TISSUE STIMULATION SYSTEM AND METHOD WITH ANATOMY AND PHYSIOLOGY DRIVEN PROGRAMMING

• US 20120083857A1
• Filed: 09/24/2011
• Published: 04/05/2012
• Est. Priority Date: 10/05/2010
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Bradley, Kerry, Hershey, Bradley
• Application Number:
  US13/244,435
• Publication Number:
  US 20120083857A1
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An external control device for use with a tissue stimulation device and at least one tissue stimulation lead having a plurality of electrodes implanted within a patient comprises a user interface configured for allowing a user to enter first information defining a therapeutic indication and second information defining the location of the at least one tissue stimulation lead relative to an anatomical reference, at least one processor configured for analyzing the first and second information and generating a set of stimulation parameters based on the analysis, and output circuitry configured for transmitting the at least one stimulation parameter set to the tissue stimulation device.

Claims

1. An external control device for use with a tissue stimulation device and at least one tissue stimulation lead having a plurality of electrodes implanted within a patient, comprising:

a user interface configured for allowing a user to enter first information defining a therapeutic indication and second information defining the location of the at least one tissue stimulation lead relative to an anatomical reference;

at least one processor configured for analyzing the first and second information and generating at least one set of stimulation parameters based on the analysis; and

output circuitry configured for transmitting the at least one stimulation parameter set to the tissue stimulation device.

2. The external control device of claim 1, wherein the therapeutic indication is chronic pain.

3. The external control device of claim 1, wherein the anatomical reference is the spine of the patient.

4. The external control device of claim 3, wherein location is defined relative to a vertebral level of the spine.

5. The external control device of claim 3, wherein the location is defined as a mediolateral position relative to a physiological centerline of the spine.

6. The external control device of claim 1, wherein the second information further defines a type of the at least one tissue stimulation lead.

7. The external control device of claim 1, wherein the second information further defines a number of the at least one tissue stimulation lead.

8. The external control device of claim 1, wherein the at least one tissue stimulation leads comprises a plurality of tissue stimulation leads, and the second information further defines positions of the tissue stimulation leads relative to each other.

9. The external control device of claim 1, wherein the user interface is configured for allowing the user to optimize the at least one stimulation parameter set.

10. The external control device of claim 1, further comprising memory storing a database containing a plurality of reference therapeutic indications and a plurality of desired stimulation targets respectively corresponding to the reference therapeutic indications, wherein the at least one processor is configured for analyzing the first information by comparing the defined therapeutic indication to the stored reference therapeutic indications and selecting at least one of the desired stimulation targets based on this comparison, for analyzing the second information by comparing the defined location of the at least one tissue stimulation lead to a location of the at least one desired stimulation target within the anatomical reference, and for selecting one or more of the electrodes adjacent the at least one desired stimulation target based on this comparison, wherein the at least one stimulation parameter set includes the one or more selected electrodes.

11. The external control device of claim 10, wherein the corresponding reference therapeutic indications are different pain regions.

12. The external control device of claim 10, wherein the corresponding reference therapeutic indications and desired stimulation targets are empirically determined.

13. The external control device of claim 10, wherein the database further contains a plurality of pulsewidth values respectively corresponding to the reference therapeutic indications, and the at least one processor is configured for selecting one of the pulsewidth values based on the comparison of the defined therapeutic indication to the stored reference therapeutic indications, wherein the at least one stimulation parameter set includes the selected pulsewidth value.

14. The external control device of claim 10, wherein the database further contains a plurality of anode-cathode pattern respectively corresponding to the reference therapeutic indications, and the at least one processor is configured for selecting one of the anode-cathode patterns based on the comparison of the defined therapeutic indication to the stored reference therapeutic indications, and selecting the electrodes based on the selected anode-cathode separation.

15. The external control device of claim 1, wherein the at least one processor is configured for analyzing the first information and second information using a heuristic set of rules.

16. The external control device of claim 15, wherein the at least one stimulation parameter set comprises a pulse width, and wherein the heuristic set of rules comprises selecting a relatively low pulse width value as the pulse width if the defined therapeutic indication is of the type that is treated via stimulation of dorsal roots and/or large nerve fibers, and selecting a relatively high pulse width value as the pulse width if the defined therapeutic indication is of the type that is treated via stimulation of dorsal columns and/or small nerve fibers.

17. The external control device of claim 16, wherein the relatively low pulse width value is in the range of 50-300 μ

s, and the relatively high pulse width value is in the range of 300-2000 μ

s.

18. The external control device of claim 15, wherein the at least one stimulation parameter set comprises an active electrode combination, and wherein the heuristic set of rules comprises selecting a relatively narrow anode-cathode separation for the active electrode combination if the defined therapeutic indication is of the type that is treated via stimulation of midline dorsal column nerve fibers, selecting a relatively medial anode-cathode separation for the active electrode combination if the defined therapeutic indication is of the type that is treated via stimulation of lateral dorsal column nerve fibers, and selecting a relatively wide anode-cathode separation for the active electrode combination if the defined therapeutic indication is of the type that is treated via stimulation of dorsal root nerve fibers.

19. The external control device of claim 18, wherein the relatively narrow anode-cathode separation is less than 8 mm, the relatively medial anode-cathode separation is in the range of 8 to 24 mm, and the relatively wide anode-cathode separation is greater than 24 mm.

20. The external control device of claim 15, wherein the at least one stimulation parameter set comprises an active electrode combination, and the set of heuristic rules comprises selecting for the electrode combination a cathode over the midline dorsal column fibers if the active electrode combination is caudal to the dorsal root fibers innervating a tissue region associated with the defined therapeutic indication, and selecting for the electrode combination a cathode lateral to the midline dorsal column fibers if the active electrode combination is at the same level as the dorsal root fibers innervating the tissue region associated with the defined therapeutic indication.

21. The external control device of claim 1, wherein the output circuitry comprises telemetry circuitry.

22. The external control device of claim 1, further comprising a housing containing the user interface, at least one processor, and output circuitry.