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 detent 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: 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: Disclosed herein are implantable medical devices and systems, and methods for used therewith, that selectively perform atrial overdrive pacing while an intrinsic atrial rate of a patient is within a specified range.

Abstract: Described herein are methods, devices, and systems for identifying false R-R intervals, and false arrhythmia detections, resulting from R-wave undersensing or intermittent AV conduction block. Each of one or more of the R-R intervals is classified as being a false R-R interval in response to a duration the R-R interval being greater than a first specific threshold, and the duration the R-R interval being within a second specified threshold of being an integer multiple of at least X other R-R intervals for which information is obtained, wherein the integer multiple is at least 2, and wherein X is a specified integer that is 1 or greater. When performed for R-R intervals in a window leading up to a detection of a potential arrhythmic episode, results of the classifying can be used to determine whether the potential arrhythmic episode was a false positive detection.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.

Abstract: An implantable medical device includes an electrode and an insulative material secured to the electrode via an adhesive. The electrode includes a metal substrate and a metal coating. The metal substrate includes a connection segment and an active segment along a length of the metal substrate. The metal coating is disposed on an outer surface of the metal substrate along the connection segment and the active segment. The insulative material surrounds the connection segment of the metal substrate without surrounding the active segment, and the adhesive adheres to the metal coating on the connection segment.

Abstract: A blade for a cutting instrument includes a handle, a body, and at least three cutting edges along the body. The body has first and second sides extending along a longitudinal center axis. The body has a proximal end at the handle and a distal tip remote from the handle. The at least three cutting edges are oriented at corresponding angles with respect to the longitudinal center axis and are asymmetrically distributed with respect to the longitudinal center axis.

Abstract: An implantable medical device (IMD) that includes a transceiver configured to broadcast an advertising data packet that includes a unique identifier, and to receive a scan request data packet from an external device. A memory stores program instructions, and stores an approved device list, and one or more processors are configured to execute the program instructions to identify a device identifier (ID) from the scan request data packet received, apply an advertising filter to determine if the scan request data packet is from an authorized external device based on the device ID and the approved device list, based on the determination by the advertising filter, deny transmission of a scan response data packet from the transceiver when the advertising filter determines that the scan request data packet is from an unauthorized external device, and establish a communication session with an authorized external device independent of the scan request data packet.

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: An atrial leadless pacemaker (aLP), of a dual chamber leadless pacemaker system that also includes a ventricular leadless pacemaker (vLP), senses intrinsic atrial events and for each intrinsic atrial event that is sensed determines a respective atrial-to-atrial interval (AA interval) that corresponds to a duration between the intrinsic atrial event and an immediately preceding intrinsic atrial event. Additionally, the aLP, based on the determined AA intervals, selectively transmits and selectively abstains from transmitting atrial event messages to the vLP. When the aLP abstains from transmitting atrial event messages to the vLP, the aLP conserves power thereby increasing its longevity. The aLP can also be configured to operate in a similar manner for paced atrial events, to further conserve power. The vLP utilizes its VV interval timer to determine when to deliver ventricular stimulation, during those times that the aLP abstains from transmitting atrial event messages to the vLP.

Abstract: Embodiments described herein can reduce a burden associated with analyzing EGM segments obtained from an IMD that monitors for arrhythmic episodes. Respective EGM data and respective classification data is obtained for each arrhythmic episode detected by the IMD during a period of time. A representative R-R interval or HR for each of the arrhythmic episodes is also obtained, wherein a manner for determining the representative R-R interval or HR depends on the type of the arrhythmic episode, such that for at least two different types of arrhythmic episodes the manners differ. One or more arrhythmic episodes is/are selected for which corresponding EGM segments are to be displayed for each type of arrhythmic episode, wherein the selecting is performed based on the representative R-R intervals or HRs that are determined for the plurality of arrhythmic episodes. Additional and alternative embodiments are also described herein.

Abstract: Fabricating a capacitor includes forming conduits in a porous layer of material. The porous layer of material has particles that each includes a dielectric on a core. The formation of the conduits causes a portion of the dielectric to convert from a first phase to a second phase. The method also includes removing at least a portion of the second phase of the dielectric from the porous layer of material.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

Abstract: A transport system for delivery or retrieval of a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator transport system includes a docking cap supported by a bearing within a bearing housing. The bearing allows relative rotation between a torque shaft connected to the docking cap and an outer catheter connected to the bearing housing. The bearing housing and the docking cap include respective bearing retainers that constrain the bearing within the bearing housing without a weld attachment. The weldless retainers of the biostimulator transport system provide a robust mechanical securement of the bearing that is not vulnerable to corrosion. Other embodiments are also described and claimed.

Abstract: Disclosed herein is an IMD configured to communicate with another IMD and/or an external device using conducted communication. The fully-differential receiver has a pair of inputs, a pair of outputs, and a plurality of active stages therebetween. The pair of inputs of the fully-differential receiver are coupled to electrodes of the IMD. The fully-differential receiver is configured to operate in first and second modes. When operating in the first mode, the fully-differential receiver draws a first amount of current and is configured to monitor for a wakeup signal within a first frequency range. When operating in the second mode, the fully-differential receiver draws a second amount of current that is higher than the first amount of current, and is configured to receive one or more message content pulses within a second frequency range that is higher than the first frequency range.

Abstract: Computer-implemented methods and systems are provided that receive, at an implantable medical device (IMD), a programming package comprising a collection of configuration change requests, transaction credentials, and a signature indicative of a source of the programming package. The transaction credentials include a first hash of the collection of configuration change requests. The IMD validates an external device as the source by decrypting the signature using a key that is uniquely associated with the external device. The IMD verifies the transaction credentials and the configuration change requests of the programming package, and generates a second hash of the collection of configuration change requests. Responsive to both (i) the second hash matching the first hash and (ii) the transaction credentials and the configuration change requests being verified, the IMD executes the collection of configuration change requests to update an operating configuration of the IMD.

Abstract: Described herein are methods, devices, and systems for identifying false R-R intervals, and false arrhythmia detections, resulting from R-wave undersensing or intermittent AV conduction block. Each of one or more of the R-R intervals is classified as being a false R-R interval in response to a duration the R-R interval being greater than a first specific threshold, and the duration the R-R interval being within a second specified threshold of being an integer multiple of at least X other R-R intervals for which information is obtained, wherein the integer multiple is at least 2, and wherein X is a specified integer that is 1 or greater. When performed for R-R intervals in a window leading up to a detection of a potential arrhythmic episode, results of the classifying can be used to determine whether the potential arrhythmic episode was a false positive detection.

Abstract: A system and method for monitoring heart function based on heart sounds (HS) is provided. The system includes electrodes configured to sense electrical cardiac activity (CA) signals over a period of time. An HS sensor is configured to sense HS signals over the period of time. The system includes memory to store specific executable instructions and includes one or more processors that, when executing the specific executable instructions, is configured to: identify a characteristic of interest (COI) of a heartbeat from the CA signals. The processors overlay a HS search window onto an HS segment of the HS signals based on the COI from the CA signals and calculate a center of mass (COM) for at least one of S1 or S2 HS based on the HS segment of the HS signals within the search window to obtain a corresponding at least one of S1 COM or S2 COM.

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 leadless biostimulator includes a housing, and distal and proximal electrodes disposed on or integrated into the housing. The distal electrode includes an electrode body and an electrode tip mounted on a distal end of the electrode body, wherein the electrode tip is electrically conductive and configured to be placed in contact with a stimulation site. The electrode tip includes a distal tip end facing a surrounding environment and opposite a proximal tip end. The electrode tip defines a tip hole extending through the electrode tip along a longitudinal axis of the housing from the distal tip end to the proximal tip end. The tip hole comprises a through hole having a first diameter at the distal tip end and a second diameter at the proximal tip end of the tip electrode, wherein the first diameter of the tip hole is less than the second diameter of the tip hole.