Regional therapies for treatment of pain

• US 7,890,166 B2
• Filed: 03/14/2006
• Issued: 02/15/2011
• Est. Priority Date: 06/09/2005
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Heruth, Kenneth T., Lent, Mark S., Schendel, Michael J.
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/375,492
• Publication Number:
  US 20070021802A1
• Time in Patent Office: 1,799 Days
• Field of Search: 607/2, 607/46, 607/3
• US Class Current: 607/3
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

Enhanced therapies for treating pain are described. The therapies include subcutaneous stimulation of tissue in proximity to a source of pain at low frequencies (less than about 20 Hz) and high frequencies (greater than about 50 Hz). The therapies further include administering a pain treating agent at a predetermined time relative to application of the high or low frequency stimulation. Delivery of the pain treating agent via an implantable infusion system is described. Coordination of output of an infusion device and a pulse generator to provide coordinated therapy is also discussed.

Claims

1. A method for treating pain in a subject in need thereof, the method comprising:

applying a first electrical signal having a frequency less than about 20 Hz to a first region of subcutaneous tissue in proximity to a source of pain of the subject to treat the pain;

applying a second electrical signal having a frequency greater than about 50 Hz to a second region of subcutaneous tissue in proximity to the source of pain of the subject to treat the pain, wherein the first and second regions are the same or different; and

beginning an administration of a first pain treating agent to the subject at a predetermined time that is a predetermined time interval before or after an onset of an application of the first or second electrical signal.

2. The method of claim 1, wherein beginning the administration of the first pain treating agent comprises administering an opioid agonsist.

3. The method of claim 2, wherein beginning the administration of the opioid agonist comprises administering a μ

-opioid agonist.

4. The method of claim 3, wherein administering the μ

-opioid agonist comprises administering the μ

-opioid agonist intrathecally.

5. The method of claim 4, wherein administering the μ

-opioid agonist comprises administering the agonist while applying the first electrical signal.

6. The method of claim 5, further comprising administering a δ

-opioic agonist while applying the second electrical signal.

7. The method of claim 6, wherein administering the δ

-opioid agonist and administering the μ

-opioid agonist comprises administering the agonists intrathecally.

8. The method of claim 6, wherein applying the first signal and applying the second signal comprises alternating between the first signal and the second signal and wherein administering the μ

-opioid agonist comprises administering the agonist in response to shifting from the first signal to the second signal and administering the δ

-opioid agonist comprises administering the agonist in response to shifting from second signal to the first signal.

9. The method of claim 4, wherein administering the μ

-opioid agonist comprises administering the agonist about 30 minutes to about 120 minutes prior to applying the first electrical signal.

10. The method of claim 9, further comprising administering a δ

-opioid agonist intrathecally about 30 to about 120 minutes prior to applying the second electrical signal.

11. The method of claim 10, wherein applying the first signal and applying the second signal comprises alternating between the first signal and the second signal and wherein administering the μ

-opioid agonist comprises administering the agonist about 30 minutes to about 120 minutes prior to shifting from the first signal to the second signal and administering the δ

-opioid agonist comprises administering the agonist about 30 minutes to about 120 minutes prior to shifting from second signal to the first signal.

12. The method of claim 2, wherein administering the opioid agonist comprises administering a δ

-opioid agonist.

13. The method of claim 12, wherein administering the δ

-opioid agonist comprises administering the δ

-opioid agonist intrathecally.

14. The method of claim 13, wherein administering the δ

-opioid agonist comprises administering the δ

-opioid agonist while applying the second electrical signal.

15. The method of claim 13, wherein administering the δ

-opioid agonist comprises administering the δ

-opioid agonist about 30 minutes to about 120 minutes prior to applying the second electrical signal.

16. The method of claim 1, wherein beginning the administration of the first pain treating agent comprises administering an alpha₂-adrenergic agonist.

17. The method of claim 16, wherein administering an alpha₂-adrenergic agonist comprises administering clonidine.

18. The method of claim 17, wherein administering clonidine comprises administering clonidine while applying the second electrical signal.

19. The method of claim 18, wherein administering clonidine comprises administering clonidine intrathecally.

20. The method of claim 16, wherein administering an alpha₂-adrenergic agonist comprises administering moxonidine.

21. The method of claim 20, wherein administering moxonidine comprises administering moxonidine while applying the second electrical signal.

22. The method of claim 21, wherein administering monoxidine comprises administering monoxidine intrathecally.

23. The method of claim 1, wherein beginning the administration of the first pain treating agent comprises administering the pain treating agent via an implantable infusion device.

24. The method of claim 1,

wherein the predetermined time comprises a first predetermined time, and the predetermined time interval comprises a first predetermined time interval,

the method further comprising beginning an administration of a second pain treating agent to the subject at a second predetermined time that is a second predetermined time interval before or after an onset of the application of the first or second electrical signal.

25. The method of claim 24, wherein administering the first pain treating agent comprises administering the agent while applying the first electrical signal, and wherein administering the second pain treating agent comprises administering the agent while applying the second electrical signal.

26. The method of claim 1, wherein beginning the administration of the first pain treating agent to the subject comprises administering the agent intrathecally.

27. The method of claim 1, wherein beginning the administration of the first pain treating agent to the subject comprises administering the agent subcutaneously.

28. The method of claim 27, wherein administering the agent subcutaneously comprises administering the agent in a third subcutaneous region in proximity to the source of pain of the subject, wherein one or more of the first, second, and third subcutaneous regions are the same or different.

29. The method of claim 27, wherein administering the agent subcutaneously comprises administering the agent in proximity to a structure of the back of the subject.

30. The method of claim 1, wherein beginning the administration of the first pain treating agent to the subject comprises administering the agent to the brain of the subject.

31. The method of claim 30, wherein administering the agent to the brain of the subject comprises administering the agent intracerebroventricularly or intraparenchymally.

32. The method of claim 30, wherein administering the agent to the brain of the subject comprises administering the agent via the spinal cord of the subject.

33. The method of claim 32, wherein administering the agent to the brain of the subject via the spinal cord comprises administering the agent from about 90 minutes to about 180 minutes prior to applying the first or second electrical signal.

34. The method of claim 1, wherein beginning the administration of the first pain treating agent comprises administering the first pain treating agent according to programming instructions that effect the predetermined time interval between the administration of the first pain treating agent and the onset of the application of the first or second electrical signal.

36. The method of claim 1, wherein a device controls the delivery of the first pain treating agent, and stores data defining the predetermined time interval.

43. The method of claim 1, wherein the predetermined time interval is based on at least one of an identity or a method of delivery of the first pain treating agent.

35. A method for treating pain and reducing tolerance associated with the treatment, the method comprising:

applying a first electrical signal having a frequency less than about 20 Hz to a first region of subcutaneous tissue in proximity to the source of pain of the subject to treat the pain;

applying a second electrical signal having a frequency greater than about 50 Hz to a second region of subcutaneous tissue in proximity to the source of pain of the subject to treat the pain, wherein the first and second regions are the same or different; and

administering a first pain treating agent to the subject,

wherein the application of the first electrical signal, the second electrical signal, and the first pain treating agent occur in a cyclic manner.

37. The method of claim 35, wherein the application of the first electrical signal, the second electrical signal, and the first pain treating agent occur according to preprogrammed instructions that effect the cyclic manner in which the first electrical signal, the second electrical signal, and the first pain treating agent are applied.

38. The method of claim 37, wherein administering the first pain treating agent comprises administering an opioid agonist.

39. The method of claim 38, wherein administering the opioid agonist comprises administering morphine.

40. The method of claim 37, wherein administering the first pain treating agent comprises administering the agent intrathecally.

41. The method of claim 37, further comprising administering a second pain treating agent, wherein the application of the first electrical signal, the second electrical signal, the first pain treating agent, and the second pain treating agent occur in a cyclic manner.

42. The method of claim 41, wherein administering the first pain treating agent comprises administering a μ

-opioid agonist and administering the second pain treating agent comprises administering a δ

-opioid agonist or clonidine.