Abstract: An implantable medical device and method are provided for implant within a patient. The device comprises a case. Radio frequency (RF) communication components are housed within the case. A header is mounted to an exterior surface of the case along an edge of the case. An antenna is coupled to the RF communication components. The antenna has an inverted E shape. The inverted E shaped antenna is within the header. The inverted E shaped antenna includes a conducting arm joined to first, second and third branches that are oriented within the header to extend toward the edge of the case underneath the header. The first branch of the antenna is conductively open and, no more than weakly coupled, with respect to the case. The second branch is located between the first and third branches. The second branch is configured to convey an RF signal feed. The third branch has a shunt to ground connection to the case. The case forms a ground plane for the antenna.

Abstract: Methods and devices are is provided for controlling a pacing therapy utilizing left ventricular multi-point pacing (MPP). The method and device provide electrodes configured to be located proximate to an atrial (A) site, a right ventricular (RV) site and multiple left ventricular (LV) sites of the heart. The method and device utilizes one or more processors. The processors determine atrial-ventricular conduction delays (AVCD) between the A site and multiple corresponding LV sites and determines pacing latencies at the LV sites. The processors adjusts the AVCDs, based on the pacing latency at the corresponding LV sites, to form atrial-ventricular latency adjusted (ARPL) conduction delays for the corresponding LV sites, calculates interventricular pacing (VV) delays for combinations of the LV sites based on the corresponding ARPL conduction delays and manages pacing therapy, that utilizes left ventricular MPP, based on the VV delays for the corresponding LV sites.

Abstract: Disclosed herein are implantable medical devices (IMDs) including a receiver and a battery, and methods for use therewith. The receiver includes first and second differential amplifiers, each of which monitors for a predetermined signal within a frequency range and drains power from the battery while enabled, and while not enabled drains substantially no power from the battery. To remove undesirable input offset voltages, each of the differential amplifiers, while enabled, is selectively put into an offset correction phase during which time the predetermined signal is not detectable by the differential amplifier. At any given time at least one of the first and second differential amplifiers is enabled without being in the offset correction phase so that at least one of the differential amplifiers is always monitoring for the predetermined signal. In this manner, the receiver is never blind to signals, including the predetermined signals, sent by another IMD.

Abstract: Methods and devices are provided comprising an implantable lead having electrodes configured to be located proximate to a heart, the electrodes defining a sensing vector through a region of interest in the heart. The method and system collect an intra-cardiac electrogram (EGM) signal associated with an event of interest and determining an global amplitude characteristic (GAC) and a global slope characteristic (GSC) from the EGM signal under control of one or more processors within an implantable medical device (IMD). A QRS start time is defined, within the EGM signal, based on the GSC and determining a local amplitude characteristic (LAC) for a segment of the EGM signal within a search window of the GAC under control of one or more processors within an implantable medical device (IMD) A QRS end time is defined, within the EGM signal, based on the LAC; and calculating a QRS duration based on the QRS start time and QRS end time under control of one or more processors within an implantable medical device (IMD).

Abstract: Devices and methods are provided for a leadless implantable medical device (LIMD) comprising a housing. An electrode is disposed on the housing. An electronics circuit is disposed in the housing and is configured to sense cardiac signals, and/or generate and deliver pacing signals to the electrode. A transceiver circuit is disposed in the housing, and is configured to communicate wirelessly with an external device. A fixation antenna electrically separate from the electrode is disposed on a distal portion of the housing and is electrically coupled to the transceiver circuit, and configured to operate as an antenna for communication between the transceiver circuit and the external device.

Abstract: Disclosed herein is an implantable electronic device having a housing containing an electrical circuit. The implantable electronic device further includes an antenna assembly coupled to the electrical circuit. The antenna assembly has an antenna with a dielectric antenna body within which an antenna trace is disposed. Portions of the antenna trace are disposed in offset transverse layers in a non-overlapping arrangement, thereby reducing capacitive coupling between the layers of the antenna trace. In certain implementations, the antenna assembly has one or more capacitive features that selectively overlap portions of the antenna trace and facilitate tuning of the antenna.

Abstract: Devices and methods are provided for an implantable medical device (IMD) comprising a device housing having electronic components therein, a feedthrough assembly joined to the device housing, an antenna assembly, and a header body mounted to the device housing and enclosing the antenna assembly and feedthrough assembly. The antenna assembly including an inner conductor, a dielectric material, and an outer conductor arranged to form a coaxial structure.

Abstract: Methods for implanting a puke 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: Methods and devices include making an incision at a single site of a patient. The single site located at an anterior of a chest or abdomen. The method also includes inserting a tunneling tool through the incision at the single site and preparing a first tunnel to a subcutaneous posterior location. A path of the first tunnel at least one of i) extends over a plurality of Intercostal gaps of the chest or ii) extends along and within one of the intercostal gaps. The method also includes positioning a first lead having an electrode within the first tunnel and preparing a second tunnel to a subcutaneous parasternal location along the chest. The method also includes positioning a second lead having an electrode within the second tunnel and positioning a pulse generator within a subcutaneous pocket and operatively coupling the first and second leads to the pulse generator.

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 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: Methods and systems are provided for detecting arrhythmias in cardiac activity. The methods and systems declare a current beat, from the CA signals, to be a candidate beat or an ineligible beat based on whether the current beat satisfies the rate based selection criteria. The determining and declaring operations are repeated for multiple beats to form an ensemble of candidate beats. The method and system calculate a P-wave segment ensemble from the ensemble of candidate beats, perform a morphology-based comparison between the P-wave segment ensemble and at least one of a monophasic or biphasic template, declare a valid P-wave to be present within the CA signals based on the morphology-based comparison, and utilize the valid P-wave in an arrhythmia detection process to determine at least one of an arrhythmia entry, arrhythmia presence or arrhythmia exit.

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: 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: A system for implanting an implantable medical device (IMD) within a patient may include an IMD including an attachment member, and a delivery catheter including at least one tethering device having at least a portion positioned within a restrainer. The tethering device(s) is configured to removably tether to the attachment member of the IMD. The restrainer is configured to maintain the tethering device(s) in alignment along a delivery path of the delivery catheter.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: The present disclosure provides systems and methods for automatically determining pace and sense configurations for an implantable cardiac device. A method of operating an implantable cardiac device includes automatically determining, during a detection phase, a pace and sense configuration for the implantable cardiac device based on a plurality of first impedance measurements. The method further includes confirming, during a confirmation phase, the pace and sense configuration based on a plurality of second impedance measurements, and operating the implantable cardiac device in accordance with the pace and sense configuration.

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: A renal denervation feedback method is described that performs a baseline measurement of renal nerve plexus electrical activity at a renal vessel; denervates at least some tissue proximate the renal vessel after performing the baseline measurement; performs a post-denervation measurement of renal nerve plexus electrical activity at the renal vessel, after the denervating; and assesses denervation of the renal vessel based on a comparison of the baseline measurement and the post-denervation measurement of renal nerve plexus electrical activity at the renal vessel.

Abstract: A method of fabricating a battery electrode includes forming a mixture including an electrode material and a binder; forming an electrode blank from the mixture; heating the electrode blank at a predetermined temperature for a predetermined time to form an annealed electrode blank; and laminating the annealed electrode blank to a current collector. The current collector may include a conductive carbon coating. In such event, the method may further include heating the current collector at a selected temperature for a selected time prior to laminating the annealed electrode blank to the current collector.