TWO STAGE ANCHOR AND MITRAL VALVE ASSEMBLY

• US 20150359629A1
• Filed: 03/31/2015
• Published: 12/17/2015
• Est. Priority Date: 06/12/2014
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Ganesan, Kavitha, Venkatasubramanian, Ramji T., Forsberg, Andrew T., Peterson, Alex A., Schweich, Cyril J. Jr., Mortier, Todd J.
• Granted Patent: US 9,974,647 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2250/006 modular

Abstract

Systems and methods for medical interventional procedures, including approaches to valve implantation. In one aspect, the methods and systems involve a modular approach to mitral valve therapy.

Claims

1. A prosthetic mitral valve system configured to be implanted in multiple stages, comprising:

an anchoring structure configured to be received adjacent a native mitral valve, the anchoring structure including sub-annular projections configured to engage a sub-annular commissural gutter of the native mitral valve, the anchoring structure including a retention structure configured to reside above an annulus of the native mitral valve, the retention structure comprising at least one supra-annular arch segment extending between adjacent sub-annular projections; and

an artificial valve assembly configured to be implanted separately from the anchoring structure and to be received by the anchoring structure.

2. The system of claim 1, further comprising supra-annular arch segments extending between each pair of adjacent sub-annular projections such that the supra-annular arch segments form a continuous ring-like structure configured to mechanically engage with the valve assembly.

3. The system of claim 2, wherein the supra-annular arch segments are at least partially covered with fabric.

4. The system of claim 2, wherein the anchoring structure comprises three supra-annular arch segments.

5. The system of claim 1, wherein the retention structure further comprises bridge supports extending between each pair of adjacent supra-annular arch segments.

6. The system of claim 1, wherein the anchoring structure includes an anti-SAM component.

7. The system of claim 1, wherein the anchoring structure includes a central hub.

8. A method of implanting a prosthetic heart valve, the method comprising:

implanting an anchor structure adjacent a native valve of a heart by placing sub-annular projections of the anchor structure within an anatomical sub-annular gutter of the native valve and by placing a retention structure of the anchor structure above an annulus of the native valve, the retention structure comprising at least one supra-annular arch segment extending between adjacent sub-annular projections;

advancing a valve delivery catheter into the heart;

advancing an artificial valve out of the delivery catheter and into the heart; and

connecting the artificial valve to the implanted anchor structure.

9. The method of claim 8, wherein the anchor structure further comprises supra-annular arch segments extending between each pair of adjacent sub-annular projections such that the supra-annular arch segments form a continuous ring-like structure configured to mechanically engage with the artificial valve.

10. The method of claim 8, wherein the prosthetic heart valve is implanted at a mitral valve annulus without substantially reshaping the annulus.

11. The method of claim 8, wherein placing the anchor structure within the anatomical sub-annular gutter of the native valve comprises positioning one or more anchor feet of the anchor structure within the anatomical sub-annular gutter.

12. The method of claim 8, wherein implantation of the anchor structure has little or no impact on functions of the native heart valve.

13. The method of claim 8, wherein the anchor structure includes a hub, and the implanting the anchor structure comprises releasably connecting a push rod to the hub and using the push rod to facilitate the placing the anchor structure within the anatomical sub-annular gutter of the native valve.

14. A prosthetic mitral valve system comprising:

an anchoring structure configured to be received adjacent a native mitral valve, the anchoring structure including one or more sub-annular projections configured to engage a sub-annular gutter of the native mitral valve to position the anchoring structure relative to the native mitral valve, the anchoring structure including a retention structure configured to reside above an annulus of the native mitral valve, the retention structure comprising at least one supra-annular arch segment extending between adjacent sub-annular projections.

15. The system of claim 14, further comprising supra-annular arch segments extending between each pair of adjacent sub-annular projections such that the supra-annular arch segments form a continuous ring-like structure configured to mechanically engage with the valve assembly.

16. The system of claim 14, wherein the anchoring structure includes an anti-SAM component.

17. The system of claim 14, wherein the retention structure further comprises bridge supports extending between each pair of adjacent supra-annular arch segment.

18. The system of claim 14, wherein the anchoring structure includes a central hub.

19. The system of claim 14, further comprising a prosthetic valve assembly, comprising:

an external outer surface configured to mechanically engage within an internal space defined by the anchoring structure; and

an annulus passageway smaller in diameter than the outer surface.

20. The system of claim 14, further comprising a prosthetic valve assembly configured to be positioned within an internal space defined by the anchoring structure, the prosthetic valve assembly comprising:

an expandable frame with a stent structure having an inferior end and a superior end, the inferior end having a non-circular axial opening larger than a circular axial opening in the superior end;

three arches disposed at the superior end of the expandable frame, each arch having an apex at the superior end and defining three troughs therebetween,

three posts attached to each trough respectively and extending in an inferior direction; and

tissue attached to the three arches and three posts to define three leaflets of the prosthetic valve assembly.