NON-INVASIVE METHODS AND DEVICES FOR INDUCING EUPHORIA IN A PATIENT AND THEIR THERAPEUTIC APPLICATION

• US 20110190569A1
• Filed: 02/10/2011
• Published: 08/04/2011
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Raffle, John T., Errico, Joseph P., Simon, Bruce
• Granted Patent: US 9,089,719 B2
• Time in Patent Office: Days
• US Class Current: 600/26
• CPC Class Codes: A61M 2021/0055 with electric or electro-magnetic fields
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61N 1/18 Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A novel non-invasive magnetic stimulator is used to modulate electrical activity of a patient'"'"'s vagus nerve. Parameters of the stimulation are selected in such a way as to induce a state of euphoria in the patient. The methods and devices may be used for anesthesia, or to treat insomnia, depression, or premenstrual syndromes. They may be used as substitution withdrawal tools for individuals who otherwise would depend on substances and behaviors to achieve a euphoric state of mind, particularly individuals who abusively consume drugs, alcohol or food, or who exhibit behavioral disorders such as compulsive gambling. The devices and methods may also be used to prevent, manage, or relieve stress.

Claims

1. A method for modulating the state of mind of a patient comprising applying energy transcutaneously through an outer skin surface of a patient to generate an electrical impulse at or near a selected nerve within the patient sufficient to induce euphoria.

2. The method of claim 1 wherein the applying energy step is carried out by transcutaneously passing an electrical current through an outer skin surface of the patient.

3. The method of claim 1 wherein the applying energy 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.

4. The method of claim 1 wherein the electrical impulse is sufficient to stimulate nerve fibers that control or mediate the induction of euphoria.

5. The method of claim 1 wherein the selected nerve is a vagus nerve.

6. The method of claim 5 wherein the selected nerve is a right branch of the vagus nerve.

7. The method of claim 5 wherein the selected nerve is a left branch of the vagus nerve.

8. The method of claim 5 wherein a left branch and a right branch of the vagus nerve are stimulated simultaneously.

9. The method of claim 1 wherein the applying energy step is carried out by:

generating a time-varying magnetic field that is located essentially entirely outside of the patient;

shaping an electric field that is induced by said magnetic field; and

conducting an electric current that is induced by said magnetic field through an outer skin surface of the patient to modulate the selected nerve.

10. The method of claim 1 wherein the selected nerve is at least approximately 1-2 cm below an outer skin surface of the patient.

11. The method of claim 10 further comprising substantially constraining the electric current from modulating one or more nerves in a region between the outer skin surface and the selected nerve.

12. The method of claim 9 wherein the generating step comprises generating the time-varying magnetic field within an enclosed coil.

13. The method of claim 12 wherein the shaping step comprises generating a second time-varying magnetic field within a second enclosed coil positioned near or adjacent to the first enclosed coil.

14. The method of claim 12 wherein the shaping step comprises positioning a conducting medium around a portion of the enclosed coil such that the direction of the electrical field is constrained within the conducting medium.

15. The method of claim 9 wherein the conducting step is carried out by electrically coupling the induced electric field to the target region allowing current to flow through the outer skin surface of the patient.

16. The method of claim 1 wherein the electric impulse is sufficient to cause dopaminergic neurons originating in the ventral tegmental area of the brain to stimulate neurons or tissue to which said dopaminergic neurons project.

17. The method of claim 16 wherein the stimulation by dopaminergic neurons is modulated by endogenous opioids and cannabinoids.

18. The method of claim 1 wherein the patient is in need of dissociative anesthesia.

19. The method of claim 1 wherein the patient is in need of sleep.

20. The method of claim 1 wherein the patient is depressed.

21. The method of claim 1 wherein the patient abuses drugs or alcohol and wherein the induced euphoria substitutes for consumption of said drugs or alcohol.

22. The method of claim 1 wherein the patient has an eating disorder and wherein the induced euphoria terminates an eating binge.

23. The method of claim 1 wherein the patient has bulimia nervosa and wherein the induced euphoria is used to cause the patient to eat.

24. The method of claim 1 wherein the induced euphoria is used to prevent or relieve psychosocial stress.

25. The method of claim 1 wherein the patient compulsively gambles or shops and wherein the induced euphoria substitutes for said compulsive gambling or shopping.

26. An apparatus for applying energy transcutaneously to a target region within a patient needing an altered state of mind, comprising:

a source of energy for generating an energy field that is located essentially entirely exterior to an outer skin surface of the patient, the energy field being sufficient to transcutaneously pass through the outer skin surface and generate an electrical impulse at or near the target region; and

wherein the electrical impulse is sufficient to modulate activity of a selected nerve at the target region to induce euphoria in the patient.

27. The apparatus of claim 26 further comprising a conduction medium, wherein the source of energy is configured to generate an electric field that induces an electrical current sufficient to pass through the conduction medium to the outer skin surface of the patient.

28. The apparatus set forth in claim 26 wherein the selected nerve is a vagus nerve of the patient.

29. The apparatus set forth in claim 26 wherein the electrical field has an amplitude of greater than 10 V/m.

30. The apparatus set forth in claim 26 wherein the electrical field has a gradient of greater than 2 V/m/mm.

31. The apparatus set forth in claim 26 wherein the electrical field comprises bursts of pulses with a frequency of about 5 Hz to about 100 Hz.

32. The apparatus set forth in claim 26 wherein the electrical field comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

33. A method for treating depression in a patient comprising applying an electrical impulse to a selected nerve within the patient, the electrical impulse being sufficient to acutely treat depression in the patient by altering a mood of the patient within about 5 minutes to about 4 hours.

34. The method of claim 33 wherein the electrical impulse is sufficient to alter the mood of the patient within about 5 minutes to about 1 hour.

35. The method of claim 33 wherein the electrical impulse is sufficient to decrease a Montgomery-Asberg Depression Rating Scale of the patient by at least 25%.

36. The method of claim 33 wherein the electrical impulse is sufficient to decrease a Montgomery-Asberg Depression Rating Scale of the patient by at least 50%.

37. The method of claim 33 wherein the electrical impulse is sufficient to cause dopaminergic neurons originating in the ventral tegmental area of the brain to stimulate neurons or tissue to which said dopaminergic neurons project.

38. The method of claim 37 wherein the stimulation by dopaminergic neurons is modulated by endogenous opioids and cannabinoids.

39. A method for treating depression in a patient comprising applying an electrical impulse to a selected nerve in the patient sufficient to cause a release of endogenous opoids within the patient and treat the depression.