TRANSCATHETER HEART VALVE FOR REPLACING NATURAL MITRAL VALVE

• US 20170128199A1
• Filed: 11/08/2016
• Published: 05/11/2017
• Est. Priority Date: 11/10/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Gurovich, Nikolay, Jafari, Mohammad, Tayeb, Liron, Tamir, Ilan, Yohanan, Ziv, Nir, Noam, Maimon, David, Manash, Boaz
• Granted Patent: US 10,470,876 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 2/2418 Scaffolds therefor, e.g. support stents

Abstract

Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A prosthetic valve may comprise a radially compressible main body and a one-way valve portion. The prosthetic valve may further comprise one or more ventricular anchors coupled to the main body and disposed outside of the main body. The ventricular anchors may be configured such that a reduced profile of the prosthetic valve is possible. A space may be provided between an outer surface of the main body and the ventricular anchors for receiving native mitral valve leaflets. The prosthetic valve may include an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for receiving the native mitral valve leaflets between the ventricular anchors and the main body are described.

Claims

1. A prosthetic valve for implantation within a heart, comprising:

a main body comprising a frame and a one-way valve positioned within the frame; and

a first ventricular anchor coupled to the frame of the main body, the first ventricular anchor comprising a spiral portion configured such that a leaflet of a native valve of the heart may be held securely between the spiral portion and the frame of the main body.

2. The prosthetic valve of claim 1, further comprising an atrial sealing member adapted for placement above an annulus of the native valve.

3. The prosthetic valve of claim 1, wherein the spiral portion has an oval shape.

4. The prosthetic valve of claim 1, wherein the spiral portion has a circular shape.

5. The prosthetic valve of claim 1, further comprising a second ventricular anchor coupled to the frame of the main body, the second ventricular anchor comprising a second spiral portion configured such that a leaflet of a native valve of the heart may be held securely between the second spiral portion and the frame of the main body.

6. The prosthetic valve of claim 1, further comprising padding configured to cover at least a portion of the first ventricular anchor.

7. The prosthetic valve of claim 6, wherein the padding is a moveable padding pocket that may be moved on to the first ventricular anchor after implantation in the heart.

8. The prosthetic valve of claim 7, wherein the padding pocket automatically moves on to the first ventricular anchor when the prosthetic valve is expanded from a compressed state to an expanded state.

9. The prosthetic valve of claim 1, wherein the first ventricular anchor is coupled to the frame by a spring-shaped connection that distributes strain over a relatively large region of the spring-shaped connection when the ventricular anchor is bent outwardly.

10. The prosthetic valve of claim 1, wherein a first end of the first ventricular anchor is coupled to the frame by a first pivot connection and a second end of the first ventricular anchor is coupled to the frame by a second pivot connection, such that when the main body is in an expended configuration, the first pivot connection and the second pivot connections are positioned at different heights relative to a first end of the main body, and such that when the main body is in an compressed configuration, the first pivot connection and the second pivot connection are positioned at similar height relative to the first end of the main body.

11. The prosthetic valve of claim 1, wherein the first ventricular anchor comprises two or more wires forming the first ventricular anchor.

12. A prosthetic valve for implantation within a native mitral valve, comprising:

a main body comprising a tubular frame and a one-way valve positioned within the frame, the main body sized for placement within a native mitral valve; and

a first ventricular anchor comprising a first set of struts, wherein the first set of struts are at least partially disconnected from an adjacent portion of the frame such that the first set of struts can expand outwardly away from the frame for positioning behind a posterior leaflet of the native mitral valve.

13. The prosthetic valve of claim 12, wherein the first set of struts has a zig-zag shape and is located along an outflow portion of the prosthetic valve.

14. The prosthetic valve of claim 12, further comprising a second ventricular anchor comprising a second set of struts, wherein the second set of struts are at least partially disconnected from the frame such that the second set of struts can expand outwardly away from the frame for positioning behind an anterior leaflet of the native mitral valve.

15. A prosthetic valve for implantation within a heart, comprising:

a main body comprising a frame including a first anchor-receiving region; and

a first ventricular anchor coupled to the frame and having a shape corresponding to the first anchor-receiving region such that the first ventricular anchor is capable of fitting within the anchor-receiving region of the frame.

16. The prosthetic valve of claim 15, wherein the first anchor-receiving region forms a first window in the frame.

17. The prosthetic valve of claim 16, wherein the first window and the first ventricular anchor are configured to receive a leaflet of a native valve of the heart such that the first window and the first ventricular anchor apply pinching forces in a direction parallel or generally parallel to the leaflet.

18. The prosthetic valve of claim 16, further comprising a skirt disposed within the first window.

19. The prosthetic valve of claim 18, wherein the skirt comprises a biocompatible cloth.

20. The prosthetic valve of claim 15, further comprising a second ventricular anchor having a shape similar to a second anchor-receiving region of the frame and being coupled to the frame such that the second ventricular anchor fits within the second anchor-receiving region of the frame.