GEOMETRIC CONTROL OF BENDING CHARACTER IN PROSTHETIC HEART VALVE LEAFLETS

• US 20140172078A1
• 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., Hartman, Cody L.
• Granted Patent: US 10,966,820 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 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 particular shapes that control bending character. In accordance with an embodiment, a prosthetic valve comprises a plurality of leaflets. Each leaflet includes a central region and two side regions on opposite sides of the central region. 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 two side regions have a shape substantially that of a triangle and each are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

Claims

1. A prosthetic valve, comprising:

a plurality of leaflets, each leaflet having two side regions and a central region between the two side regions, the central region having a shape that is different from that of the two side regions.

2. The prosthetic valve of claim 1, wherein the central region is substantially planar.

3. The prosthetic valve of claim 1, wherein the two side regions and the central region are substantially planar.

4. The prosthetic valve of claim 1, wherein the central region is planar, and the two side regions have a spherical or cylindrical component to their shape.

5. A prosthetic valve, comprising:

a leaflet frame having a generally tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top; and

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

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

7. The prosthetic valve of claim 6, wherein each of the two side regions and the central region are substantially planar when the prosthetic valve is in a closed position under unpressurized conditions.

8. The prosthetic valve of claim 5, 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 onto the tubular shape of the leaflet frame, the isosceles trapezoid 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.

9. The prosthetic valve of claim 8, further comprising a vertical element extending from where the adjacent isosceles trapezoids meet, the vertical element having a length extending to the leaflet frame second end.

10. The prosthetic valve of claim 5, wherein the film is coupled to an outer surface of the leaflet frame, wherein the film defines the leaflet extending from each of the leaflet windows.

11. The prosthetic valve of claim 5, wherein the film is coupled to an inner surface of the leaflet frame, wherein the film defines the leaflet extending from each of the leaflet windows.

12. The prosthetic valve of claim 5, wherein the film is coupled to an inner surface and an outer surface of the leaflet frame, wherein the film defines the leaflet extending from each of the leaflet windows.

13. The prosthetic valve of claim 5, wherein the leaflet frame defines three interconnected leaflet windows having a substantially triangular shape.

14. The prosthetic valve of claim 5, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window.

15. The prosthetic valve of claim 5, wherein the leaflet frame comprises a plurality of spaced apart leaflet windows each defining substantially an isosceles triangle interconnected by a base element therebetween, 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.

16. The prosthetic valve of claim 5, wherein the leaflet frame comprises a plurality of spaced apart interconnected leaflet windows, each leaflet window defining substantially isosceles trapezoids, wherein each leaflet window side is defined by the window sides of the isosceles trapezoid, and wherein each leaflet window base is defined by a base element.

17. The prosthetic valve of claim 5, wherein the prosthetic valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

18. The prosthetic valve of claim 5, wherein the leaflet comprises a polymeric material.

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

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

21. The prosthetic valve of claim 5, 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.

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

23. The prosthetic valve of claim 21, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

24. The prosthetic valve of claim 21, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

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

26. A prosthetic valve, comprising:

a plurality of leaflets, each leaflet having a shape substantially that of an isosceles trapezoid having two leaflet sides, a leaflet base, and a free edge opposite the leaflet base, wherein the two leaflet sides diverge from the leaflet base.

27. The prosthetic valve of claim 26, wherein the two leaflet sides of the leaflet define the shape of a triangle.

28. The prosthetic valve of claim 26, wherein the leaflet base is substantially flat.

29. A prosthetic valve, 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, a leaflet base and a 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 substantially that of a triangle and each are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

30. The prosthetic valve of claim 29, wherein each of the two side regions and the central region are substantially planar when the prosthetic valve is in a closed position and in a non-pressurized condition.

31. A method of forming a prosthetic heart valve, comprising:

providing a leaflet frame having a generally tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top;

providing a film;

wrapping the film about the leaflet frame bringing more than one layer of the film into contact with additional layers of the film defining at least one leaflet extending from each of the leaflet windows, wherein each leaflet has substantially a shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a free edge opposite the leaflet base, wherein the two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat, wherein the leaflet base is coupled to the window base and wherein each of the two leaflet sides are coupled to one of the two window sides providing a generally annular support structure; and

bonding the layers of film to itself and to the leaflet frame.

32. The method of forming a prosthetic heart valve of claim 31, wherein providing a leaflet frame comprises providing a leaflet frame having a plurality of spaced apart leaflet windows each defining substantially an isosceles triangle interconnected by a base element therebetween, 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.

33. The method of forming a prosthetic heart valve of claim 31, wherein providing a leaflet frame comprises providing a leaflet frame having a plurality of spaced apart interconnected leaflet windows each defining substantially isosceles trapezoids, wherein each leaflet window side is defined by the window sides of the isosceles trapezoid, and wherein each leaflet window base is defined by a base element.

34. The method of forming a prosthetic heart valve of claim 31, wherein wrapping the film about the leaflet frame comprises wrapping a first film about an inner surface of the leaflet frame and a second film about an outer surface of the leaflet frame, wherein the leaflets are defined by the first film and the second film bonded together in the leaflet windows.