# US 2019/0167427 A1 · Implantable heart valve devices, mitral valve repair devices and associated systems and methods

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- Number: US 2019/0167427 A1
- Document ID: US20190167427A1
- Status: Published application
- Kind: A1
- Application number: 16/273,065
- Filed: 2019-02-11
- Published: 2019-06-06
- Earliest claimed: 2015-08-21
- Assignees: Twelve, Inc.
- Applicants: Twelve, Inc.
- Inventors: Hanson Gifford, III
- Web page: https://patentgrep.com/patent/US20190167427A1

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2/2487: {Devices within the heart chamber, e.g. splints}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0061: swellable
- A61F 2210/0085: hardenable in situ, e.g. epoxy resins
- A61F 2230/0004: Rounded shapes, e.g. with rounded corners
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0063: Nested prosthetic parts
- A61F 2250/0069: Sealing means
- 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

Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration, and an appendage, such as a flap or apron extending from the support. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet, and the appendage is configured to extend beyond an edge of the posterior leaflet toward the anterior leaflet.

## Claims

### Claim 1

A repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, the repair device comprising:
a support having (a) a contracted configuration in which the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae and (b) an extended configuration in which the support projects anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet sufficiently to improve coaptation of the posterior and anterior leaflets; and
an appendage, wherein in the extended configuration, the appendage extends beyond an edge of the posterior leaflet toward the anterior leaflet.

### Claim 2 (depends on 1)

The repair device of claim 1, wherein the support comprises an extension unit configured to push at least a portion of the posterior leaflet towards the anterior leaflet of the native mitral valve, and wherein the extension unit is expandable from the contracted configuration to the extended configuration.

### Claim 3 (depends on 2)

The repair device of claim 2 wherein the extension unit comprises an inflatable or fillable member.

### Claim 4 (depends on 3)

The repair device of claim 3, further comprising a port in communication with the inflatable or fillable member for delivering a fluid thereto.

### Claim 5 (depends on 2)

The repair device of claim 2 wherein the support comprises an elongated spine, the extension unit being coupled to the spine.

### Claim 6 (depends on 5)

The repair device of claim 5 wherein the extension unit is substantially more flexible than the spine in the contracted configuration.

### Claim 7 (depends on 5)

The repair device of claim 5 wherein the spine has a longitudinal axis and the extension unit is configured to expand in a direction transverse to the longitudinal axis.

### Claim 8 (depends on 5)

The repair device of claim 5 wherein the spine is curved in an unconstrained state and the extension unit is configured to expand in a radial direction relative to the spine.

### Claim 9 (depends on 2)

The repair device of claim 2 wherein the extension unit comprises a flexible cover extending around the spine.

### Claim 10 (depends on 19)

The repair device of claim 19 wherein the flexible cover is inflatable or fillable with a fluid.

### Claim 11 (depends on 2)

The repair device of claim 2 wherein the extension unit is substantially more rigid in the expanded configuration.

### Claim 12 (depends on 1)

The repair device of claim 1 wherein the support is configured to be held in the subannular position without penetrating the leaflet or heart wall tissue.

### Claim 13 (depends on 1)

The repair device of claim 1 wherein the support is configured to reside substantially entirely on the subannular side of the leaflet.

### Claim 14 (depends on 1)

The repair device of claim 1 wherein the support is configured to allow the posterior leaflet to move between a partially closed position and a completely closed position during a cardiac cycle.

### Claim 15 (depends on 1)

The repair device of claim 1 wherein the support maintains the posterior leaflet of the native mitral valve in a partially closed position so as to sealingly engage the anterior leaflet of the native mitral valve during a portion of a cardiac cycle.

### Claim 16 (depends on 1)

The repair device of claim 1 wherein the repair device has a triangular or polygonal cross-section.

### Claim 17 (depends on 1)

The repair device of claim 1 wherein the support comprises a spine and an extension unit coupled to the spine, and wherein:
the extension unit is expandable from the contracted configuration to the extended configuration;
the extension unit includes a plurality of projections and depressions; and
the projections expand between and engage chordae tendineae attached to the posterior leaflet.

### Claim 18 (depends on 17)

The repair device of claim 17 wherein the extension unit is preformed to include the plurality of projections when in a deployed configuration.

### Claim 19 (depends on 17)

The repair device of claim 17 wherein the extension unit includes at least one bladder configured to receive filler material, and wherein the extension unit is expandable with the filler material to form the plurality of projections when the repair device is in a deployed configuration.

### Claim 20 (depends on 1)

The repair device of claim 1 wherein the support expands to form a “C” shape to conform to a portion of the native mitral valve.
