EP3826537A1 - Procédé pour l'obtention d'un échantillon d'haleine d'un sujet et dispositif - Google Patents

Procédé pour l'obtention d'un échantillon d'haleine d'un sujet et dispositif

Info

Publication number
EP3826537A1
EP3826537A1 EP19744670.1A EP19744670A EP3826537A1 EP 3826537 A1 EP3826537 A1 EP 3826537A1 EP 19744670 A EP19744670 A EP 19744670A EP 3826537 A1 EP3826537 A1 EP 3826537A1
Authority
EP
European Patent Office
Prior art keywords
droplet mist
exhaled
coughed
subject
breath sample
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.)
Pending
Application number
EP19744670.1A
Other languages
German (de)
English (en)
Inventor
Franz Laermer
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 EP3826537A1 publication Critical patent/EP3826537A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • 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
    • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0085—Inhalators using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/105—Filters
    • A61M16/106—Filters in a path
    • A61M16/1065—Filters in a path in the expiratory path
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1075—Preparation of respiratory gases or vapours by influencing the temperature
    • A61M16/109—Preparation of respiratory gases or vapours by influencing the temperature the humidifying liquid or the beneficial agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/0083—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements for taking gas samples
    • A61B2010/0087—Breath samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
    • A61M15/0016—Details of inhalators; Constructional features thereof with inhalation check valves located downstream of the dispenser, i.e. traversed by the product
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3303—Using a biosensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3646—General characteristics of the apparatus related to heating or cooling by heat accumulators, e.g. ice, sand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3673—General characteristics of the apparatus related to heating or cooling thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation

Definitions

  • the present invention relates to a method for obtaining a breath sample from a subject and a device which is provided for obtaining a breath sample from a subject.
  • various proteins or other substances can be isolated from a breath sample obtained, which can be used to draw conclusions about an existing cancer of the lungs, a metabolic disorder in the lungs, an infection of the lungs or also about existing systemic diseases, for example cancers, or general Infections, allow.
  • tuberculosis bacteria can be isolated from the breath sample obtained as part of a tuberculosis screening.
  • certain bacteria or viruses can be isolated from a breath sample, further analyzed and, if necessary, identified.
  • genetic material in particular DNA
  • Analytical methods required for this, in particular molecular biological methods have been established. Such analytical methods are also accessible to automated processing, so that they can be used, for example, as part of a screening for a larger population group.
  • breath samples as part of an optimization of medical Therapies are used, for example in the monitoring of antibiotic therapy for a bacterial infection or in the monitoring and optimization of cancer therapy.
  • the general advantage of examining breath samples is that the breath sample can generally be obtained in a very simple and non-invasive manner for the patient.
  • the invention provides a method for obtaining a breath sample from a subject, in which method the subject has a
  • the droplet mist is preferably colder than the ambient temperature.
  • the material then exhaled and / or coughed up by the subject is collected as a breath sample. With this procedure it is possible to be of particular interest and diagnostics
  • Water droplets take off from the surfaces of the bronchial system there material, for example salts, bacteria, fungal spores, viruses, mobile cancer cells, DNA, RNA, proteins, etc. At the same time, contact with the cold or at least subjectively perceived as cold
  • the temperature of the droplet mist is preferably below the ambient temperature.
  • the ambient temperature is usually the temperature in closed rooms in which the method is used, i.e. room temperature (approx. 18 - 22 ° C).
  • the temperature of the droplet mist is preferably between 0 ° C. and 15 ° C.
  • the droplet mist is therefore also referred to as a cold droplet mist.
  • Respiratory condensate collection can be collected.
  • Water vapor is less suitable as a carrier for biological sample material because only very small molecules can be absorbed.
  • droplet mist of the method described here can be obtained much more valuable analytical sample material.
  • the method described here is suitable, for example, for use in the context of tuberculosis screening.
  • a tuberculosis Screening is traditionally a patient's sputum sample
  • the droplet mist is generated using an ultrasonic atomizer known per se.
  • the generation of the fog by ultrasound has the particular advantage that the
  • Droplet generation does not require heating of the liquid to be atomized. With the ultrasound treatment itself, there is only a slight heating of the liquid to be atomized. However, the nebulization and droplet shape of the liquid with the associated evaporative cold may be sufficient to create a subjective sensation of cold and a cough that is triggered by it. In a particularly preferred manner, the feeling of cold is increased by cooling the mist generated and / or the liquid to be atomized. In a very simple and practical embodiment, for example, ice can be inserted into the liquid to be atomized. In another embodiment can
  • a Peltier element or another cooling element can be provided which cools the liquid to be atomized and / or the mist itself.
  • Devices for ultrasonic nebulization are known per se and are available at low cost. Suitable devices are installed, for example, in so-called home inhalers, which can in principle be used for the method described here.
  • the droplet mist is inhaled first and then the exhaled and / or coughed up material is caught.
  • a suitable device can be provided for this, via which the droplet mist is first inhaled.
  • the exhaled flow is then blown back into the device and diverted within the device, for example with the aid of a check valve, to a suitable collecting vessel.
  • the exhaled flow or the exhaled and / or coughed material is during the
  • Collection process preferably carried out over a filter (e.g. a filter frit) to which the material to be analyzed is bound.
  • a filter e.g. a filter frit
  • bacteria, viruses, fungi, fungal spores, DNA, RNA and / or proteins contained in the exhaled stream can be bound to a filter and collected before the material is further processed and e.g. is analyzed immunologically or molecular biologically.
  • Processes which can be automated can advantageously be used for an analysis, for example lab-on-chip systems which are particularly suitable, in particular, for screening processes or other processes with high sample throughput.
  • the invention further comprises a device for obtaining a
  • the device comprises a device for generating a droplet mist, the temperature of which is preferably below the ambient temperature. Furthermore, a device is provided for sucking in the droplet mist by the test subject and for collecting exhaled and / or coughed up material.
  • the droplet mist is preferably generated using ultrasound technology.
  • a storage vessel is provided in addition to the actual ultrasound transmitter for storing the liquid to be atomized. In particular, this is an aqueous solution, for example water.
  • aqueous solution for example dissolved common salt (NaCl), in particular in a physiological or isotonic concentration of about 0.9 g / l water (154 mmol / l).
  • NaCl dissolved common salt
  • Such a physiological saline solution has the same osmotic pressure as blood, so that the
  • Droplets of the mist based on the saline solution are not absorbed or absorbed by the lungs and can leave the lungs particularly well when coughed up.
  • the storage vessel for storing the liquid to be atomized expediently has an air inflow opening and one
  • Ultrasound transmitter made.
  • the ultrasound generator for example, the water supply in the storage vessel can be slowly atomized. Furthermore, there is preferably cooling in the device for generating the
  • a Peltier cooling element can be provided for this purpose, which cools the liquid supply in the storage vessel.
  • the liquid to be atomized can be cooled, for example, by one or more ice cubes.
  • the liquid supply to be atomized is preferably kept at a temperature in the range between 0 ° C. and 15 ° C., in particular between 0 ° C. and 5 ° C., since the triggered cough stimulation is increased by these temperature ranges.
  • Liquid stocks or the cooling of the droplet mist can also depend on the ambient conditions. In areas with a high ambient temperature (e.g. Africa) is a sufficiently high one
  • Cooling capacity makes sense to ensure the cold of the droplet mist.
  • the ultrasound transmitter and the cooling device can, for example, be operated electrically, for example by means of a mobile battery operation or also a network operation.
  • the storage container itself can be a disposable item, for example a corresponding plastic container.
  • Storage vessel and other parts of the device as a disposable item has the particular advantage that the vessel and the other parts can be disposed of after use and that there is no risk of infection for people who will later use the device. Special disinfection measures can then be dispensed with.
  • the device for sucking in the droplet mist and for collecting the exhaled / coughed out material can be equipped with a check valve so that the exhaled flow with the exhaled and / or coughed up material can be diverted into one or more collection vessels.
  • at least one filter is preferably in or
  • Containers provided, the filter for binding or for
  • the filter can be, for example, an S1O2 frit or another suitable filter material, with which bacteria, fungi, fungal spores, viruses, cells, DNA, RNA and / or proteins can be retained. Filters made of porous Teflon are particularly suitable,
  • Suitable pore sizes are in particular in the range from 0.01 to 10 pm, in particular from 0.2 to 5 pm, preferably from 0.5 to 2 pm.
  • filter materials that are used in sterile filtration and that are available as commercially available bacterial filters or pathogen filters are suitable.
  • suitable filters can also be made dependent on the material to be analyzed, whereby, for example, filters other than for (eg 5 - 10 pm pore size) are suitable for the detection of bacteria (e.g. tuberculosis bacteria) or cells the detection of certain proteins or DNA or RNA (e.g. pore size 0.1 - 1 pm). Filters with a pore size of 0.5 - 2 pm are suitable for many applications.
  • Filter materials have the particular advantage that the foils can be used over a large area, for example by flanging on a funnel equipped with the foil. This lowers the breathing resistance when coughing out, making the application more pleasant and easier for the test subject.
  • the material to be examined can, for example, be rinsed off the flat filter, e.g. in a lab-on-chip system.
  • coughed up material consists of one or more disposable items.
  • the collecting vessels can, for example, be conventional Eppendorf ® filter vessels or filter frits.
  • the rest of the device for sucking in the droplet mist and for collecting or filtering the exhaled and / or coughed airflow is preferably intended for single use to avoid contamination with potentially infectious material.
  • the corresponding articles can be manufactured, for example, as plastic parts, which can be provided very inexpensively and can be easily adapted to the corresponding requirements. It can also be provided, for example, that the storage vessel for storing the liquid to be atomized and the device for sucking in the droplet mist and for collecting exhaled and / or coughed up material are provided as a one-piece article.
  • Fig. 1 is a schematic sectional view of a device for obtaining a breath sample from a subject
  • Fig. 2 View of a device for sucking in a droplet mist and for collecting the exhaled and / or coughed up material as part of the device according to the invention.
  • the device 10 comprises a device 114 for generating a droplet mist 100, the droplet mist being generated in this embodiment by means of an ultrasound generator 101.
  • the liquid 102 to be atomized, in particular an aqueous liquid or pure Water (tap water) is located in a storage vessel 103.
  • ultrasound By applying ultrasound to the storage vessel 103 by means of the
  • Ultrasonic generator 101 which in this example has a high-frequency
  • the storage vessel 103 comprises one
  • Air inflow opening 104 and a droplet mist outlet opening 105 The air enters through the air inflow opening 104, here indicated by an arrow, and the droplet mist 100 leaves the storage vessel 103 through the
  • Droplet mist outlet opening 105 again indicated by an arrow.
  • a droplet mist is used for the method according to the invention, the temperature of which is preferably below the ambient temperature and which triggers a mild coughing sensation in the test subject when the droplet mist is inhaled.
  • the cold droplet mist can be created in different ways.
  • a Peltier cooling element 106 is provided, which can be operated, for example, with direct current (DC).
  • Cooling element 106 becomes the aqueous solution or water 102 in the
  • Storage vessel 103 cooled so that the droplet mist 100 formed is cold.
  • ice or an ice cube can be placed in the liquid 102. It is also possible in this way to generate a cold droplet mist 100.
  • the evaporation cold caused by the nebulization of the droplets generated may under certain circumstances be sufficient to trigger a subjective feeling of cold and a cough in the test subject.
  • a conventional, commercially available device with an ultrasound function and, if appropriate, a cooling function can be used, into which the storage vessel 103 with the liquid 102 to be atomized
  • the storage vessel 103 can be coupled to the actual ultrasound generator / cooler via a further coupling medium, in particular a liquid.
  • the storage vessel 103 can be designed as a disposable item, for example in a cost-effective manner made of plastic, which is shaped accordingly. In this way, the storage container 103 can be disposed of after use.
  • the ultrasound generator 101 and the Peltier cooling element 106 which may be present can be provided for mains operation or also for mobile battery operation.
  • the device 10 further comprises a device 126 via which the
  • Droplet mist 100 can be sucked in by the subject and into which the subject exhales or coughs out, so that the
  • Device 126 is also provided for collecting the exhaled and / or coughed material.
  • the device 126 is preferably designed as a disposable item, so that it can be disposed of after use in order to rule out possible contagion from infectious material in another subject.
  • the device 126 comprises a suction opening or a suction pipe 107 through which the droplet mist 100 passes through the
  • the suction pipe 107 can be configured as a mouthpiece. In other versions, a mouthpiece on the
  • Intake pipe 107 for example, be plugged on or screwed on.
  • the suction pipe 107 also serves to blow in the exhaled and / or coughed-out air stream after the inhalation of the droplet mist.
  • a check valve 108 is provided between the suction pipe 107 and the end of the device 126, via which the droplet mist 100 generated flows into the device 126.
  • the exhaled air flow is diverted into a collecting vessel 109 by means of this check valve 108.
  • This collecting vessel 109 can be designed, for example, in the form of a commercially available Eppendorf® filter vessel, which can be plugged onto a corresponding lateral opening or a lateral nozzle 110 of the suction pipe 107.
  • the collecting vessel 109 comprises a filter 111, in particular a filter frit, for example made of silicon oxide, on which the exhaled and / or coughed up material is collected.
  • the collecting vessel is provided with an outflow opening 112 through which the blown in exhaled air can flow out in the direction of the arrow.
  • the collecting vessel 109 with the filter 111 contained therein can be removed in a simple manner and in particular the filter 111 can be removed for a further analysis of the material and be processed further.
  • the device 126 is connected to the device (mist generator) 114 such that the generated droplet mist 100 can flow through the device 126.
  • the device 126 can be in the
  • Droplet mist outlet opening 105 for example, can be inserted or screwed on via a connecting piece 113.
  • a suitable seal or thread can be provided for this in the area of the connection.
  • the connection piece 113 at the rear of the check valve 108 can be inserted, for example, directly into the droplet mist outlet opening 105, further sealing means being able to be provided here in order to provide a tight seal
  • the check valve 108 is expediently implemented as a simple mechanical check valve, so that the droplet mist 100 or the water droplet-air mixture from the mist generator 114, which is formed in particular by the storage vessel 103, the ultrasound transmitter 101 and possibly the Peltier cooling element 106, is only sucked in , but can no longer flow back.
  • Check valves 108 of this type can be made of plastic, for example, and are available at low cost.
  • the device 126 can first be connected to the device 114 or the storage vessel 103 before the coupling of the ultrasound and possibly the Peltier cooling
  • the process of inhaling the droplet mist 100 and blowing the exhaled stream into the device 126 can be repeated one or more times. After sampling is complete, the entire device 126 can be separated from the mist generator 114.
  • the collecting vessel (s) 109 can, for example, be broken off or unscrewed and the biological material contained therein, which can optionally be bound to the filter 111, can be analyzed, for example, using molecular biology, for example with the aid of lab-on-chip analyzes.
  • Disposable items can be designed after removing the receptacles 109 the entire device 126 and, if appropriate, the storage vessel 103 are disposed of, since these parts may be contaminated with pathogens. These parts can also be stored temporarily with disinfectant solution and later disposed of, for example burned.
  • the device 126 and also the storage vessel 103 can be manufactured as one or more inexpensive plastic parts that do not represent a significant cost factor.
  • the suction pipe 107 can be manufactured with the nozzle 110 and the check valve 108 and the connecting part 113 as a one-piece article. It is also possible to combine these elements as a one-piece article together with the storage vessel 103. This makes the application particularly simple, since only one or more collecting vessels 109 have to be plugged onto the nozzle (s) 110 and the storage vessel 103 has to be inserted into the corresponding ultrasound / cooling device for the preparation of the sampling.
  • FIG. 2 shows a device 206 for sucking in the droplet mist and for collecting the exhaled / coughed out material, the device 206 being provided for two collecting vessels 209. These collecting vessels 209, each with a filter 211, are connected to nozzles 210
  • the device 206 is configured comparable to the device 126 from FIG. 1, a check valve 208 being provided in the interior of the device 206. With the area 213, the device 206 can be integrated into a
  • Droplet mist outlet opening of a storage vessel for the liquid of a mist generator to be atomized can be inserted or screwed on, wherein a corresponding thread can be provided.
  • the devices described here serve to obtain a breath sample from a test subject, the droplet mist generated in the devices, which preferably has a temperature below the ambient temperature, being inhaled and interacting with the surface of the test person's respiratory tract, biological material located there being absorbed and at the same time a cough is generated which leads to coughing up with
  • Sample material loaded water droplets leads.
  • the exhaled aerosol is forced through a preferably provided check valve of the essentially disposable device through the preferably provided filters of the collecting vessels, so that the biological sample material on the
  • Filtering is withheld.
  • the collecting vessels with the filters loaded in this way can be separated off and, for example, fed to a molecular biological analysis and diagnosis process, preferably in lab-on-chip systems.
  • These devices and methods are particularly suitable for screening bacterial infections of the lungs, for example one
  • systemic diseases caused by bacteria, fungi or viruses or tumor diseases can be diagnosed and / or monitored using this method and the devices described.

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

Abstract

Procédé et dispositif (10) pour l'obtention d'un échantillon d'haleine d'un sujet, dans lesquels le sujet inspire un brouillard de gouttelettes (100), qui a de préférence une température plus froide que la température ambiante. Le matériau expiré et/ou expectoré par le sujet est ensuite recueilli comme échantillon d'haleine dans un ou plusieurs récipients collecteurs (109).
EP19744670.1A 2018-07-25 2019-07-23 Procédé pour l'obtention d'un échantillon d'haleine d'un sujet et dispositif Pending EP3826537A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102018212411.6A DE102018212411A1 (de) 2018-07-25 2018-07-25 Verfahren zur Gewinnung einer Atemprobe eines Probanden und Vorrichtung
PCT/EP2019/069734 WO2020020853A1 (fr) 2018-07-25 2019-07-23 Procédé pour l'obtention d'un échantillon d'haleine d'un sujet et dispositif

Publications (1)

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EP3826537A1 true EP3826537A1 (fr) 2021-06-02

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EP19744670.1A Pending EP3826537A1 (fr) 2018-07-25 2019-07-23 Procédé pour l'obtention d'un échantillon d'haleine d'un sujet et dispositif

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US (1) US20210315483A1 (fr)
EP (1) EP3826537A1 (fr)
CN (1) CN112423662A (fr)
DE (1) DE102018212411A1 (fr)
WO (1) WO2020020853A1 (fr)

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CN111388018B (zh) * 2020-03-20 2023-09-19 威图姆卡医疗中心 采集下呼吸道样本的方法及其装置、空气消毒方法及其装置
EP4166921A4 (fr) * 2020-06-16 2023-12-13 Panasonic Intellectual Property Management Co., Ltd. Dispositif de collecte
GB202110582D0 (en) * 2021-07-22 2021-09-08 Owlstone Med Ltd Breath sampling device

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US20210315483A1 (en) 2021-10-14
DE102018212411A1 (de) 2020-01-30
WO2020020853A1 (fr) 2020-01-30
CN112423662A (zh) 2021-02-26

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