Method and apparatus for detecting seizures

• US 9,439,596 B2
• Filed: 10/06/2015
• Issued: 09/13/2016
• Est. Priority Date: 07/05/2011
• Status: Active Grant

• Current Assignee: Novela Neurotechnologies, Inc.
• Original Assignee: Brain Sentinel, Inc.
• Inventors: Leininger, James R., Herring, Russell M., Girouard, Michael R., Cavazos, Jose E., Jones, Edward R., Broad, William E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/876,455
• Publication Number:
  US 20160045150A1
• Time in Patent Office: 343 Days
• US Class Current: 1/1
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• 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 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 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 detecting seizures with motor manifestations including detecting EMG signals, isolating from the EMG signals spectral data for a plurality of frequency bands, and calculating a T-squared value there from. The T-squared values may be detected in real time, such as in a patient'"'"'s home environment, and the T-squared data may be compared to a threshold T-squared value to determine whether an alarm is sent.

Claims

1. A system for monitoring a patient for seizure activity comprising:

a detection unit mountable to said patient, the detection unit comprising;

one or more electromyography electrodes configured to provide an electromyography signal representing seizure-related muscle activity;

a first processor in communication with said one or more electromyography electrodes, said first processor configured to receive said electromyography signal, determine electromyography data from said electromyography signal, and process said electromyography signal to determine whether said seizure activity is occurring; and

a transceiver in communication with said first processor, said transceiver configured to receive said electromyography data and to transmit said electromyography data if the first processor determines that said seizure activity is present;

a base station configured to receive said electromyography data from said transceiver;

one or more environmental transceivers associated with one or more objects present within a home setting for said patient, each of said one or more environmental transceivers being configured to transmit a proximity signal to said base station, the proximity signal being dependent upon whether a respective environmental transceiver among said one or more environmental transceivers is within an operating distance from said detection unit; and

said base station comprising a second processor configured for;

processing said proximity signal dependent upon whether the respective environmental transceiver among said one or more environmental transceivers is within an operating distance from said detection unit;

based on said proximity signal, selecting a first template file among a plurality of template files, each of said plurality of template files including one or more seizure detection threshold settings;

processing said electromyography data based on said one or more seizure detection threshold settings included in said first template file applied to confirm the presence of said seizure activity; and

initiating transmission of an alarm to a remote caregiver if said seizure activity is confirmed.

2. The system of claim 1 further comprising:

an input/output device included in said detection unit, said input/output device configured to allow said patient or an authorized party to activate said input/output device and to identify one or more occurrences when said detection unit determined that said seizure activity is present but that said patient or said authorized party determined that no seizure was actually occurring

wherein the second processor is further configured for;

automatically adjusting said one or more seizure detection threshold settings included in said first template file based on an identification of one or more times said patient or said authorized party activated said input/output device in order to establish one or more adjusted seizure detection threshold settings;

applying said one or more adjusted seizure detection threshold settings in a processing of recorded data from previous seizures that were correctly identified during a number of previous monitoring periods; and

calculating whether the applying of said one or more adjusted seizure detection threshold settings would have resulted in said system missing detection of any of said previous seizures.

3. The system of claim 2 wherein said second processor is further configured to apply the one or more adjusted seizure detection threshold settings to monitor said patient if said one or more adjusted seizure detection threshold settings would have correctly identified said previous seizures.

4. The system of claim 1 further comprising:

an input/output device included in said base station, said input/output device configured to allow said patient or said authorized party to activate said input/output device and identify occurrences when seizure activity was confirmed by said system but said patient or said authorized party determined that no seizure was actually occurring;

wherein the second processor is further configured for;

automatically adjusting said one or more seizure detection threshold settings included in said first template file based on an identification of one or more times said patient or said authorized party activated said input/output device in order to establish one or more adjusted seizure detection settings;

applying said one or more adjusted seizure detection settings in processing of recorded data from previous seizures that were correctly identified during a number of previous monitoring periods; and

calculating whether the applying of said one or more adjusted seizure detection settings would have resulted in the system missing detection of any of said previous seizures.

5. The system of claim 4 wherein said second processor is further configured to apply the one or more adjusted seizure detection settings to monitor said patient if said one or more adjusted seizure detection settings would have correctly identified said previous seizures.

6. The system of claim 5 wherein said one or more adjusted seizure detection settings are communicated to said first processor.

7. The system of claim 1 wherein said one or more objects include at least one of a crib, bed, chair, toilet, door, wall, toothbrush and an item of clothing.

8. The system of claim 1 wherein said one or more objects include an article of clothing customarily worn during physical exercise.

9. The system of claim 1 wherein said detection unit further comprises a microphone configured to record audio data, the detection unit being configured to transmit said audio data to said base station.

10. The system of claim 1 wherein said base station is further configured to send said electromyography data to a storage database.

11. A system for monitoring a patient for seizure activity comprising:

a detection unit mountable to a patient, the detection unit comprising;

one or more electromyography electrodes configured to provide an electromyography signal representing seizure-related muscle activity;

a first processor in communication with said one or more electromyography electrodes, said first processor configured to receive said electromyography signal, determine electromyography data from said electromyography signal, and process said electromyography signal to determine whether said seizure activity is present; and

a transceiver in communication with said first processor, said transceiver configured to receive said electromyography data and to transmit said electromyography data;

an input/output device in communication with a base station, said input/output device configured to allow said patient or said authorized party to activate said input/output device to identify occurrences when said seizure activity was either determined and/or confirmed by either of said detection unit and/or said base station but said patient or said authorized party determined that no seizure was actually occurring in order to identify false-positive detection events;

said base station configured to receive said electromyography data, the base station comprising a second processor configured for;

processing said electromyography data to confirm the presence of said seizure activity;

receiving a false-positive signal from said input/output device indicating any of said occurrences when no seizure was actually occurring; and

initiating sending of an alarm to a remote caregiver if said seizure activity is confirmed.

12. The system of claim 11 wherein the second processor is further configured for:

automatically adjusting one or more seizure detection threshold settings used to confirm the presence of said seizure activity based on an identification of one or more times said second processor received a false-positive signal from said input/ouput device in order to establish one or more adjusted seizure detection threshold settings.

13. The system of claim 12 wherein the second processor is further configured for:

applying said one or more adjusted seizure detection threshold settings in processing of recorded data from previous seizures that were correctly identified during a number of previous monitoring periods;

calculating whether said one or more adjusted seizure detection threshold settings would have resulted in the system missing detection of any of said previous seizures; and

verifying that use of said one or more adjusted seizure detection threshold settings would have resulted in detection of said previous seizures while minimizing false-positive detection events.

14. The system of claim 11 further comprising:

one or more environmental transceivers associated with one or more objects present within a home-setting for said patient, each of said one or more environmental transceivers being configured to transmit a proximity signal to said base station, the proximity signal being dependent upon whether the respective environmental transceiver is within a certain distance of said detection unit.

15. The system of claim 14 wherein said one or more objects include an article of clothing customarily worn during physical exercise.

16. The system of claim 14 wherein said one or more objects include at least one of a crib, bed, chair, toilet, door, wall, toothbrush and an item of clothing.

17. A method of monitoring a patient for seizure activity comprising:

detecting an electromyography signal resulting from muscle motor activity of the patient using a mobile detection unit mounted to one or more of an arm band, adhesive tape, or item of clothing so as to allow positioning of one or more electromyography electrodes over a muscle of the patient;

processing with a processor said electromyography signal to determine whether seizure activity is present;

wherein the processing of said electromyography signal includes selection of one or more seizure detection thresholds included among a plurality of selectable seizure detection thresholds;

identifying a location of the patient within a monitoring locale;

wherein said selection of one or more seizure detection thresholds is based on said location of the patient.

18. The method of claim 17 further comprising:

sending an environment signal to said processor;

wherein said environment signal identifies said location of the patient;

said environment signal being sent from one or more environmental transceivers associated with one or more objects present within a home-setting for said patient, said environment signal based on a position of said mobile detection unit with respect to at least one of said one or more environmental transceivers.

19. The method of claim 18 wherein said one or more environmental transceivers include a first environmental transceiver located in said patient'"'"'s bathroom and a second environmental transceiver located on said patient'"'"'s bed.