MEASURING THE "ON-SKIN" TIME OF A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) DEVICE IN ORDER TO MINIMIZE SKIN IRRITATION DUE TO EXCESSIVE UNINTERRUPTED WEARING OF THE SAME

• US 20170368345A1
• Filed: 06/13/2017
• Published: 12/28/2017
• Est. Priority Date: 11/15/2011
• Status: Active Grant

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Kong, Xuan, Gozani, Shai N.
• Granted Patent: US 10,293,159 B2
• Time in Patent Office: Days
• 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 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/321 Electromedical belts
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3603 Control systems

Abstract

Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, the apparatus comprising: a stimulation unit for electrically stimulating at least one nerve of the user; an electrode array connectable to the stimulation unit, the electrode array comprising a plurality of electrodes for electrical stimulation of the at least one nerve of the user; a monitoring unit electrically connected to the stimulation unit for monitoring the on-skin status of the electrode array; an analysis unit for analyzing the on-skin status of the electrode array to determine the effective on-skin time of the electrode array; and a feedback unit for alerting the user when the analysis unit determine that the effective on-skin time exceeds a threshold.

Claims

1-23. -23. (canceled)

24. A method for monitoring the on-skin time of a transcutaneous electrical nerve stimulation (TENS) device, said method comprising the steps of:

applying an electrode array to the skin of the user to provide contact between the electrode array and the skin of the user;

electrically stimulating at least one nerve of the user with an electrical stimulator connected to the electrode array;

monitoring the electrode array to determine if the electrode array is positioned on the skin of the user and, if the electrode array is positioned on the skin of the user, recording that determination as an on-skin condition;

calculating a duration of time of the on-skin condition in time; and

providing the user with feedback of the duration of time of the on-skin condition.

25. A method according to claim 24 wherein monitoring said electrode array is accomplished with the same electrical stimulation as that used to stimulate the at least one nerve of the user.

26. A method according to claim 24 wherein monitoring said electrode array is accomplished with electrical stimulation different from that used to stimulate the at least one nerve of the user.

27. A method according to claim 26 wherein monitoring said electrode array is accomplished with electrical stimulation pulses having a constant current intensity level.

28. A method according to claim 26 wherein monitoring said electrode array is accomplished with electrical stimulation pulses having a constant voltage intensity level.

29. A method according to claim 24 wherein monitoring the said electrode array is accomplished with electrical stimulation having an intensity level providing therapeutic benefit to the user.

30. A method according to claim 24 wherein monitoring said electrode array is accomplished with electrical stimulation having an intensity below the electrotactile sensation threshold of the user.

31. A method according to claim 24 wherein monitoring said electrode array is determined by comparing a target stimulation intensity level with an actual stimulation intensity level delivered by the electrical stimulator through said electrode array to the user.

32. A method according to claim 24 wherein monitoring said electrode array to determine if the electrode array is positioned on the skin of the user is determined by comparing a target threshold value with an actual voltage-divider output when the electrical stimulation is a constant voltage source applied to an input of the voltage-divider.

33. A method according to claim 32 wherein the voltage-divider output is a voltage drop across an electronic component.

34. A method according to claim 33 wherein the voltage-divider input is applied to said electronic component and a stimulator load, wherein the stimulator load is the electrode-skin interface created by said electrode array placed on the skin of the user and connected to said electrical stimulator.

35. A method according to claim 24 wherein the duration of time of the on-skin condition is a total sum of consecutive time intervals during which the electrode array is positioned on the skin of the user.

36. A method according to claim 24 wherein the duration of time of the on-skin condition is calculated as an effective on-skin time duration, wherein the effective on-skin time duration is a total sum of weighted consecutive time intervals during which said electrode array is determined to be of on-skin condition.

37. A method according to claim 36 wherein the weight factor for each time interval is a function of current intensity passing through the stimulator load during that time interval.

38. A method according to claim 36 wherein the weight factor for each time interval is a function of measured impedance value of the stimulator load for that time interval.

39. A method according to claim 24 wherein the user is provided with a feedback with a display of the duration of time of the on-skin condition.

40. A method according to claim 24 wherein the user is provided with a feedback only when the duration of time of the on skin condition exceeds a threshold.

41. A method according to claim 40 wherein the feedback is a sequence of electrical stimulation pulses delivered to the user.

42. A method according to claim 40 wherein the feedback is a sequence of mechanical vibration pulses delivered to the user.

43. A method according to claim 40 wherein the feedback is provided by a notification to a separate, authenticated device.

44. A method according to claim 43 wherein said device comprises a smartphone connected with to the TENS device via a wireless communication protocol.

45. A method according to claim 24 wherein the duration of time of the on-skin condition is a total sum of consecutive time intervals during which the electrode array is positioned on the skin of the user within a time period.

46. A method according to claim 45 wherein said time period is a calendar day.

47. A method according to claim 45 wherein said time period is a rolling 24-hour time window.

48. A method according to claim 40 wherein said threshold is a function of skin conditions of the user.

49. A method according to claim 24 wherein said feedback is a display of a utilization profile of TENS therapy according to the duration of the on-skin condition.

50. A method for monitoring the on-skin time of a transcutaneous electrical nerve stimulation (TENS) device, said method comprising the steps of:

creating a profile of a user;

applying an electrode array to the skin of the user to provide contact between the electrode array and the skin of the user;

electrically stimulating at least one nerve of the user with an electrical stimulator connected to the electrode array;

monitoring the electrode array to determine if the electrode array is positioned on the skin of the user and, if the electrode array is positioned on the skin of the user, recording that determination as an on-skin condition;

calculating a duration of time of the on-skin condition; and

providing the user with feedback of the duration of time of the on-skin condition, wherein the feedback depends upon the profile of the user.

51. A method according to claim 50 wherein said profile comprises demographic characteristics of the user.

52. A method according to claim 50 wherein said profile comprises at least one health condition of the user.

53. A method according to claim 52 wherein the health condition comprises at least one skin condition of the user.

54. A method according to claim 53 wherein said skin condition comprises at least one from the group consisting of dry skin, sensitive skin, and normal skin.