Therapeutic window determination

• US 10,086,203 B2
• Filed: 12/14/2017
• Issued: 10/02/2018
• 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.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/842,105
• Publication Number:
  US 20180104495A1
• Time in Patent Office: 292 Days
• Field of Search: 607 59
• 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, wherein the efficacy threshold value is determined based on a volume of tissue activation expected to result from delivery of electrical stimulation by an electrode to a patient;

determining, by the processor, that an adverse-effects threshold value of the at least one electrical stimulation parameter is unknown; and

selecting, by the processor and in response to determining that the adverse-effects threshold value of the at least one stimulation parameter is unknown, a predetermined adverse-effects threshold value of the at least one stimulation parameter.

2. The method of claim 1, wherein determining the efficacy threshold value comprises selecting the efficacy threshold value from a memory.

3. The method of claim 1, further comprising:

determining, by the processor, a therapeutic window of the at least one electrical stimulation parameter for the electrode based on the efficacy threshold value and the predetermined adverse-effects threshold value; and

storing the therapeutic window with an indication of the electrode in a memory.

4. The method of claim 1, further comprising:

determining, by the processor, a therapeutic window of the at least one electrical stimulation parameter for the electrode based on the efficacy threshold value and the predetermined adverse-effects threshold value; and

controlling, by the processor, a medical device to deliver the electrical stimulation to the patient according to a value of the electrical stimulation parameter that is within the therapeutic window.

5. The method of claim 1, wherein the volume of tissue activation comprises a first volume of tissue activation, 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 overlaps with one or more first regions of tissue of the patient, wherein the predetermined adverse-effects threshold value comprises a second value of the at least one electrical stimulation parameter, and wherein delivery of electrical stimulation by the electrode and according to the predetermined adverse-effects threshold value is expected to result in a second volume of tissue activation that does not overlap with one or more second regions of tissue of the patient that are different from the one or more first regions of tissue.

6. The method of claim 5, 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 expected to result from delivery of electrical stimulation with the third value of the at least one electrical stimulation parameter by the electrode;

determining whether the third volume of tissue activation overlaps with the one or more first regions of tissue, wherein the one or more first regions of tissue are associated with efficacious electrical stimulation;

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 expected to result from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the electrode;

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

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

7. The method of claim 5, wherein determining that the adverse-effects threshold value of the at least one stimulation parameter is unknown comprises:

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

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

determining whether the third volume of tissue activation overlaps with the one or more second regions of tissue, wherein the one or more second regions of tissue are associated with adverse effects of electrical stimulation;

in response to determining the third volume of tissue activation does not overlap with the one or more second 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 expected to result from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the electrode;

determining whether the fourth volume of tissue activation overlaps with the one or more second regions of tissue; and

in response to determining the fourth volume of tissue activation does not overlap with the one or more second regions of tissue, determining that the adverse-effects threshold is unknown.

8. The method of claim 7, wherein the predetermined adverse-effects threshold value comprises a sum of a predetermined incremental value of the at least one electrical stimulation parameter and a predetermined maximum value of the at least one electrical stimulation parameter, the predetermined incremental value comprising a difference between the third value of the at least one electrical stimulation parameter and the fourth value of the at least one electrical stimulation parameter.

9. A system comprising:

a memory; and

a processor configured to;

determine an efficacy threshold value of at least one electrical stimulation parameter, wherein the efficacy threshold value is determined based on a volume of tissue activation expected to result from delivery of electrical stimulation by an electrode to a patient,

determine that an adverse-effects threshold value of the at least one electrical stimulation parameter is unknown, and

select, from the memory and in response to determining that the adverse-effects threshold value of the at least one stimulation parameter is unknown, a predetermined adverse-effects threshold value of the at least one stimulation parameter.

10. The system of claim 9, wherein the processor is configured to determine the efficacy threshold value by at least selecting the efficacy threshold value from the memory.

11. The system of claim 9, wherein the processor is further configured to:

determine a therapeutic window of the at least one electrical stimulation parameter for the electrode based on the efficacy threshold value and the predetermined adverse-effects threshold value, and

store the therapeutic window with an indication of the electrode in the memory.

12. The system of claim 9, further comprising a medical device, wherein the processor is further configured to:

determine a therapeutic window of the at least one electrical stimulation parameter for the electrode based on the efficacy threshold value and the predetermined adverse-effects threshold value, and

control the medical device to deliver the electrical stimulation to the patient according to a value of the electrical stimulation parameter that is within the therapeutic window.

13. The system of claim 9, wherein the volume of tissue activation comprises a first volume of tissue activation, 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 overlaps with one or more first regions of tissue of the patient, wherein the predetermined adverse-effects threshold value comprises a second value of the at least one electrical stimulation parameter, and wherein delivery of electrical stimulation by the electrode and according to the predetermined adverse-effects threshold value is expected to result in a second volume of tissue activation that does not overlap with one or more second regions of tissue of the patient that are different from the one or more first regions of tissue.

14. The system of claim 13, 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 expected to result from delivery of electrical stimulation with the third value of the at least one electrical stimulation parameter by the electrode,

determining whether the third volume of tissue activation overlaps with the one or more first regions of tissue, wherein the one or more first regions of tissue are associated with efficacious electrical stimulation,

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 expected to result from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the electrode,

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

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

15. The system of claim 13, wherein the processor is configured to determine that the adverse-effects threshold value of the at least one stimulation parameter is unknown by at least:

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

determining a third volume of tissue activation expected to result from delivery of electrical stimulation with the third value of the at least one electrical stimulation parameter by the electrode,

determining whether the third volume of tissue activation overlaps with the one or more second regions of tissue, wherein the one or more second regions of tissue are associated with adverse effects of electrical stimulation, and

in response to determining the third volume of tissue activation does not overlap with the one or more second 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 expected to result from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the electrode,

determining whether the fourth volume of tissue activation overlaps with the one or more second regions of tissue, and

in response to determining the fourth volume of tissue activation does not overlap with the one or more second regions of tissue, determining that the adverse-effects threshold is unknown.

16. The system of claim 15, wherein the predetermined adverse-effects threshold value comprises a sum of a predetermined incremental value of the at least one electrical stimulation parameter and a predetermined maximum value of the at least one electrical stimulation parameter, the predetermined incremental value comprising a difference between the third value of the at least one electrical stimulation parameter and the fourth value of the at least one electrical stimulation parameter.

17. A system comprising:

means for determining an efficacy threshold value of at least one electrical stimulation parameter, wherein the means for determining the efficacy threshold value is configured to determine the efficacy threshold value based on a volume of tissue activation expected to result from delivery of electrical stimulation by an electrode to a patient;

means for determining that an adverse-effects threshold value of the at least one electrical stimulation parameter is unknown; and

means for selecting, in response to a determination that the adverse-effects threshold value of the at least one stimulation parameter is unknown, a predetermined adverse-effects threshold value of the at least one stimulation parameter.

18. The system of claim 17, wherein the volume of tissue activation comprises a first volume of tissue activation, wherein the means for determining the efficacy threshold value comprises means for determining a first value of the at least one electrical stimulation parameter at which the first volume of tissue activation overlaps with one or more first regions of tissue of the patient, wherein the means for selecting the predetermined adverse-effects threshold value comprises means for selecting a second value of the at least one electrical stimulation parameter, and wherein delivery of electrical stimulation by the electrode and according to the predetermined adverse-effects threshold value is expected to result in a second volume of tissue activation that does not overlap with one or more second regions of tissue of the patient that are different from the one or more first regions of tissue.

19. A non-transitory 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, wherein the instructions cause the processor to determine the efficacy threshold value based on a volume of tissue activation expected to result from delivery of electrical stimulation by an electrode to a patient;

determine that an adverse-effects threshold value of the at least one electrical stimulation parameter is unknown; and

select, in response to determining that the adverse-effects threshold value of the at least one stimulation parameter is unknown, a predetermined adverse-effects threshold value of the at least one stimulation parameter.

20. The non-transitory computer-readable medium of claim 19, wherein the volume of tissue activation comprises a first volume of tissue activation, wherein the instructions that cause the processor to determine the efficacy threshold value comprise instructions that cause the processor to determine a first value of the at least one electrical stimulation parameter at which the first volume of tissue activation overlaps with one or more first regions of tissue of the patient, wherein the instructions that cause the processor to select the predetermined adverse-effects threshold value comprise instructions that cause the processor to select a second value of the at least one electrical stimulation parameter, and wherein delivery of electrical stimulation by the electrode and according to the predetermined adverse-effects threshold value is expected to result in a second volume of tissue activation that does not overlap with one or more second regions of tissue of the patient that are different from the one or more first regions of tissue.

21. A method comprising:

determining, by a processor, that an efficacy threshold value of at least one electrical stimulation parameter is unknown;

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

determining, by the processor, a therapeutic window of the at least one electrical stimulation parameter for the electrode based on the adverse-effects threshold value and the determination that the efficacy threshold value is unknown.

22. The method of claim 21, wherein determining the adverse-effects threshold value comprises selecting the adverse-effects threshold value from a memory.

23. The method of claim 21, wherein determining the therapeutic window comprises determining the therapeutic window has a value of zero.

24. The method of claim 21, wherein the volume of tissue activation comprises a first volume of tissue activation, wherein determining that the efficacy threshold value of the at least one electrical stimulation parameter is unknown comprises determining that a first value of the at least one electrical stimulation parameter at which a second volume of tissue activation expected to result from delivery of the electrical stimulation by the electrode overlaps with one or more first regions of tissue of the patient is unknown, and wherein determining the adverse-effects threshold value comprises determining a second value of the at least one electrical stimulation parameter at which the first volume of tissue activation overlaps with one or more second regions of tissue of the patient that are different from the one or more first regions of tissue.

25. The method of claim 24, wherein determining that the efficacy threshold value of the at least one electrical stimulation parameter is unknown further comprises:

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

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

determining whether the third volume of tissue activation overlaps with the one or more first regions of tissue, wherein the one or more first regions of tissue are associated with efficacious electrical stimulation;

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 expected to result from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the electrode;

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

in response to determining the fourth volume of tissue activation does not overlap with the one or more first regions of tissue, determining that the efficacy threshold is unknown.

26. A system comprising:

a memory; and

a processor configured to;

determine that an efficacy threshold value of at least one electrical stimulation parameter is unknown,

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

determine a therapeutic window of the at least one electrical stimulation parameter for the electrode based on the adverse-effects threshold value and the determination that the efficacy threshold value is unknown; and

store the therapeutic window in the memory.

27. The system of claim 26, wherein the processor is configured to determine the adverse-effects threshold value by at least selecting the adverse-effects threshold value from the memory.

28. The system of claim 26, wherein the processor is configured to determine the therapeutic window by at least determining that the therapeutic window has a value of zero.

29. The system of claim 26, wherein the volume of tissue activation is a first volume of tissue activation, wherein the processor is configured to determine that the efficacy threshold value of the at least one electrical stimulation parameter is unknown by at least determining that a first value of the at least one electrical stimulation parameter at which a second volume of tissue activation expected to result from delivery of the electrical stimulation by the electrode overlaps with one or more first regions of tissue of the patient is unknown, and wherein the processor is configured to determine the adverse-effects threshold value by at least determining a second value of the at least one electrical stimulation parameter at which the first volume of tissue activation overlaps with one or more second regions of tissue of the patient that are different from the one or more first regions of tissue.

30. The system of claim 26, wherein the processor is configured to determine that the efficacy threshold value of the at least one electrical stimulation parameter is unknown by at least:

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

determining a third volume of tissue activation expected to result from delivery of electrical stimulation with the third value of the at least one electrical stimulation parameter by the electrode,

determining whether the third volume of tissue activation overlaps with the one or more first regions of tissue, wherein the one or more first regions of tissue are associated with efficacious electrical stimulation,

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 expected to result from delivery of electrical stimulation with the fourth value of the at least one electrical stimulation parameter by the electrode,

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

in response to determining the fourth volume of tissue activation does not overlap with the one or more first regions of tissue, determining that the efficacy threshold is unknown.

31. A method comprising:

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

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

determining, by the processor, that the efficacy threshold value is not less than or equal to the adverse-effects threshold value;

determining, by the processor and based on determining that the efficacy threshold value is not less than or equal to the adverse-effects threshold value, a therapeutic window of the at least one electrical stimulation parameter for the electrode is zero; and

storing the therapeutic window with an indication of the electrode in a memory.

32. The method of claim 31, 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 overlaps with one or more first regions of tissue of the patient that are associated with efficacious electrical stimulation.

33. The method of claim 32, wherein determining the adverse-effects threshold value comprises determining a second value of the at least one electrical stimulation parameter at which the second volume of tissue activation overlaps with one or more second regions of tissue that are associated with adverse-effects of electrical stimulation.

34. A system comprising:

a memory; and

a processor configured to;

determine an efficacy threshold value of at least one electrical stimulation parameter, wherein the efficacy threshold value is determined based on a first volume of tissue activation expected to result from delivery of electrical stimulation by an electrode to a patient,

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

determine that the efficacy threshold value is not less than or equal to the adverse-effects threshold value,

determine, based on determining that the efficacy threshold value is not less than or equal to the adverse-effects threshold value, a therapeutic window of the at least one electrical stimulation parameter for the electrode is zero, and

store the therapeutic window with an indication of the electrode in the memory.

35. The system of claim 34, 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 overlaps with one or more first regions of tissue of the patient that are associated with efficacious electrical stimulation.

36. The system of claim 35, wherein the processor is configured to determine the adverse-effects threshold value by at least determining a second value of the at least one electrical stimulation parameter at which the first volume of tissue activation overlaps with one or more second regions of tissue that are associated with adverse-effects of electrical stimulation.