Abstract: Systems and methods are disclosed to an ambulatory medical device. The ambulatory medical device comprising an activity sensor configured to produce an activity signal representative of activity level of a patient, a heart sound sensor configured to produce a heart sound signal, and a control circuit. The control circuit is configured to detect a change in activity level of the patient using the activity signal, enable monitoring of the heart sound signal in response to detecting the change in activity level, measure intensity of an S3 heart sound in the heart sound signal, and produce an indication of pulmonary hypertension (PH) when the measured intensity of the S3 heart sound exceeds a PH detection threshold intensity.

Abstract: Systems and methods for monitoring heart failure (HF) status in a patient are discussed. An exemplary system includes a gait analyzer circuit than can receive gait or balance information, and generate a gait feature such as gait speed or a gait pattern. The system includes a HF detector circuit that can detect patient HF status, or to predict patient risk of a future worsening heart failure (WHF) event, using the gait feature. In some examples, the system may trigger sensing physiologic information according to the detected gait, and detect patient HF status using the sensed physiologic information. The system can initiate or adjust a heart failure therapy according to the HF status or the WHF risk.

Abstract: Embodiments of the present disclosure relate to imaging a body part using sounds. In embodiments, a system comprises a motion sensor and a processing device communicatively coupled to the motion sensor. The motion sensor is configured to sense an acceleration wave produced by a sound emitted by a source and generate acceleration measurements in response to sensing the acceleration wave, wherein the source is associated with the body part of a subject. The processing device is configured to receive the acceleration measurements and determine a location of the source using a location of the motion sensor and the acceleration measurements. In addition, the processing device is configured to image the body part of the subject using the determined location of the source and the acceleration measurements.

Abstract: An ambulatory medical device includes a multi-axis posture sensor and processing circuitry. The multi-axis posture sensor is configured to provide an electrical posture sensor output representative of alignment of respective first, second, and third non-parallel axes of the ambulatory medical device with the gravitational field of the earth. The processing circuitry is configured to determine that the subject avoids lying on their left side using the posture sensor output, and compute a metric predictive of one or both of orthopnea and trepopnea in response to determining that the subject avoids lying on their left side.

Abstract: Systems and methods for monitoring heart failure status in a patient are discussed. A medical-device system receives physiological and clinical information of the patient, and classifies the patient into one of a plurality of phenotypes using the received information. The plurality of phenotypes each can be characterized by a cluster physiological, clinical, demographic, or comorbidity features in a multi-dimensional feature space. Based on the classified phenotype, a heart failure detector determines a heart failure detection setting for the patient, and detects a heart failure status in the patient using the heart failure detection setting. A therapy circuit can deliver or adjust a heart failure therapy in response to the detected heart failure status.

Abstract: Systems and methods for detecting and managing heart failure are discussed. A medical-device system receives heart sound information sensed from the patient, generates a heart sound metric using the received heart sound information, and generate a heart failure indicator indicating whether the patient has a heart failure with preserved ejection fraction (HFpEF) or a heart failure with reduced ejection fraction (HFrEF) based at least in part on the heart sound metric. The medical-device system can detect a transition from HFpEF to HFrEF. A therapy circuit can deliver or adjust a heart failure therapy in response to the detected transition from HFpEF to HFrEF.

Abstract: Systems and methods for monitoring heart failure status in a patient are discussed. A medical-device system includes a storage device to store a correspondence between one or more heart failure comorbidities and corresponding one or more heart failure detection settings, and a heart failure detector circuit to detect a heart failure status of the patient. The heart failure detector circuit receives physiological information and heart failure comorbidity information of the patient, determines a detection setting for the patient based on the received comorbidity information and the stored correspondence, and detect a heart failure status using the received physiological information and the identified detection setting. A therapy circuit can deliver or adjust a heart failure therapy in response to the detected heart failure status.

Abstract: Systems and methods for recognizing and classifying breathing patterns based on spatial analysis of chest wall or abdominal movement or acceleration are described. A medical-device system comprises a receiver circuit to receive respiration information of a patient, and a breath analyzer circuit to determine from the respiration information two or more spatial respiration components, such as accelerations of chest wall or abdominal movement in respective directions along the anatomical axes. The breath analyzer circuit can classify a breathing pattern as one of either chest breathing or diaphragmatic breathing based on the determined spatial respiration components. The classified breathing pattern can be used for detecting a physiological event such as worsening heart failure or for assessing the patient's risk of having metabolic disorders.

Abstract: Systems, devices, and methods for monitoring and assessing blood glucose level in a patient are discussed. An exemplary system receives physiologic information from a patient using an ambulatory medical device. The physiologic information is correlated to, and different from, a direct glucose level measurement. The system determines a glucose index indicative of an abnormal blood glucose level using the received physiologic information by the two or more physiologic sensors. The system may use the glucose index to initiate or adjust a therapy, or to trigger a glucose sensor, separate from the two or more physiologic sensors, to directly measure blood glucose concentration.

Abstract: A method includes obtaining test criteria for a monitor configured to be attached to a user; obtaining reference data; determining, based on the test criteria and the reference data, a detached state of the monitor. The determining the detached state includes performing a set of tests indicated in the test criteria. The set of tests includes a first test corresponding to a first power consumption by the monitor; and a second test different from the first test. The second test corresponds to a second power consumption by the monitor, and the second power consumption is larger than the first power consumption. The method further includes automatically modifying, in response to the determining the detached state, an operating mode of the monitor.

Abstract: A medical system may include a left atrial appendage closure device including an expandable framework and a proximal hub centered on a central longitudinal axis of the framework. An insert may be disposed within the proximal hub and include a collar configured to engage the proximal hub, a recess extending into the insert from a proximal end, and a post member disposed within the recess. The post member may be radially spaced apart from the collar and may extend proximally from a distal end of the recess to a proximal surface. The insert may include a first connection structure disposed distal of the proximal surface. The medical system may include a delivery catheter having a second connection structure configured to engage the first connection structure in a delivery configuration. The distal end of the delivery catheter includes a hollow portion configured to receive the post member in the delivery configuration.

Abstract: Disclosed are medical devices with an acceleration sensor for generating acceleration data, at least two electrodes for generating electrocardiogram (ECG) data, a processor, and memory. The memory, which may be a non-transitory computer readable medium, contains computer-executable instructions that, when executed by the processor, causes the processor to perform the following: obtain the acceleration data and the ECG data from a first range of time and a second range of time different from the first range, generate respiration data based on the acceleration data, and determine that the medical device has flipped in orientation during the second range of time by comparing the respiration data and the ECG data of the first range of time with the respiration data and the ECG data of the second range of time.

Abstract: Systems and methods for monitoring patients with respiratory diseases are described. A system may include a sensor circuit configured to sense one or more physiological signals indicative of respiratory sounds, and a spectral analyzer to generate first and second spectral contents at respective first and second frequency bands. The system may produce a respiratory anomaly indicator using the first and second spectral contents, or additionally with other physiological parameters. The system may detect an onset or progression of a target respiratory condition such as asthma or chronic obstructive pulmonary disease using the respiratory anomaly indicator, or to trigger or adjust a therapy.

Abstract: Systems and methods for detecting heart sound information from a subject's head are described. A system embodiment includes a headgear to be worn on the subject's head, and first and second sensors to sense respectively first and second physiologic signals each representing vibration, motion, or displacement conducted through patient body tissue. The sensed physiologic signals contain heart sound information. At least one of the first or the second sensor is included in the headgear, and placed at a head location to sense a physiologic signal indicative of heart sounds. The system includes a processor to generate a composite signal using the sensed first and second physiologic signals. The system may generate a heart sound metric using the composite signal, and detect a cardiac event such as an arrhythmia or worsening heart failure.

Abstract: A system and method for communication between an IMD and an external reader includes bringing a portion of a patient's body into contact with a device-body contact surface of an external reader. The reader transmits a first transdermal carrier wave from the contact surface into the patient's body, where the first carrier wave includes a request for communication with the IMD. The transdermal carrier waves are electrical conductive waves, optical waves, or acoustic waves. Upon detection of the first carrier wave, the IMD transmits a second transdermal carrier wave including a request for an access key from the reader and the reader replies by transmitting a third transdermal carrier wave including the access key back to the IMD. If the access key is valid, the IMD transmits information by radio frequency (RF) in an RF communication mode or a fourth transdermal carrier wave including data from the IMD.

Abstract: Systems and methods for detecting a physiological event or estimating a physiological parameter using ambulatory electrograms of a subject are discussed. An exemplary system includes a computing device that can receive ambulatory electrograms collected by an ambulatory medical device (AMD) associated with a subject, and apply the ambulatory electrograms to a trained machine learning model to estimate a physiological parameter or to detect a physiological event in the subject. The same or a different machine learning model can be trained to detect an operating status of the AMD using the ambulatory electrograms. The system comprises an output device to output the estimated physiological parameter, the detected physiological event, or the detected device operating status a user or a process such as to initiate or titrate a therapy.

Abstract: A medical system includes a physiological monitoring system configured to sense a physiological signal and record physiological signal data indicative of the patient's physiological state. The physiological monitoring system including a controller, a storage device, at least one sensor operatively coupled to the controller, and a first communication component. The system includes a mobile device configured to facilitate sensor placement, the mobile device comprising a controller, a display device, and a second communication component configured to facilitate communication between the physiological monitoring system and the mobile device. The controller of the mobile device is configured to provide a graphical user interface (GUI) on the display device, the GUI including information about a proper placement of the at least one sensor, wherein the proper placement is determined based on the physiological signal data.

Abstract: Embodiments herein relate to sensor based authentication between an implantable medical device (IMD) and an external device. In an embodiment, the IMD includes a wireless communication module and an internal inertial measurement unit (IMU) capable of measuring vibrations, movement, or rotation. The IMD is configured to record an internal IMU signal from the internal IMU. The external device includes a wireless communication module and an external IMU. The external device is configured to record an external IMU signal from the external IMU. The system further includes a data processing system to receive a first level communication that can include the internal IMU signal, the external IMU signal, or both, compare data from the internal IMU signal with data from the external IMU signal, and authorize a second level communication based on results of the comparison step.

Abstract: This document discusses, among other things, systems and methods to determine an indication of heart failure with preserved ejection fraction (HFpEF) of a subject using a determined change in cardiac acceleration information of the subject at exertion relative to cardiac acceleration information of the subject at rest. The system can include a signal receiver circuit configured to receive cardiac acceleration information of a subject and exertion information of the subject, and an assessment circuit configured to determine the change in cardiac acceleration information of the subject at exertion relative to cardiac acceleration information of the subject at rest, and to determine an indication of HFpEF of the subject using the determined change in cardiac acceleration information.

Abstract: A medical system for monitoring a left atrial pressure in a heart of a patient may include an implantable device including an expandable framework and a first sensor secured to the expandable framework and an external component configured to communicate wirelessly with the implantable device. The first sensor may be configured to detect a first measurement. The first sensor may be a pressure sensor and the first measurement may be the left atrial pressure. The implantable device or the external component may include a processor configured to create a first trend for the first measurement. The processor may be configured to use the first trend to modify the first measurement prior to outputting a corrected result.