# US 11,304,806 B2 · Prosthetic valve with atrial tissue anchors having variable flexibility and ventricular tissue anchors having constant flexibility

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- Number: US 11,304,806 B2
- Document ID: US11304806B2
- Status: Granted
- Kind: B2
- Application number: 16/136,082
- 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/US11304806B2

## 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

Prosthetic valves and methods of implanting prosthetic valves may be provided, including an expandable prosthetic valve for implantation within a native heart valve. The prosthetic valve may include an annular valve body and atrial anchoring arms configured to extend radially outward from the annular valve body. Each atrial anchoring arm may have a proximal arm end and a distal arm end. The flexibility of at least one atrial anchoring arm may vary substantially from the proximal arm end thereof to the distal arm end thereof. The prosthetic valve may also include a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. Each ventricular anchoring leg may have a proximal leg end and a distal leg end. Each ventricular anchoring leg may have a substantially constant flexibility from the proximal leg end to the distal leg end.

## Claims

### Claim 1

An expandable prosthetic valve for implantation within a native heart valve, the prosthetic valve configured to have a contracted configuration and an expanded configuration, the prosthetic valve comprising:
an annular valve body;
a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body, each atrial anchoring arm having a proximal arm end and a distal arm end, wherein at least one of the plurality of atrial anchoring arms comprises:
a proximal portion,
a flexible distal portion situated between the proximal portion and the distal arm end of the at least one atrial anchoring arm, and
a tissue grasping feature situated at a distal end of the proximal portion, the tissue grasping feature being the portion of the proximal portion with the largest width; and
a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body, each ventricular anchoring leg having a proximal leg end and a distal leg end, wherein each of the ventricular anchoring legs has a substantially constant flexibility from the proximal leg end to the distal leg end; and
an annular outer frame;
wherein, when the prosthetic valve is in the expanded configuration, the tissue grasping feature of the proximal portion of the at least one atrial anchoring arm is positioned the same distance from a center of the annular valve as the distal leg end of at least one of the ventricular anchoring legs;
further wherein a connector pin is situated at an intersection of at least one venticular anchoring leg and two adjacent struts of the annular outer frame.

### Claim 2 (depends on 1)

The prosthetic valve of claim 1, wherein the flexibility of the at least one atrial anchoring arm increases from the proximal arm end of the at least one atrial anchoring arm to the distal arm end of the at least one atrial anchoring arm.

### Claim 3 (depends on 1)

The prosthetic valve of claim 1, wherein the flexible distal portion of the at least one atrial anchoring arm includes a structure having multiple curves.

### Claim 4 (depends on 3)

The prosthetic valve of claim 3, wherein the structure having multiple curves includes a serpentine pattern.

### Claim 5 (depends on 3)

The prosthetic valve of claim 3, wherein the at least one atrial anchoring arm includes a transition location and the structure having multiple curves is situated distal to the transition location.

### Claim 6 (depends on 3)

The prosthetic valve of claim 3, wherein the structure having multiple curves does not extend to the distal arm end of the at least one atrial anchoring arm.

### Claim 7 (depends on 3)

The prosthetic valve of claim 3, wherein the inflexible proximal portion of the at least one atrial anchoring arm is positioned proximal to the structure having multiple curves.

### Claim 8 (depends on 7)

The prosthetic valve of claim 7, wherein a cross-sectional area of the structure having multiple curves is smaller than a cross-sectional area of the inflexible proximal portion of the at least one atrial anchoring arm.

### Claim 9 (depends on 7)

The prosthetic valve of claim 7, wherein the tissue grasping feature of the at least one atrial anchoring arm comprises an opening.

### Claim 10 (depends on 9)

The prosthetic valve of claim 9,
wherein the at least one ventricular anchoring leg includes an opening, and
wherein the opening of the tissue grasping feature and the opening of the at least one ventricular anchoring leg are substantially equidistant from the center of the annular valve body.

### Claim 11 (depends on 1)

The prosthetic valve of claim 1, wherein the at least one atrial anchoring arm includes a transition location and is configured for greater flexibility distal the transition location than proximal the transition location.

### Claim 12 (depends on 11)

The prosthetic valve of claim 11, wherein the at least one atrial anchoring arm distal the transition location has a cross-sectional area smaller than a cross-sectional area of the at least one atrial anchoring arm proximal the transition location.

### Claim 13 (depends on 11)

The prosthetic valve of claim 11, wherein the at least one atrial anchoring arm distal the transition location is more flexible than the at least one ventricular anchoring leg.

### Claim 14 (depends on 1)

The prosthetic valve of claim 1, wherein the distal arm end of the at least one atrial anchoring arm comprises an opening.

### Claim 15 (depends on 1)

The prosthetic valve of claim 1, wherein each atrial anchoring arm and each ventricular anchoring leg has a single location of connection to the annular valve body.

### Claim 16 (depends on 1)

The prosthetic valve of claim 1, wherein radially external to the locations of connection between the atrial anchoring arms and the annular valve body, no connection is made between the plurality of atrial anchoring arms.

### Claim 17 (depends on 1)

The prosthetic valve of claim 1, wherein the at least one atrial anchoring arm is configured to extend radially outward beyond the distal leg end of the at least one ventricular anchoring leg.

### Claim 18 (depends on 1)

The prosthetic valve of claim 1, wherein each of the plurality of ventricular anchoring legs has substantially the same flexibility.

### Claim 19 (depends on 1)

The prosthetic valve of claim 1, wherein the annular valve body comprises:
an annular outer frame; and
an inner frame configured at least partially within the annular outer frame.

### Claim 20 (depends on 19)

The prosthetic valve of claim 19, wherein the plurality of atrial anchoring arms is configured to extend from the inner frame and the plurality of ventricular anchoring legs is configured to extend from the annular outer frame.

### Claim 21 (depends on 1)

The prosthetic valve of claim 1, wherein the proximal leg end of the at least one of the plurality of ventricular anchoring legs includes an attachment location for joining a first and second portion of the annular valve body.