Replacement cardiac valves and methods of use and manufacture

• US 10,548,721 B2
• Filed: 09/18/2015
• Issued: 02/04/2020
• Est. Priority Date: 12/09/2014
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Inventors: Wallace, Dan, Grogan, Aaron, Noe, Spencer, Gregg, Peter
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US14/858,230
• Publication Number:
  US 20160158003A1
• Time in Patent Office: 1,600 Days
• Field of Search: 623 126, 623 214, 623 217, 623 218
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/24 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 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
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Prosthetic mitral valves and their methods of manufacture and use.

Claims

1. A replacement mitral valve, comprising:

an anchor assembly comprising a ventricular anchor, an annular central portion, and an atrial anchor, wherein the anchor assembly includes a plurality of first apertures extending therethrough;

a cylindrical strut frame disposed radially within the anchor assembly, wherein the cylindrical strut frame is not integral with the anchor assembly and includes a plurality of strut members and a frame portion including a plurality of arches which define a plurality of peaks and a plurality of valleys at a proximal end of the strut frame, the plurality of valleys being spaced circumferentially around the strut frame, and a plurality of second apertures extending through the plurality of valleys, each of the plurality of second apertures being located at an apex of one of the plurality of valleys; and

a plurality of couplers, each coupler extending through one of the first apertures and one of the second apertures to couple the cylindrical strut frame to the anchor assembly at each of the first and second apertures,

wherein the replacement mitral valve is configured to self-expand from a constrained configuration to an expanded configuration in which the ventricular anchor and the atrial anchor are flared radially outward relative to the annular central portion, and the plurality of strut members extend further distally than the plurality of peaks.

2. The replacement mitral valve of claim 1, wherein at least one of the plurality of arches is disposed between each of the adjacent strut members.

3. The replacement mitral valve of claim 1, wherein the plurality of strut members are integral with the frame portion.

4. The replacement mitral valve of claim 1, wherein each of the plurality of strut members includes first and second legs that extend from the frame portion and come together to form a substantially triangular shape.

5. The replacement mitral valve of claim 1, wherein each of the plurality of couplers is a rivet.

6. The replacement mitral valve of claim 1, wherein the cylindrical strut frame comprises a plurality of diamond-shaped cells.

7. The replacement mitral valve of claim 1, wherein the replacement mitral valve is configured to foreshorten upon expansion of the anchor assembly from the constrained configuration to the expanded configuration.

8. The replacement mitral valve of claim 1, wherein the cylindrical strut frame has a different stiffness than the anchor assembly.

9. The replacement mitral valve of claim 1, wherein the annular central portion and the cylindrical strut frame form a composite cylinder.

10. The replacement mitral valve of claim 1, wherein each of the plurality of first and second apertures is circular.

11. The replacement mitral valve of claim 1, wherein each of the first and second apertures is preformed in the anchor assembly and the cylindrical strut frame prior to coupling.

12. The replacement mitral valve of claim 1, wherein the each of the first apertures is axially aligned with one of the second apertures.

13. A replacement mitral valve, comprising:

an anchor assembly comprising a ventricular anchor, an annular central portion, and an atrial anchor;

a cylindrical strut frame disposed radially within the anchor assembly and including a plurality of strut members and a frame portion including a plurality of arches defining a plurality of peaks and a plurality of valleys at a proximal end of the strut frame, the plurality of valleys being spaced circumferentially around the strut frame; and

a plurality of rivets, each rivet extending through the annular central portion and through an apex of one of the plurality of valleys of the cylindrical strut frame to secure the cylindrical strut frame to the anchor assembly;

wherein the replacement mitral valve is configured to self-expand from a constrained configuration to an expanded configuration in which the ventricular anchor and the atrial anchor are flared radially outward relative to the annular central portion, and the plurality of strut members extend further distally than the plurality of peaks.

14. The replacement mitral valve of claim 13, wherein the anchor assembly comprises a plurality of preformed first apertures and the cylindrical strut frame includes a plurality of preformed second apertures, the first and second apertures being axially aligned with one another, wherein each of the rivets extends through one of the preformed first apertures and one of the preformed second apertures.

15. The replacement mitral valve of claim 13, wherein the replacement mitral valve is configured to foreshorten upon expansion of the anchor assembly from the constrained configuration to the expanded configuration.

16. The replacement mitral valve of claim 13, wherein the cylindrical strut frame has a different stiffness than the anchor assembly.