Methods for attaching and wearing a neurostimulator

• US 9,333,334 B2
• Filed: 02/27/2015
• Issued: 05/10/2016
• Est. Priority Date: 05/25/2014
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync, Inc.
• Inventors: Jeffery, Douglas, Hamlin, Jay Frederick, Goldwasser, Isy, Law, Wing, Demers, Remi, Wetmore, Daniel Z., Pal, Sumon K., Charlesworth, Jonathan, Tyler, William J.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US14/634,661
• Publication Number:
  US 20150335876A1
• Time in Patent Office: 438 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0404 for external use A61N1/06 takes precedence
• 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 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition

Abstract

Methods for attaching a wearable neurostimulator to a user'"'"'s head (or head and neck) using a cantilever electrode apparatuses for neuromodulation. In practice an electrode assembly may mate with the wearable neuromodulation devices so that the device is worn over one portion of the electrode assembly while the rest of the electrode assembly attaches to another portion of the body. The neuromodulator may be worn on a portion of the electrode assembly in a cantilevered manner (e.g., held at one end while the opposite end is free-floating), which allows the rigid neuromodulation device to conform to a variety of user head sizes and shapes.

Claims

1. A method of attaching an electrical stimulator to a user'"'"'s head using an electrode apparatus formed of a flat substrate extending in a plane having a first electrode portion and a second electrode portion, a first active region on a back of the substrate in the first electrode portion, and a second active region on the back of the substrate in the second electrode portion, wherein the first and second electrode portions are connected by a connecting region of the substrate that extends in a path that is 2 inches or longer, the method comprising:

adhesively securing the first active region of the electrode apparatus to the user'"'"'s head in a first location;

bending the connecting region out of the plane;

adhesively securing the second active region of the electrode apparatus to the user'"'"'s head in a second location; and

coupling a wearable electrical stimulator to a first and second connector extending proud from the first electrode portion at a region that is off-center on a bottom of the wearable electrical stimulator so that the wearable electrical stimulator is worn on the user in the first location, allowing one end region of the electrical stimulator to be held securely while an opposite end region may move, wherein the wearable electrical stimulator is coupled either before or after adhesively securing the first active region of the electrode apparatus to the user'"'"'s head.

2. The method of claim 1, wherein adhesively securing the first active region comprises adhesively securing the first active region to the user'"'"'s temple.

3. The method of claim 1, wherein adhesively securing the second active region comprises adhesively securing the second active region to the user'"'"'s neck or to the skin behind the user'"'"'s ear.

4. The method of claim 1, wherein coupling the wearable electrical stimulator comprises securing the wearable electrical stimulator to the first electrode portion in a cantilevered attachment.

5. The method of claim 1, wherein coupling the wearable electrical stimulator to the first and second connector extending proud from the first electrode portion comprises snapping the wearable electrical stimulator onto the first and second connectors wherein the first and second connectors are separated from each other by between about 0.7 and 0.8 inches.

6. The method of claim 1, wherein coupling the wearable electrical stimulator to the first and second connector comprises snapping the wearable electrical stimulator onto the first and second connectors.

7. The method of claim 1, wherein adhesively securing the first active region comprises attaching a hydrogel on the first active region against the user'"'"'s head in the first location.

8. The method of claim 1, wherein coupling the wearable electrical stimulator comprises connecting an underside of the wearable electrical stimulator to the first and second connectors to make an electrical contact with the wearable electrical stimulator and the first and second active regions.

9. A method of attaching an electrical stimulator to a user'"'"'s head using an electrode apparatus formed of a flat substrate extending in a plane having a first electrode portion and a second electrode portion, a first active region on a back of the substrate in the first electrode portion, and a second active region on the back of the substrate in the second electrode portion, wherein the first and second electrode portions are spaced apart and connected by a connecting region of the substrate that extends in a path that is 2 inches or longer, the method comprising:

adhesively securing the first active region of the electrode apparatus to the user'"'"'s head in a first location;

bending the connecting region out of the plane;

adhesively securing the second active region of the electrode apparatus to the user'"'"'s head in a second location; and

coupling a back surface of a wearable electrical stimulator to a first connector and to a second connector that both extend proud from the first electrode portion, so that the wearable electrical stimulator cantilevers from the first electrode portion and is secured to the first electrode portion at a first back surface region of the wearable electrical device while a second back surface region of the wearable electrical device is not secured and is free to move relative to the first electrode portion, wherein the wearable electrical stimulator is coupled either before or after adhesively securing the first active region of the electrode apparatus to the user'"'"'s head.

10. The method of claim 9, wherein adhesively securing the first active region comprises adhesively securing the first active region to the user'"'"'s temple.

11. The method of claim 9, wherein adhesively securing the second active region comprises adhesively securing the second active region to the user'"'"'s neck or to the skin behind the user'"'"'s ear.

12. The method of claim 9, wherein coupling the back surface of the wearable electrical stimulator to the first and second connector comprises snapping the wearable electrical stimulator onto the first and second connectors, wherein the first and second connectors are separated from each other by between about 0.7 and 0.8 inches.

13. The method of claim 9, wherein coupling the back surface of the wearable electrical stimulator to the first and second connector comprises snapping the wearable electrical stimulator onto the first and second connectors.

14. The method of claim 9, wherein coupling the back surface of the wearable electrical stimulator further comprises making electrical contact between the wearable electrical stimulator and the first and second active regions through the first and second connectors.

15. The method of claim 9, further comprising applying electrical stimulation from the wearable electrical stimulator between the first active region and the second active region.

16. A method of attaching an electrical stimulator to a user'"'"'s head using an electrode apparatus formed of a flat substrate extending in a plane having a first electrode portion and a second electrode portion, a first active region on a back of the substrate in the first electrode portion, and a second active region on the back of the substrate in the second electrode portion, wherein the first and second electrode portions are connected by a connecting region of the substrate that extends in a path that is 2 inches or longer, the method comprising:

adhesively securing the first active region of the electrode apparatus to the user'"'"'s head in a first location;

bending the connecting region out of the plane;

adhesively securing the second active region of the electrode apparatus to the user'"'"'s head in a second location; and

coupling a wearable electrical stimulator to an electrical and mechanical connector extending proud from the first electrode portion so that the wearable electrical stimulator cantilevers from the first electrode portion and is secured to the first electrode portion at a first back surface region of the wearable electrical device while a second back surface region of the wearable electrical device is not secured and is free to move relative to the first electrode portion, wherein the wearable electrical stimulator is coupled either before or after adhesively securing the first active region of the electrode apparatus to the user'"'"'s head.

17. The method of claim 16, wherein adhesively securing the first active region comprises adhesively securing the first active region to the user'"'"'s temple.

18. The method of claim 16, wherein adhesively securing the second active region comprises adhesively securing the second active region to the user'"'"'s neck or to the skin behind the user'"'"'s ear.

19. The method of claim 16, wherein coupling the wearable electrical stimulator to the electrical and mechanical connector comprises snapping the wearable electrical stimulator onto the mechanical and electrical connector.