Method and apparatus for classification of seizure type and severity using electromyography

• US 10,226,209 B2
• Filed: 12/02/2014
• Issued: 03/12/2019
• Est. Priority Date: 10/15/2010
• Status: Active Grant

• Current Assignee: Novela Neurotechnologies, Inc.
• Original Assignee: Brain Sentinel, Inc.
• Inventors: Girouard, Michael R.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/100,741
• Publication Number:
  US 20160296157A1
• Time in Patent Office: 1,561 Days
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method and apparatus for monitoring a patient for seizure activity including collecting and processing EMG signal data and categorizing the detected data to execute risk stratification. A transmission protocol that is tailored for detected events may be selected and executed.

Claims

1. A method of triggering a seizure detection alarm, the method comprising:

providing a portable EMG detection unit including one or more EMG electrodes and including a portable EMG detection unit processor;

collecting an EMG signal using said portable EMG detection unit, the portable EMG detection unit configured for executing a first seizure detection routine and a second seizure detection routine;

executing said first seizure detection routine using said portable EMG detection unit to generate a first output response, said first seizure detection routine configured to be responsive to tonic-phase seizure activity based on detection of a threshold amplitude level of said EMG signal;

executing said second seizure detection routine using said portable EMG detection unit to generate a second output response, said second seizure detection routine configured to respond selectively to clonic-phase seizure activity based on detection of qualified transient elevations in said EMG signal, said transient elevations being qualified based on a duration of elevation;

communicating said first output response and said second output response to said portable EMG detection unit processor;

using said portable EMG detection unit processor for categorizing whether one or more detected events are associated with different types of seizure activity based on whether said one or more detected events are associated with said first output response, said second output response, or a combination of said first output response and said second output response;

selecting an alarm transmission protocol included among a group of selectable alarm transmission protocols based on said categorizing of said one or more detected events;

wherein said alarm transmission protocols include sending one or more warning messages or one or more emergency messages, to one or more caregivers;

said one or more warning messages being configured to inform at least one of said one or more caregivers that a seizure may have occurred;

said one or more emergency messages being configured to instruct at least one of said one or more caregivers to check on the health status of said patient; and

executing said alarm transmission protocol.

2. The method of claim 1 wherein said one or more warning messages indicate that said patient is at a low risk of experiencing adverse effects of a detected event.

3. The method of claim 1 wherein said first seizure detection routine is further configured to provide an output in response to muscle motor manifestations that are weaker than typically manifested during tonic-phase seizure activity.

4. The method of claim 1 further comprising providing said patient with an ability to select a selectable status identifier, said selectable status identifier indicating whether the patient is in a selectable patient state.

5. The method of claim 4 wherein said selectable patient state is selected from a patient state indicating that said patient is at home alone, a patient state indicating that said patient is at home in the presence of another person, and a patient state indicating that said patient is sleeping.

6. The method of claim 4 wherein said selecting of said alarm transmission protocol is dependent on said selectable patient state.

7. The method of claim 1 further comprising:

collecting sensor data using one or more microelectromechanical inertial detection elements configured for determining an orientation of said patient; and

evaluating a risk of falling for said patient based on said sensor data;

wherein said selecting of said alarm transmission protocol is dependent on said risk of falling.

8. The method of claim 1 further comprising:

collecting sensor data using an oximeter configured to measure levels of saturated oxygen for said patient; and

including said sensor data in an estimate of a risk of said patient experiencing adverse effects of said seizure activity;

wherein said selecting of said alarm transmission protocol is dependent on said estimate of said risk of said patient experiencing adverse effects of said seizure activity.

9. A system for monitoring a patient for seizure activity and executing an alarm, the system comprising:

a portable EMG detection unit including one or more EMG electrodes configured to provide an EMG signal, a portable EMG detection unit processor, and a transceiver;

said portable EMG detection unit processor configured to;

receive said EMG signal;

process said EMG signal to detect one or more events indicating an increased risk of said seizure activity;

analyze said EMG signal using a combination of at least two seizure detection routines configured for the detection of said one or more events;

wherein said at least two seizure detection routines include a first seizure detection routine configured to initiate a positive response to tonic-phase seizure activity based on a detection of a threshold level EMG signal amplitude, and a second seizure detection routine configured to initiate a positive response selectively to clonic-phase seizure activity based on detection of transient elevations in signal qualified based on a duration width;

categorize whether one or more detected events are associated with different types of seizure activity based on whether said one or more events are associated with a response in said first seizure detection routine, a response in said second seizure detection routine, or a response in a combination of said first seizure detection routine and said second seizure detection routine; and

select an alarm transmission protocol included among a group of selectable alarm transmission protocols based on the categorization of said one or more events;

wherein said alarm transmission protocols include sending one or more warning messages, one or more emergency messages, or a combination of both said one or more warning messages and said one or more emergency messages to one or more caregivers;

wherein said one or more warning messages are configured to inform at least one of said one or more caregivers that a seizure may have occurred;

wherein said one or more emergency messages are configured to instruct at least one of said one or more caregivers to check on the health status of said patient; and

said transceiver configured to transmit said one or more warning messages, said one or more emergency messages, or a combination of said one or more warning messages and said one or more emergency messages to a base station or one or more caregivers based on said selected alarm transmission protocol.

10. The system of claim 9 further comprising:

one or more microelectromechanical inertial detection elements configured for determining an orientation of said patient;

wherein said processor is further configured to evaluate a risk of falling for said patient based on data from said one or more microelectromechanical inertial detection elements; and

wherein said selection of said alarm transmission protocol is dependent on said risk of falling.

11. The system of claim 9 further comprising:

one or more oximeters configured to measure levels of saturated oxygen for said patient;

wherein said processor is further configured to include data from said one or more oximeters in an estimate of a risk of said patient experiencing adverse effects of a seizure; and

wherein said selection of said alarm transmission protocol is dependent on said estimate of risk of said patient experiencing adverse effects of a seizure.