Combination therapy including peripheral nerve field stimulation

• US 8,620,435 B2
• Filed: 06/09/2006
• Issued: 12/31/2013
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rooney, Ethan A., Wahlstrand, Carl D., King, Gary W., Cross, Thomas E. Jr., Heruth, Kenneth T., Wacnik, Paul W., Evanson, Jeffrey S.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US11/450,133
• Publication Number:
  US 20070073356A1
• Time in Patent Office: 2,762 Days
• Field of Search: 607/46
• US Class Current: 607/46
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

Abstract

Delivery of peripheral nerve field stimulation (PNFS) in combination with one or more other therapies is described. The other therapy delivered in combination with PNFS may be, for example, a different type of neurostimulation, such as spinal cord stimulation (SCS), or a drug. PNFS and the other therapy may be delivered simultaneously, in an alternating fashion, according to a schedule, and/or selectively, e.g., in response to a request received from a patient or clinician. A combination therapy that includes PNFS may be able to more completely address complex or multifocal pain than would be possible through delivery of either PNFS or other therapies alone. Further, the combination of PNFS with one or more other therapies may reduce the likelihood that neural accommodation will impair the perceived effectiveness PNFS or the other therapies.

Claims

1. A method for treating pain of a patient comprising:

delivering peripheral nerve field stimulation to a region of a body of the patient in which a patient experiences pain via at least one electrode implanted in the region; and

delivering spinal cord stimulation to the patient via at least one electrode implanted in an epidural space of the patient in combination with the peripheral nerve field stimulation.

2. The method of claim 1, wherein delivering peripheral nerve field stimulation via at least one electrode implanted in the region comprises delivering peripheral nerve field stimulation via at least one electrode implanted within or between at least one of an intra-dermal, deep dermal, or subcutaneous layer of the region.

3. The method of claim 1, wherein delivering peripheral nerve field stimulation and spinal cord stimulation comprises delivering the peripheral nerve field stimulation and the spinal cord stimulation from a single implantable medical device.

4. The method of claim 1, wherein delivering peripheral nerve field stimulation and spinal cord stimulation comprises delivering the peripheral nerve field stimulation and the spinal cord stimulation simultaneously.

5. The method of claim 1, wherein delivering peripheral nerve field stimulation and spinal cord stimulation comprises alternating delivery of the peripheral nerve field stimulation and the spinal cord stimulation.

6. The method of claim 1, wherein delivering the spinal cord stimulation in combination with the peripheral nerve field stimulation comprises delivering the spinal cord stimulation and the peripheral nerve field stimulation according to at least one of different stimulation parameters or different duty cycles.

7. The method of claim 1, wherein delivering the spinal cord stimulation in combination with the peripheral nerve field stimulation comprises:

delivering the spinal cord stimulation and the peripheral nerve field stimulation according to different programs within a group that includes a plurality of programs; and

delivering each successive stimulation pulse from an implantable medical device according to a different one of the programs.

8. The method of claim 1, wherein delivering peripheral nerve field stimulation to a region of a body of the patient in which a patient experiences pain comprises delivering peripheral nerve field stimulation to an axial region of a back of the patient.

9. A method for treating pain of a patient comprising:

delivering peripheral nerve field stimulation to a region of a body of the patient in which a patient experiences pain via at least one electrode implanted in the region; and

delivering at least one therapeutic agent to the patient intrathecally in combination with the peripheral nerve field stimulation.

10. The method of claim 9, wherein delivering at least one therapeutic agent comprises delivering at least one of an opioid, cannabinoid, local anesthetic, baclofen, adenosine, alpha blocker, anti-inflammatory, steroid, muscle relaxant, antidepressant, or antiepileptic.

11. A system for treating pain of a patient comprising:

at least one electrode implanted in a region of a body of the patient in which a patient experiences pain;

at least one electrode implanted in an epidural space of the body of the patient;

means for delivering peripheral nerve field stimulation via the at least one electrode implanted in the region of the body of the patient in which the patient experiences pain; and

means for delivering spinal cord stimulation to the patient via the at least one electrode implanted in the epidural space of the body of the patient.

12. The system of claim 11, wherein the at least one electrode implanted in the region of the body of the patient in which the patient experiences pain is implanted within or between at least one of an intra-dermal, deep dermal, or subcutaneous layer of the region.

13. The system of claim 11, wherein the means for delivering peripheral nerve field stimulation and the means for delivering spinal cord stimulation comprise means for delivering the peripheral nerve field stimulation and the spinal cord stimulation simultaneously.

14. The system of claim 11, wherein the means for delivering peripheral nerve field stimulation and the means for delivering spinal cord stimulation comprise means for alternating delivery of the peripheral nerve field stimulation and the spinal cord stimulation.

15. The system of claim 11, wherein the means for delivering peripheral nerve field stimulation and the means for delivering spinal cord stimulation comprise means for delivering the peripheral nerve field stimulation and the spinal cord stimulation according to a least one of different stimulation parameters or duty cycles.

16. The system of claim 11, wherein the at least one electrode implanted in the region of the body of the patient in which the patient experiences pain comprises at least one electrode implanted in an axial region of a back of the patient.

17. A system for treating pain of a patient comprising:

at least one electrode implanted in a region of a body of the patient in which a patient experiences pain;

means for delivering peripheral nerve field stimulation via the at least one electrode; and

means for delivering at least one therapeutic agent to the patient intrathecally in combination with the peripheral nerve field stimulation.

18. The system of claim 17, wherein the means for delivering at least one therapeutic agent comprises means for delivering at least one of an opioid, cannabinoid, local anesthetic, baclofen, adenosine, alpha blocker, anti-inflammatory, steroid, muscle relaxant, antidepressant, or antiepileptic.

19. A system for treating pain of a patient comprising:

a first set of one or more electrodes implanted in a first region of a body of the patient in which the patient experiences pain;

a second set of one or more electrodes implanted in an epidural space of the patient; and

an implantable medical device coupled to the first and second sets of electrodes that delivers peripheral nerve field stimulation via the first set of electrodes and spinal cord stimulation via the second set of a electrodes.

20. The system of claim 19, wherein the first set of electrodes is implanted in an axial region of a back of the patient.

21. The system of claim 19, wherein the implantable medical device delivers the peripheral nerve field stimulation and the spinal cord stimulation simultaneously.

22. The system of claim 19, wherein the implantable medical device alternates delivery of the peripheral nerve field stimulation and the spinal cord stimulation.

23. The system of claim 19, wherein the implantable medical device selectively delivers at least one of the peripheral nerve field stimulation or the spinal cord stimulation based on at least one of a command received from a patient or a schedule.

24. The system of claim 19, wherein the implantable medical device delivers the peripheral nerve field stimulation and the spinal cord stimulation according to at least one of different stimulation parameters or duty cycles.

25. The system of claim 19, wherein the implantable medical device delivers stimulation according to a group of programs, the group of programs includes at least one peripheral nerve field stimulation program and at least one spinal cord stimulation program, and the implantable medical device delivers each successive pulse of a plurality of stimulation pulses according to a different one of the programs of the program group.

26. A system for treating pain of a patient comprising:

a first implantable medical device that delivers peripheral nerve field stimulation to a region of a body of the patient in which the patient experiences pain; and

a second medical device that delivers spinal cord stimulation to the patient via at least one electrode implanted in an epidural space of the patient.

27. The system of claim 26, wherein the first and second medical devices communicate to coordinate delivery of the peripheral nerve field stimulation and the spinal cord stimulation.

28. The system of claim 26, wherein the second medical device is implantable.

29. The system of claim 26, wherein the first implantable medical device comprises a housing implantable within the region of the body in which the patient experiences pain and an array of electrodes located on the housing, and delivers the peripheral nerve field stimulation via the electrodes located on the housing.

30. The system of claim 26, wherein the first implantable medical device delivers peripheral nerve field stimulation to an axial region of a back of the patient.

31. A system for treating pain of a patient comprising:

a first implantable medical device that delivers peripheral nerve field stimulation to a region of a body of the patient in which the patient experiences pain; and

a second medical device that delivers at least one therapeutic agent to the patient intrathecally.