Devices and methods for monitoring physiological information relating to sleep with an implantable device

• US 8,369,940 B2
• Filed: 10/14/2011
• Issued: 02/05/2013
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Sun, Felice, Pless, Benjamin D, Gibb, Barbara
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/274,037
• Publication Number:
  US 20120035431A1
• Time in Patent Office: 480 Days
• Field of Search: 600/544
• US Class Current: 600/544
• 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 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• 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 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

Described here are implantable devices and methods for monitoring physiological information relating to sleep. The implantable devices are generally designed to include at least one sensor for sensing physiological information, a processor for processing the physiological information using low computational power to detect a sleep stage, and a battery. The detected sleep stage information may then be used to indicate sleep quality, identify or monitor a medical condition, or guide treatment thereof.

Claims

1. A method for monitoring physiological information relating to sleep comprising:

sensing physiological information;

detecting a plurality of half waves in the sensed physiological information based on a local maximum amplitude and a subsequent local minimum amplitude, or based on a local minimum amplitude and a subsequent local maximum amplitude;

determining a duration and an amplitude of each half wave of the plurality of detected half waves;

binning each half wave into a bin of a plurality of different bins based on the determined duration and the amplitude of the half wave, wherein the determined duration is within a range of a plurality of different duration ranges and the determined amplitude of the half wave is within a range of a plurality of different amplitude ranges, each bin being characterized by a duration range having a preset minimum duration threshold and a preset maximum duration threshold and an amplitude range having a preset minimum amplitude threshold and a preset maximum amplitude threshold;

counting, for each bin of the plurality of different bins, a number of occurrences of half waves within the bin; and

determining a detection of an occurrence of at least one sleep state or stage if the number of occurrences of half waves within specified bins corresponds to the at least one sleep state or stage.

2. The method of claim 1 further comprising storing at least a portion of the physiological information or the half wave physiological information.

3. The method of claim 1 further comprising transmitting at least a portion of the physiological information or the half wave physiological information to a remote location.

4. The method of claim 1 further comprising:

determining whether detected occurrences of the at least one sleep state or stage indicate a physiological condition; and

treating the physiological condition.

5. The method of claim 4, wherein the physiological condition is selected from the group consisting of a neurological condition, a psychological condition, a cardiac condition, a respiratory condition, and a sleep condition.

6. The method of claim 4, wherein treating the physiological condition comprises providing stimulation to a patient.

7. The method of claim 6, wherein providing stimulation comprises selecting stimulation based on which at least one sleep state or stage is detected.

8. The method of claim 7, wherein selecting stimulation comprises selecting the frequency, pulse-width, amplitude, duration, or the stimulation montage.

9. The method of claim 7, wherein selecting stimulation comprises initiating or terminating stimulation based on which at least one sleep state or stage is detected.

10. The method of claim 4, wherein treating the physiological condition comprises delivering a drug.

11. The method of claim 10, wherein delivering the drug delivery initiating or terminating drug delivery based on which at least one sleep state or stage is detected.

12. The method of claim 1, further comprising processing the physiological information based on histogram counts.

13. The method of claim 1, further comprising processing the physiological information based on threshold detections.

14. The method of claim 1, wherein the specified bins correspond to delta, theta, alpha and beta frequency ranges.

15. The method of claim 14 further comprising determining a sleep stage from an absolute number of occurrences of the half waves in the specified bins corresponding to delta, theta, alpha and beta frequency ranges.

16. The method of claim 14 further comprising determining a sleep stage from a relative number of occurrences of the half waves in the specified bins corresponding to delta, theta, alpha and beta frequency ranges.

17. The method of claim 14 further comprising determining a sleep stage from a power of the half waves in the specified bins corresponding to delta, theta, alpha and beta frequency ranges.

18. A method for monitoring physiological information relating to sleep comprising:

sensing physiological information;

detecting a plurality of half waves in the sensed physiological information based on a local maximum amplitude and a subsequent local minimum amplitude, or based on a local minimum amplitude and a subsequent local maximum amplitude;

determining a duration and an amplitude of each half wave of the plurality of detected half waves;

determining, for each half wave, whether the duration is within a range of a plurality of different duration ranges, and whether the amplitude of the half wave exceeds an amplitude threshold based on background activity of physiological information, each different duration range having a preset minimum duration threshold and a preset maximum duration threshold,

for each duration range of the plurality of different duration ranges, counting a number of occurrences of half waves within each duration range; and

determining a detection of an occurrence of at least one sleep state or stage if the number of occurrences of half waves exceeding the amplitude threshold and within the specified duration ranges corresponds to the at least one sleep state or stage.

19. The method of claim 18, wherein the specified duration ranges correspond to delta, theta, alpha and beta frequency ranges.

20. The method of claim 19 further comprising determining the at least one sleep state or stage from an absolute number of occurrences of the half waves in the specified duration ranges corresponding to delta, theta, alpha and beta frequency ranges.

21. The method of claim 19 further comprising determining the at least one sleep state or stage from a relative number of occurrences of the half waves in the specified duration ranges corresponding to delta, theta, alpha and beta frequency ranges.

22. A method for monitoring physiological information relating to sleep comprising:

sensing physiological information;

detecting a plurality of half waves in the sensed physiological information based on a local maximum amplitude and a subsequent local minimum amplitude, or based on a local minimum amplitude and a subsequent local maximum amplitude;

determining a duration and an amplitude of each half wave of the plurality of detected half waves;

binning each half wave into a bin of a plurality of different bins based on the determined duration and the amplitude of the half wave, wherein the determined duration is within a range of a plurality of different duration ranges and the determined amplitude of the half wave is within a range of a plurality of different amplitude ranges, each bin being characterized by a duration range having a preset minimum duration threshold and a preset maximum duration threshold and an amplitude range having a preset minimum amplitude threshold and a preset maximum amplitude threshold;

counting, for each bin of the plurality of different bins, a number of occurrences of half waves within the bin; and

determining a detection of an occurrence of at least one sleep state or stage based on a ratio of the number of occurrences of half waves of two specified bins corresponding to the at least one sleep state or stage.

23. The method of claim 22, wherein the specified bins correspond to delta, theta, alpha and beta frequency ranges.

24. The method of claim 23 further comprising determining the at least one sleep state or stage from the ratio of the number of occurrences of the half waves in the specified bins corresponding to delta, theta, alpha and beta frequency ranges.