Portable Sampling Device and Method for Sampling Drug Substances From Exhaled Breath

Abstract

A portable drug testing device for handheldly collecting a sample from exhaled breath of a subject for further sensor based analysis. The portable drug testing device comprising a housing comprising at least one inlet and at least one outlet for the exhaled breath to exit through, and a sampling membrane arranged in the housing. a tubular element having a mouthpiece section for the subject to exhale into, and a selective trap section in fluid communication with the mouthpiece and the inlet of the housing having a non-straight gas flow path for letting aerosols pass through the tubular element. The sampling membrane is arranged to collect the aerosols from the exhaled breath. The portable drug testing device further comprises a volume measure unit for determining that a pre-defined volume of the exhaled breath has passed through the sampling membrane.

Claims

1-5. (canceled)

6. A portable drug sampling device for handheldly collecting a sample from exhaled breath of a subject for further sensor-based analysis, comprising: a housing comprising at least one inlet and at least one outlet for said exhaled breath to exit through, and a permeable sampling membrane arranged in said housing transversal to a flow of exhaled breath passing through said sampling membrane, and wherein said sampling membrane comprises at least one layer of non-woven filtration; and wherein said sampling membrane is arranged to collect aerosols from said exhaled breath passing through said sampling membrane.

7. The device according to claim 6, further comprising a volume measure unit configured to measure a volume proportional to a pre-defined volume of said exhaled breath that has passed through said sampling membrane.

8. The device according to claim 6, further comprising a tubular element having a mouthpiece section for said subject to exhale into.

9. The device according to claim 8, wherein a port is arranged downstream said mouthpiece and upstream said sampling membrane and wherein said port is adapted to extract a defined portion of said exhaled breath into said measure unit.

10. The device according to claim 8, further comprising a volume measure unit comprising a gas volume collecting element having a volume and wherein: a port is arranged downstream said mouthpiece and upstream said sampling membrane and wherein said port is adapted to extract a defined portion of said exhaled breath into said volume measure unit; and wherein said volume of said gas volume collecting element is proportional to said defined volume of said exhaled breath.

11. The device according to claim 10, wherein said volume collecting element is a non-elastic bag with a predetermined volume.

12. The device according to claim 6, wherein said filter membrane comprises at least one further layer being a spunbonded carrier.

13. The device according to claim 6, wherein said filter membrane is made of a blend of acrylic fibers and polypropylene fibers.

14. The device according to claim 6, wherein said aerosols comprise non-volatile compounds of at least one drug substance in said exhaled breath.

15. The device according to claim 14, wherein said drug substance comprises one or more of: an amphetamine, MDMA, cannabis, a cannabinoid, an opiate, 6-AM, cocaine, a benzodiazepine, propoxyphene, methadone, buprenorphine, tramadol, LSD, cathinone, GHB, meprobamate, Z-drugs, tryptamine, and an anabolic steroid.

16. The device according to claim 6, further comprising plugs configured and dimensioned to seal the housing inlet and outlet after use and removal of the tubular element.

17. The device according to claim 6, wherein the sampling membrane is attached to walls of the housing; the housing comprises at least two connectable parts, a first part including said inlet and a second part including said outlet.

18. A portable sampling device for collecting a sample from exhaled breath of a subject, comprising: a housing comprising at least one inlet and at least one outlet for said exhaled breath to exit through, and a sampling element arranged in said housing for collecting aerosols from the exhaled breath by a tubular element having a lumen in flow connection with an inlet of said collection device; said tubular element comprises at least two baffles arranged on opposite sides of said lumen to provide a none straight path through the tubular element, said baffles protrude into said lumen with at a distance larger than a radius of said lumen.

19. The device according to claim 18, wherein the tubular element is a straight tube.

20. The device according to claim 18, wherein a volume measure unit is arranged for determining that a pre-defined volume of said exhaled breath has passed through the sampling device.

21. The device according to claim 18, wherein a mouthpiece section is arranged for the subject to exhale into, and in fluid communication with the tubular element and said inlet of the housing.

22. The device according to claim 20, wherein the volume measure unit is configured to measure a volume proportional to said pre-defined volume of the exhaled breath.

23. The device according to claim 20, wherein a port is arranged downstream the mouthpiece which is adapted to extract a defined portion of the exhaled breath into the volume measure unit.

24. The device according to claim 18, wherein the sample is aerosols from the exhaled breath which comprise non-volatile compounds of at least one drug substance in the exhaled breath.

25. The device according to claim 18, wherein the sample is aerosols from the exhaled breath which comprise non-volatile compounds of at least one bio-marker in the exhaled breath.

26. The device according to claim 24, wherein the aerosols from the exhaled breath which comprise non-volatile compounds of at least one drug substance in the exhaled breath and wherein the drug substance is comprised in the list comprising Amphetamine, ecstasy, Cannabis, THC and cannabinoids, Opiates, heroin, morphine, 6-AM, Cocaine, Benzodiazepines, Propoxyphene, Methadone, Buprenorphine, Tramadol, LSD, Designer/Internet drugs, Kathinon, GHB, Meprobamat, Z-drugs, Tryptamines, or Anabolic steroids.

27. The device according to claim 18, wherein the sample is aerosols from the exhaled breath, wherein the aerosols comprise liquid droplets carrying non-volatile drug substances or compounds.

28. A method of screening a person for drugs and/or biomarkers in exhaled breath of a subject, comprising: collecting a sample of aerosols from the exhaled breath in a sampling element comprising, a tubular element having a lumen in flow connection with an inlet of said collection device; said tubular element comprises at least two baffles arranged on opposite sides of said lumen to provide a none straight path through the tubular element, said baffles protrude into said lumen with at a distance larger than a radius of said lumen; extracting a collected content from the collection device; and employing a sensor unit for detecting traces of pf drugs and/or biomarkers in the content.

29. The method according to claim 28, wherein the sample is aerosols from the exhaled breath which comprise non-volatile compounds of at least one drug substance in the exhaled breath.

30. The method according to claim 28, wherein the sample is aerosols from the exhaled breath which comprise non-volatile compounds of at least one bio-marker in the exhaled breath.

31. The method according to claim 30, wherein the aerosols from the exhaled breath which comprise non-volatile compounds of at least one drug substance in the exhaled breath and wherein the drug substance is comprised in the list comprising Amphetamine, ecstasy, Cannabis, THC and cannabinoids, Opiates, heroin, morphine, 6-AM, Cocaine, Benzodiazepines, Propoxyphene, Methadone, Buprenorphine, Tramadol, LSD, Designer/Internet drugs, Kathinon, GHB, Meprobamat, Z-drugs, Tryptamines, or Anabolic steroids.

32. The method according to claim 28, wherein the sample is aerosols from the exhaled breath, wherein the aerosols comprise liquid droplets carrying non-volatile drug substances or compounds.

33. The method according to claim 28, wherein the content is extracted using a solvent.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] For the purpose of illustrating the invention, the drawings show aspects of one or more embodiments of the invention. However, it should be understood that the present invention is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:

[0053] FIG. 1A-C are schematic illustrations showing an embodiment of a tubular element with a mouthpiece section, and a selective trap section designed to mainly permit aerosols from exhaled breath from a subject to pass through;

[0054] FIG. 2 is a schematic illustration illustrating an embodiment of a portable device configured to collect a sample from exhaled breath of a subject;

[0055] FIG. 3 is an embodiment of a portable sampling device showing a housing with a sampling element being a filter membrane;

[0056] FIG. 4A is depicting a tubular section;

[0057] FIGS. 4B and C are depicting a portable sampling device at different stages of use;

[0058] FIG. 5 is showing a flow-chart illustrating a method for using a portable device configured to collect a sample from exhaled breath of a subject; and

[0059] FIG. 6 illustrates a system for detecting the presence or determining the quantitative amount of at least one drug compound in exhaled breath.

DETAILED DESCRIPTION

[0060] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

[0061] In an embodiment of the invention according to FIG. 1A-C a tubular element with a mouthpiece section and a selective trap section is depicted. The selective trap section of the tubular element is designed to permit primarily aerosols to pass through. Hence denying saliva and/or mucus and/or larger particles and/or aggregated to enter the housing and thereby avoiding the sampling membrane to be clogged.

[0062] The tubular element is a conduit with a coaxial lumen having transversal baffles. The cross-section of the lumen could have any shape but is preferably circular or oval. In FIG. 1A two complementary cross-section views 10, 11 along the length of a tubular element with a mouthpiece section are shown. The shape of the two parts are close to two half-pipes, wherein both parts comprising open ends 101, 102 which will form an inlet, being a mouthpiece section, and an outlet, when put together. The section between the inlet 101 and outlet 102 is a selective trap section 111 (see FIG. 1B). In FIG. 1A, part 10 comprises two transversal baffles 103 and part 11 one. Hence the total number of baffles 103 seated in the lumen 104 in the illustrated embodiment of the tubular element is three. In reality any suitable number of baffles needed to obtain the needed effect could be seated in the lumen of the tubular element. The section of the tubular element with the baffles 103 forms the selective trap section 111

[0063] The transversal baffles 103 may be perpendicular to the inner wall 105 of the lumen 104 (as depicted in FIG. 1A). Alternatively and/or additionally, in some embodiments the transversal baffles 103 may have any suitable angle relative the inner wall 105 of the lumen 104.

[0064] In FIG. 1B a cross-section of the tubular element is depicted from a different view, showing the height of the transversal baffles and the path the exhaled breath must travel from the inlet 101 to the outlet 102. In the upper cross-section view the height 106 of the baffles 103 are shown related to the radius 107 of the lumen. The baffles 103 protrude into the lumen 104 at least a distance being the same as the radius 107. Preferably the height 106 of the baffles 103 should be taller than the length of the radius 107 of the lumen 104. The baffles 103 are in FIG. 2B depicted as perpendicular to the inner wall 105 of the lumen 104. In reality each baffle 103 could have any suitable angle relative the inner wall 105 of the lumen 104 as long as they extend into the lumen the same distance as the radius 107 or longer.

[0065] The baffles 103 in the selective trap section 111 should be spaced to optimizing passing of aerosols and at the same time minimizing the amount of saliva and/or mucus and/or particles and/or aggregates 108 permitted through the tubular element to the outlet 102. Alternatively and/or additionally, in some embodiments the spacing is depending on the height and/or the angle of the baffles 103.

[0066] Further in FIG. 1B, the arrows in the lower cross-section show the non-straight travel of exhaled breath and of the aerosols through selective trap section 111 of the tubular element. The aerosols will easily travel from the inlet 101 to the outlet 102 while the heavier or larger in size particles or aggregates 108 that may clog a sampling membrane will be denied by the baffles 103. The selective trap section 111 of tubular element may therefore act as a pre-filter.

[0067] Alternatively and/or additionally, in some embodiments of the invention the baffles 103 include orifices sized to mainly permit aerosols to pass through the orifices.

[0068] In FIG. 1C the mouthpiece section 12 is depict. The inlet 109 could have any shape but one that has shown to be particularly suitable and comfortable is an oval shape. 110 depict the contours of the tubular section previously described in FIGS. 4 A and B.

[0069] In FIG. 2 is a schematic illustration showing an embodiment of a portable system configured to collect a sample from exhaled breath of a subject. Sampling system 20 is configured to collect a sample from exhaled breath of a subject 201. The subject will exhale through a mouthpiece and a tubular element 202 being in flow communication with a housing 204 via at least one inlet 203. The mouthpiece and tubular element 202 may be of same size or type as a conventional used for alcohol-test. Preferably the mouthpiece and tubular element 202 is configured to mainly permit aerosols to pass through. Even more preferably configured according to the previously described invention.

[0070] The housing 204 could be made of any suitably material or combinations thereof such as, metal, plastic, glass or ceramics

[0071] The housing 204 comprises a sampling membrane 205 for collecting the non-volatile drug substances from the exhaled breath. The exhaled breath exits the housing through at least one outlet 206. The portable system is sealed after being used and sent to a laboratory 207 to be analyzed. Analysis of the amount of illicit drugs could be performed using a range of methods but preferably methods are Surface enhanced Raman spectroscopy (SERS) or mass-spectroscopy, for example Liquid-chromatography mass-spectroscopy (LCMS).

[0072] Alternatively and/or additionally, in some embodiments the portable sampling system is made to be a disposable product. When designed to be a disposable product the housing as well as the mouthpiece is preferably made of a plastic material.

[0073] The sampling system and elements for collecting drug substances should be kept clean and preferable be aseptic but could also be used sterile.

[0074] Alternatively and/or additionally, in some embodiments of the invention a volume measure unit 208 may be used for detecting the amount of exhaled breath from the tested subject. Preferably the volume measure unit 208 comprising a port arranged downstream the mouthpiece section and upstream the sampling membrane 205. Preferably the port is attached to the tubular element. A pre-defined fraction or portion of the exhaled breath will be extracted through the port and used for calculating the amount of exhaled breath passed through the sampling membrane 205. Preferably the volume measure unit 208 is further comprising a gas volume collecting element, preferably a bag, in communication with the port. The gas volume collecting element has a predefined volume when expanded. The volume of exhaled breath through passed through the sampling membrane 205 may be proportional to the volume of the bag when full.

[0075] Alternatively to a gas volume collecting element, such as a bag, a flow meter could be used with an indicator, such as indicators changing colour, may be used to indicate when a pre-determined volume has passed through the sampling membrane.

[0076] In FIG. 3 is an embodiment of a portable sampling system 30 is depicted comprising a housing 301, with a sampling membrane 302, a tubular element 303 with a mouthpiece section 308 and a selective trap section, and a volume measure unit comprising a port 307 and a gas volume collecting element 304. The volume measure unit is used for calculating the volume of exhaled breath passing through the sampling membrane 302.

[0077] The sampling membrane could be placed anywhere in the housing 301. Preferably the sampling membrane is fastened to the inner walls of the housing 301. The housing 301 is preferably constructed out of two or more parts, a first part with an inlet 305 and one part with at least one outlet 306.

[0078] The mouthpiece section 308 and tubular element 303 is detachable and in fluid communication with the housing 301 via the inlet 305. The tubular element 303 is acting as a pre-filter for filtering out saliva and/or mucus and/or large particles and/or aggregates from the exhaled breath, according to what has previously been described. Thus a cleaner sampling membrane, such as a filter membrane, to be analyzed is obtained which may result in better and more accurate analysis. Other advantages with using a tubular element 303 is the prevention of contamination between subjects and sample

[0079] Alternatively and/or additionally, in some embodiments the mouthpiece section 308 and tubular element 303 is not detachable but integrated with the first part of the housing 301.

[0080] Connected either to the tubular element 303 or between the mouthpiece section 308 and the inlet 305 is a port 307 for extracting a portion or fraction of the exhaled breath from the subject. The extracted exhaled breath is used to blow up a gas volume measuring element 304, such as non-elastic bag or an elastic balloon. In this embodiment a non-elastic bag made of plastic is used since it requires less force to be blown up and will automatically stop when full.

[0081] When the bag is full the exhaled breath passing through the sampling membrane can be calculated since it will be proportional to volume of the bag. For example, by extracting a tenth of the volume exhaled by the subject, a full two liter bag means that 18 liter has passed through the sampling membrane (20 liter exhaled in total).

[0082] Additionally, in some embodiments the port may comprise a one-way valve so that the extracted breath will only enter the bag but not leave.

[0083] Alternatively and/or additionally, in some embodiments the port utilizes the back pressure created by the sampling membrane to extract the exhaled breathe through the port 307.

[0084] Alternatively, in some embodiments, a flow meter could be used with an indicator, such as indicators changing colour, may be used to indicate when a pre-determined volume has passed through the sampling membrane.

[0085] The extracted portion or fraction of the exhaled breath being measured is proportional to the predefined volume of exhaled breath passing through the sampling membrane. Thus by measuring this fraction or portion and by knowing the ratio of air being extracted and air passing through the sampling membrane the total amount of exhaled breath passing through the sampling membrane may be determined.

[0086] The exhaled breathe will, after flowing through the tubular element 303, travel into the housing 301 and be brought into contact with the sampling membrane, preferably a filter membrane.

[0087] The drug substances being non-volatile compounds conveyed by aerosols in the exhaled breath is collected by the sampling membrane, such as preferably a filter membrane, as the exhaled breath is permeated through the sampling membrane.

[0088] It should be noted that the sampling membrane 302 which being a filter membrane is not to be confused with an electronic or chemical sampling units and/or traps. The sampling element 302 is a physical entity on which the drug substance is collected. Collection may in different embodiments be based on various principles, singly or in combination, comprising depositing, catching, fastening, condensing of non-volatile constituents on the sampling element 302.

[0089] Using a filter membrane allows for a low pressure drop through the portable system 30 making it easy and comfortable to exhale through it. This is important since many drug addicts experience problems with their lungs.

[0090] In the embodiment depicted in FIG. 3, the filter membrane is placed to block the path for the exhaled breath through the portable system 30. In other embodiments the filter could be placed along the side of any of the walls of the housing 301.

[0091] There are many possibilities for fastening the filter membrane is needed, either by using a separate support structure retaining the filter, which may be an element that is either fastened to the inside walls of the housing 301 or a segment being slide onto a first part of the housing during the assembly before the second part of the housing is mounted.

[0092] Alternatively and/or additionally, in some embodiments the filter membrane is fastened direct onto the inside walls of the housing 301, either by glue or by heat and thereby melting a small part of the edge of the filter membrane.

[0093] The second part of the housing is either screwed or slid onto the first part of the housing. The second part comprises at least one outlet 306. Alternatively and/or additionally, in some embodiment the housing 301 comprises at least two outlets 306. This will aid to avoid a subject being tested to block the outlet and thereby blowing up the measuring element 304 with minimum exhaled breath being permeated through the filter membrane

[0094] In an embodiment of the portable device 30 the sampling element 302 is a filter membrane made of synthetic and/or half-synthetic fibers for the exhaled breath to diffuse through.

[0095] The filter membrane will have a structure that catches the aerosols and thereby collects the drug substances being exhaled while letting gas pass through. The aerosol particles comprise the non-volatile drug compounds. Preferably the filter membrane is operable to collect the aerosols from the air with a high volumetric capacity while maintaining a low pressure drop across the filter substrate.

[0096] Alternatively and/or additionally, in some embodiments the filter membrane may be an electrostatic filter made of fibers.

[0097] Alternatively and/or additionally, in some embodiments the filter membrane may be of a non-woven polymeric fibrous that may be an electret.

[0098] Alternatively and/or additionally, in some embodiments the filter membrane is an electrostatic filter being preferably a non-woven filter membrane comprising a blend of acrylic fibers and polypropylene fibers. The filter membrane could have a density (sometimes called grade or weight) in the range 23 up to 500 g/m2. But it has been shown that the range 130 up to 300 g/m2 is preferred. Even more preferably is the range 200 up to 280 g/m2.

[0099] Alternatively and/or additionally, in some embodiments the non-woven layer could be attached to at least further layer. Further layers could be used to enhance a filter membrane's physical properties or improve filtration performance. The extra layer could be a carrier, preferably a polypropylene spunbonded carrier. The spunbond carrier may have a scrim weight in the range 10 up to 20 g/m2, preferably 15 g/m2.

[0100] For example a three layered filter membrane comprising one non-woven layer with a density of 250 g/m2 and two layers being carriers each with a scrim weight of 15 g/m2 will have an air flow resistance of about 36 Pa at 9.5 m/min media velocity.

[0101] Alternatively and/or additionally, in some embodiments, the filter membrane may be corrugated to enhance the filtering area within a given housing volume.

[0102] The portable system is configured and adapted to have a sensitive for illicit drugs high enough to obtain results of a standard that could be used as proof in court. Other advantages are that the test may be performed anywhere at a low cost and short lead time before obtaining a result. Since no specially trained personnel are needed and the test is does not need to be performed at, for example, a hospital.

[0103] Other advantages are that the invented portable sampling system is neither invasive, e.g. Blood sampling, nor intruding on personal integrity, e.g. urine sampling. Even known issues with methods used today, related to samples and specimens taken from a subject to be tested are avoided. For instance for blood samples, and especially for urine samples are a risk of the subject exchanging the samples or using clean samples from another subject to avoid being discovered with traces of illicit drugs. The suspected subject can also be tested immediately and does not need to be transported to have the test done later. Hence a more accurate result of the level of an illicit drug at the time of for example an arrest can be obtained.

[0104] In FIG. 4A-C one embodiment of the invention is illustrated at different stages. FIG. 4A depicts a tubular element 40 before being assembled and mounted. 401 shows the mouthpiece section with an inlet, 402 shows the selective trap section of the tubular element, 403 shows the outlet, 404 the port for extracting a portion of the exhaled breath and 405 shows the baffles used to obtain the non-straight gas flow path.

[0105] FIG. 4B illustrates the device 41 when being ready to be used: 401 shows the mouthpiece section; 402 the tubular section comprising the baffles; 407 is the inlet to the housing 406; 408 shows the outlet from the housing 406; 404 is the port for extracting a portion of the exhaled breath for determining the volume of exhaled breath passing the sampling membrane. The illustration does not show the volume measure unit (i.e. the bag) attached to the extraction port 404.

[0106] FIG. 4C is illustrating a used sampling device 42. The mouthpiece section and tubular element is detached and plugs 409, 410 are mounted to the inlet 407 and the outlet 408 of the housing 406. This will seal off the housing 406 and the sampling membrane comprised inside. At this stage the portable sampling device 42 is ready to be sent to a laboratory, for example by post. In FIG. 4C it is shown that the housing 406 is made of two parts 411 and 412 mounted together

[0107] The process of manufacturing a portable device according to the embodiments described herein when the housing is made in plastic could be formed the following way (reference to the parts shown in FIG. 4A-C): a first part, for example, 412 of a housing is heated and thereby enlarging the circumference of the first part 412. When seating a filter membrane in close proximity to the large opening being approximately the middle of the device, at least one compound in the filter membrane will melt at the edge of the filter membrane. This will stick or fastening the filter membrane to the inner wall of the first part 412. The first part of the housing 412 could then be slid or screwed or snapped onto the second part 411. Thus a tight fit may be obtained when the first part 412 cools off and its circumference decreases.

[0108] FIG. 5 is a flow-chart illustrating a method 50 for using a portable system configured to collecting a sample 502 from exhaled breath from a subject. Briefly, FIG. 5 illustrates detecting the presence and/or determining the quantitative amount 503 of at least one illicit drug substance or compound in a collected sample. The illicit drug compounds will be collected as aerosols, being non-volatile particles and/or compounds, from the exhaled breath. The method comprising of: A subject exhaling 501 into the invented portable system; a sampling unit will collect a sample 502 comprises drug substances or compounds; the collected sample will be extracted from the sampling membrane and analyzed 503 using mass-spectroscopy or SERS.

[0109] With reference to FIG. 5, a subject will exhale 501 in and out; preferably the subject will exhale into the portable system until a specific volume of exhaled breath has been passed through the sampling membrane, such as preferably a filter membrane.

[0110] Alternatively and/or additionally, in some embodiments the subject has to exhale either for a certain time or for a fixed number of times such as 1 to 10 times into a portable system. When breathing a fixed number of times each exhale could be set to last for a fixed time.

[0111] To measure a specific volume, one preferred method is to use a port between either located on the mouthpiece or between the mouthpiece and the inlet of the housing. A portion of the exhaled breath will be extracted 504 through the port and blow up an element such as a non-elastic bag. Hence when the bag is full, the volume of said bag will be proportional to the volume passed through the sampling membrane.

[0112] Alternatively and/or additionally, in some embodiments a bag with elastic properties can be used.

[0113] A deep breath is preferred to reach exhaled breath from deep lying lung portions such as the central or the peripheral lung regions.

[0114] The exhaled breath will then be collected 502 by the sampling element, i.e. an easy to breathe through filter membrane, suitably for collecting drug substances before it exits the system. The filter membrane is preferably made of synthetics and/or half synthetics fibers; preferably the filter membrane has electrostatic-properties. Using a filter membrane will create a small, light weighted and easy to use method that can be used everywhere by anyone to detect if a subject is under influence of an illicit drug. The sampling method is of such high quality that the obtained results are of a court approved standard. These results are obtain using a method that is neither invasive, e.g. Blood sampling, nor intruding on personal integrity, e.g. urine sampling. Hence the known drawbacks with these methods are prevented.

[0115] After being used, the housing of the sampling system will sealed off by sealing the inlet and the outlet and be sent to a laboratory, whereby the collected compounds in the filter are removed and analyzed 503 using an appropriate analyzing method such as mass-spectroscopy or SERS.

[0116] FIG. 6 illustrates a system 60 for detecting the presence or determining the quantitative amount of at least one drug compound in exhaled breath. The system comprising a portable drug testing device 602 for handheldly collecting a sample from exhaled breathe from a subject 601. The device 602 could be according to any embodiment described herein. Further, the system 60 comprises a sensor unit 603 for analyzing the collected compounds in the testing device 602. The sensor could be any know type of sensor but preferably mass spectroscopy or SERS. To be able to analyze the collected sample the content of the filter membrane in the device 602 is extracted. This could be done for example by using a solvent to be analyzed using the sensor unit 603. Another method is heating the filter and thereby evaporating the content of the filter for example onto a SERS surface.

[0117] In the following further examples of implementations of the invention and how an analysis may be performed is demonstrated. These original observations demonstrate drug testing based on sampling of expired air.

Example 1

[0118] Sampling of drugs of abuse from exhaled human breath using filter membrane.

[0119] Table 1 shows sampling of methadone from exhaled breath using a filter membrane comprising one layer being a non-woven electrostatic filter with a blend of acrylic fibers and polypropylene fibers with a density of 250 g/m2 and two carriers each with a scrim weight of 15 g/m2. The tests were performed at 4 different occasions. The first column shows the diameter of the used filter, the second the sampling time the third the amount of methadone collected per minute the fourth the obtained range of methadone among the tested subjects and the fifth column the number of subjects tested.

TABLE-US-00001 TABLE 1 Diameter Sampling Methadone of filter time pg/min mm min mean ? SD Range n 47 3 86 ? 52 18-168 6 32 3 112 ? 89 47-266 5 32 3 92 ? 62 28-199 6 32 1 204 ? 116 21-326 6

[0120] Table 2 shows sampling of methadone in breath from a pre-study when using variable densities of the electrostatic filter membrane. Type is the density of the non-woven layer at each test, the other headlines are the same as for table 1.

TABLE-US-00002 TABLE 2 Methadone Type pg/min (g/m2) mean ? SD Range n 150 74.4 ? 80.4 24-216 5 250 71.0 ? 90.1 19-231 5 300 91.8 ? 110 20-287 5

[0121] Table 3 shows sampling of methadone in exhaled breath using two different thicknesses of the electrostatic filter membrane inserted in a sampling device. The subject exhales through the tubular section comprising baffles to trapping large particles and saliva. The tables show that the aerosols will not be trapped by the baffles in the tubular element.

TABLE-US-00003 TABLE 3 Constructed sampler Filter Methadone pg/min thickness mean ? SD Range n 1 40 ? 27 12-85 5 2 42 ? 28 17-90 5

Biomarkers

[0122] Additionally and/or alternatively, some embodiments of the invention, provides for a portable sampling device for collecting aerosols comprising biomarkers from exhaled breath of a subject for further sensor based analysis. By sampling biomarkers from exhaled breath the device may help providing vital information for early detection and/or diagnosis of diseases or illnesses as well as monitoring of disease progression and/or therapy response.

[0123] Devices, systems and methods for sampling non-volatile biomarkers are in accordance with the devices, systems and methods for sampling of drug substances and/or compounds herein described.

[0124] Some known non-volatile biomarker that may be transported by aerosols in exhaled breath is comprised in the list comprising lipids, peptides, nucleotides, prostanoids, proteins, DNA or RNA.

[0125] These biomarkers may be used for diagnosis of diseases or illnesses, such as cancer (such as lung cancer), asthma, inflammation, infection (such as tuberculosis) and/or oxidative stress or other medical conditions.

[0126] In conjunction with the hereinabove described embodiments for sampling drug substances or compounds, which being equally suitable to be used as a portable sampling device for collecting aerosols comprising biomarkers from exhaled breath of a subject for further sensor based analysis, some preferred aspects of the invention provides for a portable sampling device for collecting aerosols comprising biomarkers from exhaled breath of a subject for further sensor based analysis. The portable sampling device comprising a housing comprising at least one inlet and at least one outlet for the exhaled breath to exit through, and a sampling membrane arranged in the housing. The sampling membrane is arranged to collect the aerosols from said exhaled breath.

[0127] Additionally, some embodiments further comprising a tubular element having a mouthpiece section for the subject to exhale into, and a selective trap section in fluid communication with the mouthpiece and the inlet of the housing. The selective trap section has a non-straight gas flow path for letting primarily aerosols pass through said tubular element.

[0128] Additionally, some embodiments, further comprising a volume measure unit for determining that a pre-defined volume of said exhaled breath has passed through said sampling membrane.

[0129] Additionally, some embodiments, wherein said tubular element is detachable from said housing or wherein said tubular element is an integrated part of the housing.

[0130] Additionally and/or alternatively, in some embodiments the volume measure unit is configured to measure a volume proportional to the pre-defined volume of the exhaled breath.

[0131] Additionally and/or alternatively, in some embodiments a port is arranged downstream the mouthpiece and upstream the sampling membrane and wherein the port is adapted to extract a defined portion of the exhaled breath into the volume measure unit.

[0132] Additionally and/or alternatively, in some embodiments, the volume measure unit comprising a gas volume collecting element, such as a bag, having a volume and wherein a port is arranged downstream the mouthpiece and upstream the sampling membrane and wherein the port is adapted to extract a defined portion of the exhaled breath into the volume measure unit. The volume of said gas volume collecting element is proportional to the pre-defined volume of the exhaled breath.

[0133] Additionally and/or alternatively, in some embodiments the volume collecting element is a non-elastic bag with a predetermined volume.

[0134] Additionally and/or alternatively, in some embodiments the sampling membrane is a filter membrane, preferably an electrostatic filter membrane.

[0135] The device according to the invention provides for method to sample aerosols comprise non-volatile biomarkers in exhaled breath. The aerosols comprise non-volatile compounds of at least one biomarker in the exhaled breath and wherein the biomarker is comprised in the list comprising lipids, peptides, nucleotides, prostanoids, proteins, DNA or RNA.

[0136] A further aspect of the invention is a use of the device, for non-invasive sampling of exhaled breath detection of biomarkers which may be used for diagnosis of diseases or illnesses, such as cancer, inflammation, infection and/or oxidative stress.

[0137] A yet further aspect provides for a method of diagnosis a medical condition of a subject, comprising collecting a sample from exhaled breath of a subject, such as by using the disclosed device, for sensor based analysis of the sample. The method comprising the step of having the subject exhaling into said device; collecting aerosols from the exhaled breath in a sampling membrane of the device; sealing the device off; extracting a content from the sampling membrane; and employing a sensor unit, such as off-site or on-site, for detecting traces of biomarkers in the content, and diagnosing said subject based on a result obtained from the sensor unit.

[0138] Additionally, some embodiments of this aspect further comprising measuring a pre-defined fraction of the exhaled breath volume for determining a specific total volume of the exhaled breath passing through the sampling membrane. When the specific total volume is determined as having passed through the sampling membrane terminating the exhalation.

[0139] The present invention has been described above with reference to specific embodiments. However, other alternatively and/or additionally embodiments than the above described are equally possible within the scope of the invention. Different method steps than those described above, performing the method by hardware or software, may be provided within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims

[0140] The foregoing has been a detailed description of illustrative embodiments of the invention. It is noted that in the present specification and claims appended hereto, conjunctive language such as is used in the phrases at least one of X, Y and Z and one or more of X, Y, and Z, unless specifically stated or indicated otherwise, shall be taken to mean that each item in the conjunctive list can be present in any number exclusive of every other item in the list or in any number in combination with any or all other item(s) in the conjunctive list, each of which may also be present in any number. Applying this general rule, the conjunctive phrases in the foregoing examples in which the conjunctive list consists of X, Y, and Z shall each encompass: one or more of X; one or more of Y; one or more of Z; one or more of X and one or more of Y; one or more of Y and one or more of Z; one or more of X and one or more of Z; and one or more of X, one or more of Y and one or more of Z.

[0141] Various modifications and additions can be made without departing from the spirit and scope of this invention. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order to provide a multiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments, what has been described herein is merely illustrative of the application of the principles of the present invention. Additionally, although particular methods herein may be illustrated and/or described as being performed in a specific order, the ordering is highly variable within ordinary skill to achieve aspects of the present disclosure. Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of this invention.

[0142] Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present invention.