Abstract: A medical delivery device for delivering a medical device includes a navigable elongated member, a deployment bay, and a compression mechanism. The deployment bay may be configured to house the medical device as the medical device is navigated to the target site. The deployment bay may be at a distal end of the delivery device and may include a distal opening through which the medical device may be deployed. The compression mechanism is configured to longitudinally compress in response to a predetermined force such that the elongated member and deployment bay are relatively closer together along a longitudinal axis of the delivery device.

Abstract: A deflectable shaft catheter may include a handle extending laterally from a hub of the catheter to form an acute angle therewith, wherein the handle contains a wire controller and a guide that rotates in plane with the angle. A spring biased slider of the wire controller, for the aforementioned handle, or an in-line handle sans the guide, may include first and second parts between which a proximal end of the wire extends and bends into a bore formed in the first part. Alternately, the slider includes an elastomeric core sandwiched between first and second parts thereof. The slider may further include a cavity in which a spring member biases the proximal end of the wire toward a distal end of the cavity, but only forces the wire to the cavity distal end, if a predetermined spring force of the member is greater than an opposing force along the wire.

Abstract: A detachable handle assembly for a tool, the tool for creating a sub-sternal tunnel in a patient. The handle assembly includes a lock-and-release mechanism by which the tunneling assembly is attached to the handle, the mechanism being operable to detach the handle from the tunneling assembly. The handle assembly also may include a knob that interlocks with the tunneling assembly, the knob being configured for engagement by fingers of an adult hand to apply a force to rotate a boring tip of the tunneling assembly.

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: 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 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: 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: 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: 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: 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: 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 medical delivery device for delivering a medical device includes a navigable elongated member, a deployment bay, and a compression mechanism. The deployment bay may be configured to house the medical device as the medical device is navigated to the target site. The deployment bay may be at a distal end of the delivery device and may include a distal opening through which the medical device may be deployed. The compression mechanism is configured to longitudinally compress in response to a predetermined force such that the elongated member and deployment bay are relatively closer together along a longitudinal axis of the delivery device.

Abstract: This disclosure describes various tools and associated methods suitable for gaining access to extravascular spaces. The various tools and associated methods utilize a boring tip that may rotate to aid in safely and effectively crossing diaphragmatic attachments. The boring tip may, in some instances not have any sharp edge. For example, the boring tip may have a dome shape but including at least one surface recessed and offset from a summit of the dome shape. Various mechanisms may be used to control rotation of the boring tip as described herein.

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: This disclosure describes various examples of multi-purpose tools and associated methods for safely gaining access to extravascular spaces. The multi-purpose tools described herein are particularly suited for safely gaining access to the sub-sternal space underneath the sternum/ribcage as well as tunneling subcutaneously above the ribcage for the purpose of positioning of a medical electrical lead. This eliminates the need for separate tools for tunneling in different extravascular spaces by providing a single tool capable of the multiple uses.

Abstract: This disclosure describes various tools and associated methods suitable for gaining access to extravascular spaces. The various tools and associated methods utilize a boring tip that may rotate to aid in safely and effectively crossing diaphragmatic attachments. The boring tip may, in some instances not have any sharp edge. For example, the boring tip may have a dome shape but including at least one surface recessed and offset from a summit of the dome shape. Various mechanisms may be used to control rotation of the boring tip as described herein.

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.