Devices for delivering non-invasive neuromodulation to a patient

• US 9,993,640 B2
• Filed: 12/03/2014
• Issued: 06/12/2018
• 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: Guarraia, Mark, Petrie, Aidan, Fisk, Justin, Muratori, Adam, Wallace, Jeffrey M., Morang, Jeffrey C.
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): Edwards, Philip C
• Application Number:
  US14/559,045
• Publication Number:
  US 20160158534A1
• Time in Patent Office: 1,287 Days
• Field of Search: 607134
• 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

Abstract

A mouthpiece for providing non-invasive neuromodulation to a patient. The mouthpiece includes an elongated housing having a center of gravity located within a posterior region, a positioning pad attached 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, 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. In some embodiments, the mouthpiece includes at least one locator disposed along the anterior region of the elongated housing for contacting a patient'"'"'s teeth to securely position the mouthpiece within the patient'"'"'s mouth.

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 positioning pad, having an anterior and a posterior region, the positioning pad attached 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;

a first locator traversing a width of a transition region connecting a plateau of the anterior region of the elongated housing to a plateau of the posterior region of the elongated housing, the first locator integral with the top surface, the first locator contacting a patient'"'"'s upper teeth to securely position the mouthpiece within the patient'"'"'s mouth; 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 wherein the first locator comprises an inverted trench, a trench, or a step.

3. The mouthpiece of claim 1 further comprising a second locator traversing an anterior region of the printed circuit board, the second locator mechanically coupling to a patient'"'"'s lower teeth to secure a position of the mouthpiece within the patient'"'"'s mouth.

4. The mouthpiece of claim 3 wherein the second locator comprises an inverted trench, a trench, a contour or a step.

5. The mouthpiece of claim 1 wherein the elongated housing comprises a plastic material having a hardness of shore 90A.

6. The mouthpiece of claim 1 wherein the positioning pad comprises a biocompatible material having a hardness of shore 30A.

7. The mouthpiece of claim 1 wherein the first locator prevents the posterior region of the elongated housing, the posterior region of the positioning pad, and the posterior region of the printed circuit board from contacting the patient'"'"'s tonsils, throat, and circumvallate papillae.

8. The mouthpiece of claim 1 wherein the patient'"'"'s upper teeth and lower teeth comprise at least one of a patient'"'"'s central incisors, lateral incisors, or canines.

9. 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 positioning pad attached to the top surface of the elongated housing for minimizing contact between a patient'"'"'s upper teeth and the non-planar exterior top surface of the elongated housing;

a first locator traversing a width of a transition region connecting a plateau of an anterior region of the positioning pad to a plateau of a posterior region of the positioning pad, the first locator integral with a top surface of the positioning pad and engaging the patient'"'"'s upper teeth to securely position the mouthpiece within the patient'"'"'s mouth; 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.

10. The mouthpiece of claim 9 wherein the first locator comprises an inverted trench, a trench, a contour or a step.

11. The mouthpiece of claim 9 wherein the first locator has a U-shaped cross section, a V-shaped cross section, or a cross section shaped like an inverted step.

12. The mouthpiece of claim 9 further comprising a second locator traversing an anterior region of the printed circuit board, the second locator mechanically coupling to a patient'"'"'s lower teeth to secure a position of the mouthpiece within the patient'"'"'s mouth.

13. The mouthpiece of claim 9 wherein the second locator comprises a trench, an inverted trench, a contour or a step.

14. The mouthpiece of claim 9 wherein the elongated housing comprises a plastic material having a hardness of shore 90A.

15. The mouthpiece of claim 9 wherein the positioning pad comprises a biocompatible material having a hardness of shore 30A.

16. The mouthpiece of claim 9 wherein the locator prevents the posterior region of the elongated housing, the posterior region of the positioning pad, and the posterior region of the printed circuit board from contacting the patient'"'"'s tonsils, throat, and circumvallate papillae.

17. The mouthpiece of claim 9 wherein the patient'"'"'s upper teeth and lower teeth comprise at least one of a patient'"'"'s central incisors, lateral incisors, or canines.

18. 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 positioning pad attached to the top surface of the elongated housing for minimizing contact between a patient'"'"'s upper teeth and the non-planar exterior top surface of the elongated housing;

a first locator traversing a width of a transition region connecting a plateau of an anterior region of the mouthpiece to a plateau of a posterior region of the mouthpiece, the first locator defining a position of the mouthpiece within the patient'"'"'s mouth; 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.