Replacement cardiac valves and methods of use and manufacture

• US 10,433,953 B2
• Filed: 08/04/2017
• Issued: 10/08/2019
• 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:
  US15/669,788
• Publication Number:
  US 20170325941A1
• Time in Patent Office: 795 Days
• 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 frame extending along a longitudinal axis comprising;

a flared ventricular anchor having a first plurality of interconnected arcuate portions extending around an outer perimeter thereof;

a flared atrial anchor having a first frame and a separate second frame, the first frame having a second plurality of interconnected arcuate portions extending around an outer perimeter of the flared atrial anchor, the second frame having a third plurality of interconnected arcuate portions extending around the outer perimeter of the flared atrial anchor, wherein there are more arcuate portions in the first plurality than in each of the second plurality and third plurality, and wherein the flared ventricular anchor is stiffer than the flared atrial anchor in a direction parallel to the longitudinal axis; and

a central portion, the flared ventricular anchor and the flared atrial anchor flared radially outward relative to the central portion when the replacement valve is in an expanded configuration;

a strut frame attached to the anchor frame; and

a plurality of leaflets attached to the strut frame;

wherein the replacement mitral valve is configured to self-expand from a collapsed configuration to the expanded configuration.

2. The replacement mitral valve of claim 1, wherein there are twice as many arcuate portions in the first plurality than in the second plurality.

3. The replacement mitral valve of claim 1, wherein the strut frame is an annular strut frame positioned radially within the anchor frame.

4. The replacement mitral valve of claim 1, wherein the strut frame extends distally past the anchor frame.

5. The replacement mitral valve of claim 1, wherein the anchor frame comprises a plurality of diamond-shaped cells.

6. The replacement mitral valve of claim 1, wherein the strut frame is attached to the anchor frame with a plurality of rivets.

7. The replacement mitral valve of claim 1, wherein the arcuate portions of the first plurality of arcuate portions or the second plurality of arcuate portions are substantially triangular-shaped.

8. The replacement mitral valve of claim 1, wherein the arcuate portions of the first plurality of arcuate portions are configured to point towards the ventricle when the replacement valve is implanted.

9. The replacement mitral valve of claim 1, wherein each of the arcuate portions of the first plurality of interconnected arcuate portions, the second plurality of interconnected arcuate portions and the third plurality of interconnected arcuate portions includes peaks forming a radial outermost portions of the anchors and valleys, a linear distance between valleys of the arcuate portions of the first plurality being less than a linear distance between valleys of the arcuate portions of the second and third plurality.

10. The replacement mitral valve of claim 1, further including hooks extending from the replacement mitral valve, the hooks configured to enhance engagement with native tissue when the replacement valve is implanted.

11. A replacement mitral valve, comprising:

an anchor frame comprising;

a ventricular anchor having a plurality of interconnected ventricular cells extending around an outer perimeter thereof;

an atrial anchor having a first frame and a separate second frame each having a plurality of interconnected atrial cells extending around an outer perimeter thereof, wherein there are more ventricular cells than atrial cells and wherein a linear distance between ventricular valleys of the ventricular cells is less than a linear distance between atrial valleys of the atrial cells; and

a central portion, the ventricular anchor and the atrial anchor flared radially outward relative to the central portion;

an annular strut frame positioned radially within and attached to the anchor frame; and

a plurality of leaflets attached to the annular strut frame.

12. The replacement mitral valve of claim 11, wherein there are twice as many ventricular cells than atrial cells.

13. The replacement mitral valve of claim 11, wherein the replacement mitral valve is configured to self-expand from a collapsed configuration to the expanded configuration.

14. The replacement mitral valve of claim 11, wherein the annular strut frame extends distally past the anchor frame.

15. The replacement mitral valve of claim 11, wherein the ventricular cells are diamond-shaped cells.

16. The replacement mitral valve of claim 11, wherein the annular strut frame is attached to the anchor frame with a plurality of rivets.

17. The replacement mitral valve of claim 11, wherein the ventricular cells are configured to point towards the ventricle when the replacement valve is implanted.

18. The replacement mitral valve of claim 11, further including hooks extending from the replacement mitral valve, the hooks configured to enhance engagement with native tissue when the replacement valve is implanted.

19. A replacement mitral valve, comprising:

an anchor frame comprising;

a ventricular anchor having a first plurality of interconnected arcuate portions extending around an outer perimeter thereof;

an atrial anchor having a first frame and a separate second frame, the first frame having a second plurality of interconnected arcuate portions extending around an outer perimeter of the atrial anchor, the second frame having a third plurality of interconnected arcuate portions extending around the perimeter of the atrial anchor, wherein there are more arcuate portions in the first plurality than in each of the second plurality and third plurality; and

a central portion, the ventricular anchor and the atrial anchor flared radially outward relative to the central portion when the replacement valve is in an expanded configuration;

a strut frame attached to the anchor frame; and

a plurality of leaflets attached to the strut frame;

wherein the replacement mitral valve is configured to self-expand from a collapsed configuration to the expanded configuration to compress native cardiac tissue between the first plurality of arcuate portions and the second plurality of arcuate portions.

20. The replacement mitral valve of claim 19, wherein the ventricular anchor is stiffer than the atrial anchor.

21. The replacement mitral valve of claim 19, wherein each of the arcuate portions of the first plurality of interconnected arcuate portions, the second plurality of interconnected arcuate portions and the third plurality of interconnected arcuate portions includes peaks forming radially outermost portions of the anchors and valleys, a linear distance between valleys of the arcuate portions of the first plurality being less than a linear distance between valleys of the arcuate portions of the second and third plurality.