WO2021116253A1 - Procédé de fonctionnement dynamique pour dispositif d'analyse de gaz respiratoire - Google Patents

Procédé de fonctionnement dynamique pour dispositif d'analyse de gaz respiratoire Download PDF

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Publication number
WO2021116253A1
WO2021116253A1 PCT/EP2020/085439 EP2020085439W WO2021116253A1 WO 2021116253 A1 WO2021116253 A1 WO 2021116253A1 EP 2020085439 W EP2020085439 W EP 2020085439W WO 2021116253 A1 WO2021116253 A1 WO 2021116253A1
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WO
WIPO (PCT)
Prior art keywords
operating method
sensor
operating
cleaning
data
Prior art date
Application number
PCT/EP2020/085439
Other languages
German (de)
English (en)
Inventor
Markus Thuersam
Kathrin Scheck
Klaus Mueller
Ramona HARTMANN
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 WO2021116253A1 publication Critical patent/WO2021116253A1/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
    • 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
    • G01N33/0004Gaseous mixtures, e.g. polluted air
    • G01N33/0009General constructional details of gas analysers, e.g. portable test equipment
    • G01N33/007Arrangements to check the analyser
    • 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
    • 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
    • A61B2560/0242Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • 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
    • A61B2560/0242Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • 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
    • A61B2560/0242Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0252Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using ambient temperature

Definitions

  • certain respiratory diseases can be recognized and monitored. For example, by determining the nitrogen monoxide concentration in exhaled air, a measure of the inflammation of the lungs in asthma can be estimated.
  • the nitrogen monoxide concentration can be determined using a device disclosed in EP 1384069 B1.
  • the invention relates to an operating method for a device for analyzing breathing air, breathing air being analyzed with a sensor of the device for one or more analytes in the breathing air.
  • breathing air generally means a gas or gas mixture that can be inhaled or exhaled by a user of the device, in particular air.
  • the method can be used to analyze exhaled air, that is to say gas exhaled by the user, also referred to as breathing gas.
  • the device can in particular be a device described above according to EP 1384069 B1, which allows measurement of nitrogen monoxide (NO) or nitrous oxide (NO2) via a gas-sensitive layer on the gate electrode of a field effect transistor.
  • the operating method can be used to determine an amount or concentration of one or more analytes in the exhaled air, in particular to measure one or more analytes in exhaled air, for example of nitrogen monoxide.
  • a nitrogen monoxide concentration in the exhaled air is also referred to as the FeNO value (“fraction of exhaled nitric oxide”), which typically reflects the NO concentration in the “parts per billion” range (ppb for short).
  • the measured value can therefore in particular be the FeNO value.
  • the operating method here includes, in particular, operating the sensor at an operating temperature, in particular at a measurement temperature, cleaning the sensor or determining a measurement result.
  • the operating method preferably comprises operating the sensor at an operating temperature, determining a measurement result and cleaning the sensor, with the sensor cleaning being able to be carried out as required before or after the sensor is operated.
  • the operating method presented is based on the knowledge that an accuracy and a reliability of the measurement result both from Ambient conditions as well as prior use of the device can depend, in particular if the measurement is carried out using a gas-sensitive layer.
  • the invention therefore supports a meaningful and reliable measurement regardless of prior use and regardless of environmental conditions.
  • Ambient conditions are to be understood as meaning, in particular, air humidity, air pressure, temperature and components, for example particles such as dust or pollen or gases such as nitrogen monoxide, in the air.
  • Such environmental conditions can adversely affect the functioning of the device and in particular of the sensor of the device.
  • substances or substances from the air can accumulate on the gas-sensitive layer of the sensor and lead to a falsified measurement, thus “poisoning” the sensor. This can be a problem in particular with sensors for measuring nitrogen oxides.
  • the operating method is adapted as a function of environmental data. This has the advantage that negative environmental conditions can be compensated for by adapting the operating method and a desired accuracy of the measurement is obtained or even made possible in the first place.
  • the environmental data can be collected by an environmental sensor.
  • the environmental sensor can comprise, for example, one or more sensors for measuring air humidity, air pressure, temperature, gases and / or particles.
  • the environmental sensor can be part of the device or part of a base station of the device.
  • a base station is to be understood in particular as a device which is designed to communicate with the device, to serve as an interface for operating the device and / or to charge or clean the device.
  • environmental data can be called up from a second device, in particular from a mobile device, for example a smartphone or a mobile computer.
  • a mobile device for example a smartphone or a mobile computer.
  • the environmental data in particular via the Internet, can also be obtained from external sources such as weather services.
  • usage data can also be taken into account for adapting the operating method.
  • the usage data can in particular include data on the sensor, or sensor data for short, for example sensor data from previous measurements, which at least help determine a current state of the sensor.
  • the usage data can preferably also be data relating to the user of the device, in short user data.
  • the user data can be designed as user profiles.
  • the user data can represent properties of the user, in particular physiological properties. Due to individual physiologies, users can have different typical vital parameters that reflect the basic functions of their bodies. For example, users can have different typical FeNO values, so-called FeNO levels.
  • the invention advantageously enables these different user data to be used for an improved, well-defined measurement.
  • the usage data and in particular the user data can be called up from the second device, in particular from a smartphone or from the base station via which a user can be identified.
  • the usage data that is or can be assigned to this user can advantageously be taken into account for the adaptation of the operating method. This promotes the individual adaptation of the operating procedure for an even more precise and reliable measurement.
  • Both environmental conditions and usage data are preferably taken into account for adapting the operating method. This is based on the knowledge that a simultaneous consideration of prior use and environmental conditions is advantageous for an effective adaptation of the operating procedure, if necessary while utilizing synergy effects. In other words, the use of both types of data, environmental conditions and usage data, advantageously enables an even more reliable measurement by adapting the operating method, also known as the operating strategy. This training creates a particularly dynamic operating procedure.
  • the invention has the advantage that due to the consideration of the environmental conditions and / or the usage data, a needs-oriented adaptation of the operating method is made possible.
  • it is advantageously possible to switch from sensor cleaning, which otherwise has to be carried out frequently and regularly, to needs-based cleaning, which prevents premature aging of the sensor and thus the device and also saves resources required for cleaning.
  • the adaptation of the operating method includes a change, in particular an increase, in the operating temperature.
  • the operating temperature can in particular be a temperature during the measurement of the breathing air by the sensor, also the measurement temperature.
  • it can be a temperature of the sensor, preferably a temperature of the gas-sensitive layer, preferably during the measurement.
  • it can also be a temperature of the breathing gas to be measured, for example a temperature to which the part of the breathing gas to be measured is brought, in particular in the device.
  • the senor can have a sensitivity to other substances in the breathing air, for example a sensitivity to water or other gases, so that an operating temperature is increased if the environmental data indicate an increased amount or concentration of one of these substances, for example increased humidity.
  • the operating temperature could also be lowered below a standard operating temperature if necessary.
  • the level of the operating temperature correlates with the amount or concentration of the detected Substance, for example proportional.
  • the change in operating temperature can also be limited to a predetermined range in order to avoid operating temperatures that are too high or too low, for example a temperature range for the sensor temperature between 30 and 140 ° C, preferably between 40 and 130 ° C, very preferably between 40 and 105 ° C.
  • the adaptation of the operating method alternatively or additionally comprises a change in the sensor cleaning, in particular a change in a point in time or a duration of the sensor cleaning or in the sensor temperature at which the sensor is cleaned.
  • the sensor cleaning can include a temporary increase in the temperature of the sensor, that is, so-called bake-out, and / or rinsing the sensor with a cleaning fluid.
  • the cleaning fluid can be, for example, filtered breathing air, filtered ambient air, a gas or a gas mixture, for example in order to clean a surface of the sensor from undesirably adhering particles or other elements.
  • the temperature of the sensor during the bakeout can be set higher than a standard bakeout temperature for more thorough bakeout, for example an increase in a standard bakeout temperature from 90 ° C to 105 ° C.
  • the change in sensor cleaning takes place depending on the usage data of one or more previous analyzes of breathing air, in particular depending on the frequency and (amount of) measurement results, preferably time courses of measurement results, previous measurements or analyzes.
  • previous use can also determine a state of the device, in particular of the sensor. For example, a measurement of a high concentration of analytes or a large number of measurements in a given time can lead to particularly severe contamination of the device and / or the sensor, so that a longer duration of the sensor cleaning than a standard duration and / or a stronger temporary increase in the Temperature of the sensor is particularly advantageous.
  • the duration and / or the temperature of the sensor cleaning correlate with the amount or concentration of the previous one Measurement established substance and / or the frequency of the measurements in a certain period of time, for example proportionally.
  • the change in the duration and / or bakeout temperature can, however, also be limited to a predetermined range in order to avoid durations that are too short or too long.
  • a standard cleaning time of 40 to 50 seconds can be extended to a period of up to 120 seconds, for example.
  • the (in particular proportional) change in a duration of the sensor cleaning can optionally also comprise a (in particular proportional) change in the duration of a flushing of the sensor with cleaning fluid, optionally including a change in an underlying control of a pump of the device for pumping the cleaning fluid.
  • the adaptation of the operating method includes an adaptation of the determined measurement result.
  • the measurement result can be adapted as a function of environmental data if the influence of the environmental data on the measurement can at least be estimated.
  • a correlation between an interfering gas and a measurement result can be taken into account, this correlation, for example, being stored in a lookup table, preferably in the device.
  • an influence of air humidity on a falsification of a concentration of the analyte to be determined, in particular NO or NO 2 can be estimated and the operating method and thus the measurement result can be adapted accordingly.
  • the operating method is only adapted if one or more values from the environmental data exceed one or more threshold values. Additionally or alternatively, the operating method is only adapted if one or more values from the usage data exceed one or more threshold values.
  • the invention also relates to a device for analyzing the breathing air, the device being set up to carry out the operating method according to the invention.
  • the device can in particular be based on the device disclosed in EP 1384069 B1 and have a configurable computer or processor for operating the operating method according to the invention.
  • the device can have a communication interface for receiving environmental data and / or usage data.
  • the operating method can also be adapted via an at least partial evaluation of the environmental data and / or usage data in a separate device, the device being set up to communicate with the device, in particular via a wireless communication interface such as WLAN, Bluetooth® or Cellular.
  • This separate device can in particular be an IT infrastructure in the context of cloud computing.
  • the change to be made to the operating method can be represented in the form of a configuration file, in particular when processing the environmental data and / or the usage data outside the device.
  • the device in particular a processor of the device, can preferably be set up to adapt the operating method by processing this configuration file.
  • the subject matter of the invention is also a computer program which, when executed on a computer, in particular when executed by the device according to the invention, causes the computer to execute the operating method according to the invention.
  • the computer program can be stored at least temporarily on a machine-readable data carrier.
  • FIG 1 shows an embodiment of the device according to the invention
  • FIG. 2 shows a flow diagram of an exemplary embodiment of the operating method according to the invention.
  • Figures 1 and 2 show an embodiment of the operating method 600 according to the invention and the device 100 according to the invention.
  • Figure 1 shows schematically the interaction between the device 100 and a smartphone 200 and a base station 1000 for the device 100 and with an IT infrastructure on the Internet
  • FIG. 2 comprises a flow chart of an exemplary embodiment for operating method 600.
  • the device 100 is a device for analyzing the breathing air, or breathing gas analyzer 100 for short, which is based, for example, on the device according to EP 1384069 B1 and thus serves to determine the FeNO value.
  • the base station 1000 is a device which is designed to communicate with the device 100, to serve as an interface for operating the device 100, to charge the device 100 or to clean it.
  • the base station 1000 can also be designed to receive the device 100 in a partially form-fitting manner.
  • the device 100 is set up to communicate with the base station 1000 and / or with another mobile device, for example a smartphone 200. Furthermore, a communication interface 110 of the device can be designed to communicate directly with the Internet, for example via WLAN.
  • the operating method 600 comprises operating the sensor 120 at an operating temperature 603, determining a measurement result 604 and / or cleaning the sensor 602.
  • the operating method 600 is adapted depending on environmental data and / or usage data. This means in particular that the operation at operating temperature 603 and the sensor cleaning 602, as explained below, are only carried out when necessary and to an adapted extent.
  • environmental data and / or usage data can be called up and received by the device 100 via the communication interface 110.
  • the device 100 can also have one or more environmental sensors 130 in order to independently acquire environmental data on environmental conditions.
  • the device 100 can be set up to carry out the operating method 600.
  • the operating method 600 could be carried out at least partially outside the device 100, in particular on an IT infrastructure, for example on the base station 1000, on the smartphone 200 (for example via an app) or on an IT infrastructure 2000 in the context of cloud Computing, so that the device 100 can correspondingly partially be controlled by the base station 1000, the smartphone 200 or the IT infrastructure 2000.
  • the environmental data and / or usage data can be collected outside the device 100 in these units.
  • the adaptation of the operating method 600 can initially comprise processing the environment data and / or usage data and, therefrom, generating a configuration file, the device 100 being set up to adapt the operating method 600 in accordance with the content of the configuration file.
  • the operating method is preferably adapted as a function of the use of the device 100. If the device 100 is used by many different patients in a professional medical environment, it can be useful to refer to the operating method (for example to the FeNO level). If the device is used predominantly by a patient in the home environment, the FeNO level is usually relatively stable and the sensor status is primarily influenced by the ambient conditions. As a result, the operating procedure may have to be adapted less frequently.
  • the ambient data for example the ambient humidity and the ambient temperature, can optionally be measured by the ambient sensor 130 of the device at regular intervals, for example twice a day or every hour.
  • the environmental data is preferably recorded independently of an FeNO measurement, so that the required information is already available in the device 100 at the time of the FeNO measurement.
  • a smartphone 200 can alternatively be used to obtain the ambient conditions in order to collect this data. These data could also be provided using sensors of the smartphone 200 or via sources from the Internet.
  • the environmental data are preferably stored at least until either new environmental data are available or a sensor cleaning has been carried out and it can be assumed that the signal level of the sensor could be brought back to a normal level.
  • the subsequent time required for cleaning, also called regeneration, of the sensor 120 can depend on the FeNO level of a user. With higher FeNO values, the regeneration takes longer at the same sensor temperature than with lower values. In this way, a predetermined duration of a sensor cleaning can advantageously be adapted. For example, with comparatively low FeNO values between 0 and 20 ppb, for example, a cleaning time of 40 seconds can be set, with average FeNO values of, for example 20 to 80 ppb, a cleaning time between 50 and 100 seconds, the duration in particular correlating positively with the value , and at high FeNO values of, for example, 80 to 300 ppb, a cleaning time of up to 120 seconds.
  • the setting of the cleaning duration can advantageously be based on the stored typical FeNO values of the user and a predetermined duration of a sensor cleaning can be adjusted accordingly.
  • the duration of the sensor cleaning can positively correlate with the FeNO level that can be assigned to the user, in particular in a proportional manner, as exemplified above.
  • the usage data can in particular also include so-called historical data, that is to say data on past measurements.
  • This historical data can also contain data on environmental conditions during past measurements. For example, a cleaning duration and / or bakeout temperature of the sensor 120 can be increased on the basis of standard values, in particular increased proportionally, if there was an increased air humidity in a previous measurement.
  • the operating method 600 according to the invention can advantageously be used in a doctor's practice in which typically different patients use the device 100 in a mostly air-conditioned room.
  • the ambient conditions are relatively constant due to the air conditioning and are preferably set for the intended use of the device 100, so that, for example, the influence of ambient humidity should be relatively small.
  • the FeNO levels of individual patients can vary widely.
  • the operating method 600 can be configured in such a way that, based on a standard setting, which includes a predefined standard operating temperature and standard cleaning, the operating method 600 is adapted when FeNO values are measured which exceed a high threshold value .
  • the adaptation can then include an increase in the duration and / or temperature of the cleaning, so that the sensor cleaning is carried out correspondingly more thoroughly.
  • a standard cleaning time of 50 seconds and / or a standard cleaning temperature of the sensor from 90 ° C. to up to 100 seconds or up to 105 ° C. can be increased if an FeNO value greater than 100 ppb is measured. This is followed by the operating procedure preferably carried out again with the standard setting until the threshold value is again exceeded.
  • the operating method 600 according to the invention can advantageously also be used in the home environment of a patient.
  • the FeNO values of a patient are usually largely constant.
  • the device 100 may be stored in the bathroom, where the ambient temperature and humidity change significantly due to showering and / or heating and ventilation processes.
  • the sensor 120 is also exposed to the most varied of conditions, which in turn, as already described above, can affect the sensitivity.
  • the device 100 can regularly record the ambient conditions or receive the information about the ambient conditions via a further device such as the base station 1000, so that the operating method 600 can advantageously be adapted as described above.
  • the operating method can be adapted in such a way that the sensor cleaning includes a longer bakeout period before the next measurement in order to lower the sensor signal back to an original level.
  • the heating time of, for example, 50 seconds could be extended by 20 seconds if a relative humidity of more than 60% is measured, preferably at an ambient temperature between 21 and 25 ° C.
  • the device 100 can also be set up to carry out cleaning, preferably including heating, during a resting phase of the device 100, that is, while the device is in a stand-by mode, and is preferably switched on automatically from time to time for this purpose without the user having to do anything .
  • cleaning preferably including heating
  • the user would no longer have to wait for the device to be ready for measurement than under normal conditions, but would always find the device in a state ready for measurement

Abstract

L'invention concerne un procédé de fonctionnement (600) pour un dispositif (100) destiné à analyser l'air respiratoire, l'air respiratoire étant analysé au moyen d'un capteur (120) du dispositif (100) pour rechercher un ou plusieurs analytes dans ledit air respiratoire. Ce procédé de fonctionnement (600) consiste notamment à faire fonctionner le capteur (120) à une température de fonctionnement (603), à déterminer un résultat de mesure (604) et/ou à nettoyer le capteur (602). Selon l'invention, le procédé de fonctionnement (600) est adapté en fonction de données d'environnement et/ou de données d'utilisation. L'invention concerne en outre un dispositif (100) correspondant.
PCT/EP2020/085439 2019-12-13 2020-12-10 Procédé de fonctionnement dynamique pour dispositif d'analyse de gaz respiratoire WO2021116253A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019219516.4 2019-12-13
DE102019219516.4A DE102019219516A1 (de) 2019-12-13 2019-12-13 Dynamisches Betriebsverfahren für eine Vorrichtung zur Atemgasanalyse

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Publication Number Publication Date
WO2021116253A1 true WO2021116253A1 (fr) 2021-06-17

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DE (1) DE102019219516A1 (fr)
WO (1) WO2021116253A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1384069B1 (fr) 2001-04-30 2006-06-21 Siemens Aktiengesellschaft Dispositif et procede de mesure quantitative d'oxydes d'azote contenus dans de l'air expire et leur utilisation
US20070107728A1 (en) * 2005-11-16 2007-05-17 Cardiopulmonary Technologies, Inc. Side-stream respiratory gas monitoring system and method
DE102011003291A1 (de) * 2011-01-28 2012-08-02 Siemens Aktiengesellschaft Betriebsverfahren für einen Gassensor und Gassensor
US20170059245A1 (en) * 2014-03-26 2017-03-02 Panasonic Healthcare Holdings Co., Ltd. Exhalation measuring device and method for controlling exhalation measuring device
US20170224250A1 (en) * 2016-02-04 2017-08-10 Hosiden Corporation Breath component measurement apparatus
DE102017124256A1 (de) * 2016-10-29 2018-05-03 Sendsor Gmbh Sensor und Verfahren zum Messen der Eigenschaften des Atemgas
US20190257802A1 (en) * 2014-01-02 2019-08-22 Arizona Board Of Regents On Behalf Of Arizona State University Specific, reversible, and wide-dynamic range sensor for real time detection of carbon dioxide

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1384069B1 (fr) 2001-04-30 2006-06-21 Siemens Aktiengesellschaft Dispositif et procede de mesure quantitative d'oxydes d'azote contenus dans de l'air expire et leur utilisation
US20070107728A1 (en) * 2005-11-16 2007-05-17 Cardiopulmonary Technologies, Inc. Side-stream respiratory gas monitoring system and method
DE102011003291A1 (de) * 2011-01-28 2012-08-02 Siemens Aktiengesellschaft Betriebsverfahren für einen Gassensor und Gassensor
US20190257802A1 (en) * 2014-01-02 2019-08-22 Arizona Board Of Regents On Behalf Of Arizona State University Specific, reversible, and wide-dynamic range sensor for real time detection of carbon dioxide
US20170059245A1 (en) * 2014-03-26 2017-03-02 Panasonic Healthcare Holdings Co., Ltd. Exhalation measuring device and method for controlling exhalation measuring device
US20170224250A1 (en) * 2016-02-04 2017-08-10 Hosiden Corporation Breath component measurement apparatus
DE102017124256A1 (de) * 2016-10-29 2018-05-03 Sendsor Gmbh Sensor und Verfahren zum Messen der Eigenschaften des Atemgas

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