Therapeutic window determination

• US 9,457,188 B2
• Filed: 03/03/2014
• Issued: 10/04/2016
• Est. Priority Date: 03/03/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kaemmerer, William F.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/195,489
• Publication Number:
  US 20150246233A1
• Time in Patent Office: 946 Days
• Field of Search: 607/59
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A therapeutic window for at least one electrode of a medical system may be determined based on a volume of tissue expected to be activated (“VTA”) by electrical stimulation delivered by the at least one electrode. In some examples, a processor determines the therapeutic window for a particular electrode by at least determining an efficacy threshold based on the VTA expected to result from the delivery of electrical stimulation according to a set of electrical stimulation parameter values including the stimulation parameter at the efficacy threshold, and determining an adverse-effects threshold based on the VTA expected to result from the delivery of electrical stimulation according to a set of electrical stimulation parameter values including the stimulation parameter at the adverse-effects threshold.

Claims

1. A method comprising:

determining, by a processor, an efficacy threshold value of at least one electrical stimulation parameter based on a first volume of tissue activation expected to result from delivery of electrical stimulation by at least one electrode to a patient; and

determining, by the processor, an adverse-effects threshold value of the at least one stimulation parameter based on a second volume of tissue activation expected to result from delivery of electrical stimulation by the at least one electrode to the patient.

2. The method of claim 1, further comprising determining, by the processor, a therapeutic window of the electrical stimulation parameter for the electrode based on the efficacy threshold and the adverse-effects threshold.

3. The method of claim 2, further comprising storing the therapeutic window with an indication of the at least one electrode in a memory of a device.

4. The method of claim 1, wherein determining the efficacy threshold value comprises determining a first value of the at least one electrical stimulation parameter at which the first volume of tissue activation resulting from delivery of the electrical stimulation by the at least one electrode overlaps with one or more first regions of tissue of the patient, and wherein determining the adverse-effects threshold comprises determining a second value of the at least one electrical stimulation parameter at which the second volume of tissue activation resulting from delivery of electrical stimulation by the at least one electrode overlaps with one or more second regions of tissue of the patient different than the one or more first regions.

5. The method of claim 4, wherein determining the first value of the at least one electrical stimulation parameter comprises:

selecting a third value of the at least one electrical stimulation parameter;

determining a third volume of tissue activation resulting from delivery of electrical stimulation with the third value of the at least one electrical stimulation parameter by the at least one electrode;

determining whether the third volume of tissue activation overlaps with the one or more first regions of tissue;

in response to determining the third volume of tissue activation overlaps with the one or more first regions of tissue, selecting the third value as the first value;

in response to determining the third volume of tissue activation does not overlap with the one or more first regions of tissue, increasing the third value to a fourth value of the at least one electrical stimulation parameter;

determining a fourth volume of tissue activation resulting from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the at least one electrode; and

determining whether the fourth volume of tissue activation overlaps with the one or more first regions of tissue.

6. The method of claim 1, wherein determining the efficacy threshold and the adverse-effects threshold comprises, for each electrode of a plurality of electrodes:

determining a first value of the at least one electrical stimulation parameter at which the first volume of tissue activation resulting from delivery of electrical stimulation with the first value by the electrode overlaps with one or more first regions of tissue of the patient; and

determining a second value of the at least one electrical stimulation parameter at which the second volume of tissue activation resulting from delivery of electrical stimulation with the second value by the electrode overlaps with one or more second regions of tissue of the patient.

7. The method of claim 6, further comprising:

determining a therapeutic window based on the respective first and second values of the at least one electrical stimulation parameter for each of the plurality of electrodes; and

associating each of the plurality of the therapeutic windows with the respective electrode in a memory of a device.

8. The method of claim 7, further comprising selecting, by the processor, at least one electrode of the plurality of electrodes based on the associated therapeutic windows.

9. The method of claim 8, wherein selecting the at least one electrode comprises selecting the at least one electrode associated with a largest one of the therapeutic windows.

10. The method of claim 7, further comprising generating, by the processor, a graphical user interface that includes indications of each electrode of the plurality of electrodes and the respective therapeutic windows for each electrode of the plurality.

11. The method of claim 6, wherein the one or more first regions of tissue are associated with efficacious electrical stimulation and the one or more second regions of tissue are associated with adverse effects of electrical stimulation.

12. The method of claim 6, wherein determining the first value of the at least one electrical stimulation parameter value comprises:

determining the first volume of tissue activation;

registering the first volume of tissue activation to a three-dimensional grid comprising a plurality of voxels, each voxel having a value;

determining whether the first volume of tissue activation overlaps with the one or more first regions of tissue, wherein determining whether the first volume of tissue activation overlaps with the one or more first regions of tissue comprises;

determining, by the processor, voxels of the grid common to the first volume of tissue activation and at least one first region of tissue of the one or more first regions of tissue;

determining a score based on the values assigned to the voxels common to the first volume of tissue activation and the at least one first region of tissue;

comparing the score to a threshold score value; and

determining the first volume of tissue activation overlaps with the one or more first regions of tissue based on the comparison.

13. The method of claim 6, wherein determining the first value of the at least one electrical stimulation parameter value comprises:

determining the first volume of tissue activation;

registering the first volume of tissue activation to a three-dimensional grid comprising a plurality of voxels, wherein the one or more first regions of tissue are defined by a subset of voxels of the three-dimensional grid; and

determining whether the first volume of tissue activation overlaps with the one or more first regions of tissue based on a number of voxels common to at least one first region of tissue and the first volume of tissue activation.

14. The method of claim 6, further comprising, determining the first volume of tissue activation, wherein determining the first volume of tissue activation comprises:

determining an electrical field model representing where electrical stimulation will propagate from the at least one electrode when a medical device delivers, via the at least one electrode, electrical stimulation according to the first value of the at least one stimulation parameter value; and

determining, based on the electric field model and patient anatomy data, tissue of the patient that will be activated by the electrical stimulation, wherein the tissue of the patient that will be activated by the electrical stimulation defines the first volume of tissue activation.

15. A system comprising:

a memory; and

a processor configured to determine an efficacy threshold value of at least one stimulation parameter based on a first volume of tissue activation expected to result from delivery of electrical stimulation by at least one electrode to a patient, to determine an adverse-effects threshold value of the at least one stimulation parameter based on a second volume of tissue activation expected to result from delivery of electrical stimulation by the at least one electrode to the patient, and to store the efficacy threshold value and the adverse-effects threshold value in the memory.

16. The system of claim 15, further wherein the processor is configured to determine a therapeutic window for the electrode based on the efficacy threshold and the adverse-effects threshold, and store the therapeutic window with an indication of the at least one electrode in a memory of device.

17. The system of claim 15, wherein the processor is configured to determine the efficacy threshold value by at least determining a first value of the at least one electrical stimulation parameter at which the first volume of tissue activation resulting from delivery of the electrical stimulation by the at least one electrode overlaps with one or more first regions of tissue of the patient, and wherein the processor is configured to determine the adverse-effects threshold by at least determining a second value of the at least one electrical stimulation parameter at which the second volume of tissue activation resulting from delivery of electrical stimulation by the at least one electrode overlaps with one or more second regions of tissue of the patient.

18. The system of claim 17, wherein the processor is configured to determine the first value of the at least one electrical stimulation parameter by at least:

selecting a third value of the at least one electrical stimulation parameter;

determining a third volume of tissue activation resulting from delivery of electrical stimulation with the third value of the at least one electrical stimulation parameter by the at least one electrode;

determining whether the third volume of tissue activation overlaps with the one or more first regions of tissue;

in response to determining the third volume of tissue activation overlaps with the one or more first regions of tissue, selecting the third value as the first value;

in response to determining the third volume of tissue activation does not overlap with the one or more first regions of tissue, increasing the third value to a fourth value of the at least one electrical stimulation parameter;

determining a fourth volume of tissue activation resulting from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the at least one electrode; and

determining whether the fourth volume of tissue activation overlaps with the one or more first regions of tissue.

19. The system of claim 15, wherein the processor is configured to determine the efficacy threshold and the adverse-effects threshold by at least, for each electrode of a plurality of electrodes:

determining a first value of the at least one electrical stimulation parameter at which the first volume of tissue activation resulting from delivery of electrical stimulation with the first value by the electrode overlaps with one or more first regions of tissue of the patient; and

determining a second value of the at least one electrical stimulation parameter at which the second volume of tissue activation resulting from delivery of electrical stimulation with the second value by the electrode overlaps with one or more second regions of tissue of the patient.

20. The system of claim 19, wherein the processor is configured to determine a therapeutic window based on the respective first and second values of the at least one electrical stimulation parameter, and associate the therapeutic window with the electrode in the memory of a device.

21. The system of claim 20, wherein the processor is configured to select at least one electrode of the plurality of electrodes based on the associated therapeutic windows.

22. The system of claim 21, wherein the processor is configured to select the at least one electrode associated with a largest therapeutic window.

23. The system of claim 20, further comprising a display, wherein the processor is configured to generate a graphical user interface that includes indications of each electrode of the plurality and the respective therapeutic windows, and present the graphical user interface via the display.

24. The system of claim 19, wherein the one or more first regions of tissue are associated with efficacious electrical stimulation and the one or more second regions of tissue are associated with adverse effects of electrical stimulation.

25. The system of claim 19, wherein the processor is configured to determine the first value of the at least one electrical stimulation parameter value by at least:

determining the first volume of tissue activation;

registering the first volume of tissue activation to a three-dimensional grid comprising a plurality of voxels, each voxel having a value;

determining whether the first volume of tissue activation overlaps with the one or more first regions of tissue, wherein determining whether the first volume of tissue activation overlaps with the first region of tissue comprises;

determining, by the processor, voxels of the grid common to the first volume of tissue activation and at least one first region of tissue of the one or more first regions of tissue;

determining a score based on the values assigned to the voxels common to the first volume of tissue activation and the at least one first region of tissue;

comparing the score to a threshold score value; and

determining the first volume of tissue activation overlaps with the one or more first regions of tissue based on the comparison.

26. The system of claim 19, wherein the processor is configured to determine the first value of the at least one electrical stimulation parameter value by at least:

determining the first volume of tissue activation;

registering the first volume of tissue activation to a three-dimensional grid comprising a plurality of voxels, wherein the one or more first regions of tissue are defined by a subset of voxels of the three-dimensional grid; and

determining whether the first volume of tissue activation overlaps with the one or more first regions of tissue based on a number of voxels common to at least one first region of tissue and the first volume of tissue activation.

27. The system of claim 19, wherein the processor is configured to determine the first volume of tissue activation by at least:

determining an electrical field model representing where electrical stimulation will propagate from the at least one electrode when a medical device delivers, via the at least one electrode, electrical stimulation according to the first value of the at least one stimulation parameter value; and

determining, based on the electric field model and patient anatomy data, tissue of the patient that will be activated by the electrical stimulation, wherein the tissue of the patient that will be activated by the electrical stimulation defines the first volume of tissue activation.

32. The system of claim 15 further comprising an external programmer, the external programmer comprising the processor and the memory.

33. The system of claim 25, further comprising an implantable medical device, the implantable medical device comprising the processor.

28. A system comprising:

means for determining an efficacy threshold value of at least one electrical stimulation parameter based a first volume of tissue activation expected to result from delivery of electrical stimulation by at least one electrode to a patient; and

means for determining an adverse-effects threshold value of the at least one stimulation parameter based on second volume of tissue activation expected to result from delivery of electrical stimulation by the at least one electrode to the patient.

29. The system of claim 28, further comprising means for determining a therapeutic window for the electrode based on the efficacy threshold and the adverse-effects threshold.

30. A computer-readable medium comprising instructions that, when executed by a processor, cause the processor to:

determine an efficacy threshold value of at least one electrical stimulation parameter based a first volume of tissue activation expected to result from delivery of electrical stimulation by at least one electrode to a patient; and

determine an adverse-effects threshold value of the at least one stimulation parameter based on a second volume of tissue activation expected to result from delivery of electrical stimulation by the at least one electrode to the patient.

31. The computer-readable medium of claim 30, further comprising instructions that cause the processor to determine a therapeutic window for the electrode based on the efficacy threshold and the adverse-effects threshold.