Methods and devices for treating primary headache

• US 9,233,246 B2
• Filed: 03/29/2014
• Issued: 01/12/2016
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Errico, Joseph P., Raffle, John T., Simon, Bruce J.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/229,894
• Publication Number:
  US 20140213842A1
• Time in Patent Office: 654 Days
• US Class Current: 1/1
• 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. An apparatus for treating a primary headache in a patient, the apparatus comprising:

a housing comprising an electrically permeable contact surface configured to contact an outer skin surface of the patient;

a source of energy configured to generate an electric field within the housing, wherein the electric field is sufficient to transmit an electric current through the outer skin surface of the patient to a vagus nerve of the patient, wherein the electric current comprises bursts of pulses with each of the bursts comprising a frequency from about 1 Hz to about 100 Hz and with each of the pulses comprising a duration from about 100 microseconds to about 400 microseconds; and

wherein the electric current is sufficient to generate an electric field at the vagus nerve, wherein the electric field is above a threshold for generating an action potential within a fiber of the vagus nerve, wherein the fiber is responsible for activating a neural pathway to cause a release of an inhibitory neurotransmitter within a brain of the patient to at least partially relieve one or more symptoms of the primary headache.

2. The apparatus of claim 1, wherein the housing further comprises one or more electrodes and a conduction medium positioned between the one or more electrodes and the electrically permeable contact surface.

3. The apparatus of claim 2, wherein the conduction medium is positioned in electrical contact with a portion of an outer surface of the housing to at least partially restrict a direction of the electric field generated by the source of energy and the one or more electrodes.

4. The apparatus of claim 2 wherein the conductive medium comprises a solution of electrolytes.

5. The apparatus of claim 2 wherein the conductive medium comprises a conductive gel.

6. The apparatus of claim 1, wherein each of the pulses is generated from a signal that is not modulated by another signal.

7. The apparatus of claim 1, wherein each of the pulses comprises a duration of about 200 microseconds.

8. The apparatus of claim 1 wherein the source of energy comprises one or more electrodes coupled to a signal generator within the housing.

9. The apparatus of claim 1, wherein the source of energy comprises one or more toroids within the housing, wherein the one or more toroids is configured to generate a magnetic field sufficient to induce the electric field.

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

11. The apparatus of claim 1, wherein the electric current is sufficient to at least partially relieve a pain associated with the primary headache.

12. The apparatus of claim 1 wherein the headache is a migraine headache.

13. The apparatus of claim 1 wherein the headache is a cluster headache.

14. The apparatus of claim 1 wherein the headache is a tension headache.

15. The apparatus of claim 1 wherein the headache is a sinus headache.

16. The apparatus of claim 1, wherein at least one of the pulses comprises a sinusoidal waveform and a frequency from about 2.5 KHz to about 10 KHz.

17. The apparatus of claim 16 wherein at least one of the pulses comprises a frequency of about 5000 Hz.

18. The apparatus of claim 1, wherein each of the bursts of pulses comprises a frequency from about 10 Hz to about 35 Hz.

19. The apparatus of claim 1, wherein the inhibitory neurotransmitter comprises GABA.

20. The apparatus of claim 1, wherein the inhibitory neurotransmitter comprises serotonin.

21. The apparatus of claim 1, wherein the inhibitory neurotransmitter comprises norepinephrine.

22. The apparatus of claim 1, wherein a sufficient level of the inhibitory neurotransmitter is released in the brain of the patient to reduce a level of a glutamate in the brain.

23. A method comprising:

treating a primary headache in a patient, wherein the treating comprises;

accessing a device comprising a housing and a source of energy, wherein the housing comprises an electrically permeable contact surface configured to contact an outer skin surface of the patient, wherein the source of energy is configured to generate an electric field within the housing, wherein the electric field is sufficient to transmit an electric current through the outer skin surface of the patient to a vagus nerve of the patient, wherein the electric current comprises bursts of pulses with each of the bursts comprising a frequency from about 1 Hz to about 100 Hz and with each of the pulses comprising a duration from about 100 microseconds to about 400 microseconds, wherein the electric current is sufficient to generate an electric field at the vagus nerve, wherein the electric field is above a threshold for generating an action potential within a fiber of the vagus nerve, wherein the fiber is responsible for activating a neural pathway to cause a release of an inhibitory neurotransmitter within a brain of the patient to at least partially relieve one or more symptoms of the primary headache;

contacting the outer skin surface of the patient with the electrically permeable contact surface; and

generating the electric field within the housing via the source of energy.