REPLACEMENT HEART VALVES AND THEIR METHODS OF USE AND MANUFACTURE

• US 20170079782A1
• Filed: 12/02/2016
• Published: 03/23/2017
• Est. Priority Date: 05/09/2014
• Status: Active Grant

• Current Assignee: Foldax, Inc.
• Original Assignee: Foldax, Inc.
• Inventors: Beith, Jason G.
• Granted Patent: US 10,918,477 B2
• Time in Patent Office: Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A prosthetic valve has a support structure that meets with a plurality of leaflets capable of transitioning between open and closed states. The support structure can include a base frame with a polymer coating and the leaflets can be artificial. The interface between the support structure and each leaflet can be at least partially convex when viewed from an exterior of the support structure along a normal to a plane formed by a central axis of the support structure and a central axis of the leaflet.

Claims

1. A prosthetic heart valve, comprising:

a support structure having a first end, a second end, and a central axis extending therebetween, wherein the support structure is substantially cylindrical; and

only three artificial leaflets, each leaflet having a movable part with a base along the support structure and a free edge allowed to move independent of the support structure, wherein the base is the intersection between the movable part and the support structure,

wherein the movable part of each leaflet is movable between a closed position and an open position, and

wherein a profile of the base of the movable part of a first leaflet of the three artificial leaflets is at least partially convex when viewed from an exterior side of the support structure normal to a plane that passes through the central axis and that bisects the first leaflet when in the first position.

2. The prosthetic heart valve of claim 1, wherein the profile of the base of the first leaflet is at least partially convex and at least partially concave when viewed from the exterior side of the support structure.

3. The prosthetic heart valve of claim 1, wherein the profile of the base of the first leaflet is entirely convex when viewed from the exterior side of the support structure.

4. The prosthetic heart valve of claim 1, wherein a profile of the base of the movable part of a second leaflet of the three artificial leaflets is at least partially convex when viewed from an exterior side of the support structure normal to a plane that passes through the central axis and that bisects the second leaflet when in the first position.

5. The prosthetic heart valve of claim 4, wherein a profile of the base of the movable part of a third leaflet of the three artificial leaflets is at least partially convex when viewed from an exterior side of the support structure normal to a plane that passes through the central axis and that bisects the third leaflet when in the first position.

6. The prosthetic heart valve of claim 1, wherein the support structure comprises an annular base portion at the first end, wherein the first end is a blood inlet end.

7. The prosthetic heart valve of claim 6, wherein the support structure comprises a sewing cuff at the annular base portion.

8. The prosthetic heart valve of claim 6, wherein the support structure comprises a plurality of extensions from the annular base portion, with the base of each leaflet meeting two adjacent ones of the extensions.

9. The prosthetic heart valve of claim 6, wherein the prosthetic heart valve is adapted for use as a prosthetic aortic valve and the annular base portion has a scalloped terminus.

10. The prosthetic heart valve of claim 6, wherein the prosthetic heart valve is adapted for use as a prosthetic mitral valve and the annular base portion has a flat terminus.

11. The prosthetic heart valve of claim 1, wherein the three artificial leaflets are polymeric.

12. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is not radially collapsible for placement into an intravascular delivery device and wherein the prosthetic heart valve is not radially collapsible for placement in a trans-apical delivery device.

13. The prosthetic heart valve of claim 1, wherein the support structure and the three artificial leaflets comprise the same material.

14. The prosthetic heart valve of claim 1, wherein the support structure and the plurality of leaflets are formed of different materials.

15. The prosthetic heart valve of claim 1, wherein each of the artificial leaflets is a discrete body.

16. The prosthetic heart valve of claim 1, wherein the base of each of the artificial leaflets is integrally formed to the support structure.

17. The prosthetic heart valve of claim 1, wherein the base of each of the three of leaflets is a casting boundary with the support structure.

18. The prosthetic heart valve of claim 1, wherein the support structure comprises an inner lumen surface between the first end and the second end, and wherein the entirety of the inner lumen surface is substantially cylindrical.

19. The prosthetic heart valve of claim 1, wherein the support structure is cylindrical.

20. The prosthetic heart valve of claim 1, wherein the plane passes through a central axis of the first leaflet that extends between the base and the free edge of the first leaflet.