Methods of manufacturing devices for the neurorehabilitation of a patient

• US 9,415,210 B2
• Filed: 12/03/2014
• Issued: 08/16/2016
• Est. Priority Date: 12/03/2014
• Status: Active Grant

• Current Assignee: Helius Medical, Inc. (Helius Medical Technologies, Inc.)
• Original Assignee: Neurohabilitation Corporation (Helius Medical Technologies, Inc.)
• Inventors: Fearis, Paul, Fisk, Justin, Muratori, Adam, Siwinski, Shane, Gordon, Joseph M.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/559,105
• Publication Number:
  US 20160158536A1
• Time in Patent Office: 622 Days
• Field of Search: 607/134
• 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 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0548 Oral electrodes
• 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
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke

Abstract

A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece including an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar exterior top surface and internal structural members disposed within the housing, the internal structural members elastically responding to biting forces generated by the patient, a spacer attached to the top surface of the housing for limiting contact between a patient'"'"'s upper teeth and the exterior top surface of the elongated housing, and a printed circuit board mounted to a bottom portion of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient'"'"'s tongue.

Claims

1. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar exterior top surface;

a spacer attached to the top surface of the housing for minimizing contact between a patient'"'"'s upper teeth and the exterior top surface of the elongated housing;

a first printed circuit board mounted to a bottom portion of the elongated housing, the first printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient'"'"'s tongue;

a rim extending from a bottom portion of the elongated housing, the rim being concentric with a perimeter of the first printed circuit board and surrounding the perimeter of the first printed circuit board and having a u-shaped cross section; and

a first well shaped to accommodate an adhesive, the adhesive bonding the first printed circuit board to the elongate housing.

2. The mouthpiece of claim 1 wherein a portion of the rim rests below the first printed circuit board and is configured to prevent a patient'"'"'s teeth from contacting the printed circuit board.

3. The mouthpiece of claim 1 wherein the first printed circuit board is non-planar and the plurality of electrodes are located on a non-planar surface of the first printed circuit board.

4. The mouthpiece of claim 1 wherein the first printed circuit board has a curved shape and the plurality of electrodes are located on a curved surface of the first printed circuit board.

5. The mouthpiece of claim 1 wherein the plurality of electrodes has a first density at an anterior region of the first printed circuit board and a second density at a posterior region of the first printed circuit board, wherein the first density is greater than the second density.

6. The mouthpiece of claim 1 further comprising a second printed circuit board mounted above the first printed circuit board.

7. The mouthpiece of claim 1 wherein the rim is an integral part of the elongated housing.

8. The mouthpiece of claim 1 wherein the rim is dimensioned to define the first well between the bottom portion of the elongated housing and the perimeter of the first printed circuit board.

9. The mouthpiece of claim 1 wherein the rim covers a bottom portion of the first printed circuit board along the perimeter thereof.

10. The mouthpiece of claim 1 wherein the rim covers a side portion of the first printed circuit board along the perimeter thereof.

11. The mouthpiece of claim 1 wherein the rim covers a bottom portion and a side portion of the first printed circuit board along the perimeter thereof.

13. The mouthpiece of claim 1 wherein a portion of the rim rests below the first printed circuit board and prevents a patient'"'"'s teeth from contacting the first printed circuit board.

14. The mouthpiece of claim 1 wherein the first printed circuit board is non-planar and the plurality of electrodes are located on a non-planar surface of the first printed circuit board.

15. The mouthpiece of claim 1 wherein the first printed circuit board has a curved shape and the plurality of electrodes are located on a curved surface of the first printed circuit board.

16. The mouthpiece of claim 1 wherein the plurality of electrodes has a first density at an anterior region of the first printed circuit board and a second density at a posterior region of the first printed circuit board, wherein the first density is greater than the second density.

17. The mouthpiece of claim 1 further comprising a second printed circuit board mounted above the first printed circuit board.

18. The mouthpiece of claim 1 wherein the rim is an integral part of the elongated housing.

19. The mouthpiece of claim 1 wherein the rim is dimensioned to define the first well between the bottom portion of the elongated housing and the perimeter of the first printed circuit board.

20. The mouthpiece of claim 1 wherein the rim is concentric with the perimeter of the first printed circuit board.

21. The mouthpiece of claim 1 wherein the rim covers a bottom portion of the first printed circuit board along the perimeter thereof.

22. The mouthpiece of claim 1 wherein the rim covers a side portion of the first printed circuit board along the perimeter thereof.

23. The mouthpiece of claim 1 wherein the rim covers a bottom portion and a side portion of the first printed circuit board along the perimeter thereof.

24. The mouthpiece of claim 1 further comprising a second well configured to accommodate adhesive that overflows from the first well.

12. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar exterior top surface;

a spacer attached to the top surface of the housing for minimizing contact between a patient'"'"'s upper teeth and the exterior top surface of the elongated housing;

a first printed circuit board mounted to a bottom portion of the elongated housing, the first printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient'"'"'s tongue;

a rim extending from a bottom portion of the elongated housing, the rim being concentric with a perimeter of the first printed circuit board and surrounding the perimeter of the first printed circuit board; and

a beveled well configured to accommodate an adhesive, the adhesive bonding at least two orthogonal surfaces of the first printed circuit board to the elongated housing.