Multi-frame prosthetic heart valve

• US 10,321,986 B2
• Filed: 03/15/2013
• Issued: 06/18/2019
• 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.
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Nelson, Christine L
• Application Number:
  US13/833,650
• Publication Number:
  US 20140172077A1
• Time in Patent Office: 2,286 Days
• 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 tubular shape that define a leaflet frame circumference, an inner lumen, an inner surface at the inner lumen, and an outer surface opposite the inner surface, the leaflet frame defining a plurality of leaflet windows;

an outer frame having a tubular shape defining an inner lumen and an inner surface at the inner lumen of the outer frame and an outer surface opposite the inner surface of the outer frame, the leaflet frame being coaxially disposed at least partially within the inner lumen of the outer frame; and

a film, the leaflet frame and outer frame being coupled at least in part by a contiguous portion of the film that extends between the outer surface of the leaflet frame and the inner surface of the outer frame, circumferentially around the entire leaflet frame circumference and is contained between and couples the leaflet frame and outer frame and prevents relative axial movement between the outer frame and the leaflet frame and contact between the outer frame and the leaflet frame, wherein the film defines a plurality of leaflets, with one leaflet extending from each of the leaflet windows.

2. The prosthetic valve of claim 1, wherein each 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.

3. The prosthetic valve of claim 2, wherein the leaflet frame defines three interconnected leaflet windows, each leaflet window having a triangular shape.

4. The prosthetic valve of claim 1, wherein the film that defines the plurality of leaflets is coupled to an outer surface of the leaflet frame.

5. 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.

6. 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.

7. The prosthetic valve of claim 1, wherein between each of the plurality of leaflet windows there is defined an isosceles triangle interconnected to each other by a base element, wherein each leaflet window comprises two leaflet window sides and a leaflet window base, the two leaflet window sides 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.

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

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

10. The prosthetic valve of claim 1, wherein each leaflet comprises a polymeric material.

11. The prosthetic valve of claim 1, wherein each leaflet comprises a laminate.

12. The prosthetic valve of claim 11, wherein the laminate has more than one layer of a fluoropolymer membrane.

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

14. The prosthetic valve of claim 13, wherein the film comprises less than about 80% fluoropolymer by weight.

15. The prosthetic valve of claim 13, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

16. The prosthetic valve of claim 13, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

17. The prosthetic valve of claim 13, wherein the fluoropolymer membrane comprises ePTFE.

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

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

20. 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.

21. The prosthetic valve of claim 1, wherein the leaflet frame and the outer frame are coupled together by a contiguous portion of the film in which the leaflet frame is nested into the outer frame in a telescoping manner.

22. The prosthetic valve of claim 1, wherein the contiguous portion of the film coupling the leaflet frame and outer frame that extends circumferentially around the outside of the leaflet frame defines a fold along a generally circumferential line.

23. A prosthetic valve comprising:

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

an outer frame having a tubular shape, the leaflet frame being coaxially disposed at least partially within the outer frame; and

a film that extends between the leaflet frame and 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 extending circumferentially around the entire leaflet frame circumference and being contained between and coupling the leaflet frame and outer frame operable to prevent relative movement and contact therebetween, wherein the outer frame includes frame elements that overlay the leaflet windows in cooperative arrangement so as to provide structural support over the leaflet windows, wherein the film defines a plurality of leaflets, with one leaflet extending from each of the leaflet windows.

24. The prosthetic valve of claim 23, wherein the film is disposed between the leaflet frame and the outer frame.

25. The prosthetic valve of claim 23, wherein the leaflet frame and outer frame are separated by the film and are not in contact with each other.

26. The prosthetic valve of claim 23, wherein each 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.

27. The prosthetic valve of claim 26, wherein the leaflet frame defines three interconnected leaflet windows, each leaflet window having a triangular shape.

28. The prosthetic valve of claim 23, wherein the film that defines the plurality of leaflets is coupled to an outer surface of the leaflet frame.

29. The prosthetic valve of claim 23, wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top.

30. The prosthetic valve of claim 23, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

31. The prosthetic valve of claim 23, wherein between each of the plurality of leaflet windows there is defined an isosceles triangle interconnected to each other by a base element, wherein each leaflet window comprises two leaflet window sides and a leaflet window base, the two leaflet window sides are 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.

32. The prosthetic valve of claim 23, wherein the prosthetic valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

33. The prosthetic valve of claim 23, wherein each leaflet is moveable between an open and closed position.

34. The prosthetic valve of claim 23, wherein the leaflet comprises a polymeric material.

35. The prosthetic valve of claim 23, wherein the leaflet comprises a laminate.

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

37. The prosthetic valve of claim 23, wherein each leaflet comprises a film having at least one layer of a fluoropolymer membrane having a plurality of pores and an elastomer present in the pores of at least one layer of fluoropolymer membrane.

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

39. The prosthetic valve of claim 37, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

40. The prosthetic valve of claim 37, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

41. The prosthetic valve of claim 37, wherein the fluoropolymer membrane comprises ePTFE.

42. The prosthetic valve of claim 23, wherein either or both of the leaflet frame and outer frame defines an open pattern of apertures operable to allow the outer frame to be compressed and expanded between different diameters.

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

44. The prosthetic valve of claim 23, wherein the leaflet frame and the outer frame are coupled together by a contiguous portion of the film in which the leaflet frame is nested into the outer frame in a telescoping manner.

45. The prosthetic valve of claim 23, wherein the contiguous portion of the film coupling the leaflet frame and outer frame that extends circumferentially around the outside of the leaflet frame defines a fold along a generally circumferential line.