ELECTRICAL AND MAGNETIC STIMULATORS USED TO TREAT MIGRAINE/SINUS HEADACHE AND COMORBID DISORDERS

• US 20110230701A1
• Filed: 05/17/2011
• Published: 09/22/2011
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Raffle, John T., Errico, Joseph P., Simon, Bruce J.
• Granted Patent: US 8,676,330 B2
• Time in Patent Office: Days
• US Class Current: 600/9
• 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 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 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 the selected the 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 electric 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.

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

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

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

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

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

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

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

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

24. A method of treating a headache in a patient comprising applying an electrical impulse to one or more selected nerves in a parasympathetic nervous system of a patient, the electrical impulse being sufficient to at least partially relieve pain associated with the headache.

25. The method of claim 24 wherein the applying step is carried out by transmitting an electric current through an outer skin surface of the patient to the selected nerves.

26. The method of claim 24 wherein the one or more selected nerves are associated with the vagus nerve.

27. The method of claim 25 wherein the transmitting step is carried out by generating an electric field external to the patient, wherein the electrical field comprises bursts of pulses with a frequency of about 5 to about 100 bursts per second.

28. The method of claim 27 wherein the pulses are full sinusoidal waves.

29. The method of claim 27 wherein the electrical field comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

30. A device for treating a headache in a patient comprising:

a housing having an electrically permeable contact surface for contacting an outer skin surface of a patient;

an energy source within the housing configured to generate an electric field sufficient to transmit an electric current through the outer skin surface of the patient to a nerve at a target region within the patient, wherein the electric current is sufficient to at least partially relieve pain associated with the headache.

31. The device of claim 30 wherein the energy source comprises one or more electrodes coupled to a signal generator within the housing.

32. The device of claim 31 further comprising a conducting medium within the housing between electrodes and the electrically permeable contact surface.

33. The device of claim 32 further comprising a battery within the housing for providing energy to the signal generator.

34. The device of claim 31 wherein the electric field comprises bursts of pulses with a frequency of about 5 to about 100 bursts per second.

35. The device of claim 34 wherein the electric field comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

36. The device of claim 30 wherein the energy source comprises one or more toroids within the housing configured to generate a magnetic field sufficient to induce the electric field.

37. The device of claim 36 further comprising a conduction medium within the housing between the toroids and the electrically permeable contact surface.

38. The device of claim 30 wherein the electric current is sufficient to stimulate a vagus nerve of the patient.

39. The device of claim 30 wherein the housing is a handheld device configured for contacting a neck of a patient.