Methods and apparatus for transcranial stimulation

• US 8,682,449 B2
• Filed: 08/27/2009
• Issued: 03/25/2014
• Est. Priority Date: 04/10/2008
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US12/548,569
• Publication Number:
  US 20090319002A1
• Time in Patent Office: 1,671 Days
• Field of Search: 607/45, 607/115, 607/139
• US Class Current: 607/115
• CPC Class Codes: A61N 1/0408 Use-related aspects
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

Systems, apparatus and methods are described for applying electric current to neurons in the brain to treat disorders and to improve motor and/or memory functions in a patient. In a method according to the invention, an electrode is positioned adjacent to and spaced from the skin surface of the patient'"'"'s head and an electric current is applied through the electrode to a target region in the brain to modulate one or more neurons in the target region. The electrode is housed within an enclosure and spaced from the skin surface so that the electrode does not directly contact the patient'"'"'s tissue, which reduces the potential for collateral tissue damage or necrosis and shields the electrode from the patient'"'"'s tissue which substantially inhibits Faradic products (e.g., H⁺, OH⁻, H₂O₂) of the electrode from reaching the target site.

Claims

1. A method for treating a disorder in a patient comprising:

housing an electrode within an enclosure comprising an electrically conductive tissue contact element and a fluid passage;

positioning the electrode within the fluid passage;

contacting the electrically conductive tissue contact element to a skin surface of a head of the patient;

delivering an electrically conductive fluid through the fluid passage to electrically couple the electrode to the contact element; and

applying an electrical impulse through the electrode to a target region in a brain of the patient, wherein the electrical impulse is sufficient to modulate one or more neurons in the target region of the brain.

2. The method of claim 1 wherein the positioning step includes spacing the electrode at least 3 cm away from the skin surface.

3. The method of claim 1 wherein the positioning step includes spacing the electrode at least 8 cm from the skin surface.

4. The method of claim 1 wherein the electrically conductive tissue contact element comprises a gel material.

5. The method of claim 1 wherein the electrode is a first electrode, the electrically conductive tissue contact element is a first electrically conductive tissue contact element and the tissue passage is a first tissue passage, the method further comprising positioning a second electrode adjacent to and spaced from the skin surface housing the second electrode within a second enclosure comprising a second electrically conductive tissue contact element and a second fluid passage;

positioning the second electrode within the second fluid passage;

contacting the second electrically conductive tissue contact element to the skin surface;

delivering an electrically conductive fluid through the second fluid passage to electrically couple the second electrode to the second contact element; and

applying the electrical impulse from the first electrode through the target region to the second electrode.

6. The method of claim 1 wherein the electrode is an anode.

7. The method of claim 1 wherein the electrode is a cathode.

8. The method of claim 1 wherein the electrical impulse is a direct current between about 0.01 to 100 mA.

9. The method of claim 1 wherein the electrical impulse is a direct current between about 1 to 10 mA inclusive.

10. The method of claim 1 wherein the electrical impulse is sufficient to alter a firing rate of the one or more neurons in the target region.

11. The method of claim 1 wherein the electrically conductive fluid is saline.

12. The method of claim 1 wherein the electrically conductive fluid is a buffered conductive solution.

13. The method of claim 1 wherein the disorder is selected from the group consisting essentially of depression, epilepsy, fibromyalgia, schizophrenia, stroke and acute pain.

14. The method of claim 1 wherein the target region is selected from the group consisting essentially of the motor cortex, visual cortex, and prefrontal cortex of the brain.

15. A system for treating a patient'"'"'s brain comprising:

a source of energy;

an enclosure having a contact element and a fluid passage, the contact element being sized and shaped for contacting an outer skin surface on a patient'"'"'s head;

an electrode housed within the fluid passage of the enclosure and electrically coupled to the source of energy and the contact element of the enclosure; and

wherein the source of energy is configured to apply an electrical impulse through the electrode and the contact element of the enclosure to a target region in the patient'"'"'s brain sufficient to modulate one or more neurons in the target region.

16. The system of claim 15 further comprising a source of electrically conductive fluid positioned within the fluid passage for electrically coupling the electrode to the contact element.

17. The system of claim 16 wherein the contact element comprises a gel material.

18. The system of claim 15 wherein the enclosure is a first enclosure, the electrode is a first electrode, the contact element is a first contact element and the fluid passage is a first fluid passage, the method further comprising:

a second enclosure having a second contact element and a second fluid passage, the second contact element being sized and shaped for contacting the outer skin surface of the patient'"'"'s head; and

a second electrode housed within the second fluid passage of the second enclosure and electrically coupled to the source of energy, wherein the source of electrical energy is configured to apply the electrical impulse from the first electrode through the target region to the second electrode.

19. The system of claim 15 wherein the electrical impulse is a direct current between about 0.01 to 100 mA.

20. The system of claim 15 wherein the electrical impulse is a direct current between about 1 to 10 mA inclusive.