Means and method for the treatment of neurological disorders

• US 6,128,538 A
• Filed: 11/29/1999
• Issued: 10/03/2000
• 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): Kamm, William E.
• Application Number:
  US09/450,303
• Time in Patent Office: 309 Days
• Field of Search: 607/45, 600/544, 600/545
• US Class Current: 607/45
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

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 system for the treatment of neurological disorders of a human patient, the system comprising:

at least two electrodes adapted to be located within the patient'"'"'s body with at least one electrode of the at least two electrodes located within the patient'"'"'s body being a brain electrode adapted to be placed within the patient'"'"'s head;

a control module adapted to be implanted within the patient'"'"'s body for transmitting output signals from the control module responsive to at least one input electrical signal originating in the patient'"'"'s brain, the control module including electronic circuitry, the electronic circuitry of the control module including a data recording means;

electrical conducting means for providing electrical connections between the electrodes and the electronic circuitry of the control module; and

external equipment means adapted to be located external to the human patient for providing two-way communication between the external equipment means and the control module for (1) receiving data transmission from the control module and (2) transmitting signals to be received by the control module for defining the output signals from the control module, whereby said output signals provide a stimulation signal to terminate a neurological event.

2. The system of claim 1 wherein the data recording means is adapted to record the at least one input electrical signal originating in the patient'"'"'s brain.

3. The system of claim 1 wherein the data recording means is adapted to simultaneously record at least two input electrical signals originating in the patient'"'"'s brain.

4. The system of claim 1 wherein the data recording means includes analog-to-digital conversion and a digital memory, the digital memory being is adapted to store data that is received and processed by the electronic circuitry of the control module.

5. The system of claim 4 wherein the digital memory is adapted to record data for a first time period which is the time period before the detection of the neurological event.

6. The system of claim 5 wherein the first time period is between 0.1 and 30 minutes.

7. The system of claim 4 wherein the digital memory is adapted to record data for a second time period which is the time period after the detection of the neurological event.

8. The system of claim 7 wherein the second time period is between 0.1 and 30 minutes.

9. The system of claim 4 wherein the digital memory is adapted to record data for both a first time period which is the time period before the detection of the neurological event and for a second time period which is the time period after the detection of the neurological event.

10. The system of claim 9 wherein the first time period is between 0.1 and 30 minutes and the second time period is between 0.1 and 30 minutes.

11. The system of claim 4 wherein the data recording means is adapted to store in the digital memory, the data to be stored including data that corresponds to the energy level of each one of at least two different frequency bands of the at least one input electrical signal originating in the patient'"'"'s brain, wherein each frequency band is obtained by a transformation into the frequency domain of the at least one electrical signal originating in the patient'"'"'s brain.

12. The system of claim 4 wherein the data recording means is adapted to store within the digital memory, the data to be stored originating from a specific set of electrodes which set of electrodes is less than the total number of electrodes located within the patient '"'"'s body.

13. The system of claim 4 wherein the data recording means is adapted to store within the digital memory the number of neurological events detected over a predetermined time period, which predetermined time period is programmed into the control module by a signal from the external equipment means.

14. The system of claim 4 wherein the data recording means is adapted to store within the digital memory the time and date of occurrence of each neurological event that is detected.

15. The system of claim 4 further including means for stopping the neurological event, the data recording means being further adapted to store within the digital memory the time and date of each activation of the means for stopping the neurological event.

16. The system of claim 1 wherein the electronic circuitry further includes a real time clock.

17. The system of claim 16 wherein the real time clock is adapted to be set by a signal transmitted from the external equipment means.

18. The system of claim 1 wherein at least one of the input electrical signals originating in the patient'"'"'s brain is an EEG signal and the electronic circuitry of the control module is adapted to processes that EEG signal so as to change its wave shape as a function of time, the data recording means being adapted to record the processed EEG signal.

19. The system of claim 18 wherein the external equipment means is adapted to transmit a signal to the data recording means to initiate the recording of at least one of the processed EEG signals generated within the electronic circuitry of the control module.

20. The system of claim 19 wherein the external equipment means that is adapted to transmit a signal to cause the data recording means to initiate the recording of at least one processed EEG signal is a patient'"'"'s initiating device means for transmitting electrical signals to be received by the control module, the patient'"'"'s initiating device means being situated external to the patient and generally being operated by the patient.

21. The system of claim 19 wherein the external equipment means that is adapted to transmit a signal to cause the data recording means to record at least one processed EEG signal is a physician'"'"'s workstation means for transmitting electrical signals to be received by the control module, the physician'"'"'s workstation means being is situated external to the patient and generally being operated by a physician.

22. The system of claim 1 wherein the control module is adapted to be placed within the patient'"'"'s chest.

23. A system for the detection of neurological events characterized by a signal from within the brain of a human patient, the system comprising:

at least two electrodes adapted to be located within the patient'"'"'s body with at least one electrode of the at least two electrodes located within the patient'"'"'s body being a brain electrode adapted to be placed within the patient'"'"'s head, the brain electrode adapted to obtain electrical signals from the brain of the human patient;

a control module implanted within the patient'"'"'s body, the control module including an event detection sub-system and data recording means, the event detection sub-system being adapted to identify the occurrence of a neurological event by processing at least one electrical signal obtained by the at least one brain electrode, the data recording means being adapted to store the time and date of the occurrence of the neurological event;

electrical conducting means which provide electrical connections between the at least one electrode and the control module;

external equipment means adapted to be located external to the human patient for providing two-way communication between the external equipment means and the control module, the two-way communication being adapted to transmit the dates and times of the occurrences of neurological events stored by the data recording means of the control module to the external equipment means.