# US 11,432,928 B2 · Implant and method for improving coaptation of an atrioventricular valve

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- Number: US 11,432,928 B2
- Document ID: US11432928B2
- Status: Granted
- Kind: B2
- Application number: 16/491,696
- Filed: 2018-02-27
- Published: 2020-08-27
- Granted: 2022-09-06
- Earliest claimed: 2017-03-06
- Assignees: Avvie GmbH
- Applicants: Avvie GmbH
- Inventors: Werner Mohl
- Web page: https://patentgrep.com/patent/US11432928B2

## CPC

- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2230/0006: circular
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- 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

An implant for improving coaptation of an atrioventricular valve, the atrioventricular valve having a native first leaflet, a native second leaflet and an annulus and controlling blood flow from an upstream side to a downstream side of the valve, the implant comprising a support structure configured to be fixed to the annulus or to the native first leaflet, the implant further comprising a flexible artificial leaflet structure mounted to the support structure and comprising a rim section that is shaped to coapt with the native second leaflet, wherein said rim section comprises pockets that are open towards said downstream side and capable of being filled with blood from the downstream side each time the valve is closed.

## Claims

### Claim 1

An implant for improving coaptation of an atrioventricular valve, the atrioventricular valve having a native first leaflet, a native second leaflet and an annulus and controlling blood flow from an upstream atrial side to a downstream ventricular side of the valve, the implant comprising:
a support structure configured to be fixed to the annulus or to the native first leaflet; and
a flexible artificial leaflet structure mounted to the support structure and comprising a rim section that is shaped to coapt with the native second leaflet such that a gap between the native first leaflet and the native second leaflet is closed,
wherein said rim section is configured to be arranged in the gap between the native first leaflet and the native second leaflet and comprises a plurality of pockets that are open towards said downstream ventricular side and capable of being filled with blood from the downstream ventricular side each time the valve is closed; and
wherein the pockets in a center of the rim section have a greater cross-section than the pockets in side regions of the rim section.

### Claim 2 (depends on 1)

The implant according to claim 1, wherein the plurality of pockets are arranged in at least one row forming the rim section of the artificial leaflet structure.

### Claim 3 (depends on 1)

The implant according to claim 1, wherein the pockets each have a rounded surface for coapting with the native second leaflet.

### Claim 4 (depends on 1)

The implant according to claim 1, wherein the artificial leaflet structure comprises a base section arranged between the rim section and the support structure.

### Claim 5 (depends on 4)

The implant according to claim 4, wherein the base section comprises pockets that are open towards said downstream ventricular side and capable of being filled with blood from the downstream ventricular side or at least one closed cavity designed to be filled with a filling material different from blood.

### Claim 6 (depends on 1)

An implant delivery and deployment device, comprising:
the implant according to claim 1; and
a tubular housing, wherein the support structure and the artificial leaflet structure are deployable from a first position, in which the support structure and the artificial leaflet structure are arranged within the tubular housing, into a second position, in which the support structure is deployed and the artificial leaflet structure is deployed to coapt with the native second leaflet.

### Claim 7 (depends on 1)

The implant according to claim 1, wherein the support structure is substantially U-shaped, C-shaped or semi-circular or circular so as to fit the shape of the annulus.

### Claim 8 (depends on 1)

The implant according to claim 1, wherein the support structure is made from a shape memory material.

### Claim 9 (depends on 1)

The implant according to claim 1, wherein the support structure comprises a collar angled radially outwardly and adapted to lie on the upstream atrial side of the annulus.

### Claim 10 (depends on 1)

The implant according to claim 1, the implant further comprising retention means fixed to the support structure so as to prevent prolapse of the artificial leaflet structure.

### Claim 11 (depends on 10)

The implant according to claim 10, wherein the retention means, on one end thereof, are connected to the support structure and, on the other end thereof, are connected to the artificial leaflet structure.

### Claim 12 (depends on 10)

The implant according to claim 10, wherein the retention means comprise a flexible net or a plurality of flexible wires or yarns.

### Claim 13 (depends on 12)

The implant according to claim 12, wherein the flexible net, wires or yarns are embedded into or fixed to the artificial leaflet structure.

### Claim 14 (depends on 1)

The implant according to claim 1, wherein the support structure comprises fixing means for fixing the support structure to the annulus or to the native first leaflet.

### Claim 15 (depends on 14)

The implant according to claim 14, wherein the fixing means comprise a first fixing element and a second fixing element movable relative to each other so as to be able to squeeze a section of the native annulus or the native first leaflet between them.

### Claim 16 (depends on 1)

The implant according to claim 1, wherein a) the atrioventricular valve is a mitral valve and the first native leaflet is a posterior leaflet of the mitral valve orb) the atrioventricular valve is a tricuspid valve and the first native leaflet is an anterior or posterior leaflet of the tricuspid valve.

### Claim 17

A method of improving coaptation of an atrioventricular valve, the atrioventricular valve having an annulus, a native first leaflet and a native second leaflet, the method comprising:
providing an implant for controlling blood flow from an upstream atrial side to a downstream ventricular side of the valve, the implant comprising:
a support structure configured to be fixed to the annulus or to the native first leaflet; and
a flexible artificial leaflet structure mounted to the support structure and comprising a rim section that is shaped to coapt with the native second leaflet such that a gap between the native first leaflet and the native second leaflet is closed,
wherein said rim section is configured to be arranged in the gap between the native first leaflet and the native second leaflet and comprises a plurality of pockets that are open towards said downstream ventricular side and capable of being filled with blood from the downstream ventricular side each time the valve is closed, and
wherein the pockets in a center of the rim section have a greater cross-section than the pockets in side regions of the rim section;
wherein the implant is arranged in a tubular housing,
advancing the tubular housing by means of a catheter through a body vessel of a patient into the heart;
deploying the implant from the tubular housing; and
fixing the support structure relative to the annulus or the native first leaflet so that the artificial leaflet structure can coapt with the native second leaflet.

### Claim 18 (depends on 17)

The method according to claim 17, wherein the tubular housing is advanced into the heart by means of a catheter transatrially, transseptally, transfemorally or transapically.

### Claim 19 (depends on 17)

The method according to claim 17, wherein the step of fixing the support structure relative to the annulus comprises arranging the support structure at least partially within the inner circumferential surface of the annulus and expanding the support element in a radial direction towards the inner circumferential surface of the annulus.

### Claim 20 (depends on 3)

The implant according to claim 3, wherein the rounded surface of the pockets is semicircular.

### Claim 21 (depends on 8)

The implant according to claim 8, wherein the shape memory material is Nitinol and is at least in part in a form of a mesh.
