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: In some examples a medical device system includes an implantable medical lead configured to be delivered through an incision site on a body of a patient and an anchoring sleeve surrounding a portion of the lead and including an engagement mechanism configured to: engage with patient tissue at the incision site; and assist closure of an incision in the patient tissue at the incision site.

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: Various embodiments of a medical lead system are disclosed. The lead system includes a lead body that includes a lumen that extends along the lead body between an inlet adjacent to a proximal end of the lead body and an outlet adjacent to a distal end of the lead body; a fixation member; and a distal balloon connected to an exterior surface of the distal end of the lead body and fluidly connected to the outlet of the lumen. The medical lead system further includes a pressure sensor fluidly connected to the inlet of the lumen of the lead body and configured to sense a pressure within an interior volume of the distal balloon and communicate a signal indicative of the pressure to a clinician. The fixation member is further configured to extend distal to the distal balloon when the distal balloon is in an inflated configuration.

Abstract: Methods for creating a pathway for an implantable defibrillation lead within a patient, the patient having a torso with a center, left side, and a high sternal area. The method comprises creating an incision at a first location on the left side of the torso, advancing a first medical device and a second medical device through the incision and through the subcutaneous tissue toward a second location proximate the center of the torso, deflecting a distal end of the first medical device at the second location toward a third location proximate the high sternal area, advancing a distal portion of the second medical device out through the distal end of the first medical device toward the third location, and positioning a sheath within the torso, the sheath spanning a distance between the first location and the second location and a distance between the second location and the third location.

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 material removal device includes a housing and a removal element positioned within the housing. The housing defines an opening sized to receive an implantable medical lead of a medical device. The housing is sealed when the implantable medical lead is advanced through the opening. The housing defines a chamber. The removal element is configured to remove material from an outer surface of the implantable medical lead. The chamber is configured to retain the material.

Abstract: An apparatus for removing at least one elastomeric terminal component on a proximal end of a medical lead includes a first arm and a second arm. The first arm and the second arm are connected to each other and move in opposition between an open position and a closed position. Opposed mating portions on the first and second arms are configured to retain the proximal end of the lead when the apparatus is in the closed position. An elongate cutting implement enclosed within the second arm includes a cutting blade oriented at an angle such that, when the apparatus is in the closed position, the cutting blade forms a slit in at least a portion of the elastic terminal component.

Abstract: A lead extender comprises a connector defining a chamber having an inner wall and an opening into the chamber, the chamber configured to receive a proximal portion of a cut implantable medical lead through the opening. The connector comprises a locking mechanism configured to lock the proximal portion of the cut implantable medical lead to the inner wall of the chamber. The lead extender further comprises an extension line, having a distal end attached to the connector, the extension line configured to extend through a lumen of an extraction tool to the proximal end controlled by the operator for extracting the cut implantable medical lead from a patient.

Abstract: An example impkintable medical lead includes a first defibrillation electrode and a second, defibrillation electrode, the first and second, defibrillation electrodes configured to deliver first electrical therapy comprising anti tachyarrhythmia shocks. The implantable medical lead also includes a pace electrode disposed longitudinally 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 implantable medical lead further includes an inflatable shield disposed over a portion of an outer surface of the pace electrode, wherein the inflatable shield is configured to extend laterally away from the pace electrode upon inflation, wherein the inflatable shield is configured to impede an electric field of at least, one of the first and second the electrical therapies in a direction away from a heart of the patient.

Abstract: A system for extracting a transvenous endocardial lead includes a lead extender with a collet configured to releasably engage a pin of a connector on the lead, and a locking ring configured to maintain the engagement of the collet on the pin of the connector. The system further includes a lead extraction sheath having a sheath body with a tapered distal region, wherein a wall of the tapered distal region and a wall of the sheath body include an arrangement of openings configured to allow insertion of the lead extender and a body of the endocardial lead.

Abstract: An implantable medical lead includes a first defibrillation electrode and a second defibrillation electrode. The implantable medical lead further includes a pacing electrode configured to deliver a pacing pulse that generates an electric field proximate to the pacing electrode. The implantable medical lead further includes a shield disposed over a portion of an outer surface of the pacing electrode and extending laterally away from the pacing electrode. The shield is configured to impede the electric field in a direction from the pacing electrode away from a heart. The implantable medical lead further includes a conductive surface disposed on the shield and electrically coupled to the pacing electrode.

Abstract: An implantable medical device has a therapy module configured to generate a composite pacing pulse including a series of at least two individual pulses. The therapy module is configured to generate the composite pacing pulse by generating a first pulse of the at least two individual pulses by selectively coupling a first portion of a plurality of capacitors to an output signal line and generate a second pulse of the at least two individual pulses by selectively coupling a second portion of the plurality of capacitors to the output signal line.

Abstract: An example implantable medical lead includes a first defibrillation electrode and a second, defibrillation electrode, the first and second, defibrillation electrodes configured to deliver first electrical therapy. Tire implantable medical lead also includes a. pace electrode disposed longitudinally between the first defibrillation electrode and die second defibrillation electrode, the pace electrode configured to deliver second electrical therapy comprising pacing pulses. The implantable medical lead further includes a shield disposed over a portion of an outer surface of the pace electrode and extending laterally away from the pace electrode, wherein the shield comprises an asymmetric shape about a longitudinal axis of the shield, wherein die shield is configured to impede an electric field of at least one of the first and second electrical therapies in a direction away from a. heart of the patient.

Abstract: Implantable medical electrical leads having electrodes arranged such that a defibrillation coil electrode and a pace/sense electrode(s) are concurrently positioned substantially over the ventricle when implanted as described. The leads include an elongated lead body having a distal portion and a proximal end, a connector at the proximal end of the lead body, a defibrillation electrode located along the distal portion of the lead body, wherein the defibrillation electrode includes a first electrode segment and a second electrode segment proximal to the first electrode segment by a distance. The leads may include at least one pace/sense electrode, which in some instances, is located between the first defibrillation electrode segment and the second defibrillation electrode segment.

Abstract: This disclosure describes implantable medical leads and medical device systems utilizing the leads. In some examples, an implantable medical lead comprises a first defibrillation electrode and a second defibrillation electrode, the first and second defibrillation electrodes configured to deliver anti-tachyarrhythmia 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 implantable medical lead further comprises a shield disposed between the first defibrillation electrode and the second defibrillation electrode and over a portion of an outer surface of the pace electrode, wherein the shield is configured to impede the electric field in a direction from the pace electrode away from a heart.

Abstract: A medical device is configured to deliver therapeutic electrical stimulation pulses by generating frequency modulated electrical stimulation pulse signals. The medical device includes a pulse signal source and a modulator. The pulse signal source generates an electrical stimulation pulse signal having a pulse width. The modulator may include a high frequency modulator configured to modulate a frequency of the pulse signal from a starting frequency down to a minimum frequency during the pulse width. The modulator may include a low frequency bias generator to modulate the offset of the pulse signal between a minimum offset and a maximum offset in other examples.

Abstract: An extra-cardiovascular implantable cardioverter defibrillator (ICD) having a low voltage therapy module and a high voltage therapy module is configured to select, by a control module of the ICD, a pacing output configuration from at least a low-voltage pacing output configuration of the low voltage therapy module and a high-voltage pacing output configuration of the high voltage therapy module. The high voltage therapy module includes a high voltage capacitor having a first capacitance and the low voltage therapy module includes a plurality of low voltage capacitors each having up to a second capacitance that is less than the first capacitance. The ICD control module controls a respective one of the low voltage therapy module or the high voltage therapy module to deliver extra-cardiovascular pacing pulses in the selected pacing output configuration via extra-cardiovascular electrodes coupled to the ICD.

Abstract: A lead body having a defibrillation electrode positioned along a distal portion of the lead body is described. The defibrillation electrode includes a plurality of electrode segments spaced a distance apart from each other. At least one of the plurality of defibrillation electrode segments includes at least one coated portion and at least one uncoated portion. The at least one coated portion is coated with an electrically insulating material configured to prevent transmission of a low voltage signal (e.g., a pacing pulse) while allowing transmission of a high voltage signal (e.g., a cardioversion defibrillation shock). The at least one uncoated portion is configured to transmit both low voltage and high voltage signals. The lead may also include one or more discrete electrodes proximal, distal or between the defibrillation electrode segments.

Abstract: An extra-cardiovascular medical device is configured to select a capacitor configuration from a capacitor array and deliver a low voltage, pacing pulse by discharging the selected capacitor configuration across an extra-cardiovascular pacing electrode vector. In some examples, the medical device is configured to determine the capacitor configuration based on a measured impedance of the extra-cardiovascular pacing electrode vector.