Method and apparatus for detecting seizures including loose electrode monitoring

• US 10,342,451 B2
• Filed: 10/22/2014
• Issued: 07/09/2019
• Est. Priority Date: 10/23/2013
• Status: Active Grant

• Current Assignee: Novela Neurotechnologies, Inc.
• Original Assignee: Brain Sentinel, Inc.
• Inventors: Girouard, Michael R., Halleck, Michael E., Halleck, Michael D.
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US15/030,349
• Publication Number:
  US 20160242668A1
• Time in Patent Office: 1,721 Days
• CPC Class Codes: A61B 5/276 Protection against electrode failure
• 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 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6844 Monitoring or controlling distance between sensor and tissue

Abstract

Apparatuses and methods for monitoring a patient for seizure activity and for verifying the contact integrity of electrodes included among an EMG sensor may include generating a test signal of known periodicity and applying the signal to at least one electrode in a sensor system. The test signal may be monitored to verify contact integrity of the electrodes.

Claims

1. A method of monitoring a patient for seizure activity by collecting data with an electromyography sensor and for checking the contact integrity of electrodes included in the sensor, the method comprising:

positioning a pair of detection electrodes and a common electrode on the skin of a patient on or near at least one muscle in order to provide a group of positioned electrodes, said pair of detection electrodes being connected to inputs of a differential amplifier, said electromyography sensor being configured to maintain an imbalance potential at said inputs of said differential amplifier when said contact integrity is maintained between the skin and said group of positioned electrodes, wherein the imbalance potential enhances amplification of a test signal collected by said pair of detection electrodes;

applying said test signal to said common electrode;

collecting a signal from said pair of detection electrodes;

analyzing said collected signal for characteristics of seizure activity;

analyzing said collected signal for detection of said test signal; and

determining based on the detection of said test signal whether said contact integrity is maintained between the skin and said group of positioned electrodes.

2. The method of claim 1 wherein said determination of whether said contact integrity is maintained between the skin and said group of positioned electrodes includes establishing whether a threshold amplitude level of said test signal is met.

3. The method of claim 1 wherein said group of positioned electrodes are configured such that when said contact integrity between the skin and said group of positioned electrodes declines, an amplitude of said detected test signal decreases.

4. The method of claim 1 wherein said electromyography sensor is portable and configured for use in an ambulatory or home setting.

5. The method of claim 1 wherein at least one of the detection electrodes in said pair of detection electrodes is connected to at least one input in said inputs of said differential amplifier in series through a resistive element.

6. The method of claim 5 wherein said resistive element is an about 20Ω

to an about 200Ω

resistor.

7. The method of claim 1 wherein said imbalance potential is established through a low pass filter connected to at least one of the detection electrodes in said pair of detection electrodes.

8. The method of claim 1

said pair of detection electrodes having different impedance values, the impedance value difference being suitable to maintain said imbalance potential between the inputs of said differential amplifier when said contact integrity is maintained between the patient'"'"'s skin and said group of positioned electrodes.

9. The method of claim 8, a first detection electrode in said pair of detection electrodes having an input impedance of about 2 KΩ

to about 20 KΩ

; and

the second detection electrode in said pair detection electrodes having an input impedance magnitude of about 1% to about 10% lower than the input magnitude of the first detection electrode.

10. The method of claim 8, wherein at least one of the impedance values for the detection electrodes in said pair of detection electrodes being greater for applied frequencies above about 1 KHz than for applied frequencies within a range of about 20 Hz to about 500 Hz.

11. The method of claim 1

said positioning of electrodes being sufficient to create said imbalance potential when said contact integrity is maintained between the skin and said group of positioned electrodes.

12. The method of claim 1

at least one of said pair of detection electrodes being connected to an electrical component having sufficient impedance to create said imbalance potential when said contact integrity is maintained between the skin and said group of positioned electrodes.

13. The method of claim 12 wherein said electrical component is an about 20Ω

to an about 200Ω

resistor.

14. The method of claim 1, the test signal being a time-varying test signal within the frequency range of about 1 KHz to about 5 KHz;

and

said analyzing said collected signal for seizure activity including evaluating the collected signal for muscle electrical activity in a frequency range between about 20 Hz to about 500 Hz.

15. The method of claim 1, said analyzing said collected signal for seizure activity includes determining whether said collected signal meets a threshold value of a characteristic related to muscle electrical activity.

16. The method of claim 15 wherein said threshold value is a T-squared statistical value calculated from an EMG power spectrum.

17. The method of claim 15 wherein said threshold value comprises detection of a plurality of EMG data bursts.

18. The method of claim 1 wherein the test signal is a time-varying test signal with a controlled period.

19. The method of claim 18, said analyzing the collected signal for detection of said test signal comprising:

partitioning the collected signal into an analysis window,

the analysis window being an integral number of multiples of the test signal period; and

determining whether one or more repetitive characteristics that match the periodicity of the test signal are detected in the analysis window.

20. The method of claim 19, a phase delay between the analysis window and the applied test signal being constant.

21. The method of claim 19, said analysis window being some integral multiple of oscillations of a clock or oscillator;

and

the test signal period being controlled using said clock or oscillator.

22. The method of claim 19 wherein said repetitive characteristic is selected from a group of characteristics including phase delay, signal amplitude, number of positive amplitude peaks, and number of negative amplitude peaks.

23. The method of claim 18 wherein said analyzing the collected signal for said detection of said test signal comprises:

partitioning the collected signal into an analysis window;

the analysis window being an integral number of multiples of the test signal period;

determining a number of positive and/or negative amplitude peaks; and

determining whether the number of positive and/or negative amplitude peaks matches an expected value.