaflet between the open and closed positions, each of the first and second leaflet pivot structures comprising:

an inflow projection extending from the inner circumferential surface of the housing and adapted to contact one of the winglet portions in one of the open and closed positions; and

a closing projection extending from the inner circumferential surface of the housing and adapted to contact one of the winglet portions in the closed position, wherein the closing projection and the inflow projection are configured and spaced from one another to direct flow through the at least one opening through the circumferential surface.

39. The mechanical prosthetic heart valve of claim 38, wherein the at least one opening through the circumferential surface is proximate the opening and closing projections.

40. The mechanical prosthetic heart valve of claim 37, wherein the main portion of the at least one leaflet includes leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces, and wherein the inner surface generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface.

41. The mechanical prosthetic heart valve of claim 40 wherein the distance between the inner and outer surfaces is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the at least one leaflet has an airfoil cross section.

42. The mechanical prosthetic heart valve of claim 37, wherein the annular housing is formed from a metallic material.

43. The mechanical prosthetic heart valve of claim 37, wherein the at least one leaflet is formed from pyrolytic carbon.

44. A mechanical early-closing prosthetic heart valve, the valve comprising:

an annular housing having an inner circumferential surface; and

at least one leaflet disposed adjacent to the inner circumferential surface and capable of rotation between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve, the at least one leaflet comprising an early-closure means for creating a tendency for the leaflet to rotate toward the closed position such that the leaflet is substantially closed prior to initiation of back flow of blood through the heart valve.

45. The mechanical early-closing prosthetic heart valve of claim 44, whereby the at least one leaflet is more than 50% closed prior to the initiation of back flow of blood through the heart valve.

46. The mechanical early-closing prosthetic heart valve of claim 45, whereby the at least one leaflet is more than 60% closed prior to the initiation of back flow of blood through the heart valve.

47. The mechanical early-closing prosthetic heart valve of claim 46, whereby the at least one leaflet is more than 70% closed prior to the initiation of back flow of blood through the heart valve.

48. The mechanical early-closing prosthetic heart valve of claim 47, whereby the at least one leaflet is more than 80% closed prior to the initiation of back flow of blood through the heart valve.

49. The mechanical early-closing prosthetic heart valve of claim 48, whereby the at least one leaflet is more than 90% closed prior to the initiation of back flow of blood through the heart valve.

50. The mechanical early-closing prosthetic heart valve of claim 46, wherein the at least one leaflet further comprises:

a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces; and

first and second winglet portions situated on opposite ends of the at least one leaflet to facilitate rotation of the at least one leaflet, each of the winglet portions having a first side proximate the annular housing and a second side opposite thereto.

51. The mechanical early-closing prosthetic heart valve of claim 50, wherein the early-closure means comprises a configuration wherein the inner surface of the at least one leaflet has a convex curvature from the leading edge surface to the trailing edge surface and the outer surface has a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface.

52. The mechanical early-closing prosthetic heart valve of claim 51, wherein the early-closure means comprises a configuration wherein the distance between the inner and outer surfaces of the at least one leaflet is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the at least one leaflet has an airfoil cross section.

53. The mechanical early-closing prosthetic heart valve of claim 50, wherein at least one opening through the annular housing is provided to allow blood flow across the first side of at least one of the winglet portions when the at least one leaflet is in the open position.

54. A mechanical early-closing prosthetic heart valve, the valve comprising:

an annular housing having an inner circumferential surface; and

at least one leaflet disposed adjacent to the inner circumferential surface and capable of rotation between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve, the at least one leaflet comprising surfaces with complex curvatures and means for creating a tendency for the at least one leaflet to rotate toward the closed position such that the at least one leaflet is substantially closed prior to the initiation of back flow of blood through the heart valve.

55. The mechanical early-closing prosthetic heart valve of claim 54, wherein the surfaces with complex curvatures causes the at least one leaflet to begin to rotate toward a closed position about when a maximum flow rate has been achieved through the valve.

56. The mechanical early-closing prosthetic heart valve of claim 54, wherein the at least one leaflet further comprises:

a main portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces; and

first and second winglet portions situated on opposite ends of the at least one leaflet to facilitate rotation of the at least one leaflet, each of the winglet portions having a first side proximate the annular housing and a second side opposite thereto.

57. The mechanical early-closing prosthetic heart valve of claim 56, wherein the complex curvatures comprise a configuration wherein the inner surface of the at least one leaflet has a convex curvature from the leading edge surface to the trailing edge surface and the outer surface has a convex curvature proximate the leading edge surface and a concave curvature proximate the trailing edge surface.

58. The mechanical early-closing prosthetic heart valve of claim 57, wherein the complex curvatures comprise a configuration wherein the distance between the inner and outer surfaces of the at least one leaflet is greater proximate the leading edge surface than the distance between the inner and outer surfaces proximate the trailing edge surface such that the at least one leaflet has an airfoil cross section.

59. The mechanical early-closing prosthetic heart valve of claim 56, wherein at least one opening through the inner circumferential surface is provided to allow blood flow across the first side of at least one of the winglet portions when the at least one leaflet is in the open position.