Electric modulation of sympathetic nervous system

• US 20030181958A1
• Filed: 09/13/2002
• Published: 09/25/2003
• Est. Priority Date: 03/22/2002
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Leptos Biomedical, Inc. (Abbott Laboratories)
• Inventors: Dobak, John D. III
• Granted Patent: US 7,239,912 B2
• Time in Patent Office: Days
• US Class Current: 607/58
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity

Abstract

A method for the treatment of obesity or other disorders, by electrical activation or inhibition of the sympathetic nervous system. This activation or inhibition can be accomplished by electrically stimulating the greater splanchnic nerve or other portion of the sympathetic nervous system using an implantable pulse generator. This nerve activation can result in reduced food intake and increased energy expenditure. Reduced food intake may occur through a variety of mechanisms that reduce appetite and cause satiety. Increased adrenal gland hormone levels will result in increased energy expenditure. Fat and carbohydrate metabolism, which are also increased by sympathetic nerve activation, will accompany the increased energy expenditure.

Claims

1. A method for treating a medical condition by electrically modulating the sympathetic nervous system.

2. The method recited in claim 1, wherein said modulation comprises activation of the sympathetic nervous system.

3. The method recited in claim 2, wherein said activation comprises activation of the splanchnic nerve to induce weight loss.

4. The method recited in claim 3, wherein said activation of the splanchnic nerve induces weight loss by reducing appetite.

5. The method recited in claim 4, wherein said activation of the splanchnic nerve reduces appetite by reducing plasma ghrelin hormone levels.

6. The method recited in claim 3, wherein said activation of the splanchnic nerve induces weight loss by increasing energy expenditure.

7. The method recited in claim 6, wherein said activation of the splanchnic nerve increases energy expenditure by increasing plasma catecholamine levels.

8. The method recited in claim 3, wherein said activation of the splanchnic nerve induces weight loss by normalizing catecholamine levels.

9. The method recited in claim 3, wherein said activation of the splanchnic nerve induces weight loss by inducing satiety.

10. The method recited in claim 9, wherein said activation reduces gastric motility.

11. The method recited in claim 9, wherein said activation increases pyloric sphincter tone.

12. The method recited in claim 9, wherein said activation delays gastric emptying.

13. The method recited in claim 2, wherein said activation comprises activation of the sympathetic chain ganglia.

14. The method recited in claim 13, wherein said activation of sympathetic chain ganglia comprises activation of ganglia in the thoracic region from T4 to T12.

15. The method recited in claim 2, wherein said activation comprises activation of peripheral sympathetic ganglia.

16. The method recited in claim 15, wherein said activation of peripheral ganglia comprises activation of at least one ganglia selected from the group of the celiac ganglia, the superior mesenteric ganglia, and the inferior mesenteric ganglia.

17. The method recited in claim 2, wherein said activation comprises:

activation of the splanchnic nerve to reduce plasma ghrelin levels, thereby reducing appetite;

activation of the splanchnic nerve to increase plasma glucose levels, thereby reducing appetite; and

activation of the splanchnic nerve to increase plasma catecholamine levels, thereby increasing energy expenditure.

18. The method recited in claim 2, wherein said activation comprises activation of the splanchnic nerve to reduce insulin secretion.

19. The method recited in claim 2, wherein said activation of the sympathetic nervous system treats Type II diabetes.

20. The method recited in claim 2, wherein said activation comprises activation of the splanchnic nerve to treat irritable bowel syndrome.

21. The method recited in claim 1, wherein said modulation comprises inhibition of the sympathetic nervous system.

22. The method recited in claim 21, wherein said inhibition comprises inhibition of the splanchnic nerve to relieve pain.

23. The method recited in claim 21, wherein said inhibition comprises inhibition of the splanchnic nerve to treat anorexia.

24. The method recited in claim 1, wherein said modulation comprises modulation of the celiac ganglia.

25. The method recited in claim 1, wherein said modulation comprises modulation of the sympathetic chain ganglia.

26. A method for treating obesity, comprising:

monitoring a selected patient parameter; and

electrically activating the sympathetic nervous system of said patient to achieve a desired level in said monitored parameter.

27. The method recited in claim 26, wherein:

said monitored parameter is plasma catecholamine level; and

said electrical activation comprises activation of the sympathetic nervous system to achieve an increased plasma catecholamine level, thereby increasing energy expenditure.

28. The method recited in claim 26, wherein:

said monitored parameter is plasma catecholamine level; and

said electrical activation comprises activation of the sympathetic nervous system to achieve normalization of reduced catecholamine levels.

29. The method recited in claim 26, wherein:

said monitored parameter is plasma ghrelin level; and

said electrical activation comprises activation of the sympathetic nervous system to achieve a decreased plasma ghrelin level, thereby decreasing appetite.

30. The method recited in claim 26, wherein:

said monitored parameter is mean arterial blood pressure; and

said electrical activation comprises activation of the sympathetic nervous system with stimulation parameters that prevent a rise in mean arterial blood pressure.

31. The method recited in claim 26, wherein said monitored parameter is mean arterial blood pressure, said method further comprising simultaneously delivering an alpha-adrenergic receptor blocking drug to said patient.

32. A method for treating a medical condition, comprising:

electrically activating the sympathetic nervous system; and

simultaneously administering an alpha-adrenergic receptor blocking drug.

33. A method for treating a medical disorder, comprising:

monitoring a patient vital sign and a second selected patient parameter; and

electrically activating the sympathetic nervous system of said patient to achieve a desired change in said second selected patient parameter while limiting change in said vital sign.

34. The method recited in claim 33, wherein:

said medical disorder being treated is obesity;

said vital sign is mean arterial blood pressure;

said monitored parameter is plasma catecholamine level;

said electrical activation comprises activation of the sympathetic nervous system to achieve an increased plasma catecholamine level, thereby increasing at-rest energy expenditure; and

said electrical activation has a signal-on time no greater than the signal-off time, thereby preventing an increase in mean arterial blood pressure.

35. The method recited in claim 33, wherein:

said medical disorder being treated is obesity;

said vital sign is mean arterial blood pressure;

said monitored parameter is plasma ghrelin level;

said electrical activation comprises activation of the sympathetic nervous system to achieve a decreased plasma ghrelin level, thereby decreasing appetite; and

said electrical activation has a signal-on time no greater than the signal-off time, thereby preventing an increase in mean arterial blood pressure.

36. The method recited in claim 33, wherein:

said medical disorder being treated is obesity;

said vital sign is mean arterial blood pressure;

said monitored parameter is plasma glucose level;

said electrical activation comprises activation of the sympathetic nervous system to achieve an increased plasma glucose level, thereby decreasing appetite; and

said electrical activation has a signal-on time no greater than the signal-off time, thereby preventing an increase in mean arterial blood pressure.

37. The method recited in claim 33, wherein:

said medical disorder being treated is Type II diabetes;

said vital sign is mean arterial blood pressure;

said monitored parameter is insulin level;

said electrical activation comprises activation of the sympathetic nervous system to achieve a decreased insulin level, thereby reducing insulin resistance; and

said electrical activation has a signal-on time no greater than the signal-off time, thereby preventing an increase in mean arterial blood pressure.

38. A procedure for implanting an electrode on the splanchnic nerve, comprising:

providing an introducer needle insulated except at its tip;

inserting said introducer needle into a patient;

applying an electrical pulse to said introducer needle;

varying the current amplitude of said electrical pulse;

monitoring for at least one change in at least one vital sign indicative of proximity of said introducer needle to the splanchnic nerve, said at least one vital sign change being selected from the group of a rise in mean arterial pressure and a decrease in heart rate; and

inserting an electrode and lead assembly through said introducer needle to place said electrode adjacent to the splanchnic nerve.

39. A method for activating the splanchnic nerve to treat obesity, said method comprising:

applying a current pulse to the splanchnic nerve; and

selecting the duration of said current pulse to be no greater than the chronaxie of the splanchnic nerve.

40. The method recited in claim 39, further comprising selecting said duration of said pulse to be between 100 microseconds and 400 microseconds.

41. A method for activating the splanchnic nerve to treat obesity, said method comprising:

implanting a pulse generator within a patient, said pulse generator having programmable signal-on and signal-off times;

applying a current pulse to the splanchnic nerve with said pulse generator; and

programming said signal-on and signal-off times to maintain plasma epinephrine levels between 50 pg/ml and 1000 pg/ml.

42. A method for activating the splanchnic nerve to treat obesity, said method comprising:

implanting a pulse generator within a patient, said pulse generator having programmable treatment parameters;

applying a current pulse to the splanchnic nerve with said pulse generator; and

programming said treatment parameters to maintain plasma ghrelin levels below 250 pg/ml.

43. A method for treating a medical condition, comprising:

providing a pulse generator having programmable stimulation parameters;

programming said parameters to stimulate type B neurons; and

activating the sympathetic nervous system with said pulse generator.

44. The method recited in claim 43, wherein said stimulation parameters comprise current amplitude and pulse width, said method further comprising programming said pulse generator to produce a pulse having a current amplitude and a pulse width adapted to activate type B neurons.

45. A method for treating obesity, comprising unipolar stimulation of the splanchnic nerve.

46. The method recited in claim 45, further comprising:

placing a first electrode in general proximity to the splanchnic nerve; and

generating a sufficiently large energy field with said first electrode to electrically couple with a second electrode remote from said first electrode, said energy field being sufficiently large to stimulate a splanchnic nerve in general proximity to said first electrode.

47. The method recited in claim 46, further comprising:

implanting a pulse generator within a patient, remote from said splanchnic nerve, said pulse generator having an external portion adapted to function as said remote second electrode; and

applying a current pulse to said first electrode with said pulse generator, said current pulse being sufficiently large to electrically couple said first electrode with said external portion of said pulse generator.

48. The method recited in claim 47, further comprising providing a housing on said pulse generator adapted to function as said second electrode.