# US 10,765,514 B2 · Annuloplasty technologies

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- Number: US 10,765,514 B2
- Document ID: US10765514B2
- Status: Granted
- Kind: B2
- Application number: 15/782,687
- Filed: 2017-10-12
- Published: 2018-02-22
- Granted: 2020-09-08
- Earliest claimed: 2015-04-30
- Assignees: Valtech Cardio, Ltd.
- Applicants: Valtech Cardio, Ltd.
- Inventors: Ehud Iflah; Tal Reich; Tal Sheps; Ilia Hariton; Haim Brauon; Meir Kutzik; Alexei Koifman; Yaron Herman
- Web page: https://patentgrep.com/patent/US10765514B2

## CPC

- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- 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 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2448: {D-shaped rings}
- A61B 2017/00323: {Cables or rods}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0441: {the shaft being a rigid coil or spiral}
- A61B 2017/0446: {Means for attaching and blocking the suture in the suture anchor}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/0649: {Coils or spirals}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2250/0004: adjustable
- A61F 2250/001: for adjusting a diameter
- 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

Apparatus is provided including a percutaneously-implantable implant and an adjustment device. The adjustment device can comprise an adjustment mechanism, coupled to the implant, and configured to change a dimension of the implant upon actuation of the adjustment mechanism and a lock. The adjustment device can have a locked state in which the lock inhibits actuation of the adjustment mechanism and an unlocked state in which the adjustment mechanism is actuatable. The adjustment device can be reversibly movable between the locked state and the unlocked state. The apparatus can include a longitudinal guide member and an adapter. An unlocking mechanism can be configured such that, while the adapter is coupled to the adjustment device, actuation of the unlocking mechanism moves the lock between the locked state and the unlocked state. Other applications are also described.

## Claims

### Claim 1

Apparatus, comprising:
a percutaneously-implantable implant;
an adjustment device, comprising:
an adjustment mechanism, coupled to the implant, and configured to change a dimension of the implant upon actuation of the adjustment mechanism; and
a lock:
having a locked state in which the lock inhibits actuation of the adjustment mechanism,
having an unlocked state in which the adjustment mechanism is actuatable, and
reversibly movable between the locked state and the unlocked state;
a longitudinal guide member;
an adjustment tool; and
an adapter:
coupled to the guide member,
comprising a fastener that couples the adapter to the adjustment device, and is intracorporeally decouplable from the adjustment device,
configured to be percutaneously delivered while coupled to the adjustment device,
comprising a trunk that is shaped to define a channel and a lateral opening, and
comprising an unlocking mechanism that comprises the channel and a pin that (i) is disposed and slidable within the channel, and (ii) comprises an appendage that protrudes laterally out of the lateral opening, the unlocking mechanism configured such that, while the adapter is coupled to the adjustment device, actuation of the unlocking mechanism moves the lock between the locked state and the unlocked state,
wherein the adjustment tool:
is percutaneously advanceable along the guide member to the adapter, subsequently to implantation of the implant,
comprises an adjustment-mechanism interface, dimensioned to interface with the adjustment mechanism, and to actuate the adjustment mechanism via the interface between the adjustment-mechanism interface and the adjustment mechanism, and
comprises an adapter interface:
comprising a force applicator that is axially slidable with respect to the adapter,
dimensioned to interface with the adapter, and to be slidable over a proximal portion of the trunk to a sufficient extent that the force applicator reaches the appendage, and
configured to move the lock into the unlocked state by, while the adapter is coupled to the adjustment device, actuating the unlocking mechanism by applying, with the force applicator, an axial force to the pin such that the pin slides within the channel.

### Claim 2 (depends on 1)

The apparatus according to claim 1, wherein the actuation of the unlocking mechanism moves the lock from the locked state to the unlocked state by the unlocking mechanism pressing on a depressible portion of the lock.

### Claim 3 (depends on 2)

The apparatus according to claim 2, wherein the lock is biased to be in the locked state in the absence of the pressing of the depressible portion.

### Claim 4 (depends on 1)

The apparatus according to claim 1, wherein:
the adjustment device is shaped to define a first screw thread, and
the fastener (i) is shaped to define a second screw thread that couples the fastener to the adjustment device by engaging the first screw thread, and (ii) is intracorporeally decouplable from the adjustment device by the second screw thread being unscrewed from the first screw thread.

### Claim 5 (depends on 1)

The apparatus according to claim 1, wherein the adjustment tool is configured to decouple the adapter from the adjustment device.

### Claim 6 (depends on 5)

The apparatus according to claim 5, wherein the adjustment-mechanism interface and the adapter interface are independently controllable.

### Claim 7 (depends on 5)

The apparatus according to claim 5, wherein the adjustment tool is configured to decouple the adapter from the adjustment device independently of actuating the unlocking mechanism.

### Claim 8 (depends on 1)

The apparatus according to claim 1, wherein a transverse cross-section of the proximal portion of the trunk has an external shape that is non-circular, and the tool is configured to decouple the adapter from the adjustment device by applying torque to the trunk via the adapter interface.

### Claim 9 (depends on 1)

The apparatus according to claim 1, wherein a distal portion of the adapter interface is angled such that, in response to sliding of the adapter interface axially over the proximal portion of the trunk, the adapter interface automatically assumes a pre-determined rotational orientation with respect to the trunk.

### Claim 10 (depends on 9)

The apparatus according to claim 9, wherein the distal portion of the adapter interface is angled such that in the pre-determined rotational orientation the force applicator is aligned with the appendage.

### Claim 11 (depends on 1)

The apparatus according to claim 1, wherein the force applicator is angled such that, in response to sliding of the adapter interface axially over the proximal portion of the trunk, the adapter interface automatically assumes a pre-determined rotational orientation with respect to the trunk.

### Claim 12 (depends on 11)

The apparatus according to claim 11, wherein the force applicator is angled such that in the pre-determined rotational orientation the force applicator is aligned with the appendage.

### Claim 13 (depends on 12)

The apparatus according to claim 12, wherein, while the adapter interface assumes the pre-determined rotational orientation in which the force applicator is aligned with the appendage, a non-circular shape of the proximal portion of the trunk inhibits the adapter interface from rotating further in response to further sliding of the adapter interface axially over the trunk.

### Claim 14 (depends on 1)

The apparatus according to claim 1, wherein the trunk is shaped to define one or more shoulders that are angled such that, in response to sliding of the adapter interface axially over the shoulders, the adapter interface automatically assumes a pre-determined rotational orientation with respect to the trunk.

### Claim 15 (depends on 14)

The apparatus according to claim 14, wherein a distal portion of the adapter interface is angled such that in the pre-determined rotational orientation the force applicator is aligned with the appendage.

### Claim 16

Apparatus, comprising:
a percutaneously-implantable implant;
an adjustment device, comprising:
an adjustment mechanism, coupled to the implant, and configured to change a dimension of the implant upon actuation of the adjustment mechanism; and
a lock:
having a locked state in which the lock inhibits actuation of the adjustment mechanism,
having an unlocked state in which the adjustment mechanism is actuatable, and
reversibly movable between the locked state and the unlocked state;
a longitudinal guide member;
an adjustment tool; and
an adapter:
coupled to the guide member,
comprising a fastener that couples the adapter to the adjustment device, and is intracorporeally decouplable from the adjustment device,
configured to be percutaneously delivered while coupled to the adjustment device,
comprising a trunk that is shaped to define a channel and a lateral opening, and
comprising a pin that (i) is disposed and slidable within the channel, (ii) comprises an appendage that protrudes laterally out of the lateral opening, and (iii) is configured such that, while the adapter is coupled to the adjustment device, axial sliding of the pin moves the lock between the locked state and the unlocked state,
wherein the adjustment tool:
is percutaneously advanceable along the guide member to the adapter, subsequently to implantation of the implant,
comprises an adjustment-mechanism interface, dimensioned to interface with the adjustment mechanism, and to actuate the adjustment mechanism via the interface between the adjustment-mechanism interface and the adjustment mechanism, and
comprises an adapter interface:
comprising a force applicator that is slidable over a proximal portion of the trunk to a sufficient extent that the force applicator reaches the appendage, and
configured to move the lock into the unlocked state by, while the adapter is coupled to the adjustment device, axially sliding the pin within the channel by applying, with the force applicator, an axial force to the appendage.

### Claim 17 (depends on 16)

The apparatus according to claim 16, wherein the axial sliding of the pin moves the lock from the locked state to the unlocked state by the pin pressing on a depressible portion of the lock.

### Claim 18 (depends on 17)

The apparatus according to claim 17, wherein the lock is biased to be in the locked state in the absence of the pressing of the depressible portion.

### Claim 19 (depends on 17)

The apparatus according to claim 17, wherein:
the adjustment device is shaped to define a first screw thread, and
the fastener (i) is shaped to define a second screw thread that couples the fastener to the adjustment device by engaging the first screw thread, and (ii) is intracorporeally decouplable from the adjustment device by the second screw thread being unscrewed from the first screw thread.

### Claim 20 (depends on 17)

The apparatus according to claim 17, wherein the adjustment tool is configured to decouple the adapter from the adjustment device.

### Claim 21 (depends on 20)

The apparatus according to claim 20, wherein the adjustment-mechanism interface and the adapter interface are independently controllable.

### Claim 22 (depends on 20)

The apparatus according to claim 20, wherein the adjustment tool is configured to decouple the adapter from the adjustment device independently of axially sliding the pin.

### Claim 23 (depends on 16)

The apparatus according to claim 16, wherein a transverse cross-section of the proximal portion of the trunk has an external shape that is non-circular, and the tool is configured to decouple the adapter from the adjustment device by applying torque to the trunk via the adapter interface.

### Claim 24 (depends on 16)

The apparatus according to claim 16, wherein a distal portion of the adapter interface is angled such that, in response to sliding of the adapter interface axially over the proximal portion of the trunk, the adapter interface automatically assumes a pre-determined rotational orientation with respect to the trunk.

### Claim 25 (depends on 24)

The apparatus according to claim 24, wherein the distal portion of the adapter interface is angled such that in the pre-determined rotational orientation the force applicator is aligned with the appendage.

### Claim 26 (depends on 16)

The apparatus according to claim 16, wherein the force applicator is angled such that, in response to sliding of the adapter interface axially over the proximal portion of the trunk, the adapter interface automatically assumes a pre-determined rotational orientation with respect to the trunk.

### Claim 27 (depends on 26)

The apparatus according to claim 26, wherein the force applicator is angled such that in the pre-determined rotational orientation the force applicator is aligned with the appendage.

### Claim 28 (depends on 27)

The apparatus according to claim 27, wherein, while the adapter interface assumes the pre-determined rotational orientation in which the force applicator is aligned with the appendage, a non-circular shape of the proximal portion of the trunk inhibits the adapter interface from rotating further in response to further sliding of the adapter interface axially over the trunk.

### Claim 29 (depends on 16)

The apparatus according to claim 16, wherein the trunk is shaped to define one or more shoulders that are angled such that, in response to sliding of the adapter interface axially over the shoulders, the adapter interface automatically assumes a pre-determined rotational orientation with respect to the trunk.

### Claim 30 (depends on 29)

The apparatus according to claim 29, wherein a distal portion of the adapter interface is angled such that in the pre-determined rotational orientation the force applicator is aligned with the appendage.