WO2009002237A1 - Méthode et dispositif destinés à la détection du sommeil paradoxal - Google Patents

Méthode et dispositif destinés à la détection du sommeil paradoxal Download PDF

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Publication number
WO2009002237A1
WO2009002237A1 PCT/SE2007/000631 SE2007000631W WO2009002237A1 WO 2009002237 A1 WO2009002237 A1 WO 2009002237A1 SE 2007000631 W SE2007000631 W SE 2007000631W WO 2009002237 A1 WO2009002237 A1 WO 2009002237A1
Authority
WO
WIPO (PCT)
Prior art keywords
impedance
medical device
sensor
implantable medical
rem sleep
Prior art date
Application number
PCT/SE2007/000631
Other languages
English (en)
Inventor
Andreas Blomqvist
Michael Broome
Original Assignee
St. Jude Medical Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St. Jude Medical Ab filed Critical St. Jude Medical Ab
Priority to PCT/SE2007/000631 priority Critical patent/WO2009002237A1/fr
Publication of WO2009002237A1 publication Critical patent/WO2009002237A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37282—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by communication with experts in remote locations using a network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02405—Determining heart rate variability
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4812—Detecting sleep stages or cycles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3702—Physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36521—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure the parameter being derived from measurement of an electrical impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36585—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by two or more physical parameters

Definitions

  • the present invention relates to an implantable medical device such as a pacemaker or an implantable cardioverter or any other similar device.
  • the present invention relates to a method and a device for detecting REM sleep using an implantable medical device.
  • BACKGROUND In implantable medical devices such as pacemakers and implantable cardioverter/defibrillators a number of different sensors are provided.
  • the sensors are i.a. used for controlling the operation of the implantable medical device.
  • an increased memory capacity in implantable medical devices has paved the way for introduction of diagnostic abilities for trending various conditions and diseases. In some cases signals collected are even used for prediction of critical events.
  • an REM sleep detection circuitry in an implantable medical device that based on sensor signals available to the implantable medical device, in particular an impedance sensor signal, can determine if a person is in REM sleep, an REM detector that is reliable and which can be used without any external input is obtained.
  • an impedance signal used for determining an REM sleep stage can be supplemented with other signal available in an implantable medical device in order to increase the accuracy of the determination whether an REM sleep stage exists or not.
  • Such other signals may include, but are not limited to signals indicative of, heart rate, heart rate variability, position sensor signals, accelerometer signals, SvO2 sensor signals and blood pressure sensor signals.
  • the impedance can be measured between any electrode(s) present in the implantable device and the casing of the implantable device or between any electrodes of the implantable device.
  • the measured impedance signal is then used as an input signal to an REM sleep detector.
  • the REM detector can be adapted to extract the heart rate and/ or the heart rate variability from the impedance signal provided.
  • the IEGM signal is a good indicator of REM sleep because an increased heart rate indicates REM sleep. Also an increased variability of the heart rate is a good indicator of REM sleep.
  • an REM detector is used for determining when and/ or how trend data for use in trending should be recorded.
  • REM sleep is different from regular sleep if data is recorded both during an REM sleep condition and during regular sleep the data will be corrupt or at least not representing conditions that are similar.
  • data used for trending is separated so that data collected during REM sleep is classified as one set of data whereas data collected during regular sleep is classified as another set of data.
  • trending can be made on data that are collected during conditions that are similar and which is not affected by different sleep stages.
  • the ratio between a trended parameter during REM sleep and during regular sleep is formed to provide a measurement useful for detecting a worsened condition.
  • FIG. 1 is a general view of an implanted medical device
  • Fig. 2a is a general view illustrating the major logical components of an REM detector adapted to be integrated in an implantable medical device
  • FIG. 2b is a schematic view of a heart beat signal used for post capturing detection of REM sleep periods.
  • Fig. 3 is a flow chart illustrating steps performed when detecting REM sleep
  • Fig. 4 is a flow chart illustrating different steps performed when collecting trending data in an implantable medical device provided with an REM detector.
  • FIG. 5 is a view illustrating how an implantable medical device can be made to communicate with other electronic devices located outside a patient carrying an implanted medical device
  • a view of a medical device 100 implanted in a patient is shown.
  • the exemplary medical device can for example be a pacemaker implanted in a patient.
  • the pacemaker 100 comprises a casing being hermetically sealed and biological inert.
  • the casing is typically conductive and may then serve as an electrode.
  • One or more pacemaker leads, whereof only two are shown in Fig. 1 namely a ventricular lead 102 and an atrial lead 104, are electrically coupled to the pacemaker 100 in a conventional manner.
  • the leads 102 and 104 extend into the heart 106 via a vein 108 of the patient.
  • One or more conductive electrodes for receiving electrical cardiac signals and/or for delivering electrical pacing to the heart 106 are arranged near the distal ends of the leads 102 and, 104. Impedance measurements may be performed between any of the electrodes, the casing of the pacemaker 100 may then serve as one electrode.
  • the implanted medical device comprises an REM (Rapid Eye Movement) sleep detector.
  • REM sleep is a sleep condition characterized by rapidly moving eyes while sleeping.
  • a person in REM sleep typically has an increased heart rate and also typically has an increased variability with regard to the heart rate.
  • the respiration frequency typically increases as well as the respiratory amplitude.
  • FIG. 2 a diagram of an REM sleep detector 200 adapted to be integrated in an implantable medical device is shown.
  • the REM detector comprises an input terminal 201 for receiving a number of signals sensed by the implantable medical device.
  • the REM detector is adapted to receive sensor signals representing the impedance between two or more electrodes of the implantable medical device as sensed by one or more impedance sensors provided in the implantable medical device.
  • sensors adapted to generate signals corresponding to the cardiogenic impedance Zc and/ or the respiratory impedance Zr may by employed.
  • the REM detector may receive input sensor signals from sensors adapted to sense signals indicative of, heart rate, heart rate variability, position sensor signals, accelerometer signals, SvO2 (mixed venous oxyhemoglobin) sensor signals and blood pressure sensor signals or any other signals available in the implantable medical device that can serve to facilitate the determination of an existing REM sleep condition.
  • sensors adapted to sense signals indicative of, heart rate, heart rate variability, position sensor signals, accelerometer signals, SvO2 (mixed venous oxyhemoglobin) sensor signals and blood pressure sensor signals or any other signals available in the implantable medical device that can serve to facilitate the determination of an existing REM sleep condition.
  • the sensor signals are used to derive a number of output signals representing different physical parameters such as heart rate, heart rate variability, peak-to-peak variation in heart beat respiration frequency etc, all of which may be extracted from an impedance sensor signal.
  • Each of the measured physical parameters is compared to a threshold value in respective comparison units 203 to determine if an REM sleep condition is present. If all or at least a predetermined number of the measured physiological parameters exceed their respective threshold values the REM sleep detector is adapted to generate an output signal indicating REM sleep in a decision module 205.
  • the determination of REM sleep or non REM sleep is made at a later stage and data is only collected and stored during sleep.
  • data can be classified as related to REM sleep or Non REM sleep depending on the outcome of an analysis of the collected and stored data.
  • sleep data related to physical parameters indicative of REM sleep such as heart rate, heart rate variability, peak-to-peak variation in heart beat respiration frequency etc and which can be captured by the medical device are stored in a memory.
  • Processing of data to determine REM sleep stages is then performed afterwards.
  • Fig. 2b a schematic view of a heart beat signal used for post capturing detection of REM sleep periods is shown.
  • the heart rate during the hours 2 to 4 in the night is schematically shown.
  • Periods with increased heart rate is classified as REM sleep.
  • Other physiological parameters such as heart rate, heart rate variability, peak-to-peak variation in heart beat respiration frequency etc may of course also be used. In particular a number of parameters may be cross correlated to determine periods of REM sleep.
  • the physiological parameters are sensed using one or more impedance sensors.
  • the impedance sensor signals are then processed to derive signals representing physiological parameters such as heart rate, heart rate variability, peak-to-peak variation in heart beat, respiration frequency etc.
  • an impedance sensor for sensing the cardiogenic impedance Zc, i.e. impedance varying with the heart beat
  • an impedance sensor for sensing the respiratory impedance Zr, i.e. impedance varying with breathing.
  • Some of the signals that can be .derived from the impedance sensors can also be derived from an IEGM sensor if such a sensor is present.
  • an IEGM sensor can be used as a supplement to verify the heart beat rate and heart beat variability.
  • physiological parameters derived from signals generated by one or many impedance sensors are supplemented by sensor signals generated by other sensors present in the implantable medical device for example sensors adapted to sense signals indicative of, heart rate, heart rate variability, position sensor signals, accelerometer signals, SvO2 (mixed venous oxyhemoglobin) sensor signals and blood pressure sensor signals etc.
  • Detecting REM sleep can be used to filter out data in a trending algorithm. Trending algorithms are dependent on a data set that is collected under similar conditions in order to generate a reliable trend. A sleeping person is likely to generate data useful and suitable for trending because sampling conditions during sleep are likely to be similar over time. IN addition some heart failure syndromes are known to worsen when a person is lying down.
  • a flow chart illustrating steps performed in a procedure when detecting REM sleep and generating trend data is shown.
  • a first criteria it is checked if the time is such that the patient normally would be asleep.
  • the internal clock of the implantable medical device can be checked to see if the time is within some preset time interval, for example between 2 and 4 in the night.
  • the procedure checks if the patient is in a rest state. This can be performed by checking readings from an accelerometer or a position sensor if such sensors are present.
  • an input signal from an REM sleep detector is received. If the REM sensor output signal indicates that the patient is not in an REM sleep stage in a step 307, trend data is collected for use in a trending algorithm in a step 309.
  • FIG. 4 a flowchart illustrating different steps performed when collecting trending data in an implantable medical device provided with an REM detector in accordance with another embodiment is shown.
  • a step 401 and 403 it is determined that the patient is sleeping. This can for example be performed as in the embodiment described in conjunction with Fig. 3 by first in the step 401 checking the time of the internal clock of the implantable medical device and then in the step 403 checking that the patient is in a resting state.
  • trend data of one or many sensor signals is collected in a step 405.
  • impedance signals such the cardiogenic Zc and/or respiratory Zr impedance may be collected.
  • Other sensor signals may also be collected depending on the type of diagnosis the trending data is to be used for.
  • the trending data from a sleeping patient is either designated as REM sleep data or sleep data.
  • the determination whether collected data is REM sleep data or sleep data is performed in a step 407.
  • the data thus collected can then be either stored internally within the implantable medical device or transferred directly to an external device provided to store the trending data.
  • the storing of trending data is performed in a step 409. In either case the trending data collected during REM sleep and regular, non-REM, sleep may be stored in two different data sets 409a and 409 b.
  • a step 411 trending is performed using the trend data collected in REM sleep and/or regular sleep.
  • data collected during regular sleep is used when performing trending of a physiological parameter. This may be advantageous because the data collected during regular sleep and filtered from REM sleep can be expected to have been collected during very similar conditions thereby increasing the reliability of the trend.
  • only data collected during REM sleep is used when performing- trending of a physiological parameter. This may be advantageous because the data collected during REM sleep, apart from being collected during similar conditions, is also collected during a higher cardiogenic workload, which in turn increases the likelihood of detecting an abnormal state early since abnormal states usually are first spotted during a higher workload.
  • both REM sleep data and regular sleep data are combined in a suitable way to create a trend for a combined set of data.
  • the ratio between the REM sleep data and the regular sleep data from time periods close in time can be trended against the corresponding ratio at other times.
  • the ratio is trended and that may provide an even more precise trend of the trended parameter.
  • Other relationships between data collected during REM sleep and non-REM sleep may also be studied and trended. For example, the difference or a correlation may be studied.
  • Stored data can also be further processed. For example during a period of sleep a number of
  • REM sleep sessions and regular sleep sessions may occur. For each such session only a number of parameters representing the data to be trended may be permanently stored and used by the trending tool used.
  • the implantable medical device can have two memories, one first memory for storing recently collected data and another second memory for storing parameters representing the trended parameter.
  • the first memory can be emptied as soon as the relevant data has been processed and stored as one or many data values in the second memory.
  • the trending tool then only has to upload data from the second memory to generate the trend for the trended parameter(s) which saves time and memory.
  • the data used for trending can be transferred to a device located outside the implantable medical device. As stated above this can be performed either in real time or, if the implantable medical device is provided with a memory at a time interval such that the memory does not become full before being transferred to the outside device.
  • an implantable medical device 20 implanted in a patient 40 comprises a device 37 for transmitting information from the device 20 to entities outside the patient.
  • the device 37 may also act to receive data or instructions from outside entities.
  • the implantable medical device can communicate with a cellular device such as a mobile telephone 42 or a stationary transmitter/receiver 41.
  • the cellular device 42 or the stationary transmitter/receiver 41 can then be connected to a processor unit 44 for example via a network 43.
  • the processor unit can for example be a trending tool adapted to receive trend data to be processed by the trending tool 44.
  • the processed data can then be displayed to a doctor treating the patient or stored in a memory 45 for future use.
  • Using the method and device as described herein will provide an efficient REM sleep detector using an impedance signal as input signal, and which hence can detect REM sleep using only sensor signals present in an implantable medical device and which hence enables REM sleep detection of a patient carrying an implantable medical device such as an implanted pacemaker or a cardioverter/defibrillator.
  • the methods and devices as described herein may also be used in an implantable medical monitor device used for monitoring physiological parameters.
  • REM sleep detector in particular inside an implantable medical device, enables better trending and prediction of monitored conditions or diseases. This is because REM sleep data can be separated from other data whereby stable and uniform conditions for data collection are achieved. Stable and uniform data sampling conditions is one of the most important if not the most important aspect for obtaining a reliable result when using data in a trending tool. This is because no matter how a sophisticated trending/prediction tool that is used, if data is not comparable or representative the tool cannot provide a useful output.

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  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Molecular Biology (AREA)
  • Surgery (AREA)
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  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Electrotherapy Devices (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne l'utilisation, dans une méthode et un dispositif, d'un détecteur de sommeil paradoxal efficace faisant usage d'un signal d'impédance comme signal d'entrée, pouvant détecter un sommeil paradoxal uniquement à partir de signaux de détection. Ce détecteur est situé dans un dispositif médical implantable. Ainsi, il est possible de détecter un sommeil paradoxal chez un patient transportant un dispositif médical implantable, tel qu'un stimulateur cardiaque implanté ou un cardioverter/défibrillateur.
PCT/SE2007/000631 2007-06-27 2007-06-27 Méthode et dispositif destinés à la détection du sommeil paradoxal WO2009002237A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/SE2007/000631 WO2009002237A1 (fr) 2007-06-27 2007-06-27 Méthode et dispositif destinés à la détection du sommeil paradoxal

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2007/000631 WO2009002237A1 (fr) 2007-06-27 2007-06-27 Méthode et dispositif destinés à la détection du sommeil paradoxal

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WO2009002237A1 true WO2009002237A1 (fr) 2008-12-31

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PCT/SE2007/000631 WO2009002237A1 (fr) 2007-06-27 2007-06-27 Méthode et dispositif destinés à la détection du sommeil paradoxal

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050081847A1 (en) * 2003-09-18 2005-04-21 Kent Lee Automatic activation of medical processes
US20050113710A1 (en) * 2003-09-18 2005-05-26 Stahmann Jeffrey E. Implantable device employing movement sensing for detecting sleep-related disorders
US20050209512A1 (en) * 2004-03-16 2005-09-22 Heruth Kenneth T Detecting sleep
WO2006068566A1 (fr) * 2004-12-23 2006-06-29 St. Jude Medical Ab Dispositif medical
US20070270706A1 (en) * 2006-05-22 2007-11-22 Pekka Merilainen Determination of sleep depth

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050081847A1 (en) * 2003-09-18 2005-04-21 Kent Lee Automatic activation of medical processes
US20050113710A1 (en) * 2003-09-18 2005-05-26 Stahmann Jeffrey E. Implantable device employing movement sensing for detecting sleep-related disorders
US20050209512A1 (en) * 2004-03-16 2005-09-22 Heruth Kenneth T Detecting sleep
WO2006068566A1 (fr) * 2004-12-23 2006-06-29 St. Jude Medical Ab Dispositif medical
US20070270706A1 (en) * 2006-05-22 2007-11-22 Pekka Merilainen Determination of sleep depth

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