Truncated leaflet for prosthetic heart valves

• US 10,463,478 B2
• Filed: 08/28/2015
• Issued: 11/05/2019
• 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., Hartman, Cody L.
• Primary Examiner(s): Snow, Bruce E
• Application Number:
  US14/839,334
• Publication Number:
  US 20150366663A1
• Time in Patent Office: 1,530 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/00 Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• 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 having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets that are coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Claims

1. A prosthetic valve having an inflow end, an outflow end, and a valve axis extending between the in flow end and the outflow end of the prosthetic valve and comprising:

a leaflet frame defining a plurality of leaflet windows, the leaflet frame including a base element defining a leaflet window base of each of the plurality of leaflet windows, the base element extending transverse to the valve axis; and

a plurality of leaflets that are coupled to the base element of the leaflet frame, each leaflet including a leaflet free edge configured to abut an adjacent leaflet free edge when the plurality of leaflets transition from an open position to a closed position to stop fluid flow through the prosthetic valve, a first leaflet side coupled to the leaflet frame, a second leaflet side coupled to the leaflet frame, and a leaflet base opposite the leaflet free edge, the leaflet base being truncated in a plane that is transverse to the valve axis such that the leaflet base is flat, the leaflet base being coupled along the base element of the leaflet frame to define an attachment line that is straight, perpendicular relative to the longitudinal axis of the prosthetic valve, and which extends in the plane that is transverse to the valve axis.

2. The prosthetic valve of claim 1, in which truncation of each leaflet is located inferior and exterior to a line joining apices of two adjacent commissural posts of the leaflet frame.

3. The prosthetic valve of claim 1, in which the leaflet is truncated in a straight line across the leaflet base.

4. The prosthetic valve of claim 1, wherein the leaflet frame has a tubular shape, the prosthetic valve further comprising a film that is coupled to the leaflet frame and defining at least one of the plurality of leaflets, wherein the two leaflet sides diverge from the leaflet base, and wherein each of the two leaflet sides is coupled to the leaflet frame.

5. The prosthetic valve of claim 4, 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 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 two side regions have a shape of a triangle where each of the two side regions are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

6. The prosthetic valve of claim 5, wherein the central region is planar when the prosthetic valve is in a closed position under unpressurized conditions.

7. The prosthetic valve of claim 5, wherein the central region is planar when the prosthetic valve is in a closed position.

8. The prosthetic valve of claim 5, wherein the central region is planar.

9. The prosthetic 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, and further wherein each of the plurality of leaflet windows has two sides that diverge from one of the one or more leaflet window bases.

10. The prosthetic valve of claim 9, further comprising a commissure post extending axially from where adjacent ones of the plurality of adjacent leaflet windows meet, the commissure post having a length extending to the leaflet frame second end.

11. The prosthetic valve of claim 4, wherein the film is coupled to an outer surface of the leaflet frame.

12. The prosthetic valve of claim 4, wherein the film is coupled to an inner surface of the leaflet frame.

13. The prosthetic valve of claim 4, wherein the film is coupled to an inner surface and an outer surface of the leaflet frame.

14. The prosthetic valve of claim 4, wherein the leaflet frame defines three interconnected leaflet windows having a triangular shape.

15. The prosthetic valve of claim 4, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

16. The prosthetic valve of claim 4, wherein the prosthetic valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

17. The prosthetic valve of claim 4, wherein the leaflet comprises a polymeric material.

18. The prosthetic valve of claim 17, wherein the leaflet comprises a laminate.

19. The prosthetic valve of claim 18, wherein the laminate has more than one layer of a fluoropolymer membrane.

20. The prosthetic valve of claim 4, wherein the film has at least one layer of a fluoropolymer membrane having a plurality of pores and an elastomer present in the pores of the at least one layer of fluoropolymer membrane.

21. The prosthetic valve of claim 20, wherein the film comprises less than about 80% fluoropolymer membrane by weight.

22. The prosthetic valve of claim 20, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

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

24. The prosthetic valve of claim 20, wherein the fluoropolymer membrane comprises ePTFE.

25. The prosthetic valve of claim 1, 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 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 two side regions have a shape of a triangle where each of the two side regions are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

26. The prosthetic valve of claim 25, wherein the central region is planar when the prosthetic valve is in a closed position under unpressurized conditions.

27. The prosthetic valve of claim 25, wherein the central region is planar when the prosthetic valve is in a closed position.

28. The prosthetic valve of claim 25, wherein the central region is planar.

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

30. The prosthetic valve of claim 29, wherein the leaflet comprises a laminate.

31. The prosthetic valve of claim 30, wherein the laminate has more than one layer of a fluoropolymer membrane.

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

33. The prosthetic valve of claim 32, wherein the film comprises less than about 80% fluoropolymer membrane by weight.

34. The prosthetic valve of claim 32, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

35. The prosthetic valve of claim 32, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

36. The prosthetic valve of claim 32, wherein the fluoropolymer membrane comprises ePTFE.

37. The prosthetic valve of claim 1, wherein the leaflet frame includes a plurality of frame elements that define a plurality of isosceles triangles interconnected to each other by the base element.

38. The prosthetic valve of claim 37, 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 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 two side regions have a shape of a triangle where each of the two side regions are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

39. The prosthetic valve of claim 38, wherein the central region is planar when the prosthetic valve is in a closed position under unpressurized conditions.

40. A prosthetic valve having an inflow end, an outflow end, and a valve axis extending between the inflow end and the outflow end of the prosthetic valve and comprising:

a leaflet frame including a leaflet window base element extending in a plane that is transverse to the valve axis and defining a base of one or more leaflet windows; and

a plurality of leaflets that are coupled to the leaflet window base element of the leaflet frame, each leaflet including a leaflet free edge configured to abut an adjacent leaflet free edge when the plurality of leaflets transition from an open position to a closed position to stop fluid flow through the prosthetic valve, a first leaflet side coupled to the leaflet frame, a second leaflet side coupled to the leaflet frame, and a leaflet base opposite the leaflet free edge, the leaflet base being truncated in a plane that is transverse to the valve axis such that the leaflet base is flat, the prosthetic valve defining a radius in the plane that is transverse to the valve axis and the leaflet base defining a width between the first leaflet side and the second leaflet side, the entire width of the leaflet base being coupled to the leaflet window base element of the leaflet frame such that the leaflet base is continuously attached to the base element of the leaflet frame.