Granted Patent B2

US 12,193,934 · App. 17/938,880 · Granted Jan 14, 2025

Inventors: Juan F. Granada (Upper Saddle River, NJ); Gary Erzberger (Plymouth, MN); Michael P. Corcoran (Woodbury, MN); Dan Wallace (Santa Cruz, CA); Matteo Montorfano (Milan, IT); Alaide Chieffo (Milan, IT)

Assignee: Cephea Valve Technologies, Inc.

A61F2/2436A61F2/2409A61F2/2412A61F2/2418A61F2/2427A61F2/2439A61F2002/9665A61F2220/0008A61F2230/0065

Abstract

Claims (36)

1. A method of delivering a prosthetic mitral valve comprising:

delivering a first anchor portion of the prosthetic mitral valve from a delivery sheath such that the first anchor portion begins to self-expand inside a first heart chamber on a first side of a mitral valve annulus;

after the first anchor portion begins to self-expand, moving the first anchor portion such that the first anchor portion contacts the mitral valve annulus;

during or after moving the first anchor portion, delivering a central portion of the prosthetic mitral valve from the delivery sheath such that the central portion self-expands, the central portion being positioned between the first anchor portion and a second anchor portion of the prosthetic mitral valve, wherein retention hooks extend from the central portion; and

after moving the first anchor portion, delivering the second anchor portion from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that (a) the central portion has a central diameter and applies a radial force outwardly against the mitral valve annulus; and (b) the second anchor portion self-expands and has a second diameter greater than the central diameter.

2. The method of claim 1 , wherein prosthetic mitral valve is delivered by passing the prosthetic mitral valve through (i) an apex of the heart or (ii) a venous system into a left heart via a transeptal puncture.

3. The method of claim 1 , wherein the first heart chamber is a ventricle and the second heart chamber is an atrium.

4. The method of claim 3 , wherein the first anchor portion is a distal anchor portion and the second anchor portion is a proximal anchor portion.

5. The method of claim 1 , wherein the first anchor portion comprises a first portion of a first outer frame and a first portion of a second outer frame.

6. The method of claim 5 , wherein the second anchor portion comprises a second portion of the first outer frame and a second portion of the second outer frame.

7. The method of claim 6 , wherein, in an expanded condition of the prosthetic mitral valve, the first anchor portion is substantially parallel to the second anchor portion.

8. The method of claim 1 , wherein the retention hooks are curved.

9. The method of claim 1 , wherein, in an expanded condition of the prosthetic mitral valve, the retention hooks extend toward the central portion of the prosthetic mitral valve.

10. The method of claim 1 , wherein the first anchor portion and the second anchor portion are connected to one another through the central portion.

11. The method of claim 1 , wherein struts extend distally from at least one of the first anchor portion and the central portion, the struts being configured to secure prosthetic leaflets.

12. The method of claim 1 , wherein moving the first anchor portion includes pulling the first anchor proximally.

13. The method of claim 1 , wherein in an implanted condition of the prosthetic mitral valve, the first anchor portion has a first diameter that is greater than the central diameter.

14. The method of claim 13 , wherein in the implanted condition of the prosthetic mitral valve, the first diameter and the second diameter are greater than a diameter of the mitral valve annulus.

15. The method of claim 14 , wherein in the implanted condition of the prosthetic mitral valve, the first diameter is the same as the second diameter.

16. The method of claim 1 , wherein after delivering the central portion and after delivering the second anchor portion, retracting a distal tip of the delivery sheath from a left ventricle and through the prosthetic mitral valve and into a left atrium.

17. A method of delivering a prosthetic mitral valve comprising:

folding and compressing the prosthetic mitral valve within a delivery sheath;

delivering a first anchor portion of the prosthetic mitral valve from the delivery sheath such that the first anchor portion begins to self-expand inside a first heart chamber on a first side of a mitral valve annulus;

after the first anchor portion begins to self-expand, moving the first anchor portion such that the first anchor portion contacts the mitral valve annulus;

during or after moving the first anchor portion, delivering a central portion of the prosthetic mitral valve from the delivery sheath such that the central portion self-expands, the central portion being positioned between the first anchor portion and a second anchor portion of the prosthetic mitral valve; and

after moving the first anchor portion, delivering the second anchor portion from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that (a) the central portion has a central diameter and applies a radial force outwardly against the mitral valve annulus; and (b) the second anchor portion self-expands and has a second diameter greater than the central diameter.

18. The method of claim 17 , further comprising:

after the first anchor portion begins to self-expand, resheathing the prosthetic mitral valve into the delivery sheath;

repositioning the prosthetic mitral valve relative to the mitral valve annulus; and

re-deploying the prosthetic mitral valve from the delivery sheath.

19. A method of delivering a prosthetic mitral valve comprising:

delivering a first anchor portion of the prosthetic mitral valve from a delivery sheath such that the first anchor portion begins to self-expand inside a first heart chamber on a first side of a mitral valve annulus;

after the first anchor portion begins to self-expand, moving the first anchor portion such that the first anchor portion contacts the mitral valve annulus;

during or after moving the first anchor portion, delivering a central portion of the prosthetic mitral valve from the delivery sheath such that the central portion self-expands, the central portion being positioned between the first anchor portion and a second anchor portion of the prosthetic mitral valve; and

after moving the first anchor portion, delivering the second anchor portion from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that (a) the central portion has a central diameter and applies a radial force outwardly against the mitral valve annulus; and (b) the second anchor portion self-expands and has a second diameter greater than the central diameter,

wherein in an implanted condition of the prosthetic mitral valve, the central portion lines the mitral valve annulus while the first anchor portion and the second anchor portion pinch tissue of the mitral valve annulus therebetween.

Assignments (1)

Continuity (6)

References Cited (400)