Sensitivity analysis for selecting therapy parameter sets

• US 8,032,224 B2
• Filed: 03/26/2007
• Issued: 10/04/2011
• Est. Priority Date: 03/16/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Werder, Jonathan C., LaPorte, Steve R., Heruth, Kenneth T., Miesel, Keith A., Graves, Nina M.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/691,413
• Publication Number:
  US 20080071324A1
• Time in Patent Office: 1,653 Days
• Field of Search: None
• US Class Current: 607/46
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/36521 : the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 : controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36557 : controlled by chemical substances in blood
• CPC Class Codes: A61N 1/37241 : providing test stimulations
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Techniques for controlling delivery of a therapy to a patient by a medical device, such as an implantable medical device (IMD), involve a sensitivity analysis of a performance metric. The performance metric may relate to efficacy or side effects of the therapy. For example, the performance metric may comprise a sleep quality metric, an activity level metric, a movement disorder metric for patients with Parkinson'"'"'s disease, epilepsy, or the like. The sensitivity analysis identifies values of therapy parameters that defines a substantially maximum or minimum value of the performance metric. The identified therapy parameters are a baseline therapy parameter set, and a medical device may control delivery of the therapy based on the baseline therapy parameter set.

Claims

1. A method comprising:

delivering at least one of a movement disorder therapy, psychological disorder therapy, or deep brain stimulation therapy to a patient via a medical device according to each of a plurality of therapy parameter sets, each of the parameter sets including a value for each of a plurality of therapy parameters;

monitoring a value of a performance metric of the patient for each of the plurality of therapy parameter sets;

conducting a sensitivity analysis of the performance metric for each of the plurality of therapy parameters based on the monitored values of the performance metric; and

identifying a value for each of the therapy parameters based on the sensitivity analysis,

wherein the performance metric comprises a sleep quality metric.

2. The method of claim 1, further comprising receiving a range for at least one therapy parameter in the therapy parameter sets and generating the plurality of therapy parameter sets with different values of the therapy parameter distributed over the range.

3. The method of claim 1, wherein identifying a value comprises identifying a value corresponding to one of a maximum value and a minimum value of the performance metric.

4. The method of claim 1, further comprising delivering the therapy to the patient based on a baseline therapy parameter set that includes the identified values.

5. The method of claim 4, wherein delivering the therapy to the patient based on a baseline therapy parameter set comprises delivering the therapy to the patient via one of the medical device or another medical device.

6. The method of claim 4, further comprising perturbing at least one therapy parameter of the baseline therapy parameter set, monitoring a perturbed value of the performance metric in response to the perturbed therapy parameter, comparing the perturbed value of the performance metric to the value of the performance metric for the baseline therapy parameter set and adjusting the therapy based on the comparison.

7. The method of claim 1, further comprising determining the sleep quality metric by:

monitoring a frequency of an electroencephalogram (EEG) signal;

identifying a sleep state based on the frequency of the EEG signal; and

determining the sleep quality metric based on the sleep state.

8. The method of claim 1, wherein the performance metric comprises a patient feedback metric.

9. The method of claim 1, wherein the performance metric comprises at least one of an activity level metric or a posture metric.

10. The method of claim 1, wherein the performance metric comprises at least one of a movement disorder metric or a side-effects metric.

11. A medical device comprising:

a therapy module to deliver at least one of a movement disorder therapy, psychological disorder therapy, or deep brain stimulation to a patient according to each of a plurality of therapy parameter sets, each of the therapy parameter sets including a value for each of a plurality of therapy parameters; and

a processor to monitor a value of a performance metric of the patient for each of the plurality of therapy parameter sets, conduct a sensitivity analysis of the performance metric for each of the plurality of therapy parameters based on the monitored values of the performance metric, and identify a value for each of the therapy parameters based on the sensitivity analysis,

wherein the processor monitors a sleep quality metric.

12. The medical device of claim 11, further comprising telemetry circuitry to receive a range for at least one therapy parameter in the therapy parameter sets, wherein the processor generates the plurality of therapy parameter sets with different values of the therapy parameter distributed over the range.

13. The medical device of claim 11, further comprising a memory to store a range for at least one therapy parameter in the therapy parameter sets, wherein the processor generates the plurality of therapy parameter sets with different values of the therapy parameter distributed over the range and stores the plurality of therapy parameter sets in the memory.

14. The medical device of claim 11, wherein the processor controls delivery of the therapy by the therapy module based on a baseline therapy parameter set that includes the identified values.

15. The medical device of claim 14, wherein the processor perturbs at least one therapy parameter of the baseline therapy parameter set, monitors a perturbed value of the performance metric in response to the perturbed therapy parameter, compares the perturbed value of the performance metric to the value of the performance metric for the baseline therapy parameter set and adjusts the therapy based on the comparison.

16. The medical device of claim 11, wherein the processor:

monitors a frequency of an electroencephalogram (EEG) signal;

identifies a sleep state based on the frequency of the EEG signal; and

determines the sleep quality metric based on the sleep state.

17. The medical device of claim 11, wherein the performance metric comprises a patient feedback metric.

18. The medical device of claim 11, wherein the medical device comprises an implantable medical device.

19. The medical device of claim 11, wherein the medical device comprises at least one of a neurostimulator or a pump.

20. The medical device of claim 11, wherein the medical device comprises at least one of a trial neurostimulator or a trial pump.

21. The medical device of claim 11, wherein the medical device delivers the therapy to the patient to treat chronic pain.

22. The medical device of claim 11, wherein the performance metric comprises at least one of an activity level metric or a posture metric.

23. The medical device of claim 11, wherein the performance metric comprises at least one of a movement disorder metric or a side-effects metric.

24. A non-transitory computer-readable medium comprising instructions that cause a programmable processor to:

monitor a value of a performance metric of a patient for each of a plurality of therapy parameter sets, wherein a medical device delivers at least one of a movement disorder therapy, psychological disorder therapy, or deep brain stimulation to the patient according to each of the therapy parameter sets, and each of the parameter sets includes a value for each of a plurality of therapy parameters;

conduct a sensitivity analysis of the performance metric for each of the plurality of therapy parameters based on the monitored values of the performance metric; and

identify a value for each of the plurality of therapy parameters based on the sensitivity analysis,

wherein the performance metric comprises a sleep quality metric.

25. The medium of claim 24, further comprising instructions that cause the processor to receive a range for at least one therapy parameter in the therapy parameter sets and generate the plurality of therapy parameter sets with different values of the therapy parameter distributed over the range.

26. The medium of claim 24, further comprising instructions that cause the processor to perturb at least one therapy parameter of a baseline therapy parameter set that includes the identified therapy parameter values, monitor a perturbed value of the performance metric in response to the perturbed therapy parameter, compare the perturbed value of the performance metric to the value of the performance metric for the baseline therapy parameter set and adjust the therapy based on the comparison.

27. The medium of claim 24, wherein the performance metric comprises a patient feedback metric.

28. The medium of claim 24, wherein the performance metric comprises at least one of an activity level metric or a posture metric.

29. The medium of claim 24, wherein the performance metric comprises at least one of a movement disorder metric or a side-effects metric.

30. A system comprising:

a therapy device that delivers at least one of a movement disorder therapy, psychological disorder therapy, or deep brain stimulation to a patient according to each of a plurality of therapy parameter sets, each of the therapy parameter sets including a value for each of a plurality of therapy parameters;

a monitor that monitors values of at least one physiological parameter of a patient for each of the plurality of therapy parameter sets; and

a computing device that receives the physiological parameter values from the monitor, identifies a value of a performance metric of the patient for each of the plurality of parameter sets based on the physiological parameter values, conducts a sensitivity analysis of the performance metric for each of the plurality of therapy parameters based on the monitored values of the performance metric, and identifies a value for each of the therapy parameters based on the sensitivity analysis,

wherein the performance metric comprises a sleep quality metric.

31. The system of claim 30, wherein one of the therapy device and the computing device comprises the monitor.

32. The system of claim 30, wherein the computing device comprises a programming device.

33. The system of claim 30, wherein the computing device receives a range for at least one therapy parameter in the therapy parameter sets and generates the plurality of therapy parameter sets with different values of the therapy parameter distributed over the range.

34. The system of claim 30, wherein the computing device conducts the sensitivity analysis to determine a value for at least one therapy parameter corresponding to one of a maximum value and a minimum value of the performance metric.

35. The system of claim 30, wherein one of the therapy device or another therapy device receives a baseline therapy parameter set that includes the identified values from the computing device, and delivers the therapy to the patient according to the baseline therapy parameter set.

36. The system of claim 35, wherein the computing device directs the therapy device or the other therapy device to perturb at least one therapy parameter of the baseline therapy parameter set and monitors a perturbed value of the performance metric in response to the perturbed therapy parameter.

37. The system of claim 36, wherein the computing device compares the perturbed value of the performance metric to the value of the performance metric for the baseline therapy parameter set and updates the baseline therapy parameter set based on the comparison, and one of the therapy device or the other therapy device receives the updated baseline therapy parameter set from the computing device to adjust the therapy based on the updated baseline therapy parameter set.

38. The system of claim 30, wherein the computing device:

monitors a frequency of an electroencephalogram (EEG) signal;

identifies a sleep state based on the frequency of the EEG signal; and

determines the sleep quality metric based on the sleep state.

39. The system, of claim 30, wherein the performance metric comprises a patient feedback metric.

40. The system of claim 30, wherein the therapy device comprises an implantable medical device.

41. The system of claim 30, wherein the therapy device comprises at least one of a neurostimulator or a pump.

42. The system of claim 30, wherein the therapy device comprises at least one of a trial neurostimulator or a trial pump.

43. The system of claim 30, wherein the performance metric comprises at least one of an activity level metric or a posture metric.

44. The system of claim 30, wherein the performance metric comprises at least one of a movement disorder metric or a side-effects metric.