US 10,520,439 B2 · System and method for drug detection in exhaled breath

Abstract

A portable system (10) is disclosed for collecting a sample from exhaled breath of a subject. Drug substance in the exhaled breath are detected or determined. The sample is collected for further analysis using mass-spectroscopy. The system comprises a sampling unit (14) and a housing (12) arranged to hold the sampling unit (14), the sampling unit (14) is adapted to collect non-volatile and volatile compounds of the at least one drug substance from the exhaled breath from the subject. The housing (12) has at least one inlet (15) for the subject to exhale into the housing (12) to the sampling unit (14) and at least one outlet (16) for the exhaled breath to exit through.

Drawings

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Drawings

Claims24

Dependent claims

A portable system configured to collect a sample of non-volatile compounds from exhaled breath of a subject, said system comprising:

a housing made from two parts, a first part and a second part, being joined together to define an interior space, wherein the first part comprises an inlet for said subject to exhale into said housing and the second part comprises an outlet for said exhaled breath to exit through;
a sampling unit arranged transversely across said interior space by being attached to walls of said housing and dividing the interior space to form a first chamber within said first part wherein exhaled breath is received through the inlet thereby forcing exhaled breath flowing from said inlet to said outlet to pass through said sampling unit,
wherein said sampling unit comprises an electrostatic nonwoven polymeric fibrous web filter membrane, wherein said filter membrane is adapted to collect non-volatile compounds, carried by aerosols, from said exhaled breath from said subject;
and wherein said non-volatile compound is extractable from said filter membrane using a solvent for analysis with liquid chromatography-mass-spectroscopy;
a detachable mouthpiece element connectable to said inlet;
and
a flow sensor arranged at said detachable mouthpiece and being configured to determine flow of exhaled breath through the housing;
wherein said sampling unit is removably disposed in said housing with a collecting element disposed therein, and wherein said system consists essentially of said first part with the detachable mouthpiece and flow sensor, said second part with said outlet and said sampling unit, and wherein said outlet is sized to form substantially the whole back of the second part of the housing.

5 more elements

A method for portably collecting a sample from exhaled breath of a subject, and for detecting the presence or determining the quantitative amount of at least one non-volatile compound carried by aerosols from a lung in said exhaled breath, said method comprising:

collecting said sample comprising at least one non-volatile compound from said subject using a system comprising a housing made from two parts, a first part and a second part, being joined to define an interior space with an inlet for exhaling into said housing and an outlet for said exhaled breath to exit through, a sampling unit arranged transversely across said interior space by being attached to walls of said housing to form a first chamber into which exhaled breath is received through the inlet, thereby forcing exhaled breath flowing from said inlet to said outlet to pass through said sampling unit, wherein said sampling unit comprises an electrostatic nonwoven polymeric fibrous web filter membrane, wherein said filter membrane is adapted to collect at least one non-volatile compound of said at least one drug substance from said exhaled breath from said subject, said system unit further comprises a detachable mouthpiece connectable to said inlet;
and a flow sensor arranged at said detachable mouthpiece configured to determine flow of exhaled breath through said housing;
and wherein said sampling unit is removably disposed in said housing with a collecting element disposed therein, and wherein said system consists essentially of said first part with the detachable mouthpiece and flow sensor, said second part with said outlet and said sampling unit, and wherein said outlet is sized to form substantially the whole back of the second part of the housing;
extracting said at least one non-volatile compound from said filter membrane using a solvent comprising methanol;
and
analyzing said extracted at least one non-volatile compound using liquid chromatography-mass-spectroscopy or Surface Enhanced Ra man Spectroscopy.

3 more elements

A portable system configured to collect a sample of non-volatile compounds from exhaled breath of a subject, said system comprising:

a portable, hand-held housing made from two parts, a first part and a second part, being joined together to define an interior space with an inlet for said subject to exhale into said housing and an outlet for said exhaled breath to exit through;
a removable sampling unit disposed in the housing comprising an electrostatic nonwoven polymeric fibrous web filter membrane configured and specifically adapted to collect non-volatile compounds carried by aerosols having a particle size of 0.2-0.7 μm in exhaled breath, said sampling unit further being configured and specifically adapted for extraction of said non-volatile compound from said filter membrane using a solvent for analysis with liquid chromatography-mass-spectroscopy;
a detachable mouthpiece element connectable to said inlet;
and
a flow sensor arranged at said detachable mouthpiece configured to determine flow of exhaled breath through the housing;
wherein said removable sampling unit is arranged transversely a cross said interior space by being attached to walls of said housing and dividing the interior space to form a first chamber wherein exhaled breath is received through the inlet thereby forcing exhaled breath flowing from said inlet to said outlet to pass through said sampling unit;
wherein said housing, said sampling unit and said filter membrane are configured to provide a substantially straight flow path for exhaled breath from said detachable mouthpiece through the outlet with a back pressure, when said subject exhales into the inlet, of not higher than about 2 cm water at an exhalation flow rate of about 0-9 liter/min;
and
wherein said system consists essentially of said first part with the inlet, the detachable mouthpiece and flow sensor, said second part with said outlet and said sampling unit, and wherein said outlet is sized to form substantially the whole back of the second part of the housing.

6 more elements

Dependencies are inferred from the claim text.

Description9,091 words

Summary2,525 words

#This invention pertains in general to the field of systems and methods for collecting a sample from exhaled breath of a subject, and for detecting the presence or determining the quantitative amount of at least one drug substance in said exhaled breath. More particularly the invention relates to such portable systems.

#It is known that exhaled breath is commonly used in alcohol testing and today's technology makes it possible to perform on-site breath testing with legally defensible results using infrared spectroscopy.

#Testing for other illicit drugs of abuse traditionally requires blood or urine samples. Alternatively specimens comprising hair, sweat or oral fluid could be used. Blood sampling is invasive and requires medically trained personnel, why test subject often have to be transported to a hospital for sampling. This is time and effort consuming. With long lead times the test result will be too old. Urine sampling is considered intruding on personal integrity. Even other issues related to samples and specimens taken from a subject to be tested arise. For instance for blood samples, and especially for urine samples are at risk of the subject exchanging the samples or using clean samples from another subject to avoid being discovered with traces of illicit drugs.

Brief description of the drawings10 figures

#These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which

#FIG. 1 is a schematic illustration that shows an embodiment of a portable system configured to collect a sample from exhaled breath of a subject;

#FIG. 2a-c is an embodiment showing a housing with the sampling unit comprising collecting element being a filter membrane;

Detailed description6,291 words

#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.

#In an embodiment of the invention according to FIG. 1 a portable sampling system 10 is shown. The system comprises a housing 12 for holding the sampling unit 14. The housing 12 could either be one sole element or be constructed out of two or more parts. The housing could be made of any material or combinations thereof such as, metal, plastic, glass or ceramics.

#The housing 12 comprises at least one inlet 15 that is designed to allow a subject to exhale in. The inlet is in one embodiment dimensioned to fit an optional mouth piece 11 preferably of the same size or type as a conventional mouth piece used for alcohol-test. The mouth piece 11 prevents contamination between subjects to sample.

Facts

Application

13/394,609Filed 9 Sep 2010 · us provisional application

Priority

9 Sep 2009

Published

US 2012/0302907 A129 Nov 2012

Granted

31 Dec 2019

Term ends

15 Dec 2031

Estimated · how

20 years from earliest known nonprovisional domestic filing plus recorded patent term adjustment, including 462 days of adjustment. Maintenance-fee lapses, terminal disclaimers and statutory extensions have not been checked. The continuity chain may be incomplete; this is not an enforceability determination.

Classification17 codes

G01N 21/658
Raman scattering: enhancement Raman, e.g. surface plasmons
A61B 5/082
Measuring devices for evaluating the respiratory organs: evaluation by breath analysis, e.g. determination of the chemical composition of exhaled…
A61B 5/097
Measuring devices for evaluating the respiratory organs: devices for facilitating collection of breath or for directing breath into or through…
A61B 5/412
Detecting, measuring or recording for evaluating the immune or lymphatic systems: detecting or monitoring sepsis

Timeline

9 Sep 2009Priority claimedParent application 61/240,752
9 Sep 2010Application filedUS 13/394,609
29 May 2012Assigned to Sensa Bues ABassignment of assignor's interest
29 Nov 2012PublishedUS 2012/0302907 A1
31 Dec 2019GrantedUS 10,520,439 B2
12 Oct 2020Assigned to Kipa ABsecurity interest
12 Oct 2026TodayWithin its term
15 Dec 2031Term endsEstimated, includes 462 days of adjustment

System and method for drug detection in exhaled breath

Life of this patent

System and method for drug detection in exhaled breath

Life of this patent

Life of this patent

Abstract

Drawings

Drawings

Claims24

Description9,091 words

Drawings

Classification17 codes

Life of this patent

Description9,091 words