Systems and methods for providing non-invasive neurorehabilitation of a patient

• US 9,789,306 B2
• Filed: 12/03/2014
• Issued: 10/17/2017
• 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: Sabourin, Richard W., Wallace, Jeffrey M., Fearis, Paul, Muratori, Adam
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/558,784
• Publication Number:
  US 20160158563A1
• Time in Patent Office: 1,049 Days
• Field of Search: 607 60, 600301
• 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 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

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, control circuitry mounted within the elongated housing, and a cable for connecting to a controller. 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

1. A method for providing non-invasive neurorehabilitation of a patient, the method comprising:

connecting a mouthpiece to a controller;

transmitting a numeric sequence generated by a first processor within the controller to the mouthpiece;

generating a first hash code by a second processor within the mouthpiece, the first hash code based on the received numeric sequence and a secret key stored in memory within the mouthpiece, wherein the secret key is shared between the mouthpiece and the controller;

transmitting the first hash code from the mouthpiece to the controller;

generating a second hash code by the first processor within the controller, the second hash code based on a random number and the secret key;

comparing, by the first processor, the first hash code with the second 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, the neurostimulation being delivered by the controller via the mouthpiece.

2. The method of claim 1 further comprising connecting the mouthpiece to the controller via a cable.

3. The method of claim 1 further comprising providing power to the controller.

4. The method of claim 1 further comprising delivering electrical neurostimulation via an electrode array to the patient'"'"'s intraoral cavity.

5. A method for providing non-invasive neurorehabilitation of a patient via a controller and a mouthpiece, the method comprising:

connecting the mouthpiece to the controller;

generating a first hash code based on a unique serial number and a secret key shared between the mouthpiece and the controller;

storing the unique serial number and the first hash code in memory located in the mouthpiece;

transmitting the first hash code and the unique serial number from the mouthpiece to the controller;

generating a second hash code in a first processor in the controller, the second hash code based on the unique serial number and the secret key;

permitting 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, the neurostimulation being delivered by the controller via the mouthpiece.

6. The method of claim 5 further comprising connecting the mouthpiece to the controller via a cable.

7. The method of claim 5 further comprising providing power to the controller.

8. The method of claim 5 further comprising delivering electrical neurostimulation via an electrode array to the patient'"'"'s intraoral cavity.

9. The method of claim 5 wherein the first hash code is an SHA-256 hash code.

10. A mouthpiece for providing neurorehabilitation to a patient, the mouthpiece receiving electrical neurostimulation signals from a controller and selectively delivering the received electrical neurostimulation signals to the 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 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 intraoral cavity;

control circuitry mounted within a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a memory mounted within a top portion of the elongated housing;

and a processor mounted within the top portion of the elongated housing, the processor configured to (i) receive a numeric sequence from the controller, (ii) generate a first hash code based on the received numeric sequence and a secret key stored in the memory, wherein the secret key is shared between the mouthpiece and the controller, (iii) transmit the first hash code to the controller, and (iv) receive communications from the controller only if a second hash code based on the numeric sequence and the shared secret key generated at the controller matches the first hash code.

11. A mouthpiece for providing neurorehabilitation to a patient, the mouthpiece receiving electrical neurostimulation signals from a controller and selectively delivering the received electrical neurostimulation signals to the 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 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 intraoral cavity;

control circuitry mounted within a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a memory mounted within the top portion of the elongated housing;

and a processor mounted within the top portion of the elongated housing, the processor configured to (i) store a first hash code and a unique serial number, the first hash code based on the unique serial number and a shared secret key shared between the mouthpiece and the controller, (ii) transmit the first hash code and the unique serial number to the controller, and, (iii) receive communications from the controller only if a second hash code based on the unique serial number and the shared secret key generated at the controller matches the first hash code.

12. The mouthpiece of claim 11 wherein the first hash code is an SHA-256 hash code.