Implantable apparatus for treating neurological disorders

• US 6,647,296 B2
• Filed: 08/17/2001
• Issued: 11/11/2003
• Est. Priority Date: 10/27/1997
• Status: Expired due to Term

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Upton, Adrian R.M.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/932,535
• Publication Number:
  US 20010051819A1
• Time in Patent Office: 816 Days
• Field of Search: 600/372-373, 600/377, 600/378, 600/544, 600/545, 607/1, 607/30-32, 607/45, 607/46, 607/58-60, 607/116
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• 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 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

Disclosed is a multiple electrode, closed-loop, responsive system for the treatment of certain neurological diseases such as epilepsy, migraine headaches and Parkinson'"'"'s disease. Brain electrodes would be placed in close proximity to the brain or deep within brain tissue. When a neurological event such as the onset of an epileptic seizure occurs, EEG signals from the electrodes are processed by signal conditioning means in a control module that can be placed beneath the patient'"'"'s scalp, within the patient'"'"'s chest, or situated externally on the patient. Neurological event detection means in the control module will then cause a response to be generated for stopping the neurological event. The response could be an electrical signal to brain electrodes or to electrodes located remotely in the patient'"'"'s body. The response could also be the release of medication or the application of a sensory input such as sound, light or mechanical vibration or electrical stimulation of the skin. The response to the neurological event can originate from devices either internal or external to the patient. The system also has the capability for multi-channel recording of EEG related signals that occur both before and after the detection of a neurological event. Programmability of many different operating parameters of the system by means of external equipment provides adaptability for treating patients who manifest different symptoms and who respond differently to the response generated by the system.

Claims

1. A responsive system for treating a neurological disorder in a patient, the system comprising:

a control module adapted to be implanted in the patient; and

a plurality of electrodes connected to the control module, at least one of which is adapted to be located within the cranium of the patient;

wherein the control module includes an event processing microcomputer implementing a detection algorithm biased to allow false positive detections; and

wherein the control module is adapted to analyze an input electrical signal originating in the brain of the patient and received by the control module, to detect a neurological event in the input electrical signal using the event processing microcomputer, and to initiate application of an output electrical signal from the control module to the patient'"'"'s brain in response to the detected neurological event.

2. The responsive system for treating a neurological disorder of claim 1, wherein at least one electrode of the plurality of electrodes is adapted to be implanted on the brain of the patient.

3. The responsive system for treating a neurological disorder of claim 1, wherein at least one electrode of the plurality of electrodes is adapted to be implanted in the brain of the patient.

4. The responsive system for treating a neurological disorder of claim 3, wherein at least one electrode of the plurality of electrodes is adapted to be implanted substantially new a Locus of neurological activity.

5. The responsive system for treating a neurological disorder of claim 1, wherein the output electrical signal comprises a electrical stimulation signal.

6. The responsive system for treating a neurological disorder of claim 5, wherein the electrical stimulation signal is therapeutic.

7. The responsive system for treating a neurological disorder of claim 6, wherein the electrical stimulation signal is intended to terminate or prevent a seizure.

13. The responsive system for treating a neurological disorder of claim 1, wherein the control module is implanted intracranially.

14. The responsive system for treating a neurological disorder of claim 13, wherein the control module is implanted in a recess formed in the patient'"'"'s cranium.

15. The responsive system for treating a neurological disorder of claim 14, wherein the recess defines a hole in the patient'"'"'s cranium.

16. The responsive system for treating a neurological disorder of claim 1, further comprising an insulated lead connecting at least one electrode of the plurality of electrodes to the control module.

17. The responsive system for treating a neurological disorder of claim 16, wherein the output electrical signal is transmitted to at least one electrode of the plurality of electrodes via the lead.

18. The responsive system for treating a neurological disorder of claim 16, wherein the input electrical signal is received from at least one electrode of the plurality of electrodes via the lead.

19. The responsive system for treating a neurological disorder of claim 1, wherein:

the control module comprises a data communication subsystem;

the responsive system further comprises at least one piece of external equipment including an external data interface; and

wherein the data communication subsystem and the external data interface cooperatively enable a communication data link between the control module and the external equipment.

20. The responsive system for treating a neurological disorder of claim 19, wherein the data communication link is bi-directional.

21. The responsive system for treating a neurological disorder of claim 19, wherein the data communication link is wireless.

22. The responsive system for treating a neurological disorder of claim 19, wherein the external equipment is adapted to transmit at least one programmable parameter to the control module.

23. The responsive system for treating a neurological disorder of claim 19, wherein the external equipment is adapted to retrieve data from the control module.

24. The responsive system for treating a neurological disorder of claim 23, wherein the data comprises stored EEG information.

25. The responsive system for treating a neurological disorder of claim 19, wherein the external equipment includes a physician'"'"'s workstation.

26. The responsive system for treating a neurological disorder of claim 19, wherein the external equipment includes a patient'"'"'s initiating device.

8. The responsive system for treating a neurological disorder of claim includes a pulse.

9. The responsive system for treating a neurological disorder of claim 8, wherein the pulse is biphasic.

10. The responsive system for treating a neurological disorder of 1, wherein the input electrical signal comprises an BEG signal.

11. The responsive system for treating a neurological disorder of claim 10, wherein the event processing microcomputer is adapted to process and analyze the EEG signal to identify the neurological event.

12. The responsive system for treating a neurological disorder of 11, wherein the event detection subsystem is adapted to cause the control module to produce the output electrical signal in response to the identification of a neurological event.