MULTI-FRAME PROSTHETIC HEART VALVE

• US 20140172077A1
• Filed: 03/15/2013
• 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., Crawford, Daniel A., Hagaman, Logan R., Hartman, Cody L.
• Granted Patent: US 10,321,986 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

Described embodiments are directed toward prosthetic valves and systems and methods of making prosthetic valves. In accordance with an embodiment, a prosthetic valve comprises and leaflet frame, and outer frame and a film. The leaflet frame has a generally tubular shape defining a plurality of leaflet windows. The outer frame has a generally tubular shape. The leaflet frame is coaxially disposed at least partially within the outer frame. The leaflet frame and outer frame is coupled at least in part by a contiguous portion of the film. At least a portion of the contiguous portion of the film is contained between and coupling the leaflet frame and outer frame operable to prevent relative movement and contact therebetween. The film defines a leaflet extending from each of the leaflet windows.

Claims

1. A prosthetic valve comprising:

a leaflet frame having a generally tubular shape, the leaflet frame defining a plurality of leaflet windows;

an outer frame having a generally tubular shape; and

a film, the leaflet frame being coaxially disposed at least partially within the outer frame, the leaflet frame and outer frame being 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 operable to prevent relative movement and contact therebetween, wherein the film defines a leaflet extending from each of the leaflet windows.

2. The prosthetic valve of claim 1, wherein the film that defines the leaflet extends between the leaflet frame and the outer frame.

3. The prosthetic valve of claim 1, wherein the leaflet has a 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.

4. The prosthetic valve of claim 1, wherein the film defines at least one leaflet coupled to an outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

5. The prosthetic valve of claim 1, wherein the film defines at least one leaflet coupled to an inner surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

6. The prosthetic valve of claim 1, wherein the film defines at least one leaflet coupled to an inner surface and an outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

7. The prosthetic valve of claim 1, wherein the leaflet frame defines three interconnected leaflet windows having a substantially triangular shape.

8. The prosthetic valve of claim 1, wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top.

9. The prosthetic valve of claim 1, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

10. The prosthetic valve of claim 1, wherein the leaflet window is defined by window frame elements corresponding to leaflet sides and leaflet base, wherein the film is coupled to the window frame elements and extends across the leaflet window defining the leaflet.

11. The prosthetic valve of claim 1, wherein the 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.

12. The prosthetic valve of claim 1, wherein the prosthetic valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

13. The prosthetic valve of claim 1, wherein the leaflet is moveable between an open and closed position.

14. The prosthetic valve of claim 1, wherein the leaflet comprises a polymeric material.

15. The prosthetic valve of claim 1, wherein the leaflet comprises a laminate.

16. The prosthetic valve of claim 15, wherein the laminate has more than one layer of a fluoropolymer membrane.

17. The prosthetic 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 substantially all of the pores of at least one layer of fluoropolymer membrane.

18. The prosthetic valve of claim 17, wherein the film comprises less than about 80% fluoropolymer membrane by weight.

19. The prosthetic valve of claim 17, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

20. The prosthetic valve of claim 17, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

21. The prosthetic valve of claim 17, wherein the fluoropolymer membrane comprises ePTFE.

22. The prosthetic valve of claim 1, wherein either or both of the leaflet frame and outer frame defines a generally open pattern of apertures operable to allow the outer frame to be compressed and expanded between different diameters.

23. The prosthetic valve of claim 1, wherein either or both of the leaflet frame and outer frame comprise a shape memory material.

24. The prosthetic valve of claim 1, 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.

25. A prosthetic valve comprising:

a leaflet frame having a generally tubular shape, the leaflet frame defining a plurality of leaflet windows;

an outer frame having a generally tubular shape; and

a film, the leaflet frame being coaxially disposed at least partially within the outer frame, wherein the outer frame includes frame elements that overlay leaflet windows that are defined by the leaflet frame in cooperative arrangement so as to provide structural support over the leaflet windows, wherein the film defines a leaflet extending from each of the leaflet windows.

26. The prosthetic valve of claim 25, wherein the film is disposed between the leaflet frame and the outer frame.

27. The prosthetic valve of claim 25, wherein the leaflet frame and outer frame are separated by the film and are not in contact with each other.

28. The prosthetic valve of claim 25, wherein the film that defines the leaflet extends between the leaflet frame and the outer frame.

29. The prosthetic valve of claim 25, wherein the leaflet has a 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.

30. The prosthetic valve of claim 25, wherein the film defines at least one leaflet coupled to an outer surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

31. The prosthetic valve of claim 25, wherein the film defines at least one leaflet coupled to an inner surface of the leaflet frame, wherein the film defines a leaflet extending from each of the leaflet windows.

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

33. The prosthetic valve of claim 25, wherein the leaflet frame defines three interconnected leaflet windows having a substantially triangular shape.

34. The prosthetic valve of claim 25, wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top.

35. The prosthetic valve of claim 25, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

36. The prosthetic valve of claim 25, wherein the leaflet window is defined by window frame elements corresponding to leaflet sides and leaflet base, wherein the film is coupled to the window frame elements and extends across the leaflet window defining the leaflet.

37. The prosthetic valve of claim 25, wherein the 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.

38. The prosthetic valve of claim 25, wherein the prosthetic valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

39. The prosthetic valve of claim 25, wherein the leaflet is moveable between an open and closed position.

40. The prosthetic valve of claim 25, wherein the leaflet comprises a polymeric material.

41. The prosthetic valve of claim 25, wherein the leaflet comprises a laminate.

42. The prosthetic valve of claim 41, wherein the laminate has more than one layer of a fluoropolymer membrane.

43. The prosthetic valve of claim 25, wherein the leaflet comprises a film having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer present in substantially all of the pores of at least one layer of fluoropolymer membrane.

44. The prosthetic valve of claim 43, wherein the film comprises less than about 80% fluoropolymer membrane by weight.

45. The prosthetic valve of claim 43, wherein the elastomer comprises (per)fl uoroalkylvinylethers (PAVE).

46. The prosthetic valve of claim 43, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

47. The prosthetic valve of claim 43, wherein the fluoropolymer membrane comprises ePTFE.

48. The prosthetic valve of claim 25, wherein either or both of the leaflet frame and outer frame defines a generally open pattern of apertures operable to allow the outer frame to be compressed and expanded between different diameters.

49. The prosthetic valve of claim 25, wherein either or both of the leaflet frame and outer frame comprise a shape memory material.

50. A method of making a valve, comprising:

wrapping a first layer of a 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.

51. A method of making a prosthetic 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;

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