Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same

Abstract

A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame has a supra-annular region, a subannular region, and a transannular region therebetween. The flow control component is mounted to the outer frame such that at least a portion of the flow control component is disposed in the transannular region. The prosthetic valve has a delivery configuration for side-delivery via a delivery catheter and is expandable when the prosthetic valve is released from the delivery catheter. The subannular region of the outer frame is disposable in a first configuration as the prosthetic valve is seated in an annulus of a native heart valve and is transitionable to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

1 .- 19 . (canceled) 
     
     
         20 . A side-deliverable prosthetic heart valve, the prosthetic valve comprising:
 an outer frame having a supra-annular member, a subannular member, and a transannular member coupled therebetween; and   a flow control component having an inner frame and a plurality of leaflets mounted within the inner frame, the flow control component mounted to the outer frame such that a portion of the flow control component is disposed in the transannular member.   
     
     
         21 . The prosthetic valve of  claim 20 , wherein the prosthetic valve is compressible along a first axis and foldable along a second axis orthogonal to the first axis to place the prosthetic valve in a delivery configuration for side-delivery though a lumen of a delivery catheter, the first axis and the second axis being orthogonal to an axis extending through the lumen of the delivery catheter. 
     
     
         22 . The prosthetic valve of  claim 21 , wherein the supra-annular member forms at least an outer loop having the first axis and an inner loop having a third axis parallel to and offset from the first axis. 
     
     
         23 . The prosthetic valve of  claim 21 , wherein each of the supra-annular member and the subannular member includes a wireframe formed from a single workpiece, the transannular member has a first half and a second half coupled to the first half and forming a proximal hinge point and a distal hinge point therebetween, the axis of the lumen of the delivery catheter extending through the proximal hinge point and the distal hinge point when the prosthetic valve is in the delivery configuration and disposed in the lumen of the delivery catheter. 
     
     
         24 . The prosthetic valve of  claim 21 , wherein the supra-annular member forms a spline having a waypoint configured to removably receive a portion of a delivery system, the delivery catheter being included in the delivery system. 
     
     
         25 . The prosthetic valve of  claim 21 , wherein the supra-annular member forms an outer loop and an inner loop, the flow control component is mounted to the inner loop of the supra-annular member. 
     
     
         26 . The prosthetic valve of  claim 25 , wherein the supra-annular member forms a spline that suspends the inner loop from the outer loop to limit an amount of stress transferred to the flow control component when the prosthetic valve is in the delivery configuration. 
     
     
         27 . The prosthetic valve of  claim 25 , wherein the supra-annular member forms a spline that suspends the inner loop from the outer loop to limit an amount of stress transferred to the flow control component as the prosthetic valve is seated into an annulus of the native heart valve. 
     
     
         28 . The prosthetic valve of  claim 27 , wherein the spline extends between a proximal side of the outer loop and a proximal side of the inner loop and is bowed in a direction of the first axis. 
     
     
         29 . The prosthetic valve of  claim 28 , wherein the supra-annular member includes a biocompatible material covering the inner loop and the outer loop and extending therebetween, the spline exerting a force of the biocompatible material to limit an amount of flex in the biocompatible material when the prosthetic valve is deployed in the annulus of the native heart valve. 
     
     
         30 . The prosthetic valve of  claim 20 , wherein the supra-annular member forms an outer loop, an inner loop, and a spline coupled to the outer loop and the inner loop. 
     
     
         31 . The prosthetic valve of  claim 30 , wherein the spline suspends the inner loop from the outer loop. 
     
     
         32 . The prosthetic valve of  claim 30 , wherein the spline forms a waypoint configured to removably receive a portion of a delivery system. 
     
     
         33 . The prosthetic valve of  claim 32 , wherein the portion of the delivery system includes a guidewire catheter and a guidewire extendable through a lumen of the guidewire catheter, the guidewire catheter extending through the waypoint, below the flow control component, and through a distal anchoring element formed by the subannular member. 
     
     
         34 . The prosthetic valve of  claim 32 , wherein the portion of the delivery system includes an actuator, the subannular member being transitionable from a first configuration to a second configuration in response to an actuation of the actuator. 
     
     
         35 . The prosthetic valve of  claim 34 , wherein the actuation of the actuator is a first actuation, the subannular member being transitionable from the second configuration to a third configuration in response to a second actuation of the actuator, the subannular member allowing the prosthetic valve to be seated in an annulus of a native heart valve when in the second configuration, the subannular member engaging annular tissue to secure the prosthetic valve in the annulus when in the third configuration. 
     
     
         36 . The prosthetic valve of  claim 35 , wherein the subannular member forms a proximal anchoring element that is movable by the actuator to transition the subannular member between the first configuration, the second configuration, and the third configuration. 
     
     
         37 . The prosthetic valve of  claim 36 , wherein the proximal anchoring element has at least one protrusion that facilitates engagement with native tissue on a proximal side of the annulus when the subannular region is in the third configuration. 
     
     
         38 .- 71 . (canceled) 
     
     
         72 . An outer frame for a prosthetic heart valve, the outer frame comprising:
 a supra-annular member forming an outer loop, an inner loop, and a spline at least partially suspending the inner loop from the other loop, the outer loop forming a distal supra-annular anchoring element and a proximal supra-annular anchoring element, the inner loop being coupleable to a flow control component having an inner frame and a plurality of leaflets mounted within the inner frame;   a subannular member forming a distal subannular anchoring element and a proximal subannular anchoring element; and   a transannular member coupling the supra-annular member to the subannular member.   
     
     
         73 . The outer frame of  claim 72 , wherein the outer frame is compressible along a first axis extending through the transannular member and foldable along a second axis orthogonal to the first axis to place the prosthetic valve in a delivery configuration for side-delivery through a delivery catheter. 
     
     
         74 . The outer frame of  claim 72 , wherein the spline suspends the inner loop from the outer loop to limit an amount of stress transferred to the flow control component when the flow control component is coupled to the inner loop and the outer valve is in the delivery configuration. 
     
     
         75 . The outer frame of  claim 72 , wherein the spline suspends the inner loop from the outer loop to limit an amount of stress transferred to the flow control component when the flow control component is coupled to the inner loop and the outer frame and flow control component are seated into an annulus of the native heart valve. 
     
     
         76 . The outer frame of  claim 72 , wherein the supra-annular member is removably coupleable to a delivery system, the delivery catheter being included in the delivery system. 
     
     
         77 . The outer frame of  claim 76 , wherein the delivery system includes a yoke that is removably coupleable to the outer frame. 
     
     
         78 . The outer frame of  claim 76 , wherein the supra-annular member includes a drum extending between the inner loop and the outer loop, the drum being formed from a biocompatible material. 
     
     
         79 . The outer frame of  claim 78 , wherein the spline is bowed in a direction along an axis extending through the transannular member such that the spline exerts a force on the drum to limit an amount of flex in the drum during at least one of diastole or systole of the heart when the outer frame and flow control component are seated into an annulus of the native heart valve. 
     
     
         80 . The outer frame of  claim 78 , wherein a proximal portion of the drum forms a set of loops, the delivery system includes a yoke and a set of tethers, each tether from the set of tethers being removably threaded through a different loop from the set of loops to removably couple the yoke to the supra-annular member. 
     
     
         81 . The outer frame of  claim 80 , wherein the spline defines a waypoint that removably receives a portion of the delivery system when the yoke is removably coupled to the supra-annular member. 
     
     
         82 . The outer frame of  claim 81 , wherein the portion of the delivery system includes a guidewire catheter, the distal subannular anchoring element includes a guidewire coupler movably coupleable to a guidewire catheter extending through the waypoint. 
     
     
         83 . The outer frame of  claim 81 , wherein the portion of the delivery system includes an actuator, the proximal subannular anchoring element is removably coupleable to the actuator and is movable between a first position and a second position in response to an actuation of the actuator. 
     
     
         84 . The outer frame of  claim 83 , wherein a perimeter of the subannular member when the proximal subannular anchoring element is in the first position is smaller than a perimeter of the subannular member when the proximal subannular anchoring element is in the second position. 
     
     
         85 . The outer frame of  claim 83 , wherein a proximal portion of an anterior wall of the transannular member and a proximal portion of a posterior wall of the transannular member are moveable relative to the waypoint in response to the actuation of the actuator. 
     
     
         86 . The outer frame of  claim 72 , wherein the outer loop has a first axis and the inner loop has a second axis parallel to and offset from the first axis. 
     
     
         87 . The outer frame of  claim 72 , wherein the proximal anchoring element of the subannular member forms at least one protrusion. 
     
     
         88 . The outer frame of  claim 87 , wherein the at least one protrusion is at least one bead coupled to the proximal anchoring element. 
     
     
         89 . The outer frame of  claim 72 , wherein each of the supra-annular member and the subannular member includes a wireframe formed from a single workpiece. 
     
     
         90 . The outer frame of  claim 89 , wherein the transannular member includes a wireframe having a first half and a second half coupled to the first half and forming a proximal hinge and a distal hinge therebetween. 
     
     
         91 . The outer frame of  claim 90 , wherein the wireframe of the transannular member forms a plurality of cells, a proximal portion of the wireframe of the transannular member defines a notch. 
     
     
         92 . The outer frame of  claim 91 , wherein the proximal anchoring element is movable to transition the subannular member between a first configuration and a second configuration, the notch increasing a flexibility of a proximal side of the outer frame allowing the proximal anchoring element to move relative to the wireframe of the transannular member. 
     
     
         93 . The outer frame of  claim 89 , wherein the transannular member is formed at least in part from a biocompatible fabric. 
     
     
         94 .- 119 . (canceled)