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 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: 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: 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: 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 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: 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: 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: 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: 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: 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: Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.

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.

Abstract: Methods and implantable medical devices (IMDs) are provided for monitoring a cardiac function of a heart. A heart sound sensor is configured to sense heart sound signals of the subject. The IMD includes a memory to store program instructions. The IMD includes a processor that, when executing the program instructions, is configured to identify S2 signal segment from the heart sound signals, analyze the S2 signal segment to identify a pulmonary valve signal (P2 signal) and an aortic valve signal (A2 signal) within an S2 signal segment of the heart sound signals. The processor is configured to determine a time interval between the A2 and P2 signals, characterize the S2 signal segment to exhibit a first type of S2 split based on the time interval, and identify a cardiac condition based on a comparison of the first type of S2 split and a cardiac condition matrix.

Abstract: A battery includes a case having a feedthrough port, a feedthrough assembly disposed in the feedthrough port, and a cell stack disposed within the case. The feedthrough port includes an inner conductor and an insulator core separating the inner conductor from the case. The cell stack includes an anode, a cathode, and a separator insulating the anode from the cathode, wherein the anode and cathode are offset from one another. An insulating boot surrounding the cell stack insulates the cell stack from the case. The insulating boot has an opening configured to receive therein the feedthrough assembly, which may include overmolded insulation. The interior surfaces and interior walls of the battery case may be thermal spray-coated with a dielectric material to prevent lithium dendrite formation between cathode and anode surfaces.

Abstract: Described herein are methods, systems, and devices for estimating remaining longevity of an IMD powered by a battery that at any given time has a battery voltage (BV) and a remaining battery capacity (RBC). Such a method can include estimating the RBC using a first technique when the battery is operating within a t least one of one or more plateau regions, estimating the RBC using a second technique, that differs from the first technique when the battery is operating within a decline region, and estimating the remaining longevity of the IMD based on at least one of the estimates of the RBC. Additionally, historical battery data can be stored and used to estimate the RBC, e.g., when the battery is operating within a heavy usage and recovery period. RBC estimation can also depend on whether the IMD is close to its recommended replacement time (RRT).