Medical devices for the detection, prevention and/or treatment of neurological disorders, and methods related thereto

• US 20060173510A1
• Filed: 10/17/2005
• Published: 08/03/2006
• Est. Priority Date: 10/16/2003
• Status: Active Grant

• Current Assignee: Board of Supervisors of Louisiana State University Agricultural & Mechanical College (Louisiana State University System), Louisiana Tech University Foundation (Louisiana Tech University)
• Original Assignee: Louisiana Tech University Foundation (Louisiana Tech University)
• Inventors: Besio, Walter G., Patwardhan, Ravish, Fasiuddin, Mohammed
• Granted Patent: US 8,190,248 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition

Abstract

Disclosed are devices and methods for detecting, preventing, and/or treating neurological disorders. These devices and methods utilize electrical stimulation, and comprise a unique concentric ring electrode component. The disclosed methods involve the positioning of multiple electrodes on the scalp of a mammal; monitoring the mammal'"'"'s brain electrical patterns to identify the onset of a neurological event; identifying the location of the brain electrical patterns indicative of neurological event; and applying transcutaneous or transcranial electrical stimulation to the location of the neurological event to beneficially modify brain electrical patterns. The disclosed methods may be useful in the detection, prevention, and/or treatment of a variety of indications, such as epilepsy, Parkinson'"'"'s Disease, Huntington'"'"'s disease, Alzheimer'"'"'s disease, depression, bipolar disorder, phobia, schizophrenia, multiple personality disorder, migraine or headache, concussion, attention deficit hyperactivity disorder, eating disorder, substance abuse, and anxiety. The disclosed methods may also be used in combination with other peripheral stimulation techniques.

Claims

1. A medical device, comprising a control module, one or more electrodes, and a power supply, wherein, the control module comprises an electrode arbiter, a detection sub-system, an impedance sub-system, a memory sub-system, a stimulation sub-system, a communication sub-system, and a central processing unit, and wherein each of the one or more electrodes comprises a multi-polar configuration.

2. A medical device according to claim 1, wherein the detection sub-system comprises one or more amplifiers, one or more analog-to digital converters, and a digital signal processor.

3. A medical device according to claim 1, wherein the impedance sub-system comprises one or more impedance signal generators and an impedance controller.

4. A medical device according to claim 1, wherein the stimulation sub-system comprises one or more stimulation signal generators, a stimulation controller, and a high voltage supply.

5. A medical device according to claim 1, wherein the one or more electrodes comprise at least one outer conductive element and one central conductive element, wherein the at least one outer conductive element surrounds the central conductive element.

6. A medical device according to claim 5, wherein the conductive elements are arranged in a concentric geometric configuration of a ring, a square, a rectangle, an ellipse, or a polygon comprising any number of sides.

7. A medical device according to claim 5, wherein the conductive elements are arranged to form a gap therebetween, and wherein the gap is equal to the width of the at least one outer conductive element.

8. A medical device according to claim 5, wherein the conductive elements are arranged to form a gap therebetween, and wherein the gap is less than or equal to the width of the at least one outer conductive element.

9. A medical device according to claim 5, wherein the one or more electrodes are surface type or implantable type.

10. A medical device according to claim 5, wherein the one or more electrodes are fabricated from a metal, a non-metallic conductive material, or a combination thereof, wherein the metal or the non-metallic conductive material is biocompatible, or comprises a conductive biocompatible coating.

11. A medical device according to claim 4, wherein the one or more stimulation signal generators provide electrical signals with waveforms, wherein the waveforms are mono-phasic, bi-phasic, or multi-phasic.

12. A medical device according to claim 4, wherein the one or more stimulation signal generators provide electrical signals having a frequency in the range of from about 0.1 Hz to about 2500 Hz, a pulse width in the range of from about 10 μ

sec to about 10 sec, and a duration of from about 15 sec to about 30 min.

13. A medical device according to claim 4, wherein the one or more stimulation signal generators provide voltage in the range of from about 500 mV to about 2 kV, or current in the range of from about 0.01 mA to about 1000 mA.

14. A medical device according to claim 1, wherein the device is used in the detection, prevention, treatment of a neurological disorder, or any combination thereof.

15. A medical device according to claim 14, wherein the neurological disorder is epilepsy or another seizure disorder, Parkinson'"'"'s Disease, Huntington'"'"'s disease, Alzheimer'"'"'s disease, Pick'"'"'s disease, Parkinsonism, rigidity, hemiballism, choreoathetosis, dystonia, akinesia, bradykinesia, hyperkinesia, other movement disorder, depression, bipolar disorder, anxiety, phobia, schizophrenia, multiple personality disorder, substance abuse, attention deficit hyperactivity disorder, eating disorder, impaired control of aggression, or impaired control of sexual behavior, headache, or chronic headache, migraine, concussion, post-concussive syndrome, stress-related disorder, or any combination thereof.

16. A medical method, comprising:

a. positioning of at least one two or more element electrode on a portion of a mammal;

b. monitoring patterns of brain electrical signals of the mammal to identify the presence or onset of a neurological event;

c. applying electrical stimulation to beneficially modify the brain electrical patterns,

wherein, the stimulation is applied transcutaneously, transcranially, or a combination thereof, and

wherein the method is performed for detecting, preventing or treating a neurological disorder, or any combination thereof.

17. A medical method according to claim 16, further comprising identifying the location of the brain electrical patterns indicative of neurological event prior to the applying of electrical stimulation.

18. A medical method according to claim 16, wherein the at least two or more element electrode is positioned on or under the scalp, or surgically implanted on, in, or near the brain, or any combination thereof.

19. A medical method according to claim 16, wherein the electrical stimulation is applied in the form of sustained current, pulsed current, specific pulse pattern, sustained voltage, pulsed voltage, or any combination thereof.

20. A medical method according to claim 16, wherein the electrical stimulation is applied at a frequency in the range of from about 0.1 Hz to about 2500 Hz, a pulse width in the range of from about 10 qsec to about 10 sec, and for a duration of from about 15 sec to about 30 min.

21. A medical method according to claim 16, wherein the electrical stimulation is applied at a frequency in the range of from about 10 Hz to about 250 Hz, a pulse width in the range of from about 50 qsec to about 250 qsec, and for a duration of from about 30 sec to about 5 min.

22. A medical method according to claim 16, wherein the one or more stimulation signal generators provide voltage in the range of from about 500 mV to about 2 kV, or current in the range of from about 0.01 mA to about 1000 mA.

23. A medical method according to claim 16, wherein the one or more stimulation signal generators provide voltage in the range of from about 30 V to about 100 V, or current in the range of from about 5 mA to about 75 mA.

24. A medical method according to claim 16, wherein the neurological disorder is epilepsy or another seizure disorder, Parkinson'"'"'s Disease, Huntington'"'"'s disease, Alzheimer'"'"'s disease, Pick'"'"'s disease, Parkinsonism, rigidity, hemiballism, choreoathetosis, dystonia, akinesia, bradykinesia, hyperkinesia, other movement disorder, depression, bipolar disorder, anxiety, phobia, schizophrenia, multiple personality disorder, substance abuse, attention deficit hyperactivity disorder, eating disorder, impaired control of aggression, or impaired control of sexual behavior, headache, or chronic headache, migraine, concussion, post-concussive syndrome, stress-related disorder, or any combination thereof.

25. A medical method according to claim 17, wherein the electrical signals directly localize at least two specific volumes of tissue via at least nine electrodes arranged in a specific configuration.

26. A medical method according to claim 17, wherein the electrical signals directly localize at least two specific volumes of tissue via a three-pole or greater concentric electrode configuration.

27. A medical method according to claim 17, wherein the electrical signals directly localize at least two specific volumes of tissue via at least nine single-element electrodes arranged in a specific configuration.

28. A medical method according to claim 16 further comprising an at least three element electrode wherein brain electrical signals are monitored by detecting an electrical potential between a first two elements of the electrode and a second two elements of the electrode.

29. A medical method according to claim 28 further utilizing said electric potentials to detect a location of the brain electrical signals within a volume of a body of the mammal.

30. A medical method according to claim 16 further comprising an at least three element electrode wherein stimulation is applied by generating a voltage between at least two elements of the electrode.

31. A medical method according to claim 30, wherein at least two electrodes are utilized to direct stimulation to a specific location within a volume of a body of the mammal.