WO2020249749A1 - Piège à humidité pour un dispositif mesurant un composant dans l'air expiré - Google Patents

Piège à humidité pour un dispositif mesurant un composant dans l'air expiré Download PDF

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Publication number
WO2020249749A1
WO2020249749A1 PCT/EP2020/066333 EP2020066333W WO2020249749A1 WO 2020249749 A1 WO2020249749 A1 WO 2020249749A1 EP 2020066333 W EP2020066333 W EP 2020066333W WO 2020249749 A1 WO2020249749 A1 WO 2020249749A1
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WIPO (PCT)
Prior art keywords
moisture trap
moisture
mouthpiece
desiccant
patient
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Application number
PCT/EP2020/066333
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English (en)
Inventor
Bal JOHAL
Helen Westbrook
Original Assignee
Circassia Ab
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Filing date
Publication date
Application filed by Circassia Ab filed Critical Circassia Ab
Publication of WO2020249749A1 publication Critical patent/WO2020249749A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording 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
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D53/00—Separation of gases or vapours; Recovering vapours of volatile solvents from gases; Chemical or biological purification of waste gases, e.g. engine exhaust gases, smoke, fumes, flue gases, aerosols
    • B01D53/26—Drying gases or vapours
    • B01D53/261—Drying gases or vapours by adsorption

Definitions

  • the present disclosure relates to the field of diagnostic measurement of endogenous nitric oxide (NO) in exhaled breath, devices for performing such measurements, and in particular to a moisture trap for preventing the build-up of condensate in such devices.
  • NO endogenous nitric oxide
  • NIOX ® (AEROCRINE AB, Sweden) was the first tailor-made NO analyser for routine clinical use with asthma patients. This first device, which was based on chemiluminescence for the detection of nitric oxide, has been followed by NIOX MINO ® (CIRCASSIA AB, Sweden) and VERO ® (CIRCASSIA AB, Sweden), both based on electrochemical detection.
  • Endogenous NO is present in trace quantities in exhaled air, low values being 25 ppb (parts-per-billion) or less. Values between 25 ppb and 50 ppb should be interpreted cautiously and with reference to the clinical context, whereas values over 50 ppb are held to indicate eosinophilic inflammation or asthma. When detecting and quantifying so low concentrations, the sensitivity and accuracy of measurement becomes paramount and variations in for example temperature, humidity, and flow can influence the measurement.
  • FeNO FeNO have built-in pressure sensors / flow sensors.
  • One example is the use of differential pressure transducers, where the pressure drop across an orifice or constriction in a flow channel is measured and the flow rate calculated. The flow rate of the patient exhalation is measured, and the patient can receive feed-back which assists in maintaining the exhalation flow within the required interval (50 ml/s ⁇ 5 ml/s). Performing a correct exhalation into the device however requires some practice. While some patients manage already on the first or second try, others require repeated attempts before a successful measurement is achieved.
  • Exhaled breath contains water vapour.
  • the average amount of water vapour in a ten second exhalation at 24 °C at 60 % relative humidity (RH) is 448 pg. If a patient has difficulties performing a correct exhalation, and needs to try again and again, the same patient will exhale humid breath into the device repeatedly within a short period of time, which may result in the build-up of moisture in the device.
  • Electrochemical sensors for detecting nitric oxide frequently have a certain cross-sensitivity for CO2, which increases with reduced moisture in the sample. In fact, some sensors need at least 20 % RH to function correctly.
  • the present disclosure makes available a new, practical and surprisingly effective solution to the aforementioned problems.
  • a moisture trap adapted for use with a device for diagnostic measurement of nitric oxide (NO) in exhaled breath said device comprising a handpiece for receiving exhaled breath, a channel leading from said handpiece into said device, a flow sensor and/or a pressure sensor measuring the flow and/or pressure of exhaled breath in said channel, and a sensor or sensing element that produces a detectable signal corresponding to the concentration of nitric oxide in said exhaled breath, wherein said moisture trap comprises a particle filter material (8) and a desiccant material (10), wherein said desiccant is arranged next to said particle filter material and adapted for positioning inside a mouthpiece or patient filter, or between said mouthpiece and said channel, for example adjacent to said mouthpiece.
  • NO nitric oxide
  • the desiccant material is chosen from molecular sieves, bentonite clay, silica gel beads, silica gel grains, granules or particles, and combinations thereof.
  • the amount of desiccant material is dependent on the type of material, but is preferably chosen in the interval of 0.1 g to 20 g, more preferably about 1 g to about 10 g, and most preferably about 1 - 5 g.
  • the particle filter material is chosen from natural and synthetic fibers, such as but not limited to cellulose, polypropylene and glass fiber materials, or combinations thereof.
  • the particle filter material encloses said desiccant material forming a composite filter pad.
  • the moisture trap includes a perforated foil on at least one side, the perforations arranged to distribute the flow of exhaled breath evenly through the filter.
  • the moisture trap has a perforated foil on both sides thereof, the perforations being arranged substantially around the periphery of one foil, and substantially in the centre of the other foil.
  • the foil is made of metal or polymer.
  • the moisture trap is adapted for placement between a patient filter / mouthpiece and a handpiece. [021] According to yet another embodiment, freely combinable with the above, the moisture trap is integrated into a patient filter / mouthpiece.
  • the moisture trap is a single use item, intended for use with one patient and discarded after use.
  • Figure 1 is a photograph showing one example of a device for diagnostic
  • FIG. 2 (a) and (b) show an example of a patient mouthpiece 4, in two perspective views, where (a) shows an opening 5 which the patient can close his/her lips around, and exhale into. In the second view (b) the inside of said mouthpiece is shown, illustrating lugs 6 for engaging with the handle.
  • the exact design of a mouthpiece can vary, but it needs to fill the basic function of offering a hygienic, single-use interface for the patient to breath into, preventing cross-contamination of the device and the transmission of disease between patients.
  • Fig. B shows schematically a moisture trap 9 according to an aspect of the present invention, here a bag or pouch of a filter material 8 shown in cross-section containing a desiccant material 10 in granulate or particulate form.
  • FIG. 4 shows schematically an exploded view of another a moisture trap 90 according to an aspect of the present invention, where a filter material bag 8 is surrounded by two perforated foils, where on one foil 11 a number of perforations 12 are arranged around the perimeter of the foil, while on another foil 14 a number of perforations 15 are positioned near the centre.
  • the perforations are not drawn to scale, and the exact number, size and position of the perforations may vary.
  • Fig. 5 shows a moisture trap 900 according to an embodiment, where an outer layer of filter material covers the foil on one or both sides of the moisture trap, here shown by layers 16 and 17, which may be of the same material, or different.
  • FIG. 6 shows a cross-section of a moisture trap 90, where a flow path is indicated by white arrows, entering through a peripheral perforation 12 of foil 11, passing through the filter material 8 and the desiccant 10, and exiting through a central perforation 15 of foil 14.
  • Fig. 7 is a graph illustrating the build-up of moisture during use of a test set-up simulating the use of an apparatus for the diagnostic measurement of NO.
  • Time is plotted along the x-axis where the brackets indicate the duration of exhalations, typically 10 sec.
  • One shorter, unsuccessful exhalation is indicated with *.
  • the relative humidity is plotted along the y-axis, and a moisture limit shown as a horizontal dotted line.
  • the dotted curve to the left and the dashed curve to the right show the moisture build-up at 85 % RH and 60 % RH respectively. At the higher humidity, the accumulated moisture reaches a pre-set limit already after three successful and one unsuccessful exhalation.
  • Fig. 8 is a graph showing the weight increase of different desiccant arrangements normalised for 360 uses.
  • the two uppermost curves correspond to 19 g and 14.3 g of desiccant, and the three lower curves correspond to 1 g, 2.7 g, and 2.8 g of desiccant.
  • the results show that while a high amount of desiccant exhibits the largest and most enduring weight increase, also a small amount works well. Here, already 1 g of desiccant works well.
  • Fig. 9 schematically shows, in partial cut-out view, how a handle 2, 200 having a mouthpiece 4, 400, holds a moisture trap 9, 90, 900.
  • the handle is connected to a tube 3, 300 leading to a device 1, 100 for diagnostic measurement of endogenous nitric oxide (NO) in exhaled breath, comprising a pressure sensor 110 and a sensor or element 120 for the detection and quantification of NO.
  • NO endogenous nitric oxide
  • mouthpiece is here used to describe the physical interphase between a patient and an apparatus for measuring endogenous NO in exhaled breath. When performing a test, the patient exhales into said mouthpiece. A mouthpiece is for single-use and discarded when the patient has performed successful exhalations and a FeNO value has been obtained.
  • the term "handle” or “handpiece” refers to an element of a set-up for diagnostic measurement of endogenous nitric oxide (NO) in exhaled breath, which a patient can comfortably hold when exhaling.
  • the handle constitutes a physical interface between the patient and the device, in that the handle holds in one end a mouthpiece or patient filte, and in the other end connects to the device for NO measurement.
  • the present disclosure makes available a moisture trap (9, 90, 900) adapted for use with a device (1) for diagnostic measurement of nitric oxide (NO) in exhaled breath said device comprising a handpiece (2) for receiving exhaled breath, a channel (3) leading from said handpiece into said device (1), a flow sensor and/or a pressure sensor (110) measuring the flow and/or pressure of exhaled breath in said channel, and a sensor or sensing element (120) that produces a detectable signal corresponding to the concentration of nitric oxide in said exhaled breath, wherein said moisture trap (9, 90, 900) comprises a particle filter material (8) and a desiccant material (10), wherein said desiccant is arranged next to said particle filter material and adapted for positioning inside a mouthpiece or patient filter (4), or between said mouthpiece (4) and said channel (3).
  • a moisture trap (9, 90, 900) comprises a particle filter material (8) and a desiccant material (10), wherein said desiccant is arranged next to
  • nitric oxide can be one of many different types of sensors or sensing elements, the most preferred being an electrochemical sensor.
  • Other techniques for detecting and quantifying nitric oxide include chemiluminescence, ultrasonic sensors, graphene-hemin sensors, optical / colorimetric sensors based on e.g. solgel- trapped reagents changing color in the presence of nitric oxide.
  • said desiccant material is chosen from molecular sieves, bentonite clay, silica gel beads, silica gel grains, granules or particles, and combinations thereof.
  • the desiccant material is a food grade silica gel material, either in bead, grain or granular form.
  • Silica gel is available in many different qualities from numerous suppliers, for example from Sigma-Aldrich ® (MERCK KGaA, Darmstadt, Germany).
  • the amount of desiccant material is dependent on the type of material, but is preferably chosen in the interval of 0.1 g to 20 g, more preferably about 1 g to about 10 g, and most preferably about 1 - 5 g. Surprisingly, already a small amount of desiccant material, such as 1 g of a food grade silica gel desiccant, proved to be effective.
  • said particle filter material is chosen from natural and synthetic fibers, such as cellulose, polypropylene and glass fiber materials, or combinations thereof.
  • the filter material can be a woven or non-woven material, for example a woven or non-woven fabric, a filter paper or a porous membrane.
  • Particle filter materials are available from different suppliers, for example GVS Filtration Inc., Findlay, OH, USA.
  • said particle filter material (8) encloses said desiccant material (10) forming a composite filter pad (9).
  • the particle filter can be shaped as a bag or pouch, and folded, glued or hot melted to form a closed pad containing the desiccant material.
  • Two round pieces of filter material can be joined at the edges, for example glued or heat sealed to form a pad enclosing the desiccant material.
  • the filter material can also be bonded across the pad in a quilt-like fashion, minimizing movement of the desiccant material.
  • said moisture trap (90, 900) includes a perforated foil (11, 14) on at least one side, the perforations arranged to distribute the flow of exhaled breath evenly through the filter.
  • said moisture trap (90, 900) has a perforated foil (11, 14) on both sides, the perforations (12, 15) being arranged substantially around the periphery of one foil, and substantially in the centre of the other foil.
  • Said holes can be punched or laser cut using techniques well known to a person skilled in the art. The exact size, number and placement of the holes can be optimized to distribute the flow of exhaled air through the entire volume of desiccant material.
  • the holes on one foil are offset in relation to the holes on the other foil, extending the flow path of the airflow through the filter pad.
  • said foil is made of metal or polymer, for example aluminium foil or a plastic foil.
  • said moisture trap (9, 90, 900) according to claim 1, adapted for placement between a patient filter / mouthpiece (4) and a handpiece (2).
  • the moisture trap (9, 90, 900) according to any of the above
  • a patient filter / mouthpiece (4) is integrated into a patient filter / mouthpiece (4).
  • the patient filter / mouthpiece comes with a moisture trap in place, and that the user only needs to affix one item to the handle before performing or instructing a patient to perform the exhalation.
  • the filter material (8) and optionally the foil or foils (11, 14) and optionally the filter or filters (16, 17) can seal against the inside of the patient filter along the periphery of the moisture trap.
  • Integrated can also mean that the moisture trap is a separate entity, but that it is inserted into the mouthpiece, for example pressure-fitted or snap-fitted into the
  • the layer on the proximal side of the moisture trap (900) serves to capture droplets of moisture condensing on the foils, and in particular on the first perforated foil (11).
  • the moisture trap is a single use item, intended for use with one patient only and discarded after use.
  • the moisture trap is preferably produced in a sanitary and dry environment, and then assembled and enclosed in water-tight packaging, preferably a polymer film, a metallized polymer film or the like, to guarantee the hygiene and sufficient shelf-life of the moisture trap.
  • water-tight packaging preferably a polymer film, a metallized polymer film or the like.
  • the exhalation phase is only 10 seconds. It was shown by the inventors that, during exhalation, only a fraction of the moisture in the exhaled air is absorbed by the desiccant. Instead, the moisture condensates on the surfaces of the handpiece, and when the perforated foils are included in the moisture trap, on the surfaces of these foils. However, as the inventive moisture trap is arranged adjacent to the handpiece, this condensed moisture will be absorbed by the desiccant material after conclusion of the exhalation, when the device measures and calculates the concentration of nitric oxide in the exhaled breath.
  • This phase after the patient has exhaled into the device, through the mouthpiece and the handpiece, can last 30 seconds or longer.
  • the mouthpiece with the moisture trap is left in place until a successful exhalation has been performed, and the result (the measured NO concentration) displayed.
  • the moisture trap surprisingly acts to dry the inner surfaces of the handpiece, where moisture has condensed during the exhalation. This is a major advantage, as the condensed moisture is a more serious problem than the moisture as such.
  • the moisture forms droplets which can travel in the flow channel / tubing and risk blocking and ultimately damaging
  • the moisture trap thus surprisingly serves multiple functions, both as a particle filter protecting the patient during inhalation, and "protecting" the device when the patient exhales, and the desiccant sandwiched between two layers of filter material serves to dry - to some extent - the exhalation air, but importantly also serves to absorb and thus dry out the handpiece after the exhalation itself, between subsequent exhalations.
  • the moisture trap does not completely dry out the exhaled breath, which is an advantage as at least one type of sensors, the electrochemical sensors, require about 20 % RH for proper function.
  • the moisture trap is easy to remove and replace, and also economical to manufacture.
  • the particle filter / patient filter creates a barrier between the device and the patient, preventing any transfer of bacterial or viruses via the device.
  • the filter material also fills a dual function as filter and as holder or envelope for the desiccant material. This makes it possible to replace currently used commercial patient filters with the combined filter and desiccant assembly with no or minimal alterations of the mouthpiece.
  • the small desiccant volume makes it possible to include the inventive moisture trap in existing mouthpieces without any significant alteration of their design.
  • a mechanical dew catcher was constructed by BD-printing and assembling parts creating a convoluted flow path and a condensation chamber.
  • the dew catcher was connected to the tube 3 between the handle 2 and the body 1 of a device (a NIOX VERO ® , shown in Fig. 1).
  • 20 dew catchers were tested in clinical use and found to function as intended, i.e. a significant quantity of moisture was collected in the condensation chamber.
  • This experimental mechanical dew catcher however had to be opened, emptied and cleaned daily. The emptying and cleaning received very negative feedback from the users. Due to a potential biohazard risk, special care was necessary when emptying and disposing of the collected moisture.
  • a test set-up was constructed as follows: A NIOX VERO ® handle and mouthpiece was connected to a sealed climate chamber producing moist, warm air at approx. 35 °C and 97 % RH to simulate a patient's breath. A vacuum pump was used to draw air at a constant rate of 3 l/min, the flow adjusted manually using a flow meter and a finely adjustable flow control. Directly when exiting the handle and mouthpiece, the flow of moist air was led into a cooled condensate collection chamber. A standard "breath” or device “use” was taken to be 10 seconds in duration, as per current NIOX VERO ® user manual.
  • a timer was used to ensure that the duration of flow was equivalent to the number of exhalations required by each individual test.
  • Different moisture traps containing different amounts of desiccant were inserted in a mouthpiece, modified when necessary, and attached to the handle.
  • the handle, tube and moisture traps were weighed before and after 40, 60, 120 and 180 seconds of continuous flow, and after completion of the experiment, and the weight increase taken as a measure of their effectiveness.
  • Silica gel (SiCh) was tested in the form of grains or beads having a bead size of 1.4 - 3.0 mm (Clariant Co., Charlotte, NC, USA). The beads are bright orange when dry and turn dark blue when fully saturated with moisture.
  • the combined mouthpiece and patient filter are intended to be used by one patient only and discarded after use. As it is likely to be used for a maximum of 5 - 10 exhalations, even assuming that occasional patients have difficulties performing a correct exhalation, it was investigated if the amount of desiccant could be minimized. It was seen that for the first 100 seconds, corresponding to 10 uses, the performance of a moisture trap assembly containing only 0.9 g desiccant was practically equal to that of 19.0 g desiccant.
  • a humidity sensor (Binder GmbH, Tuttlingen, Germany) was connected downstream in the experimental set-up described in Example 2, using a moisture trap including 2.6 g desiccant. The humidity in the system was measured every 20 seconds for 6 minutes at a flow of 3 l/min. The result showed that the RH rises continuously even though the desiccant unit is extracting moisture from the air upstream of the measurement point. The results show that inclusion of a moisture trap including desiccant does not make the air reaching the electrochemical sensor too dry. In fact, the use of a desiccant ensures helps to stabilize the RH in the air reaching the sensor.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
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  • Public Health (AREA)
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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Un piège à humidité comprend un matériau de filtre (8) et un matériau déshydratant (10) conçu pour être positionné à l'intérieur d'un embout buccal de patient à usage unique (4). Ledit dispositif peut en outre comprendre une feuille perforée (11, 14) distribuant le flux d'air exhalé à travers le matériau déshydratant. Le piège à humidité peut être un article séparé ou une partie intégrée d'un embout buccal de patient.
PCT/EP2020/066333 2019-06-14 2020-06-12 Piège à humidité pour un dispositif mesurant un composant dans l'air expiré WO2020249749A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201920897780.2 2019-06-14
CN201920897780.2U CN211927449U (zh) 2019-06-14 2019-06-14 一种水分捕获设备

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023041846A1 (fr) * 2021-09-15 2023-03-23 Lifa Air Oyj Appareil de déshumidification amélioré pour tester des maladies respiratoires

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993005709A1 (fr) 1991-09-27 1993-04-01 Lars Erik Gustafsson Procede et dispositif d'examen de l'etat des poumons
WO1995002181A1 (fr) 1993-07-06 1995-01-19 Kjell Alving Systeme permettant de determiner les niveaux de no dans l'air expire et methodes de diagnostic des troubles lies a des niveaux de no anormaux
WO2004058125A2 (fr) 2002-12-20 2004-07-15 The Charlotte-Mecklenburg Hospital Authority Dispositif portatif jetable pour la collecte d'un condensat d'air exhale
US20120065535A1 (en) * 2009-04-08 2012-03-15 Klaus Abraham-Fuchs Gas analysis apparatus having a combination of gas dehumidifier and gas converter
US20150201865A1 (en) * 2012-09-28 2015-07-23 Arizona Board Of Regents On Behalf Of Arizona State University Mouthpiece for accurate detection of exhaled no
WO2017153755A1 (fr) 2016-03-08 2017-09-14 University Of Northumbria At Newcastle Dispositif de collecte de condensat d'air expiré et son kit de pièces
US20180056302A1 (en) * 2010-03-19 2018-03-01 Invoy Technologies, Llc Sensor for analytes in a fluid and related method
US20180146886A1 (en) * 2016-11-28 2018-05-31 Spirosure, Inc. Handpiece for Respiratory Monitor

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Publication number Priority date Publication date Assignee Title
WO1993005709A1 (fr) 1991-09-27 1993-04-01 Lars Erik Gustafsson Procede et dispositif d'examen de l'etat des poumons
WO1995002181A1 (fr) 1993-07-06 1995-01-19 Kjell Alving Systeme permettant de determiner les niveaux de no dans l'air expire et methodes de diagnostic des troubles lies a des niveaux de no anormaux
WO2004058125A2 (fr) 2002-12-20 2004-07-15 The Charlotte-Mecklenburg Hospital Authority Dispositif portatif jetable pour la collecte d'un condensat d'air exhale
US20120065535A1 (en) * 2009-04-08 2012-03-15 Klaus Abraham-Fuchs Gas analysis apparatus having a combination of gas dehumidifier and gas converter
US20180056302A1 (en) * 2010-03-19 2018-03-01 Invoy Technologies, Llc Sensor for analytes in a fluid and related method
US20150201865A1 (en) * 2012-09-28 2015-07-23 Arizona Board Of Regents On Behalf Of Arizona State University Mouthpiece for accurate detection of exhaled no
WO2017153755A1 (fr) 2016-03-08 2017-09-14 University Of Northumbria At Newcastle Dispositif de collecte de condensat d'air expiré et son kit de pièces
US20180146886A1 (en) * 2016-11-28 2018-05-31 Spirosure, Inc. Handpiece for Respiratory Monitor

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Title
"Am J Respir Crit Care Med", vol. 160, 1999, MEDICAL SECTION OF THE AMERICAN LUNG ASSOCIATION, article "Recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide in adults and children", pages: 2104 - 2117
THE EUROPEAN RESPIRATORY JOURNAL PUBLISHED GUIDELINES (ERS TASK FORCE REPORT, vol. 10, 1997, pages 1683 - 1693

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023041846A1 (fr) * 2021-09-15 2023-03-23 Lifa Air Oyj Appareil de déshumidification amélioré pour tester des maladies respiratoires

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