Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: A delivery system for delivery of an implantable stented device to a body lumen that includes an elongated member having a distal tip and a proximal end portion, a wire connection member positioned between the distal tip and proximal end portion of the elongated member, and a plurality of capturing wires extending from a distal end of the wire connection member. Each of the capturing wires includes a distal end having a lower portion that is moveable relative to an upper portion between an open position and a closed position, and a slot defined by the upper and lower portions when they are in the closed position.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: Prosthetic heart valve devices, heart valve replacement systems and associated methods for percutaneous heart valve replacement are disclosed herein. A transcatheter heart valve prosthesis configured in accordance herewith includes an expandable frame having a plurality of commissure posts extending therefrom, a radially expandable inflow member attached to the plurality of commissure posts, and a locking mechanism operably coupled to a wire. The wire is at least partially slideably disposed within a channel formed in a wall of the inflow member and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the inflow member into a deployed configuration that at least partially engages tissue at the native heart valve.

Abstract: The present disclosure relates to numerous delivery devices and methods for transcatheter prosthetic heart valve loading, deployment and delivery utilizing at least one suture. Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.

Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: A delivery system for percutaneously deploying a valve prosthesis. The system includes a catheter assembly including a delivery sheath capsule and a handle having an oscillating device. The capsule is configured to compressively retain the valve prosthesis during implantation. After the valve prosthesis is partially exposed during implantation, the oscillating device can create a vibratory motion to reduce the friction between the valve prosthesis and the delivery sheath capsule in order to recapture the valve prosthesis.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: A modular valve prosthesis includes an anchor stent and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the aorta and a proximal arm component extending from a proximal end of the tubular frame member and configured to be deployed in the sinuses of the aortic valve. The anchor stent further includes attachment members extending from an internal surface of the tubular frame member. The valve component includes a valve frame configured to be deployed within the tubular frame member of the anchor stent such that the valve frame engages with the attachment members of the tubular frame member and a prosthetic valve coupled to the valve frame.

Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.

Abstract: A transcatheter heart valve prosthesis configured in accordance herewith includes an expandable frame having a plurality of commissure posts extending therefrom, a radially expandable tubular component attached to the plurality of commissure posts, and a locking mechanism operably coupled to a wire. The wire is at least partially slideably disposed within a channel formed in a wall of the tubular component and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the tubular component into a deployed configuration that at least partially engages tissue at the native heart valve.

Abstract: A modular valve prosthesis includes an anchor stent and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the aorta and a proximal arm component extending from a proximal end of the tubular frame member and configured to be deployed in the sinuses of the aortic valve. The anchor stent further includes attachment members extending from an internal surface of the tubular frame member. The valve component includes a valve frame configured to be deployed within the tubular frame member of the anchor stent such that the valve frame engages with the attachment members of the tubular frame member and a prosthetic valve coupled to the valve frame.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: A system for percutaneous delivery of a stented prosthetic heart valve. The system includes a delivery device with a self-expanding prosthetic heart valve attached thereto and a delivery sheath with an opening on a distal end thereof. The delivery sheath includes a funnel on a proximal end thereof. The delivery device is inserted into the funnel of the delivery sheath. As the delivery device is advanced into the funnel, the expanded heart valve is compressed by the shape of the funnel into a crimped arrangement. The delivery device further advances the heart valve distally within the delivery sheath past the delivery sheath opening. The delivery device is advanced relative to the delivery sheath in transitioning the heart valve from a crimped arrangement to the expanded and deployed arrangement.

Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: Aspects of the disclosure relate to devices and methods for preparing an existing, implanted prosthetic aortic valve for subsequent prosthetic aortic valve implantation. To prepare the existing valve, a valve preparation device is delivered to the valve and valve leaflets are severed either via mechanical cutting or electrodes so that the leaflets cannot obstruct a blood flow path once a prosthetic valve is subsequently implanted within the valve. Similarly, in alternate embodiments, devices and methods of the disclosure can be used for preparing a native aortic valve for delivery and implantation of a prosthetic valve.

Abstract: Disclosed embodiments and methods provide solutions for coupling and decoupling of a delivery device from a stented prosthetic heart valve with one or more release mechanisms. In situations when one or more sutures get tangled or caught upon attempted retraction of the delivery device and sutures after deployment of the stented prosthetic heart valve, a secondary release mechanism can be provided to sever the suture(s) or release the suture(s) from the delivery device. Exemplary secondary release mechanisms include high resistance inserts, cutters and balloon expandable devices. Methods of releasing the sutures from the delivery device or severing the suture(s) are also disclosed.