# US 11,890,193 B2 · System and method for reducing tricuspid regurgitation

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- Number: US 11,890,193 B2
- Document ID: US11890193B2
- Status: Granted
- Kind: B2
- Application number: 17/083,127
- Filed: 2020-10-28
- Published: 2021-02-11
- Granted: 2024-02-06
- Earliest claimed: 2015-12-30
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Michael W. Sutherland; Steven D. Cahalane
- Web page: https://patentgrep.com/patent/US11890193B2

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- 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 2/2451: {Inserts in the coronary sinus for correcting the valve shape}
- A61B 2017/00867: {shape memory effect}
- 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 2017/0445: {cannulated, e.g. with a longitudinal through-hole for passage of an instrument}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0496: {for tensioning sutures}
- A61F 2/2466: {Delivery devices therefor}
- 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

A first anchor is anchored inside a coronary sinus of a heart of a subject. A second anchor can be driven into a tricuspid annulus of the heart. A distal portion of the second anchor can be disposed adjacent and parallel to a center portion of the second anchor. The second anchor can be seated against a surface of the annulus, for example, such that (i) the distal portion is disposed perpendicular to the center portion, (ii) the center portion extends through the annulus, and (iii) a proximal portion of the second anchor is disposed in the atrium. A distance between the first and second anchors can be reduced by applying tension to a tensioning member coupled to the first anchor and the proximal portion of the second anchor. Other embodiments are also described.

## Claims

### Claim 1

A method for use at a tricuspid valve of a heart of a subject, the tricuspid valve having an annulus and being disposed between a right atrium and a right ventricle of the heart, the heart having a coronary sinus, and the method comprising:
using a first delivery device:
transluminally advancing a first anchor to the coronary sinus, and
anchoring the first anchor inside the coronary sinus;
using a second delivery device:
transluminally advancing a second anchor to the right atrium, the second anchor including a proximal portion, a center portion, and a distal portion that is pivotally coupled to the center portion, and
anchoring the second anchor at a site that is across the annulus from the coronary sinus by:
while the distal portion is disposed adjacent and parallel to the center portion, driving the distal portion from the right atrium, through the annulus at the site, and into the right ventricle,
seating the distal portion against a ventricular surface of the annulus such that (i) the distal portion is disposed perpendicular to the center portion, (ii) the center portion extends through the annulus, and (iii) the proximal portion is disposed in the right atrium;
while the first anchor remains anchored inside the coronary sinus and the second anchor remains anchored to the site, reducing a distance between the first and second anchors by applying tension to a tensioning member coupled to (i) the proximal portion of the second anchor and (ii) the first anchor; and
maintaining the tension by locking a lock member to the tensioning member.

### Claim 2 (depends on 1)

The method according to claim 1, further comprising sliding the lock member along the tensioning member to the right atrium subsequently to anchoring the second anchor at the site.

### Claim 3 (depends on 1)

The method according to claim 1, further comprising, prior to anchoring the second anchor, forming an aperture at the site by puncturing the annulus with a wire, and wherein driving the distal portion through the annulus at the site comprises driving the distal portion through the aperture.

### Claim 4 (depends on 1)

The method according to claim 1, wherein:
transluminally advancing the second anchor to the right atrium comprises transluminally advancing the second anchor to the right atrium while the second anchor is disposed within the second delivery device, with the distal portion disposed adjacent and parallel to the center portion, and
anchoring the second anchor at the site comprises exposing the second anchor from the second delivery device such that the distal portion pivots automatically to become disposed perpendicular to the center portion.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the tricuspid valve has an anterior leaflet, a septal leaflet, and a posterior leaflet, and wherein reducing the distance between the first and second anchors comprises reducing the distance between the first and second anchors such that the posterior leaflet becomes in effect eliminated.

### Claim 6 (depends on 1)

The method according to claim 1, wherein:
advancing the first anchor comprises advancing the first anchor while the first anchor is collapsed around a deflated balloon of a balloon catheter of the first delivery device, and
anchoring the first anchor comprises plastically expanding the first anchor within the coronary sinus by inflating the balloon.

### Claim 7 (depends on 1)

The method according to claim 1, wherein:
the tensioning member is a second tensioning member, and is coupled to the first anchor via a first tensioning member,
reducing the distance comprises reducing the distance by applying tension to the first and second tensioning members, and
maintaining the tension comprises maintaining the tension by locking the lock member to the first and second tensioning members.

### Claim 8 (depends on 7)

The method according to claim 7, wherein locking the lock member to the first and second tensioning members comprises locking the lock member to the first and second tensioning members such that the lock becomes implanted in the right atrium.

### Claim 9 (depends on 1)

The method according to claim 1, wherein anchoring the first anchor inside the coronary sinus comprises anchoring the first anchor inside the coronary sinus prior to transluminally advancing the second anchor to the right atrium.

### Claim 10 (depends on 9)

The method according to claim 9, wherein anchoring the first anchor inside the coronary sinus comprises anchoring the first anchor inside the coronary sinus with the tensioning member coupled to the first anchor, and wherein transluminally advancing the second anchor to the right atrium comprises sliding the second anchor over the tensioning member toward the right atrium.

### Claim 11 (depends on 10)

The method according to claim 10, wherein locking the lock member to the tensioning member comprises locking the lock member to the tensioning member such that the second anchor is disposed, on the tensioning member, between the lock member and the first anchor.

### Claim 12 (depends on 1)

The method according to claim 1, wherein:
transluminally advancing the first anchor to the coronary sinus comprises transluminally advancing the first anchor to the coronary sinus while the first anchor is maintained in a collapsed state within the first delivery device, and
anchoring the first anchor comprises radially expanding the first anchor within the coronary sinus.

### Claim 13 (depends on 12)

The method according to claim 12, wherein anchoring the first anchor comprises ejecting the first anchor from the first delivery device within the coronary sinus such that the first anchor self-expands within the coronary sinus.

### Claim 14

A method of treatment at a tricuspid valve of a heart of a subject, the tricuspid valve having an annulus and being disposed between a right atrium and a right ventricle of the heart, the heart having a coronary sinus, and the method comprising:
transluminally advancing a first anchor to the coronary sinus and anchoring the first anchor inside the coronary sinus;
transluminally advancing a second anchor to the right atrium while the second anchor is disposed within a delivery device, the second anchor including a proximal portion, a center portion, and a distal portion, and
anchoring the second anchor at a site that is across the annulus from the coronary sinus by:
driving the distal portion from the right atrium into the annulus at the site, and
exposing the second anchor from the delivery device such that the distal portion pivots automatically to become disposed orthogonal to the center portion;
while the first anchor remains anchored inside the coronary sinus and the second anchor remains anchored to the site, reducing a distance between the first and second anchors by applying tension to a tensioning member coupled to (i) the proximal portion of the second anchor and (ii) the first anchor; and
maintaining the tension by locking a lock member to the tensioning member.

### Claim 15 (depends on 14)

The method according to claim 14, further comprising sliding the lock member along the tensioning member to the right atrium subsequently to anchoring the second anchor at the site.

### Claim 16 (depends on 14)

The method according to claim 14, further comprising, prior to anchoring the second anchor, forming an aperture at the site by puncturing the annulus with a wire, and wherein driving the distal portion through the annulus at the site comprises driving the distal portion through the aperture.

### Claim 17 (depends on 14)

The method according to claim 14, wherein the tricuspid valve has an anterior leaflet, a septal leaflet, and a posterior leaflet, and wherein reducing the distance between the first and second anchors comprises reducing the distance between the first and second anchors such that the posterior leaflet becomes in effect eliminated.

### Claim 18 (depends on 14)

The method according to claim 14, wherein:
advancing the first anchor comprises advancing the first anchor while the first anchor is collapsed around a deflated balloon of a balloon catheter, and
anchoring the first anchor comprises plastically expanding the first anchor within the coronary sinus by inflating the balloon.

### Claim 19 (depends on 14)

The method according to claim 14, wherein:
the tensioning member is a second tensioning member, and is coupled to the first anchor via a first tensioning member,
reducing the distance comprises reducing the distance by applying tension to the first and second tensioning members, and
maintaining the tension comprises maintaining the tension by locking the lock member to the first and second tensioning members.
