Electrical and magnetic stimulators used to treat migraine/sinus headache and comorbid disorders

• US 8,676,330 B2
• Filed: 05/17/2011
• Issued: 03/18/2014
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US13/109,250
• Publication Number:
  US 20110230701A1
• Time in Patent Office: 1,036 Days
• Field of Search: 607 1- 2, 607/46, 607 62- 63, 607/115, 607/139, 607/142, 607/149
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Non-invasive electrical nerve stimulation devices and magnetic stimulation devices are disclosed, along with methods of treating medical disorders using energy that is delivered noninvasively by such devices. The disorders comprise migraine and other primary headaches such as cluster headaches, including sinus symptoms that resemble an immune-mediated response (“sinus” headaches), irrespective of whether those symptoms arise from an allergy that is co-morbid with the headache. The disclosed methods may also be used to treat other disorders that may be co-morbid with migraine headaches, such as anxiety disorders. In preferred embodiments of the disclosed methods, one or both of the patient'"'"'s vagus nerves are stimulated non-invasively. In other embodiments, parts of the sympathetic nervous system and/or the adrenal glands are stimulated.

Claims

1. A method of treating a headache in a patient comprising:

positioning a device adjacent to a skin surface of a neck of the patient;

generating one or more electrical impulses with the device; and

transmitting the electrical impulses to selected nerve fibers in the patient, the electrical impulses being sufficient to cause dopaminergic neurons originating in a ventral tegmental area of the brain to stimulate neurons or tissue to which said dopaminerqic neurons project and to at least partially relieve pain associated with the headache.

2. The method of claim 1 wherein the electrical impulses are sufficient to at least partially relieve said pain within 5 minutes of the transmitting step.

3. The method of claim 1 wherein wherein the electrical impulses are transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the selected nerve fibers.

4. The method of claim 3 wherein the transmitting step is carried out by transcutaneously passing an electrical current through the outer skin surface of the patient to a target region within the patient.

5. The method of claim 4 further comprising generating an electrical field at or near the device and shaping the electrical field such that the electrical field is sufficient to modulate a nerve at the target region;

and wherein the electric field is not sufficient to substantially modulate a nerve or muscle between the outer skin surface and the target region.

6. The method of claim 3 wherein the transmitting step is carried out by generating a magnetic field exterior to the patient sufficient to induce an electrical impulse at or near the selected nerve within the patient.

7. The method of claim 3 wherein the nerve is at least approximately 1-2 cm below an outer skin surface of the patient.

8. The method of claim 1 wherein the electrical impulse is substantially constrained from modulating one or more nerves in a region between the outer skin surface and the selected nerve.

9. The method of claim 1 wherein the selected nerve fibers are associated with a vagus nerve of the patient.

10. The method of claim 1 wherein the selected nerve fibers are associated with a right branch of the vagus nerve.

11. The method of claim 1 wherein the electrical impulses are sufficient to cause selected release of catecholamines within the patient.

12. The method of claim 1 wherein the electrical impulses are sufficient to cause the release of catecholamines from an adrenal gland of the patient.

13. The method of claim 1 wherein the selected nerve fibers are afferent parasympathetic nerves.

14. The method of claim 1 wherein the electrical impulses comprise bursts of pulses with a frequency of about 5 Hz to about 100 Hz.

15. The method of claim 1 wherein the electrical impulses are sufficient to cause the release of an antihistamine.

16. The method of claim 1 where the electrical impulses are sufficient to modulate serotonergic neurons in the raphe nucleus.

17. The method of claim 1 wherein the electrical impulses are sufficient to modulate neurons in the trigeminocervical complex.

18. The method of claim 1 wherein the electrical impulses are sufficient to modulate neurons in the hypothalamus.

19. The method of claim 1 wherein the headache is a migraine headache.

20. The method of claim 1 wherein the headache is a cluster headache.

21. The method of claim 1 wherein the headache is a tension headache.

22. The method of claim 1 wherein the headache is a sinus headache.

23. A method of treating a headache in a patient comprising:

positioning a device adjacent to a skin surface of a neck of the patient;

generating one or more electrical impulses with the device; and

transmitting the electrical impulses to selected nerve fibers in the patient, the electrical impulses being sufficient to modulate serotonergic neurons in the raphe nucleus and to at least partially relieve pain associated with the headache.

24. The method of claim 23 wherein the electrical impulses are sufficient to at least partially relieve said pain within 5 minutes of the transmitting step.

25. The method of claim 23 wherein wherein the electrical impulses are transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the selected nerve fibers.

26. The method of claim 25 wherein the transmitting step is carried out by transcutaneously passing an electrical current through the outer skin surface of the patient to a target region within the patient.

27. The method of claim 26 further comprising generating an electrical field at or near the device and shaping the electrical field such that the electrical field is sufficient to modulate a nerve at the target region;

and wherein the electric field is not sufficient to substantially modulate a nerve or muscle between the outer skin surface and the target region.

28. The method of claim 25 wherein the transmitting step is carried out by generating a magnetic field exterior to the patient sufficient to induce an electrical impulse at or near the selected nerve within the patient.

29. The method of claim 25 wherein the nerve is at least approximately 1-2 cm below an outer skin surface of the patient.

30. The method of claim 23 wherein the electrical impulse is substantially constrained from modulating one or more nerves in a region between the outer skin surface and the selected nerve.

31. The method of claim 23 wherein the selected nerve fibers are associated with a vagus nerve of the patient.

32. The method of claim 23 wherein the selected nerve fibers are associated with a right branch of the vagus nerve.

33. The method of claim 23 wherein the electrical impulses are sufficient to cause the selected release of catecholamines within the patient.

34. The method of claim 23 wherein the electrical impulses are sufficient to cause the release of catecholamines from an adrenal gland of the patient.

35. The method of claim 23 wherein the selected nerve fibers are afferent parasympathetic nerves.

36. The method of claim 23 wherein the electrical impulses comprise bursts of pulses with a frequency of about 5 Hz to about 100 Hz.

37. The method of claim 23 where the electrical impulses are sufficient to cause dopaminergic neurons originating in a ventral tegmental area of the brain to stimulate neurons or tissue to which said dopaminergic neurons project.