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 biostimulator, such as a leadless cardiac pacemaker, having a patch antenna integrated into a housing, is described. The housing includes an annular wall that contains electronic circuitry of the biostimulator and provides a ground plane of the antenna. The patch antenna includes a meandering trace embedded in a curved dielectric layer that is mounted on the annular wall. The trace provides a conductor of the antenna and the dielectric layer provides a dielectric substrate of the antenna between the conductor and the ground plane. The electronic circuitry contained within the annular wall is electrically connected to the trace via an electrical feedthrough that passes through the annular wall and the dielectric layer. The electrical feedthrough places the electronic circuitry in communication with the antenna to transmit or receive wireless communication signals from an external device. Other embodiments are also described and claimed.

Abstract: Disclosed herein are implantable medical devices and systems, and methods for used therewith, that selectively perform atrial pacing at an atrial pacing rate that is faster than an intrinsic atrial rate of a patient while the patient is experiencing an atrial tachycardia or atrial fibrillation and the intrinsic atrial rate of the patient is within the specified range, to attempt to convert the arrhythmia to a normal sinus rhythm.

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: Embodiments describe herein generally pertain to implantable medical device (IMDs), and methods for use therewith, that can be used to automatically switch an IMD from its normal operational mode to magnetic resonance imaging (MRI) safe mode, and vice versa, within increased specificity. A controller of an IMD is configured to use an accelerometer to determine whether a positional condition associated with a patient is detected, and control sampling of a magnetic field sensor or at least one signal output therefrom, such that a first sampling rate is used when the positional condition is detected, and a second sampling rate, that is slower than the first sampling rate, is used when the positional condition is not detected, to thereby conserve power. Based on results of the sampling, the controller determines whether a magnetic field condition is detected, and in response thereto performs a mode switch to an MRI safe mode.

Abstract: A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.

Abstract: A system is provided that includes one or more electrodes configured to be implanted proximate to a sensing site, and a memory configured to store first and second sets of filter parameters that define first and second noise stop bands. The system also includes an implantable medical device (IMD) that has inputs configured to receive sensed signals, the sensed signals include frequency components associated with physiology activity and frequency components associated with noise. The IMD also includes a band-stop filter communicating with the sensing channel inputs. When executing program instructions, a processor switches the band-stop filter from the first set of filter parameters to the second set of filter parameters to shift from the first noise stop band to the second noise stop band based on the noise in the environment of the patient.

Abstract: A method and device for managing establishment of a communications link between an external instrument (EI) and an implantable medical device (IMD) are provided. The method stores, in a memory in at least one of the IMD or the EI, a base scanning schedule that defines a pattern for scanning windows over a scanning state. The method enters the scanning state during which a receiver scans for advertisement notices during the scanning windows. At least a portion of the scanning windows are grouped in a first segment of the scanning state. The method stores, in the memory, a scan reset pattern for restarting the scanning state. Further, the method automatically restarts the scanning state based on the scan reset pattern to form a pseudo-scanning schedule that differs from the base scanning schedule and establishes a communication session between the IMD and the EI.

Abstract: Methods and devices for managing establishment of a communications link between an external instrument (EI) and an implantable medical device (IMD) are provided. A method performed by the EI includes scanning one or more channels for an advertisement notice transmitted by the IMD in accordance with a scanning schedule, wherein the scanning schedule defines a temporal pattern of scanning windows that are separated by one or more scanning intervals. The method also includes changing the scanning schedule, in response to a duration of the scanning the one or more channels exceeding a predetermined threshold without a valid advertisement notice being received by the EI from the IMD, and scanning the one or more channels for the advertisement notice in accordance with the scanning schedule as changed, wherein the scanning schedule as changed defines a different temporal pattern of scanning windows that are separated by one or more scanning intervals.

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, 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 dual chamber LP system includes an aLP and a vLP that collectively provide AAI+VVI operation, and selectively transition from the AAI+VVI operation to collectively providing coordinated dual chamber operation (e.g., DDD operation, but not limited thereto), and vice versa. While providing the AAI operation, the aLP performs atrial pacing when an intrinsic atrial event is not detected within a specified AA interval, performs atrial sensing, and inhibits the atrial pacing when the intrinsic atrial event is detected within the specified AA interval. While providing the VVI operation, the vLP performs ventricular pacing when an intrinsic ventricular event is not detected within a specified VV interval, performs ventricular sensing, and inhibits the ventricular pacing when the intrinsic ventricular event is detected within the specified VV interval.

Abstract: A system includes, or is for use with, an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP) configured to communicate with one another and collectively provide DDD operation when an a2v message transmitted by the aLP is successfully received by the vLP and a v2a message transmitted by the vLP is successfully received by the aLP, during a cardiac cycle. The aLP and the vLP are also configured to collectively provide VDD operation, DDI operation or VDI operation at least some times when an a2v message transmitted by the aLP is not successfully received by the vLP, and/or a v2a message transmitted by the vLP is not successfully received by the aLP. One or more processors of the system is/are configured to determine an AV synchrony metric for the period of time, and provide one or more responses based thereon. Related methods are also described.

Abstract: A system and method for determining an arrhythmia risk are provided and include memory to store specific executable instructions and a machine learning (ML) model trained to predict an arrhythmia with a characteristic of interest (COI) that exhibits a non-physiologic behavior. One or more processors are configured to execute the specific executable instructions to obtain CA signals collected by an implantable medical device (IMD), wherein the COI exhibits a physiologic behavior and apply the ML model to the CA signals to identify a risk factor that a patient will experience the arrhythmia at a future point in time even though the COI in the CA signals, exhibits a physiologic behavior.

Abstract: A system and method are provided for managing atrial-ventricular (AV) delay adjustments. An AV interval is measured that corresponds to an interval between an atrial paced (Ap) event or an atrial sensed (As) event and a sensed ventricular (Vs) event. A candidate AV delay is set based on the AV interval and a bundle branch adjustment (BBA) value. A QRS characteristic of interest (COI) is measured while utilizing the candidate AV delay in connection with delivering a pacing therapy. The BBA value is adjusted and the candidate AV delay is reset based on the BBA value as adjusted. A collection of QRS COIs and corresponding candidate AV delays are obtained and one of the candidate AV delays is selected as a BBA AV delay. The pacing therapy is managed, based on the BBA AV delay.

Abstract: Embodiments reduce burden associated with analyzing EGM segments obtained from an IMD that monitors for arrhythmic episodes. Respective EGM data and respective classification data is obtained for each arrhythmic episode detected by the IMD during a period of time. A representative R-R interval or HR for each of the arrhythmic episodes is determine by the IMD, wherein a manner for determining the representative R-R interval or HR depends on the type of the arrhythmic episode, such that for at least two different types of arrhythmic episodes the manners differ. An external system(ES) obtains data from the IMD, directly or indirectly, and selects arrhythmic episode(s) for which corresponding EGM segments are to be displayed for each type of arrhythmic episode, wherein the selecting is performed based on the representative R-R intervals or HRs determined by the IMD for the arrhythmic episodes. Additional and alternative embodiments are also described herein.

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: 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: The present disclosure provides systems and methods for optimizing pacing parameters of a cardiac pacing device implanted in a patient. The systems and methods measure a plurality of hemodynamic responses of the patient. Each hemodynamic response is associated with the cardiac pacing device configured with one candidate pacing parameter set of a plurality of candidate pacing parameter sets. Each candidate pacing parameter set is classified as electrically equivalent to a reference pacing parameter set according to a classification criterion. The systems and methods further identify an optimal hemodynamic response from the plurality of hemodynamic responses, and select a final candidate pacing parameter set corresponding to the optimal hemodynamic response.

Abstract: A valve bypass tool, and a biostimulator transport system having such a valve bypass tool, is described. The valve bypass tool includes an annular seal to seal against a protective sheath of the biostimulator transport system. The valve bypass tool is slidably mounted on the protective sheath and includes a bypass sheath to insert into an access introducer. The valve bypass tool can lock onto the access introducer by mating a locking tab of the valve bypass tool with a locking groove of the access introducer. The locking tab can have a detent that securely fastens the components to resist decoupling when the biostimulator transport system is advanced through the access introducer into a patient anatomy. Other embodiments are also described and claimed.