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

• US 9,981,127 B2
• Filed: 12/03/2014
• Issued: 05/29/2018
• 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, Muratori, Adam, Fisk, Justin, Petrie, Aidan, Wallace, Jeffrey M., Morang, Jeffrey C.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US14/558,775
• Publication Number:
  US 20160158544A1
• Time in Patent Office: 1,273 Days
• Field of Search: 607 47, 607 63
• 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 1/0551 Spinal or peripheral nerve 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
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

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 controller for delivering electrical control signals to a mouthpiece during a non-invasive neuromodulation therapy session, the controller comprising:

an elongated u-shaped element configured to rest upon a patient'"'"'s shoulders;

an electronic receptacle located at a terminus of the three-dimensional u-shaped element for connecting to a cable, the cable providing an electrical connection from the controller to a plurality of electrodes located on the mouthpiece; and

a microcontroller located within the three-dimensional u-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining an amplitude and duration of electrical signals delivered to the patient'"'"'s tongue via the plurality of electrodes, wherein an amplitude of the electrical signals delivered to a posterior portion of the tongue is larger than an amplitude of the electrical signals delivered to an anterior portion of the tongue.

2. The controller of claim 1 further comprising:

an accelerometer for measuring an activity level of the patient; and

a data logger for logging information related to the activity level of the patient.

3. The controller of claim 1 further comprising an audio alarm for indicating at least one of the end of a therapy session, a low electrical signal delivered to the patient'"'"'s tongue, activation/deactivation of the controller, or pausing of the electrical signals delivered to the patient'"'"'s tongue.

4. The controller of claim 1 further comprising:

a power switch for activating and deactivating the controller; and

one or more intensity buttons for controlling the intensity of electrical signals delivered to the mouthpiece by the controller.

5. The controller of claim 1 further comprising a display for presenting information and receiving input from the patient.

6. The controller of claim 1 further comprising a battery for providing a current to the mouthpiece.

7. The controller of claim 1 further comprising a motor for causing the u-shaped element to vibrate.

8. The controller of claim 1 further comprising:

at least one printed circuit board for mounting electrical isolation circuitry, battery management circuitry, and a microcontroller;

at least one printed circuit board for mounting a play button, a pause button, and the electronic receptacle; and

at least one circuit board for mounting one or more intensity buttons.

9. The controller of claim 1 further comprising circuitry for sensing a current delivered to a patient'"'"'s tongue via the mouthpiece.

10. The controller of claim 1 wherein the cable forms an integral portion of the mouthpiece.

11. A controller for delivering electrical control signals to a mouthpiece during a non-invasive neuromodulation therapy session, the controller comprising:

a coextensively dimensioned element configured to rest in proximity to a patient'"'"'s face;

a receptacle located at a central portion of a first surface of the coextensively dimensioned element, the receptacle providing an electrical and mechanical connection to the mouthpiece;

a display located on a second surface of the coextensively dimensioned element, the display providing visual indications to the patient;

a cable providing an electrical connection from the controller to a plurality of electrodes located on the mouthpiece and

a microcontroller located within the coextensively dimensioned element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining an amplitude and duration of electrical signals delivered to the patient'"'"'s tongue via the plurality of electrodes, wherein an amplitude of the electrical signals delivered to a posterior portion of the tongue is larger than an amplitude of the electrical signals delivered to an anterior portion of the tongue.

12. The controller of claim 11 further comprising:

an accelerometer for measuring an activity level of the patient; and

a data logger for logging the activity level of the patient, transmissions to or from the controller, the intensity of electrical signals delivered to the mouthpiece, and information received circuitry configured to determine if the patient'"'"'s tongue is in contact with the mouthpiece.

13. The controller of claim 11 further comprising an audio alarm for indicating at least one of the end of a therapy session, a low electrical signal delivered to the patient'"'"'s tongue, activation/deactivation of the controller, or pausing of the electrical signals delivered to the patient'"'"'s tongue.

14. The controller of claim 11 further comprising:

a power switch for activating and deactivating the controller; and

one or more intensity buttons located on a third surface of the coextensively dimensioned element, the intensity buttons controlling the intensity of electrical signals delivered to the mouthpiece by the controller.

15. The controller of claim 11 wherein the display is configured to present information received by the microcontroller to the patient and receive input from the patient.

16. The controller of claim 11 further comprising a battery for providing a current to the mouthpiece.

17. The controller of claim 11 further comprising a motor for causing the coextensively dimensioned element to vibrate.

18. The controller of claim 11 further comprising:

at least one printed circuit board for mounting electrical isolation circuitry, battery management circuitry, and a microcontroller;

at least one printed circuit board for mounting a play button and a pause button;

at least one printed circuit board for mounting the circuitry associated with the receptacle and

at least one circuit board for mounting one or more intensity buttons.

19. The controller of claim 11 further comprising circuitry for sensing a current delivered to a patient'"'"'s tongue via the mouthpiece.

20. A controller for delivering electrical control signals to a mouthpiece during a non-invasive neuromodulation therapy session, the controller comprising:

an elongated u-shaped element configured to rest upon a patient'"'"'s shoulders;

an electronic receptacle located at a terminus of the three-dimensional u-shaped element for connecting to a cable;

internal electronic drive circuitry for supplying current to a plurality of electrodes located on the mouthpiece and

a microcontroller located within the three-dimensional u-shaped element, the microcontroller configured to send electrical control signals to the mouthpiece, the electrical control signals determining an amplitude and duration of electrical signals delivered to the patient'"'"'s tongue via the plurality of electrodes, wherein an amplitude of the electrical signals delivered to a posterior portion of the tongue is larger than an amplitude of the electrical signals delivered to an anterior portion of the tongue.