Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

A medical device system may include an elongate shaft having a lumen extending to a distal end of the elongate shaft, wherein a proximal portion of the elongate shaft is configured to disengage from a distal portion of the elongate shaft; a medical device disposed proximate the distal end of the elongate shaft; a release wire disposed within the lumen of the elongate shaft, wherein the release wire releasably attaches the medical device to the distal end of the elongate shaft; and an introducer sheath slidably disposed over the elongate shaft, wherein the introducer sheath is configured to disengage the proximal portion of the elongate shaft from the distal portion of the elongate shaft.

This invention relates to the design and function of a single-tether compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed combats the process of wear on anchoring tethers over time by using a plurality of stent-attached, centering tethers, which are themselves attached to a single anchoring tether, which extends through the ventricle and is anchored to a securing device located on the epicardium.

A method for implanting a stent includes contracting a self-expanding/forcibly-expanding stent of a shape-memory material set to a given shape to a reduced implantation size with a delivery system having drive wires. The stent has a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the self-expanding stent occurs. The contracted stent is inserted into a native annulus in which the stent is to be implanted. The drive wires are rotated with the delivery system to forcibly expand the stent into the native annulus. While rotating the drive wires, a torque applied to the drive wires is determined with the delivery system. Rotation of the drive wires is stopped based upon a value of the determined torque.

An assembly for replacement of a native aortic heart valve includes a radially collapsible prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes an annular frame with attachment posts, wherein each of the posts has an axial post portion and a transverse post portion having a greater circumferential dimension than the axial post portion. The delivery apparatus includes an inner shaft with a valve connection portion for releasably coupling to the attachment posts and an outer shaft having a sheath for maintaining the prosthetic heart valve in a radially compressed state. Rotation of a control knob on a handle causes the sheath to retract for uncovering a portion of the prosthetic heart valve. Further rotation of the control knob allows the posts to decouple from the delivery apparatus such that the prosthetic heart valve self-expands to a fully expanded state.

The present invention is directed toward prosthetic heart valves that include an expandable frame provided with expansion and locking assemblies, which can be kept in a locked state by a twist formed along a portion of a wire of each expansion and locking assemblies. The present invention is further directed toward delivery assemblies that include actuation assemblies configured to actuate the expansion and locking assemblies, and to methods of utilizing the actuation assemblies and the expansion and locking assemblies.

A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

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.

An implantable device is disclosed. The device includes a leaflet frame subcomponent and an anchor frame subcomponent that are configured to be delivered in a series configuration and subsequently nested or telescoped in-situ.

A medical device release system may include an elongated rod having an enlarged distal end, a ring element slidingly disposed over the elongated rod, and two or more pins. The ring element may have a center channel sized and shaped to receive the elongated rod, wherein the enlarged distal end of the rod is larger than an inner diameter of the center channel, preventing the ring element from disengaging from the distal end of the rod. The two or more pins may each have a proximal end attached to the ring element and a distal end extending longitudinally and radially away from the ring element, the distal ends configured for releasable connection to a medical device.