WO2020148030A1 - Dispositif pour le prélèvement d'un échantillon d'haleine sous forme gazeuse d'une personne testée - Google Patents

Dispositif pour le prélèvement d'un échantillon d'haleine sous forme gazeuse d'une personne testée Download PDF

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Publication number
WO2020148030A1
WO2020148030A1 PCT/EP2019/084624 EP2019084624W WO2020148030A1 WO 2020148030 A1 WO2020148030 A1 WO 2020148030A1 EP 2019084624 W EP2019084624 W EP 2019084624W WO 2020148030 A1 WO2020148030 A1 WO 2020148030A1
Authority
WO
WIPO (PCT)
Prior art keywords
collecting
breath sample
air
sensor
air flow
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2019/084624
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German (de)
English (en)
Inventor
Michael Stumber
Joachim Platzer
Katrin Luckert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Robert Bosch GmbH
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 WO2020148030A1 publication Critical patent/WO2020148030A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices

Definitions

  • the present invention relates to a device for collecting a gaseous breath sample from a subject, a method for collecting a gaseous breath sample from a subject, and a computer program and an electronic control device for carrying out this method.
  • the air exhaled by a person contains various medicinal and in particular diagnostically interesting substances (biomarkers).
  • biomarkers Various apparatuses are already known with which breath samples can be obtained, which can then be examined primarily for diagnostic purposes or for the purpose of basic research. For example, the nitrogen monoxide content as a volatile substance in the exhaled air is examined in order to determine inflammatory processes or chronic pulmonary diseases such as. B.
  • the international patent application WO 2009/053958 A1 describes a device for monitoring the exhaled air that works with a pump that generates a negative pressure.
  • a pressure sensor monitors a pressure drop in a breathing tube to indicate a blockage and to deactivate the pump.
  • the concentration of carbon dioxide in a patient's expiratory air can be monitored in real time.
  • the international patent application WO 2014/009324 A2 describes a separating device for collecting exhaled air with a first Container and a second container.
  • a respiratory flow directing device is provided so that the patient's respiratory flow can be directed either into the first container or into the second container.
  • the second container can be a flexible, foldable breathing bag in which the exhaled air can be collected, for example, to be sent for analysis.
  • the diagnostically interesting alveolar air can be separated from so-called dead space air (from the pharynx, mouth, nose and bronchial system), so that only the alveolar air is collected in the second container.
  • Device for the fractional collection of breathing gas which aims at sensed parameters.
  • the invention provides a device for collecting a gaseous
  • a test person's breath sample is ready, with which a predeterminable volume of a gaseous breath sample can be collected in a standardized manner and made available for further analyzes.
  • the device comprises a mouthpiece for entering the subject's exhaled air into the system and at least one collection unit for collecting the gaseous breath sample.
  • the collecting unit can preferably be equipped with a collecting bag, in particular with a disposable collecting bag.
  • the essence of the invention is that the device works with a sensor-controlled device for standardizing the exhalation maneuver and at the same time for regulating the air flow within the device, at least one device being provided to avoid the suction of ambient air or the drainage of already collected breath samples from one Failure to serve the air flow, for example after the exhalation process has ended.
  • Support and standardization of the subject's exhalation is generated in the device in a sensor-controlled manner, in particular a suppression, preferably in the collecting unit and in particular for expanding the collecting bag. This can be done through a defined pumping capacity or
  • the invention provides a device which is suitable for avoiding this unwanted pressure equalization.
  • This can be, in particular, a valve control or suitable valves and / or a pump control.
  • This device can therefore also be one or more means for avoiding the suction of
  • the collecting unit has a valve device for quick ventilation, wherein this valve device can be controlled in the manner described above. With this, a quick pressure equalization in the
  • Collection vessel can be brought about, without there being a falsification of the breath sample collected.
  • This embodiment is particularly advantageous when using disposable collection bags within the collection unit, since the breath sample is collected in the collection bag and no gas exchange between the gas fluid in the collection unit and the Bag content occurs.
  • the negative pressure generated in the collecting vessel can be compensated for the atmosphere and thus the suction of ambient air can be prevented.
  • a corresponding vent valve of the collecting vessel can, for example, in response to a signal from the
  • Pressure sensor in the area of the mouthpiece which signals the absence of the air flow, can be controlled or opened.
  • the collecting unit can have an upstream closure device so that the gas path in the direction of the mouthpiece is closed as soon as the exhalation process is ended.
  • the closure device can be arranged, for example, between the mouthpiece and the collecting unit.
  • the end of the exhalation process can be determined, for example, via a pressure sensor in the area of the mouthpiece.
  • the closure device can be, for example, a flap or a valve, in particular a pinch valve.
  • Closure device can be started without a suppression in particular having to be built up again.
  • the sensor-controlled device for regulating the air flow in particular also for generating a negative pressure in the collecting unit, can be, for example, a bellows function or a mechanical device for generating a negative pressure in the device.
  • the pump which pump is preferably arranged downstream of the collecting unit.
  • the pump can also be designed as a cylinder with a piston movable therein or as a bellows, in the interior of which the collection unit with the collection bag is preferably located.
  • the general use is one
  • Patients can be regulated and standardized in a particularly precise manner. This can be done, in particular, with a negative pressure generated by the pump will be worked.
  • the breathing resistance during the exhalation process can be reduced by support by means of the pump and in particular to a predeterminable flow or a predefinable area for the
  • Respiratory flow can be regulated.
  • the sensor for the sensor-controlled pump is in particular a pressure sensor. The beginning of an exhalation of the patient can thus be identified by means of a measured pressure change and the pump can then be started.
  • a flow meter can be provided, for example, which enables a measurement of the air mass flow or the air volume flow. This current can also be regulated.
  • the total exhaled volume can be calculated and the collected volume standardized.
  • the collecting vessel comprises a collecting bag for the breath sample
  • the pump device or pump can preferably be set up by generating a negative pressure in the collecting vessel
  • a suitable control of the pump can alternatively or additionally be provided.
  • the pressure behavior of the filling process in the gas path is measured or calculated and / or simulated.
  • the control of the pump or the pump profile can be
  • Airflow can be minimized.
  • Mass flow sensor can integrate the sample volume and thus a
  • Adjustment of the pump and valve profile can be carried out.
  • the device comprises a bypass line, in particular a switchable bypass line, for bypassing the collecting unit. At least one changeover valve is provided for this bypass line.
  • Control of the changeover valve can be switched directly to the bypass and thus an incorrect filling of the collecting bag with ambient air can be prevented.
  • a bypass line can also be used in a particularly preferred manner for fractionation of the exhaled air.
  • the dead volume of the oral pharynx which is not representative of the alveolar volume of the lungs, can be guided past the collection unit via the bypass line and discarded. Only when alveolar air is exhaled does the device switch to the collection unit, so that only the diagnostically interesting alveolar air gets into the collection bag. This fractionation of the exhaled air can be combined with a CC ⁇ sensor system.
  • the dead volume in the pharynx contains less CO 2 than the exhaled air in the lungs.
  • the CC ⁇ content in the air flow can be measured by a CC ⁇ sensor system.
  • the air flow can be directed through the bypass (bypass line) bypassing the collection unit until a predeterminable threshold value for CO 2 is reached. If the CCh threshold is reached, the exhaled air through the main gas path is used for sampling and thus for
  • Collection bag or directed to the collection unit.
  • the device can include a temperature control device, in particular for moderate heating.
  • a moderate heating in particular in the area of the gas line and the collecting unit, can prevent moistening of the device, that is to say, fogging (condensation). An inadvertent formation of such condensate could falsify analysis results of the gaseous breath sample collected.
  • a chemical dehumidifier can also be used if no breathing condensate is collected.
  • the device comprises at least one device for collecting breathing condensate.
  • This can be a simple condensate trap, for example.
  • a centrifugal separator cyclone
  • a temperature-controlled or coolable centrifugal separator is provided. It is advantageous if the centrifugal separator works as a cold trap in order to obtain a breathing air condensate particularly effectively by cooling the exhaled air.
  • a simultaneous (parallel) collection of breathing gas and breathing condensate is possible. Particles and / or aerosols can also be separated using a centrifugal separator.
  • a saliva trap can be provided in order to avoid falsifying the analysis results.
  • the device can comprise at least one filter or a filter system. This can be used to separate potentially disruptive particles and / or aerosols that could also falsify an analysis result.
  • the filter or the filter system can be designed as a bacterial filter, which can be combined with a dehumidifier function. Depending on the type of sample to be collected, for example collection of breathing gas only or collection of a combination of breathing gas and
  • the filter usage can be adjusted modularly.
  • the sensor-controlled device for regulating the air flow can be a pump or, if appropriate, a mechanical device for generating a negative pressure, e.g. B. have a bellows.
  • the device can be assigned a reservoir or a container which is provided to compensate for pulsations which are triggered by the pressure changes.
  • Regulation of the air flow or outside a mass flow sensor can be provided, which can be used in particular to standardize the volume of the breath sample collected.
  • the invention further comprises a method for collecting a gaseous breath sample from a test subject, in which the device described is used.
  • the air flow within the device is regulated by the sensor-controlled device. A falsification of the
  • the lung-extracted fraction of the exhaled air is selected using a CC ⁇ sensor system.
  • the initially exhaled volume can be discarded as a diagnostically uninteresting dead volume.
  • the first 100 to 150 ml exhaled can be discarded before the actual collection begins. This fractionation can be carried out in a particularly preferred manner
  • a simultaneous (parallel) collection of breathing gas and breathing condensate takes place using at least one centrifugal separator known per se within the device.
  • a centrifugal separator can also be used, for example, to separate disruptive particles, aerosols or condensates in order to avoid falsification of the analysis result based on the gaseous sample collected. It is also possible for several fractions of the exhaled air to be collected in parallel, for example by splitting the gas path with openings in several collecting bags.
  • the method can be designed as a computer program that is set up to carry out the steps of the described method.
  • the invention comprises an electronic control device for performing the described method.
  • This control unit can, for example, as
  • Control device for the device can be designed, by means of this
  • Control unit of the air flow is regulated within the device and in particular suitable valves (e.g. ventilation valve of the collecting unit or Shut-off valve of the collection unit) or the pump to avoid the
  • Breath test after the exhalation process or if there is no airflow can be controlled accordingly.
  • Fig. 1 shows a schematic representation of a device for collecting a
  • FIG. 2 shows an embodiment of the device according to the invention as a block diagram
  • FIG. 3 shows a further embodiment of the device according to the invention as a block diagram
  • FIG. 4 simplified representation of the principle of the collection unit of
  • FIG. 5 shows a further embodiment of the device according to the invention with a bypass line as a block diagram.
  • FIG. 1 shows a possible embodiment of a device 10 according to the invention.
  • the mouthpiece 11 is equipped with a pressure sensor 12.
  • a pressure sensor 12 This is followed by a hose line piece 13 and optionally a breath condensate trap 14 and optionally a further hose line piece or connecting piece 15.
  • the pressure sensor 12 can also be on the Hose line piece 13 may be arranged.
  • a filter system 16, 17 can be connected to the hose line piece 15, which, for example, ensures that the exhaled air dries and separates contaminants such as bacteria or other particles.
  • the exhaled air then passes into a collecting vessel 18, which preferably has a collecting bag 19 for the
  • the collection bag 19 can be inserted as a disposable bag into the collection vessel 18 (reusable) of the device 10 and can be removed after the collection has taken place in order to carry out the breath sample for a further analysis.
  • Commercial products such as, for example, Polypropylene Fitted Breeze-Gas Analysis Bags (SKC) can be used as collection bags.
  • SSC Polypropylene Fitted Breeze-Gas Analysis Bags
  • Pump unit 20 regulates, the pump power being controlled via the pressure sensor 12.
  • the pump unit 20 comprises the actual pump 21. Instead of a pump, in other configurations, one can optionally be used
  • Negative pressure can be provided. If the collecting vessel 18 comprises a collecting bag 19 for the breath sample, the pump unit 20 can preferably be set up to cause or at least to support the expansion of the collecting bag 19 for collecting the breath sample by generating a negative pressure in the collecting vessel 18. Furthermore, a mass flow sensor 22 and a reservoir or container 23 for one
  • Pulsation compensation can be provided by the pump activity.
  • FIG. 1 shows in principle two alternatives, with one
  • a closure device 30 can be provided between the optional filter system 16, 17 and the collecting unit with the collecting vessel 18 and the collecting bag 19, which is therefore located in the gas path upstream of the collecting unit 18, 19.
  • the closure device 30 can also be located upstream of the filter system 16, 17 or at another position, for example.
  • the closure device 30 can be designed, for example, as a flap or valve or as a pinch valve and is closed when the air flow fails, which can be determined, for example, by means of the pressure sensor 12 or also the flow sensor 22, so that when the or Interrupting the exhalation into the device 10 no ambient air can flow into the collecting bag 19 via the mouthpiece 11.
  • Pressure equalization can be provided in the receptacle 18 for quick ventilation to the atmosphere by means of a ventilation valve 31.
  • Vent valve 31 are actuated, so that a rapid pressure equalization takes place without the volume inside the collecting bag 19 being influenced.
  • This device can be used with particular advantage when larger volumes of breath samples are to be collected. Several exhalation procedures are required to collect such a sample volume. So several exhalations are pooled, so to speak. In order to be able to implement the interruption of the air flow that is inevitably required without falsifying the sample volume, the inventive method is
  • the closure device 30 or the venting valve 31 can optionally be dispensed with if the pump control is adapted in such a way that the pump activity is adapted in accordance with the fill level in the collecting bag 19 and a subsequent flow is thereby minimized.
  • the pump control is adapted in such a way that the pump activity is adapted in accordance with the fill level in the collecting bag 19 and a subsequent flow is thereby minimized.
  • FIG. 2 shows a device 10 for collecting a gaseous breath sample in a schematic manner as a block diagram, wherein this scheme can in principle be applied to the device 10 from FIG. 1.
  • the dotted elements indicate disposable parts.
  • the hatched elements indicate
  • a mouthpiece 11 possibly with a saliva trap
  • a pressure sensor 12 is assigned.
  • a hose section or hose system 13 which can optionally be connected to a condensate trap (see FIG. 3).
  • the collecting unit 18 can optionally be temperature-controlled or heated in order to avoid condensation of the breathing gas at this point.
  • Other elements, in particular the gas lines, can also be tempered to make them undesirable
  • the collecting unit 18 is designed as a reusable part of the device 10, whereas the sample bag 19 and also the mouthpiece 11, the
  • Hose system 13 and the dehumidifier and filter 16, 17 can be realized as disposable parts in order to avoid cross-contamination between different test subjects.
  • the air flow within the device 10 is regulated via a control unit or pump unit 20, the pump unit being the actual pump 21, a reservoir 23 and one
  • Mass flow sensor 22 and includes an inlet valve 24 and an outlet 25.
  • This control unit (pump unit) 20 and also the pressure sensor 12, the signals of which flow into the control of the pump 21, are designed as reusable parts of the device 10.
  • the dehumidifier and filter unit 16, 17 serves as device protection.
  • the collecting unit 18 has a sealed connection for the sample bag or collecting bag 19 as well
  • Reusable parts 20 to 25 which prevents contamination through these reusable parts.
  • FIG. 3 shows a further embodiment of a collecting device 100.
  • the device 100 is largely comparable to the device 10 shown in FIG. 2. Corresponding elements are provided with the same reference symbols.
  • the device 100 additionally has a centrifugal separator (cyclone) 50.
  • cyclone temperature-controlled centrifugal separator
  • This preferably temperature-controlled (coolable) centrifugal separator 50 can be provided for realizing online sample preparation for the separation of particles and aerosols.
  • a simple condensate trap can also be provided, for example.
  • a centrifugal separator a simple condensate trap
  • the gas path of the device can be split in order, for example, to collect gaseous breath samples in parallel in several collecting bags.
  • FIG. 4 shows a section of a device 200 in which a bypass line 150 is provided to bypass the collecting unit 18.
  • the bypass line 150 is arranged upstream of the device protection unit or the dehumidifier and filter unit 16, 17 and between the collection unit 18, 19 and the pump unit or the control unit 20 and is connected via a valve 151 between the control unit 20 and the collection unit 18, 19 switchable.
  • the collecting bag 19 and the pump of the control unit 20 can be defined or predefined
  • Gas volumes in the collection unit 18 or in the collection bag 19 interact, comparable to microfluidic systems.
  • FIG. 5 shows such a device 200 with a bypass line from FIG. 4 as a block diagram. Many of the elements correspond to the devices from FIGS. 2 and 3 and are provided with corresponding reference numerals.
  • the hose system 130 is configured with a branch or a T-piece and / or a valve, so that the hose system can form a bypass 150 (preferably as a disposable part), which bypasses the collecting unit 18 and is led directly to the pump unit 20.
  • a bypass 150 preferably as a disposable part
  • Bypass line 150 makes it possible to carry out a fractional collection of the breathing air, in particular the initial dead volume of one
  • Exhalation process can be performed around the collection unit 18 or the sample bag 19 and only the diagnostically relevant exhaled air can be collected from the lungs.
  • a CC ⁇ sensor 152 In order to control this fractional collection, a CC ⁇ sensor 152,
  • This device 200 With the switchable bypass 150, it is also particularly advantageous to avoid pressure equalization in the collecting unit 18 at one
  • Absence of the air flow and a concomitant falsification of the volume in the sample bag 19 can be used by using the valve in the hose system 130 to switch to the bypass 150 in the absence of the air flow, i.e. when the exhalation is interrupted or stopped, in order to incorrectly fill it or emptying the
  • the device according to the invention allows the collection of an integrated or pooled exhalation volume from several
  • the breath collection can thus be defined via a specifiable exhalation volume and thus normalized.
  • Devices for collecting gaseous breath samples were generally not suitable for standardizing the breathing maneuver and collecting a defined volume.
  • the combination of a sensor-controlled and preferably pump-assisted collection of the exhaled breathing gas presented here, for example in a collection bag, which, for example, provides a laboratory connection for further laboratory analysis, with the solution to the problems caused by the regulation of the air flow, can bring the benefits of a standardized collection larger, gaseous breath sample volume can be used.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un dispositif (10) pour recueillir un échantillon d'haleine sous forme gazeuse d'une personne testée et comprend un embout buccal (11) pour introduire l'air expiré de la personne testée et au moins une unité de collecte (18) pour recueillir l'échantillon d'haleine sous forme gazeuse. Le dispositif comprend un dispositif (20) commandé par capteur pour réguler le flux d'air à l'intérieur du dispositif. En outre, au moins un dispositif (30 ; 31) permet d'empêcher l'admission d'air ambiant ou l'évacuation de l'échantillon d'haleine prélevé en cas de manque de débit d'air.
PCT/EP2019/084624 2019-01-14 2019-12-11 Dispositif pour le prélèvement d'un échantillon d'haleine sous forme gazeuse d'une personne testée Ceased WO2020148030A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019200322.2 2019-01-14
DE102019200322.2A DE102019200322A1 (de) 2019-01-14 2019-01-14 Vorrichtung zur Sammlung einer gasförmigen Atemprobe eines Probanden

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WO2020148030A1 true WO2020148030A1 (fr) 2020-07-23

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PCT/EP2019/084624 Ceased WO2020148030A1 (fr) 2019-01-14 2019-12-11 Dispositif pour le prélèvement d'un échantillon d'haleine sous forme gazeuse d'une personne testée

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WO (1) WO2020148030A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008060165A1 (fr) * 2006-11-12 2008-05-22 Syft Technologies Limited Amélioration de procédés et d'appareils de recueil d'air expiré ou en rapport avec ceux-ci
WO2009053958A1 (fr) 2007-10-25 2009-04-30 Oridion Medical (1987) Ltd. Système d'échantillonnage de gaz respiratoire
US20130245483A1 (en) * 2010-12-08 2013-09-19 Rudiger Eichler Apparatus and method for the collection of samples of exhaled air
US20130253360A1 (en) * 2010-12-01 2013-09-26 Zhejiang University Integrated analysis device for simultaneously detecting ebcs and vocs in human exhaled breath
WO2014009324A2 (fr) 2012-07-09 2014-01-16 Roland Stangl Dispositif de séparation d'air expiré pour collecter un échantillon d'air respiratoire
WO2017137365A1 (fr) * 2016-02-12 2017-08-17 Robert Bosch Gmbh Dispositif d'analyse d'un milieu gazeux
US20170303823A1 (en) 2016-04-25 2017-10-26 Owlstone Medical Limited Method for Collecting a Selective Portion of a Subject's Breath
WO2018166928A1 (fr) * 2017-03-17 2018-09-20 Koninklijke Philips N.V. Système et procédé d'annulation active d'impulsions de pression

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL148468A (en) * 2002-03-03 2012-12-31 Exalenz Bioscience Ltd Breath collection system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008060165A1 (fr) * 2006-11-12 2008-05-22 Syft Technologies Limited Amélioration de procédés et d'appareils de recueil d'air expiré ou en rapport avec ceux-ci
WO2009053958A1 (fr) 2007-10-25 2009-04-30 Oridion Medical (1987) Ltd. Système d'échantillonnage de gaz respiratoire
US20130253360A1 (en) * 2010-12-01 2013-09-26 Zhejiang University Integrated analysis device for simultaneously detecting ebcs and vocs in human exhaled breath
US20130245483A1 (en) * 2010-12-08 2013-09-19 Rudiger Eichler Apparatus and method for the collection of samples of exhaled air
WO2014009324A2 (fr) 2012-07-09 2014-01-16 Roland Stangl Dispositif de séparation d'air expiré pour collecter un échantillon d'air respiratoire
WO2017137365A1 (fr) * 2016-02-12 2017-08-17 Robert Bosch Gmbh Dispositif d'analyse d'un milieu gazeux
US20170303823A1 (en) 2016-04-25 2017-10-26 Owlstone Medical Limited Method for Collecting a Selective Portion of a Subject's Breath
WO2018166928A1 (fr) * 2017-03-17 2018-09-20 Koninklijke Philips N.V. Système et procédé d'annulation active d'impulsions de pression

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