WO2001028428A1 - Dispositif de prelevement d'echantillons - Google Patents

Dispositif de prelevement d'echantillons Download PDF

Info

Publication number
WO2001028428A1
WO2001028428A1 PCT/GB2000/003983 GB0003983W WO0128428A1 WO 2001028428 A1 WO2001028428 A1 WO 2001028428A1 GB 0003983 W GB0003983 W GB 0003983W WO 0128428 A1 WO0128428 A1 WO 0128428A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
probe
sampler device
sample
reservoir
Prior art date
Application number
PCT/GB2000/003983
Other languages
English (en)
Inventor
Dennis Marshall-Fraser
Original Assignee
Marshall Fraser Dennis
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
Priority claimed from GBGB9924449.3A external-priority patent/GB9924449D0/en
Application filed by Marshall Fraser Dennis filed Critical Marshall Fraser Dennis
Priority to AU78085/00A priority Critical patent/AU7808500A/en
Priority to JP2001531028A priority patent/JP2003511186A/ja
Priority to EP00968131A priority patent/EP1223866A1/fr
Priority to CA002386987A priority patent/CA2386987A1/fr
Publication of WO2001028428A1 publication Critical patent/WO2001028428A1/fr

Links

Classifications

    • 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
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/94Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • 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
    • A61B10/0096Casings for storing test 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
    • A61B2010/0009Testing for drug or alcohol abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0067Types of closures or fasteners
    • A61B2050/0083Snap connection

Definitions

  • This invention relates to a portable device for taking samples from subjects for testing the presence of drugs or other substances in the body, and for storage of samples.
  • Drug abuse extends to all walks of life and persons in positions of trust such as heavy plant operators, airline pilots, train drivers, bus drivers etc. are sometimes randomly or routinely tested for drug abuse.
  • Current devices for testing for drugs are time consuming, cumbersome and require specialist knowledge to operate and frequently rely upon taking a blood sample from a subject
  • Samples taken from a subject alternatively or additionally may be held in storage for other tests in particular DNA tests. In this case it is desirable that test samples should be held in safe storage for prolonged periods of time until further tests, or research can be carried out.
  • the present invention provides a simple device for taking an sample from the mouth of a subject and storage means for storing said device and sample in a tamper evident container.
  • a sampler device comprising a probe for taking a sample, and a container into which the probe is an irreversible snap-fit after the taking of the sample.
  • the probe is preferably shaped for taking material from the gingival cavity of mammals.
  • the probe further comprises a stem with a handle and a shield located between the handle and the stem.
  • the shield forms a snap-fit lid to the container after the stem is inserted into the container and may include a sealing lip on the side of the shield adjacent the stem for sealing the container once the sample probe is retained therein.
  • the distal end portion of the stem has an absorbent sample collecting area which absorbs bodily exudates, preferably from inside the mouth and jaw.
  • the absorbent area comprises a pad of high salt concentrate which is covered in a semi-permeable membrane.
  • the container comprises and inner liquid retaining reservoir and an outer plastic sleeve cover into which the reservoir is sealed, the cover having an aperture with a tear-away lid, which aperture may closed after removal of the lid, by the probe when inserted.
  • the shield forms the snap-in lid for said aperture and the seal on the shield sits against the reservoir.
  • Each handle and/or cover may be given a unique bar code so that taken samples once sealed into the container cannot be mixed up or wrongly identified with other samples.
  • the handle and/or shield may be formed with a thinned down area to guide and permit a hyperdermic needle to be inserted through the lid for removing test samples from the container, and preferably the handle has a guide channel to the thinned area.
  • the reservoir may be formed from an optically transparent material e.g. glass or transparent plastics material, and the sleeve has openings therein on opposite sides of the reservoir to allow a directed light beam to pass through the container to excite or illuminate any suitable chemical solution stored within the reservoir.
  • the openings are located in the lower portion of the container so that any light beam passing through the container will not be distorted by the meniscus of any solution at the correct level within the reservoir.
  • a combination of enzymes and antibodies may be targeted at the direct metabolites of drugs and these may be detected in fluoroscene based solutions using optical transmissions through the solution to excite any the metabolites or derivatives thereof, as is described in US patent 5164504.
  • Other materials may be tested in situ in the tube using other chemistries and various light transmission and absorption techniques.
  • the container may be formed as a one piece container having optical windows formed in the lower half of the container.
  • a sample container having an aperture with a tear-away portion lid allowing a sample to be placed in the container through the aperture, and an irreversible snap fit lid which is insertable into the aperture to lock the sample therein.
  • Fig. 1 is a side view of a sample taking probe
  • Fig. 2 is an end elevation of the probe of Fig.l
  • Fig. 3 is a side view of a container reservoir
  • Fig. 4 is an end elevation of the reservoir of Fig.2
  • Fig. 5 is a side view of a container cover which fits over the reservoir
  • Fig. 6 is an end elevation of the cover shown in Fig.5
  • Fig. 7 is a side view of the cover and reservoir when assembled
  • Fig. 8 is an end view of the assembly of Fig.7
  • Fig. 9 is a side view of the container and probe in an assembled state
  • Fig. 10 is an end view of the container and probe shown in Fig 9
  • Fig. 11 shows an alternative container in the open and closed conditions.
  • a probe 11 for taking samples from the mouth or jaw of a person or animal suspected of drug abuse.
  • the probe 11 has a stem 12 with a handle 13 at one end with transverse rectangular shield 14 located between the stem and handle.
  • the distal end portion 15 of the stem is broadened out and has pad 16 on each side of the end portion which is formed from an absorptive material .
  • an absorptive material is a hypertonic salt as is described in US 5830 410.
  • the shield 14 on its side adjacent the stem 12 has a pair of resilient undercut catches 17 at opposite ends thereof, and a rectangular collar 18 around the stem 12.
  • the collar 18 has a peripheral seal 19 formed thereon.
  • the handle 13 may have a vertical channel 20 located therein extending into the shield to form a thinned or weakened area 20A which permits easier penetration of a hyperdermic needle allowing the extraction of fluids for tests. The rupture of the area 20A will also indicate if a sample has been tampered with.
  • a container 70 which will be used together with the probe 11.
  • the container comprises an inner reservoir 20 and an outer sleeve-like cover 40.
  • the reservoir 20 is shown in detail in Figs 3 & 4 and comprises a rectangular section hollow body made from an optically transparent material such as glass, or plastics material e.g polystyrene, thermoplastic polyester, polymethylmethacrylate etc.
  • the reservoir body 20 has an opening 21 at its upper end surrounded by a flat peripheral lip 22.
  • a seal 23 is set back from the upper end of the body 20 and in use co-operates with a recess in the cover 40.
  • An indicator mark 24 on the side of the tube indicates the level to which the reservoir should be filled with chemical solutions.
  • the reservoir is filled through the opening 21 with a suitable solution of detection chemicals which react with a sample contained on the probe.
  • the cover 40 is best shown in Figs 5 & 6. and comprises a sleeve-like body having a rectangular section cavity 41 with an opening 47 at its upper end sealed by a tear-off closure 42 and which is open at its lower end to receive a reservoir 20.
  • a tab 43 on the closure 42 assists removal of the closure 42 in use.
  • the cavity 41 accommodates the reservoir 20 which is a sliding fit therein.
  • a peripheral recess 44 in the inner surface of the cavity is set back from closure 42 and in use cooperates with the seal 23 on the reservoir body 20.
  • Cut-outs or openings 45 are located on opposite sides of the cover 40. The cut outs are preferably in the form of arches and have inclined edges 46, the use of which will explained later in the text.
  • the reservoir 20 is filled with detection solution and is then assembled within the cover 40.
  • the seal 23 on the reservoir engages in the recess 44 to both seal the solution in the assembled container 70 and locks the reservoir within the cover.
  • the container 70 is now both tamper evident and tamper proof.
  • the probe and assembled container are supplied as a matched pair in sealed bags.
  • the distal end portion 15 of the probe 11 is placed in a suspects mouth between the gums and the cheek for a predetermined time period, probably about three minutes.
  • the pads 16 collect the bioexudate.
  • the shield 14 prevents any cross contamination between the handle and the stem and between the testers hands and suspects mouth.
  • the cover 42 is removed from the sealed container 70 by tearing off said cover, and the stem 12 of the probe 11 is pushed into the solution within the reservoir 20.
  • the catches 17 on the shield 14 engage within opening 47 on the cover to lock the probe within the container 70.
  • the seal 19 on the shield seats against the lip 22 around the mouth 21 of the reservoir to seal the taken sample and detection fluid within the container.
  • the locked in probe provides a tamper evident closure device once the sample has been placed within the detection fluid and the shield 14 snapped into place.
  • the assembled probe/container may now be placed into an optical testing instrument or reader, which forms no part of the present invention, and which may operate by for example, light absorption techniques such as luminescence, fluoroscene, and colorimetric techniques.
  • the cut-outs 45 in the lower portion of the cover allow for optical transmission through the reservoir 20 and detection fluid when the container is placed in the reader so that integrity of the sample and test fluid is not breached for testing.
  • the arch shaped inclined edges 46 to the cut outs provide a location device within the reader and light proof seals.
  • the cut outs 45 are located in the lower portion of the container to prevent any optical interference between the meniscus of the solution within the container 70 and any light beam passed through the sample during the reading of the test instrument.
  • the handle 13 of the probe and/or the container 70 may carry a bar code which can be assigned to a particular suspect in order to prevent mis matches between samples and suspects.
  • the container 170 may be formed as a single hollow component with an optically clear window 175 provided in the lower portion of the fluid container.
  • the container is provided with a tear-off closure 172 as before allowing a probe to be inserted and locked within the container.

Abstract

L'invention porte sur un dispositif de prélèvement d'échantillons dans la bouche d'un patient ou d'un animal comprenant une sonde (11) buccale et un récipient (70), où l'on place la sonde (11) après la prise, muni d'un cran (17, 47) permettant un encliquetage irréversible après insertion de la sonde (11).
PCT/GB2000/003983 1999-10-18 2000-10-17 Dispositif de prelevement d'echantillons WO2001028428A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU78085/00A AU7808500A (en) 1999-10-18 2000-10-17 Sample taking device
JP2001531028A JP2003511186A (ja) 1999-10-18 2000-10-17 試料採取装置
EP00968131A EP1223866A1 (fr) 1999-10-18 2000-10-17 Dispositif de prelevement d'echantillons
CA002386987A CA2386987A1 (fr) 1999-10-18 2000-10-17 Dispositif de prelevement d'echantillons

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB9924449.3 1999-10-18
GBGB9924449.3A GB9924449D0 (en) 1999-10-18 1999-10-18 Rapid drug detection system
GB0021698.6 2000-09-05
GB0021698A GB2355525A (en) 1999-10-18 2000-09-05 Sampling device for oral cavity

Publications (1)

Publication Number Publication Date
WO2001028428A1 true WO2001028428A1 (fr) 2001-04-26

Family

ID=26244964

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/003983 WO2001028428A1 (fr) 1999-10-18 2000-10-17 Dispositif de prelevement d'echantillons

Country Status (6)

Country Link
EP (1) EP1223866A1 (fr)
JP (1) JP2003511186A (fr)
CN (1) CN1379641A (fr)
AU (1) AU7808500A (fr)
CA (1) CA2386987A1 (fr)
WO (1) WO2001028428A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1389445A2 (fr) * 2002-08-14 2004-02-18 Cozart Bioscience Limited Dispositif pour la collecte, l'analyse et le transport de fluide oral
EP1692255A2 (fr) * 2003-11-12 2006-08-23 Trustees Of Boston University Extraction d'acide nucleique de cellules epitheliales de la bouche
JP2014153127A (ja) * 2013-02-06 2014-08-25 Railway Technical Research Institute トイレの尿汚れ判定用の採取器具、トイレの尿汚れ判定キット及びトイレの尿汚れの判定方法
US9920374B2 (en) 2005-04-14 2018-03-20 Trustees Of Boston University Diagnostic for lung disorders using class prediction
US10526655B2 (en) 2013-03-14 2020-01-07 Veracyte, Inc. Methods for evaluating COPD status
US10570454B2 (en) 2007-09-19 2020-02-25 Trustees Of Boston University Methods of identifying individuals at increased risk of lung cancer
US10731223B2 (en) 2009-12-09 2020-08-04 Veracyte, Inc. Algorithms for disease diagnostics
US10927417B2 (en) 2016-07-08 2021-02-23 Trustees Of Boston University Gene expression-based biomarker for the detection and monitoring of bronchial premalignant lesions
US11639527B2 (en) 2014-11-05 2023-05-02 Veracyte, Inc. Methods for nucleic acid sequencing

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434227B (zh) * 2013-09-21 2017-05-10 邹建文 一种一次往返自锁口腔细胞采集与保存装置
US9527241B2 (en) 2013-12-20 2016-12-27 Xerox Corporation Three dimensional (3D) printing of epoxy, hardener, and parts of an object to be assembled later
CN104306029A (zh) * 2014-11-04 2015-01-28 温鑫 一种显色的组织渗液采样和检测装置
CN106190801A (zh) * 2016-07-17 2016-12-07 佛山市大臻医学检验所有限公司 分离式口腔采样拭子

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4522302A (en) * 1984-03-05 1985-06-11 Sterling Drug Inc. Pre-sterilized medical procedure kit packages
EP0442600A2 (fr) * 1990-02-11 1991-08-21 Charles Terrence Macartney Tube pour la collection d'échantillons biologiques
US5164504A (en) 1991-01-16 1992-11-17 Abbott Laboratories Haptens, tracers, immunogens and antibodies for immunoassays for cotinine derivatives
EP0734686A1 (fr) * 1995-03-30 1996-10-02 Ortho Pharmaceutical Corporation Dispositif domestique de prélèvement d'un échantillon de fluide oral et son emballage postal
WO1997020502A1 (fr) * 1995-12-01 1997-06-12 Lamprecht Ag Dispositif de prelevement d'echantillons de salive
US5830410A (en) 1989-09-21 1998-11-03 Epitope, Inc. Oral collection device and kit

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4522302A (en) * 1984-03-05 1985-06-11 Sterling Drug Inc. Pre-sterilized medical procedure kit packages
US5830410A (en) 1989-09-21 1998-11-03 Epitope, Inc. Oral collection device and kit
EP0442600A2 (fr) * 1990-02-11 1991-08-21 Charles Terrence Macartney Tube pour la collection d'échantillons biologiques
US5164504A (en) 1991-01-16 1992-11-17 Abbott Laboratories Haptens, tracers, immunogens and antibodies for immunoassays for cotinine derivatives
EP0734686A1 (fr) * 1995-03-30 1996-10-02 Ortho Pharmaceutical Corporation Dispositif domestique de prélèvement d'un échantillon de fluide oral et son emballage postal
WO1997020502A1 (fr) * 1995-12-01 1997-06-12 Lamprecht Ag Dispositif de prelevement d'echantillons de salive

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1389445A2 (fr) * 2002-08-14 2004-02-18 Cozart Bioscience Limited Dispositif pour la collecte, l'analyse et le transport de fluide oral
EP1389445A3 (fr) * 2002-08-14 2004-05-19 Cozart Bioscience Limited Dispositif pour la collecte, l'analyse et le transport de fluide oral
EP1692255A2 (fr) * 2003-11-12 2006-08-23 Trustees Of Boston University Extraction d'acide nucleique de cellules epitheliales de la bouche
EP1692255A4 (fr) * 2003-11-12 2010-12-08 Univ Boston Extraction d'acide nucleique de cellules epitheliales de la bouche
US9920374B2 (en) 2005-04-14 2018-03-20 Trustees Of Boston University Diagnostic for lung disorders using class prediction
US10808285B2 (en) 2005-04-14 2020-10-20 Trustees Of Boston University Diagnostic for lung disorders using class prediction
US10570454B2 (en) 2007-09-19 2020-02-25 Trustees Of Boston University Methods of identifying individuals at increased risk of lung cancer
US10731223B2 (en) 2009-12-09 2020-08-04 Veracyte, Inc. Algorithms for disease diagnostics
JP2014153127A (ja) * 2013-02-06 2014-08-25 Railway Technical Research Institute トイレの尿汚れ判定用の採取器具、トイレの尿汚れ判定キット及びトイレの尿汚れの判定方法
US10526655B2 (en) 2013-03-14 2020-01-07 Veracyte, Inc. Methods for evaluating COPD status
US11639527B2 (en) 2014-11-05 2023-05-02 Veracyte, Inc. Methods for nucleic acid sequencing
US10927417B2 (en) 2016-07-08 2021-02-23 Trustees Of Boston University Gene expression-based biomarker for the detection and monitoring of bronchial premalignant lesions

Also Published As

Publication number Publication date
CA2386987A1 (fr) 2001-04-26
JP2003511186A (ja) 2003-03-25
EP1223866A1 (fr) 2002-07-24
CN1379641A (zh) 2002-11-13
AU7808500A (en) 2001-04-30

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