Devices and methods for non-invasive electrical stimulation and their use for Vagal nerve stimulation

• US 10,363,415 B2
• Filed: 05/09/2016
• Issued: 07/30/2019
• Est. Priority Date: 08/19/2010
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Malamud, Deborah L
• Application Number:
  US15/149,406
• Publication Number:
  US 20160250465A1
• Time in Patent Office: 1,177 Days
• 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. A device comprising:

an enclosure hosting a contact surface;

a power source positioned within the enclosure and configured to generate an electric field comprising bursts of pulses having a frequency from about 5 bursts per second to about 100 bursts per second with each of the pulses generated from a signal that is not modulated by another signal;

an electrode coupled to the power source and positioned within the enclosure;

an electrically conductive medium positioned between the electrode and the contact surface, wherein the power source is configured to transmit the electric field from the electrode through the electrically conductive medium and the contact surface transcutaneously through an outer skin surface of a patient to a nerve within the patient at a target region within the patient beneath the outer skin surface such that the electric field is able to modulate the nerve and thereby treat at least one of a disorder or a disease of the patient.

2. The device of claim 1, wherein each of the pulses has a duration from about 100 microseconds to about 400 microseconds.

3. The device of claim 2, wherein each of the pulses has a duration of about 200 microseconds.

4. The device of claim 1, wherein the electric field is configured to drive an electric current through the electrically conductive medium and through the outer skin surface without causing substantial pain to the patient.

5. The device of claim 1, wherein the electric field includes a plurality of electric fields.

6. The device of claim 1, wherein the electrically conductive medium is positioned within the enclosure.

7. The device of claim 1, wherein the electrically conductive medium is positioned outside of the enclosure.

8. The device of claim 1, wherein the nerve includes a vagus nerve.

9. The device of claim 1, wherein the target region is within a neck of the patient.

10. The device of claim 1, wherein the at least one of the disease or the condition includes at least one of a migraine headache, a tension headache, a sinus headache, a cluster headaches, an allergic rhinitis, a post-operative ileus, a dysfunction associated with TNF-alpha in Alzheimer'"'"'s disease, a postoperative cognitive dysfunction, a postoperative delirium, a rheumatoid arthritis, an asthmatic bronchoconstriction, a urinary incontinence, an overactive bladder, a sphincter of Oddi dysfunction, an essential tremor, an Alzheimer'"'"'s disease, a mild cognitive impairment (MCI), a Parkinson'"'"'s disease, a dementia, or a multiple sclerosis.