Detecting sleep to evaluate therapy

• US 8,332,038 B2
• Filed: 09/30/2011
• Issued: 12/11/2012
• 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., Werder, Jonathan C., LaPorte, Steve R., Graves, Nina M.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/249,862
• Publication Number:
  US 20120022340A1
• Time in Patent Office: 438 Days
• Field of Search: 607/2, 607/41, 607/48, 607/45
• US Class Current: 607/45
• 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 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/40 Respiratory characteristics
• CPC Class Codes: A61M 2230/62 Posture
• 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 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system includes one or more sensors and a processor. Each of the sensors generates a signal as a function of at least one physiological parameter of a patient that may discernibly change when the patient is asleep. The processor monitors the physiological parameters, and determines whether the patient is asleep based on the parameters. In some embodiments, the processor determines plurality of sleep metric values, each of which indicates a probability of the patient being asleep, based on each of a plurality of physiological parameters. The processor may average or otherwise combine the plurality of sleep metric values to provide an overall sleep metric value that is compared to a threshold value in order to determine whether the patient is asleep. In addition, an electroencephalogram signal may be used to identify sleep states of the patient.

Claims

1. A method for evaluating an efficacy of a movement disorder therapy comprising:

monitoring at least one physiological parameter of a patient via an implantable medical device that delivers the movement disorder therapy to the patient;

monitoring sleep patterns of the patient with the implantable medical device based on the physiological parameter;

determining sleep quality information based on the sleep patterns; and

presenting the sleep quality information in conjunction with information regarding the delivery of the movement disorder therapy to a user to allow the user to evaluate the efficacy of the movement disorder therapy,

wherein the movement disorder therapy delivered by the implantable medical device to the patient treats a movement disorder selected from a group consisting of;

tremor;

Parkinson'"'"'s disease;

multiple sclerosis;

spasticity; and

epilepsy.

2. The method of claim 1, wherein monitoring sleep patterns comprises:

determining a value of a sleep probability metric that indicates a probability of the patient being asleep based on the physiological parameter; and

determining whether the patient is asleep based on the sleep probability metric value.

3. The method of claim 2,

wherein monitoring at least one physiological parameter comprises monitoring a plurality of physiological parameters,

wherein determining a value of a sleep probability metric comprises determining a value for each of a plurality of sleep probability metrics that each indicate a probability of the patient being asleep, each of the values determined based on a respective one of the physiological parameters, and

wherein determining whether the patient is asleep comprises determining whether the patient is asleep based on the plurality of sleep probability metric values.

4. The method of claim 3, wherein determining whether the patient is asleep based on the plurality of sleep probability metric values comprises:

applying a weighting value to at least one of the sleep probability metric values; and

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

5. The method of claim 2, further comprising comparing the value of the sleep probability metric to a plurality of thresholds, wherein monitoring sleep patterns of the patient comprises determining a sleep state of the patient based on the comparison.

6. The method of claim 5, wherein determining a sleep state of the patient comprises determining whether the patient is in one of an S3 or S4 sleep state.

7. The method of claim 1,

wherein monitoring at least one physiological parameter of a patient comprises monitoring an electroencephalogram (EEG) of the patient, and

wherein monitoring sleep patterns of the patient comprises determining a sleep state of the patient based on a frequency of the EEG.

8. The method of claim 7, wherein determining a sleep state of the patient comprises determining whether the patient is in one of an S3 or S4 sleep state.

9. The method of claim 1, further comprising:

determining a value of a sleep quality metric based on the sleep patterns, wherein presenting the sleep quality information in conjunction with information regarding the delivery of the movement disorder therapy to the user comprises presenting the value of the sleep quality metric to the user; and

associating the value of the sleep quality metric with a therapy parameter set used to deliver the movement disorder therapy to the patient when the sleep quality metric value was determined, wherein presenting the sleep quality information in conjunction with information regarding the delivery of the movement disorder therapy to the user comprises presenting the value of the sleep quality metric and the associated therapy parameter set to the user.

10. The method of claim 1, further comprising associating the sleep quality information with a therapy parameter set used to deliver the movement disorder therapy to the patient when the sleep quality information was determined, wherein presenting the sleep quality information in conjunction with information regarding the delivery of the movement disorder therapy to the user comprises presenting the sleep quality information and the associated therapy parameter set to the user.

11. The method of claim 1, wherein the movement disorder therapy delivered by the implantable medical device to the patient includes deep brain stimulation.

12. The method of claim 1, wherein the movement disorder therapy delivered by the implantable medical device to the patient treats tremor.

13. A medical system comprising:

a sensor that generates a signal as a function of at least one physiological parameter of a patient;

an implantable medical device that delivers a movement disorder therapy, monitors the at least one physiological parameter of the patient based on the signal output by the sensor, and monitors sleep patterns of the patient based on the physiological parameter;

a processor that determines sleep quality information based on the sleep patterns for evaluation of an efficacy of the movement disorder therapy; and

a computing device that provides the sleep quality information in conjunction with information regarding the delivery of the movement disorder therapy to a user to allow the user to evaluate the efficacy of the movement disorder therapy,

wherein the movement disorder therapy delivered by the implantable medical device to the patient treats a movement disorder selected from a group consisting of;

tremor;

Parkinson'"'"'s disease;

multiple sclerosis;

spasticity; and

epilepsy.

14. The medical system of claim 13, wherein the processor determines a value of a sleep probability metric that indicates a probability of the patient being asleep based on the physiological parameter, and determines whether the patient is asleep based on the sleep probability metric value.

15. The medical system of claim 14,

further comprising a plurality of sensors, each of the sensors generating a respective signal as a function of at least one of a plurality of physiological parameters,

wherein the processor monitors the plurality of physiological parameters, determines a value for each of a plurality of sleep probability metrics that each indicate a probability of the patient being asleep, each of the values determined based on a respective one of the physiological parameters, and determines whether the patient is asleep based on the plurality of sleep probability metric values.

16. The medical system of claim 15, wherein the processor applies a weighting value to at least one of the sleep probability metric values, and determines a value of an overall sleep probability metric based on the plurality of sleep probability metric values.

17. The medical system of claim 14, wherein the processor compares the value of the sleep probability metric to a plurality of thresholds, and monitors sleep patterns by determining a sleep state of the patient based on the comparison.

18. The medical system of claim 17, wherein the processor determines whether the patient is in one of an S3 or S4 sleep state.

19. The medical system of claim 13,

wherein the sensor comprises an electrode coupled to the implantable medical device,

wherein the implantable medical device monitors an electroencephalogram (EEG) of the patient via the electrode, and

wherein the processor monitors sleep patterns of the patient by determining a sleep state of the patient based on a frequency of the EEG.

20. The medical system of claim 19, wherein the processor determines whether the patient is in one of an S3 or S4 sleep state.

21. The medical system of claim 13, wherein the implantable medical device comprises at least one of an implantable neurostimulator or an implantable pump.

22. The medical system of claim 13,

wherein the processor associates the sleep quality information with a therapy parameter set used to deliver the movement disorder therapy to the patient when the sleep quality information was determined, and

wherein the computing device provides the sleep quality information and the associated therapy parameter set to the user.

23. The medical system of claim 13, wherein the movement disorder therapy delivered by the implantable medical device to the patient includes deep brain stimulation.

24. The medical system of claim 13, wherein the movement disorder therapy delivered by the implantable medical device to the patient treats epilepsy.

25. A medical system comprising:

means for monitoring at least one physiological parameter of a patient via an implantable medical device that delivers a movement disorder therapy to the patient;

means for monitoring sleep patterns of the patient with the implantable medical device based on the physiological parameter;

means for determining sleep quality information based on the sleep patterns for evaluation of an efficacy of the movement disorder therapy; and

means for presenting the sleep quality information in conjunction with information regarding the delivery of the movement disorder therapy to a user to allow the user to evaluate the efficacy of the movement disorder therapy,

wherein the movement disorder therapy delivered by the implantable medical device to the patient treats a movement disorder selected from a group consisting of;

tremor;

Parkinson'"'"'s disease;

multiple sclerosis;

spasticity; and

epilepsy.

26. The medical system of claim 25, wherein the means for monitoring sleep patterns comprises means for determining a value of a sleep probability metric that indicates a probability of the patient being asleep based on the physiological parameter.

27. The medical system of claim 25, wherein the means for monitoring sleep patterns comprises means for identifying whether that patient is in at least one of a S1, S2, S3, S4 or rapid eye movement (REM) sleep state.

28. The medical system of claim 25, further comprising means for associating the sleep quality information with a therapy parameter set used to deliver the movement disorder therapy to the patient when the sleep quality information was determined.

29. The medical system of claim 25, wherein the movement disorder therapy delivered by the implantable medical device to the patient includes deep brain stimulation.

30. The medical system of claim 25, wherein the movement disorder therapy delivered by the implantable medical device to the patient treats spasticity.