Methods of manufacturing devices for the neurorehabilitation of a patient

• US 9,415,209 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: Fisk, Justin, Guarraia, Mark, Petrie, Aidan, Gordon, Joseph M., David-Hegerich, Faith, Siwinski, Shane, Muratori, Adam, Wallace, Jeffrey M.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/559,080
• Publication Number:
  US 20160158535A1
• 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 (i) a non-planar exterior top surface and (ii) an interpenetrating network of ribs disposed within the housing, at least some of the ribs aligned parallel to a longitudinal axis of the elongate housing and at least some of the ribs aligned perpendicular to a longitudinal axis of the elongated housing the interpenetrating network of ribs forming pockets in a posterior region of the elongated housing and 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.

2. The mouthpiece of claim 1 further comprising ribs aligned parallel to a longitudinal axis of the elongated housing.

3. The mouthpiece of claim 1 further comprising ribs aligned perpendicular to a longitudinal axis of the elongated housing.

4. The mouthpiece of claim 1 further comprising ribs aligned parallel to a longitudinal axis of the elongated housing and ribs aligned perpendicular to a longitudinal axis of the elongated housing.

5. The mouthpiece of claim 1 further comprising integrated circuits located in the pockets.

6. The mouthpiece of claim 2 wherein the ribs have a rectangular cross section.

7. The mouthpiece of claim 2 wherein the ribs are comprised of arches.

8. The mouthpiece of claim 1 further comprising one or more columns extending away from an interior surface of the elongated housing, the one or more columns configured to contact the mounted printed circuit board.

9. The mouthpiece of claim 1 wherein the structural elements can withstand a force of 700 Newtons without causing plastic deformation of the mouthpiece.

10. The mouthpiece of claim 1 further comprising a rectangular sheet embedded on an interior surface of the elongated housing and located in a posterior region of the elongated housing, the rectangular sheet connecting the interpenetrating network of ribs.

11. The mouthpiece of claim 2 further comprising a curvilinear sheet embedded on an interior surface of the elongated housing and located in a region connecting the anterior region and the posterior region of the elongated housing, the curvilinear sheet connecting the ribs aligned parallel to a longitudinal axis of the elongated housing.

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 (i) a non-planar exterior top surface and (ii) an interpenetrating network of ribs disposed within the housing, at least some of the ribs aligned parallel to a longitudinal axis of the elongate housing and at least some of the ribs aligned perpendicular to a longitudinal axis of the elongated housing, the interpenetrating network of ribs forming pockets in a posterior region of the elongated housing and elastically responding to biting forces generated by the patient; 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.

13. The mouthpiece of claim 12 further comprising ribs aligned parallel to a longitudinal axis of the elongated housing.

14. The mouthpiece of claim 12 further comprising ribs aligned perpendicular to a longitudinal axis of the elongated housing.

15. The mouthpiece of claim 12 further comprising ribs aligned parallel to a longitudinal axis of the elongated housing and ribs aligned perpendicular to a longitudinal axis of the elongated housing.

16. The mouthpiece of claim 12 further comprising integrated circuits located in the pockets.

17. The mouthpiece of claim 13 wherein the ribs have a rectangular cross section.

18. The mouthpiece of claim 13 wherein the ribs are comprised of arches.

19. The mouthpiece of claim 12 further comprising one or more columns extending away from an interior surface of the elongated housing, the one or more columns configured to contact the mounted printed circuit board.

20. The mouthpiece of claim 12 wherein the structural elements can withstand a force of 700 Newtons without causing plastic deformation of the mouthpiece.