Systems and methods of delivering therapy using an ambulatory medical device
Inventors
Kaib, Thomas E. • Linder, Marshal W.
Assignees
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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.
Core Innovation
The disclosed invention relates to an ambulatory medical device capable of delivering therapy to a patient, including a user interface pod with at least one response mechanism. The controller monitors the state of each response mechanism and detects a physiological parameter having a value indicative of a health disorder of the patient, such as a cardiac rhythm disorder, and notifies the patient of impending therapy delivery in response to the detection of the physiological parameter.
After notifying the patient of impending therapy delivery, the controller monitors the state of each at least one response mechanism within a first predetermined time period. The controller delays therapy delivery in response to detection of a change in the state in a single response mechanism within the first predetermined time period, and repeatedly prompting and delaying until required responsiveness is verified.
The invention supports reducing false positives and accidental activations by using state-change detection tied to patient responsiveness. Patient notification modalities include a display, an audible speaker alert, and tactile vibration, and additional responsiveness checks are described using patient motion/accelerometer for consciousness or fall detection. The device includes different operation modes for single-button versus two-buttons simultaneously to further reduce accidental activations.
Claims Coverage
The document contains three independent claims that define an ambulatory medical device, a non-transitory computer-readable medium, and a method of operating the ambulatory medical device. Across these independent claims, the main inventive features are user interface pod state monitoring within a first predetermined time period and delaying therapy delivery when a change is detected in a single response mechanism, after detection of a physiological parameter and notification of impending therapy delivery.
Patient-facing response mechanism state monitoring for therapy delay
An ambulatory medical device, corresponding instructions, and a method provide a user interface pod comprising at least one response mechanism having a state capable of being activated by one response button; the controller monitors the state of each response mechanism within a first predetermined time period and delays therapy delivery in response to detection of a change in the state in a single response mechanism within that first predetermined time period.
Detect physiological parameter and notify of impending therapy delivery
The controller detects a physiological parameter having a value indicative of a health disorder of the patient and notifies the patient of impending therapy delivery in response to the detection of the physiological parameter.
Together, the independent claims focus on a patient user interface pod with response mechanism state detection and controller logic that, after detection of a physiological parameter and patient notification, delays therapy delivery when a state change is detected in a single response mechanism during a first predetermined time period.
Stated Advantages
Reduces false positives and accidental activations.
Documented Applications
Wearable/ambulatory therapy-delivery context, including wearable defibrillators that detect arrhythmias via ECG and request patient responsiveness to delay therapy delivery.
Patient notification during impending therapy delivery using a user interface pod with display, audible speaker alerts, and tactile vibration.
Emergency-use communication via a speaker communicating emergency instructions to the patient or a bystander during an emergency event.
Responsiveness verification using patient motion/accelerometer for consciousness or fall detection as additional checks.
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