Electrical stimulation device and method for the treatment of dysphagia

• US 20070156182A1
• Filed: 01/04/2006
• Published: 07/05/2007
• Est. Priority Date: 01/04/2006
• Status: Active Grant

• Current Assignee: Accelerated Care Plus Corp. (Hanger, Inc.)
• Original Assignee: Accelerated Care Plus Corp. (Hanger, Inc.)
• Inventors: Castel, J., Palermo, Francis
• Granted Patent: US 7,660,636 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

An electrical stimulation device and method for the treatment of dysphagia is disclosed. In a preferred embodiment, the electrical stimulation device includes one or more channels of electrodes each of which includes a first electrode positioned in electrical contact with tissue of a target region of a patient and a second electrode positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of the patient. A series of electrical pulses are then applied to the patient through the one or more channels of electrodes in accordance with a procedure for treating dysphagia. The series of electrical pulses may comprise: a plurality of cycles of a biphasic sequential pulse train pattern; a plurality of cycles of a biphasic overlapping pulse train pattern; a plurality of cycles of a triphasic sequential pulse train pattern; a plurality of cycles of a triphasic overlapping pulse train pattern; a functional pulse train pattern; a low-frequency pulse train pattern; or a frequency-sequenced pulse burst train pattern. Various exemplary embodiments of the invention are disclosed.

Claims

1. A method for treating dysphagia in a patient by electrical stimulation, said method comprising:

providing a first channel comprising two electrodes, wherein a first electrode of said first channel is positioned in electrical contact with tissue of a first target region of said patient and a second electrode of said first channel is positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient;

providing a second channel comprising two electrodes, wherein a first electrode of said second channel is positioned in electrical contact with tissue of a second target region of said patient and a second electrode of said second channel is positioned in electrical contact with tissue of said posterior neck region or said posterior thoracic region of said patient;

applying a series of electrical pulses to said patient through said first and second channels in accordance with a procedure for treating dysphagia.

2. The method of claim 1, wherein said first electrode of said first channel is positioned so as to stimulate a motor point of a first buccinator muscle of said patient and said first electrode of said second channel is positioned bilaterally so as to stimulate a motor point of a second buccinator muscle of said patient.

3. The method of claim 2, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient

4. The method of claim 1, wherein said first electrode of said first channel is positioned so as to stimulate a motor point of a first masseter muscle of said patient and said first electrode of said second channel is positioned bilaterally so as to stimulate a motor point of a second masseter muscle of said patient.

5. The method of claim 3, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

6. The method of claim 1, wherein said first electrode of said first channel and said first electrode of said second channel are positioned so as to stimulate a tongue muscle of said patient.

7. The method of claim 6, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

8. The method of claim 1, wherein said first electrode of said first channel is positioned so as to stimulate a motor point of a first trapezius muscle of said patient and said first electrode of said second channel is positioned bilaterally so as to stimulate a motor point of a second trapezius muscle of said patient.

9. The method of claim 8, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

10. The method of claim 1, wherein said first electrode of said first channel is positioned so as to stimulate a first median nerve of said patient and said first electrode of said second channel is positioned bilaterally so as to stimulate a second median nerve of said patient.

11. The method of claim 10, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

12. The method of claim 10, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C4, C5, C6, and/or C7 cervical vertebrae of said patient.

13. The method of claim 10, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the thoracic paraspinal muscles in said posterior thoracic region near the T4, T5, and/or T6 thoracic vertebrae of said patient.

14. The method of claim 1, wherein said first electrode of said first channel is positioned so as to stimulate a motor point of a firstly located first dorsal interosseous muscle of said patient and said first electrode of said second channel is positioned bilaterally so as to stimulate a motor point of a secondly located first dorsal interosseous muscle of said patient.

15. The method of claim 14, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

16. The method of claim 14, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C4, C5, C6, and/or C7 cervical vertebrae of said patient.

17. The method of claim 14, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the thoracic paraspinal muscles in said posterior thoracic region near the T4, T5, and/or T6 thoracic vertebrae of said patient.

18. The method of claim 1, wherein said first electrode of said first channel and said first electrode of said second channel are positioned bilaterally so as to stimulate the thoracic paraspinal muscles in said posterior thoracic region near the T4, T5, and/or T6 thoracic vertebrae of said patient.

19. The method of claim 18, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

20. The method of claim 18, wherein said second electrode of said first channel and said second electrode of said second channel are positioned bilaterally so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C5, C6, and/or C7 cervical vertebrae of said patient.

21. The method of claim 1, wherein said first electrode of said first channel is positioned to stimulate a motor point of a firstly located first dorsal interosseous muscle of said patient and said second electrode of said first channel is positioned so as to stimulate said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient, and said first electrode of said second channel is positioned so as stimulate the thoracic paraspinal muscles in said posterior thoracic region near the T4, T5, and/or T6 thoracic vertebrae of said patient and said second electrode of said second channel is positioned so as to stimulate the posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

22. The method of claim 1, wherein said series of electrical pulses comprises a plurality of cycles of a biphasic sequential pulse train pattern.

23. The method of claim 22, wherein said biphasic sequential pulse train pattern comprises a first phase of electrical pulses applied to said first channel and a second phase of electrical pulses applied to said second channel, wherein said second phase of electrical pulses commences after termination of said first phase of electrical pulses.

24. The method of claim 1, wherein said series of electrical pulses comprises a plurality of cycles of a biphasic overlapping pulse train pattern.

25. The method of claim 21 wherein said biphasic overlapping pulse train pattern comprises a first phase of electrical pulses applied to said first channel and a second phase of electrical pulses applied to said second channel, wherein said second phase of electrical pulses commences before termination of said first phase of electrical pulses.

26. The method of claim 1, wherein said series of electrical pulses comprises a plurality of cycles of a triphasic sequential pulse train pattern.

27. The method of claim 26, wherein said triphasic sequential pulse train pattern comprises a first phase of electrical pulses applied to said first channel, a second phase of electrical pulses applied to said second channel, and a third phase of electrical pulses applied to said first channel, wherein said second phase of electrical pulses commences after termination of said first phase of electrical pulses and wherein said third phase of electrical pulses commences after termination of said second phase of electrical pulses.

28. The method of claim 1, wherein said series of electrical pulses comprises a plurality of cycles of a triphasic overlapping pulse train pattern.

29. The method of claim 28, wherein said triphasic overlapping pulse train pattern comprises a first phase of electrical pulses applied to said first channel, a second phase of electrical pulses applied to said second channel, and a third phase of electrical pulses applied to said first channel, wherein said second phase of electrical pulses commences before termination of said first phase of electrical pulses and wherein said third phase of electrical pulses commences before termination of said second phase of electrical pulses.

30. The method of claim 1, wherein said series of electrical pulses comprises a functional pulse train pattern applied to said first and second channels so as to mimic electrical sequencing of particular muscles involved in swallowing during normal functioning activity.

31. The method of claim 1, wherein said electrical stimulation is applied transcutaneously to said patient.

32. The method of claim 1, wherein said electrical stimulation is applied percutaneously to said patient.

33. The method of claim 1, wherein each of said electrical pulses has a pulse duration of between 30 microseconds and 100 microseconds.

34. The method of claim 1, wherein each of said electrical pulses has a current amplitude of between 25 milliamps and 140 milliamps.

35. A method for treating dysphagia in a patient by electrical stimulation, said method comprising:

providing at least one channel comprising two electrodes, wherein a first electrode is positioned in electrical contact with tissue of a target region of said patient and a second electrode is positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient; and

applying a series of electrical pulses to said patient through said channel in accordance with a procedure for treating dysphagia.

36. The method of claim 35, wherein said first electrode is positioned so as to stimulate a motor point of a buccinator muscle of said patient.

37. The method of claim 35, wherein said first electrode is positioned so as to stimulate a motor point of a masseter muscle of said patient.

38. The method of claim 35, wherein said first electrode is positioned so as to stimulate a tongue muscle of said patient.

39. The method of claim 35, wherein said first electrode is positioned so as to stimulate a motor point of a trapezius muscle of said patient.

40. The method of claim 35, wherein said first electrode is positioned so as to stimulate a median nerve of said patient.

41. The method of claim 35, wherein said first electrode is positioned so as to stimulate a motor point of a first dorsal interosseous muscle of said patient.

42. The method of claim 35, wherein said first electrode is positioned so as to stimulate a thoracic paraspinal muscle of said patient.

43. The method of claim 35, wherein said second electrode is positioned so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3 and/or C4 cervical vertebrae of said patient.

44. The method of claim 35, wherein said second electrode is positioned so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C5, C6, and/or C7 cervical vertebrae of said patient.

45. The method of claim 35, wherein said second electrode is positioned so as to stimulate the thoracic paraspinal muscles in said posterior thoracic region near the T4, T5, and/or T6 thoracic vertebrae of said patient.

46. The method of claim 35, wherein said series of electrical pulses comprises a low-frequency pulse train pattern.

47. The method of claim 46, wherein said low-frequency pulse train pattern comprises individual electrical pulses generated at a frequency of between 0.1 Hz and 200 Hz.

48. The method of claim 35, wherein said series of electrical pulses comprises a frequency-sequenced pulse burst train pattern with a carrier frequency of between 500 Hz and 100,000 Hz.

49. The method of claim 48, wherein said frequency-sequenced pulse burst train pattern comprises a first sequence of modulated electrical pulses generated at a burst frequency of between 0.1 Hz and 5 Hz, a second sequence of modulated electrical pulses generated at a burst frequency of between 5 Hz and 20 Hz, and a third sequence of modulated electrical pulses generated at a burst frequency of between 20 Hz and 250 Hz.

50. The method of claim 48, wherein said frequency-sequenced pulse burst train pattern comprises a first sequence of modulated electrical pulses generated at a burst frequency of between 5 Hz and 20 Hz, a second sequence of modulated electrical pulses generated at a burst frequency of between 0.1 Hz and 5 Hz, and a third sequence of modulated electrical pulses generated at a burst frequency of between 20 Hz and 250 Hz.

51. The method of claim 48, wherein said frequency-sequenced pulse burst train pattern comprises a first sequence of modulated electrical pulses generated at a burst frequency of between 20 Hz and 250 Hz, and a second sequence of modulated electrical pulses generated at a burst frequency of between 0.1 Hz and 5 Hz.

52. The method of claim 35, wherein said electrical stimulation is applied transcutaneously to said patient.

53. The method of claim 35, wherein said electrical stimulation is applied percutaneously to said patient.

54. The method of claim 35, wherein each of said electrical pulses has a pulse duration of between 30 microseconds and 100 microseconds.

55. The method of claim 35, wherein each of said electrical pulses has a current amplitude of between 25 milliamps and 140 milliamps.

56. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least first and second channels of electrodes; and

an electronic control unit connected to said first and second channels of electrodes and programmed to apply a plurality of cycles of a biphasic sequential pulse train pattern to said first and second channels of electrodes in accordance with a procedure for treating dysphagia.

57. The electrical stimulation device of claim 56, wherein said biphasic sequential pulse train pattern comprises a first phase of electrical pulses applied to said first channel and a second phase of electrical pulses applied to said second channel, wherein said second phase of electrical pulses commences after termination of said first phase of electrical pulses.

58. The electrical stimulation device of claim 56, wherein said first channel comprises a first positive electrode adapted to be positioned in electrical contact with tissue of a first target region of said patient and a first negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient, and wherein said second channel comprises a second positive electrode adapted to be positioned in electrical contact with tissue of a second target region of said patient and a second negative electrode adapted to be positioned in electrical contact with tissue of said posterior neck region or said posterior thoracic region of said patient.

59. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least first and second channels of electrodes; and

an electronic control unit connected to said first and second channels of electrodes and programmed to apply a plurality of cycles of a biphasic overlapping pulse train pattern to said first and second channels of electrodes in accordance with a procedure for treating dysphagia.

60. The electrical stimulation device of claim 59, wherein said biphasic overlapping pulse train pattern comprises a first phase of electrical pulses applied to said first channel and a second phase of electrical pulses applied to said second channel, wherein said second phase of electrical pulses commences before termination of said first phase of electrical pulses.

61. The electrical stimulation device of claim 59, wherein said first channel comprises a first positive electrode adapted to be positioned in electrical contact with tissue of a first target region of said patient and a first negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient, and wherein said second channel comprises a second positive electrode adapted to be positioned in electrical contact with tissue of a second target region of said patient and a second negative electrode adapted to be positioned in electrical contact with tissue of said posterior neck region or said posterior thoracic region of said patient.

62. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least first and second channels of electrodes; and

an electronic control unit connected to said first and second channels of electrodes and programmed to apply a plurality of cycles of a triphasic sequential pulse train pattern to said first and second channels of electrodes in accordance with a procedure for treating dysphagia.

63. The electrical stimulation device of claim 62, wherein said triphasic sequential pulse train pattern comprises a first phase of electrical pulses applied to said first channel, a second phase of electrical pulses applied to said second channel, and a third phase of electrical pulses applied to said first channel, wherein said second phase of electrical pulses commences after termination of said first phase of electrical pulses and wherein said third phase of electrical pulses commences after termination of said second phase of electrical pulses.

64. The electrical stimulation device of claim 62, wherein said first channel comprises a first positive electrode adapted to be positioned in electrical contact with tissue of a first target region of said patient and a first negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient, and wherein said second channel comprises a second positive electrode adapted to be positioned in electrical contact with tissue of a second target region of said patient and a second negative electrode adapted to be positioned in electrical contact with tissue of said posterior neck region or said posterior thoracic region of said patient.

65. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least first and second channels of electrodes; and

an electronic control unit connected to said first and second channels of electrodes and programmed to apply a plurality of cycles of a triphasic overlapping pulse train pattern to said first and second channels of electrodes in accordance with a procedure for treating dysphagia.

66. The electrical stimulation device of claim 65, wherein said triphasic overlapping pulse train pattern comprises a first phase of electrical pulses applied to said first channel, a second phase of electrical pulses applied to said second channel, and a third phase of electrical pulses applied to said first channel, wherein said second phase of electrical pulses commences before termination of said first phase of electrical pulses and wherein said third phase of electrical pulses commences before termination of said second phase of electrical pulses.

67. The electrical stimulation device of claim 65, wherein said first channel comprises a first positive electrode adapted to be positioned in electrical contact with tissue of a first target region of said patient and a first negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient, and wherein said second channel comprises a second positive electrode adapted to be positioned in electrical contact with tissue of a second target region of said patient and a second negative electrode adapted to be positioned in electrical contact with tissue of said posterior neck region or said posterior thoracic region of said patient.

68. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least first and second channels of electrodes; and

an electronic control unit connected to said first and second channels of electrodes and programmed to apply a functional pulse train pattern to said first and second channels of electrodes in accordance with a procedure for treating dysphagia, wherein said functional pulse train pattern mimics electrical sequencing of particular muscles involved in swallowing during normal functioning activity.

69. The electrical stimulation device of claim 68, wherein said first channel comprises a first positive electrode adapted to be positioned in electrical contact with tissue of a first target region of said patient and a first negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient, and wherein said second channel comprises a second positive electrode adapted to be positioned in electrical contact with tissue of a second target region of said patient and a second negative electrode adapted to be positioned in electrical contact with tissue of said posterior neck region or said posterior thoracic region of said patient.

70. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least one channel comprising a positive electrode adapted to be positioned in electrical contact with tissue of a target region of said patient and a negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient; and

an electronic control unit connected to said channel and programmed to apply a low-frequency pulse train pattern to said channel in accordance with a procedure for treating dysphagia.

71. The electrical stimulation device of claim 70, wherein said low-frequency pulse train pattern comprises individual electrical pulses generated at a frequency of between 0.1 Hz and 200 Hz.

72. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least one channel comprising a positive electrode adapted to be positioned in electrical contact with tissue of a target region of said patient and a negative electrode adapted to be positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of said patient; and

an electronic control unit connected to said channel and programmed to apply a frequency-sequenced pulse burst train pattern to said channel in accordance with a procedure for treating dysphagia.

73. The electrical stimulation device of claim 72, wherein said frequency-sequenced pulse burst train pattern has a carrier frequency of between 500 Hz and 100,000 Hz and comprises a first sequence of modulated electrical pulses generated at a burst frequency of between 0.1 Hz and 5 Hz, a second sequence of modulated electrical pulses generated at a burst frequency of between 5 Hz and 20 Hz, and a third sequence of modulated electrical pulses generated at a burst frequency of between 20 Hz and 250 Hz.

74. The electrical stimulation device of claim 72, wherein said frequency-sequenced pulse burst train pattern has a carrier frequency of between 500 Hz and 100,000 Hz and comprises a first sequence of modulated electrical pulses generated at a burst frequency of between 5 Hz and 20 Hz, a second sequence of modulated electrical pulses generated at a burst frequency of between 0.1 Hz and 5 Hz, and a third sequence of modulated electrical pulses generated at a burst frequency of between 20 Hz and 250 Hz.

75. The electrical stimulation device of claim 72, wherein said frequency-sequenced pulse burst train pattern has a carrier frequency of between 500 Hz and 100,000 Hz and comprises a first sequence of modulated electrical pulses generated at a burst frequency of between 20 Hz and 250 Hz, and a second sequence of modulated electrical pulses generated at a burst frequency of between 0.1 Hz and 20 Hz.

76. An electrical stimulation device for treating dysphagia in a patient, said electrical stimulation device comprising:

at least one channel comprising a positive electrode and a negative electrode, wherein one of said electrodes of said channel is adapted to be positioned in electrical contact with tissue of a target region of said patient and the other of said electrodes of said channel is adapted to be positioned in electrical contact with tissue of a posterior neck region of said patient; and

an electronic control unit connected to said channel and programmed to apply a series of electrical pulses to said channel in accordance with a procedure for treating dysphagia.

77. The electrical stimulation device of claim 76, wherein said positive electrode is positioned so as to stimulate a motor point of a muscle of said patient selected from the group consisting of a buccinator muscle of said patient;

a masseter muscle of said patient;

a tongue muscle of said patient;

a trapezius muscle of said patient;

a first dorsal interosseous muscle of said patient, and a thoracic paraspinal muscle of said patient.

78. The method of claim 76, wherein said negative electrode is positioned so as to stimulate the cervical paraspinal muscles in said posterior neck region near the C1, C2, C3, and/or C4 cervical vertebrae of said patient.

79. The electrical stimulation device of claim 76, further comprising one or more additional channels of electrodes.