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 method for preparing a prosthetic valve and a delivery system for an implantation procedure. The method comprises (a) obtaining a tray, the tray containing the delivery system, the prosthetic valve coupled to the delivery system, and a valve cover in which the prosthetic valve is disposed. The tray comprises a storage cavity comprising an open end, a floor, and a peripheral side wall defining the depth of the cavity, wherein the prosthetic valve and the valve cover are disposed in the storage cavity; and a mounting surface that substantially immobilizes and maintains the valve cover and prosthetic valve within the storage cavity. The method further comprises (b) at least partially filing the storage cavity with a first hydrating fluid to completely immerse the prosthetic valve; and (c) removing the delivery device with the prosthetic valve from the tray, including disengaging the prosthetic valve from the mounting surface.

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: One method of implanting a prosthetic valve includes advancing the valve into a patient with a delivery apparatus. The valve includes apices circumferentially-spaced apart relative to each other. At least some of the apices include first apertures. The delivery apparatus includes release arms and a sheath. The release arms include second apertures for receiving the apices. At least one of the second apertures of the release arms has a different length than another one of the second apertures. The method also includes positioning the valve at a location, retracting a sheath of the delivery apparatus relative to the valve, allowing the valve to self-expand from a radially compressed state to a radially expanded state, and while the valve is coupled to the delivery apparatus, pivoting the valve relative about the release arms such that an axis of the valve is tilted relative to an axis of the delivery apparatus.

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 located distally to the valve. A removable tab is disposed between the distal end of the frame and the nose cone. The tab assists in maintaining the position of the nose cone relative to the distal end of the frame.

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 a crimped or collapsed condition. The delivery system also includes a nosecone with a tapered distal end and a proximal end enlarged to have a diameter larger than the capsule. Surprisingly, the proximal end of the nosecone, despite having a larger profile than the capsule, reduces an average peak push force for advancing the delivery system through an introducer sheath. Also disclosed are features, such as protrusions and ridges, supported on an outside of the capsule for reducing push force.

Abstract: A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system includes a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.

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.

Abstract: A prosthetic implant delivery assembly can include a prosthetic implant and an elongate catheter. The prosthetic implant can include an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The catheter can include a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent can be releasably and pivotably coupled to at least one the arms of the catheter such that the stent can pivot about the at least one of the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

Abstract: A delivery catheter is in various embodiments configured to deliver an anchoring device to a native valve annulus of a patient's heart, where the anchoring device can better secure a prosthesis at the native annulus. The delivery catheter can includes a distal section that includes one or more spines or is laser cut to assume a particular shape for better facilitating delivery of the anchoring device at the implant site and can include a flexible tube, a first pull wire, and a second pull wire. The flexible tube can comprise a bore extending between the first end and the second end sized for passing the anchoring device therethrough. The distal portion can comprise a first flexing section and a second flexing section. Actuation of the first pull wire and the second pull wire can cause the flexible tube to move from a first configuration to a second configuration.

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: 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: 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: Docking devices can be configured to be positioned at a native valve of a human heart to provide structural support for docking a prosthetic valve. The docking devices generally have coiled structures that define an inner space in which the prosthetic valve can be held. Some docking devices can be adjusted from a first wider configuration which facilitates easier advancement of the docking device around the valve anatomy, to a second narrower configuration after the docking device has been delivered to more securely hold the prosthetic valve. The docking device may also be better held in position at the native valve after adjustment to the narrower configuration. Some docking devices include a stabilization segment or double coil configuration, where a main coil region is configured to securely hold a prosthetic valve, while a stabilization coil region is configured to more stably hold the docking device at the native valve.

Abstract: A prosthetic implant delivery assembly can include a prosthetic implant and an elongate catheter. The prosthetic implant can include an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The catheter can include a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent can be releasably and pivotably coupled to at least one the arms of the catheter such that the stent can pivot about the at least one of the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

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 located distally to the valve. A removable tab is disposed between the distal end of the frame and the nose cone. The tab assists in maintaining the position of the nose cone relative to the distal end of the frame.

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 a crimped or collapsed condition. The delivery system also includes a nosecone with a tapered distal end and a proximal end enlarged to have a diameter larger than the capsule. Surprisingly, the proximal end of the nosecone, despite having a larger profile than the capsule, reduces an average peak push force for advancing the delivery system through an introducer sheath. Also disclosed are features, such as protrusions and ridges, supported on an outside of the capsule for reducing push force.

Abstract: A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system comprises a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.