Abstract: The disclosure describes techniques and systems for delivering an implantable medical device. In one example, an implantable medical device (IMD) delivery system may include an elongated member comprising a first distal end configured to mate with the IMD, a resilient member disposed along at least a portion of the elongated member, a housing configured to accept a first proximal end of the elongated member and a second proximal end of the resilient member, a rotation control mechanism wherein user movement of the rotation control mechanism causes rotation of the elongated member with respect to the housing and a fixation element of the IMD into tissue, and a deflection control mechanism wherein user movement of the deflection control mechanism causes longitudinal displacement of the resilient member along a longitudinal axis of the elongated member and the housing resulting in angular deflection of the first distal end of the elongated member.

Abstract: An implantable medical device is tethered to a delivery catheter by a length of a tether, which extends through an attachment feature of the device and between a free end thereof and a secured end thereof, wherein the secured end is fixedly coupled to a tubular member of the catheter in proximity to a distal end thereof, and the free end is engaged against an inner surface of a sidewall that extends within the tubular member. The free end of the tether may be engaged against the inner surface by an enlarged distal tip of an elongate wire that extends within a lumen defined by the inner surface of the sidewall. An operator may move the distal tip of the wire out through a distal opening of the lumen, thereby pushing the free end of the tether out from engagement with the surface, to untether the device from the catheter.

Abstract: An inner member of an improved assembly for a delivery system includes a first segment formed by a multi-lumen tubing surrounded by a braided tubing, and a second segment formed by a single-lumen tubing that extends within a distal portion of the braided tubing. The single-lumen tubing accommodates an antenna of a medical device, is in fluid communication with three lumens of the multi-lumen tubing, and opens into a flared distal end of the inner member. A distal-most portion of an outer tube of the system contains the flared distal end and an enclosure of the medical device abutting the distal end. A pull wire of the assembly extends within another lumen of the multi-lumen tubing and between the single-lumen tubing and the distal extent of the braided tubing, and is coupled to a pull band mounted in a cone member that forms the flared distal end.

Abstract: A tether assembly for a delivery tool that deploys an implantable medical device includes an elongate shaft and an attachment member coupled to a distal end of the shaft, wherein the attachment member includes an external thread and an end wall, the end wall extending orthogonally with respect to a direction of travel within a valley of the external thread to provide a hard stop for a threaded attachment bore of the medical device, when the bore is mated with the external thread. The tether assembly may extend within a lumen defined by an elongate tube of an inner assembly of the delivery tool, such that the attachment member thereof is located in proximity to a distal member of the inner assembly, the distal member being coupled to a distal end of the tube and forming a distal opening of the lumen.

Abstract: An inner member of an improved assembly for a delivery system includes a first segment formed by a multi-lumen tubing surrounded by a braided tubing, and a second segment formed by a single-lumen tubing that extends within a distal portion of the braided tubing. The single-lumen tubing accommodates an antenna of a medical device, is in fluid communication with three lumens of the multi-lumen tubing, and opens into a flared distal end of the inner member. A distal-most portion of an outer tube of the system contains the flared distal end and an enclosure of the medical device abutting the distal end. A pull wire of the assembly extends within another lumen of the multi-lumen tubing and between the single-lumen tubing and the distal extent of the braided tubing, and is coupled to a pull band mounted in a cone member that forms the flared distal end.

Abstract: A tool has an outer assembly, which includes a deployment tube, extending around, and moveable with respect to an inner assembly of the tool; the inner assembly includes a single pull wire and a distal member configured to engage an end of an implantable medical device. The deployment tube includes an articulating segment located just proximal to an enlarged distal-most portion, which contains the device and the distal member. Relatively soft and stiff sections of a composite sidewall define the articulating segment and extend alongside one another, such that, when the pull wire is actuated, the composite sidewall causes bending of the segment in two directions. A handle assembly of the tool includes a control member for the pull wire, and may further include a flushing subassembly that has a connector port located at an end of the handle assembly that is opposite a proximal port of the handle.

Abstract: A tether holder has a locking portion, for securing a proximal end of a tether, and a pin portion that may fit within a receptacle of a handle assembly of a tool. A distal member of an inner assembly of the tool engages an implantable medical device, from which the tether extends, through at least one lumen of the inner assembly and out through a proximal port of the handle assembly, which is located in proximity to the receptacle. An enlarged distal-most portion of a deployment tube of the tool contains the distal member and the device, and is moveable, relatively to the inner assembly and the device, to deploy the device out through a distal opening of the tool. The handle assembly may also include a flush lumen and a tether engaging conduit, both in fluid communication with the at least one lumen of the inner assembly.

Abstract: Apparatus and methods are disclosed for controlling deployment of a self-expanding support structure of a prosthetic valve that flares in a proximal direction upon implantation in vivo. A tubular delivery sheath having a side opening that proximally extends within a side wall thereof is used to deploy the prosthetic valve with the self-expanding support structure in a controlled manner. The prosthetic valve is distally advanced within a lumen of the delivery sheath with the self-expanding support structure held in a compressed delivery configuration within the delivery sheath lumen. The self-expanding support structure of the prosthetic valve is aligned with the side opening of the delivery sheath and the prosthetic valve is rotated relative to the delivery sheath whereby the self-expanding support structure is laterally released from the delivery sheath lumen through the side opening to gradually transition from the compressed delivery configuration to a flared deployed configuration.

Abstract: A cuff device configured to treat a site of a lesion in a vessel includes a flexible material having a first surface and a second surface. The flexible material is configured to be wrapped around an exterior surface of the vessel so that the first surface of the flexible material is in contact with an exterior surface of the vessel. The cuff device includes an opening that extends from the first surface to the second surface. The opening is constructed and arranged to allow a needle of a syringe to pass therethrough.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the bilumen proximal shaft to a coaxial distal shaft.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the trilumen proximal shaft to a coaxial distal shaft.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the bitumen proximal shaft to a coaxial distal shaft.