Single-pulse activation of the cholinergic anti-inflammatory pathway to treat chronic inflammation

• US 8,788,034 B2
• Filed: 05/09/2012
• Issued: 07/22/2014
• Est. Priority Date: 05/09/2011
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Levine, Jacob A., Faltys, Michael A.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US13/467,928
• Publication Number:
  US 20120290035A1
• Time in Patent Office: 804 Days
• Field of Search: 607/2, 607 72- 76
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

Described herein are methods and systems for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation. In particular, described herein are single supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >4 hours, greater than 12 hours, greater than 24 hours, greater than 48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation. These methods and devices are particularly of interest in treatment of inflammatory bowel disease (IBD).

Claims

1. A system for treating chronic inflammation in a patient, the system comprising:

an implantable microstimulator configured to apply a low duty-cycle stimulation to a vagus nerve, wherein the low duty-cycle stimulation provides no more than a single supra-threshold pulse every four hours; and

a controller configured to set a dose for the microstimulator wherein the dose comprises the single supra-threshold pulse followed by an off-period of at least four hours, wherein the single supra-threshold pulse is configured to reduce a level of inflammation in the patient.

2. The system of claim 1, wherein the off-period is at least 24 hours.

3. The system of claim 1, wherein the off-period is at least 48 hours.

4. The system of claim 1, wherein the single supra-threshold pulse has a pulse amplitude of less than 5 mA.

5. The system of claim 1, wherein the single supra-threshold pulse has a pulse amplitude of less than 3 mA.

6. The system of claim 1, wherein the single supra-threshold pulse has a pulse amplitude of less than 2 mA.

7. The system of claim 1, wherein the single supra-threshold pulse is biphasic.

8. The system of claim 1, wherein the chronic inflammation is intestinal inflammation.

9. The system of claim 1, wherein the chronic inflammation is inflammatory bowel disease.

10. The system of claim 1, wherein the chronic inflammation is Crohn'"'"'s disease.

11. A method of treating chronic inflammation in a patient, the method comprising:

implanting a microstimulator; and

applying only a single supra-threshold stimulus pulse from the microstimulator to the vagus nerve followed by an off-time of at least 4 hours; and

reducing a level of inflammation in the patient.

12. The method of claim 11, wherein the off-time is at least 24 hours.

13. The method of claim 11, wherein the off-time is at least 48 hours.

14. The method of claim 11, wherein the single supra-threshold stimulus pulse has a pulse amplitude of less than 5 mA.

15. The method of claim 11, wherein the single supra-threshold stimulus pulse has a pulse amplitude of less than 3 mA.

16. The method of claim 11, wherein the single supra-threshold stimulus pulse has a pulse amplitude of less than 2 mA.

17. The method of claim 11, wherein the single supra-threshold stimulus pulse is biphasic.

18. The method of claim 11, wherein the chronic inflammation is intestinal inflammation.

19. The method of claim 11, wherein the chronic inflammation is inflammatory bowel disease.

20. The method of claim 11, wherein the chronic inflammation is Crohn'"'"'s disease.