IP Library Granted Patent US 11,197,994
Granted Patent B2
US 11,197,994 · App. 16/384,016 · Granted Dec 14, 2021

Systems for providing non-invasive neurorehabilitation of a patient

Inventors: Mark Guarraia (Cranston, RI); Adam Muratori (Greenville, RI); Justin Fisk (Providence, RI); Aidan Petrie (Jamestown, RI); Jeffrey M. Wallace (Saunderstown, RI); Daniel P. Smith (Portsmouth, RI)
Assignee: Helius Medical, Inc
A61N1/0548A61N1/0456A61N1/0476A61N1/0529A61N1/36025A61N1/36031A61N1/36034A61N1/0484
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Quick Facts
Patent No.
US 11,197,994
App. No.
16/384,016
Granted
Dec 14, 2021
Kind
B2
Abstract

A system for providing non-invasive neuromodulation to a patient includes a mouthpiece and a controller. The mouthpiece includes an elongated housing, a printed circuit board, and control circuitry mounted within the elongated housing. The controller includes an elongated u-shaped element, an electronic receptacle, and a microcontroller. A method for providing non-invasive neurorehabilitation of a patient including connecting a mouthpiece to a controller, transmitting a numeric sequence to the mouthpiece, generating a first hash code, transmitting the first hash code to the controller, generating a second hash code, comparing the second hash code with the first hash code, enabling electrical communication between the mouthpiece and the controller only if the first hash code matches the second hash code, contacting the mouthpiece with the patient's intraoral cavity, and delivering neurostimulation to the patient's intraoral cavity.

Claims (29)

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

a mouthpiece comprising:

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

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;

control circuitry mounted within the elongated housing for communicating wirelessly and controlling electrical signals delivered to the electrodes; and

a controller comprising:

an elongated u-shaped element having first and second arms that separate an anterior portion from a posterior portion, the anterior portion of the elongated u-shaped element located at a first distance from a central portion of one of the arms and having a first mass, and the posterior portion of the elongated u-shaped element located at a second distance from a central portion of the other of the arms and having a second mass, the product of the first mass and the first distance being larger than the product of the second mass and the second distance;

an electronic receptacle located at the anterior portion of the u-shaped element;

a microcontroller located within the elongated u-shaped element, the microcontroller configured to exchange electrical signals with the mouthpiece via a wireless connection, the electrical signals comprising information used to determine an amplitude and duration of electrostimulation energy pulses delivered to the patient's tongue; and

at least one of (i) an accelerometer for measuring an activity level of the patient, (ii) a data logger for logging information related to the activity level of the patient, (iii) tongue sense circuitry for determining if a patient's tongue is in contact with the plurality of electrodes located on the bottom portion of the mouthpiece, (iv) a clock for determining a total time of usage of the mouthpiece, or (v) an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

2. The system of claim 1 wherein the length of the elongated-u-shaped element is approximately 200 mm.

3. The system of claim 1 wherein the width of the elongated-u-shaped element is approximately 120 mm.

4. The system of claim 1 wherein the anterior portion includes a first portion having a first width of approximately 35 mm and a second portion having a second width of approximately 35 mm, the first portion being attached to the first arm, and the second portion being attached to the second arm.

5. The system of claim 1 wherein the first mass is greater than the second mass.

6. The system of claim 1 wherein the first mass is smaller than the second mass.

7. The system of claim 1 wherein the central portions of the arms are configured to contact a patient's shoulders, and the first and second distances cause the controller to substantially conform to the patient's shoulders.

8. The system of claim 1 wherein the arms have a radius of curvature in the range of 20-30 cm in a sagittal plane of the patient to cause the controller to substantially conform to a patient's shoulders.

9. The system of claim 1 wherein the width of the elongated u-shaped element is between 60% and 80% of the length of the elongated u-shaped element.

10. The system of claim 1 wherein the width of the elongated u-shaped element is approximately 60% of the length of the elongated u-shaped element.

11. The system of claim 1 wherein an interior contour of the posterior portion has a radius of curvature in the range of 20-60 mm in a transverse plane of the patient.

12. The system of claim 1 wherein an interior contour of the posterior portion has a radius of curvature of approximately 40 mm in a transverse plane of the patient.

13. The system of claim 1 wherein an exterior contour of the posterior portion has a radius of curvature in the range of 10-40 mm in a transverse plane of the patient.

14. The system of claim 1 wherein an exterior contour of the posterior portion has a radius of curvature of approximately 25 mm in a transverse plane of the patient.

15. The system of claim 1 wherein a contour of the first and second arms has a radius of curvature in the range of 330-430 mm in a transverse plane of the patient.

16. The system of claim 1 wherein a contour of the first and second arms has a radius of curvature of approximately 380 mm in a transverse plane of the patient.

17. The system of claim 1 wherein the anterior portion includes an opening having a width in the range of 30-60 mm.

18. The system of claim 1 wherein the anterior portion includes an opening having a width of approximately 45 mm.

19. The system of claim 1 further comprising a battery for providing a current to the mouthpiece.

20. The system of claim 19 further comprising an optical indicator that indicates a power level of the battery.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2026
From: HELIUS MEDICAL, INC
To: BIONESS MEDICAL, INC.
Reel/Frame 075701/0640 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 12, 2019
From: GUARRAIA, MARK; MURATORI, ADAM; FISK, JUSTIN; PETRIE, AIDAN; WALLACE, JEFFREY M.; SMITH, DANIEL P.
To: NEUROHABILITATION CORPORATION
Reel/Frame 050022/0087 →
CHANGE OF NAME Recorded Aug 12, 2019
From: NEUROHABILITATION CORPORATION
To: HELIUS MEDICAL, INC
Reel/Frame 050022/0157 →
Continuity (4)
Continuation 15484077 · Apr 10, 2017
Continuation 14727100 · Jun 1, 2015
Continuation 14558768 · Dec 3, 2014
Related Publication 20190240480A1 · Aug 8, 2019