Abstract: A medical device assembly includes a medical device and a detachable hemostasis valve. The medical device includes a hub that defines a lumen extending through the hub, and a normally open seal that is disposed within the hub, and an access sheath cap that is adapted to reversibly close the normally open seal. The normally open seal includes an aperture extending through the normally open seal that is coaxial with the lumen. The detachable hemostasis valve includes a valve hub that is adapted to be removably secured to the access sheath cap and a normally closed seal assembly that is disposed within the valve hub.

Abstract: A steering mechanism includes an axial translation mechanism including an elongate shaft having first and second helical threads extending along the elongate shaft, a first carriage member operatively engaged with the first helical thread, and a second carriage member operatively engaged with the second helical thread. Rotation of the elongate shaft translates the first and second carriage members in opposite directions. A bi-directional steerable catheter includes a handle including the steering mechanism, and an elongate sheath extending distally from the handle. The axial translation mechanism is coupled to first and second steering wires extending within the elongate sheath. The first carriage member is coupled to the first steering wire, and the second carriage member is coupled to the second steering wire. The first helical thread may axially overlap the second helical thread. The elongate shaft may include clockwise discontinuous threading overlaid with counterclockwise discontinuous threading.

Abstract: A variety of medical procedures utilize two or more medical device components, including medical device components where a first medical device component is advanced within a second medical component. An example would be an elongate dilator used in combination with a guide catheter. The guide catheter and the elongate dilator may be adapted to provide a unidirectional rotational lock mechanism that allows the guide catheter and the elongate dilator to lock together in only one relative rotational orientation such that rotating one of the components causes rotation of both components.

Abstract: An access sheath valve device includes an elongate body defining an inner chamber, a valve seal disposed within the inner chamber, a lip seal member fixed to an inner circumferential surface of the valve seal, and a compression member disposed on the elongate body and configured to be moved between a first position allowing the valve seal to be in an opened configuration and a second position which compresses the valve seal into a closed configuration. The lip seal member is configured to passively seal around a catheter disposed through the valve seal while the compression member is in the first position and the valve seal is in the opened configuration.

Abstract: A guide catheter for accommodating a left atrial appendage closure (LAAC) device being advanced towards a left atrial appendage (LAA) includes an elongate shaft extending from a proximal region to a distal region and a guide catheter hub that is coupled to the proximal region of the elongate shaft. The guide catheter hub includes a hub body, a proximal cap that is secured to the hub body and that includes a proximal cap extension defining a lumen extending through the proximal cap extension. An actuation member is slidingly disposed within the hub body and includes a central bore defining a lumen extending through the actuation member and a handle extending radially outwardly from the central bore. A flat seal is disposed within the actuation member. Advancing the actuation member towards the proximal cap causes the proximal cap extension to extend through the flat seal.

Abstract: A guide catheter that is adapted to accommodate a left atrial appendage closure (LAAC) device being advanced towards a left atrial appendage (LAA) includes an elongate shaft extending from a proximal region to a distal region and a guide catheter hub that is coupled to the proximal region of the elongate shaft. The guide catheter hub includes a hub body, a Tuohy seal disposed relative to the hub body, a flat seal disposed relative to the hub body, and a mechanism disposed relative to the hub body that is adapted to releasably open the flat seal.

Abstract: Delivery devices for an occlusive implant and method for making and using delivery devices are disclosed. An example delivery device may include a delivery sheath having a sheath body and a distal tip region. A tip reinforcing member may be coupled to the distal tip region. The tip reinforcing member may define a plurality of distal arm segments. The distal arm segments are configured to shift between a first configuration and an expanded configuration. A core member may be slidably disposed within the delivery sheath. An occlusive implant may be releasably coupled to the core member.

Abstract: A delivery system for an occlusive implant includes a delivery sheath assembly and a hub assembly. The delivery sheath assembly includes a delivery sheath defining a delivery lumen adapted to accommodate an occlusive implant releasably secured to a core wire. A proximal fitting is secured to the delivery sheath. The hub assembly includes a hub body, a distal hub secured relative to the hub body and adapted to engage the proximal fitting of the delivery sheath assembly, a proximal hub secured to the hub body, and a side port coupled to hub body and adapted for flushing an interior of the delivery system. The delivery system includes one or more features that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly when the core wire is rotationally locked to the proximal hub.

Abstract: A variety of medical procedures utilize two or more medical device components, including medical device components where a first medical device component is advanced within a second medical component. An example would be an elongate dilator used in combination with a guide catheter. The guide catheter and the elongate dilator may be adapted to provide a rotational lock mechanism that allows the guide catheter and the elongate dilator to lock together such that rotating one of the components causes rotation of both components. In some instances, the guide catheter and the elongate dilator may cooperate to also provide a relative axial lock between the two components.

Abstract: An assembly for delivering an implantable medical device, the assembly includes an implantable medical device including an attachment feature and a delivery device that is adapted to releasably secure the implantable medical device, the delivery device including an attachment element adapted to create an interference fit with the attachment feature of the implantable medical device. The delivery device is adapted to enable a user to selectively disengage the interference fit between the attachment element of the delivery device and the attachment feature of the implantable medical device with a short linear motion when the delivery device is positioned proximate a delivery site for the implantable medical device.