Abstract: A biostimulator, such as a leadless cardiac pacemaker, including an electrical feedthrough assembly mounted on a housing, is described. An electronics compartment of the housing can contain an electronics assembly to generate a pacing impulse, and the electrical feedthrough assembly can include an electrode tip to deliver the pacing impulse to a target tissue. A monolithically formed electrode body can have a pin integrated with a cup. The pin can be electrically connected to the electronics assembly, and the cup can be electrically connected to the electrode tip. Accordingly, the biostimulator can transmit the pacing impulse through the monolithic pin and cup to the target tissue. The cup can hold a filler having a therapeutic agent for delivery to the target tissue and may include retention elements for maintaining the filler at a predetermined location within the cup.

Abstract: Embodiments described herein relate to an implantable device that include an inductor coil, a storage capacitor, active circuitry, and a sensor, but doesn't include an electrochemical cell, and methods for use therewith. During first periods of time, the storage capacitor accumulates and stores energy received via the inductor coil from a non-implanted device. During second periods of time, interleaved with the first periods of time, and during which energy is not received from the non-implanted device, the active circuitry of the implantable device is powered by the energy stored on the storage capacitor and is used to perform at least one of a plurality of predetermined operations of the implantable device, including, e.g., obtaining a sensor measurement from the sensor of the implantable device, transmitting a communication signal including a sensor measurement to the non-implanted device, and/or receiving a communication signal from the non-implanted device.

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 include sensing circuitry configured to define a sensing channel to collect biological signals, memory configured to store program instructions, a processor configured to implement the program instructions to at least one of analyze the biological signals, manage storage of the biological signals or deliver a therapy, and communication circuitry configured to wirelessly communicate with at least one other implantable or external device, the communication circuitry configured to transition between a sleep state, a partial awake state and a fully awake state.

Abstract: Devices and methods for dynamically controlling sensitivity associated with detecting R-waves while maintaining the fixed detection threshold are described herein. One such method includes sensing an analog signal indicative of cardiac electrical activity, converting the analog signal indicative of cardiac electrical activity to a digital signal indicative of cardiac electrical activity, and detecting R-waves by comparing the digital signal indicative of cardiac electrical activity to a fixed detection threshold to thereby detect threshold crossings that corresponds to R-waves. The method further includes selectively adjusting a gain applied to the digital signal indicative of cardiac electrical activity to thereby selectively adjust a sensitivity associated with the detecting R-waves, while maintaining the fixed detection threshold.

Abstract: Methods and devices for managing establishment of a communications link between an external instrument (EI) and an implantable medical device (IMD) are provided. The methods and devices comprise storing, in memory in at least one of the IMD or the EI an advertising schedule defining a pattern for advertisement notices. The advertisement notices are distributed un-evenly and separated by unequal advertisement intervals. The method transmits, from a transmitter in at least one of the IMD or the EI the advertisement notices. The advertisement notices are distributed as defined by the advertising schedule. The method establishes a communication session between the IMD and the EI.

Abstract: Embodiments disclosed herein use multiple AF discriminators to determine whether to classify an AF detection as a false positive. One method includes detecting R-waves within an EGM or ECG signal, determining R?R intervals based on the R-waves, detecting AF based on the R?R intervals, and using one or more time-based AF discriminators to analyze one or more temporal features of the EGM or ECG signal within a window leading up to the AF detection to thereby determine whether to classify the AF detection as a false positive. In response to not classifying the AF detection as a false positive using the one or more time-based AF discriminators, one or more morphology-based AF discriminators are used to analyze one or more morphological features of the EGM or ECG signal within the window leading up to the AF detection to thereby determine whether to classify the AF detection as a false positive.

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: A computer implemented method and system to detect P-waves in cardiac activity is provided. The system includes memory to store specific executable instructions. One or more processors are configured to execute the specific executable instructions for obtaining far field cardiac activity (CA) signals for a series of beats, applying a P-wave template to at least one sub-segment of the CA signals to obtain an alignment indicator and calculating an amplitude dependence (AD) indicator based at least in part on the P-wave template and the at least one sub-segment. The system analyzes the alignment indicator based on a first criteria, compares the AD indicator with a second criteria, designates a candidate P-wave to be an actual P-wave based on the analyzing and comparing and records results of the designating.

Abstract: A computer implemented method for detecting arrhythmias in cardiac activity including obtaining far field cardiac activity (CA) signals for a series of beats. For at least a portion of the beats, the one or more processors perform, on a beat by beat basis: a) identifying first and second feature of interests (FOI) from a segment of the CA signal that corresponds to a current beat; and b) classifying the current beat into one of first and second groups. The method also includes designating one of the first and second groups to be a primary group based on a relation between the first and second groups, and for the beats in the primary group, selecting one of the first and second FOIs as the R-wave FOI. The method also includes rejecting an arrhythmia detection based on the P-waves detected.

Abstract: A method for managing power during communication with an implantable medical device, including establishing a communications link, utilizing a power corresponding to a session start power, to initiate a current session between an implantable medical device (IMD) and external device. A telemetry break condition of the communications link is monitored during the current session. The power utilized by the IMD is adjusted between low and high power levels, during the current session based on the telemetry break condition. The number of sessions is counted, including the current session and one or more prior sessions, in which the IMD utilized the higher power level, and a level for the session start power to be utilized to initiate a next session following the current session is adaptively learned based on the counting of the number of sessions.

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: Embodiments described herein relate to an implantable device that include an inductor coil, a storage capacitor, active circuitry, and a sensor, but doesn't include an electrochemical cell, and methods for use therewith. During first periods of time, the storage capacitor accumulates and stores energy received via the inductor coil from a non-implanted device. During second periods of time, interleaved with the first periods of time, and during which energy is not received from the non-implanted device, the active circuitry of the implantable device is powered by the energy stored on the storage capacitor and is used to perform at least one of a plurality of predetermined operations of the implantable device, including, e.g., obtaining a sensor measurement from the sensor of the implantable device, transmitting a communication signal including a sensor measurement to the non-implanted device, and/or receiving a communication signal from the non-implanted device.

Abstract: A tool adapted for insertion into a physiological lumen of a patient is provided. The tool includes a hub, a core extending distally from the hub, and a printed circuit board (PCB) assembly. The PCB assembly includes a PCB substrate coupled to the core and an electronic component disposed on the PCB substrate and electrically coupled to the hub. The tool further includes an outer sheath disposed about each of the core and the PCB assembly.an outer sheath disposed about each of the core and the PCB assembly. The PCB substrate may be in the form of a ring disposed at a distal end or about the core or may be a flexible PCB substrate adapted to be wrapped about the core and coupled to the core using an adhesive backing.

Abstract: Disclosed herein is an electrode feedthru assembly for an electronic device and method of manufacturing. The feedthru assembly includes a ferrule, an electrode assembly, and an elastomer. The ferrule includes a bore through which the electrode assembly is positioned. The electrode assembly includes an electrode wire attached to a crimp pin. The crimp pin includes a crimp terminal portion and a pin terminal portion, the crimp terminal portion crimped to the a portion of the electrode wire to form a connected portion of the electrode assembly. The elastomer is disposed in the bore of the ferrule between the ferrule and the electrode assembly. The elastomer is configured to electrically isolate the ferrule from the electrode assembly and to encapsulate at least the connected portion of the electrode assembly.

Abstract: Methods for manufacturing implantable electronic devices include forming an antenna of the implantable electronic device by delivering an antenna trace within a dielectric antenna body. The antenna trace includes a first trace portion disposed in a first transverse layer and defining a first trace path and a second trace portion disposed in a second transverse layer longitudinally offset from the first transverse layer and defining a second trace path. If projected to be coplanar, the first trace path defines a trace boundary and the second trace path is within the trace boundary.

Abstract: A capacitor and methods of processing an anode metal foil are presented. The capacitor includes a housing, one or more anodes disposed within the housing, one or more cathodes disposed within the housing, one or more separators disposed between an adjacent anode and cathode, and an electrolyte disposed around the one or more anodes, one or more cathodes, and one or more separators within the housing. The one or more anodes each include a metal foil that includes a first plurality of tunnels through a thickness of the metal foil in a first ordered arrangement, the first ordered arrangement being a close packed hexagonal array arrangement, and having a first diameter, and a second plurality of tunnels through the thickness of the metal foil having a second ordered arrangement and a second diameter greater than the first diameter.

Abstract: Described herein is an implantable medical device (IMD) that wirelessly communicates another IMD, and methods for use therewith. Such a method can include receiving one or more implant-to-implant (i2i) communication signals from the other IMD using a communication receiver of the IMD, measuring a strength of at least one of the one or more received i2i communication signals or a surrogate thereof, and updating a strength metric based on the measured strength or surrogate thereof. The method further includes determining, based on the updated strength metric, whether to increase, decrease, or maintain the sensitivity of the communication receiver of the IMD, and responding accordingly such that the sensitivity is sometimes increased, sometimes decreased, and sometimes maintained. The method can also include selectively causing a transmitter of the IMD to transmit an i2i communication signal to the other IMD requesting that the other IMD adjust its transmission strength.

Abstract: Described herein are implantable medical devices (IMDs), and methods for use therewith, that enable monitoring of impedance associated with a pathway (e.g., including a lead) used to selectively deliver stimulation pulses to patient tissue. A method involves measuring or storing a first voltage indicative of the energy stored on a reservoir capacitor (Cres) just prior to a stimulation pulse being delivered via the pathway, as well as measuring or storing a second voltage indicative of the energy stored on the Cres just after the stimulation pulse is delivered via the pathway. The method also includes monitoring the impedance associated with the pathway based on a difference between the first and second voltages, which may involve determining a count value indicative of how long it takes to discharge the first voltage to drop to the second voltage, wherein the count value is a surrogate of the impedance associated with the pathway.

Abstract: Anode foil, preferably aluminum anode foil, is etched using a process of treating the foil in an electrolyte bath composition comprising a perfluoroalkylsulfonate, a sulfate, a halide, and an oxidizing agent. The anode foil is etched in the electrolyte bath composition by passing a direct current charge through the bath. The etched anode foil is suitable for use in an electrolytic capacitor.

Abstract: A computer implemented method and device for providing dual chamber sensing with a single chamber leadless implantable medical device (LIMD) are provided. The method is under control of one or more processors in the LIMD configured with specific executable instructions. The method obtains a far field (FF) cardiac activity (CA) signals for activity in a remote chamber of a heart and compares the far field CA signals to a P-wave template to identify an event of interest associated with the remote chamber. The method sets an atrial-ventricular (AV) delay based on the P-wave identified and delivers pacing pulses at a pacing site of interest to a local chamber based on the AV delay.