Replacement cardiac valves and methods of use and manufacture

Patent metadata

Field	Value
Publication number	US-10869755-B2
Application number	US-201514677320-A
Country	US
Kind code	B2
Filing date	Apr 2, 2015
Priority date	Dec 9, 2014
Publication date	Dec 22, 2020
Grant date	Dec 22, 2020

Abstract

Prosthetic mitral valves and their methods of manufacture and use.

First claim

What is claimed is:

1. A replacement mitral valve having a proximal and a distal end, comprising:
a self-expandable anchor comprising a ventricular anchor, a central portion, and an atrial anchor having a first frame with a plurality of first arches and a second frame with a plurality of second arches at least a portion of which overlap the plurality of first arches at the proximal end of the replacement mitral valve, the self-expandable anchor having a self-expanded configuration in which the ventricular anchor and the atrial anchor are flared radially outward relative to the central portion and relative to a longitudinal axis of the device such that the replacement mitral valve is configured to be secured within a mitral valve orifice, the ventricular anchor having a ventricular stiffness at radial outer portion of the ventricular anchor in a direction parallel to the longitudinal axis when the expandable anchor is in the self-expanded configuration and the atrial anchor having an atrial stiffness at radial outer portion of the atrial anchor in a direction parallel to the longitudinal axis when the expandable anchor is in the self-expanded configuration, the ventricular stiffness greater than the atrial stiffness; and
a plurality of replacement leaflets secured to the expandable anchor.

2. The replacement mitral valve of claim 1 wherein the ventricular anchor has a plurality of ventricular arches with a first thickness, either one of the plurality of first arches and plurality of second arches has a second thickness less than the first thickness, and wherein the thickness dimensions is measured radially when the expandable anchor is in a collapsed configuration.

3. The replacement mitral valve of claim 2 , wherein the second thickness being the thickness of the plurality of first arches, the plurality of second arches having a third thickness less than the first thickness.

4. The replacement mitral valve of claim 3 wherein the second thickness is the same as the third thickness.

5. The replacement mitral valve of claim 1 , the ventricular anchor having a plurality of ventricular arches with ventricular peaks and valleys, the first frame with the a plurality of first arches includes atrial peaks and valleys, the linear distance between ventricular valleys being less than the linear distance between atrial valleys, when the expandable anchor is in the expanded configuration.

6. The replacement mitral valve of claim 5 wherein the second frame with the plurality of second arches includes peaks and valleys, the linear distance between ventricular valleys also being less than the linear distance between valleys of the second frame.

7. The replacement mitral valve of claim 1 , the ventricular anchor having a plurality of ventricular arches with ventricular peaks and the atrial anchor having a plurality of atrial arches defining atrial peaks, wherein midpoints of the ventricular peaks have greater stiffness in the axial direction than midpoints of the atrial peaks.

8. The replacement mitral valve of claim 1 wherein the plurality of ventricular arches are stiffer than each of the first arches and the second arches in the axial direction.

9. The replacement mitral valve of claim 1 having a ventricular end and an atrial end, the two ends being the radially outermost points of either side of a midline of the expandable anchor when the anchor is in the expanded configuration.

10. The replacement mitral valve of claim 1 wherein the ventricular anchor comprises, when the expandable anchor is in a collapsed configuration, a plurality of triangular arches pointing towards a ventricular end of the replacement mitral valve, and the central portion comprises a plurality of triangular central arches pointing towards an atrial end of the replacement mitral valve.

11. The replacement mitral valve of claim 1 wherein at least a portion of the plurality of first arches and at least a portion of the plurality of second arches each comprise a protuberance at a midpoint of the arch.

12. The replacement mitral valve of claim 1 wherein the ventricular anchor comprises a plurality of arches having triangular configurations.

13. The replacement mitral valve of claim 12 wherein the plurality of arches define a plurality of peaks and a plurality of valleys, the height of the peaks being greater than the linear distance between adjacent valleys, the height being measured orthogonal to the linear distance between adjacent valleys.

14. The replacement mitral valve of claim 13 wherein the ventricular anchor comprises a plurality of arches each having the same triangular configuration with a rounded end.

15. The replacement valve of claim 1 further comprising a plurality of struts secured to the self-expandable anchor and the replacement leaflets.

16. The replacement valve of claim 15 further comprising a cylindrical strut frame secured to the self-expandable anchor, the strut frame comprising the plurality of struts.

17. The replacement valve of claim 16 wherein the strut frame is secured to the central portion of the expandable anchor.

18. The replacement valve of claim 17 wherein the strut frame includes a plurality of apertures and the central portion comprises a plurality of apertures, each of the plurality of apertures on the strut frame is aligned with an aperture on the central portion, the central portion secured to the strut frame at the location of the aligned apertures.

19. A replacement mitral valve, comprising:
a self-expandable anchor comprising a ventricular anchor, a central portion, and an atrial anchor, the self-expandable anchor having a self-expanded configuration in which the ventricular anchor and the atrial anchor are flared radially outward relative to the central portion such that the replacement mitral valve is configured to be secured within a mitral valve orifice, wherein the ventricular anchor has a plurality of ventricular arches defining ventricular peaks and valleys and the atrial anchor has a plurality of atrial arches defining atrial peaks and valleys, a ventricular linear distance between ventricular valleys being less than an atrial linear distance between atrial valleys and a ventricular height from ventricular valleys to ventricular peaks being less than an atrial height between atrial peaks and atrial valleys when the expandable anchor is in the expanded configuration such that the ventricular arches are stiffer than the atrial arches;
a cylindrical strut frame disposed radially within and secured to a radially inner portion of the self-expandable anchor;
a plurality of attachment elements connecting the cylindrical strut frame to the expandable anchor; and
a plurality of replacement leaflets secured to the self-expandable anchor.

20. The replacement mitral valve of claim 19 wherein the atrial anchor is secured to the central portion but not integral with the central portion and the ventricular anchor is integral with the central portion.

21. The replacement mitral valve of claim 20 wherein the atrial anchor is secured to the central portion at a plurality of couplings.

22. The replacement mitral valve of claim 21 wherein the atrial anchor comprises an annular frame, and wherein the annular frame is secured to the central portion at a plurality of couplings.

23. The replacement mitral valve of claim 22 wherein the atrial anchor comprises a second annular frame, wherein the second frame is secured to the central portion at a second plurality of coupl

Assignees

• Cephea Valve Tech Inc

Inventors

• Granada Juan F
• Erzberger Gary
• Corcoran Michael P
• Wallace Dan
• Montorfano Matteo
• Chieffo Alaide
• Thaure Thierry
• Grogan Aaron
• Gregg Peter

Classifications

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title

• A61B2017/00243

  cardiac · CPC title

• A61F2240/002

  Designing or making customized prostheses · CPC title