# US 12,109,110 B2 · Percutaneous tricuspid valve repair devices and methods

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- Number: US 12,109,110 B2
- Document ID: US12109110B2
- Status: Granted
- Kind: B2
- Application number: 18/358,760
- Filed: 2023-07-25
- Published: 2023-11-23
- Granted: 2024-10-08
- Earliest claimed: 2022-04-29
- Assignees: Tangent Cardiovascular, Inc.
- Applicants: Tangent Cardiovascular, Inc.
- Inventors: Nathan Daniel Brown
- Web page: https://patentgrep.com/patent/US12109110B2

## CPC

- A61F 2/2415: {Manufacturing methods}
- 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 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- 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)}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61B 2017/00243: {cardiac}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/00349: {Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue (A61B17/06066 takes precedence)}
- A61B 2017/00358: {Snares for grasping}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0404: {Buttons}
- A61B 2017/0406: {Pledgets}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/0437: {the barbs being resilient or spring-like}
- A61B 2017/0458: {Longitudinal through hole, e.g. suture blocked by a distal suture knot}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/047: {having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body}
- A61B 2017/0472: {Multiple-needled, e.g. double-needled, instruments}
- A61B 2017/0488: {Instruments for applying suture clamps, clips or locks}
- A61B 2017/06042: {located close to needle tip}
- A61F 2/2451: {Inserts in the coronary sinus for correcting the valve shape}
- A61F 2/2487: {Devices within the heart chamber, e.g. splints}
- A61F 2002/8483: {Barbs}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- 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 ventricular surface anchor can be placed against a first right ventricular surface, wherein the first ventricular surface anchor is connected to a first tension member. A first tension anchor against a tension anchor surface of a heart, wherein the first tension anchor is connected to a second tension member. The first tension member connected to the first ventricular surface anchor can extend towards the second tension member connected to the first tension anchor; and the first tension member and the second tension member, can be draw the first right ventricular surface toward the first tension anchor. The surface anchor can include a nitinol frame forming an outer perimeter and a hole. The nitinol frame can have an austenite state in a deployed configuration when a temperature of the nitinol frame is body temperature. The surface anchor can also include a grommet comprising a distal tubular portion connected to a proximal finger portion.

## Claims

### Claim 1

A method of tricuspid valve repair comprising:
anchoring a first ventricular surface anchor against a first right ventricular surface, wherein the first ventricular surface anchor is connected to a first tension member;
anchoring a first tension anchor against a first tension anchor surface of a heart, wherein the first tension anchor is connected to a second tension member;
anchoring a second tension anchor to a second tension anchor surface of the heart, wherein the second tension anchor is connected to a third tension member;
extending the first tension member connected to the first ventricular surface anchor towards the second tension member connected to the first tension anchor;
extending the third tension member connected to the second tension anchor towards the first tension member connected to the first ventricular surface anchor; and
with the first tension member, the second tension member, and the third tension member, drawing the first right ventricular surface toward the first tension anchor;
wherein the third tension member is connected to the first tension member and the second tension member via a tension member lock.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first tension anchor surface is against a left atrial surface of an interatrial septum inferior to a Fossa Ovalis.

### Claim 3 (depends on 1)

The method of claim 1, wherein the first tension anchor surface is at a right ventricular surface of an interventricular septum.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first tension anchor surface is at a left ventricular surface of an interventricular septum.

### Claim 5 (depends on 1)

The method of claim 1, wherein the first tension anchor surface is at a coronary sinus close to a right atrium.

### Claim 6 (depends on 1)

The method of claim 1, further comprising anchoring a second ventricular surface anchor against a right ventricular surface near an anterior portion of a tricuspid annulus;
wherein the second ventricular surface anchor is connected to a third tension member;
wherein a center of the first ventricular surface anchor is spaced between 0.5 and 4 centimeters from a center of the second ventricular surface anchor; and
extending the first tension member connected to the first ventricular surface anchor and the second tension member connected to the second ventricular surface anchor towards the first tension anchor; and
with the first tension member, the second tension member, and the third tension member, drawing the first right ventricular surface and the right ventricular surface near the anterior portion of the tricuspid annulus toward the first tension anchor.

### Claim 7 (depends on 1)

The method of claim 1, wherein the first right ventricular surface is near an anterior portion of a tricuspid annulus.

### Claim 8 (depends on 1)

The method of claim 1, wherein the first right ventricular surface is within a right ventricular outflow tract.

### Claim 9 (depends on 1)

The method of claim 1, wherein the first right ventricular surface is within a pulmonary artery proximal to a pulmonary valve.

### Claim 10 (depends on 1)

The method of claim 1, wherein drawing the first right ventricular surface toward the first tension anchor further comprises:
advancing a tensioning lock over the first tension member and the second tension member to a location proximal the first tension anchor to draw the first right ventricular surface toward the first tension anchor;
locking the tensioning lock to maintain tension on the first tension member and the second tension member; and
trimming excess material of the first tension member and the second tension member.

### Claim 11 (depends on 10)

The method of claim 10, wherein locking the tensioning lock comprises:
adjusting the tensioning lock from a first configuration which can allow tension members to move freely relative to the tensioning lock to a second configuration which prevents the tension members from moving freely relative to the tensioning lock.

### Claim 12 (depends on 1)

The method of claim 1, further comprising advancing a grommet over the first tension member connected to the first ventricular surface anchor;
wherein the grommet is positioned against an atrial surface of the heart opposite a ventricular surface anchor attached to the first tension member.

### Claim 13 (depends on 1)

The method of claim 1, wherein the first tension member and the second tension member are portions of a single tension element.

### Claim 14

A method of tricuspid valve repair comprising:
anchoring a first ventricular surface anchor near an anterior portion of a tricuspid annulus, wherein the first ventricular surface anchor is connected to a first tension member;
anchoring a second ventricular surface anchor near a right ventricular surface of a posterior portion of the tricuspid annulus, wherein the second ventricular surface anchor is connected to a second tension member;
anchoring a first tension anchor against a left atrial surface of an interatrial septum, wherein the first tension anchor is connected to a third tension member;
extending the first tension member connected to the first ventricular surface anchor and the second tension member connected to the second ventricular surface anchor towards the third tension member connected to the first tension anchor; and
with the first tension member, the second tension member, and the third tension member, drawing the anterior portion of the tricuspid annulus and the posterior portion of the tricuspid annulus toward the first tension anchor.

### Claim 15

A tricuspid valve repair system comprising:
two or more surface anchor systems, each surface anchor system comprising:
a surface anchor comprising a nitinol wire frame defined at its perimeter by a nitinol wire, and comprising an internal nitinol wire feature within an area defined by a perimeter formed by the nitinol wire frame;
wherein the nitinol wire frame comprises an austenite state in a deployed configuration when a temperature of the nitinol wire frame is body temperature;
a tether assembly comprising a plurality of tethers, wherein a tether extends from each of the two or more surface anchor systems and connects at a tether connection point; and
a tether lock advanced over the tether connection point, the tether lock configured to limit relative movement between the two or more surface anchor systems.

### Claim 16 (depends on 15)

The tricuspid valve repair system of claim 15, further comprising a grommet and a grommet lock.

### Claim 17 (depends on 16)

The tricuspid valve repair system of claim 16, wherein the grommet is a flat grommet comprising an expandable nitinol frame;
wherein the flat grommet is disposed upon the tether assembly through a hole in the flat grommet; and
wherein the expandable nitinol frame of the grommet comprises an austenite state in a deployed configuration when a temperature of the expandable nitinol frame is a human body temperature.

### Claim 18 (depends on 16)

The tricuspid valve repair system of claim 16, wherein the grommet is a T-bar grommet comprising a singular rigid member with a length along a long axis which is longer than a width along a short axis,
wherein the width of the T-bar grommet is configured to accommodate the T-bar grommet within an inner diameter of a delivery catheter;
wherein the T-bar grommet is disposed upon the tether assembly through a hole at or near a center of the T-bar grommet; and
wherein the T-bar grommet can be pivoted about the tether assembly such that the long axis of the T-bar grommet is approximately parallel to an axis of the tether assembly for insertion into the delivery catheter for deployment; and
wherein subsequent to deploying from the delivery catheter, the T-bar grommet can be pivoted about the tether assembly such that a longer axis of the T-bar grommet is at an angle relative to the axis of the tether assembly.

### Claim 19 (depends on 15)

The tricuspid valve repair system of claim 15, wherein the nitinol wire frame of the surface anchor is formed by laser cutting a nitinol sheet or strip.
