Systems for providing non-invasive neurorehabilitation of a patient

• US 9,616,222 B2
• Filed: 06/01/2015
• Issued: 04/11/2017
• 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: Guarraia, Mark, Muratori, Adam, Fisk, Justin, Petrie, Aidan, Wallace, Jeffrey M., Smith, Daniel P.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/727,100
• Publication Number:
  US 20160158538A1
• Time in Patent Office: 680 Days
• Field of Search: None
• 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 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 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

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 width of the elongated-u-shaped element corresponds to approximately the 60^th percentile of adult male neck widths.

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

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

5. 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.

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

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

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

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

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

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

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

22. 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 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;

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

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

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.

23. The system of claim 22 further comprising a battery for providing a current to the mouthpiece.

24. The system of claim 23 further comprising an optical indicator that indicates a power level of the battery.

25. The system of claim 22 wherein the width of the elongated-u-shaped element corresponds to approximately the 60^th percentile of adult male neck widths.

26. The system of claim 22 wherein the length of the elongated-u-shaped element is approximately 200 mm.

27. The system of claim 22 wherein the width of the elongated-u-shaped element is approximately 120 mm.

28. The system of claim 22 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.

29. The system of claim 22 wherein the first mass is greater than the second mass.

30. The system of claim 22 wherein the first mass is smaller than the second mass.

31. The system of claim 22 wherein the first and second distances are determined based on the location of the arms configured to contact a patient'"'"'s shoulders.

32. The system of claim 22 wherein the first and second distances are determined based on a portion of the arms configured to contact a patient'"'"'s shoulders.

33. The system of claim 22 wherein the arms have a radius of curvature of in the range of 20 to 30 cm in a sagittal plane of the patient to cause the controller to substantially conform to a patient'"'"'s shoulders.

34. The system of claim 22 wherein the width of the elongated u-shaped element is between 60% and 80% of the length of the elongated u-shaped element.

35. The system of claim 22 wherein the width of the elongated u-shaped element is approximately 60% of the length of the elongated u-shaped element.

36. The system of claim 22 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.

37. The system of claim 22 wherein an interior contour of the posterior portion has a radius of curvature of approximately 40 mm in a transverse plane of the patient.

38. The system of claim 22 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.

39. The system of claim 22 wherein an exterior contour of the posterior portion has a radius of curvature of approximately 25 mm in a transverse plane of the patient.

40. The system of claim 22 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.

41. The system of claim 22 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.

42. The system of claim 22 wherein the anterior portion includes an opening having a width in the range of 30-60 mm.

43. The system of claim 22 wherein the anterior portion includes an opening having a width of approximately 45 mm.