Systems and methods for heart valve therapy

• US 10,603,167 B2
• Filed: 08/24/2017
• Issued: 03/31/2020
• 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:
  US15/685,596
• Publication Number:
  US 20180000586A1
• Time in Patent Office: 950 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:

an anchor assembly configured for coupling with a native mitral valve and comprising a hub member configured for releasable attachment to a delivery catheter; and

a valve assembly coupleable with the anchor assembly and comprising an occluder,

wherein, the anchor assembly comprises an expandable anchor frame including the hub member and a first sub-annular support arm extending from the hub member, wherein the first sub-annular support arm extends to a first anchor foot having a first surface configured for engagement with a first sub-annular gutter of the native mitral valve, while the anchor assembly is engaged with the native mitral valve.

2. The prosthetic mitral valve of claim 1, wherein the anchor assembly defines an interior anchor assembly space, wherein the valve assembly is releasably coupleable within the interior anchor assembly space.

3. 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 first surface is at least 14 millimeters.

4. The prosthetic mitral valve of claim 1, wherein the valve assembly comprises a generally D-shaped outer periphery and 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.

5. The prosthetic mitral valve of claim 1, wherein the expandable anchor frame includes a second sub-annular support arm extending from the hub member, wherein the second sub-annular support arm extends to a second anchor foot having a second surface configured for engagement with a second sub-annular gutter of the native mitral valve, wherein an angle defined between the first and second sub-annular support arms is between 100 degrees to 135 degrees.

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

advancing, using a delivery catheter, an anchor assembly of the prosthetic mitral valve system through the vasculature of a patient toward an annulus of a native mitral valve, the anchor assembly comprising a hub member that is releasably attached to the delivery catheter, the anchor assembly defining an interior anchor assembly space in which a valve assembly of the prosthetic mitral valve system is received;

interlocking the valve assembly within the interior anchor assembly space; and

anchoring the anchor assembly at the native mitral valve, wherein the anchor assembly comprises an expandable anchor frame including the hub member and a first sub-annular support arm extending from the hub member, wherein the first sub-annular support arm extends to a first anchor foot having a first surface that is engaged with a first sub-annular gutter of the native mitral valve while the anchor assembly is anchored at the native mitral valve.

7. The method of claim 6, wherein a distance measured parallel to a longitudinal axis of the valve assembly from a distal-most end of the anchor assembly to the first surface is at least 14 millimeters.

8. The method of claim 6, wherein the valve assembly comprises a generally D-shaped outer periphery and 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. The method of claim 6, wherein the expandable anchor frame includes a second sub-annular support arm extending from the hub member, wherein the second sub-annular support arm extends to a second anchor foot having a second surface that is engaged with a second sub-annular gutter of the native mitral valve while the anchor assembly is anchored at the native mitral valve, and wherein an angle defined between the first and second sub-annular support arms is between 100 degrees to 135 degrees.

10. The method of claim 6, wherein the expandable anchor frame includes a second sub-annular support arm extending from the hub member, wherein the second sub-annular support arm extends to a second anchor foot having a second surface that is engaged with a second sub-annular gutter of the native mitral valve while the anchor assembly is anchored at the native mitral valve, and wherein the respective first and second surfaces of the first and second sub-annular support arms are placed at respective high collagen annular trigone regions of the native mitral valve while the anchor assembly is anchored at the native mitral valve.

11. A prosthetic mitral valve system, comprising:

an anchor assembly configured for coupling with a native mitral valve and comprising a hub member configured for releasable attachment to a delivery catheter; and

a valve assembly coupleable with the anchor assembly and comprising an occluder,

wherein the anchor assembly includes a proximal end and a distal end and, while the anchor assembly is engaged with the native mitral valve, the hub member is situated at the distal end of the anchor assembly, and

wherein the anchor assembly comprises an expandable anchor frame including the hub member and a first sub-annular support arm extending from the hub member, wherein the first sub-annular support arm extends to a first anchor foot having a first surface configured for engagement with a first sub-annular gutter of the native mitral valve.

12. The prosthetic mitral valve of claim 11, wherein the anchor assembly defines an interior anchor assembly space, wherein the valve assembly is coupleable within the interior anchor assembly space.

13. The prosthetic mitral valve of claim 11, wherein a distance measured parallel to a longitudinal axis of the valve assembly from the distal end of the anchor assembly to the first surface is at least 14 millimeters.

14. The prosthetic mitral valve of claim 11, wherein the valve assembly comprises a generally D-shaped outer periphery and 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. The prosthetic mitral valve of claim 11, wherein the anchor assembly comprises a second sub-annular support arm extending from the hub member, wherein the first and second sub-annular support arm extends to a second anchor foot having a second surface configured for engagement with a second sub-annular gutter of the native mitral valve, wherein an angle defined between the first and second sub-annular support arms is between 100 degrees to 135 degrees.