MODULATION OF THE CHOLINERGIC ANTI-INFLAMMATORY PATHWAY TO TREAT PAIN OR ADDICTION

• US 20110106208A1
• Filed: 11/01/2010
• Published: 05/05/2011
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Levine, Jacob A., Faltys, Michael A.
• Granted Patent: US 8,996,116 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Methods and devices for the treatment of chronic pain by modulation of the cholinergic anti-inflammatory pathway. In particular, the methods and systems described herein may be used to enhance chronic pain therapies such as spinal cord stimulation (SCS). Thus, the present invention describes devices and methods for modulation of the cytokine pathway by stimulation of the neuronal cholinergic anti-inflammatory pathway (NCAP) to enhance the treatment of chronic pain by SCS. The use of NCAP in conjunction with SCS may potentiate the effects of SCS and/or prevent the desensitization of the patient to SCS.

Claims

1. A method of enhancing spinal cord stimulation (SCS) therapy to treat chronic pain, the method comprising:

electrically stimulating the neuronal cholinergic anti-inflammatory pathway; and

concurrently treating the patient with spinal cord stimulation.

2. The method of claim 1, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises stimulating the vagus nerve.

3. The method of claim 1, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises stimulating in an amount sufficient to disrupt or counter the release of inflammatory cytokines from glial cells.

4. The method of claim 1, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises electrically stimulating the vagus nerve with between about 0.5 to about 2.0 mA of current.

5. The method of claim 1, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises electrically stimulating the vagus nerve vagus nerve for approximately 1 minute once per day.

6. The method of claim 1, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises electrically stimulating the vagus nerve with between about 0.5 to about 2.0 mA of current to the vagus nerve for approximately 1 minute once per day.

7. The method of claim 1, wherein the step of concurrently treating the patient with spinal cord stimulation comprises electrically stimulating the spinal cord or spinal nerves.

8. The method of claim 1, wherein the step of concurrently treating the patient with spinal cord stimulation comprises treating the patient with spinal cord stimulation after the stimulation of the neuronal cholinergic anti-inflammatory pathway in an amount sufficient to disrupt or counter the release of inflammatory cytokines from glial cells.

9. The method of claim 1, wherein the step of concurrently treating the patient with spinal cord stimulation comprises treating the patient with spinal cord stimulation within 1 day of stimulating the neuronal cholinergic anti-inflammatory pathway.

10. The method of claim 1, wherein the step of concurrently treating the patient with spinal cord stimulation comprises electrically stimulating the spinal cord or spinal nerves independent of the stimulation of the neuronal cholinergic anti-inflammatory pathway.

11. A method of enhancing spinal cord stimulation to treat chronic pain, the method comprising electrically stimulating the vagus nerve in an amount sufficient to disrupt or counter the release of inflammatory cytokines from glial cells in a patient concurrently being treated with spinal cord stimulation, whereby the electrical stimulation of the vagus nerve enhances the effect of the spinal cord stimulation.

12. A method of enhancing spinal cord stimulation to treat chronic pain, the method comprising stimulating the vagus nerve at between about 0.1 mA to about 5 mA for less than 10 minutes at least once daily in a patient concurrently being treated with spinal cord stimulation.

13. A system for enhancing spinal cord stimulation (SCS) to treat chronic pain, the system comprising:

at least one neuronal cholinergic anti-inflammatory pathway (NCAP) electrode configured to apply electrical energy to the vagus nerve;

an NCAP controller configured to regulate the stimulation of the vagus nerve by the NCAP electrode;

at least one SCS electrode; and

an SCS controller configured to regulate the application of SCS to the spinal cord or spinal nerves to treat chronic pain.

14. The system of claim 13, wherein the NCAP controller and the SCS controller are enclosed within an implantable pulse generator.

15. The system of claim 13, wherein the NCAP controller is part of an NCAP implantable pulse generator and the SCS controller is part of an SCS implantable pulse generator.

16. The system of claim 13, wherein the SCS controller is configured to operate independently of the NCAP controller.

17. The system of claim 13, wherein the NCAP controller is configured to provide stimulation to a vagus nerve from the NCAP electrodes of between about 0.1 and about 5 mA for less than 10 minutes per day.

18. The system of claim 13, wherein the NCAP controller is configured to provide stimulation to a vagus nerve from the NCAP electrodes of between about 0.1 mA and about 2 mA for less than 1 minute daily.

19. A method of treating chronic pain by enhancing the effectiveness of a narcotic, the method comprising:

electrically stimulating the neuronal cholinergic anti-inflammatory pathway; and

concurrently treating the patient with a narcotic to treat chronic pain.

20. The method of claim 19, wherein the steps of electrically stimulating and concurrently treating the patient are repeated daily for more than one week.

21. The method of claim 19, wherein the steps of electrically stimulating and concurrently treating the patient are repeated daily for more than one month.

22. The method of claim 19, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises stimulating the vagus nerve.

23. The method of claim 19, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises stimulating in an amount sufficient to disrupt or counter the release of inflammatory cytokines from glial cells.

24. The method of claim 19, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises electrically stimulating the vagus nerve with between about 0.5 to about 2.0 mA of current.