Systems and methods for heart valve therapy

• US 10,449,039 B2
• Filed: 03/17/2016
• Issued: 10/22/2019
• Est. Priority Date: 03/19/2015
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Ganesan, Kavitha, Venkatasubramanian, Ramji T., Schweich, Jr., Cyril J., Mortier, Todd J.
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/072,588
• Publication Number:
  US 20160270911A1
• Time in Patent Office: 1,314 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2250/006 modular

Abstract

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. For example, this document describes prosthetic heart valve designs and techniques that reduce or prevent obstructions of the left ventricular outflow tract that may otherwise result from systolic anterior motion of an anterior leaflet of the native mitral valve.

Claims

1. A prosthetic mitral valve system comprising:

a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame; and

an anchor assembly comprising an expandable anchor frame, the anchor assembly configured to selectively couple with the valve assembly, the expandable anchor frame comprising;

a systolic anterior motion (SAM) containment member that is configured to be at least partially disposed behind an anterior leaflet of a native mitral valve when the expandable anchor frame is engaged with the native mitral valve;

a hub member located at an end of the expandable anchor frame; and

a plurality of elongate members attached to and extending from the hub member, each elongate member including a sub-annular projection configured to engage ventricular tissue proximate to an annulus of the native mitral valve when the expandable anchor frame is engaged with the native mitral valve,

wherein the SAM containment member is attached to and extends between two adjacent elongate members of the plurality of elongate members.

2. The prosthetic mitral valve system of claim 1, wherein the expandable valve frame of the valve assembly is configured to be in a collapsed condition positioned inwardly of the expandable anchor frame of the anchor assembly when the expandable anchor frame is engaged with the native mitral valve, and the expandable valve frame of the valve assembly is configured to subsequently expand when positioned inwardly of the expandable anchor frame of the anchor assembly so as to selectively couple the anchor assembly and the valve assembly.

3. The prosthetic mitral valve system of claim 2, wherein a space is defined between an outwardly facing periphery of the valve assembly and the SAM containment member that is configured to loosely contain the anterior leaflet when the prosthetic mitral valve system is engaged with the native mitral valve.

4. The prosthetic mitral valve system of claim 1, wherein the SAM containment member further comprises an attachment element.

5. The prosthetic mitral valve system of claim 4, further comprising a delivery system for deploying the anchor assembly, wherein the delivery system comprises a catheter with a threaded distal end portion that is configured to threadedly engage with a complimentarily threaded eyelet defined by the attachment element.

6. The prosthetic mitral valve system of claim 4, further comprising a delivery system for deploying the anchor assembly, wherein the delivery system comprises a control wire configured to engage with the attachment element.

7. The prosthetic mitral valve system of claim 1, wherein the expandable anchor frame includes a single SAM containment member.

8. A prosthetic mitral valve system comprising:

an expandable frame with an occluder coupled thereto, wherein the expandable frame comprises;

a systolic anterior motion (SAM) containment member that is configured to be at least partially disposed behind an anterior leaflet of a native mitral valve when the expandable frame is engaged with the native mitral valve, the SAM containment member comprising an attachment element;

a hub member located at an end of the expandable anchor frame; and

a plurality of elongate members attached to and extending from the hub member, each elongate member including a sub-annular projection configured to engage ventricular tissue proximate to an annulus of the native mitral valve when the expandable frame is engaged with the native mitral valve,

wherein the SAM containment member is attached to and extends between two adjacent elongate members of the plurality of elongate members; and

a delivery system for transcatheter deployment of the expandable frame within the native mitral valve, wherein the delivery system is releasably coupleable with the attachment element.

9. The prosthetic mitral valve system of claim 8, wherein the attachment element comprises an eyelet.

10. The prosthetic mitral valve system of claim 9, wherein the eyelet includes eyelet threads, and wherein the delivery system comprises a member with threads that are complementary with the eyelet threads.

11. The prosthetic mitral valve system of claim 9, wherein the delivery system comprises a control wire that engages with the eyelet.

12. The prosthetic mitral valve system of claim 8, wherein the expandable frame includes a single SAM containment member, and the expandable frame is an expandable anchor frame;

and wherein the occluder is mounted to an expandable valve frame of a valve assembly, the expandable valve frame being configured to be in a collapsed condition positioned inwardly of the expandable anchor frame when the expandable anchor frame is engaged with the native mitral valve, and the expandable valve frame of the valve assembly is configured to subsequently expand when positioned inwardly of the expandable anchor frame so as to couple the expandable anchor frame and the occluder of the valve assembly.

13. An anchor assembly of a prosthetic mitral valve system, the anchor assembly comprising:

an expandable anchor frame that is adjustable between a radially compressed delivery condition and a radially expanded deployed condition in which the expandable anchor frame is configured to engage with a native mitral valve, the anchor assembly configured to selectively mate with a subsequently deliverable valve assembly of a prosthetic mitral valve system, wherein the expandable anchor frame comprises;

a systolic anterior motion (SAM) containment member that is configured to be at least partially disposed behind an anterior leaflet of the native mitral valve when the expandable anchor frame is engaged with the native mitral valve;

a hub member located at an end of the expandable anchor frame; and

a plurality of elongate members attached to and extending from the hub member, each elongate member including a sub-annular projection configured to engage ventricular tissue proximate to an annulus of the native mitral valve when the expandable anchor frame is engaged with the native mitral valve,

wherein the SAM containment member is attached to and extends between two adjacent elongate members of the plurality of elongate members.

14. The anchor assembly of claim 13, wherein the SAM containment member further comprises an attachment element configured to releasably engage with a portion of a delivery system.

15. The anchor assembly of claim 14, wherein the attachment element comprises an eyelet.

16. The anchor assembly of claim 13, wherein the expandable anchor frame includes a single SAM containment member.