Therapeutic window determination

• US 9,861,821 B2
• Filed: 09/08/2016
• Issued: 01/09/2018
• 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:
  US15/259,865
• Publication Number:
  US 20160375253A1
• Time in Patent Office: 488 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:

receiving, by a processor, an input indicative of at least one of an efficacious result or an adverse-effect result of a delivery of electrical stimulation therapy to a patient by a medical device according to at least one electrical stimulation parameter value;

determining, by the processor, a volume of tissue activation expected to result from the delivery of electrical stimulation to the patient according to the at least one electrical stimulation parameter value;

determining, by the processor, one or more voxels of a grid that overlap with the volume of tissue activation, wherein the grid comprises a plurality of voxels, and wherein each voxel of the plurality of voxels is associated with a respective voxel value; and

modifying, by the processor and based on the input, a voxel value of at least one of the one or more voxels of the grid that overlap with the volume of tissue activation.

2. The method of claim 1, wherein the input is based on a sensed physiological signal of the patient.

3. The method of claim 2, wherein the sensed physiological signal of the patient comprises a bioelectrical brain signal of the patient.

4. The method of claim 2, further comprising sensing, by a sensing module, the physiological signal of the patient.

5. The method of claim 1, wherein receiving the input comprises receiving the input via a user interface.

6. The method of claim 1, further comprising controlling the medical device to deliver the electrical stimulation therapy to the patient according to the at least one electrical stimulation parameter value.

7. The method of claim 1, wherein determining, by the processor, the one or more voxels of the grid that overlap with the volume of tissue activation comprises registering, by the processor, the volume of tissue activation to the grid, wherein the grid corresponds to at least one region of a brain of the patient.

8. The method of claim 1, wherein the input is indicative of the efficacious result, and wherein modifying the voxel value comprises increasing the voxel value of the at least one of the one or more voxels based on the input.

9. The method of claim 8, further comprising determining, by the processor, whether the at least one of the one or more voxels is fully within the volume of tissue activation, wherein increasing the voxel value comprises one of increasing the voxel value by a first value based on determining that the at least one of the one or more voxels is fully within the volume of tissue activation, or increasing the voxel value by a second value based on determining that the at least one of the one or more voxels is partially within the volume of tissue activation, wherein the second value is less than the first value.

10. The method of claim 1, wherein the input is indicative of the adverse-effect result, and wherein modifying the voxel value comprises decreasing the voxel value of the at least one of the one or more voxels based on the input.

11. The method of claim 1, further comprising:

determining, by the processor and after modifying the voxel value, a score based on the values associated with the plurality of voxels of the grid, wherein the score represents an outcome of the electrical stimulation therapy delivered to the patient according to the at least one electrical stimulation parameter value, and

selecting, by the processor and based on the score, at least one updated electrical stimulation parameter value for the electrical stimulation therapy.

12. The method of claim 11, wherein the input comprises a first input and the volume of tissue activation comprises a first volume of tissue activation, the method further comprising:

receiving, by the processor, a second input indicative of at least one of an efficacious result and an adverse-effect result of the delivery of electrical stimulation therapy to the patient by the medical device according to the at least one updated electrical stimulation parameter value;

determining, by the processor, a second volume of tissue activation expected to result from the delivery of electrical stimulation to the patient according to the at least one updated electrical stimulation parameter value;

determining, by the processor, one or more voxels of the grid that overlap with the second volume of tissue activation; and

modifying, by the processor and based on the second input, a voxel value of at least one of the one or more voxels of the grid that overlap with the second volume of tissue activation.

13. The method of claim 12, further comprising controlling the medical device to deliver the electrical stimulation therapy to the patient according to the at least one updated electrical stimulation parameter value.

14. The method of claim 1, further comprising selecting, by the processor, the grid from a plurality of grids associated with respective medical conditions, wherein selecting the grid comprises selecting the grid from the plurality of grids based on a medical condition of the patient.

15. The method of claim 1, wherein the volume of tissue activation represents a volume of tissue within a brain of the patient.

16. The method of claim 1, wherein the grid comprises a three-dimensional grid, and wherein each voxel of the plurality of voxels represents a three-dimensional volume of tissue.

17. A system comprising:

a memory that stores a grid comprising a plurality of voxels, wherein each voxel of the plurality of voxels is associated with a respective voxel value; and

a processor configured to;

receive an input indicative of at least one of an efficacious result or an adverse-effect result of a delivery of electrical stimulation therapy to a patient by a medical device according to at least one electrical stimulation parameter value,

determine a volume of tissue activation expected to result from the delivery of electrical stimulation to the patient according to the at least one electrical stimulation parameter value,

determine one or more voxels of the grid that overlap with the volume of tissue activation, and

modify, based on the input, a voxel value of at least one of the one or more voxels of the grid that overlap with the volume of tissue activation.

18. The system of claim 17, wherein the input is based on a sensed physiological signal of the patient.

19. The system of claim 18, wherein the sensed physiological signal of the patient comprises a bioelectrical brain signal of the patient.

20. The system of claim 18, further comprising a sensing module configured to sense the physiological signal of the patient.

21. The system of claim 17, further comprising a user interface, wherein the processor is configured to receive the input via the user interface.

22. The system of claim 17, further comprising the medical device, wherein the processor is further configured to control the medical device to deliver the electrical stimulation therapy to the patient according to the at least one electrical stimulation parameter value.

23. The system of claim 17, wherein the processor is configured to determine the one or more voxels of the grid that overlap with the volume of tissue activation by at least registering the volume of tissue activation to the grid, wherein the grid corresponds to at least one region of a brain of the patient.

24. The system of claim 17, wherein the input is indicative of the efficacious result, and wherein the processor is configured to modify the voxel value by at least increasing the voxel value of the at least one of the one or more voxels based on the input.

25. The system of claim 24, wherein the processor is configured to determine whether the at least one of the one or more voxels is fully within the volume of tissue activation, and increase the voxel value of the at least one of the one or more voxels by one of increasing the voxel value by a first value based on determining that the at least one of the one or more voxels is fully within the volume of tissue activation, or increasing the voxel value by a second value based on determining that the at least one of the one or more voxels is partially within the volume of tissue activation, wherein the second value is less than the first value.

26. The system of claim 17, wherein the input is indicative of the adverse-effect result, and wherein the processor is configured to modify the voxel value by at least decreasing the voxel value of the at least one of the one or more voxels based on the input.

27. The system of claim 17, wherein the processor is further configured to:

determine, after modifying the voxel value of the one or more voxels of the grid that overlap with the volume of tissue activation, a score based on the values associated with the plurality of voxels of the grid, wherein the score represents one of an outcome of the electrical stimulation therapy delivered to the patient according to the at least one electrical stimulation parameter value, and

select, based on the score, at least one updated electrical stimulation parameter value for the electrical stimulation therapy.

28. The system of claim 27, wherein the input comprises a first input and the volume of tissue activation comprises a first volume of tissue activation, wherein the processor is further configured to:

receive a second input indicative of at least one of an efficacious result and an adverse-effect result of the delivery of electrical stimulation therapy to the patient by the medical device according to the at least one updated electrical stimulation parameter value,

determine a second volume of tissue activation expected to result from the delivery of electrical stimulation to the patient according to the at least one updated electrical stimulation parameter value,

determine one or more voxels of the grid that overlap with the second volume of tissue activation, and

modify, based on the second input, a voxel value of at least one of the one or more voxels of the grid that overlap with the second volume of tissue activation.

29. The system of claim 28, further comprising the medical device, wherein the processor is further configured to control the medical device to deliver the electrical stimulation therapy to the patient according to the at least one updated electrical stimulation parameter value.

30. The system of claim 17, wherein the processor is further configured to select the grid from a plurality of grids stored by the memory based on a medical condition of the patient, the plurality of grids being associated with respective medical conditions.

31. The system of claim 17, wherein the volume of tissue activation represents a volume of tissue within a brain of the patient.

32. The system of claim 17, wherein the grid comprises a three-dimensional grid, and wherein each voxel of the plurality of voxels represents a three-dimensional volume of tissue.

33. A system comprising:

means for receiving an input indicative of at least one of an efficacious result or an adverse-effect result of a delivery of electrical stimulation therapy to a patient by a medical device according to at least one electrical stimulation parameter value;

means for determining a volume of tissue activation expected to result from the delivery of electrical stimulation to the patient according to the at least one electrical stimulation parameter value;

means for determining one or more voxels of a grid that overlap with the volume of tissue activation, wherein the grid comprises a plurality of voxels, and wherein each voxel of the plurality of voxels is associated with a respective voxel value; and

means for modifying, based on the input, a voxel value of at least one of the one or more voxels of the grid that overlap with the volume of tissue activation.

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

receive an input indicative of at least one of an efficacious result or an adverse-effect result of a delivery of electrical stimulation therapy to a patient by a medical device according to at least one electrical stimulation parameter value;

determine a volume of tissue activation expected to result from the delivery of electrical stimulation to the patient according to the at least one electrical stimulation parameter value;

determine one or more voxels of a grid that overlap with the volume of tissue activation, wherein the grid comprises a plurality of voxels, and wherein each voxel of the plurality of voxels is associated with a respective voxel value; and

modify, based on the input, a voxel value of at least one of the one or more voxels of the grid that overlap with the volume of tissue activation.