Transcutaneous electrical nerve stimulation using novel unbalanced biphasic waveform and novel electrode arrangement

• US 10,112,040 B2
• Filed: 11/14/2016
• Issued: 10/30/2018
• Est. Priority Date: 11/15/2011
• Status: Active Grant

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Herb, Glenn, Aguirre, Andres, Kong, Xuan, Gozani, Shai N.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US15/350,261
• Publication Number:
  US 20170056643A1
• Time in Patent Office: 715 Days
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• 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 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

The present invention is directed to transcutaneous electrical nerve stimulation (TENS) devices which utilize novel stimulation waveforms and novel arrangements of TENS electrodes to improve the efficiency of power consumption while enhancing therapeutic effects.

Claims

1. Apparatus for providing transcutaneous electrical nerve stimulation to a user, said apparatus comprising:

a stimulation unit for electrically stimulating nerves using asymmetric biphasic electrical pulses, wherein during the first phase and the second phase of an asymmetric biphasic electrical pulse, said stimulation unit generates a voltage at an anode that is higher than a voltage at a cathode so as to allow current to flow from the anode to the cathode, and wherein said stimulation unit delivers a larger amount of electrical charge in the second phase of the asymmetric biphasic electrical pulse than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage setting in both phases of the asymmetric biphasic electrical pulse to deliver the same current intensity by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse;

a control unit for controlling the electrical stimulation delivered by said stimulation unit; and

an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on one limb of the user, said first electrode overlays a first nerve on the limb of user but not a second nerve on the limb of the user and said second electrode overlays the second nerve on the limb of the user but not the first nerve on the limb of the user;

whereby, the first electrode activates the first nerve during the first phase of the asymmetric biphasic electrical pulse and the second electrode activates the second nerve during the second phase of the asymmetric biphasic electrical pulse.

2. Apparatus according to claim 1 wherein said control unit is configured to cause said stimulation unit to deliver discrete asymmetric biphasic electrical pulses.

3. Apparatus according to claim 2 wherein the discrete asymmetric biphasic electrical pulses are current-regulated.

4. Apparatus according to claim 2 wherein each phase of the discrete asymmetric biphasic electrical pulses has a rectangular shape.

5. Apparatus according to claim 2 wherein there is a time delay between the first and second phases of the discrete asymmetric biphasic electrical pulses.

6. Apparatus according to claim 5 wherein said time delay is 100 microseconds.

7. Apparatus according to claim 2 wherein the polarity of the first phase of the discrete asymmetric biphasic electrical pulses varies.

8. Apparatus according to claim 7 wherein the polarity of the first phase of the discrete asymmetric biphasic electrical pulses alternates with each discrete asymmetric biphasic electrical pulse.

9. Apparatus according to claim 7 wherein the polarity of the first phase of each discrete asymmetric biphasic electrical pulse varies so as to ensure that an equal amount of positive and negative charges flow into each electrode within a predetermined time period.

10. Apparatus according to claim 9 wherein said predetermined time period is one-tenth of a second.

11. Apparatus according to claim 2 wherein the discrete asymmetric biphasic electrical pulses are delivered at a constant frequency.

12. Apparatus according to claim 11 wherein the frequency is approximately 80 Hz.

13. Apparatus according to claim 2 wherein the discrete asymmetric biphasic electrical pulses are delivered at a random frequency.

14. Apparatus according to claim 13 wherein said random frequency ranges between approximately 60 Hz and approximately 100 Hz.

15. Apparatus according to claim 1 wherein said apparatus is powered by a portable power source.

16. Apparatus according to claim 15 wherein said portable power source unit is a low-voltage battery.

17. Apparatus according to claim 16 wherein the voltage of said low-voltage battery is less than 5 volts.

18. Apparatus according to claim 1 wherein said electrode array comprises a third electrode and a fourth electrode, said third electrode and said fourth electrode being mounted to said substrate with a predetermined arrangement, so that said third electrode overlays the first nerve on the limb of the user but not the second nerve on the limb of the user and said fourth electrode overlays the second nerve on the limb of the user but not the first nerve on the limb of the user.

19. Apparatus according to claim 1 wherein said electrode array comprises a third electrode and a fourth electrode, said third electrode and said fourth electrode being mounted to said substrate with a predetermined arrangement, so that said third electrode overlays a third nerve on the limb of the user and said fourth electrode overlays a fourth nerve on the limb of the user.

20. Apparatus according to claim 1 wherein not all of said electrodes in said electrode array are connected to said stimulation unit at the same time.

21. Apparatus according to claim 1 wherein said control unit controls the anode voltage of said stimulation unit.

22. Apparatus according to claim 21 wherein said control unit controls said anode voltage based on the cathode voltage.

23. Apparatus according to claim 21 wherein said control unit controls said anode voltage based on measurements of the asymmetric biphasic electrical pulses.

24. Apparatus according to claim 23 wherein said measurements are only made on the first phase of the asymmetric biphasic electrical pulses.

25. Apparatus according to claim 23 wherein said measurements are only made on the second phase of the asymmetric biphasic electrical pulses.

26. Apparatus according to claim 23 wherein said measurements are made on the first and second phases of the asymmetric biphasic electrical pulses.

27. Apparatus according to claim 21 wherein said control unit controls said anode voltage based on (i) the cathode voltage, and (ii) measurements of the asymmetric biphasic electrical pulses.

28. Apparatus according to claim 23 wherein said measurements comprise the amplitude ratio between the actual stimulation current and a target stimulation current at a specific time within the asymmetric biphasic electrical pulses.

29. Apparatus according to claim 23 wherein said measurements comprise the ratio between the actual total charge and the target total charge of the asymmetric biphasic electrical pulses.

30. Apparatus according to claim 23 wherein said anode voltage is set to a minimum value so that said measurements of the asymmetric biphasic electrical pulses meet pre-determined criteria.

31. Apparatus according to claim 1 wherein said control unit controls the amplitude and duration of the first and second phases of the asymmetric biphasic electrical pulses.

32. Apparatus according to claim 31 wherein the amplitude and duration of the first and second phases of the asymmetric biphasic electrical pulses are independently controlled by said stimulation unit.

33. Apparatus according to claim 32 wherein the asymmetric biphasic electrical pulses have the same amplitude but different duration, for the first and second phases of each asymmetric biphasic electrical pulse.

34. Apparatus according to claim 33 wherein the duration of the second phase of an asymmetric biphasic electrical pulse is longer than the duration of the first phase of the asymmetric biphasic electrical pulse.

64. Apparatus according to claim 1 wherein the at least first and second electrodes are mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on the one limb of the user, said first electrode overlays a first nerve on the limb of the user but not a second nerve on the limb of the user and said second electrode overlays the second nerve on the limb of the user but not the first nerve on the limb of the user and said first electrode and said second electrode both overlay a third nerve on the limb of the user.

35. A method for providing transcutaneous electrical nerve stimulation therapy to a user, said method comprising:

providing a stimulation unit for generating asymmetric biphasic electrical pulses, wherein the asymmetric biphasic electrical pulses are generated by creating a voltage difference between an anode voltage and a cathode voltage, and the amount of electrical charge delivered in the second phase of an asymmetric biphasic electrical pulse is larger than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage during the first and second phases of the asymmetric biphasic electrical pulse to deliver the same current intensity by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse;

providing an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on one limb of the user, said first electrode overlays a first nerve on the limb of user but not a second nerve on the limb of user and said second electrode overlays the second nerve on the limb of user but not the first nerve on the limb of user; and

using said stimulation unit and said electrode array to apply asymmetric biphasic electrical pulses to the skin of a user, whereby, the first electrode activates the first nerve during the first phase of the asymmetric biphasic electrical pulse and the second electrode activates the second nerve during the second phase of the asymmetric biphasic electrical pulse.

36. A method according to claim 35 wherein the asymmetric biphasic electrical pulses are delivered at a constant frequency.

37. A method according to claim 35 wherein the asymmetric biphasic electrical pulses are delivered are at a random frequency, wherein said random frequency is within a predetermined range.

38. A method according to claim 35 wherein the first and second phases of the asymmetric biphasic electrical pulses are separated by a time delay.

39. A method according to claim 38 wherein said time delay is 100 microseconds.

40. A method according to claim 35 wherein the asymmetric biphasic electrical pulses vary the polarity of the first phase of the asymmetric biphasic electrical pulses.

41. A method according to claim 40 wherein the first phase of the asymmetric biphasic electrical pulses alternates with every asymmetric biphasic electrical pulse.

42. A method according to claim 40 wherein the pattern of alternations of the first phases of the asymmetric biphasic electrical pulses ensures that an equal amount of positive and negative charges flow into each electrode within a predetermined time period.

43. A method according to claim 42 wherein said predetermined time period is one-tenth of a second.

44. A method according to claim 35 wherein the amplitude of the two phases of the asymmetric biphasic electrical pulses are independently controlled.

45. A method according to claim 35 wherein the duration of the two phases of the asymmetric biphasic electrical pulses are independently controlled.

46. A method according to claim 44 wherein the amplitude of the second phase of an asymmetric biphasic electrical pulse is larger than the amplitude of the first phase of the asymmetric biphasic electrical pulse.

47. A method according to claim 45 wherein the duration of the second phase of an asymmetric biphasic electrical pulse is larger than the duration of the first phase of the asymmetric biphasic electrical pulse.

48. A method according to claim 35 wherein the anode voltage of said stimulation unit is controllable.

49. A method according to claim 35 wherein the cathode voltage of said stimulation unit is controllable.

50. A method according to claim 48 wherein the anode voltage ranges from approximately 20 volts to approximately 100 volts.

51. A method according to claim 48 wherein the anode voltage is powered by an energy source with an output voltage lower than the anode voltage.

52. A method according to claim 48 wherein the anode voltage is controlled to a target value.

53. A method according to claim 52 wherein said target value for the anode voltage is adjusted so that the cathode voltage is within a desired range.

54. A method according to claim 53 wherein said desired range is between approximately 1 volt and approximately 5 volts.

55. A method according to claim 52 wherein said target value for the anode voltage is adjusted so that measurements of the asymmetric biphasic electrical pulses meet pre-determined criteria.

56. A method according to claim 55 wherein said measurements comprise the amplitude ratio between the actual stimulation current and a target stimulation current at a specific time within each of the asymmetric biphasic electrical pulses and said pre-determined criteria is greater than a ratio threshold.

57. A method according to claim 55 wherein said measurements comprise the ratio between the actual charge and the target charge for each of the asymmetric biphasic electrical pulses and said pre-determined criteria is greater than a ratio threshold.

58. A method according to claim 56 wherein said ratio threshold is 0.8.

59. A method according to claim 57 wherein said ratio threshold is 0.9.

60. A method according to claim 55 wherein said measurements comprise a combination of an amplitude ratio and a charge ratio, wherein said amplitude ratio is the ratio between the actual stimulation current and the target stimulation current at a specific time within the asymmetric biphasic electrical pulses, and further wherein said charge ratio is the ratio between the actual current charge and the target current charge of the asymmetric biphasic electrical pulses.

61. A method according to claim 55 wherein said measurements relate to the first phase of the asymmetric biphasic electrical pulses.

62. A method according to claim 55 wherein said measurements relate to the second phase of the asymmetric biphasic electrical pulses.

63. A method according to claim 55 wherein said measurements relate to the first and second phases of the asymmetric biphasic electrical pulses.

65. A method according to claim 35 wherein the at least first and second electrodes are mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on the one limb of the user, said first electrode overlays a first nerve on the limb of the user but not a second nerve on the limb of the user and said second electrode overlays the second nerve on the limb of the user but not the first nerve on the limb of the user and said first electrode and said second electrode both overlay a third nerve on the limb of the user.

66. A method for providing transcutaneous electrical nerve stimulation therapy to a user, said method comprising:

providing a stimulation unit for generating asymmetric biphasic electrical pulses, wherein the asymmetric biphasic electrical pulses are generated by creating a voltage difference between an anode voltage and a cathode voltage, and the amount of electrical charge delivered in the second phase of an asymmetric biphasic electrical pulse is larger than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage during the first and second phases of the asymmetric biphasic electrical pulse by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse;

providing an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on the user, said first electrode overlays a first nerve but not a second nerve and said second electrode overlays the second nerve but not the first nerve; and

using said stimulation unit and said electrode array to apply asymmetric biphasic electrical pulses to the skin of a user;

wherein the anode voltage of said stimulation unit is controllable;

wherein the anode voltage is controlled to a target value;

wherein said target value for the anode voltage is adjusted so that measurements of the asymmetric biphasic electrical pulses meet pre-determined criteria;

and further wherein said measurements comprise the amplitude ratio between the actual stimulation current and a target stimulation current at a specific time within each of the asymmetric biphasic electrical pulses.

67. A method for providing transcutaneous electrical nerve stimulation therapy to a user, said method comprising:

providing a stimulation unit for generating asymmetric biphasic electrical pulses, wherein the asymmetric biphasic electrical pulses are generated by creating a voltage difference between an anode voltage and a cathode voltage, and the amount of electrical charge delivered in the second phase of an asymmetric biphasic electrical pulse is larger than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage during the first and second phases of the asymmetric biphasic electrical pulse by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse;

providing an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on the user, said first electrode overlays a first nerve but not a second nerve and said second electrode overlays the second nerve but not the first nerve; and

using said stimulation unit and said electrode array to apply asymmetric biphasic electrical pulses to the skin of a user;

wherein the anode voltage of said stimulation unit is controllable;

wherein the anode voltage is controlled to a target value;

wherein said target value for the anode voltage is adjusted so that measurements of the asymmetric biphasic electrical pulses meet pre-determined criteria;

and further wherein said measurements comprise the ratio between the actual charge and the target charge for each of the asymmetric biphasic electrical pulses.

68. A method for providing transcutaneous electrical nerve stimulation therapy to a user, said method comprising:

providing a stimulation unit for generating asymmetric biphasic electrical pulses, wherein the asymmetric biphasic electrical pulses are generated by creating a voltage difference between an anode voltage and a cathode voltage, and the amount of electrical charge delivered in the second phase of an asymmetric biphasic electrical pulse is larger than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage during the first and second phases of the asymmetric biphasic electrical pulse by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse;

providing an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on the user, said first electrode overlays a first nerve but not a second nerve and said second electrode overlays the second nerve but not the first nerve; and

using said stimulation unit and said electrode array to apply asymmetric biphasic electrical pulses to the skin of a user;

wherein the anode voltage of said stimulation unit is controllable;

wherein the anode voltage is controlled to a target value;

wherein said target value for the anode voltage is adjusted so that measurements of the asymmetric biphasic electrical pulses meet pre-determined criteria;

and further wherein said measurements comprise a combination of an amplitude ratio and a charge ratio, wherein said amplitude ratio is the ratio between the actual stimulation current and the target stimulation current at a specific time within the asymmetric biphasic electrical pulses, and further wherein said charge ratio is the ratio between the actual current charge and the target current charge of the asymmetric biphasic electrical pulses.