Modulation of the cholinergic anti-inflammatory pathway to treat pain or addiction

• US 8,996,116 B2
• Filed: 11/01/2010
• Issued: 03/31/2015
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Faltys, Michael A., Levine, Jacob A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US12/917,197
• Publication Number:
  US 20110106208A1
• Time in Patent Office: 1,611 Days
• Field of Search: 607/2, 607/3, 607/46, 607116-118
• 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 of a patient, the method comprising:

electrically stimulating the neuronal cholinergic anti-inflammatory pathway for less than 10 minutes per day;

treating the patient with spinal cord stimulation, wherein the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway comprises stimulating in an amount sufficient to disrupt or counter a release of inflammatory cytokines from glial cells; and

timing the electrical stimulation of the neuronal cholinergic anti-inflammatory pathway and the spinal cord stimulation such that an effect on pain from the step of electrically stimulating the neuronal cholinergic anti-inflammatory pathway overlaps with an effect on pain from the step of 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 electrically stimulating the vagus nerve with between about 0.5 to about 2.0 mA of current.

4. 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.

5. 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.

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

7. The method of claim 1, wherein the step of 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.

8. The method of claim 1, wherein the step of 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.

9. A method of enhancing spinal cord stimulation to treat chronic pain, the method comprising electrically stimulating the vagus nerve for less than 10 minutes per day in an amount sufficient to disrupt or counter the release of inflammatory cytokines from glial cells in a patient being treated with spinal cord stimulation;

and timing the electrical stimulation of the vagus nerve and the spinal cord stimulation such that the electrical stimulation of the vagus nerve enhances the effect of the spinal cord stimulation by providing an effect on pain from the vagus nerve stimulation that overlaps with an effect on pain from the spinal cord stimulation.

10. 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 per day in a patient being treated with spinal cord stimulation;

and timing the stimulation of the vagus nerve and the spinal cord stimulation such that an effect on pain from the step of stimulating the vagus nerve overlaps with an effect on pain from the step of treating the patient with spinal cord stimulation.