# US 12,213,883 B2 · Method and apparatus for transvascular implantation of neo chordae tendinae

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- Number: US 12,213,883 B2
- Document ID: US12213883B2
- Status: Granted
- Kind: B2
- Application number: 18/317,691
- Filed: 2023-05-15
- Published: 2023-11-16
- Granted: 2025-02-04
- Earliest claimed: 2016-12-30
- Assignees: Pipeline Medical Technologies, Inc.
- Applicants: Pipeline Medical Technologies, Inc.
- Inventors: Gordon B. Bishop; Randall T. Lashinski
- Web page: https://patentgrep.com/patent/US12213883B2

## CPC

- A61F 2/2457: {Chordae tendineae prostheses}
- 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 17/08: Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2466: {Delivery devices therefor}
- 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 17/0487: {Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks (suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122)}
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/00358: {Snares for grasping}
- A61B 2017/0406: {Pledgets}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/0441: {the shaft being a rigid coil or spiral}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0488: {Instruments for applying suture clamps, clips or locks}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/06052: {Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle}
- A61B 2018/00369: {Heart valves}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- 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)

## Abstract

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium, through the mitral valve, and into the left ventricle. A ventricular anchor is deployed from the catheter and into a wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter. A leaflet anchor is deployed to secure a mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the catheter. The leaflet suture is secured to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium. Also disclosed is an assembled in situ mitral valve leaflet restraint, having a neo papillary muscle and a neo chordae tendinea.

## Claims

### Claim 1

A method of securing a leaflet anchor to a mitral valve leaflet, the method comprising:
positioning a catheter having a distal end on an atrial side of the mitral valve leaflet;
grasping the mitral valve leaflet;
after grasping the mitral valve leaflet, advancing a piercing element through the mitral valve leaflet;
after advancing the piercing element through the mitral valve leaflet, securing the leaflet anchor to the mitral valve leaflet via the piercing element; and
coupling the leaflet anchor at the mitral valve leaflet to a tissue anchor attached to a ventricle.

### Claim 2 (depends on 1)

The method of claim 1, wherein securing the leaflet anchor to the mitral valve via the piercing element comprises delivering the leaflet anchor through the piercing element to a ventricular side of the mitral valve leaflet.

### Claim 3 (depends on 1)

The method of claim 1, wherein grasping the mitral valve leaflet comprises sticking the mitral valve leaflet to a cryo-catheter.

### Claim 4 (depends on 1)

The method of claim 1, wherein grasping the mitral valve leaflet comprises grasping the mitral valve leaflet with a suction tube.

### Claim 5 (depends on 1)

The method of claim 1, wherein grasping the mitral valve leaflet comprises grasping the mitral valve leaflet with a mechanical gripper.

### Claim 6 (depends on 1)

The method of claim 1, wherein the piercing element is a needle.

### Claim 7

A method of securing a leaflet anchor system to a mitral leaflet valve, the method comprising:
locating a mitral valve leaflet;
grasping the mitral valve leaflet to limit movement of the mitral valve leaflet caused by a heartbeat;
advancing a tissue piercing element through a distal end of a delivery shaft;
piercing the mitral leaflet valve with the tissue piercing element; and
delivering a leaflet anchor of the leaflet anchor system through the tissue piercing element to a ventricular side of the mitral valve leaflet.

### Claim 8 (depends on 7)

The method of claim 7 further comprising coupling the leaflet anchor at the mitral valve leaflet to a tissue anchor attached to a ventricle.

### Claim 9 (depends on 7)

The method of claim 7, wherein grasping the mitral valve leaflet comprises grasping the mitral valve leaflet with a suction tube.

### Claim 10 (depends on 7)

The method of claim 7, wherein grasping the mitral valve leaflet comprises grasping the mitral valve leaflet with a mechanical gripper.

### Claim 11 (depends on 7)

The method of claim 7, wherein the tissue piercing element is a needle.