SYSTEMS AND METHODS FOR VAGAL NERVE STIMULATION

• US 20170151433A1
• Filed: 02/13/2017
• Published: 06/01/2017
• Est. Priority Date: 08/31/2011
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Granted Patent: US 10,286,211 B2
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• 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
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

In a device, system and method for electrical stimulation of the vagus nerve to treat or prevent disorders in a patient, the device comprises a handheld device having one or more electrode interfaces for contacting the outer skin surface of a patient, and a power source and a signal generator coupled to the electrode/interfaces for applying one or more electrical impulses to a deep nerve within the patient, such as the vagus nerve. In certain embodiments, the device further comprises a filter situated in series between the signal generator and the electrode/interfaces for filtering out undesired high frequency components of the electrical impulses to create a cleaner, smoother signal. The filter may comprise an electrically conductive medium and/or a low-pass filter between the signal generator and the electrode/interface.

Claims

1. A method for modulating a nerve within a body of a patient, the method comprising:

contacting an electrically conductive interface of a handheld device against an outer skin surface of a patient, wherein the handheld device comprises an enclosure with an interior and an electrode positioned within the interior, wherein the electrode is coupled to the electrically conductive interface;

generating an electrical impulse within the handheld device;

transmitting the electrical impulse through the electrode and the electrically conductive interface of the enclosure transcutaneously through the outer skin surface of the patient to the nerve, wherein the nerve is located at a target region below the outer skin surface; and

filtering a high frequency component from the electrical impulse with a filter housed within the enclosure, wherein the filter is coupled to the electrode.

2. The method of claim 1, wherein the filter comprises an electrically conductive fluid.

3. The method of claim 2, wherein the electrically conductive fluid comprises a conductive gel.

4. The method of claim 1, wherein the filter comprises a low-pass filter.

5. The method of claim 1, wherein the electrical impulse is sufficient to modulate a nerve within the target region and insufficient to substantially modulate a nerve in a vicinity of the outer skin surface.

6. The method of claim 1, wherein the generating step comprises generating an electric field comprising bursts of sinusoidal pulses with silent inter-burst periods such that each of the bursts has a frequency from about 5 Hz to about 100 Hz.

7. The method of claim 6, wherein the sinusoidal pulses have a frequency from about 1 KHz to about 20 MHz.

8. The method of claim 6, wherein the sinusoidal pulses have a frequency from about 1 KHz to about 10 MHz.

9. The method of claim 6, wherein the sinusoidal pulses have a frequency of about 5 KHz.

10. The method of claim 1, wherein the electrically conductive interface comprises stainless steel.

11. The method of claim 6, wherein the bursts each have a frequency from about 10 Hz to about 35 Hz.

12. The method of claim 1, wherein the electrical impulse is generated via a source of energy.

13. The method of claim 1, wherein the nerve comprises a vagus nerve and the contacting step comprises contacting the electrically conductive interface with an outer skin surface of a neck of the patient.

14. A method for modulating a nerve within a body of a patient, the method comprising:

contacting an exterior portion of a housing with an outer skin surface of the patient;

generating an electrical impulse via a source of energy located in an interior of the housing;

transmitting the electrical impulse from the source of energy through an electrode in the interior of the housing and through the exterior portion of the housing such that the electrical impulse passes transcutaneously through the outer skin surface of the patient to the nerve within a target region below the outer skin surface of the patient; and

filtering out a high frequency component from the electrical impulse with a filter positioned within the interior portion of the housing.

15. The method of claim 14, wherein the filter comprises a low-pass filter electrically coupling the electrode with the exterior portion of the housing.

16. The method of claim 14, wherein the filter comprises an electrically conductive fluid electrically coupling the electrode with the exterior portion of the housing.

17. The method of claim 16, wherein the electrically conductive fluid comprises an electrically conductive gel.

18. The method of claim 14, wherein the generating step comprises generating an electrical field comprising bursts of sinusoidal pulses with silent inter-burst periods such that each of the bursts has a frequency from about 5 Hz to about 100 Hz.

19. The method of claim 18, wherein the sinusoidal pulses have a frequency from about 1 KHz to about 20 MHz.

20. The method of claim 18, wherein the sinusoidal pulses have a frequency from about 1 KHz to about 10 MHz.

21. The method of claim 18, wherein the sinusoidal pulses have a frequency of about 5 KHz.

22. The method of claim 18, wherein the bursts each have a frequency from about 10 Hz to about 35 Hz.

23. The method of claim 15, wherein the nerve comprises a vagus nerve and the contacting step comprises contact the exterior portion of the housing with an outer skin surface of a neck of the patient.