System and method for providing percutaneous electrical therapy

• US 6,671,557 B1
• Filed: 10/10/2000
• Issued: 12/30/2003
• Est. Priority Date: 10/10/2000
• Status: Expired due to Fees

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Meagan Medical, Inc.
• Inventors: Gliner, Brad
• Primary Examiner(s): PASCHALL, MARK H
• Application Number:
  US09/686,993
• Time in Patent Office: 1,176 Days
• Field of Search: 607/53, 607/68, 607/69, 607/46, 607/70-74, 607/45, 607/2
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A system and method for providing percutaneous electrical nerve stimulation therapy to a patient renders the therapy effective for a large patient population and a broad range of patient conditions. The method includes the steps of inserting an electrode into the patient and applying an electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over the range of frequencies. The range of frequencies may have a minimum frequency of at most about 20 Hz and a maximum frequency of at least about 40 Hz. In addition, the electrical signal may be compensated for changes in frequency. The compensation may be in the form of amplitude adjustment or pulse with adjustment to provide effective signal energy over the entire range of applied frequencies.

Claims

1. A method of providing percutaneous electrical therapy to a patient having a body, the method comprising:

percutaneously inserting an electrode into the patient; and

applying an electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 20 Hz and having a maximum frequency of at least about 40 Hz.

2. The method of claim 1 wherein applying the electrical signal comprises applying an electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 4 Hz and having a maximum frequency of at least about 50 Hz.

3. The method of claim 1 wherein applying the electrical signal comprises applying an electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 2 Hz and having a maximum frequency of at least about 100 Hz.

4. The method of claim 1 wherein applying the electrical signal comprises applying an electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 2 Hz and having a maximum frequency of at least about 200 Hz.

5. The method of claim 1 wherein the plurality of frequencies comprises more than seven frequencies.

6. The method of claim 1 wherein the electrical signal comprises a plurality of pulses, each consecutive pair of pulses being separated by an interpulse interval.

7. The method of claim 6 wherein the interpulse interval of at least a portion of the electrical signal varies with each pulse.

8. The method of claim 6 wherein successive interpulse intervals of at least a portion of the electrical signal vary in a predetermined manner.

9. The method of claim 6 wherein successive interpulse intervals of at least a portion of the electrical signal vary monotonically.

10. The method of claim 9 wherein the successive interpulse intervals of at least a portion of the electrical signal increase monotonically.

11. The method of claim 9 wherein the successive interpulse intervals of at least a portion of the electrical signal decrease monotonically.

12. The method of claim 6 wherein successive interpulse intervals of at least a portion of the electrical signal vary randomly.

13. The method of claim 6 wherein successive interpulse intervals of at least a portion of the electrical signal vary in a randomly generated and repeated manner.

14. The method of claim 6 wherein successive interpulse intervals of at least a portion of the electrical signal are constant.

15. The method of claim 6 wherein successive interpulse intervals of multiple portions of the electrical signal are constant.

16. The method of claim 6 wherein the pulse is a biphasic pulse.

17. The method of claim 1, further comprising compensating the electrical signal for changes in frequency of the electrical signal.

18. The method of claim 17 wherein compensating the electrical signal comprises adjusting the amplitude of the electrical signal in relation to the frequency of the electrical signal.

19. The method of claim 18 wherein adjusting the amplitude includes adjusting the amplitude of the electrical signal in an inverse relation to the frequency of the electrical signal.

20. The method of claim 18 wherein adjusting the amplitude includes adjusting the amplitude of the electrical signal in inverse relation to the log of the frequency of the electrical signal.

21. The method of claim 18 wherein adjusting the amplitude includes adjusting the amplitude (A) of the electrical signal in accordance with the formula:

22. The method of claim 18 wherein adjusting the amplitude comprises adjusting the amplitude of current of the electrical signal in relation to the frequency of the electrical signal.

23. The method of claim 18 wherein adjusting the amplitude comprises adjusting the amplitude of voltage of the electrical signal in relation to the frequency of the electrical signal.

24. The method of claim 17 wherein compensating the electrical signal comprises adjusting the duration of pulses comprising the electrical signal.

25. The method of claim 24 wherein adjusting the duration of pulses includes adjusting the duration of the pulses in an inverse relation to the frequency of the electrical signal.

26. The method of claim 24 wherein adjusting the duration of pulses includes adjusting the duration of the pulses in inverse relation to the square root of the frequency of the electrical signal.

27. The method of claim 24 wherein adjusting the duration of pulses includes adjusting the duration of the pulses in accordance with the formula:

28. A system for providing percutaneous electrical therapy to a patient having a body, the system comprising:

electrode means percutaneously insertable into the patient; and

signal generating means for applying an electrical signal between the electrode means and the patient'"'"'s body, the signal generating means including frequency varying means for applying the electrical signal between the electrode means and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 20 Hz and having a maximum frequency of at least about 40 Hz.

29. The system of claim 28 wherein the frequency varying means includes means for applying the electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 4 Hz and having a maximum frequency of at least about 50 Hz.

30. The system of claim 28 wherein the frequency varying means includes means for applying the electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range having a minimum frequency of at most about 2 Hz and having a maximum frequency of at least about 100 Hz.

31. The system of claim 28 wherein the frequency varying means includes means for applying the electrical signal between the electrode and the patient'"'"'s body at a plurality of frequencies that automatically vary over a range of at most about 2 Hz to at least about 200 Hz.

32. The system of claim 28 wherein the plurality of frequencies comprises more than seven frequencies.

33. The system of claim 28 wherein the electrical signal comprises a plurality of pulses, each consecutive pair of pulses being separated by an interpulse interval.

34. The system of claim 33 wherein the frequency varying means varies the interpulse interval of at least a portion of the electrical signal with each pulse.

35. The system of claim 33 wherein the frequency varying means varies interpulse intervals of at least a portion of the electrical signal in a predetermined manner.

36. The system of claim 33 wherein the frequency varying means varies successive interpulse intervals of at least a portion of the electrical signal monotonically.

37. The system of claim 36 wherein the frequency varying means increases successive interpulse intervals of at least a portion of the electrical signal monotonically.

38. The system of claim 36 wherein the frequency varying means decreases successive interpulse intervals of at least a portion of the electrical signal monotonically.

39. The system of claim 33 wherein the frequency varying means randomly varies successive interpulse intervals of at least a portion of the electrical signal.

40. The system of claim 33 wherein the frequency varying means varies successive interpulse intervals of at least a portion of the electrical signal in a randomly generated and repeated manner.

41. The system of claim 33 wherein the frequency varying means maintains successive interpulse intervals of at least a portion of the electrical signal constant.

42. The system of claim 33 wherein the frequency varying means maintains successive interpulse intervals of multiple portions of the electrical signal constant.

43. The system of claim 33 wherein the pulse is a biphasic pulse.

44. The system of claim 28 further including compensating means for compensating the electrical signal for changes in frequency of the electrical signal.

45. The system of claim 44 wherein the compensating means adjusts the amplitude of the electrical signal in relation to the frequency of the electrical signal.

46. The system of claim 44 wherein the compensating means adjusts the amplitude of the electrical signal in an inverse relation to the frequency of the electrical signal.

47. The system of claim 44 wherein the compensating means adjusts the amplitude of the electrical signal in inverse relation to the log of the frequency of the electrical signal.

48. The system of claim 44 wherein the compensating means adjusts the amplitude (A) of the electrical signal in accordance with the formula:

49. The system of claim 46 wherein the compensating means adjusts the amplitude of the electrical signal in relation to the frequency of the electrical signal.

50. The system of claim 46 wherein the compensating means adjusts the amplitude of the voltage of the electrical signal in relation to the frequency of the electrical signal.

51. The system of claim 44 wherein the compensating means adjusts duration of pulses comprising the electrical signal.

52. The system of claim 44 wherein the compensating means adjusts the duration of the pulses in an inverse relation to the frequency of the electrical signal.

53. The system of claim 44 wherein the compensating means adjusts the duration of the pulses in inverse relation to the square root of the frequency of the electrical signal.

54. The system of claim 44 wherein the compensating means adjusts the duration of the pulses in accordance with the formula:

55. A system for providing percutaneous electrical therapy to a patient having a body, the system comprising:

at least one electrode percutaneously insertable into the patient; and

a signal generator adapted to be coupled between the at least one electrode and the patient'"'"'s body and that generates an electrical signal at a plurality of frequencies that automatically vary over a range of frequencies having a minimum frequency of at most about 20 Hz and having a maximum frequency of at least about 40 Hz.

56. The system of claim 55 wherein the signal generator varies the electrical signal over a range of frequencies having a minimum frequency of at most about 4 Hz and having a maximum frequency of at least about 50 Hz.

57. The system of claim 55 wherein the signal generator varies the electrical signal over a range of frequencies having a minimum frequency of at most about 2 Hz and having a maximum frequency of at least about 100 Hz.

58. The system of claim 55 wherein the signal generator varies the electrical signal over a range of frequencies of at most about 2 Hz to at least about 200 Hz.

59. The system of claim 55 wherein the plurality of frequencies comprises more than seven frequencies.

60. The system of claim 55 wherein the signal generator generates the electrical signal by generating a plurality of pulses and separating each consecutive pair of pulses by an interpulse interval.

61. The system of claim 60 wherein the signal generator varies the interpulse interval after each pulse of at least a portion of the electrical signal.

62. The system of claim 60 wherein the signal generator varies the interpulse intervals of at least a portion of the electrical signal in a predetermined manner.

63. The system of claim 60 wherein the signal generator varies successive interpulse intervals of at least a portion of the electrical signal monotonically.

64. The system of claim 63 wherein the signal generator increases successive interpulse intervals of at least a portion of the electrical signal monotonically.

65. The system of claim 63 wherein the signal generator decreases successive interpulse intervals of at least a portion of the electrical signal monotonically.

66. The system of claim 60 wherein the signal generator randomly varies successive interpulse intervals of at least a portion of the electrical signal.

67. The system of claim 60 wherein the signal generator varies successive interpulse intervals of at least a portion of the electrical signal in a randomly generated and repeated manner.

68. The system of claim 60 wherein the signal generator maintains successive interpulse intervals of at least a portion of the electrical signal constant.

69. The system of claim 60 wherein the signal generator maintains successive interpulse intervals of multiple portions of the electrical signal constant.

70. The system of claim 60 wherein the pulses generated by the signal generator are biphasic pulses.

71. The system of claim 55 wherein the signal generator adjusts the electrical signal for changes in frequency of the electrical signal.

72. The system of claim 71 wherein the signal generator adjusts the amplitude of the electrical signal in relation to the frequency of the electrical signal.

73. The system of claim 71 wherein the signal generator adjusts the amplitude of the electrical signal in an inverse relation to the frequency of the electrical signal.

74. The system of claim 71 wherein the signal generator adjusts the amplitude of the electrical signal in inverse relation to the log of the frequency of the electrical signal.

75. The system of claim 71 wherein the signal generator adjusts the amplitude (A) of the electrical signal in accordance with the formula:

76. The system of claim 73 wherein the signal generator adjusts the amplitude of the current of the electrical signal in relation to the frequency of the electrical signal.

77. The system of claim 73 wherein the signal generator adjusts the amplitude of the voltage of the electrical signal in relation to the frequency of the electrical signal.

78. The system of claim 71 wherein the signal generator adjusts duration of the pulses comprising the electrical signal for changes in frequency of the electrical signal.

79. The system of claim 71 wherein the signal generator adjusts the duration of the pulses in an inverse relation to the frequency of the electrical signal.

80. The system of claim 71 wherein the signal generator adjusts the duration of the pulses in inverse relation to the log of the frequency of the electrical signal.

81. The system of claim 71 wherein the signal generator adjusts the duration of the pulses in accordance with the formula: