Collecting sleep quality information via a medical device

• US 7,717,848 B2
• Filed: 04/15/2004
• Issued: 05/18/2010
• 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): Mallari; Patricia C
• Application Number:
  US10/826,925
• Publication Number:
  US 20050209513A1
• Time in Patent Office: 2,224 Days
• Field of Search: 600/300, 600/301, 600/481, 600/500, 600/529, 600/532, 600/533, 607/6, 607/7
• US Class Current: 600/300
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• 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 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• 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 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

At least one of a medical device, such as an implantable medical device, and a programming device determines values for one or more metrics that indicate the quality of a patient'"'"'s sleep. Sleep efficiency, sleep latency, and time spent in deeper sleep states are example sleep quality metrics for which values may be determined. In some embodiments, determined sleep quality metric values are associated with a current therapy parameter set. In some embodiments, a programming device presents sleep quality information to a user based on determined sleep quality metric values values. A clinician, for example, may use the sleep quality information presented by the programming device to evaluate the effectiveness of therapy delivered to the patient by the medical device, to adjust the therapy delivered by the medical device, or to prescribe a therapy not delivered by the medical device in order to improve the quality of the patient'"'"'s sleep.

Claims

1. A medical system comprising:

a medical device that delivers a therapy to a patient, and monitors at least one physiological parameter of the patient based on a signal received from at least one sensor;

a processor tat determines a plurality of values of a metric that is indicative of sleep quality over time, each of the values of the sleep quality metric determined based on values of the at least one physiological parameter determined during delivery of the therapy by the medical device according to at least one of a plurality of therapy parameter sets, and associates each of the determined values of the sleep quality metric with the at least one of the plurality of therapy parameter sets and, for each of the plurality of therapy parameter sets, determines a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set, wherein the representative value for each therapy parameter set comprises one of a mean value or a median value; and

a memory that receives the sleep quality metric values, the representative values, and an indication of the therapy parameter sets associated with the sleep quality metric values and representative values.

2. The medical system of claim 1, wherein the medical device monitors at least one of activity level, posture, heart rate, respiration rate, respiratory volume, and core temperature.

3. The medical system of claim 1, wherein the medical device monitors at least one of blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity, arterial blood flow, melatonin level within a bodily fluid, and galvanic skin response.

4. The medical system of claim 1, wherein the sleep quality metric comprises sleep efficiency, and the processor identifies when the patient is attempting to sleep, identifies when the patient is asleep, and determines a percentage of time that the patient is asleep while the patient is attempting to sleep as the value of the sleep quality metric.

5. The medical system of claim 1, wherein the sleep quality metric comprises sleep latency, and the processor identifies a first time when the patient begins attempting to sleep, identifies a second time when the patient falls asleep, and determines an amount of time between the first and second times as the value of the sleep quality metric.

6. The medical system of claim 1, wherein the processor identifies when the patient is asleep, and determines an amount of time that the patient is asleep during a period as the value of the sleep quality metric.

7. The medical system of claim 1, wherein the processor identifies when the patient is asleep, and identifies at least one of a number of arousal events and a number of apnea events during a period of sleep as the value of the sleep quality metric.

8. The medical system of claim 1, wherein the processor identifies when the patient is within a sleep state, and determines an amount of time that the patient was within the sleep state.

9. The medical device of claim 8, wherein the sleep state comprises at least one of an S3 sleep state and an S4 sleep state.

10. The medical system of claim 1, wherein the processor determines a value of each of a plurality of sleep quality metrics, and determines a value of an overall sleep quality metric based on the plurality of sleep quality metric values.

11. The medical system of claim 10, wherein the processor applies a weighting factor to at least one of the plurality of sleep quality metric values to determine the value of the overall sleep quality metric.

12. The medical system of claim 1, further comprising a programming device to present sleep quality information to a user based on the sleep quality metric values determined by the processor.

13. The medical system of claim 12, wherein the user comprises a clinician, and the programming device comprises a clinician programmer that presents at least one of a trend diagram, a histogram and a pie chart to the clinician based on the sleep quality metric values.

14. The medical system of claim 12, wherein the user comprises a patient, and the programming device comprises a patient programmer that presents a message related to sleep quality to the patient based on the sleep quality metric values.

15. The medical system of claim 1, further comprising a programming device that presents a list of the therapy parameter sets and the associated representative values to a user, and orders the list of therapy parameter sets according to the associated representative values.

16. The medical system of claim 1,

wherein the processor determines a plurality of values over time for each of a plurality of metrics that are indicative of sleep quality, each of the values of each of the sleep quality metrics determined based on values of the at least one physiological parameter that were determined during delivery of the therapy according to at least one of a plurality of therapy parameter sets, and associates each of the determined values with the at least one of the plurality of therapy parameter sets, and

wherein, for each of the plurality of therapy parameter sets, the processor determines a representative value for each of the sleep quality metrics based on the values of that sleep quality metric associated with the therapy parameter set.

17. The medical system of claim 16, further comprising a programming device that presents a list of the therapy parameter sets and the associated representative values to a user, and orders the list of therapy parameter sets according to the representative values of a user-selected one of the sleep quality metrics.

18. The medical system of claim 1, wherein the processor comprises a processor of the medical device.

19. The medical system of claim 1, further comprising a programming device, wherein the processor comprises a processor of the programming device.

20. The medical system of claim 1, wherein the medical device comprises an implantable medical device.

21. The medical system of claim 20, wherein the implantable medical device comprises at least one of an implantable neurostimulator or an implantable drug pump.

22. The medical system of claim 1, wherein the medical device comprises at least one of a trial neurostimulator or a trial pump.

23. A medical system comprising:

means for monitoring at least one physiological parameter of a patient;

means for determining a plurality of values of a metric that is indicative of sleep quality over time, each of the values of the sleep quality metric determined based on the at least one physiological parameter;

means for identifying which of a plurality of therapy parameter sets was used by a medical device to deliver therapy to the patient when each of the plurality of sleep quality metric values was determined;

means for associating each of the determined values of the sleep quality metric with the at least one of the plurality of therapy parameter sets based on the identification; and

means for determining a representative value of the sleep quality metric for each of the plurality of therapy parameter sets based on the values of the sleep quality metric associated with the therapy parameter set, wherein the representative value for each therapy parameter set comprises one of a mean value or a median value.

24. The medical system of claim 23, further comprising means for presenting sleep quality information to a user based on the plurality of values.

25. The medical system of claim 23, further comprising:

means for presenting a list of the therapy parameter sets and the associated representative values to a user, and

means for ordering the list of therapy parameter sets according to the associated representative values.

26. A medical system comprising:

an implantable medical device that delivers a therapy to a patient, monitors at least one physiological parameter of the patient, determines a plurality of values of a metric that is indicative of sleep quality over time, each of the values of the sleep quality metric determined based on values of the at least one physiological parameter, associates each of the sleep quality metric values with at least one of a plurality of therapy parameter sets tat was used by the medical device to deliver the therapy to the patient when the values of the at least one physiological parameter were determined, and, for each of the plurality of therapy parameter sets, determines a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set, wherein the representative value for each therapy parameter set comprises one of a mean value or a median value; and

an external programming device including a display that receives sleep quality metric values and indications of therapy parameter sets with which the sleep quality metric values are associated from the implantable medical device, and presents sleep quality information to a user via the display based on the sleep quality metric values and the indications.

27. The medical system of claim 26,

wherein the user comprises a clinician and the programming device comprises a clinician programmer, and

wherein the programming device presents a graphical representation of the sleep quality metric values via the display.

28. The medical system of claim 27, wherein the programming device presents at least one of a trend diagram, a histogram and a pie chart via the display based on the sleep quality metric values.

29. The medical system of claim 26,

wherein the user comprises a patient and the programming device comprises a patient programmer, and

wherein the programming device presents a message related to sleep quality to the patient based on the sleep quality metric values.

30. The medical system of claim 26,

wherein the implantable medical device determines a representative value for the sleep quality metric for each of the plurality of therapy parameter sets based on the values of the sleep quality metric associated with the therapy parameter sets, and

wherein the programming device orders a list of therapy parameter sets according to the associated representative sleep quality metric values.

31. The medical system of claim 28, wherein the implantable medical device comprises at least one of an implantable neurostimulator or an implantable drug pump.