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: An implantable medical lead comprising a lead body defining a lumen. The lead body includes one or more tines substantially at a distal end of the lead body. An inner member extending within the lead body lumen is configured to rotate relative to the lead body and configured to cause a rotation of a dilator. The dilator is configured such that the rotation causes or enables a lateral translation of the dilator from a first position proximal to a lead body opening to a second position distal to the lead body opening. The implantable medical lead may include a probe wire configured to slidably translate through an inner lumen of the dilator.

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: 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: Various techniques include advancing an implantable medical device comprising a tissue-piercing electrode toward the triangle of Koch region of the right atrium or through the coronary sinus to deliver cardiac therapy to or sense electrical activity of the left ventricle in the basal region, septal region, or basal-septal region of the left ventricular myocardium of a patient's heart. The tissue-piercing electrode may include an imagable material. The implantable medical device may include an imagable member made of an imagable material coupled to a housing or a lead of the implantable medical device. Image information representing the patient's heart and the imagable material may be acquired using two-dimensional imaging. Orientation information representing the implantable medical device may be generated based on the acquired image information.

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: A lead delivery apparatus and a method of delivering a medical lead to an anatomic target site. The method includes inserting a hydraulic plug into an internal delivery lumen of a delivery shaft, and coupling a medical lead to the hydraulic plug. Hydraulic pressure is applied to the hydraulic plug through the delivery lumen, thereby moving the hydraulic plug toward an anatomic target site, and advancing the medical lead toward the target site.

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: Techniques of forming a foamed insulation material from gypsum waste are disclosed herein. One example technique includes mechanically comminuting the gypsum waste from an original size into particles of gypsum at a target size smaller than the original size and mixing the particles of the gypsum with a binder to form a mixture of particles and binder. The binder is configured to bind the particles of gypsum upon hydration. The example technique can further include performing air entrainment on the mixture until a foam is formed from the mixture having the particles of gypsum and binder. The foam has water that causes the binder to bind the particles of gypsum. The example technique can then include removing moisture from the mixture with the formed foam to form a foamed insulation material from the particles of gypsum.

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 reservoir of a system for deploying an implantable lead to an extravascular location delivers a flow of fluid through a lumen of one or both of a tunneling tool and an introducer of the system. In some cases, the tunneling tool includes a pressure sensor assembly for monitoring a change in a pressure of the flow through the lumen thereof. Alternately, or in addition, a flow-controlled passageway, through which the flow of fluid from the reservoir is delivered to the lumen of the introducer, includes a compliant chamber to hold a reserve of the fluid. Fluid from the reserve may be drawn into the lumen of the introducer as the tunneling tool is withdrawn therefrom. Alternately, the introducer may include a chamber located between two seals, wherein fluid that fills the chamber is drawn distally into the lumen of the introducer, as the tunneling tool is withdrawn therefrom.

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 intracardiac ventricular pacemaker includes a pulse generator for delivering ventricular pacing pulses, an impedance sensing circuit, and a control circuit in communication with the pulse generator and the impedance sensing circuit. The pacemaker is configured to produce an intraventricular impedance signal, detect an atrial systolic event using the intraventricular impedance signal, set an atrioventricular pacing interval in response to detecting the atrial systolic event, and deliver a ventricular pacing pulse in response to the atrioventricular pacing interval expiring.

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 system for delivery of a leadless pacemaker. The system includes a catheter with an elongate flexible tubular body with a proximal end and a distal end, wherein the distal end of the tubular body includes a delivery cup with an external surface having an inflatable compliant balloon; and a pacing capsule of the leadless pacemaker releasably retained in the delivery cup. The pacing capsule includes an arrangement of tines configured to deploy and pierce a target tissue at a desired pacing capsule implant site in a coronary sinus of a patient. The balloon, when at least partially inflated, is configured to urge the delivery cup against the target tissue during deployment of the pacing capsule.

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.