Abstract: In some examples, an implantable medical device delivery catheter comprises a handle and an elongated member disposed within the handle, the elongated member comprising an elongated member lumen configured to receive an inner tool that is configured to extend through a lumen of the delivery catheter, including the elongated member lumen, and interface with an implantable medical device. The handle further comprises a clamping assembly comprising a button configured to be actuated toward a longitudinal axis of the elongated member in a direction transverse to the longitudinal axis to compress the elongated member against the inner tool to restrain movement of the inner tool through the elongated member lumen.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: In some examples, a medical device delivery system includes a device cup configured to retain the medical device at the distal end of a catheter, the cup having a cylindrical body defining at least one vent hole extending from an exterior surface of the body to an interior surface of the body, and at least one internal rib extending inwardly from the interior surface, the rib configured to contact the medical device.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: A tool includes a handle, a plunger actuator proximate the handle, a shaft extending from the handle, a plunger, an engagement mechanism. The shaft includes a proximal end and a distal end, and the shaft defines a channel extending along a length of the shaft. A first actuation of the plunger actuator causes the plunger to translate along the length of the shaft in a distal direction. A second actuation of the plunger actuator causes the plunger to translate along the length of the shaft in a proximal direction. The engagement mechanism is disposed on the distal end and is configured to engage an implantable medical device, and release the implantable medical device in response to the plunger exerting a contact force on the implantable medical device exceeding a reaction force of the engagement mechanism when the plunger translates along the length of the shaft in the distal direction.

Abstract: An active return curve deflectable catheter includes an elongate catheter body, a fixation member, a deflection assembly, and a pull wire. The fixation member is coupled to a distal portion of the elongate catheter body. The deflection assembly includes a hub coupled to a proximal end of the elongate catheter body, a handle, and a control member. The pull wire extends from the control member through the hub assembly to the fixation member. The elongate catheter body is configured to deflect from an initial configuration to a deflected configuration in response to a pull force applied to the pull wire by actuation of the control member in a first direction.

Abstract: An apparatus for forming a passageway through tissue includes a dilator mounted to a shaft, wherein the dilator includes a first portion, which has an increasing taper from a first outer diameter to a larger second outer diameter, and a second portion, which has a decreasing taper from the first portion to a distal end of the dilator, and which includes an external non-cutting thread formed along the decreasing taper. Lumens of the dilator and shaft provide a conduit for means to pierce through the tissue, for example, an elongate wire that includes a piercing tip. In some cases, the dilator first portion is expandable to, and contractible from, the larger second outer diameter, wherein the apparatus may include a spreading member configured to slide between the shaft and the first portion. The apparatus may be included in a system with an introducer sheath.

Abstract: A deflectable catheter includes an elongate member having a wall defining a longitudinally extending lumen extending from a proximal end to a distal end, a fixation member coupled to a distal portion of the elongate member, and a pull wire extending through the wall of the elongate member from the proximal end of the elongate member to the fixation member. The pull wire is coupled to the fixation member and constrained along its length such that the elongate member is configured to deflect from an initial configuration to a deflected configuration in response to a pull force applied to the pull wire and actively return from the deflected configuration to the initial configuration in response to a push force applied to the pull wire.

Abstract: In some examples, a system includes a catheter comprising an elongated shaft defining a lumen, and a tether assembly. The tether assembly may include an elongate body, a tether head assembly attached to a distal end of the elongate body, where the tether head assembly includes an attachment mechanism configured to releasably attach to an attachment member of a medical device, and a positioning element fixedly positioned over the elongate body and configured to align the attachment mechanism with the attachment member when the tether head assembly is extended distally out of the lumen. The positioning element may include a distal end, a proximal end, and a length between the distal end and proximal end that is less than a length of the elongate body. The tether head assembly, elongate body, and positioning element may be movable within the lumen of the elongated shaft.

Abstract: A high contrast instrument, such as a radiopaque portion, can be captured and/or viewed in an image that is acquired with an imaging system, such as with a fluoroscopic imaging system. A statistical model can be used to assist in identifying a possible or probable location of a target. A user may move the instrument coil to the statistically probable location of the target to, for example, perform a procedure or carry out a task.

Abstract: An active return curve deflectable catheter includes an elongate member, a fixation member, a deflection assembly, and a pull wire. The fixation member is coupled to a distal portion of the elongate member. The deflection assembly includes a hub assembly coupled to a proximal end of the elongate member, a handle, and a control member. The pull wire extends from the control member through the hub assembly to the fixation member. The elongate member is configured to deflect from an initial configuration to a deflected configuration in response to a pull force applied to the pull wire by actuation of the control member in a first direction.

Abstract: A deflectable catheter includes an elongate member having a wall defining a longitudinally extending lumen extending from a proximal end to a distal end, a fixation member coupled to an exterior surface of the wall on a distal portion of the elongate member, and a pull wire extending through the wall of the elongate member from the proximal end of the elongate member to the fixation member. The pull wire is coupled to the fixation member and constrained along its length such that the elongate member is configured to deflect from an initial configuration to a deflected configuration in response to a pull force applied to the pull wire and actively return from the deflected configuration to the initial configuration in response to a push force applied to the pull wire.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: The present disclosure is directed to a shuttle apparatus for detachably joining a catheter to a guidewire so that the joined catheter, extending alongside the guidewire, is in sliding engagement with the guidewire without extending around the guidewire. The apparatus comprises a collar member sized for mounting in sliding engagement around a length of the guidewire, the collar member having a longitudinal axis that approximately aligns along the length, when mounted thereabout, the length being defined between a proximal-most point of the guidewire and a distal point of the guidewire, the distal point being offset proximally from a distal-most point of the guidewire. The apparatus further comprises a plug member coupled to the collar member, the plug member having a longitudinal axis, and the plug member being sized to fit within an opening of the catheter for detachable engagement therewith.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: Extravascular implant tools that utilize a bore-in mechanism to safely access extravascular locations and implant techniques utilizing these tools are described. The bore-in mechanism may include a handle and a helix extending from the handle. The bore-in mechanism is used, for example, in conjunction with a tunneling tool to traverse the diaphragmatic attachments to access a substernal location. The tunneling tool may be an open channel tunneling tool or a conventional tunneling tool (e.g., metal rod).

Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: The present disclosure is directed to a shuttle apparatus for detachably joining a catheter to a guidewire so that the joined catheter, extending alongside the guidewire, is in sliding engagement with the guidewire without extending around the guidewire. The apparatus comprises a collar member sized for mounting in sliding engagement around a length of the guidewire, the collar member having a longitudinal axis that approximately aligns along the length, when mounted thereabout, the length being defined between a proximal-most point of the guidewire and a distal point of the guidewire, the distal point being offset proximally from a distal-most point of the guidewire. The apparatus further comprises a plug member coupled to the collar member, the plug member having a longitudinal axis, and the plug member being sized to fit within an opening of the catheter for detachable engagement therewith.