Treatment of disorders by unidirectional nerve stimulation

• US 7,890,185 B2
• Filed: 11/25/2003
• Issued: 02/15/2011
• Est. Priority Date: 08/31/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Ayal, Shai, Cohen, Ehud, Gross, Yossi
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US10/722,589
• Publication Number:
  US 20040172094A1
• Time in Patent Office: 2,639 Days
• Field of Search: 607/63, 607/40, 607 45- 46, 607/62, 607148-149, 607/118
• US Class Current: 607/118
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Apparatus for treating a condition of a subject is provided. An electrode device is adapted to be coupled to longitudinal nervous tissue of the subject, and a control unit is adapted to drive the electrode device to apply to the nervous tissue a current which is capable of inducing action potentials that propagate in the nervous tissue in a first direction, so as to treat the condition. The control unit is further adapted to suppress action potentials from propagating in the nervous tissue in a second direction opposite to the first direction.

Claims

1. Apparatus for treating a condition of a subject, comprising:

a plurality of electrode devices, configured to be coupled to respective longitudinal sites of longitudinal nervous tissue of the subject having first and second types of nerve fibers, through which body-generated action potentials propagate at first and second velocities, respectively, wherein two of the plurality of electrode devices are configured to be coupled at adjacent ones of the longitudinal sites that are separated by at least 2 mm; and

a control unit, configured to;

sequentially drive the electrode devices to apply to the nervous tissue respective currents, with delays between driving each of the electrode devices that are timed to the first velocity of the propagation of the body-generated action potentials so as to minimize undesired blocking of the body-generated action potentials propagating through the first type of nerve fibers,

configure the currents to induce respective first orthodromic electrode-generated action potentials that propagate in the nervous tissue in a first direction, so as to treat the condition,

configure the currents to suppress respective second electrode-generated action potentials from propagating in the nervous tissue in a second direction opposite to the first direction, repeatedly, during a series of temporally non-contiguous periods, induce the first orthodromic electrode-generated action potentials and suppress the second electrode-generated action potentials, and

substantially withhold, during respective times between the non-contiguous periods, the inducing of the first orthodromic electrode-generated action potentials and the suppressing of the second electrode-generated action potentials.

2. Apparatus according to claim 1, wherein the control unit is configured to drive the electrode devices to configure the currents to induce the first orthodromic electrode-generated action potentials to propagate in the nervous tissue in an afferent direction with respect to a central nervous system of the subject, so as to treat the condition.

3. Apparatus according to claim 2, wherein the longitudinal tissue includes a vagus nerve of the subject, and wherein the electrode devices are configured to be coupled to the vagus nerve of the subject.

4. Apparatus according to claim 1, wherein the control unit is configured to drive the electrode devices to configure the currents to induce the first orthodromic electrode-generated action potentials to propagate in the nervous tissue in an efferent direction with respect to a central nervous system of the subject, so as to treat the condition.

5. Apparatus according to claim 4, wherein the longitudinal tissue includes a vagus nerve of the subject, and wherein the electrode devices are configured to be coupled to the vagus nerve of the subject.

6. Apparatus according to claim 1, wherein the control unit is configured to:

(a) drive the electrode devices to apply the currents, and (b) suppress the second electrode-generated action potentials, at substantially the same time.

7. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents to be capable of treating an involuntary movement disorder of the subject.

8. Apparatus according to claim 1, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to inhibit an undesired response of a central nervous system of the subject generated responsive to the electrode devices applying the currents to the nervous tissue.

9. Apparatus according to claim 1, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to inhibit an undesired sensation generated responsive to the electrode devices applying the currents to the nervous tissue.

10. Apparatus according to claim 1, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to suppress second action potentials induced responsive to the electrode devices applying the currents.

11. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating a sleep disorder of the subject.

12. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating a gastrointestinal motility disorder of the subject.

13. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating an eating disorder of the subject.

14. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating obesity of the subject.

15. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating anorexia of the subject.

16. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating a gastrointestinal tract disorder of the subject.

17. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating hypertension of the subject.

18. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating coma of the subject.

19. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating epilepsy of the subject.

20. Apparatus according to claim 1, wherein the longitudinal tissue includes a vagus nerve of the subject, and wherein the electrode devices are configured to be coupled to the vagus nerve of the subject, and wherein the control unit is configured to:

(a) configure the currents so as to be capable of treating epilepsy of the subject, and (b) suppress second electrode-generated action potentials that interfere with an ability of the subject to speak.

21. Apparatus according to claim 1, wherein the longitudinal tissue includes a vagus nerve of the subject, and wherein the electrode devices are configured to be coupled to the vagus nerve of the subject, and wherein the control unit is adapted to configure the currents so as to be capable of inducing constriction of a lower esophageal sphincter of the subject.

22. Apparatus according to claim 1, wherein the electrode devices are configured to be coupled to longitudinal nervous tissue of a central nervous system of the subject.

23. Apparatus according to claim 1, wherein the electrode devices are configured to be coupled to nervous tissue of a peripheral nervous system of the subject.

24. Apparatus according to claim 1, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to inhibit an undesired effector action responsive to driving the electrode devices to apply the currents to the nervous tissue.

25. Apparatus according to claim 24, wherein the control unit is configured to suppress second electrode-generated action potentials that induce increased acid secretion in a gastrointestinal tract of the subject.

26. Apparatus according to claim 24, wherein the control unit is configured to suppress second electrode-generated action potentials that induce muscular contraction.

27. Apparatus according to claim 24, wherein the control unit is configured to suppress second electrode-generated action potentials that induce bradycardia.

28. Apparatus according to claim 1, wherein the control unit is configured to drive the electrode devices to apply respective electric fields to the nervous tissue configured to suppress the second electrode-generated action potentials.

29. Apparatus according to claim 1, wherein two of the plurality of electrode devices are adapted to be coupled at adjacent ones of the sites that are separated by less than 4 mm.

30. Apparatus according to claim 1, and comprising a sensor adapted to sense an indication of a presence of the condition and to generate a sensor signal responsive thereto, wherein the control unit is adapted to drive the electrode devices responsive to the sensor signal.

31. Apparatus according to claim 30, wherein the sensor is configured to sense the indication by sensing at least one physiological parameter of the subject selected from the group consisting of:

electroencephalographic (EEG) waves, respiration changes, heart rate changes, an aura, and a motor effect.

32. Apparatus according to claim 30, wherein the condition includes a gastrointestinal motility disorder of the subject, and wherein the sensor is configured to sense the indication by sensing at least one physiological parameter of the subject selected from the group consisting of:

a pattern of contractions of a portion of a gastrointestinal tract of the subject, and digestion by the subject.

33. Apparatus according to claim 30, wherein the condition includes a sleep disorder of the subject, and wherein the sensor is configured to sense the indication by sensing at least one physiological parameter of the subject selected from the group consisting of:

a respiration pattern of the subject indicative of wakefulness during normal nocturnal hours, abdominal impedance changes associated with respiration by the subject indicative of the sleep disorder, a sustained abnormal period of cessation of respiration of the subject, respiration typically associated with a state of sleeplessness of the subject, electroencephalographic (EEG) activity of the subject, a sudden uncontrolled nodding of the head of the subject, abdominal impedance of the subject, and eye movement of the subject.

34. Apparatus according to claim 30, wherein the indication includes swallowing by the subject, and wherein the sensor comprises one or more electrodes configured to be implanted in a vicinity of an esophagus of the subject, and to detect the swallowing.

35. Apparatus according to claim 30, wherein the condition includes an eating disorder of the subject, and wherein the indication includes a quantity of food consumed by the subject in a predetermined period of time, and wherein the sensor is configured to sense the quantity.

36. Apparatus according to claim 30, wherein the condition includes an eating disorder of the subject, and wherein the indication includes an amount of food in a stomach of the subject, and wherein the sensor comprises one or more electrodes configured to be secured to an outer wall of the stomach, and to sense the amount of the food in the stomach.

37. Apparatus according to claim 30, wherein the sensor is configured to sense the indication by sensing electroencephalographic (EEG) activity of the subject.

38. Apparatus according to claim 30, wherein the sensor is configured to sense the indication by sensing blood pressure of the subject.

39. Apparatus according to claim 1, wherein the control unit is adapted to receive an input from the subject and to drive the electrode devices responsive to the input.

40. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating migraine headache of the subject.

41. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating depression of the subject.

42. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating tremor of the subject.

43. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating Parkinson'"'"'s disease of the subject.

44. Apparatus according to claim 1, wherein the control unit is adapted to configure the currents so as to be capable of treating stroke of the subject.

45. Apparatus for treating a condition of a subject, comprising:

a plurality of electrode devices, configured to be coupled to respective longitudinal sites of longitudinal nervous tissue of the subject having first and second types of nerve fibers, through which body-generated action potentials propagate at first and second velocities, respectively;

a sensor, configured to sense an indication of a presence of the condition and to generate a sensor signal responsive thereto; and

a control unit, configured to receive the sensor signal, and, responsive thereto, to;

sequentially drive the electrode devices to apply to the nervous tissue respective currents, with delays between driving each of the electrode devices that are timed to the first velocity of the propagation of the body-generated action potentials so as to minimize undesired blocking of the body-generated action potentials propagating through the first type of the nerve fibers,

configure the currents to induce respective first orthodromic electrode-generated action potentials that propagate in the nervous tissue in a first direction, so as to treat the condition, and

configure the currents to suppress respective second electrode-generated action potentials from propagating in the nervous tissue in a second direction opposite the first direction.

46. Apparatus according to claim 45, wherein the control unit is configured to drive the electrode devices to configure the currents to induce the first orthodromic action potentials to propagate in the nervous tissue in an afferent direction with respect to a central nervous system of the subject, so as to treat the condition.

47. Apparatus according to claim 46, wherein the longitudinal tissue includes a vagus nerve of the subject, and wherein the electrode devices are configured to be coupled to the vagus nerve.

48. Apparatus according to claim 45, wherein the control unit is configured to drive the electrode devices to configure the currents to induce the first electrode-generated orthodromic action potentials to propagate in the nervous tissue in an efferent direction with respect to a central nervous system of the subject, so as to treat the condition.

49. Apparatus according to claim 48, wherein the longitudinal tissue includes a vagus nerve of the subject, and wherein the electrode devices are configured to be coupled to the vagus nerve.

50. Apparatus according to claim 45, wherein the control unit is configured to:

(a) drive the electrode devices to apply the currents, and (b) suppress the second electrode-generated action potentials, at substantially the same time.

51. Apparatus according to claim 45, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to inhibit an undesired response of a central nervous system of the subject generated responsive to the electrode devices applying the currents to the nervous tissue.

52. Apparatus according to claim 45, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to inhibit an undesired sensation generated responsive to the electrode devices applying the currents to the nervous tissue.

53. Apparatus according to claim 45, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials so as to suppress second electrode-generated action potentials induced responsive to the electrode device applying the currents.

54. Apparatus according to claim 45, wherein the condition is selected from the group consisting of:

a gastrointestinal motility disorder of the subject, an eating disorder of the subject, obesity of the subject, anorexia of the subject, a gastrointestinal tract disorder of the subject, hypertension of the subject, and coma of the subject, and wherein the control unit is configured to configure the currents so as to be capable of treating the selected condition.

55. Apparatus according to claim 45, wherein the condition is selected from the group consisting of:

Parkinson'"'"'s disease, and tremor, and wherein the control unit is configured to configure the currents so as to be capable of treating the selected condition.

56. Apparatus according to claim 45, wherein the longitudinal tissue includes a vagus nerve of the subject, wherein the electrode devices are configured to be coupled to the vagus nerve, and wherein the control unit is configured to:

(a) configure the currents so as to be capable of treating epilepsy of the subject, and (b) suppress second electrode-generated action potentials that interfere with an ability of the subject to speak.

57. Apparatus according to claim 45, wherein the longitudinal tissue includes a vagus nerve of the subject, wherein the electrode devices are configured to be coupled to the vagus nerve, and wherein the control unit is configured to configure the currents so as to be capable of inducing constriction of a lower esophageal sphincter of the subject.

58. Apparatus according to claim 45, wherein the longitudinal tissue is selected from the group consisting of:

longitudinal nervous tissue of a central nervous system of the subject, and longitudinal nervous tissue of a peripheral nervous system of the subject, and wherein the electrode devices are configured to be coupled to the selected tissue.

59. Apparatus according to claim 45, wherein the control unit is configured to regulate the suppressing of the second electrode-generated action potentials from propagating in the second direction so as to inhibit an undesired effector action responsive to driving the electrode devices to apply the currents to the nervous tissue.

60. Apparatus according to claim 45, wherein the sensor is configured to sense the indication by sensing at least one physiological parameter of the subject selected from the group consisting of:

electroencephalographic (EEG) waves, respiration changes, heart rate changes, an aura, and a motor effect.

61. Apparatus according to claim 45, wherein the condition includes a gastrointestinal motility disorder of the subject, and wherein the sensor is configured to sense the indication by sensing at least one physiological parameter of the subject selected from the group consisting of:

a pattern of contractions of a portion of a gastrointestinal tract of the subject, and digestion by the subject.

62. Apparatus according to claim 45, wherein the condition includes a sleep disorder of the subject, and wherein the sensor is configured to sense the indication by sensing at least one physiological parameter of the subject selected from the group consisting of:

a respiration pattern of the subject indicative of wakefulness during normal nocturnal hours, abdominal impedance changes associated with respiration by the subject indicative of the sleep disorder, a sustained abnormal period of cessation of respiration of the subject, respiration typically associated with a state of sleeplessness of the subject, electroencephalographic (EEG) activity of the subject, a sudden uncontrolled nodding of the head of the subject, abdominal impedance of the subject, and eye movement of the subject.

63. Apparatus according to claim 45, wherein the indication includes swallowing by the subject, and wherein the sensor comprises one or more electrodes configured to be implanted in a vicinity of an esophagus of the subject, and to detect the swallowing.

64. Apparatus according to claim 45, wherein the condition includes an eating disorder of the subject, and wherein the indication includes a quantity of food consumed by the subject in a predetermined period of time, and wherein the sensor is configured to sense the quantity.

65. Apparatus according to claim 45, wherein the condition includes an eating disorder of the subject, and wherein the indication includes an amount of food in a stomach of the subject, and wherein the sensor comprises one or more electrodes configured to be secured to an outer wall of the stomach, and to sense the amount of the food in the stomach.

66. Apparatus according to claim 45, wherein the sensor is configured to sense the indication by sensing blood pressure of the subject.

67. Apparatus according to claim 45, wherein the control unit is configured to drive the electrode devices to apply respective electric fields to the nervous tissue configured to suppress the second electrode-generated action potentials.

68. A method for treating a condition of a subject, comprising:

identifying that the subject suffers from the condition; and

treating the condition by;

sequentially driving currents into respective longitudinal sites of a vagus nerve of the subject having a first set of fibers and a second set of fibers, through which first body-generated action potential propagate at a first velocity, and second body-generated action potentials propagate at a second velocity, respectively, the first set of fibers having diameters generally different from diameters of the second set of fibers, with delays between driving each of the currents that are timed to the first velocity so as to minimize undesired blocking of the first body-generated action potentials propagating through the first set of fibers;

configuring the currents to induce respective first orthodromic electrode-generated action potentials that propagate in the vagus nerve in a first direction, so as to treat the condition, and to suppress respective second electrode-generated action potentials from propagating in the vagus nerve in a second direction opposite to the first direction.

69. A method according to claim 68, wherein configuring the currents comprises configuring the currents to induce the first orthodromic electrode-generated action potentials to propagate in an afferent direction with respect to a central nervous system of the subject.

70. A method according to claim 68, wherein configuring the currents comprises configuring the currents to induce the first orthodromic electrode-generated action potentials to propagate in an efferent direction with respect to a central nervous system of the subject.

71. A method according to claim 68, wherein the condition is selected from the group consisting of:

a gastrointestinal motility disorder of the subject, an eating disorder of the subject, obesity of the subject, anorexia of the subject, a gastrointestinal tract disorder of the subject, hypertension of the subject, and coma of the subject, and wherein identifying comprises identifying that the subject suffers from the selected condition.

72. A method according to claim 68, wherein suppressing the second action potentials comprises suppressing the second action potentials repeatedly, during a series of temporally non-contiguous action potential suppression periods, and wherein the method comprises substantially withholding the suppressing of the second action potentials between the action potential suppression periods.

73. A method according to claim 68, and comprising sensing an indication of a presence of the condition, wherein driving the currents comprises driving the currents responsive to sensing the indication.

74. A method according to claim 68, wherein the condition is selected from the group consisting of:

migraine headache, depression, and stroke, and wherein identifying comprises identifying that the subject suffers from the selected condition.