Multi-application trial stimulator

• US 7,680,540 B2
• Filed: 07/29/2005
• Issued: 03/16/2010
• Est. Priority Date: 07/29/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Almendinger, Allen D., Arnett, Christopher M., Jensen, Steven L.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/194,088
• Publication Number:
  US 20070027501A1
• Time in Patent Office: 1,691 Days
• Field of Search: 607/2, 607/48, 607/63, 600/547
• US Class Current: 607/60
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

The disclosure relates to an electrical trial stimulator that stores multiple applications to selectively emulate the operation of different chronically implanted stimulators. Each application corresponds to a different chronically implanted stimulator. Upon selection of a particular application, the stimulator executes a set of instructions to emulate the operation of a chronically implanted stimulator that corresponds to the application. The multi-application stimulator permits a physician to select an application for stimulation therapy, and evaluate efficacy of a particular chronically implanted stimulator. In addition, the physician may select any of the other stimulation applications to emulate other stimulators. The different stimulation applications may correspond to different stimulators that deliver a similar therapy, e.g., stimulators designed to deliver spinal cord stimulation for alleviation of chronic pain. Alternatively, the applications may correspond to stimulators that deliver different types of therapy, e.g., stimulators that deliver spinal cord, deep brain, gastrointestinal, or pelvic floor stimulation.

Claims

1. An electrical stimulation system comprising:

a trial stimulator device that generates electrical stimulation, the trial stimulator device having a memory storing multiple sets of instructions, wherein each set of instructions corresponds to one of a plurality of different chronic stimulator devices; and

a programmer that programs the trial stimulator device to select one of the sets of instructions for operation of the trial stimulator device,

wherein the trial stimulator device applies the selected set of instructions to emulate operation of a corresponding chronic stimulator device.

2. The system of claim 1, wherein the trial stimulator device includes a housing for external use.

3. The system of claim 1, wherein the sets of instructions correspond to different stimulator devices configured for a substantially common therapy.

4. The system of claim 3, wherein the substantially common therapy application is selected from the group consisting of spinal cord stimulation, deep brain stimulation, gastrointestinal stimulation and pelvic floor stimulation.

5. The system of claim 1, wherein the sets of instructions correspond to different chronic stimulator devices configured for different therapies.

6. The system of claim 5, wherein the different therapies include at least two of spinal cord stimulation, deep brain stimulation, gastrointestinal stimulation and pelvic floor stimulation.

7. The system of claim 1, wherein the trial stimulator device applies the selected set of instructions as a software application running on an operating system.

8. The system of claim 1, wherein the trial stimulator device loads the selected set of instructions as an operating system for the trial stimulator device.

9. The system of claim 7, wherein the sets of instructions are stored in the memory as multiple software applications, and the trial stimulator device executes the selected set of instructions as one of the software applications to emulate the operation of the corresponding chronic stimulator device.

10. The system of claim 8, wherein the trial stimulator device loads the operating system via a boot loader executive that causes the trial stimulator to load the selected set of instructions as an operating system.

11. The system of claim 1, further comprising one or more implantable leads electrically coupled to the trial stimulator device, wherein each of the leads includes one or more electrodes.

12. The system of claim 11, further comprising a percutaneous extension that electrically couples the implantable leads to the trial stimulator device.

13. The system of claim 1, wherein the trial stimulator device is an external neurostimulator device.

14. The system of claim 1, wherein the programmer is a physician programmer used by a physician to program the trial stimulator device.

15. The system of claim 14, further comprising a patient programmer used by the patient, wherein the patient programmer is compatible with a chronic stimulator device that operates according to instructions similar to the selected set of instructions.

16. The system of claim 1, wherein the programmer is configured to select one of the sets of instructions based on a user selection.

17. The system of claim 1, wherein the programmer further comprises a display that presents a menu for user selection of one of the sets of instructions, and wherein the programmer is configured to select one of the sets of instructions based on the user selection.

18. An electrical stimulator device comprising:

a stimulation generator that generates electrical stimulation;

a memory storing multiple sets of instructions, wherein each set of instructions corresponds to one of a plurality of different chronic stimulator devices; and

a processor that selects one of the sets of instructions to control operation of the stimulation generator, wherein the processor applies the selected set of instructions to emulate operation of a corresponding chronic stimulator device.

20. The stimulator of claim 18, wherein the sets of instructions correspond to different chronic stimulator devices configured for a substantially common therapy.

21. The stimulator of claim 20, wherein the common therapy application is selected from the group consisting of spinal cord stimulation, deep brain stimulation, gastrointestinal stimulation and pelvic floor stimulation.

22. The stimulator of claim 18, wherein the sets of instructions correspond to different chronic stimulator devices configured for different therapies.

23. The stimulator of claim 22, wherein the different therapies include at least two of spinal cord stimulation, deep brain stimulation, gastrointestinal stimulation and pelvic floor stimulation.

24. The stimulator of claim 18, wherein the processor applies the selected set of instructions as a software application running on an operating system.

25. The stimulator of claim 18, wherein the processor loads the selected set of instructions as an operating system for the trial stimulator device.

26. The stimulator of claim 24, wherein the sets of instructions are stored in the memory as multiple software applications, and the processor executes the selected set of instructions as one of the software applications to emulate the operation of the corresponding chronic stimulator device.

27. The stimulator of claim 25, wherein the processor loads the operating system via a boot loader executive that causes the processor to load the selected set of instructions as an operating system.

28. The stimulator of claim 18, further comprising one or more implantable leads coupled to the stimulation generator, wherein each of the leads includes one or more electrodes.

29. The stimulator of claim 28, wherein the implantable leads are coupled to the stimulation generator via a percutaneous extension.

30. The stimulator of claim 18, wherein the trial stimulator device is an external neurostimulator device.

31. The stimulator of claim 18, wherein the processor is configured to select one of the sets of instructions in response to a command received from an external programmer, wherein the command is based on a user selection.

19. The stimulator of 18, further comprising a housing for external use.

32. A method comprising:

storing multiple sets of instructions in a memory in a trial electrical stimulator device, wherein each set of instructions corresponds to one of a plurality of different chronic stimulator devices;

selecting one of the sets of instructions to control operation of a stimulation generator within the trial electrical stimulator device; and

applying the selected set of instructions to emulate operation of a corresponding chronic stimulator device.

33. The method of claim 32, further comprising generating electrical stimulation based at least in part on the selected set of instructions.

34. The method of claim 32, wherein the sets of instructions correspond to different chronic stimulator devices configured for a substantially common therapy.

35. The method of claim 34, wherein the common therapy application is selected from the group consisting of spinal cord stimulation, deep brain stimulation, gastrointestinal stimulation and pelvic floor stimulation.

36. The method of claim 32, wherein the sets of instructions correspond to different chronic stimulator devices configured for different therapies.

37. The method of claim 36, wherein the different therapies include at least two of spinal cord stimulation, deep brain stimulation, gastrointestinal stimulation and pelvic floor stimulation.

38. The method of claim 32, further comprising applying the selected set of instructions as a software application running on an operating system.

39. The method of claim 32, further comprising loading the selected set of instructions as an operating system for the trial electrical stimulator device.

40. The method of claim 38, wherein storing the multiple sets of instructions comprises storing the multiple sets of instructions in the memory as multiple software applications, and applying the selected set of instructions comprises executing the selected set of instructions as one of the software applications to emulate the operation of the corresponding chronic stimulator device.

41. The method of claim 39, wherein loading the selected set of instructions as an operating system comprises loading the operating system via a boot loader executive.

42. The method of claim 32, wherein the trial electrical stimulator device is an external neurostimulator device.

43. The method of claim 32, wherein selecting one of the sets of instructions comprises selecting one of the sets of instructions based on a user selection.

44. The method of claim 32, further comprising displaying a menu for user selection of one of the sets of instructions, wherein selecting comprises selecting one of the sets of instructions based on the user selection.

45. A device comprising:

means for storing multiple sets of instructions in a memory in a trial electrical stimulator device, wherein each set of instructions corresponds to one of a plurality of different chronic stimulator devices;

means for selecting one of the sets of instructions to control operation of a stimulation generator within the trial electrical stimulator device; and

means for applying the selected set of instructions to emulate operation of a corresponding chronic stimulator device.

46. The device of claim 45, wherein the trial electrical stimulator device is an external neurostimulator device comprising an electrical stimulation generator that generates electrical stimulation, one or more percutaneously implantable leads electrically coupled to the electrical stimulation generator, each of the leads including one or more electrodes for delivery of the electrical stimulation.

47. The device of claim 45, further comprising means for loading the selected set of instructions as an operating system for the trial electrical stimulator device.