Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
The invention relates to anchor channels and subannular anchors for a transcatheter heart valve replacement, and in particular for an orthogonally 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 tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrially 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 delivery and deployment from a catheter at an acute angle of approach.
1. A prosthetic heart valve, comprising:
a valve frame defining a central channel extending along a central axis of the prosthetic heart valve, the valve frame including a distal subannular anchoring element and a proximal subannular anchoring element;
a flow control component mounted within the central channel and configured to permit blood flow therethrough in a direction along the central axis; and
a cinching system releasably attached to the proximal subannular anchoring element, a portion of the cinching system extending through the central channel and releasably attached to an interior of the valve frame in at least one location distal to the proximal subannular anchoring element,
the prosthetic heart valve configured to be compressed along the central axis and a lateral axis perpendicular to the central axis to place the prosthetic heart valve in a compressed configuration for side-delivery into a heart via a delivery catheter during which each of the central axis and the lateral axis is perpendicular to a longitudinal axis of the delivery catheter, the prosthetic heart valve further configured to transition from the compressed configuration to an expanded configuration when the prosthetic heart valve is released from the delivery catheter into a chamber of the heart,
the cinching system actuatable when the prosthetic heart valve is in the chamber of the heart such that a proximally directed force exerted on the cinching system transitions the proximal subannular anchoring element inwardly from a first configuration to a second configuration, in which the prosthetic heart valve is allowed to be seated in an annulus of a native heart valve, and
the cinching system actuatable after the prosthetic heart valve is seated in the annulus to allow the proximal subannular anchoring element to transition outwardly toward the first configuration to at least partially secure the prosthetic heart valve in the annulus.
2. The prosthetic heart valve of claim 1 , wherein the prosthetic heart valve in the expanded configuration has a first height along the central axis and a first lateral width along the lateral axis, and
the prosthetic heart valve in the compressed configuration has a second height along the central axis less than the first height and a second lateral width along the lateral axis less than the first lateral width.
3. The prosthetic heart valve of claim 1 , wherein the valve frame includes a valve body that defines the central channel, the valve body including a plurality of wire cells having an orientation that allows compression of the prosthetic heart valve along the central axis.
4. The prosthetic heart valve of claim 1 , wherein the valve frame includes a valve body that defines the central channel and an atrial collar that is coupled along a supra-annular portion of the valve body, the distal subannular anchoring element extending from a distal subannular portion of the valve body, and the proximal subannular anchoring element extending from a proximal subannular portion of the valve body.
5. The prosthetic heart valve of claim 4 , wherein after the cinching system is actuated to allow the proximal subannular anchoring element to transition toward the first configuration, the subannular anchoring elements are configured to be in contact with subannular tissue and the atrial collar is configured to be in contact with supra-annular tissue.
6. The prosthetic heart valve of claim 1 , wherein the cinching system includes at least one tether releasably attached to the proximal subannular anchoring element,
wherein the proximally directed force exerted to actuate the cinching system increases a tension along the at least one tether operable to pull the proximal subannular anchoring element inwardly to the second configuration, and
wherein actuating the cinching system to allow the proximal subannular anchoring element to transition toward the first configuration includes releasing at least a portion of the tension along the at least one tether to allow the proximal subannular anchoring element to transition outwardly toward the first configuration.
7. A prosthetic heart valve, comprising:
a valve frame having a valve body that defines a central channel extending along a central axis of the prosthetic heart valve, the valve frame including an atrial collar coupled to a top edge of the valve body, the atrial collar defining an opening;
a flow control component mounted within the central channel and configured to permit blood flow therethrough in a direction along the central axis; and
a cinching system releasably attached to a proximal subannular portion of the valve body, a portion of the cinching system extending through the opening of the atrial collar and attached to an interior of the valve body in at least one location distal to the proximal subannular portion of the valve body,
the prosthetic heart valve configured to be compressed along the central axis and a lateral axis perpendicular to the central axis to place the prosthetic heart valve in a compressed configuration for side-delivery into a heart via a delivery catheter during which each of the central axis and the lateral axis is perpendicular to a longitudinal axis of the delivery catheter, the prosthetic heart valve further configured to transition from the compressed configuration to an expanded configuration when the prosthetic heart valve is released from the delivery catheter into a chamber of the heart,
the cinching system actuatable when the prosthetic heart valve is in the chamber of the heart such that a proximally directed force exerted on the cinching system transitions the proximal subannular portion of the valve body inwardly from a first configuration to a second configuration, in which the prosthetic heart valve is allowed to be seated in an annulus of a native heart valve, and
the cinching system actuatable after the prosthetic heart valve is seated in the annulus to allow the proximal subannular portion of the valve body to transition outwardly toward the first configuration to at least partially secure the prosthetic heart valve in the annulus.
8. The prosthetic heart valve of claim 7 , wherein the prosthetic heart valve in the expanded configuration has a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and
the prosthetic heart valve in the compressed configuration has a second height along the central axis less than the first height and a second lateral width along the lateral axis less than the first lateral width.
9. The prosthetic heart valve of claim 7 , wherein the valve body includes a plurality of wire cells having an orientation that allows compression of the prosthetic heart valve along the central axis.
10. The prosthetic heart valve of claim 7 , wherein the atrial collar is configured to be in contact with supra-annular tissue when the prosthetic heart valve is seated in the annulus.
11. The prosthetic heart valve of claim 10 , wherein the proximal subannular portion of the valve body includes a proximal subannular anchoring element configured to be in contact with subannular tissue after the cinching system is actuated to allow the proximal subannular portion to transition toward the first configuration.
12. The prosthetic heart valve of claim 7 , wherein the cinching system includes at least one tether releasably attached to the proximal subannular portion of the valve body,
wherein the proximally directed force exerted to actuate the cinching system increases a tension along the at least one tether operable to pull the proximal subannular portion of the valve body inwardly to the second configuration, and
wherein actuating the cinching system to allow the proximal subannular portion of the valve body to transition toward the first configuration includes releasing at least a portion of the tension along the at least one tether to allow the proximal subannular portion of the valve body to transition outwardly toward the first configuration.