WO2012172011A1 - Procédé d'analyse de l'air expiré - Google Patents

Procédé d'analyse de l'air expiré Download PDF

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Publication number
WO2012172011A1
WO2012172011A1 PCT/EP2012/061342 EP2012061342W WO2012172011A1 WO 2012172011 A1 WO2012172011 A1 WO 2012172011A1 EP 2012061342 W EP2012061342 W EP 2012061342W WO 2012172011 A1 WO2012172011 A1 WO 2012172011A1
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WO
WIPO (PCT)
Prior art keywords
particle
exhalate
max
flow
determination
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.)
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Application number
PCT/EP2012/061342
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German (de)
English (en)
Inventor
Jens HOHLFELD
Heike BILLER
Hubert Lödding
Wilhelm Dunkhorst
Katharina Schwarz
Wolfgang Koch
Horst Windt
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Fraunhofer Gesellschaft zur Foerderung der Angewandten Forschung eV
Original Assignee
Fraunhofer Gesellschaft zur Foerderung der Angewandten Forschung eV
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Filing date
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Publication of WO2012172011A1 publication Critical patent/WO2012172011A1/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
    • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/497—Physical analysis of biological material of gaseous biological material, e.g. 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
    • A61B5/4842—Monitoring progression or stage of a disease
    • 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

Definitions

  • the invention relates to a method for the analysis of exhaled air (Exhalat).
  • a method for the analysis of exhaled air may e.g. as a preparatory measure in the context of the early, non-invasive diagnosis of pathological changes of the peripheral areas of the lung (P AD, peripheral airway disease), as described e.g. in obstructive
  • COPD Pulmonary disease
  • bronchiolitis obliterans Pulmonary disease
  • Fluid accumulation and / or inflammation occur i.a. also on at
  • VILI Ventilation induced lung injury
  • Nonvolatile molecules must necessarily have one
  • Drool formation process from the lung fluid out into the exhaled air The properties of the exhaled aerosols are determined on the one hand by the properties of the droplets formed in the different lung compartments and on the other by the redeposition of already generated particles in the complex lung structures during the exhalation process. In normal breathing, the particle size spectrum usually has
  • Number maximum in the particle size range less than 1 ⁇ on.
  • Epithelial fluid film lining the respiratory tract In this liquid-liquid separation, droplets emerge, which can escape with the breath and can be detected. The process is shown in FIG.
  • Liquid bridges or liquid plug 3 make it a more energetically favorable state than the smooth lined with lung fluid film 2 capillary walls 1. This state is realized in particular during exhalation.
  • the transpulmonary pressure increases and it can be used to reopen the droplets 4 at
  • This drop formation process is of the processes that are e.g. in a forced
  • the ventilated lung area where the airway can close is referred to as the "closing volume” (CV), when the lung volume at the end of an expiratory process (EELV, end expiratory volume) is less than the closing volume (EELV ⁇ CV) it for the realization of
  • Airway closures come.
  • the particles or liquid droplets generated during the reopening are then carried outside with the respiratory flow during the next exhalation process.
  • By varying the breathing depth is the
  • FIG. 2 shows typical lung function parameters which, apart from the closure volume CV, are determined by conventional measuring methods such as spirometry or body plethysmography.
  • These pulmonary function parameters shown in Fig. 2 are it is the lung capacity TLC ("total lung capacity”), the lung volume available for respiration VC (“vital capacity”), which is not ventilated
  • Residual volume RV residual volume
  • tidal volume (VT) tidal volume
  • FRC functional residual capacity
  • closing volume CV lung volume at End of the expiration process
  • EELV end expiratory volume
  • exhaled volume EV expired volume
  • Airway obstruction may cause injury to the peripheral airway.
  • the occlusion volume can be measured by the administration and detection of noble gas boluses during pulmonary function examinations.
  • the events of the reopening of the respiratory tract can also be detected and quantified by the analysis of acoustic signals. They express themselves in so-called crackling noises (crackles). In principle, the analysis of "crackles" is suitable for the early detection of peripheral lung changes.
  • monodisperse aerosols In addition to the morphometric examination of the lung, monodisperse aerosols also serve to analyze the convective transport of the respiratory gas as part of the so-called aerosol-bolus dispersion. Exhalation (dispersion) of an inhaled bolus of a low redeposition rate test aerosol allows conclusions to be drawn on pathological alterations of the respiratory tract associated with inhomogeneous ventilation of the lungs. Ventilation of the lungs is performed by the administration and detection of inert gas boli. Practically, both the gas measurements due to the complex detection and the acoustic measurements and the aerosol investigation are very complex.
  • the method should be simple to perform and as a preparatory measure for subsequent lung diagnostics, e.g. may serve as an early diagnosis of pathological changes in the peripheral areas of the lung (PED).
  • PED peripheral areas of the lung
  • This object is achieved by providing a method for analyzing an exhalate, wherein the exhalate particles having a minimum diameter d m i n (Exhalat) and a maximum diameter d max (Exhalat) comprising the measurement or determination of at least one physical size a defined first particle size fraction PI of the exhalate, wherein the physical quantity is selected from the particle number concentration Cl, the
  • Particle number flow F the number of particles N 1, the particle mass flow M 1, the Particle mass Gl or combinations thereof, wherein the first particle size fraction PI by a minimum diameter d m i n (Pl) and a maximum diameter dmax (PI) is defined such that d m i n (Pl)> d m i n (exhalation) and or
  • exhalate refers to the total exhaled volume flow and / or the total exhaled volume and / or a partial volume flow and / or a partial volume of expired respiratory gas
  • particles refers to the relative humidity in the environment of the aerosol either on liquid droplets or at a relative humidity well below 100% on solid particles present after the shrinkage of the droplets, consisting of the non-volatile substances of the liquid lining the respiratory tract as exhaled with exhalation.
  • these particles Due to their particle size distribution, these particles have a minimum diameter d m i n (exhalate) and a maximum diameter d max (exhalate) which, of course, may vary depending on the subject or respiratory pattern or depth of respiration or activity Liquid droplet in the lungs has already been discussed above with reference to FIG. Typically, the maximum diameter d max (exhalate) ⁇ 5 ⁇ in normal breathing, coughing, sneezing, speaking or forced exhalation up to d max (exhalate) ⁇ 1mm.
  • Particle subset of all present in exhaled particles defined and determined for this particle size fraction number concentration, number flow, mass flow and / or particle number, an efficient preparatory measure for subsequent lung diagnostics, eg an early diagnosis of pathological Changes in the peripheral areas of the lung (PED, peripheral airway disease) represents.
  • dmin (Pl) and d max (Pl) are chosen so that the first
  • Particle size fraction PI at most 95%, more preferably at most 90% of
  • Total number of particles in the exhalate includes.
  • Embodiment d m i n (Pl) and d max (Pl) are chosen so that the first
  • Particle size fraction PI 10% to 95%, more preferably 70% to 90% of
  • Total number of particles in the exhalate includes.
  • d m i n (Pl) is preferably ⁇ to a value in the range of 0.2 to 1 , 5 ⁇ , more preferably in the range of 0.3 ⁇ set to 0.6 ⁇ .
  • dmin (P1) is preferably adjusted to a value in the range of 0.2 ⁇ m to 100 ⁇ m, more preferably in the range of 0.3 ⁇ m set to 10 ⁇ .
  • the maximum particle diameter d max (Pl) of the first particle size fraction can be selected, for example, such that it corresponds to d max (exhalate), ie
  • the mass flow M 1 of the defined first particle size fraction PI can be the total particle mass flow or the particle partial mass flow of one or more specific components of the particles, such as certain proteins or salts. In the former case, the total mass of the particle is taken into account for the measurement or determination of the mass flow, while in the latter case only the mass of this specific component or components of the particle is taken into account for the measurement or determination of the mass flow.
  • the mass Gl of the defined first particle size fraction PI may be the total particle mass or the particle mass of one or more specific components of the particles, such as e.g. certain proteins or salts act. In the former case, the total mass of the particle is taken into account for the measurement or determination of the mass, while in the latter case only the mass of this specific component or components of the particle is taken into account for the measurement or determination of the mass.
  • Particle number concentration, the particle number flow, the number of particles, the particle mass flow and the particle mass of aerosol particles are the
  • the measurement or determination can be made, for example, with a condensation nucleus counter or a scattered light counter or an impactor or a TEOM method or a quartz balance, a measuring device for particle size determination, preferably an optical particle counter
  • Duration spectrometer (aerodynamic particle classifier), an electric mobility spectrometer, a cascade impactor (mass determination via detection of electric current or quartz crystal balance) or a Combination of these devices, optionally in combination with a known to the expert analysis method for the determination of specific
  • Condensation core counters are known per se to those skilled in the art and are also commercially available.
  • Usual condensation nucleus counters have one
  • Humidification zone in which there is a container of liquid, and a condensation zone in which the particle growth takes place by the vapor of the humidification zone condenses on the particle surface.
  • This measuring method with condensation nucleus counter permits, in contrast to pure stray light particle counts, the detection of particles with diameters smaller than 0.1 ⁇ m. Particles smaller than 0.1 ⁇ be because of their low
  • condensation nucleus counters are commercially available. In many devices, however, the sampling volume flow at 0.11 rpm is so low that, given the overall low emission rates, the statistical reliability for the Recording the counting events can be negatively influenced. Furthermore, in the devices partly harmful vapors (such as butanol) are used, which then have to be filtered consuming. Moreover, commercial devices are expensive not least because of their high technical complexity for saturating the steam and subsequently controlled cooling.
  • the condensation nucleus counter used has no humidification zone (ie no container with liquid). It is therefore preferred that the increase in the particle diameter in the condensation nucleus counter essentially, more preferably exclusively by condensation of the
  • the condensation nucleus counter is mounted in a device having a tube with inhalation and Exhalationszweig. Preferred is in
  • Inhalationszweig the tube, preferably in Exhalationszweig the tube, a filter, preferably attached to an absolute filter.
  • absolute filter is used in the context of the present invention in its usual, the expert
  • an optical particle counter is used which counts the particles and classizes them. In addition to determining the size distribution of all exhaled particles in the measuring range of the meter allows such an optical particle counter and the selective detection of individual particle size fractions.
  • Optical particle counters count and classify particles according to their requirements
  • the aerosol flow passes through a sample chamber, through which a powerful light beam is projected.
  • the scattered light emitted by each individual particle is picked up by a receiving optical system and converted into a size class arrangement into a voltage pulse corresponding to the size of the detected particle.
  • Such devices are generally known to the person skilled in the art.
  • a scattered light counter e.g. a detection range over the intensity of the light beam of the transmitting optics and the selection of the detector or its
  • Detection threshold are set. This detection range can then be set so that it with the specified minimum diameter d m i n (Pl) and / or set maximum diameter d max (Pl) of the first
  • Condensation core counter with a diameter d m i n (Pl) corresponding lower detection limit and / or a fixed maximum diameter dmax (Pl) upper detection limit.
  • the measurement or determination of the particle number concentration Cl, the particle number flow Fl, the particle number Nl, the particle mass flow Ml or the particle mass G1 of the defined first particle size fractions PI of the exhalate is carried out by a condensation nucleus counter or a scattered light counter or another of the abovementioned measuring methods a lower detection limit equal to or less than the fixed diameter d m i n (Pl), or an upper detection limit equal to or greater than the specified maximum diameter d max (Pl), the minimum diameter d m i n (Pl) and / or the maximum diameter dmax (Pl) defined first particle size fraction PI of the exhalate by a suitable pre-separation or fractionation of the exhaled aerosol
  • FIG. 3 shows the time profile of the number flow F1 for differently defined particle size fractions PI.
  • Figure 3 shows the total number of flow of all the exhaled particles, and in the upper half the respiratory flow, the negative half wave indicating exhalation (i.e., exhalation).
  • exhalation i.e., exhalation
  • Particle size distribution i. the particle concentration or the
  • Particle number flow in individual size classes makes it possible to determine the number flow and the size distribution of the aerosols in the exhalation branch of the respiration.
  • the method further comprises:
  • a physical quantity for all particles of the exhalate or for at least one defined second particle size fraction P2 which is defined by a minimum diameter d m i n (P2) and a maximum diameter d max (P2), where and or wherein the physical quantity is selected from the particle number concentration C2, the particle number flow F2, the
  • the physical variable which is determined for all exhalate particles or the defined second particle size fraction P2 is preferably the same physical quantity which is also determined for the defined first particle size fraction PI.
  • the mass flow M2 may be the total particle mass flow or the mass flow M2
  • Particle mass flow of a specific component of the particles e.g.
  • the mass M2 may be the total particle mass or the particle partial mass of a specific component of the particles, such as certain proteins or salts. In the former case, the total mass of a particle is taken into account, while in the latter case only the mass of this specific component of the particle is taken into account.
  • Condensation core counter which detects the particles via a scattered light counter, in combination with another scattered light counter, the first
  • Scattered light counter is mounted in a region in which no growth in size of the particles has yet taken place by condensation of a vapor (e.g.
  • the first scattered light counter of the total number of exhaled particles only detects those with a diameter of at least 0.5 ⁇ , during the second scattered light counter and the fine particles below 0.5 ⁇ detected because at the end or after the condensation zone and the very small particles have grown to a diameter of more than 0.5 ⁇ and thus are detectable in the scattered light counter.
  • the determination of the detection range of a scattered light counter can be effected via the intensity of the light beam of the transmitting optics and the selection of the detector or its detection threshold. According to further preferred embodiments, the measurement or
  • the characteristic value can be determined by establishing a mathematical relationship comprising at least one of the physical quantities C1, F1, N1, G1 or M1 and at least one of the physical quantities C2, F2, N2, G2 or M2.
  • the values determined or measured for Cl, Fl, Nl, Gl or Ml and the values determined or measured for C2, F2, N2, G2 or M2 are then inserted into this mathematical relationship and a characteristic value is obtained.
  • this mathematical relationship may be a
  • FIGS. 4a-4d and 5 Such representations can be found in FIGS. 4a-4d and 5.
  • FIGS. 4a-4d show the ascertained characteristic values as a function of the already exhaled volume in the exhalation process.
  • the characteristic values were determined from the ratio of the number flow of the particles with a minimum diameter dmin (P1) of 0.5 ⁇ m to the total number flow of all exhaled particles. Furthermore, the figures still show the measured total number of currents.
  • FIG. 4a shows the progression of the characteristic values as a function of the exhaled volume for a healthy non-smoker
  • FIG. 4b top right
  • FIG. 4c bottom left
  • FIG. 4d bottom right
  • FIG. III shows the progression of the characteristic values as a function of the exhaled volume for a healthy non-smoker
  • FIG. 4b top right
  • FIG. 4c bottom left
  • FIG. 4d bottom right
  • stage III a subject with severe COPD
  • FIG. 5 shows the characteristic values, which were determined as the quotient of the total number of particles to the number of particles> 0.5 .mu.m.sup.-1 the entire exhalation process for different subjects, as a function of the vital capacity of the subjects.
  • Figure 6 shows the exhaled particle concentration and simultaneously the
  • Particle size ratio in the considered time interval as a function of the already exhaled volume in the exhalation process for a subject with moderate COPD.
  • Airway closures and thus be used to optimize the ventilation strategy to avoid ventilator-induced lung injury.
  • the exhalate can be replaced by a
  • Breath or alternatively be provided by several breaths. If the exhalation is provided by several breaths, it may be preferred that at least two different breathing patterns (different breathing depths or respiratory flow rates) are used.
  • the method can be carried out for one or more breathing patterns with one or more breaths, optionally with simultaneous measurement or determination of at least one respiratory physiological variable and / or at least one lung function parameter.
  • the measurement or determination of the abovementioned physical variables during a breath is preferably carried out several times at defined time intervals.
  • the method according to the invention can also be the measurement or determination of at least one lung function parameter and / or at least one
  • the measurement or determination of at least one pulmonary function parameter or a respiratory physiological parameter may e.g. by spirometry and / or
  • Bodyplethysmography done.
  • a pneumotachograph or acoustic volume flow meter e.g. an ultrasound spirometer, used.
  • these measuring methods are known in principle to the person skilled in the art.
  • the lung capacity TLC available for respiration may be used as appropriate lung function parameters or respiratory physiological parameters
  • Tidal tidal volume VT lung volume after respiratory distress after normal expiration FRC, lung volume at the end of expiration EELV, exhaled volume or respiratory flow rate.
  • FIGS. 4 and 6 the representation of the characteristic values was carried out by way of example as a function of the exhaled volume and in FIG. 5 as a function of the vital capacity.
  • the method according to the invention can also be used for the analysis of exhalate aerosol particles, preferably non-volatile substances, such as biological molecules (eg proteins, DNA / RNA, viruses, bacteria) or non-biological substances (eg metals, pharmaceutical agents).
  • non-volatile substances such as biological molecules (eg proteins, DNA / RNA, viruses, bacteria) or non-biological substances (eg metals, pharmaceutical agents).
  • FIGS. 7a and 7b The results of such an application of the method according to the invention are shown in FIGS. 7a and 7b.
  • FIG. 7b shows the optical density, determined by optical evaluation, of the individual samples as a function of the associated deposited number of particles. There is a clear increase in the optical density as the number of particles increases.
  • the process according to the invention is preferably a
  • Computer-aided method using a computing unit which is program-technically arranged so that on the basis of the measured or
  • the present invention preferably provides a computer program for carrying out the method described above and a data carrier with this computer program.

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Abstract

La présente invention concerne un procédé d'analyse d'un échantillon d'air expiré, ledit échantillon d'air expiré comportant des particules ayant un diamètre minimal dmin(échantillon d'air expiré) et un diamètre maximal dmax(échantillon d'air expiré), comprenant la mesure ou la détermination d'au moins une grandeur physique d'une première fraction de tailles de particule définie P1 de l'échantillon d'air expiré, ladite grandeur physique étant choisie parmi la concentration en nombre de particules C1, le débit en nombre de particules F1, le nombre de particules N1, le débit en masse de particules M1, la masse de particules G1 ou leurs combinaisons, la première fraction de tailles de particule P1 étant définie par un diamètre minimal dmin(P1) et un diamètre maximal dmax(P1) tels que dmin(P1) > dmin(échantillon d'air expiré) et/ou dmax(P1) < dmax(échantillon d'air expiré).
PCT/EP2012/061342 2011-06-17 2012-06-14 Procédé d'analyse de l'air expiré Ceased WO2012172011A1 (fr)

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DE102011077772.5 2011-06-17
DE102011077772.5A DE102011077772B4 (de) 2011-06-17 2011-06-17 Verfahren zur Analyse der Ausatemluft

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2248464A1 (fr) 2009-05-07 2010-11-10 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Utilisation du courant quantitatif de particules générées de manière endogène dans l'air d'expiration de l'homme pour le diagnostic de maladies des poumons

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2701352A1 (fr) * 2007-10-02 2009-04-09 Ann-Charlotte Almstrand Recuperation et mesure de particules exhalees

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2248464A1 (fr) 2009-05-07 2010-11-10 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Utilisation du courant quantitatif de particules générées de manière endogène dans l'air d'expiration de l'homme pour le diagnostic de maladies des poumons

Non-Patent Citations (3)

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Title
HOLMGREN H ET AL: "Size distribution of exhaled particles in the range from 0.01 to 2.01/4m", JOURNAL OF AEROSOL SCIENCE, PERGAMON, AMSTERDAM, NL, vol. 41, no. 5, 1 May 2010 (2010-05-01), pages 439 - 446, XP027003156, ISSN: 0021-8502, [retrieved on 20100226] *
KATHARINA SCHWARZ ET AL: "Characterization of Exhaled Particles from the Healthy Human Lung-A Systematic Analysis in Relation to Pulmonary Function Variables", JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY, 25 May 2010 (2010-05-25), pages 371 - 379, XP055037541, Retrieved from the Internet <URL:http://online.liebertpub.com/doi/pdf/10.1089/jamp.2009.0809> [retrieved on 20120907], DOI: 10.1089/jamp.2009.0809 *
MORAWSKA L ET AL: "Size distribution and sites of origin of droplets expelled from the human respiratory tract during expiratory activities", JOURNAL OF AEROSOL SCIENCE, PERGAMON, AMSTERDAM, NL, vol. 40, no. 3, 1 March 2009 (2009-03-01), pages 256 - 269, XP025947079, ISSN: 0021-8502, [retrieved on 20081118], DOI: 10.1016/J.JAEROSCI.2008.11.002 *

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