Abstract: Certain embodiments described herein related to methods, devices, and systems that provide improved communications between first and second IMDs remotely located relative to one another and capable of communicating using both conductive communication and RF communication. Such a method can include the first IMD using conductive communication to transmit message(s) intended for the second IMD, without using RF communication, during a first period of time that a first trigger event is not detected. The method can also include the first IMD detecting the first trigger event, and in response thereto, the first IMD using RF communication to transmit message(s) intended for the second IMD during a second period of time. Thereafter, in response to first IMD detecting a second trigger event, the first IMD uses conductive communication to transmit one or more messages intended for the second IMD, without using RF communication, during a third period of time.

Abstract: A transport system for delivery or retrieval of a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator transport system includes a docking cap supported by a bearing within a bearing housing. The bearing allows relative rotation between a torque shaft connected to the docking cap and an outer catheter connected to the bearing housing. The bearing housing and the docking cap include respective bearing retainers that constrain the bearing within the bearing housing without a weld attachment. The weldless retainers of the biostimulator transport system provide a robust mechanical securement of the bearing that is not vulnerable to corrosion. Other embodiments are also described and claimed.

Abstract: Embodiments described herein can reduce a 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 also obtained, 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. One or more arrhythmic episodes is/are selected 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 that are determined for the plurality of arrhythmic episodes. Additional and alternative embodiments are also described herein.

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: Methods for implanting a pulse generator (PG) within a pectoral region of a chest of a patient and devices having the PG. The PG has a housing that includes a PG electrode. Methods also include implanting at least one lead having first and second electrode segments with the first electrode segment positioned along an anterior of the chest of the patient and the second electrode segment positioned along at least one of a posterior of the patient or a side of the patient. The first and second electrode segments are positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy.

Abstract: An implantable medical device is disclosed herein and can be in the form of an implantable medical lead or a leadless pulse generator. The implantable medical device includes a body, at least one electrode and a tube-cut helical fixation anchor. The body includes a distal end and a proximal end opposite the distal end. The at least one electrode is supported on the body. The tube-cut helical fixation anchor distally extends from the distal end. The tube-cut helical fixation anchor may be fixed or extendable/retractable relative to the distal end. The tube-cut helical fixation anchor may be a result of a manufacturing process comprising cutting the tube-cut helical fixation anchor from a thin-walled tubular body.

Abstract: The present disclosure provides systems and methods for assembling a subassembly for use in manufacturing an implantable device header. A method includes placing a first split web into a top platen, placing a second split web into a bottom platen, placing a conductor assembly and an antenna assembly in the bottom platen on top of the second split web, compressing the top and bottom platens together, heating the top and bottom platens until a predetermined temperature and a predetermined pressure are reached, such that first split web is fused to the second split web to form the subassembly, separating the top and bottom platens, and removing the formed subassembly.

Abstract: Disclosed herein is an implantable electronic device. In one embodiment, the device has a modular header-feedthru assembly and a housing. The modular header-feedthru assembly has a conductor assembly, a feedthru coupled to the conductor assembly, and a polymer header that is injected molded about the conductor assembly and at least a portion of the feedthru. The housing is welded to the feedthru.

Abstract: A chemical etch is performed on a sheet of material. An electrochemical etch is performed on the sheet of material after the chemical etch is performed on the sheet of material. A capacitor is fabricated such that an electrode included in the capacitor includes material from the sheet of material after the electrochemical etch was performed on the sheet of material. In some instances, the chemical etch included at least partially immersing the sheet of material in an etch bath that includes molybdenum. Additionally or alternately, the chemical etch can be performed for a period of time less than 60 s.

Abstract: A capacitor and a method of processing an anode metal foil are presented. The method includes electrochemically etching the metal foil to form a plurality of tunnels. Next, the etched metal foil is disposed within a widening solution to widen the plurality of tunnels. Exposed surfaces of the etched metal foil are then oxidized. The method includes removing a section of the etched metal foil, where the section of the etched metal foil includes exposed metal along an edge. The section of the etched metal foil is placed into a bath comprising water to form a hydration layer over the exposed metal on the section of the etched metal foil. The method also includes assembling the section of the etched metal foil having the hydration layer as an anode within a capacitor.

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 header-less implantable medical device, system and method are provided. The device includes an electronics module including circuitry, a battery, a receptacle assembly having an interior chamber and a receptable inlet configured to receive a lead connector assembly. A device housing has a case body that includes side walls and a peripheral edge that defines a single common chamber. The electronics module, battery and receptacle assembly are provided within the single common chamber. A connector opening is provided in the case body and joined to the receptacle inlet to form a passage through the case body into the interior chamber of the receptacle assembly.

Abstract: Described herein are methods, devices, and systems that enable a remote non-implantable device (RNID) to send commands to a leadless pacemaker (LP) implanted within a patient. The RNID provide commands to a local non-implantable device (LNID) over one or more communication networks, and the LNID sends the commands to a second implantable device (SID) by transmitting radio frequency (RF) communication signals, which include the commands, using an antenna of the LNID. After receiving the commands from the LNID, by receiving RF communication signals that include the commands using an antenna of the SID, the SID transmits conductive communication signals, which include the commands, using electrodes of the SID. The LP receives the commands from the SID by receiving the conductive communication signals, which include the commands, using electrodes of the LP, and the LP performs command responses based on the commands that originated from the RNID.

Abstract: A capacitor has an anode with one or more active layers that each includes fused particles positioned on a current collector. The current collector includes tunnels that extend from a first face of the current collector to a second face of the current collector.

Abstract: Disclosed herein is a medical leadless pacemaker delivery system adapted to engage and disengage with leadless pacemakers to allow for the repeated use of the leadless pacemaker delivery system in delivering and implanting multiple leadless pacemakers into a patient heart in a serial or repeated manner. The leadless pacemaker delivery system includes a handle, an attachment mechanism, a torque portion, and a rotation limiter. The handle includes a housing. The attachment mechanism is operably coupled to the housing and configured to actuate between a released state and an engaged state. The torque portion is operably coupled to the housing and rotatable relative to the housing to transition the attachment mechanism between the released and engaged states. The torque portion includes a shaft. The rotation limiter is in sliding engagement with the shaft between a first stop and a second stop. The rotation limiter includes a first helical thread.

Abstract: An apparatus and method for characterizing a region of interest (ROI) including measuring position and orientation data within the ROI; and generating a geometric data set to include one or more of: length, bifurcation location, angle and curvature characteristics of the ROI. Also, sequentially taking an image of a tool within the ROI; comparing tool dimensions with ROI dimensions; and estimating diameter, length, take-off angle, and/or tortuosity characteristics based on the comparisons.

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: 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 an MRI safe mode, and vice versa, within increased specificity. In certain embodiments, a controller of the IMD uses a magnetic field sensor to determine whether a first magnetic field condition is detected, and uses an accelerometer to determine whether a positional condition is detected. In response to the first magnetic field condition being detected, and the positional condition being detected, the controller can use the magnetic field sensor to determine whether a second magnetic field condition is detected, which differs from the first magnetic field condition. The controller can then cause the IMD to enter the MRI safe mode based at least in part on the first and second magnetic field conditions and the positional condition being detected.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.

Abstract: An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.