Abstract: Described herein are methods for use with an implantable system including at least an atrial leadless pacemaker (aLP). Also described herein are specific implementations of an aLP, as well as implantable systems including an aLP. In certain embodiments, the aLP senses a signal from which cardiac activity associated with a ventricular chamber can be detected by the aLP itself based on feature(s) of the sensed signal. The aLP monitors the sensed signal for an intrinsic or paced ventricular activation within a ventricular event monitor window. In response to the aLP detecting an intrinsic or paced ventricular activation itself from the sensed signal within the ventricular event monitor window, the aLP resets an atrial escape interval timer that is used by the aLP to time delivery of an atrial pacing pulse if an intrinsic atrial activation is not detected within an atrial escape interval.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: A computer implemented method and system for monitoring types of capture within a distributed implantable system having a leadless implantable medical device (LIMD) to be implanted entirely within a local chamber of the heart and having a subcutaneous implantable medical device (SIMD) to be located proximate the heart are provided. The method is under control of one or more processors of the SIMD configured with program instructions. The method collects far field (FF) evoked cardiac signals following the pacing pulses delivered by the LIMD for an event and analyzes the FF evoked cardiac signals to identify a type of HIS capture as loss of capture (LOC), selective capture, myocardial tissue-only (MT-only) capture, or a non-selective (NS) capture and records a label for the event based on the type of HIS capture identified.

Abstract: Provided are an endovascular-stent-based electrode array, a method for manufacturing the same, and an electrical stimulation system. The endovascular-stent-based electrode array includes a stent woven from stent woven wires. The stent woven wires include at least one first metal woven wire, each respective first metal woven wire includes an insulated segment and a conductive segment axially arranged, the insulated segment is electrically insulated from other stent woven wires and a human tissue, and the conductive segment is configured to perform at least one of: delivering a stimulation pulse to a nerve surrounding the human tissue, and sensing an electrical signal from the nerve surrounding the human tissue. A proximal end of the respective first metal woven wire is configured to be electrically connected to an external device, and a distal terminal end of the respective first metal woven wire is electrically insulated from the human tissue.

Abstract: Disclosed are a nerve stimulation apparatus and system, and a control method. The apparatus comprises: a pulse generator, an evoked compound action potential (ECAP) sensor, and a controller. The pulse generator is used for generate a pulse according to an instruction of the controller; the ECAP sensor is used for sensing an evoked compound action potential according to an instruction of the controller; and the controller is used for instructing, after a pulse is generated within a current pulse generation cycle, the ECAP sensor to sense an evoked compound action potential, acquiring a peak-to-peak ratio of the evoked compound action potential, and when the peak-to-peak ratio is not within a comfort range, adjusting the amplitude of a pulse to be generated within a subsequent pulse generation cycle iteratively until the peak-to-peak ratio is within the comfort range.

Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: A neural stimulation device is disclosed, including: a pulse generator, an evoked compound action potential (ECAP) sensor, and a neural stimulation controller. The neural stimulation controller instructs the ECAP sensor to sense an ECAP after a pulse is generated by the pulse generator within a first pulse generation cycle, adjust an amplitude of a pulse generated within a second pulse generation cycle in response to a peak-to-peak value of the ECAP being not in a comfort range, and adjust, according to an expected peak-to-peak value, an amplitude of a pulse generated within a third pulse generation cycle in response to a peak-to-peak value of the ECAP after the pulse is generated within the second pulse generation cycle being still not in the comfort range. The expected peak-to-peak value is in the comfort range including an amplitude dimension of the pulse and a peak-to-peak value dimension of the ECAP.

Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: Embodiments described herein relate to implantable medical devices (IMDs) and methods for use therewith. Such a method includes using an accelerometer of an IMD (e.g., a leadless pacemaker) to produce one or more accelerometer outputs indicative of the orientation of the IMD. The method can also include the IMD using an accelerometer to identify when the orientation of the IMD is such that the IMD will likely be able to successfully communicate with another IMD via one or more communication pulses sent from the IMD to the other IMD. The method also includes the IMD sending of the one or more communication pulses, that are used to communicate with the other IMD, when the orientation of the IMD is such that the IMD will likely be able to successfully communicate with the other IMD via one or more communication pulses sent from the IMD to the other IMD.

Abstract: The present disclosure provides systems and methods for applying anti-tachycardia pacing (ATP) using subcutaneous implantable cardioverter-defibrillators (SICDs). An SICD implantable in a subject includes a case including a controller, and at least one conductive lead extending from the case. The at least one conductive lead includes a plurality of coil electrodes, wherein the SICD is configured, via the controller, to apply anti-tachycardia pacing (ATP) to the subject using the at least one conductive lead.

Abstract: Described herein are methods for use with an implantable system including at least an atrial leadless pacemaker (aLP). Also described herein are specific implementations of an aLP, as well as implantable systems including an aLP. In certain embodiments, the aLP senses a signal from which cardiac activity associated with a ventricular chamber can be detected by the aLP itself based on feature(s) of the sensed signal. The aLP monitors the sensed signal for an intrinsic or paced ventricular activation within a ventricular event monitor window. In response to the aLP detecting an intrinsic or paced ventricular activation itself from the sensed signal within the ventricular event monitor window, the aLP resets an atrial escape interval timer that is used by the aLP to time delivery of an atrial pacing pulse if an intrinsic atrial activation is not detected within an atrial escape interval.

Abstract: A neural stimulation device is provided, including: a neural stimulation controller, a pulse generator, and an evoked compound action potential (ECAP) sensor. The neural stimulation controller is configured to: instruct the ECAP sensor to turn on while instructing the pulse generator to generate the pulse, instruct the ECAP sensor to sense the evoked compound action potential after instructing the pulse generator to generate the stimulation pulse and elapsing of a sensing delay time, and instruct the ECAP sensor to turn off after instructing the ECAP sensor to sense the evoked compound action potential and elapsing of an ECAP window time. The sensing delay time is the greater of a total duration of the pulse and a predetermined time.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: Implantable medical devices (IMDs), systems, and methods for use therewith are disclosed. One such method is for use by a leadless pacemaker (LP) configured to perform conductive communication with another implantable medical device (IMD). The method includes the LP storing information that specifies when, within a cardiac cycle, the LP and the other IMD implanted in a patient are likely oriented relative to one another such that conductive communication therebetween should be successful. The method also includes the LP sensing a signal indicative of cardiac activity of the patient over a plurality of cardiac cycles, and outputting one or more conductive communication pulses, during a portion of at least one of the cardiac cycles, wherein the portion of the at least one of the cardiac cycles is identified based on the signal that is sensed and the information that is stored.

Abstract: The present disclosure provides systems and methods for applying anti-tachycardia pacing (ATP) using subcutaneous implantable cardioverter-defibrillators (SICDs). An SICD implantable in a subject includes a case including a controller, and at least one conductive lead extending from the case. The at least one conductive lead includes a plurality of coil electrodes, wherein the SICD is configured, via the controller, to apply anti-tachycardia pacing (ATP) to the subject using the at least one conductive lead.

Abstract: Described herein are methods for use with an implantable system including at least an atrial leadless pacemaker (aLP). Also described herein are specific implementations of an aLP, as well as implantable systems including an aLP. In certain embodiments, the aLP senses a signal from which cardiac activity associated with a ventricular chamber can be detected by the aLP itself based on feature(s) of the sensed signal. The aLP monitors the sensed signal for an intrinsic or paced ventricular activation within a ventricular event monitor window. In response to the aLP detecting an intrinsic or paced ventricular activation itself from the sensed signal within the ventricular event monitor window, the aLP resets an atrial escape interval timer that is used by the aLP to time delivery of an atrial pacing pulse if an intrinsic atrial activation is not detected within an atrial escape interval.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: System and methods are provided herein and include a HIS electrode configured to be located proximate to a HIS bundle and to at least partially define a HIS sensing vector. They system includes memory to store program instructions and cardiac activity (CA) signals for a series of beats utilizing a candidate sensing configuration. The candidate sensing configuration is defined by i) the HIS sensing vector and ii) a sensing channel that utilizes sensing circuitry configured to operate based on one or more sensing settings to detect near field and far field activity. The system includes one or more processors that, when executing the program instructions, are configured to analyze the CA signals to obtain an atrial (A) feature of interest (FOI) and a ventricular (V) FOI for the corresponding beats within the series of beats and identify a V-A FOI relation between the A FOIs and the V FOIs across the series of beats.

Abstract: A system and method for modeling patient-specific spinal cord stimulation (SCS) is disclosed. The system and method acquire impedance and evoked compound action potential (ECAP) signals from a lead positioned proximate to a spinal cord (SC). The lead includes at least one electrode. The system and method determine a patient-specific anatomical model based on the impedance and ECAP signals, and transform a dorsal column (DC) map template based on a DC boundary of the patient-specific anatomical model. Further, the system and method map the transformed DC map template to the patient-specific anatomical model. The system and method may also include the algorithms to solve extracellular and intracellular domain electrical fields and propagation along neurons. The system and method may also include the user interfaces to collect patient responses and compare with the patient-specific anatomical model as well as using the patient-specific anatomical model for guiding SCS programming.

Abstract: System and methods are provided herein and include a HIS electrode configured to be located proximate to a HIS bundle and to at least partially define a HIS sensing vector. They system includes memory to store program instructions and cardiac activity (CA) signals for a series of beats utilizing a candidate sensing configuration. The candidate sensing configuration is defined by i) the HIS sensing vector and ii) a sensing channel that utilizes sensing circuitry configured to operate based on one or more sensing settings to detect near field and far field activity. The system includes one or more processors that, when executing the program instructions, are configured to analyze the CA signals to obtain an atrial (A) feature of interest (FOI) and a ventricular (V) FOI for the corresponding beats within the series of beats and identify a V-A FOI relation between the A FOIs and the V FOIs across the series of beats.