Abstract: Leadless pacemakers (LPs) and methods and systems for use therewith are disclosed. During a first period of time, during which an LP receives event messages from a second LP, the LP times its pacing of a first cardiac chamber based on the event messages received from the second LP so that AV synchrony is maintained, and the LP determines and stores count value(s). Based on at least one of the count value(s), the LP determines a compensation offset indicative of a drift between timing circuitry of the LP and timing circuitry of the second LP. During a second period of time, during which the LP does not receive event messages from the second LP, the LP times its pacing of the first cardiac chamber based on the compensation offset to thereby compensate for the drift so that the AV synchrony is also maintained during the second period of time.

Abstract: Leadless pacemakers (LPs) and methods and systems for use therewith are disclosed that are specifically for use with a multi (e.g., dual) chamber LP system that performs AAI+VVI operation. More specifically, an atrial LP (aLP) and a ventricular LP (vLP) collectively provide the AAI+VVI operation. Additionally, at least one of the aLP or the vLP determines a compensation offset and uses the compensation offset to compensate for drift between timing circuitry of the atrial LP and timing circuitry of the vLP while the aLP and the vLP are providing for AAI+VVI operation, so that synchronization between atrial and ventricular pacing is maintained whenever the vLP delivers ventricular pacing during two or more consecutive cardiac cycles during the AAI+VVI operation.

Abstract: An implantable lead includes an inner lead subassembly contained within and movable relative to an outer lead subassembly. The inner lead subassembly has a helical electrode to pace a target anatomy. The outer lead subassembly includes a ring electrode to sense or pace the target anatomy. A threaded interface interconnects the inner lead subassembly and the outer lead subassembly such that relative rotation of the lead subassemblies causes relative axial movement between the helical electrode and the ring electrode. Other embodiments are also described and claimed.

Abstract: The present disclosure provides systems and methods for applying anti-tachycardia pacing (ATP) using subcutaneous implantable cardioverter-defibrillators (SICDs). An SICD implantable in a subject includes a case including a controller, and at least one conductive lead extending from the case. The at least one conductive lead includes a plurality of coil electrodes, wherein the SICD is configured, via the controller, to apply anti-tachycardia pacing (ATP) to the subject using the at least one conductive lead.

Abstract: A loading tool for loading a biostimulator onto a biostimulator delivery system is described. The loading tool includes a first body portion and a second body portion connected by a hinge. A latch is mounted on the first body portion, and the latch can be locked to fasten the first body portion to the second body portion. A biostimulator can be mounted in the loading tool, and a tether of a biostimulator delivery system can be inserted through a funnel in the loading tool to engage the biostimulator. An operator can use only one hand to unlock the latch, open the loading tool, and remove the loading tool from the biostimulator prior to delivering the biostimulator into a patient. Other embodiments are also described and claimed.

Abstract: Implementations described and claimed herein provide systems and methods for delivering and retrieving a leadless pacemaker. In one implementation, a leadless pacemaker has a docking end, and the docking end has a docking projection extending from a surface. A docking cap has a body defining a chamber. A retriever has sheaths extending with lumens distally from the chamber. A snare extends between the lumens forming a first snare loop pointing in a first direction and a second snare loop pointing in a second direction with a docking space formed therebetween. The snare is movable between an engaged position and a disengaged position by translating the first snare wire and the second snare wire within the first snare lumen and the second snare lumen. The engaged position includes the first snare wire and the second snare wire tightened around the docking projection within the docking space.

Abstract: Disclosed herein is an implantable medical device (IMD), system and method for denoising biological signals. The IMD generates a biological signal representative of a physiologic parameter of a patient and normally analyzes the biological signal to detect a characteristic of interest (COI) indicative of a pathophysiologic condition of the patient. The present technology denoises, when the IMD is exposed to a noise causing condition, noisy biological signal segments of the biological signal generated while the IMD is exposed to the noise causing condition using a denoising prediction model to obtain denoised biological signal segments. The denoising prediction model is trained to predict a denoised biological signal segment from a noisy biological signal segment. The denoised biological signal segments can then be analyzed to detect the COI indicative of the pathophysiologic condition of the patient.

Abstract: Described herein is a multi-chamber implantable LP system comprising at least a first LP configured to be implanted in or on a first cardiac chamber, and a second LP configured to be implanted in or on a second cardiac chamber. For each cardiac event, of a plurality of cardiac events associated with the first cardiac chamber, the first LP is configured to determine for the cardiac event whether at least one of a plurality of predetermined conditions is satisfied. Additionally, the first LP is configured to abstain from transmitting a cardiac event message indicative of the cardiac event to the second LP, or transmit the cardiac event message indicative of the cardiac event to the second LP, based on whether there is a determination that at least one of the plurality of predetermined conditions is satisfied. Methods for use with such a multi-chamber implantable LP system are also described herein.

Abstract: A feedthrough assembly for an implantable medical device includes a housing, a solid insert, one or more conductive elements, a metal filler, and a non-corrosive sealant. The housing defines a central cavity through a height of the housing. The solid insert is disposed within the central cavity of the housing. The one or more conductive elements extend through one or more apertures defined within the solid insert and extend through the central cavity of the housing. The metal filler is disposed within a joint defined by an outer surface of the solid insert and an inner surface of the housing that defines the central cavity. The non-corrosive sealant coats a top surface of the metal filler to inhibit corrosion of the metal filler.

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: A healthcare system comprises an MR platform comprising non-transitory memory storing program instructions and patient specific records that include information associated with an implantable medical device (IMD) and a patient. The MR platform has processors that, when executing the program instructions, are configured to i) receive an MRI exam referral requesting an MRI exam associated with a first patient specific record from within the patient specific records that has a first IMD and a first patient; ii) responsive to the MRI exam referral, automatically transmit an MRI exam request alert; iii) responsive to receiving a response to the MRI exam request alert, provide access to the first patient specific record; iv) receive MRI settings associated with the first patient specific record that are configured to be programmed into the first IMD in advance of the MRI exam; and v) store the MRI settings in the patient specific record.

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: Described herein are implantable medical devices (IMDs), and methods for use therewith. In certain embodiments, a controller of an IMD controls when a pacing capacitor of the IMD is charged using a first voltage, when the pacing capacitor is being charged using a second voltage, and when the pacing capacitor is discharged to deliver a pacing pulse between anode and cathode electrodes of, or electrically coupled to, the IMD. By selectively charging the pacing capacitor for a portion of a charge duration using the second voltage, that is greater in magnitude than the first voltage that is used for delivering the pacing pulse, a magnitude of a polarization artifact superimposed on an evoked response within a cardiac electrical signal, sensed using a sensing circuit of the IMD, is reduced compared to if the pacing capacitor were instead charged using the first voltage for the entire charge duration.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, has a header assembly that includes an antenna. A header assembly includes an antenna cap having an antenna loop embedded in a cap body. The cap body includes a dielectric material, and the antenna loop extends about a central channel of the cap body. The central channel extends along a longitudinal axis over a cap length, and the cap body has a cap width transverse to the longitudinal axis. The cap body has an aspect ratio of the cap width to the cap length greater than 1. A header assembly includes an antenna loop of the antenna encased in a header body of the header assembly. The header assembly includes a fixation element. A proximal end of the fixation element is encased in the header body. Other embodiments are also described and claimed.

Abstract: A system for determining a change in position of an implanted medical device (IMD) within an implant pocket is provided. The system includes an accelerometer configured to be implanted in a patient, the accelerometer configured to obtain accelerometer data along at least one axis. The system also includes one or more processors configured to determine the patient is engaging in a determined activity over an activity period, and obtain the accelerometer data during the activity period. The one or more processors are also configured to identify postures of the patient and corresponding posture periods during the activity period based on the accelerometer data, determine a duration related to a non-standing posture identified from the postures identified, and identify a migration of the IMD within the implant pocket based on the duration of the non-standing posture exceeding a duration threshold.

Abstract: A biostimulator delivery system having a tether cable, is described. A connector can be mounted on the tether cable to connect to a biostimulator. The connector can be a protuberance that lodges within the biostimulator, or a threaded connector that screws into the biostimulator. The tether cable has a stranded cable configuration, including several strands extending about a core strand in a helical direction. The stranded cable structure resists breaking under bending stresses typically seen during a tether mode used during delivery of the biostimulator. The tether cable reliably secures the biostimulator to the delivery system in the tether mode. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.

Abstract: A method for controlling an adaptive pacing therapy that includes utilizing one or more processors to perform measuring an atrial-ventricular (AV) interval corresponding to an interval between an atrial paced (Ap) event or an atrial sensed (As) event and a sensed ventricular (Vs) event, setting an AV delay based on the AV interval, and measuring an S1 heart sound characteristic of interest (COI) while utilizing the AV delay in connection with delivering a pacing therapy by the IMD. The one or more processors also perform adjusting the AV delay, repeating the measuring, and adjusting to obtain a collection of S1 heart sound COIs and corresponding AV delays, selecting one of the AV delays, that corresponds to a select one of the S1 heart sound COIs, as a resultant AV delay, and managing the pacing therapy, utilized by the IMD, based on the resultant AV delay.

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: Systems and methods described herein improve visibility of P-waves of an EGM or ECG signal segment to be displayed on a display screen. There is a determination of whether relatively small features, including the P-waves, of the ECG or EGM signal segment would be difficult to visualize if an original signal segment range of the ECG or EGM signal segment were caused to be displayed on the display screen. In response to determining that the relatively small features of the ECG or EGM signal segment would be difficult to visualize, a portion of the EGM or ECG signal segment is displayed on the display screen in a manner that magnifies the P-waves of the EGM or ECG signal segment compared to if an entirety of the EGM or ECG signal segment within the original signal segment range were instead caused to be displayed on the display screen.