Wearable transdermal electrical stimulation devices and methods of using them

• US 8,903,494 B2
• Filed: 11/26/2013
• Issued: 12/02/2014
• Est. Priority Date: 11/26/2012
• Status: Expired due to Fees

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync, Inc.
• Inventors: Goldwasser, Isy, Tyler, William J., Lamb, Philip, Gradwohl, Raymond L., Wetmore, Daniel Z., Opitz, Alexander, Sato, Tomokazu, Charlesworth, Jonathan, Pal, Sumon K., Voss, Christopher, Cook, Steven, Demers, Remi
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/091,121
• Publication Number:
  US 20140148872A1
• Time in Patent Office: 371 Days
• Field of Search: 607/45, 607/2, 607/139
• 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 1/0492 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
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Described herein are devices, systems, and methods for transdermal electrical stimulation. Devices described herein can include self-contained, lightweight, and wearable components. The devices include a primary unit including a first transdermal electrode and a secondary unit including a second transdermal electrode. The device can be capable of wireless communication. The primary unit and secondary unit are placed at two locations on the skin of a user, for example on the head or neck of a user. The first and second transdermal electrodes are electrically connected. Electrical stimulation is driven between the two electrodes. The electrical stimulation induces a cognitive effect in a user of the device.

Claims

1. A two-part, self-contained, adherently attached, lightweight and wearable transdermal electrical stimulation device for inducing a cognitive effect in a subject, the device comprising:

a low-profile primary unit including;

a power source,

a controller including a current source configured to apply a current at a frequency of greater than 640 Hz,

a first transdermal electrode mounted on an inner surface of the primary unit;

wherein the primary unit has a maximum thickness of less than 30 mm, and

a power supply access port on the inner surface, wherein the power supply access port is covered by the first transdermal electrode to prevent access when the first transdermal electrode is mounted to the inner surface, and

a secondary unit electrically connected to the primary unit by a cable extending from the primary unit, the secondary unit including a second transdermal electrode;

wherein either the primary unit or the secondary unit or both is configured to be worn on the subject'"'"'s head or neck, and the secondary unit is configured to be independently positioned at a second location on the subject so that the controller can drive stimulation at greater than 640 Hz between the first and second electrodes to induce a cognitive effect in the subject.

2. The device of claim 1, wherein the controller is configured to apply one or more pre-determined stimulation protocols when driving stimulation between the first and second electrodes to induce a cognitive effect.

3. The device of claim 1, wherein the secondary unit is configured to be detachably coupled to the primary unit before applying the primary and secondary units to the subject.

4. The device of claim 1, wherein the primary unit is configured to be adhesively attached to the subject'"'"'s head or neck.

5. The device of claim 1, wherein the primary unit and secondary unit together weigh less than about 5 ounces.

6. The device of claim 1, wherein the device includes a visual indicator on an outer surface of the primary unit.

7. The device of claim 1, wherein the device includes an input control on an outer surface of the primary unit.

8. The device of claim 1, wherein the first and second electrodes are configured to be disposable and detachably coupled to the device.

9. The device of claim 1, wherein the controller is configured to adjust current across the first and second electrodes based on a detected impedance.

10. The device of claim 1, wherein the primary unit further comprises a wireless communications module in communication with the controller and configured to provide stimulation instructions to the controller.

11. The device of claim 1, wherein the controller is configured to cause alternating current, direct current, or a combination of alternating and direct current between the first and second electrodes.

12. The device of claim 1, wherein the device is configured to apply pulsed electrical stimulation.

13. The device of claim 1, wherein the second electrode is configured to be positioned on a neck or head of a subject.

14. The device of claim 1, wherein the first electrode is part of a replaceable cartridge configured to be detachably coupled to the primary unit.

15. The device of claim 1, wherein the first electrode and secondary unit are part of a replaceable cartridge configured to be detachably coupled to the primary unit.

16. A two-part, adherently-attached, lightweight, wearable, and self-contained transdermal electrical stimulation device for inducing a cognitive effect in a subject, the device comprising:

a low-profile primary unit having a housing at least partially enclosing;

a power source,

a wireless communications module,

a current generator connected to the power source configured to apply a current at a frequency of greater than 640 Hz;

a controller configured to receive stimulation instructions from a remotely located processor via the wireless communications module,

a replaceable cartridge including a first transdermal electrode, wherein the replaceable cartridge connects directly onto an inner surface of the housing so that the first transdermal electrode is mounted on an outer surface of the housing, and

a power supply access port on the inner surface of the housing, wherein the power supply access port is covered by the first transdermal electrode to prevent access when the first transdermal electrode is connected to the inner surface; and

a secondary unit electrically connected to the primary unit by a cable extending from the housing, the secondary unit including a second transdermal electrode;

wherein the primary unit is configured to be worn on the subject'"'"'s head or neck and the secondary unit is configured to be independently attached to a second location on the subject so that the controller controls the current generator to drive stimulation at greater than 640 Hz between the first and second electrodes based on stimulation instructions received from the remotely located processor to induce a cognitive effect in the subject.

17. A method of inducing a cognitive effect in a subject, the method comprising:

attaching a primary unit of a two-part, lightweight, wearable, and self-contained transdermal electrical stimulation device to a first location on the subject'"'"'s head or neck so that a first electrode contacts the subject'"'"'s skin, so that the primary unit does not extend further than 30 mm from the subject'"'"'s skin, wherein the primary unit contains a power source, and a controller and wherein the first electrode is part of a cartridge connected on an inner surface of the primary unit so that the first electrode is mounted on an outer surface of the primary unit;

attaching a secondary unit comprising a second electrode to a second location on the subject, wherein the secondary unit is electrically connected to the primary unit by a cable; and

driving stimulation between the first and second electrodes at a current frequency of greater than 640 Hz to induce a cognitive effect in the subject, wherein a controller in the primary unit drives stimulation; and

accessing a power supply access port on the inner surface by removing the first electrode, wherein the power supply access port is covered by the first electrode when the first electrode is connected to the inner surface.

18. The method of claim 17, further comprising separating the primary unit from the secondary unit before driving stimulation between the first and second electrodes.

19. The method of claim 17, wherein attaching the primary unit comprises adhesively attaching the primary unit to the subject'"'"'s head or neck at the first location.

20. The method of claim 17, wherein attaching the secondary unit comprises adhesively attaching the secondary unit to the subject.

21. The method of claim 17, wherein attaching the secondary unit comprises attaching the secondary unit to the subject'"'"'s neck or head.

22. The method of claim 17, further comprising wirelessly transmitting stimulation parameters from a mobile communications device to the controller in the primary unit.

23. The method of claim 17, wherein driving stimulation between the first and second electrodes to induce the cognitive effect in the subject comprises supplying a peak current of at least 2 mA during stimulation.

24. The method of claim 17, further comprising attaching a cartridge including the first electrode to the primary unit before attaching the primary unit to the subject'"'"'s head or neck.

25. A method of inducing a cognitive effect in a subject, the method comprising:

coupling a disposable first electrode and disposable second electrode to an inner surface of a reusable primary unit of a lightweight and wearable transdermal electrical stimulation apparatus, wherein the disposable first electrode is coupled to the primary unit via an electrode connector on the inner surface of the primary unit so that the first electrode is mounted on an outer surface of the primary unit and in electrical communication with a controller in the primary unit, and wherein the second electrode is electrically connected to the controller via a cable;

attaching the primary unit to a first location on the subject'"'"'s head or neck so that the first electrode contacts the subject'"'"'s skin, and so that the primary unit does not extend further than 30 mm from the subject'"'"'s skin;

independently attaching the second electrode to a second location on the subject so that the second electrode contacts the subject'"'"'s skin;

activating the controller to drive stimulation at a current frequency of greater than 640 Hz between the first and second electrodes to induce a cognitive effect in the subject, and

accessing a power supply access port on the inner surface by removing the first electrode, wherein the power supply access port is covered by the first electrode when the first electrode is connected to the inner surface.