Abstract: A prosthetic heart valve has a frame including a plurality of strut members, an inflow end, and an outflow end. A leaflet structure is situated at least partially within the frame, and a covering is disposed around an exterior of the frame. The covering includes a cushioning layer, and a first strip member folded over an inflow circumferential edge portion of the cushioning layer to form a first protective portion. A second strip member is folded over an outflow circumferential edge portion of the cushioning layer to form a second protective portion. The first strip member and the second strip member are spaced apart from each other along a longitudinal axis of the prosthetic heart valve.

Abstract: A prosthetic implant delivery assembly includes a prosthetic implant and a catheter. The prosthetic implant includes a plurality of apices with apertures. Each apex of the plurality of apices is circumferentially-spaced apart relative to an adjacent apex. The catheter includes a plurality of arms and a plurality of locking elements. Each of the arms includes an opening configured to receive a respective apex of the prosthetic implant. Each of the locking elements is configured to extend through the aperture of a respective apex of the prosthetic implant. A length of at least one of the locking elements is different than a length of another locking element such that when the prosthetic implant is coupled to the catheter by the locking elements, a longitudinal axis of the prosthetic implant can be held at a tilted position relative to a longitudinal axis of the catheter.

Abstract: Docking devices for docking a prosthetic valve at a native valve of a heart can include a coiled docking anchor and a retrieval suture. The docking device and retrieval suture can be configured for improved retention and retrieval of the docking device after deployment. The docking devices can have an end portion with a central axis. The retrieval suture can be connected to the end portion such that a line of force applied by applying tension to the retrieval suture is substantially aligned with the central axis.

Abstract: A container configured to receive a dock assembly therein for packaging is disclosed. The container can include: a base defining an engagement surface configured to receive the dock assembly; a lid configured to releasably engage with the base such that at least a portion of the dock assembly is disposed between the base and the lid; and a dock holder affixed to the container and configured to receive a first portion of the dock assembly comprising two or more adjacent coils thereon. The dock holder can comprise a protrusion configured to engage the first portion of the dock assembly and space a second portion of the dock assembly away from the dock holder.

Abstract: A docking device for docking a prosthetic valve at a native valve of a heart can include a coil comprising a plurality of turns and having a proximal end and distal end. The docking device can further include a first covering disposed around and covering the coil from the distal end to the proximal end of the coil, and a second covering disposed over the first covering. A distal end and proximal end of the second covering are spaced away from a distal end and proximal end, respectively, of the first covering.

Abstract: A docking device for docking a prosthetic valve at a native valve of a heart includes a coiled body and a high friction sleeve. The coiled body has an upper region, a central region, and a lower region. The docking device is configured to be implanted at the native valve with the upper region positioned in a first chamber of the heart, the lower region positioned in a second chamber of the heart, and the central region positioned to extend around a plurality of leaflets of the native valve. A high friction sleeve covers at least a portion of the central region. The high friction sleeve comprises a material configured to generate more friction between the prosthetic valve and the docking device than an exterior surface of the coiled body.

Abstract: A prosthetic heart valve can have one or more hermetic layers. The inner skirt and/or the outer skirt can comprise one or more hermetic layers, or the entire valve frame can be encapsulated within one or more hermetic layers. Each hermetic layer can be substantially nonporous or can have pores therein that are sized to discourage cellular ingrowth. The hermetic layer can prevent ingrowth of surrounding native tissue, thereby reducing pannus formation on the prosthetic leaflets. Alternatively or additionally, shapes of the leaflets of the valvular structure of the prosthetic valve and/or the coupling of the leaflets to the valve frame can be selected to avoid the incidence of stasis when implanted at a relatively low pressure gradient hemodynamic location. Such a prosthetic heart valve may reduce the risk of thrombosis.

Abstract: Certain examples of the disclosure concern a docking device for securing a prosthetic valve at a native valve. The docking device includes a coil having a plurality of helical turns when deployed at the native valve, an expandable member extending radially outwardly from the coil and being movable between a radially-compressed/axially-elongated state and a radially-expanded/axially-foreshortened state, and a cover member surrounding an outer surface of the expandable member. A distal end portion of the cover member and a distal end portion of the expandable member are fixedly coupled to the coil via a distal suture including a plurality of knots and a plurality of wraps. A proximal end portion of the expandable member is fixedly coupled to a proximal end portion of the cover member. The proximal end portion of the expandable member and the proximal end portion of the cover member are axially movable relative to the coil.

Abstract: Methods of implanting docking devices for prosthetic valves at a native heart valve include positioning a distal end of a delivery catheter into a first chamber of a heart, advancing a tubular body of a docking device from within the delivery catheter so that the distal end of the tubular body is advanced between native valve leaflets and positioned in a second chamber of the heart. The methods further include inserting a coil into a lumen of the docking device so that the tubular body adopts a configuration, releasing a proximal end of the docking device in the first chamber, inserting a replacement valve in an inner space of the docking device, and radially expanding the replacement valve until there is a retention force between the replacement valve and the docking device to hold the replacement valve in a stable position in the native valve.

Abstract: A delivery system for delivering a stent-mounted heart valve, or other implant, through an introducer sheath. The delivery system includes an elongate catheter supporting a capsule. The capsule contains the stent-mounted heart valve in the crimped condition. The capsule includes a protrusion extending from its outer surface for urging the sheath away from the outer surface capsule as it moves therethrough, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

Abstract: Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Abstract: A delivery system for delivering a stent-mounted heart valve, or other implant, through an introducer sheath. The delivery system includes an elongate catheter supporting a capsule. The capsule contains the stent-mounted heart valve in the crimped condition. The capsule includes a protrusion extending from its outer surface for urging the sheath away from the outer surface capsule as it moves therethrough, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath.

Abstract: Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Abstract: A prosthetic heart valve has a frame including a plurality of strut members, an inflow end, and an outflow end. A leaflet structure is situated at least partially within the frame, and a covering is disposed around an exterior of the frame. The covering includes a cushioning layer, and a first strip member folded over an inflow circumferential edge portion of the cushioning layer to form a first protective portion. A second strip member is folded over an outflow circumferential edge portion of the cushioning layer to form a second protective portion. The first strip member and the second strip member are spaced apart from each other along a longitudinal axis of the prosthetic heart valve.

Abstract: Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Prosthetic valves can have integrated coverings or flanges. Prosthetic valves can have a flange attached to the inflow end of the annular frame and designed to extend outwardly therefrom. Docking devices can be used to repair or reshape native heart valves and to secure prosthetic heart valves at a specific location and position relative to a native heart valve. Delivery systems can be used to deploy a docking device into the heart, including a lubricous sleeve in the delivery system. Packaging and storage systems suitable for the delivery systems are described.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. A stylet having at least a first bent portion extends through a lumen of the nose cone. The at least a first bent portion is disposed within the lumen of the nose cone and restricts axial movement of the elongated shaft relative to the prosthetic valve.

Abstract: A prosthetic heart valve includes a frame having a plurality of strut members, an inflow end, and an outflow end. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering has a first layer and a second layer, wherein the second layer has a plush surface. The first layer is folded over a circumferential edge portion of the second layer to form a protective portion that extends beyond the strut members in a direction along a longitudinal axis of the prosthetic heart valve.

Abstract: A valve cover apparatus for use in a medical assembly including a prosthetic valve and a valve delivery apparatus. The valve cover apparatus includes a housing, a chamber disposed within the housing for receiving a prosthetic heart valve in an at least partially expanded state, a tapered surface defining a portion of the chamber, and a lock ring that is axially movable over at least a portion of the housing between a locked position and an unlocked position. The tapered surface is enables loading and/or guiding of the prosthetic heart valve from the chamber of the valve cover apparatus into a delivery sheath of the valve delivery apparatus and transition the prosthetic heart valve to a radially compressed state. The lock ring restricts movement of the valve cover relative to the delivery sheath when in the locked position, and enables movement of the valve cover when in the unlocked position.

Abstract: A prosthetic heart valve includes a frame having an inflow end and an outflow end, and defining a longitudinal axis. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering includes a first woven portion extending circumferentially around the frame and including a plurality of texturized strands or yarns extending along the longitudinal axis of the frame. The covering further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. The texturized strands extend along the longitudinal axis of the frame from the first woven portion to the second woven portion and form a floating portion between the first woven portion and the second woven portion.