Dynamic nerve stimulation for treatment of disorders

• US 20050065575A1
• Filed: 08/18/2004
• Published: 03/24/2005
• Est. Priority Date: 09/13/2002
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Dobak, John D.
• Granted Patent: US 7,689,276 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

A method for the treatment of obesity or other disorders by electrical activation or inhibition of nerves is disclosed. This activation or inhibition can be accomplished by stimulating a nerve using an electrode. Dynamic stimulation through ramped cycling of electrical stimulation, stimulation frequency alteration, and/or duty cycle variance can produce therapeutic benefits.

Claims

1. A method of electrically modulating a nerve in a mammal, the method comprising:

providing a first electrical signal to the nerve at a first stimulation intensity during a first portion of a first stimulation time period;

applying a second electrical signal to the nerve at a second stimulation intensity during a second portion of a first stimulation time period;

ceasing or substantially reducing said applying of said second signal during a first no-stimulation period;

thereafter applying a third electrical signal to the nerve at a third stimulation intensity during a first portion of a second stimulation time period;

applying a fourth electrical signal to the nerve at a fourth stimulation intensity during a second portion of a second stimulation time period;

ceasing or substantially reducing said applying of said fourth signal during a second no-stimulation period.

2. The method of claim 1, wherein said second stimulation intensity is greater than said first stimulation intensity.

3. The method of claim 1, wherein said fourth stimulation intensity is greater than said third stimulation intensity.

4. The method of claim 1, wherein said second stimulation intensity is greater than said first stimulation intensity, and said fourth stimulation intensity is greater than said third stimulation intensity.

5. The method of claim 1, wherein said third stimulation intensity is approximately equal to said first stimulation intensity.

6. The method of claim 1, wherein the duration of said first no-stimulation period is approximately equal to the duration of said second no-stimulation period.

7. The method of claim 1, wherein the duration of said first stimulation period is approximately equal to the duration of said second stimulation period.

8. The method of claim 1, wherein the duration of said first portion of said first stimulation period is approximately equal to the duration of said second portion of said first stimulation period.

9. The method of claim 1, wherein the duration of said first portion of said second stimulation period is approximately equal to the duration of said second portion of said second stimulation period.

10. The method of claim 1, wherein said mammal is a human.

11. The method of claim 1, wherein said nerve is a splanchnic nerve.

12. The method of claim 1, wherein said nerve is a cranial nerve.

13. The method of claim 12, wherein said nerve is the vagus nerve.

14. The method of claim 1, wherein said nerve is located in the spinal cord.

15. The method of claim 1, wherein said nerve is in the autonomic nervous system.

16. The method of claim 1, wherein said nerve comprises motor fibers.

17. A method of stimulating a nerve, the method comprising:

applying a first plurality of temporally sequential electrical signals during a first plurality of respective stimulation time periods, each of said first plurality of signals having a stimulation intensity that is greater than the stimulation intensity of the preceding signal;

thereafter ceasing or substantially reducing electrical stimulation to the nerve during a first no-stimulation period;

thereafter applying a second, plurality of temporally sequential electrical signals during a second plurality of respective stimulation time periods, each of said second plurality of signals having a stimulation intensity that is greater than the stimulation intensity of the preceding signal;

thereafter ceasing or substantially reducing electrical stimulation to the nerve during a second no-stimulation period.

18. A method of stimulating a splanchnic nerve in a mammal, the method comprising the following steps:

1) electrically stimulating the nerve for a first time and at a first stimulation intensity;

2) thereafter, electrically simulating the nerve for a second time and at a second stimulation intensity, said second stimulation intensity being greater than said first stimulation intensity;

3) thereafter, providing a period during which electrical stimulation at the nerve is absent or substantially less than the second stimulation intensity.

19. The method of claim 18, further comprising repeating steps 1-3.

20. The method of claim 18, wherein a duration of said period is configured to minimize weight gain or maximize weight loss in said mammal during said period.

21. The method of claim 18, further comprising electrically stimulating the splanchnic nerve at least one additional time between said first time and said second time.

22. The method of claim 18, wherein said second stimulation intensity is about 1% to about 10,000% greater than said first stimulation intensity.

23. The method of claim 18, wherein said second stimulation intensity is about 2% to about 1,000% greater than said first stimulation intensity.

24. The method of claim 18, wherein said second stimulation intensity is about 4% to about 500% greater than said first stimulation intensity.

25. The method of claim 18, wherein said second stimulation intensity is about 8% to about 100% greater than said first stimulation intensity.

26. The method of claim 18, wherein said second stimulation intensity is about 10% to about 50% greater than said first stimulation intensity.

27. The method of claim 18, wherein said second stimulation intensity is about 15% to about 30% greater than said first stimulation intensity.

28. The method of claim 18, wherein said second stimulation intensity is about 20% greater than said first stimulation intensity.

29. The method of claim 18, wherein said first stimulation intensity is about equal to the threshold for skeletal muscle twitch in said mammal.

30. The method of claim 18, wherein said mammal is a human.

31. The method of claim 18, wherein said first time is between about 30 seconds and about 300 days.

32. The method of claim 18, wherein said first time is between about one minute and about 100 days.

33. The method of claim 18, wherein said first time is between about five minutes and about 50 days.

34. The method of claim 18, wherein said first time is between about 30 minutes and about 30 days.

35. The method of claim 18, wherein said first time is between about one hour and about seven days.

36. The method of claim 18, wherein said first time is between about four hours and about four days.

37. The method of claim 18, wherein said first time is between about six hours and about 36 hours.

38. The method of claim 18, wherein said first time is between about 20 hours and about 28 hours.

39. The method of claim 18, wherein said first time is about 24 hours.

40. The method of claim 18, wherein said second time is between about 30 seconds and about 300 days.

41. The method of claim 18, wherein said second time is between about one minute and about 100 days.

42. The method of claim 18, wherein said second time is between about five minutes and about 50 days.

43. The method of claim 18, wherein said second time is between about 30 minutes and about 30 days.

44. The method of claim 18, wherein said second time is between about one hour and about seven days.

45. The method of claim 18, wherein said second time is between about four hours and about four days.

46. The method of claim 18, wherein said second time is between about six hours and about 36 hours.

47. The method of claim 18, wherein said second time is between about 20 hours and about 28 hours.

48. The method of claim 18, wherein said second time is about 24 hours.

49. The method of claim 18, wherein said first time is approximately equal to said second time.

50. The method of claim 18, wherein said period is between about 30 seconds and about 300 days.

51. The method of claim 18, wherein said period is between about one minute and about 100 days.

52. The method of claim 18, wherein said period is between about five minutes and about 50 days.

53. The method of claim 18, wherein said period is between about 30 minutes and about 30 days.

54. The method of claim 18, wherein said period is between about one hour and about 15 days.

55. The method of claim 18, wherein said period is between about one day and about ten days.

56. The method of claim 18, wherein said period is between about two days and about seven days.

57. The method of claim 18, wherein said period is between about three days and about five days.

58. The method of claim 18, wherein said period is about four days.

59. An implantable pulse generator programmed to modulate electrically a nerve in a mammal, in the following sequence:

providing a first electrical signal to the nerve at a first stimulation intensity during a first portion of a first stimulation time period;

providing a second electrical signal to the nerve at a second stimulation intensity during a second portion of a first stimulation time period;

ceasing or substantially reducing said providing of said second signal during a first no-stimulation period;

thereafter providing a third electrical signal to the nerve at a third stimulation intensity during a first portion of a second stimulation time period;

providing a fourth electrical signal to the nerve at a fourth stimulation intensity during a second portion of a second stimulation time period;

ceasing or substantially reducing said providing of said fourth signal during a second no-stimulation period.

60. The implantable pulse generator of claim 59, wherein the implantable pulse generator is programmed in hardware to modulate the nerve.

61. The implantable pulse generator of claim 59, wherein the implantable pulse generator is programmed in software to modulate the nerve.

62. The implantable pulse generator of claim 59, further configured such that said second stimulation intensity is greater than said first stimulation intensity, and said fourth stimulation intensity is greater than said third stimulation intensity.

63. An implantable pulse generator programmed to modulate electrically a nerve in a mammal, in the following sequence:

providing a first plurality of temporally sequential electrical signals during a first plurality of respective stimulation time periods, each of said first plurality of signals having a stimulation intensity that is greater than the stimulation intensity of the preceding signal;

thereafter ceasing or substantially reducing electrical stimulation to the nerve during a first no-stimulation period;

thereafter providing a second plurality of temporally sequential electrical signals during a second plurality of respective stimulation time periods, each of said second plurality of signals having a stimulation intensity that is greater than the stimulation intensity of the preceding signal;

thereafter ceasing or substantially reducing electrical stimulation to the nerve during a second no-stimulation period.

64. The implantable pulse generator of claim 63, wherein the implantable pulse generator is programmed in hardware to modulate the nerve.

65. The implantable pulse generator of claim 63, wherein the implantable pulse generator is programmed in software to modulate the nerve.

66. An implantable pulse generator programmed to modulate electrically a nerve in a mammal, in the following sequence of steps:

1) electrically stimulating the nerve for a first time and at a first stimulation intensity;

2) thereafter, electrically simulating the nerve for a second time and at a second stimulation intensity, said second stimulation intensity being greater than said first stimulation intensity;

3) thereafter, providing a period during which electrical stimulation at the nerve is absent or substantially less than the second stimulation intensity.

67. The implantable pulse generator of claim 66, further programmed to repeat steps 1-3.

68. The implantable pulse generator of claim 66, further programmed such that said second stimulation intensity is greater than said first stimulation intensity, and said fourth stimulation intensity is greater than said third stimulation intensity.

69. The implantable pulse generator of claim 66, further programmed such that said second stimulation intensity is about 20% greater than said first stimulation intensity.

70. The implantable pulse generator of claim 66, further programmed such that said first time is between about four hours and about four days.

71. The implantable pulse generator of claim 66, further programmed such that said second time is between about four hours and about four days.

72. The implantable pulse generator of claim 66, further programmed such that said period is between about two days and about seven days.

73. The implantable pulse generator of claim 66, wherein the implantable pulse generator is programmed in hardware to modulate the nerve.

74. The implantable pulse generator of claim 66, wherein the implantable pulse generator is programmed in software to modulate the nerve.