Transdermal electrical stimulation devices for modifying or inducing cognitive state

• US 9,002,458 B2
• Filed: 06/30/2014
• Issued: 04/07/2015
• Est. Priority Date: 06/29/2013
• Status: Expired due to Fees

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync, Inc.
• Inventors: Pal, Sumon K., Charlesworth, Jonathan, Demers, Remi, Wetmore, Daniel Z., Goldwasser, Isy, Tyler, William J., Gradwohl, Raymond L., Lamb, Philip, Voss, Christopher
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US14/320,461
• Publication Number:
  US 20150005841A1
• Time in Patent Office: 281 Days
• Field of Search: None
• US Class Current: 607/45
• 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 1/0484 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 1/36034 specified by the stimulation parameters

Abstract

Portable transdermal electrical stimulation (TES) applicators for modifying a subject'"'"'s cognitive state. In general, the portable applicators described are specifically configured and adapted to be lightweight and may be wearable, and to deliver a high-intensity TES able to evoke or enhance a predetermined cognitive effect. These TES applicators may include a pair of electrodes and a TES control module comprising a processor, a timer and a waveform generator. TES control module is adapted to deliver a biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater, with a DC offset.

Claims

1. A portable transdermal electrical stimulation (TES) applicator for modifying a subject'"'"'s cognitive state, the device comprising:

a body;

a first electrode adapted to be worn on the subject'"'"'s temple region;

a second electrode adapted to be worn on a subject'"'"'s mastoid region or neck; and

a TES control module at least partially within the body and comprising a processor, a timer and a waveform generator, wherein the TES control module is adapted to deliver a pulsed, asymmetric, biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 750 Hz or greater, a duty cycle of between 30-60 percent, and an intensity of greater than 5 mA;

wherein the TES control module is configured to modulate the intensity, frequency, or intensity and frequency during stimulation based on received subject input.

2. The device of claim 1, further comprising a wireless receiver coupled to the TES control module.

3. The device of claim 1, wherein the first electrode is on an outer surface of the body.

4. The device of claim 1, wherein the first electrode is coupled to the body by a cord.

5. The device of claim 1, wherein the second electrode is coupled to the body by a cord.

6. The device of claim 1, further comprising an adhesive to secure the body to the subject.

7. The device of claim 1, further comprising a power source.

8. The device of claim 1, further comprising a manual control on the body coupled to the TES control module.

9. The device of claim 1, further comprising a capacitive discharge circuit, wherein the TES control module is configured to occasionally trigger the capacitive discharge circuit to discharge capacitance on the electrodes during the delivery of the pulsed, asymmetric, biphasic electrical stimulation.

10. The device of claim 1, further comprising a current limiter.

11. The device of claim 1, further comprising a memory connected to the TES control module and adapted to store information on the operation of the TES applicator.

12. A wearable transdermal electrical stimulation (TES) applicator for modifying a subject'"'"'s cognitive state, the device comprising:

a body adapted to be worn by the subject;

a first electrode adapted to be worn on the subject'"'"'s temple region;

a second electrode adapted to be worn on a subject'"'"'s mastoid region or neck;

a TES control module at least partially within the body, the TES control module including a power source, a processor, a timer, and a waveform generator, wherein the TES control module is adapted to deliver a pulsed, asymmetric, biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 750 Hz or greater, a duty cycle of between 30-60 percent, and an intensity of greater than 5 mA, wherein the stimulation is not charge balanced; and

a wireless receiver connected to the TES control module;

wherein the wearable TES applicator weighs less than 50 grams and is configured to modulate the intensity, frequency, or intensity and frequency during stimulation based on received subject input.

13. The device of claim 12, wherein the first electrode is on an outer surface of the body.

14. The device of claim 12, wherein the first electrode is coupled to the body by a cord.

15. The device of claim 12, wherein the second electrode is coupled to the body by a cord.

16. The device of claim 12, further comprising an adhesive on the body to secure the body to the subject'"'"'s skin.

17. The device of claim 12, wherein the power source comprises at least one battery.

18. The device of claim 12, further comprising a manual control on the body coupled to the TES control module.

19. The device of claim 12, further comprising a capacitive discharge circuit, wherein the TES control module is configured to occasionally trigger the capacitive discharge circuit to discharge capacitance on the electrodes during the delivery of the pulsed, asymmetric, biphasic electrical stimulation.

20. The device of claim 12, further comprising a current limiter.

21. The device of claim 12, further comprising a memory connected to the TES control module and adapted to store information on the operation of the TES applicator.

22. A wearable transdermal electrical stimulation (TES) applicator for modifying a subject'"'"'s cognitive state, the device comprising:

a body adapted to be worn against the subject'"'"'s skin;

a first electrode on the body and adapted to be worn on the subject'"'"'s temple region;

a second electrode adapted to be worn on the subject'"'"'s mastoid region or neck and coupled to the body by a cord; and

a TES control module at least partially within the body and comprising a processor, a timer and a waveform generator, wherein the TES control module is adapted to deliver a pulsed, asymmetric, biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 750 Hz or greater, a duty cycle of between 30-60 percent, and an intensity of greater than 5 mA, wherein the stimulation is not charge balanced;

further wherein the wearable TES applicator weighs less than 50 grams and is configured to modulate the intensity, frequency, or intensity and frequency during stimulation based on received subject input.

23. The device of claim 22, further comprising a wireless receiver coupled to the TES control module.

24. The device of claim 22, further comprising an adhesive to secure the body to the subject'"'"'s skin.

25. The device of claim 22, further comprising a power source.

26. The device of claim 22, further comprising a manual control on the body coupled to the TES control module.

27. The device of claim 22, further comprising a manual control on the body configured as a button that is coupled to the TES control module.

28. The device of claim 22, further comprising a capacitive discharge circuit, wherein the TES control module is configured to occasionally trigger the capacitive discharge circuit to discharge capacitance on the electrodes during the delivery of the pulsed, asymmetric, biphasic electrical stimulation.

29. The device of claim 22, further comprising a current limiter.

30. The device of claim 22, further comprising a memory connected to the TES control module and adapted to store information on the operation of the TES applicator.