Neural stimulation for treatment of metabolic syndrome and type 2 diabetes

• US 20060190053A1
• Filed: 01/24/2006
• Published: 08/24/2006
• Est. Priority Date: 03/22/2002
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Inventors: Dobak, John D. III
• Granted Patent: US 7,689,277 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• 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 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

Systems and methods are described for treating metabolic syndrome and/or Type 2 diabetes, and/or one or more of their attendant conditions, by neural stimulation. In one embodiment, an implantable pulse generator is electrically coupled to a peripheral nerve, such as the splanchnic nerve. Neural stimulation configured to either block transmission or stimulate transmission of the peripheral nerve may be used to treat metabolic syndrome and Type 2 diabetes.

Claims

1. A method, of treating at least one of metabolic syndrome and Type 2 diabetes, comprising electrically modulating a splanchnic nerve of a patient in a stimulation pattern that ameliorates or eliminates an attendant condition of said at least one of metabolic syndrome and Type 2 diabetes, said attendant condition comprising at least one of dyslipidemia, hypertension, hyperinsulinemia, hyperglycemia and insulin resistance.

2. The method of claim 1, wherein said stimulation pattern comprises a stimulation intensity, and

said stimulation intensity is between 0.005 and 5.0 mA-msec.

3. The method of claim 1, wherein said stimulation pattern comprises a frequency, a pulse width, and a current;

and

wherein said frequency is between 0.1 Hz and 50 Hz;

said pulse width is between 100 microseconds and 1 millisecond; and

said current is between 0.1 mA and 10 mA.

4. The method of claim 1, wherein said stimulation pattern comprises an on time and an off time;

and

wherein said off time is no less than said on time.

5. The method of claim 1, further comprising:

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

applying a second electrical signal to said 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 time period;

thereafter, applying a third electrical signal to said 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; and

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

6. The method of claim 1, further comprising:

applying a first plurality of temporally sequential electrical signals during a first plurality of respective stimulation 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 said nerve during a first no-stimulation period;

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

thereafter, ceasing or substantially reducing electrical stimulation to said nerve during a second no-stimulation period;

7. The method of claim 1, further comprising;

electrically stimulating said nerve for a first time and at a first stimulation intensity;

thereafter, electrically stimulating said nerve for a second time and at a second stimulation intensity, said second stimulation intensity being greater than said first stimulation intensity; and

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

8. The method of claim 1, wherein said attendant condition comprises dyslipidemia.

9. The method of claim 1, wherein said attendant condition comprises hypertension.

10. The method of claim 1, wherein said attendant condition comprises hyperglycemia.

11. The method of claim 1, wherein said attendant condition comprises hyperinsulinemia.

12. The method of claim 1, wherein said attendant condition comprises insulin resistance.

13. The method of claim 8, wherein said dyslipidemia comprises decreased HDL.

14. The method of claim 8, wherein said dyslipidemia comprises elevated triglycerides.

15. The method of claim 8, wherein said dyslipidemia comprises elevated LDL.

16. A method, to increase lean muscle mass of a patient, comprising electrically modulating a sympathetic nerve of a patient in a stimulation pattern effective to increase a lean muscle mass of said patient.

17. The method of claim 16, wherein a splanchnic nerve of the patient comprises said sympathetic nerve.

18. The method of claim 16, wherein said stimulation pattern comprises a frequency, a pulse width, and a current;

and

wherein said frequency is between 0.1 Hz and 50 Hz;

said pulse width is between 100 microseconds and 1 millisecond; and

said current is between 0.1 mA and 10 mA.

19. A tissue modulation device, for treating at least one of metabolic syndrome and type 2 diabetes in a patient, comprising:

a storage module having computer-readable instructions for delivering an electrical stimulation pattern to a splanchnic nerve of the patient;

said pattern being effective to ameliorate at least one attendant condition of said at least one of metabolic syndrome and type 2 diabetes in said patient; and

said attendant condition comprising at least one of dyslipidemia, hypertension, hyperinsulinemia, hyperglycemia, and insulin resistance.

20. The device of claim 19, further comprising:

an energy delivery module that is electrically coupled to said storage module;

wherein said energy delivery module is configured to deliver electrical energy to said splanchnic nerve of said patient according to said instructions.

21. The device of claim 19, wherein an implantable pulse generator comprises said storage module.

25. The device of claim 19, further comprising:

means for delivering electrical energy to said splanchnic nerve of said patient in said pattern according to said instructions;

said means for delivering electrical energy being electrically coupled to said storage module.

22. A tissue modulation device comprising:

a storage module having computer-readable instructions for delivering an electrical stimulation pattern to a splanchnic nerve;

said pattern being effective to increase a lean muscle mass of said patient.

23. The device of claim 22, further comprising:

an energy delivery module that is electrically coupled to said storage module;

wherein said energy delivery module is configured to deliver electrical energy to said splanchnic nerve of said patient according to said instructions.

24. A tissue modulation device, for treating at least one of metabolic syndrome and type 2 diabetes in a patient, comprising:

means for storing computer-readable instructions for delivering an electrical stimulation pattern to a splanchnic nerve of the patient;

said pattern being effective to ameliorate at least one attendant condition of said at least one of metabolic syndrome and type 2 diabetes in said patient; and

said attendant condition comprising at least one of dyslipidemia, hypertension, hyperinsulinemia, hyperglycemia, and insulin resistance.

26. A tissue modulation device comprising:

means for storing computer-readable instructions for delivering an electrical stimulation pattern to a splanchnic nerve of the patient;

said pattern being effective to increase a lean muscle mass of said patient.

27. The device of claim 26, further comprising:

means for delivering electrical energy to said splanchnic nerve of said patient in said pattern according to said instructions;

said means for delivering electrical energy being electrically coupled to said storage module.

28. A method, to increase a concentration of HDL in a patient, comprising:

electrically modulating a sympathetic nerve of a patient in a stimulation pattern;

said pattern being effective to increase the concentration of HDL of said patient.

29. The method of claim 28, wherein a splanchnic nerve comprises said sympathetic nerve.

30. A method, to decrease a concentration of LDL in a patient, comprising:

electrically modulating a sympathetic nerve of a patient in a stimulation pattern;

said pattern being effective to decrease the concentration of LDL in said patient.

31. The method of claim 30, wherein a splanchnic nerve comprises said sympathetic nerve.

32. A method, to decrease a concentration of serum cholesterol in a patient, comprising:

electrically modulating a sympathetic nerve of a patient in a stimulation pattern;

said pattern being effective to decrease the concentration of serum cholesterol in said patient.

33. The method of claim 32, wherein a splanchnic nerve comprises said sympathetic nerve.

34. A method, to reduce a concentration of serum triglycerides in a patient, comprising:

electrically modulating a sympathetic nerve of a patient in a stimulation pattern;

said pattern being effective to reduce the concentration of serum triglycerides in said patient.

35. The method of claim 34, wherein a splanchnic nerve comprises said sympathetic nerve.

36. A method, to treat hypertension in a patient, comprising:

electrically modulating a sympathetic nerve of a patient in a stimulation pattern;

said pattern being effective to ameliorate hypertension in said patient.