WO2022117380A1 - Dispositif d'analyse de gaz respiratoire et procédé de fonctionnement associé - Google Patents

Dispositif d'analyse de gaz respiratoire et procédé de fonctionnement associé Download PDF

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Publication number
WO2022117380A1
WO2022117380A1 PCT/EP2021/082429 EP2021082429W WO2022117380A1 WO 2022117380 A1 WO2022117380 A1 WO 2022117380A1 EP 2021082429 W EP2021082429 W EP 2021082429W WO 2022117380 A1 WO2022117380 A1 WO 2022117380A1
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WO
WIPO (PCT)
Prior art keywords
concentration
sensor
respiratory gas
analyte
reduction
Prior art date
Application number
PCT/EP2021/082429
Other languages
German (de)
English (en)
Inventor
Christoph Beck
Heike Jank
Georg Eifler
Markus Thuersam
Kathrin Scheck
Original Assignee
Robert Bosch Gmbh
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 Robert Bosch Gmbh filed Critical Robert Bosch Gmbh
Publication of WO2022117380A1 publication Critical patent/WO2022117380A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/082Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0223Operational features of calibration, e.g. protocols for calibrating sensors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/497Physical analysis of biological material of gaseous biological material, e.g. breath

Definitions

  • the present invention relates to a respiratory gas analyzer. Furthermore, the present invention relates to a method for operating the respiratory gas analysis device.
  • Respiratory gas analyzers for determining fractionated exhaled nitrogen monoxide are generally designed for the entire clinically relevant measurement range, i.e. for measuring the FeNO value in a range between 0 ppb and 300 ppb. Sufficient measurement accuracy is required in the entire measurement range in order to be able to derive meaningful therapeutic statements from the measured values.
  • FIG. 1 shows, by way of example, the relationship between the concentration C of FeNO in a breathing gas and the measurement result X of the sensor.
  • a first Working range A1 there is a linear progression of the characteristic curve K of the sensor.
  • a concentration CI can therefore be determined very precisely from a measurement result XI in this working range A1.
  • the characteristic curve K deviates from its linear progression.
  • the associated concentration C2 of the FeNO can only be determined imprecisely from a measurement result X2.
  • the respiratory gas analysis device for determining a concentration of an analyte in a respiratory gas has a flow path in which a first sensor for determining the concentration of the analyte is arranged.
  • a concentration control device is arranged upstream of the first sensor in the flow path. This is designed to reduce the concentration of the analyte by a controllable percentage.
  • the sensor can be operated in a preferred restricted working range, in particular in its linear measuring range. In particular, this can be the measuring range between 0 and 50 ppb.
  • the respiratory gas analysis device can use a sensor that is designed specifically for this work area and is therefore particularly sensitive, which increases the measurement accuracy and resolution limit of the respiratory gas analysis device. Because the sensor is only exposed to low concentrations of the analyte, the required regeneration times can also be shortened and the service life of the respiratory gas analyzer can be increased.
  • the concentration control device preferably has a filter or converter.
  • the filter can be an activated carbon filter that absorbs nitrogen dioxide. This is particularly preferred when the sensor is a nitrogen dioxide-sensitive gas sensor. Nitrogen dioxide-sensitive gas sensors are used, for example, for the indirect measurement of FeNO if the respiratory gas exhaled in the respiratory gas analyzer is first converted into nitrogen dioxide, for example through a suitable mouthpiece. was changed.
  • the converter can be set up to convert nitrogen monoxide into nitrogen dioxide. This is particularly preferred when the sensor is a nitrogen monoxide-sensitive gas sensor that determines FeNO directly.
  • the converter can contain, in particular, potassium permanganate.
  • the filter or converter has an adjustable efficiency. At 100% efficiency, the level of analyte in the respiratory gas would be diluted to 0 ppb. With an efficiency of 0%, the respiratory gas would retain its original analyte concentration.
  • the concentration control device is realized in that the flow path branches into a first partial path and a second partial path. These reunite upstream of the sensor.
  • the filter or converter is arranged in the second partial path.
  • the filter or converter preferably has an efficiency of 100%. In this way, the respiratory gas leaves the first partial path with its original analyte concentration, while a respiratory gas that is free of the analyte leaves the second partial path.
  • the respiratory gas analyzer preferably has a flow control device in each of the partial paths.
  • the flow control device can be implemented in particular in the form of a switchable valve or an adjustable throttle.
  • a separate pump it is also possible for a separate pump to be arranged in each of the partial paths. Because the respiratory gas is not delivered by a single pump, which can be located before the branching or after the junction of the partial paths, but instead is delivered by two pumps that can be controlled independently of one another, the mixing ratio of the respiratory gas flows from the two partial paths can also be adjusted .
  • the concentration of the analyte that reaches the sensor is controlled in this embodiment of the respiratory gas analyzer by adjusting the mixing ratio of the respiratory gas from the first partial path and the respiratory gas from the second partial path.
  • a second sensor is arranged in the second partial path upstream of the filter or converter. This is also set up to determine the concentration of the analyte.
  • the concentration control device When only one gas sensor is used, the sensor is always preloaded with a high concentration of the analyte before this can be reduced by the concentration control device, since the concentration control device can only be controlled as a function of measurement results from the sensor. This preload can adversely affect the life of the sensor.
  • the use of a second gas sensor enables the analyte concentration to be approximated while the respiratory gas flows exclusively through the second partial path and the first sensor is protected in this way from a possibly high analyte concentration.
  • the first sensor and the second sensor are identical. This enables a lean manufacturing process for the breath gas analyzer and both sensors can be calibrated uniformly.
  • the second sensor has a larger measuring range than the first sensor. As a result, even high concentrations of the analyte can be reliably approximated.
  • a first embodiment of the method for operating the respiratory gas analysis device is used when it has only one sensor.
  • a first reduction in the concentration of the breathing gas is initially set by means of the concentration control device.
  • the concentration reduction preferably selected in such a way that a measurement result of the first sensor in its preferred working range can also be expected for the highest possible concentration of the analyte to be assumed.
  • An approximate concentration of the analyte in the breathing gas is then determined.
  • the measurement result of the first sensor and its sensor characteristic are used. In this way, a concentration value can be obtained, which is then offset against the first reduction in concentration in order to determine the approximate concentration.
  • a second reduction in the concentration of the respiratory gas is now set, which enables the first sensor to be operated in its preferred working range. This can be done in particular via a lookup table.
  • the concentration of the analyte in the respiratory gas is then determined from a measurement result of the first sensor and its sensor characteristic, the concentration value thus obtained being offset against the second concentration reduction in order to obtain a final concentration with high accuracy.
  • the respiratory gas analyzer can be operated in a method that starts immediately with determining an approximate concentration of the analyte in the respiratory gas.
  • the approximated concentration is determined from a measurement result of the second sensor and a sensor characteristic of the second sensor. Since the second sensor is exposed to the breathing gas undiluted, no reduction in concentration has to be taken into account in this determination.
  • the concentration reduction of the respiratory gas by means of the concentration control device can then take place as a function of the approximate concentration of the analyte in the same way as the setting of the second concentration reduction of the respiratory gas if the respiratory gas analyzer has only one sensor.
  • a concentration of the analyte in the breathing gas is then determined from a measurement result of the first sensor, its sensor characteristic and the reduction in concentration.
  • the respiratory gas analysis device With the help of the respiratory gas analysis device, it is possible, regardless of whether it has one or two sensors, to set different concentrations of the analyte in a targeted manner and thus to evaluate the sensor signal at different operating points of the characteristic curves. This means that non-linear changes in the Characteristic can be detected and corrected compared to their calibration state. Breath gas analyzers are usually calibrated once before delivery. It is assumed here that the characteristic curve of the sensor, i.e. the relationship between the gas concentration to be measured and the measurable sensor signal, does not change over the lifetime of the sensor. This is often only the case under certain environmental conditions or when complex design measures are provided, and can often only be guaranteed for a limited period of time.
  • a self-diagnosis a first reduction in concentration of the respiratory gas is set using the concentration control device and then a first measurement result of the first sensor is determined.
  • a second reduction in concentration of the breathing gas is then set by means of the concentration control device, which is different from the first reduction in concentration.
  • a second measurement result of the first sensor is then determined.
  • An approximate slope of the sensor characteristic of the first sensor is determined at least from the two concentration reductions and the two measurement results.
  • two points can be defined using these two pairs of values, which are connected to each other with a straight line.
  • the gradient of this straight line then corresponds to the approximate gradient of the sensor characteristic. If the approximate gradient differs from a gradient of the sensor characteristic curve of the first sensor, which is stored for the operation of the respiratory gas analyzer, by at least a threshold value, an error handling measure is initiated.
  • This can in particular be an automatic recalibration of the first sensor or the use of the respiratory gas analysis device can be blocked or the user can be prompted to have the device serviced.
  • more than two operating points can also be taken into account, or a higher-order fit can also be carried out instead of the linearization.
  • the possibility of self-diagnosis allows an expansion of the permitted storage conditions for the breath gas analysis device, such as the ambient temperature, the air humidity and the ambient pressure.
  • the respiratory gas analysis device is set up in particular to be operated using the method.
  • FIG. 1 shows a characteristic curve of a sensor of a respiratory gas analysis device according to the prior art.
  • FIG. 2 schematically shows a flow path of a respiratory gas analysis device according to an exemplary embodiment of the invention.
  • FIG. 3 schematically shows a flow path of a respiratory gas analysis device according to another exemplary embodiment of the invention.
  • FIG. 4 schematically shows a flow path of a respiratory gas analysis device according to yet another exemplary embodiment of the invention.
  • FIG. 5 shows a flow chart of a method according to an exemplary embodiment of the invention.
  • FIG. 6 schematically shows a flow path of a respiratory gas analysis device according to yet another exemplary embodiment of the invention.
  • FIG. 7 shows a flow chart of another exemplary embodiment of a method according to the invention.
  • FIG. 8 shows a flow chart of a self-diagnosis of a respiratory gas analysis device according to an exemplary embodiment of the invention.
  • FIG. 9 shows a diagram of how a deviation in a sensor characteristic curve is detected during a self-diagnosis of a respiratory gas analysis device according to an exemplary embodiment of the invention.
  • a first sensor 21 is arranged in a flow path 10, which in the present exemplary embodiment is designed as a nitrogen dioxide sensor for indirect measurement of FeNO.
  • a filter 30 is arranged upstream of the first sensor 21 and is designed as an activated charcoal filter with adjustable efficiency. Depending on the setting, between 0% and 100% of the nitrogen dioxide flowing into the filter 30 is adsorbed on it.
  • a pump 40 is located upstream of the filter 30 and conveys the respiratory gas of a user of the respiratory gas analyzer through the flow path 10 . This is blown through a mouthpiece (not shown) into the flow path 10, in which nitrogen monoxide is converted into nitrogen dioxide.
  • the first sensor 21 and the pump 40 are likewise arranged in the flow path 10 .
  • the flow path 10 branches into a first partial path 11 and a second partial path 12.
  • the filter 30 is arranged in the second partial path 12 in this exemplary embodiment. It is not designed as an adjustable filter, but as an activated carbon filter with a constant efficiency of 100%.
  • a check valve 51, 52 is arranged in each of the partial paths 11, 12.
  • An adjustable throttle 61 , 62 is located downstream of the check valves 51 , 52 in each of the partial paths.
  • the throttle 62 is arranged between the check valve 52 and the filter 30 .
  • the two throttles 61, 62 can be adjusted independently of one another.
  • the two throttles 61, 62 are replaced by pumps 41, 42 that can be controlled independently of one another.
  • the pump 40 upstream of the branching into the two partial paths 11, 12 is omitted in this exemplary embodiment.
  • the concentration of nitrogen dioxide reaching the first sensor 21 can be controlled.
  • the filter 30 functions solely as a concentration control device due to its adjustable efficiency.
  • the concentration control device consists of the two partial paths 11, 12 and the components arranged therein.
  • a first exemplary embodiment of the method for operating a respiratory gas analysis device can be used for the respiratory gas analysis devices according to the first three exemplary embodiments of the invention. Its sequence is shown in FIG.
  • the concentration control device is initially set in such a way that only nitrogen dioxide-free respiratory gas reaches the first sensor 21 . This is continued for a period of 2 to 5 seconds, after which it can be expected that in the area of the flow path 10 and possibly the second partial path 12 up to the filter 30 a constant concentration of nitrogen dioxide has been established.
  • a reduction in concentration is determined and set, which is a final concentration measurement of the nitrogen dioxide should be taken as a basis.
  • a concentration reduction of 80% is first set 71 .
  • a sensor signal of the first sensor 21 is detected and a concentration value is determined from this measurement result using its sensor characteristic. To account for the reduction in concentration, this is multiplied by 5 to obtain an approximate concentration of nitrogen dioxide.
  • a second concentration reduction of the breathing gas is then set.
  • an optimal reduction in concentration for the final measurement is selected from the approximated concentration in a lookup table. For example, a second reduction in concentration in the range from 70% to 80% can be useful for a high approximated concentration. For very low approximate concentrations, there is no need to reduce the concentration of nitrogen dioxide at all, so that the concentration reduction is 0%.
  • a further measured value of the first sensor 21 is recorded for the second reduction in concentration in order to output a value of the fractionated exhaled nitrogen monoxide to be output by the respiratory gas analyzer.
  • a concentration value is determined from this measurement result and the sensor characteristic curve and then, taking into account the second reduction in concentration, the actual nitrogen dioxide concentration is calculated, from which the FeNO value can be inferred.
  • the third exemplary embodiment is modified in such a way that a second sensor 22 is arranged between the pump 42 arranged in the second partial path 12 and the filter 30 . This is identical to the first sensor 21.
  • the fourth exemplary embodiment is modified in such a way that the second sensor 22 is a nitrogen oxide sensor that has a larger measuring range than the first sensor 21 .
  • a second exemplary embodiment of the method for operating a respiratory gas analysis device can be used for the respiratory gas analysis devices according to the fourth and fifth exemplary embodiments of the invention. Its sequence is shown in FIG. A start 80 of the operation of the respiratory gas analysis device is performed in the same way as the start 70 in the first exemplary embodiment of the method. However, only two steps 81, 82 are then required to determine the reduction in concentration for the final determination of the nitrogen dioxide concentration. In the first step 81, a measurement result of the second sensor 22 is recorded and an approximate nitrogen dioxide concentration is calculated from this and the sensor characteristic curve of the second sensor.
  • step 82 in the same way as in step 73 of the first exemplary embodiment of the method, a reduction in the concentration of the breathing gas is set as a function of the approximate nitrogen dioxide concentration using a lookup table.
  • the final determination 83 of the nitrogen dioxide concentration and the FeNO value takes place in the same way as in step 74 of the first exemplary embodiment of the method.
  • a setting 91 in the first reduction in concentration of the respiratory gas takes place for this purpose by means of the concentration control device. This reduction in concentration is 0% in the present exemplary embodiment.
  • a first measurement result X92 Jst of the first sensor 21 is then determined 92.
  • a second reduction in concentration of the respiratory gas is then set 93 by means of the concentration control device. In the present exemplary embodiment, the second reduction in concentration is 0%.
  • a determination 94 of a second measurement result X94_actual of the first sensor 21 follows. As shown in FIG.
  • these two measurement results X92_actual, X94_actual can each be assigned concentrations C92, C94 estimated from the two concentration reductions, resulting in two points in a coordinate system.
  • An approximate slope dK2 of the sensor characteristic curve of the first sensor is determined 95 by connecting the two points with a straight line.
  • This gradient is compared 96 with the gradient dK1 of the sensor characteristic curve Kl of the first sensor 21 stored in the respiratory gas analyzer it is recognized that the first sensor 21 has aged. This expresses present in that its sensor characteristic has changed from the stored sensor characteristic K1 to a new sensor characteristic K2.
  • the measurement results X92 Jst , X94_act for the two concentrations C92, C94 also do not correspond to the measurement results X92_soll, X94_soll to be expected based on the stored sensor characteristic K1.
  • An error handling measure is now initiated 98 , which in the present exemplary embodiment can consist of a recalibration of the first sensor 21 . If, on the other hand, the test 97 shows that these two gradients do not deviate from one another by at least the threshold value, it is recognized that the first sensor 21 is OK 99.

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Abstract

L'invention concerne un dispositif d'analyse de gaz respiratoire pour déterminer une concentration d'un analyte dans un gaz respiratoire, comprenant un trajet d'écoulement (10), dans lequel un premier capteur (21) est agencé pour déterminer la concentration de l'analyte. Un dispositif de régulation de concentration est disposé dans le trajet d'écoulement (10) en amont du premier capteur (21), lequel dispositif de régulation de concentration est configuré pour réduire la concentration de l'analyte par un pourcentage contrôlable. L'invention concerne en outre un procédé de fonctionnement d'un dispositif d'analyse de gaz respiratoire.
PCT/EP2021/082429 2020-12-01 2021-11-22 Dispositif d'analyse de gaz respiratoire et procédé de fonctionnement associé WO2022117380A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020215118.0 2020-12-01
DE102020215118.0A DE102020215118A1 (de) 2020-12-01 2020-12-01 Atemgasanalysegerät und Verfahren zu seinem Betrieb

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WO2022117380A1 true WO2022117380A1 (fr) 2022-06-09

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1058846A1 (fr) * 1998-02-24 2000-12-13 WMA Airsense Analysentechnik GmbH Procede et dispositif pour identifier des composes gazeux
US20040133116A1 (en) * 2001-04-30 2004-07-08 Klaus Abraham-Fuchs Device and method for the quantitive determination of nitrogen oxides in exhaled air and application thereof
US20110077544A1 (en) * 2009-09-28 2011-03-31 Klaus Abraham-Fuchs Method for optimizing the gas conversion rate in a respiratory gas analyzer

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1883803B1 (fr) 2005-04-26 2012-06-13 Koninklijke Philips Electronics N.V. Appareil de faible cout pour detecter des composes gazeux contenant de l'azote
DE102013221061A1 (de) 2013-10-17 2015-04-23 Robert Bosch Gmbh Verfahren und Vorrichtung zur Messung der Konzentration von Stickstoffmonoxid in der Atemluft eines Patienten
US10307080B2 (en) 2014-03-07 2019-06-04 Spirosure, Inc. Respiratory monitor

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1058846A1 (fr) * 1998-02-24 2000-12-13 WMA Airsense Analysentechnik GmbH Procede et dispositif pour identifier des composes gazeux
US20040133116A1 (en) * 2001-04-30 2004-07-08 Klaus Abraham-Fuchs Device and method for the quantitive determination of nitrogen oxides in exhaled air and application thereof
US20110077544A1 (en) * 2009-09-28 2011-03-31 Klaus Abraham-Fuchs Method for optimizing the gas conversion rate in a respiratory gas analyzer

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