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

• US 10,173,048 B2
• Filed: 03/18/2014
• Issued: 01/08/2019
• 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): Cox, Thaddeus B
• Application Number:
  US14/217,821
• Publication Number:
  US 20150265830A1
• Time in Patent Office: 1,757 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 device for treating at least one of a rhinitis, a sinusitis, or a rhinosinusitis in a patient, the device comprising:

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

an energy source positioned within the housing, wherein the energy source comprises a signal generator and an electrode, wherein the electrode is coupled to the signal generator within the housing, wherein the energy source is configured to generate an electric field sufficient to transmit an electric current through the electrically permeable contact surface and through the outer skin surface of the patient to a vagus nerve of the patient, as the electrically permeable contact surface contacts the outer skin surface, wherein the electric current comprises bursts of pulses with each of the bursts having a frequency from about 5 Hz to about 100 Hz and with each of the pulses having a duration from about 200 microseconds to about 400 microseconds and is sufficient to modulate the vagus nerve to at least partially relieve a symptom selected from a group of symptoms comprising a nasal or paranasal sinus congestion, a nasal or paranasal sinus stuffiness, a nasal or paranasal sinus obstruction, a nasal or paranasal sinus inflammation, a nasal or paranasal sinus edema, a nasal or paranasal sinus vein dilation or engorgement, a nasal or paranasal sinus vein hyper-permeability, a rhinorrhea, a facial pain or pressure, a mucus discharge, a nasal or paranasal sinus itching, a sneezing, a conjunctivitis, a lacrimation, and an eye redness.

2. The device of claim 1, further comprising:

a conducting medium positioned within the housing between the electrode and the electrically permeable contact surface.

3. The device of claim 1 wherein the energy source comprises a battery.

4. The device of claim 1, wherein the electric field comprises bursts of between 1 and 20 pulses.

5. The device of claim 1, wherein the energy source comprises a toroid positioned within the housing, wherein the toroid is configured to generate a magnetic field sufficient to induce the electric field.

6. The device of claim 5, further comprising:

a conduction medium positioned within the housing between the toroid and the electrically permeable contact surface.

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 electrically permeable contact surface is configured for contacting the outer skin surface of a neck of the patient.

9. The device of claim 8, wherein the selected nerve fiber is at least approximately 2 centimeters below the outer skin surface.

10. The device of claim 1, wherein the electric current is sufficient to modulate the vagus nerve and cause the vagus nerve to generate an action potential, wherein the action potential is sufficient to cause a brain of the patient to release a neurotransmitter sufficient to at least partially relieve the symptom.

11. The device of claim 1, wherein the electric field ranges from about 10 V/m to about 600 V/m.

12. The device of claim 1, wherein the electrically permeable contact surface is configured to be positioned against a neck of the patient.

13. A device for treating at least one of a rhinitis, a sinusitis, or a rhinosinusitis in a patient, the device comprising:

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

an energy source positioned within the housing, wherein the energy source comprises a signal generator and an electrode, wherein the electrode is coupled to the signal generator within the housing, wherein the energy source is configured to generate an electric field sufficient to transmit an electric current through the electrically permeable contact surface and through the outer skin surface of the patient to a selected nerve fiber below the outer skin surface of the patient, as the electrically permeable contact surface contacts the outer skin surface, wherein the electric current comprises bursts of pulses with each of the bursts having a frequency from about 5 Hz to about 100 Hz and with each of the pulses having a duration from about 200 microseconds to about 400 microseconds and is sufficient to modulate a vagus nerve to at least partially relieve a symptom selected from a group of symptoms comprising a nasal or paranasal sinus congestion, a nasal or paranasal sinus stuffiness, a nasal or paranasal sinus obstruction, a nasal or paranasal sinus inflammation, a nasal or paranasal sinus edema, a nasal or paranasal sinus vein dilation or engorgement, a nasal or paranasal sinus vein hyper-permeability, a rhinorrhea, a facial pain or pressure, a mucus discharge, a nasal or paranasal sinus itching, a sneezing, a conjunctivitis, a lacrimation, and an eye redness.

14. The device of claim 13, further comprising:

a conducting medium positioned within the housing between the electrode and the electrically permeable contact surface.

15. The device of claim 14 wherein the energy source comprises a battery.

16. The device of claim 13, wherein the electric field comprises bursts of between 1 and 20 pulses.

17. The device of claim 13, wherein the energy source comprises a toroid positioned within the housing, wherein the toroid is configured to generate a magnetic field sufficient to induce the electric field.

18. The device of claim 17, further comprising:

a conduction medium positioned within the housing between the toroid and the electrically permeable contact surface.

19. The device of claim 13, wherein the housing is a handheld device configured for contacting a neck of the patient.

20. The device of claim 13, wherein the selected nerve fiber comprises a vagus nerve.

21. The device of claim 13, wherein the selected nerve fiber is at least approximately 1 centimeter below the outer skin surface.

22. The device of claim 13, wherein the selected nerve fiber is from about 1 centimeter to about 2 centimeters below the outer skin surface.

23. The device of claim 13, wherein the electrically permeable contact surface is configured for contacting the outer skin surface of a neck of the patient.

24. The device of claim 13, wherein the electric current is sufficient to modulate the vagus nerve and cause the vagus nerve to generate an action potential, wherein the action potential is sufficient to cause a brain of the patient to release a neurotransmitter sufficient to at least partially relieve the symptom.

25. The device of claim 13, wherein the electric field ranges from about 10 V/m to about 600 V/m.

26. The device of claim 13, wherein the electrically permeable contact surface is configured to be positioned against a neck of the patient.