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: Implantable medical devices (IMDs) described herein, and methods for use therewith described herein, reduce how often an IMD accepts a false message and/or reduce adverse effects of an IMD accepting a false message. Such IMDs can be leadless pacemakers (LPs), or implantable cardio defibrillators (ICDs), but are not limited thereto. Such embodiments can be used help multiple IMDs (e.g., multiple LPs) implanted within a same patient maintain synchronous operation, such as synchronous multi-chamber pacing.

Abstract: Systems for monitoring left atrial pressure using implantable cardiac monitoring devices and, more specifically, to a left atrial pressure sensor implanted through a septal wall are presented herein.

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: Systems and methods for managing bi-directional communication between an external device (ED) and an implantable medical device (IMD) are provided. The method comprises receiving an active ED configuration and a request for communications parameters to be used with the active ED configuration. The method further comprises identifying a pre-existing configuration, from a collection of pre-existing configurations that match the active ED configuration, the collection of pre-existing configurations having an associated collection of predefined parameter sets. The method further determines a resultant parameter set from the collection of predefined parameter sets based on the pre-existing configuration identified and returns the resultant parameter set in connection with the request, the resultant parameter set to be utilized by the ED for bi-directional communication with the IMD.

Abstract: Methods and systems are provided for detecting arrhythmias in cardiac activity. The methods and systems declare a current beat, from the CA signals, to be a candidate beat or an ineligible beat based on whether the current beat satisfies the rate based selection criteria. The determining and declaring operations are repeated for multiple beats to form an ensemble of candidate beats. The method and system calculate a P-wave segment ensemble from the ensemble of candidate beats, perform a morphology-based comparison between the P-wave segment ensemble and at least one of a monophasic or biphasic template, declare a valid P-wave to be present within the CA signals based on the morphology-based comparison, and utilize the valid P-wave in an arrhythmia detection process to determine at least one of an arrhythmia entry, arrhythmia presence or arrhythmia exit.

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: 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 SOL. 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: In at least one embodiment, a system and method for implanting an implantable medical device (IMD) within a patient may include an IMD including a housing and an attachment member, and a delivery catheter including a tethering snare that is configured to be selectively extended out of the delivery catheter and retracted into the delivery catheter. In at least one embodiment, a system and method for implanting an implantable medical device (IMD) within a patient may include an IMD including a housing and an attachment member, wherein the attachment member includes a central passage connected to a connection chamber, and a delivery catheter including first and second tethers that may be moved outwardly from and retracted into the delivery catheter.

Abstract: Fabricating an electrode for capacitor includes performing a first set of one or more preliminary oxide formation operations on a sheet of material. The method also includes performing a capacitance test on the sheet of material so as to determine the capacitance of the sheet of material after the one or more preliminary oxide formation operations. The method proceeds on a first path in response to a first result of the capacitance test and on a second path in response to a second result of the capacitance test. The first path includes performing a second set of the one or more preliminary oxide formation operations on the sheet of material so as to reduce the capacitance of the sheet of material below the determined capacitance. The second path excludes performing any preliminary oxide formation operations on the sheet of material.

Abstract: A catheter system for retrieving a leadless cardiac pacemaker from a patient is provided. The cardiac pacemaker can include a docking or retrieval feature configured to be grasped by the catheter system. In some embodiments, the retrieval catheter can include a snare configured to engage the retrieval feature of the pacemaker. The retrieval catheter can include a torque shaft selectively connectable to a docking cap and be configured to apply rotational torque to a pacemaker to be retrieved. Methods of delivering the leadless cardiac pacemaker with the delivery system are also provided.

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 delivery catheter for implanting a leadless biostimulator. The delivery catheter includes a shaft and a tubular body having a lumen and an atraumatic end. The atraumatic end includes at least one of a braided, woven or mesh construction configured to facilitate the atraumatic end changing diameter. When a distal portion of the shaft is coupled to a proximal region of the leadless biostimulator, at least one of distally displacing the tubular body relative to the shaft or proximally displacing the shaft relative to the tubular body causes the leadless biostimulator to be received in the volume of the atraumatic end and the atraumatic end to encompass the leadless biostimulator. Conversely, at least one of proximally displacing the tubular body relative to the shaft or distally displacing the shaft relative to the tubular body causes the leadless biostimulator to exit the volume of the atraumatic end.

Abstract: An implantable medical device including a can, a feedthrough and an antenna assembly. The can includes a lead connector assembly, electronics, and a metal wall defining a hermetic sealed compartment. The electronics and lead connector assembly are located in the hermetic sealed compartment. The feedthrough extends through the metal wall between the hermetic sealed compartment and exterior the metal wall. The antenna assembly includes an antenna extending along the metal wall in a spaced-apart manner from the metal wall and encased in a dielectric material. The dielectric material occupies a space between the antenna and the metal wall. The antenna is electrically connected to the electronics via an RF conductor of the feedthrough.

Abstract: A method, system and external instrument are provided. The method initiates a communication link between an external instrument (EI) and an implantable medical device (IMD), established a first connection interval for conveying data packets between the EI and IMD and monitors a connection criteria that includes at least one of a data throughput requirement. A battery indicator or link condition of the communications link is between the IMD and EI. The method further changes from the first connection interval to a second connection interval based on the connection criteria.

Abstract: A medical device and method are provided. The medical device includes a battery, a charge bank configured to store supplemental energy, memory to store program instructions, and device operational circuitry. The device operational circuitry identifies an energy demand (ED) action to be performed by the device operational circuitry in connection with at least one of monitoring a medical characteristic of interest (COI), treating the medical COI, or wirelessly communicating with a separate device. The device operational circuitry obtains an energy consumption estimate for an amount of energy to be consumed by the device operational circuitry in connection with performing the ED action and dispatches a charge instruction to charge the charge bank from the battery with supplemental energy. The device operational circuitry supplies the supplemental energy to the device operational circuitry for performing the ED action in connection with the at least one of monitoring, treating or communicating operations.

Abstract: Disclosed herein is an implantable electronic device. The device includes a housing and a header connector assembly coupled to the housing. The header connector assembly includes a DF4/IS4 assembly and a header including a bore. The DF4/IS4 assembly is locked within the bore via a locking datum arrangement that exists between the DF4/IS4 assembly and the header.

Abstract: Described herein are methods, devices, and systems for improving R-wave detection sensitivity and positive predictive value, and for improving arrhythmia detection accuracy. Certain embodiments involve determining whether to classify a potential R-wave as a false R-wave (or more specifically, an over-sensed P-wave) by determining a measure of magnitude of a first portion of the signal corresponding to a first window following the potential R-wave, determining the measure of magnitude of a second portion of the signal corresponding to a second window following the first window, and classifying the potential R-wave as a false R-wave if the measure of magnitude of the second portion of the signal is at least a specified extent larger (e.g., at least 3 times larger) than the measure of magnitude of the first portion of the signal. Certain embodiments also involve adjusting an R-wave marker for a potential R-wave that is classified as a false R-wave.

Abstract: Embodiments described herein relate to implantable medical devices (IMDs) and methods for use therewith. Such a method includes, during each of a plurality of message alert periods during which a communication capability of the IMD is enabled, determining whether a valid message is detected. In response to determining that no valid message was detected during a message alert period, the communication capability of the IMD is temporarily disable for a disable period. A length of the disable period may be increased in response to no valid message being detected during two consecutive message alert periods. A length of the disable period may be dependent on an operational mode of the IMD, such that the length of the disable period differs for different operational modes. The IMD may also enter a noise state, and remain in the noise state until the IMD receives a specified number of valid messages.

Abstract: Described herein are methods, devices, and systems that improve arrhythmia episode detection specificity, such as, but not limited to, atrial fibrillation (AF) episode detection specificity. Such a method can include obtaining an ordered list of R-R intervals within a window leading up to a detection of a potential arrhythmia episode, determining a measure of a dominant repeated R-R interval pattern within the window, and comparing the measure of the dominant repeated R-R interval pattern to a pattern threshold. If the measure of the dominant repeated R-R interval pattern is below the pattern threshold, that is indicative of a regularly irregular pattern being present, and there is a determination that the detection of the potential arrhythmia episode does not correspond to an actual arrhythmia episode. Such embodiments can beneficially be used to significantly reduce the number of false positive arrhythmia detections.