Methods of manufacturing devices for the neurorehabilitation of a patient

• US 9,656,060 B2
• Filed: 12/03/2014
• Issued: 05/23/2017
• 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: Petrie, Aidan, Siwinski, Shane, Muratori, Adam, Wallace, Jeffrey M., Gordon, Joseph M., David-Hegerich, Faith, Fisk, Justin, Guarraia, Mark
• Primary Examiner(s): Phan, Thiem
• Application Number:
  US14/559,118
• Publication Number:
  US 20160158537A1
• Time in Patent Office: 902 Days
• Field of Search: 29846, 29825, 29854, 29874, 345156, 345157, 345163, 600 23, 600587, 600590
• 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: H05K 3/284 for encapsulating mounted components H05K1/185 takes precedence
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49169 Assembling electrical component directly to terminal or elongated conductor

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 method of manufacturing a mouthpiece, the mouthpiece providing non-invasive neuromodulation to a patient, the method comprising:

providing an elongated housing having internal fins located between a non-planar interior top surface and a bottom surface defined by a perimeter of the elongated housing, the internal fins forming a channel at the anterior region of the elongated housing;

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

mounting a cable in an s-shaped pattern along the channel formed by the internal fins;

mounting a printed circuit board 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; and

connecting one end of the cable to the printed circuit board.

2. The method of claim 1 further comprising forming a 90 degree bend in the cable at an exit of elongated housing.

3. The method of claim 1 further comprising threading the cable through an elastomeric element located at the exit of the elongated housing.

4. The method of claim 1 further comprising forming two consecutive s-shapes along the cable.

5. The method of claim 1 further comprising mounting a cylindrically symmetric elastomeric element to the cable, the elastomeric element surrounding a portion of the cable and having a trench in a central portion thereof and surrounded by two regions having radii that decrease in relation to a distance from the trench.

6. The method of claim 5 further comprising forming an aperture at an anterior region of the elongated housing, the aperture configured to form mechanical connection with the trench.

7. The method of claim 5 further comprising providing a cap having an elastomeric portion and a rigid portion.

8. The method of claim 7 further comprising contacting the elastomeric portion of the cap with the printed circuit board and contacting the rigid portion of the cap with the elongated housing.

9. The method of claim 8 further comprising cooperatively forming an aperture with the cap and the elongated housing, the aperture forming a mechanical connection with the trench.

10. The method of claim 1 further comprising forming a valley located in the interior surface of the elongated housing.

11. The method of claim 10 further comprising receiving a cable in the valley.

12. The method of claim 1 further comprising forming an elastomeric sleeve around the cable, the elastomeric sleeve in contact with an anterior region of the elongated housing, the elastomeric sleeve providing resistance to bending and tensile strains in the cable.

13. The method of claim 1 further comprising applying an adhesive along the perimeter of the printed circuit board, the adhesive bonding at least two orthogonal surfaces of the first printed circuit board to the elongated housing.