Transcatheter heart valve for replacing natural mitral valve

• US 10,470,876 B2
• Filed: 11/08/2016
• Issued: 11/12/2019
• 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
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US15/345,857
• Publication Number:
  US 20170128199A1
• Time in Patent Office: 1,099 Days
• Field of Search: 623 11- 113
• 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 defining a plurality of openings and a first anchor-receiving region, and being configured to be in a radially compressed state during delivery to the heart; and

a first ventricular anchor being coupled to the frame, having a shape corresponding to the first anchor-receiving region such that the first ventricular anchor is located within the first anchor-receiving region of the frame for achieving a reduced-diameter profile of the frame when the frame is in the radially compressed state, and being configured to receive a native leaflet of a native valve of the heart between the first ventricular anchor and two or more of the plurality of openings to anchor the main body within the native valve.

2. The prosthetic valve of claim 1, wherein the first anchor-receiving region forms a first window in the frame.

3. The prosthetic valve of claim 2, further comprising a skirt disposed within the first window.

4. The prosthetic valve of claim 3, wherein the skirt comprises a biocompatible cloth.

5. The prosthetic valve of claim 1, 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.

6. A prosthetic replacement valve for implantation in a defective native mitral valve, comprising:

a tubular metallic frame formed with a plurality of openings and a plurality of anchor-receiving regions disposed along a wall of the frame;

a plurality of prosthetic leaflets mounted within the frame for regulating a flow of blood in one direction through the prosthetic replacement valve; and

a plurality of ventricular anchors coupled to the frame, each ventricular anchor having a shape corresponding to one of the anchor-receiving regions;

wherein the ventricular anchors are shaped to be received within the anchor-receiving regions of the frame during delivery of the prosthetic replacement valve to the native mitral valve for reducing a diameter of the prosthetic replacement valve, and

wherein the ventricular anchors are configured to receive and surround respective native leaflets of the defective native mitral valve between respective ventricular anchors and two or more of the plurality of openings of the tubular metallic frame when the prosthetic replacement valve is implanted in the defective native mitral valve.

7. The prosthetic valve of claim 6, wherein each anchor-receiving region forms a gap in the wall of the frame and wherein each gap corresponds to a shape of a ventricular anchor.

8. The prosthetic valve of claim 7, wherein the ventricular anchors are adapted for capturing native leaflets of the native mitral valve in a space between the ventricular anchors and the frame during implantation and wherein the native leaflets of the native mitral valve are at least partially pulled into the anchor-receiving regions.

9. The prosthetic valve of claim 7, further comprising a fabric skirt disposed within at least one gap in the wall of the frame for assisting with alignment of at least one ventricular anchor with respect to the wall of the frame.

10. The prosthetic valve of claim 9, wherein the skirt comprises a biocompatible cloth.