# US 10,869,763 B2 · Heart valve sealing devices and delivery devices therefor

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- Number: US 10,869,763 B2
- Document ID: US10869763B2
- Status: Granted
- Kind: B2
- Application number: 16/135,920
- Filed: 2018-09-19
- Published: 2019-01-17
- Granted: 2020-12-22
- 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/US10869763B2

## 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

In an exemplary method of implanting a valve repair device on a mitral valve of a patient, first and second clasps of the valve repair device are closed to grasp the leaflets of the mitral valve. First and second paddles of the valve repair device are closed to bring the leaflets of the mitral valve into contact with a coaptation or coaption element.

## Claims

### Claim 1

A method of implanting a valve repair device on a mitral valve of a patient comprising:
closing a first clasp of the valve repair device to grasp a first leaflet of the mitral valve;
closing a second clasp of the valve repair device to grasp a second leaflet of the mitral valve;
closing a first paddle of the valve repair device to bring the first leaflet of the mitral valve into contact with a coaptation element of the valve repair device, wherein the coaptation element tapers from a proximal end to a distal end; and
closing a second paddle of the valve repair device to bring the second leaflet of the mitral valve into contact with the coaptation element of the valve repair device.

### Claim 2 (depends on 1)

The method of claim 1 wherein the first paddle and the second paddle are sequentially closed.

### Claim 3 (depends on 1)

The method of claim 1 wherein the first and second paddles each comprise an inner paddle portion and an outer paddle portion and wherein each paddle is closed by moving a connection portion end of the outer paddle portion toward a connection portion of the inner paddle portion.

### Claim 4 (depends on 1)

The method of claim 1 wherein the first clasp is connected to the first paddle and the second clasp is connected to the second paddle.

### Claim 5 (depends on 4)

The method of claim 4 wherein the first clasp has a fixed portion attached to the first paddle and a moveable portion that is moveable with respect to the first paddle and wherein the second clasp has a fixed portion attached to the second paddle and a moveable portion that is moveable with respect to the second paddle.

### Claim 6 (depends on 1)

The method of claim 1 wherein closing the first clasp comprises releasing a biasing force of the first clasp and closing the second clasp comprises releasing a biasing force of the second clasp.

### Claim 7

A method of implanting a valve repair device on a mitral valve of a patient comprising:
closing a first clasp of the valve repair device to grasp a first leaflet of the mitral valve;
closing a second clasp of the valve repair device to grasp a second leaflet of the mitral valve; and
moving a cap of the valve repair device toward a coaptation element of the valve repair device to close first and second paddles of the valve repair device to bring the first and second leaflets of the mitral valve into contact with the coaptation element of the valve repair device, wherein the coaptation element tapers from a proximal end to a distal end.

### Claim 8 (depends on 7)

The method of claim 7 wherein the first and second paddles each comprise an inner paddle portion and an outer paddle portion.

### Claim 9 (depends on 8)

The method of claim 8, a connection portion of the outer paddle portion is connected to the cap and the inner paddle portion is connected to the coaptation element.

### Claim 10 (depends on 8)

The method of claim 8 wherein the inner paddle is connected to the outer paddle by a flexible joint.

### Claim 11 (depends on 8)

The method of claim 8 wherein the inner paddle portion and the outer paddle portion are integrally formed.

### Claim 12 (depends on 8)

The method of claim 8 wherein the inner paddle and the outer paddle are made from a flexible mesh material.

### Claim 13 (depends on 7)

The method of claim 7 wherein the first clasp is connected to the first paddle and the second clasp is connected to the second paddle.

### Claim 14 (depends on 13)

The method of claim 13 wherein the first clasp has a fixed portion attached to the first paddle and a moveable portion that is moveable with respect to the first paddle and wherein the second clasp has a fixed portion attached to the second paddle and a moveable portion that is moveable with respect to the second paddle.

### Claim 15 (depends on 7)

The method of claim 7 wherein the first and second paddles are biased closed.

### Claim 16 (depends on 7)

The method of claim 7 wherein the first paddle portion and the second paddle portion are attached to paddle frame that is connected to the cap.

### Claim 17 (depends on 16)

The method of claim 16 wherein the paddle frame biases the first and second paddles closed.

### Claim 18

A method of implanting a valve repair device on a mitral valve of a patient comprising:
closing a first clasp of the valve repair device to grasp a first leaflet of the mitral valve;
closing a second clasp of the valve repair device to grasp a second leaflet of the mitral valve; and
moving a cap of the valve repair device toward a coaptation element of the valve repair device to close first and second paddles of the valve repair device to bring the first and second leaflets of the mitral valve into contact with the coaptation element of the valve repair device;
wherein the first and second paddles each comprise an inner paddle portion and an outer paddle portion; and
wherein the inner paddle portion and the outer paddle portion are integrally formed.

### Claim 19 (depends on 18)

The method of claim 18, wherein the first paddle and the second paddle are sequentially closed.

### Claim 20 (depends on 18)

The method of claim 18, wherein closing the first clasp comprises releasing a biasing force of the first clasp and closing the second clasp comprises releasing a biasing force of the second clasp.

### Claim 21 (depends on 18)

The method of claim 18, a connection portion of the outer paddle portion is connected to the cap and a connection portion of the inner paddle portion is connected to the coaptation element.

### Claim 22 (depends on 18)

The method of claim 18, wherein each paddle is closed by moving the connection portion end of the outer paddle portion toward the connection portion of the inner paddle portion.

### Claim 23 (depends on 18)

The method of claim 18, wherein the inner paddle is connected to the outer paddle by a flexible joint.

### Claim 24 (depends on 18)

The method of claim 18, wherein the inner paddle and the outer paddle are made from a flexible mesh material.

### Claim 25 (depends on 18)

The method of claim 18, wherein the first clasp is connected to the first paddle and the second clasp is connected to the second paddle.

### Claim 26 (depends on 25)

The method of claim 25, wherein the first clasp has a fixed portion attached to the first paddle and a moveable portion that is moveable with respect to the first paddle and wherein the second clasp has a fixed portion attached to the second paddle and a moveable portion that is moveable with respect to the second paddle.