EP1409985A1 - Verfahren und einrichtung zum abnehmen und analysieren von ausgeatmetem atem - Google Patents

Verfahren und einrichtung zum abnehmen und analysieren von ausgeatmetem atem

Info

Publication number
EP1409985A1
EP1409985A1 EP01934950A EP01934950A EP1409985A1 EP 1409985 A1 EP1409985 A1 EP 1409985A1 EP 01934950 A EP01934950 A EP 01934950A EP 01934950 A EP01934950 A EP 01934950A EP 1409985 A1 EP1409985 A1 EP 1409985A1
Authority
EP
European Patent Office
Prior art keywords
collecting tube
condensate
valve
tube
collecting
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.)
Withdrawn
Application number
EP01934950A
Other languages
English (en)
French (fr)
Other versions
EP1409985A4 (de
Inventor
Alfred R. Baddour
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.)
Respiratory Research Inc
Respiratory Res Inc
Original Assignee
Respiratory Research Inc
Respiratory Res Inc
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 Respiratory Research Inc, Respiratory Res Inc filed Critical Respiratory Research Inc
Publication of EP1409985A1 publication Critical patent/EP1409985A1/de
Publication of EP1409985A4 publication Critical patent/EP1409985A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/22Devices for withdrawing samples in the gaseous state
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/497Physical analysis of biological material of gaseous biological material, e.g. breath
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/0004Gaseous mixtures, e.g. polluted air
    • G01N33/0009General constructional details of gas analysers, e.g. portable test equipment
    • G01N33/0011Sample conditioning
    • G01N33/0014Sample conditioning by eliminating a gas

Definitions

  • the subject invention relates generally to a method and device for determining medical conditions, and, more particularly to a method and device for condensing, storing, transporting, degassing and analyzing exhaled breath.
  • the collecting tube is inserted into an ice bucket or may even be separately cooled by refrigeration systems in order to increase the amount and speed of condensate formation.
  • use of a Teflon® collecting tube has been tried to make the tube walls more slippery to enhance the speed and amount of condensate collected. All of these arrangements tend to be either expensive, complicated, ineffective, bulky, inefficient or time-consuming to use.
  • other condensate collecting and testing devices generally do not provide the ability in a single device both to quickly and efficiently collect condensate while also delivering test substances such as gases or liquids into the condensate without contamination.
  • such devices are not typically portable and do not lend themselves easily to use by patients in their own homes.
  • Another disadvantage of devices of the prior art is that they usually do not enable patients to collect condensate samples, prepare those collected samples for testing and then also perform certain tests themselves on the samples.
  • the present invention relates to a device and method for collecting condensate from air exhaled by a subject user.
  • the device comprises a mouthpiece, a filter housing, a hollow condensate collecting tube, a movable valve inserted within the collecting tube, a cooling sleeve for placement over the collecting tube, means for moving the valve through the collecting tube and a removable airtight cap.
  • the cooling sleeve is cooled to a temperature lower than that of the collecting tube prior to being slid thereover, air is inhaled by a subject user through the mouthpiece and exhaled through the movable valve into the collecting tube.
  • the cooling sleeve is removed from around the collecting tube, the movable valve is advanced through the tube thereby wiping away condensate formed on the interior walls of the tube causing that condensate to collect in a pool around the valve.
  • an airtight cap may be placed over the end of the collecting tube nearest the condensate pool in order to seal the collecting tube prior to storage and/or shipment to a testing location.
  • the airtight cap is removed and one or more gasses or liquids is introduced into the condensate through the unique structure of the valve as called for by the particular test to be performed on the condensate.
  • gas is introduced into the condensate in order to remove carbon dioxide and permit the acidity level of the condensate to be reproducibly measured. Testing may be performed after removing samples of the condensate from the collecting tube or by means of a probe placed into contact with the condensate pool or by insertion of chemicals or chemically impregnated strips. It is a primary objective of this invention to provide a simple self-contained and portable device for efficiently collecting, storing and shipping condensate derived from the exhaled breath of a subject wherein the wettable components of such a device may be disposable.
  • An additional objective of this invention is to provide a method for collecting condensate derived from the exhaled breath of a subject which is fast, simple, efficient and performable by nonprofessional personnel.
  • a further objective of this invention is to provide a device and method in which condensate samples collected from the exhaled breath of a user may be both collected and subjected in situ to various laboratory tests, including ones for measuring pH levels, without the risk of contamination by exposure to influences external to a collecting tube.
  • a yet additional objective of this invention is to provide a condensate collecting device which may be made available for use in a patient's home or workplace.
  • a further objective of this invention is to provide a device in which condensate may be collected, stored and transported in a single unit.
  • Still another objective of this invention is to provide a condensate collecting device which makes septuple use of a valve within the device for preventing the admission of air from a condensate collecting tube during inhalation, admitting exhaled air into the condensate collecting tube, making airflow turbulent, swiping condensate off the interior walls of the tube, preventing efflux of condensate, retaining the condensate in a pool within the tube and channeling gasses or liquids into the condensate.
  • Yet another objective of this invention is to provide a simple and efficient method for deaerating or degassing collected condensate.
  • Still a further objective of this invention is to provide a malleable duckbill valve having an elliptical cross-section for placement within a non-malleable tube having a circular cross-section so that a seal is made in the duckbill valve without a pressure gradient across the valve.
  • a yet additional objective of this invention is to provide a one-way malleable duckbill valve for placement within a condensate collecting tube which encourages turbulent airflow as a subject's exhaled breath passes through.
  • Another objective of this invention is to provide a hollow duckbill valve permitting a mechanical seal to be obtained between the valve and the nose portion of a probe inserted into the hollow center of the valve.
  • Yet a further objective of this invention is to provide a hollow duckbill valve incorporating one or more passageways through which gasses or fluids will flowwhen the valve is subjected to particular mechanical stresses.
  • An additional objective of this invention is to provide a device with built-in protection for passersby against possible release into the atmosphere of microbes from the lungs of the user of the device.
  • FIG. 1 is a center cross-sectional view of the device of the invention
  • FIG. 2 is a center cross-sectional view of the individual components of the device of the invention in a disassembled state
  • FIG. 3 is a center cross-section view of the duckbill valve of this invention before insertion into a collecting tube along a plane perpendicular to the walls of a collecting tube
  • FIG. 4 is a center cross-sectional view of the duckbill valve of this invention along line A- A of FIG. 3;
  • FIG. 5 is a side view of the duckbill valve of this invention
  • FIG. 6 is a center cross-sectional view of a collecting tube into which a probe has been inserted behind a duckbill valve.
  • FIG. 7 is a center cross-sectional view of a collecting tube into which gas has been introduced under pressure to degas/deaerate condensate;
  • FIG. 8 is a schematic of equipment used in performing a second method of degassing/deaerating.
  • the device of the invention is intended to be used to condense the water normally exhaled in breath by a human subject and to gather this water in such a manner and in such volume that tests may be performed on the condensate. These tests include measuring acidity, ammonia concentration, as well as the concentration of other characteristics, chemicals and compounds of biologic interest. It may be used by an unskilled layperson, then sealed for transport to a laboratory where subsequent analysis may be performed. Alternatively, the device may also function as part of a home- or workplace-diagnostic device constructed to accept the device and perform the required measurements automatically. Additionally, it may be used in any setting without additional devices, by adding chemical reagents or test strips to detect chemical features and compounds of interest. For a better understanding of the invention, reference is now made to FIG.
  • Mouthpiece 15 may be a generally tubular T-shaped device with three open projections. On one end, mouthpiece 15 has a generally oblong projection 20 designed to be comfortably inserted between a subject user's lips.
  • the opposite end projection 25 may be generally tubular in shape, is open to the atmosphere and includes a check valve 30 situated nearby for admitting ambient air from the atmosphere through projection 25 into a subject user's mouth and lungs and for preventing an outflow of air through projection 25 during the exhalation process.
  • Projection 35 is sized so as to be removably insertable into one end of optional filter housing 40 and to be retained therein by virtue of friction between the walls of the exterior of projection 35 and the walls of the interior of the end of filter housing 40 into which it is inserted.
  • projection 35 can be placed in direct intimate contact with the inner or outer surface of collecting tube 60, and retained there by virtue of friction.
  • check valve 30 closes and forces exhaled breath to flow through projection 35.
  • Optional filter housing 40 may comprise a tube-like structure open on both ends and having a filter compartment disposed in the approximate middle thereof separating the two openings 45 and 50 of the tube. Opening 45 on one end of filter housing 40 is sized so as to receive projection 35 from mouthpiece 15.
  • Optional filter housing 40 includes an optional filter assembly 55.
  • the filter compartment and filter are circular and have a diameter of approximately four times the diameter of opening 50, although other configurations and relative dimensions may be used. Different pore size of the filter might be chosen to limit passage of particles to sizes of particular interest. As particle size might relate to site of formation or other features relevant to the airway, this optional filtering is a useful feature.
  • Optional filter assembly 55 in general functions to remove larger particles from exhaled breath prior to its entering collecting tube 60 and, depending on the filter chosen, also serves to prevent egress of infectious particles in the atmosphere during exhalation. This feature protects passersby from microbes possibly release from the lung of a subject during use of the device.
  • the structure of mouthpiece 15 serves a similar function by substantially reducing the number of salivary droplets which enter optional filter housing 40 or collecting tube 60.
  • Collecting tube 60 is a straight plastic tube open on both ends with a circular cross-section and may have a length of between approximately 3 inches and 20 inches, preferably about 8.75 inches, and a diameter of approximately Vi inch and at most approximately 2 inches, preferably about .875 inches. With tubes smaller than l inch in diameter, exhaling becomes difficult for the subject user, while with tubes larger than 2 inches in diameter, condensation efficiency is low. Regardless of the exact dimension used, the diameter of collecting tube 60 may be slightly smaller than that of opening 50 in filter housing 40, or alternatively smaller than that of projection 35, so as to fit retentively within the corresponding neck of filter housing 40 encompassing opening 50 or within projection 35.
  • the diameter of collecting tube 60 may be slightly larger than that of opening 50, or projection 35, so that the neck of filter housing 40 including opening 50, or alternatively projection 35, may be securely and retentively inserted inside one end of collecting tube 60.
  • Collecting tube 60 may also be constructed from other materials such as stainless steel, anodized aluminum, Teflon® and various types of plastics, and functions to collect, condense and store vaporized and aerosolized particles from breath exhaled thereinto.
  • the exterior of collecting tube 60 may incorporate a writable surface for subject users to identify samples with an indelible marker or other suitable writing instrument.
  • a label with named fields for information could be used or bar coding or other scannable data with identifying or destination information could be imprinted on collecting tube 60 prior to delivery.
  • Duckbill valve 65 is inserted into the lower end of collecting tube 60 a distance of approximately ⁇ inch and remains in a closed position when the device is not in use.
  • Duckbill valve 65 may be comprised of rubber or rubber-like elastomeric materials, or plastics which approximate or behave as elastomers, and functions to prevent the passage of air from the end 75 of collecting tube 60 exposed to the atmosphere during the inhaling process described below using mouthpiece 15 and to admit breath from a subject user into collecting tube 60 during the exhaling process, also described below. Its structure and function also prevent the condensate collected in collecting tube 60 from escaping during and after the breath condensate collection procedure.
  • Cooling sleeve 70 is a hollow tube sized to slide over collecting tube 60 and place the inner walls of cooling sleeve 70 into physical contact or at least close physical proximity with collecting tube 60 shortly prior to and during practice of the method of this invention. Cooling sleeve 70 may be slightly shorter than collecting tube 60 and, when in place, should not extend to a greater height than collecting tube 60. Cooling sleeve 70 may be constructed of a material such as aluminum or any high specific heat, durable, reusable material which does not deteriorate when wet and tends to retain and maintain a low temperature when cooled. In one preferred embodiment, the cooling sleeve might be a container in which chemicals can be mixed that create an endothermic reaction, thus providing substantial cooling.
  • cooling sleeve 70 When placed in position surrounding collecting tube 60 as required for practice of the method of this invention, cooling sleeve 70 functions to draw heat from the inner surface of collecting tube 60, as will be described below, so as to accelerate the condensing process occurring within the tube.
  • collecting tube 60 when properly positioned, collects on one open end somewhat beyond the corresponding end of cooling sleeve 70 and terminates approximately coequally with the end of cooling sleeve 70 on the other end.
  • collecting tube 60 may extend on the other end beyond the corresponding end of cooling sleeve 70 so as to be insertable into opening 50 of optional filter housing 40.
  • FIG. 2 provides a center cross-sectional view along a center vertical axis of device 10 of all of the principal components of device 10 in a disassembled state from the component positioned vertically the lowest, mouthpiece 15, to that positioned highest, airtight cap 80.
  • Airtight cap 80 is provided as part of device 10 for secure, retentive placement over open end 75 of collecting tube 60 after the method of the invention has been practiced but prior to storage and/or shipment of collecting tube 60 to a laboratory for analysis of condensate. Together with normally closed duckbill valve 65, airtight cap 80 seals the condensate sample within collecting tube 60 and prevents any fluid exchange with matter or air outside of collecting tube 60.
  • Airtight cap 80 may be formed from malleable plastic or another material, but its composition is not critical to practice of the invention so long as it provides a secure seal with open end 75 when placed thereover. Collecting tube 60, duckbill valve 65 and airtight cap 80 together form a disposable assembly which may be prepackaged for a single use ensuring no complicated cleaning or contamination issues arise from use of device 10.
  • Duckbill valve 65 is a critical component of device 10. It is uniformly constructed from rubber or a material with resilient, rubber-like properties.
  • FIG. 3 represents a cross-sectional view of duckbill valve 65 taken below valve leaves 100, shown in FIGS. 4 and 5 below, prior to its insertion into collecting tube 60 along a plane perpendicular to the walls of collecting tube 60 were duckbill valve 65 inserted therein. Note that since collecting tube 60 has a circular cross-section, as indicated by dotted line 85, one would normally expect duckbill valve 65 to have a correspondingly circular cross-section.
  • FIG. 4 additionally shows a center cross-sectional view of duckbill valve 65 across the center of both leaves 100 of the valve on a plane parallel to the walls of collecting tube 60 along line A- A of FIG. 3.
  • Leaves 100 incorporate malleable structures 105 with which they are attached to section 115 of the body of duckbill valve 65. An opening may be formed along the slit where leaves 100 meet each other.
  • the center of duckbill valve 65 is hollow. Due to the elliptical valve shape constrained in a circular structure, leaves 100 are biased to a closed position along malleable structures 105. Thus, when a subject user is inhaling, leaves 100 prevent the admission of air into mouthpiece 15 through collecting tube 60.
  • Duckbill valve 65 incorporates a notched area around its exterior into which is tightly and sealingly fitted a rubberized Teflon® ring 110 having an exterior diameter just slightly greater than that of the minor axis of the ellipse formed by the footprint of duckbill valve 65 when at rest. Therefore, when ring 110 is in place, it is biased and makes sealing contact with the interior walls of collecting tube 60.
  • Ring 110 may also be composed of materials other than Teflon® such as polypropylene, so long as it functions in the same way as does the Teflon® ring described. This ring serves three functions. First, it is a wiper which, as discussed below, removes condensation from the interior walls of collecting tube 60 after the subject user has completed exhalation. Second, it maintains the alignment of duckbill valve 65 in an orthogonal orientation to the walls of collecting tube 60. Finally, it functions as a valve itself as discussed next.
  • the lower part of duckbill valve 65 consists of two general sections 115 and 120. There are one or more hollow passageways 125 running diagonally upward from an initiation point 130 within the interior hollow area of duckbill valve 65 through lower section 120 into the circular notched area formed on the exterior of duckbill valve 65. Note that only one passageway 125 is required for subsequent degassif ⁇ cation or deaeration steps, although as many as ten such passageways may be preferred depending on the circumstances. Also, note that such passages are not circumferential around the valve, so that in a slightly different cross section, they would not be seen at all, revealing that upper section 115 is confluent with lower section 120 throughout most of the valve structure.
  • Lower section 120 tends to be stiffer than upper section 115 since there is a greater volume of material in lower section 120 and, unlike section 115, it is constrained from movement by direct contact with the walls of collecting tube 60.
  • section 115 has a tendency to deflect allowing the gas to pass around Teflon® ring 110 and into the portion of collecting tube 60 above duckbill valve 65.
  • First inner ring 135 is a bump-like ridge extending around the hollow inner portion of duckbill valve 65 at approximately at its base.
  • Second inner ring 140 is another bump-like ridge extending around the hollow inner portion of duckbill valve 65 at a point displaced slightly above initiation point 130 of any passageway 125.
  • FIG. 5 shows a side view of duckbill valve 65 along a plane rotated 90 degrees around a vertical axis from the view shown in FIG. 4. This represents a side view along the plane represented by the line B-B of FIG. 3. As is evident, the valve has a bilateral structural symmetry.
  • cooling sleeve 70 may be placed in a freezer for approximately 20 to 30 minutes prior to use since the larger the difference in temperature between the walls of cooling sleeve 70 and collecting tube 60 the faster and more efficiently condensation will occur and the greater the amount of condensate produced will be. It is required, however, that cooling sleeve 70 be somewhat cooler than collecting tube 60 prior to beginning to practice the method so that the condensation process will be enhanced.
  • the cooling sleeve 70 can be cooled to various temperatures depending on need.
  • the exhaled fluid and vapors collect as frozen solid material on the inside of the collecting tube 60, a feature advantageous for the assays of compounds unstable in liquid phase water, as would be the case with a cooling sleeve chilled to a somewhat higher temperature. Temperatures obtained in a home refrigerator or home freezer are satisfactory for excellent liquid phase fluid collection for most purposes, including assessing pH. Throughout practice of the method until after installation of airtight cap 80, it is preferable to keep collecting tube 60 reasonably perpendicular to the ground.
  • a subject user places projection 20 of mouth piece 15 between his or her lips and inhales.
  • Duckbill valve 65 remains closed due to the bias of flaps 100 and air is admitted into mouthpiece 15 from projection 25 through check valve 30.
  • the subject user then exhales.
  • the stream of exhaled breath is blocked from egress out of projection 25 by check valve 30 and follows the path of least resistance upward through projection 35 into optional filter housing 40, through optional filter assembly 55 and into duckbill valve 65 where leaves 100 are caused to separate and open due to the air pressure allowing the exhaled breath to enter collecting tube 60.
  • leaves 100 return to their naturally biased closed position.
  • a set number of breaths for example ten, will be sufficient.
  • cooling sleeve 70 is slid away from collecting tube 60.
  • optional filter housing 40 and collecting tube 60 are manually pulled apart and disengaged from each other.
  • projection 35 and collecting tube 60 are manually pulled apart, if the filter is not employed.
  • a piston and rod combination is provided as an accessory to device 10.
  • the piston is designed to fit within collecting tube 60 and to be placed into uniform flat contact with the entire bottom surface of duckbill valve 65 after cooling sleeve 70 and collecting tube 60 are separated.
  • the rod may be attached to the piston in advance or after insertion of the piston into collecting tube 60.
  • Pressure is then exerted against duckbill valve 65 by means of the rod and piston combination moving duckbill valve 65 vertically upwards through the inside of collecting tube 60 towards open end 75 thereof. Due to the wiper action of Teflon® ring 110, tiny drops of condensate clinging to the walls of collecting tube 60 are collected into a small pool building up around and ahead of Teflon® ring 110.
  • the rod and piston combination are removed from collecting tube 60 when duckbill valve 65 has been moved to within approximately two inches from open end 75 of collecting tube 60. At this point, airtight cap 80 is securely and sealably installed over open end 75 so that collecting tube 60 may be stored and/or shipped to another location, such as a laboratory.
  • airtight cap 80 is securely and sealably installed over open end 75 so that collecting tube 60 may be stored and/or shipped to another location, such as a laboratory.
  • the movement of duckbill valve 65 within collecting tube 60 can be deferred until after transport.
  • this piston and rod combination may also serve the additional purpose of providing a degassing mechanism, as discussed below.
  • the collected condensate may be subjected to a variety of treatments depending on the assay desired to be undertaken.
  • a degassing or deaeration of the condensate is performed.
  • Degassing or deaerification is a purification process which removes carbon dioxide from the condensate and allows for more accurate and stable measurement of acidity or pH levels. Without this deaeration step, the carbon dioxide in air diffuses in and out of the condensate, changing its pH.
  • any gas that does not contain carbon dioxide or another acid may be used for degassing prior to pH measurement including, but not limited to, argon, helium, oxygen or air that has had carbon dioxide removed from it with a carbon dioxide trap.
  • elimination of carbon dioxide could be accomplished chemically by adding an enzyme and substrate that consumes carbon dioxide and a proton (acid) in a one-to-one ratio.
  • any one of three methods may be used.
  • a probe which may also serve as the piston discussed previously, may be inserted through the bottom open end of collecting tube 60 and advanced until its further progress is blocked by contact with duckbill valve 65 whereupon pressure is exerted until the nose portion of the probe is seated within duckbill valve 65. Airtight cap 80 should then be removed.
  • FIG. 6 a partial cross-sectional view of collecting tube 60 is shown in which probe 200 has been seated within duckbill valve 65.
  • the nose portion of probe 200 has a diameter slightly wider than the diameter of first inner ring 135.
  • Probe 200 includes a hollow, multipath, cylindrical passageway 205 including one or more openings 210 which exit the nose portion of probe 200 at a height equivalent to the location of initiation point 130 within valve 65.
  • openings 210 lies between first inner ring 135 and second inner ring 140 inside valve 65.
  • Argon or another carbon dioxide-free gas may be introduced under pressure through passageways 205 of probe 200. As shown in FIG. 7, the pressurized gas follows the path indicated by the dotted lines accompanied by arrows.
  • the mechanical pressure seals formed by inner rings 135 and 140 against the nose portion of probe 200 are considerably stronger than the seal produced by ring 110 against the circular notched area formed on the exterior of duckbill valve 65. Due to the positioning of passageway(s) 125, they are not subjected to stress and exit duckbill valve 65 at a point where the valve is not subjected to mechanical stress.
  • the pressurized gas introduced through passageways 205 follows the unstressed portion of duckbill valve 65, or passageways 125.
  • upper section 115 tends to deflect when exposed to pressurized gas thereby creating a passageway for the gas to circumvent Teflon® ring 110 and escape into and bubble through condensate 215 pooled in collecting tube 60.
  • Carbon dioxide dissolved in condensate diffuses into the bubbles of the carbon dioxide- free gas.
  • the gas, now containing carbon dioxide derived from the condensate is allowed to escape into the atmosphere from collecting tube 60 through now uncapped open end 75.
  • Argon being heavier than air, assists in preventing carbon dioxide from the ambient air from recontaminating the sample.
  • duckbill valve 65 could omit ring 110 and hollow passageways 125 and probe 200.
  • gas pressure applied into collecting tube 60 below valve 65 by a positive pressure manifold would cause leaves 100 in duckbill valve 65 to open admitting the gas into the condensate pool.
  • the pressure of the gas would prevent condensate from seeping back into the open valve as would the closing bias of leaves 100 when the application of gas pressure terminated.
  • One example of such a manifold would accept the lower end of collecting tube 60, make an airtight seal with it and hold it in a vertical position while forcing gas into the tube for degassing.
  • the manifold could interface with available gas plumbing or hoses connecting to a source of gas.
  • the third method for degassing is shown in schematic form in FIG. 8.
  • airtight cap 80 is removed from collecting tube 60 which is then inserted into a device enclosing both ends of the tube.
  • a hard vacuum is applied to both ends of the tube and the area of the tube below the duckbill valve is periodically opened to the atmosphere or to a carbon dioxide-free gas source. This procedure draws the carbon dioxide out of the solution in the condensate and allows it to be removed through the vacuum pump.
  • Open end 75 of collecting tube 60 is placed in manifold 300, while the opposing end of the tube is placed in manifold 305.
  • Vacuum pump 310 is attached to open end 75 by means of manifold 300, while vacuum gauge 315 is attached to the opposing end of collecting tube 60 by means of manifold 305.
  • Three- way, two-position solenoid valve 320 is connected between vacuum pump 310 and vacuum gauge 315.
  • An adjustable orifice 325 functioning with solenoid valve 320 is used to regulate the surge of air or other gas into the lower chamber of collecting tube 60, and a filter 330 is connected to adjustable orifice 325 in order to ensure that no contaminants are introduced into the system.
  • a human may be used to determine when to vent the lower part of collecting tube 60 through manifold 305 based on readings from vacuum gauge 315.
  • a vacuum transducer coupled to a controller could be substituted for the vacuum gauge to automate the venting of the collecting tube by energizing solenoid valve 320 pursuant to a control algorithm.
  • tests might require passing other gases through or adding liquids or solids to the condensate.
  • the same structures and procedures described above may be used to collect, transport, store and otherwise accomplish these tasks.
  • Other tests that might be performed on collected samples include assays for inorganic and organic compounds, including but not limited to amino acids, volatile organic compounds, lipids and lipid oxidation products, ammonia, simple ions such as sodium and chloride, strong and weak acids and bases, surfactant, inflammatory mediators including cytokines and leukotrienes, oxidation and nitration products including hydrogen peroxide and nitrotyrosine, nucleic acids such as DNA and RNA, endotoxin and other microbial products.
  • device 10 In addition, it is important to note that the entire cycle of sampling, storage, degassing and much, if not all, of the analysis is done within device 10. Transfer of fluid to other apparati is not generally required. Furthermore, all wetted parts of device 10 can easily be made disposable to minimize contamination, cleaning, and cost. The device is fully portable and can be used even by small children. In an alternative structure, a filter may be positioned on top of collecting tube 60 to prevent infectious particles from escaping while allowing larger particles to be trapped in collecting tube 60. Finally, the device and method of this invention may be adapted for animal use in veterinarian applications.
  • a probe may be inserted through open end 75 to remove a sample of the condensate for testing purposes.
  • the testing can be performed directly within collecting tube 60.
  • a calibrated pH probe attached to a pH meter can be immersed in the collected sample to determine sample pH.
  • the sample may be removed by contact with the probe or by suction action through the probe.
  • chemicals can be added, or a chemically impregnated reagent strip can be immersed into the sample for colorimetric determination of pH and other characteristics and substances.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
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  • Food Science & Technology (AREA)
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  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
EP01934950A 2000-05-01 2001-04-30 Verfahren und einrichtung zum abnehmen und analysieren von ausgeatmetem atem Withdrawn EP1409985A4 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US20097900P 2000-05-01 2000-05-01
US200979P 2000-05-01
PCT/US2001/013895 WO2001084112A1 (en) 2000-05-01 2001-04-30 Method and device for collecting and analyzing exhaled breath

Publications (2)

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EP1409985A1 true EP1409985A1 (de) 2004-04-21
EP1409985A4 EP1409985A4 (de) 2009-01-07

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EP (1) EP1409985A4 (de)
AU (1) AU2001261091A1 (de)
WO (1) WO2001084112A1 (de)

Cited By (1)

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