Closed-loop feedback-driven neuromodulation

• US 7,324,851 B1
• Filed: 06/01/2004
• Issued: 01/29/2008
• Est. Priority Date: 08/05/1998
• Status: Expired due to Fees

• Current Assignee: Cyberonics, Inc, DiLorenzo Biomedical, LLC
• Original Assignee: NeuroVista Corporation
• Inventors: DiLorenzo, Daniel John
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US10/858,899
• Time in Patent Office: 1,337 Days
• Field of Search: 607/45
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

A neurological control system for modulating activity of any component or structure comprising the entirety or portion of the nervous system, or any structure interfaced thereto, generally referred to herein as a □nervous system component.□ The neurological control system generates neural modulation signals delivered to a nervous system component through one or more neuromodulators, comprising intracranial (IC) stimulating electrodes and other actuators, in accordance with treatment parameters. Such treatment parameters may be derived from a neural response to previously delivered neural modulation signals sensed by one or more sensors, each configured to sense a particular characteristic indicative of a neurological or psychiatric condition.

Claims

1. A method of managing epilepsy, the method comprising:

measuring one or more electrical signals from a patient'"'"'s brain with one or more intracranial electrodes;

receiving the one or more electrical signals in a unit that is implanted intracranially in the patient;

extracting parameters from the one or more electrical signals that are indicative of a seizure or predictive of a future seizure, the extracted parameters comprising at least one of a peak-to-valley times, valley-to-peak times, positive phase amplitudes, and negative phase amplitudes;

delivering one or more bursts of charge-balanced biphasic stimulus pulses to a patient'"'"'s brain when the extracted parameters are indicative of undesirable electrical activity in the patient'"'"'s brain;

monitoring the parameters after delivering the one or more bursts of charge-balanced biphasic stimulus pulses; and

delivering one or more subsequent bursts of charge-balanced biphasic stimulus pulses to the patient'"'"'s brain if the monitored parameters indicate that the patient still has undesirable electrical activity in the patient'"'"'s brain.

2. The method of claim 1 wherein undesirable electrical activity comprises undesirable changes in the electrical signals.

3. The method of claim 1 wherein undesirable electrical activity is determined by comparing at least one of the extracted parameters to at least one clinician programmed reference parameter.

4. The method of claim 3 wherein monitoring the parameters after delivery of one or more bursts of charge-balanced biphasic stimulus comprises:

extracting subsequent parameters from one or more EEG signals after the one or more bursts of charge-balanced biphasic stimulus pulses is delivered; and

comparing the subsequently extracted parameters to at least one of the parameters extracted before the delivery of the one or more bursts of charge-balanced biphasic stimulus and the clinician programmed reference parameters.

5. The method of claim 1 wherein extracting parameters comprises extracting all of the peak-to-valley times, the valley-to-peak times, the positive phase amplitudes, and the negative phase amplitudes.

6. The method of claim 1 wherein monitoring the parameters after delivering of the one or more bursts of charge-balanced biphasic stimulus pulses comprises monitoring the response in electrical activity to the one or more bursts of charge-balanced biphasic stimulus pulses.

7. The method of claim 1 wherein the undesirable electrical activity is defined by a reference parameter threshold, wherein the one or more bursts of charge-balanced biphasic stimulus pulses is delivered when the extracted parameters reach or surpass the reference parameter threshold.

8. The method of claim 1 wherein at least one parameter of the one or more subsequent bursts of charge-balanced biphasic stimulus pulses is modulated from at least one parameter of the one or more bursts of charge-balanced biphasic stimulus pulses.

9. The method of claim 8 comprising using the patient'"'"'s monitored parameters after delivery of one or more bursts of charge-balanced biphasic stimulus pulses to derive at least one parameter of the one or more subsequent bursts of charge-balanced biphasic stimulus pulses.

10. The method of claim 9 wherein at least one parameter of the one or more bursts of charge-balanced biphasic stimulus pulses and the one or more subsequent bursts of charge-balanced biphasic stimulus pulses is modulated from each other.

11. The method of claim 9 wherein the one or more bursts of charge-balanced biphasic stimulus pulses and the one or more subsequent bursts of charge-balanced biphasic stimulus pulses each comprise a plurality of bursts.

12. The method of claim 1 further comprising storing data in a memory module in the unit that is implanted intracranially in the patient, wherein the stored data is reflective of the electrical activity in the patient'"'"'s brain.

13. The method of claim 12 further comprising transmitting the stored data to a supervisory module that is external to the patient'"'"'s body.

14. The method of claim 1 wherein the one or more charge-balanced biphasic stimulus pulses and the one or more subsequent charge-balanced biphasic stimulus pulses comprise a pulse amplitude between about 10 microamps and about 10 milliamps.

15. The method of claim 1 wherein the one or more charge-balanced biphasic stimulus pulses and the one or more subsequent charge-balanced biphasic stimulus pulses comprise a pulse width between about 50 microseconds and about 100 milliseconds.

16. The method of claim 1 wherein the one or more charge-balanced biphasic stimulus pulses and one or more subsequent charge-balanced biphasic stimulus pulses comprise a frequency of pulses within the burst between about 100 Hz and about 300 Hz.

17. A method of managing epilepsy, the method comprising:

measuring one or more EEG signals from a patient'"'"'s brain;

extracting spike parameters from the one or more EEG signals from the patient'"'"'s brain that are indicative or predictive of a neural state;

delivering a first electrical stimulation to a patient when the extracted spike parameters are indicative or predictive of an undesirable neural state, wherein the first electrical stimulation comprises one or more bursts of charge-balanced biphasic stimulus waveforms;

monitoring the parameters after delivery of the first electrical stimulation to measure a patient'"'"'s neural state response to the first electrical stimulation; and

delivering a second electrical stimulation to the patient that comprises one or more bursts of charge-balanced biphasic stimulus waveforms if the patient'"'"'s neural state response indicates that the patient is still in the undesirable neural state.

18. The method of claim 17 wherein the extracted parameters comprise at least one of a peak-to-valley times, valley-to-peak times, positive phase amplitudes, and negative phase amplitudes.

19. The method of claim 18 wherein extracting spike parameters comprises extracting all of the peak-to-valley times, the valley-to-peak times, the positive phase amplitudes, and the negative phase amplitudes.

20. The method of claim 17 further comprising processing the patient'"'"'s monitored spike parameters after delivery of the first electrical stimulation to derive at least one parameter of the second electrical stimulation.

21. The method of claim 17 further comprising transmitting a communication to the patient regarding the patient'"'"'s neural state.

22. The method of claim 17 further comprising processing the extracted spike parameters to predict a future undesirable neural state.

23. A method of managing a neurological condition, the method comprising:

monitoring one or more signals from a patient;

extracting parameters from the one or more signals that are indicative or predictive of future symptomatology;

analyzing the extracted parameters;

delivering a first electrical stimulation to the patient when the analyzing is indicative or predictive of the future symptomatology;

measuring a patient'"'"'s response to the first electrical stimulation by extracting parameters from the one or more signals after the delivering of the first electrical stimulation; and

delivering a second electrical stimulation to the patient if the patient'"'"'s response to the first electrical stimulation is still indicative or predictive of the future symptomatology.

24. The method of claim 23 wherein at least one of the first electrical stimulation and second electrical stimulation comprises one or more bursts of charge-balanced biphasic stimulus pulses.

25. The method of claim 23 further comprising processing the patient'"'"'s response after delivering the first electrical stimulation to derive at least one parameter of the second electrical stimulation.

26. The method of claim 23 wherein the extracted parameters comprise spike parameters.

27. The method of claim 26 wherein the spike parameters comprise all of a peak-to-valley time, a valley-to-peak time, a positive phase amplitude, and a negative phase amplitude.

28. The method of claim 23 further comprising storing data in a memory that is indicative of the brain activity.

29. The method of claim 23 wherein the future symptomatology comprises a future seizure.