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 (A61F2/2412), 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 method of deploying a side-delivered prosthetic heart valve in an annulus of a native valve between an atrium and a ventricle of a heart of a patient, the method comprising:
exerting a force on a proximal end portion of a steerable catheter to advance the prosthetic heart valve in a compressed configuration through a lumen of a delivery catheter, a distal end of the delivery catheter disposed adjacent to the annulus of the native valve, a longitudinal axis of the prosthetic heart valve being parallel to a longitudinal axis extending through the lumen of the delivery catheter, a distal end of steerable catheter temporarily coupled to the prosthetic heart valve;
releasing the prosthetic heart valve from the lumen of the delivery catheter into the atrium, the prosthetic heart valve transitioning from the compressed configuration to an expanded configuration in response to the releasing;
placing a portion of a distal anchoring element of the prosthetic heart valve on the ventricle side of the annulus of the native valve;
actuating a cinching system at least temporarily coupled to the prosthetic heart valve to cinch at least a portion of the prosthetic heart valve to reduce a circumference of a lower portion of the prosthetic heart valve to be smaller than a circumference of the annulus of the native heart valve;
seating the prosthetic heart valve in the annulus of the native valve while at least the portion of the prosthetic heart valve is cinched; and
actuating the cinching system to release at least the portion of the prosthetic heart valve after the seating the prosthetic heart valve in the annulus to allow the circumference of the lower portion of the prosthetic heart valve to increase.
2. The method of claim 1 , wherein the distal anchoring element and a proximal anchoring element of the prosthetic heart valve are in contact with subannular tissue after the actuating the cinching system to release at least the portion of the prosthetic heart valve.
3. The method of claim 1 , wherein an atrial collar of the prosthetic heart valve is in contact with supra-annular tissue when the prosthetic heart valve is seated in the annulus of the native valve.
4. The method of claim 1 , wherein after the actuating the cinching system to release at least the portion of the prosthetic heart valve, the method further comprising:
decoupling the steerable catheter from the prosthetic heart valve;
decoupling the cinching system from the prosthetic heart valve; and
retracting each of the steerable catheter and the cinching system through the lumen of the delivery catheter.
5. The method of claim 1 , wherein the native valve is a native tricuspid valve, the placing the portion of the distal anchoring element on the ventricle side of the annulus includes placing the portion of the distal anchoring element in a right ventricular outflow track (RVOT).
6. The method of claim 1 , wherein the cinching system includes at least one tether temporarily coupled to the portion of the prosthetic heart valve.
7. The method of claim 6 , wherein the actuating the cinching system to cinch at least the portion of the prosthetic heart valve includes increasing a tension along the at least one tether, and
the actuating the cinching system to release at least the portion of the prosthetic heart valve includes releasing the tension along the at least one tether.
8. The method of claim 7 , wherein the at least one tether is temporarily coupled to a proximal anchoring element of the prosthetic heart valve, the increasing the tension along the at least one tether operable to move the proximal anchoring element from an expanded configuration to a folded configuration.