Methods and devices for treating primary headache

• US 9,043,001 B2
• Filed: 09/16/2013
• Issued: 05/26/2015
• Est. Priority Date: 11/10/2005
• 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:
  US14/028,152
• Publication Number:
  US 20140081071A1
• Time in Patent Office: 617 Days
• Field of Search: 607 1- 2, 607/46, 607 62- 63, 607/115, 607/139, 607/142, 607/149
• US Class Current: 607/149
• 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 device for treating a headache in a patient, the device comprising:

a housing comprising an electrically permeable contact surface for contacting an outer skin surface of the patient; and

an energy source housed within the housing, wherein the energy source comprising one or more toroids configured to generate a magnetic field sufficient to induce electrical signal at a nerve at a target region within the patient, wherein the electrical signal is sufficient to modulate serotonergic neurons in a raphe nucleus of the patient and to at least partially relieve a pain associated with the headache.

2. The device of claim 1, further comprising a signal generator and a battery housed within the housing to provide energy to the signal generator.

3. The device of claim 1, wherein the electrical signal comprises bursts of pulses with a frequency from about 5 bursts per second to about 100 bursts per second.

4. The device of claim 3, wherein the electrical signal comprises bursts from about 1 pulse to about 20 pulses with each of the pulses from about 50 microseconds to about 1000 microseconds in duration.

5. The device of claim 1, further comprising a conduction medium housed within the housing between the one or more toroids and the electrically permeable contact surface.

6. The device of claim 1, wherein the electrical signal is sufficient to stimulate a vagus nerve of the patient.

7. The device of claim 1, wherein the housing is a handheld device configured for contacting a neck of the patient.

8. The device of claim 1, wherein the electrical signal is sufficient to at least partially relieve said pain within about 5 minutes of application thereof.

9. The device of claim 1, wherein the electrical signal is sufficient to cause dopaminergic neurons originating in a ventral tegmental area of a brain of the patient to stimulate neurons or tissue to which said dopaminergic neurons project.

10. The device of claim 1 wherein the headache is a migraine headache.

11. The device of claim 1 wherein the headache is a cluster headache.

12. The device of claim 1 wherein the headache is a tension headache.

13. The device of claim 1 wherein the headache is a sinus headache.

14. The device of claim 1, wherein the electrical signal comprises electrical impulses having a frequency from about 1,000 Hz to about 10,000 Hz and a duty cycle from about 1% to about 10%.

15. The device of claim 14, wherein the frequency is from about 4,000 Hz to about 6,000 Hz.

16. The device of claim 14 wherein the frequency is about 5,000 Hz.

17. The device of claim 14, wherein the duty cycle is from about 2% to about 5%.

18. The device of claim 14 wherein the duty cycle is about 2.5%.

19. The device of claim 1, wherein the electrical signal comprises bursts of pulses having a burst duration from about 0.1 milliseconds to about 10 milliseconds and a burst frequency from about 10 Hz to about 50 Hz.

20. The device of claim 19, wherein the burst duration is from about 2 milliseconds to about 6 milliseconds.

21. The device of claim 19, wherein the burst frequency is from about 10 Hz to about 35 Hz.

22. The device of claim 1, wherein the electrical signal generates an electric field at a vagus nerve of the patient above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

23. The device of claim 22 wherein the inhibitory neurotransmitters comprise GABA.

24. The device of claim 22 wherein the inhibitory neurotransmitters comprise serotonin.

25. The device of claim 22 wherein the inhibitory neurotransmitters comprise norepinephrine.

26. The device of claim 22, wherein a sufficient level of the inhibitory neurotransmitters are released in the brain of the patient to reduce a level of glutamate in the brain.

27. A device for treating a headache in a patient, the device comprising:

a housing comprising an electrically permeable contact surface for contacting an outer skin surface of the patient; and

an energy source housed within the housing and 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 above a threshold for generating action potentials within fibers of a vagus nerve of the patient responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient sufficient to modulate serotonergic neurons in a raphe nucleus of the patient, and wherein a sufficient level of the inhibitory neurotransmitters are released in the brain of the patient to reduce a level of glutamate in the brain of the patient and to at least partially relieve a pain associated with the headache in the patient.

28. The device of claim 27, further comprising a signal generator housed within the housing, wherein the energy source comprises one or more electrodes coupled to the signal generator within the housing.

29. The device of claim 28, further comprising a conducting medium housed within the housing between the one or more electrodes and the electrically permeable contact surface.

30. The device of claim 28, further comprising a battery housed within the housing to provide energy to the signal generator.

31. The device of claim 27, wherein the electric current comprises bursts of pulses with a frequency from about 5 bursts per second to about 100 bursts per second.

32. The device of claim 31, wherein the electric current comprises bursts from about 1 pulse to about 20 pulses with each of the pulses from about 50 microseconds to about 1000 microseconds in duration.

33. The device of claim 27, wherein the energy source comprises one or more toroids housed within the housing and configured to generate a magnetic field sufficient to induce the electric current.

34. The device of claim 33, further comprising a conduction medium housed within the housing between the one or more toroids and the electrically permeable contact surface.

35. The device of claim 27, wherein the electric current is sufficient to stimulate the vagus nerve of the patient.

36. The device of claim 27, wherein the housing is a handheld device configured for contacting a neck of the patient.

37. The device of claim 27, wherein the electric current is sufficient to at least partially relieve said pain within about 5 minutes of application of the electrical field.

38. The device of claim 27, wherein the energy source is configured to transmit the electric current transcutaneously through the outer skin surface of the patient to generate an electrical impulse at or near a selected nerve fiber.

39. The device of claim 27, wherein the electric current is 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.

40. The device of claim 27, wherein the headache is a migraine headache.

41. The device of claim 27, wherein the headache is a cluster headache.

42. The device of claim 27, wherein the headache is a tension headache.

43. The device of claim 27, wherein the headache is a sinus headache.

44. The device of claim 27, wherein the electric field comprises electrical impulses having a frequency from about 1,000 Hz to about 10,000 Hz and a duty cycle from about 1% to about 10%.

45. The device of claim 44, wherein the frequency from about 4,000 Hz to about 6,000 Hz.

46. The device of claim 44, wherein the frequency is about 5,000 Hz.

47. The device of claim 44, wherein the duty cycle is from about 2% to about 5%.

48. The device of claim 44, wherein the duty cycle is about 2.5%.

49. The device of claim 27, wherein the electric field comprises electrical impulses which comprise bursts of pulses having a burst duration from about 0.1 milliseconds to about 10 milliseconds and a burst frequency from about 10 Hz to about 50 Hz.

50. The device of claim 49, wherein the burst duration is from about 2 milliseconds to about 6 milliseconds.

51. The device of claim 49, wherein the burst frequency is from about 10 Hz to about 35 Hz.

52. The device of claim 27, wherein the inhibitory neurotransmitters comprise GABA.

53. The device of claim 27, wherein the inhibitory neurotransmitters comprise serotonin.

54. The device of claim 27, wherein the inhibitory neurotransmitters comprise norepinephrine.

55. A device for treating a headache in a patient, the device comprising:

a housing comprising an electrically permeable contact surface for contacting an outer skin surface of the patient; and

an energy source housed within the housing and 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 above a threshold for generating action potentials within fibers of a vagus nerve of the patient responsible for activating neural pathways causing release of GABA within a brain of the patient sufficient to modulate serotonergic neurons in a raphe nucleus of the patient and to at least partially relieve a pain associated with the headache.