Truncated leaflet for prosthetic heart valves, preformed valve

• US 9,144,492 B2
• Filed: 03/15/2013
• Issued: 09/29/2015
• 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): Sweet, Thomas J
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US13/843,196
• Publication Number:
  US 20140172080A1
• Time in Patent Office: 928 Days
• Field of Search: 623/2.34, 623/2.37, 623/2.3, 623/2.1
• US Class Current: 1/1
• 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 comprising:

a leaflet frame; and

a plurality of leaflets that are coupled to the leaflet frame, each leaflet including two leaflet sides, a leaflet free edge and a leaflet base, wherein the leaflet base of each leaflet has a truncation in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame, 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 that is coupled to the leaflet frame and defining at least one leaflet extending from each of the leaflet windows, wherein each leaflet has a shape of an isosceles trapezoid having two leaflet window sides, a leaflet base and a leaflet free edge opposite the leaflet base, wherein the two leaflet sides diverge from the leaflet base, wherein the leaflet base is 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 leaflet window sides, 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 side regions have a shape of a triangle and each are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge, wherein each of the two side regions and the central region are planar when the prosthetic valve is in a closed position under unpressurized conditions.

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

3. The prosthetic valve of claim 1, in which the truncation is a straight line across the leaflet base of the leaflet and perpendicular to a valve axis.

4. 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, 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.

5. The prosthetic valve of claim 4, further comprising a commissure post extending axially from where the adjacent isosceles trapezoids meet, the commissure post having a length extending to the leaflet frame second end.

6. The prosthetic valve of claim 1, 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.

7. The prosthetic valve of claim 1, 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.

8. The prosthetic valve of claim 1, 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.

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

10. 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.

11. The prosthetic valve of claim 1, wherein the leaflet frame comprises a plurality of spaced apart leaflet windows each defining 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.

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

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

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

15. The prosthetic valve of claim 14, 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 layer of a fluoropolymer membrane having a plurality of pores and an elastomer present in the pores of the at least one layer of the 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.