Abstract: Systems and methods for detecting arrhythmias in cardiac activity are provided and include memory to store specific executable instructions. One or more processors are configured to execute the specific executable instructions for obtaining first and second far field cardiac activity (CA) data sets over primary and secondary sensing channels, respectively, in connection with a series of beats. The system detects candidate atrial features from the second CA data set, identifies ventricular features from the first CA data set and utilizes the ventricular features to separate beat segments within the second CA data set. The system automatically iteratively analyzes the beat segments by overlaying an atrial activity search window with the second CA data set and determines whether one or more of the candidate atrial features occur within the atrial activity search window.

Abstract: Disclosed herein is an implantable pulse generator for administering electrotherapy via an implantable lead. The pulse generator includes a housing and a header connector assembly coupled to the housing. The header connector assembly includes a connector assembly and a header enclosing the connector assembly. The connector assembly includes a support and a connector receptacle. The support extends at least partially about the connector receptacle and is at least partially responsible for having prevented injection molding material from entering the connector receptacle when the injection molding material was injection molded about the connector assembly in forming the header.

Abstract: An electrical feedthrough assembly, which is configured to be mounted on a housing of a leadless biostimulator, comprises an electrode body including a cup having an electrode wall extending distally from an electrode base around an electrode cavity, an electrode tip mounted on a distal end of the electrode body, and a filler in the electrode cavity between the electrode base and the electrode tip, wherein the filler includes a therapeutic agent. The electrode tip is configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A pin extends proximally from the electrode base, wherein the pin is configured to be into contact with an electrical connector of an electronics assembly within the housing of the leadless biostimulator.

Abstract: A lead delivery catheter having a slittable pull ring is described. The lead delivery catheter includes a deflection wire attached to the slittable pull ring to deflect the catheter. The slittable pull ring has several ring holes arranged in a pattern. The pull ring is located distal to a tubular braid of the lead delivery catheter, and a size and pattern of the ring holes can be similar to a size and pattern of holes in the tubular braid. The structural similarity between the pull ring and the tubular braid facilitates use of a consistent cutting force to slit through the tubular braid and the pull ring of the lead delivery catheter. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.

Abstract: A delivery system for an intracorporeal device includes a sheath defining one or more lumens shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to releasably couple with a proximal coupling feature of the intracorporeal device. The delivery system may further include a hub through which the delivery shaft and guidewire are passed. The delivery shaft may be coupled to a feature, such as a knob, that enables manipulation of the delivery shaft to decouple the distal fixation feature from the proximal fixation feature of the intracorporeal device in order to deploy the intracorporeal device within a patient.

Abstract: A valve for use in manufacturing of implantable medical devices is insertable into a bore of the medical device during a manufacturing process. The valve is configured to remain closed while the pressure differential between an internal volume of the implantable medical device and a surrounding environment is below a particular threshold and to open when the threshold is reached, thereby allowing air or other fluids to escape from the internal volume into the surrounding environment. The valves are particularly useful during certain types of coating processes that must be performed at or near vacuum and provide an effective way to prevent ingress of coating material into the internal volume of the implantable medical device.

Abstract: Implantable medical devices (IMDs), systems, and methods for use therewith are disclosed. One such method is for use by a leadless pacemaker (LP) configured to perform conductive communication with another implantable medical device (IMD). The method includes the LP storing information that specifies when, within a cardiac cycle, the LP and the other IMD implanted in a patient are likely oriented relative to one another such that conductive communication therebetween should be successful. The method also includes the LP sensing a signal indicative of cardiac activity of the patient over a plurality of cardiac cycles, and outputting one or more conductive communication pulses, during a portion of at least one of the cardiac cycles, wherein the portion of the at least one of the cardiac cycles is identified based on the signal that is sensed and the information that is stored.

Abstract: A biostimulator, such as a leadless pacemaker, has electrode(s) coated with low-polarization coating(s). A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.

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: Described herein is a fully-differential receiver for use with an implantable medical device (IMD) and configured to receive conducted communication signals that are transmitted by another IMD or an external device. The fully-differential receiver includes a fully-differential preamplifier, a fully-differential buffer, a first comparator, a second comparator, and an AC coupling network coupled between differential outputs of the fully-differential buffer and a coupled together differential pair of inputs of the first and second comparators. A differential pair of inputs of the fully-differential receiver comprise the differential pair of inputs of the fully-differential preamplifier, and a differential pair of outputs of the fully-differential receiver comprise a first output of the first comparator and a second output of the second comparator. In order to conserve power, the fully-differential receiver is selectively changed from operating in a first mode to operating in a second mode, and vice versa.

Abstract: Described herein is a fully-differential preamplifier comprising an input differential pair, an output current load, and a current source. The current source is coupled between the input differential pair and a low voltage rail and configured to control whether the fully-differential preamplifier is operating in a first mode or a second mode, wherein the preamplifier draws more current when operating in the second mode compared to when operating in the first mode. The input differential pair is coupled between the output current load and the current source. The output current load is coupled between a high voltage rail and the input differential pair. The input differential pair comprise positive and negative inputs of the fully-differential preamplifier. Nodes where the input differential pair and the output current load are coupled to one another comprise positive and negative outputs of the fully-differential preamplifier.

Abstract: In one embodiment, the present disclosure is directed to a method for providing a neural stimulation therapy to treat chronic pain of a patient. The method comprises: recording, using a neural sensing system, neural activity of the patient at one or more sites within the nervous system of the patient related to the chronic pain of the patient, modifying a computational neural modeling system to model the sensed neural activity of the patient; computing a respective neural response of the patient for each of a plurality of different temporal stimulation patterns using the modified computational neural modeling system; selecting, based on the respective neural responses, one of the plurality of temporal stimulation patterns; and programming an implantable stimulation system to provide the selected one of the plurality of temporal stimulation patterns to the patient to treat the chronic pain of the patient.

Abstract: A system and method are provided for managing atrial-ventricular (AV) delay adjustments. An AV interval is measured that corresponds to an interval between an atrial paced (Ap) event or an atrial sensed (As) event and a sensed ventricular (Vs) event. A candidate AV delay is set based on the AV interval and a bundle branch adjustment (BBA) value. A QRS characteristic of interest (COI) is measured while utilizing the candidate AV delay in connection with delivering a pacing therapy. The BBA value is adjusted and the candidate AV delay is reset based on the BBA value as adjusted. A collection of QRS COIs and corresponding candidate AV delays are obtained and one of the candidate AV delays is selected as a BBA AV delay. The pacing therapy is managed, based on the BBA AV delay.

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: A method of manufacturing a filtered feedthrough assembly for use with an implantable medical device. The method may include gold brazing an insulator to a flange at first braze joint, and gold brazing a plurality of feedthrough wire to the insulator at second braze joints. The method may further include applying a first non-conductive epoxy to the first braze joint, and applying a second non-conductive epoxy to the second braze joint. The method may further include grit blasting a face of the flange, applying a conductive epoxy to the face of the flange, and attaching an EMI filter to the conductive epoxy such that it is grounded to the flange via the conductive epoxy and not via the first braze joint or the second braze joints.

Abstract: An implantable system including an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP), and methods for use therewith, are configured or used to terminate a pacemaker mediated tachycardia (PMT). In an embodiment, in response to the aLP detecting a PMT, the aLP initiates a PMT PA interval, and the aLP does not inform the vLP, via an i2i communication, of an atrial sensed event that caused the PMT to be detected, thereby preventing the vLP from initiating a PV interval during the PMT PA interval. The aLP selectively terminates the PMT PA interval. Additionally, the aLP informs the vLP, via an i2i communication, of an intrinsic atrial event being detected during the PMT PA interval, or of an atrial paced event being performed in response to the PMT PA interval expiring without an intrinsic atrial event being detected during the PMT PA interval.

Abstract: A system and method for designating between types of activation by a pulse generator configured to deliver a left ventricular (LV) pacing pulse at an LV pacing site as part of a cardiac resynchronization therapy (CRT) are provided. The system includes a sensing channel configured to collect cardiac activity (CA) signals along at least one sensing vector extending through a septal wall between the LV and right ventricle (RV). The CA signals are indicative of one or more beats and include a pre-LV pacing segment indicative of cardiac activity preceding the LV pacing pulse and a post-LV pacing segment indicative of cardiac activity following the LV pacing pulse. The system includes memory to store program instructions. One or more processors are configured to implement the program instructions to analyze the pre-LV pacing segment to identify a first myocardium activation (MA) characteristic of interest (COI).

Abstract: An implantable lead includes a lead body, electrical conductors, and a lead anchor. The lead body includes an electrode segment configured to be positioned along a pericardial membrane of a heart and including a plurality of electrodes configured to at least one of sense electrical signals from the heart or deliver therapy to the heart. The electrical conductors extend through the lead body between distal and proximal ends of the lead body, and are configured to electrically couple the electrodes to a pulse generator. The lead anchor is configured to be secured to a chest wall. The electrical conductors extend through the lead anchor, and the electrode segment extends from the lead anchor to the pericardial membrane. The electrode segment includes a transition portion that is configured to extend a depth into a mediastinum and a contoured portion to extend alongside and curve about the pericardial membrane.

Abstract: Embodiments described herein relate to implantable medical devices (IMDs) and methods for use therewith. Such a method includes using an accelerometer of an IMD (e.g., a leadless pacemaker) to produce one or more accelerometer outputs indicative of the orientation of the IMD. The method can also include controlling communication pulse parameter(s) of one or more communication pulses (produced by pulse generator(s)) based on accelerator output(s) indicative of the orientation of the IMD. The communication pulse parameter(s) that is/are controlled can be, e.g., communication pulse amplitude, communication pulse width, communication pulse timing, and/or communication pulse morphology. Such embodiments can be used to improve conductive communications between IMDs whose orientation relative to one another may change over time, e.g., due to changes in posture and/or due to cardiac motion over a cardiac cycle.