GB2609476A - Vapour sample collection device - Google Patents

Vapour sample collection device Download PDF

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Publication number
GB2609476A
GB2609476A GB2111255.2A GB202111255A GB2609476A GB 2609476 A GB2609476 A GB 2609476A GB 202111255 A GB202111255 A GB 202111255A GB 2609476 A GB2609476 A GB 2609476A
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Prior art keywords
enclosure
collection device
sample collection
vapour sample
porous structure
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GB202111255D0 (en
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Laing Jason
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Individual
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Individual
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Priority to GB2111255.2A priority Critical patent/GB2609476A/en
Publication of GB202111255D0 publication Critical patent/GB202111255D0/en
Priority to PCT/GB2022/052053 priority patent/WO2023012482A1/en
Publication of GB2609476A publication Critical patent/GB2609476A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • 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
    • 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
    • A61B5/082Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • 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
    • G01N1/2202Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling
    • G01N1/2214Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling by sorption
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0083Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0083Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
    • A61B2010/0087Breath samples

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Physiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

A vapour sample collection device 30 for collecting a vapour sample, the vapour sample collection device comprising: an enclosure 32 for storing the vapour sample, the enclosure having an opening through which a vapour sample may enter the enclosure; and a porous structure 38 inside the enclosure. The device may include a mouthpiece for collecting a breath sample. The device may include a liquid container (54, Fig.4) attached to the enclosure containing a liquid reagent. The liquid container may be sealed, and the device may include a seal breaker (62, Fig.8) to dispense liquid into the enclosure. The device may include an actuator that may be a plunger 34. The porous structure may be helical-shaped, rigid, unitary, fixed, or free to move inside the enclosure. The device may include a sealing cap. The device may be shaped to restrict exiting of the porous structure and may include a reference identifier.

Description

VAPOUR SAMPLE COLLECTION DEVICE
This invention relates to a vapour sample collection device, a method of using a vapour sample collection device and a kit of parts for a vapour sample collection device.
It is known to collect a sample from a user using mechanical action, e.g. swabbing.
According to a first aspect of the invention, there is provided a vapour sample collection device for collecting a vapour sample, the vapour sample collection device comprising: an enclosure for storing the vapour sample, the enclosure having an opening through which a vapour sample may enter the enclosure; and a porous structure inside the enclosure.
Initially the vapour sample enters the enclosure and passes through the porous structure. The vapour sample then settles on the surfaces of the porous structure and an internal wall of the enclosure. The sample(s) collected by the porous structure and the internal wall of the enclosure may include a liquid sample (e.g. moisture), a solid sample (e.g. analytes) or a combination/mixture of both. The collected sample may be used with different types of post-sampling testing methods and/or data collection.
In comparison to an enclosure without the porous structure, the provision of the porous structure in the invention not only provides an increased surface area onto which the vapour sample can settle but also provides a plurality of porous flow paths that compresses and traps parts of the vapour sample. This enables improved sample collection. In this way the porous structure facilitates sample collection with higher loading levels when compared to an enclosure without the porous structure.
The enclosure may be in the form of a tubular enclosure. A cross-section of the tubular enclosure may come in a variety of shapes such as, for example, a circular cross-section, a square cross-section, a hexagonal cross-section and so on. The tubular enclosure may be, but is not limited to, a cylindrical tube.
The vapour sample collection device of the invention may be used in a wide range of applications requiring the collection of a vapour sample. This includes, but is not limited to, breath analysis.
In a preferred embodiment of the invention, the vapour sample collection device may be a breath sample collection device for collecting a breath sample. The breath sample collection device may include a mouthpiece through which a user may exhale into the enclosure. The mouthpiece may form part of the enclosure, and the opening may be formed in the mouthpiece. Alternatively the mouthpiece may be separate from and attachable to the opening of the enclosure. The mouthpiece may be made of an antibacterial and/or antimicrobial material.
A conventional way of collecting a sarnpie from a person is by way of mechanical action, such as swabbing a surface. However, sample collection by mechanical action not only is less reliable because it requires training to ensure proper sample collection but also can be uncomfortable if carried out on a person due to the invasive nature of the sample collection procedure.
In contrast, the breath sample collection device of the invention can be easily used by an untrained person using a natural breathing action, ensures reliable collection of the sample inside the enclosure and allows for a more comfortable and non-invasive sample collection procedure.
There are various ways of extracting the sample(s) from the porous structure for subsequent testing.
After sample collection, the porous structure may be removed from the enclosure and added to a liquid inside an external liquid container, such as a vial or a test tube. Preferably the enclosure is oriented, e.g. tilted, to allow the porous structure to fall out of the enclosure. This not only avoids the need for the user to handle the porous structure but also permits the porous structure to collect any sample settled on the internal wall as the porous structure slides out of the enclosure.
Liquid may be added into losure to come into contact with the porous structure and into contact with an internal wall of the enclosure. This allows the liquid to collect samples collected by the porous structure and settled on the internal wall.
The liquid may be selected for processing the collected sample(s). The liquid may be, for example, a reagent.
The liquid may be added into the enclosure from an external liquid container, such as an ampoule, a vial or a test tube.
In embodiments of the invention, the vapour sample collection device may include a liquid container for storing a liquid, the liquid container attached to the enclosure, wherein the liquid container may be operable to dispense the liquid into the enclosure so that the liquid comes into contact with the porous structure. In such embodiments, the vapour sample collection device may include a liquid reagent stored inside the liquid container.
The provision of the in-built liquid container enables in-situ processing of the collected sample(s) by the liquid without exposing the porous structure to the external environment, thus reducing the risks of cross-contamination and spillage.
Having the liquid come into contact with the porous structure improves the processing of the collected sample(s) by the liquid due to the higher loading levels facilitated by the porous structure. In addition the in-situ processing of the collected sample(s) by the liquid reduces the amount of time that has passed between the sample collection step and the processing step. These in turn contribute to the accuracy and reliability of subsequent tests.
Furthermore, the vapour sample collection device can be transported to another site (such as a testing laboratory or a hospital) with the liquid in contact with the porous structure throughout the transportation journey. This not only saves overall testing time due to the processing of the collected sample(s) by the liquid during the transportation journey, as opposed to adding the liquid to the collected sample(s) after arriving at the other site, but also enhances processing of the collected sample(s) by the liquid because the transportation of the vapour sample collection device to the other site causes shaking of the vapour sample collection device due to external forces and thereby improves the contact between the liquid and the porous structure.
In further embodiments of the invention, the liquid container may include a seal for sealing the liquid inside the liquid container, and the seal may be breakable to dispense the liquid into the enclosure so that the liquid comes into contact with the porous structure. This provides a reliable way of ensuring that the liquid is initially isolated from the porous structure and only comes into contact with the porous structure when required to do so.
Different ways, tools and instruments may be used to break the seal and may be separate from or part of the vapour sample collection device. In a non-limiting embodiment, the vapour sample collection device may include a seal breaker for breaking the seal. One non-limiting embodiment of the seal breaker is a perforator for piercing the seal. The perforator may include a pointed or sharp end, or a pointed or sharp edge, for piercing the seal.
Preferably the seal breaker is located inside the vapour sample collection device. More preferably the seal breaker is located inside the enclosure. For example, the seal breaker may be formed at an end of the porous structure. Forming the seal breaker at an end of the porous structure reduces the structural and manufacturing changes required to incorporate the seal breaker into the vapour sample collection device. The seal breaker may be integral with the porous structure.
in still further embodiments of the invention, the vapour sample collection device may include an actuator operable to move the liquid container into the enclosure so that the seal comes into contact with the seal breaker.
Different types of actuators may be used in the invention to move the liquid container into the enclosure so that the seal comes into contact with the seal breaker. For example, the actuator may be a plunger, the seal breaker spaced apart from the seal when the plunger is in an undeployecl position, wherein the plunger may be movable from the undeployed position to a deployed position to push the liquid container into the enclosure so that the seal comes into contact with the seal breaker. The use of a plunger as the actuator enables a one-handed operation of the actuator to break the seal and dispense the liquid into the enclosure so that the liquid comes into contact with the porous structure.
The porous structure may vary in shape, size and structure. The pores in the porous structure may vary in number and shape. The pores in the porous structure may have a regular or irregular arrangement.
The porous structure may be made from a single material or may be made from multiple materials that form a composite material. The porous structure may be made from a polymer, such as epoxy resin or polyurethane. Preferably the porous structure is made of a hydrophilic material.
The porous structure may be shaped in different ways to direct the vapour sample to follow a specific flow path, or specific flow paths, through the porous structure. This permits optimisation of the sample collection by the porous structure.
In a non-limiting embodiment, the porous structure may be shaped as a helical porous structure. The inventor has found that the helical shape of the porous structure directs the vapour sample to flow through the porous structure in a manner that further increases the loading levels of the collected sample(s). Furthermore, when liquid is dispensed into the enclosure to come into contact with the porous structure, the helical shape of the porous structure directs the liquid to more efficiently remove samples from an internal wall of the enclosure.
The porous structure may be a rigid porous structure. The rigidity of such a porous structure enhances the stability of the porous structure during the entry of the vapour sample into the enclosure so as to ensure a reliable sample collection.
The porous structure may be a sponge, such as an amorphous sponge.
The porous structure may be a unitary structure. Such a unitary structure may be manufactured using an additive manufacturing or 3D printing process such as, but not limited to, stereolithography printing, ultraviolet curing and selective laser sintering. The use of an additive manufacturing or 3D printing process enables the design and manufacture of a wide range of complex porous structures without requiring additional manufacturing equipment. It will be appreciated that an additive manufacturing or 3D printing process may also be used to manufacture a non-unitary structure of the porous structure.
In embodiments of the invention, the porous structure may have a fixed position inside the enclosure. For example, the porous structure may be attached to an internal wall of the enclosure, or the porous structure and the enclosure may be sized to provide an interference fit (also known as a friction fit) of the porous structure inside the enclosure.
In other embodiments of the invention, the porous structure may be free to move inside the enclosure. This permits the porous structure to freely move inside the enclosure to not only remove samples from an internal wall of the enclosure after the vapour sample is collected inside the enclosure but also improves the contact between the liquid and the porous structure so as enhance processing of the collected sample(s) by the liquid. Such free movement of the porous structure may take place when the vapour sample collection device is subjected to external forces while being transported from one site to another site, In further embodiments of the invention, the vapour sample collection device may include a sealing cap for sealingly dosing the opening. This provides a rel able way of retaining the vapour sample inside the enclosure.
In still further embodiments of the invention, the enclosure may be shaped to restrict the porous structure from exiting the enclosure through the opening. In a non-limiting embodiment, an internal cavity of the enclosure may be tapered towards the opening of the enclosure so that a size of the opening relative to a size of the porous structure restricts the porous structure from exiting the enclosure through the opening. In another non-limiting embodiment, the enclosure may include at least one internal retention structure (e.g. an internal shoulder) that restricts the porous structure from exiting the enclosure through the opening.
Optionally the vapour sample collection device may include a reference identifier for identifying the vapour sample collection device. Non-limiting embodiments of the reference identifier include a matrix code, a barcode, a Quick Response (QR) code, a serial code, a radio-frequency identification (RFID) tag and a microchip.
According to a second aspect of the inventor is provided a method of using a vapour sample collection device according to any one of the first aspect of the invention and its embodiments, the method comprising the steps of permitting a vapour sample to enter the enclosure through the opening and collecting the vapour sample inside the enclosure, where at least part of the vapour sample is collected by the porous structure.
The features and advantages of the first aspect of the invention and its embodiments apply mutatis mutandis to the second aspect of the invention and its embodiments The method of the invention may include the step of, after collecting the vapour sample inside the enclosure, operating the liquid container to dispense the liquid into the enclosure so that the liquid comes into contact with the porous structure. This may include operating the liquid container to dispense the reagent into the enclosure so that the reagent comes into contact with the porous structure.
The method of the invention may include the step of breaking the seal to dispense the liquid into the enclosure so that the liquid comes into contact with the porous structure.
This may include using a seal breaker, such as a perforator, to break the seal.
The method of the invention may include the step of operating the actuator to move the liquid container into the enclosure so that the seal comes into contact with the seal brea ker.
The method of the invention may include the step of moving the plunger from the undeployeci position to the deployed position to push the liquid container into the enclosure so that the seal comes into contact with the seal breaker.
The method of the invention may include the step of sealing the opening with the sealing cap after collecting the vapour sample inside the enclosure.
According to a third aspect of the invention, there is provided a kit of parts for a vapour sample collection device for collecting a vapour sample, the kit of parts comprising an enclosure and a porous structure, the enclosure and the porous structure combinable to form the vapour sample collection device according to any one of the first aspect of the invention and its embodiments.
The features and advantages of the first and second aspects of the invention and thai' embodiments apply mutatis mutandis to the third aspect of the invention and its embodiments.
The kit of parts may further include one or more other parts disclosed hereinabove with reference to the first aspect of the invention and its embodiments.
It will be appreciated that the use of the terms "first" and "second", and the like, in this patent specification is merely intended to help distinguish between similar features and is not intended to indicate the relative importance of one feature over another feature, unless otherwise specified.
Within the scope of this application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, and the claims and/or the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and all features of any embodiment can be combined in any way and/or combination, unless such features are incompatible. The applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner.
Preferred embodiments of the invention will now be described, by way of non-limiting examples, with reference to the accompanying drawings in which: Figure 1 shows a breath sample collection device according to an embodiment of the nvention; Figures 2 to 5 show components of the breath sample collection device of Figure Figures 6 and 7 shows perspective views of the breath sample collection device of Figure 1; Figures 8 and 9 show perspective and top views of a sponge of the breath sample collection device of Figure 1; Figure 10 shows the breath sample collection device of Figure 1 as a kit of parts; and Figures 11 to 15 illustrate a step-by-step process of collecting a breath sample using the breath sample collection device of Figure 1, The figures are not necessarily to scale, and certain features and certain views of the figures may be shown exaggerated in scale or in schematic form in the interests of clarity and conciseness.
Nasopharyngeal swabbing involves sticking a long swab up the nose and throat to collect a sample from the back of the nose and throat, which is then screened and analysed at a laboratory, such as screening of SARS-CoV-2 RNA by reverse-transcription polyrnerase chain reaction (RT-PCR). However, in addition to nasopharyngeal swabbing being uncomfortable and unreliable, laboratory screening and analysis can be time-consuming, thus causing delays in obtaining test results. Furthermore, there is the challenge of ensuring that the sample makes its way from the user to the laboratory in a manner that ensures reliable test results. All of these factors can adversely affect accurate and timely detection of infections to reduce transmission and mortality rates.
The following embodiments of the invention are described with reference to a breath sample collection device, it will be appreciated that the following description applies mutatis rnutandis to other types of vapour sample collection devices.
A breath sample collection device according to an embodiment of the invention is shown in Figure 1 and is designated generally by the reference numeral 30. In use, the breath sample collection device 30 is used to collect a breath sample for breath analysis.
The breath sample collection device 30 comprises an enclosure 32, an actuator 34, a mouthpiece cap 36 and a porous structure 38.
Figure 2 shows a cross-sectional view and a perspective view of the enclosure 32. The enclosure 32 is in the form of a c:ylindrical tube 32. Openings are formed at first and second ends 40,42 of the tube 32. An outer surface of the tube 32 is tapered from the second end 42 to the first end 40, An internal cavity of the tube 32 is also tapered from the second end 42 to the first end 40. Near the first end 40 of the tube 32, the bore of the internal cavity is reduced in cross-sectional size to form an internal circumferential shoulder 44. The second end 42 of the plunger 34 is flanged. The first end 40 of the tube 32 functions as a mouthpiece. By placing the mouthpiece in their mouth, a user may exhale into the tube 32 through the opening at the first end 40 of the tube 32.
Figure 3 shows a front view and a perspective view of the mouthpiece cap 36. The mouthpiece cap 36 is used to close the opening at the first end 40 of the tube 32. The mouthpiece cap 36 may include a retention ring 46 that is attached around the tube 32 in order to secure the mouthpiece cap 36 to the tube 32 when the mouthpiece cap 36 is removed from the first end 40.
Figure 4 shows a cross-sectional view and a perspective view of the actuator 34. The actuator 34 is in the form of a plunger 34 that is inserted into the second end 42 of the tube 32. In use, the plunger 34 is further insertable into the tube 32 by depression of the plunger 34. The user may use their fingers to grip the flanged second end 42 of the tube 32 while using their thumb to depress the plunger 34 into the tube 32.
A breakable seal 48 is formed at a first and 50 of the plunger 34, and an opening is formed at a second end 52 of the plunger 34, An outer surface of the plunger 34 is tapered from the second end 52 to the first end 50. An internal cavity 54 of the plunger 34 is also tapered from the second end 52 to the first end 50. The internal cavity 54 functions as a liquid container 54 for storing a liquid reagent. A plunger cap 56 is used to dose the opening at the second end 52 of the plunger 34. Figure 5 shows a side view of the plunger cap 56. The plunger cap 56 may be ternporanly removed to allow a liquid reagent to be added from an ampoule into the liquid container 54. The seal 48 acts to seal the reagent inside the liquid container 54 and thereby prevent he reagent from entering the tube 32 while the seal 43 is intact.
In the embodiment shown, the seal 43 is in the form of a thin wall of the plunger 34 that is breakable upon application of a sufficiently high force. In other embodiments, the seal 48 may take other forms, such as a foil.
The porous structure 38 is located inside the tube 32. In the embodiment shown, the porous structure 38 is a rigid sponge 38 that is formed from a hydrophilic polyurethane material and is shaped as a helical sponge 38. The sponge 33 is a unitary structure that is preferably manufactured using an additive manufacturing or 3D printing process.
An abutment ring 58 s formed at a first end 60 of the sponge 38. The sponge 38 is E5 arranged inside the tube 32 so that the abutment ring 58 axially engages the internal circumferential shoulder 44 to restrict the sponge 33 from exiting the tube 32 through the mouthpiece. This removes the risk of the user accidentally swallowing the sponge 33 when breathing into the tube 32 through the mouthpiece. Figures 6 and 7 show the axial engagement between the abutment ring 58 and the nternal circumferential shoulder 44.
Figures 8 and 9 show perspective and top views of the sponge 38. The sponge 38 includes a perforator 62 formed at a second end 64 of the sponge 38 facing the plunger 34. The perforator 62. includes a pointed end for piercing the seal 48. The perforator 62 is spaced apart from the seal 38 when the plunger 34 is in an undeployecl position.
In use, the plunger 34 is depressed from an undeployed position to a deployed position to push the liquid container 54 into the tube 32 so that the seal 48 comes into contact with the perforator 62. The pushing force on the plunger 34 is sufficiently high to cause the perforator 62 to pierce the seal 48. When the seal 33 is broken by the perforator 62, the reagent is dispensed from the liquid container 54 into the tube 32 and thereby comes into contact with the sponge 38.
The breath sample collection devce 30 may be provided to the user in pre-assemblc-.d form together with a reagent ampoule. Alternatively the user may be provided with a kit of parts comprising the tube 32, the plunger 34, the mouthpiece cap 36, the plunger cap 56, the sponge 38 and the reagent ampoule. The user may be provided with instructions on how to assemble the breath sample collection device 30 or may be directed to a website with the instructions Figure 10 shows the breath sample collection device 30 as a kit of parts.
An exemplary usc of the breath sample collection device 30 is described as follows, with reference to Figures 11 to 15.
The breath sarnpie collection device 30 includes unique reference identifiers 64,66 for identifying the breath sample collection device 30. In the embodiment shown, the unique reference identifiers 64,66 are in the form of a QR. code 64 and an alphanumeric serial code 66, as shown in Figure 11, To track the breath sample collection device 30, the user rnay register their personal details through a website or an app, scan the QR. code 64 on the tube 32 and manually input the serial code 66 into the website or app. The user may be required to download the app from an app store.
Initially the user exhales 68 into the tube 32 through the mouthpiece to provide a breath sample into the tube 32, as shown in Figure 12. The breath sample may include water droplets, mucosal dispersion and any viral units. The number of breaths into the tube 32 by the user may vary, For example, the user may breathe three times into the tube 32. This will ensure that any viral specimen or load will come from deep down in the bronchial tree of the lungs and up through the bronchial pipe, throat, nasopharynx and mouth to ensure high volume sample collection.
The breath sample passes through the sponge 38 and settles on the surfaces of the sponge 38 and the internal wall of the tube 32. The porous nature of the sponge 38 not only provides an increased surface area onto which the breath sample can settle but also provides a plurality of porous flow paths that compresses and traps parts of the breath sample for improved sample collection. Moreover, the helical shape of the sponge 38 directs the breath sample to flow through the sponge in a manner that further increases the loading levels of the collected sample. Figure 13 shows a simulation of the flow of the breath sample through the sponge 38. The dark regions, some of which are marked as 'X' in Figure 10, show that the helical shape of the sponge 38 results in high loads due to compression of the breath sample in those regions.
Alter collecting the breath sample inside the tube 32, the user closes the mouthpiece opening with the mouthpiece cap 36, as shown in Figure 14. Then the user depresses the plunger 34 to push the liquid container 54 into the tube 32 and thereby break the seal 48 using the perforator 62, as shown in Figure 15. The plunger 34 may include a mark to indicate how far the plunger 34 should be inserted into the tube 32. For example, a user may depress the plunger 34 until the mark is aligned with the second end 42 of the tube 32.
As a result of the seal 43 being broken, the reagent is dispensed into the tube 32 and conies into contact with the sponge 38. The helical shape of the sponge 38 directs the reagent to remove the sample collected by the sponge 38 and settled on the internal wall of the tube 32. This allows the reagent to begin processing of the sample. Such in-situ collection and processing of the collected sample by the reagent not only prevents exposure of the sponge 38 to the external environment, thus reducing the risks of cross-contamination and spillage, but also reduces the amount of time that has passed between the sample collection step and the processing step.
The breath sample collection device 30 then placed into a sealable transport bag, which is then transported to a laboratory for further testing.
When the breath sample collection device 30 is transported to the laboratory; the reagent continues to extract and process the collected sample due to the contact between the reagent and the sponge 38 throughout the transportation journey, In addition, the extraction and processing of the collected sample by the reagent is enhanced by the shaking of the breath sample collection device 30 during transportation. Preferably the sponge 38 is configured to freely move inside the tube 32 to further enhance the extraction and processing by the sponge removing samples from the internal wall of the tube 32 and by improved contact between the reagent and the sponge 38. 7r
The above extraction and processing of the collected sample by the reagent enables the sample to arrive at the laboratory pre-processed and ready for further testing, such as PCR testing. By reducing or removing the time spent by a laboratory technician to carry out sample extraction and processing, more tests can be carried out per day.
Once the laboratory receives the breath sample collection device 30, they too will scan the QR code 64 to link the breath sample collection device 30 to the registered user. This allows the user to be notified of the test results and other relevant information.
In other embodiments of the invention, the sponge 38 may vary in shape, size, structure and material. The pores in the sponge 38 may vary in number, shape and arrangement. In addition, the sponge 38 may be made from a single material or may be made from multiple materials that forms a composite material. Furthermore, the sponge 33 may be shaped in different ways to direct the breath sample to follow a specific flow path, or specific flow paths, through the sponge.
The listing or discussion of an apparently prior published document or apparently prior published information in this specification should not necessarily be taken as an acknowledgement that the document or information is part or the state off the art or is common general knowledge.
Preferences and options for a given aspect, feature or parameter of the invention should, unless the context indicates otherwise, be regarded as having been disclosed in combination with any and all preferences and options for all other aspects, features and parameters of the invention,

Claims (25)

  1. CLAIMS1. A vapour sample collection device for collecting a vapour sample, the vapour sample collection device comprising: an enclosure for storing the vapour sample, the enclosure having an opening through which a vapour sample may enter the enclosure; and a porous structure inside the enclosure.
  2. 2. A vapour sample collection device according to Claim 1 wherein the vapour sample collection device is a breath sample collection device for collecting a breath sample, the breath sample collection device including a mouthpiece through which a user may exhale into the enclosure.
  3. 3. A vapour sample collection device according to Claim 1, or Claim 2 including a liquid container for storing a liquid, the liquid container attached to the enclosure, wherein the liquid container is operable to dispense the liquid into the enclosure so that the liquid conies into contact with the porous structure.
  4. 4, A vapour sample collection device according to Claim 3 including MLA reagent stored inside the liquid container.
  5. O. A vapour sample collection device according to Claim 3 or Claim 4 wherein the liquid container includes a seal for sealing the liquid inside the liquid container, and wherein the seal is breakable to dispense the liquid into the enclosure so that the liquid comes into contact with the porous structure.
  6. 6. A vapour sample collection device according to Claim 5 including a seal breaker for breaking the seal.
  7. 7. A vapour sample collection device according to Claim 6 wherein the eal breaker is a perforator for piercing the seal.
  8. 8. A vapour sample collection device according to Claim 6 or Claim 7 wherein the seal breaker is formed at an end of the porous structure.
  9. 9. A vapour sample collection device according to any one of Claims 6 to 8 including an actuator operable to move the liquid container into the enclosure so that the seal comes into contact with the seal breaker. 7r
  10. 10. A vapour sample collection device according to Cairn 9 wherein the actuator is a plunger, the seal breaker spaced apart from the seal when the plunger is in an undeployed position, wherein the plunger is movable from the undeployed position to a deployed position to push the liquid container into the enclosure so that the seal comes into contact with the seal breaker.
  11. 11. A vapour sample collection device according to any one of the preceding claims wherein the porous structure is shaped as a helical porous structure.
  12. 12. A vapour sample collection device according to any one of the preceding claims wherein the porous structure is a rigid porous structure.
  13. 13. A vapour sample collection device according to any one of the preceding claims wherein the porous structure is a unitary structure. is
  14. 14. A vapour sample collection device according to any one of the preceding claims wherein the porous structure has a fixed position inside the enclosure.
  15. 15. A vapour sample collection devce according to any one of Cairns 1 to 13 wherein the porous structure is free to move inside the enclosure.
  16. 16. A vapour sample collection device according to any one of the preceding claims including a sealing cap for sealingly closing the opening.7r
  17. 17. A vapour sample collection device according to any one of the preceding claims wherein the enclosure is shaped to restrict the porous structure from exiting the enclosure through the opening.
  18. 18. A vapour sample collection device according to any one of the preceding claims including a reference identifier for identifying the vapour sample collection device.
  19. 19. A method of using a vapour sample collection device according to any one of the preceding claims, the method comprising the steps of permitting a vapour sample to enter the enclosure through the opening and collecting the vapour sample inside the enclosure, wherein at least part of the vapour sample is collected by the porous structure.
  20. 20. A method according to Claim 19 when dependent from Claim 3, the method including the step of, after collecting the vapour sample inside the enclosure, operating the liquid container to dispense the liquid into the enclosure so that the liquid conies into contact with the porous structure.
  21. 21. A method according to Claim 20 when dependent From Claim 5, the method include the step of breaking the seal to dispense the liquid into the enclosure so that the liquid conies into contact with the porous structure.
  22. 22. A method according to Claim 21 when dependent from Claim 9, the method including the step of operating the actuator to move the liquid container into the enclosure so that the seal comes into contact with the seal breaker.
  23. 23. A method according to Claim 22 when dependent from Claim 10, the method E5 including the step of moving the plunger from the undeployed position to the deployed position to push the liquid container into the enclosure so that the seal comes into contact with the seal breaker,
  24. 24. A method according to any one of Claims 19 to 23 when dependent from Claim 15, the method including the step of sealing the opening with the sealing cap after collecting the vapour sample inside the enclosure.
  25. 25. A kit of parts for a vapour sample collection device for collecting a vapour sample, the kit of parts comprising an enclosure and a porous structure, the enclosure and the porous structure combinable to form the vapour sample collection device according to any one of Claims 1 to 18
GB2111255.2A 2021-08-04 2021-08-04 Vapour sample collection device Pending GB2609476A (en)

Priority Applications (2)

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GB2111255.2A GB2609476A (en) 2021-08-04 2021-08-04 Vapour sample collection device
PCT/GB2022/052053 WO2023012482A1 (en) 2021-08-04 2022-08-04 Vapour sample collection device

Applications Claiming Priority (1)

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DE102010031051A1 (en) * 2010-03-22 2011-09-22 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Sampling module for e.g. supplying breathing air sample of patient to sample analyzer for diagnosing cancer, has sorption element for sorbing component from medium, and desorption element releasing component of medium from sorption element
EP3006915A1 (en) * 2013-05-29 2016-04-13 NTT Docomo, Inc. Skin gas measurement device and skin gas measurement method
US20170303900A1 (en) * 2016-03-08 2017-10-26 Entech Instruments Inc. Breath condensate and saliva analysis using oral rinse
GB2595572A (en) * 2020-04-15 2021-12-01 Vosbio Inc Methods, devices and kits for preparing nucleic acid samples for storage and analysis

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US10226201B2 (en) * 2015-10-29 2019-03-12 Invoy Holdings, Llc Flow regulation device for breath analysis and related method
US20190231222A1 (en) * 2016-08-08 2019-08-01 Invoy Technologies, Llc Rapid analyzer for alveolar breath analysis
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KR20050010419A (en) * 2003-07-21 2005-01-27 (주)포인트메디칼 System for diagnosing helicobacter pylori with c-14 urea breath test
DE102010031051A1 (en) * 2010-03-22 2011-09-22 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Sampling module for e.g. supplying breathing air sample of patient to sample analyzer for diagnosing cancer, has sorption element for sorbing component from medium, and desorption element releasing component of medium from sorption element
EP3006915A1 (en) * 2013-05-29 2016-04-13 NTT Docomo, Inc. Skin gas measurement device and skin gas measurement method
US20170303900A1 (en) * 2016-03-08 2017-10-26 Entech Instruments Inc. Breath condensate and saliva analysis using oral rinse
GB2595572A (en) * 2020-04-15 2021-12-01 Vosbio Inc Methods, devices and kits for preparing nucleic acid samples for storage and analysis

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WO2023012482A1 (en) 2023-02-09

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