Abstract: This disclosure is directed to a curvilinear medical electrical lead. For example, a medical electrical lead includes a lead body, a high voltage electrode positioned on the lead body, the high voltage electrode comprising a proximal coated portion, a distal coated portion, and an uncoated portion. Additionally, the medical electrical lead includes a first low voltage electrode and a second low voltage electrode distal to the first low voltage electrode, wherein a first line passes through the first low voltage electrode and the second low voltage electrode, wherein a second line passes through the first low voltage electrode and the uncoated portion, the second line forming a first angle with the first line, and wherein a third line passes through the second low voltage electrode and the uncoated portion, the third line forming a second angle with the first line.

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: 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: 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: This disclosure is directed to a curvilinear medical electrical lead. For example, a medical electrical lead includes a lead body, a high voltage electrode positioned on the lead body, the high voltage electrode comprising a proximal coated portion, a distal coated portion, and an uncoated portion. Additionally, the medical electrical lead includes a first low voltage electrode and a second low voltage electrode distal to the first low voltage electrode, wherein a first line passes through the first low voltage electrode and the second low voltage electrode, wherein a second line passes through the first low voltage electrode and the uncoated portion, the second line forming a first angle with the first line, and wherein a third line passes through the second low voltage electrode and the uncoated portion, the third line forming a second angle with the first line.

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: 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: An implantable medical device is configured to control a therapy module to couple a capacitor array comprising a plurality of capacitors to a plurality of extra-cardiovascular electrodes and control the therapy module to deliver a composite pacing pulse to a patient's heart via the plurality of extra-cardiovascular electrodes by sequentially discharging at least a portion of the plurality capacitors to produce a series of at least two individual pulses that define the composite pacing pulse.

Abstract: In some examples, an implantable medical device (IMD) that includes a pulse generator comprising a housing, electrodes, and circuitry configured to deliver cardiac pacing via the electrodes. The IMD may further include a lead including at least one of the electrodes, an elongate body, a fixation helix, and a connector segment. A width of the helix transverse to a longitudinal axis of the lead is greatest at a distal end of the helix. A proximal end of the elongate body may be connected to a distal end of the pulse generator, and the helix may be attached to a distal end of the elongate body. The pulse generator may include a first connector tab. A distal end of the connector segment may be configured to receive the proximal end of the elongate body and a proximal end of the connector segment may include at least one second connector member configured to engage the first connector tab.

Abstract: A method for creating a pathway for insertion of a medical lead, such as a defibrillation lead, the method includes creating an incision at a first location on the left side of the torso of the patient. A first medical device and a second medical device are advanced through the incision and through the subcutaneous tissue toward a second location proximate the center of the torso. The distal end of the first medical device is deflected at the second location toward a third location proximate the high sternal area. The second medical device is advanced out through the distal end of the first medical device toward the third location. A sheath is positioned within the torso, the sheath spanning the distance between the first location and the second location and the distance between the second location and the third location.

Abstract: In some examples, a system includes a medical device comprising an elongate body configured to advance through layers of tissue of a patient, a lumen extending through the elongate body, a fluid line configured to supply fluid to the lumen, and a pressure sensor positioned within the lumen or the fluid line. The system may further include processing circuitry configured to receive, from the pressure sensor, a signal corresponding to the pressure of the fluid at each of a plurality of time points, determine, for each time point: a corresponding amplitude value of the signal, a difference between two amplitude values of the signal, an amplitude oscillation status of the signal, a position of the elongate body based on the difference and the amplitude oscillation status; and provide an indication of the position of the elongate body relative to the layers of tissue.

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.

Abstract: An implantable medical lead comprising one or more tines configured to extend and/or retract from a lead body. The implantable medical lead includes a torque member within the implantable medical lead and configured to rotate a drive shaft within the implantable medical lead. The drive shaft is threadably engaged with an interior surface of the implantable medical lead and configured to convert the rotation into a lateral translation of the drive shaft. The one or more tines are configured such that the lateral translation of the torque member laterally translates the one or more tines. The one or more tines are each electrically connected to a conductor extending through a lumen of the implantable medical lead and electrically isolated from each other.

Abstract: An implantable medical lead may include an electrode at a distal portion of the lead that is configured to monitor or provide therapy to a target site. The lead may include a visible indicator that is visible to the naked eye of a clinician at a medial portion of the lead that is configured to indicate when the electrodes of the lead are longitudinally and radially aligned properly to monitor or treat the target site. A clinician may insert the lead into the patient using an introducer sheath inserted to a predetermined depth into the patient and subsequently aligning the distal portion of the lead by orienting the indicator at an entry port of the introducer sheath.

Abstract: In some examples, a system includes a medical device comprising an elongate body configured to advance through layers of tissue of a patient, a lumen extending through the elongate body, a fluid line configured to supply fluid to the lumen, and a pressure sensor positioned within the lumen or the fluid line. The system may further include processing circuitry configured to receive, from the pressure sensor, a signal corresponding to the pressure of the fluid at each of a plurality of time points, determine, for each time point: a corresponding amplitude value of the signal, a difference between two amplitude values of the signal, an amplitude oscillation status of the signal, a position of the elongate body based on the difference and the amplitude oscillation status; and provide an indication of the position of the elongate body relative to the layers of tissue.

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: 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: An implantable medical lead may include an electrode at a distal portion of the lead that is configured to monitor or provide therapy to a target site. The lead may include a visible indicator that is visible to the naked eye of a clinician at a medial portion of the lead that is configured to indicate when the electrodes of the lead are longitudinally and radially aligned properly to monitor or treat the target site. A clinician may insert the lead into the patient using an introducer sheath inserted to a predetermined depth into the patient and subsequently aligning the distal portion of the lead by orienting the indicator at an entry port of the introducer sheath.

Abstract: Techniques for detecting infections in a patient in relation to temperature values obtained from implantable temperature sensors are described. An example implantable temperature sensor may be included within a housing of an implantable medical device (IMD). In some examples, the temperature sensor may determine a plurality of temperature values over time. Processing circuitry of the IMD or of an external device may smooth the temperature values and apply an infection detection model to the smoothened temperature signal to determine an infection status of the patient.

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.