# US 11,304,805 B2 · Prosthetic valve with inflatable cuff configured to fill a volume between atrial and ventricular tissue anchors

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- Number: US 11,304,805 B2
- Document ID: US11304805B2
- Status: Granted
- Kind: B2
- Application number: 16/135,979
- Filed: 2018-09-19
- Published: 2019-03-21
- Granted: 2022-04-19
- Earliest claimed: 2017-09-19
- Assignees: Cardiovalve Ltd.
- Applicants: Cardiovalve Ltd.
- Inventors: Ilia Hariton; Meni Iamberger; Aviram Baum; Boaz Harari
- Web page: https://patentgrep.com/patent/US11304805B2

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- 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 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- 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 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2250/007: O-rings
- 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

A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body, a plurality of atrial anchoring arms configured to extend radially outward from the valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the valve body. The prosthetic valve may also include a blood-inflatable cuff situated between the arms and legs. The cuff may be configured to substantially fill a volume between the arms and the legs when the cuff is fully inflated with blood.

## Claims

### Claim 1

A prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:
an annular valve body;
a plurality of atrial anchoring arms configured to extend radially outward from the valve body;
a plurality of ventricular anchoring legs configured to extend radially outward from the valve body; and
a blood-inflatable cuff at least partially situated between the arms and legs, wherein the cuff is configured to substantially fill a volume between the arms and the legs when the cuff is fully inflated with blood,
wherein a terminal portion of the at least one arm is situated within the cuff; and
wherein at least one arm is configured to extend radially outward beyond the terminal end of at least one leg.

### Claim 2 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is fastened to at least one arm.

### Claim 3 (depends on 2)

The prosthetic valve of claim 2, wherein the cuff is fastened to the terminal portion of the at least one arm.

### Claim 4 (depends on 3)

The prosthetic valve of claim 3, wherein the cuff is fastened to a ventricular-facing surface of the terminal portion of the at least one arm.

### Claim 5 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is free of connections to any of the legs.

### Claim 6 (depends on 1)

The prosthetic valve of claim 1, wherein an entire radial length of at least one arm is situated within the cuff.

### Claim 7 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is configured to contact at least a majority of a radial length of at least one arm.

### Claim 8 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is configured to contact an atrially-facing surface of at least one arm.

### Claim 9 (depends on 1)

The prosthetic valve of claim 1, wherein at least a portion of the at least one leg is situated outside of the cuff.

### Claim 10 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is configured to contact at least a majority of a radial length of at least one leg.

### Claim 11 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is configured to extend radially outward beyond the terminal end of the at least one leg.

### Claim 12 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is formed of a plurality of sheet portions.

### Claim 13 (depends on 12)

The prosthetic valve of claim 12, wherein the cuff is formed of at least three sheet portions.

### Claim 14 (depends on 13)

The prosthetic valve of claim 13, wherein a first sheet portion of the at least three sheet portions is configured to contact at least one arm, a second sheet portion of the at least three sheet portions is configured to contact at least one leg, and a third sheet portion of the at least three sheet portions is configured to contact a radially inner surface of the valve body.

### Claim 15 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff includes at least one fluid opening fluidly connecting an interior volume of the cuff with an interior volume of the valve body.

### Claim 16 (depends on 15)

The prosthetic valve of claim 15, further comprising:
a plurality of leaflets secured within the valve body, wherein the at least one fluid opening is angularly aligned with at least one of the leaflets.

### Claim 17 (depends on 16)

The prosthetic valve of claim 16, wherein the at least one fluid opening is situated radially outward from the at least one of the leaflets.

### Claim 18 (depends on 16)

The prosthetic valve of claim 16, wherein a connection point between at least one of the leaflets and the valve body is situated in a ventricular direction relative to at least one of the fluid openings.

### Claim 19 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is substantially impervious to fluid such that blood is substantially prevented from flowing around an outer diameter of the prosthetic valve.

### Claim 20 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is substantially impervious to fluid such that blood is substantially prevented from flowing past terminal ends of the arms.

### Claim 21 (depends on 1)

The prosthetic valve of claim 1, wherein the cuff is substantially impervious to fluid such that blood is substantially prevented from flowing between an atrial side of the native mitral valve and a ventricular side of the native mitral valve, except by passing through an inner flow passage of the valve body.

### Claim 22 (depends on 1)

The prosthetic valve of claim 1,
wherein the valve body is configured to move between a radially-contracted configuration and a radially-expanded configuration, and
wherein the cuff is configured such that expansion of the valve body is substantially unimpeded by the cuff.

### Claim 23 (depends on 1)

The prosthetic valve of claim 1,
wherein the arms and legs are configured to move between radially-contracted configurations and radially-expanded configurations, and
wherein the cuff is configured such that movement of the arms and legs from the radially-contracted configurations to the radially-expanded configurations is substantially unimpeded by the cuff.

### Claim 24 (depends on 1)

The prosthetic valve of claim 1,
wherein the valve body includes an annular outer frame and an inner frame situated at least partially within the annular outer frame,
wherein the arms extend from the inner frame, and
wherein the legs extend from the outer frame.
