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: 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: 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: 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 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: 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.

Abstract: Described herein are apparatuses and methods to detect tachycardias and selectively reject false tachycardia detections due to T-wave oversensing or noise. An apparatus includes electrodes, a sensing circuit coupled to at least two of the electrodes and configured to sense a signal indicative of cardiac electrical activity, and a smoothing filter configured to filter to the sensed signal indicative of cardiac electrical activity to thereby produce a filtered signal indicative of cardiac electrical activity. The apparatus produces a difference signal indicative of cardiac electrical activity by determining a difference between the sensed and filtered signals indicative of cardiac electrical activity. The apparatus also includes at least one processor configured to detect a tachycardia, or to determine whether or not to reject a tachycardia detection, based on the difference signal. The smoothing filter and/or difference circuitry can be implemented by the at least one processor, and/or other circuitry.

Abstract: A leadless cardiac pacemaker is provided which can include any number of features. In one embodiment, the pacemaker can include a tip electrode, pacing electronics disposed on a p-type substrate in an electronics housing, the pacing electronics being electrically connected to the tip electrode, an energy source disposed in a cell housing, the energy source comprising a negative terminal electrically connected to the cell housing and a positive terminal electrically connected to the pacing electronics, wherein the pacing electronics are configured to drive the tip electrode negative with respect to the cell housing during a stimulation pulse. The pacemaker advantageously allows p-type pacing electronics to drive a tip electrode negative with respect to the can electrode when the can electrode is directly connected to a negative terminal of the cell. Methods of use are also provided.

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 method is provided for manufacturing an electrolytic capacitor for an implantable cardioverter defibrillator. The method includes forming an ester material by adding at least one acid to a glycol, and quenching the ester material for a determined period. The method also includes adding an ammonium based material to the ester material after the ester material is quenched, and adding an additional acid after adding the ammonium based material to form an electrolytic material for the electrolytic capacitor.

Abstract: Techniques for calibrating a low frequency (LF) clock of an IMD are disclosed, wherein the IMD also includes a high frequency (HF) clock. This includes determining an average, or a surrogate thereof, of how many HF clock cycles of a HF clock signal (produced by the HF clock) occur per LF clock cycle of a predetermined number N of LF clock cycles of the LF clock signal (produced by the LF clock), wherein N is an integer that is at least 2. This also includes comparing the average or a surrogate thereof to a corresponding target value that the average or the surrogate thereof would be equal to if the frequency of the LF clock signal equaled a target frequency for the LF clock, wherein the corresponding target value need not be an integer. The LF clock is calibrated by adjusting the frequency thereof based on results of the comparing.

Abstract: A leadless biostimulator has a housing including an electronics compartment, an electronics assembly mounted in the electronics compartment, a proximal electrode that disposed on and/or integrated into the housing, and an electrical feedthrough assembly. The electrical feedthrough assembly includes a distal electrode and a flange. The flange is mounted on the housing. The distal electrode is electrically isolated from the flange by an insulator and configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A mount is mounted on the flange and thereby mounted on the electrical feedthrough assembly. A fixation element is mounted on the mount and configured to facilitate fixation of the leadless biostimulator to tissue of a patient.

Abstract: A method and device for dynamic device based AV delay adjustment is provided. The method comprises electrodes that are configured to be located proximate to an atrial (A) site and a right ventricular (RV) site. The method utilizes one or more processors for detecting an atrial paced (Ap) event or atrial sensed (As) event, and measures an AV interval corresponding to an interval between the Ap event or the As event and a sensed ventricular (Vs) event. The AV interval is associated with a current heart rate (HR). The method automatically dynamically adjusts a first AV delay based directly on the measured AV interval, identifies a scale factor associated with the current HR, calculates a second AV delay by scaling the first AV delay based on the scale factor and manages a pacing therapy, utilized by the IMD, based on the first and second AV delays.

Abstract: Systems and methods for implanting a medical device 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. The cavity contacts are positioned to engage the lead contacts of the lead connector when the lead connector is inserted into the adaptor cavity.

Abstract: A system and method are provided. The system includes a HIS electrode configured to be located proximate to a HIS bundle. A pulse generator is coupled to the HIS electrode and is configured to deliver HIS bundle pacing (HBP), a right atrial (RA) electrode is located in a right atrium, a sensing circuitry coupled to the RA electrode and defines an RA sensing channel that does not utilize the HIS electrode. The system includes a memory including program instructions. The system includes a processor is configured to collect cardiac activity (CA) signals over the RA sensing channel utilizing the RA electrode. The CA signals include a far field (FF) component associated with a ventricular event (VE). The processor analyzes the FF component to identify first and second FF component (FFC) characteristics of interest (COI) of the ventricular event and utilizes the first FFC COI to apply a first capture class (CC) discriminator to distinguish between first and second capture classes.

Abstract: A method includes mixing a solvent with a dry cathode mixture to form a slurry. The dry cathode mixture includes a cathode active material, a conductive diluent, and a polymeric binder. The method further includes removing the solvent from the slurry to form a composition and calendering, in a first calendering step, the composition to form a sheet. The calendering the composition includes passing the composition between calender rollers.

Abstract: A method of screening a battery for failure mechanisms is provided. The method may include activating an electrochemical cell. Within 5 minutes to two hours of activating the cell, the open circuit voltage of the cell is measured over a period of time to determine a voltage versus time function. The cell is then screened for the presence of a failure mechanism by checking the voltage versus time function for a failure criteria.