# US 12,178,444 B2 · Clip removal systems and methods

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- Number: US 12,178,444 B2
- Document ID: US12178444B2
- Status: Granted
- Kind: B2
- Application number: 17/306,407
- Filed: 2021-05-03
- Published: 2021-11-11
- Granted: 2024-12-31
- Earliest claimed: 2020-05-06
- Assignees: Evalve, Inc.
- Applicants: Evalve, Inc.
- Inventors: Shengmin Mei; Gabriel R. Gonzales; Alexander Chu; Richard Thomas Childs
- Web page: https://patentgrep.com/patent/US12178444B2

## CPC

- A61B 17/1285: {for minimally invasive surgery}
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 17/3205: Excision instruments
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0136: {Handles therefor}
- A61B 2017/00243: {cardiac}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/320052: {Guides for cutting instruments}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00369: {Heart valves}
- A61B 2018/00601: {Cutting}
- A61B 2018/1422: {Hook}
- A61B 2018/1452: {including means for cutting (A61B2018/146 takes precedence)}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A system configured to detach an interventional implant from a cardiac valve includes a guide catheter and a capture mechanism routable through the guide catheter. The capture mechanism comprises a capture hypotube with a container portion/space configured to receive an interventional implant connected to cardiac valve tissue. The capture mechanism also includes a cutting arm axially moveable relative to the capture hypotube. The capture hypotube and the cutting arm each include cutting elements that are brought together upon actuation of the cutting arm to thereby cut the cardiac valve tissue surrounding the interventional implant to free the implant from the cardiac valve.

## Claims

### Claim 1

A capture mechanism configured for capturing an interventional implant previously implanted at cardiac valve tissue, the capture mechanism comprising:
a capture hypotube having a container portion disposed distal a cutout portion and adjacent a terminal distal end of the capture hyptotube, the container portion being disposed at a fixed position distal a cutout portion, the container portion being configured to receive and house the interventional implant;
a cutting arm axially translatable around an outer surface of and rotatable relative to the capture hypotube;
a first cutting element disposed at an edge of the capture hypotube; and
a second cutting element disposed at an edge of the cutting arm and oriented to face the first cutting element,
wherein axial translation of the cutting arm relative to the capture hypotube brings the first cutting element into contact with the second cutting element, thereby causing both first cutting element and second cutting element to cut cardiac tissue disposed therebetween.

### Claim 2 (depends on 1)

The capture mechanism of claim 1, wherein the container portion is adjacent the cutout portion that faces laterally and is configured to receive the interventional implant.

### Claim 3 (depends on 2)

The capture mechanism of claim 2, further comprising an axial actuator configured to translate axially relative to the capture hypotube, the axial actuator being configured to extend into the cutout portion to thereby enable the interventional implant to be pushed from the cutout portion toward the adjacent container portion.

### Claim 4 (depends on 2)

The capture mechanism of claim 2, wherein the cutting arm is configured to cover the cutout portion when in an advanced position relative to the capture hypotube and to uncover and expose the cutout portion when in a retracted position relative to the capture hypotube.

### Claim 5 (depends on 2)

The capture mechanism of claim 2, wherein the container portion is disposed at a distal end of the capture hypotube, and wherein the cutout portion is disposed proximal of the container portion.

### Claim 6 (depends on 1)

The capture mechanism of claim 1, wherein the first cutting element, the second cutting element, or both comprise sharpened edges.

### Claim 7 (depends on 1)

The capture mechanism of claim 1, wherein the first cutting element, the second cutting element, or both comprise serrated and/or wavy edges.

### Claim 8 (depends on 1)

The capture mechanism of claim 1, wherein the first cutting element, the second cutting element, or both comprise a lateral cutting edge.

### Claim 9 (depends on 1)

The capture mechanism of claim 1, wherein the first cutting element, the second cutting element, or both comprise electrodes conductive to radio frequency energy.

### Claim 10 (depends on 9)

The capture mechanism of claim 9, wherein the capture hypotube and the cutting arm are formed from a conductive material and are coated with an insulating coating, except that the first and second cutting elements remain uncoated.

### Claim 11 (depends on 1)

The capture mechanism of claim 1, wherein the cutting arm is formed as a hypotube.

### Claim 12 (depends on 11)

The capture mechanism of claim 11, wherein the cutting arm hypotube is disposed outside of the capture hypotube.

### Claim 13 (depends on 1)

The capture mechanism of claim 1, wherein the first cutting element faces proximally and the second cutting element faces distally.

### Claim 14 (depends on 1)

The capture mechanism of claim 1, wherein the first cutting element faces distally and the second cutting element faces proximally.

### Claim 15 (depends on 14)

The capture mechanism of claim 14, wherein the cutting arm comprises a hook, and wherein the cutting arm is configured to extend beyond a distal end of the capture hypotube to form a cavity between the distal end of the capture hypotube and a proximal side of the hook.

### Claim 16 (depends on 15)

The capture mechanism of claim 15, wherein the first cutting element being disposed at the distal end of the capture hypotube and the second cutting element being disposed at the proximal side of the hook.

### Claim 17

A system for detaching an interventional implant from a cardiac valve, the system comprising:
a guide catheter having a proximal end and a distal end, the distal end of the guide catheter being steerable to a position adjacent a cardiac valve; and
a capture mechanism routable through the guide catheter and configured to extend beyond the distal end of the guide catheter, the capture mechanism comprising:
a capture hypotube having a container portion distally disposed therein, the container portion being configured to receive and house the interventional implant,
an axial actuator disposed within the capture hypotube and configured to distally translate axially into a cutout portion to thereby enable the interventional implant to be distally pushed from the cutout portion into the container portion,
a cutting arm axially translatable around an outer surface of and rotatable relative to the capture hypotube,
a first cutting element disposed at an edge of the capture hypotube, and
a second cutting element disposed at an edge of the cutting arm and oriented to face the first cutting element,
wherein axial translation of the cutting arm relative to the capture hypotube brings the first cutting element into contact with the second cutting element, thereby causing both first cutting element and second cutting element to cut cardiac tissue disposed therebetween.

### Claim 18 (depends on 17)

The system of claim 17, further comprising a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control operatively connected to the capture mechanism to enable actuation of the cutting arm to thereby provide translation and/or rotation of the cutting arm relative to the capture hypotube.

### Claim 19

A method of detaching an interventional implant from a cardiac valve within a body, the method comprising:
providing a system for detaching an interventional implant from a cardiac valve, the system comprising
a guide catheter having a proximal end and a distal end, the distal end of the guide catheter being steerable to a position adjacent a cardiac valve; and
a capture mechanism routable through the guide catheter and configured to extend beyond the distal end of the guide catheter, the capture mechanism comprising
a capture hypotube having a container portion disposed distal a cutout portion and adjacent a terminal distal end of the capture hyptotube, the container portion being disposed at a fixed position distal a cutout portion, the container portion being configured to receive and house the interventional implant,
a cutting arm axially translatable around an outer surface of and rotatable relative to the capture hypotube,
a first cutting element disposed at an edge of the capture hypotube, and
a second cutting element disposed at an edge of the cutting arm and oriented to face the first cutting element,
wherein axial translation of the cutting arm relative to the capture hypotube brings the first cutting element into contact with the second cutting element, thereby causing both first cutting element and second cutting element to cut cardiac tissue disposed therebetween;
positioning the distal end of the guide catheter near a targeted cardiac valve, the targeted cardiac valve including an interventional implant affixed to cardiac valve tissue;
extending the capture mechanism distally beyond the distal end of the guide catheter;
capturing the interventional implant within the container portion of the capture hypotube; and
actuating the cutting arm to cut cardiac tissue and thereby detach the interventional implant from the cardiac tissue.
