Device and methods for non-invasive electrical stimulation and their use for vagal nerve stimulation

• US 8,874,205 B2
• Filed: 03/30/2011
• Issued: 10/28/2014
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce, Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): ANTHONY, JESSICA LYNN
• Application Number:
  US13/075,746
• Publication Number:
  US 20110230938A1
• Time in Patent Office: 1,308 Days
• Field of Search: 607/41, 607 66- 71, 607148-151, 607/72, 607/115, 607/145
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• 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 non-invasive electrical stimulation device 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 which the electrode(s) are in contact. The stimulation device is configured to produce a peak pulse voltage 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 between the vicinity of the target nerve and patient'"'"'s skin. Current is passed through the electrodes in bursts of preferably five sinusoidal pulses, wherein each pulse within a burst has a duration of preferably 200 microseconds, and bursts repeat at preferably at 15-50 bursts per second.

Claims

1. An apparatus for applying energy transcutaneously to a target region within a mammal comprising:

a source of energy for generating an electric impulse comprising bursts of pulses with each burst having a frequency of 1 Hz to 100 Hz and with each pulse generated from a signal that is not modulated by another signal and each pulse having a duration of 100 to 400 microseconds;

a conduction medium through which the electric impulse penetrates an outer skin surface of the mammal;

at least one electrode;

an enclosure for housing the source of energy and the conduction medium, wherein the source of energy is a source of electrical energy coupled to first and second electrodes; and

wherein the source of energy and the conduction medium are configured to shape the electrical impulse such that the electrical impulse is sufficient to modulate a nerve within the target region without causing substantial pain and wherein the electrical impulse is not sufficient to substantially modulate a nerve or muscle between the outer skin surface and the target region.

2. The apparatus of claim 1 wherein the source of energy, the electrode and the conduction medium are configured to orient an electric field generated by the source of energy and the electrode substantially parallel with the nerve within the target region.

3. The apparatus of claim 2 wherein the electric field has an amplitude of greater than 10 V/m.

4. The apparatus of claim 2 wherein the electric field has a gradient of greater than 2 V/m/mm.

5. The apparatus of claim 1 wherein the conduction medium is positioned in electrical contact with a portion of an outer surface of the enclosure to at least partially restrict a direction of an electric field generated by the source of energy and the electrode.

6. The apparatus of claim 5 wherein at least a portion of the outer surface of the enclosure comprises material that is permeable to charged particles.

7. The apparatus of claim 6 wherein the portion of the outer surface of the enclosure comprises an ion-permeable material.

8. The apparatus of claim 1 wherein the target region is a nerve located at least 1-2 cm beyond the outer skin surface.

9. The apparatus of claim 1 wherein the target region is a nerve located at least 2-5 cm beyond the outer skin surface.

10. The apparatus of claim 1 wherein each pulse has a duration of 200 microseconds.

11. The apparatus of claim 1 wherein the conductive medium comprises a solution of electrolytes.

12. The apparatus of claim 1 wherein the conductive medium comprises a conductive gel.

13. A method for modulating one or more nerves at a target location within a body of a mammal comprising:

positioning an electrically permeable surface of an enclosure in contact with an outer skin surface of the mammal'"'"'s body;

generating an electrical impulse within the enclosure comprising bursts of pulses with each burst having a frequency of 1 Hz to 100 Hz and with each pulse generated from a signal that is not modulated by another signal and each pulse having a duration of 100 to 400 microseconds;

conducting the electrical impulse from one or more electrodes in the enclosure through a conductive medium within the enclosure and through the outer skin surface of the mammal'"'"'s body such that the electrical impulse is sufficient to modulate one or more nerves within the target region without causing substantial pain; and

generating an electric field wherein the electric field has an amplitude of greater than 10 V/m.

14. The method of claim 13 wherein the positioning step is carried out by positioning a portion of a handheld device in contact with the outer skin surface of the mammal'"'"'s body.

15. The method of claim 13 wherein the conducting step is carried out by spacing the one or more electrodes away from the outer skin surface and conducting the electric impulse from the electrodes through the conductive medium and through the electrically permeable surface of the enclosure to the outer skin surface.

16. The method of claim 13 wherein each pulse has a duration of 200 microseconds.

17. The method of claim 13 further comprising constraining the electric impulse from modulating one or more nerves in a second region between the outer skin surface and the target region.

18. The method of claim 17 wherein the constraining step comprises positioning the conductive medium around a portion of the electrode such that a direction of a generated electric field is constrained within the conductive medium.

19. The method of claim 17 wherein the constraining step comprises positioning an electrical insulator around a portion of the electrode such that a component of a generated electric field normal to the surface of the insulator is zero.

20. A device for directing a therapeutic electric current in tissue comprising:

at least two electrodes within an enclosure configured to generate electric fields comprising bursts of 1-20 pulses with a frequency of 5 to 100 bursts per second with each pulse generated from a signal that is not modulated by another signal and each pulse having a duration of 100 to 400 microseconds;

a conduit containing a conductive medium located outside of the at least two electrodes, said conductive medium configured to contact the tissue at two spatially distinct locations; and

wherein said conduit is positioned relative to the at least two electrodes such that the electric fields drive the electric current through the conductive medium and through the tissue without causing substantial pain.

21. A device for applying a therapeutic electric signal to tissue, comprising:

a power source configured to generate an electric current;

one or more electrodes each having a distal end;

a volume of conductive fluid directly in contact with the distal end of the one or more electrodes;

a non-conductive housing containing said power source;

said electrodes and the volume of conductive fluid;

a pair of electrically conductive ports in said housing, positionable against said tissue; and

wherein the volume of conductive fluid substantially surrounds the distal ends of the electrodes and spaces the electrodes from the electrically conductive ports such that electric current flows from the electrodes through the volume of conductive fluid to the electrically conductive ports.

22. The device of claim 21 wherein the conductive fluid is contained within the non-conductive housing such that electric current generated by the power source cannot flow solely within the non-conductive housing when the ports are positioned against the tissue.