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

• US 7,894,890 B2
• Filed: 02/09/2007
• Issued: 02/22/2011
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Sun, Felice, Gibb, Barbara, Pless, Benjamin D.
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): Dietrich; Joseph M
• Application Number:
  US11/704,451
• Publication Number:
  US 20080195166A1
• Time in Patent Office: 1,474 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. An implantable device for monitoring physiological information relating to sleep comprising:

at least one sensor configured to sense physiological information; and

a processor coupled to the at least one sensor and configured to process the physiological information to detect at least one sleep state or stage, the processor configured to detect 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,

configured to determine a duration and an amplitude of each half wave of the plurality of detected half waves,

configured to determine, for each half wave, whether the duration is within a range of a plurality of different duration ranges, and whether the amplitude of said half wave is within a range of a plurality of different amplitude ranges, each different duration range having a preset minimum duration threshold and a preset maximum duration threshold, each different amplitude range having a preset minimum amplitude threshold and a preset maximum amplitude threshold,

configured, for each duration range of the plurality of different duration ranges, to count a number of occurrences of half waves within said each duration range for each amplitude range of the plurality of different amplitude ranges, and

configured to determine a detection of an occurrence of the at least one sleep state or stage if the number of occurrences of half waves within specified amplitude ranges and specified duration ranges correspond to the at least one sleep state or stage.

2. The device of claim 1 further comprising a memory configured to store at least a portion of the physiological information or the processed physiological information.

3. The device of claim 1 further comprising a wireless system configured to transmit at least a portion of the physiological information or the processed physiological information to a remote location.

4. The device of claim 1, wherein the physiological information comprises electrographic information.

5. The device of claim 4, wherein the electrographic information is obtained from an electroencephalogram (EEG) signal.

6. The device of claim 4, wherein the electrographic information is obtained from an electrocorticogram (ECoG) signal.

7. The device of claim 1, wherein the processor is further configured to determine whether detected occurrences of the at least one sleep state or stage indicate a physiological condition and to generate a control signal in response to a determined physiological condition, the device further comprising at least one stimulation electrode coupled to the processor to provide a stimulus in response to the control signal.

8. The device of claim 1, wherein the at least one sensor is an electrode that is also configured to provide stimulation in response to a control signal, wherein the processor is further configured to determine whether detected occurrences of the at least one sleep state or stage indicate a medical condition and to generate the control signal in response to a determined physiological condition.

9. The device of claim 1 further comprising a drug pump coupled to the processor to release a drug in response to a control signal from the processor wherein the processor is further configured to generate the control signal response to the determined at least one sleep state or stage.

10. The device of claim 1 further comprising a component coupled to the processor to record the sensed physiological information, processed physiological information, or events in response to a patient trigger.

11. The device of claim 1 further comprising a component coupled to the processor to record the sensed physiological information, processed physiological information, or events, wherein the component includes a sensor configured to sense a change in magnetic field and initiate said recording in response thereto.

12. The device of claim 1, wherein the processor further processes the physiological information to generate an index indicative of quality of sleep.

13. The device of claim 1, wherein the sensor is either a depth electrode or a cortical electrode and is configured for monopolar or bipolar sensing.

14. The implantable device of claim of claim 1, further comprising a plurality of buffers, each buffer corresponding to one range of the plurality of different duration ranges, wherein the processor is configured to store the half waves in a buffer corresponding to the determined duration range.

15. The implantable device of claim of claim 14, further comprising a plurality of histogram counters, each histogram counter being coupled to a corresponding buffer, each histogram counter counting the detected half waves stored in the corresponding buffer in a plurality of time intervals.

16. The implantable device of claim 14, wherein the duration ranges correspond to delta, theta, alpha and beta frequency ranges.

17. The implantable device of claim 16, wherein the processor is configured to determine a sleep stage from an absolute number of occurrences of the half waves in the duration ranges corresponding to delta, theta, alpha and beta frequency ranges.

18. The implantable device of claim 16, wherein the processor is configured to determine a sleep stage from a relative number of occurrences of the half waves in the duration ranges corresponding to delta, theta, alpha and beta frequency ranges.

19. The implantable device of claim 16, wherein the processor is configured to determine a sleep stage from a power of the half waves in the duration ranges corresponding to delta, theta, alpha and beta frequency ranges.

20. The implantable device of claim 19, wherein the processor is configured to determine the power of the half waves in the duration ranges corresponding to delta, theta, alpha and beta frequency ranges from the area under the half waves in the duration ranges.

21. The implantable device of claim 19, wherein the processor is configured to determine the power of the half waves in the duration ranges corresponding to delta, theta, alpha and beta frequency ranges by squaring the amplitudes of the half waves in each of the duration ranges, multiplying the squared amplitudes times the duration of the half waves in each of the duration ranges, and summing the multiplied squared amplitudes in each of the duration ranges.

22. The implantable device of claim 1, wherein the processor is configured to determine a detection of an occurrence of the at least one sleep state or stage if the number of occurrences of half waves within the amplitude ranges and duration ranges associated with the at least one sleep state or stage exceed a predetermined number corresponding to the at least one sleep state or stage.

23. An implantable device for monitoring physiological information relating to sleep comprising:

at least one sensor configured to sense physiological information; and

a processor coupled to the at least one sensor and configured to process the physiological information to detect at least one sleep state or stage, the processor configured to detect 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,

configured to determine a duration and an amplitude of each half wave of the plurality of detected half waves,

configured to determine, for each half wave, whether the duration and the amplitude of said half wave is within a bin of a plurality of different bins, each bin being characterized by a duration range having a preset minimum duration and a preset maximum duration and an amplitude range having a preset minimum amplitude and a preset maximum amplitude,

configured, for each bin, to count a number of occurrences of half waves within said bin, and

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