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

• US 7,242,984 B2
• Filed: 01/06/2004
• Issued: 07/10/2007
• 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:
  US10/753,205
• Publication Number:
  US 20050119703A1
• Time in Patent Office: 1,281 Days
• Field of Search: 607/45, 607/46, 607/58
• 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 1/36082 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 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 system for neural modulation in the treatment of disease, comprising:

a system enclosure, in mechanical communication with a calvarium;

a control circuit enclosed within said system enclosure and in electronic communication with an output stage circuit, wherein said control circuit employs a calculation of seizure prediction; and

a stimulating electrode array, in electronic communication with said output stage circuit,

wherein said control circuit is configured to monitor an impedance of the stimulating electrode array.

2. The system of claim 1 comprising one or more sensors in communication with the control circuit, wherein the one or more sensors are configured to measure one or more signals from a nervous system component of a patient.

3. The system of claim 2 wherein at least one of the one or more sensors is disposed intracranially.

4. The system of claim 1 wherein said stimulating electrode array is configured to deliver stimulation to a vagus nerve of a patient.

5. The system as recited in claim 1, wherein said control circuit employs a calculation of a measure of chaos.

6. The system as recited in claim 1, wherein said control circuit employs a calculation of entropy.

7. The system as recited in claim 1, wherein said control circuit employs a calculation of a Lyupanov exponent.

8. The system as recited in claim 1, wherein said control circuit employs a calculation of a maximal state control.

9. A system for neural modulation in the treatment of disease, comprising:

a system enclosure, in mechanical communication with a calvarium;

a control circuit enclosed within said system enclosure and in electronic communication with an output stage circuit, wherein said control circuit employs a calculation of seizure prediction, and wherein said control circuit comprises a non-linear control law to generate a control law output signal that specifies parameters of a neuromodulation signal that is delivered by the output stage circuit, and

a stimulating electrode array, in electronic communication with said output stage circuit.

10. A system for neural modulation of a patient for the treatment of epilepsy, the system comprising:

a signal processor configured to process one or more signals received from a patient;

an output assembly in communication with the signal processor, the output assembly being configured to analyze the processed one or more signals for seizure prediction, wherein the output assembly calculates and generates a neural modulation signal when a seizure is predicted; and

one or more electrodes that are in communication with the output assembly, the one or more electrodes configured to deliver the neural modulation signal to the patient,

wherein the one or more signals comprise EEG signals, and wherein the seizure prediction employs analyzing spike parameters of the EEG signals.

11. The system of claim 10 further comprising a system enclosure that is configured to be coupled with a calvarium.

12. The system of claim 10 wherein the output assembly comprises:

a control circuit that is configured to analyze the processed one or more signals to calculate parameters of the neural modulation signal and generate an output signal; and

an output stage circuit that receives the output signal from the control circuit and generates the neural modulation signal with parameters that are specified by the output signal.

13. The system of claim 10 wherein seizure prediction employs, a calculation of entropy.

14. The system of claim 10 wherein seizure prediction employs a calculation of chaos.

15. The system of claim 10 wherein the spike parameters comprise at least one of peak-to-valley times, valley-to-peak times, positive phase amplitudes, and negative phase amplitudes.

16. The system of claim 10 wherein the one or more electrodes deliver the neural modulation signal directly to a vagus nerve.