# US 10,945,843 B2 · Heart valve sealing devices and delivery devices therefor

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- Number: US 10,945,843 B2
- Document ID: US10945843B2
- Status: Granted
- Kind: B2
- Application number: 16/150,437
- Filed: 2018-10-03
- Published: 2019-01-31
- Granted: 2021-03-16
- Earliest claimed: 2017-04-18
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Sergio Delgado; Eric Robert Dixon; David M. Taylor
- Web page: https://patentgrep.com/patent/US10945843B2

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61B 17/00: Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20)
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- 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 2/243: {Deployment by mechanical expansion}
- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2457: {Chordae tendineae prostheses}
- A61L 27/04: Metals or alloys
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 2017/00243: {cardiac}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0464: {for soft tissue}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- 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 2/2466: {Delivery devices therefor}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/009: magnetic
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
- A61F 2230/0004: Rounded shapes, e.g. with rounded corners
- A61F 2230/0008: elliptical or oval
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2230/0045: Omega-shaped
- A61F 2230/0069: cylindrical
- A61F 2230/0093: Umbrella-shaped, e.g. mushroom-shaped
- A61F 2240/00: Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F 2250/0036: differing in thickness
- A61F 2250/006: modular
- A61F 2250/0069: Sealing means
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

An exemplary valve repair device for repairing a native valve of a patient has a cap, and a paddle. The paddle has an inner paddle portion and an outer paddle portion. The inner paddle portion and the outer paddle portion are formed from a continuous strip of metal fabric. The outer paddle portion is connected to the cap. The cap is moveable away from the inner paddle portion to open the paddle.

## Claims

### Claim 1

A valve repair device for repairing a native valve of a patient, the valve repair device comprising:
a coaption element;
a cap;
a paddle having an inner paddle portion and an outer paddle portion;
wherein the inner paddle portion and the outer paddle portion are formed from a continuous strip of metal fabric;
wherein the inner paddle portion is connected to the coaption element;
wherein the outer paddle portion is connected to the cap;
wherein the cap is moveable away from the coaption element to open the paddle.

### Claim 2 (depends on 1)

The valve repair device of claim 1 wherein the strip of metal fabric is shapeset.

### Claim 3 (depends on 1)

The valve repair device of claim 1 wherein the metal fabric comprises nitinol.

### Claim 4 (depends on 1)

The valve repair device of claim 1 wherein the inner paddle, the outer paddle, and the coaption element are integrally formed.

### Claim 5 (depends on 1)

The valve repair device of claim 1 wherein the coaption element is made from a metal fabric.

### Claim 6 (depends on 1)

The valve repair device of claim 1 further comprising a paddle frame and wherein the strip of woven metal fabric is attached to the paddle frame.

### Claim 7 (depends on 6)

The valve repair device of claim 6 wherein the paddle frame biases the inner and outer paddle portions to the closed position.

### Claim 8 (depends on 6)

The valve repair device of claim 6 wherein the paddle frame comprises a metal and has a round three-dimensional shape.

### Claim 9 (depends on 8)

The valve repair device of claim 8 wherein the strip of metal fabric is attached to a connection portion of the paddle frame.

### Claim 10 (depends on 6)

The valve repair device of claim 6 wherein the paddle frame has a width that is wider than the width of the inner and outer paddles.

### Claim 11 (depends on 1)

The valve repair device of claim 1 wherein a connection portion of the inner paddle is moveable away from a connection portion of the outer paddle to open the inner and outer paddles.

### Claim 12 (depends on 11)

The valve repair device of claim 11 wherein moving the cap away from the coaption element moves the connection portion of the outer paddle and the connection portion of the paddle frame away from the connection portion of the coaption element to flex the paddle frame outward and open the inner and outer paddles.

### Claim 13 (depends on 1)

The valve repair device of claim 1 wherein the strip of metal fabric has a substantially constant width.

### Claim 14 (depends on 1)

The valve repair device of claim 1 wherein the metal fabric is a braided metal fabric.

### Claim 15

A valve repair device for repairing a native valve of a patient, the valve repair device comprising:
a cap;
a paddle having an inner paddle portion and an outer paddle portion;
wherein the inner paddle portion and the outer paddle portion are formed from a continuous strip of metal fabric;
wherein the outer paddle portion is connected to the cap;
wherein the cap is moveable away from the inner paddle portion to open the paddle;
a coaption element that is integrally formed with the inner paddle and the outer paddle.

### Claim 16 (depends on 15)

The valve repair device of claim 15 wherein the coaption element is made from a metal fabric.

### Claim 17

A valve repair device for repairing a native valve of a patient, the valve repair device comprising:
a cap;
a paddle frame;
a paddle having an inner paddle portion and an outer paddle portion;
wherein the inner paddle portion and the outer paddle portion are formed from a continuous strip of metal fabric;
wherein the strip of woven metal fabric is attached to the paddle frame;
wherein the outer paddle portion is connected to the cap;
wherein the cap is moveable away from the inner paddle portion to open the paddle.

### Claim 18 (depends on 17)

The valve repair device of claim 17 wherein the paddle frame biases the inner and outer paddle portions to the closed position.

### Claim 19 (depends on 17)

The valve repair device of claim 17 wherein the paddle frame comprises a metal and has a round three-dimensional shape.

### Claim 20 (depends on 19)

The valve repair device of claim 19 wherein the strip of metal fabric is attached to a connection portion of the paddle frame.

### Claim 21 (depends on 17)

The valve repair device of claim 17 wherein the paddle frame has a width that is wider than the width of the inner and outer paddles.

### Claim 22 (depends on 21)

The valve repair device of claim 21 wherein the strip of metal fabric has a substantially constant width.