# US 11,439,506 B2 · Systems and methods for heart valve therapy

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- Number: US 11,439,506 B2
- Document ID: US11439506B2
- Status: Granted
- Kind: B2
- Application number: 16/801,004
- Filed: 2020-02-25
- Published: 2020-07-02
- Granted: 2022-09-13
- Earliest claimed: 2014-10-23
- Assignees: Caisson Interventional, LLC
- Applicants: Caisson Interventional, LLC
- Inventors: Kavitha Ganesan; Ramji Venkatasubramanian; Andrew T. Forsberg; Cyril J. Schweich, Jr.; Todd J. Mortier; Erik O. Martz; Douglas J. Krone
- Web page: https://patentgrep.com/patent/US11439506B2

## CPC

- A61F 2/2448: {D-shaped rings}
- A61F 2/2403: {with pivoting rigid closure members (check valves with hinged closure members in general F16K15/03)}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2230/0078: hyperboloidal
- A61F 2250/0063: Nested prosthetic parts
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 1

A prosthetic heart valve for implanting at a native valve annulus having a sub-annular gutter, the prosthetic heart valve comprising:
an anchor assembly configured for coupling with a native heart valve and comprising a hub member configured for releasable attachment to a delivery catheter;
wherein, the anchor assembly comprises an expandable anchor frame defining an interior space and including the hub member and a first sub-annular support arm extending to a first surface configured for engagement with the sub-annular gutter of the native heart valve; and
a valve assembly connected to the interior space of the anchor assembly and comprising an occluder having an open configuration adapted to allow open blood flow and a closed configuration adapted to occlude blood flow.

### Claim 2 (depends on 1)

The prosthetic heart valve of claim 1 wherein the anchor assembly is configured for coupling with a native mitral valve.

### Claim 3 (depends on 1)

The prosthetic heart valve of claim 1 wherein the occluder, in the closed configuration, completely blocks blood flow.

### Claim 4 (depends on 1)

The prosthetic heart valve of claim 1 wherein the anchor and the valve assembly are two distinct structures and further wherein the valve assembly is coupled with the anchor assembly.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 5)

The prosthetic heart valve of claim 5 wherein the first anchor surface of the expandable anchor frame is positioned to contact a first anterior portion of the sub-annular gutter and the second anchor surface of the expandable anchor frame is positioned to contact a first posterior portion of the sub-annular gutter.

### Claim 7 (depends on 6)

The prosthetic heart valve of claim 6 wherein the expandable anchor frame includes a third anchor surface and a fourth anchor surface, the third anchor surface positioned to contact a second anterior portion of the sub-annular gutter and the fourth anchor surface positioned to contact a second posterior portion of the sub-annular gutter.

### Claim 8 (depends on 7)

The prosthetic heart valve of claim 7 wherein, in an implanted configuration, the first anchor surface and the third anchor surface are spaced apart from each other by a distance of between about 30 mm to about 45 mm.

### Claim 9 (depends on 7)

The prosthetic heart valve of claim 7 wherein the anchor surfaces are positioned at locations adapted to minimize inhibition of the native heart valve leaflets.

### Claim 10 (depends on 1)

The prosthetic heart valve of claim 1 wherein the first the anchor surface includes an atraumatic surface adapted to inhibit the first anchor surface from penetrating the tissue of the native heart valve.

### Claim 11

A method of implanting a prosthetic heart valve at a native heart valve annulus having a sub-annular gutter, the method comprising:
providing a prosthetic heart valve including an expandable anchor frame having a hub member configured for releasable attachment to a delivery catheter and a first sub-annular support arm extending to a first anchor surface configured for engagement with the sub-annular gutter of the native heart valve, and the prosthetic heart valve further including a valve assembly coupleable with the anchor assembly and including an occluder having an open configuration adapted to allow open blood flow and a closed configuration adapted to occlude blood flow;
coupling a delivery catheter to the hub of the expandable anchor frame;
advancing expandable anchor frame using the delivery catheter to the native heart valve site; and
deploying the expandable anchor frame such that the first anchor surface engages the sub-annular gutter of the native heart valve.

### Claim 12 (depends on 11)

The method of claim 11 wherein the expandable anchor frame is adapted for coupling with a native mitral valve and further wherein the expandable anchor frame includes a second sub-annular support arm extending to a second anchor surface configured for engagement with the sub-annular gutter of the native mitral valve, wherein an angle between the first and second sub-annular support arms is between 100 degrees and 135 degrees.

### Claim 13 (depends on 12)

The method of claim 12 wherein the first anchor surface of the expandable anchor frame is positioned to contact a first anterior portion of the sub-annular gutter and the second anchor surface of the expandable anchor frame is positioned to contact a first posterior portion of the sub-annular gutter.

### Claim 14 (depends on 11)

The method of claim 11 wherein the deploying step includes positioning the first anchor surface ata location of the sub-annular gutter that minimizes inhibition of the native heart valve leaflets.

### Claim 15 (depends on 11)

The method of claim 11 wherein the occluder, in the closed configuration, completely blocks blood flow.

### Claim 16 (depends on 11)

The method of claim 11 wherein the first the anchor surface includes an atraumatic surface adapted to inhibit the first anchor surface from penetrating the tissue of the native heart valve.

### Claim 17 (depends on 11)

The method of claim 11 further comprising the step of releasing the delivery catheter from the hub of the expandable anchor frame and withdrawing the catheter from the native heart valve site.

### Claim 18 (depends on 17)

The method of claim 17 further comprising advancing the valve assembly to the native mitral valve site.

### Claim 19 (depends on 18)

The method of claim 18 further comprising releasing the valve assembly such that it expands and couples with an interior surface of the expandable anchor frame.

### Claim 20 (depends on 11)

The method of claim 11 wherein, before the advancing step, the valve assembly is coupled with the expandable anchor frame such that the valve assembly and expandable anchor frame are advanced together to the native mitral valve site.
