Abstract: Described herein are methods, devices, and systems that use electrogram (EGM) or electrocardiogram (ECG) data for sleep apnea detection. An apparatus and method detect potential apnea events (an apnea or hypopnea event) using a signal indicative of cardiac electrical activity of a patient's heart, such as an EGM or ECG. Described herein are also methods, devices, and systems for classifying a patient as being asleep or awake, which can be used to selectively enable and disable sleep apnea detection monitoring, as well as in other manners.

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: The present invention relates to a composition, for prevention or treatment of cancer diseases, comprising CD8+ T cells activated by CD4+ T cell-derived extracellular vesicles as an active ingredient. It was found that the secretion of extracellular vesicles from cytokine-activated CD4+ T cells increases and the extracellular vesicles enhance proliferation and activity of CD8+ T cells to induce the death of cancer cells, thereby augmenting an anticancer effect. Thus, the present invention provides the CD8+ T cells activated by CD4+ T cell-derived extracellular vesicles as a pharmaceutical agent or an immunotherapeutic agent for cancer diseases, and a method for activating CD8+ T cells by using CD4+ T cell-derived extracellular vesicles to prepare CD8+ T cells showing excellent anticancer activity as described above.

Abstract: Described herein are methods for use with an implantable system including at least an atrial leadless pacemaker (aLP). Also described herein are specific implementations of an aLP, as well as implantable systems including an aLP. In certain embodiments, the aLP senses a signal from which cardiac activity associated with a ventricular chamber can be detected by the aLP itself based on feature(s) of the sensed signal. The aLP monitors the sensed signal for an intrinsic or paced ventricular activation within a ventricular event monitor window. In response to the aLP detecting an intrinsic or paced ventricular activation itself from the sensed signal within the ventricular event monitor window, the aLP resets an atrial escape interval timer that is used by the aLP to time delivery of an atrial pacing pulse if an intrinsic atrial activation is not detected within an atrial escape interval.

Abstract: A system is provided that includes a first electrode configured to be located within a septal wall, and a second electrode configured to be located outside of the septal wall. The system also includes an impedance circuit configured to measure impedance along an impedance monitoring (IM) vector between the first and second electrodes. One or more processors are also provided that are configured to obtain impedance data indicative of an impedance along the IM vector with the first electrode located at different depths within the septal wall, the impedance data including a set of data values associated with different depths of the first electrode within the septal wall. The one or more processors are also configured to determine when the first electrode is located at a target depth within the septal wall based on the impedance data.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: The present invention relates to a composition containing IL-2 or an expression promoter or activator thereof as an active ingredient for prevention or treatment of cancer disease. In the present invention, it was discovered that when treating cancer cells with IL-2, an anticancer effect was enhanced by inhibiting the secretion of cancer cell-derived exosomes and the expression of PD-L1 inducing immune escape of T cells. IL-2 was also discovered to effectuate the anticancer effect directly on cancer cells compared to conventional techniques exhibiting an immune anticancer effect by activating cytotoxic T cells. Thus, IL-2 or an expression promoter or activator thereof can be advantageously used in a composition for prevention or treatment of cancer diseases.

Abstract: Described herein are apparatuses and methods for classifying a patient as being asleep or awake. Such an apparatus can include an accelerometer and a processor. The accelerometer, alone or in combination with the processor, is used to determine an activity level of the patient and a posture of the patient. The processor is configured to classify the patient as being asleep in response to both (i) the posture of the patient being recumbent or reclined for at least a sleep latency duration, and (ii) the activity level of the patient not exceeding an activity threshold for at least the sleep latency duration; and classify the patient as being awake in response to at least one of (iii) the posture of the patient being upright for at least an awake latency duration, or (iv) the activity level of the patient exceeding the activity threshold for at least the awake latency duration.

Abstract: A method and device for dynamic device based AV delay adjustment are provided. The method provides electrodes that are configured to be located proximate to an atrial (A) site and a right ventricular (RV) site. The method utilizes one or more processors, in an implantable medical device (IMD), for detecting an atrial paced (Ap) event or atrial sensed (As) event. The method determines a measured AV interval corresponding to an interval between the Ap event or the As event and a ventricular sensed event and calculates a percentage-based (PB) offset based on the measured AV interval. The method automatically dynamically adjusting an AV delay, utilized by the IMD, based on the measured AV interval and the PB offset and manages a pacing therapy, utilized by the IMD, based on the AV delay after the adjusting operation.

Abstract: Described herein are methods, devices, and systems that use electrogram (EGM) or electrocardiogram (ECG) data for sleep apnea detection. An apparatus and method detect potential apnea events (an apnea or hypopnea event) using a signal indicative of cardiac electrical activity of a patient's heart, such as an EGM or ECG. Variations in one or more morphological or temporal features of the signal over several cardiac cycles are determined and used to detect a potential apnea event in a measurement period. Checks can then be made for a number of factors which could result in a false detection of an apnea event and if such factors are not present, an apnea event is recorded. Described herein are also methods, devices, and systems for classifying a patient as being asleep or awake, which can be used to selectively enable and disable sleep apnea detection monitoring, as well as in other manners.

Abstract: An implantable medical device and computer implemented methods comprise a sensing circuit configured to sense cardiac activity (CA) signals. An accelerometer is configured to be implanted in a patient and obtain accelerometer data along at least one axis. A memory is configured to store program instructions and device parameters associated with each ventricular arrhythmia (VA) therapy in a collection of VA therapies with different levels of intensity. One or more processors execute the program instructions and are configured to analyze the CA signals over one or more cardiac beats, determine a VA episode based on the analysis of the CA signals, determine a posture of the patient based on the accelerometer data in response to the determination of the VA episode, and select a first VA therapy from the collection of VA therapies based on the posture.

Abstract: System for arrhythmia detection and confirmation includes implantable medical device (IMD) having a sensing circuit for sensing cardiac activity (CA) for one or more cardiac cycles and generating one or more CA signals. An implantable pressure sensor (IPS) includes IPS sensing circuit for sensing pressure during the one or more cardiac cycles and generating one or more pressure signals. IMD and IPS include communications circuits for communicating with each other and/or an external device. One or both of IMD or IPS includes memory for storing program instructions and processor(s) for analyzing one of the CA or pressure signals, for one or more cardiac cycles, to detect a candidate arrhythmia. In response to detecting candidate arrhythmia, the processor(s) obtain another one of CA or pressure signals for cardiac cycles corresponding to the one or more cardiac cycles, and confirm or deny candidate arrhythmia based on the other one of the signals.

Abstract: A method and device for dynamic device based AV delay adjustment are provided. The method provides electrodes that are configured to be located proximate to an atrial (A) site and a right ventricular (RV) site. The method utilizes one or more processors, in an implantable medical device (IMD), for detecting an atrial paced (Ap) event or atrial sensed (As) event. The method determines a measured AV interval corresponding to an interval between the Ap event or the As event and a ventricular sensed event and calculates a percentage-based (PB) offset based on the measured AV interval. The method automatically dynamically adjusting an AV delay, utilized by the IMD, based on the measured AV interval and the PB offset and manages a pacing therapy, utilized by the IMD, based on the AV delay after the adjusting operation.

Abstract: Computer implemented methods and systems for monitoring cardiac activity (CA) signals, for a series of beats, over first and second sensing channels having different first and second detection thresholds, respectively. The methods and systems also include analyzing the CA signals over the first and second sensing channels utilizing the first and second detection thresholds, respectively, during an event prediction window to detect a presence of sensed events. The methods and systems also include determining amplitudes of the sensed events detected. The methods and systems also include calculating at least one of an amplitude distribution or amplitude trend for the sensed events detected over the first and second channels and adjusting at least one of the first or second detection thresholds based on the at least one of the amplitude distribution or amplitude trend.

Abstract: A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes a burrowing nose to allow the biostimulator to embed within a target tissue. The embedded biostimulator has a reduced exposed length within a heart chamber, and is less likely to interfere with adjacent heart structures. Embodiments include burrowing ridges on a nose or a housing of the biostimulator to affix the embedded biostimulator to the target tissue. Other embodiments are also described and claimed.

Abstract: Methods and implantable medical devices (IMDs) are provided for monitoring a cardiac function of a heart. A heart sound sensor is configured to sense heart sound signals of the subject. The IMD includes a memory to store program instructions. The IMD includes a processor that, when executing the program instructions, is configured to identify S2 signal segment from the heart sound signals, analyze the S2 signal segment to identify a pulmonary valve signal (P2 signal) and an aortic valve signal (A2 signal) within an S2 signal segment of the heart sound signals. The processor is configured to determine a time interval between the A2 and P2 signals, characterize the S2 signal segment to exhibit a first type of S2 split based on the time interval, and identify a cardiac condition based on a comparison of the first type of S2 split and a cardiac condition matrix.

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: A biostimulator and a pace mapping system for deep septal pacing. The biostimulator includes a pacing element that extends distally beyond a fixation element. The pacing element is insulated between a distal tip of the fixation element and a distal portion of the pacing element. The pace mapping system can be used to determine a distance between a septal wall of a heart septum and a bundle branch within the septum. The pacing element can be selected based on the distance, and delivered into the septum to pace the bundle branch. Other embodiments are also described and claimed.

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: 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.