Device and Method for Determining a Comparison Value of Biodata
Contents
1. 0198 In conjunction with the basis module the pneumol ogy module can determine the following values 0199 RDI AHI apnea hypopnea differentiation 0200 arousals that are related to a respiratory event 0201 differentiation of RERAs and arousals that are related to apnea hypopnea events 0202 differentiation of obstructive and central events 0203 flattening 0204 snoring 0205 upper airway resistance syndrome 0206 respiratory effort work of breathing 0207 Cardiology Module 0208 The cardiology module makes it possible to record an EKG A position sensor can be adapted to supplement it This module can be adapted to the data bus of the basic module for carrying out additional analyses In accordance with the invention it is proposed that the connection between the basic module and or pneumology module and cardiology module be realized as a plug connection which can be handled quickly and easily The cardiology module can also be used alone without the basic module and or pneumology module 0209 Thecardiology module can determine the following values 0210 EKG 0211 heart rate variability 0212 pulse transit time PTT 0213 position dependent events 0214 In accordance with the invention it is proposed that other modules be adapted as needed 0215 Individual device components are described in detail below 0216 electrodes for the electrophysiological channels 0217 effort sensors thoracic and2. 0280 FIG 7 shows the measured signal 49 as a raw plethysmogram The plethysmogram 49 is subject to fluctua tions A CWF signal 50 is extracted from the plethysmogram 49 The CWF signal 50 contains information about the fluc tuations of the plethysmogram For example the fluctuation can represent the pulse wave amplitude It is also possible to represent the integral of the plethysmogram as a CWF 0281 FIG 8 shows a possible embodiment of the CWF signal Here the amplitudes 51 of the plethysmogram 49 were used to determine the CWF signal In this case the CWF 50 represents the amplitude level of the plethysmogram 49 0282 However it is also possible to use the PTT or other signals that are subject to fluctuations to determine a CWF 0283 In accordance with the invention different signals can be combined to detect relevant fluctuations of the pulse wave and use them for the evaluation 0284 Thorax Sensor and Abdomen Sensor 0285 Thorax and abdomen sensors are used to detect tho racic and abdominal respiratory movements 0286 Inthis regard respiratory movements cause variable tensile stresses on the measuring pickups in the fastening belts The measuring pickups use the piezoelectric effect to convert the movements to electrical signals 0287 The abdominal sensor together with the abdominal belts detects the abdominal respiratory movements The sen sor is made of a plastic that is nonirritating to the skin 0288 Electroph
3. carboxyhemoglobin HbCO methemoglobin MetHb sulfinethemoglobin HbSulf bilirubin and glucose To this end the sensors have at least one light source which alternatively and or supplementally emits wavelengths selected from the following group of wavelength ranges 150 nm 15 400 nm 15 460 nm 15 480 nm 15 520 nm 15 550 nm 15 560 nm 15 606 nm 15 617 nm 15 620 nm 15 630 nm 15 650 nm 15 660 nm 15 705 nm 15 710 nm 15 720 nm 15 805 nm 15 810 nm 15 880 nm 15 890 15 905 nm 15 910 nm 15 950 nm 15 980 nm 15 980 nm 15 1000 nm 15 1030 nm 15 1050 nm 15 1100 nm 15 1200 nm 15 1310 nm 15 1380 nm 15 1450 nm 15 1600 nm 15 1650 nm 15 1670 nm 15 1730 nm 15 1800 nm 15 2100 nm 15 2250 nm 15 2500 nm 15 2800 nm 15 0279 The device of the invention computes a quality index for each oxygen saturation value that is determined This quality index characterizes the quality or accuracy of the measured SpO2 value If the signal is disturbed by move ments the number of values is small When the signals are undisturbed the number of values is large Accordingly a disturbed test signal generates a low quality value while an undisturbed test signal results in a high quality value The quality signal assumes values between 0 and 100 In the evaluation of SpO2 long term measurements the quality sig nal can be helpful for it indicates artifacts that occurred during the measurement
4. analyzed offline The software allows the input of comments by the user Manual reclassification of the analytical results by the evaluator is possible 0241 After receiving directions from technical personnel and reading the patient instructions for use the patient is able to apply the sensors and the device himself 0242 The device of the invention processes and stores all measured signals on the integrated memory unit e g Com pactFlash card The data are read out either via a USB cable or by reading out the CompactFlash card with a reader In clinical operation the device of the invention can transmit the recorded data online either wirelessly or by cable connec tion to the software where the data is additionally stored 0243 During online monitoring with the device of the invention networks present in hospitals can be used Ifdata is lost e g if the patient leaves the examination room this data can be supplemented with the data stored on the Compact Flash card The device of the invention is powered by a replaceable battery pack so that it is independent of the power network Stored measured values are not lost during a battery change The device can also be permanently powered and operated with the data transmission cable 0244 The device of the invention can also have an optional position sensor The position sensor records whether and when the patient is prone supine or lying on his side The device can also
5. movement signals and respi ratory effort can be added 27 A device in accordance with claim 1 wherein a module that is designed to determine other cardiological parameters such as EKG and heart rate can be added 28 A device in accordance with claim 1 wherein a data input device is provided for inputting patient data for example age sex and state of health 29 A device in accordance with claim 1 wherein a display device and or an output device is provided for the display and or output of analytical results 30 A device in accordance with claim 1 wherein means are provided for fastening the device on the body of an indi vidual 31 A device for determining and analyzing biophysical data of an individual which consists of at least one sensor device for the noninvasive measurement of at least two sig nals such as a plethysmogram and CWF continuous wave fluctuation signals derived from it SpO2 and pulse rate and an analyzer connected to the sensor device for analyzing transient and or periodically recurring patterns of the mea sured signals which analyzer has at least one module for the US 2009 0240119 Al evaluation of information that is related to the frequency or amplitude of the signals or the parameters derived from them 32 A method for determining and analyzing biophysical data of an individual in which at least one sensor device is used for the noninvasive measurement of at least two signals especially
6. power supply unit Classification according o EN 60601 1 type of protection against electric shock degree of protection against electric shock Electromagnetic compatibility EMC according to EN 60601 1 2 noise suppression immunity to noise Type of protection against water penetration Relative humidity during operation and storage Ila 80 x 150 x 34 About 300 g 5 C to 40 C 10 C to 60 C 3 7 V de 7 5 V de About 340 mW About 10 hours About 20 hours 12 hours Input 100 240 V 50 60 Hz 400 mA Output 7 5 V de Protective class II Type BF The test parameters and limiting values can be requested from the manufacturer if necessary EN 55011 EN 61000 4 Parts 2 to 6 Part 11 IPX 0 25 to 95 noncondensing Hopping frequency f 2402 k MHz k 0 78 Guard band 2 MHz lt f lt 3 5 MHz in the USA Japan Europe Rechargeable Battery 0330 Type of rechargeable battery Li ion Voltage 37 V Capacity 2 15 Ah Overvoltage 435 V Max charging current 1A Discharge current normal lt 1 A Temperature range 20 to 85 C Charging cycles 500 Charging time with the device About 3 hours at 25 C and shut off empty battery Position Sensor 0331 Position sensor Range of values Accuracy position CPAP BiPAP SmartPAP 0332 pressure measurement range Accuracy sensor integrated in the device right side left side prone supine standing about 45 15 0 to 4
7. USB port supported by Windows 0314 connections at least three free USB interfaces for connecting a card reader a USB connecting cable to the data logger and a Bluetooth USB adapter 0315 graphics card supported by Microsoft Windows minimum resolution 1024x768 16 bit color depth 0316 monitor 17 or larger CRT monitor or 15 or larger TFT monitor 0317 mouse Windows compatible mouse 0318 printer supported by Microsoft Windows 0319 network network card 10 100 Mbit only if the network USB server is used 0320 Software 0321 The software is used for analysis and offers alterna tive evaluation proposals The evaluation of the automatically prepared analytical results is the responsibility of the physi cian With each new programming of the device of the inven tion the clock time in the basic device is synchronized with the system clock time of the PC Ifdata transmission to the PC is interrupted the measurement data continues to be stored in the device In the software the signals are represented as the zero line All data can be read out 0322 As with the EMG s bipolar derivations are also used for the EKG The polysomnographic derivation of the device of the invention is based on the Einthoven derivation The reference electrode in the device of the invention is the ground electrode on any part of the body 0323 The device of the invention can be attached to the patient by means of belts which can be guided i
8. basic module has inter faces for adapting individual supplementary modules for determining additional biophysical data such as EKG heart rate respiratory flow and PTT pulse transit time Sep 24 2009 0031 A plethysmogram is preferably recorded for example with a pulse oximeter and or a multiple wavelength pulse spectrometer according to DE 10 2005 020022 A1 DE 102 13 692 Al and DE 103 21 338 Al The terms pulse oximeter and pulse spectrometer are used synonymously here The pulse oximeter and or pulse spectrometer use at least two wavelengths selected from the range of 400 to 2500 nm to determine at least the following parameters pulse rate plethysmogram and oxygen saturation SpO2 and or SaO2 Therefore in the discussion which follows the terms SpO2 and SaO2 are used synonymously 0032 Atleast one CWP continuous wave parameter and preferably at least two CWP s are extracted from the plethys mogram 0033 In accordance with the invention different signals can be combined to detect relevant fluctuations in the pulse wave and to use them for the evaluation 0034 For example it is possible to undertake a differen tiation of obstructive and central respiratory disorders on the basis of patterns detected in a CWF signal derived from the plethysmogram In this regard the characteristic patterns have frequency components that are related to the respiratory rate 0035 Signal analysis over a predeterminable perio
9. claim 10 wherein a CWF is computed from at least one test signal 14 A method in accordance with claim 10 wherein a CWF is computed from at least one test signal and the CWP 15 A method in accordance with claim 10 wherein the CWE is evaluated for device control 16 A device for determining and analyzing biophysical data of an individual which consists of a basic module with a power supply a memory unit and at least one sensor device for the noninvasive measurement of at least one test signal that represents cardiac activity and or respiratory activity which is selected from the following group pulse rate plethysmogram oxygen saturation respiratory signal and Sep 24 2009 heart signal and an analyzer connected to the sensor device for extracting at least one CWP continuous wave parameter from the test signal and or a device for determining at least one CWF continuous wave fluctuation wherein the CWF continuous wave fluctuation is determined from the CWP and or the test signal 17 A device in accordance with claim 1 wherein a classi fier compares at least one CWF datum and or quantities derived from it with stored data in order to identify physi ological pathophysiological events from this information 18 A device in accordance with claim 1 wherein a classi fier compares at least one CWF datum and or quantities derived from it with other test signals and or CWP s in order to identify physiological pathophys
10. connected to an evaluation unit which can be realized as a personal computer In this regard the evaluation unit comprises a CD ROM drive with CD 36 a charger 37 with a power supply unit 38 and plug 39 a charge data transfer cable 40 anda USB cable 41 A converter box 42 is equipped with a jack 43 for the charge data transfer cable 40 a USB jack 44 and a charger jack 45 Data transmission from the mobile unit to the evaluation unit can also be effected directly by removing the memory card 46 from the mobile unit and inserting it into the evaluation unit 0273 FIG 4 shows a device belt 47 and an abdominal belt 48 for assisting mobile use The belts are used to fasten the device of the invention on a user The belt is closed with a buckle The belt can be adjusted to the girth of the body by adjusting the hook tapes The belt consists of an elastic loop tape that is nonirritating to the skin 0274 The left side of FIG 5 shows the use of the device of the invention with a respiratory flow snoring sensor 16 and the right side shows its use for pressure measurement in a ventilator mask The device is fastened on the user and is connected to a pulse oximetry sensor and a respiratory flow snoring sensor left or is connected to a ventilator hose with a pneumo T adapter right 0275 FIG 6 shows a device connected to an evaluation unit which is realized here as a personal computer Data is transmitted to a PC via a medically accepta
11. for extracting at least one CWP continuous wave parameter from the test signal and or a device for determining at least one CWF continuous wave fluctuation such that the CWF continuous wave fluctuation is prefer ably determined from the CWP and or the test signal 0133 A classifier compares at least one CWF datum and or quantities derived from it with stored data in order to identify physiological pathophysiological events from this information The events in question include for example apnea with it being possible in accordance with the inven tion to distinguish between central and obstructive apneas 0134 In another embodiment a classifier compares at least one CWF datum and or quantities derived from it with other test signals and or CWP s in order to identify physi ological pathophysiological events from this information 0135 Atleast some of the results of the analyzer and or at least some of the results of the classifier are output basically immediately acoustically and or graphically preferably viaa display 0136 In accordance with the invention to identify physi ological events at least two signals that are temporally related are evaluated 0137 The device of the invention can be expanded with supplementary modules for measuring other signals To this end the modules are preferably adapted as plug and play modules Supplementary sensor devices are preferably adapted for this purpose 0138 To th
12. for measuring the therapeutic pressure applied in the mask Inspiratory and expiratory pressure fluctuations are conveyed from the mask to the device via the pressure mea surement hoses The exhalation of air generates a slight posi tive pressure and the inhalation of air a slight negative pres sure The breaths taken by the patient can be derived from the pressure differences Snoring sounds are measured by rapid pressure changes The therapeutic pressure is derived from the static component of the pressure signal The pneumo T adapter 28 is used together with xPAP machines during thera peutic stabilization and therapeutic monitoring The pneumo T adapter can be used together with the respiratory flow oral sensor 27 to detect mouth breathing and mouth leakage The pneumo T adapter has a standard tapered socket ISO 22 for connection to therapy masks 0300 EXG Electrodes 0301 The quantity detected with the electrodes is poten tial difference A potential difference between two points of the body is being measured Since the measurement on the skin surface is made noninvasively the measurable potential differences are small They are on the order of uV in the case of EEG s EOG s and EMG s and on the order of mV in the case of EKG s 0302 Bluetooth USB Adapter 0303 With the Bluetooth USB adapter data can be wire lessly received or transmitted online by the device of the invention the device can be configured and app
13. have an optional effort sensor integrated in the housing Integration reduces cleaning and increases the ser vice life of the sensor 0245 A sensor test impedance check can be initiated by a push button 0246 During a sensor test impedance check it can be determined by means of light emitting diodes or an integrated display whether the electrodes and which electrodes are applied properly or poorly 0247 In addition the device of the invention has a yellow light emitting diode in the battery pack next to the battery symbol to indicate whether the rechargeable battery is pres ently charged This information could also be indicated by a symbol on the integrated display It is also possible to make an inquiry about the charge state via the software since a capac ity monitoring system is integrated in the rechargeable bat tery 0248 The stored data can be transmitted to the PC via the USB cable or via the converter box in which a galvanic separation is integrated The rechargeable battery can also be charged via the converter box with the power supply unit that is also provided A battery pack can also be charged when it is not inserted in the device 0249 Function of the Software 0250 The data transmitted during the measurement are stored and visualized The data read in after the measurement are automatically analyzed according to time and value cri teria The software can carry out for example the following automatic a
14. of measurement data with a synchronized time recording bringing together the time information and the measure ment data information analysis of the measurement data with the time information being taken into account carrying out the analysis as a pattern recognition in which at least in intervals the course of the measurement with respect to time of at least one parameter can be detected and is evaluated with respect to a typical individual pattern and or progressive pattern analysis as to whether identified individual patterns and or patterns of development are comparable in a user spe cific way with definable threshold values and analysis as to whether identified threshold value deviations of the user specific individual patterns and or patterns of development are quantified and or can be qualified 10 A method in accordance with claim 9 wherein at least one user specific risk index value that is representative of a heart specific and or circulation specific and or respiration specific parameter of the user can be determined from the quantification and or qualification of the threshold value deviations 11 A method for evaluating at least one test signal detected with the use of at least one sensor wherein a CWP continu ous wave parameter is computed from the test signal 12 A method in accordance with claim 11 wherein a CWF continuous wave fluctuation is computed from the CWP 13 A method in accordance with
15. quality of life or life expectancy 0008 Similarly no device presently exists which makes it possible on the basis of combinations of the parameters it measures to provide information about whether existing therapeutic measures and therapeutic dosages for the disease which is possibly but not necessarily diagnosed with the same device are qualitatively and or quantitatively suitable 0009 The device and method of the invention also concern a modular system for determining biophysical data of an individual which consists of at least one sensor device for the noninvasive measurement of at least two signals 0010 This is intended for determining for example sleep related disorders and or cardiovascular diseases and or metabolic diseases and for aiding in the making of a diagno sis At present a determination of sleep related disturbances or disorders is always made by a specialized physician and usually overnight in a sleep laboratory A polysomnograph is usually used for this purpose Due to the small number of specialized physicians trained in this discipline and the small number of sleep laboratories many patients often have to wait long periods of time before a diagnosis can be made if indeed a diagnosis is ever made 0011 Therefore one of the objectives of the invention is to make available a device that allows a diagnosis to be made quickly easily and inexpensively In addition expanded information compared to the pre
16. s on the device of the invention when in the next step the sensor test is ended by closing the impedance window in the software 0327 During the sensor test all channels i e including effort sensors and pulse oximetry sensors as well as ther mistors and eyeglasses are tested for the presence ofa signal Ifthe LED is off this means The sensor is connected and is transmitting a physiological signal 0328 An impedance test always runs once through all configured channels and then shows its result until the win dow is closed or a new test is started Air pressure during operation and storage Data recording medium Data transmission online Readout of the stored data 0329 Sep 24 2009 continued 700 to 1060 hPa CompactFlash card max 512 MB wireless by radio signal at 2 4 GHz USB 1 1 or higher galvanically separated USB 1 1 or higher Removal of the CompactFlash card reading in by CompactFlash card reader Radio Module Carrier frequency Transmit power 2400 MHz to 2483 5 MHz 0 dBm average Class 2 Product Class according to 93 42 EU Dimensions W x H x D Weight device without sensors Temperature range Operation Storage Power supply voltage basic device Power supply voltage rechargeable battery Mean power consumption Rechargeable battery operating time wireless online ambulatory Max recording time for a measurement Electrical connection
17. sensor are at least two light emitting diodes and a receiver diode 0263 Several SpO2 values are determined for each pulse wave split pulse wave algorithm 0264 The measured pulse rate variations correspond with sufficient accuracy to the heart rate variations that are trig gered by a sleep apnea syndrome 0265 The variation of the pulse wave especially the amplitude of the pulse wave is determined by photoplethys mography 0266 The device of the invention computes a quality index for each oxygen saturation value that is determined This quality index characterizes the quality or accuracy of the measured SpO2 value 0267 Ifthe signal is disturbed by movements the number of values is small When the signals are undisturbed the number of values is large Accordingly a disturbed test signal generates a low quality value while an undisturbed test signal results in a high quality value The quality signal assumes values between 0 and 100 In the evaluation of SpO2 long term measurements the quality signal can be helpful for it indicates artifacts that occurred during the measurement 0268 FIG 1 shows a mobile unit with a pressure connec tion 1 for connection with a pressure measurement hose electrode connections 2 an RIB 3 and a connection 4 for an abdomen sensor 35 not shown The drawing also shows LED s 5 which will be explained in greater detail below a button 6 and a battery compartment latch 7 Also
18. signals such as a plethysmogram and CWF con tinuous wave fluctuation signals derived from it SpO2 and pulse rate and an analyzer connected to the sensor device for analyzing transient and or periodically recurring patterns of the measured signals This is supplemented by a module for the evaluation of information that is related to the frequency or amplitude of the signals or the parameters derived from them 0147 In a supplementary embodiment the device for determining and analyzing biophysical data of an individual consists of a basic module with a power supply a memory unit and at least one sensor device for the noninvasive mea surement of at least one test signal that represents the respi ratory activity for example oxygen saturation respiratory signal or flow signal and at least one additional sensor device for the noninvasive measurement of at least one test signal that represents the cardiac activity for example oxygen satu ration blood pressure pulse rate EKG or plethysmogram and an analyzer connected to the sensor device for extracting at least one CWP continuous wave parameter from at least one of the test signals 0148 For example conclusions can be drawn about apneas hypopneas and other respiratory disturbances By using at least one sensor device for the noninvasive measure ment of at least one test signal that represents the respiratory activity and at least one other sensor device for the noninva sive
19. the PTT pulse transit time In accordance with the invention any parameter that describes a characteristic of a segment of the plethysmogram may be represented as a CWP 0003 If CWP s are considered as a function of time a CWF continuous wave fluctuation signal can be computed from it which is subject to fluctuations that are relevant for the signal analysis The CWF signal thus contains informa tion about the fluctuations of the plethysmogram or of the CWP s derived from it It is possible to represent one of the following quantities as a CWF signal the pulse wave ampli tudes parameters related to the integral over an interval of the plethysmogram ratios of different integrals over different intervals of the plethysmogram portions of the plethysmo gram that are correlated with respiration angles of rise of the pulse waves angles of fall of the pulse waves ratios of angles of rise to angles of fall durations of pulse wave rises dura tions of pulse wave falls ratios of the durations of rises to the durations of falls the envelope of the pulse wave maxima or pulse wave minima quantities related to the PTT pulse tran sit time the median line of the plethysmogram and the pulse rate However it is also possible to use the PTT or other signals that are subject to fluctuations to determine a CWF In accordance with the invention any fluctuation of the plethys mogram every CWP and every combination of different CWP s
20. 0 hPa 0 6 hPa US 2009 0240119 Al Pulse Oximetry Clip Sensor 0333 SpO2 measurement range SpO2 accuracy Pulse Rate 0334 50 to 100 70 lt SpO2 lt 100 better than 2 SpO2 accuracy Measurement range Pulse accuracy 30 to 250 bpm 1 bpm up to 2 from the displayed value Signal quality gt 90 Respiratory Flow 0335 Respiratory flow 3 thermistors as a composite snoring sensor Respiratory flow snoring eyeglasses Respiratory flow oral sensor signal no measuring function at ambient temperatures of 33 38 C inspiratory expiratory pressure fluctuations one thermistor no measuring function at ambient temperatures of 33 38 C Electrophysiological Signals 0336 Channel EKG Dynamic range 5 mV physical range of values Resolution 12 bit Lower frequency 0 16 Hz imit Upper frequency 100 Hz imit Accuracy 3 Adjustable are Specification nput impedance EEG EMG EOG 500 uV 250 uV 500 uV 12 bit 12 bit 12 bit 0 5 Hz 2 7 Hz 0 5 Hz 100 Hz 500 Hz 100 Hz 3 3 3 EMG EOG EEG EKG as EMG EOG EEG EKG About 40 MQ Technical Data of Nonmedical Components Flow Differential Pressure 0337 Pneumo T adapter tapered socket according to standard ISO 22 Sep 24 2009 continued Sensor differential pressure inspiratory expiratory pressure fluctuations Effort Sensors Thorax Abdomen 0338 Thorax sensor Method sensor integrated in the
21. 047 An alternative signal analysis can be accomplished by comparing and or correlating threshold values 0048 Signal analysis can be further assisted by plotting a hierarchy of signals and or a decision tree 0049 One possibility for signal acquisition consists in the evaluation of a CWF continuous wave fluctuation signal 0050 For example the amplitudes 51 of the plethysmo gram 49 are used to determine a CWF signal In this case the CWE 50 represents the amplitude levels of the individual pulse waves of the plethysmogram 49 0051 However it is also possible to use the PTT or other signals that are subject to fluctuations to determine a CWF US 2009 0240119 Al 0052 In accordance with the invention different signals can be combined to detect relevant fluctuations of the pulse wave and to use for the evaluation 0053 Another possibility for signal acquisition consists in the evaluation of an oxygen saturation signal 0054 Another possibility for signal acquisition consists in the evaluation of a pulse rate or heart rate signal 0055 Another possibility for signal acquisition consists in the evaluation of a PTT pulse transit time 0056 A supplementary possibility for signal acquisition consists in the evaluation of an EEG signal 0057 It is likewise contemplated that an EKG signal be evaluated 0058 It is likewise contemplated that an EMG signal be evaluated 0059 Another measurement variant consists in
22. 086 A further increase in the quality of prediction can be realized by evaluating the medication of the individual 0087 A further increase in the quality of prediction can be realized by evaluating reference values of other persons as additional parameters 0088 In accordance with the invention at least the follow ing signals are determined for example with a pulse oxime ter sensor continuous wave fluctuation CWF SpO2 pulse rate 0089 In addition suitable sensors can be added to record and analyze respiratory signals such as flow pressure or snoring heart rate and PTT pulse transit time The use of EKG signals EEG signals and EMG signals for the evalua tion is likewise contemplated In addition blood pressure and CO2 concentration can be recorded and used for the evalua tion 0090 At least one of the following methods is used to evaluate the signals 0091 pattern recognition 0092 signal analysis harmonic transient 0093 frequency analysis 0094 slope analysis 0095 histograms distributions derivatives integra tions 0096 combination of statistically different factors measured values determined values 0097 event data long term trend 0098 threshold value comparison US 2009 0240119 Al 0099 correlation 0100 hierarchy of signals 0101 decision tree 0102 digital filtering 0103 wavelet analysis 0104 temporary storage of signal segments CWP seg ments or CWF segm
23. 9 autonomic micro arousal index 0180 sleep quality index 0181 index for respiratory events 0182 autonomic status 0183 characteristic value for current concentration ability 0184 characteristic value for high tiredness 0185 characteristic value for high sleep pressure 0186 autonomic rest 0187 index for cardiovascular risk vascular disease rhythmological disease cardiac insufficiency 0188 leakage therapeutic success 0189 index for the progression of a disease 0190 Pneumology Module 0191 This module can be adapted to the data bus of the basic module to carry out additional analyses In accordance with the invention it is possible to realize the connection between the basic module and the pneumology module as a plug connection which can be handled quickly and easily The pneumology module can also be used by itself without US 2009 0240119 Al the basic module The pneumology module has at least one effort sensor system and one sensor device for determining a respiratory flow signal 0192 Possible Sensors 0193 effort sensors thoracic and abdominal movements 0194 respiratory flow snoring sensor thermistors and microphone 0195 respiratory flow snoring eyeglasses pressure sensor 0196 oral thermistor for determining mouth breathing in therapeutic monitoring 0197 pneumo T adapter for determining respiratory flow snoring and xPAP pressure differential pressure sensor
24. US 20090240119A1 as United States a2 Patent Application Publication o Pub No US 2009 0240119 A1 Schwaibold et al 43 Pub Date Sep 24 2009 54 DEVICE AND METHOD FOR DETERMINING 30 Foreign Application Priority Data A COMPARISON VALUE OF BIODATA AND FOR RECORDING BIODATA Apr 7 2006 DE oe 10 2006 018 040 2 Apr 7 2006 DE nee 10 2006 018 041 0 76 Inventors Matthias Schwaibold Karlsruhe Publication Classification DE Dirk Sommermeyer 51 Int Cl Karlsruhe DE Bernd Sch ller A61B 5 00 2006 01 Karlsruhe DE 52 US CL nase 600 301 57 ABSTRACT Correspondence Address FRIEDRICH KUEFFNER 317 MADISON AVENUE SUITE 910 NEW YORK NY 10017 US 21 Appl No 12 225 980 22 PCT Filed Apr 4 2007 86 PCTNo PCT DE2007 000614 371 c 1 2 4 Date Jun 1 2009 The method and the device are used for evaluating recorded measurement data In particular the use of the method and of the device makes it possible to detect the individual risk of a living being in respect of certain disease states and if appro priate to automatically evaluate correspondingly recognized risks in a device control Measurement data in respect of heart specific and or circulation specific parameters or respi ration specific parameters of a patient are preferably recorded and evaluated The measurement data are determined over a defined period of time and the measurement data are evalu ated taking into account t
25. abdominal move ments 0218 pulse oximetry sensor for determining oxygen saturation pulse rate pulse wave CWF and PTT 0219 respiratory flow snoring sensor thermistors and microphone 0220 respiratory flow snoring eyeglasses pressure sensor 0221 oral thermistor for determining mouth breathing in therapeutic monitoring 0222 pneumo T adapter for determining respiratory flow snoring and xPAP pressure pressure sensor 0223 Converter Box and Power Supply Unit 0224 The converter box is used for cable connected data transmission of the data stored in the device The data is transmitted via a galvanically separated USB interface At the Sep 24 2009 same time the device of the invention is charged by the power supply unit or is permanently supplied with current 0225 PC Software 0226 The PC software serves to detect store process visualize evaluate document and archive patient specific biophysical signals This assists with the establishment of a diagnosis therapeutic stabilization and therapeutic monitor ing of sleep disturbances 0227 Device Software 0228 The device software serves to detect store process and evaluate biophysical signals This assists with the estab lishment of a diagnosis therapeutic stabilization and thera peutic monitoring of sleep disturbances The device software communicates with the PC software via a secure data trans mission protocol 0229 Nonmedical Electrical Devi
26. aluator is possible 0237 After receiving directions from technical personnel and reading the patient instructions for use the patient is able to apply the sensors and the device himself 0238 In the case of online analysis in the device there is the possibility of directly responding to the analytical results for example by remote control of another device It is pos sible in the case of anesthesia to control for example drug metering devices and or ventilation machines in the case of operators or pilots of a wide variety of transportation means e g cars trucks trains airplanes etc to activate alarms autopilot systems or the like on the basis of analytical results e g lack of ability to concentrate high level of tiredness high sleep pressure or in the case of sleep medicine to operate a therapeutic device e g a CPAP machine by remote control 0239 Itis basically possible to use the device of the inven tion both in the prevention of various diseases risk determi nation for secondary diseases and in real time scenarios in which a direct response is made to currently detected patterns US 2009 0240119 Al 0240 The PC software is used for the visualization evalu ation documentation and patient specific archiving of long term studies on the diagnostics of for example sleep distur bances cardiovascular diseases and diabetes The system is configured for this and the transmitted data is automatically
27. ble memory a power supply via battery rechargeable battery and a data bus controller as a connection for additional modules and a display for display ing computed indices current measured values and current battery rechargeable battery states For relaying the deter mined data the basic module allows bidirectional data exchange with other devices for example with APAP machines FIG 9 shows how the basic module 53 an adapted pneumology module 54 and an adapted cardiology module 55 are positioned on a common carrier 58 on the arm 57 of a user Bidirectional data transmission is possible via the connected cable 56 Alternative application sites for the device of the invention are the finger toe nose ear and forehead 0168 Thedevice ofthe invention has fewer input channels than standard polysomnographs and is thus considerably less expensive smaller lighter and more energy efficient 0169 Sensors 0170 Pulse oximetry sensor for recording a plethysmo gram and determining oxygen saturation and pulse rate 0171 The basic module can determine the following val ues 0172 pulse rate 0173 oxygen saturation SpO2 0174 RDI and AHI in each case differentiated as obstructive or central 0175 risk value for obstructive respiratory tract disease 0176 risk value for central respiratory disturbance 0177 risk value for PLM periodic leg movement 0178 characteristic value for the recovery function of sleep 017
28. ble power supply unit with an all purpose cable for charging the rechargeable battery and for transmitting the stored data via a galvanically separated USB interface of the converter box The converter box is used for cable connected data transmission ofthe data stored in the device The data is transmitted galvanically separately viaa USB interface At the same time the device of the invention is charged via the power supply unit or perma nently supplied with current The PC software runs on the PC The PC software serves to detect store process visualize evaluate document and archive patient specific biophysical signals This assists with the establishment of a diagnosis therapeutic stabilization and therapeutic monitoring of sleep disturbances 0276 The pulse oximetry sensor 34 measures the pulse oximetry signals the oxygen saturation of the blood and the pulse rate of the patient The main components of the sensor are at least two light emitting diodes and a receiver diode For example several SpO2 values are determined for each pulse wave split pulse wave algorithm 0277 The measured pulse rate variations correspond with sufficient accuracy to the heart rate variations that are trig gered by a sleep apnea syndrome Sep 24 2009 0278 Optionally sensors are used which alternatively and or additionally make it possible to determine the concen tration of hemoglobin cHb oxyhemoglobin HbO2 deoxyhemoglobin HbDe
29. by pattern recognition and com pared with stored values In particular the change of the amplitude of the pulse wave is analyzed The result of the comparison yields a patient specific risk index that is suitable for predicting the risk of a cardiovascular disease The device of the invention is small and portable Power is supplied alternatively by batteries rechargeable batteries and or a power cable 0130 The measured data are stored in the device on a CompactFlash card and transmitted to the PC online via cable or optionally wirelessly For ambulatory use the data stored in the device can either be transmitted to the PC via a USB interface or read into the software by reading out the CompactFlash card via a reader 0131 The device of the invention for determining and analyzing biophysical data of an individual consists of a basic module with a power supply a memory unit and at least one sensor device for the noninvasive measurement of at least one test signal that represents cardiac activity and or respiratory activity The sensor device can be selected for example from the following group EKG sphygmomanometer cuff pulse oximeter impedance sensor and Doppler sensor 0132 The test signal that represents the cardiac activity and or the respiratory activity is selected from the following group pulse rate plethysmogram oxygen saturation respi ratory signal and heart signal The sensor device is connected to an analyzer
30. ces 0230 reader for reading out the data stored on the Com pactFlash card 0231 online module for wireless data transmission Bluetooth USB adapter 0232 USB TCP IP converter 0233 PC system external accessories 0234 The device of the invention generates information signals e g rechargeable battery charge status which are graphically visualized and stored by the display and or the PC system These information signals serve to check for the presence of signals to be recorded and to check the proper functioning of the device This makes it possible to avoid faulty recordings and an otherwise necessary repetition of the overnight measurement is avoided 0235 The automatic analyses CWF PTT SpO2 pulse rate PLM snoring analysis sleep stage analysis arousal analysis and cardiorespiratory analysis can be carried out online in the device and or offline from the signals stored in the PC and assist the evaluator in diagnosing sleep distur bances and in initiating and monitoring therapy 0236 The PC software is used for the visualization evalu ation documentation and patient specific archiving of long term studies on the diagnostics of for example sleep distur bances cardiovascular diseases and diabetes The system is configured for this and the transmitted data is automatically analyzed offline The software allows the input of comments by the user Manual reclassification of the analytical results by the ev
31. d of time is assisted if the sensor is connected to a first memory unit for storing a detected test signal 0036 To carry out pattern analysis of the detected signal it is proposed that the evaluation unit have a pattern analyzer for analyzing the behavior of the signal with respect to time 0037 To further improve the evaluation possibilities it is proposed that the comparator be provided with a second memory unit for storing the calculated index value 0038 A typical evaluation sequence is carried out by evaluating the amplitude behavior of the test signal 0039 It is also contemplated that the slope of the test signal be evaluated 0040 In accordance with another embodiment of the invention it is proposed that the frequency of the test signal be evaluated 0041 With respect to the predictive sensitivity it has been found to be especially advantageous for the intensity of change of the test signal to be evaluated 0042 Comprehensive signal analysis can be accom plished by carrying out pattern recognition 0043 Additional signal analysis can be accomplished by carrying out periodic and or transient signal analysis 0044 Supplementary signal analysis can be accomplished by carrying out a frequency analysis 0045 An alternative signal analysis can be accomplished by carrying out an analysis of the slope 0046 A signal analysis can be accomplished by forming histograms and or distributions and or derivatives 0
32. device piezoelectric measurement Snoring 0339 Respiratory flow snoring sensor Respiratory flow snoring eyeglasses Pneumo T adapter integrated microphone pressure sensor pressure sensor Method logarithmic mean value of the sound pressure signal microphone or of the pressure fluctuations pressure sensor Electrodes 0340 Touch safe plug connector 1 5 mm according to DIN 42802 1 A device for determining a reference value of biophysi cal data body parameters of an individual for determining an individual risk said device consisting of at least one sensor for the noninvasive measurement of at least two signals which are selected from the following group CWF continu ous wave fluctuation SpO2 heart rate and PTT pulse tran sit time and an evaluation unit connected to the sensor where the evaluation unit has at least one analyzer which determines signal ranges that can be defined by signal analy sis wherein a comparator coordinates the signal ranges tak ing additional parameters into account such as existing bio physical data of the individual and or static data sets and that the result can be output as an index value 2 A device in accordance with claim 1 wherein the param eters of the biophysical data of the individual include such as medication age sex diagnostic data and the like 3 A device in accordance with claim 1 wherein the static data sets can be compiled from
33. ents 0105 entropy standard deviation 0106 methods of chaos theory 0107 The result produced by the device of the invention is a risk index specific to the patient This index can be expressed for example as a percentage For this purpose the medical history of the patient is preferably considered along with the current measurement data for the determination of the risk index At least on read out memory in the vicinity of the device is used as a data base 0108 In addition the following output options are alter natively and or additionally provided in accordance with the invention 0109 indication of the cardiovascular risk stress 0110 indication of the risk of developing diabetes 0111 indication of the risk of developing inflammatory conditions 0112 indication of autonomic functional disturbances and diseases related to them 0113 indication of classes and or risk groups 0114 Inaccordance with the invention a differentiation of the risk classes is also provided On the basis of the output of the device of the invention it is possible for example for a physician to initiate targeted treatment 0115 In accordance with a preferred variant of the inven tion first the CWP is computed from at least one test signal The CWF is then optionally determined from the original test signal the CWP or both the test signal and the CWP 0116 The determined CWF can be used for example as part of an automated diagn
34. groups of individuals such as medication age sex diagnostic data and the like 4 A device in accordance with claim 1 wherein the com parator can be connected to peripheral devices such as com puters printers and display devices US 2009 0240119 Al 5 A device in accordance with claim 1 wherein the evalu ation unit is designed for determining a CWP continuous wave parameter from at least one detected test signal 6 A device in accordance with claim 5 wherein the evalu ation unit is designed for determining a CWF continuous wave fluctuation from at least one detected test signal 7 A device in accordance with claim 1 wherein the evalu ation unit is designed for determining a CWF from the CWP 8 A device in accordance with claim 1 wherein the evalu ation unit is designed for determining the CWF both from at least one detected test signal and the CWP 9 A method for determining an individual risk for an individual especially a cardiovascular risk comprising the following steps determination of measurement data of at least one heart specific and or circulation specific and or respiration specific parameter of the user selected from the group comprising continuous wave fluctuation CWF SpO2 SaO2 pulse rate heart rate pulse transit time PTT and blood pressure by means of at least one noninvasive sensor device determination of the measurement data over a period of at least one minute determination
35. he time information A particularly effective implementation of the method can be based on pat tern recognition in which individual patterns and or sequence patterns are evaluated Patent Application Publication Sep 24 2009 Sheet 1 of 10 US 2009 0240119 Al Fig 1 Patent Application Publication Sep 24 2009 Sheet 2 of 10 US 2009 0240119 Al N iL Ss N 34 33 16 N 18 19 21 20 EN 29 RA 30 l 32 Patent Application Publication Sep 24 2009 Sheet 3 of 10 US 2009 0240119 Al Pad io on Patent Application Publication Sep 24 2009 Sheet 4 of 10 US 2009 0240119 Al sy D i Patent Application Publication Sep 24 2009 Sheet 5 of 10 US 2009 0240119 A1 Fig 5 Patent Application Publication Sep 24 2009 Sheet 6 of 10 US 2009 0240119 Al O D LL Patent Application Publication Sep 24 2009 Sheet 7 of 10 US 2009 0240119 Al Fig 7 49 gt Patent Application Publication Sep 24 2009 Sheet 8 of 10 US 2009 0240119 Al 52 Fig 8 51 49 N 50 US 2009 0240119 A1 Sep 24 2009 Sheet 9 of 10 Patent Application Publication Fig 9 Patent Application Publication Sep 24 2009 Sheet 10 of 10 US 2009 0240119 Al Grund Modul Option rund Modul PulsOx 53 Pneumologie VRR Fig 10 US 2009 0240119 Al DEVICE AND METHOD FOR DETERMINING A COMPARISON VALUE OF BIODATA AND FOR RECORDING BIODATA 0001 The device and the me
36. iological events from this information 19 A device in accordance with claim 1 wherein at least some of the results of the analyzer and or at least some of the results of the classifier are output basically immediately acoustically and or graphically 20 A device in accordance with claim 1 wherein to iden tify physiological events at least two signals that are tempo rally related are evaluated 21 A device in accordance with claim 1 wherein supple mentary modules can be adapted for measuring other signals 22 A device in accordance with claim 1 wherein at least one interface is installed in the basic module and or in supple mentary modules where this interface allows data to be read out and or other devices especially therapeutic devices to be controlled 23 A device in accordance with claim 1 wherein supple mentary sensor devices can be adapted for measuring other signals 24 A device in accordance with claim 1 wherein sensor devices are selected from the group comprising EKG EMG EOG EEG pulse oximetry blood pressure impedance mea surement ultrasound Doppler CO2 respiratory flow snor ing mouth thorax abdomen and position sensors 25 A device in accordance with claim 1 wherein a module that is designed to determine other biophysical data can be added 26 A device in accordance with claim 1 wherein a module that is designed to determine other respiratory parameters such as respiratory flow PTT
37. is end at least one interface is installed in the basic module and or in supplementary modules 0139 The interface also allows data to be read out and or other devices especially therapeutic devices to be con trolled 0140 At least the following alternative or supplementary adaptable sensor devices are provided EKG EMG EOG EEG pulse oximetry blood pressure impedance measure ment ultrasound Doppler CO2 respiratory flow snoring mouth thorax abdomen position sensors US 2009 0240119 Al 0141 The sensor devices can be supplemented in the form of a module that is designed for example to determine res piratory parameters such as respiratory flow PTT movement signals and respiratory effort 0142 The sensor devices can also be supplemented in the form of a module that is designed for example to determine cardiological parameters such as EKG and heart rate 0143 A data input device is provided for inputting patient data for example age sex and state of health 0144 A display is provided as a means of displaying ana lytical results Acoustic alarms are also provided 0145 In accordance with the invention at least the basic module is detachably mounted on the body of a patient with fastening means such as belts 0146 In another embodiment the device for determining and analyzing biophysical data of an individual consists of at least one sensor device for the noninvasive measurement of at least two
38. isease nor the pure determination of the frequency and severity of the occurrence of certain pathophysiological events The goal rather is to use the detected signals to deter mine the tested person s individual level of risk for suffering secondary diseases that adversely affect quality of life or life expectancy Likewise the form of therapy and the therapeutic dosage that are optimum for the person can be derived from the determined risk In addition the success of a therapy that is already in use can be measured 0017 By evaluating at least two signals selected from the following group CWF continuous wave fluctuation SpO2 heart rate and PTT pulse transit time for example by the use of photoplethysmography it is possible to determine the interactions of a plurality of physiological and pathophysi ological processes In addition it is possible that with the use of a significantly reduced number of measuring sensors com pared to the prior art namely only one measuring sensor for example in the form of a pulse oximetry sensor information can be obtained that is comparable to that provided by prior art methods for example in regard to respiratory disorders sleep disorders diabetes inflammatory reactions vascular conditions and cardiovascular diseases 0018 Itis thus possible to obtain individual information about a patient s state of heath with respect to 0019 cardiovascular risk 0020 stress 0021 diabe
39. lication monitoring can be carried out 0304 Network USB Server 0305 The device of the invention can be operated over a network with the USB server The USB server in conjunction with the Bluetooth USB adapter enables the device of the invention to receive data wirelessly In addition the device can be configured and application monitoring can be carried out The device of the invention can also be cable connected via the converter box 0306 CompactFlash Card Reader 0307 Data stored on the CompactFlash card can be read out by the device of the invention with the CompactFlash card reader The device of the invention can also be config Sep 24 2009 ured via the CompactFlash card reader and or several Com pactFlash cards with different configurations can be installed 0308 Optional Modules 0309 Supplementary PC software allows the therapeutic monitoring data to be read out and displayed the remote control of all cited therapeutic apparatus via the software and the PC assisted evaluation of titration data from a ventilator titration instrument 0310 Combination with Therapeutic Systems 0311 The device of the invention can be combined as a monitoring system with current CPAP bilevel and APAP titration home ventilator therapeutic systems The system can be connected quickly and easily by the pneumo T adapter which is inserted between the hose and the mask eripheral Devices 0312 Peripheral Devi 0313
40. may be represented as CWF signals 0004 A problem that exists is that of determining a risk index which assists with the diagnosis stabilization and monitoring of individuals and can be determined by hospital tests and ambulatory tests 0005 In many diseases there are dependent relationships on or interactions with cardiovascular diseases which can affect the quality of life of the patient In the past it has been possible to determine these kinds of phenomena only statis tically for a group of patients and not for a specific patient Sep 24 2009 0006 Various measuring methods for determining indi vidual parameters related to the autonomic regulation of the cardiovascular system are already known Measuring meth ods of this type are described for example in U S Pat No 5 862 805 WO 91 11956 US 2002 0029000 WO 02 067776 and EP 0 995 592 However so far no methods and devices have been disclosed which relate to a compre hensive evaluation of individual measured values for the com prehensive consideration of individual factors in the determi nation of an individual risk index 0007 In particular no device presently exists which makes it possible on the basis of the parameters it measures to make predictions about the individual risk that the patient s present disease which is possibly but not necessarily diag nosed with the same device might lead to the development of secondary diseases that adversely affect
41. measurement of at least one test signal that represents the cardiac activity it is possible to draw conclusions about dis eases of the cardiovascular system and or the respiratory sys tem for example by pattern analysis 0149 Additional embodiments are described below 0150 Application portion consisting of 0151 basic module 0152 cardiology module 0153 pneumology module 0154 application parts 0155 battery rechargeable battery e g lithium ion 0156 battery 0157 medically acceptable power supply unit sec ondary side with all purpose cable for charging the rechargeable battery and for transmitting the stored data to a PC via a galvanically separated USB inter face converter box 0158 PC Software 0159 The software can be operated under the operating systems Windows 2000 SP 2 and higher Windows XP Pro fessional and Home Edition Sep 24 2009 0160 Nonmedical electrical devices 0161 power supply unit primary side 0162 USB TCP IP converter 0163 Bluetooth USB adapter 0164 CompactFlash card reader 0165 PC system external accessories 0166 Basic Module 0167 The basic module consists of a pulse oximeter a possible interface for controlling other devices e g thera peutic devices possible additional interfaces for additional optional sensors e g connection of a respiratory flow snor ing sensor a communications interface for example USB or a wireless protocol a reada
42. n eyes a b c located on the sides of the device The belts can be adjusted to the girth of the patient by hook tapes The belt consists of an elastic loop tape that is nonirritating to the skin 0324 Carrying Out a Sensor Test 0325 To check that all of the sensors are properly con nected a test can be performed after the sensors and devices have been attached This is done by pressing the button 6 Operation Device Sensor test During the sensor test the LED of the sensor now is running being tested blinks fast 4 x per second Sensor test The LED of the corresponding signal stops OK blinking after completion of the impedance test impedance of the electrode lt 5 kQ OK or sensor signal present Sensor The LED of the corresponding signal blinks slowly testing after completion of the impedance test means impedance of the electrode lt 10 kQ not optimal US 2009 0240119 Al continued Operation Device but of acceptable quality Green LED s blink slowly at 0 5 Hz The LED of the corresponding signal blinks fast after completion of the impedance test impedance of the electrode gt 10 kQ or no sensor signal check electrode and sensor unacceptable signal quality Green LED s blink fast at 1 Hz Sensor test not OK 0326 After successful application of all configured elec trodes sensors no LED is still lighted on the device of the invention There is then no longer any change in state of the LED
43. nalyses 0251 CWF analysis 0252 snoring analysis 0253 cardiorespiratory analysis 0254 arousal analysis 0255 sleep stage analysis Sep 24 2009 0256 On the basis of the analytical results and the dis played signals the present results can be evaluated according to definable criteria 0257 Function of the Optional Sensors 0258 Respiratory Flow Snoring Eyeglasses 0259 The respiratory flow snoring eyeglasses in conjunc tion with the pressure sensor integrated in the device of the invention record the respiratory flow and snoring Inspiration is recorded by the negative pressure that is generated and expiration is recorded by the positive pressure that is gener ated Snoring produces pressure fluctuations in the nostrils and these fluctuations are likewise recorded When the patient is breathing with his mouth closed pressure measurement responds more sensitively to small flow limitations than ther mal measurement Pressure measurement is independent of the ambient temperature and in addition allows visual evalu ation of the flow contour with respect to time During mouth breathing the signals can be attenuated Alternatively there fore the respiratory flow oral sensor is used at the same time 0260 Pulse Oximetry Sensor 0261 The pulse oximetry signals the oxygen saturation of the blood the pulse rate and a CWF signal are measured by the pulse oximetry sensor 0262 The main components of the
44. of prediction can be achieved if in the evaluation of periods of activation of the autonomic nervous system at least one other parameter is evaluated The increase in the quality of prediction can be achieved by comparing the change of various detected param eters or parameters derived from the detected parameters at the time of an activation of the autonomic nervous system in intensity type and sequence with respect to time 0069 To eliminate disturbances or singular events it is proposed that in the determination of the index the cumula tive number and the intensity of activation periods of the autonomic nervous system be taken into consideration 0070 Itis conducive to a simple measurement setup if the sensor determines the heart rate 0071 Inparticular itis contemplated that the sensor deter mines the variability of the heart rate 0072 It is also possible for the sensor to determine the PTT 0073 Itis also possible for the sensor to determine a CWF 0074 Alternatively it is possible for the sensor to deter mine the pulse amplitude Sep 24 2009 0075 To suppress problems it is helpful to carry out arti fact detection and elimination before the evaluation of the determined parameters 0076 Detection of short term signal changes is assisted by evaluating a maximum value of the test signal detected by the sensor that appears within a predetermined interval of time 0077 A measuring method that is simple
45. ostic system However besides that it is also possible to evaluate the CWF directly for a device control 0117 In order to carry out more extensive analysis the CWE can be compared with stored values or patterns or with current measured values 0118 The invention is explained below with reference to practical examples 0119 FIG 1 shows several views ofa device for determin ing values 0120 FIG 2 shows adaptable sensors of the device 0121 FIG 3 shows peripherals of the device 0122 FIG 4 shows belts for attaching the device 0123 FIG 5 shows the use of the device with adapted sensors 0124 FIG 6 shows a device with a connected computer and display device 0125 FIG 7 shows a diagram of a sensor recording with a raw sensor signal and an extracted signal CWF signal 0126 FIG 8 shows a plethysmogram and an extracted signal CWF signal for representing the amplitude levels 0127 FIG 9 shows an arm cuff with a basic module and two supplementary modules mounted on it 0128 FIG 10 shows a basic diagram with a basic module and two supplementary modules assigned to it 0129 In a preferred embodiment of the invention the device makes it possible to make a fast determination of the risk index by using a pulse oximetry sensor to make essen tially simultaneous determinations of at least three signals Sep 24 2009 namely CWF oxygen saturation of the blood and pulse rate The signals are analyzed
46. shown are a connection 8 for a battery charge cable data transfer cable and a rechargeable battery 9 Preferably a second pressure connection 10 is provided The functionality of the unit is further enhanced by a thorax sensor 11 and a connection 12 for a pulse oximeter sensor 0269 An insert card with application sites is provided on the back of the mobile unit FIG 1 also shows a Z electrode 14 and a connection 15 The connection 15 is used for con necting to a respiratory flow snoring sensor 16 or a respira tory flow oral sensor 27 which are shown in FIG 2 The connection 1 is provided for connection with respiratory US 2009 0240119 Al flow snoring eyeglasses 22 or a pressure measurement hose 28 The connections 1 10 are used together for connecting with a pneumo T adapter 33 0270 In addition to the sensors for connection to the mobile unit that have already been mentioned FIG 2 shows sensor beads 17 a sleeve 18 a microphone 19 a mounting plate 20 and a sensor plug 21 The drawings also show a sleeve 23 canulas 24 a clip 25 and a connection 26 for the respiratory flow snoring eyeglasses 22 0271 The pressure measurement hose 28 comprises a connecting piece 29 a connecting hose 30 a plastic hose 32 and a thread 31 for a CPAP connection Other sensors shown in the drawings are a pulse oximetry sensor 34 and an abdo men sensor 35 0272 FIG 3 shows components for the data transfer The mobile unit is typically
47. tes 0022 inflammatory states 0023 autonomic functional disturbances and diseases related to them 0024 risk index percent 0025 class risk groups 0026 differentiation of the risk factors treatment nec essary yes no 0027 A further objective of the invention is to provide a modular device that makes it possible to quickly and easily adapt modules that can be supplemented as needed 0028 Likewise there are no devices at all that can be adapted according to need but rather the polysomnographs that are presently in use are equipped with all channels even when only a few channels would be sufficient and useful for the current investigation 0029 Therefore another objective of the present inven tion is to design a device of the aforementioned type in such a way that it is possible to realize individual applicability to a patient in the sense that for an individual patient only the specific modules that are actually necessary are used for the analysis To carry out more extensive analyses additional modules can be quickly and easily adapted to the basic mod ule A special advantage of the device of the invention is that even medical laymen but certainly at least medical personnel or physicians with no special training in this field are imme diately able to apply the device of the invention to the patient quickly and correctly 0030 In accordance with the invention this objective is achieved by virtue of the fact that a
48. the evalu ation of the oxygen saturation of the blood 0060 Another measurement variant consists in the evalu ation of the hemoglobin concentration of the blood 0061 To determine respiratory parameters it is proposed that a respiratory pattern be evaluated 0062 To determine other parameters it is proposed that supplementary evaluations of the following can be per formed snoring arousal blood pressure CO2 sleep stages skin conductance depth of sleep sleep fragmentation activ ity of the parasympathetic nervous system absolutely or in relation to the sympathetic nervous system and vascular compliance 0063 A measurement principle that is simple to realize consists in the evaluation of optical density of at least one body region 0064 Inaccordance with a typical evaluation method it is provided that a signal analysis is carried out with respect to presently existing periodic signal components 0065 An evaluation of especially predictive signal pat terns is realized by carrying out an analysis with respect to a maximum signal change 0066 In particular it has been found to be advantageous to assign the index of a cumulative autonomic resting intensity to the regulation of the cardiovascular system 0067 The detection of especially predictive events is accomplished by carrying out a signal analysis with respect to a period of activation of the autonomic nervous system 0068 A further increase in the quality
49. thod pertain to a system for determining a reference value of biophysical data body parameters of an individual for determining individual risk which system consists of at least one sensor for the noninva sive measurement of at least two signals which are selected from the following group CWF continuous wave fluctua tion SpO2 heart rate and PTT pulse transit time and an evaluation unit connected to the sensor wherein the evalua tion unit has at least one analyzer which determines signal ranges that can be defined by signal analysis 0002 Preferably a plethysmogram is used which is recorded for example with a pulse oximeter Various CWP s continuous wave parameters are extracted from the plethys mogram CWP s are various fluctuating parameters that each describe a characteristic of the plethysmogram For example the following quantities can be computed as CWP s the pulse wave amplitude the integral over certain intervals of the plethysmogram the ratio of different integrals over different intervals of the plethysmogram a portion of the plethysmo gram that is correlated with respiration the angle of rise of each pulse wave the angle of fall of each pulse wave the ratio of the angle of rise to the angle of fall the duration of a pulse wave rise the duration of a pulse wave fall the ratio of the duration of rise to the duration of fall the pulse wave maxi mum the pulse wave minimum and a quantity related to
50. to apply consists in carrying out the signal acquisition with the use of photop lethysmography 0078 An increase in the sensitivity of the system can be realized by carrying out the signal analysis within at least one predeterminable frequency band 0079 To take interactions into consideration it is pro posed that at least one other body parameter is evaluation by the evaluation unit 0080 For example it is possible to evaluate the age of the individual as an additional body parameter 0081 It is also possible to evaluate the sex of the indi vidual as an additional body parameter 0082 Alternatively or additionally it is also possible to evaluate the weight of the individual as an additional body parameter Alternatively or additionally it is also possible to evaluate one or more risk factors that are already known for example risk factors for cardiovascular disease as additional body parameters 0083 Alternatively or additionally it is also possible to evaluate one or more factors that are already known which affect the autonomic regulation especially medication as additional body parameters 0084 Alternatively or additionally it is also possible to evaluate one or more additionally determined parameters e g arterial oxygen saturation as additional body param eters 0085 Past events can be taken into consideration by evalu ating the medical history of the individual as an additional body parameter 0
51. two signals selected from the group comprising a plethysmogram with CWF continuous wave fluctuation sig nals derived from it SpO2 signals and pulse rate and in which Sep 24 2009 an analyzer connected to the sensor device determines tran sient and or periodically recurring patterns of the measured signals wherein with respect to the results of the evaluation that information which is related to the frequency and or amplitude of the signals or parameters derived from them is further processed
52. viously used polysomnog raphy is to be made available by evaluating parameters of the pulse wave This expanded information should relate espe cially to the activity and evaluation of the autonomic nervous system 0012 In particular there are no devices at all with fewer input channels than polysomnographs which allow the estab lishment of a diagnosis that is comparable to that of a poly somnograph or is superior with respect to specific questions 0013 Therefore another objective of the invention is to design a device and a method of the aforementioned type in such a way that individual applicability to a patient can be realized 0014 In accordance with the invention these objectives are achieved by the features of claim 1 and by the steps of the method specified in claim 5 0015 In this connection at least one sensor for the non invasive measurement of at least two signals which are selected from the following group CWF continuous wave fluctuation SpO2 heart rate and PTT pulse transit time is connected to an evaluation unit the evaluation unit has at least one analyzer the analyzer determines signal ranges that can be defined by signal analysis a comparator analyzes the US 2009 0240119 Al signal ranges taking additional parameters into account and the result of the analysis is transmitted as an index value to a connected output device 0016 The goal of the invention is thus neither the diagno sis of a d
53. ysiological Signals 0289 The electrophysiological signals are measured by electrodes Gold cup electrodes or adhesive electrodes can be used for this purpose 0290 electroencephalogram EEG 0291 electrooculogram EOG US 2009 0240119 Al 0292 0293 electromyogram EMG electrocardiogram 0294 Respiratory Flow Snoring Sensor 0295 Nasal and oral respiratory flow and snoring sounds are detected with the respiratory flow snoring sensor The sensor beads consist of thermistors They detect the respira tory flow by the temperature of the exhaled and inhaled air The microphone records the snoring sounds of the patient 0296 Respiratory Flow Oral Sensor 27 0297 Oral respiratory flow is detected with the respiratory flow oral sensor during diagnosis with the respiratory flow snoring eyeglasses therapeutic stabilization or therapeutic monitoring The sensor beads consist of thermistors They detect the respiratory flow by the temperature of the exhaled and inhaled air The respiratory flow oral sensor 27 is used during diagnosis together with the respiratory flow snoring eyeglasses or during therapeutic stabilization or therapeutic monitoring for detecting mouth breathing together with the pneumo T adapter 28 0298 Pneumo T Adapter 28 0299 The pneumo T adapter is used together with a nasal mask for therapeutic monitoring It is used for recording the respiratory flow and the snoring of the patient during therapy and
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