Devices and methods for non-invasive capacitive electrical stimulation and their use for vagus nerve stimulation on the neck of a patient

• US 9,717,904 B2
• Filed: 01/25/2016
• Issued: 08/01/2017
• Est. Priority Date: 03/10/2011
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Raffle, John T., Simon, Bruce J., Errico, Joseph P.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/005,904
• Publication Number:
  US 20160136423A1
• Time in Patent Office: 554 Days
• Field of Search: 607 2, 607 61, 607 66
• CPC Class Codes: A61M 2021/0022 by the tactile sense, e.g. vibrations
• CPC Class Codes: A61M 2021/0027 by the hearing sense
• CPC Class Codes: A61M 2021/0044 by the sight sense
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 21/00 Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0496 characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives
• 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: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 : Antimigraine agents
• CPC Class Codes: A61P 25/16 : Anti-Parkinson drugs
• CPC Class Codes: A61P 25/22 : Anxiolytics
• CPC Class Codes: A61P 25/24 : Antidepressants
• CPC Class Codes: A61P 25/28 : for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

A non-invasive electrical stimulator shapes an elongated electric field of effect that can be oriented parallel to a long nerve, such as a vagus nerve in a patient'"'"'s neck, producing a desired physiological response in the patient. The stimulator comprises a source of electrical power, at least one electrode and a continuous electrically conducting medium in contact with the electrodes. The conducting medium is also in contact with an interface element that may conform to the contour of a target body surface of the patient when the interface element is applied to that surface. When the interface element is made of insulating (dielectric) material, and disclosed stimulation waveforms are used, the power source need not supply high voltage, in order to capacitively stimulate the target nerve. The stimulator produces a peak pulse that is sufficient to produce a physiologically effective electric field in the vicinity of a target nerve.

Claims

1. A method for treating a medical disorder of a patient, the method comprising:

generating one or more electrical impulses, wherein each of the one or more electrical impulses comprises bursts of pulses;

transmitting the one or more electrical impulses through an outer skin surface of the patient to a nerve at a target region within the patient such that the one or more electrical impulses modulate the nerve to treat the medical disorder; and

pairing the one or more electrical impulses with a time-varying sensory stimulation.

2. The method of claim 1, further comprising:

positioning an interface coupled to one or more electrodes against the outer skin surface of the patient; and

transmitting the one or more electrical impulses through the interface.

3. The method of claim 1, wherein each of the bursts comprises a frequency from about 1 Hz to about 100 Hz and each of the pulses comprises a duration from about 20 microseconds to about 1000 microseconds.

4. The method of claim 1, wherein each of the bursts comprises a frequency from about 10 Hz to about 35 Hz.

5. The method of claim 1, wherein the bursts of pulses are generated from a single signal which is not modulated by another signal.

6. The method of claim 2, wherein the transmitting comprises transmitting the one or more electrical impulses from the one or more electrodes through a volume of electrically conductive fluid to the interface.

7. The method of claim 6, wherein the electrically conductive fluid comprises an electrically conductive gel.

8. The method of claim 2, wherein the positioning comprises housing the one or more electrodes and the interface within a handheld device and positioning the handheld device against the outer skin surface of the patient.

9. The method of claim 1, wherein at least one of the pulses comprises a duration of about 200 microseconds.

10. The method of claim 1, wherein the transmitting comprises transmitting the one or more electrical impulses through the outer skin surface of a neck of the patient to a vagus nerve of the patient such that the one or more electrical impulses is sufficient to stimulate a fiber of the vagus nerve.

11. The method of claim 1, wherein the medical disorder comprises a disorder selected from a group consisting of a primary headache, a migraine headache, a cluster headache, a tension headache, and a sinus headache.

12. The method of claim 2, wherein the interface comprises at least one of a dielectric material, a material which is permeable to a charged particle or a porous material.

13. The method of claim 2, wherein the interface comprises a stainless steel.

14. The method of claim 2, wherein the interface comprises a plurality of membranes and the one or more electrodes comprise a device, the device further comprises a plurality of electrodes corresponding to the membranes, wherein the method further comprising:

spacing the electrodes from each of the membranes by about 0.25 to about 4 times a diameter of a corresponding membrane from the membranes.

15. The method of claim 1, wherein each of the one or more electrical impulses is sinusoidal.

16. The method of claim 1, wherein the paired sensory stimulation comprises at least one of bright light, sound, tactile stimulation, or electrical stimulation of the tongue.

17. The method of claim 1, wherein the paired sensory stimulation comprises electrical stimulation of the tongue to simulate at least one of odor and taste.

18. The method of claim 1, wherein the paired sensory stimulation pulsates with the same frequency as the one or more electrical impulses.

19. The method of claim 1, wherein the paired sensory stimulation is applied in a manner so as to enhance the therapeutic effect.

20. The method of claim 1, wherein the paired sensory stimulation comprises bright light to enhance the role of the hypothalamus in producing the desired therapeutic effect.

21. A method for treating a medical disorder of a patient, the method comprising:

positioning an interface of a handheld device against an outer skin surface of the patient;

generating an electrical impulse at one or more electrodes within the handheld device;

transmitting the electrical impulse from the one or more electrodes through a conduction medium to the interface, through the interface, and transcutaneously, through the outer skin surface of the patient to a nerve at a target region below the outer skin surface to treat the medical disorder; and

pairing the electrical impulse with a time-varying sensory stimulation.

22. The method of claim 21, wherein the electrical impulse comprises sinusoidal bursts of sinusoidal pulses followed by a silent inter-burst period which repeats itself over a time period.

23. The method of claim 21, wherein the conduction medium comprises a volume of electrically conductive gel filling a space between the one or more electrodes and the interface within an enclosure of the handheld device.

24. The method of claim 21, wherein the interface comprises a plurality of membranes and the handheld device further comprises a plurality of electrodes corresponding to the membranes, wherein the method further comprises spacing each of the electrodes from a corresponding one of each of the membranes by about 0.25 to about 4 times a diameter of the corresponding one of each of the membranes, wherein the conduction medium electrically couples the membranes with the electrodes.

25. The method of claim 21, wherein the electrical impulse comprises bursts of pulses with a frequency from about 5 bursts per second to about 100 bursts per second, wherein each of the pulses comprises a duration from about 20 microseconds to about 1000 microseconds.

26. The method of claim 21, wherein the electrical impulse comprises bursts of sinusoidal pulses followed by a silent inter-burst period that repeats itself over a time period from about 1 Hz to about 100 Hz and the sinusoidal pulses comprise a frequency from about 1 KHz to about 50 KHz.

27. The method of claim 26, wherein the time period is from about 10 Hz to about 35 Hz.

28. The method of claim 26, wherein the frequency of the sinusoidal pulses is from about 1 Hz to about 10 Hz.

29. The method of claim 25, wherein the bursts of pulses are generated from a single signal which is not modulated by another signal.

30. The method of claim 21, wherein the positioning comprises positioning the interface of the handheld device against an outer surface of a neck of the patient and the nerve is a vagus nerve of the patient, wherein the electrical impulse is sufficient to stimulate the vagus nerve.

31. The method of claim 21, wherein the electrical impulse is sinusoidal.

32. The method of claim 21, wherein the paired sensory stimulation comprises at least one of bright light, sound, tactile stimulation, or electrical stimulation of the tongue.

33. The method of claim 21, wherein the paired sensory stimulation comprises electrical stimulation of the tongue to simulate at least one of odor and taste.

34. The method of claim 21, wherein the paired sensory stimulation pulsates with the same frequency as the one or more electrical impulses.

35. The method of claim 21, wherein the paired sensory stimulation is applied in a manner so as to enhance the therapeutic effect.

36. The method of claim 21, wherein the paired sensory stimulation comprises bright light to enhance the role of the hypothalamus in producing the desired therapeutic effect.