Abstract: Described herein are methods, devices, and systems that monitor heart rate and/or for arrhythmic episodes based on sensed intervals that can include true R-R intervals as well as over-sensed R-R intervals. True R-R intervals are initially identified from an ordered list of the sensed intervals by comparing individual sensed intervals to a sum of an immediately preceding two intervals, and/or an immediately following two intervals. True R-R intervals are also identified by comparing sensed intervals to a mean or median of durations of sensed intervals already identified as true R-R intervals. Individual intervals in a remaining ordered list of sensed intervals (from which true R-R intervals have been removed) are classified as either a short interval or a long interval, and over-sensed R-R intervals are identified based on the results thereof. Such embodiments can be used, e.g., to reduce the reporting of and/or inappropriate responses to false positive tachycardia detections.

Abstract: Systems and methods for improving conducted i2i communication between first and second implantable medical device (IMDs) are described, wherein at least one of the IMDs comprises a leadless pacemaker (LP). Respective information is stored within each of the first and second IMDs that specifies a primary communication window (PCW) for performing the conducted communication with one another when using a primary conducted communication protocol (PCCP), and also specifies an alternate communication window (ACW) for performing the conducted communication with one another when using an alternate conducted communication protocol (ACCP). At least one of the first and second IMDs monitors quality metric of the conducted communication therebetween while the PCCP is being used, and in response to the quality metric falling below a corresponding threshold, the first and second IMDs perform conducted i2i communication with one another in accordance with the ACCP during the ACW of one or more cardiac cycles.

Abstract: An implantable medical device includes a header body and a septum assembly. The header body includes a first welding surface and a septum bore extending inwardly from an outer surface to an inner cavity. The septum assembly is at least partially disposed within the septum bore of the header assembly and includes a septum configured to allow insertion of a tool through the septum into the inner cavity and to otherwise provide a seal. The septum assembly further includes a retainer within which at least a portion of the septum is retained. The retainer includes a welding feature coupled to the retainer body, the welding feature providing a second welding surface. The retainer is coupled to the header body by welding the first welding surface to the second welding surface.

Abstract: A method is provided for establishing a communication session with an implantable medical device (“IMD”). The method includes configuring an IMD and an external device to communicate with one another through a protocol that utilizes a dedicated advertisement channel. The advertisement period and the scan period of the protocol are independent of one another such that the advertisement and scan periods at least partially overlap intermittently after a number of cycles. When the external device detects one of the advertisement notices, the method includes establishing a communications link between the external device and the IMD.

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: 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: Delivery of implantable active agent delivery components includes implanting a distal lead end of a lead into tissue at an implantation site. A delivery stylet is then inserted through a lead lumen of the lead. The delivery stylet includes a stylet body having a distal stylet end and an active agent delivery component detachably coupled to the distal stylet end. The active agent delivery component is inserted into the tissue at the implantation site by extending the distal stylet end of the delivery stylet from a distal lead end of the lead such that the active agent delivery component is inserted into the tissue at the implantation site. The active agent delivery component is then detached within the tissue at the implantation site and the delivery stylet may be retracted and removed from the lead lumen.

Abstract: A device includes an electrode stack including a plurality of conductive anodes, a plurality of conductive cathodes, a plurality of separators arranged between the conductive anodes and the conductive cathodes, and a dielectric material disposed on a surface of each of the conductive anodes. The stack has a top surface, a bottom surface, and an edge extending between the top surface and the bottom surface. A continuous electrically insulating film overlies the edge, peripheral portions of the top surface and peripheral portions of the bottom surface so that a central portion of the top surface and a central portion of the bottom surface are exposed. An electrolyte is disposed between the conductive anodes and the conductive cathodes.

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: 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: The present disclosure provides a grip sensor for quantifying pain experienced by a patient during spinal cord stimulation (SCS). The grip sensor includes an electronics enclosure, an annular outer shell substantially surrounding the electronics enclosure and sized to be held by the patient, a pressure sensor embedded in the outer shell and communicatively coupled to the electronics enclosure, the pressure sensor configured to measure a grip strength of the patient as SCS is applied to the patient, and a plurality of galvanic skin response sensors communicatively coupled to the electronics enclosure and configured to measure an electrical impedance of the skin of the patient as SCS is applied to the patient.

Abstract: A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.

Abstract: Described herein are methods, devices, and systems that monitor heart rate and/or for arrhythmic episodes based on sensed intervals that can include true R-R intervals as well as over-sensed R-R intervals. True R-R intervals are initially identified from an ordered list of the sensed intervals by comparing individual sensed intervals to a sum of an immediately preceding two intervals, and/or an immediately following two intervals. True R-R intervals are also identified by comparing sensed intervals to a mean or median of durations of sensed intervals already identified as true R-R intervals. Individual intervals in a remaining ordered list of sensed intervals (from which true R-R intervals have been removed) are classified as either a short interval or a long interval, and over-sensed R-R intervals are identified based on the results thereof. Such embodiments can be used, e.g., to reduce the reporting of and/or inappropriate responses to false positive tachycardia detections.

Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

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: Certain embodiments described herein related to methods, devices, and systems that provide improved communications between first and second IMDs remotely located relative to one another and capable of communicating using both conductive communication and RF communication. Such a method can include the first IMD using conductive communication to transmit message(s) intended for the second IMD, without using RF communication, during a first period of time that a first trigger event is not detected. The method can also include the first IMD detecting the first trigger event, and in response thereto, the first IMD using RF communication to transmit message(s) intended for the second IMD during a second period of time. Thereafter, in response to first IMD detecting a second trigger event, the first IMD uses conductive communication to transmit one or more messages intended for the second IMD, without using RF communication, during a third period of time.

Abstract: Methods, devices and program products are provided for managing a pacing therapy using an implantable medical device (IMD). The methods, devices and program products sense cardiac activity (CA) signals at electrodes located proximate to multiple left ventricular (LV) sites and a right ventricular (RV) site of the heart and utilizing one or more processors to measure activation times between the multiple LV sites and the RV site based on the CA signals. The processors program an order of activation for the multiple LV sites based on the activation times and identify an RV activation time and a septum activation time based on the CA signals. The processors calculate a septum to RV activation time (SRAT) based on the RV and septum activation times and program an AVSRAT delay based on the SRAT.

Abstract: An implantable medical device, external device and method for managing a wireless communication are provided. The IMD includes a transceiver configured to communicate wirelessly, with an external device (ED), utilizing a protocol that utilizes multiple physical layers. The transceiver is configured to transmit information indicating that the transceiver is configured with first, second, and third physical layers (PHYs) for wireless communication. The IMD includes memory configured to store program instructions. The IMD includes one or more processors configured to execute instructions to obtain an instruction designating one of the first, second and third PHY to be utilized for at least one of transmission or reception, during a communication session, with the external device and manage the transceiver to utilize, during the communication session, the one of the first, second and third PHY as designated.

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 the IMD using an accelerometer to identify when the orientation of the IMD is such that the IMD will likely be able to successfully communicate with another IMD via one or more communication pulses sent from the IMD to the other IMD. The method also includes the IMD sending of the one or more communication pulses, that are used to communicate with the other IMD, when the orientation of the IMD is such that the IMD will likely be able to successfully communicate with the other IMD via one or more communication pulses sent from the IMD to the other IMD.

Abstract: Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.