THERAPEUTIC WINDOW DETERMINATION

• US 20180369590A1
• Filed: 08/30/2018
• Published: 12/27/2018
• 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.
• Granted Patent: US 10,441,792 B2
• Time in Patent Office: Days
• 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:

prior to implantation of a lead comprising a plurality of electrodes at a target implantation site within a patient, determining, by a processor, for each electrode of the plurality of electrodes and for each implantation site of a plurality of implantation sites, a therapeutic window of an electrical stimulation parameter based on an efficacy threshold value of the electrical stimulation parameter and an adverse-effects threshold value of the stimulation parameter, wherein the therapeutic window indicates at least one value of the electrical stimulation parameter associated with delivery of efficacious electrical stimulation via the electrode at the implantation site to the patient; and

selecting, by the processor, at least one implantation site of the plurality of implantation sites as the target implantation site based on therapeutic windows associated with the at least one implantation site.

2. The method of claim 1, wherein selecting the at least one implantation site as the target implantation site based on the therapeutic windows associated with the at least one implantation site comprises:

determining an implantation site of the plurality of implantation sites that is associated with a relatively largest therapeutic window; and

selecting the implantation site that is associated with the largest therapeutic window as the target implantation site.

3. The method of claim 1, wherein selecting the at least one implantation site as the target implantation site based on the therapeutic windows associated with the at least one implantation site comprises:

determining an implantation site of the plurality of implantation sites that is associated with a greatest number of therapeutic windows greater than or equal to a predetermined threshold; and

selecting the implantation site that is associated with the greatest number of therapeutic windows greater than or equal to the predetermined threshold as the target implantation site.

4. The method of claim 1, further comprising:

generating, by the processor, a graphical user interface that includes indications of each electrode of the plurality of electrodes, indications of each implantation site of the plurality of implantation sites, and the respective therapeutic window for each electrode of the plurality of electrodes at each implantation site of the plurality of implantation sites; and

presenting, via a display, the graphical user interface.

5. The method of claim 1, further comprising, for each electrode of the plurality of electrodes and for each implantation site of the plurality of implantation sites, determining, by the processor, at least one of the efficacy threshold value or the adverse-effects threshold value based on patient-specific anatomy data.

6. The method of claim 5, wherein the patient-specific anatomy data comprises a patient-specific brain atlas.

7. The method of claim 5, wherein the patient-specific anatomy data is generated based on a computed tomography (CT) scan of the patient, magnetic resonance imaging (MM) of the patient, an X-ray image of the patient, or a fluoroscopic image of the patient.

8. The method of claim 1, further comprising, for each electrode of the plurality of electrodes and for each implantation site of the plurality of implantation sites:

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

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

9. The method of claim 8, wherein:

determining the efficacy threshold value comprises determining a first value of the electrical stimulation parameter at which the first volume of tissue activation expected to result from delivery of the electrical stimulation via the electrode at the implantation site to the patient overlaps with one or more first regions of tissue of the patient; and

determining the adverse-effects threshold comprises determining a second value of the electrical stimulation parameter at which the second volume of tissue activation expected to result from delivery of the electrical stimulation via the electrode at the implantation site to the patient overlaps with one or more second regions of tissue of the patient different than the one or more first regions.

10. The method of claim 9, wherein the one or more first regions of tissue are associated with delivery of efficacious electrical stimulation via the electrode at the implantation site to the patient and the one or more second regions of tissue are associated with adverse effects of delivery of electrical stimulation via the electrode at the implantation site to the patient.

11. The method of claim 9, wherein determining the first value of the electrical stimulation parameter 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.

12. The method of claim 9, further comprising determining, by the processor, 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 electrode when a medical device delivers, via the electrode at the implantation site to the patient, electrical stimulation according to the first value of the 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.

13. The method of claim 1, further comprising controlling, by the processor, a medical device to deliver electrical stimulation via at least one electrode of the plurality of electrodes at the target implantation site to the patient.

14. A system comprising:

a memory configured to store information identifying a plurality of implantation sites; and

a processor configured to;

determine, prior to implantation of a lead comprising a plurality of electrodes at a target site within a patient, for each electrode of the plurality of electrodes, and for each implantation site of the plurality of implantation sites, a therapeutic window of an electrical stimulation parameter based on an efficacy threshold value of the electrical stimulation parameter and an adverse-effects threshold value of the stimulation parameter, wherein the therapeutic window indicates at least one value of the electrical stimulation parameter associated with delivery of efficacious electrical stimulation via the electrode at the implantation site to the patient; and

select at least one implantation site of the plurality of implantation sites as the target implantation site based on therapeutic windows associated with the at least one implantation site.

15. The system of claim 14, wherein the processor is configured to select the at least one implantation site as the target implantation site based on the therapeutic windows associated with the at least one implantation site by at least:

determining an implantation site of the plurality of implantation sites that is associated with a relatively largest therapeutic window; and

selecting the implantation site that is associated with the largest therapeutic window as the target implantation site.

16. The system of claim 14, wherein the processor is configured to select the at least one implantation site as the target implantation site based on the therapeutic windows associated with the at least one implantation site by at least:

determining an implantation site of the plurality of implantation sites that is associated with a greatest number of therapeutic windows greater than or equal to a predetermined threshold; and

selecting the implantation site that is associated with the greatest number of therapeutic windows greater than or equal to the predetermined threshold as the target implantation site.

17. The system of claim 14, further comprising a display, wherein the processor is further configured to:

generate a graphical user interface that includes indications of each electrode of the plurality of electrodes and of each implantation site of the plurality of implantation sites and the respective therapeutic window for each electrode of the plurality of electrodes at each implantation site of the plurality of implantation sites; and

present, via a display, the graphical user interface.

18. The system of claim 14, wherein the processor is further configured to determine, for each electrode of the plurality of electrodes and for each implantation site of the plurality of implantation sites, at least one of the efficacy threshold value or the adverse-effects threshold value based on patient-specific anatomy data.

19. The system of claim 18, wherein the patient-specific anatomy data comprises a patient-specific brain atlas.

20. The system of claim 18, wherein the patient-specific anatomy data is generated based on a computed tomography (CT) scan of the patient, magnetic resonance imaging (MM) of the patient, an X-ray image of the patient, or a fluoroscopic image of the patient.

21. The system of claim 14, wherein the processor is further configured to, for each electrode of the plurality of electrodes and for each implantation site of the plurality of implantation sites:

determine the efficacy threshold value of the electrical stimulation parameter based on a first volume of tissue activation expected to result from delivery of electrical stimulation via the electrode at the implantation site to the patient; and

determine the adverse-effects threshold value of the electrical stimulation parameter based on a second volume of tissue activation expected to result from delivery of electrical stimulation via the electrode at the implantation site to the patient.

22. The system of claim 21, wherein the processor is configured to determine the efficacy threshold value by at least determining a first value of the electrical stimulation parameter at which the first volume of tissue activation expected to result from delivery of the electrical stimulation via the electrode at the implantation site to the patient 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 electrical stimulation parameter at which the second volume of tissue activation expected to result from delivery of the electrical stimulation via the electrode at the implantation site to the patient overlaps with one or more second regions of tissue of the patient different than the one or more first regions.

23. The system of claim 22, wherein the processor is configured to determine the first value of the electrical stimulation parameter 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.

24. The system of claim 22, wherein the processor is configured to determine the first volume of tissue activation, wherein determining the first volume of tissue activation by at least:

determining an electrical field model representing where electrical stimulation will propagate from the electrode when a medical device delivers, via the electrode at the implantation site to the patient, electrical stimulation according to the first value of the 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.

25. The system of claim 14, further comprising a medical device, wherein the processor is further configured to control the medical device to deliver electrical stimulation via at least one electrode of the plurality of electrodes at the target implantation site to the patient.

26. A system comprising:

means for determining, prior to implantation of a lead comprising a plurality of electrodes at a target implantation site within a patient, for each electrode of the plurality of electrodes, and for each implantation site of a plurality of implantation sites, a therapeutic window of an electrical stimulation parameter based on an efficacy threshold value of the electrical stimulation parameter and an adverse-effects threshold value of the stimulation parameter, wherein the therapeutic window indicates at least one value of the electrical stimulation parameter associated with delivery of efficacious electrical stimulation via the electrode at the implantation site to the patient; and

means for selecting at least one implantation site of the plurality of implantation sites as the target implantation site based on therapeutic windows associated with the at least one implantation site.

27. The system of claim 26, wherein the means for selecting the at least one implantation site as the target implantation site based on the therapeutic windows associated with the at least one implantation site comprises:

means for determining an implantation site of the plurality of implantation sites that is associated with a relatively largest therapeutic window; and

means for selecting the implantation site that is associated with the largest therapeutic window as the target implantation site.

28. The system of claim 26, wherein the means for selecting the at least one implantation site as the target implantation site based on the therapeutic windows associated with the at least one implantation site comprises:

means for determining an implantation site of the plurality of implantation sites that is associated with a greatest number of therapeutic windows greater than or equal to a predetermined threshold; and

means for selecting the implantation site that is associated with the greatest number of therapeutic windows greater than or equal to the predetermined threshold as the target implantation site.

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

determine, prior to implantation of a lead comprising a plurality of electrodes at a target site within a patient, for each electrode of the plurality of electrodes, and for each implantation site of a plurality of implantation sites, a therapeutic window of an electrical stimulation parameter based on an efficacy threshold value of the electrical stimulation parameter and an adverse-effects threshold value of the stimulation parameter, wherein the therapeutic window indicates at least one value of the electrical stimulation parameter associated with delivery of efficacious electrical stimulation via the electrode at the implantation site to the patient; and

select at least one implantation site of the plurality of implantation sites as the target implantation site based on therapeutic windows associated with the at least one implantation site.

30. The non-transitory computer-readable medium of claim 29, wherein the instructions further comprise instructions that, when executed by the processor, cause the processor to:

determine an implantation site of the plurality of implantation sites that is associated with a greatest number of therapeutic windows greater than or equal to a predetermined threshold; and

select the implantation site that is associated with the greatest number of therapeutic windows greater than or equal to the predetermined threshold as the target implantation site.

31. The non-transitory computer-readable medium of claim 29, wherein the instructions further comprise instructions that, when executed by the processor, cause the processor to:

determine an implantation site of the plurality of implantation sites that is associated with a greatest number of therapeutic windows greater than or equal to a predetermined threshold; and

select the implantation site that is associated with the greatest number of therapeutic windows greater than or equal to the predetermined threshold as the target implantation site.