# US 11,439,507 B2 · Tether attachment assembly for epicardial pads and devices and methods of delivery for same

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- Number: US 11,439,507 B2
- Document ID: US11439507B2
- Status: Granted
- Kind: B2
- Application number: 17/052,704
- Filed: 2019-05-13
- Published: 2021-08-05
- Granted: 2022-09-13
- Earliest claimed: 2018-06-01
- Assignees: Tendyne Holdings, Inc.
- Applicants: Tendyne Holdings, Inc.
- Inventors: Preston James Huddleston; Zachary Vidlund
- Web page: https://patentgrep.com/patent/US11439507B2

## 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 2/2481: {Devices outside the heart wall, e.g. bags, strips or bands}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2457: {Chordae tendineae prostheses}
- 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 2017/00243: {cardiac}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0448: {Additional elements on or within the anchor}
- A61B 2017/045: {snug fit within the anchor}
- A61B 2017/0451: {Cams or wedges holding the suture by friction}
- A61B 2017/0453: {threaded elements, e.g. set screws}
- A61B 2017/0464: {for soft tissue}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2466: {Delivery devices therefor}
- 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

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes a tether fixer assembly configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The fixer assembly defines a lumen configured to receive therethrough a tether extending from the prosthetic valve and a movable portion. The fixer assembly is movable between a first configuration, in which the movable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether. The fixer assembly can be disposed against an epicardial pad positioned on the outside surface of the heart when in the second configuration to secure the prosthetic valve, the epicardial pad and tether in a desired position within the heart.

## Claims

### Claim 1

A system, comprising:
a prosthetic heart valve having a tether extending therefrom and outside a heart when the prosthetic heart valve is disposed within the heart;
an epicardial pad configured to be disposed outside of the heart to secure the prosthetic heart valve in a desired position within the heart, the epicardial pad defining an opening through which the tether is configured to extend; and
a fixer assembly configured to be coupled to the epicardial pad, the fixer assembly defining a lumen configured to receive a portion of the tether extending from the epicardial pad therethrough, the fixer assembly including a movable portion and being movable between a first configuration in which the moveable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether, the fixer assembly configured to secure the epicardial pad to the tether to secure the prosthetic heart valve in the desired position within the heart,
wherein the fixer assembly includes a first end, a second end, an elongate member extending from the first end to the second end and defining the lumen, and at least one actuation member extending between the first end and the second end, the actuation member configured to move the fixer assembly between the first configuration and the second configuration upon actuation,
wherein the actuation member is a screw.

### Claim 2

A system, comprising:
a prosthetic heart valve having a tether extending therefrom and outside a heart when the prosthetic heart valve is disposed within the heart;
an epicardial pad configured to be disposed outside of the heart to secure the prosthetic heart valve in a desired position within the heart, the epicardial pad defining an opening through which the tether is configured to extend; and
a fixer assembly configured to be coupled to the epicardial pad, the fixer assembly defining a lumen configured to receive a portion of the tether extending from the epicardial pad therethrough, the fixer assembly including a movable portion and being movable between a first configuration in which the moveable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether, the fixer assembly configured to secure the epicardial pad to the tether to secure the prosthetic heart valve in the desired position within the heart,
wherein the fixer assembly is expandable and has an inflated condition and a deflated condition,
wherein upon transition from the deflated condition to the inflated condition, an outer diameter of the fixer assembly remains fixed and an inner diameter of the fixer assembly decreases, the inner diameter at least partially defining the
lumen.

### Claim 3 (depends on 2)

The system of claim 2, wherein the fixer assembly include at least one fastening device positioned on an interior surface of the fixer assembly, the fastening device including a tip oriented toward the lumen.

### Claim 4 (depends on 3)

The system of claim 3, wherein the tip of the fastening device engages the tether when the fixer assembly is in the inflated condition.

### Claim 5

A system, comprising:
a prosthetic heart valve having a tether extending therefrom and outside a heart when the prosthetic heart valve is disposed within the heart;
an epicardial pad configured to be disposed outside of the heart to secure the prosthetic heart valve in a desired position within the heart, the epicardial pad defining an opening through which the tether is configured to extend; and
a fixer assembly configured to be coupled to the epicardial pad, the fixer assembly defining a lumen configured to receive a portion of the tether extending from the epicardial pad therethrough, the fixer assembly including a movable portion and being movable between a first configuration in which the moveable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether, the fixer assembly configured to secure the epicardial pad to the tether to secure the prosthetic heart valve in the desired position within the heart,
wherein the fixer assembly includes a proximal engagement portion having a top plate and an intermediate plate, and a distal portion having a bottom plate,
wherein the intermediate plate defines a curved track, a curved movable portion having a piercing tip and being movably received within the curved track.

### Claim 6 (depends on 5)

The system of claim 5, wherein in the first configuration of the fixer assembly, the curved movable portion does not traverse the lumen, and in the second configuration of the fixer assembly, the curved movable portion does traverse the lumen.

### Claim 7 (depends on 6)

The system of claim 6, further comprising:
a delivery device having a sheath, an actuation device configured to transition the fixer assembly from the first condition to the second condition, and an engagement portion for releasably engaging the fixer assembly.

### Claim 8 (depends on 7)

The system of claim 7, wherein at least one of the top plate and the intermediate plate define notches that are configured to mate with the engagement portion of the delivery device to maintain a rotational position of the fixer assembly while the notches are mated with the engagement portion of the delivery device.

### Claim 9 (depends on 7)

The system of claim 7, wherein the actuation device is configured to drive the curved movable portion along the curved track.

### Claim 10 (depends on 7)

The system of claim 7, wherein the fixer assembly includes a lock mechanism that allows the curved movable portion to move along the curved track in a first direction, but prevents the curved movable portion from moving along the curved track in a second direction opposite the first direction.