Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.
1. A method of using a control device to selectively control a side-deliverable transcatheter prosthetic valve during at least one of delivery and deployment, the control device including at least a control catheter and a yoke coupled to a distal end of the control catheter, the method comprising:
routing a distal end of a first tether through the control catheter, through a first side of the yoke, around a first attachment portion of an attachment tether on a supra-annular surface of the prosthetic valve, and back through the first side of the yoke and the control catheter such that each of a proximal end and the distal end of the first tether is proximal to a handle of the control device;
routing a distal end of a second tether through the control catheter, through a second side of the yoke, around a second attachment portion of the attachment tether, and back through the second side of the yoke and the control catheter such that each of a proximal end and the distal end of the second tether is proximal to the handle;
routing a distal end of a tension member through the control catheter, through a plurality of attachment points of a proximal subannular anchoring element, and back through the control catheter such that each of a proximal end and the distal end of the tension member is proximal to the handle;
increasing a tension along the first tether and the second tether to secure the yoke against the supra-annular surface of the prosthetic valve;
advancing the prosthetic valve through a lumen of a delivery catheter while the yoke is secured against the supra-annular surface of the prosthetic valve;
releasing the prosthetic valve from a distal end of the delivery catheter;
increasing a tension along the tension member to transition the proximal subannular anchoring element of the prosthetic valve from a first configuration to a second configuration after the releasing the prosthetic valve;
seating the prosthetic valve in an annulus of a native valve in response to a force exerted by the yoke on the supra-annular surface of the prosthetic valve;
releasing the tension along the tension member to allow the proximal subannular anchoring element to transition from the second configuration toward the first configuration after the seating the prosthetic valve; and
decoupling the control device from the prosthetic valve.
2. The method of claim 1 , wherein the advancing the prosthetic valve through the lumen of the delivery catheter includes pushing the prosthetic valve through the lumen of the delivery catheter in response to a distal force exerted by the yoke on the prosthetic valve while the yoke is secured against the supra-annular surface of the prosthetic valve.
3. The method of claim 1 , wherein the advancing the prosthetic valve through the lumen of the delivery catheter includes advancing the prosthetic valve in a delivery configuration through the lumen of the delivery catheter such that a distal subannular anchoring element of the prosthetic valve is distal to a flow control component of the prosthetic valve.
4. The method of claim 1 , wherein the control device further includes a guidewire catheter that extends through the control catheter, through the supra-annular surface of the prosthetic valve, and through a distal subannular anchoring element of the prosthetic valve.
5. The method of claim 4 , wherein the guidewire catheter is disposable over a guidewire and has a stiffness greater than a stiffness of the guidewire, the stiffness of the guidewire catheter sufficient to limit the degrees of freedom associated with movement of the prosthetic valve during deployment.
6. The method of claim 5 , wherein the guidewire catheter defines an axis, the seating the prosthetic valve in the annulus of the native valve includes the yoke exerting the force on the supra-annular surface of the prosthetic valve to move the prosthetic valve along the axis defined by the guidewire catheter or to rotate the prosthetic valve about the axis defined by the guidewire catheter.
7. The method of claim 1 , wherein the increasing the tension along the tension member to transition the proximal subannular anchoring element from the first configuration to the second configuration is operable to bow a distal end of the control catheter in a supra-annular direction when the yoke is secured against the supra-annular surface of the prosthetic valve.
8. The method of claim 7 , wherein the control catheter in a bowed configuration being oriented relative to the prosthetic valve such that a distally directed force exerted along the control catheter pushes a proximal end of the prosthetic valve in a subannular direction to seat at least the proximal end of the prosthetic valve in the annulus of the native valve.
9. The method of claim 1 , wherein the increasing the tension along the tension member swings at least a portion of the proximal subannular anchoring element in at least one of a posterior direction or an anterior direction.
10. The method of claim 1 , wherein:
the increasing the tension along the first tether and the second tether to secure the yoke against the surface of the prosthetic valve includes exerting a proximal force on each of the proximal end and the distal end of the first tether and each of the proximal end and the distal end of the second tether, and
the increasing the tension along the tension member to transition the proximal subannular anchoring element from the first configuration to the second configuration includes exerting a proximal force on each of the proximal end and the distal end of the tension member.
11. The method of claim 10 , wherein the decoupling of the control device from the prosthetic valve includes:
exerting a proximal force on one of the proximal end or the distal end of the first tether to (i) release the first side of the yoke from the first portion of the attachment tether and (ii) withdraw the first tether from the first side of the yoke and at least a portion of the control catheter;
exerting a proximal force on one of the proximal end or the distal end of the second tether to (i) release the second side of the yoke from the second portion of the attachment tether and (ii) withdraw the second tether from the second side of the yoke and at least a portion of the control catheter; and
exerting a proximal force on one of the proximal end or the distal end of the tension member to withdraw the tension member from the plurality of attachment points of the proximal subannular anchoring element and at least a portion of the control catheter.
12. The method of claim 11 , further comprising:
withdrawing the control device from the patient via the delivery catheter.