# US 2026/0306255 A1 · Atrioventricular Valve Modification Systems, Devices, and Methods

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- Number: US 2026/0306255 A1
- Document ID: US20260306255A1
- Status: Published application
- Kind: A1
- Application number: 19/632,914
- Filed: 2026-03-30
- Published: 2026-10-08
- Earliest claimed: 2025-04-04
- Assignees: Evalve, Inc.
- Applicants: Evalve, Inc.
- Inventors: Saurabh Datta; Preston James Huddleston; Caitlyn E. Harrington; Clara Park; Cynthia Siu; Taylor Nasby
- Web page: https://patentgrep.com/patent/US20260306255A1

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61N 1/0573: {chacterised by means penetrating the heart tissue, e.g. helix needle or hook}
- A61N 2001/058: {Fixing tools}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A method of implanting a prosthetic atrioventricular valve into a native atrioventricular valve includes delivering a fixation device to the native valve, and applying the fixation device to engage and approximate free edges of two leaflets of the native valve. After applying the fixation device, the prosthetic valve is delivered to the native valve while the prosthetic valve is in a collapsed condition. The prosthetic valve is then be deployed into the native valve so that the prosthetic valve expands into engagement with the native valve. A transcatheter positioning device for an atrioventricular valve modification device delivery system is also provided. The positioning device comprises a positioning member having an undeployed configuration for delivery of the positioning device to an atrioventricular valve modification device delivery site in the heart of a patient and a deployed configuration for the positioning member to engage and reposition an object in the heart.

## Claims

### Claim 1

A method of implanting a prosthetic atrioventricular valve into a native atrioventricular valve of a heart of a patient, wherein the patient has a pacemaker lead extending from an atrium of the heart to a ventricle of the heart through the native atrioventricular valve, the method comprising:
delivering a fixation device to the native atrioventricular valve;
applying the fixation device to engage and approximate free edges of two native leaflets of the native atrioventricular valve so that a portion of the pacemaker lead becomes trapped between the fixation device and an adjacent commissure of the native atrioventricular valve;
while the pacemaker lead is trapped, delivering the prosthetic atrioventricular valve to the native atrioventricular valve while the prosthetic atrioventricular valve is in a collapsed condition; and
deploying the prosthetic atrioventricular valve into the native atrioventricular valve so that the prosthetic atrioventricular valve expands into engagement with the native atrioventricular valve.

### Claim 2 (depends on 1)

The method of claim 1, wherein the native atrioventricular valve is a native tricuspid valve, the two native leaflets engaged and approximated by the fixation device are a septal leaflet and a posterior leaflet of the native tricuspid valve, and the commissure is a commissure connecting the septal leaflet to the posterior leaflet.

### Claim 3 (depends on 1)

The method of claim 1, wherein the steps of applying the fixation device and deploying the prosthetic atrioventricular valve are performed as part of a single procedure performed in the same day.

### Claim 4 (depends on 1)

The method of claim 1, wherein the method includes implanting a pacemaker into the patient so that the pacemaker lead extends from the atrium to the ventricle through the native atrioventricular valve, and the steps of (i) implanting the pacemaker, (ii) applying the fixation device, and (iii) deploying the prosthetic atrioventricular valve are performed as part of a single procedure performed in the same day.

### Claim 5

A method of modifying a native atrioventricular valve within a heart of a patient, the native atrioventricular valve having a pacemaker lead or leads passing therethrough from the atrium associated with the atrioventricular valve to the ventricle associated with the atrioventricular valve, the method comprising:
delivering a first fixation device to the ventricle, the first fixation device comprising first fixation elements; and
applying the first fixation elements to engage the lead or leads of the pacemaker along with one or more of a) one or more chordae tendineae, b) a papillary muscle, and/or c) a moderator band in the ventricle, to secure the lead or leads of the pacemaker thereto.

### Claim 6 (depends on 5)

The method of claim 5, wherein the step of applying the first fixation elements comprises positioning the lead or leads at or adjacent a commissure defined between two native leaflets of the native atrioventricular valve.

### Claim 7 (depends on 5)

The method of claim 5, further comprising delivering a second fixation device to the native atrioventricular valve, the second fixation device comprising second fixation elements; and
applying the second fixation elements to engage and approximate second edge portions of two native leaflets of the native atrioventricular valve.

### Claim 8 (depends on 7)

The method of claim 7, wherein the first fixation device is smaller than the second fixation device.

### Claim 9 (depends on 7)

The method of claim 7, wherein the first fixation elements have a first fixation element length and the second fixation elements have a second fixation element length, the first fixation element length being shorter than the second fixation element length.

### Claim 10 (depends on 9)

The method of claim 9, wherein the first fixation element length is 0.05 inches (1.3 mm) shorter than the second fixation element length.

### Claim 11 (depends on 9)

The method of claim 9, wherein the first fixation element length is 0.265 inches (6.73 mm) and the second fixation element length is 0.315 inches (8.00 mm).

### Claim 12 (depends on 9)

The method of claim 9, wherein the first fixation device further comprises first gripper elements for cooperating with a respective one of the first fixation elements to grip tissue therebetween, the first gripper elements having a first gripper element length, and the second fixation device further comprises second gripper elements for cooperating with a respective one of the second fixation elements to grip tissue therebetween, the second gripper elements having a second gripper element length, the first gripper element length being shorter than the second gripper element length.

### Claim 13 (depends on 12)

The method of claim 12, wherein the first gripper element length is 0.05 inches (1.3 mm) shorter than the second gripper element length.

### Claim 14 (depends on 12)

The method of claim 12, wherein the first gripper element length is 0.256 inches (6.50 mm) and the second gripper element length is 0.306 inches (7.77 mm).

### Claim 15 (depends on 5)

The method of claim 5, further comprising positioning the lead or leads using a positioning member.

### Claim 16 (depends on 15)

The method of claim 15, wherein the positioning member has an undeployed configuration for delivery, and a deployed configuration for the positioning member to engage and reposition the lead or leads in the heart.

### Claim 17 (depends on 16)

The method of claim 16, wherein the positioning member comprises a shape-memory material configured to assume the deployed configuration when the positioning member is unconstrained.

### Claim 18 (depends on 17)

The method of claim 17, wherein in the deployed configuration the positioning member comprises a hook shaped portion, a loop shaped portion, or a double loop shaped portion.

### Claim 19 (depends on 17)

The method of claim 17, wherein in the deployed configuration the positioning member comprises a heart shaped portion, a wishbone shaped portion, or an S shaped portion.

### Claim 20

A method of modifying a native atrioventricular valve, the method comprising:
modifying the atrioventricular valve using a first transcatheter atrioventricular valve modification device;
modifying the atrioventricular valve using a second transcatheter atrioventricular valve modification device;
wherein the first transcatheter atrioventricular valve modification device differs from the second transcatheter atrioventricular valve modification device.
