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

• US 8,874,227 B2
• Filed: 07/15/2011
• Issued: 10/28/2014
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/183,765
• Publication Number:
  US 20110276112A1
• Time in Patent Office: 1,201 Days
• Field of Search: 607/2, 607/66, 607/61
• US Class Current: 607/61
• 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 is configured to produce a peak pulse that is sufficient to produce a physiologically effective electric field in the vicinity of a target nerve, but not to substantially stimulate other nerves and muscles that lie in the vicinity of the target nerve and patient'"'"'s skin.

Claims

1. A device for applying energy transcutaneously to a target nerve within a patient comprising:

a handheld enclosure having an interface comprised of a dielectric material on at least a portion of an outer surface of the handheld enclosure, the interface having an inner surface and an outer surface;

a source of energy for generating an electric field in the vicinity of a target nerve;

an electrode housed within the enclosure and coupled to the source of energy, wherein the electrode is electrically coupled to the inner surface of the interface; and

wherein the source of energy is configured for applying an electrical impulse to the electrode such that the electrical field is capacitively coupled across the interface and the outer surface of the patient'"'"'s skin to generate an electrical impulse at the target nerve within the patient sufficient to modulate the target nerve.

2. The device of claim 1 wherein the source of energy is configured to generate the electrical impulse by applying a voltage of less than 600 volts to the electrode.

3. The device of claim 2 wherein the voltage is less than 100 volts.

4. The device of claim 2 wherein the voltage is less than 50 volts.

5. The device of claim 1 wherein the dielectric material has a dielectric constant greater than 3.

6. The device of claim 1 wherein the dielectric material is Mylar.

7. The device of claim 1 wherein the electrical field comprises bursts of pulses with a frequency of about 5 to about 100 bursts per second.

8. The device of claim 7 wherein the pulses are full sinusoidal waves.

9. The device of claim 1 wherein the electrical field comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

10. The device of claim 1 wherein the electrical field has an amplitude of greater than 10 V/m.

11. The device of claim 1 wherein the electrical field has a gradient of greater than 2 V/m/mm.

12. The device of claim 1 wherein the electrical impulse is sufficient to generate an action potential in a nerve fiber within the target nerve.

13. The device of claim 1 wherein the target nerve is a vagus nerve.

14. The device of claim 1 wherein the target nerve is located at least 1-2 cm beneath the outer surface of the patient'"'"'s skin.

15. The device of claim 1 where the target nerve is located at least 2-5 cm beneath the outer surface of the patient'"'"'s skin.

16. The device of claim 1 further comprising a conducting medium coupling the electrode to the interface.

17. The device of claim 16 wherein the conducting medium comprises an electrically conductive gel.

18. The device of claim 1 further comprising a handheld housing enclosing the source of energy and the electrode, wherein the interface comprises a surface of the handheld housing.

19. A method for the transcutaneous capacitive stimulation of a target nerve within a patient comprising:

positioning a first surface of a dielectric interface of a device adjacent to a skin surface of the patient;

positioning one or more electrodes adjacent to a second surface of the dielectric interface, the second surface opposite the first surface;

generating an electric field with the device such that one or more electrical impulses are capacitively coupled across the dielectric interface and transmitted to the target nerve, the electrical impulses being sufficient to modulate electrophysiological signals in the target nerve.

20. The method of claim 19 wherein the electrical impulses contain effective Fourier components at frequencies greater than 1 kHz.

21. The method of claim 19 wherein the generating step is carried out by producing a voltage of less than 100 volts at an electrode within the device.

22. The method of claim 19 wherein the voltage is less than 50 volts.

23. The method of claim 19 wherein the dielectric material has a dielectric constant greater than 3.

24. The method of claim 19 wherein the dielectric interface comprises Mylar.

25. The method of claim 19 wherein the electrical impulses comprise bursts of pulses with a frequency of about 5 to about 100 bursts per second.

26. The method of claim 19 wherein the electrical impulses are full sinusoidal waves.

27. The method of claim 19 wherein the electrical impulses comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

28. The method of claim 19 wherein the target nerve is a vagus nerve.

29. The method of claim 19 further comprising electrically coupling the interface to an electrode with an electrically conductive medium.

30. The method of claim 29 wherein the electrically conductive medium comprises a conductive gel.

31. A method for applying energy to a target nerve within a patient comprising:

generating a first electric charge on an inside surface of a dielectric patient contact surface on a handheld device; and

inducing a second electric charge from the first electric charge on an outside surface of the dielectric patient contact surface such that the second electric charge is transmitted to the target nerve with sufficient energy to modulate said target nerve.

32. The method of claim 31 wherein the target nerve is a vagus nerve.