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 implantable medical device assembly includes a mounting structure, an electrode protruding from a surface of the structure, between opposing sides thereof, and tissue-penetrating fixation tines, each extending from a corresponding shoulder of the structure surface, adjacent to the opposing sides. In a relaxed condition, each tine extends away from the surface and then bends toward a proximal end of the structure and back toward the surface. In an extended condition, each tine bends toward a distal end of the structure and extends along the corresponding shoulder. A holding member of a delivery tool has opposing sidewalls defining a cavity, wherein each sidewall includes a rail-like edge that fits in sliding engagement with a corresponding shoulder, to deform a corresponding tine into the extended condition, when an operator passes the assembly into the cavity. Applying a push force, to move the assembly back out form the cavity, releases the tines.

Abstract: The medical device may comprise an elongate body having a proximal portion, a distal portion, and defining a lumen therethrough. Also, the medical device may include an expandable element coupled to the distal portion of the elongate body and in fluid communication with the lumen. The expandable element may define a first end and a second end, the second end being proximal to the first end. The medical device may further include a cannula surrounding at least a portion of the elongate body and the cannula may define a proximal end and a distal end. The distal end of the cannula may be disposed proximal and adjacent to the second end of the expandable element. An outer dimeter of the cannula may be substantially equal to or lesser than an outer diameter of the expandable element when inflated. The medical device may be maneuvered through a patient's body.

Abstract: A medical fixation device which may include an elongate body with a proximal portion, a distal portion, and define a longitudinal axis extending therethrough. A first fixation member on the proximal portion of the elongate body and a second fixation member on the distal portion of the elongate body may also be included with the medical fixation device. The first fixation member and the second fixation member may each have a delivery configuration in which the first fixation member and the second fixation member are collapsed along the longitudinal axis, and an anchoring configuration in which the first fixation member and the second fixation member each extend radially outward from the elongate body, define a septal aperture therebetween, and each have a tip facing away from each other.

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: 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: 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: 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 method and device apparatus to deliver a pacing therapy capable of remodeling a patient's heart over a period of time that includes monitoring one or more parameters in response to a delivered cardiac remodeling pacing, determining whether the cardiac remodeling pacing has an effect on cardiac normalization in response to the monitoring, and adjusting the cardiac remodeling pacing in response to the determined effect on cardiac normalization. The method and device may also perform short-term monitoring of one or more parameters in response to the delivered cardiac remodeling pacing, monitor one or more long-term parameter indicative of a long-term effect of the delivered cardiac remodeling pacing, determine the long-term effect of the delivered cardiac remodeling pacing on cardiac normalization in response to the monitoring, and adjust the cardiac remodeling pacing in response to one or both of the short-term monitoring and the determined long-term effect on cardiac normalization.

Abstract: A method and device apparatus to deliver a pacing therapy capable of remodeling a patient's heart over a period of time that includes delivering remodeling pacing during a first interval, the first interval comprising a first rate and a first duration, determining whether to adjust one or both of the first rate and the first duration during delivery of remodeling pacing during a next interval subsequent to the first interval, and delivering remodeling pacing during the next interval in response to the determining, wherein the next interval comprises one of the first rate and the first duration of the first interval and the adjusted one or both of the first rate and the first duration.

Abstract: A medical system comprising a guiding catheter having an inflation lumen. The inflation lumen extends within a handle and a shaft of the guiding catheter. An inflatable sleeve has a proximal end and a distal end, with the ends attached to the guiding catheter. A sealed interior portion of the inflatable sleeve is bounded by the inflatable sleeve and the shaft of the guiding catheter, and in fluid communication with a distal port of the inflation lumen. The system further comprises a delivery catheter defining a delivery lumen and configured for sliding engagement within the guide lumen of the guiding catheter.

Abstract: An implantable medical device system includes a pacemaker and an implantable cardioverter defibrillator (ICD). The pacemaker is configured to confirm a hemodynamically unstable rhythm based on an activity metric determined from an activity sensor signal after detecting a ventricular tachyarrhythmia and withhold anti-tachycardia pacing (ATP) pulses in response to confirming the hemodynamically unstable rhythm. The pacemaker may deliver ATP when a hemodynamically unstable rhythm is not confirmed based on the activity metric. The ICD is configured to detect the ATP and withhold a shock therapy in response to detecting the ATP in some examples.

Abstract: An operator advances a delivery catheter through a guiding catheter, after positioning an inflatable sleeve of the guiding catheter in proximity to a target implant site on an epicardial surface. By inflating the positioned sleeve, the operator displaces the epicardial surface to create a gap that accommodates a reach of the delivery catheter. With the delivery catheter extending distally from the guiding catheter, the operator can activate the reach of the delivery catheter within the gap, and then advance the lead out through a distal-most opening of the delivery catheter. The reach may orient a fixation member of the advanced lead relative to the epicardial surface so the operator can secure the lead to the surface. The sleeve of the guiding catheter is preferably non-compliant and has a maximum diameter of at least twice the reach of the delivery catheter, when inflated.

Abstract: An implantable medical device assembly includes a mounting structure, an electrode protruding from a surface of the structure, between opposing sides thereof, and tissue-penetrating fixation tines, each extending from a corresponding shoulder of the structure surface, adjacent to the opposing sides. In a relaxed condition, each tine extends away from the surface and then bends toward a proximal end of the structure and back toward the surface. In an extended condition, each tine bends toward a distal end of the structure and extends along the corresponding shoulder. A holding member of a delivery tool has opposing sidewalls defining a cavity, wherein each sidewall includes a rail-like edge that fits in sliding engagement with a corresponding shoulder, to deform a corresponding tine into the extended condition, when an operator passes the assembly into the cavity. Applying a push force, to move the assembly back out form the cavity, releases the tines.

Abstract: An implantable medical device system includes a pacemaker and an implantable cardioverter defibrillator (ICD). The pacemaker is configured to confirm a hemodynamically unstable rhythm based on an activity metric determined from an activity sensor signal after detecting a ventricular tachyarrhythmia and withhold anti-tachycardia pacing (ATP) pulses in response to confirming the hemodynamically unstable rhythm. The pacemaker may deliver ATP when a hemodynamically unstable rhythm is not confirmed based on the activity metric. The ICD is configured to detect the ATP and withhold a shock therapy in response to detecting the ATP in some examples.

Abstract: An implantable medical device assembly includes a mounting structure, an electrode, and fixation tines. The electrode protrudes from a surface of the structure, offset proximally from a distal end of the structure, and approximately centered between first and second sides of the structure. Each tine extends away from the surface—a first adjacent the first side, and a second adjacent the second side. Each tine is elastically deformable from a relaxed condition, in which the tine extends toward a proximal end of the structure, to an extended condition, in which the tine extends away from the distal end of the structure. A delivery tool has first and second longitudinally extending sidewalls to receive passage of the structure therebetween. When the structure distal end is located between proximal ends of the sidewalls, a rail-like edge of each sidewall receives, and elastically deforms to the extended condition, a corresponding tine.

Abstract: An implantable medical device assembly includes a mounting structure, an electrode protruding from a surface of the structure, between opposing sides thereof, and tissue-penetrating fixation tines, each extending from a corresponding shoulder of the structure surface, adjacent to the opposing sides. In a relaxed condition, each tine extends away from the surface and then bends toward a proximal end of the structure and back toward the surface. In an extended condition, each tine bends toward a distal end of the structure and extends along the corresponding shoulder. A holding member of a delivery tool has opposing sidewalls defining a cavity, wherein each sidewall includes a rail-like edge that fits in sliding engagement with a corresponding shoulder, to deform a corresponding tine into the extended condition, when an operator passes the assembly into the cavity. Applying a push force, to move the assembly back out form the cavity, releases the tines.

Abstract: An implantable medical device system includes a pacemaker and an implantable cardioverter defibrillator (ICD). The pacemaker is configured to confirm a hemodynamically unstable rhythm based on an activity metric determined from an activity sensor signal after detecting a ventricular tachyarrhythmia and withhold anti-tachycardia pacing (ATP) pulses in response to confirming the hemodynamically unstable rhythm. The pacemaker may deliver ATP when a hemodynamically unstable rhythm is not confirmed based on the activity metric. The ICD is configured to detect the ATP and withhold a shock therapy in response to detecting the ATP in some examples.

Abstract: An implantable medical device system includes a pacemaker and an implantable cardioverter defibrillator (ICD). The pacemaker is configured to confirm a hemodynamically unstable rhythm based on an activity metric determined from an activity sensor signal after detecting a ventricular tachyarrhythmia and withhold anti-tachycardia pacing (ATP) pulses in response to confirming the hemodynamically unstable rhythm. The pacemaker may deliver ATP when a hemodynamically unstable rhythm is not confirmed based on the activity metric. The ICD is configured to detect the ATP and withhold a shock therapy in response to detecting the ATP in some examples.

Abstract: Techniques for systems and methods for remotely monitoring a patient are provided. The system comprises a plurality of input sources operable to acquire patient-specific information corresponding to a condition of a patient. A patient-centric threshold is computed based on relevant environmental, cultural, societal, religion, and economic data for evaluation of the acquired physiological parameters. Risk stratification is performed to determine the risk level of the patient based on the patient-centric threshold, and a recommendation is generated. The recommendation includes a treatment/care plan that can consist of prescriptions and patient education tailored to the risk stratification and patient-specific information.