ELECTRICAL AND MAGNETIC STIMULATORS USED TO TREAT MIGRAINE/SINUS HEADACHE, RHINITIS, SINUSITIS, RHINOSINUSITIS, AND COMORBID DISORDERS

• US 20110276107A1
• Filed: 07/15/2011
• Published: 11/10/2011
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Raffle, John T., Errico, Joseph P., Simon, Bruce
• Granted Patent: US 8,676,324 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36021 for treatment of pain
• 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

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 rhinitis or sinusitis or rhinosinusitis 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 a symptom selected from a group of symptoms comprising nasal or paranasal sinus congestion, nasal or paranasal sinus stuffiness, nasal or paranasal sinus obstruction, nasal or paranasal sinus inflammation, nasal or paranasal sinus edema, nasal or paranasal sinus vein dilation or engorgement, nasal or paranasal sinus vein hyper-permeability, rhinorrhea, facial pain or pressure, mucus discharge, nasal or paranasal sinus itching, sneezing, conjunctivitis, lacrimation, and eye redness.

2. The method of claim 1 wherein the electrical impulses are sufficient to at least partially relieve said symptom within 30 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 9 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 a release of catecholamines within the patient.

12. The method of claim 1 wherein the electrical impulses are sufficient to cause a 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 inhibit a parasympathetic nerve innervating a nose and/or paranasal sinus;

wherein glandular secretion and/or vasodilation is inhibited.

16. The method of claim 1 wherein the electrical impulses are sufficient to stimulate a sympathetic nerve innervating a nose and/or paranasal sinus;

wherein venous sinusoids and/or collecting veins are constricted and/or wherein outflow veins are dilated.

17. The method of claim 1 wherein the electrical impulses are sufficient to inhibit hyper-responsiveness of a nerve that participates in an autonomic nasal and/or paranasal sinus reflex;

wherein a stimulus threshold in a sensory nerve is increased; and

/or a sensory ganglion is inhibited; and

/or synaptic transmission within the central nervous system is inhibited; and

/or signal-filtering of an autonomic ganglion is modulated; and

/or potentiation of an autonomic nerve terminal is modulated.

18. The method of claim 1 wherein the electrical impulses are sufficient to inhibit the synthesis or release of histamine from a sympathetic nerve innervating a nose and/or paranasal sinus, and/or to inhibit the synthesis or activity of a histamine receptor of a sympathetic nerve innervating a nose and/or paranasal sinus.

19. The method of claim 1 wherein the electrical impulses are sufficient to inhibit communication between mast cells and a parasympathetic nerve innervating a nose and/or paranasal sinus.

20. The method of claim 1 wherein the electrical impulses are sufficient to inhibit communication between mast cells and a nerve innervating a nose and/or paranasal sinus, wherein said nerve contains substance P and/or calcitonin gene related peptide.

21. The method of claim 1 wherein the rhinitis is allergic rhinitis.

22. The method of claim 1 wherein the rhinitis is non-allergic rhinitis or mixed rhinitis.

23. The method of claim 1 wherein the sinusitis or rhinosinusitis is acute or chronic.

24. A method of treating rhinitis or sinusitis or rhinosinusitis 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 a symptom selected from a group of symptoms comprising nasal or paranasal sinus congestion, nasal or paranasal sinus stuffiness, nasal or paranasal sinus obstruction, nasal or paranasal sinus inflammation, nasal or paranasal sinus edema, nasal or paranasal sinus vein dilation or engorgement, nasal or paranasal sinus vein hyper-permeability, rhinorrhea, facial pain or pressure, mucus discharge, nasal or paranasal sinus itching, sneezing, conjunctivitis, lacrimation, and eye redness.

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 rhinitis or sinusitis or rhinosinusitis 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 a symptom selected from a group of symptoms comprising nasal or paranasal sinus congestion, nasal or paranasal sinus stuffiness, nasal or paranasal sinus obstruction, nasal or paranasal sinus inflammation, nasal or paranasal sinus edema, nasal or paranasal sinus vein dilation or engorgement, nasal or paranasal sinus vein hyper-permeability, rhinorrhea, facial pain or pressure, mucus discharge, nasal or paranasal sinus itching, sneezing, conjunctivitis, lacrimation, and eye redness.

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

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

33. The device of claim 32 wherein the energy source comprises a battery.

34. The device of claim 31 wherein the signal generator is configured to generate an electric field comprising 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.