Portable Sampling Device and Method for Detection of Biomarkers in Exhaled Breath

• US 20150033824A1
• Filed: 03/08/2013
• Published: 02/05/2015
• Est. Priority Date: 03/08/2012
• Status: Active Grant

• Current Assignee: Sensa Bues AB
• Original Assignee: Sensa Bues AB
• Inventors: Hammarlund, Bo, Beck, Olof
• Granted Patent: US 10,359,417 B2
• Time in Patent Office: Days
• US Class Current: 73/23.3
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: G01N 33/4975 other than oxygen, carbon dioxide or alcohol, e.g. organic vapours

Abstract

A portable method and sampling device for collecting aerosols comprising biomarkers from exhaled breath of a subject for further sensor based analysis. The sampling device (41) comprising a housing (406) comprising at least one inlet (407) and at least one outlet (408) 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.

Claims

1. A method of detecting biomarkers from exhaled breath of a subject, comprising:

collecting a sample of aerosols in a sampling membrane of a collection device;

extracting a content from said sampling membrane; and

employing a sensor unit for detecting traces of biomarkers in said content.

2. The method of claim 1, comprising investigating a health status of a subject based on an analysis of said traces of biomarkers.

3. The method of claim 2, wherein said investigating comprises diagnosing a medical condition of said subject, and said method further includes diagnosing said subject based on a measurement signal or result obtained from said sensor unit related to said biomarkers.

4. The method according to claim 1, including measuring a pre-defined fraction of said exhaled breath volume for determining a specific total volume of said exhaled breath passing through said sampling membrane, and when said specific total volume is determined as having passed through said sampling membrane terminating said exhalation.

5. The method according to claim 1, including sealing said device before sending it to a lab for extracting said content.

6. The method according to claim 1, including performing on-site analysis.

7. The method according to claim 1, wherein said content is extracted from said sampling membrane using a solvent.

8. The method according to claim 7, wherein said solvent with said extracted content is placed on a surface of said sensor unit and evaporated.

9. The method according to claim 1, wherein said sampling membrane is a filter membrane, preferably an electrostatic filter membrane.

10. The method according to claim 9, wherein said filter membrane comprises at least one layer of non-woven filtration media with a specific weight in the range of 23 g/m³ to 500 g/m³.

11. The method according to claim 9, wherein said filter membrane comprises at least on further layer being a spunbonded carrier with a scrim weight of 10 to 20 g/m³.

12. The method according to claim 9, wherein said filter membrane has a filter surface to be passed by exhaled gas of approximately 800 mm² and a pressure drop of 36 Pa at 9.5 m/min media velocity.

13. The method according to claim 9, wherein said filter membrane is made of a blend of acrylic fibers and polypropylene fibers.

14. The method according to claim 9, further comprising a tubular element connected to an inlet of said collection device for preventing contaminants, such as big particles and/or aggregates and/or saliva and/or mucus, from being collected by said sampling membrane.

15. The method according to claim 14, wherein said tubular element comprises:

an inlet, an outlet in connection with a lumen;

at least two baffles positioned in a selective trap section, each having a height of at least a length of a radius of the lumen;

and wherein said baffles are arranged on different sides of the lumen to deny an exhaled breath a straight path through said lumen of said conduit, whereby primarily aerosols in said exhaled breath are permitted to pass though said tubular element.

16. The method according to claim 15, wherein each baffle comprises orifices with a size that only permit said aerosols to pass through.

17. The method according to claim 1, wherein said aerosols comprise non-volatile biomarkers in said exhaled breath;

wherein said aerosols comprise non-volatile compounds of at least one biomarker in said exhaled breath and wherein said biomarker is comprised in the list comprising lipids, peptides, nucleotides, prostanoids, proteins, DNA or RNA.

18. A portable sampling device for collecting aerosols comprising biomarkers 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 sampling membrane arranged in said housing; and

wherein said sampling membrane is arranged to collect said aerosols from said exhaled breath.

19. The device according to claim 18, further comprising a tubular element having a mouthpiece section for said subject to exhale into, and a selective trap section in fluid communication with said mouthpiece and said inlet of said housing, said selective trap section has a non-straight gas flow path for letting primarily aerosols pass through said tubular element.

20. The device according to claim 19, further comprising a volume measure unit for determining that a pre-defined volume of said exhaled breath has passed through said sampling membrane.

21. The device according to claim 19, wherein said tubular element is detachable from said housing.

22. The device according to claim 20, said volume measure unit comprises 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 predefined volume of said exhaled breath.

23. The device according to claim 22, wherein said volume collecting element is a non-elastic bag with a predetermined volume.

24. The device according to claim 18, wherein said sampling membrane is a filter membrane.

25. The device according to claim 24, wherein said filter comprises at least one layer of non-woven filtration media with a specific weight in the range of 23 g/m³ to 500 g/m³.

26. The device according to claim 25, wherein said filter membrane comprises at least one further layer being a spunbonded carrier with a scrim weight of 10 to 20 g/m³.

27. The device according to claim 24, wherein said filter membrane has a filter surface to be passed by exhaled gas of approximately 800 mm² and a pressure drop of 36 Pa at 9.5 m/min media velocity.

28. The device according to claim 24, wherein said filter membrane is made of a blend of acrylic fibers and polypropylene fibers.

29. The device according to claim 18, wherein said housing has at least two outlets.

30. The device according to claim 19, wherein said tubular element further comprises:

an inlet, an outlet in connection with a lumen;

at least two baffles positioned in said selective trap section, each having a height of at least a length of a radius of the lumen;

and wherein said baffles are arranged on different sides of the lumen to deny an exhaled breath a straight path through said lumen of said conduit, whereby primarily aerosols in said exhaled breath are permitted to pass though said tubular element.

31. The device according to claim 30, wherein each baffle defines orifices with a size that only permit said aerosols to pass through.

32. The device according to claim 18, wherein said aerosols comprise non-volatile biomarkers in said exhaled breath;

wherein said aerosols comprise non-volatile compounds of at least one biomarker in said exhaled breath and wherein said biomarker is comprised in the list comprising lipids, peptides, nucleotides, prostanoids, proteins, DNA or RNA.

33. A method for non-invasive sampling of exhaled breath for diagnosis of diseases or illnesses, such as cancer, inflammation, infection and/or oxidative stress, comprising sampling said exhaled breath using a portable sampling device as recited in claim 18.

34. A system for diagnosing a patient by detecting the presence and/or determining the quantitative amount of at least one biomarker in said exhaled breath, said system comprising a device of claim 18, and a senor unit for analyzing a sample collected from exhaled breath of a subject by means of said device.