Closed-loop feedback-driven neuromodulation

• US 7,403,820 B2
• Filed: 05/25/2005
• Issued: 07/22/2008
• Est. Priority Date: 08/05/1998
• Status: Expired due to Fees

• Current Assignee: Cyberonics, Inc
• Original Assignee: NeuroVista Corporation
• Inventors: DiLorenzo, Daniel John
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/138,621
• Publication Number:
  US 20050222626A1
• Time in Patent Office: 1,154 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 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep 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 a neurological disorder, the method comprising:

measuring one or more signals from a patient;

extracting one or more parameters from the one or more signals that are indicative of the patient'"'"'s neurological disorder;

using the one or more parameters in a non-linear control law to determine parameters of a neuromodulation signal; and

delivering the neuromodulation signal with the parameters determined by the non-linear control law to the patient.

2. The method of claim 1 wherein the neurological disorder comprises epilepsy.

3. The method of claim 1 wherein the non-linear control law comprises a deadband.

4. The method of claim 1 wherein the non-linear control law is adapted to increase an amplitude of parameters of the neuromodulation signal when the one or more parameters from the one or more signals is above a reference threshold.

5. The method of claim 1 wherein the non-linear control law is adapted to reduce an amplitude of parameters of the neuromodulation signal or have a zero amplitude when the one or more parameters from the one or more signals is below a reference threshold.

6. The method of claim 1 further comprising conditioning the one or more signals prior to extracting the one or more parameters, wherein conditioning comprises amplifying and filtering.

7. The method of claim 1 wherein the one or more parameters are extracted in a unit that is implanted in the patient'"'"'s body, the method further comprising wirelessly transmitting the one or more extracted parameters to a patient interface module or supervisory module that is external to the patient'"'"'s body.

8. The method of claim 1 further comprising storing the one or more extracted parameters in a memory.

9. The method of claim 1 wherein the one or more parameters comprises at least one of spectral energy characteristics and spike characteristics.

10. A system for managing a neurological disorder, the system comprising:

one or more electrodes that are configured to measure one or more signals from the patient;

a signal processor that is in communication with the one or more electrodes, the signal processor adapted to extract one or more parameters from the one or more signals and process the extracted one or more parameters to estimate a neurological disease state or predict a future neurological disease state; and

a controller that receives the estimated neurological disease state and uses a non-linear control law to generate a neuromodulation signal for delivery to a nervous system component of the patient.

11. The system of claim 10 wherein the neurological disorder comprises epilepsy.

12. The system of claim 10 further comprising a reference module in communication with the controller that stores a reference neurological disease state.

13. The system of claim 12 wherein the reference module is configured to dynamically adjust the reference neurological disease state.

14. The system of claim 12 wherein the reference neurological disease state is dynamically adjusted based at least in part on an input from the controller.

15. The system of claim 10 wherein the non-linear control law comprises a deadband, wherein for specified estimated neurological disease states no neuromodulation signal is delivered to the nervous system component.

16. The system of claim 10 wherein the signal processor and controller are disposed within a unit that is implanted in a patient'"'"'s body, wherein the system further comprises at least one of a supervisory module and patient interface module that is external to the patient'"'"'s body, wherein at least one of the supervisory module and patient interface module is in wireless communication with the controller.

17. The system of claim 16 wherein at least one of the supervisory module and patient interface module are adapted to wirelessly receive at least one of parameters of the non-linear control law and the one or more extracted parameters.

18. The system of claim 10 wherein the nervous system component comprises a vagus nerve, wherein the neuromodulation signal is delivered to one or more electrodes coupled to the vagus nerve.

19. The system of claim 10 wherein the neuromodulation signal comprises electrical stimulation or medication.

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

measuring one or more EEG signals from the patient;

extracting one or more parameters from the one or more EEG signals;

estimating a patient'"'"'s epileptic disease state using the extracted one or more parameters; and

inputting at least one of the epileptic disease state and one or more extracted parameters into a non-linear control law to determine parameters for a neuromodulation signal that is to be delivered to a nervous system component of the patient.

21. The method of claim 20 wherein parameters of the neuromodulation signal are a function of a difference between a reference epileptic disease state and the estimated epileptic disease state.

22. The method of claim 21 further comprising dynamically adjusting the reference epileptic disease state.

23. The method of claim 20 wherein estimating the patient'"'"'s epileptic disease state further comprises processing one or more extrinsic factors.

24. The method of claim 23 wherein extrinsic factors comprise known cyclical variations of the one or more EEG signals.

25. The method of claim 23 wherein the one or more extrinsic factors comprise a patient'"'"'s sleep state.

26. The method of claim 23 wherein the one or more extrinsic factors comprise a patient'"'"'s pharmacological dosing.

27. The method of claim 23 wherein the one or more extrinsic factors comprise consumption of a meal.

28. The method of claim 23 wherein the one or more extrinsic factors comprise variations in the one or more EEG signals in response to a previously delivered neuromodulation signal.

29. The method of claim 20 wherein the estimated epileptic disease state is predictive of a future seizure.

30. The method of claim 20 wherein the non-linear control law comprises a deadband.

31. The method of claim 20 wherein the one or more parameters are extracted in a unit that is implanted in the patient'"'"'s body, the method further comprising wirelessly transmitting the one or more extracted parameters to a patient interface module or supervisory module that is external to the patient'"'"'s body.

32. The method of claim 20 further comprising storing the one or more extracted parameters in a memory.