# US 10,945,842 B2 · Annular augmentation device for cardiac valve repair

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- Number: US 10,945,842 B2
- Document ID: US10945842B2
- Status: Granted
- Kind: B2
- Application number: 15/629,505
- Filed: 2017-06-21
- Published: 2018-02-08
- Granted: 2021-03-16
- Earliest claimed: 2016-08-04
- Assignees: Evalve, Inc.
- Applicants: Evalve Inc.
- Inventors: Michael F. Wei; Chad J. Abunassar
- Web page: https://patentgrep.com/patent/US10945842B2

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- 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 2/2466: {Delivery devices therefor}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- 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

The present disclosure relates to repair devices for repair of regurgitant mitral valves. A repair device includes a body having a perimeter defining an upper side and a lower side. An annular groove is disposed along a posterior section of the perimeter of the device and is configured to receive posterior rim tissue of a mitral valve annulus. First and second anchors extend from the body in an anterior direction. The first and second anchors are configured to engage with respective commissures of the mitral valve to assist in securing the repair device in position. The repair device is structured to minimize or eliminate imparting or transmitting radially outward forces along an anterior section so as to avoid imparting forces to the septum to avoid hindering the function of the aortic valve and the left ventricular outflow tract.

## Claims

### Claim 1

A repair device configured for repairing tissue at a targeted anatomical location, the repair device comprising:
a body having a perimeter that defines an upper side and a lower side, the perimeter having a posterior section and an anterior section, the body being shaped so as to define an annular groove disposed along at least a portion of the posterior section, the annular groove being configured to receive tissue of the targeted anatomical location when the repair device is deployed at the targeted anatomical location;
a first anchor extending from the body in an anterior direction, the first anchor comprising an atraumatic end; and
a second anchor extending from the body in the anterior direction, the second anchor comprising an atraumatic end,
wherein the first and second anchors are configured to engage with tissue to prevent movement of the repair device from the targeted anatomical location when the repair device is deployed at the targeted anatomical location, and
wherein each of the first anchor and second anchor includes a flexible upper section and a flexible lower section configured to grip tissue therebetween.

### Claim 2 (depends on 1)

The repair device of claim 1, wherein the first and second anchors are substantially coplanar with the annular groove.

### Claim 3 (depends on 1)

The repair device of claim 1, wherein the body has a crescent shape with a convex side and a concave side, the convex side defining the posterior section and the concave side defining the anterior section.

### Claim 4 (depends on 3)

The repair device of claim 3, wherein the first anchor extends from a first intersection between the convex side and the concave side, and wherein the second anchor extends from a second intersection between the convex side and the concave side.

### Claim 5 (depends on 1)

The repair device of claim 1, wherein the annular groove extends across more than 50% of the perimeter of the body.

### Claim 6 (depends on 1)

The repair device of claim 1, wherein at least one of the first anchor or second anchor is formed from one or more coiled or spiraled wire elements.

### Claim 7 (depends on 1)

The repair device of claim 1, wherein the upper and lower sections are biased toward one another.

### Claim 8 (depends on 1)

The repair device of claim 1, wherein the repair device is radially outwardly biased along the posterior section and is not radially outwardly biased along the anterior section.

### Claim 9 (depends on 1)

The repair device of claim 1, wherein at least the body of the repair device includes a wire framework formed from a superelastic wire material.

### Claim 10 (depends on 9)

The repair device of claim 9, wherein the body further includes a cover or an insert integrated with the wire framework.

### Claim 11 (depends on 1)

The repair device of claim 1, wherein at least a portion of the repair device is formed from an expandable porous polymer.

### Claim 12

A repair device configured for repairing a regurgitant mitral valve, the repair device comprising:
a crescent-shaped body having a perimeter that defines an upper side and a lower side, the perimeter having a posterior section defined by a convex side of the crescent-shaped body and an anterior section defined by a concave side of the crescent-shaped body, the body being shaped so as to define an annular groove disposed along at least a portion of the posterior section, the annular groove being configured to receive tissue of a posterior rim of a targeted mitral valve when the repair device is deployed at the targeted mitral valve;
a first anchor extending from the anterior section, the first anchor comprising an atraumatic end; and
a second anchor extending from the anterior section, the second anchor comprising an atraumatic end,
wherein the first and second anchors are configured to engage with commissure tissue of the mitral valve to prevent movement of the repair device from the targeted mitral valve when the repair device is deployed at the targeted mitral valve, each of the first anchor and second anchor including a flexible upper section and a flexible lower section configured to grip tissue therebetween, and
wherein the repair device is radially outwardly biased along the posterior section and is not radially outwardly biased along the anterior section.

### Claim 13 (depends on 12)

The repair device of claim 12, wherein the at least one of the first anchor or second anchor is formed from one or more coiled or spiraled wire elements.

### Claim 14 (depends on 12)

The repair device of claim 12, wherein the upper and lower sections are biased toward one another.

### Claim 15 (depends on 12)

The repair device of claim 12, wherein at least the body of the repair device includes a wire framework formed from a superelastic wire material.

### Claim 16 (depends on 12)

The repair device of claim 12, wherein the body is configured in size and shape to enable an anterior leaflet of the targeted mitral valve to coapt and seal against the body.

### Claim 17 (depends on 6)

The repair device of claim 6, wherein the one or more coiled or spiraled wire elements includes multiple wire turns.

### Claim 18 (depends on 13)

The repair device of claim 13, wherein the one or more coiled or spiraled wire elements includes multiple wire turns.
