Abstract: Computer implemented methods and systems for detecting noise in cardiac activity are provided. The method and system obtain a far field cardiac activity (CA) data set that includes far field CA signals for a series of beats, overlay a segment of the CA signals with a noise search window, and identify turns in the segment of the CA signals. The method and system determine whether the turns exhibit a turn characteristic that exceed a turn characteristic threshold, declare the segment of the CA signals as a noise segment based on the determining operation, shift the noise search window to a next segment of the CA signal and repeat the identifying, determining and declaring operations; and modify the CA signals based on the declaring the noise segments.

Abstract: Computer implemented methods and systems are provided that comprise, under control of one or more processors of a medical device, where the one or more processors are configured with specific executable instructions. The methods and systems obtain motion data indicative of at least one of a posture or a respiration cycle; obtain cardiac activity (CA) signals for a series of beats; identify whether a characteristic of interest (COI) from at least a first segment of the CA signals exceeds a COI limit; analyze the motion data to determine whether at least one of the posture or respiration cycle at least in part caused the COI to exceed the COI limit. Based on the analyzing operation, the methods and systems automatically adjust a CA sensing parameter utilized by the medical device to detect R-waves in subsequent CA signals; and detect an arrhythmia based on a presence or absence of one or more of the R-waves in at least a second segment of the CA signals.

Abstract: A computer implemented method for determining heart arrhythmias based on cardiac activity that includes under control of one or more processors of an implantable medical device (IMD) configured with specific executable instructions to obtain far field cardiac activity (CA) signals at electrodes located remote from the heart, and obtain acceleration signatures, at an accelerometer of the IMD, indicative of heart sounds generated during the cardiac beats. The IMD is also configured with specific executable instructions to declare a candidate arrhythmia based on a characteristic of at least one R-R interval from the cardiac beats, and evaluate the acceleration signatures for ventricular events (VEs) to re-assess a presence or absence of at least one R-wave from the cardiac beats and based thereon confirming or denying the candidate arrhythmia.

Abstract: A computer implemented method and system 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 far field cardiac activity (CA) signals and applies a direction related responsiveness (DRR) filter to the CA signals to produce DRR filtered signals. The method compares a current sample from the CA signals to a prior sample from the DRR filtered signals to identify a direction characteristic of the CA signals and defines the DRR filter based on a timing constant that is set based on the direction characteristic identified. The method analyzes the CA signals in connection with the DRR filtered signals to identify a peak characteristic of the CA signals and determines peak to peak intervals between successive peak characteristic. The method detects at least one of noise or an arrhythmia based on the peak to peak intervals and records results of the detecting.

Abstract: A computer implemented method and system are provided for detecting premature ventricular contractions (PVCs) in cardiac activity. The method and system obtain cardiac activity (CA) signals for a series of beats, and, for at least a portion of the series of beats, calculate QRS scores for corresponding QRS complex segments from the CA signals. The method and system calculate a variability metric for QRS scores across the series of beats, calculate a QRS complex template using QRS segments from the series of beats, calculate correlation coefficients between the QRS complex template and the QRS complex segments, compare the variability metric to a variability threshold and the correlation coefficients to a correlation threshold, and designate the CA signals to include a predetermined level of PVC burden based on the determining.

Abstract: For use by an implantable system including a first and second leadless pacemakers (LPs) implanted, respectively, in first and second cardiac chambers, a method comprises storing, within memory of the first LP, a paced activation morphology template corresponding to far-field signal components expected to be present in an EGM sensed by the first LP when a pacing pulse delivered to the second cardiac chamber by the second LP captures the second cardiac chamber. The method also includes the first LP comparing a morphology of a portion of an EGM sensed by the first LP to the paced activation morphology template to determine whether a match therebetween is detected, and determining whether capture of the second cardiac chamber occurred or failed to occur, based on whether the first LP detects a match between the morphology of the portion of the EGM and the paced activation morphology template.

Abstract: Systems and methods for implanting a lead. The system includes an active guidewire having proximal and distal ends. The distal end includes a guidewire anchor that is configured to be attached to a target SOI. The active guidewire is configured to be utilized to electrically map the target SOI by at least one of delivering stimulation energy through the active guide wire to the target SOI or sensing an evoked response at the target SOI from the guidewire. The system also includes a lead having a lead body with proximal and distal ends and with a lumen extending between the proximal and distal ends. The distal end of the lead body is configured to receive the proximal end of the active guidewire. The lumen is configured to permit the lead body to be advanced over the active guidewire.

Abstract: Systems and methods are provided for implanting a medical device. An implantable lead comprises a lead body, with electrodes positioned at the distal end and a lead connector positioned at the proximal end. The lead body has a body outer envelope configured to fit within a lumen of an introducer sheath and the lead connector has a connector outer envelope configured to fit within the lumen of the introducer sheath. A lead adaptor is configured to interconnect the implantable lead and the pulse generator. The lead adaptor has an insertable connector that includes mating contacts and an adaptor cavity that includes cavity contacts. The cavity contacts are positioned to engage the lead contacts of the lead connector when the lead connector is inserted into the adaptor cavity. The insertable connector is configured to be inserted into the connector cavity of the pulse generator.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: Systems, devices, and methods for monitoring for atrial capture are disclosed. Such a method, for use within an implantable system including an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP), includes storing within a memory of the vLP a paced atrial activation morphology template corresponding to far-field atrial signal components expected to be present in a vEGM sensed by the vLP when an atrial pacing pulse delivered by the aLP captures atrial tissue. The vLP senses a vEGM and compares a morphology of a portion of the sensed vEGM to the paced atrial activation morphology template to determine whether a match therebetween is detected. Additionally, the vLP determines whether atrial capture occurred or failed to occur (responsive to an atrial pacing pulse), based on whether the vLP detects a match between the morphology of a portion of the sensed vEGM and the paced atrial activation morphology template.

Abstract: A computer implemented method and system for confirming a device documented arrhythmia in cardiac activity are provided. The method is under control of one or more processors configured with executable instructions. The method obtains a cardiac activity (CA) data set that includes CA signals for a series of cardiac events and includes device documented (DD) markers within the series of cardiac events. The device documented markers are indicative of atrial fibrillation (AF) detected by the ICM utilizing an on-board R-R interval irregularity (ORI) process to analyze the CA signals. The method applies a feature enhancement function to the CA signals to form modified CA signals with enhanced sinus features and analyzes the enhanced sinus features in the modified CA signals. The method utilized a confirmatory feature detection process to identify false AF detection by the ORI process. The method records a result of the analysis identifying false AF detection by the ORI process.

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: An implantable lead includes a lead body, electrical conductors, and a lead anchor. The lead body includes an electrode segment configured to be positioned along a pericardial membrane of a heart and including a plurality of electrodes configured to at least one of sense electrical signals from the heart or deliver therapy to the heart. The electrical conductors extend through the lead body between distal and proximal ends of the lead body, and are configured to electrically couple the electrodes to a pulse generator. The lead anchor is configured to be secured to a chest wall. The electrical conductors extend through the lead anchor, and the electrode segment extends from the lead anchor to the pericardial membrane. The electrode segment includes a transition portion that is configured to extend a depth into a mediastinum and a contoured portion to extend alongside and curve about the pericardial membrane.

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 to detect P-waves in cardiac activity is provided. The system includes memory to store specific executable instructions. One or more processors are configured to execute the specific executable instructions for obtaining far field cardiac activity (CA) signals for a series of beats, applying a P-wave template to at least one sub-segment of the CA signals to obtain an alignment indicator and calculating an amplitude dependence (AD) indicator based at least in part on the P-wave template and the at least one sub-segment. The system analyzes the alignment indicator based on a first criteria, compares the AD indicator with a second criteria, designates a candidate P-wave to be an actual P-wave based on the analyzing and comparing and records results of the designating.

Abstract: Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.

Abstract: Systems and methods for implanting a lead. The system includes an active guidewire having proximal and distal ends. The distal end includes a guidewire anchor that is configured to be attached to a target SOI. The active guidewire is configured to be utilized to electrically map the target SOI by at least one of delivering stimulation energy through the active guide wire to the target SOI or sensing an evoked response at the target SOI from the guidewire. The system also includes a lead having a lead body with proximal and distal ends and with a lumen extending between the proximal and distal ends. The distal end of the lead body is configured to receive the proximal end of the active guidewire. The lumen is configured to permit the lead body to be advanced over the active guidewire.

Abstract: Methods, devices and program products are provided for determining an early battery depletion condition for a battery powered device. The method determines a charge consumption drawn externally from a battery cell by the device for a select period of time, obtains a measured cell voltage for the battery cell of the medical device, calculates a projected cell voltage based on the charge consumption and usage conditions, and declares an early depletion condition based on a relation between the measured and projected cell voltages.

Abstract: A computer implemented method and device for providing dual chamber sensing with a single chamber leadless implantable medical device (LIMD) are provided. The method is under control of one or more processors in the LIMD configured with specific executable instructions. The method obtains a far field (FF) cardiac activity (CA) signals for activity in a remote chamber of a heart and compares the far field CA signals to a P-wave template to identify an event of interest associated with the remote chamber. The method sets an atrial-ventricular (AV) delay based on the P-wave identified and delivers pacing pulses at a pacing site of interest to a local chamber based on the AV delay.

Abstract: Systems and methods for implanting a medical device are provided and include an implantable lead comprising a lead body having a distal end and a proximal end. The implantable lead has electrodes positioned at the distal end and has a lead connector positioned at the proximal end. The lead connector includes lead contacts that are communicatively coupled to the electrodes positioned at the distal end. The lead body has a body outer envelope configured to fit within a lumen of an introducer sheath and the lead connector has a connector outer envelope configured to fit within the lumen of the introducer sheath. A pulse generator has a connector cavity. The lead adaptor is configured to interconnect the implantable lead and the pulse generator. The lead adaptor has an insertable connector that includes mating contacts and an adaptor cavity that includes cavity contacts.