Collecting activity information to evaluate incontinence therapy

• US 7,590,453 B2
• Filed: 04/30/2007
• Issued: 09/15/2009
• Est. Priority Date: 03/16/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Miesel, Keith A.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/796,811
• Publication Number:
  US 20070293737A1
• Time in Patent Office: 869 Days
• Field of Search: 607/3, 607/41, 607/9, 607/46, 607/48, 600/585, 600/587
• US Class Current: 607/41
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/6838 Clamps or clips
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• 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

Abstract

A medical device delivers a therapy to a patient. The medical device may periodically determine an activity level of the patient, and associate each determined activity level with a current therapy parameter set. A value of at least one activity metric is determined for each of a plurality of therapy parameter sets based on the activity levels associated with that therapy parameter set. A list of the therapy parameter sets is presented to a user, such as a clinician, for evaluation of the relative efficacy of the therapy parameter sets. The list may be ordered according to the one or more activity metric values to aid in evaluation of the therapy parameter sets. Where values are determined for a plurality of activity metrics, the list may be ordered according to the one of the activity metrics selected by the user.

Claims

1. A method comprising:

monitoring a signal that varies as a function of patient activity;

periodically determining an activity level of the patient based on the signal, wherein periodically determining an activity level comprises periodically determining a number of activity counts;

associating each of the determined activity levels with a therapy parameter set used by a medical device to deliver a therapy to a patient to treat incontinence when the activity level was determined; and

determining a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets.

2. The method of claim 1, wherein determining a value of an activity metric comprises determining at least one of a mean or a median of activity levels associated with the therapy parameter set.

3. The method of claim 2, wherein determining a value of an activity metric comprises:

comparing the at least one of the mean and the median activity level to at least one threshold; and

selecting the activity metric value from a plurality of predetermined possible activity metric values based on the comparison.

4. The method of claim 1, wherein determining a value of an activity metric for a therapy parameter set comprises:

comparing each of the activity levels associated with the therapy parameter set to a threshold value; and

determining at least one of a percentage of time above the threshold and a percentage of time below the threshold.

5. The method of claim 1, wherein determining a value of an activity metric for a therapy parameter set comprises:

comparing each of the activity levels associated with the therapy parameter set to a threshold value; and

determining an average length of time that consecutively determined activity levels associated with the therapy parameter set were above the threshold.

6. The method of claim 1, wherein determining an activity metric value for each of a plurality of therapy parameter sets comprises determining an average number of activity counts per a unit of time for each of the plurality of therapy parameter sets based on the numbers of activity counts associated with the therapy parameter sets.

7. The method of claim 1, wherein periodically determining an activity level comprises periodically determining a value of at least one physiological parameter of the patient.

8. The method of claim 7, wherein periodically determining a value of a physiological parameter comprises periodically determining at least one of a heart rate, a respiration rate, respiratory volume, a core temperature or a muscular activity level.

9. The method of claim 1, further comprising presenting a list of the plurality of therapy parameter sets and activity metric values associated with the therapy parameter sets.

10. The method of claim 9, further comprising ordering the list of therapy parameter sets according to the associated activity metric values.

11. The method of claim 10, wherein ordering the list comprises ordering the list according to a user selected one of the activity metrics.

12. The method of claim 1, wherein determining a value of an activity metric comprises:

determining a value of each of a plurality of activity metrics; and

determining a value of an overall activity metric based on the plurality of activity metric values.

13. The method of claim 1, further comprising presenting a graphical representation of the determined activity levels.

14. The method of claim 1, wherein monitoring the signal that varies as a function of patient activity comprises monitoring the signal from an accelerometer.

15. A medical system comprising:

a medical device that delivers a therapy to a patient to treat incontinence; and

a processor that monitors a signal that varies as a function of patient activity, periodically determines an activity level of the patient based on the signal, associates each of the determined activity levels with a therapy parameter set used by the medical device to deliver the therapy to the patient when the activity level was determined, and determines a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets,

wherein, for each of the therapy parameter sets, the processor determines at least one of a mean or a median of activity levels associated with the therapy parameter set.

16. The medical system of claim 15, wherein the medical device includes the processor.

17. The medical system of claim 15, further comprising a programming device that includes the processor.

18. The medical system of claim 15, wherein the processor periodically determines an activity level by periodically determining a value of at least physiological parameter of the patient.

19. The medical system of claim 15, further comprising a display to present a list of the plurality of therapy parameter sets and activity metric values associated with the therapy parameter sets.

20. The medical system of claim 19, further comprising a programming device that includes the display.

21. The medical system of claim 15, wherein the processor determines a value of each of a plurality of activity metrics, and determines a value of an overall activity metric based on the plurality of activity metric values.

22. The medical system of claim 15, wherein the medical device comprises an implantable medical device.

23. The medical system of claim 15, wherein the medical device comprises a trial neurostimulator.

24. The medical system of claim 15, further comprising an accelerometer, wherein the accelerometer generates the signal that varies as a function of patient activity.

25. A medical system comprising:

a medical device that delivers a therapy to a patient to treat incontinence; and

a processor that monitors a signal that varies as a function of patient activity, periodically determines an activity level of the patient based on the signal, associates each of the determined activity levels with a therapy parameter set used by the medical device to deliver the therapy to the patient when the activity level was determined, and determines a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets,

wherein, for each of the therapy parameter sets, the processor compares each of the activity levels associated with the therapy parameter set to a threshold value, and determines as the activity metric value for the therapy parameter set at least one of a percentage of time above the threshold and a percentage of time below the threshold.

26. The medical system of claim 25, further comprising an accelerometer, wherein the accelerometer generates the signal that varies as a function of patient activity.

27. A medical system comprising:

a medical device that delivers a therapy to a patient to treat incontinence; and

a processor that monitors a signal that varies as a function of patient activity, periodically determines an activity level of the patient based on the signal, associates each of the determined activity levels with a therapy parameter set used by the medical device to deliver the therapy to the patient when the activity level was determined, and determines a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets,

wherein, for each of the plurality of parameter sets, the processor compares each of the activity levels associated with the therapy parameter set to a threshold value, and determines an average length of time that consecutively determined activity lexels were above the threshold as the activity metric value for the parameter set.

28. A method comprising:

monitoring a signal that varies as a function of patient activity;

periodically determining an activity level of the patient based on the signal;

associating each of the determined activity levels with a therapy parameter set used by a medical device to deliver a therapy to a patient to treat incontinence when the activity level was determined; and

determining a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets, wherein determining a value of an activity metric comprises determining at least one of a mean or a median of activity levels associated with the therapy parameter set.

29. The method of claim 28, wherein determining a value of an activity metric comprises:

comparing the at least one of the mean and the median activity level to at least one threshold; and

selecting the activity metric value from a plurality of predetermined possible activity metric values based on the comparison.

30. A method comprising:

monitoring a signal that varies as a function of patient activity;

periodically determining an activity level of the patient based on the signal;

associating each of the determined activity levels with a therapy parameter set used by a medical device to deliver a therapy to a patient to treat incontinence when the activity level was determined; and

determining a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets, wherein determining a value of an activity metric for a therapy parameter set comprises;

comparing each of the activity levels associated with the therapy parameter set to a threshold value; and

determining at least one of a percentage of time above the threshold and a percentage of time below the threshold.

31. A method comprising:

monitoring a signal that varies as a function of patient activity;

periodically determining an activity level of the patient based on the signal;

associating each of the determined activity levels with a therapy parameter set used by a medical device to deliver a therapy to a patient to treat incontinence when the activity level was determined; and

determining a value of an activity metric for each of a plurality of therapy parameter sets based on activity levels associated with the therapy parameter sets, wherein determining a value of an activity metric for a therapy parameter set comprises;

comparing each of the activity levels associated with the therapy parameter set to a threshold value; and

determining an average length of time that consecutively determined activity levels associated with the therapy parameter set were above the threshold.