Abstract: A wearable medical device configured to monitor a patient for cardiac arrhythmias includes a water-resistant belt, ECG sensing electrodes, and therapy electrodes discrete from the ECG sensing electrodes. At least some of the ECG sensing electrodes and therapy electrodes are disposed on one or more common adhesive backings configured to be adhesively attached to the patient's torso. The wearable medical device also includes an elongated cable, including a removable connector, and a control unit configured to be removably electrically coupled to the electrodes via the removable connector. The control unit is configured to monitor a sensed ECG of the patient, and responsive to a detection of cardiac arrhythmia, provide at least one defibrillating pulse to at least one of the therapy electrodes. The control unit is housed in a waterproof case formed from a waterproof material that is sealed to prevent ingress of water during operation in a wet environment.

Abstract: A remote alarm for use with a wearable medical device. The remote alarm is configured to receive alarms, voice messages and prompts issued by the wearable medical device and to repeat those alarms, voice messages and prompts in a manner that can more easily be perceived by a patient wearing the wearable medical device or a bystander. The remote alarm can be configured to receive a communication from the wearable medical device, and in response, to identify one or more messages to be provided to the patient or a bystander. The messages may be provided audibly, visually, tactilely or combinations thereof. The remote alarm may further be configured to take certain actions depending upon the content of the communication, such as sending a telephone message to alert emergency personnel to the identity, location and medical condition of the patient, or sending an email.

Abstract: A wearable arrhythmia monitoring and treatment device for improving confidence in determined arrhythmias prior to treatment includes a plurality of sensing electrodes, one or more therapy electrodes, and an electrode signal acquisition circuit having a plurality of inputs. The electrode signal acquisition circuit is configured to sense a respective signal provided by each of a plurality of different pairings of the plurality of sensing electrodes. The wearable arrhythmia monitoring and treatment device includes a monitoring and detection circuit including at least one processor configured to analyze the respective signals provided by each of the plurality of different pairings of the plurality of sensing electrodes, change a confidence level in a determined arrhythmia condition based on the respective signals provided by the plurality of different pairings of the plurality of sensing electrodes, and initiate a therapy to the patient via the one or more therapy electrodes based on the confidence level.

Abstract: An ambulatory medical device capable of delivering therapy to a patient is provided. The ambulatory medical device comprises at least one controller operatively connected to at least one sensor configured to detect a health disorder of the patient, at least one treatment element configured to deliver therapy to the patient, and at least one response mechanism configured to be actuated by the patient, the at least one response mechanism having one of a first state and a second state. The at least one controller being configured to delay delivery of the therapy to patient for a first predetermined period of time responsive to detection of the health disorder and the at least one response mechanism having the first state, and to deliver the therapy to the patient in response to continued detection of the health disorder, the at least one response mechanism remaining in the first state.

Abstract: In at least one example, a medical device is provided. The medical device includes at least one therapy electrode, at least one electrocardiogram (ECG) electrode, at least one acoustic sensor, and at least one processor coupled with the at least one acoustic sensor, the at least one ECG electrode, and the at least one therapy electrode. The at least one processor can receive at least one acoustic signal from the at least one acoustic sensor, receive at least one electrode signal from the ECG electrode, detect at least one unverified cardiopulmonary anomaly using the at least one electrode signal, and verify the at least one unverified cardiopulmonary anomaly with reference to data descriptive of the at least one acoustic signal.

Abstract: A wearable treatment device for monitoring physical activity and providing therapy to a subject includes a garment, cardiac sensing electrodes configured to detect cardiac information for the subject, at least one activity sensor configured to monitor at least one of motion or position for the subject, treatment electrodes configured to deliver treatment shocks to the subject, and a controller. The controller is configured to guide the subject through a physical activity, measure the subject's performance of the physical activity using the detected cardiac information for the subject and the monitored at least one of motion or position for the subject, monitor the detected cardiac information for the subject to identify whether the subject is experiencing a treatable arrhythmia, and determine a confidence level for an identified treatable arrhythmia using the monitored at least one of motion or position for the subject.

Abstract: A patient management system for generating customized patient reports for users is provided. The system includes communications circuitry configured to receive first physiological data from a plurality of monitoring medical devices and receive second physiological data from a plurality of therapeutic medical devices. The system also includes at least one processor configured to perform instructions configured to cause the at least one processor to receive a selection from an end user regarding a customized report on at least one of the first physiological data from the plurality of monitoring medical devices or the second physiological data from the plurality of therapeutic medical devices, determine at least one information field for the customized report based on an access level of the end user, and compile the customized report including the at least one information field and using the at least one of the first physiological data or the second physiological data.

Abstract: A wearable medical device includes a waterproof harness, a plurality of ECG sensing electrodes configured to detect a patient's ECG, and a plurality of therapy electrodes configured to provide at least one biphasic shock to the patient. The device includes a control unit in electronic communication with the ECG sensing electrodes and therapy electrodes and configured to monitor the sensed ECG and, in response to detecting a cardiac arrhythmia, provide the biphasic shock(s). The control unit is comprised within a waterproof case. The device includes a water-resistant or waterproof connection pod that is configured to electrically couple the ECG sensing electrodes, therapy electrodes, and control unit. The connection pod provides the sensed ECG signal to the control unit and the biphasic shock current to the therapy electrodes. The device includes a user interface device in electronic communication with the control unit that includes at least one patient responsiveness button.

Abstract: A wearable medical device for detecting and treating life-threatening arrhythmias includes a wearable vest portion, sensing electrodes, therapy pads, at least one motion sensor, and a cardiac monitor. The cardiac monitor is configured to detect whether the patient is experiencing a treatable arrhythmia using an ECG signal and in response, determine a confidence level for the detected treatable arrhythmia using outputs from the at least one motion sensor. Determining the confidence level includes detecting patient motion prior to the detection of the treatable arrhythmia. Determining the confidence level further includes increasing the confidence level in response to determining that the patient is motionless coinciding with the detection of the treatable arrhythmia, or decreasing the confidence level in response to determining the patient motion after the detection of the treatable arrhythmia. The cardiac monitor is configured to determine whether to deliver a treatment shock based on the confidence level.

Abstract: A wearable monitoring and therapeutic device includes at least two sensing electrodes, including at least one of conductive thread sewn into a garment and/or a metallic surface sewn into the garment. The device includes at least two therapy electrodes and the garment, wherein the garment is configured to be worn about a torso of a subject. The garment includes a breathable and stretchable fabric, an elastic material, and a loose material. The device includes at least one defibrillator component including a power source, a conductive wiring configured to stretch to accommodate the subject's chest size and enhance comfort and couple any of the at least two therapy electrodes and the at least two sensing electrodes to the at least one defibrillator component, an alarm module operatively coupled to the at least one defibrillator component, and one or more response buttons operatively coupled to that at least one defibrillator component.

Abstract: An ambulatory medical device includes two or more response mechanisms; a memory storing an active operation mode parameter identifying an active operation mode from a plurality of operation modes; a controller connected with the two or more response mechanisms; and a therapy manager component executable by the controller and configured to identify the active operation mode, detect a physiological parameter indicative of a health disorder of the patient, request that the patient change the state of one of the two or more response mechanisms in response to detection of the physiological parameter, monitor the state of each of the two or more response mechanisms within a first predetermined period, and delay therapy to the patient in response to detection of a first change in the state of one of the two or more response mechanisms within the predetermined period and identification of a first mode as the active operation mode.

Abstract: A non-invasive bodily-attached ambulatory medical monitoring and treatment device with pacing is provided. The noninvasive ambulatory pacing device includes a battery, at least one therapy electrode coupled to the battery, a memory storing information indicative of a patient's cardiac activity, and at least one processor coupled to the memory and the at least one therapy electrode. The at least one processor is configured to identify a cardiac arrhythmia within the information and execute at least one pacing routine to treat the identified cardiac arrhythmia.

Abstract: A system including an ambulatory medical treatment device is provided. The ambulatory medical treatment device includes a memory, a treatment component configured to treat a patient, at least one processor coupled to the memory and the treatment component, a user interface component, and a system interface component. The user interface component is configured to receive an update session request and to generate the update session identifier responsive to receiving the request. The system interface component is configured to receive an encoded request including an identifier of an update session and device update information, to decode the encoded request to generate a decoded request including the device update information and the identifier of the update session, to validate the decoded request by determining that the update session identifier matches the identifier of the update session, and to apply the device update information to the ambulatory medical treatment device.

Abstract: A wearable medical device comprises a harness, a therapy electrode and an electrocardiogram (ECG) sensing electrode included within the harness, an audio transducer coupled to the therapy electrode or to the ECG electrode and configured to monitor heart sounds of a user of the wearable therapeutic device, and a controller configured to receive signals from the audio transducer regarding the heart sounds of the user and to transmit data regarding the heart sounds to an external system for processing and analysis.

Abstract: A wearable defibrillator for use in monitoring patient movement and cardiac activity and treating a patient includes a garment configured to be worn by the patient, treatment electrodes configured to apply an electric current to the patient, and an alarm module configured to provide audio, visual, and haptic notifications. The notifications are configured to indicate that an electric current will be administered imminently and prompt the patient to provide a response input. The wearable defibrillator includes a motion sensor configured to detect motion and body position of a patient, and a controller in electrical communication with the alarm module and the motion sensor. The controller is configured to monitor for the response input after the prompt, determine, based on the detected motion and body position, whether the patient is sleeping, and cause a change in one or more characteristics of the prompt on determining that the patient is sleeping.

Abstract: Disclosed is a wearable cardiac therapeutic system including a plurality of therapy electrodes disposed in a garment and a fluid pressure source including a barrel configured to house the conductive gel and an actuation mechanism. A therapy controller is configured to detect an arrhythmic event in a patient based on sensed electrical activity of the patient's heart, initiate an activation signal indicating that the conductive gel is to be released on to the body of the patient, and cause the delivery of one or more electrical therapeutic shocks to the heart of the patient. Gel activator circuitry is configured to receive the activation signal from the therapy controller, and cause the fluid pressure source to expel the conductive gel onto the body of the patient proximate the one or more of the therapy electrodes and prior to the delivery of the one or more electrical shocks to the patient.

Abstract: A wearable therapeutic device to facilitate care of a subject is provided. The wearable therapeutic device can include a garment having a sensing electrode. The garment includes at least one of an inductive element and a capacitive element, and a controller identifies an inductance of the inductive element or a capacitance of the capacitive element, and determines a confidence level of information received from the sensing electrode based on the inductance or the capacitance. The wearable therapeutic device also includes an alarm module coupled with the controller and configured to provide a notification to a subject based on the confidence level.

Abstract: A patient management system for generating customized patient reports for users is provided. The system includes communications circuitry configured to receive first physiological data from a plurality of monitoring medical devices and receive second physiological data from a plurality of therapeutic medical devices. The system also includes at least one processor configured to perform instructions configured to cause the at least one processor to receive a selection from an end user regarding a customized report on at least one of the first physiological data from the plurality of monitoring medical devices or the second physiological data from the plurality of therapeutic medical devices, determine at least one information field for the customized report based on an access level of the end user, and compile the customized report including the at least one information field and using the at least one of the first physiological data or the second physiological data.

Abstract: In one example, an ambulatory medical device is provided. The ambulatory medical device includes a plurality of subsystems, at least one sensor configured to acquire data descriptive of a patient, a user interface and at least one processor coupled to the at least one sensor and the user interface. The at least one processor is configured to identify subsystem status information descriptive of an operational status of each subsystem of the plurality of subsystems and to provide a device health report for the ambulatory medical device via the user interface, the device health report being based on the operational status of each subsystem.

Abstract: A wearable therapeutic device is provided. The wearable therapeutic device includes a garment, and the garment includes an electrode and a conductive thread. A control unit is coupled to the conductive thread and identifies an electrical connection between a conductive surface of the electrode and the conductive thread, and an alarm module can provide information about the positioning of the electrode in the garment based on the electrical connection.