Determination of sleep quality for neurological disorders

• US 10,300,283 B2
• Filed: 04/08/2014
• Issued: 05/28/2019
• Est. Priority Date: 03/16/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Heruth, Kenneth T., Werder, Jonathan C., LaPorte, Steve R., Graves, Nina M.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US14/247,923
• Publication Number:
  US 20140222101A1
• Time in Patent Office: 1,876 Days
• Field of Search: 600481, 600544, 600301, 600500, 600547, 607 2, 607 45
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• 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 1/36025 : for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36064 : Epilepsy
• CPC Class Codes: A61N 1/36067 : Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 : Pain
• 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
• CPC Class Codes: A61N 1/36521 : the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 : controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36557 : controlled by chemical substances in blood
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

A device determines values for one or more metrics that indicate the quality of a patient'"'"'s sleep based on sensed physiological parameter values. Sleep efficiency, sleep latency, and time spent in deeper sleep states are example sleep quality metrics for which values may be determined. The sleep quality metric values may be used, for example, to evaluate the effectiveness of a therapy delivered to the patient by a medical device. In some embodiments, determined sleep quality metric values are automatically associated with the therapy parameter sets according to which the medical device delivered the therapy when the physiological parameter values were sensed, and used to evaluate the effectiveness of the various therapy parameter sets. The medical device may deliver the therapy to treat a non-respiratory neurological disorder, such as epilepsy, a movement disorder, or a psychological disorder. The therapy may be, for example, deep brain stimulation (DBS) therapy.

Claims

1. A medical system comprising:

a medical device configured to deliver a therapy within a cranium of a patient to treat a neurological disorder of the patient;

a sensor configured to sense, via at least one electrode of a lead positioned within the cranium of the patient, electrical activity of the brain of the patient during the delivery of the therapy to the patient, the at least one electrode being in communication with the medical device; and

a processor configured to;

associate each of a plurality of different frequency bands of the sensed electrical activity of the brain of the patient with a respective one or more sleep states of a plurality of sleep states of the patient, wherein the plurality of sleep states comprise at least two of a rapid eye movement (REM) state, a non-rapid eye movement (NREM) S1 state, an NREM S2 state, an NREM S3 state, or an NREM S4 state;

compare relative power levels of the plurality of different frequency bands of the sensed electrical activity of the brain of the patient to one another;

determine that a first relative power of a first frequency band of the plurality of different frequency bands is greater than a relative power of each of the other frequency bands of the plurality of different frequency bands;

determine, based upon the determination that the first relative power of the first frequency band is greater than the relative power of each of the other frequency bands, that the patient is within a first sleep state of the plurality of sleep states associated with the first frequency band; and

select therapy parameters for the delivery of the therapy based on the determination that the patient is within the first sleep state,

wherein the medical device is configured to deliver the therapy according to the therapy parameters selected by the processor based on the determination that the patient is within the first sleep state.

2. The medical system of claim 1, further comprising a user interface configured to present a message related to sleep quality of the patient based on the determination that the patient is within the first sleep state.

3. The medical system of claim 1,

wherein the medical device is configured to deliver the therapy according to a plurality of therapy parameter sets, and

wherein the processor is configured to, for each of the plurality of therapy parameter sets, associate a particular therapy parameter set of the plurality of therapy parameter sets with each sleep state of the plurality of sleep states based on electrical activity of the brain during the delivery of the therapy according to the particular therapy parameter set.

4. The medical system of claim 1, wherein the therapy includes at least one of:

an epilepsy therapy, a movement disorder therapy, or a psychological disorder therapy.

5. The medical system of claim 1, wherein the medical device is configured to be coupled to at least one lead implanted within the brain and configured to deliver deep brain stimulation (DBS) via the at least one lead.

6. The medical system of claim 5, wherein the medical device is configured for implantation beneath a scalp of the patient.

7. The medical system of claim 1, wherein the processor is housed within the medical device.

8. The medical system of claim 1, wherein the processor selects different therapy parameter sets for the therapy from the medical device based on the determination that the patient is within the first sleep state of the plurality of sleep states.

9. The medical system of claim 1, wherein one of the frequency bands of the plurality of different frequency bands includes frequencies between 30 Hertz and 50 Hertz.

10. The medical system of claim 1, wherein the therapy comprises neurostimulation therapy.

11. The medical system of claim 10, wherein the therapy parameters comprise at least one of:

a pulse amplitude;

a pulse width;

a pulse frequency;

a duty cycle;

a selection of one or more electrodes for delivery of the therapy;

or

a polarity for each of the selected one or more electrodes.

12. The medical system of claim 1, wherein the therapy comprises drug therapy delivered via an implantable pump.

13. The medical system of claim 12, wherein the therapy parameters comprise at least one of:

a flow rate of delivery of the drug therapy; and

a delivery timing for the drug therapy.

14. The medical system of claim 1, wherein the therapy comprises thermal therapy.

15. A medical system comprising:

a medical device configured to deliver a therapy within a cranium of a patient to treat a neurological disorder of the patient;

a sensor configured to sense, via at least one electrode of a lead positioned within the cranium of the patient, electrical activity of the brain of the patient during the delivery of the therapy to the patient, the at least one electrode being in communication with the medical device; and

a processor configured to;

associate a first frequency band of a plurality of different frequency bands of the sensed electrical activity of the brain of the patient with a respective first sleep state of a plurality of sleep states of the patient, wherein the plurality of sleep states comprise at least two of a rapid eye movement (REM) state, a non-rapid eye movement (NREM) S1state, an NREM S2 state, an NREM S3 state, or an NREM S4 state;

determine that a first power level of the first frequency band of the plurality of different frequency bands of the sensed electrical activity of the brain of the patient is greater than a first predetermined level for a first predetermined amount of time;

determine, in response to the determination that the first power level is greater than the first predetermined level for the first predetermined amount of time, that the patient is within the first sleep state; and

select therapy parameters for the delivery of the therapy based on the determination that the patient is within the first sleep state;

wherein the medical device is configured to deliver the therapy according to the therapy parameters selected by the processor based on the determination that the patient is within the first sleep state.

16. The medical system of claim 15, wherein the first frequency band is within a range of about 4 Hertz to about 8 Hertz and the first sleep state is at least one of the NREM S1 state or the NREM S2 state.

17. The medical system of claim 15, wherein the first frequency band is within a range of about 1 Hertz to about 3 Hertz and the first sleep state is at least one of the NREM S3 state or the NREM S4 state.

18. The medical system of claim 15, wherein the first frequency band is within a range of about 10 Hertz to about 50 Hertz and the first sleep state is the REM state.