Electrical and magnetic stimulators used to treat migraine/sinus headache, rhinitis, sinusitis, rhinosinusitis, and comorbid disorders

• US 10,279,163 B2
• Filed: 03/18/2014
• Issued: 05/07/2019
• Est. Priority Date: 03/10/2011
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Abreu, Michael J D
• Application Number:
  US14/217,762
• Publication Number:
  US 20150265836A1
• Time in Patent Office: 1,876 Days
• 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 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• 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 2/002 in combination with another treatment
• 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

Transcutaneous 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 nasal or paranasal sinus symptoms that resemble an immune-mediated response (“sinus” headaches). The devices and methods may also be used to treat rhinitis, sinusitis, or rhinosinusitis, irrespective of whether those disorders are co-morbid with a headache. They may also be used to treat other disorders that may be co-morbid with migraine or cluster 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 primary headache in a patient, the method comprising:

positioning a housing in contact with an outer skin surface of a neck of the patient;

generating an electrical impulse with a power supply housed within the housing; and

transmitting, as the housing is in contact with the outer skin surface of the neck of the patient, the electrical impulse from the housing non-invasively and transcutaneously through the outer skin surface of the neck of the patient to a nerve fiber of a vagus nerve in the patient, wherein the electrical impulse at least partially relieves a symptom of the primary headache and thereby treats the primary headache.

2. The method of claim 1, wherein the transmitting comprises transcutaneously passing an electric current through the outer skin surface of the patient to a target region within the patient.

3. The method of claim 2, further comprising:

generating an electric field at or near the housing; and

shaping the electric field such that the electric field modulates a nerve at the target region; and

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

4. The method of claim 1, wherein the positioning comprises positioning an electrically permeable surface of the housing adjacent to the skin surface of the neck of the patient and the generating comprises generating the electrical impulse with a power source and a pulse generator located within the housing.

5. The method of claim 4, wherein the transmitting comprises applying the electrical impulse to an electrode within the housing and transmitting the electrical impulse through a conductive gel within the housing to the electrically permeable surface.

6. The method of claim 1, wherein the electrical impulse at least partially relieves the symptom within 30 minutes of the transmitting.

7. The method of claim 1, wherein the electrical impulse is transmitted transcutaneously through the outer skin surface of the patient to generate an electrical impulse at or near the nerve fiber.

8. The method of claim 1, wherein the transmitting comprises generating a magnetic field exterior to the patient to induce an electrical impulse at or near the nerve fiber within the patient.

9. The method of claim 1, wherein the nerve fiber is at least approximately 1-2 cm below the outer skin surface of the patient.

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

11. The method of claim 1 wherein the primary headache is migraine.

12. The method of claim 1 wherein the primary headache is cluster headache.

13. The method of claim 1 wherein the primary headache is tension-type headache.

14. The method of claim 1, wherein the primary headache is trigeminal autonomic cephalalgia.

15. The method of claim 1, wherein the nerve fiber is an afferent parasympathetic nerve.

16. The method of claim 1, wherein the electrical impulse comprises bursts of pulses with a frequency from about 5 Hz to about 100 Hz.

17. The method of claim 1, wherein the electrical impulse comprises bursts from 1 to 20 pulses with each of the pulses from about 50 to about 1000 microseconds in duration.

18. The method of claim 1, wherein the electrical impulse increases an inhibitory neurotransmitter in a brain of the patient.

19. A method of treating a primary headache in a patient, the method comprising:

positioning a housing in contact with an outer skin surface of a neck of the patient;

generating an electrical impulse with a power supply housed within the housing;

transmitting, as the housing is in contact with the outer skin surface of the neck of the patient, the electrical impulse from the housing non-invasively and transcutaneously through the outer skin surface of the patient to a nerve fiber of a vagus nerve, wherein the nerve fiber is, at least approximately 1-2 cm below the outer skin surface of the patient; and

wherein the electrical impulse at least partially relieves a symptom of the primary headache and thereby treats the primary headache.

20. The method of claim 19 wherein the transmitting step is carried out by transcutaneously passing an electric current through the outer skin surface of the patient to a target region within the patient.

21. The method of claim 20, further comprising:

generating an electric field at or near the housing; and

shaping the electric field such that the electric field modulates a nerve at the target region; and

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

22. The method of claim 19, wherein the positioning comprises positioning an electrically permeable surface of the housing adjacent to the skin surface of the neck of the patient and the generating comprises generating the electrical impulse with a power source and a pulse generator located within the housing.

23. The method of claim 22, wherein the transmitting comprises applying the electrical impulse to an electrode within the housing and transmitting the electrical impulse through a conductive gel within the housing to the electrically permeable surface.

24. The method of claim 19, wherein the electrical impulse at least partially relieves the symptom within 30 minutes of the transmitting.

25. The method of claim 19, wherein the electrical impulse is transmitted transcutaneously through the outer skin surface of the patient to generate an electrical impulse at or near the nerve fiber.

26. The method of claim 19, wherein the transmitting comprises generating a magnetic field exterior to the patient to induce an electrical impulse at or near the nerve fiber within the patient.

27. The method of claim 19 wherein the electrical impulse is substantially constrained from modulating a nerve in a region between the outer skin surface and the nerve fiber.

28. The method of claim 19 wherein the primary headache is migraine.

29. The method of claim 19 wherein the primary headache is cluster headache.

30. The method of claim 19 wherein the nerve fiber is an afferent parasympathetic nerve.

31. The method of claim 19, wherein the electrical impulse comprises bursts of pulses with a frequency from about 5 Hz to about 100 Hz.

32. The method of claim 19, wherein the electrical impulse comprises bursts from 1 to 20 pulses with each of the pulses from about 50 to about 1000 microseconds in duration.

33. The method of claim 19 wherein the primary headache is tension-type headache.

34. The method of claim 19, wherein the primary headache is trigeminal autonomic cephalalgia.

35. The method of claim 19, wherein the electrical impulse increases an inhibitory neurotransmitter in a brain of the patient.