AU2019364688B2

AU2019364688B2 - Sample analysis device and sampling element for a sample analysis device

Info

Publication number: AU2019364688B2
Application number: AU2019364688A
Authority: AU
Inventors: Verena Zimmermann
Original assignee: Securetec Detektions Systeme AG
Current assignee: Securetec Detektions Systeme AG
Priority date: 2018-10-24
Filing date: 2019-10-24
Publication date: 2024-09-26
Anticipated expiration: 2039-10-24
Also published as: DE202018106075U1; EP3870028A1; WO2020084030A1; AU2019364688A1

Abstract

The present invention relates to a sample analysis device (10, 110) for analysing at least one human body fluid sample, in particular a saliva sample, said device comprising at least one base body (12, 112), at least one analysis element (14, 114) for the body fluid sample, at least one sampling element (18, 118) for the body fluid sample, and at least one air duct (24, 124) for the passage of human respiratory air, wherein: the base body (12, 112) has the analysis element (14, 114); in the assembled state, the sampling element (18, 118) is detachably fastened to the base body (12, 112) and forms at least one analysis contact area with the analysis element (14, 114) for the transfer of the body fluid sample to the analysis element (14, 114); the air duct (24, 124) is attached to the sampling element (18, 118); the sampling element (18, 118) also comprises at least one sampling area (36, 136) for the body fluid sample; the air duct (24, 124) comprises at least one open end for blowing in air; and the open end is located adjacent to the sampling area (36, 136). The invention also relates to a sampling element (18, 118).

Description

Sample Analysis Device and Extraction Element for a Sample Analysis Device

1. FIELD OF THE INVENTION The present invention relates to a sample analysis device for analyzing at least one human body fluid sample and to an extraction element for such a sample analysis device.

2. BACKGROUND OF THE INVENTION

Test systems for prohibited substances such as drug tests are already known from prior art.

Such drug test systems are known, for example, from patent publications EP 2 564 196 B1, EP 2 637 021 A1, EP 2 823 309 B1, EP 2 722 669 A1 or EP 2 909 633 A1. In these systems, in particular saliva samples are brought into contact with corresponding test strips, so that the presence of corresponding drugs or drug consumption can be concluded by means of corresponding markings.

In particular, patent publication EP 2 823 309 B1 describes such a rapid drug test.

In addition, it is known from prior art to provide methods and devices for determining the blood alcohol level by analyzing the respiratory air using a measuring apparatus. For instance, an example of this is described in patent publication EP 0 510 484 A2.

At present, existing test systems are designed either for alcohol or as a rapid drug test.

It would be desirable to further develop a sample analysis device and an extraction element of the above-mentioned type in an advantageous manner, in particular to the effect that the handling can be improved and further fields of applications can be opened up.

3. SUMMARY OF THE INVENTION

According to the invention, a sample analysis device for analyzing at least one human body fluid sample is provided, in particular for analysing a saliva sample, the device comprising at least one base body, at least one analysis element for the body

21098355_1 (GHMatters) P115943.AU fluid sample, at least one extraction element for the body fluid sample and at least one air guiding channel for the passage of human respiratory air, the base body comprising the analysis element, the extraction element, in the mounted state, being detachably fastened to the base body and, together with the analysis element, forming at least one analysis contact area for transferring the body fluid sample to the analysis element, the air guiding channel being attached to the extraction element, the extraction element further comprising at least one extraction area for the body fluid sample, wherein the air guiding channel comprises at least one open end for insufflating air and wherein the open end is arranged so as to be adjacent to the extraction area, wherein the extraction element comprises at least one mouth contact area in which the extraction area is arranged wherein the extraction area comprises at least one extraction hollow protrusion which is open on one side, and wherein the extraction area comprises at least one fleece pad for receiving the body fluid sample.

The basic idea of the invention is that a sample analysis device can be used both as a drug test or for analyzing a body fluid sample and simultaneously for analyzing the respiratory air. In particular, the extraction element for the samples, i.e. a sample of a body fluid such as a saliva sample, as well as a sample of respiratory air is made easily available for this purpose. In particular, a difficulty with drug users is that they may only be able to provide a small amount of saliva, as they have a so-called "dry mouth". This is especially a problem in the case of cannabis users. Due to the fact that the air guiding channel and the corresponding insufflation opening are located in the extraction area for extracting the body fluid sample, it is possible to extract both respiratory air and a saliva sample in a single sampling step. This is due to the fact that the insufflation of air already requires the sample donor to bring the extraction element to his or her mouth and that then it is comparatively easy for him or her to moisten the corresponding extraction area for the body fluid sample with saliva.

In addition, it may be provided that the extraction element comprises at least one mouth contact area in which the extraction area is arranged. The mouth contact area may be a mouthpiece or an integrally formed mouthpiece at which the sample donor can blow through the extraction element and the corresponding air guiding channel.

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In addition, the extraction area is provided as part of the mouth contact area, with which the saliva sample can be extracted.

Then, the extraction area preferably collects saliva, which can be subsequently transferred to a drug (rapid) test.

Here, it is conceivable to supply the saliva collected in this way to an appropriate test, e.g. one or more test strips.

For example, this may be a lateral flow drug test. Such a system is known, for example, from patent publication EP 2 823 309 B1.

The analysis of the respiratory air is, in particular, a test for determining the so-called "breath alcohol", i.e. the alcohol content of the respiratory air.

The extraction element may be designed as a purely mechanical element.

In particular, it may be provided that the extraction element does not have any electronics. It may be designed in such a way that it is used exclusively for conducting the insufflated respiratory air for sampling and for collecting saliva for the drug (rapid) test.

The extraction area may comprise at least one extraction hollow protrusion which is open on one side. This facilitates, for example, the production of the extraction element by means of plastic injection molding. The forming of the extraction area itself is also simplified thereby. In particular, it is conceivable that no material accumulations are required in this case, but rather that corresponding hollow protrusions may be provided, which may also facilitate sample extraction accordingly or may serve as a supporting framework for corresponding absorbents or as saliva sample extraction means as such.

The extraction hollow protrusion may comprise at least one open protrusion end and at least one closed protrusion end opposite said end. Such a design allows for a particularly stable and at the same time material-saving shaping. Such a design can also be realized at low cost.

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The extraction area itself may be provided with at least one fleece pad for receiving the body fluid sample. The fleece pad may be an absorbent fleece that can easily absorb saliva, for example, but at the same time can also release it if it is pressed onto corresponding test strips of the sample analysis device.

The fleece pad may be fastened to the extraction hollow protrusion by means of at least one material connection, in particular a welded connection. Fastening by means of a welded connection ensures that the fleece is not contaminated by, for example, an adhesive or the like, which would impair the absorbency of the fleece pad. A welded connection allows for a secure material connection that is also appropriately durable, even over a long storage period. It is also conceivable to create such a connection by means of soldering or an appropriate heat spot (or any other contour, such as a heat line) during assembly.

Furthermore, it may be provided that the fleece pad is fastened to the closed protrusion end. This allows for a secure attachment to the extraction hollow protrusion. At the same time, the closed protrusion end also allows for the fleece pad to be securely supported, so that it can be appropriately supported by the protrusion end also in the course of sample taking.

Furthermore, it may be provided the air guiding channel is formed in a one-piece or multi-piece design. In particular, it is conceivable that the air guiding channel has a multi-piece design. In the case of a multi-piece design, in particular a two-piece design, the air guiding channel is divided into several channels so that the air flow is divided accordingly. The appropriate division of the air flow also makes it conceivable and possible to appropriately frame a viewing window on the extraction device, so that in the case of a bifurcated air guiding channel a corresponding viewing window can be provided between the two air guiding channels. The viewing window serves to view the corresponding display areas of the sample analysis device, in which it can be displayed whether or not drugs have been consumed.

Furthermore, it may be provided that the air guiding channel branches, in sections, into at least one first partial air guiding channel and at least one second partial air guiding channel.

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The air guiding channel may comprise at least one further open end to which at least one adapter piece for connecting at least one breathalyzer can be attached. However, it is also conceivable that the adapter piece is integrally molded directly onto the air guiding channel. The adapter piece allows for connection to a corresponding blow tube or connector piece of a breathalyzer.

The adapter piece may have a geometry which is adaptable to different breathalyzers. In particular, it is conceivable that the adapter piece has an at least partially frustoconical section or a conical section. Thus, it is possible to attach different connection tubes for the breathalyzer with different diameters to the adapter piece or onto the adapter piece and thereby to establish a corresponding air guiding connection.

The adapter piece may have at least one predetermined breaking point. By means of the predetermined breaking point, it can be made possible to break off the adapter piece at this location, for example, to be able to connect the air guiding channel directly to a tube or a breathalyzer.

The air guiding channel may also extend asymmetrically between its two ends in the direction of its longitudinal axis or be formed so as to be asymmetric. By means of an asymmetrical design, for example, the air guiding channel can be placed around a corresponding viewing window of the extraction element, in case the air guiding channel is not divided.

The sample analysis device can be manufactured by means of injection molding and/or additive manufacturing. For example, it is conceivable to design the extraction element in at least two pieces, with the air guiding channels being placed as a separate piece onto a base element of the extraction element and then glued and/or welded there accordingly. Welding is preferred. However, it is also conceivable to correspondingly build up the air guiding channel on the base element of the extraction element by means of additive manufacturing (3D printing).

The sample analysis device may be designed as a passive sample analysis device. In particular, it is conceivable that the sample analysis device does not have an energy source such as a battery or an electrical energy source. Due to the saliva

21098355_1 (GHMatters) P115943.AU sample and corresponding capillary forces in the test strip as well as additional markers that are used there, a corresponding indication can be provided. Furthermore, it is not necessary either to provide an electronic connection between the sample analysis device and a possible breathalyzer.

Furthermore, the present invention relates to an extraction element for a sample analysis device as described above. The extraction element comprises the features of the extraction element as described above, i.e., in particular in addition to the air guiding channel for the passage of human respiratory air, which is attached to the extraction element, further at least one extraction area for the body fluid sample, the air guiding channel comprising at least one open end for the purpose of insufflating air and the open end being arranged adjacent to the extraction area.

Further details and advantages of the invention will become apparent from the following description of non-limiting, illustrative embodiments shown in the drawings.

4. BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a perspective view of a first embodiment of a sample analysis device according to the present invention with an adapter piece on the extraction element;

Fig. 2 is a perspective view of the extraction element according to the embodiment of Fig. 1;

Fig. 3 is a view of the extraction area of the extraction element according to Fig. 2;

Fig. 4 shows another embodiment of a sample analysis device according to the present invention;

Fig. 5 is a perspective view of the extraction element for the embodiment according to Fig. 4; and

Fig. 6 is a view of the extraction area of the embodiment according to Fig. 5.

5. DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Fig. 1 shows a perspective view of a first embodiment of the sample analysis device 10 for analyzing saliva.

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Here, the sample analysis device 10 is a multi-drug test, as it is known, for example, from Securetec as, for instance, DrugWipe 5S or DrugWipe 6S. More detailed information can also be found in patent publication EP 2 823 309 B1.

The sample analysis device 10 comprises a base body 12.

In the base body 12, an analysis element 14 in the form of one test strip or several test strips 16 is provided for the body fluid sample, for example saliva.

Furthermore, an extraction element 18 is provided, by means of which the saliva sample can be taken and be pressed onto the test strips 16 in a corresponding manner upon reinsertion in the base body 12.

Furthermore, a slide 20 is provided which can be displaced relative to the base body 12 and release an analysis liquid reservoir 22.

An analysis liquid can be stored in the analysis liquid reservoir 22, which can be released accordingly by applying pressure on the reservoir and then, by means of corresponding reactions, can make the drug test results visible in the viewing window in a corresponding manner.

Furthermore, as can be seen from Fig. 1, an air guiding channel 24 is arranged on the extraction element 18.

The air guiding channel 24 comprises a mouthpiece 26 and an adapter piece 28.

Starting from the mouthpiece 26, the air guiding channel 24 is divided into two partial air channels 30 and overall is adapted symmetrically.

Subsequently, the partial air channels 30 converge again toward the adapter piece 28.

The adapter piece 28 has a geometry that can be adapted to different breathalyzers.

This is achieved by providing a frustoconical section 32 which is suitable for multiple diameter sizes of adapter pieces for breathalyzers.

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Furthermore, the adapter piece 28 is provided with a predetermined breaking point 34, so that the adapter piece 28 can also be broken off accordingly and a tube section can be directly connected to the end of the air guiding channel 24.

The extraction element 18 comprises an extraction area 36 in the area of the mouthpiece 26.

The extraction area 36 comprises three extraction hollow protrusions 38.

A fleece pad 40 is attached to each of the extraction hollow protrusions 38 with weld spots 42 by means of ultrasonic welding.

The extraction hollow protrusions 38 comprise an open protrusion end 38a and a closed protrusion end 38b opposite this end.

The fleece pad 40 is fastened to the closed protrusion end 38b in a corresponding manner and is also supported over the surface area.

Fig. 2 shows a perspective view of the extraction element 18 shown in Fig. 1, which is mounted on the sample analysis device 10 accordingly in Fig. 1.

Fig. 3 shows the extraction element 18 allowing a view onto the mouthpiece 26 as well as the extraction area 36.

The extraction element 18 is manufactured by injection molding.

However, the air guiding channel 24 is manufactured as an injection-molded part, which is placed on the base body 12 of the extraction element 18 accordingly and welded there.

A laser welding process is mentioned as a conceivable process.

The mode of operation of the sample analysis device 10 is as follows:

The extraction device 18 is removed from the base body 12 of the sample analysis device 10 and the sample donor takes the mouthpiece 26 into the mouth, which also allows the extraction area 36 to come close to the sample donor's tongue. Consequently, this also allows the sample donor to use his/her tongue to moisten the fleece pads 40 and provide a saliva sample.

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Subsequently, respiratory air can be delivered through the mouthpiece 26 to a connected breathalyzer.

The breathalyzer is connected via the adapter piece 28, on which a corresponding connection tube is slid onto the conical connection surface 32.

The drug test function is described in patent publication EP 2 823 309 B1, for example.

Fig. 4 shows a further embodiment of a sample analysis device 110.

The sample analysis device 110 has the same structural and functional features as described above in connection with the sample analysis device 10 shown and described in Figs. 1 to 3.

Regarding the sample analysis devices 110 described in Figs. 4 to 6, identical or comparable features of the sample analysis device 10 are provided with identical reference numerals; however, said reference numerals are increased by the value 100.

There is only the following difference:

The adapter piece 28 is replaced by a pipe connector piece 128, whereby a corresponding pipe can be inserted in the ring slot 128a on the pipe connector piece 128.

As a matter of fact, the structure and the function are identical such as in connection with the sample analysis device 10, as described above.

It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms part of the common general knowledge in the art, in Australia or any other country.

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not

21098355_1 (GHMatters) P115943.AU to preclude the presence or addition of further features in various embodiments of the invention.

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List of reference numerals

sample analysis device 12 base body 14 analysis element 16 test strip 18 extraction element slide 22 analysis liquid reservoir 24 air guiding channel 26 mouthpiece 28 adapter piece partial air channels 32 frustoconical section 34 predetermined breaking point 36 extraction area 38 extraction hollow protrusions 38a open protrusion end 38b closed protrusion end fleece pad 42 weld spot

110 sample analysis device 112 base body 114 analysis element 116 test strip 118 extraction element 120 slide 122 analysis liquid reservoir 124 air guiding channel 126 mouthpiece 128 pipe connector piece

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128a ring slot 130 partial air channels 132 frustoconical section 134 predetermined breaking point 136 extraction area 138 extraction hollow protrusions 138a open protrusion end 138b closed protrusion end 140 fleece pad 142 weld spot

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Claims

1. A sample analysis device for analyzing at least one human body fluid sample, in particular a saliva sample, comprising at least one base body, at least one analysis element for the body fluid sample, at least one extraction element for the body fluid sample and at least one air guiding channel for the passage of human respiratory air, the base body comprising the analysis element, the extraction element, in the mounted state, being detachably fastened to the base body and, together with the analysis element, forming at least one analysis contact area for transferring the body fluid sample to the analysis element, the air guiding channel being attached to the extraction element, the extraction element further comprising at least one extraction area for the body fluid sample, wherein the air guiding channel comprises at least one open end for insufflating air and wherein the open end is arranged so as to be adjacent to the extraction area, wherein the extraction element comprises at least one mouth contact area in which the extraction area is arranged, wherein the extraction area comprises at least one extraction hollow protrusion which is open on one side, and wherein the extraction area comprises at least one fleece pad for receiving the body fluid sample.

2. The sample analysis device according to claim 1, characterized in that the extraction hollow protrusion comprises at least one open protrusion end and at least one closed protrusion end opposite said end.

3. The sample analysis device according to claim 1, characterized in that the fleece pad is fastened to the extraction hollow protrusion by means of at least one welded connection, in particular an ultrasonic spot welded connection.

4. The sample analysis device according to claim 1 or claim 3, characterized in that the fleece pad is fastened to the closed protrusion end.

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5. The sample analysis device according to any of the preceding claims, characterized in that the air guiding channel is formed in a one-piece or multi-piece, especially in a two-piece design.

6. The sample analysis device according to any of the preceding claims, characterized in that the air guiding channel branches, in sections, into at least one first partial air guiding channel and at least one second partial air guiding channel.

7. The sample analysis device according to any of the preceding claims, characterized in that the air guiding channel comprises at least one further open end to which at least one adapter piece for connecting at least one breathalyzer can be attached.

8. The sample analysis device according to claim 7, characterized in that the adapter piece has at least a geometry which is adaptable to various breathalyzers.

9. The sample analysis device according to claim 7 or claim 8, characterized in that the adapter piece comprises a frustoconical section.

10. The sample analysis device according to any of claims 7 to 9, characterized in that the adapter piece comprises at least one predetermined breaking point.

11. The sample analysis device according to any of claims 7 to 10, characterized in that the air guiding channel extends asymmetrically between its two ends in the direction of its longitudinal axis.

12. The sample analysis device according to any of the preceding claims, characterized in that the sample analysis device is manufactured by means of injection molding and/or additive manufacturing.

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13. The sample analysis device according to any of the preceding claims, characterized in that the sample analysis device is designed as a passive sample analysis device.

14. An extraction element for a sample analysis device according to any of the preceding claims, wherein the extraction element comprises the features of the extraction element.

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