Zoll Medical Corporation

Medrad, Inc.

John G Clark

Thomas E Kaib

Shane S Volpe

Edward J Donnelly

Trisha A Pavel

Marshal W Linder

Steven J Szymkiewicz

Patrick Hresko

Grace Owens

Mark F Roberto

Rachel H Carlson

David M Reilly

Alan D Hirschman

Phillip Hier Amsler

Melissa Smith

Ryan D Macel

John A Stulen

Eric M Toft

Ross H Potter

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.

Water resistant wearable medical device

A wearable defibrillator configured to provide changing alarms. The wearable defibrillator includes one or more physiological sensors including one or more ECG electrodes, one or more defibrillator electrodes, and a wearable medical device controller including a memory and at least processor coupled to the memory. The at least one processor is configured to monitor ECG signals from the one or more ECG electrodes, detect a cardiac abnormality in the patient based on the ECG signals, issue an alarm in response to detecting an event of interest, determine that no predetermined response to the issued alarm has been received, analyze information relating to historical alarms issued to the patient and historical patient responses to alarms stored in the memory to determine a patient tendency towards a particular alarm response pattern, and change the issued alarm according to the determined patient tendency towards the particular alarm response pattern.

System and method for adapting alarms in a wearable medical device

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.

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.

Patient assurance system and method

A wearable defibrillator includes one or more environmental sensors including an accelerometer, one or more ECG sensors configured to acquire ECG data, and an alarm manager and at least one processor operatively coupled to the one or more ECG sensors and the accelerometer. The at least one processor is configured to detect a cardiac abnormality in the patient, identify a notification having one or more characteristics, and detect an environmental condition of the wearable defibrillator. The accelerometer is configured to detect a presence or lack of patient motion, and/or detect a body position of the patient as the detected environmental condition. The at least one processor is configured to determine whether one or more factors exist that inhibit the patient's ability to recognize the notification, on determining their existence, adapt the one or more characteristics of the notification and provide an adapted notification, and issue the adapted notification.

A wearable medical device is provided for monitoring the cardiac health of a patient, for example, for indications of cardiac anomalies, where the device includes ECG sensors in electrical contact with the patient's body, therapy electrodes for providing electrical therapy to the patient's heart, and a control unit having at least one touch control with force sensor disposed on its housing for contacting with a finger. Signals from the touch control may be analyzed to identify force application below a first force threshold and at or above a second force threshold below the first force threshold, and, responsive to detecting such application of force, user input may be registered. User inputs to the at least one touch control may be used to delay therapy by the therapy electrodes.

Response mechanisms

According to another example, a wearable medical device controller is provided. The device controller includes a memory and a processor coupled to the memory. The processor is configured to determine a correlation between a phenomenon identifiable by the wearable medical device controller and at least one response pattern associated with a patient and store, responsive to detecting the correlation, an adaptation path to address the at least one response pattern, the adaptation path specifying an adaptation of at least one characteristic of an alarm. The at least one response pattern may include a plurality of response patterns and the adaptation path may reflect adaptations made to address at least some of the plurality of response patterns.

A wearable ambulatory external defibrillator system includes a garment configured to be worn by a patient and including electrocardiogram (ECG) sensing electrodes integrated into the garment, therapy delivery electrodes configured to deliver a therapy, and a wearable medical device controller including at least one processor. The at least one processor is configured to issue a first instance of an alarm in response to an indication of a cardiac abnormality and/or an event concerning one or more components of the system. The first instance of the alarm includes a visual alarm. The at least one processor is further configured to determine that no response to the first instance of the alarm was received within a target response time, adapt at least one characteristic of the alarm, and issue a second instance of the alarm having the at least one adapted characteristic. The second instance of the alarm includes an auditory alarm.

An external medical device is provided which is configured to provide a user with access to one or more training modules. The external medical device includes one or more electrodes configured to detect a cardiac activity of a patient, an audio and/or visual output, and a controller coupled to the audio and/or visual output. The controller is configured to: detect at least one of a predetermined event and a device use pattern; and responsive to detecting the at least one of the predetermined event and the device use pattern, provide the patient access to one or more training modules relating to a use or a configuration of the external medical device via the audio and/or visual output. The device can also include a user interface configured to provide access to at least one training module according to a schedule of training modules for the patient.

Training modules for an external medical device

An external wearable medical device includes an electrode to detect patient cardiac activity; a therapy electrode to provide a therapy in response to detecting an arrhythmia event; a GUI display comprising a caregiver interface and a patient interface; and a processor configured to provide, to the caregiver interface, a first set of information that includes information for operating the device in conjunction with the patient and an alert history of the device including an indication of one or more detected arrhythmia events, provide, to the patient interface, a second set of information that includes information for allowing the patient to cause the device to suspend providing the therapy and a direction to the patient to contact a caregiver responsive to detecting an event affecting at least one of the device and the patient, and responsive to detecting the event, automatically transmitting a notification of the event to an external entity.

Systems for medical device interactions

A method of determining responsiveness of a patient wearing a wearable defibrillator configured to deliver therapy to the patient includes sensing an electrocardiogram signal of the patient wearing the wearable defibrillator via a plurality of ECG sensing electrodes, and determining whether a defibrillation treatment should be provided to the patient via at least one treatment electrode. The method includes causing a user interface to provide a patient prompt from the wearable defibrillator responsive to determining that the defibrillation treatment should be provided to the patient. The method includes receiving a first signal indicative of a first patient response within a time interval, receiving a second signal indicative of a second patient response within the time interval, and withholding the defibrillation treatment to the patient via the at least one treatment electrode in response to receiving both the first signal and the second signal within the time interval.

Medical device configured to test for user responsiveness

A wearable medical device includes a water-resistant harness, and a plurality of ECG sensing electrodes and a plurality of therapy electrodes disposed on the harness. The plurality of therapy electrodes are configured to provide at least one defibrillating biphasic shock. The device includes a control unit comprised within a waterproof case. The control unit is configured to monitor ECG information of the patient based on a sensed ECG signal, and responsive to detection of a cardiac arrhythmia, provide the at least one defibrillating biphasic shock. The device includes a water-resistant or waterproof connection pod configured to electrically couple to the plurality of ECG sensing electrodes, the plurality of therapy electrodes, and the control unit, and to provide the sensed ECG signal from the plurality of ECG sensing electrodes to the control unit and the at least one defibrillating biphasic shock from the control unit to the plurality of therapy electrodes.

An external medical device includes monitoring circuitry configured to monitor a cardiac condition of a patient using the external medical device; and a controller configured to: receive at least one of patient input and non-patient user input of a patient's ability; determine a patient interaction mode of the external medical device based on the at least one of the patient input and the non-patient user input; and adapt the patient interaction mode of the external medical device over time based on the at least one of the patient input and the non-patient user input.

Device administered tests and adaptive interactions

An augmented-reality system for providing information relating to a wearable medical device and/or a patient wearing a medical device. An augmented-reality enabled computing device includes an image acquisition device, a user interface operatively coupled to the image acquisition device, the user interface configured to receive streaming images of a scene having one or more predetermined recognizable features, and a processor operably connected to the user interface. The processor is configured receive the streaming images, analyze the one or more predetermined recognizable features to determine a context of the scene, retrieve information relating to at least one of the medical device and the patient wearing the medical device, the information corresponding to the determined context of the scene, and augment the received streaming images with contextual information relating to at least one of the medical device and the patient wearing the medical device.

Augmented reality information system for use with a medical device

An ambulatory medical device is provided. The device includes battery lock circuitry configured to transmit a lock signal at a beginning of a battery lock period of the ambulatory medical device and transmit an unlock signal upon detecting an unlock triggering event indicating an end of the battery lock period of the ambulatory medical device. The device also includes a battery being configured to be securely disposed within a chamber of the ambulatory medical device in a first locked manner and provide power to the ambulatory medical device and a battery lock configured to mechanically engage the battery in a second locked manner upon receiving the lock signal indicating the beginning of the battery lock period of the ambulatory medical device and mechanically disengage the battery from the second locked manner upon receiving the unlock signal signaling the end of the battery lock period.

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Pittsburgh, PA, United States of America

John G Clark