# US 10,478,303 B2 · Device, system, and method for transcatheter treatment of valvular regurgitation

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- Number: US 10,478,303 B2
- Document ID: US10478303B2
- Status: Granted
- Kind: B2
- Application number: 16/275,665
- Filed: 2019-02-14
- Published: 2019-06-13
- Granted: 2019-11-19
- Earliest claimed: 2017-03-13
- Assignees: Polares Medical Inc.
- Applicants: Polares Medical Inc.
- Inventors: Alexander K. Khairkhahan
- Web page: https://patentgrep.com/patent/US10478303B2

## CPC

- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses}
- A61F 2/2457: {Chordae tendineae prostheses}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2466: {Delivery devices therefor}
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 2017/00243: {cardiac}
- A61B 2017/00358: {Snares for grasping}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00871: {polymeric}
- A61B 2017/0649: {Coils or spirals}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/378: {using ultrasound}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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 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 extending downward from the superior zone,
wherein the inferior zone comprises a leaflet configured to move relative to the inferior edge such that a distance between the leaflet and the inferior edge is configured to increase during systole and configured to decrease during diastole.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

The coaptation assistance element of claim 2, wherein the leaflet is coupled to the frame.

### Claim 4 (depends on 2)

The coaptation assistance element of claim 2, wherein the frame is nitinol.

### Claim 5 (depends on 1)

The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises an annular hub.

### Claim 6 (depends on 1)

The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises one or more chords coupling the leaflet to at least one edge.

### Claim 7 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet comprises biological tissue.

### Claim 8

A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising:
a first 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 extending downward from the superior zone,
wherein the inferior zone comprises a leaflet configured to expand such that a thickness of the leaflet is configured to increase during systole and a thickness of the leaflet is configured to decrease during diastole.

### Claim 9 (depends on 8)

The coaptation assistance element of claim 8, wherein the coaptation assistance element comprises a frame.

### Claim 10 (depends on 9)

The coaptation assistance element of claim 9, wherein the leaflet is coupled to the frame.

### Claim 11 (depends on 9)

The coaptation assistance element of claim 9, wherein the frame is nitinol.

### Claim 12 (depends on 8)

The coaptation assistance element of claim 8, wherein the coaptation assistance element comprises an annular hub.

### Claim 13 (depends on 8)

The coaptation assistance element of claim 8, wherein the leaflet is inflatable.

### Claim 14 (depends on 8)

The coaptation assistance element of claim 8, wherein the leaflet is inflated with hydrogel, collagen, or a polymer.

### Claim 15 (depends on 8)

The coaptation assistance element of claim 8, wherein the leaflet configured to inflate and deflate with each heartbeat.

### Claim 16 (depends on 8)

The coaptation assistance element of claim 8, wherein the leaflet comprises a balloon.