Neurostimulation site screening

• US 7,231,256 B2
• Filed: 03/11/2005
• Issued: 06/12/2007
• 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
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US11/078,467
• Publication Number:
  US 20060206163A1
• Time in Patent Office: 823 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

The disclosure describes a process 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 neurostimulation screening device comprising:

a transcutaneous electrical neurostimulation electrode array for application to an epidermal region adjacent a neuralgic region of a patient; and

a controller coupled to the transcutaneous electrical neurostimulation electrode array to selectively apply stimulation energy to different combinations of electrodes within the array at different stimulation regions, and record patient feedback relating to perceived efficacy of the different combinations,

wherein the controller comprises at least one input medium to mark one or more of the stimulation regions when the patient feedback is favorable.

2. The screening device of claim 1, wherein the transcutaneous neurostimulation electrode array comprises an electrode array patch having an adhesive layer for attachment to the epidermal region.

3. The screening device of claim 1, wherein the controller comprises a joystick input device to select the different combinations of electrodes in response to up, down, left, or right movements.

4. The screening device of claim 1, wherein the controller presents the one or more marked stimulation regions for selection by a user.

5. The screening device of claim 1, wherein the controller selects one of the stimulation regions from the one or more marked stimulation regions.

6. The screening device of claim 1, wherein the patient feedback includes a pain assessment.

7. The screening device of claim 1, wherein the transcutaneous electrical neurostimulation electrode array is sized to cover a substantial portion of a back of a neck of a patient.

8. The screening device of claim 1, wherein the transcutaneous electrical neurostimulation electrode array is shaped to generally conform to a substantial portion of a back of a neck of a patient.

9. A neurostimulation screening device comprising:

an array of percutaneous needle electrodes for penetration of an epidermal region adjacent a neuralgic region of a patient; and

a controller coupled to the needle electrodes to selectively apply stimulation energy to different combinations of the needle electrodes within the array at different stimulation sites, wherein the controller comprises an input device to record patient feedback relating to perceived efficacy of the different combinations, and at least one input medium to mark one or more of the stimulation sites when the patient feedback is favorable.

10. The screening device of claim 9, wherein the controller comprises a joystick input device to select the different combinations of needle electrodes in response to up, down, left, or right movements.

11. The screening device of claim 9, wherein the controller presents the one or more marked stimulation sites for selection by a user.

12. The screening device of claim 9, wherein the controller selects one of the stimulation sites from the one or more marked stimulation sites.

13. The screening device of claim 9, wherein the patient feedback includes a pain assessment.

14. A neurostimulation screening device comprising:

a transcutaneous electrical neurostimulation electrode array for application to an epidermal region adjacent a neuralgic region of a patient;

an array of percutaneous needle electrodes for penetration of the epidermal region adjacent the neuralgic region of a patient; and

a controller to selectively apply stimulation energy to different combinations of electrodes within the transcutaneous electrical neurostimulation electrode array at different stimulation regions, and selectively apply stimulation energy to different combinations of the needle electrodes within the array at different stimulation sites within one of the stimulation regions.

15. The screening device of claim 14, wherein the controller comprises an input device to record patient feedback relating to perceived efficacy of the different combinations of electrodes within the transcutaneous electrical neurostimulation electrode array, and at least one input medium to mark one or more of the stimulation regions when the patient feedback is favorable.

16. The screening device of claim 15, wherein the controller presents the one or more marked stimulation regions for selection by a user.

17. The screening device of claim 15, wherein the controller selects one of the stimulation regions from the one or more marked stimulation regions.

18. The screening device of claim 15, wherein the patient feedback includes a pain assessment.

19. The screening device of claim 14, wherein the transcutaneous electrical neurostimulation electrode array comprises an electrode array patch having an adhesive layer for attachment to the epidermal region.

20. The screening device of claim 14, wherein the controller comprises a joystick input device to select the different combinations of electrodes within the transcutaneous electrical neurostimulation electrode array in response to up, down, left, or right movements.

21. The screening device of claim 14, wherein the transcutaneous electrical neurostimulation electrode array is sized to cover a substantial portion of a back of a neck of a patient.

22. The screening device of claim 14, wherein the transcutaneous electrical neurostimulation electrode array is shaped to generally conform to a substantial portion of a back of a neck of a patient.

23. The screening device of claim 14, wherein the controller comprises a joystick input device to select the different combinations of needle electrodes in response to up, down, left, or right movements.

24. The screening device of claim 14, wherein the controller comprises an input device to record patient feedback relating to perceived efficacy of the different combinations of needle electrodes, and at least one input medium to mark one or more of the stimulation sites when the patient feedback is favorable.

25. The screening device of claim 24, wherein the controller presents the one or more marked stimulation sites for selection by a user.

26. The screening device of claim 24, wherein the controller selects one of the stimulation sites from the one or more marked stimulation sites.

27. The screening device of claim 24, wherein the patient feedback includes a pain assessment.