Non-invasive vagus nerve stimulation devices and methods to treat or avert atrial fibrillation

• US 10,213,601 B2
• Filed: 09/04/2015
• Issued: 02/26/2019
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Kahelin, Michael
• Application Number:
  US14/846,137
• Publication Number:
  US 20150374983A1
• Time in Patent Office: 1,271 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Energy is transmitted noninvasively to a patient using electrode-based stimulation devices or magnetic stimulation devices that are designed to non-invasively stimulate nerves selectively. The devices produce impulses that are used to treat atrial fibrillation, by stimulating a vagus nerve of a patient. The devices are also used to forecast the imminent onset of atrial fibrillation and then avert it by stimulating a vagus nerve.

Claims

1. A device for at least one of treating atrial fibrillation or averting an imminent episode of atrial fibrillation in a patient, the device comprising:

a housing having an electrically permeable contact surface for contacting an outer skin surface of the patient; and

an energy source within the housing configured to generate an electric field sufficient to transmit an electrical impulse through the outer skin surface of the patient to a vagus nerve at a target region within the patient;

wherein the electrical impulse comprises bursts of pulses with each of the bursts having a frequency of about 3 Hz to about 100 Hz, each of the bursts comprising a plurality of pulses, and each of the pulses having a duration of about 50 microseconds to about 1000 microseconds, and wherein the electrical impulse is sufficient to modulate the vagus nerve such that the vagus nerve transmits an action potential sufficient to at least one of treat the atrial fibrillation or avert the imminent episode of atrial fibrillation.

2. The device of claim 1, wherein the energy source comprises a pulse generator and an electrode coupled to the pulse generator within the housing.

3. The device of claim 2, wherein the pulse generator is configured to generate an electric current within the housing and to transmit the electric current transcutaneously through the outer skin surface of the patient to the nerve at the target region.

4. The device of claim 2, further comprising:

a volume of electrically conductive fluid within the housing between the electrode and the electrically permeable contact surface.

5. The device of claim 1, wherein the energy source comprises a battery.

6. The device of claim 1, wherein the energy source comprises a toroid within the housing, wherein the toroid is configured to generate a magnetic field sufficient to induce an electric current at the target region.

7. The device of claim 1, wherein the electrical impulse is sufficient to stimulate the vagus nerve of the patient.

8. The device of claim 1, wherein the housing comprises a handheld device configured for contacting the outer skin surface of a neck of the patient.

9. The device of claim 1, wherein the bursts of pulses comprise sinusoidal waves.

10. The device of claim 1, wherein the electrical impulse is sufficient to terminate the atrial fibrillation.

11. The device of claim 1, wherein each of the bursts comprises at least two pulses.