Nerve stimulation for treatment of obesity, metabolic syndrome, and Type 2 diabetes

• US 7,702,386 B2
• Filed: 01/24/2007
• Issued: 04/20/2010
• Est. Priority Date: 03/22/2002
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Leptos Biomedical, Inc. (Abbott Laboratories Incorporated)
• Inventors: Dobak, John D., Neisz, Hans
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Oropeza; Frances P
• Application Number:
  US11/657,877
• Publication Number:
  US 20070203521A1
• Time in Patent Office: 1,182 Days
• Field of Search: 600/373, 600/377, 600/593, 607/2, 607/115, 607/116, 607/133
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

The disclosure provides a description of a tissue modulation device, for treating at least one of obesity, metabolic syndrome, and Type 2 diabetes in a patient. In some embodiments, the device includes a storage module having computer-readable instructions for delivering an electrical stimulation pattern to a splanchnic nerve of the patient. The stimulation pattern includes at least one on-time. The on-time includes at least one of a suprathreshold period and a subthreshold period. The splanchnic nerve is selected from the group consisting of the greater splanchnic nerve, the lesser splanchnic nerve, and the least splanchnic nerve. The pattern is effective to ameliorate at least one attendant condition of obesity, metabolic syndrome, and Type 2 diabetes in the patient. The attendant condition includes dyslipidemia, hypertension, hyperinsulinemia, hyperglycemia, and/or insulin resistance.

Claims

1. A method, for treating at least one of obesity, Type 2 diabetes, and metabolic syndrome in a patient, comprising:

providing a pulse generator, the pulse generator having a programmable stimulation pattern configured to deliver energy to an at least one nerve fiber group in a splanchnic nerve with a signal-on time that comprises a subthreshold period and a suprathreshold period and wherein the stimulation pattern comprises a frequency, a pulse width and a current, wherein the frequency is between about 0.1 Hz and 500 Hz, the pulse width is between about 100 microseconds and about 1 millisecond, and the current is between about 0.1 mA and about 10 mA;

electrically stimulating the nerve fiber group during the subthreshold period, wherein the subthreshold period comprises a period in which the energy delivered to the nerve fiber group is below the threshold for exciting the nerve fiber group;

electrically activating the nerve fiber group during the suprathreshold period, wherein the suprathreshold period comprises a period in which the energy delivered to the nerve fiber group meets or exceeds a threshold for exciting the nerve fiber group;

and wherein the stimulation pattern is configured to ameliorate or eliminate the at least one of obesity, metabolic syndrome, and Type 2 diabetes in the patient.

2. The method of claim 1, further comprising programming the stimulation pattern so as to keep the patient'"'"'s blood pressure within safe limits.

3. The method of claim 1, wherein the suprathreshold period comprises a frequency that is less than the subthreshold period.

4. The method of claim 1, further comprising selecting a patient with a waistline of greater than 35 inches.

5. The method of claim 1, wherein the programmable stimulation pattern comprises the signal-on time and a signal-off time

wherein the signal-off time is no less than the signal-on time.

6. The method of claim 1, wherein the stimulation pattern comprises a substantially continuous signal-on time, wherein the signal-on time is comprised of at least one suprathreshold period and at least one subthreshold period.

7. The method of claim 1, wherein the subthreshold period is greater than the suprathreshold period.

8. The method of claim 1, wherein the suprathreshold period is greater than the subthreshold period.

9. The method of claim 1, wherein the step of electrically activating the nerve group comprises selectively activating an A fiber group, a B fiber group, a C fiber group or combinations thereof.

10. The method of claim 1, wherein the programmable stimulation pattern comprises an intermittent electrical signal, comprising a frequency, a pulse width and a current, wherein the intermittent signal comprises a stimulation time period and a no stimulation time period and wherein the stimulation time period comprises the signal-on time and a signal-off time and wherein the intermittent electrical signal changes frequently enough and substantially enough to prevent compensation.

11. The method of claim 10, wherein the subthreshold period comprises a current and the current increases after the signal-off time.

12. The method of claim 10, wherein the suprathreshold current increases after the signal-off time.

13. The method of claim 10, wherein the subthreshold current decreases after the signal-off time.

14. The method of claim 10, wherein the suprathreshold current decreases after the signal-off time.

15. The method of claim 1, wherein the suprathreshold period comprises a pulse width and the subthreshold period comprises a pulse width and wherein the suprathreshold pulse width is greater than the subthreshold pulse width.

16. The method of claim 1, wherein the patient comprises lean muscle mass and wherein the lean muscle mass is maintained.

17. The method of claim 1, wherein the patient comprises at least one attendant condition selected from the group consisting of insulin resistance, hyperglycemia, dyslipidemia, hypertension, and hyperinsulinemia.

18. The method of claim 17, further comprising selecting a patient with insulin resistance.

19. The method of claim 17, further comprising selecting a patient with hyperglycemia.

20. The method of claim 17, further comprising selecting a patient with dyslipidemia.

21. The method of claim 20, wherein the dyslipidemia comprises decreased HDL.

22. The method of claim 20, wherein the dyslipidemia comprises elevated triglycerides.

23. The method of claim 20, wherein the dyslipidemia comprises elevated LDL.

24. The method of claim 17, further comprising selecting a patient with hypertension.

25. The method of claim 17, further comprising selecting a patient with hyperinsulinemia.

26. The method of claim 1, wherein the suprathreshold period comprises a frequency and wherein the frequency is less than 10 Hz.

27. The method of claim 1, wherein the signal-on time comprises at least two subthreshold periods and at least one suprathreshold period.

28. The method of claim 1, where in the splanchnic nerve is selected from the group consisting of the greater splanchnic nerve, lessor splanchnic nerve and least splanchnic nerve.

29. A method of treating at least one of obesity, type 2 diabetes, and metabolic syndrome comprising:

providing a pulse generator, the pulse generator having a programmable stimulation pattern configured to deliver energy to a C fiber group in a splanchnic nerve with a signal-on time that comprises a subthreshold period and a suprathreshold period and wherein the stimulation pattern comprises a frequency, a pulse width and a current, wherein the frequency is between about 0.1 Hz and 500 Hz, the pulse width is between about 100 microseconds and about 1 millisecond, and the current is between about 0.1 mA and about 10 mA;

electrically stimulating the C fiber group during the subthreshold period,

electrically stimulating the C fiber group during the subthreshold period, wherein the subthreshold period comprises a period in which the energy delivered to the C fiber group is below the threshold for exciting the C fiber group;

electrically activating the C fiber group during the suprathreshold period, wherein the suprathreshold period comprises a period in which the energy delivered to the C fiber group meets or exceeds a threshold for exciting the C fiber group;

and wherein the stimulation pattern is configured to ameliorate or eliminate the at least one of obesity, metabolic syndrome, and Type 2 diabetes in the patient.

30. The method of claim 29, wherein the signal-on time comprises at least two subthreshold periods and at least one suprathreshold period.

31. The method of claim 29, further comprising programming the stimulation pattern so as to keep the patient'"'"'s blood pressure within safe limits.

32. The method of claim 29, wherein the suprathreshold period comprises a frequency that is less than the subthreshold period.

33. The method of claim 29, further comprising selecting a patient with a waistline of greater than 35 inches.

34. The method of claim 29, wherein the programmable stimulation pattern comprises the signal-on time and a signal-off time, wherein the signal-off time is no less than the signal-on time.

35. The method of claim 29, wherein the stimulation pattern comprises a substantially continuous signal-on time, wherein the signal-on time is comprised of at least one suprathreshold period and at least one subthreshold period.

36. The method of claim 29, wherein the subthreshold period is greater than the suprathreshold period.

37. The method of claim 29, wherein the suprathreshold period is greater than the subthreshold period.

38. The method of claim 29, wherein the programmable stimulation pattern comprises an intermittent electrical signal, comprising a frequency, a pulse width and a current, wherein the intermittent signal comprises a stimulation time period and a no stimulation time period and wherein the stimulation time period comprises the signal-on time and a signal-off time and wherein the intermittent electrical signal changes frequently enough and substantially enough to prevent compensation.

39. The method of claim 29, wherein the subthreshold period comprises a current and the current increases after the signal-off time.

40. The method of claim 29, wherein the suprathreshold current increases after the signal-off time.

41. The method of claim 29, wherein the subthreshold current decreases after the signal-off time.

42. The method of claim 29, wherein the suprathreshold current decreases after the signal-off time.

43. The method of claim 29, wherein the suprathreshold period comprises a pulse width and the subthreshold period comprises a pulse width and wherein the suprathreshold pulse width is greater than the subthreshold pulse width.

44. The method of claim 29, wherein the patient comprises lean muscle mass and wherein the lean muscle mass is maintained.

45. The method of claim 29, wherein the patient comprises at least one attendant condition selected from the group consisting of insulin resistance, hyperglycemia, dyslipidemia, hypertension, and hyperinsulinemia.

46. The method of claim 45, further comprising selecting a patient with insulin resistance.

47. The method of claim 45, further comprising selecting a patient with hyperglycemia.

48. The method of claim 45, further comprising selecting a patient with dyslipidemia.

49. The method of claim 48, wherein the dyslipidemia comprises decreased HDL.

50. The method of claim 48, wherein the dyslipidemia comprises elevated triglycerides.

51. The method of claim 48, wherein the dyslipidemia comprises elevated LDL.

52. The method of claim 45, further comprising selecting a patient with hypertension.

53. The method of claim 45, further comprising selecting a patient with hyperinsulinemia.

54. The method of claim 29, wherein the suprathreshold period comprises a frequency and wherein the frequency is less than 10 Hz.

55. The method of claim 29, wherein the subthreshold period comprises a current and the current increases after the signal-off time.

56. The method of claim 29, where in the splanchnic nerve is selected from the group consisting of the greater splanchnic nerve, lessor splanchnic nerve and least splanchnic nerve.

57. A method of treating at least one of obesity, type 2 diabetes, and metabolic syndrome comprising:

providing a pulse generator, the pulse generator having a programmable stimulation pattern configured to deliver energy to a B fiber group in a splanchnic nerve with a signal-on time that comprises a subthreshold period and a suprathreshold period and wherein the stimulation pattern comprises a frequency, a pulse width and a current, wherein the frequency is between about 0.1 Hz and 500 Hz, the pulse width is between about 100 microseconds and about 1 millisecond, and the current is between about 0.1 mA and about 10 mA;

electrically stimulating the B fiber group during the subthreshold period,

electrically stimulating the B fiber group during the subthreshold period, wherein the subthreshold period comprises a period in which the energy delivered to the B fiber group is below the threshold for exciting the B fiber group;

electrically activating the B fiber group during the suprathreshold period, wherein the suprathreshold period comprises a period in which the energy delivered to the B fiber group meets or exceeds a threshold for exciting the B fiber group;

and wherein the stimulation pattern is configured to ameliorate or eliminate the at least one of obesity, metabolic syndrome, and Type 2 diabetes in the patient.

58. The method of claim 57, wherein the signal-on time comprises at least two subthreshold periods and at least one suprathreshold period.

59. The method of claim 57, further comprising programming the stimulation pattern so as to keep the patient'"'"'s blood pressure within safe limits.

60. The method of claim 57, wherein the suprathreshold period comprises a frequency that is less than the subthreshold period.

61. The method of claim 57, further comprising selecting a patient with a waistline of greater than 35 inches.

62. The method of claim 57, wherein the programmable stimulation pattern comprises the signal-on time and a signal-off time, wherein the signal-off time is no less than the signal-on time.

63. The method of claim 57, wherein the stimulation pattern comprises a substantially continuous signal-on time, wherein the signal-on time is comprised of at least one suprathreshold period and at least one subthreshold period.

64. The method of claim 57, wherein the subthreshold period is greater than the suprathreshold period.

65. The method of claim 57, wherein the suprathreshold period is greater than the subthreshold period.

66. The method of claim 57, wherein the programmable stimulation pattern comprises an intermittent electrical signal, comprising a frequency, a pulse width and a current, wherein the intermittent signal comprises a stimulation time period and a no stimulation time period and wherein the stimulation time period comprises the signal-on time and a signal-off time and wherein the intermittent electrical signal changes frequently enough and substantially enough to prevent compensation.

67. The method of claim 57, wherein the suprathreshold current increases after the signal-off time.

68. The method of claim 57, wherein the subthreshold current decreases after the signal-off time.

69. The method of claim 57, wherein the suprathreshold current decreases after the signal-off time.

70. The method of claim 57, wherein the suprathreshold period comprises a pulse width and the subthreshold period comprises a pulse width and wherein the suprathreshold pulse width is greater than the subthreshold pulse width.

71. The method of claim 57, wherein the patient comprises lean muscle mass and wherein the lean muscle mass is maintained.

72. The method of claim 57, wherein the patient comprises at least one attendant condition selected from the group consisting of insulin resistance, hyperglycemia, dyslipidemia, hypertension, and hyperinsulinemia.

73. The method of claim 72, further comprising selecting a patient with insulin resistance.

74. The method of claim 72, further comprising selecting a patient with hyperglycemia.

75. The method of claim 72, further comprising selecting a patient with dyslipidemia.

76. The method of claim 75, wherein the dyslipidemia comprises decreased HDL.

77. The method of claim 75, wherein the dyslipidemia comprises elevated triglycerides.

78. The method of claim 75, wherein the dyslipidemia comprises elevated LDL.

79. The method of claim 72, further comprising selecting a patient with hypertension.

80. The method of claim 72, further comprising selecting a patient with hyperinsulinemia.

81. The method of claim 57, wherein the suprathreshold period comprises a frequency and wherein the frequency is less than 10 Hz.

82. The method of claim 57, where in the splanchnic nerve is selected from the group consisting of the greater splanchnic nerve, lessor splanchnic nerve and least splanchnic nerve.