# US 10,765,515 B2 · Distal anchor apparatus and methods for mitral valve repair

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- Number: US 10,765,515 B2
- Document ID: US10765515B2
- Status: Granted
- Kind: B2
- Application number: 15/950,458
- Filed: 2018-04-11
- Published: 2018-10-11
- Granted: 2020-09-08
- Earliest claimed: 2017-04-06
- Assignees: University of Maryland, Baltimore; Harpoon Medical, Inc.
- Applicants: University of Maryland, Baltimore; Harpoon Medical, Inc.
- Inventors: Michael Nicholas D'ambra; Felino V. Cortez, Jr.; James S. Gammie; Peter Wilson; Stephen Epstein; Stephen Cournane; Julie Marie Etheridge; Peter Boyd
- Web page: https://patentgrep.com/patent/US10765515B2

## CPC

- A61F 2/2466: {Delivery devices therefor}
- 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)}
- A61F 2/2457: {Chordae tendineae prostheses}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2487: {Devices within the heart chamber, e.g. splints}
- 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 2017/00526: {Methods of manufacturing}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/00986: {Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts}
- A61B 2017/0406: {Pledgets}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0475: {using sutures having a slip knot}
- 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 2090/036: {abutting on tissue or skin}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2451: {Inserts in the coronary sinus for correcting the valve shape}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- 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

Described herein are devices and methods for mitral valve repair. The devices and methods implant a plurality of distal anchors at an annulus of the mitral valve (e.g., the posterior annulus) and tension artificial chordae to pull the portion of the annulus toward an opposite edge and inward into the ventricle. This can effectively reduce the size of the orifice and increase coaptation. The anchor points of the artificial chordae can be offset from the apex of the heart to achieve a targeted force vector on the annulus. In addition, some embodiments include distal anchors implanted in the posterior leaflet in addition to those at the posterior annulus. This allows differential tensioning to be applied to provide for greater flexibility in treating various configurations of mitral valves to improve coaptation.

## Claims

### Claim 1

A method for implanting artificial chordae to improve coaptation, the method comprising:
inserting a first artificial chordae having a first distal anchor disposed at a distal end portion of the first artificial chordae through an apex region of a heart, through a ventricle of the heart, and to a proximal side of a posterior annulus of the mitral valve, the first distal anchor disposed in a delivery configuration;
puncturing the posterior annulus to define an opening in the posterior annulus, the first artificial chordae extending through the opening so that the first distal anchor is positioned on a distal side of the posterior annulus;
deploying the first distal anchor so that the first distal anchor is moved to a deployed configuration to secure the first artificial chordae to the posterior annulus;
anchoring a proximal end portion of the first artificial chordae to the heart at a location that is basal to a true apex of the heart to apply a force on the posterior annulus, the force being directed anteriorly towards the anterior annulus and downward toward the ventricle;
inserting a second artificial chordae having a second distal anchor disposed at a distal end portion of the second artificial chordae through the apex region of the heart, through the ventricle of the heart, and to a proximal side of a posterior leaflet of the mitral valve, the second distal anchor disposed in a delivery configuration;
puncturing the posterior leaflet to define an opening in the posterior leaflet, the second artificial chordae extending through the opening so that the second distal anchor is positioned on a distal side of the posterior leaflet;
deploying the second distal anchor so that it is moved to a deployed configuration to secure the second artificial chordae to the posterior leaflet; and
anchoring a proximal end portion of the second artificial chordae to the heart to apply a force on the posterior leaflet, the force being directed anteriorly towards the anterior leaflet and downward toward the ventricle.

### Claim 2 (depends on 1)

The method of claim 1, further comprising implanting a third artificial chordae in the posterior annulus, the third artificial chordae having a third distal anchor at a distal end portion.

### Claim 3 (depends on 2)

The method of claim 2, wherein the third distal anchor of the third artificial chordae is deployed less than about 7 mm from the first distal anchor on the posterior annulus.

### Claim 4 (depends on 2)

The method of claim 2, further comprising implanting less than or equal to four artificial chordae, each artificial chordae having a distal anchor at a respective distal end portion.

### Claim 5 (depends on 4)

The method of claim 4, wherein each of the distal anchors of the respective implanted artificial chordae are positioned at least about 3 mm and less than or equal to about 7 mm from a nearest distal anchor on the posterior annulus.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first artificial chordae is inserted at least about 1 cm lateral to the left coronary artery.

### Claim 7 (depends on 6)

The method of claim 6, wherein the first artificial chordae is inserted at least about 2 cm basal from a true apex of the heart.

### Claim 8 (depends on 1)

The method of claim 1, wherein the proximal end portion of the second artificial chordae is anchored to the heart in a different location from the proximal end portion of the first artificial chordae.

### Claim 9 (depends on 1)

The method of claim 1 further comprising applying a first tension to the first artificial chordae and a second tension different from the first tension to the second artificial chordae.

### Claim 10 (depends on 9)

The method of claim 9, wherein the first tension is greater than the second tension.

### Claim 11 (depends on 1)

The method of claim 1, wherein a first delivery device is used to implant the first artificial chordae and a second delivery device different from the first delivery device is used to implant the second artificial chordae.

### Claim 12

A method comprising:
inserting a first artificial chordae through an apex region of a heart, through a ventricle of the heart, and to a proximal side of a posterior annulus of the mitral valve, the first artificial chordae having a first distal anchor disposed in a delivery configuration;
deploying the first distal anchor so that the first distal anchor is moved to a deployed configuration to secure the first artificial chordae to the posterior annulus;
anchoring a proximal end portion of the first artificial chordae at a location that is basal to a true apex of the heart wherein a first tension on the first artificial chordae is directed anteriorly towards the anterior annulus and downward toward the ventricle;
inserting a second artificial chordae through the apex region of the heart, through the ventricle of the heart, and to a proximal side of a posterior leaflet of the mitral valve, the second artificial chordae having a second distal anchor disposed in a delivery configuration;
deploying the second distal anchor so that the second distal anchor is moved to a deployed configuration to secure the second artificial chordae to the posterior leaflet; and
anchoring a proximal end portion of the second artificial chordae at a location that is basal to the true apex of the heart wherein a second tension on the second artificial chordae causes the posterior leaflet to move downward toward the ventricle to increase coaptation.

### Claim 13 (depends on 12)

The method of claim 12, wherein the first tension is greater than the second tension.

### Claim 14 (depends on 12)

The method of claim 12, further comprising adjusting the first tension after anchoring of the second artificial chordae.

### Claim 15 (depends on 14)

The method of claim 14, further comprising adjusting the second tension independent of adjustments to the first tension.

### Claim 16 (depends on 12)

The method of claim 12, wherein the second tension is configured to cause the surface of coaptation to be at least about 4 mm.

### Claim 17 (depends on 12)

The method of claim 12, wherein the combination of the first tension and the second tension decreases a distance between the anterior annulus and the posterior annulus by at least about 10%.

### Claim 18 (depends on 12)

The method of claim 12, wherein the first artificial chordae is anchored to the heart in a different location from the second artificial chordae.

### Claim 19 (depends on 12)

The method of claim 12, wherein the second tension is configured to cause the second distal anchor to be below the anterior leaflet during coaptation.

### Claim 20 (depends on 12)

The method of claim 12, further comprising implanting a third artificial chordae in the posterior annulus, the third artificial chordae having a third distal anchor at a distal end portion.