JP2003511186A - Sampling device - Google Patents

Abstract

(57) [Summary] A sampler device for collecting a test sample from the mouth of a human or animal includes a probe 11 inserted into the mouth or chin, and a container 70 into which the probe 11 is inserted after collecting the sample. Stop means 17, 47 are provided to form an irreversible snap fit after insertion of the probe 11.

Description

Detailed Description of the Invention

[0001]

【Technical field】

The present invention relates to a portable device for taking a sample from a subject and storing the sample for testing for the presence of a drug or other substance in the body.

[0002]

BACKGROUND OF THE INVENTION

Drug abuse spreads to all social classes, which makes it difficult for humans engaged in credible tasks, such as workers in heavy industry plants, pilots in planes, train drivers, and bus drivers, to learn about drug abuse. Occasionally tested randomly or regularly. Current drug testing devices are time consuming, cumbersome, require specialized knowledge to operate, and often require a blood sample to be taken from the subject.

Detecting drugs and other substances in the bloodstream of motorists is particularly needed, and there is a need for a quick and easy method for obtaining “on the spot” samples on the road. It is rare. It is also desirable that all samples be kept in a safe tamper-proof condition and consistent with the particular subject.

Samples obtained selectively or additionally from a subject (animal, plant or human) can be kept in storage for other tests, in particular DNA tests. In this case, it is desirable to maintain safe storage for an extended period of time until further testing or studies can be conducted.

[0005]

[Object of the Invention]

The present invention provides a simple device for taking a sample from the mouth of a subject, and a storage means for storing the device and sample in a tamper evident container.

[0006]

SUMMARY OF THE INVENTION According to the present invention, there is provided a sampler device comprising a probe for collecting a sample, and a container into which the probe can be irreversibly snap-fitted after collecting the sample.

[0007] The probe is preferably shaped to allow material to be taken from the gingival cavity of a mammal. Preferably, the probe comprises a stem having a handle and a shield disposed between the stem of the handle. The shield forms a snap-fit lid on the container after inserting the stem into the container and also allows the stem to be sealed so that the container can be sealed once and once the sample probe is retained therein. Sealing lips may be provided on the sides of adjacent shields. The distal portion of the stem preferably has a sample collection area of adsorbent that absorbs body exudates from within the mouth and jaw. This adsorbent region comprises a pad of high salt concentrate covered with a semipermeable membrane.

[0008] Preferably, the container comprises an inner liquid-holding reservoir and an outer plastic sleeve cover within which the reservoir is sealed, the cover comprising an opening having a tear-away lid, the opening comprising: When the probe is inserted after removing the lid, it should be possible to close with the probe. Preferably, the shield forms a snap-fit lid for the opening and the seal on the shield is seated against the reservoir.

Each handle and / or cover has a unique bar code so that once the sample is collected and once it is sealed in the container, it will not mix with other samples or be misidentified. be able to.

The handle and / or shield can be formed with a region that narrows to guide the hypodermic needle for removal of the test sample from the container and allow insertion through the lid, and preferably. , The handle should have a guide passage to the narrowing area.

The reservoir can be formed of an optically transparent material, such as glass or a transparent plastic material, and the sleeve can be made of any suitable chemical solution stored in the reservoir. It has openings formed on either side of the reservoir to allow a light beam directed to be excited or illuminated to pass through the container. Preferably, the opening is formed in the lower part of the container so that all light beams passing through the container are not distorted by the meniscus of any solution at the correct height in the reservoir.

A combination of enzymes and antibodies in the drug's direct metabolites can be targeted, which will excite any metabolite or derivative thereof as described in US Pat. No. 5,164,504. Therefore, by allowing light to pass through the solution, it can be detected in the solution utilizing fluorescence. Other chemistries and various light transmission and absorption techniques can be used to test other materials in situ within the tube.

The container can be formed as a one-piece container having an optical window formed in the lower half of the container. Further, according to the present invention, an opening having a peeling portion lid that allows the sample to be put into the container through the opening, and an irreversible snap-fit type lid that can be inserted into the opening to confine the sample inside. There is provided a sample container in which the above is formed.

[0014]   The present invention will be described by way of example with reference to the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION Referring now to FIGS. 1 and 2, a probe 11 for drawing a sample from the mouth or jaw of a human or animal suspected of drug abuse is illustrated. The probe 11 includes a stem 12 having a handle 13 at one end, and a lateral rectangular shield 14 is arranged between the stem and the handle. The end portion 15 of the stem is flared outwards,
Pads 16 are provided on each side of the end made of adsorptive material. Such materials are
It is a salt of high osmotic pressure, as in US Pat. No. 5,380,410.

The shield 14 on its side adjacent to the stem 12 has a pair of elastic undercut catches 17 at both ends thereof and a rectangular collar 18 around the stem 12. The collar 18 has a peripheral seal 19 formed on the collar.
The handle 13 may have a vertical passage 20 arranged to form a narrowing or weakened area 20A, which weakened area allows easier penetration of a hypodermic needle and is fluid for testing. To be able to aspirate. In addition, this area 20
The breakage of A indicates that an illegal tampering action was performed on the sample.

Referring now to FIGS. 7 and 8, a container 70 for use with the probe 11 is illustrated. The container comprises an inner reservoir 20 and an outer sleeve-like cover 40.

The reservoir 20 is shown in detail in FIGS. 3 and 4, and may be made of glass or, for example,
It comprises a hollow body of rectangular cross section made of an optically transparent material such as a plastic material such as polystyrene, thermoplastic polyester, polymethylmethacrylate, etc. The reservoir body 20 has an opening 21 at its upper end surrounded by a flat peripheral lip 22. The seal 23 is drawn from the upper end of the main body 20,
In use, it cooperates with the recess of the cover 40. Indicator sign 24 on the side of the tube
Indicates the height at which the reservoir should be filled with the chemical solution.

In use, a suitable detection chemistry that reacts with the sample retained on the probe is loaded into the reservoir through opening 21. The cover 40 is best shown in FIGS. 5 and 6 and comprises a sleeve-like body at the upper end of which is formed a cavity 41 of rectangular cross section having an opening 47 sealed by a tear closure 42. The opening opens at its lower end to receive the reservoir 20. The tabs 43 on the closure 42 serve to remove the closure 42 during use. The cavity 41 has a reservoir 2 slidably fitted therein.
Accept 0. A peripheral recess 44 on the inner surface of the cavity is recessed from the closure 42 and also cooperates with the seal 23 of the reservoir body 20 during use. Notches or openings 45 are formed on both sides of the cover 40. The notch is preferably arcuate in shape and has a beveled edge 46 whose use is described below.

Referring again to FIGS. 7 and 8, the reservoir 20 is filled with the detection solution and then
It is assembled in the cover 40. The seal 23 in the reservoir engages the recess 44, seals the solution in the assembled container 70 and locks the reservoir in the cover. The container 70 is now tamper-proof and tamper-proof.

In use, the probe and assembled container are supplied in matched pairs in a sealed bag. The end portion 15 of the probe 11 is probably a predetermined time of about 3 minutes,
Place in suspect's mouth between gum and cheek. The pad 16 collects the exudates of organisms.
The shield 14 prevents cross-contamination of the handle and stem, and the handle of the tester and the suspect's mouth.

The cover 42 is removed from the sealed container 70 by peeling off the cover, and the stem 12 of the probe 11 is pushed into the solution in the reservoir 20. The capture portion 17 of the shield 14 engages within the cover opening 47 to lock the probe within the container 70.
A shield seal 19 sits against the lip 22 around the reservoir inlet 21 to seal the sample and detection fluid in the container. The locked probe provides a tamper-evident closure device once and once the sample has been placed in the detection fluid and the shield 14 snapped into place.

The assembled probe / container can then be placed in an optical test device or reader that does not form part of the invention, eg luminescence, fluorescence and colorimetric It can be operated by light absorption technology such as the technology.

The notch 45 in the lower portion of the cover allows optical transmission through the reservoir 20 and the detection fluid when the container is placed in the reader, and the integrity of the sample and test fluid is detrimental to the test. It will not be done.

An arched beveled edge 46 to the notch provides a reservoir placement device and a light-tight seal. The notch 45 is formed in the lower portion of the container and prevents any optical interference between the meniscus of the solution in the container 70 and any light beam that passes through the sample during reading of the test device.

The handle 13 of the probe and / or container 70 can carry a bar code that can be assigned to a particular suspect to prevent inconsistencies between the sample and the suspect.

In another embodiment of the invention illustrated in FIG. 11, container 170 is formed as a single hollow component with an optically transparent window 175 below the fluid container. You can As is conventional, the container is provided with a tear closure 172 to allow the probe to be inserted and locked into the container.

[Brief description of drawings]

[Figure 1]   It is a side view of a sampling probe.

[Fig. 2]   2 is an end view of the probe of FIG. 1. FIG.

[Figure 3]   FIG. 7 is a side view of a container reservoir.

[Figure 4]   FIG. 3 is an end view of the reservoir of FIG. 2.

[Figure 5]   FIG. 6 is a side view of a container cover that fits over the reservoir.

[Figure 6]   FIG. 6 is an end view of the cover shown in FIG. 5.

[Figure 7]   It is a side view of a cover and a reservoir when assembled.

[Figure 8]   FIG. 8 is an end view of the assembly of FIG. 7.

[Figure 9]   It is a side view of a container and a probe in an assembled state.

[Figure 10]   FIG. 10 is an end view of the container and probe illustrated in FIG. 9.

FIG. 11   FIG. 6 is a view of one alternative container in the open and closed states.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, MZ, SD, SL, SZ, TZ, UG , ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, C U, CZ, DE, DK, EE, ES, FI, GB, GE , GH, GM, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, L S, LT, LU, LV, MD, MG, MK, MN, MW , MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, T T, UA, UG, US, UZ, VN, YU, ZA, ZW

Claims (17)

[Claims] 1. A sampler device for collecting a sample for testing from the mouth of a human or an animal, wherein the probe is inserted into the mouth or the jaw, and after the sample is collected, the probe is irreversibly snap-fitted. A sampler device equipped with a whole container. 2. The sampler device according to claim 1, wherein the probe further comprises a stalk having a handle, and a shield disposed between the handle and the probe. 3. The sampler device according to claim 2, wherein the shield is
A sampler device that forms a snap-fit lid on the container after the stem of the probe is inserted into the container. 4. The sampler device of claim 2 or 3, wherein the shield comprises a shield adjacent to the stem so that the container can be sealed once the sample probe is retained therein. A sampler device with a sealing lip on the side. 5. The sampler device according to any one of claims 1 to 4, wherein the end portion of the stem portion has an adsorbent sample collecting portion that absorbs exudates. 6. A sampler device according to claim 1, wherein the container comprises an inner liquid holding reservoir and an outer plastic sleeve cover within which the reservoir is sealed. A sampler device, wherein the cover comprises an opening with a tear lid, the probe being capable of closing the lid when the probe is inserted after removing the lid. 7. The sampler device of claim 6, wherein the shield forms a snap fit lid for the opening and the seal of the shield seats against the reservoir. 8. The sampler device of claim 6 or 7, wherein the reservoir is formed of a transparent material and the sleeve allows the light beam to pass through the container. A sampler device having openings formed on both sides. 9. The sampler device of claim 8, wherein the opening is located in the lower portion of the container. 10. The sampler device according to claim 1, wherein the container includes a hollow body having an optically transparent window portion arranged in a lower portion of the main body. apparatus. 11. The sampler device according to claim 1, wherein the probe and / or the container is provided with a unique barcode identification item. 12. The sampler device according to any one of claims 1 to 11, wherein the container is provided with a tamper indicating closure prior to assembly with the probe. 13. The sampler device according to claim 1, wherein the probe forms a tamper-evident closure for the container after assembly with the container. 14. A sampler device according to any one of the dependent claims of claim 2, wherein the shield allows a hypodermic needle to be inserted through the lid so that the test sample can be removed from the container. A sampler device in which a region that becomes thinner is formed. 15. The sampler device of claim 14, wherein the handle has a guide passage to a tapered region formed therein. 16. In a sampler container, an opening formed with a lid of a tear portion that allows a sample to be put into the container through the opening, and an irreversible member that can be inserted into the opening so that the sample can be locked therein. A sampler container having a snap fit type lid. 17. The sampler container of claim 16, wherein the snap fit lid forms a fluid tight seal with the opening.