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: 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: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.

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: Described herein are methods, devices, and systems that monitor heart rate and/or for arrhythmic episodes based on sensed intervals that can include true R-R intervals as well as over-sensed R-R intervals. True R-R intervals are initially identified from an ordered list of the sensed intervals by comparing individual sensed intervals to a sum of an immediately preceding two intervals, and/or an immediately following two intervals. True R-R intervals are also identified by comparing sensed intervals to a mean or median of durations of sensed intervals already identified as true R-R intervals. Individual intervals in a remaining ordered list of sensed intervals (from which true R-R intervals have been removed) are classified as either a short interval or a long interval, and over-sensed R-R intervals are identified based on the results thereof. Such embodiments can be used, e.g., to reduce the reporting of and/or inappropriate responses to false positive tachycardia detections.

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: 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: Methods and devices herein are provided for managing atrial (A) pacing in connection with premature atrial contracts (PAC). The methods and devices obtain an atrial pace-on-PAC (APAC) interval and cardiac activity (CA) signals. The methods and devices are configured to: i) during a first cardiac beat; following a ventricular paced (VP) or ventricular sensed (VS) event, activate a timer for a post ventricular-atrial refractory period (PVARP) interval; and determine whether a first atrial refractory (AR) event occurs during the PVARP interval; ii) during a second cardiac beat; in response to the detecting that the first AR event occurred, initiate an APAC interval; during the APAC interval for the second cardiac beat, determine whether a second AR event occurs; and update a count of APAC events when the second AR event occurs; and iii) repeat i) and ii) for multiple cardiac beats, to track the count of APAC events.

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 biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

Abstract: A capacitor is fabricated by generating a sheet of material that has a first active region that includes tunnels extending into an electrode metal. The sheet of material has a first inactive region that includes the electrode metal but does not include the tunnels extending into the electrode metal. The first inactive region has a first shape that includes multiple first projections that each projects from a perimeter of a circle. An electrode is removed from the sheet of material such that the electrode includes a portion of the inactive region. Additionally or alternately, fabricating a capacitor include using a first etching solution to etch a first sheet of material so as to generate a spent etchant. At least one chemical component is recovered from the spent etchant. A second etching solution is used to etch a second sheet of material. The second etchant includes at least one of the chemical components that was recovered from the spent etchant.

Abstract: Disclosed herein is an implantable electronic device for use with an implantable medical lead. The implantable electronic device includes a housing and a header connector assembly coupled to the housing and adapted to receive the proximal lead end of the implantable medical lead. The header connector assembly includes a connector assembly including a connector, a feedthrough extending through the housing, and a conductor coupling the feedthrough to the connector. The conductor includes a first conductor segment and a second conductor segment offset from the first conductor segment and each of the first conductor segment and the second conductor segment are resistance welded to the connector.

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: Described herein are methods, devices and system for determining whether an R-wave detection should be classified as a false R-wave detection due to T-wave oversensing (TWO) or P-wave oversensing (PWO). One such method includes comparing a specific morphological characteristic (e.g., peak amplitude) associated with the R-wave detection to the specific morphological characteristic associated with each R-wave detection in a first set of earlier detected R-wave detections to thereby determine whether first TWO or PWO morphological criteria are met, and in a second set of earlier detected R-wave detections to thereby determine whether second TWO or PWO morphological criteria are met, wherein the second set differs from the first set but may have some overlap with the first set. The method also includes determining whether to classify the R-wave detection as a false R-wave detection, based on whether one of the first or second TWO or PWO morphological criteria are met.

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: An implantable pulse generator including a header, a can, and a filtered feedthrough assembly. The header including lead connector blocks. The can coupled to the header and including a wall and an electronic substrate housed within the wall. The filtered feedthrough assembly including a flange mounted to the can and having a feedthrough port, a plurality of feedthrough wires extending through the feedthrough port, and an insulator brazed to the feedthrough port of the flange. The filtered feedthrough assembly further including a capacitor having the plurality of feedthrough wires extending there through, an insulating washer positioned between and abutting the insulator and the capacitor at least in the area of the braze joint such that the capacitor and the braze joint are non-conductive, and an electrically conductive material adhered to the capacitor and the flange for grounding of the capacitor.

Abstract: A computer implemented method and system for detecting premature ventricular contractions (PVCs) are provided. The method is under control of one or more processors configured with specific executable instructions. The method obtains a cycle length (CL) distribution metric that plots a series of cardiac beats into one of a set of transition types based on R-R interval (RRI) difference pairs associated with the cardiac beats. The CL distribution metric plots the cardiac beats based on a comparison between combinations of the RRI difference pairs for corresponding combinations of the cardiac beats. The method calculates a distribution characteristic for the cardiac beats, from the series of cardiac beats that exhibit a first transition type from the set of transition types and calculates a discrimination score based on the distribution characteristic of the cardiac beats across the CL distribution metric.

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 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.