Neurostimulation site screening

• US 7,676,271 B2
• Filed: 03/22/2007
• Issued: 03/09/2010
• Est. Priority Date: 03/11/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Skime, Robert M., Wahlstrand, Carl D.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US11/689,943
• Publication Number:
  US 20070162087A1
• Time in Patent Office: 1,083 Days
• Field of Search: 607/46, 600/548, 600/554
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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

Abstract

A process is described for non-invasively screening a patient to select a stimulation site for treatment of head, neck or facial pain and tension symptoms caused by disorders such as occipital neuralgia. The screening process involves application of a transcutaneous stimulation screening device, a percutaneous micro-electrode screening device, and a temporary implantable screening device to the patient to select a site for chronic implantation.

Claims

1. A method comprising:

applying transcutaneous electrical neurostimulation to multiple stimulation regions on an epidermal surface adjacent a neuralgic region of a patient;

selecting one of the stimulation regions based on perceived efficacy of the transcutaneous electrical neurostimulation in the selected stimulation region;

applying percutaneous electrical neurostimulation to multiple stimulation sites within the selected stimulation region; and

selecting one of the stimulation sites based on perceived efficacy of the percutaneous electrical neurostimulation in the selected stimulation site.

2. The method of claim 1, wherein selecting one of the stimulation regions based on perceived efficacy includes selecting one of the stimulation regions based on patient feedback, and selecting one of the stimulation sites based on perceived efficacy includes selecting one of the stimulation sites based on patient feedback.

3. The method of claim 1, wherein the patient feedback includes a pain assessment.

4. The method of claim 1, wherein applying transcutaneous electrical neurostimulation includes applying the transcutaneous electrical neurostimulation via an array of electrodes distributed on a patch applied to the epidermal region.

5. The method of claim 1, wherein applying transcutaneous electrical neurostimulation includes applying the transcutaneous electrical neurostimulation via an array of electrodes in a transcutaneous electrical neurostimulation electrode array that is sized to cover a substantial portion of a back of a neck of a patient.

6. The method of claim 1, wherein applying transcutaneous electrical neurostimulation includes applying the transcutaneous electrical neurostimulation via an array of electrodes in a transcutaneous electrical neurostimulation electrode array that is shaped to generally conform to a substantial portion of a back of a neck of a patient.

7. The method of claim 1, further comprising performing imaging to select the epidermal region.

8. The method of claim 1, wherein applying percutaneous electrical neurostimulation includes applying the percutaneous electrical neurostimulation via an array of electrode needles that penetrate the epidermal region.

9. The method of claim 1, further comprising subcutaneously implanting a temporary neurostimulator at the selected stimulation site to provide temporary electrical neurostimulation to the patient for evaluation of the efficacy of the temporary electrical neurostimulation at the stimulation site.

10. The method of claim 9, wherein the temporary neurostimulator is battery operated and has a battery lifetime of at least one day.

11. The method of claim 1, further comprising determining whether to subcutaneously implant a chronic neurostimulator at the selected stimulation site based on the efficacy of the temporary electrical neurostimulation.

12. The method of claim 11, further comprising subcutaneously implanting the chronic neurostimulator.

13. The method of claim 1, further comprising applying the transcutaneous electrical neurostimulation and the percutaneous electrical neurostimulation to at least partially alleviate symptoms of occipital neuralgia.

14. The method of claim 1, further comprising delivering electrical neurostimulation to the selected stimulation site via an implanted neurostimulator.

15. The method of claim 1, further comprising implanting a neurostimulator to deliver neurostimulation to the selected stimulation site.

16. The method of claim 1, further comprising subcutaneously implanting a neurostimulator to deliver neurostimulation to the selected stimulation site.

17. A method comprising:

applying a transcutaneous electrical stimulation electrode array to an epidermal region adjacent a neuralgic region of a patient;

selectively applying transcutaneous electrical stimulation to different stimulation regions via different combinations of electrodes within the transcutaneous electrical stimulation electrode array;

receiving patient feedback relating to perceived efficacy of the transcutaneous electrical stimulation within the stimulation regions;

selecting one of the stimulation regions based on the perceived efficacy of the transcutaneous electrical stimulation within the selected stimulation region;

applying a percutaneous electrical stimulation electrode array to the epidermal region adjacent the neuralgic region of the patient; and

selectively applying percutaneous electrical stimulation to different stimulation sites within the selected stimulation region via different combinations of electrodes within the percutaneous electrical stimulation electrode array.

18. The method of claim 17, further comprising:

receiving patient feedback relating to perceived efficacy of the percutaneous electrical stimulation of electrodes within the stimulation sites; and

selecting one of the stimulation sites based on the perceived efficacy of the percutaneous electrical stimulation within the selected stimulation site.

19. The method of claim 18, further comprising delivering electrical stimulation to the selected stimulation site via an implanted stimulator.

20. The method of claim 18, further comprising implanting an electrical stimulator to deliver electrical stimulation to the selected stimulation site.

21. The method of claim 18, further comprising subcutaneously implanting an electrical stimulator to deliver electrical stimulation to the selected stimulation site.

22. The method of claim 18, wherein the patient feedback includes a pain assessment.

23. The method of claim 17, wherein the transcutaneous electrical stimulation electrode array includes an array of electrodes distributed on a patch applied to the epidermal region.

24. The method of claim 17, wherein the transcutaneous electrical stimulation electrode array is sized to cover a substantial portion of a back of a neck of a patient.

25. The method of claim 24, wherein the transcutaneous electrical stimulation electrode array is shaped to generally conform to a substantial portion of a back of a neck of a patient.

26. The method of claim 17, wherein the percutaneous electrical stimulation electrode array includes an array of electrode needles that penetrate the epidermal region.

27. The method of claim 17, further comprising applying electrical stimulation to the selected stimulation site via an implanted stimulator, wherein the electrical stimulation applied via the implanted stimulator is selected to at least partially alleviate symptoms of occipital neuralgia.

28. A method comprising:

applying transcutaneous electrical stimulation to multiple stimulation regions of an epidermal region adjacent a neuralgic region of a patient;

selecting one the stimulation regions based on efficacy of the transcutaneous electrical stimulation within the selected stimulation region;

applying percutaneous electrical stimulation to multiple stimulation sites within the selected stimulation region; and

selecting one of the stimulation sites based on efficacy of the percutaneous electrical stimulation within the selected stimulation site.

29. The method of claim 28, further comprising applying electrical stimulation to the selected stimulation site via an implanted stimulator.

30. The method of claim 29, wherein the electrical stimulation applied via the implanted stimulator is selected to at least partially alleviate symptoms of occipital neuralgia.