Abstract: Embodiments of the present technology described herein are directed to implantable systems for performing cardiac resynchronization therapy (CRT), methods for use therewith, and leadless pacemakers for use therewith. Such a system can include a first leadless pacemaker configured to be implanted in or on the right atrial (RA) chamber and selectively pace the RA chamber, a second leadless pacemaker configured to be implanted in or on the right ventricular (RV) chamber and selectively pace the RV chamber, and a third leadless pacemaker configured to be implanted in or on the left ventricular (LV) chamber and selectively pace the LV chamber, wherein one of the leadless pacemaker is designated a master leadless pacemaker. In certain embodiments, the master leadless pacemaker determines a VV delay and an AV delay and coordinates CRT using such delays.

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 controlling communication pulse parameter(s) of one or more communication pulses (produced by pulse generator(s)) based on accelerometer output(s) indicative of the orientation of the IMD. The communication pulse parameter(s) that is/are controlled can be, e.g., communication pulse amplitude, communication pulse width, communication pulse timing, and/or communication pulse morphology. Such embodiments can be used to improve conductive communications between IMDs whose orientation relative to one another may change over time, e.g., due to changes in posture and/or due to cardiac motion over a cardiac cycle.

Abstract: A system and method for controlling non-paresthesia stimulation of neural tissue of a patient. The method delivers a non-paresthesia stimulation waveform, senses sensory action potential (SAP) signals from the neural tissue of interest and analyzes the SAP signals to obtain SAP activity data for at least one of an SAP C-fiber component or an SAP A-delta fiber component. The method determines whether the SAP activity data satisfies a criteria of interest and adjusts at least one of the therapy parameters to change the non-paresthesia stimulation waveform when the SAP activity data does not satisfy the criteria of interest.

Abstract: Computer implemented methods, systems and devices are provided to monitor for potential heart failure (HF). Cardiac activity (CA) data is obtained and filtered to obtain respiration data indicative of a respiration pattern. The respiration data is analyzed to determine one or more respiration characteristics of interest (COI) that are recorded along with collection time information to form an HF monitoring log. Additionally or alternatively, the CA data is analyzed to detect an event of interest. The cardiac activity data is filtered to obtain respiration data indicative of a respiration pattern, and the respiration data is analyzed for respiration induced under detection of the event of interest from the CA data.

Abstract: An implantable system includes a first leadless pacemaker (LP1) implanted in or on a first chamber of a heart and a second leadless pacemaker (LP2) implanted in or on a second chamber of the heart. The LP1 is configured to time delivery of one or more pacing pulses delivered to the first chamber of the heart based on timing of cardiac activity associated with the second chamber of the heart detected by the LP1 itself. The LP1 is also configured to transmit implant-to-implant (i2i) messages to the LP2. The LP2 is configured to time delivery of one or more pacing pulses delivered to the second chamber of the heart based on timing of cardiac activity associated with the second chamber of the heart as determined based on one or more i2i messages received by the LP2 from the LP1.

Abstract: Methods and devices include making an incision at a single site of a patient. The single site located at an anterior of a chest or abdomen. The method also includes inserting a tunneling tool through the incision at the single site and preparing a first tunnel to a subcutaneous posterior location. A path of the first tunnel at least one of i) extends over a plurality of Intercostal gaps of the chest or ii) extends along and within one of the intercostal gaps. The method also includes positioning a first lead having an electrode within the first tunnel and preparing a second tunnel to a subcutaneous parasternal location along the chest. The method also includes positioning a second lead having an electrode within the second tunnel and positioning a pulse generator within a subcutaneous pocket and operatively coupling the first and second leads to the pulse generator.

Abstract: Computer implemented methods and systems for detecting arrhythmias in cardiac activity are provided. The method is under control of one or more processors configured with specific executable instructions. The method obtains a far field cardiac activity (CA) data set that includes far field CA signals for beats. The method applies a feature enhancement function to the CA signals to form an enhanced feature in the CA data set. The method calculates an adaptive sensitivity level and sensitivity limit based on the enhanced feature from one or more beats within the CA data set and automatically iteratively analyzes a beat segment of interest by comparing the beat segment of interest to the current sensitivity level to determine whether one or more R-waves are present within the beat segment of interest.

Abstract: Computer implemented methods, systems and devices are provided to monitor for potential heart failure (HF). Cardiac activity (CA) data is obtained and filtered to obtain respiration data indicative of a respiration pattern. The respiration data is analyzed to determine one or more respiration characteristics of interest (COI) that are recorded along with collection time information to form an HF monitoring log. Additionally or alternatively, the CA data is analyzed to detect an event of interest. The cardiac activity data is filtered to obtain respiration data indicative of a respiration pattern, and the respiration data is analyzed for respiration induced under detection of the event of interest from the CA data.

Abstract: Methods and systems are provided herein for pacing a HIS bundle of a patient heart using an implantable medical device (IMD). The methods and systems obtain cardiac activity (CA) signals over a HIS sensing channel, the HIS sensing channel utilizing a HIS electrode; identify at least one of a P-wave duration (PWD), an intrinsic atrial-HIS (AH) delay, or an intrinsic atrial conduction delay (IACD); calculate an atrial oversensing avoidance (AOA) window based on at least one of the PWD, AH delay or IACD; analyze the CA signals, obtained over the HIS sensing channel during the AOA window, for an atrial activity (AA) component; based on the analyzing operation, adjust a ventricular event (VE) sensitivity profile utilized by the HIS sensing channel; monitor the CA signals, obtained over the HIS sensing channel during an alert window based on the VE sensitivity profile, for a ventricular component indicative of a ventricular event; and manage HIS bundle pacing based on the ventricular event.

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: Methods and systems for dynamically modifying pacing timing and backup pacing delivery in cardiac stimulation devices include applying pacing impulses, measuring corresponding responses, and, based on such responses, automatically modifying timing or operational settings of the stimulation device to improve pacing functionality. Among other things, the approaches described herein reduce unnecessary backup pacing impulses in HIS bundle pacing applications, facilitate fusion in bundle branch block applications, and automatically enable or disable backup pacing in response to achieving QRS complex correction.

Abstract: A computer implemented method and system is provided for managing neural stimulation therapy. The method comprises under control of one or more processors configured with program instructions. The method delivers a series of candidate stimulation waveforms having varied stimulation intensities to at least one electrode located proximate to nervous tissue of interest. A parameter defines the candidate stimulation waveforms is changed to vary the stimulation intensity. The method identifies a first candidate stimulation waveform that induces a paresthesia-abatement effect, while continuing to induce a select analgesic effect. The method further identifies a second candidate stimulation waveform that does not induce the select analgesic effect. The method sets a stimulation therapy based on the first and second candidate stimulation waveforms.

Abstract: A computer implemented method and system is provided for managing neural stimulation therapy. The method comprises under control of one or more processors configured with program instructions. The method delivers a series of candidate stimulation waveforms having varied stimulation intensities to at least one electrode located proximate to nervous tissue of interest. A parameter defines the candidate stimulation waveforms is changed to vary the stimulation intensity. The method identifies a first candidate stimulation waveform that induces a paresthesia-abatement effect, while continuing to induce a select analgesic effect. The method further identifies a second candidate stimulation waveform that does not induce the select analgesic effect. The method sets a stimulation therapy based on the first and second candidate stimulation waveforms.

Abstract: Embodiments of the present technology described herein are directed to implantable systems for performing cardiac resynchronization therapy (CRT), methods for use therewith, and leadless pacemakers for use therewith. Such a system can include a first leadless pacemaker configured to be implanted in or on the right atrial (RA) chamber and selectively pace the RA chamber, a second leadless pacemaker configured to be implanted in or on the right ventricular (RV) chamber and selectively pace the RV chamber, and a third leadless pacemaker configured to be implanted in or on the left ventricular (LV) chamber and selectively pace the LV chamber, wherein one of the leadless pacemaker is designated a master leadless pacemaker. In certain embodiments, the master leadless pacemaker determines a VV delay and an AV delay and coordinates CRT using such delays.

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: 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 curate 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: Systems and methods for His bundle pacing and classifying response to pacing impulses include applying, using a pulse generator, an impulse through a stimulating electrode to induce a response from a patient heart. A response to the impulse is measured using at least one sensing electrode and time-domain based characteristics of the response are analyzed to determine whether His bundle capture has occurred and, if so, what type of capture has occurred.

Abstract: Systems and methods for His bundle pacing and classifying response to pacing impulses include applying, using a pulse generator, an impulse through a stimulating electrode to induce a response from a patient heart. A response to the impulse is measured using at least one sensing electrode and frequency characteristics of the response are analyzed to determine whether His bundle capture has occurred and, if so, what type of capture has occurred. To facilitate analysis, the response measured from the patient heart may also be filtered to pass or stop frequencies indicative of certain capture types.

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: A method and system for managing an implantable medical device (IMD) based on left ventricular hypertrophy (LVH) are provided. The method collects cardiac activity (CA) signals from one or more implantable electrodes at corresponding sensing sites. The method utilizes one or more processors to perform identifying a characteristic of interest from the CA signals, analyzing the characteristic of interest from the CA signals to identify an LVH state indicative of at least one of an occurrence or degree of LVH experienced by the patient, calculating a DFT expectation based on the LVH state and determining, based on the DFT expectation, at least one of i) a defibrillation shock parameter or ii) a maximum energy capacity of the IMD for implant.