Transdermal electrical stimulation at the neck to induce neuromodulation

• US 9,956,405 B2
• Filed: 05/22/2017
• Issued: 05/01/2018
• Est. Priority Date: 12/18/2015
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thyne Global Incorporated
• Inventors: Goldwasser, Isy, Jeffery, Douglas, Pal, Sumon K., Law, Wing
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US15/601,394
• Publication Number:
  US 20170252562A1
• Time in Patent Office: 344 Days
• Field of Search: 607 45
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

Described herein are methods and apparatuses for the application of transdermal electrical stimulation (TES) in order to modulate a user'"'"'s cognitive state to induce a state of calm or relaxation. The apparatuses described herein include neck-worn devices having electrodes (or configured to connect to electrodes, including automatically self-connecting to electrodes) adapted to couple to the midline of the back of user'"'"'s neck. A neck-worn controller may be configured as a cord, band, wire, torc, necklace, loop, strap, or the like, and may be rigid or semi-rigid and may be worn at least partially around the subject'"'"'s neck. The controller may controllably apply one or more waveforms to the electrodes of the electrode pad (e.g., patch) to deliver TES adapted to induce or enhance a relaxed cognitive state.

Claims

1. A method of applying transdermal electrical stimulation (TES) to the back of a user'"'"'s neck to induce a relaxed state, the method comprising:

placing an anode and a cathode along a midline of a back of the user'"'"'s neck between a region over the user'"'"'s C3 cervical region and the user'"'"'s T2 thoracic region, wherein the anode is separated from the cathode by between 0.8 and 2.2 inches;

applying electrical energy between the anode and the cathode to deliver TES; and

inducing, in the user, a relaxed state by the application of TES.

2. The method of claim 1, wherein placing comprises adhesively attaching the anode and the cathode.

3. The method of claim 1, wherein placing comprises placing the anode and the cathode so that the anode is separated from the cathode by between 0.8 inches and 2.0 inches, and wherein the anode and the cathode are arranged along the midline of the user'"'"'s body so that the anode is over the user'"'"'s C4-C7 region and the cathode is over the user'"'"'s C7-T2 region.

4. The method of claim 1, wherein placing comprises adhesively attaching an electrode pad comprising the anode and the cathode to the back of a user'"'"'s neck so that the anode and the cathode are arranged along the midline of the user'"'"'s neck.

5. The method of claim 1, wherein placing the anode comprises placing a neck-worn TES controller around the neck of the user wherein the TES controller is configured to apply electrical energy between the anode and the cathode.

6. The method of claim 1, wherein applying electrical energy comprises applying TES by delivering electrical energy between the anode and the cathode, wherein the electrical energy comprises a carrier wave having a frequency that is greater than 250 Hz that is amplitude modulated at a frequency that is ten percent or less of the frequency of the carrier wave, further wherein the amplitude modulation is varied at least once every 40 seconds.

7. The method of claim 6, wherein the amplitude modulation is varied by varying the shape of an envelope of the amplitude modulation.

8. The method of claim 6, wherein the amplitude modulation is varied by varying one or both of a symmetry ratio and a flat ratio of the amplitude modulation.

9. The method of claim 1, wherein a surface area of one of the anode is greater than 1.25 times the surface area of the cathode.

10. The method of claim 1, wherein placing comprises attaching a wearable TES controller to the anode and the cathode.

11. The method of claim 1, wherein inducing the relaxed state comprises one or more of:

reducing stress, reducing anxiety, improving sleep, and improve mood.

12. The method of claim 1, wherein inducing a relaxed state comprises lowering one or more of:

blood pressure, heart rate, and skin conductance.

13. A method of applying transdermal electrical stimulation (TES) to induce a relaxed state, the method comprising:

placing an anode and a cathode to a back of the user'"'"'s neck along a midline of a long axis of the user'"'"'s body extending anterior to posterior, wherein the anode is positioned over the user'"'"'s C3-C7 region and the cathode is positioned over the user'"'"'s C7-T2 region, wherein the anode and the cathode form part of an electrode pad, and wherein the anode is separated from the cathode by between 0.8 and 2.0 inches;

applying TES by delivering electrical energy between the anode and the cathode, wherein the electrical energy comprises a carrier wave having a frequency that is greater than 250 Hz that is amplitude modulated at a frequency that is ten percent or less the frequency of the carrier wave; and

inducing, in the user, a relaxed state by the application of TES.

14. The method of claim 13, wherein placing comprises placing a TES controller around the user'"'"'s neck or shoulders wherein the TES controller is configured to apply electrical energy between the anode and the cathode.

15. The method of claim 13, wherein placing comprises attaching a wearable TES controller to the anode and the cathode.

16. The method of claim 13, wherein applying TES by delivering electrical energy comprises applying the energy at a rise time of between 1 and 20 microseconds.

17. The method of claim 16, wherein the rise-time is varied between 1 and 20 microseconds.

18. The method of claim 13, wherein applying TES comprises applying the carrier wave with a rise time of between 1 and 20 microseconds.

19. The method of claim 18, wherein the rise-time is varied between 1 and 20 microseconds.

20. The method of claim 13, wherein a surface area of one of the anode is greater than 1.25 times the surface area of the cathode.

21. The method of claim 13, wherein inducing the relaxed state comprises one or more of:

reducing stress, reducing anxiety, improving sleep, and improve mood.

22. The method of claim 13, wherein inducing a relaxed state comprises lowering one or more of:

blood pressure, heart rate, and skin conductance.

23. A method of applying transdermal electrical stimulation (TES) to the back of a user'"'"'s neck, the method comprising:

placing an anode and a cathode along a midline of a back of the user'"'"'s neck between a region over the user'"'"'s C3 cervical region and the user'"'"'s T2 thoracic region, wherein the anode is separated from the cathode by between 0.6 and 1.3 inches;

applying electrical energy between the anode and the cathode to deliver TES; and

modulating, in the user, the user'"'"'s parasympathetic drive and the user'"'"'s sympathetic drive by the application of TES.