Methods and apparatuses for transdermal stimulation of the outer ear

• US 10,426,945 B2
• Filed: 01/04/2016
• Issued: 10/01/2019
• Est. Priority Date: 01/04/2015
• Status: Active Grant

• Current Assignee: IST, LLC
• Original Assignee: Thync Global, Inc.
• Inventors: Tyler, William J., Law, Wing, Jeffery, Douglas, Piersiak, Rafal
• Primary Examiner(s): Voorhees, Catherine M
• Application Number:
  US15/536,148
• Publication Number:
  US 20170368329A1
• Time in Patent Office: 1,366 Days
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 21/00 Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
• 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: A61M 2210/0662 Ears
• CPC Class Codes: A61N 1/0408 Use-related aspects
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• 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 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36036 of the outer, middle or inner ear
• CPC Class Codes: G10L 15/02 Feature extraction for speech recognition; Selection of recognition unit

Abstract

Transdermal electrical stimulation (TES) applicators that are wearable and configured to attached to a subject'"'"'s pinna (ear) and adapted to apply TES to modulate the subject'"'"'s cognitive and/or physiological state. These apparatuses may be configured so that they can be worn against the ear (e.g., the cymba of the ear) to deliver TES. Also described herein are methods of using them to modulate a subject'"'"'s cognitive state. These TES applicators may also be adapted to function as audio headphones for concurrent delivery of TES and audible signals (e.g., music).

Claims

1. A wearable pinna transdermal electrical stimulation (TES) device for modifying a subject'"'"'s cognitive state by applying TES to the subject'"'"'s pinna, the device comprising:

a first body adapted to be worn in a pinna region of a first ear;

a second body adapted to be worn in a pinna region of a second ear;

a first electrode on the first body;

a second electrode on the second body; and

a wearable TES controller coupled to the first and second bodies and comprising a power source, a processor, a timer, and a waveform generator, wherein the TES controller is adapted to deliver an asymmetric biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a peak intensity of greater than 0.20 mA and a frequency of between 3 kHz and 50 kHz, wherein the TES controller is adapted to shift the frequency of the asymmetric biphasic electrical stimulation during the delivery of the asymmetric biphasic electrical stimulation in bursts of increased frequency or decreased frequency waveforms.

2. The device of claim 1, wherein the TES controller is adapted to deliver pulsed asymmetric biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a duty cycle of between 20 and 50 percent and a peak intensity of between 0.25 mA and 5 mA.

3. The device of claim 1, wherein the first electrode is on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna.

4. The device of claim 1, wherein the second electrode is coupled to the second body.

5. The device of claim 1, wherein the first electrode is a component of a removable and disposable electroconductive earbud attachment to the wearable device.

6. The device of claim 1, wherein the second electrode is a component of a removable and disposable electroconductive earbud attachment to the wearable device.

7. The device of claim 1, further comprising an adhesive on a body to secure the body to the subject'"'"'s skin, wherein the adhesive is configured to contact the skin of the subject'"'"'s pinna.

8. The device of claim 1, wherein the power source comprises at least one battery.

9. The device of claim 1, further comprising a manual control on the first or second body coupled to the controller.

10. The device of claim 1, further comprising a capacitive discharge circuit, wherein the TES controller is configured to occasionally trigger the capacitive discharge circuit to discharge capacitance on the electrodes during the delivery of the electrical stimulation, wherein the capacitive discharge circuit is configured to generate a gradual capacitive discharging pulse with controlled time constant and peak value.

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

12. The device of claim 1, further comprising a memory connected to the TES controller and adapted to store information on the operation of the TES device.

13. The device of claim 1, wherein the first or second electrodes are on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna and wherein the wearable applicator is in contact with at least one region of the wearer'"'"'s pinna.

14. The device of claim 1, wherein the first electrode is on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna and wherein a region of the wearable applicator is covered with a malleable and conductive material for contacting a region of the subject'"'"'s pinna.

15. The device of claim 1, wherein the first electrode is on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna and wherein a region of the first electrode is covered with a malleable and conductive material for contacting a region of the subject'"'"'s pinna.

16. The device of claim 15, wherein the malleable and conductive material comprises a conductive polymer.

17. The device of claim 15, wherein the conductive material is conductive foam, conductive silicon, or conductive rubber.

18. The device of claim 1, wherein the first electrode is on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna and wherein the first electrode is integrated with the wearable applicator.

19. The device of claim 1, wherein the first electrode is on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna and wherein the wearable applicator further comprises a speaker configured to deliver an auditory signal.

20. The device of claim 1, wherein the first electrode is on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject'"'"'s pinna and wherein the first electrode can be coupled or uncoupled from the wearable applicator.

23. The device of claim 1, wherein the TES controller is adapted to deliver auditory stimulation via the first and second bodies, wherein the auditory stimulation comprises two fundamental frequencies that differ by a frequency associated with a target brain rhythm.

21. A wearable pinna transdermal electrical stimulation (TES) device for modifying a subject'"'"'s cognitive state by applying TES to the subject'"'"'s pinna, the device comprising:

a body adapted to be worn by the subject in the subject'"'"'s ear;

a first electrode coupled to a body and configured to be worn in a pinna region of the subject'"'"'s ear;

a second electrode coupled to the body; and

a wearable TES controller coupled to the first and second bodies and comprising a power source, a processor, a timer, and a waveform generator, wherein the TES controller is adapted to deliver an electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a peak intensity of 0.20 mA or greater, a duty cycle of greater than 10% and a frequency between 3 kHz and 50 kHz, wherein the TES controller is adapted to shift the frequency of the asymmetric biphasic electrical stimulation during the delivery of the asymmetric biphasic electrical stimulation in bursts of increased frequency or decreased frequency waveforms.

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

a first body adapted to be worn in a pinna region of a first ear;

a second body adapted to be worn in a pinna region of a second ear;

a first electrode removably attached to the first body;

a second electrode removably attached to the second body; and

a wearable TES controller coupled to the first and second bodies and comprising a power source, a processor, a timer, and a waveform generator, wherein the TES controller is adapted to deliver an electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a peak intensity of greater than 0.20 mA and a frequency between 3 kHz and 50 kHz, wherein the TES controller is adapted to shift the frequency of the asymmetric biphasic electrical stimulation during the delivery of the asymmetric biphasic electrical stimulation in bursts of increased frequency or decreased frequency waveforms.