Monitoring an epilepsy disease state with a supervisory module

• US 9,415,222 B2
• Filed: 07/21/2008
• Issued: 08/16/2016
• Est. Priority Date: 08/05/1998
• Status: Expired due to Term

• Current Assignee: DiLorenzo Biomedical, LLC
• Original Assignee: Cyberonics, Inc
• Inventors: DiLorenzo, Daniel John
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US12/177,060
• Publication Number:
  US 20090018609A1
• Time in Patent Office: 2,948 Days
• Field of Search: 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1114 Tracking parts of the body
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/313 for electromyography [EMG]
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4803 Speech analysis specially adapted for diagnostic purposes
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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

Systems and methods for monitoring an epilepsy disease state in a human patient are described. The system includes patient components and a supervisory module. The patient components include: an implantable electrode array for collecting neurological signals, an implantable recording electrode signal processor for processing the neurological signals collected by the electrode array, and a disease state estimator for estimating the patient'"'"'s disease state. The supervisory module receives the patient'"'"'s disease state from the patient components and displays a time history of the patient'"'"'s disease state.

Claims

1. A system for monitoring a disease state in a human patient, comprising:

patient components, said patient components comprising;

an implantable electrode array for collecting neurological signals;

an acoustic sensor mounted the patient'"'"'s head;

an accelerometer mounted in the patient'"'"'s head;

an implanted unit comprising an implantable recording electrode signal processor for processing the neurological signals collected by the electrode array, said implanted unit being coupled to the accelerometer and configured to monitor head movement and position with respect to gravity using the accelerometer, said implanted unit being coupled to the acoustic sensor and further configured to monitor respiratory pattern, latency of vocal signals reaching a steady state threshold amplitude level, and frequency of vocal signals using the acoustic sensor;

a disease state estimator coupled to the implanted unit, said disease state estimator being configured to estimate the patient'"'"'s disease state based at least in part on the respiratory pattern, the latency of vocal signals reaching the steady state threshold amplitude level, and the frequency of vocal signals; and

a supervisory module external to the patient'"'"'s body for receiving the patient'"'"'s disease state from the patient components and displaying a time history of the patient'"'"'s disease state.

2. The system of claim 1, wherein the patient components further comprise a patient interface module for monitoring the patient'"'"'s disease state, said patient interface module being external to the patient'"'"'s body.

3. The system of claim 1, wherein the patient components further comprise an electromyography electrode array positioned in the patient'"'"'s neck for monitoring electromyographic signals.

4. The system of claim 1, wherein the disease state estimator estimates the patient'"'"'s disease state based on acceleration signals from the accelerometer and neurological signals from the implantable electrode array.

5. The system of claim 4, wherein the disease state estimator estimates the patient'"'"'s disease state based on high frequency head vibration signals from the acoustic sensor.

6. The system of claim 4, wherein the disease state estimator estimates the patient'"'"'s disease state based on muscle vibration and speech production signals from the acoustic sensor.

7. The system of claim 1, wherein the patient components further comprise EMG sensors for monitoring eyelid movement to determine frequency of eye blinking.

8. The system of claim 1, wherein the implantable electrode array comprises an intracranial electrode array.

9. The system of claim 1, wherein the implantable electrode array comprises an extracranial electrode array.

10. The system of claim 1, wherein the time history of the patient'"'"'s disease state includes responses to pharmacologic dosing.

11. The system of claim 1, wherein the patient components further comprise an implantable recording unit adapted to receive and record neurological signals from the implantable electrode array.

12. The system of claim 11, wherein the implantable recording unit is implanted in the patient'"'"'s head.

13. The system of claim 11, wherein the implantable recording unit is implanted in the patient'"'"'s subclavian pocket.

14. A method of monitoring a disease state in a human patient, comprising:

collecting neurological signals with an implantable electrode array;

processing the neurological signals collected by the electrode array with an implantable recording electrode signal processor;

monitoring respiratory pattern, latency of vocal signals reaching a steady state threshold amplitude level, and frequency of vocal signals 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;

estimating the patient'"'"'s disease state with a disease state estimator based at least in part on the head movement and position with respect to gravity, the respiratory pattern, the latency of vocal signals reaching the steady state threshold amplitude level, and the frequency of vocal signals; and

displaying a time history of the patient'"'"'s disease state on a supervisory module.

15. The method of claim 14, further comprising monitoring the patient'"'"'s disease state using a patient interface module external to the patient'"'"'s body.

16. The method of claim 14, further comprising monitoring electromyographic signals using an electromyography electrode array positioned in the patient'"'"'s neck.

17. The method of claim 14, wherein the estimating the patient'"'"'s disease state is performed based on acceleration signals from the accelerometer and neurological signals from the implantable electrode array.

18. The method of claim 17, wherein estimating the patient'"'"'s disease state is further based on high frequency head vibration signals from the acoustic sensor.

19. The method of claim 14, further comprising monitoring eyelid movement using EMG sensors to determine frequency of eye blinking.

20. The method of claim 14, further comprising monitoring one or more vital signs with a vital signs monitor.

21. The method of claim 20, further comprising monitoring of the one or more vital signs with the supervisory module.

22. The method of claim 20, further comprising monitoring of the one or more vital signs with a patient interface module external to the patient'"'"'s body.

23. The method of claim 14, wherein said collecting neurological signals comprises collecting intracranial neurological signals.

24. The method of claim 14, wherein said collecting neurological signals comprises collecting extracranial neurological signals.

25. The method of claim 14, wherein the time history of the patient'"'"'s disease state includes responses to pharmacologic dosing.