# US 10,441,266 B2 · Post-implantation tension adjustment in cardiac implants

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- Number: US 10,441,266 B2
- Document ID: US10441266B2
- Status: Granted
- Kind: B2
- Application number: 15/903,619
- Filed: 2018-02-23
- Published: 2018-09-06
- Granted: 2019-10-15
- Earliest claimed: 2017-03-01
- Assignees: 4Tech Inc.
- Applicants: 4Tech Inc.
- Inventors: Paolo Denti; Andrea Guidotti; Kevin Lynn; Idan Tobis
- Web page: https://patentgrep.com/patent/US10441266B2

## 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)}
- 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 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses}
- A61F 2/848: having means for fixation to the vessel wall, e.g. barbs
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0412: {having anchoring barbs or pins extending outwardly from suture anchor body}
- A61B 2017/0462: {One way system, i.e. also tensioning the suture}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0496: {for tensioning sutures}
- 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

A method of treating a heart of a patient is provided, including implanting a first tissue anchor in cardiac tissue of the patient, the first tissue anchor attached to one or more tethers that are fixed to a coupling element. A second tissue anchor is implanted in the patient. The coupling element is coupled to a first coupling site of the second tissue anchor, thereby coupling the first tissue anchor to the second tissue anchor via the one or more tethers. Thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, tension is increased between the first and the second tissue anchors by decoupling the coupling element from the first coupling site and coupling the coupling element to a second coupling site of the second tissue anchor. Other embodiments are also described.

## Claims

### Claim 1

A method of treating a heart of a patient, comprising:
implanting a first tissue anchor in cardiac tissue of the patient, the first tissue anchor attached to one or more tethers that are fixed to a coupling element;
implanting a second tissue anchor in the patient;
coupling the coupling element to a first coupling site of the second tissue anchor, thereby coupling the first tissue anchor to the second tissue anchor via the one or more tethers; and
thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, increasing tension between the first and the second tissue anchors by decoupling the coupling element from the first coupling site and coupling the coupling element to a second coupling site of the second tissue anchor,
wherein a tissue-growth-inhibiting coating coats (a) the coupling element, (b) the first and the second coupling sites, or (c) the coupling element and the first and the second coupling sites.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the one or more tethers are slack before increasing the tension.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the coupling element comprises a hook.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the coupling element is shaped so as to define an opening, and wherein coupling the coupling element to the first coupling site comprises coupling the opening to the first coupling site.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the second tissue anchor comprises a stent that comprises a plurality of struts, which define the first and the second coupling sites.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the first and the second coupling sites extend radially inward to facilitate the coupling of the coupling element to the first and the second coupling sites from within the stent.

### Claim 7 (depends on 6)

The method according to claim 6, wherein one or more of the struts extend radially inward at the first and the second couplings sites to facilitate the coupling of the coupling element to the first and the second coupling sites from within the stent.

### Claim 8 (depends on 6)

The method according to claim 6, wherein the second tissue anchor comprises hooks at the first and the second coupling sites, respectively.

### Claim 9 (depends on 5)

The method according to claim 5, wherein at least one of the struts is oriented axially along the stent, and the axially-oriented strut defines the first and the second coupling sites.

### Claim 10 (depends on 9)

The method according to claim 9, wherein the first and the second coupling sites extend radially inward to facilitate the coupling of the coupling element to the first and the second coupling sites from within the stent.

### Claim 11 (depends on 1)

The method according to claim 1, wherein increasing the tension comprises increasing the tension after allowing at least one week for tissue growth on the first tissue anchor.

### Claim 12 (depends on 1)

The method according to claim 1, wherein increasing the tension comprises increasing the tension within two months after implanting the first tissue anchor.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the coupling element is a first coupling element, and the one or more tethers are additionally fixed to a second coupling element, and wherein coupling the coupling element to the first coupling site comprises coupling one or more of the first and the second coupling elements to a plurality of first coupling sites.

### Claim 14 (depends on 1)

The method according to claim 1, wherein coupling the coupling element to the first coupling site comprises coupling the coupling element to the first coupling site after implanting the first and the second tissue anchors.

### Claim 15 (depends on 1)

The method according to claim 1, wherein coupling the coupling element to the first coupling site comprises coupling the coupling element to the first coupling site before implanting the first and the second tissue anchors.

### Claim 16 (depends on 1)

The method according to claim 1, wherein coupling the coupling element to the first coupling site comprises coupling the coupling element to the first coupling site after implanting the first tissue anchor and before implanting the second tissue anchor.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the coupling element is coated with the tissue-growth-inhibiting coating.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the first and the second coupling sites are coated with the tissue-growth-inhibiting coating.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the first tissue anchor comprises a helical tissue-anchoring element.

### Claim 20 (depends on 1)

The method according to claim 1, wherein implanting the first tissue anchor comprises implanting the first tissue anchor in the vicinity of the tricuspid valve of the patient.

### Claim 21 (depends on 1)

The method according to claim 1, wherein implanting the second tissue anchor comprises implanting the second tissue anchor in a blood vessel selected from the group consisting of: a superior vena cava (SVC), an inferior vena cava (IVC), and a coronary sinus.

### Claim 22 (depends on 1)

The method according to claim 1, wherein the coupling element and the first and the second coupling sites are coated with the tissue-growth-inhibiting coating.

### Claim 23

A method of treating a heart of a patient, comprising:
implanting a first tissue anchor in cardiac tissue of the patient, the first tissue anchor attached to one or more tethers that are fixed to a coupling element;
implanting a second tissue anchor in the patient;
coupling the coupling element to a first coupling site of the second tissue anchor, thereby coupling the first tissue anchor to the second tissue anchor via the one or more tethers; and
thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, increasing tension between the first and the second tissue anchors by decoupling the coupling element from the first coupling site and coupling the coupling element to a second coupling site of the second tissue anchor,
wherein the second tissue anchor comprises a stent that comprises a plurality of struts, which define the first and the second coupling sites,
wherein at least one of the struts is oriented axially along the stent, and the axially-oriented strut defines the first and the second coupling sites, and
wherein the axially-oriented strut is wider than others of the struts so as to serve as a backbone for the stent.
