# US 11,298,229 B2 · Device, system, and method for transcatheter treatment of valvular regurgitation

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,298,229 B2
- Document ID: US11298229B2
- Status: Granted
- Kind: B2
- Application number: 16/685,338
- Filed: 2019-11-15
- Published: 2020-07-02
- Granted: 2022-04-12
- Earliest claimed: 2017-03-13
- Assignees: Polares Medical Inc.
- Applicants: Polares Medical Inc.
- Inventors: Alexander K. Khairkhahan
- Web page: https://patentgrep.com/patent/US11298229B2

## 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-apposing valve body element and a leaflet surface, wherein the leaflet-apposing valve body element is configured to increase the distance between the leaflet-apposing valve body element and the leaflet surface in an expanded state.

### Claim 2 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element comprises a synthetic polymer material.

### Claim 3 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element comprises a biological material.

### Claim 4 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element comprises a bioprosthetic valve.

### Claim 5 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element comprises a coaptation surface.

### Claim 6 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element comprises a reinforced surface.

### Claim 7 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element comprises at least one fixed end and at least one free end.

### Claim 8 (depends on 1)

The coaptation assistance element of claim 1, wherein the leaflet-apposing valve body element is configured to mimic the cardiac cycle by movement of the leaflet-apposing valve body element.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 9)

The coaptation assistance element of claim 9, wherein the leaflet-apposing valve body element is coupled to the struts.

### Claim 11 (depends on 1)

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

### Claim 12

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-apposing valve body element configured to expand outward based on the motion of the heart or blood flow or pressure build-up within the heart of the patient.

### Claim 13 (depends on 12)

The coaptation assistance element of claim 12, wherein the leaflet-apposing valve body element is configured to expand and contract with each heartbeat, permitting proper blood flow through the heart valve.

### Claim 14 (depends on 12)

The coaptation assistance element of claim 12, wherein the coaptation assistance element comprises struts.

### Claim 15 (depends on 14)

The coaptation assistance element of claim 14, wherein the leaflet-apposing valve body element is coupled to the struts.

### Claim 16 (depends on 12)

The coaptation assistance element of claim 12, wherein the leaflet-apposing valve body element is flexible.

### Claim 17 (depends on 12)

The coaptation assistance element of claim 12, wherein the leaflet-apposing valve body element is configured to provide a coaptation surface for the anterior leaflet to seal against.

### Claim 18 (depends on 12)

The coaptation assistance element of claim 12, wherein the leaflet-apposing valve body element comprises a permeable material.

### Claim 19 (depends on 12)

The coaptation assistance element of claim 12, wherein the coaptation assistance element is configured to anchored to the annulus.

### Claim 20 (depends on 12)

The coaptation assistance element of claim 12, wherein the coaptation assistance element comprises a hub.