# US 12,178,704 B2 · Wide clip with nondeformable wings

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,178,704 B2
- Document ID: US12178704B2
- Status: Granted
- Kind: B2
- Application number: 18/303,363
- Filed: 2023-04-19
- Published: 2023-08-10
- Granted: 2024-12-31
- Earliest claimed: 2019-07-15
- Assignees: Evalve, Inc.
- Applicants: Evalve, Inc.
- Inventors: Chad Abunassar; Jessie Garcia; Gabriel Gonzales; Samir Jain; Casey Barbarino; Santosh Prabhu
- Web page: https://patentgrep.com/patent/US12178704B2

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2230/0093: Umbrella-shaped, e.g. mushroom-shaped
- A61F 2250/0036: differing in thickness
- A61F 2250/0037: differing in height or in length
- 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

Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled to the central assembly. The at least one arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides. The at least one arm further includes first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension. The fixation device further includes at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

## Claims

### Claim 1

A fixation device for fixation of leaflets of a heart valve comprising:
a central assembly;
at least one arm moveably coupled to the central assembly, the at least one arm comprising:
a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides,
first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension;
wherein the first and second wing extensions each have a first end edge and a second end edge, wherein the first end edge extends between the respective body lateral side and the outer lateral edge and is located proximate the first end of the body portion, and the second end edge extends between the respective body lateral side and the outer lateral edge and is located proximate the second end of the body portion, and
wherein the first end edge extends from the body lateral side at a first end angle defined between the first end edge and the longitudinal axis, wherein the first end angle is between 30 and 60 degrees; and
at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

### Claim 2 (depends on 1)

The device of claim 1, wherein the maximum arm width is between about 1.40 and 1.60 times the body portion width.

### Claim 3 (depends on 1)

The device of claim 1, wherein the maximum arm width is about 1.50 times the body portion width.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first end angle is 45 degrees.

### Claim 5 (depends on 1)

The device of claim 1, wherein a first end lead dimension is defined along the body portion by a distance between the first end of the body portion and an intersection of the first end edge and the respective body lateral side, wherein the first end lead dimension is between about 0.15 inch and 0.25 inch.

### Claim 6 (depends on 5)

The device of claim 5, wherein the first end lead dimension is 0.19 inch.

### Claim 7 (depends on 1)

The device of claim 1, wherein a second end lead dimension is defined along the body portion by a distance between the second end of the body portion and an intersection of the second end edge and the respective body lateral side, wherein the second end lead dimension is between 0.05 inch and 0.15 inch.

### Claim 8 (depends on 1)

The device of claim 1, wherein a first end lead dimension is defined along the body portion by a distance between the first end of the body portion and an intersection of the first end edge and the respective body lateral side, and a second end lead dimension is defined along the body portion by a distance between the second end of the body portion and an intersection of the second end edge and the respective body lateral side, and the second end lead dimension is less than one third of the first end lead dimension.

### Claim 9 (depends on 1)

The device of claim 1, wherein the second end edge extends from the second end of the body portion at a second end angle defined between the second end edge and the longitudinal axis, wherein the second end angle is between 30 and 60 degrees.

### Claim 10 (depends on 1)

The device of claim 1, wherein the first end edge, the lateral outer edge, and the second end edge of each of the first and second wing extensions form a continuous complex curve.

### Claim 11 (depends on 1)

The device of claim 1, wherein the at least one arm further has a recessed trough along the longitudinal axis, the trough having a trough width sized greater than a width of the at least one gripping element.

### Claim 12 (depends on 1)

The device of claim 1, wherein the trough width increases from the first end of the body portion to the second end of the body portion.

### Claim 13 (depends on 1)

The device of claim 1, wherein the first and second wing extensions and the body portion are a single piece.

### Claim 14 (depends on 1)

The device of claim 1, wherein each first and second wing extension in end cross-section extends laterally from the respective body lateral side and then extends perpendicularly to the outer lateral edge.

### Claim 15 (depends on 14)

The device of claim 14, wherein the fixation device comprises a second arm moveably coupled to the central assembly, the second arm comprising a body portion having a first end and a second end, the second end being moveable between a closed position and an open position, wherein in the closed position, the at least one arm is sized to surround the second arm on at least three sides of the at least one arm.

### Claim 16 (depends on 1)

The device of claim 1, wherein each first and second wing extension in end cross-section extends at a wing extension angle defined between the wing extension and a reference axis extending through the opposing body lateral sides of each respective first and second wing extension, wherein the wing extension angle is between 125 and 145 degrees.

### Claim 17 (depends on 1)

The device of claim 1, wherein the at least one gripping element has at least one friction element along a length thereof, and wherein when the at least one gripping element is located proximate the at least one arm the plurality of friction elements are disposed along a length defined between the intersection of the first end edge and the respective body lateral side, and the intersection of the second end edge and the respective body lateral side.

### Claim 18 (depends on 1)

The device of claim 1, wherein the fixation device further comprises:
a second arm moveably coupled to the central assembly, the second arm comprising a second body portion having a first end and a second end, the second end being moveable between a closed position and an open position; and
a second gripping element moveable relative to the second arm to capture a native leaflet therebetween.

### Claim 19

A fixation device for fixation of leaflets of a heart valve comprising:
a central assembly;
at least one arm moveably coupled to the central assembly, the at least one arm comprising:
a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides,
first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension;
wherein the first and second wing extensions each have a first end edge and a second end edge, wherein the first end edge extends between the respective body lateral side and the outer lateral edge and is located proximate the first end of the body portion, and the second end edge extends between the respective body lateral side and the outer lateral edge and is located proximate the second end of the body portion, and
wherein the second end edge extends from the respective body lateral side at a second end angle defined between the second end edge and the longitudinal axis, wherein the second end angle is between 30 and 60 degrees; and
at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

### Claim 20 (depends on 19)

The device of claim 19, wherein the second end angle is 45 degrees.
