# US 12,213,661 B2 · Mitral valve fixation device removal devices and methods

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- Number: US 12,213,661 B2
- Document ID: US12213661B2
- Status: Granted
- Kind: B2
- Application number: 16/856,704
- Filed: 2020-04-23
- Published: 2020-08-06
- Granted: 2025-02-04
- Earliest claimed: 2014-03-17
- Assignees: Evalve, Inc.
- Applicants: Evalve, Inc.
- Inventors: Raghuveer Basude; Kent Dell; Arundhati Kabe; Gaurav Krishnamurthy; Michael F. Wei
- Web page: https://patentgrep.com/patent/US12213661B2

## CPC

- A61B 17/0467: {Instruments for cutting sutures (surgical cutting instruments A61B17/32)}
- A61B 17/0644: {penetrating the tissue, deformable to closed position}
- A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2466: {Delivery devices therefor}
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 2017/00243: {cardiac}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/22097: {Valve removal in veins}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Procedures may be performed on the heart after the installation of a mitral valve fixation device. In order to prepare the heart for such procedures, the fixation device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart. The fixation device may be partitioned so that one portion may remain attached to each leaflet of the mitral valve. In another example, the leaflets may be cut along the edges of the distal element(s) of the fixation device, so as to cut the fixation device from the leaflet(s). Systems and devices for performing such procedures endovascularly are disclosed. Fixation devices with improved access to a release harness are also disclosed.

## Claims

### Claim 1

A system for removing a mitral valve fixation device, the system comprising:
a cutting assembly disposed at a distal end of a first catheter member, the cutting assembly comprising:
an annular cutting member; and
a lumen formed by at least a portion of the cutting member, the lumen being configured to receive the mitral valve fixation device;
a cutting member receiving member into which a portion of the cutting member penetrates during cutting of a leaflet tissue coapted by the mitral valve fixation device; and
an elongate member extending proximally from the cutting member receiving member and into the lumen, the elongate member being configured to control movement of the cutting member receiving member, the elongate member being disposed within the lumen non-concentric to a central axis of the lumen.

### Claim 2 (depends on 1)

The system of claim 1, wherein the cutting member receiving member is formed of a material softer than the cutting member.

### Claim 3 (depends on 1)

The system of claim 1, further comprising a capture assembly separate from the cutting assembly, the capture assembly being configured to grip the mitral valve fixation device.

### Claim 4 (depends on 1)

The system of claim 1, wherein the elongate member is formed of a metal or plastic.

### Claim 5 (depends on 1)

The system of claim 1, wherein the cutting member receiving member is disk-shaped.

### Claim 6 (depends on 1)

The system of claim 1, wherein the cutting member is fixed and the cutting member receiving member is movable in relation to the cutting member.

### Claim 7 (depends on 1)

The system of claim 1, wherein the cutting member is parallel to a distal end of the elongate member.

### Claim 8 (depends on 1)

The system of claim 1, wherein a connection between the cutting member and a surface of the cutting member receiving member is substantially continuous upon engagement from the relative movement of the cutting edge and the cutting member receiving member.

### Claim 9 (depends on 1)

The system of claim 1, wherein the elongate member is disposed proximate an interior surface of the lumen.

### Claim 10

A system for removing a mitral valve fixation device, the system comprising:
a guide elongate member; and
a cutting assembly selectively disposed within and extending from the guide elongate member, the cutting assembly comprising:
an annular cutting member; and
a lumen formed by at least a portion of the cutting member, the lumen being configured to receive an entirety of the mitral valve fixation device;
a cutting member receiving member into which a portion of the cutting member penetrates during cutting of leaflet tissue coapted by the mitral valve fixation device, wherein, the leaflet tissue disposed between the cutting member and the cutting member receiving member is cut through relative movement of the cutting member and the cutting member receiving member; and
a second elongate member extending proximally from the cutting member receiving member and into the lumen, the second elongate member being configured to control movement of the cutting member receiving member, the second elongate member disposed within the lumen proximate to a wall of the lumen.

### Claim 11 (depends on 10)

The system of claim 10, wherein the cutting member receiving member is formed of two different materials.

### Claim 12 (depends on 10)

The system of claim 10, further comprising a capture assembly separate from the cutting assembly, the capture assembly being configured to grip the mitral valve fixation device.

### Claim 13 (depends on 12)

The system of claim 12, wherein the second elongate member is configured to advance and retract the cutting member receiving member.

### Claim 14 (depends on 12)

The system of claim 12, wherein the capture assembly comprises a snare or lasso structure.

### Claim 15 (depends on 10)

The system of claim 10, wherein the cutting member is not parallel to a distal end of the elongate member.

### Claim 16 (depends on 10)

The system of claim 10, wherein the cutting member is fixed and the cutting member receiving member is movable in relation to the cutting member.

### Claim 17

A system for removing a mitral valve fixation device, the system comprising:
a guide elongate member; and
a cutting assembly selectively disposed within and extending from the guide elongate member, the cutting assembly comprising:
a cutting member forming an annular opening, the cutting member including an annular blade;
a lumen communicating with the annular opening, the annular opening and the lumen being configured to receive an entirety of the mitral valve fixation device;
a cutting member receiving member that intersects with the cutting member during relative movement of the cutting member receiving member and the cutting member to cut leaflet tissue coapted by the mitral valve fixation device, the cutting member receiving member comprising a cutting member receiving surface that cooperates with the cutting member, the cutting member receiving surface extending to a periphery of the cutting member receiving member disposed transverse to a longitudinal axis of the guide elongate member; and
a second elongate member extending from the periphery of the cutting member receiving surface proximally into the lumen, the second elongate member being configured to control movement of the cutting member receiving member, the second elongate member disposed within the lumen proximate to a wall of the lumen and non-concentric with a central axis of the lumen.

### Claim 18 (depends on 17)

The system of claim 17, wherein the guide elongate member comprises a metal or plastic.

### Claim 19 (depends on 18)

The system of claim 18, wherein the cutting member is made of a harder material than a portion of the cutting member receiving member.

### Claim 20 (depends on 19)

The system of claim 19, wherein the cutting member or the cutting member receiving member is configured to move to cut the leaflet tissue.

### Claim 21 (depends on 20)

The system of claim 20, wherein the cutting member is fixed and the cutting member receiving member is movable in relation to the cutting member.
