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

• US 9,326,724 B2
• Filed: 10/28/2014
• Issued: 05/03/2016
• 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:
  US14/525,710
• Publication Number:
  US 20150112222A1
• Time in Patent Office: 553 Days
• US Class Current: 1/1
• 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 of detecting a sleep state or sleep stage by analyzing electrical signals from a patient'"'"'s brain with an implantable device, the method comprising:

sensing electrical signals on a plurality of sensing channels;

applying a first sensing channel of the plurality of sensing channels to a first detection channel, the first detection channel configured to determine whether at least one analysis of the electrical signals sensed on the first sensing channel results in an affirmative outcome;

applying a second sensing channel of the plurality of sensing channels to a second detection channel, the second detection channel configured to determine whether at least one analysis of the electrical signals sensed on the second sensing channel results in an affirmative outcome; and

applying the result of the at least one analysis of the first detection channel and the result of the at least one analysis of the second detection channel to a logic operation, wherein an output of the logic operation indicates whether a sleep state or sleep stage has been detected by the implantable device.

2. The method of claim 1, wherein the at least one analysis of the electrical signals sensed on the first sensing channel determines the sleep stage or sleep state, and the at least one analysis of the electrical signals sensed on the second sensing channel determines the sleep stage or sleep state.

3. The method of claim 2, wherein the logic operation is such that the output of the logic operation indicates the sleep state or sleep stage has been detected when the result of the at least one analysis of the first detection channel and the result of the at least one analysis of the second detection channel are both affirmative outcomes.

4. The method of claim 2, wherein the logic operation is such that the output of the logic operation indicates the sleep state or sleep stage has been detected when at least one of the results of the at least one analysis of the first detection channel and the at least one analysis of the second detection channel, is an affirmative outcome.

5. The method of claim 1, wherein the at least one analysis of the electrical signals sensed on the first sensing channel determines a noise level below a threshold, and the at least one analysis of the electrical signals sensed on the second sensing channel determines the sleep stage or sleep state.

6. The method of claim 5, wherein the logic operation is such that the output of the logic operation indicates the sleep state or sleep stage as has been detected when the result of the at least one analysis of the first detection channel and the result of the at least one analysis of the second detection channel are both affirmative outcomes.

7. The method of claim 1, wherein the implantable device is further configured so that the result of the at least one analysis of the first detection channel persists for a period of time so that the first detection channel result and the second detection channel result can be applied to the logic operation even when there is no precise temporal synchronization of the analyses carried out on each of the first detection channel and the second detection channel.

8. The method of claim 1, wherein the electrical signals sensed on the first sensing channel are sensed from a first region of the brain and the electrical signals sensed on the second sensing channel are sensed from a second region of the brain different from the first region of the brain.

9. The method of claim 8, wherein the first region is within the left hemisphere of the patient'"'"'s brain and the second region is in the right hemisphere of the patient'"'"'s brain.

10. The method of claim 1, wherein the sleep state or stage comprise one of stage 1 sleep, stage 2 sleep, stage 3 sleep or stage 4 sleep.

11. An active implantable medical device for detecting a sleep state or sleep stage, the device comprising:

a plurality of sensing channel configured to sense electrical signals from a patient'"'"'s brain;

a plurality of detection channels configured to analyze the received electrical signals;

a controller configured to;

apply a first sensing channel of the plurality of sensing channels to a first detection channel, the first detection channel configured to determine whether at least one analysis of the electrical signals sensed on the first sensing channel results in an affirmative outcome;

to apply a second sensing channel of the plurality of sensing channels to a second detection channel, the second detection channel configured to determine whether at least one analysis of the electrical signals sensed on the second sensing channel results in an affirmative outcome; and

event detector logic configured to apply the result of the at least one analysis of the first detection channel and the result of the at least one analysis of the second detection channel to a logic operation, wherein an output of the logic operation indicates whether a sleep state or sleep stage has been detected by the implantable device.

12. The device of claim 11, wherein the first detection channel is configured such that the at least one analysis of the electrical signals sensed on the first sensing channel determines the sleep stage or sleep state, and the second detection channel is configured such that the at least one analysis of the electrical signals sensed on the second sensing channel determines the sleep stage or sleep state.

13. The device of claim 12, wherein the logic operation is such that the output of the logic operation indicates the sleep state or sleep stage has been detected when the result of the at least one analysis of the first detection channel and the result of the at least one analysis of the second detection channel are both affirmative outcomes.

14. The device of claim 12, wherein the logic operation is such that the output of the logic operation indicates the sleep state or sleep stage has been detected when at least one of the results of the at least one analysis of the first detection channel and the at least one analysis of the second detection channel, is an affirmative outcome.

15. The device of claim 11, wherein the first detection channel is configured such that the at least one analysis of the electrical signals sensed on the first sensing channel determines a noise level below a threshold, and the second detection channel is configured such that the at least one analysis of the electrical signals sensed on the second sensing channel determines the sleep stage or sleep state.

16. The device of claim 15, wherein the logic operation is such that the output of the logic operation indicates the sleep state or sleep stage has been detected when at least one of the results of the at least one analysis of the first detection channel and the at least one analysis of the second detection channel, is an affirmative outcome.

17. The device of claim 11, wherein the implantable device is further configured so that the result of the at least one analysis of the first detection channel persists for a period of time so that the first detection channel result and the second detection channel result can be applied to the logic operation even when there is no precise temporal synchronization of the analyses carried out on each of the first detection channel and the second detection channel.

18. The device of claim 11, wherein the electrical signals sensed on the first sensing channel are sensed from a first region of the brain and the electrical signals sensed on the second sensing channel are sensed from a second region of the brain different from the first region of the brain.

19. The device of claim 18, wherein the first region is within the left hemisphere of the patient'"'"'s brain and the second region is in the right hemisphere of the patient'"'"'s brain.

20. The device of claim 11, wherein the sleep state or stage comprise one of stage 1 sleep, stage 2 sleep, stage 3 sleep or stage 4 sleep.

21. An active implantable medical device for detecting a sleep state or sleep stage, the device comprising:

a plurality of sensing channels configured to sense electrical signals from a patient'"'"'s brain;

a first detection channel configured to determine whether at least one analysis of electrical signals sensed on a first sensing channel of the plurality of sensing channels results in an affirmative outcome;

a second detection channel configured to determine whether at least one analysis of electrical signals sensed on a second sensing channel of the plurality of sensing channels results in an affirmative outcome; and

event detector logic configured to apply the result of the at least one analysis of the first detection channel and the result of the at least one analysis of the second detection channel to a logic operation, wherein an output of the logic operation indicates whether a sleep state or sleep stage has been detected by the implantable device.