IP Library Granted Patent US 11,896,481
Granted Patent B2
US 11,896,481 · App. 16/440,340 · Granted Feb 13, 2024

Truncated leaflet for prosthetic heart valves

Inventors: William C. Bruchman (Camp Verde, AZ); Cody L. Hartman (Flagstaff, AZ)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2409A61F2/24A61F2/2412A61F2/2415A61F2/2418A61F2230/00A61F2230/0023A61F2230/0026A61F2240/001
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Quick Facts
Patent No.
US 11,896,481
App. No.
16/440,340
Granted
Feb 13, 2024
Kind
B2
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 (29)

1. A prosthetic valve with three or more leaflets having an inflow end and an outflow end, the prosthetic valve comprising:

a frame assembly having a central longitudinal axis and including a leaflet frame and a cover having a generally tubular shape, the cover being coupled to the leaflet frame such that the cover at least partially covers the leaflet frame, the leaflet frame defining a plurality of leaflet windows, the plurality of leaflet windows each defining an isosceles trapezoid and including a leaflet window side and a leaflet window base, the leaflet frame having a cylindrical shape; and

a plurality of leaflets coupled to the frame assembly, 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 frame assembly, a second leaflet side coupled to the frame assembly, and a leaflet base coupled to the frame assembly along the leaflet base, the leaflet base forming a line of attachment along the frame assembly, the leaflet base being positioned opposite the leaflet free edge and being flat in a plane transverse to the central longitudinal axis of the frame assembly, the leaflet frame including a flat portion with which the leaflet base forms the line of attachment.

2. The prosthetic valve of claim 1 , wherein the leaflet frame includes a plurality of commissure posts and each leaflet base of the plurality of leaflets is located inferior and exterior to a line joining apices of two adjacent commissure posts of the leaflet frame.

3. The prosthetic valve of claim 1 , wherein the leaflet frame has a tubular shape.

4. The prosthetic valve of claim 1 , wherein the prosthetic valve comprises a film that is coupled to the leaflet frame and which defines at least one of the plurality of leaflets.

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

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

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

8. The prosthetic valve of claim 1 , wherein each leaflet of the plurality of leaflets includes a central region that is planar when the plurality of leaflets are each in a closed position under unpressurized conditions.

9. The prosthetic valve of claim 8 , wherein each central region of each of the leaflets includes two sides that converge.

10. The prosthetic valve of claim 1 , wherein the leaflet frame comprises a leaflet frame outflow end and a leaflet frame inflow end opposite the leaflet frame outflow end, and further wherein the leaflet frame defines a plurality of leaflet windows from which the plurality of leaflets extend, each of the plurality of leaflet windows having two sides that diverge in a direction toward the leaflet frame outflow end.

11. The prosthetic valve of claim 10 , wherein the leaflet frame further comprises a plurality of commissure posts extending axially from adjacent windows of the plurality of leaflet windows, each commissure post having a length extending toward the leaflet frame outflow end.

12. The prosthetic valve of claim 10 , wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window of the plurality of leaflet windows.

13. The prosthetic valve of claim 1 , wherein the plurality of leaflet windows includes leaflet frame defines three interconnected leaflet windows, the three interconnected leaflet windows being interconnected by a base element, the three interconnected leaflet windows each defining an isosceles trapezoid.

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

15. The prosthetic valve of claim 1 , wherein each of the plurality of leaflets includes a synthetic material.

16. The prosthetic valve of claim 1 , wherein each of the plurality of leaflets comprises a laminate material.

17. The prosthetic valve of claim 16 , wherein each of the plurality of leaflets is a single layer of the laminate material.

18. The prosthetic valve of claim 1 , wherein each of the plurality of leaflets comprises a fluoropolymer membrane.

19. The prosthetic valve of claim 1 , wherein each of the plurality of leaflets comprises a biological tissue material.

20. The prosthetic valve of claim 1 , wherein the plurality of leaflets are cut leaflets, the leaflet base including a cut edge, the cut edge of the leaflet base being coupled to the frame assembly.

21. The prosthetic valve of claim 1 , wherein the plurality of leaflets are molded leaflets.

22. The prosthetic valve of claim 1 , wherein the leaflet base is bonded to the leaflet frame along the line of attachment.

23. The prosthetic valve of claim 1 , wherein the leaflet base is coupled to the leaflet frame at a center of the leaflet base.

24. The prosthetic valve of claim 1 , wherein the leaflet window side diverges outwardly at an obtuse angle from the leaflet window base.

25. A prosthetic valve with three or more leaflets 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 assembly including a leaflet frame and a tubular cover, the leaflet frame assembly defining a plurality of leaflet attachment lines extending in a plane that is transverse to the valve axis, the leaflet attachment lines being defined on flat portions of the leaflet frame assembly, the leaflet frame including a flat portion with which the leaflet base forms the line of attachment, the leaflet frame defining a plurality of leaflet windows, the plurality of leaflet windows each defining an isosceles trapezoid and including a leaflet window side and a leaflet window base, the leaflet frame having a cylindrical shape; and

a plurality of leaflets each having a first side, a second side opposite the first side, a leaflet free edge and a leaflet base opposite to the leaflet free edge that is flat and which is coupled to one of the plurality of leaflet attachment lines defined by the leaflet frame assembly along the leaflet base forming a line of attachment along the leaflet frame assembly at the flat portions of the leaflet frame assembly.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2023
From: W. L. GORE & ASSOCIATES, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 064164/0030 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 15, 2023
From: BRUCHMAN, WILLIAM C; HARTMAN, CODY L
To: W. L. GORE & ASSOCIATES, INC.
Reel/Frame 062707/0584 →
Continuity (4)
Continuation 14839334 · Aug 28, 2015
Continuation 13843196 · Mar 15, 2013
Provisional Application 61739721 · Dec 19, 2012
Related Publication 20200000578A1 · Jan 2, 2020
Cited By (2)
US 12,636,144 US 12,648,846