Systems for providing non-invasive neurorehabilitation of a patient

• US 9,072,889 B1
• Filed: 12/03/2014
• Issued: 07/07/2015
• 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, Fisk, Justin, Petrie, Aidan, Wallace, Jeffrey M., Muratori, Adam
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/558,768
• Time in Patent Office: 216 Days
• Field of Search: None
• 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 1/36025 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 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a cable with a first end attached to the anterior portion of the elongated housing and having a connector at a second end for connecting to a controller, the cable delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

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

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; and

an accelerometer for measuring an activity level of the patient.

2. The system of claim 1 further comprising at least one of a data logger for logging information related to the activity level of the patient, 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, a clock for determining a total time of usage of the mouthpiece, or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

3. The system of claim 1 further comprising 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.

4. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a cable with a first end attached to the anterior portion of the elongated housing and having a connector at a second end for connecting to a controller, the cable delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

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

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; and

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

5. The system of claim 4 further comprising at least one of 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, a clock for determining a total time of usage of the mouthpiece, or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

6. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a cable with a first end attached to the anterior portion of the elongated housing and having a connector at a second end for connecting to a controller, the cable delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

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

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; and

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.

7. The system of claim 6 further comprising at least one of a clock for determining a total time of usage of the mouthpiece or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

8. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a cable with a first end attached to the anterior portion of the elongated housing and having a connector at a second end for connecting to a controller, the cable delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

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

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; and

a clock for determining a total time of usage of the mouthpiece.

9. The system of claim 8 further comprising an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

10. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes;

a cable with a first end attached to the anterior portion of the elongated housing and having a connector at a second end for connecting to a controller, the cable delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

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

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; and

an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

11. 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 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 controlling electrical signals delivered to the electrodes;

a first communication module delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

a second communication module within the housing coupled to and in communication with the first communication module; and

a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals determining an amplitude and duration of electrostimulation energy pulses delivered to the patient'"'"'s tongue; and

an accelerometer for measuring an activity level of the patient.

12. The system of claim 11 further comprising at least one of a data logger for logging information related to the activity level of the patient, 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, a clock for determining a total time of usage of the mouthpiece, or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

13. The system of claim 11 further comprising a data logger for logging information related to the activity level of the patient.

14. 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 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 controlling electrical signals delivered to the electrodes;

a first communication module delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

a second communication module within the housing coupled to and in communication with the first communication module; and

a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals determining an amplitude and duration of electrostimulation energy pulses delivered to the patient'"'"'s tongue; and

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

15. The system of claim 14 further comprising at least one of 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, a clock for determining a total time of usage of the mouthpiece, or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

16. 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 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 controlling electrical signals delivered to the electrodes;

a first communication module delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

a second communication module within the housing coupled to and in communication with the first communication module; and

a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals determining an amplitude and duration of electrostimulation energy pulses delivered to the patient'"'"'s tongue; and

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.

17. The system of claim 16 further comprising at least one of a clock for determining a total time of usage of the mouthpiece or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

18. 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 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 controlling electrical signals delivered to the electrodes;

a first communication module delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

a second communication module within the housing coupled to and in communication with the first communication module; and

a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals determining an amplitude and duration of electrostimulation energy pulses delivered to the patient'"'"'s tongue; and

a clock for determining a total time of usage of the mouthpiece.

19. The system of claim 18 further comprising an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

20. 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 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 controlling electrical signals delivered to the electrodes;

a first communication module delivering electrical current to the electrodes via the control circuitry; and

a controller comprising;

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

a second communication module within the housing coupled to and in communication with the first communication module; and

a microcontroller located within the housing and configured to exchange electrical signals with the mouthpiece, the electrical signals determining an amplitude and duration of electrostimulation energy pulses delivered to the patient'"'"'s tongue; and

an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

21. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes; and

a mobile device 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; and

an accelerometer for measuring an activity level of the patient.

22. The system of claim 21 further comprising at least one of a data logger for logging information related to the activity level of the patient, 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, a clock for determining a total time of usage of the mouthpiece, or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

23. The system of claim 21 further comprising 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 and a data logger for logging information related to the activity level of the patient.

24. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes; and

a mobile device 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; and

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

25. The system of claim 24 further comprising at least one of 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, a clock for determining a total time of usage of the mouthpiece, or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

26. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes; and

a mobile device 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; and

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.

27. The system of claim 26 further comprising at least one of a clock for determining a total time of usage of the mouthpiece or an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

28. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes; and

a mobile device 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; and

a clock for determining a total time of usage of the mouthpiece.

29. The system of claim 28 further comprising an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.

30. 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 a top portion of the elongated housing for controlling electrical signals delivered to the electrodes; and

a mobile device 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; and

an audio indicator that can warn the patient when the remaining battery charge is inadequate to complete a therapy session.