Apparatus and method for closed-loop intracranial stimulation for optimal control of neurological disease

• US 9,421,373 B2
• Filed: 11/15/2006
• Issued: 08/23/2016
• Est. Priority Date: 08/05/1998
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: DiLorenzo, Daniel John
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US11/600,527
• Publication Number:
  US 20070073355A1
• Time in Patent Office: 3,569 Days
• Field of Search: 607/45
• US Class Current: 1/1
• 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 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• 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
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

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 intracranial (IC) stimulating electrodes 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 or psychiatric disease state of a patient, the method comprising:

measuring first signals from an accelerometer mounted in the patient'"'"'s head, wherein measuring said first signals comprises monitoring head movement and position with respect to gravity using the accelerometer;

extracting first parameters from the first signals that are indicative of a first disease state of the patient;

measuring second signals from an acoustic sensor mounted in the patient'"'"'s head, wherein measuring said second signals comprises monitoring respiratory pattern, latency of vocal signals reaching a steady state threshold amplitude level, and frequency of vocal signals;

extracting second parameters from the second signals that are indicative of the first disease state of the patient;

initiating delivery of a first neural modulation signal to the patient using an implanted stimulator when the first and second extracted parameters indicate that a patient status is in the first disease state, the patient status being calculated primarily from the first signals from the accelerometer and the second signals from the acoustic sensor;

automatically monitoring the patient'"'"'s response to the delivered first neural modulation signal; and

initiating delivery of a subsequent second neural modulation signal using the implanted stimulator when the response to the delivered first neural modulation signal indicates that the subsequent second neural modulation signal is needed to transition the patient status to a second disease state.

2. The method of claim 1 wherein the neurological disease state comprises epilepsy or Parkinson'"'"'s disease and the first disease state comprises a seizure or tremor.

3. The method of claim 1, wherein the subsequent second neural modulation signal is needed when a desired change in brain activity is not achieved with the delivered first neural modulation signal.

4. The method of claim 1, wherein at least one of the first neural modulation signal and the subsequent second neural modulation signal comprise a pulse train of waveforms that include one or more bursts of waveforms.

5. The method of claim 4, wherein the one or more bursts each comprise one or more charge balanced biphasic stimulus pulses.

6. The method of claim 5 wherein an anodic phase and a cathodic phase of the charge balanced biphasic stimulus pulses are asymmetrical.

7. The method of claim 1 wherein the first neural modulation signal and the subsequent second neural modulation signal each comprise electrical stimulation of a nervous system component.

8. The method of claim 1 wherein the accelerometer is one of a plurality of accelerometers.

9. The method of claim 1 wherein the patient status comprises using a physiological sensor communicating with the patient.

10. The method of claim 9 wherein the physiological sensor is configured to sense patient respiration.

11. The method of claim 1 wherein the first neural modulation signal is derived at least in part from a comparison of a disease state estimate and a reference input corresponding to a target disease state, wherein the disease state estimate is based at least in part on the first signals from the accelerometer and the second signals from the acoustic sensor.

12. The method of claim 1, further comprising calculating a standard deviation of the frequency of the vocal signals, wherein the standard deviation is included in the second parameters.

13. A method of managing a neurological or psychiatric disease state of a patient, the method comprising:

measuring first signals from an accelerometer mounted in the patient'"'"'s head, wherein measuring said first signals comprises monitoring head movement and position with respect to gravity using the accelerometer;

extracting first parameters from the first signals that are indicative of a first disease state of the patient;

measuring second signals from an acoustic sensor mounted in the patient'"'"'s head, wherein measuring said second signals comprises monitoring respiratory pattern, latency of vocal signals reaching a steady state threshold amplitude level, and frequency of vocal signals;

extracting second parameters from the second signals that are indicative of the first disease state of the patient;

initiating delivery of a first neural modulation signal to the patient using an implanted stimulator when the first signals and the second signals indicate that a patient status is in the first disease state, the patient status being calculated primarily from the first signals from the accelerometer and the second signals from the acoustic sensor;

monitoring the patient'"'"'s response to the first neural modulation signal; and

initiating delivery of a subsequent second neural modulation signal configured to transition the patient to a second disease state when the patient'"'"'s response to the first neural modulation signal continues to indicate that the patient status is in the first disease state.

14. The method of claim 13 wherein the neurological disease state comprises epilepsy or Parkinson'"'"'s disease and the first disease state comprises a seizure or tremor.

15. The method of claim 13, wherein monitoring the patient'"'"'s response to the delivered first neural modulation signal comprises determining whether undesirable brain activity is present.

16. The method of claim 13, wherein delivery of the subsequent second neural modulation signal is initiated when a desired change in brain activity is not achieved with the first neural modulation signal.

17. The method of claim 13, wherein at least one of the first neural modulation signal and the subsequent second neural modulation signal comprise a pulse train of waveforms that include one or more bursts of waveforms.

18. The method of claim 17, wherein the one or more bursts each comprise one or more charge balanced biphasic stimulus pulses.

19. The method of claim 18 wherein an anodic phase and a cathodic phase of the charge balanced biphasic stimulus pulses are asymmetrical.

20. The method of claim 13 wherein the first neural modulation signal and the subsequent second neural modulation signal each comprise electrical stimulation of a nervous system component.

21. The method of claim 13 wherein the first neural modulation signal is derived at least in part from a comparison of a disease state estimate and a reference input corresponding to a target disease state, wherein the disease state estimate is based at least in part on the first signals from the accelerometer and the second signals from the acoustic sensor.

22. A method of managing epilepsy in a patient, the method comprising:

monitoring high frequency head vibration, muscle vibration, speech production, and respiratory pattern using an acoustic sensor mounted in the patient'"'"'s head;

monitoring head movement and position with respect to gravity using an accelerometer mounted in the patient'"'"'s head;

initiating delivery of a first neural modulation signal to the patient using an implanted stimulator when the patient'"'"'s neural activity indicates that a patient status is in a disease state, the patient status being calculated primarily from data provided by the accelerometer and the acoustic sensor;

automatically monitoring the patient'"'"'s response after delivering the first neural modulation signal; and

initiating delivery of a second neural modulation signal to the patient using the implanted stimulator when the monitored response continues to indicate that the patient status is in the disease state.

23. The method of claim 22 wherein the first neural modulation signal and the second neural modulation signal each comprise electrical stimulation, wherein the first neural modulation signal and the second neural modulation signal each comprise at least one different parameter.

24. The method of claim 22 wherein the first neural modulation signal and the second neural modulation signal each comprise electrical stimulation and the first neural modulation signal and the second neural modulation signal each comprise same parameters.