# US 2023/0404757 A1 · Device, system, and method for transcatheter treatment of valvular regurgitation

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- Number: US 2023/0404757 A1
- Document ID: US20230404757A1
- Status: Published application
- Kind: A1
- Application number: 18/343,337
- Filed: 2023-06-28
- Published: 2023-12-21
- Earliest claimed: 2017-03-13
- Assignees: Polares Medical Inc.
- Applicants: Polares Medical Inc.
- Inventors: Alexander K. Khairkhahan; Janine C. Robinson; Alan R. Klenk; Anuja Patel; Zaya Tun; Robert Quintos; Brett Snyder
- Web page: https://patentgrep.com/patent/US20230404757A1

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0006: circular
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- 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 invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

## Claims

### Claim 1

A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising:
a first coaptation surface and an opposed second surface;
a first lateral edge, a second lateral edge, an inferior edge, and a superior edge; and
a superior zone and an inferior zone, the superior zone configured to reside in the plane of an annulus of the heart valve, the inferior zone comprising the first coaptation surface and the opposed second surface,
wherein the inferior zone comprises a laminate layer such that a thickness of the inferior zone is greater than a thickness of a portion of the superior zone.

### Claim 2 (depends on 1)

The coaptation assistance element of claim 1, wherein the laminate layer comprises ePTFE.

### Claim 3 (depends on 1)

The coaptation assistance element of claim 1, wherein the thickness of the inferior zone is at least about 25% thicker than the thickness of the portion of the superior zone.

### Claim 4 (depends on 1)

The coaptation assistance element of claim 1, wherein the thickness of the inferior zone is at least about 50% thicker than the thickness of the portion of the superior zone.

### Claim 5 (depends on 1)

The coaptation assistance element of claim 1, wherein the peripheral edge of the coaptation assistance element comprises a raised atraumatic edge surrounding only partially around the coaptation assistance element.

### Claim 6 (depends on 5)

The coaptation assistance element of claim 5, wherein the peripheral edge of the coaptation assistance element comprises a raised atraumatic edge surrounding only the inferior zone of the coaptation assistance element.

### Claim 7 (depends on 5)

The coaptation assistance element of claim 5, wherein the raised edge comprises a suture.

### Claim 8 (depends on 5)

The coaptation assistance element of claim 5, wherein the peripheral edge of the coaptation assistance element comprises spaced apart barbs extending radially outwardly from the peripheral edge of only the superior zone of the coaptation assistance element.

### Claim 9 (depends on 1)

The coaptation assistance element of claim 1, further comprising a hub spaced inward from each of the first lateral edge, the second lateral edge, the inferior edge, and the superior edge; and
an active anchor configured to couple to the hub and configured to be rotated relative to the hub to selectively deploy the active anchor at a first target location; and
a plurality of struts spaced around the hub and extending outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart and a second strut configured to be implanted within the heart such that the first coaptation surface coapts with a first leaflet of the heart valve and the opposed second surface overlays a second leaflet of the heart valve.

### Claim 10 (depends on 1)

The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises a layer of mesh.