Sleep stage detection

• US 9,072,870 B2
• Filed: 09/25/2008
• Issued: 07/07/2015
• Est. Priority Date: 01/25/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wu, Jianping, Molnar, Gregory F., Miyazawa, Gabriela C., Denison, Timothy J.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US12/238,105
• Publication Number:
  US 20090192556A1
• Time in Patent Office: 2,476 Days
• Field of Search: 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/08 : Other bio-electrical signals
• CPC Class Codes: A61M 2230/10 : Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• 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 1/36078 : Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/70 : relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Therapy delivery to a patient may be controlled based on a determined sleep stage of the patient. In examples, the sleep stage may be determined based on a frequency characteristic of a biosignal indicative of brain activity of the patient. A frequency characteristic may include, for example, a power level within one or more frequency bands of the biosignal, a ratio of the power level in two or more frequency bands, or a pattern in the power level of one or more frequency bands over time. A therapy program may be selected or modified based on the sleep stage determination. Therapy may be delivered during the sleep stage according to the selected or modified therapy program. In some examples, therapy delivery may be controlled after making separate determinations of a sleep stage based on the biosignal and another physiological parameter, and confirming that the sleep stage determinations are consistent.

Claims

1. A method comprising, with one or more processors:

receiving a biosignal that is indicative of activity within a brain of a patient;

determining a frequency characteristic of the biosignal;

determining a sleep stage of the patient based on the frequency characteristic of the biosignal, wherein the sleep stage occurs during a sleep state of the patient, the sleep state comprising a plurality of sleep stages; and

controlling a therapy module configured to be implanted in the patient to deliver deep brain electrical stimulation therapy to the brain of the patient during the sleep state based on the determined sleep stage, wherein controlling the therapy module to deliver deep brain electrical stimulation therapy comprises, in response to detecting a Stage 1 sleep stage, controlling the therapy module to deliver deep brain electrical stimulation therapy that improves performance of motor tasks by the patient relative to a patient state in which the patient is not receiving the deep brain electrical stimulation therapy, the motor tasks including initiating or maintaining movement.

2. The method of claim 1, wherein the biosignal comprises a local field potential within the brain of the patient.

3. The method of claim 2, wherein the local field potential comprises at least one of an electroencephalogram (EEG) or an electrocorticogram (ECoG).

4. The method of claim 1, wherein the frequency characteristic comprises a power level of the biosignal within one or more frequency bands.

5. The method of claim 4, wherein the one or more frequency bands comprises at least one of a frequency band in a range of about 10 Hertz to about 30 Hertz or in a range of about 5 Hertz to about 10 Hertz.

6. The method of claim 1, wherein the frequency characteristic comprises a ratio of power levels in two or more frequency bands of the biosignal.

7. The method of claim 6, wherein the frequency characteristic comprises the ratio of power levels in at least one of a beta frequency band and an alpha frequency band of the biosignal, a sigma frequency band and a high beta frequency band of the biosignal or a theta frequency band and an alpha beta frequency band of the biosignal.

8. The method of claim 1, wherein the frequency characteristic comprises a trend in a power level of the biosignal within one or more frequency bands over time.

9. The method of claim 1, wherein determining the sleep stage based on the frequency characteristic comprises determining whether the patient is in one of a plurality of sleep stages that are associated with the frequency characteristic.

10. The method of claim 1, wherein controlling the therapy module to deliver therapy to the patient comprises selecting a therapy program from a plurality of stored therapy programs based on the determined sleep stage and controlling the therapy module to deliver the therapy to the patient according to the selected therapy program.

11. The method of claim 1, wherein controlling the therapy module to deliver therapy to the patient comprises modifying at least one therapy parameter value of a stored therapy program based on the determined sleep stage and controlling the therapy module to deliver the therapy to the patient according to the modified stored therapy program.

12. The method of claim 1, wherein controlling the therapy module to deliver therapy to the patient comprises at least one of activating or deactivating therapy delivery by the therapy module to the patient based on the determined sleep stage.

13. The method of claim 1, wherein controlling the therapy module to deliver therapy to the patient further comprises controlling the therapy module to deliver a therapeutic agent to the patient.

14. The method of claim 1, further comprising determining, with the one or more processors, whether the patient is in the sleep state.

15. The method of claim 14, further comprising determining, with the one or more processors, an activity level of the patient, wherein determining whether the patient is in the sleep state comprises determining whether the patient is in the sleep state based on the activity level of the patient.

16. The method of claim 14, further comprising monitoring, with the one or more processors, a physiological parameter of the patient, wherein the physiological parameter comprises at least one of an activity level, posture, heart rate, electrocardiogram morphology or core temperature, wherein determining whether the patient is in the sleep state comprises determining whether the patient is in the sleep state based on the physiological parameter.

17. The method of claim 1, wherein the sleep stage comprises a first sleep stage and the frequency characteristic comprises a first frequency characteristic, the method further comprising, with the one or more processors:

determining a second frequency characteristic of the biosignal;

determining a second sleep stage of the patient based on the second frequency characteristic of the biosignal; and

controlling the therapy module to deliver therapy to the patient during the second sleep stage based on the determined second sleep stage.

18. The method of claim 1, further comprising, with the one or more processors:

determining a first sleep stage determination based on the frequency characteristic of the biosignal;

receiving a physiological signal indicative of a physiological parameter of the patient, wherein the physiological signal is different than the biosignal; and

determining a second sleep stage determination based on the physiological signal,

wherein determining the sleep stage of the patient further comprises determining the sleep stage based on the first and second sleep stages determinations.

19. The method of claim 18, wherein the physiological parameter comprises at least one of an activity level, posture, heart rate, respiration rate, respiratory volume, blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity, core temperature, arterial blood flow or galvanic skin response of the patient.

20. The method of claim 1, wherein determining the sleep stage of the patient based on the frequency characteristic of the biosignal comprises:

comparing the frequency characteristic of the biosignal to at least one of a threshold value or a template; and

determining a sleep stage of the patient based on the comparison between the frequency characteristic of the biosignal and the at least one of the threshold value or the template.

21. The method of claim 20, wherein the threshold value and the template are determined based on information specific to the patient.

22. The method of claim 20, wherein determining the sleep stage of the patient comprises determining a sleep stage group based on the comparison between the frequency characteristic of the biosignal and the at least one of the threshold value or the template, the sleep stage group comprising at least two different sleep stages.

23. The method of claim 20, wherein the frequency characteristic comprises a first frequency characteristic within a first frequency band, the method further comprising, with the one or more processors, determining a second frequency characteristic of the biosignal within a second frequency band that is different than the first frequency band, wherein comparing the frequency characteristic of the biosignal to at least one of the threshold value or the template comprises comparing a ratio of the first and second frequency characteristics to the threshold value, and determining the sleep stage of the patient comprises determining the sleep stage of the patient based on the comparison of the ratio to the threshold value.

24. A system comprising:

a therapy module configured to be implanted in a patient and deliver deep brain electrical stimulation therapy to a brain of the patient;

a sensing module configured to sense a biosignal generated within the brain of the patient; and

a processor configured to receive the biosignal from the sensing module, determine a frequency characteristic of the biosignal, determine a sleep stage of the patient based on the frequency characteristic of the biosignal, wherein the sleep stage occurs during a sleep state of the patient, the sleep state comprising a plurality of sleep stages, and control the therapy module to deliver deep brain electrical stimulation therapy to a target tissue site within the brain of the patient during the sleep state based on the determined sleep stage,

wherein the processor is configured to control the therapy module to deliver the deep brain electrical stimulation therapy based on the determined sleep stage by at least, in response to detecting a Stage 1 sleep stage, controlling the therapy module to deliver deep brain electrical stimulation therapy that improves performance of motor tasks by the patient relative to a patient state in which the patient is not receiving the deep brain electrical stimulation therapy, the motor tasks including initiating or maintaining movement.

25. The system of claim 24, further comprising an implantable medical device that comprises the sensing module and the therapy module.

26. The system of claim 24, further comprising an implantable medical device that comprises the processor.

27. The system of claim 24, further comprising a medical device programmer that comprises the processor.

28. The system of claim 24, wherein the biosignal comprises a local field potential within the brain of the patient.

29. The system of claim 24, wherein the frequency characteristic comprises a power level of the biosignal within one or more frequency bands.

30. The system of claim 29, wherein the one or more frequency bands comprises at least one of a frequency band in a range of about 10 Hertz to about 30 Hertz or in a range of about 5 Hertz to about 10 Hertz.

31. The system of claim 24, wherein the frequency characteristic comprises a ratio of power levels in two or more frequency bands of the biosignal.

32. The system of claim 24, wherein the frequency characteristic comprises a trend in a power level of the biosignal within one or more frequency bands over time.

33. The system of claim 24, further comprising a memory that stores a plurality of therapy programs, wherein the processor is configured to control the therapy module to deliver the therapy to the target tissue site within the patient by at least selecting a therapy program from the plurality of therapy programs stored by the memory based on the determined sleep stage and controlling the therapy module to deliver deep brain electrical stimulation therapy to the target tissue site according to the selected therapy program.

34. The system of claim 24, further comprising a memory that stores a therapy program, wherein the processor is configured to control the therapy module to deliver the therapy to the target tissue site within the patient by at least modifying at least one therapy parameter value of the therapy program stored by the memory based on the determined sleep stage and controlling the therapy module to deliver therapy to the tissue site according to the modified stored therapy program.

35. The system of claim 24, wherein the processor is configured to control the therapy module to deliver the therapy to the target tissue site within the patient by at least one of activating or deactivating therapy delivery by the therapy module to the patient based on the determined sleep stage.

36. The system of claim 24, wherein the processor is configured to determine whether the patient is in the sleep state.

37. The system of claim 36, further comprising a motion sensor configured to generate a motion signal indicative of patient motion, wherein the processor is configured to receive the motion signal, determine an activity level of the patient based on the motion signal, and determine whether the patient is in the sleep state based on the activity level of the patient.

38. The system of claim 36, wherein the sensing module comprises a first sensing module, the system further comprising a second sensing module configured to generate a physiological signal indicative of a physiological parameter of the patient, wherein the physiological parameter comprises at least one of an activity level, posture, heart rate, electrocardiogram morphology, or core temperature, wherein the processor is configured to receive the physiological signal and determine whether the patient is in the sleep state based on the physiological signal.

39. The system of claim 24, wherein the frequency characteristic comprises a first frequency characteristic within a first frequency band, and the processor is configured to determine a second frequency characteristic of the biosignal within a second frequency band that is different than the first frequency band, and determine the sleep stage of the patient based on the first and second frequency characteristics.

40. The system of claim 24, wherein the sensing module comprises a first sensing module, the system further comprising a second sensing module configured to generate a physiological signal indicative of a physiological parameter of the patient, wherein the physiological signal is different than the biosignal, wherein the processor is configured to determine a first sleep stage determination based on the frequency characteristic of the biosignal, receive the physiological signal from the second sensing module, determine a second sleep stage determination based on the physiological signal, and determine the sleep stage of the patient based on the first and second sleep stages determinations.

41. The system of claim 24, wherein the processor is configured to determine the sleep stage of the patient by at least determining the patient is in at least one of an awake state, a first sleep stage or a second sleep stage based on the frequency characteristic of the biosignal, and activate therapy delivery to the patient if the patient is in the awake state or the first sleep stage and deactivate or decrease an intensity of therapy delivered to the patient if the patient is in the second sleep stage.

42. The system of claim 24, wherein the processor is configured to determine the sleep stage of the patient based on the frequency characteristic of the biosignal by at least comparing the frequency characteristic of the biosignal to at least one of a threshold value or a template, and determining a sleep stage of the patient based on the comparison between the frequency characteristic of the biosignal and the at least one of the threshold value or the template.

43. The system of claim 42, wherein the processor is configured to determine whether the patient is in a sleep stage group based on the comparison between the frequency characteristic of the biosignal and the at least one of the threshold value or the template to determine the sleep stage of the patient.

44. The system of claim 24, wherein the therapy is configured to manage patient symptoms associated with the determined sleep stage.

45. The system of claim 24, wherein the processor is configured to select the target tissue site from a plurality of target tissue sites based on the determined sleep stage.

46. The system of claim 24, wherein the therapy module is further configured to deliver a therapeutic agent to the patient.

47. The system of claim 24, wherein the therapy comprises therapy configured to manage a neurological disorder of the patient.

48. The system of claim 47, wherein the neurological disorder comprises at least one of epilepsy or a movement disorder.

49. The system of claim 24, wherein the processor is configured to determine the sleep stage of the patient by at least determining whether the patient is in at least one of an awake state, a first sleep stage or a second sleep stage based on the frequency characteristic of the biosignal, and wherein the processor is further configured to control the therapy module to activate therapy delivery to the patient in response to determining the patient is in the awake state or the first sleep stage and control the therapy module to deactivate or decrease an intensity of therapy delivered to the patient in response to determining the patient is in the second sleep stage.

50. The system of claim 49, wherein the first sleep stage comprises at least one of a Stage 1 or rapid eye movement sleep stage.

51. The system of claim 49, wherein the second sleep stage comprises at least one of a Deep Sleep or Stage 2 sleep stage.

52. The system of claim 24, wherein the sensing module is configured to sense the biosignal generated within the brain of the patient by at least sensing an electroencephalogram (EEG) signal.

53. The system of claim 24, wherein the sensing module is configured to sense the biosignal generated within the brain of the patient by at least sensing an electrocorticogram (ECoG) signal.

54. The system of claim 24, further comprising a memory that stores a plurality of therapy parameter values, wherein the processor is configured to control the therapy module by at least:

selecting at least one therapy parameter value from the plurality of therapy parameter values based on the determined sleep stage; and

controlling the therapy module to deliver the deep brain electrical stimulation therapy to the patient during the sleep state according to the at least one therapy parameter value.

55. The system of claim 24, wherein the processor is further configured to control the therapy module to deliver the deep brain electrical stimulation therapy based on the determined sleep stage by at least, in response to detecting a REM sleep stage, controlling the therapy module to deliver deep brain electrical stimulation therapy that minimizes movement of the patient relative to the patient state in which the patient is not receiving electrical stimulation therapy.

56. The system of claim 24, wherein the sensing module is configured to sense the biosignal generated within a subthalamic nucleus of the brain of the patient, wherein the frequency characteristic comprises an activity level in a beta band of the biosignal, and wherein the processor is configured to determine the sleep stage of the patient based on the activity level in the beta band of the biosignal sensed within the subthalamic nucleus.

57. The system of claim 56, wherein the therapy module is configured to deliver the deep brain electrical stimulation therapy to a basal ganglia structure of the brain of the patient, and wherein the processor is configured to control the therapy module to deliver the deep brain electrical stimulation therapy to the basal ganglia structure in response to detecting the Sleep 1 sleep stage.

58. A system comprising:

means for receiving a biosignal that is indicative of activity within a brain of a patient;

means for determining a frequency characteristic of the biosignal;

means for determining a sleep stage of the patient based on the frequency characteristic of the biosignal, wherein the sleep stage occurs during a sleep state of the patient, the sleep state comprising a plurality of sleep stages; and

means for controlling an implantable therapy module to deliver deep brain electrical stimulation therapy to a target tissue site within the brain of the patient during the sleep state based on the determined sleep stage, the means for controlling comprising means for controlling the implantable therapy module to, in response to detection of a Stage 1 sleep stage by the means for determining, deliver deep brain electrical stimulation therapy that improves performance of motor tasks by the patient relative to a patient state in which the patient is not receiving the deep brain electrical stimulation therapy, the motor tasks including initiating or maintaining movement.

59. The system of claim 58, wherein the means for determining the sleep stage of the patient is configured to determine the sleep stage of the patient by at least comparing the frequency characteristic of the biosignal to at least one of a threshold value or a template and determining the sleep stage of the patient based on the comparison between the frequency characteristic of the biosignal and the at least one of the threshold value or the template.

60. The system of claim 58, further comprising means for storing a plurality of therapy parameter values, wherein the means for controlling the implantable therapy module comprises:

means for selecting at least one therapy parameter value from the plurality of therapy parameter values based on the determined sleep stage; and

means for controlling the therapy module to deliver the deep brain electrical stimulation therapy to the patient during the sleep state according to the at least one therapy parameter value.

61. A non-transitory computer-readable medium comprising instructions that cause a processor to:

receive a biosignal that is indicative of activity within a brain of a patient;

determine a frequency characteristic of the biosignal;

determine a sleep stage of the patient based on the frequency characteristic of the biosignal, wherein the sleep stage occurs during a sleep state of the patient, the sleep state comprising a plurality of sleep stages; and

control an implantable therapy module to deliver deep brain electrical stimulation therapy to a target tissue site within the brain of the patient during the sleep state based on the determined sleep stage, wherein the instructions cause the processor to, in response to detecting a Sleep 1 sleep stage, control the implantable therapy module to deliver the deep brain electrical stimulation therapy that improves performance of motor tasks by the patient relative to a patient state in which the patient is not receiving the deep brain electrical stimulation therapy, the motor tasks including initiating or maintaining movement.

62. The non-transitory computer-readable medium of claim 61, wherein the instructions cause the processor to determine the sleep stage of the patient by at least comparing the frequency characteristic of the biosignal to at least one of a threshold value or a template and determining a sleep stage of the patient based on the comparison between the frequency characteristic of the biosignal and the at least one of the threshold value or the template.