Devices and methods for delivering a prosthetic heart valve using supra-annular support
A delivery system includes a delivery sheath with a control device and at least one supra-annular support being movable through a lumen of the delivery sheath. The control device includes a connection member coupled to a distal end of a control catheter. The connection member is configured to removably couple to the prosthetic valve at a proximal position along a supra-annular portion of the prosthetic valve. The control device is operable to advance the prosthetic valve in a compressed configuration through the delivery sheath and to at least partially deploy the prosthetic valve in an expanded configuration into a native valve annulus. The supra-annular support(s) is/are removably coupleable at one or more positions along the supra-annular portion of the prosthetic valve and is/are configured to stabilize or actuate at least a portion of the prosthetic valve relative to an annular plane of a native heart valve during deployment.
1 . A delivery system for delivering and deploying a side-deliverable prosthetic heart valve that includes a transannular member configured to extend through an annulus of a native heart valve, a supra-annular member coupled to an upper edge of the transannular member, and a subannular member coupled to a lower edge of the transannular member, the delivery system comprising:
a delivery sheath;
a control device movable through a lumen of the delivery sheath, the control device including a control catheter and a connection member coupled to a distal end of the control catheter, the connection member configured to removably couple to the prosthetic valve at a proximal position along the supra-annular member of the prosthetic valve, the control device operable to advance the prosthetic valve in a compressed configuration through the lumen of the delivery sheath and into a chamber of a heart and deploy the prosthetic valve in an expanded configuration from the chamber of the heart into the annulus of the native heart valve; and
at least one supra-annular support movable through the lumen of the delivery sheath and outside of the control catheter, the at least one supra-annular support being separate from the control device and configured to removably couple to an attachment point at a distal position along the supra-annular member of the prosthetic valve, the at least one supra-annular support configured to stabilize or actuate at least a distal supra-annular portion of the prosthetic valve relative to an annular plane of the native heart valve during deployment.
2 . The delivery system of claim 1 , wherein the connection member forms a yoke configured to contact the supra-annular portion of the prosthetic valve.
3 . The delivery system of claim 2 , wherein the yoke has a first arm and a second arm arranged in a Y-shape, the at least one supra-annular support is configured to removably couple to the attachment point along the supra-annular member of the prosthetic valve at a position distal to and laterally outward of one of the first arm of the yoke or the second arm of the yoke.
4 . The delivery system of claim 3 , wherein the at least one supra-annular support is at least one of a catheter, a cable, or a hypotube having a rigidity sufficient to transmit a distally directed force exerted on a proximal end portion thereof to the supra-annular member of the prosthetic valve operable to push a portion of the prosthetic valve toward the annulus.
5 . The delivery system of claim 1 , wherein the at least one supra-annular support includes at least one tether that is removably coupleable to the attachment point.
6 . The delivery system of claim 5 , wherein the at least one tether is configured to transition from a first configuration to a second configuration in response to a proximally directed force exerted on a proximal end portion thereof.
7 . The delivery system of claim 6 , wherein the at least one tether in the second configuration forms a substantially fixed-length connection between a distal end portion of the delivery sheath and the distal supra-annular portion of the prosthetic valve.
8 . The delivery system of claim 1 , wherein the prosthetic valve has a valve frame and a flow control component mounted in the valve frame, the valve frame including the supra-annular member, the transannular member, and the subannular member, and
the at least one supra-annular support includes at least one tether that is removably coupleable to the attachment point, the attachment point being along a distal portion of the supra-annular member of the valve frame.
9 . The delivery system of claim 8 , wherein the at least one tether is removably coupleable to the attachment point such that a proximally directed force exerted on a proximal end portion of the at least one tether actuates the distal portion of the supra-annular member of the valve frame.
10 . The delivery system of claim 9 , wherein the at least one tether actuating the distal portion of the supra-annular member of the valve frame includes moving the distal portion of the supra-annular member of the valve frame in a proximal direction away from native tissue defining or surrounding at least a distal portion of the annulus.
11 . The delivery system of claim 1 , wherein the subannular member coupled to the lower edge of the transannular member is configured to be disposed in a ventricle of the heart, and the supra-annular member coupled to the upper edge of the transannular member is configured to be maintained in an atrium of the heart.
12 . A delivery system for delivering and deploying a side-deliverable prosthetic heart valve that includes a transannular member configured to extend through an annulus of a native heart valve, a supra-annular member coupled to an upper edge of the transannular member, and a subannular member coupled to a lower edge of the transannular member, the delivery system comprising:
a delivery sheath;
a control device movable through a lumen of the delivery sheath, the control device including a control catheter and a connection member coupled to a distal end of the control catheter, the connection member configured to removably couple to a proximal portion of the supra-annular member of the prosthetic valve, the control device operable to advance the prosthetic valve in a compressed configuration through the lumen of the delivery sheath and into a chamber of a heart and deploy the prosthetic valve in an expanded configuration from the chamber of the heart into the annulus of the native heart valve; and
a supra-annular support disposed outside of the control catheter and movable through the lumen of the delivery sheath, the supra-annular support being separate from the control catheter and configured to removably couple to an attachment point at or along a distal portion of the supra-annular member of the prosthetic valve, the supra-annular support configured to transition from a first state to a second state when the prosthetic valve is in the expanded configuration, the supra-annular support in the second state forming a substantially fixed-length connection between the delivery sheath and the distal portion of the supra-annular member of the prosthetic valve.
13 . The delivery system of claim 12 , further comprising:
a delivery catheter including a distal end configured to be advanced through a vasculature of a patient and into the chamber of the heart and a proximal end disposed outside the patient, the delivery sheath being movable through a lumen of the delivery catheter.
14 . The delivery system of claim 12 , wherein the connection member of the control device is configured to removably couple to the proximal portion of the supra-annular member of the prosthetic valve via a set of tethers.
15 . The delivery system of claim 12 , wherein the supra-annular support is at least one tether.
16 . The delivery system of claim 12 , wherein the attachment point is at least one suture.
17 . The delivery system of claim 12 , wherein the prosthetic valve has a valve frame and a flow control component mounted in the valve frame, the valve frame including the supra-annular member, the transannular member, and the subannular member, and
the attachment point is at least one suture attached to the distal portion of the supra-annular member of the valve frame.
18 . The delivery system of claim 17 , wherein the supra-annular support is configured to removably couple to the attachment point such that a distal end portion of the supra-annular support extends through an opening at or along the distal portion of the supra-annular member of the valve frame.
19 . The delivery system of claim 18 , wherein the distal end of the supra-annular support forms a loop configured to be disposed about a guidewire catheter removably coupled to the subannular member of the valve frame.
20 . The delivery system of claim 19 , wherein deploying the prosthetic valve in the expanded configuration from the chamber of the heart into the native annulus is such that a distal wall of the prosthetic valve is placed in contact with native tissue forming at least a portion of the annulus, and
the distal portion of the supra-annular support is configured to be secured relative to the attachment point in response to the contact between the distal wall of the valve and the native tissue forming at least the portion of the annulus.
21 . The delivery system of claim 12 , wherein the subannular member coupled to the lower edge of the transannular member is configured to be disposed in a ventricle of the heart, and the supra-annular member coupled to the upper edge of the transannular member is configured to be maintained in an atrium of the heart.
22 . A method of delivering and deploying a side-deliverable prosthetic valve into a native valve annulus of a heart, the prosthetic valve including a transannular member configured to extend through the native valve annulus, a supra-annular member coupled to an upper edge of the transannular member, and a subannular member coupled to a lower edge of the transannular member, the method comprising:
removably coupling a connection member of a control device to a proximal portion of the supra-annular member of the prosthetic valve;
removably coupling a supra-annular support to an attachment point along a distal portion of the supra-annular member of the prosthetic valve, the supra-annular support being separate from and disposed outside of a control catheter of the control device and movable through a lumen of a delivery sheath;
advancing the control device and the prosthetic valve in a compressed configuration through a lumen of a delivery catheter to place a distal end portion of the control device and the prosthetic valve into a chamber of the heart, the prosthetic valve in an expanded configuration when in the chamber of the heart;
transitioning the supra-annular support from a first state to a second state to form a substantially rigid connection between a distal end of the delivery catheter and the distal portion of the supra-annular member;
seating the prosthetic valve in the native valve annulus while the supra-annular support is in the second state; and
decoupling each of the connection member of the control device and the supra-annular support from the supra-annular member of the prosthetic valve after the seating.
23 . The method of claim 22 , wherein the supra-annular support includes at least a support catheter.
24 . The method of claim 23 , wherein the transitioning the supra-annular support from the first state to the second state includes exerting a distally directed force on a proximal end portion of the support catheter, and
the seating the prosthetic valve in the native valve annulus while the supra-annular support is in the second state includes transmitting, via the support catheter, at least a portion of the distally directed force to the distal portion of the supra-annular member of the prosthetic valve, thereby pushing at least a distal portion of the prosthetic valve into the native valve annulus.
25 . The method of claim 23 , wherein the seating the prosthetic valve in the native annulus includes seating the prosthetic valve such that the subannular member of the prosthetic valve is disposed in a ventricle of the heart, the transannular member of the prosthetic valve extends through the native valve annulus, and the supra-annular member is maintained in an atrium of the heart.
26 . The method of claim 22 , wherein the supra-annular support is at least one tether.
27 . The method of claim 26 , wherein a proximal end of the at least one tether is proximal to the delivery catheter, the method further comprising:
exerting a proximally directed force on the proximal end of the at least one tether to increase a tension along the at least one tether, the increased tension along the at least one tether operable to transition the at least one tether from the first state to the second state.
28 . The method of claim 27 , further comprising:
actuating the distal portion of the supra-annular member in response to the proximally directed force exerted on the proximal end of the at least one tether, the actuating operable to move the distal portion of the supra-annular member in a proximal direction away from native tissue defining or surrounding at least a distal portion of the native valve annulus.
29 . The method of claim 26 , wherein the removably coupling the at least one tether to the attachment point is such that a distal end portion of the at least one tether extends through an opening along a distal portion of the prosthetic valve to allow a loop at a distal end of the at least one tether to be disposed about a guidewire catheter that is removably coupled to the subannular member of the prosthetic valve.
30 . The method of claim 29 , wherein after the seating the prosthetic valve in the native valve annulus the method further comprising:
moving the guidewire catheter in a proximal direction such that a distal end of the guidewire catheter is at least partially disposed in the delivery catheter and decoupled from the subannular member of the prosthetic valve; and
releasing the loop at the distal end of the at least one tether from the guidewire catheter in response the guidewire catheter moving in the proximal direction.