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

• US 9,333,347 B2
• Filed: 07/22/2014
• Issued: 05/10/2016
• Est. Priority Date: 08/19/2010
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Malamud, Deborah
• Application Number:
  US14/337,930
• Publication Number:
  US 20140336730A1
• Time in Patent Office: 658 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• 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: A61N 2/006 for magnetic stimulation of nerve tissue

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, the apparatus comprising:

a housing comprising a contact surface configured to contact an outer skin surface of the mammal;

a source of energy, housed within the housing, to generate an electrical impulse comprising bursts of pulses with each of the bursts having a frequency from about 1 Hz to about 100 Hz and with each of the pulses having a duration from about 100 to about 400 microseconds; and

at least one electrode, housed within the housing, coupled to the source of energy and the contact surface, wherein the at least one electrode is configured to transmit the electrical impulse through the contact surface to the target region such that an electric field is generated at the target region having an amplitude greater than about 10 V/m to modulate a nerve within the target region, and wherein the at least one electrode is configured to transmit the electrical impulse through the outer skin surface of the mammal.

2. The apparatus of claim 1, further comprising:

a conduction medium housed within the housing, wherein the conduction medium is positioned between the at least one electrode and the contact surface.

3. The apparatus of claim 2, wherein the source of energy is a source of electrical energy coupled to first and second electrodes from the at least one electrode.

4. The apparatus of claim 2, wherein the conduction medium is positioned in electrical contact with a portion of the contact surface to at least partially restrict a direction of an electric field generated by the source of energy and the at least one electrode.

5. The apparatus of claim 2, wherein the conduction medium comprises a solution of electrolytes.

6. The apparatus of claim 2, wherein the conduction medium comprises a conductive gel.

7. The apparatus of claim 1 wherein the target region is a nerve located from about 1 to about 2 cm beyond the outer skin surface.

8. The apparatus of claim 1 wherein the target region is a nerve located from about 2 to about 5 cm beyond the outer skin surface.

9. The apparatus of claim 1 wherein the electric field has a gradient of greater than about 2 V/m/mm.

10. The apparatus of claim 1 wherein each of the pulses has a duration of about 200 microseconds.

11. The apparatus of claim 1, wherein the nerve comprises a vagus nerve, wherein the housing is configured to contact an outer skin surface of a neck of the mammal.

12. The apparatus of claim 1, wherein the source of energy is configured to transmit an electric current from the at least one electrode through the contact surface to the nerve, and wherein the source of energy is configured to transmit the electric current through the outer skin surface of the mammal.