GEOMETRIC PROSTHETIC HEART VALVES

• US 20140172083A1
• Filed: 12/18/2013
• Published: 06/19/2014
• Est. Priority Date: 12/19/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Hartman, Cody L.
• Granted Patent: US 10,039,638 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter

Abstract

Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.

Claims

1. A prosthetic heart valve comprising:

a leaflet frame having a generally tubular shape, the leaflet frame defining a plurality of leaflet windows each defining an attachment zone; and

a film defining at least one leaflet extending from each of the leaflet windows, wherein each leaflet attachment zone has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base, wherein the two leaflet sides of the leaflet attachment zone diverge from the leaflet base, wherein the leaflet base is substantially flat.

2. The prosthetic heart valve of claim 1, wherein each leaflet includes a central region and two side regions on opposite sides of the central region, wherein a central region is defined by a shape substantially that of an isosceles triangle defined by two central region sides, the leaflet base and the leaflet free edge, wherein the two central region sides converge from the leaflet base.

3. The prosthetic heart valve of claim 1, wherein the leaflet frame comprises a leaflet frame first end and a leaflet frame second end opposite the leaflet frame first end, the leaflet window having a shape determined, at least in part, by wrapping a two dimensional isosceles trapezoid pattern onto the tubular shape of the leaflet frame, the isosceles trapezoid pattern having a base and two sides that diverge from the base, and wherein a side from adjacent isosceles trapezoids meet at the leaflet frame second end.

4. The prosthetic heart valve of claim 2, further comprising a commissure post extending from where the adjacent isosceles trapezoids meet, the commissure post having a length extending to a leaflet frame second end.

5. The prosthetic heart valve of claim 1, wherein the leaflet defines a leaflet base comprising a fold at an interface between portions of the film that are coupled with the leaflet frame and portions of the film that are not coupled with the leaflet frame.

6. The prosthetic heart valve of claim 1, wherein the film defines one or more leaflets, the leaflets defining a shape of a trapezoid wherein frame elements bound two leaflet sides, one leaflet side being a leaflet free edge, and the leaflet base is a horizontal truncation bound only by the film.

7. The prosthetic heart valve of claim 1, wherein the film defining at least one leaflet that is coupled to a leaflet frame outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

8. The prosthetic heart valve of claim 1, wherein the film defining at least one leaflet that is coupled to a leaflet frame inner surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

9. The prosthetic heart valve of claim 1 further comprising:

an outer frame having a generally tubular shape, the leaflet frame and outer frame are coupled at least in part by a contiguous portion of the film, at least a portion of the contiguous portion of the film being contained between and coupling the leaflet frame and outer frame that minimizes relative movement and prevents contact between the leaflet frame and outer frame, wherein the film defines a leaflet extending from each of the leaflet windows.

10. The prosthetic heart valve of claim 9, wherein each leaflet has a leaflet base that is substantially flat.

11. The prosthetic heart valve of claim 9, wherein the leaflet frame defines three interconnected leaflet windows, each leaflet window having a substantially triangular shape.

12. The prosthetic heart valve of claim 9, wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top.

13. The prosthetic heart valve of claim 9, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

14. The prosthetic heart valve of claim 9, wherein the leaflet window is defined by frame elements corresponding to the leaflet sides and leaflet base, wherein the film is coupled to the frame elements and extends across the leaflet window defining the leaflet.

15. The prosthetic heart valve of claim 9, comprising a plurality of leaflets, wherein each leaflet includes a central region and two side regions on opposite sides of the central region, wherein the central region is defined by a shape substantially that of an isosceles triangle defined by two central region sides, the leaflet base and the leaflet free edge, wherein the two central region sides converge from the leaflet base, and wherein each of the side regions have a shape substantially that of a triangle and each of the side regions are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

16. The prosthetic heart valve of claim 15, wherein each of the two side regions and the central region are substantially planar when the prosthetic heart valve is in a closed position.

17. The prosthetic heart valve of claim 9, wherein the leaflet frame comprises a plurality of spaced apart leaflet windows each defining substantially an isosceles triangle interconnected by a base element, wherein each leaflet window side is defined by a side of one triangle and a side of an adjacent triangle, and wherein each leaflet window base is defined by the base element.

18. The prosthetic heart valve of claim 9, wherein the leaflet frame comprises a plurality of spaced apart interconnected leaflet windows each defining substantially isosceles trapezoids, wherein each leaflet window side is defined by the sides of the isosceles trapezoid, and wherein each leaflet window base is defined by a base element.

19. The prosthetic heart valve of claim 9, wherein the prosthetic heart valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

20. The prosthetic heart valve of claim 9, wherein the leaflet is moveable between an open and closed position.

21. The prosthetic heart valve of claim 9, wherein the film that defines the leaflet extends between the leaflet frame and the outer frame.

22. The prosthetic heart valve of claim 9, wherein the leaflet has a leaflet base comprising a fold at an interface between portions of the film that are coupled with the leaflet frame and portions of the film that are not coupled with the leaflet frame.

23. The prosthetic heart valve of claim 9, wherein the film defines at least one leaflet that is coupled to a leaflet frame outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

24. The prosthetic heart valve of claim 9, wherein the film defines at least one leaflet that is coupled to a leaflet frame inner surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

25. The prosthetic heart valve of claim 9, wherein the film defines at least one leaflet that is coupled to a leaflet frame inner surface and a leaflet frame outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

26. The prosthetic heart valve of claim 9, wherein the leaflet frame defines three interconnected leaflet windows having a substantially triangular shape.

27. The prosthetic heart valve of claim 9, wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top.

28. The prosthetic heart valve of claim 9, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

29. The prosthetic heart valve of claim 9, wherein the leaflet window is defined by window frame elements corresponding to the leaflet sides and the leaflet base, wherein the film is coupled to the window frame elements and extends across the leaflet window defining the leaflet.

30. The prosthetic heart valve of claim 9, wherein the leaflet frame comprises a plurality of spaced apart leaflet windows each defining substantially an isosceles triangle interconnected by a base element, wherein each leaflet window side is defined by a side of one triangle and a side of an adjacent triangle, and wherein each leaflet window base is defined by the base element.

31. The prosthetic heart valve of claim 9, wherein the prosthetic heart valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

32. The prosthetic heart valve of claim 9, wherein the leaflet is moveable between an open and closed position.

33. The prosthetic heart valve of claim 9, wherein the leaflet comprises a polymeric material.

34. The prosthetic heart valve of claim 9, wherein the leaflet comprises a laminate.

35. The prosthetic heart valve of claim 34, wherein the laminate has more than one layer of a fluoropolymer membrane.

36. The prosthetic heart valve of claim 1, wherein the leaflet comprises a film having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer present in at least a portion of the pores of at least one layer of fluoropolymer membrane.

37. The prosthetic heart valve of claim 36, wherein the film comprises less than about 80% fluoropolymer membrane by weight.

38. The prosthetic heart valve of claim 36, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

39. The prosthetic heart valve of claim 36, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

40. The prosthetic heart valve of claim 36, wherein the fluoropolymer membrane comprises ePTFE.

41. The prosthetic heart valve of claim 36, wherein the leaflet frame and outer frame defines a generally open pattern of apertures operable to allow the outer frame and the leaflet frame to be compressed and expanded between different diameters.

42. The prosthetic heart valve of claim 36, wherein either or both of the leaflet frame and outer frame comprise a shape memory material.

43. The prosthetic heart valve of claim 36, an outer frame having a generally tubular shape, the leaflet frame and outer frame are coupled at least in part by a contiguous portion of the film, at least a portion of the contiguous portion of the film being contained between and coupling the leaflet frame and outer frame that minimizes relative movement and prevents contact between the leaflet frame and outer frame, wherein the film defines a leaflet extending from each of the leaflet windows, wherein the outer frame includes frame elements that overlay the leaflet windows that are defined by the leaflet frame in cooperative arrangement so as to provide structural support over the leaflet windows.

44. The prosthetic heart valve of claim 36, wherein the leaflet has a leaflet base comprising a fold at an interface between portions of the film that are coupled with the leaflet frame and portions of the film that are not coupled with the leaflet frame.

45. The prosthetic heart valve of claim 36, wherein the film defines at least one leaflet that is coupled to a leaflet frame outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

46. The prosthetic heart valve of claim 36, wherein the film defines at least one leaflet that is coupled to a leaflet frame inner surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

47. The prosthetic heart valve of claim 36, wherein the film defines at least one leaflet that is coupled to a leaflet frame inner surface and a leaflet frame outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

48. The prosthetic heart valve of claim 36, wherein the leaflet frame defines three interconnected leaflet windows having a substantially triangular shape.

49. The prosthetic heart valve of claim 36, wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top.

50. The prosthetic heart valve of claim 36, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

51. The prosthetic heart valve of claim 36, wherein the leaflet window is defined by window frame elements corresponding to leaflet sides and a leaflet base, wherein the film is coupled to the window frame elements and extends across the leaflet window defining the leaflet.

52. A method of making a valve, comprising:

wrapping a first layer of film into a tubular form about a mandrel;

providing a leaflet frame having a generally tubular shape, the leaflet frame having a leaflet frame inner surface and a leaflet frame outer surface, the leaflet frame defining a plurality of leaflet windows having a window top;

providing an outer frame having a generally tubular shape, the outer frame having an outer frame inner surface and an outer frame outer surface;

placing the leaflet frame and the outer frame over the first layer of film with the leaflet frame and outer frame spaced apart from each other defining a bridge portion therebetween, the leaflet frame inner surface and the outer frame inner surface in contact with the first layer of film;

forming a second layer of film over the leaflet frame and the outer frame in contact with the leaflet frame outer surface and the outer frame outer surface;

coupling the first layer of film and the second layer of film to each other and to the leaflet frame and the outer frame;

cutting the first layer of film and the second layer of film across the window top within the leaflet window so as to define a leaflet free edge;

masking with release material a portion of the film disposed in the leaflet window that defines the leaflet to prevent further bonding of the leaflet during subsequent processing steps;

wrapping a third layer of film into a tubular form over the second layer of film and over the release material that is over the leaflet window, overlapping the leaflet frame, the outer frame, and over the bridge portion between the leaflet frame and outer frame;

coupling the third layer of film and the second layer of film to each other forming an assembly;

removing the assembly from the mandrel;

disposing coaxially and at least partially the leaflet frame into the outer frame, folding and overlapping at least partially the bridge portion so as to contain the bridge portion between the leaflet frame and the outer frame;

placing the assembly back on the mandrel; and

coupling the bridge portion to itself and to the third layer of film adjacent the leaflet frame outer surface and the first layer adjacent the outer frame inner surface in nesting engagement.

53. A method of making a prosthetic heart valve, comprising:

wrapping a first layer of film into a tubular form about a mandrel;

providing a leaflet frame having a generally tubular shape, the leaflet frame having a leaflet frame inner surface and a leaflet frame outer surface, the leaflet frame defining a plurality of leaflet windows having a window top;

placing the leaflet frame over the first layer of film, the leaflet frame inner surface in contact with the first layer of film;

forming a second layer of film over the leaflet frame in contact with the leaflet frame outer surface; and

coupling the first layer of film and the second layer of film to each other and to the leaflet frame.