# US 2021/0330459 A1 · Anchor hook for side-delivery transcatheter heart valve prosthesis

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- Number: US 2021/0330459 A1
- Document ID: US20210330459A1
- Status: Published application
- Kind: A1
- Application number: 17/372,022
- Filed: 2021-07-09
- Published: 2021-10-28
- Earliest claimed: 2019-01-10
- Assignees: VDyne, Inc.
- Applicants: VDyne, Inc.
- Inventors: Mark CHRISTIANSON; Robert VIDLUND; Chad PERRIN; Craig EKVALL
- Web page: https://patentgrep.com/patent/US20210330459A1

## CPC

- A61F 2/2436: {Deployment by retracting a sheath}
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61B 2017/00243: {cardiac}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2017/00358: {Snares for grasping}
- A61B 2017/0647: {having one single leg, e.g. tacks}
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0017: Angular shapes
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- 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

The invention relates to an anchor hook and methods of using the same for subannular anchoring of a transcatheter heart valve replacement, and in particular for an orthogonally delivered (side-delivered) transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the mitral or tricuspid valve from the inferior vena cava or superior vena cava, or trans-septally to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring a delivery catheter to bend 90 degrees during deployment.

## Claims

### Claim 1

An anchoring system for a transcatheter prosthetic heart valve, the anchoring system comprising:
an anchor channel disposed within the valve and having a lumen with an internal diameter;
a delivery catheter having an outer diameter smaller than the internal diameter of the anchor channel and having a lumen therethrough;
an anchor hook disposed within a distal end of the lumen of the delivery catheter and having:
an elongated shaft portion having a proximal end,
a plurality of anchoring tabs or barbs disposed along the shaft portion biased to an expanded configuration in which the tabs or barbs extend away from the central axis of the shaft portion to a radius from the central axis larger than the inner diameter of the anchor channel, and movable to a closed or compressed configuration in which the tabs or barbs are folded towards the shaft portion to a radius from the central axis smaller than the inner diameter of the anchor channel, and
a hook portion at a distal end of the elongated shaft portion, the hook portion disposed within the lumen of the delivery catheter in a compressed configuration in which the hook portion is folded towards the shaft portion and biased towards an expanded configuration in which the hook portion extends away from a central axis of the shaft portion; and
an elongated pusher releasably engageable with the proximal end of the shaft portion, extending proximally through the delivery catheter,
the anchoring system being operable to have the distal end of the delivery catheter disposed within the lumen of the anchor channel, to have the anchor hook pushed distally out of the delivery catheter and through the anchor channel to a position in which the hook portion extends out of the anchor channel and moves to its expanded configuration, and to have the anchoring tabs or barbs engage the lumen of the anchor channel.

### Claim 2 (depends on 1)

The anchoring system of claim 1, wherein the anchor hook portion includes a tether mount, the shaft portion includes a tether loop at the proximal end thereof, and further comprising a tether coupled to the tether mount and extending proximally through the tether loop and through the lumen of the delivery catheter,
the anchoring system being further operable to retrieve the anchor hook by application of a proximal force to the tether to urge the hook portion from its expanded configuration to its compressed configuration and to withdraw the anchor hook proximally through the anchor channel.

### Claim 3 (depends on 1)

The anchoring system of claim 1, wherein the channel is integrated into or attached to one of an interior surface or an exterior surface of a valve body portion of the transcatheter prosthetic heart valve.

### Claim 4 (depends on 1)

The anchoring system of claim 1, wherein the shaft portion is selected from a single elongated member with the anchoring tabs or barbs extending away from the elongated member, or a chain of diamond-shaped cells with the anchoring tabs or barbs extending from lateral points of the diamond-shaped cells.

### Claim 5 (depends on 1)

The anchoring system of claim 1, wherein the hook portion is selected from a single diamond-shaped cell, or a diamond-shaped cell with one or more anchoring tabs or barbs extending from lateral points of the diamond-shaped cell.

### Claim 6 (depends on 1)

The anchoring system of claim 1, wherein the anchor hook is a first anchor hook, the catheter is a first catheter, the tether is a first tether, the anchor channel is a first anchor channel, and the anchoring system further comprising:
a second anchor channel,
a second anchor hook disposed in a distal end of a second delivery catheter, and
a second tether coupled to a proximal end of the second anchor hook and extending proximally through the second delivery catheter.

### Claim 7 (depends on 1)

The anchoring system of claim 1, wherein the anchor hook is compressed within a cylindrical channel integrated into or attached to a valve body portion of the transcatheter prosthetic heart valve, and wherein the cylindrical channel extends through the valve body vertically or at an angle up to 45 degrees from vertical, wherein vertical is parallel to a central atrial-to-ventricle axis of the transcatheter prosthetic heart valve.

### Claim 8 (depends on 1)

The anchoring system of claim 1, wherein the elongated shaft has between 2-6 tabs or barbs, and wherein the anchor channel is a cylinder of polyester or is cylinder lined with polyester.

### Claim 9 (depends on 1)

A side-delivered transcatheter prosthetic heart valve having an anchoring system, the valve comprising:
the anchoring system of claim 1;
a self-expanding annular support frame, the anchoring system mounted on or within the annular support frame, said annular support frame having a central channel and an outer perimeter wall circumscribing a central vertical axis in an expanded configuration, said annular support frame having a distal side and a proximal side,
a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,
wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration is oriented along a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis, and expandable to an expanded configuration having a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis,
wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter.

### Claim 10 (depends on 9)

The valve of claim 9, wherein the central channel has a radio-opaque marker.

### Claim 11 (depends on 9)

The valve of claim 9, wherein the central channel is braided polyethylene, treated pericardial tissue, ePTFE, or Nitinol.

### Claim 12 (depends on 9)

The valve of claim 9, wherein the annular support frame further comprises:
a distal anchoring tab mounted on the distal side of the annular support frame; and
a proximal anchoring tab mounted on the proximal side of the annular support frame.

### Claim 13 (depends on 9)

The valve of claim 9, wherein the annular support frame is comprised of a plurality of compressible wire cells having an orientation and cell geometry substantially orthogonal to the central vertical axis to minimize wire cell strain when the annular support frame is configured in a vertical compressed configuration, a rolled compressed configuration, or a folded compressed configuration.

### Claim 14

(canceled)

### Claim 15 (depends on 9)

The valve of claim 9, wherein the annular support frame is comprised of a braided, wire, or laser-cut wire frame, and the annular support frame is covered with a biocompatible material.

### Claim 16

(canceled)

### Claim 17 (depends on 9)

The valve of claim 9, wherein the annular support frame has an inner surface and an outer surface, the inner surface and the outer surface covered with a biocompatible material selected from the following consisting of:
the inner surface covered with pericardial tissue,
the outer surface covered with a woven synthetic polyester material, and
both the inner surface covered with pericardial tissue and the outer surface covered with a woven synthetic polyester material.

### Claim at position 18

-21. (canceled)

### Claim 22 (depends on 9)

The valve of claim 9, wherein each of the distal anchoring tab and the proximal anchoring tab is comprised of a wire loop, a wire frame, a laser cut frame, an integrated frame section, or a stent,
the distal anchoring tab extends from about 10-40 mm away from the distal side of the annular support frame, and
the proximal anchoring tab extends from about 10-40 mm away from the proximal side of the annular support frame.

### Claim 23

(canceled)

### Claim 24 (depends on 9)

The valve of claim 9, further comprising:
an upper distal anchoring tab attached to a distal upper edge of the annular support frame, the upper distal anchoring tab comprised of a wire loop, a wire frame, a laser cut frame, an integrated frame section, or a stent, and
the upper distal anchoring tab extends from about 2-20 mm away from the distal side of the annular support frame.

### Claim at position 22

-26. (canceled)

### Claim 27

A method for deploying an anchor hook system for a prosthetic transcatheter heart valve, comprising:
(i) advancing a delivery catheter through a lumen of an anchor channel of a transcatheter heart valve to a subannular position;
(ii) expelling an anchor hook out of a distal end of the delivery catheter by applying a distally-directed force to an elongated pusher that is disposed within the delivery catheter and engaged with a proximal end of a shaft portion of the anchor hook, the anchor hook having a hook portion on the distal end of the shaft portion, the hook portion being biased from a compressed configuration in which the hook portion is folded towards the shaft portion and an expanded configuration in which the hook portion extends away from the shaft portion, the anchor hook further having anchoring tabs or barbs disposed along the shaft portion and biased to an expanded configuration in which they extend away from a central axis of the shaft portion to a radius from the central axis that is larger than the inner diameter of the anchor channel lumen, the anchoring tabs or barbs being in a compressed configuration in the delivery catheter in which they extend away from the central axis of the shaft portion to a radius from the central axis that is smaller than the inner diameter of the anchor channel lumen,
wherein the hook portion and the anchoring tabs or barbs are in their respective compressed configurations when disposed within the delivery catheter, and the hook portion and the anchoring tabs or barbs self-expand to their respective expanded configurations when expelled from the delivery catheter; and
(iii) pulling the shaft portion of the anchor hook into the anchor channel by pulling the elongated pusher in a proximal direction,
wherein pulling the shaft portion retracts the hook portion in a proximal direction and captures native leaflet tissue or native chordae tendineae within or on the hook portion of the anchor hook, and the retracted hook portion presses the native leaflet tissue or native chordae tendineae against a subannular portion of the prosthetic transcatheter heart valve or a subannular surface of the native annulus, and wherein pulling the shaft portion of the anchor hook into the anchor channel draws the opened/expanded tabs/barbs into the anchor channel and create a tensioning force with the tabs/barbs pressing against an interior surface of the anchor channel.

### Claim 28 (depends on 27)

The method of claim 27, wherein the anchor channel is a mesh or braid and the tabs or barbs penetrate or grip the interior surface of the anchor channel.

### Claim at position 25

-30. (canceled)

### Claim 31 (depends on 27)

The method of claim 27, further comprising the step of:
retrieving the anchor hook, wherein the delivery catheter slides over the shaft portion while the tabs or barbs are engaging the anchor channel, and flattens the tabs or barbs back towards or against the shaft portion, thus disengaging the tabs or barbs from the anchor channel,
wherein the delivery catheter is advanced distally to a subannular/ventricular position to release the hook portion from the captured native tissue,
wherein a tether that is attached to the anchor hook is pulled proximally and folds the hook portion against the shaft portion,
wherein the entire anchor hook is then pulled into the delivery catheter, and
wherein the delivery catheter is withdrawn and/or the anchor hook is redeployed.

### Claim at position 27

-41. (canceled)