Transcutaneous electrical nerve stimulator with automatic detection of user sleep-wake state

• US 10,279,179 B2
• Filed: 04/15/2014
• Issued: 05/07/2019
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Gozani, Shai, Kong, Xuan, Ferree, Tom
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US14/253,628
• Publication Number:
  US 20140309709A1
• Time in Patent Office: 1,848 Days
• Field of Search: 607 47
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3603 Control systems

Abstract

Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising:

• • a housing;
  • stimulation means for electrically stimulating at least one nerve;
  • an electrode releasably mounted to the housing and connectable to the stimulation means for electrical stimulation of the at least one nerve;
  • monitoring means for monitoring the user'"'"'s body orientation and movement;
  • analysis means for analyzing said orientation and movement; and
  • control means for controlling the output of the stimulation means in response to said analysis of said orientation and movement.

Claims

1. Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising:

a housing;

stimulation means for electrically stimulating at least one nerve;

an electrode releasably mounted to the housing and connectable to the stimulation means for electrical stimulation of the at least one nerve;

monitoring means for monitoring the user'"'"'s body orientation and movement;

analysis means for analyzing said body orientation and movement monitored by the monitoring means to determine a state of the user when the body orientation of the user is recumbent; and

control means for automatically modifying the output of the stimulation means in response to the determination of the state of the user when the body orientation of the user is recumbent.

2. Apparatus according to claim 1 wherein the body orientation and movement are used to determine whether the user is in a sleep state or a wake state.

3. Apparatus according to claim 1 wherein the body orientation and movement are used to estimate the user'"'"'s activity level.

4. Apparatus according to claim 1 wherein the body orientation and movement are used to classify the user'"'"'s activity type.

5. Apparatus according to claim 1 wherein said monitoring of the user'"'"'s body orientation and movement is accomplished with at least one accelerometer.

6. Apparatus according to claim 5 wherein the axis directions of the accelerometer are known and fixed with respect to a specific anatomical location of the user when a tight mechanical coupling is established between the monitoring means and the anatomical location.

7. Apparatus according to claim 6 wherein the anatomical location is the upper calf area of the user.

8. Apparatus according to claim 6 wherein the required tight mechanical coupling between the monitoring means and the anatomical location is created when a strap holds the housing, monitoring means, and electrode at the anatomical location.

9. Apparatus according to claim 8 wherein the strap includes a tension gauge to measure tightness between the monitoring means and the anatomical location.

10. Apparatus according to claim 9 wherein the tight mechanical coupling between the monitoring means and the anatomical location is confirmed through a comparison of the tension measured by the tension gauge with a tension threshold.

11. Apparatus according to claim 8 wherein the tight mechanical coupling between the monitoring means and the anatomical location is confirmed by detecting contact of said electrode with the skin of the user.

12. Apparatus according to claim 5 wherein the analysis means maps acceleration measurements from the accelerometer to the user'"'"'s body orientation and body movement.

13. Apparatus according to claim 12 wherein the user'"'"'s body orientation is determined by analyzing the projection value of the earth gravity acceleration vector on at least one axis of the accelerometer.

14. Apparatus according to claim 13 wherein the estimated projection value of the earth gravity acceleration vector is a function of at least one projection measurement from the accelerometer over an epoch.

15. Apparatus according to claim 14 wherein the function is an average.

16. Apparatus according to claim 14 wherein the length of an epoch is one minute.

17. Apparatus according to claim 14 wherein the projection value is expressed as an angle between said accelerometer axis and the horizontal plane.

18. Apparatus according to claim 17 wherein the absolute value of the angle is compared with a threshold in order to determine the user'"'"'s body orientation as upright or recumbent.

19. Apparatus according to claim 18 wherein the user'"'"'s body orientation is considered to be recumbent if the absolute value of the angle is below the threshold.

20. Apparatus according to claim 18 wherein the angle threshold has a target value and an offset.

21. Apparatus according to claim 20 wherein the target value is 30°

.

22. Apparatus according to claim 20 wherein the target value is 45°

.

23. Apparatus according to claim 20 wherein the target value is a function of at least one real world condition.

24. Apparatus according to claim 23 wherein the at least one real world condition comprises at least one from the group consisting of an ambient light condition, the time of the day, and a recent sleep time period pattern of the user.

25. Apparatus according to claim 20 wherein the offset has a hysteresis component to eliminate rapid orientation changes to and from the recumbent position.

26. Apparatus according to claim 25 wherein the hysteresis component is 2.5 degrees.

27. Apparatus according to claim 20 wherein the offset comprises a component which is three times the standard error of the estimated mean value of the projection.

28. Apparatus according to claim 20 wherein the offset is positive if the prior user position is recumbent.

29. Apparatus according to claim 20 wherein the offset is negative if the prior user position is upright.

30. Apparatus according to claim 12 wherein the body orientation is determined according to the majority of the body orientations of at least one most recent epochs.

31. Apparatus according to claim 12 wherein the body orientation is determined according to whether the user'"'"'s body orientation remains the same for at least one most recent epoch.

32. Apparatus according to claim 1 wherein the analyzing means classifies the user state as “

in-bed”

if the body orientation is recumbent.

33. Apparatus according to claim 12 wherein the body movement measure is a function of at least one body activity level count derived from the acceleration measurements.

34. Apparatus according to claim 33 wherein the function is the median function.

35. Apparatus according to claim 33 wherein the function is the weighted average function.

36. Apparatus according to claim 33 wherein the number of body activity level counts is 20.

37. Apparatus according to claim 33 wherein each body activity level count is an average of an accelerometer signal over an epoch.

38. Apparatus according to claim 37 wherein an epoch is one minute in duration.

39. Apparatus according to claim 37 wherein the accelerometer signal comprises an instantaneous acceleration signal.

40. Apparatus according to claim 39 wherein the instantaneous acceleration signal is the square root of summation of squared values of filtered accelerometer measurements along each of its three axes.

41. Apparatus according to claim 40 wherein the accelerometer measurements are filtered by a band-pass filter.

42. Apparatus according to claim 1 wherein the analyzing means classify the user state as “

low activity”

if the user'"'"'s body movement measure is below a threshold value.

43. Apparatus according to claim 42 wherein the threshold value is 0.1 g.

44. Apparatus according to claim 1 wherein the analyzing means classify the user state as sleep if the body orientation of the user is recumbent and if the user'"'"'s body movement measure is below a threshold value.

45. Apparatus according to claim 1 wherein the control means modifies the stimulation means output when the user is determined to be “

in-bed”

or is in sleep state.

46. Apparatus according to claim 1 wherein the control means re-starts stimulation means after a timer is expired when the user is in sleep state.

47. Apparatus according to claim 46 wherein the timer defines the interval when the stimulation means is off.

48. Apparatus according to claim 47 wherein the timer duration is one hour.

49. Apparatus according to claim 47 wherein the timer duration is shortened if an increase in the user'"'"'s body movement measure is observed in multiple periods during which the stimulation means are off.

50. Apparatus according to claim 1 wherein when the body orientation of the user is recumbent, the analyzing means classifies the user state as “

in-bed”

, wherein when the user'"'"'s body movement measure is below a threshold value, the analyzing means classifies the user state as “

low activity”

, and further wherein the control means modifies the operation of the stimulation means when the “

low activity”

user state changes from on to off and the “

in-bed”

user state status is on.

51. Apparatus according to claim 50 wherein the modification to the stimulation means adjusts stimulation intensity level.

52. Apparatus according to claim 50 wherein the modification to the stimulation means adjusts stimulation pulse frequency.

53. Apparatus for transcutaneous electrical nerve stimulation in a user, said apparatus comprising:

a housing;

stimulation means within the housing for electrically stimulating nerves;

monitoring means within the housing for measuring orientation and activity levels of the user to determine a state of the user when the body orientation of the user is recumbent; and

control means for automatically modifying the electrical stimulation provided to the skin of the user in response to the determination of the state of the user when the body orientation of the user is recumbent.

54. Apparatus for providing therapeutic transcutaneous electrical nerve stimulation to a user, the apparatus comprising:

a housing;

stimulation means for electrically stimulating at least one nerve;

monitoring means for monitoring the user'"'"'s body orientation and movement;

analysis means for analyzing said body orientation and movement monitored by the monitoring means to determine whether the user is in a sleep state or a wake state; and

control means for automatically modifying the output of the stimulation means in response to the determination of the sleep-wake state of the user so that therapeutic stimulation is delivered to the user in a sleep state.

55. Apparatus according to claim 54 wherein the control means modifies the output of the stimulation means so that a first therapeutic stimulation intensity level is delivered to the at least one nerve of the user when the user is determined to be in a wake state and a second therapeutic stimulation, with an intensity level lower than the first therapeutic stimulation intensity, is delivered to the at least one nerve of the user when the user is determined to be in a sleep state.

56. Apparatus according to claim 54 wherein the control means modifies the output of the stimulation means so that a first therapeutic stimulation intensity level is delivered to the at least one nerve of the user when the user is determined to be in a sleep state and a second therapeutic stimulation, with an intensity level higher than the first therapeutic stimulation intensity, is delivered to the at least one nerve of the user when the user is determined to be likely to transition to a wake state.