Wearable transdermal electrical stimulation devices and methods of using them

• US 9,440,070 B2
• Filed: 12/02/2014
• Issued: 09/13/2016
• Est. Priority Date: 11/26/2012
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thyne Global Incorporated
• Inventors: Goldwasser, Isy, Tyler, William J., Charlesworth, Jonathan, Pal, Sumon K., Wetmore, Daniel Z., Jeffery, Douglas, Law, Wing
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/558,604
• Publication Number:
  US 20150088224A1
• Time in Patent Office: 651 Days
• Field of Search: 607/2, 607/36, 607/45
• US Class Current: 1/1
• 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

Apparatuses (e.g., devices, systems), and methods for transdermal electrical stimulation (TES). Apparatuses described herein can be self-contained, lightweight, and wearable. The apparatus may include a primary unit (TES stimulator) and an electrode portion that includes a first transdermal electrode and a second transdermal electrode and mates with the TES stimulator. The first electrode and secondary electrode are placed at two locations on the skin of a user, for example on the head and/or neck of a user. Electrical stimulation driven between the two electrodes may induce a cognitive effect in a user of the device.

Claims

1. A lightweight and wearable transdermal electrical stimulation system for inducing a cognitive effect in a subject, the system comprising:

an electrode portion, the electrode portion including;

a first electrode on a first base region,

a second electrode on a second base region,

a connecting region extending between the first and second electrodes, wherein the connecting region is between 3 and 12 inches long, and

a first connector on the first base region, wherein the connector is in electrical communication with the first electrode; and

a durable low-profile primary unit having a maximum thickness of 30 mm, the primary unit including;

a housing having a first outer surface that is curved inward,

a power supply within the housing;

a controller within the housing, the controller including a current source configured to provide a current at a frequency of greater than 640 Hz to the receiver, and

a receiver at the first outer surface, the receiver configured to electrically connect the first connector to the controller,

wherein the first base region of the electrode portion is configured to connect to the first outer surface of the primary unit so that the first connector connects to the receiver, and wherein when the first electrode is attached to a first position on the subject'"'"'s head and the second electrode is attached to a second position on the subject'"'"'s head or neck, the controller is configured to apply stimulation at greater than 640 Hz between the first and second electrodes to induce a cognitive effect in the subject.

2. The system of claim 1, wherein the first base region, the second base region and the connecting region comprises a flex circuit.

3. The system of claim 1, wherein the connecting region comprises a cable.

4. The system of claim 1, wherein the connecting region comprises a flex circuit.

5. The system of claim 1, wherein the disposable electrode portion comprises a second connector on the first base region that is in electrical connection with the second electrode.

6. The system of claim 5, wherein the second connector comprises a snap connector extending proud from a back side of the first base region.

7. The system of claim 1, wherein the first connector on the first base region comprises a snap connector extending proud of the first base region.

8. The system of claim 1, wherein the first and second electrodes are configured to adhesively attach to the subject.

9. The system of claim 1, wherein the first base is configured to adhesively attach to the first outer surface.

10. The system of claim 1, wherein the maximum diameter of the housing is less than about 10 cm.

11. A lightweight and wearable transdermal electrical stimulation system for inducing a cognitive effect in a subject, the system comprising:

a disposable electrode portion, the disposable electrode portion including;

a first electrode on a front side of a first base region,

a second electrode on a front side of a second base region,

a connecting region extending between the first and second electrodes, wherein the connecting region is between 3 and 12 inches long, and

a first connector comprising a snap connector extending proud from a back side of the first base region, wherein the first connector is in electrical communication with the first electrode; and

a second connector on the first base region that is in electrical connection with the second electrode; and

a durable, low-profile primary unit having a maximum thickness of 30 mm, the primary unit including;

a housing having a first outer surface that is curved inward to conform to the subject'"'"'s head,

a first receiver at the first outer surface, the first receiver configured to electrically and mechanically connect to the first connector,

a second receiver at the first outer surface, the first receiver configured to electrically and mechanically connect to the second connector, and

a controller within the housing, the controller including a current source configured to provide a current at a frequency of greater than 640 Hz between the first and second receivers,

wherein the first base region is configured to releasably connect to the first outer surface so that the first connector connects to the first receiver and the second connector connects to the second receiver, wherein the primary unit will be worn on a first position on the subject'"'"'s head when the first electrode is attached to the subject'"'"'s head at the first position, and wherein the second electrode is configured to attach to a second position on the subject'"'"'s head or neck.

12. The system of claim 11, wherein the first base region, the second base region and the connecting region comprises a flex circuit.

13. The system of claim 11, wherein the connecting region comprises a cable.

14. The system of claim 11, wherein the connecting region comprises a flex circuit.

15. The system of claim 11, wherein the second connector comprises a snap connector extending proud from a back side of the first base region.

16. The system of claim 11, wherein the first connector on the first base region comprises a snap connector extending proud of the first base region.

17. The system of claim 11, wherein the first and second electrodes are configured to adhesively attach to the subject.

18. The system of claim 11, wherein the first base is configured to adhesively attach to the first outer surface.

19. The system of claim 11, wherein the maximum diameter of the housing is less than about 10 cm.

20. A lightweight and wearable transdermal electrical stimulation system for inducing a cognitive effect in a subject, the system comprising:

a disposable electrode portion, the disposable electrode portion including;

a first electrode on a front side of a first base region,

an adhesive configured to secure the first electrode to a subject'"'"'s head,

a second electrode on a front side of a second base region,

an adhesive configured to secure the second electrode to a subject'"'"'s head or neck,

a flexible connecting base region extending between 3 and 12 inches between the first and second electrodes, further wherein the first base region, second base region and connecting base region all comprise regions of a substrate, and

a first connector comprising a snap connector extending proud from a back side of the first base region, wherein the first connector is in electrical communication with the first electrode; and

a second connector comprising a snap connector extending proud from the back side of the first base region, wherein the second connector is in electrical connection with the second electrode through an electrical connection on the connecting base region; and

a durable, low-profile primary unit having a maximum thickness of 30 mm and a weight of less than 5 ounces, the primary unit including;

a housing having a first outer surface that is curved inward to conform to the subject'"'"'s head,

a first receiver at the first outer surface, the first receiver configured to electrically and mechanically connect to the first connector,

a second receiver at the first outer surface, the first receiver configured to electrically and mechanically connect to the second connector,

a power supply within the housing, and

a controller within the housing, the controller including a current source configured to provide a current at a frequency of greater than 640 Hz between the first and second receivers,

wherein the first base region is configured to releasably connect to the first outer surface so that the first connector connects to the first receiver and the second connector connects to the second receiver, wherein the primary unit will be worn on a first position on the subject'"'"'s head when the first electrode is attached to the subject'"'"'s head at the first position, and wherein the second electrode is configured to attach to a second position on the subject'"'"'s head or neck.