Systems and methods for heart valve therapy

• US 9,750,607 B2
• Filed: 03/31/2015
• Issued: 09/05/2017
• Est. Priority Date: 10/23/2014
• 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., Schweich, Jr., Cyril J., Mortier, Todd J., Martz, Erik O., Krone, Douglas J.
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US14/674,349
• Publication Number:
  US 20160113768A1
• Time in Patent Office: 889 Days
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

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 that interface with native mitral valve structures to create a fluid seal, thereby minimizing mitral regurgitation and paravalvular leaks. This document also describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. In addition, this document describes prosthetic heart valve designs and techniques that reduce the risk of interference between the prosthetic valves and chordae tendineae.

Claims

1. A prosthetic mitral valve system comprising:

a valve assembly comprising;

a frame member defining an outer profile and an interior frame member space; and

an occluder disposed within the interior frame member space, the occluder having an open configuration and a closed configuration,

wherein the frame member comprises a proximal end frame portion and a distal end frame portion, wherein an outer periphery of the distal end frame portion comprises a generally flat region and a generally round region, and wherein at least some portions of the generally flat region extend distally toward the interior frame member space; and

an anchor assembly defining an interior anchor assembly space, wherein the valve assembly is selectively mate-able with the interior anchor assembly space, wherein the anchor assembly comprises an expandable anchor frame including a hub and a sub-annular support arm extending from the hub, wherein the sub-annular support arm extends to an anchor foot having a surface configured for engagement with a sub-annular gutter of a native mitral valve.

2. The prosthetic mitral valve of claim 1, wherein a distance measured parallel to a longitudinal axis of the valve assembly from a distal-most end of the anchor assembly to the surface is at least 14 millimeters.

3. The prosthetic mitral valve of claim 1, wherein the distal end frame portion comprises a generally D-shaped outer periphery, and wherein the proximal end frame portion comprises a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

4. A method of using a prosthetic mitral valve system, comprising:

prior to implanting a valve assembly, engaging an anchor assembly of the prosthetic mitral valve system with tissue proximate to an annulus of the native mitral valve, the anchor assembly defining an interior anchor assembly space, and wherein said anchoring the valve assembly comprises interlocking the valve assembly within the interior anchor assembly space, wherein the anchor assembly comprises an expandable anchor frame including a hub and a sub-annular support arm extending from the hub, wherein the sub-annular support arm extends to an anchor foot having a surface configured for engagement with a sub-annular gutter of the native mitral valve;

advancing the valve assembly of the prosthetic mitral valve system toward the annulus of the native mitral valve, the valve assembly comprising;

a frame member defining an outer profile and an interior frame member space; and

an occluder disposed within the interior frame member space, the occluder having an open configuration and a closed configuration,

wherein the frame member comprises a proximal end frame portion and a distal end frame portion, wherein an outer periphery of the distal end frame portion comprises a generally flat region and a generally round region, and wherein at least some portions of the generally flat region extend toward the interior frame member space; and

anchoring the valve assembly at the native mitral valve such that the generally flat region is adjacent to an anterior native leaflet of the native mitral valve.

5. The method of claim 4, wherein a distance measured parallel to a longitudinal axis of the valve assembly from a distal-most end of the anchor assembly to the surface is at least 14 millimeters.

6. The method of claim 4, wherein the distal end frame portion comprises a generally D-shaped outer periphery, and wherein the proximal end frame portion comprises a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

7. A prosthetic mitral valve system that is implantable at a native mitral valve, the prosthetic mitral valve system comprising:

an anchor assembly defining an interior anchor assembly space and a longitudinal axis, the anchor assembly comprising an expandable anchor frame including a hub and a sub-annular support arm extending from the hub, wherein the sub-annular support arm extends to an anchor foot having a surface configured for engagement with a sub-annular gutter of the native mitral valve; and

a valve assembly comprising;

an expandable valve frame defining an outer profile and an interior frame member space; and

an occluder disposed within the interior frame member space, the occluder having an open configuration and a closed configuration,

wherein the valve assembly is releasably engageable with the anchor assembly within the interior anchor assembly space, and wherein a distance measured parallel to the longitudinal axis from a distal-most end of the anchor assembly to the surface is at least 14 millimeters.

8. The prosthetic mitral valve system of claim 7, wherein the valve assembly comprises a distal end frame portion having a generally D-shaped outer periphery, and wherein the valve assembly comprises a proximal end frame portion having a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

9. A method of using a prosthetic mitral valve system, the method comprising:

advancing an anchor assembly of the prosthetic mitral valve system toward an annulus of a native mitral valve, the anchor assembly defining an interior anchor assembly space and longitudinal axis, the anchor assembly comprising an expandable anchor frame including a hub and one or more sub-annular support arms extending from the hub, wherein each of the one or more sub-annular support arm extends to an anchor foot configured to engage with a sub-annular gutter of the native mitral valve; and

engaging the anchor assembly of the prosthetic mitral valve system with tissue proximate the native mitral valve such that a surface of each anchor foot is engaged with the sub-annular gutter, and such that the hub is positioned distal of the distal-most area of coaptation between anterior and post leaflets of the native mitral valve.

10. The method of claim 9, further comprising delivering a valve assembly of the prosthetic mitral valve system to the anchor assembly after engaging the anchor assembly with said tissue proximate the native mitral valve, a valve assembly comprising:

an expandable valve frame defining an outer profile and an interior frame member space, and an occluder disposed within the interior frame member space, the occluder having an open configuration and a closed configuration.

11. The method of claim 10, wherein the valve assembly comprises a distal end frame portion having a generally D-shaped outer periphery, and wherein the valve assembly comprises a proximal end frame portion having a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

12. The method of claim 10, wherein a distance measured parallel to a longitudinal axis of the valve assembly from a distal-most end of the anchor assembly to the surface of at least one anchor foot is at least 14 millimeters.

13. A prosthetic mitral valve system comprising:

an anchor assembly comprising an expandable anchor frame and a set of sub-annular anchor feet configured to engage with a sub-annular gutter of a native mitral valve; and

a valve assembly comprising;

an expandable valve frame defining an outer profile and an interior frame member space, a tissue layer disposed over at least a portion of the outer profile, and an occluder mounted within the interior frame member space,

wherein an outwardly facing periphery of the tissue layer along the valve assembly is positioned to abut native leaflets of the mitral valve when the set of anchor feet of the anchor assembly is engaged with the sub-annular gutter.

14. The prosthetic mitral valve system of claim 13, wherein the valve assembly comprises a distal end frame portion having a generally D-shaped outer periphery, and wherein the valve assembly comprises a proximal end frame portion having a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

15. A method of sealing between a prosthetic mitral valve system and native leaflets of a mitral valve, the method comprising:

anchoring an anchor assembly of the prosthetic mitral valve system with tissue proximate to an annulus of a native mitral valve, the anchor assembly defining an interior anchor assembly space and longitudinal axis, the anchor assembly comprising an expandable anchor frame including a hub and one or more sub-annular support arms extending from the hub, wherein each of the one or more sub-annular support arm extends to an anchor foot that engages with a sub-annular gutter of the native mitral valve; and

delivering a valve assembly of the prosthetic mitral valve system to engage with the anchor assembly, the valve assembly comprising;

an expandable valve frame defining an outer profile and an interior frame member space;

a tissue layer disposed over at least a portion of the outer profile; and

an occluder disposed within the interior frame member space, the occluder having an open configuration and a closed configuration,

wherein the tissue layer of the valve assembly abuts with native leaflets of the mitral valve while each anchor foot of the anchor assembly is engaged with the sub-annular gutter.

16. The method of claim 15, wherein the valve assembly comprises a distal end frame portion having a generally D-shaped outer periphery, and wherein the valve assembly comprises a proximal end frame portion having a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.