Target therapy delivery site selection

• US 10,252,055 B2
• Filed: 03/13/2014
• Issued: 04/09/2019
• Est. Priority Date: 01/25/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stypulkowski, Paul H., Giftakis, Jonathon E.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/207,926
• Publication Number:
  US 20140194945A1
• Time in Patent Office: 1,853 Days
• Field of Search: 607 45, 607 48, 607 52, 607 53, 607 62, 607 68, 607116
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

In some examples of selecting a target therapy delivery site for treating a patient condition, a relatively high frequency electrical stimulation signal is delivered to at least two areas within a first region (e.g., an anterior nucleus of the thalamus) of a brain of a patient, and changes in brain activity (e.g., as indicated by bioelectrical brain signals) within a second region (e.g., a hippocampus) of the brain of the patient in response to the delivered stimulation are determined. The target therapy delivery site, an electrode combination, or both, may be selected based on the changes in brain activity.

Claims

1. A method comprising:

mapping functional connections between a first region of a brain of a patient and a second region of the brain, wherein mapping functional connections comprises;

controlling a stimulation generator to deliver electrical stimulation to a plurality of different areas of the first region of the brain of the patient, wherein the electrical stimulation is delivered to each area of the plurality of different areas of the first region of the brain at different times; and

for each area of the plurality of different areas of the first region of the brain, determining a level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area; and

with a processor, selecting at least one of the areas of the plurality of different areas of the first region of the brain as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

2. The method of claim 1, wherein the first and second regions are within a Circuit of Papez of the brain.

3. The method of claim 2, wherein the Circuit of Papez includes an anterior nucleus of a thalamus, an internal capsule, a cingulate, a hippocampus, a fornix, an entorhinal cortex, mammillary bodies, and a mammillothalamic tract.

4. The method of claim 1, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

5. The method of claim 1, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.

6. The method of claim 1, further comprising sensing a bioelectrical brain signal in the second region of the brain of the patient, wherein determining, for each area of the plurality of different areas of the first region of the brain, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises determining the level of brain activity in the second region of the brain of the patient based on the sensed bioelectrical brain signal.

7. The method of claim 1, further comprising sensing a bioelectrical brain signal in the first region of the brain of the patient, wherein determining, for each area of the plurality of different areas of the first region, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises determining the level of brain activity in the second region of the brain of the patient based on the sensed bioelectrical brain signal.

8. The method of claim 1, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain of the patient comprises controlling the stimulation generator to deliver electrical stimulation to a first area of the first region of the brain via a subset of electrodes of a lead, and wherein determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises determining, with the stimulation generator, a first level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the first area, the method further comprising:

receiving an indication that the lead has been moved within the brain of the patient;

after receiving the indication, controlling the stimulation generator to deliver electrical stimulation to a second area of the first region of the brain via the subset of electrodes, wherein the plurality of different areas comprises the second area; and

after the stimulation generator delivers electrical to the second area of the first region of the brain, determining a second level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the second area of the first region.

9. The method of claim 8, further comprising:

determining whether the second level of brain activity in the second region of the brain of the patient is less than the first level of brain activity in the second region,

wherein if the second level is less than the first level, controlling the stimulation generator to deliver electrical stimulation to a third area of the first region of the brain via the subset of electrodes, wherein the plurality of different areas comprises the third area, and after the stimulation generator delivers electrical stimulation to the third area of the first region, determining a third level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the third area of the first region, and

wherein if the second level is not less than the first level, selecting the first area of the first region of the brain of the patient as the target therapy delivery site.

10. The method of claim 1, wherein the plurality of different areas of the first region comprises a first area and a second area, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain of the patient and, for each area of the plurality of different areas, determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises:

controlling the stimulation generator to deliver electrical stimulation to the first area of the first region of the brain of the patient, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz;

immediately after the stimulation generator delivers electrical stimulation to the first area of the first region, determining a first level of brain activity in the second region of the brain of the patient;

controlling the stimulation generator to deliver electrical stimulation to the second area of the first region of the brain, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz; and

immediately after the stimulation generator delivers electrical stimulation to the second area of the first region, determining a second level of brain activity in the second region of the brain of the patient,

wherein selecting at least one of the areas of the first region of the brain of the patient as the target therapy delivery site comprises, with the processor, selecting one of the first area or the second area of the first region of the brain of the patient as the target therapy delivery site based on the first and second levels of brain activity in the second region of the brain.

11. The method of claim 1, wherein selecting at least one of the areas of the plurality of different areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain comprises selecting the area of the plurality of different areas associated with a lowest level of brain activity in the second region.

12. The method of claim 1, while an implantable medical lead comprising a plurality of electrodes in the first region of the brain of the patient is implanted in the first region of the brain, controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region comprises, for each area of the plurality of different areas, controlling the stimulation generator to deliver to the first region using a different subset of electrodes of the lead.

13. The method of claim 1, further comprising associating the level of brain activity in the second region with the respective area of the first region and storing the level of brain activity in the second region and associated area of the first region in a memory of a device.

14. The method of claim 1, wherein the level of brain activity comprises at least one of a time domain characteristic or a frequency domain characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient.

15. The method of claim 1, wherein the level of brain activity comprises at least one of a change in a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient relative to a baseline characteristic of the bioelectrical brain signal.

16. The method of claim 1, wherein determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area of the plurality of different areas of the first region comprises determining the level of brain activity in the second region of the brain while electrical stimulation is being delivered to the area.

17. The method of claim 1, wherein determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area of the plurality of different areas of the first region comprises determining the level of brain activity in the second region of the brain after terminating the delivery of electrical stimulation to the area.

18. The method of claim 1, further comprising:

for each area of the plurality of areas, generating a metric based on the level of brain activity in the second region resulting from the delivery of the electrical stimulation to the area, wherein the metric indicates a relative level of brain activity in the second region resulting from delivery of electrical stimulation to the respective area of the first region; and

displaying, via a display of a device, indications of each area of the plurality of areas and the respective metric.

19. The method of claim 18, wherein the metric comprises at least one of a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient, a graphical representation of the bioelectrical brain signal, an indication of a distribution of power in the bioelectrical brain signal, a power level of the bioelectrical brain signal at a frequency of about 2 Hertz, or a change in a characteristic of a bioelectrical brain signal relative to a baseline characteristic of the bioelectrical brain signal.

20. The method of claim 1, further comprising controlling the stimulation generator to deliver electrical stimulation therapy to the target therapy delivery site.

21. The method of claim 1, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region comprises controlling the stimulation generator to deliver electrical stimulation via each electrode combination of a plurality of electrode combinations, and wherein selecting at least one of the areas of the plurality of different areas of the first region as the target therapy delivery site based on the associated level of brain activity in the second region of the brain comprises selecting at least one electrode combination of the plurality of electrode combinations based on the associated level of brain activity in the second region of the brain.

22. A system comprising:

a stimulation generator configured to generate and deliver electrical stimulation;

a sensing module; and

a processor configured to map functional connections between a first region of a brain of a patient and a second region of the brain, wherein the processor is configured to map the functional connections by at least controlling the stimulation generator to deliver electrical stimulation to each area of a plurality of different areas of the first region of the brain at a different time, and determining, for each area of the plurality of different areas of the first region and based on a bioelectrical brain signal sensed by the sensing module, a level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area.

23. The system of claim 22, wherein the processor is further configured to select at least one of the areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

24. The system of claim 22, wherein the first and second regions are within a Circuit of Papez of the brain.

25. The system of claim 24, wherein the Circuit of Papez includes an anterior nucleus of a thalamus, an internal capsule, a cingulate, a hippocampus, a fornix, an entorhinal cortex, mammillary bodies, and a mammillothalamic tract.

26. The system of claim 22, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

27. The system of claim 22, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.

28. The system of claim 22, wherein the sensing module is configured to sense the bioelectrical brain signal in the second region of the brain of the patient and the processor is configured to determine, for each area of the plurality of different areas of the first region, the level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal sensed in the second region of the brain.

29. The system of claim 22, wherein the sensing module is configured to sense the bioelectrical brain signal in the first region of the brain of the patient and the processor is configured to determine, for each area of the plurality of different areas of the first region, the level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal sensed in the first region of the brain.

30. The system of claim 22, further comprising a lead comprising electrodes, wherein the processor is configured to control the stimulation generator to deliver stimulation to a first area of the first region via a subset of the electrodes of the lead, and determine the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area by at least determining a first level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the first area, wherein the processor is further configured to receive an indication that the lead has been moved within the brain of the patient and, after receiving the indication, control the stimulation generator to deliver stimulation to a second area of the first region via the subset of electrodes, wherein the plurality of different areas comprises the second area, and, determine a second level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the second area of the first region, and wherein the processor is configured to determine whether the second level of brain activity in the second region of the brain of the patient is less than the first level of brain activity in the second region, and, in response to determining the second level is less than the first level, control the stimulation generator to deliver stimulation to a third area of the first region via the subset of electrodes, wherein the plurality of different areas comprises the third area, and determine a third level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the third area of the first region, and wherein the processor is configured to, in response to determining the second level is not less than the first level, select the first area of the first region of the brain of the patient as the target therapy delivery site.

31. The system of claim 22, wherein the plurality of different areas of the first region of the brain comprises a first area and a second area, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain of the patient and, for each area of the plurality of different areas, determine the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area by at least:

controlling the stimulation generator to deliver electrical stimulation to the first area of the first region of the brain of the patient, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz;

immediately after the stimulation generator delivers the electrical stimulation to the first area of the first region, determining a first level of brain activity in the second region of the brain of the patient;

after determining the first level of brain activity in the second region of the brain, controlling the stimulation generator to deliver stimulation to the second area of the first region of the brain, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz; and

immediately after the stimulation generator delivers electrical stimulation to the second area of the first region, determining a second level of brain activity in the second region of the brain of the patient,

wherein the processor is configured to select one of the first area or the second area of the first region of the brain of the patient as the target therapy delivery site based on the first and second levels of brain activity in the second region of the brain.

32. The system of claim 22, further comprising a memory, wherein the processor is configured to associate the level of brain activity in the second region with the respective area of the first region of the brain and stores the level of brain activity in the second region and associated area of the first region in the memory.

33. The system of claim 22, wherein the level of brain activity comprises at least one of time domain characteristic or a frequency domain characteristic of the bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient.

34. The system of claim 33, wherein the level of brain activity comprises an amplitude of the bioelectrical brain signal sensed in the at least one of the first region or the second region of the brain of the patient.

35. The system of claim 33, wherein the level of brain activity comprises a power level of the bioelectrical brain signal at a frequency of about 2 Hertz.

36. The system of claim 22, wherein the level of brain activity comprises at least one of a change in a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient relative to a baseline characteristic of the bioelectrical brain signal.

37. The system of claim 22, further comprising a display, wherein the processor is configured to, for each area of the plurality of areas, generate a metric based on the level of brain activity in the second region resulting from the delivery of the electrical stimulation to the area, wherein the metric indicates a relative level of brain activity in the second region resulting from delivery of electrical stimulation to the respective area, and present, via the display, indications of each area of the plurality of areas and the respective metric.

38. The system of claim 37, wherein the metric comprises at least one of a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient, a graphical representation of the bioelectrical brain signal, an indication of a distribution of power in the bioelectrical brain signal, a power level of the bioelectrical brain signal at a frequency of about 2 Hertz, or a change in a characteristic of a bioelectrical brain signal relative to a baseline characteristic of the bioelectrical brain signal.

39. The system of claim 22, further comprising a medical device programmer comprising the processor.

40. The system of claim 22, wherein the processor is configured to control the stimulation generator to generate and deliver electrical stimulation therapy to the target therapy delivery site.

41. The system of claim 22, wherein the processor is configured to determine, for each area of the plurality of different areas of the first region of the brain, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal while the stimulation generator is delivering the electrical stimulation to the area.

42. The system of claim 22, wherein the processor is configured to determine, for each area of the plurality of different areas of the first region of the brain, the level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal after the stimulation generator terminates delivery of the electrical stimulation to the area.

43. The system of claim 22, further comprising a plurality of electrodes, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain by at least controlling the stimulation generator to deliver electrical stimulation to the first region via each of a plurality of combinations of electrodes of the plurality of electrodes, and wherein the processor is configured to select at least one of the areas of the plurality of different areas of the first region of the brain as the target therapy delivery site based on the associated level of brain activity in the second region of the brain by at least selecting at least one electrode combination of the plurality of electrode combinations based on the associated level of brain activity in the second region of the brain.

44. The system of claim 22, wherein the processor is configured to select at least one of the areas of the plurality of different areas of the first region of the brain of the patient as the target therapy delivery site based on the associated level of brain activity in the second region of the brain by at least selecting the area of the plurality of different areas associated with a lowest level of brain activity in the second region.

45. A system comprising:

means for delivering electrical stimulation to a brain of a patient;

means for mapping functional connections between a first region of a brain of a patient and a second region of the brain, wherein the mapping functional connections comprises;

means for controlling the means for delivering electrical stimulation to deliver electrical stimulation to each area of a plurality of different areas of the first region of the brain at different times; and

means for determining, for each area of the plurality of different areas of the first region, a level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area; and

means for selecting at least one of the areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

46. The system of claim 45, wherein the first and second regions are within a Circuit of Papez of the brain.

47. The system of claim 45, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

48. The system of claim 45, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.

49. The system of claim 45, further comprising means for sensing a bioelectrical brain signal of the brain of the patient, wherein the means for determining, for each area of the plurality of different areas of the first region, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area is configured to determine the level of brain activity in the second region based on the sensed bioelectrical brain signal.

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

map functional connections between a first region of a brain of a patient and a second region of the brain by at least;

controlling a stimulation generator to deliver electrical stimulation to a plurality of different areas of the first region of the brain of the patient, wherein the electrical stimulation is delivered to each area of the plurality of different areas of the first region of the brain at different times; and

for each area of the plurality of different areas of the first region of the brain, determining a level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area; and

select at least one of the areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

51. The computer readable medium of claim 50, wherein the first and second regions are within a Circuit of Papez of the brain.

52. The computer readable medium of claim 50, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

53. The computer readable medium of claim 50, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.