COLLECTION OF CLINICAL DATA FOR GRAPHICAL REPRESENTATION AND ANALYSIS

• US 20120302912A1
• Filed: 05/25/2012
• Published: 11/29/2012
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A., Reinhold, John J.
• Granted Patent: US 9,358,398 B2
• Time in Patent Office: Days
• US Class Current: 600/554
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A method of treating a patient and an external programmer for use with a neurostimulator. Electrical stimulation energy is serially conveyed into tissue of the patient via different combinations of electrodes implanted within the patient, thereby creating one or more clinical effects for each of the different electrode combinations. An influence of each of the different electrode combinations on the clinical effect(s) is determined. A graphical indication of the one or more clinical effects is generated based on the determined electrode combination influences. A graphical representation of the electrodes is displayed. The graphical indication of the clinical effect(s) is displayed adjacent the graphical electrode representation, such that a user can view an extent to which each of the different electrode combinations influences the clinical effect(s).

Claims

1. A method of treating a patient, comprising:

conveying electrical stimulation energy into tissue of the patient via different combinations of electrodes implanted within the patient, thereby creating one or more clinical effects for each of the different electrode combinations;

determining an influence of each of the different electrode combinations on the one or more clinical effects;

generating a graphical indication of the one or more clinical effects based on the determined electrode combination influences;

displaying a graphical representation of the electrodes; and

displaying the graphical indication of the one or more clinical effects adjacent the graphical electrode representation, such that a user can determine an extent to which each of the different electrode combinations influences the one or more clinical effects.

2. The method of claim 1, wherein each of the electrode combinations has only one electrode.

3. The method of claim 1, wherein at least one of the electrode combinations comprises a fractionalized electrode combination.

4. The method of claim 1, wherein the one or more clinical effects comprises a therapeutic effect.

5. The method of claim 1, wherein the one or more clinical effects comprises a side-effect.

6. The method of claim 1, further comprising incrementally increasing an intensity level of the conveyed electrical stimulation energy for each of the different electrode combinations, wherein the influence of the each different electrode combination on the one or more clinical effects is determined for each of the incremental intensity levels.

7. The method of claim 6, wherein the one or more clinical effects comprises one or more therapeutic effects, and the influence of the each different electrode combination on the one or more therapeutic effects is determined by determining the range of incremental intensity levels at which a metric of the one or more therapeutic effects occurs.

8. The method of claim 7, wherein the one or more clinical effects further comprises one or more side-effects, and the influence of the each different electrode combination on the one or more side-effects is determined by determining the incremental intensity level at which a metric of the one or more side-effects initially occurs.

9. The method of claim 8, wherein the influence of the each different electrode combination on the one or more therapeutic effects is further determined by determining the highest intensity level at which the one or more therapeutic effect metrics occur prior to the initial occurrence of the one or more side-effect metrics.

10. The method of claim 9, wherein the graphical indication of the one or more clinical effects comprises a bar map having a plurality of bars, each of which indicates for the each different electrode combination the highest intensity level at which the one or more therapeutic effect metrics occur prior to the initial occurrence of the one or more side-effect metrics.

11. The method of claim 10, wherein the therapeutic effect metric is a perception threshold of the one or more therapeutic effects, and the side-effect metric is one of a perception threshold of the one or more side-effects, an uncomfortable threshold of the one or more side-effects, and an intolerable threshold of the one or more side-effects.

12. The method of claim 7, wherein the therapeutic effect metric is a relative level of the one or more therapeutic effects.

13. The method of claim 12, wherein the one or more therapeutic effects comprises a plurality of therapeutic effects, and the relative level is a composite score as a function of individual scores of the therapeutic effects.

14. The method of claim 12, wherein the graphical indication of the one or more clinical effects comprises a bar map for each of the electrode combinations, each bar map having a bar indicating the relative level of the one or more therapeutic effects at the each incremental intensity level.

15. The method of claim 7, wherein the influence of the each different electrode combination on the one or more clinical effects is determined by determining the electrode combinations that most influence the one or more therapeutic effects, and wherein the graphical indication of the one or more clinical effects comprises at least one target tissue region displayed adjacent the electrode combinations in the graphical electrode representation determined to most influence the one or more therapeutic effects.

16. The method of claim 15, wherein the influence of the each different electrode combination on the one or more clinical effects is determined by determining the electrode combinations that most influence the side-effect, and wherein the graphical indication of the one or more clinical effects comprises at least one non-target tissue region displayed adjacent the electrode combinations in the graphical electrode representation determined to most influence the side-effect.

17. The method of claim 15, further comprising estimating one of an electric field or a region of tissue activation at the highest incremental intensity level at which the one or more therapeutic effects occurs for the each different electrode combination, wherein the target tissue region is based on the estimated electric field or region of tissue activation.

18. The method of claim 1, wherein the electrical stimulation energy is conveyed from a neurostimulator, the method further comprising programming the neurostimulator based on the determined extent to which the each different electrode combination influences the one or more clinical effects.

19. The method of claim 1, further comprising recording data in computer memory indicating the determined influence of the each different electrode combination on the one or more clinical effects.

20. The method of claim 1, wherein the tissue is brain tissue.

21. An external programmer for use with a neurostimulator, comprising:

output circuitry configured for communicating with the neurostimulator;

control circuitry configured for instructing the neurostimulator via the output circuitry to convey electrical stimulation energy into tissue of a patient via different combinations of electrodes implanted within the patient, thereby creating one or more clinical effects for each of the different electrode combinations; and

processing circuitry configured for determining an influence of each of the different electrode combinations on the one or more clinical effects, and generating a graphical indication of the one or more clinical effects based on the determined electrode combination influences;

wherein the control circuitry is further configured for instructing a display device to display the graphical indication of the one or more clinical effects adjacent a graphical representation of the electrodes, such that the user can view an extent to which each of the different electrode combinations influences the one or more clinical effects.

22. The external programmer of claim 21, further comprising a user interface configured for allowing a user to enter clinical information on the one or more clinical effects for the each different electrode combination, wherein the processing circuitry is configured for determining the influence of the each different electrode combination on the one or more clinical effects based on the clinical information entered by the user.

23. The external programmer of claim 21, further comprising monitoring circuitry configured for monitoring the one or more clinical effects for the each different electrode combination, wherein the processing circuitry is configured for determining the influence of the each different electrode combination on the one or more clinical effects based on the monitored one or more clinical effects.

24. The external programmer of claim 21, wherein each of the electrode combinations has only one electrode.

25. The external programmer of claim 21, wherein at least one of the electrode combinations comprises a fractionalized electrode combination.

26. The external programmer of claim 21, wherein the one or more clinical effects comprises a therapeutic effect.

27. The external programmer of claim 21, wherein the one or more clinical effects comprises a side-effect.

28. The external programmer of claim 21,

wherein the control circuitry is further configured for instructing the neurostimulator via the output circuitry to incrementally increase an intensity level of the conveyed electrical stimulation energy for each of the different electrode combinations;

and

wherein the processing circuitry is configured for determining the influence of the each different electrode combination on the one or more clinical effects for each of the incremental intensity levels.

29. The external programmer of claim 28, wherein the one or more clinical effects comprises one or more therapeutic effects, and the processing circuitry is configured for determining the influence of the each different electrode combination on the one or more therapeutic effects by determining the range of incremental intensity levels at which a metric of the one or more therapeutic effects occurs.

30. The external programmer of claim 29, wherein the one or more clinical effects further comprises one or more side-effects, and the processing circuitry is further configured for determining the influence of the each different electrode combination on the one or more side-effects by determining the incremental intensity level at which a metric of the one or more side-effects initially occurs.

31. The external programmer of claim 30, wherein the processing circuitry is further configured for determining the influence of the each different electrode combination on the one or more therapeutic effects by determining the highest intensity level at which the one or more therapeutic effect metrics occur prior to the initial occurrence of the one or more side-effect metrics.

32. The external programmer of claim 31, wherein the graphical indication of the one or more clinical effects comprises a bar map having a plurality of bars, each of which indicates for the each different electrode combination the highest intensity level at which the one or more therapeutic effect metrics occur prior to the initial occurrence of the one or more side-effect metrics.

33. The external programmer of claim 32, wherein the therapeutic effect metric is a perception threshold of the one or more therapeutic effects, and the side-effect metric is one of a perception threshold of the one or more side-effects, an uncomfortable threshold of the one or more side-effects, and an intolerable threshold of the one or more side-effects.

34. The external programmer of claim 29, wherein the therapeutic effect metric is a relative level of the one or more therapeutic effects.

35. The external programmer of claim 34, wherein the one or more therapeutic effects comprises a plurality of therapeutic effects, and the relative level is a composite score as a function of individual scores of the therapeutic effects.

36. The external programmer of claim 34, wherein the graphical indication of the one or more clinical effects comprises a bar map for each of the electrode combinations, each bar map having a bar indicating the relative level of the one or more therapeutic effects at the each incremental intensity level.

37. The external programmer of claim 29, wherein the processing circuitry is configured for determining the influence of the each different electrode combination on the one or more clinical effects by determining the electrode combinations that most influence the one or more therapeutic effects, and wherein the graphical indication of the one or more clinical effects comprises at least one target tissue region displayed adjacent the electrode combinations in the graphical electrode representation determined to most influence the one or more therapeutic effects.

38. The external programmer of claim 37, wherein the processing circuitry is further configured for determining the influence of the each different electrode combination on the one or more clinical effects by determining the electrode combinations that most influence the side-effect, and wherein the graphical indication of the one or more clinical effects comprises at least one non-target tissue region displayed adjacent the electrode combinations in the graphical electrode representation determined to most influence the side-effect.

39. The external programmer of claim 37, wherein the processing circuitry is further configured for estimating one of an electric field or a region of tissue activation at the highest incremental intensity level at which the one or more therapeutic effects occurs for the each different electrode combination, wherein the target tissue region is based on the estimated electric field or region of tissue activation.

40. The external programmer of claim 21, wherein the control circuitry is further configured for programming the neurostimulator via the output circuitry based on the extent to which the each different electrode combination influences the one or more clinical effects.

41. The external programmer of claim 21, further comprising memory configured for storing data indicating the determined influence of the each different electrode combination on the one or more clinical effects.

42-102. -102. (canceled)