Brain signal telemetry and seizure prediction

• US 9,854,985 B2
• Filed: 03/30/2007
• Issued: 01/02/2018
• Est. Priority Date: 12/09/2002
• Status: Active Grant

• Current Assignee: BSG Corp.
• Original Assignee: Bio-Signal Group Corp.
• Inventors: Donnett, James G., Szabo, Imre, Mathe, Kalman, Fenton, Andre
• Primary Examiner(s): NEGIN, RUSSELL SCOTT
• Application Number:
  US11/694,816
• Publication Number:
  US 20080077039A1
• Time in Patent Office: 3,931 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

An ambulatory intrinsic brain signal processor circuit is coupled to a plurality of electrodes. The signal processor circuit can include a digital multiplexer circuit coupled to the electrodes to multiplex brain signal data from different electrodes together into a multiplexed data stream. An ambulatory transceiver circuit wirelessly communicates information to and from a remote transceiver. A controller circuit permits a user to control which of the electrodes contribute data, a data resolution, and whether the data includes one or both of neural action or local field potential data. Seizure prediction components and methods are also described.

Claims

1. An apparatus comprising:

an ambulatory intrinsic brain signal processor circuit, configured to be coupled to a plurality of electrodes, the signal processor circuit comprising;

a digital multiplexer circuit, configured to be coupled to the electrodes, and configured to multiplex brain signal data from different electrodes together into a multiplexed data stream;

an ambulatory transceiver circuit, configured to wirelessly communicate information to a remote transceiver, and configured to wirelessly receive user-programming information from the remote transceiver; and

a controller circuit, configured to;

select N user-specified electrodes that contribute data to the multiplexed data stream;

select a data resolution of the electrodes that contribute data to the multiplexed data stream; and

select, for each particular electrode that contributes data to the multiplexed data stream, one, from between user-selectable choices including all three, of the following settings;

(1) neural action potential data, from which neural field potential data has been reduced or removed;

(2) neural field potential data, from which neural action potential data has been reduced or removed; and

(3) both neural action potential and neural field potential data, and wherein the user-selected one of the three settings is used to automatically select an appropriate gain or frequency setting of a sense amplifier corresponding to the particular electrode; and

a Normal template, providing an indication of a set of correlations of brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one neurologically non-abnormal time period of the subject;

a Non-Normal template, providing an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one pre-neurologically-abnormal time period or neurologically abnormal time period of the subject;

a monitoring circuit, configured to form, during a sampling time period, an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, using the at least two different locations of a brain of the subject; and

an upcoming neurologically-abnormal-state prediction circuit, configured to predict an upcoming neurologically abnormal state at least in part by comparing the indication of the set of correlations obtained during the sampling time period to each of the Normal and Non-Normal templates.

2. The apparatus of claim 1, further comprising a plurality of electrode assemblies, each electrode assembly including:

at least one electrode, configured to be coupled to a brain of a subject;

a brain signal sense amplifier circuit, coupled to the electrode, and configured to sense an intrinsic brain signal and to output a resulting sensed brain signal that is indicative of the intrinsic brain signal;

a filter circuit, coupled to the sense amplifier circuit, the filter circuit including a user-programmable frequency filtering characteristic configured to allow a user to select one, from between user-selectable choices including all three, of the following settings;

(1) passing neural action potential frequencies in a range from about 300 Hz to about 6 kHz;

(2) passing neural field potential frequencies in a range from about 0.5 Hz to about 500 Hz; and

(3) passing both neural action potential and neural field potential frequencies; and

an analog-to-digital converter (“

ADC”

) circuit, coupled to the filter circuit, the ADC configured to digitize brain signal information passed by the filter circuit, the digitizing occurring in close proximity to the electrode.

3. The apparatus of claim 2, wherein the sense amplifier circuit is configured to include:

a first input, configured to be coupled to a first signal sensing electrode that is configured for sensing a localized neural action potential signal;

a second input, configured to be coupled to a reference signal sensing electrode that is configured for sensing a neural field potential signal; and

wherein the amplifier is configured to reduce or remove a common-mode neural field potential signal present between the reference signal sensing electrode and the first signal sensing electrode, and to output a resulting differential signal indicative of a neural action potential.

4. The apparatus of claim 2, wherein the sense amplifier circuit comprises a user-programmable gain.

5. The apparatus of claim 4, wherein the user-programmable gain includes a neural action potential setting and a neural field potential setting, wherein the neural action potential setting and the neural field potential setting provide different gain values.

6. The apparatus of claim 2, wherein the ADC comprises a sampling rate and sampling resolution that are both user-programmable for each individual electrode that is specified by the user to contribute to the multiplexed data stream.

7. The apparatus of claim 6, wherein at least one of the sampling rate and the sampling resolution includes a neural action potential setting and a neural field potential setting, wherein the neural action potential setting and the neural field potential setting provide at least one of different sampling rate values and different sampling resolution values.

8. The apparatus of claim 1, further comprising an ambulatory memory device, configured to store brain signal information.

9. The apparatus of claim 8, wherein the controller circuit is configured to provide user control over whether a particular electrode'"'"'s data contribution to the multiplexed data stream is at least one of:

provided to the transmitter for communication to remote receiver or provided to the ambulatory memory device for storage.

10. The apparatus of claim 1, further comprising a physiological event detector, communicatively coupled to the controller circuit to trigger at least one of storage or communication of brain signal information in response to detecting a specified physiological event.

11. The apparatus of claim 10, wherein the physiological event detector comprises at least one of:

(1) a heart rate detector;

(2) a neural field potential pattern detector; and

(3) a neural action potential pattern detector.

12. The apparatus of claim 1, further comprising a remote user interface comprising:

the remote transceiver;

a digital demultiplexer circuit, coupled to the remote transceiver; and

a user interface controller circuit, coupled to the digital demultiplexer circuit and the remote transceiver, the user interface controller circuit configured to receive a user instruction.

13. The apparatus of claim 12, wherein the remote user interface includes at least one of:

(1) a digital recorder circuit; and

(2) a digital-to-analog converter (DAC) circuit and an analog recorder circuit.

14. The apparatus of claim 1, comprising:

the Normal template providing an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one non-seizure time period of the subject, wherein the non-seizure time period excludes a time period during a seizure, and wherein the non-seizure time period excludes at least a first specified time period preceding the seizure;

the Non-Normal template providing an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one pre-seizure time period or seizure time period of the subject, wherein the pre-seizure time period is less or equal to a second specified time period before the seizure, and wherein the seizure occurs during the seizure time period;

the monitoring circuit configured to form, during a sampling time period, an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, using the at least two different locations of a brain of the subject; and

the upcoming neurologically-abnormal-state prediction circuit comprising an upcoming seizure prediction circuit, configured to predict an upcoming seizure at least in part by comparing the indication of the set of correlations obtained during the sampling time period to each of the Normal and Non-Normal templates.

15. The apparatus of claim 1, comprising a data integrity circuit, communicatively coupled to receive data contributed by a particular electrode, and configured to determine whether data contributed by a particular electrode includes a valid or useful information about an intrinsic neural signal.

16. The apparatus of claim 1, comprising a data compression circuit, communicatively coupled to receive data contributed by a particular electrode, and configured to extract parameterized information about a neural event and a corresponding time.

17. The apparatus of claim 1, wherein the upcoming neurologically-abnormal-state prediction circuit is further configured to:

provide an alert to a therapy control module to deliver therapy if an upcoming seizure is predicted.

18. An apparatus comprising:

a plurality of electrode assemblies, each electrode assembly including;

at least one electrode, configured to be coupled to a brain of a subject;

a brain signal sense amplifier circuit, coupled to the electrode, and configured to sense an intrinsic brain signal and to output a resulting sensed brain signal that is indicative of the intrinsic brain signal;

a filter circuit, coupled to the sense amplifier circuit, the filter circuit including a user-programmable frequency filtering characteristic configured to select one, from between user-selectable choices including all three, of the following settings;

(1) passing neural action potential frequencies in a range from about 300 Hz to about 6 kHz;

(2) passing neural field potential frequencies in a range from about 0.5 Hz to about 500 Hz; and

(3) passing both neural action potential and neural field potential frequencies;

an analog-to-digital converter (“

ADC”

) circuit, coupled to the filter circuit, the ADC circuit configured to digitize brain signal information passed by the filter circuit, the digitizing occurring in close proximity to the electrode;

an ambulatory memory device, configured to store brain signal information;

an ambulatory signal processor circuit, coupled to the electrode assemblies, the signal processor circuit including;

a digital multiplexer circuit, coupled to the electrode assemblies, and configured to multiplex data from different electrode assemblies together into a multiplexed data stream;

a transceiver circuit, configured to communicate information to a remote transceiver; and

a controller circuit, configured to control the digital multiplexer to select;

which N user-specified electrodes contribute data to the multiplexed data stream;

a data resolution of each electrode contributing data to the multiplexed data stream;

whether a particular electrode'"'"'s data contribution to the multiplexed data stream is at least one of;

provided to the transmitter for communication to the remote receiver or provided to the ambulatory memory device for storage; and

whether data contributed by a particular electrode includes a user-selected one of user-selectable choices including all three of;

(1) neural action potential data, from which neural field potential data has been reduced or removed;

(2) neural field potential data, from which neural action potential data has been reduced or removed; and

(3) both neural action potential and neural field potential data, wherein the user-selected one of the three choices is used to automatically select an appropriate gain or frequency setting of a sense amplifier corresponding to the particular electrode; and

a Normal template, providing an indication of a set of correlations of brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one neurologically non-abnormal time period of the subject;

a Non-Normal template, providing an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one pre-neurologically-abnormal time period or neurologically abnormal time period of the subject;

a monitoring circuit, configured to form, during a sampling time period, an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, using the at least two different locations of a brain of the subject; and

an upcoming neurologically-abnormal-state prediction circuit, configured to predict an upcoming neurologically abnormal state at least in part by comparing the indication of the set of correlations obtained during the sampling time period to each of the Normal and Non-Normal templates.

19. The apparatus of claim 18, wherein the upcoming neurologically-abnormal-state prediction circuit is further configured to:

provide an alert to a therapy control module to deliver therapy if an upcoming seizure is predicted.

20. An apparatus comprising:

ambulatory means for acquiring brain signals at different locations of a subject'"'"'s brain; and

ambulatory means for receiving information from user input to select;

which N user-specified electrodes at the respective different locations contribute data to a monitored data stream;

a data resolution of the locations that contribute data to the monitored data stream; and

whether data contributed by a particular location includes a user-selected one, from between user-selectable choices including all three of the following;

(1) neural action potential data, having frequencies a range from about 300 Hz to about 6 kHz, from which neural field potential data has been reduced or removed;

(2) neural field potential data, having frequencies in a range from about 0.5 Hz to about 500 Hz, from which neural action potential data has been reduced or removed; and

(3) both neural action potential and neural field potential data, and wherein the user-selected one of the three choices is used to automatically select an appropriate gain or frequency setting of a sense amplifier corresponding to the particular electrode; and

a Normal template, providing an indication of a set of correlations of brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one neurologically non-abnormal time period of the subject;

a Non-Normal template, providing an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, during at least one pre-neurologically-abnormal time period or neurologically abnormal time period of the subject;

a monitoring circuit, configured to form, during a sampling time period, an indication of a set of correlations of the brain potentials between all N user-specified electrodes contributing to the multiplexed data stream, using the at least two different locations of a brain of the subject; and

an upcoming neurologically-abnormal-state prediction circuit, configured to predict an upcoming neurologically abnormal state at least in part by comparing the indication of the set of correlations obtained during the sampling time period to each of the Normal and Non-Normal templates.

21. The apparatus of claim 20, wherein the upcoming neurologically-abnormal-state prediction circuit is further configured to:

provide an alert to a therapy control module to deliver therapy if an upcoming seizure is predicted.

22. A method comprising:

acquiring brain signals at different locations of an ambulatory subject'"'"'s brain;

receiving, at the ambulatory subject, information from user input to control;

which N user-selected electrodes at the different locations contribute data to a monitored data stream;

a data resolution of the locations that contribute data to the monitored data stream; and

whether data contributed by a particular location includes a user-selected one, from between user-selectable choices including all three of;

(1) neural action potential data having frequencies in a range from about 300 Hz to about 6 kHz, from which neural field potential data has been reduced or removed;

(2) neural field potential data having frequencies in a range from about 0.5 Hz to about 500 Hz, from which neural action potential data has been reduced or removed; and

(3) both neural action potential and neural field potential data;

using the user-selected one of the three settings to automatically select an appropriate gain or frequency setting of a sense amplifier corresponding to the particular electrode;

receiving a Normal template providing an indication of a set of correlations between all N user-specified locations that contribute data to the monitored data stream, during at least one neurologically non-abnormal time period of a subject;

receiving a Non-Normal template providing an indication of a set of correlations between all N user-specified locations that contribute data to the monitored data stream, during at least one pre-neurologically-abnormal time period or neurologically abnormal time period of the subject;

monitoring intrinsic brain potentials using at least two different locations of a brain of the subject and forming an indication of a set of correlations of the brain potentials between all N user-specified locations that contribute data to the monitored data stream, including at the at least two different locations during a sampling time period; and

predicting an upcoming seizure at least in part by comparing the indication of the set of correlations of the brain potentials obtained during the sampling time period to each of the Normal and Non-Normal templates.

23. The method of claim 22, comprising, at an assembly carrying an electrode:

sensing an intrinsic brain signal to provide a resulting sensed brain signal that is indicative of the intrinsic brain signal;

filtering the sensed brain signal, including configuring a filter characteristic by using user input to select one from user selectable choices including all three of;

(1) passing neural action potential frequencies in a range from about 300 Hz to about 6 kHz;

(2) passing neural field potential frequencies in a range from about 0.5 Hz to about 500 Hz; and

(3) passing both neural action potential and neural field potential frequencies; and

digitizing the filtered sensed brain signal.

24. The method of claim 22, comprising:

sensing a first intrinsic brain signal with respect to a reference signal;

sensing a second intrinsic brain signal with respect to the reference signal; and

combining the first and second intrinsic brain signals into a differential signal indicative of a difference between the first and second intrinsic brain signals and reducing or removing a common mode signal represented by the reference signal.

25. The method of claim 22, comprising providing, at the subject, a user-programmable gain that includes a neural action potential setting and a neural field potential setting, wherein the neural action potential setting and the neural field potential setting provide different gain values.

26. The method of claim 22, comprising providing, at the subject, at least one of a user-programmable sampling rate and a user-programmable sampling resolution, wherein at least one of the user-programmable sampling rate and the user-programmable sampling resolution includes a neural action potential setting and a neural field potential setting, wherein the neural action potential setting and the neural field potential setting provide at least one of different sampling rate values and different sampling resolution values.

27. The method of claim 22, comprising storing, at the subject, brain signal information, including providing user control over whether a particular electrode'"'"'s data contribution to the monitored data stream is at least one of:

provided to the transmitter for communication to the remote receiver or stored at the subject.

28. The method of claim 22, comprising:

detecting a physiological event of the subject; and

triggering at least one of storage and communication of brain signal information in response to detecting the physiological event.

29. The method of claim 28, wherein the detecting the physiological event comprises at least one of:

detecting a heart rate;

detecting a specified neural field potential pattern; and

detecting a specified neural action potential pattern.

30. The method of claim 22, comprising:

receiving the Normal template providing an indication of a set of correlations of brain potentials between all N user-specified locations contributing to the monitored data stream, during at least one non-seizure time period of a subject, wherein the non-seizure time period excludes a seizure time period of a seizure, and wherein the non-seizure time period excludes at least a first specified time period preceding the seizure;

receiving the Non-Normal template providing an indication of the set of correlations of brain potentials between all N user-specified locations contributing to the monitored data stream, during at least one pre-seizure time period or seizure time period of the subject, wherein the pre-seizure time period is less or equal to a second specified time period before the seizure, and wherein the seizure occurs during the seizure time period;

monitoring intrinsic brain potentials using at least two different locations of a brain of the subject and forming an indication of a set of correlations of the brain potentials between all N user-specified locations contributing to the monitored data stream, including at the at least two different locations during a sampling time period; and

predicting an upcoming seizure at least in part by comparing the indication of the set of correlations of the brain potentials obtained during the sampling time period to each of the Normal and Non-Normal templates.

31. The method of claim 22, comprising determining whether data contributed by a particular location includes a valid or useful information about an intrinsic neural signal.

32. The method of claim 22, comprising extracting, from data contributed by a particular location, parameterized information about a neural event and a corresponding time.

33. The method of claim 22, comprising:

providing an alert to a therapy control module to deliver therapy if an upcoming seizure is predicted.