Systems and methods for vagal nerve stimulation

• US 9,566,426 B2
• Filed: 05/23/2014
• Issued: 02/14/2017
• 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.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/286,412
• Publication Number:
  US 20140257438A1
• Time in Patent Office: 998 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36034 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

Devices, systems and methods are disclosed for electrical stimulation of the vagus nerve to treat or prevent disorders in a patient. The devices comprise a handheld device having one or more electrode interfaces for contacting the outer skin surface of a patient, 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. 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 device for modulating a nerve within a body of a patient, the device comprising:

a handheld device comprising an enclosure with an interior, an electrode positioned within the interior, and an electrically conductive interface configured for a contact with an outer skin surface of the patient;

a source of energy housed within the interior of the enclosure;

a signal generator housed within the enclosure and coupled to the source of energy and the electrode, wherein the signal generator is configured to apply an 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 at a target region below the outer skin surface; and

a filter housed within the enclosure and electrically coupling the electrode with the electrically conductive interface, wherein the filter is configured to filter out a high frequency component from the electrical impulse.

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

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

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

5. The device 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 device of claim 1, wherein the source of energy is configured to generate 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.

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

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

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

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

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

12. A device for modulating one or more nerves within a body of a patient, the device comprising:

a handheld device comprising an enclosure with an interior and one or more electrodes configured for a contact with an outer skin surface of the patient;

a source of energy housed within the interior of the enclosure;

a signal generator housed within the enclosure and coupled to the source of energy, wherein the signal generator is configured to apply an electrical impulse through the one or more electrodes transcutaneously through the outer skin surface of the patient to a nerve at a target region below the outer skin surface; and

an electrically conductive fluid housed within the enclosure and electrically coupling the signal generator with the one or more electrodes.

13. The device of claim 12 wherein the electrically conductive fluid comprises a conductive gel.

14. The device of claim 12, 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.

15. The device of claim 12, wherein the source of energy is configured to generate 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.

16. The device of claim 15, wherein the sinusoidal pulses have a frequency from about 1 KHz to about 20 KHz.

17. The device of claim 15, wherein the sinusoidal pulses have a frequency from about 1 KHz to about 10 KHz.

18. The device of claim 15 wherein the sinusoidal pulses have a frequency of about 5 KHz.

19. The device of claim 15, wherein the one or more electrodes comprises stainless steel.

20. The device of claim 15, wherein the bursts each have a frequency from about 10 Hz to about 35 Hz.

21. A device comprising:

a housing comprising an interior portion and an exterior portion;

a source of energy positioned within the interior portion;

a signal generator positioned within the interior portion, wherein the signal generator is coupled to the source of energy, wherein the signal generator is configured to generate an electrical impulse;

a electrode positioned within the interior portion, wherein the electrode is coupled to the signal generator;

a filter positioned within the interior portion, wherein the filter is coupled to the electrode, wherein the filter is configured to filter out a high frequency component from the electrical impulse;

a conductive surface coupled to the filter, wherein the exterior portion comprises the conductive surface,

wherein the conductive surface conducts the electrical impulse transcutaneously to a nerve at a target region below an outer skin surface of a patient when the conductive surface contacts the outer skin surface and the electrical impulse travels from the signal generator to the conductive surface through the electrode and the filter.

22. The device of claim 21, wherein the filter comprises a low-pass filter.