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WO2025176304A1 - Outil de collecte d'échantillonnage pour collecter des échantillons à partir de grandes surfaces et procédé de transfert dans un tube à essai - Google Patents

Outil de collecte d'échantillonnage pour collecter des échantillons à partir de grandes surfaces et procédé de transfert dans un tube à essai

Info

Publication number
WO2025176304A1
WO2025176304A1 PCT/EP2024/054576 EP2024054576W WO2025176304A1 WO 2025176304 A1 WO2025176304 A1 WO 2025176304A1 EP 2024054576 W EP2024054576 W EP 2024054576W WO 2025176304 A1 WO2025176304 A1 WO 2025176304A1
Authority
WO
WIPO (PCT)
Prior art keywords
swab
collection tool
sampling collection
handle part
tool according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/054576
Other languages
English (en)
Inventor
Daniel Alexander BÄR
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nemis Technologies Ag
Original Assignee
Nemis Technologies Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nemis Technologies Ag filed Critical Nemis Technologies Ag
Priority to PCT/EP2024/054576 priority Critical patent/WO2025176304A1/fr
Publication of WO2025176304A1 publication Critical patent/WO2025176304A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/38—Swabs having a stick-type handle, e.g. cotton tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0216—Sampling brushes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N2001/028—Sampling from a surface, swabbing, vaporising

Definitions

  • the invention relates to a sampling collection tool with a cylindrical swab part for collecting samples from a surface and a handle part for grabbing the sampling collection tool .
  • the handle part is connected to the cylindrical swab part and both parts form together a T-shaped or L-shaped structure .
  • Sampling collection tools are typically used for collecting samples of bio-related substances and particles from surfaces , and in particular for collecting microorganisms such as bacteria, yeasts , molds and viruses or abiotic substances and particles having biological ef fects such as active pharmaceutical compounds or toxins . Such tools are used for monitoring safe operation of medical institutions and manufacturing plants for food, medicines and the like .
  • microorganisms typically, such samples are collected using contact plates , dipslides , swabs , sponges or wipes . Contact plates and dipslides are simple to use and colonies of bacteria can be counted directly on the device .
  • contact plates and dipslides are only suitable for small , relatively flat and well accessible sampling spots and they potentially contaminate the sampling surface with the enrichment medium often containing nutrients for the target organism and selective agents ( e . g . antibiotics ) . Therefore , those tools are not suited for detecting microorganisms in demanding manufacturing environments .
  • Swabs are the preferred method for sampling small surfaces up to 100 cm 2 .
  • the main advantage of swabs is that the sample can easily be trans ferred to a test tube for further processing and analysis of the sample .
  • a normal swab it is di f ficult to swab larger surfaces , which can make it di f ficult to collect samples that are widely scattered or to collect suf ficient material for the analysis , which can lead to false negative results . Therefore , sponges and wipes are typically recommended and used for sampling of larger surfaces of 1 ' 000 cm 2 or more .
  • Some sponge models also come with a handle in order to avoid cross-contamination by the user and to facilitate sampling of hard-to-reach areas and various models exist where the handle can also be removed from the sponge with a release mechanism or simply by breaking it of f , because the handle is potentially disturbing further processing due to its si ze and because it can introduce contaminants .
  • the handles often used in conj unction with sponges , do not allow to apply suf ficient pressure on the surface to remove ef ficiently biofilms .
  • the problem to be solved by the present invention is therefore to provide a sampling collection tool which is easy to use and suitable for sampling larger surfaces with relatively high pressure and which allows to trans fer the sample directly into a test tube , containing a low volume of enrichment medium or extraction solution, for further processing and analysis on site , without requiring a laboratory .
  • a sampling collection tool comprises ,
  • a cylindrical swab part for collecting samples from a surface , in particular samples of bio-related substances and particles , and in particular microorganisms such as bacteria, yeasts , molds and viruses or other ( e . g . radioactive ) substances and particles important in the context of safe operation of medical institutions and manufacturing plants for food, medicines and the like .
  • the cylindrical swab part is used to wipe a surface and to collect the samples .
  • the cylindrical swab part and the handle part form together a T-shaped or L-shaped structure and the sampling collection tool is configured such that the handle part can be decoupled from the swab part with little ef fort .
  • the T-shaped or L-shaped structure allows to easily grab the sampling collection tool at the handle part and wiping it with a comparably large swab part over a surface . Samples can be collected easily from a large surface , a uni form and high pressure can be applied while sampling .
  • the cylindrical swab part comprises a surface layer for collecting samples .
  • the surface layer can extend over a part of the surface of the swab part .
  • the surface layer extends over the whole length of the swab part , and/or the surface layer covers at least most of the area opposite to the handle part .
  • the surface layer can be made of flocked nylon fibers , in particular with a fiber length between 0 . 3 and 3 . 0 mm, or cotton, rayon, synthetic sponge , gauze , or cloth .
  • Such a surface layer is optimi zed for collecting samples from a surface . Collection is ef ficient and the analysis result is reliable .
  • the sample collection tool can comprise a coupling mechanism, in particular a mechanical coupling mechanism, for decoupling the handle part from the swab part .
  • the coupling mechanism is configured for coupling and decoupling the handle part with the swab part .
  • a mechanical coupling mechanism means , that the swab part is form-locked and/or friction-locked with the handle part . This definition excludes that the handle part needs to be broken away for disconnecting the swab part from the handle part .
  • the j oint can be configured to rotate the handle part with respect to the cylindrical swab part within the plane spanned by the T-shaped or L-shaped structure .
  • the handle part can be decoupled from the swab part by fissuring, ripping, breaking or tearing-of f .
  • the swab part can be shaped as a hollow cylinder, in particular with a C-shaped cross section .
  • the swab part comprises an elongated shape with two ends , wherein one or both of the end' s tapers .
  • Another obj ect of the present invention is to provide a method for easily and reliably trans ferring the sample to a test tube for further processing and analysis . This problem is solved by a method with the following steps :
  • the swab part can be decoupled from the handle part and the swab part can be dropped into the test tube without touching the swab part with something else than an inner surface of the test tube . This method allows to trans fer the collected sample with minimal ef fort and risk of contamination .
  • Fig . 3 shows the sampling collection tool wherein the inner structure of the swab part is visible ;
  • Fig . 4b shows a sectional view of the head of the handle part , wherein the section line is shown in Fig . 4d;
  • Fig . 4d shows the handle part of the sampling collection tool in side view
  • Fig . 5a to 5g show the method of releasing the swab part from the handle part into a test tube without touching the swab part with something else than an inner surface of the test tube .
  • the sampling collection tool comprises a cylindrical swab part 1 and a handle part 2 .
  • the handle part 2 is used for grabbing the sampling collection tool and the swab part 1 is used for collecting samples from a surface .
  • the sampling collection tool forms a T-shaped structure .
  • the handle part 2 forms the stem of the T-shape and the swab part 1 forms the head of the T-Shape .
  • the swab part 1 has a length Lx and the handle part 2 has a length L 2 .
  • Length L 2 is 1 . 5 times larger than L 2 , or with other words , the swab part 1 is 0 . 66 as long as the handle part 2 .
  • Length L 2 is approximately 5 cm and length L 2 is approximately 7 . 5 cm .
  • Both the swab part 1 and the handle part 2 are manufactured by inj ection moulding or 3D-printing .
  • the swab part 1 is mainly shaped as an elongated hollow cylinder with an elongated opening 18 extending over the entire length of the swab part , i . e . the swab part 1 forms a hollow cylinder with a C-shaped cross section as shown in Fig . 4b .
  • the swab part 1 has a first end 11 and a second end 12 .
  • the first end 11 forms a taper and the second end 12 forms a flat end .
  • the swab part 1 comprises a protruding blade-shaped element 13 extending along nearly the whole length of the swab part 1 .
  • the taper at the first end 11 and the blade-shaped element 13 can be used for scratching samples from the surface or from other di f ficult to access surfaces .
  • the swab part 1 shaped as a hollow cylinder, forms an inner channel 44 with a length L 3 extending over approximately one third of the length L 2 of the swab part 1 and the inner channel 44 has an outlet 14 at the second end 12 of the swab part 1 .
  • the swab part 1 comprises a surface layer 15 for collecting samples .
  • the surface layer 15 extends over the whole length L 2 of the swab part 1 . It is not required that the surface layer 15 extends over the whole circumference of the cylinder shape . It is suf ficient , i f the surface layer is arranged opposite to the handle part 2 , wherein the opposite side 16 is indicated by several arrows .
  • the surface layer is made of flocked nylon fibers , which have an average length of approximately 1 . 0 mm .
  • the swab part 1 is produced by dipping it into an adhesive in a first step and by flocking the nylon fibres on the outer surface of the swab part 1 in a second step .
  • the flocked nylon fibers are then aligned in an electromagnetic chamber to stand perpendicular to the cylinder surface creating a felt-like surface . Due to their properties , flocked swabs are reported to be very ef fective to collect microorganisms .
  • the sampling collection tool comprises a coupling mechanism 3 for coupling the swab part 1 with the handle part 2 . It is a mechanical coupling mechanism, i . e . , the swab part 1 is form-locked and/or friction- locked with the handle part 2 .
  • the coupling mechanism 3 comprises a locking mechanism 4 for locking the handle part 2 with the swab part 1 in the coupled state .
  • the locking mechanism 4 comprises a clamp 41 arranged at handle part 2 and a recess 42 arranged inside the hollow part of the swab part 1 .
  • the clamp 41 and the recess 42 lock the handle part 2 against all degrees of freedom except for moving in the direction of the main axis 17 .
  • a protrusion 45 of the handle part 2 attaching against a curvature 46 of the swab part 1 in the coupled state locks the handle part 2 against moving in direction of the main axis 17 towards the second end 12 .
  • the coupling mechanism comprises a j oint 43 for rotating the handle part 2 with respect to the swab part 1 .
  • the j oint 43 is configured to rotate the handle part 2 with respect to the swab part 1 within the plane spanned by the T-shaped structure of the sampling collection tool and it locks the handle part 2 against moving in direction of the main axis 17 towards the first end 11 .
  • the j oint 43 is arranged inside an inner channel 44 of the swab part 1 .
  • the inner channel 44 has the shape of a pipe and forms together with the remaining part of the swab part 1 a hollow, C-shaped cylinder .
  • the inner channel 44 has a length L 3 and extends only over approximately one third of the length Lx of the swab part 1 .
  • the j oint 43 is formed as a sliding element which can slide inside the inner channel 44 .
  • the j oint 43 can slide from the coupled position as shown in Fig . 3 until the second end 12 of the swab part 1 and leave the inner channel 44 through the outlet 14 of the swab part 1 .
  • Fig . 5a until 5g show the method of releasing the swab part 1 from the handle part 2 into a test tube 5 .
  • the swab part 1 can be dropped into the test tube 5 without touching the swab part 1 with something else than an inner surface of the test tube 5 .
  • the swab part 1 can be decoupled from the handle part 2 reversibly, i . e . the swab part 1 and the handle part 2 can be decoupled and coupled multiple times .
  • Fig . 5b shows how the swab part 1 is inserted into the test tube 5 with the first end 11 .
  • the swab part 1 and the test tube 5 are vertically aligned .
  • the test tube is made of plastic or glass and is completely shown in Fig . 5e to 5g .
  • the sampling collection tool is slightly rotated such that the swab part 1 pushes against the inner wall of the test tube 5 at positions 51 and 52 . Due to the inability of the swab part 1 to rotate further inside the test tube 5 , the user can unlock the locking mechanism 3 by simply continuing to rotate the handle part 2 counter clockwise with respect to the swab part 1 .
  • the direction of rotation is illustrated by the arrow referenced by number 53 .
  • the rotation is guided by the j oint 43 arranged inside the inner channel 44 . Unlocking the locking mechanism 3 means clamp 41 is moved out of the recess 42 .
  • the rotation of the handle part 2 is illustrated by Fig . 5c, 5d and 5e .
  • the handle part 2 After having rotated the handle part 2 over a certain angle , the handle part 2 is aligned more vertically, such that the swab part 1 starts moving downwards the bottom of the test tube by help of gravity while the j oint 43 slides inside the inner channel 44 along the main axis 17 of the swab part 1 through the whole inner channel 44 . Finally, the j oint 43 leaves the inner channel 44 through the outlet 14 at the second end 12 of the swab part 1 and the handle part 2 completely decouples from the swab part 1 . The swab part 1 falls vertically to the bottom 54 of the test tube 5 .
  • a reagent can be released into the test tube 5 either as tablet , powder or as liquid and the reagent can pass through the hollow swab part 1 , i . e . through the elongated opening 18 , to the bottom 54 of the test tube 5 where it enters into contact with a medium that was already present in the test tube .
  • the sampling collection tool is packaged in a pouch equipped with a gas-permeable membrane .
  • the pouch and the sampling collection tool inside the pouch are sterili zed with ethylene oxide .
  • the sampling collection tool can also be packed in an air- and water-tight , sealed pouch which in addition can contain a wetting solution, in this case the sampling collection tool can be sterili zed by irradiation (UV or X-ray) .
  • Di f ferent tests were performed to confirm the functionality and the reliability of the described sampling collection tool .
  • One exemplary test procedure is as follows : - An overnight culture of Salmonella Typhi- murium ATCC 14028 was diluted in Tryptic Soy Broth to approximately 1 . 0E+ 05 cfu/ml .
  • the sampling collection tool was unpacked from its sterile pouch and the swab part was fully immersed in sterile NEMIS N-LightTM Neutrali zer (wetting solution) which had been filled into a standard sterile , disposable reagent reservoir for multichannel pipets .
  • the handle part was uncoupled from the swab part and the swab part was released into a standard sterile 15 ml screw cap tubes containing 5 ml buf fered peptone water as resuspension solution .
  • the surface of the sampling tool was rinsed by inverting, rolling, shaking and vortexing the tubes for 30 sec, thereby resuspending the collected bacterial cells .
  • the recovery rate of dried Salmonella cells from stainless steel was found to be on average 19 . 1 % , wherein the recovery rate is the percentage of cfu ( colony forming units ) recovered from cfu initially inoculated on the stainless steel plate sampled with the described collection device .
  • the recovery rate of dried Salmonella cells determined in a similar experiment for a commercially available , pre-wetted sponge product was in the same range .

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un outil de collecte d'échantillonnage qui comprend une partie écouvillon (1) cylindrique pour collecter des échantillons à partir d'une surface et une partie poignée (2) pour saisir l'outil de collecte d'échantillonnage qui est reliée à la partie écouvillon (1) cylindrique. La partie écouvillon (1) cylindrique et la partie poignée (2) forment une structure en forme de T ou en forme de L. L'outil de collecte d'échantillonnage est conçu de telle sorte que la partie poignée (2) peut être découplée de la partie écouvillon (1) par rotation de la partie poignée par rapport à la partie écouvillon pour transférer la partie écouvillon (1) cylindrique dans un tube à essai pour un traitement et une analyse ultérieurs.
PCT/EP2024/054576 2024-02-22 2024-02-22 Outil de collecte d'échantillonnage pour collecter des échantillons à partir de grandes surfaces et procédé de transfert dans un tube à essai Pending WO2025176304A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2024/054576 WO2025176304A1 (fr) 2024-02-22 2024-02-22 Outil de collecte d'échantillonnage pour collecter des échantillons à partir de grandes surfaces et procédé de transfert dans un tube à essai

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2024/054576 WO2025176304A1 (fr) 2024-02-22 2024-02-22 Outil de collecte d'échantillonnage pour collecter des échantillons à partir de grandes surfaces et procédé de transfert dans un tube à essai

Publications (1)

Publication Number Publication Date
WO2025176304A1 true WO2025176304A1 (fr) 2025-08-28

Family

ID=90053705

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/054576 Pending WO2025176304A1 (fr) 2024-02-22 2024-02-22 Outil de collecte d'échantillonnage pour collecter des échantillons à partir de grandes surfaces et procédé de transfert dans un tube à essai

Country Status (1)

Country Link
WO (1) WO2025176304A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070249961A1 (en) * 2006-02-17 2007-10-25 Morrison Allan D Biological sample collection device
US20110004122A1 (en) * 2009-04-26 2011-01-06 Jangbit Sangha Unitized system for collection, drying transport and analysis
US20130096463A1 (en) * 2010-04-21 2013-04-18 Puritan Medical Products Company, Llc Collection device and material
US20130116596A1 (en) * 2010-03-26 2013-05-09 Dna Genotek Inc. Sample collection tool
US20150241401A1 (en) * 2014-02-18 2015-08-27 Aemtek, Inc. Methods, systems and devices for batch sampling
US20180164189A1 (en) * 2016-12-09 2018-06-14 Rapiscan Systems, Inc. Sampling device including mechanical force feedback mechanism
US20190086305A1 (en) * 2017-09-21 2019-03-21 Becton, Dickinson And Company Sampling systems and techniques to collect hazardous contaminants with high pickup and shedding efficiencies
US20190120727A1 (en) * 2017-09-21 2019-04-25 Becton, Dickinson And Company Hazardous contaminant collection kit and rapid testing
US20200340887A1 (en) * 2019-04-25 2020-10-29 Fremonta Corporation Powered sampling device
US20220370257A1 (en) * 2021-04-09 2022-11-24 Illinois Tool Works Inc. Angled sampling swabs

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070249961A1 (en) * 2006-02-17 2007-10-25 Morrison Allan D Biological sample collection device
US20110004122A1 (en) * 2009-04-26 2011-01-06 Jangbit Sangha Unitized system for collection, drying transport and analysis
US20130116596A1 (en) * 2010-03-26 2013-05-09 Dna Genotek Inc. Sample collection tool
US20130096463A1 (en) * 2010-04-21 2013-04-18 Puritan Medical Products Company, Llc Collection device and material
US20150241401A1 (en) * 2014-02-18 2015-08-27 Aemtek, Inc. Methods, systems and devices for batch sampling
US20180164189A1 (en) * 2016-12-09 2018-06-14 Rapiscan Systems, Inc. Sampling device including mechanical force feedback mechanism
US20190086305A1 (en) * 2017-09-21 2019-03-21 Becton, Dickinson And Company Sampling systems and techniques to collect hazardous contaminants with high pickup and shedding efficiencies
US20190120727A1 (en) * 2017-09-21 2019-04-25 Becton, Dickinson And Company Hazardous contaminant collection kit and rapid testing
US20200340887A1 (en) * 2019-04-25 2020-10-29 Fremonta Corporation Powered sampling device
US20220370257A1 (en) * 2021-04-09 2022-11-24 Illinois Tool Works Inc. Angled sampling swabs

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