Anchor hook for side-delivery transcatheter heart valve prosthesis
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.
1. An anchoring system for a transcatheter prosthetic heart valve, the anchoring system comprising:
an anchor channel of the transcatheter prosthetic heart valve, an interior surface of the anchor channel defining a lumen;
a delivery catheter having an outer diameter and having a lumen extending therethrough, at least a portion of the delivery catheter configured to be advanced though the lumen of the anchor channel, the outer diameter of the delivery catheter being smaller than an internal diameter of the lumen of the anchor channel;
an anchor hook configured to be disposed within a distal end of the lumen of the delivery catheter and having:
an elongated shaft portion having a proximal end that forms a proximal tether loop,
a plurality of anchoring tabs or barbs disposed along the elongated shaft portion and biased to an expanded configuration in which the tabs or barbs extend away from a central axis of the elongated 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 central axis of the elongated 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 configured to be disposed within the lumen of the delivery catheter in a compressed configuration in which the hook portion is folded towards the central axis of the elongated shaft portion and biased towards an expanded configuration in which the hook portion extends away from the central axis of the elongated shaft portion; and an elongated pusher releasably engageable with the proximal end of the elongated shaft portion and configured to extend proximally through the delivery catheter,
a tether coupled to a tether mount of the hook portion and extending proximally through the proximal tether loop and the lumen of the delivery catheter,
the anchoring system being operable to have (i) the distal end of the delivery catheter disposed within the lumen of the anchor channel, (ii) the anchor hook pushed in a distal direction out of the delivery catheter and through the anchor channel, via the elongated pusher, to a position in which the hook portion extends out of the anchor channel and transitions to its expanded configuration, and (iii) the anchoring tabs or barbs engage the interior surface of the anchor channel to limit movement of the anchor hook in the distal direction,
the anchoring system being further operable to retrieve the anchor hook by application of a proximal force on the tether to urge the hook portion from its expanded configuration to its compressed configuration and to withdraw the anchor hook in a proximal direction into the anchor channel.
2. The anchoring system of claim 1 , wherein the delivery catheter is configured to extend through a valve body portion of the transcatheter prosthetic heart valve via the anchor channel, the anchor channel being integrated into or attached to one of an interior surface or an exterior surface of the valve body portion of the transcatheter prosthetic heart valve.
3. The anchoring system of claim 1 , wherein the elongated 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.
4. The anchoring system of claim 1 , wherein the hook portion is one of 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.
5. The anchoring system of claim 1 , wherein the anchor hook is a first anchor hook, the delivery catheter is a first delivery catheter, the anchor channel is a first anchor channel, and the anchoring system further comprising:
a second anchor hook disposed in a distal end of a second delivery catheter; and
a second anchor channel of the transcatheter prosthetic heart valve, an interior surface of the second anchor channel defining a lumen, at least a portion of the second delivery catheter configured to be advanced through the lumen of the second anchor channel.
6. The anchoring system of claim 1 , wherein at least a portion of the anchor hook is configured to be compressed within the anchor channel,
wherein the anchor channel extends through a valve body portion of the transcatheter prosthetic heart valve vertically or at an angle up to 45 degrees from vertical, and
wherein vertical is parallel to a central atrial-to-ventricle axis of the transcatheter prosthetic heart valve.
7. The anchoring system of claim 1 , wherein the elongated shaft has between 2-6 tabs or barbs configured to engage the interior surface of the anchor channel when the anchor hook is distal to the delivery catheter.
8. The anchoring system of claim 1 , wherein the anchoring system is configured such that:
the elongated pusher is configured to push, in response to a distally-directed force exerted on the elongated pusher and when the distal end of the delivery catheter is disposed within the lumen of the anchor channel, the anchor hook distally out of the delivery catheter and the anchor channel allowing the hook portion to transition to the expanded configuration to capture native leaflet tissue or native chordae tendineae within or on the hook portion of the anchor hook, and
the elongated pusher is configured to pull, in response to a proximally-directed force exerted on the elongated pusher and after the hook portion transitions to the expanded configuration, the anchor hook proximally into the anchoring channel and causes the hook portion to press the native leaflet tissue or native chordae tendineae against a subannular portion of the transcatheter prosthetic heart valve or a subannular surface of a native annulus of a heart.
9. The anchoring system of claim 8 , wherein the anchoring system is further configured such that exerting the proximally-directed force on the elongated pusher pulls the anchor hook proximally into the anchoring channel and causes the tabs or barbs in their expanded configuration to be at least partially compressed and pulled into the anchor channel such that the tabs or barbs press against the interior surface of the anchor channel creating a tension force therebetween operable to limit movement of at least the hook portion in the distal direction.