Abstract: An apparatus and method for characterizing a region of interest (ROI) including measuring position and orientation data within the ROI; and generating a geometric data set to include one or more of: length, bifurcation location, angle and curvature characteristics of the ROI. Also, sequentially taking an image of a tool within the ROI; comparing tool dimensions with ROI dimensions; and estimating diameter, length, take-off angle, and/or tortuosity characteristics based on the comparisons.

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: Embodiments describe herein generally pertain to implantable medical device (IMDs), and methods for use therewith, that can be used to automatically switch an IMD from its normal operational mode to an MRI safe mode, and vice versa, within increased specificity. In certain embodiments, a controller of the IMD uses a magnetic field sensor to determine whether a first magnetic field condition is detected, and uses an accelerometer to determine whether a positional condition is detected. In response to the first magnetic field condition being detected, and the positional condition being detected, the controller can use the magnetic field sensor to determine whether a second magnetic field condition is detected, which differs from the first magnetic field condition. The controller can then cause the IMD to enter the MRI safe mode based at least in part on the first and second magnetic field conditions and the positional condition being detected.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.

Abstract: An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.

Abstract: Certain embodiments of the present technology described herein relate to detecting atrial oversensing in a His intracardiac electrogram (His IEGM), characterizing atrial oversensing, determining when atrial oversensing is likely to occur, and or reducing the chance of atrial oversensing occurring. Some such embodiments characterize and/or avoid atrial oversensing within a His IEGM. Other embodiments of the present technology described herein relate to determining whether atrial capture occurs in response to His bundle pacing (HBP). Still other embodiments of the present technology described herein relate to determining whether AV node capture occurs in response to HBP.

Abstract: A leadless biostimulator, and an electrical feedthrough assembly for use therewith, are described herein. The 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 a housing of the leadless biostimulator, and wherein the electrical feedthrough assembly is configured to be mounted on the housing of the leadless biostimulator.

Abstract: Certain embodiments of the present technology described herein relate to detecting atrial oversensing in a His intracardiac electrogram (His IEGM), characterizing atrial oversensing, determining when atrial oversensing is likely to occur, and or reducing the chance of atrial oversensing occurring. Some such embodiments characterize and/or avoid atrial oversensing within a His IEGM. Other embodiments of the present technology described herein relate to determining whether atrial capture occurs in response to His bundle pacing (HBP). Still other embodiments of the present technology described herein relate to determining whether AV node capture occurs in response to HBP.

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: Systems and methods for His bundle pacing and classifying response to pacing impulses include applying, using a pulse generator, an impulse through a stimulating electrode to induce a response from a patient heart. A response to the impulse is measured using at least one sensing electrode and time-domain based characteristics of the response are analyzed to determine whether His bundle capture has occurred and, if so, what type of capture has occurred.

Abstract: A retrieval system for a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator retrieval system includes a docking cap rotatably coupled to an outer catheter by a bearing. A torque shaft extends through the outer catheter and attaches to the docking cap to transmit torque to the docking cap to cause rotation of the docking cap relative to the outer catheter. The rotating docking cap can transmit torque to an attachment feature of a biostimulator received within the docking cap. The attachment feature can be captured by a snare that extends through the torque shaft. A cincher tube extends through the torque shaft around the snare, and advances over the snare independently from the torque shaft that is attached to the docking cap, to cinch the snare onto the attachment feature. Other embodiments are also described and claimed.

Abstract: Methods, devices and program products are provided for under control of one or more processors within an implantable medical device (IMD). Sensing near field (NF) and far field (FF) signals are between first and second combinations of electrodes coupled to the IMD. The method applies an arrhythmia detection algorithm to the NF signals for identifying events within the NF signal and designates events marker based thereon and monitors the event markers to detect a candidate arrhythmia condition in the NF signals. The candidate under-detected condition comprises at least one of an under-detected arrhythmia or over-sensing. In response to detection of the candidate arrhythmia condition, the method analyzes the FF signals for a presence of an under-detected arrhythmia indicator. The method delivers an arrhythmia therapy based on the presence of the under-detected arrhythmia indicator in the FF signals and the candidate under-detected arrhythmia condition in the NF signals.

Abstract: Described herein are external devices, and methods for use therewith, that are configured to communicate with one or more implantable medical devices (IMDs) implanted within a patient using conductive communication, wherein the external device includes or is communicatively coupled to at least three external electrodes that are in contact with the patient. Certain such methods involve the external device identifying, for each IMD, of the plurality of IMDs, which one of the plurality of communication vectors is a preferred communication vector for communicating with the IMD, based on respective indicators of conductive communication quality that are determined for the plurality of communication vectors. Certain embodiments involve determining when there should be a reassessment of which one of the plurality of communication vectors is the preferred communication vector for communicating with an IMD, and in response thereto, identifying an updated preferred communication vector for communicating with the IMD.

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: Computer implemented methods, devices and systems for monitoring a trend in heart failure (HF) progression are provided. The method comprises sensing left ventricular (LV) activation events at multiple LV sensing sites along a multi-electrode LV lead. The activation events are generated in response to an intrinsic or paced ventricular event. The method implements program instructions on one or more processors for automatically determining a conduction pattern (CP) across the LV sensing sites based on the LV activation events, identifying morphologies (MP) for cardiac signals associated with the LV activation events and repeating the sensing, determining and identifying operations, at select intervals, to build a CP collection and an MP collection. The method calculates an HF trend based on the CP collection and MP collection and classifies a patient condition based on the HF trend to form an HF assessment.

Abstract: A valve bypass tool, and a biostimulator transport system having such a valve bypass tool, is described. The valve bypass tool includes an annular seal to seal against a protective sheath of the biostimulator transport system. The valve bypass tool is slidably mounted on the protective sheath and includes a bypass sheath to insert into an access introducer. The valve bypass tool can lock onto the access introducer by mating a locking tab of the valve bypass tool with a locking groove of the access introducer. The locking tab can have a decent that securely fastens the components to resist decoupling when the biostimulator transport system is advanced through the access introducer into a patient anatomy. Other embodiments are also described and claimed.

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: Batteries having hybrid electrode configurations are disclosed herein. In one embodiment, a battery comprises an electrode assembly. The electrode assembly comprises a first cathode including a first cathode active material, a second cathode including a second cathode active material different from the first cathode active material, a first anode disposed between the first cathode and the second cathode, a first separator interposed between the first cathode and the first anode, and a second separator interposed between the second cathode and the first anode.

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 system for monitoring blood pressure includes an implantable medical device (IMD) and an external device (ED). The IMD senses an electrogram (EGM) signal, identifies a feature thereof indicative of a ventricular depolarization, and transmits a conductive communication signal through patient tissue indicating when the ventricular depolarization occurred. The ED is worn against skin and configured to receive the conductive communication signal. The ED is also configured to sense a plethysmography (PG) signal and identify a feature thereof indicative of when a pulse wave responsive to the ventricular depolarization reaches a region of the patient adjacent the ED, and determine a delay time (TD) indicative of how long it takes the pulse wave to travel from the patient's heart to the region of the patient adjacent to the ED. The TD is a surrogate of the patient's blood pressure and useful for monitoring the patient's blood pressure and/or changes therein.