Dynamic nerve stimulation employing frequency modulation

• US 20080033511A1
• Filed: 06/11/2007
• Published: 02/07/2008
• 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
• Granted Patent: US 7,937,145 B2
• Time in Patent Office: Days
• US Class Current: 607/66
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61B 6/482 involving multiple energy imaging
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Described are apparatus and methods for electrically modulating a nerve in a mammal. An electrical signal that includes a signal intensity pattern and a signal frequency pattern is delivered to a nerve. The combination of the signal intensity pattern and the signal frequency pattern is effective to result in weight loss, fat loss, and/or lean-mass gain, in a mammal. In some embodiments the nerve is modulated in response to a physiological parameter. In some embodiments, the physiological parameter is measured by a sensor.

Claims

1. An implantable medical device that outputs a configured electrical signal effective to modulate a nerve in a mammal;

wherein the electrical signal comprises;

a stimulation intensity pattern that varies at least one of a current amplitude and a pulse width in the signal; and

a stimulation frequency pattern that varies frequency in the signal;

wherein the combination of the stimulation intensity pattern and the stimulation frequency pattern in the electrical signal, as applied to a nerve in the mammal, is effective to result in at least one of a loss of fat mass and a gain in lean mass of the mammal.

2. The device of claim 1, wherein the stimulation intensity pattern and stimulation frequency pattern are varied over time, independently of each other.

3. The device of claim 1, wherein the stimulation intensity pattern comprises:

stimulating at a first intensity during at least a portion of a first interval;

stimulating at a second intensity during at least a portion of a second interval.

4. The device of claim 1, wherein the device is configured to deliver the stimulation intensity pattern at least once in a 24 hour period.

5. The device of claim 3, wherein the first intensity comprises a current of about 2.5 mA to about 5.0 mA.

6. The device of claim 3, wherein the second intensity comprises a current of about 0 mA to about 1.0 mA.

7. The device of claim 3, wherein the first intensity comprises a current of about 3.5 mA and the second intensity comprises a current of about 0.5 mA.

8. The device of claim 1, wherein the stimulation frequency pattern comprises at least one change in frequency.

9. The device of claim 8, wherein the at least one change in frequency occurs at a constant rate.

10. The device of claim 9, wherein the at least one change in frequency occurs by at least one increment.

11. The device of claim 10, where the at least one increment of about 1 Hz to about 20 Hz.

12. The device of claim 10, where the at least one increment of about 2 Hz to about 10 Hz.

13. The device of claim 1, wherein the stimulation frequency pattern comprises:

a first stimulation frequency applied during a first portion of the stimulation frequency pattern;

a second stimulation frequency applied during a second portion of the stimulation frequency pattern; and

a third stimulation frequency applied during a third portion of the stimulation frequency pattern.

14. The device of claim 13, wherein the first stimulation frequency is about 10 Hz, the second stimulation frequency is about 20 Hz, and the third stimulation frequency is about 30 Hz.

15. The device of claim 14, wherein the stimulation frequency pattern further comprises a fourth stimulation frequency applied during a fourth portion of the stimulation frequency pattern.

16. The device of claim 15, wherein the fourth stimulation frequency is about 40 Hz.

17. The device of claim 1, further configured to deliver the stimulation frequency pattern at least once in a 24 hour period.

18. The device of claim 1, further configured to modulate a sympathetic nerve.

19. The device of claim 1, further configured to modulate a splanchnic nerve, wherein the splanchnic nerve comprises at least one of a greater splanchnic nerve, a lesser splanchnic nerve, and a least splanchnic nerve.

20. The device of claim 1, wherein the nerve comprises a parasympathetic nerve.

21. The device of claim 1, wherein the nerve comprises a vagus nerve.

22. The device of claim 1, wherein the device is configured to deliver the electrical signal in response to a physiological parameter.

23. The device of claim 22, wherein the physiological parameter is at least one of eating, a blood glucose level, a blood insulin level, a blood cholesterol level, a blood HDL level, a blood LDL level, a ghrelin level, a leptin level, a catecholamine level, an adipokine level, and an arterial pressure.

24. The device of claim 22, further comprising a sensor configured to measure the physiological parameter, and wherein the device is configured to deliver the electrical signal in response to a signal received from the sensor.

25. The device of claim 24, wherein the sensor is positionable within the body of the mammal.

26. The device of claim 1, configured to be implanted in a human patient.

27. The device of claim 26, configured to deliver the electrical signal in response to a command from the patient.

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

configuring an electrical signal to comprise;

a stimulation intensity pattern that varies at least one of a current amplitude and a pulse width in the signal; and

a stimulation frequency pattern that varies frequency in the signal; and

applying the electrical signal to a nerve in the mammal;

wherein the combination of the stimulation intensity pattern and the stimulation frequency pattern in the electrical signal, as applied to a nerve in the mammal, is effective to result in at least one of a loss of fat mass and a gain in lean mass of the mammal.

29. The method of claim 28, wherein the stimulation intensity pattern and stimulation frequency pattern are varied over time, independently of each other.

30. The method of claim 28, wherein the stimulation intensity pattern comprises:

stimulating at a first intensity during at least a portion of a first interval;

stimulating at a second intensity during at least a portion of a second interval.

31. The method of claim 30, wherein the stimulation intensity pattern is repeated at least once in a 24 hour period.

32. The method of claim 30, wherein the first intensity is about 2.5 mA to about 5 mA.

33. The method of claim 30, wherein the second intensity is about 0 mA to about 1.0 mA.

34. The method of claim 30, wherein the first intensity comprises a current of about 3.5 mA and the second intensity comprises a current of about 0.5 mA.

35. The method of claim 30, wherein the stimulation frequency pattern comprises at least one change in frequency.

36. The method of claim 35, wherein the at least one change in frequency occurs at a constant rate.

37. The method of claim 36, wherein the at least one change in frequency occurs by at least one increment.

38. The method of claim 37, wherein the at least one increment is about 1 Hz to about 20 Hz.

39. The method of claim 37, wherein the at least one increment is about 2 Hz to about 10 Hz.

40. The method of claim 28, wherein the stimulation frequency pattern comprises:

applying the electrical signal at a first stimulation frequency during a first portion of the stimulation frequency pattern;

applying the electrical signal at a second stimulation frequency during a second portion of the stimulation frequency pattern;

applying the electrical signal at a third stimulation frequency during a third portion of the stimulation frequency pattern.

41. The method of claim 35, wherein the first stimulation frequency is about 10 Hz, the second stimulation frequency is about 20 Hz, and the third stimulation frequency is about 30 Hz.

42. The method of claim 35, further comprising applying the electrical signal at a fourth stimulation frequency during a fourth portion of the stimulation frequency pattern.

43. The method of claim 42, wherein the fourth frequency is about 40 Hz.

44. The method of claim 35, wherein the stimulation frequency pattern is repeated at least once in a 24 hour period.

45. The method of claim 28, wherein the nerve comprises a sympathetic nerve.

46. The method of claim 28, wherein the nerve comprises a splanchnic nerve, wherein the splanchnic nerve comprises at least one of a greater splanchnic nerve, a lesser splanchnic nerve, and a least splanchnic nerve.

47. The method of claim 28, wherein the nerve comprises a parasympathetic nerve.

48. The method of claim 28, wherein the nerve comprises a vagus nerve.

49. The method of claim 28, wherein the electrical signal is applied in response to a physiological parameter.

50. The method of claim 49, wherein the physiological parameter comprises at least one of eating, a blood glucose level, a blood insulin level, a blood cholesterol level, a blood HDL level, a blood LDL level, a ghrelin level, a leptin level, a catecholamine level, an adipokine level, and an arterial pressure.

51. The method of claim 49, wherein the electrical signal is applied in response to a signal from a sensor configured to measure the physiological parameter.

52. The method of claim 51, wherein the sensor is positionable within the body of the mammal.

53. The method of claim 28, wherein the mammal is a human patient.

54. The method of claim 53, wherein the electrical signal is applied in response to a command from the patient.