AU7808500A

AU7808500A - Sample taking device

Info

Publication number: AU7808500A
Application number: AU78085/00A
Authority: AU
Inventors: Denis Marshall-Fraser
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-10-18
Filing date: 2000-10-17
Publication date: 2001-04-30
Also published as: WO2001028428A1; CA2386987A1; CN1379641A; EP1223866A1; JP2003511186A

Description

WO 01/28428 PCT/GBOO/03983 Sample Taking Device Field This invention relates to a portable device for taking 5 samples from subjects for testing the presence of drugs or other substances in the body, and for storage of samples. Background of the Invention Drug abuse extends to all walks of life and persons in 10 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 15 frequently rely upon taking a blood sample from a subject The detection of drugs and other substances in the bloodstream of motorists, in particular, is becoming a necessity and a quick simple method of obtaining an 'on 20 the-spot' sample at the road side is desirable. It is also desirable that any sample is held in a secure tamper proof condition and can be matched with a particular subject. Samples taken from a subject ( animal, plant or person) 25 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 WO 01/28428 PCT/GBOO/03983 2 research can be carried out. Object of the Invention The present invention provides a simple device for taking an sample from the mouth of a subject and storage means for 5 storing said device and sample in a tamper evident container. Statements of Invention According to the invention there is provided a sampler 10 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 15 gingival cavity of mammals. Preferably, 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 20 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 25 which is covered in a semi-permeable membrane. Preferably the container comprises and inner liquid retaining reservoir and an outer plastic sleeve cover into WO 01/28428 PCT/GBOO/03983 3 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. Preferably, the shield forms the snap-in lid for said aperture and the 5 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. 10 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 15 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 20 reservoir to allow a directed light beam to pass through the container to excite or illuminate any suitable chemical solution stored within the reservoir. Preferably the openings are located in the lower portion of the container so that any light beam passing through the container will 25 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 WO 01/28428 PCT/GB00/03983 4 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. 5 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 10 optical windows formed in the lower half of the container. Also according to the invention there is provided a sample container having an aperture with a tear-away portion lid allowing a sample to be placed in the container through the 15 aperture, and an irreversible snap fit lid which is insertable into the aperture to lock the sample therein. Description of Drawings The invention will be described by way of example and with 20 reference to the accompanying drawings in which: Fig. 1 is a side view of a sample taking probe, Fig. 2 is an end elevation of the probe of Fig.1, Fig. 3 is a side view of a container reservoir, Fig. 4 is an end elevation of the reservoir of 25 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 WO 01/28428 PCT/GBOO/03983 5 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, 5 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, and Fig. 11 shows an alternative container in the open 10 and closed conditions. Detailed Description of the Invention With reference now to Fig.1 and Fig.2, there is shown a probe 11 for taking samples from the mouth or jaw of a 15 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 20 from an absorptive material. Such a 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, 25 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 WO 01/28428 PCT/GBOO/03983 6 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. 5 Now with reference to Figs 7 & 8, there is shown 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. 10 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, 15 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 20 the level to which the reservoir should be filled with chemical solutions. In use the reservoir is filled through the opening 21 with a suitable solution of detection chemicals which react with 25 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 WO 01/28428 PCT/GBOO/03983 7 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 5 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 10 preferably in the form of arches and have inclined edges 46, the use of which will explained later in the text. Referring again to Figs 7 & 8, the reservoir 20 is filled with detection solution and is then assembled within the 15 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. 20 In use 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. 25 The shield 14 prevents any cross contamination between the handle and the stem and between the testers hands and suspects mouth.

WO 01/28428 PCT/GBOO/03983 8 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 5 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 10 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 15 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 20 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. 25 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 WO 01/28428 PCT/GBOO/03983 9 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. 5 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. 10 In another embodiment of the invention shown in Fig 11, 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 15 with a tear-off closure 172 as before allowing a probe to be inserted and locked within the container. 20 25

Claims

1. A sampler device for taking samples for testing from the mouth of a person or animal and comprising a probe for 5 insertion into a mouth or jaw , and a container into which the probe is an irreversible snap-fit after the taking of a sample.

2. A sampler device as claimed in Claim 1, wherein the 10 probe further comprises a stem with a handle, and a shield located between the handle and the probe.

3. A sampler device as claimed in Claim 2 wherein the shield forms a snap-fit lid with the container after the 15 stem of the probe is inserted into the container.

4. A sampler device as claimed in Claim 2 or Claim 3 wherein the shield includes a sealing lip on the side of the shield adjacent the stem for sealing the container once 20 the sample probe is retained therein.

5. A sampler device as claimed in any one of Claims 1 to 4 wherein the distal end portion of the stem has an absorbent sample collecting portion which absorbs exudates. 25

6. A sampler device as claimed in any one of Claims 1 to 5 wherein the container comprises and inner liquid retaining reservoir and an outer plastic sleeve cover into which the WO 01/28428 PCT/GBOO/03983 11 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. 5

7. A sampler device as claimed in Claim 6 when depending from Claim 2 wherein the shield forms the snap-in lid for said aperture and the seal on the shield sits against the reservoir. 10

8. A sampler device as claimed in Claim 6 or Claim 7 wherein the reservoir is formed from a transparent material and the sleeve has openings therein on opposite sides of the reservoir to allow a light beam to pass through the container 15

9. A sampler device as claimed in Claim 8 wherein the openings are located in the lower portion of the container.

10. A sampler device as claimed in any one of Claims 1 to 20 5 wherein the container comprises a hollow body with a optically transparent windows located in the lower portion of the body.

11. A sampler device as claimed in any one of Claims 1 to 25 10 wherein the probe and/or container are provided with a unique bar code identification. WO 01/28428 PCT/GBOO/03983 12

12. A sampler as claimed in any one of Claims 1 to 11 wherein the container is provided with a tamper evident closure prior to assembly with the probe. 5

13. A sampler device as claimed in any one of Claims 1 to 12 wherein the probe forms a tamper evident closure with the container after assembly thereto.

14. A sampler device as claimed in any claim dependent from 10 Claim 2, wherein the shield is formed with a thinned down area to permit a hyperdermic needle to be inserted through the lid for removing test samples from the container.

15. A sampler device as claimed in Claim 14 wherein the 15 handle has a guide channel to the thinned area formed therein.

16. A sample container having an aperture with a tear-away portion lid allowing a sample to be placed in the container 20 through the aperture, and an irreversible snap fit lid which is insertable into the aperture to lock the sample therein.

17. A sample container as Claimed in Claim 16, wherein the 25 snap fit lid makes a fluid tight seal with the aperture.