Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet

• US 9,968,443 B2
• Filed: 04/24/2013
• Issued: 05/15/2018
• 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): LOPEZ, LESLIE ANN
• Application Number:
  US13/869,524
• Publication Number:
  US 20140172081A1
• Time in Patent Office: 1,847 Days
• Field of Search: 623 212- 218, 623 238
• 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 valve leaflets of a particular shape that allows redundant coaptation height in the leaflets when a planar segment is present in each leaflet.

Claims

1. A prosthetic valve comprising:

a leaflet frame; and

a plurality of leaflets coupled to the leaflet frame, each leaflet having a center, each leaflet including a leaflet free edge and a leaflet base opposite from the leaflet free edge, wherein each of the plurality of leaflets flexes about the respective leaflet base of the plurality of leaflets and each leaflet having a planar zone including the center of the leaflet and being without creases or folds, wherein the planar zone is planar, wherein the planar zone defines a shape having an area, wherein the area is larger nearer the leaflet base than the leaflet free edge, wherein the planar zone extends to the leaflet free edge defining a truncated top having a top width as measured along the leaflet free edge greater than zero, each leaflet having a coaptation zone defined by an area adjacent the leaflet free edge that is in contact with an adjacent leaflet when the leaflets are in a closed position and a vertical coaptation zone defining a coaptation height as a length of the coaptation zone measured in an axial direction, wherein the coaptation height is greater than a thickness of the leaflet, wherein the planar zone not including the vertical coaptation zone is planar when the prosthetic valve is in a closed position under unpressurized conditions.

2. The prosthetic valve of claim 1, the leaflet frame having a tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides, and a leaflet window base, two adjacent leaflet window sides terminating at a commissure post, a majority of the planar zone of each leaflet being located exterior to a line joining apices of two adjacent commissure posts.

3. The prosthetic valve of claim 2, wherein the leaflet frame comprises a leaflet frame first end and a leaflet frame second end opposite the leaflet frame first end, each leaflet window having a shape determined, at least in part, by wrapping a two dimensional isosceles trapezoid onto a 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.

4. The prosthetic valve of claim 3, 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.

5. The prosthetic valve of claim 1, wherein each planar zone has a shape of an isosceles trapezoid.

6. The prosthetic valve of claim 1, wherein each leaflet has a shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge.

7. The prosthetic valve of claim 1, wherein the leaflet frame has a tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides and a leaflet window base, wherein for each leaflet and its respective leaflet window the leaflet base is coupled to the leaflet window base and two leaflet sides are coupled to one of the two leaflet window sides, and the planar zone extends to the leaflet base.

8. The prosthetic valve of claim 1, the leaflet frame having a 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 of the leaflets extending from each of the leaflet windows, wherein each leaflet has a shape of an isosceles trapezoid having two leaflet window sides, the leaflet base and the leaflet free edge, wherein the two leaflet sides diverge from the leaflet base, wherein each leaflet base is flat, wherein for each leaflet and its respective leaflet window the leaflet ease is coupled to the leaflet window base and wherein each of the two leaflet sides are coupled to one of the two window sides.

9. The prosthetic valve of claim 8, wherein the film is coupled to an outer surface of the leaflet frame, wherein the film defines each leaflet extending from its respective leaflet window.

10. The prosthetic valve of claim 8, wherein the film is coupled to an inner surface of the leaflet frame, wherein the film defines each leaflet extending from its respective leaflet window.

11. The prosthetic valve of claim 8, wherein the film is coupled to an inner surface and an outer surface of the leaflet frame, wherein the film defines each leaflet extending from its respective leaflet window.

12. The prosthetic valve of claim 1, wherein each leaflet is defined by two leaflet sides, the leaflet base and the leaflet free edge, wherein each leaflet includes a central region and two side regions on opposite sides of the central region, wherein each central region is defined by a shape of an isosceles trapezoid 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 of a triangle and are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge, wherein the central region is planar.

13. The prosthetic valve of claim 12, wherein for each leaflet each of the two side regions and the central region are planar when the prosthetic valve is in the closed position under unpressurized conditions.

14. 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.

15. The prosthetic valve of claim 1, wherein the leaflet frame comprises a plurality of spaced apart interconnected leaflet windows, each leaflet window defining an isosceles trapezoid, wherein each leaflet window side is defined by two sides of the isosceles trapezoid, and wherein each leaflet window comprises a base defined by a base element.

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

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

18. The prosthetic valve of claim 17, wherein each 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 1, wherein each leaflet comprises a film having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer present in the pores of 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.