Abstract: Medical devices including a balloon and methods of making medical devices including a balloon are provided. The medical device includes a tubular element, a balloon, and a barrier between the tubular element and the balloon. When air is pushed into one end of the medical device, the balloon may be inflated. The method includes applying a barrier to a tubular element, applying an elastomer solution to the barrier and at least a part of the tubular element to form a coating, and curing the coating to form the balloon.

Abstract: Medical devices including a balloon-actuated sheath are provided. The medical devices include a tubular body, a tooltip, a balloon, and a tubular sheath translatably coupled to the balloon. Medical devices including a balloon-actuated distal cap are provided. The medical devices include a tubular body, a tooltip, a balloon, and a distal cap translatably coupled to the balloon. When air is pushed into one end of the medical device, the balloon may inflate, translating the tubular sheath or distal cap along a longitudinal axis from a retracted position to an extended position. When in the extended position, the tubular sheath at least partially surrounds the tooltip. When in the extended position, the distal cap at least partially opens fluid communication between the tooltip and the environment.

Abstract: An implantable medical lead includes a lead body extending from a proximal end to a distal end. The lead body includes an inner insulation layer and an outer insulation layer. The lead further includes a sleeve mechanically supported by the lead body at the distal end of the lead body. The lead further includes an uninsulated conductor coil. The uninsulated conductor coil includes a first portion having a first inner diameter, and a second portion having a second inner diameter and extending distally from the outer insulation layer. The first portion is positioned between the inner insulation layer and the outer insulation layer. The second inner diameter is greater than the first inner diameter. An outer surface of the second portion is exposed.

Abstract: This disclosure describes an implantable medical electrical lead and an ICD system utilizing the lead. The lead includes a lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration. The lead includes a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance. The lead also includes at least one electrode disposed between adjacent sections of the plurality of defibrillation sections. The at least one electrode is configured to deliver a pacing pulse to the heart and/or sense cardiac electrical activity of the heart.

Abstract: A locking mechanism for a connector to an implantable controller includes a housing of the implantable controller defining a housing bore sized to receive the connector. A set screw is releasably coupled to the housing and disposed at an oblique angle with respect to the housing, the set screw being configured to engage at least a portion of the connector when the set screw is fully inserted within the housing to lock the connector within the housing.

Abstract: This disclosure describes an implantable medical electrical lead and an ICD system utilizing the lead. The lead includes a lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration. The lead includes a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance. The lead also includes at least one electrode disposed between adjacent sections of the plurality of defibrillation sections. The at least one electrode is configured to deliver a pacing pulse to the heart and/or sense cardiac electrical activity of the heart.

Abstract: A bore plug for an implantable medical device. The bore plug includes an elongate body having a proximal portion, a distal portion, and defining a major longitudinal axis therethrough, the distal portion being sized and configured to be received within a bore of the implantable medical device. The distal portion includes a lubricating element configured to lubricate the bore when the distal portion is at least one from the group consisting of inserted within and withdrawn from the bore.

Abstract: A system includes a lead with a balloon, wherein the lead defines an inflation lumen in fluid communication with the balloon. The system further includes an implantable medical device with a housing defining a fastener opening and a lead lumen. The lead lumen is configured to receive a proximal portion of the lead. The system further includes a fastener defining a fastener lumen. The fastener is configured to engage the fastener opening and the proximal portion of the lead to retain the proximal portion within the lead lumen. The fastener lumen is in fluid communication with the lead lumen and the inflation lumen, such that a pump in fluid communication with the fastener lumen inflates the balloon when the proximal portion of the lead is within the lead lumen.

Abstract: An example medical device system includes an implantable medical lead including a first defibrillation electrode and a second defibrillation electrode, the first and second defibrillation electrodes configured to deliver antitachyarrhythmia shocks, and a pace electrode disposed between the first defibrillation electrode and the second defibrillation electrode, the pace electrode configured to deliver a pacing pulse that generates an electric field proximate to the pace electrode. The medical device system includes a shield configured to be implanted in a patient separately from the implantable medical lead and disposed anterior at least one of the electrodes, wherein the shield is configured to impede an electric field of the electrical therapy in a direction from at least one of the first defibrillation electrode, the second defibrillation electrode, or the pace electrode away from a heart of the patient.

Abstract: A fixation mechanism of an implantable lead includes a plurality of depressions of an outermost surface of the lead and a relatively flexible sleeve mounted around the outermost surface. The depressions are spaced apart from one another along a length, and each extends circumferentially, wherein a longitudinal center-to-center spacing between each adjacent depression is uniform along the length, and each depression is of substantially the same size. The sleeve has an internal surface in sliding engagement with the outermost surface of the lead, and an external surface, in which suture grooves are formed. A longitudinal center-to-center spacing between adjacent suture grooves may be substantially the same as, or a multiple of, the longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead. The sleeve may also include a ridge protruding from the internal surface, aligned with, or offset (by center-to-center spacing of depressions) from, the grooves.

Abstract: A header for a controller for an implantable medical device. The header includes at least one bore sized and configured to receive a corresponding connector for the implantable medical device. At least one elongate thermally conducting element is disposed within the header and proximate the at least one bore, the at least one elongate thermally conducting element being configured to conduct heat away from the at least one bore and spread heat within the header when the corresponding connector is received within the at least one bore and is communication with the implantable medical device.

Abstract: A bore plug for an implantable medical device. The bore plug includes an elongate body having a proximal portion, a distal portion, and defining a major longitudinal axis therethrough, the distal portion being sized and configured to be received within a bore of the implantable medical device. The distal portion includes a lubricating element configured to lubricate the bore when the distal portion is at least one from the group consisting of inserted within and withdrawn from the bore.

Abstract: A furcated driveline connector configured to couple to an implantable blood pump.

Abstract: A medical lead system including an elongated lead body configured to extend through vasculature of a patient. The lead body mechanically supports a fixation member extending distal to a distal end of the lead body. A balloon is affixed to a distal portion of the lead body. The balloon is configured to inflate to extend distal to the distal end of the lead body. The fixation member is configured to extend within a distal cavity defined by the inflated balloon. The medical lead system is configured such that an electrode mechanically supported by the fixation member may electrically communicate with tissue of the patient when the balloon is in the inflated configuration.

Abstract: A tethering assembly for securing a medical device includes a shaft and a wire that extends in sliding engagement within a proximal lumen, a channel, and a distal receptacle of the shaft. A retainer zone of the shaft, through which the channel extends, stops a transition segment of the wire, which extends between a proximal and a distal segment of the wire, from moving into the shaft receptacle, thereby restraining a distal-most tip of the wire from moving through a distal-most opening of the receptacle. When a projecting member of the device has entered a secure zone of the receptacle, via movement through the distal-most opening and a tapering passageway thereof, the distal-most tip of the wire, which may be spring-biased, can move distally into the passageway so that the tip blocks the projecting member from moving distally, back through the passageway.

Abstract: A tethering assembly for securing a medical device includes a shaft and a wire that extends in sliding engagement within a proximal lumen, a channel, and a distal receptacle of the shaft. A retainer zone of the shaft, through which the channel extends, stops a transition segment of the wire, which extends between a proximal and a distal segment of the wire, from moving into the shaft receptacle, thereby restraining a distal-most tip of the wire from moving through a distal-most opening of the receptacle. When a projecting member of the device has entered a secure zone of the receptacle, via movement through the distal-most opening and a tapering passageway thereof, the distal-most tip of the wire, which may be spring-biased, can move distally into the passageway so that the tip blocks the projecting member from moving distally, back through the passageway.

Abstract: An improved assembly for securing an implantable medical device for retrieval from an implant site includes a plurality of snares, wherein distal openings of a first snare carrier lumen and a second snare carrier lumen have a pre-set offset established therebetween. First and second snare shafts, to which first and second snare loops are coupled, respectively, extend within the corresponding snare carrier lumens such that each loop is located in proximity to the corresponding distal opening of the lumen. The pre-set offset allows an operator to simultaneously position the snare loops around the device; and, when the operator retracts the snare shafts to collapse the snare loops until the loops fit snuggly around the device, the pre-set offset can help to align the device for retrieval.

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.