# US 11,026,672 B2 · Method and apparatus for cardiac procedures

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- Number: US 11,026,672 B2
- Document ID: US11026672B2
- Status: Granted
- Kind: B2
- Application number: 16/012,195
- Filed: 2018-06-19
- Published: 2018-12-20
- Granted: 2021-06-08
- Earliest claimed: 2017-06-19
- Assignees: Harpoon Medical, Inc.; University of Maryland, Baltimore
- Applicants: Harpoon Medical, Inc.; University of Maryland, Baltimore
- Inventors: William Niland; Felino V. Cortez, Jr.; James S. Gammie; Michael Nicholas D'ambra; Peter Wilson; Stephen Cournane
- Web page: https://patentgrep.com/patent/US11026672B2

## CPC

- 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 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0483: {Hand-held instruments for holding sutures (A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30)}
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2457: {Chordae tendineae prostheses}
- A61B 17/0485: {Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet}
- A61B 2017/00243: {cardiac}
- A61B 2017/0406: {Pledgets}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/3425: {for internal organs, e.g. heart ports}
- A61B 2017/3492: {against the outside of the body}
- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61F 2/2466: {Delivery devices therefor}
- 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

Described herein are methods and apparatus for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.

## Claims

### Claim 1

A method for twisting sutures together to approximate anchor implants attached to targeted tissue, the method comprising:
attaching two or more cords to targeted tissue, each of the two or more cords including a distal anchor implant and a suture extending proximally from the distal anchor implant;
securing proximal end portions of the sutures of the two or more cords to a twister device;
operating the twister device to cause the sutures of the two or more cords to intertwine;
releasing the proximal end portions of the sutures of the two or more cords from the twister device; and
anchoring the proximal end portions of the sutures of the two or more cords to prevent unwinding of the sutures of the two or more cords.

### Claim 2 (depends on 1)

The method of claim 1, wherein the targeted tissue is within the heart and the twister device is positioned outside of the heart so that it is operated outside of the heart.

### Claim 3 (depends on 2)

The method of claim 2, wherein anchoring the proximal end portions of the sutures of the two or more cords includes securing the proximal end portions to an external wall of the heart.

### Claim 4 (depends on 2)

The method of claim 2 further comprising inserting a portion of the twister device into a valve introducer that provides access to the targeted tissue within the heart.

### Claim 5 (depends on 1)

The method of claim 1, wherein the targeted tissue includes a leaflet of a mitral valve.

### Claim 6 (depends on 5)

The method of claim 5, wherein the targeted tissue includes a posterior leaflet.

### Claim 7 (depends on 5)

The method of claim 5, wherein the targeted tissue includes an anterior leaflet.

### Claim 8 (depends on 1)

The method of claim 1 further comprising adjusting a tension of the sutures of the two or more cords.

### Claim 9 (depends on 8)

The method of claim 8, wherein adjusting a tension of the sutures of the two or more cords occurs simultaneously with operating the twister device to cause the sutures of the two or more cords to intertwine.

### Claim 10 (depends on 1)

The method of claim 1, wherein operating the twister device to cause the sutures of the two or more cords to intertwine results in a point of intersection that approaches the targeted tissue to change a force vector on the two or more cords attached to the targeted tissue.

### Claim 11 (depends on 1)

The method of claim 1, wherein the distal anchors of the two or more cords are secured to tissue within a heart and the proximal end portions of the sutures of the two or more cords are anchored to an external wall of the heart.

### Claim 12 (depends on 11)

The method of claim 11, wherein a portion of the twister device to which the proximal end portions of the sutures of the two or more cords are secured is located outside of the heart.

### Claim 13 (depends on 1)

The method of claim 1, wherein the targeted tissue is within a heart so that the distal anchor implants of the two or more cords are attached to the targeted tissue within the heart and the proximal end portions of the sutures extend outside of the heart.

### Claim 14 (depends on 1)

The method of claim 1, wherein operating the twister device to cause the sutures of the two or more cords to intertwine improves coaptation of a mitral valve.

### Claim 15 (depends on 1)

The method of claim 1, wherein attaching two or more cords to targeted tissue includes deploying each of the distal anchor implants of the two or more cords on a distal side of the targeted tissue with each of the sutures of the two or more cords passing through the targeted tissue to extend proximally from the targeted tissue.

### Claim 16 (depends on 1)

The method of claim 1, wherein anchoring includes tying one or more knots in the proximal end portions of the two or more cords to secure the proximal end portions to anchor tissue.

### Claim 17 (depends on 1)

The method of claim 1, wherein anchoring includes securing the proximal end portions of the two or more cords to maintain an axial force on each of the sutures of the two or more cords.

### Claim 18 (depends on 17)

The method of claim 17, wherein the axial force is directed proximally from the distal anchor implants of the two or more cords.

### Claim 19 (depends on 17)

The method of claim 17, wherein the axial force pulls the distal anchor implants of the two or more cords proximally and toward each other.