WO2006063979A1

WO2006063979A1 - Container for urine sample

Info

Publication number: WO2006063979A1
Application number: PCT/EP2005/056693
Authority: WO
Inventors: Daniele Triva; Robert P. Rennie
Original assignee: Copan Innovation Limited
Priority date: 2004-12-13
Filing date: 2005-12-12
Publication date: 2006-06-22
Also published as: ITMI20042360A1

Abstract

The present invention relates to a device for taking, collecting and transporting specimens for urine analysis in which a substantially tubular container (11) is open at both the upper (12) and lower (13) ends, to said upper end there being sealedly connected a cap (14) from which a rod (15) terminating with a loop (16) extends into said container, spongy material (18) being provided at said lower end (13) for specimen collection.

Description

CONTAINER FOR URINE SAMPLE

FIELD OF THE INVENTION

The present invention relates to a device for taking, collecting and transporting specimens for urine analysis. BACKGROUND OF THE INVENTION

In diagnosis, the system generally in use for urine analysis is taking a specimen from the collection bottle by means of a pipette, with which the dosed specimen is transferred into a test tube normally containing a urinary tract bacterial colony overgrowth inhibitor, or a bacteriostat (for example boric acid). The test tube is closed with a cap and sent for analysis. This can be carried out immediately or within a maximum time period of generally a few hours if the specimen is stored in the refrigerator. The analysis is continued by immersing a rod terminating with a loop into the test tube containing the specimen, which provides for the collection of a minimum quantity of specimen and its transfer for example onto a petri dish for bacterial inoculation.

There are various problems connected with said known methods of analysis: in the first place, transfer of the specimen firstly from the flask to the test tube and then from this latter to the dish involves the two-fold risk of liquid wastage with attendant contamination of the analysis environment, and also contamination risks to the analyst.

Moreover, in this manner dosing the specimen by pipette is only an approximation, with consequent variation in the quantity of dosed specimen compared to the pre- established quantity of bacteriostat, and therefore variation in the stability and storage of the specimen. Furthermore, the dosage of specimen taken by the loop can also be insufficient, with the consequent risk of false analysis results. SUMMARY

In order to solve these problems, but also to achieve other advantages which will be described hereinafter, the present invention proposes principally a device for taking, collecting and transporting specimens for urine analysis characterised by comprising a substantially tubular container open at both the upper and lower ends, sealedly connected to a cap from which there extends into said container a rod terminating with a means for transferring said specimen, preferably a loop, at said lower end there being provided spongy material for specimen collection, said spongy material being able, if under sufficient pressure, to slide inside said tubular container from a first position relative to said lower end in which said spongy material remains outside said container, to a second position in which said spongy material is pushed inside said container until it reaches in proximity to said loop. With the aim of better understanding the characteristics and advantages of the invention, non-limiting examples of practical embodiment are described hereinafter, with reference to the figures of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows an elevational view of a device of the invention in the rest position, corresponding to said first position.

Figure 2 shows a longitudinal cross-section of the device of fig 1. Figure 3 shows a longitudinal cross-section of the device in a different operative position, corresponding to said second position. Figure 4 shows a detail of figure 3.

Figure 5 shows a perspective view of a component of the device suitable for supporting said spongy material.

Figure 6 shows a longitudinal cross-section of another embodiment of the device of the invention in the rest position, corresponding to said first position. Figure 7 shows a longitudinal cross-section of the device of fig. 6 in a different operative position corresponding to said second position. DETAILED DESCRIPTION OF THE INVENTION

With reference to these figures, a device 10 for taking, collecting and transporting specimens for urine analysis comprises a substantially tubular container 11 open at both the upper 12 and lower 13 ends, made of a plastic material sufficiently pliable when pressed with the fingers. To the upper end 12 there is connected an essentially cylindrical or frusto-conical cap 14 provided lowerly with a perimetral seat 19 able to receive by interference the circular edge of the end 12 to achieve its sealed closure. Centrally, from the body of the cap 14 a rod 15 rigidly extends terminating with a loop 16. In the example shown in the figure, the dimensions of said rod are such that when the cap is inserted, the rod extends inside the container for about two thirds of its length, so that the loop 16 is situated inside the container at a distance from the lower end 13 of about a third of the length of the container itself. Spongy material 18 is coupled to said lower end, for example a strip of polyurethane foam capable of absorbing liquids to allow collection of the specimen. It can preferably be provided, for example saturated, with a suitable suitably dosed bacteriostat. Said spongy material is applied by means of a support 17 in the form of a basket able to receive it and retain it in its interior by the effect of curved arms 20 which extend from an annular base 21 and intersect each other at 22. Said support 17 is also made of a pliable plastic material which allows the suitably dimensioned annular base 21 to be inserted into the container 11 from the lower end 13 and to engage it by interference, it being however able if under a sufficient pressure to slide along the inside of said tubular container as far as a second position in which said spongy material is positioned near said loop. In this respect, means can be provided to lock the support 17 in this position, such as for example a collar or a rib or teeth provided on the inner wall of the container 11 , or on the base of the support itself, to prevent it moving from the final operative position.

The device is provided with a cap 23 for also closing the container at its lower end 13, which is structurally totally similar to the cap 14 (except that in this case no rod is fixed thereto) and hence also achieving sealed closure by the effect of a perimetral seat 24 able to receive by interference the circular edge of the end 13. To achieve this sealed closure the interference can preferably be achieved, for both cap 14 and cap 23, by providing the respective perimetral seats 19 and 24 with pliable flanges 25 shown in the detail of figure 4. In an embodiment as shown in figures 6 and 7, means can also be provided to provisionally lock the support 17 to the inner wall of the container 11 in the said first position, to prevent it from accidentally moving from the said first position before reaching the said second position under a sufficient pressure. To such purpose, in the example of fig. 6 and 7 an annular seat 26 is provided in the form of a circular groove around the wall of the container 11. Projections 27 are provided around the annular base 21 of the support 17 to engage said annular seat 26 of the container. In the embodiment of figs. 6 and 7, it can also be seen that the rod 15 extends axially inside the container 11 , and the lower end 13 of the container has an enlarged diameter compared to that of the container 11 in order to facilitate the positioning of the support 17 inside it. The corresponding cap 23 as shown in fig.7 has a corresponding enlarged shape.

The device is supplied to users in sterile packaging within which it is arranged in the rest position shown in figures 1 , 2 and 6, in which said spongy material 18 contained in the support 17 remains outside of said container. Preferably, the device inside the packaging is wrapped in a sheath of material impermeable to liquids, for example a thin film of plastic material, easily removable, for example along a preferential tearing line.

The operation of the device shown in the example is the following: the operator who is to carry out taking of a urine specimen from the collection bottle opens a pack, grips the device arranged in the position shown in figures 1 , 2 and 6 and wrapped in said impermeable sheath, and without removing the protective sheath immerses into the bottle its lower end 13 from which the support 17 carrying the spongy material 18 projects, this rapidly absorbing a volume of liquid equal to its capacity. This done, the operator pushes the container base at its lower end 13 against the bottom of the bottle until the support 17 with its saturated spongy material re-enters completely into the inside of said container. In this way, the saturated spongy material passes from a first position, shown in figure 1 , relative to said lower end in which said spongy material contained in the support 17 remains outside said container, to a second position, shown in figure 3, in which said spongy material contained in the support 17 is pushed, together with this latter, into said container until it reaches in proximity to said loop 16, as can be seen in figure 3, into the immediate vicinity of this latter but without coming into direct contact with it.

At this point the operator removes the device from the bottle of urine, easily pulls off the sheath that wraps the container 11 which has hence remained dry, holds the cap 23 previously extracted from the pack and seals the lower end 13 of the container 10. The container is now ready to be sent to the analysis, either directly or after proper refrigerated storage.

On undertaking the analysis, the analyst can proceed either manually with a single device or with many devices in an automated multiple plate system. The analyst proceeds in both cases by moderately pressing on the lower part of the closed container, at the support 17 containing the spongy material 18 saturated with specimen. This can be achieved either by the analyst using finger pressure or by the automated equipment using suitable means for mechanical compression or the like. This compression achieves the effect of squeezing a quantity of specimen from the saturated spongy material 18 to reach in this manner the loop 16 immediately above it and to which it adheres. At this point by removing from the upper end of the device the cap 14 with the relative rod 15 with loop 16 bearing the specimen, the analyst can proceed to inoculating the plates. In the automated system, the compression movement for squeezing the spongy material could also correspond conveniently with a lifting movement of the cap 14 and the opening of each of the containers inserted in the apparatus, thus preparing for extraction of the loop bearing the specimen.

The loop therefore acts as a means for transferring the specimen from the collection means, i.e. the spongy material, to the plate. In a modified embodiment of the invention, said function can be alternatively achieved by a suitable absorbent material, for example a layer of spongy or hydrophilic material, deposited on the end of said rod, for example by flocking, a method which allows the amount of absorbent material to be dosed with greater precision, thus its absorption capacity is also measured with equal precision. Numerous other structural modifications of the aforedescribed examples can be made to the invention, for example relating to the shape of the container and the caps, the position and dimensions of the rod and the loop inside the container, the nature of the spongy material and the means for its support and attachment to the container. In particular, the dimensions of the rod and the relative positioning of the loop in the container can be different from those shown in the illustrative drawings.

From the aforestated, it can be understood how the device of the invention allows taking, collecting and transporting the urine specimen by using a single means from the moment of taking to the analysis. In essence, compared to the aforestated known art, the device of the invention performs the functions both of a pipette for taking the specimen from the bottle of urine and of a test tube for storing the specimen and its transport to the analysis. Among other things the risk of liquid spilling on taking from the original bottle is hence avoided. A notable characteristic of the invention lies in the fact that the means, namely the loop, designated for transferring the specimen to be analysed to the inoculation stage, comes into contact with the urine only at the moment at which said transfer is to take place following the compressing and squeezing operation on the spongy material as aforedescribed. This ensures that the quantity of specimen required for analysis is effectively collected by the loop.

As to the aforementioned drawbacks of the known art, the spongy material is shown to enable the absorption of a virtually constant volume of specimen, therefore avoiding the drawback of mutual dose variation between specimen and bacteriostat, and hence instability of the specimen, typical of the prior art.

As the specimen is completely absorbed by the spongy material, there will be no free liquid in the device and risk of its spillage and contamination on the exterior is consequently reduced. Further advantages of the invention are the possibility of its being applied to an automated analysis system, as well as the possibility of introducing a bacteriostat into the spongy material directly during its manufacturing stage, for example in the foaming stage of the polyurethane material.

Claims

1. Device (10) for taking, collecting and transporting specimens for urine analysis characterised by comprising a substantially tubular container (11) open at both the upper (12) and lower (13) ends, to said upper end there being sealedly connected a cap (14) from which a rod (15) terminating with a loop (16) extends into said container, spongy material (18) being provided at said lower end (13) for specimen collection, said spongy material being able, if under sufficient pressure, to slide inside said tubular container from a first position relative to said lower end in which said spongy material remains outside said container, to a second position in which said spongy material is pushed inside said container until it reaches in proximity to said means (16) for transferring the specimen.

2. Device as claimed in claim 1 characterised in that said means (16) for transferring specimen is a loop.

3. Device as claimed in claim 1 characterised in that said container (11) is made from a plastic material sufficiently pliable under finger pressure.

4. Device as claimed in claim 1 characterised in that said cap (14) is provided lowerly with a perimetral seat (19) able to receive by interference the circular edge of said end (12) to achieve its sealed closure.

5. Device as claimed in claim 1 characterised in that said spongy material (18) is applied by means of a sliding support (17) in the form of a basket able to receive and retain it in its interior.

6. Device as claimed in claim 5 characterised in that said sliding support (17) in the form of a basket retains said spongy material (18) by the effect of curved arms (20) which extend from an annular base (21) suitably dimensioned to be inserted into the container (11) from the lower end (13) and to be engaged thereat by interference, it being able when under a sufficient pressure to slide along the inside of said tubular container.

7) Device as claimed in claim 5 characterised in that said sliding support (17) in the form of a basket is provided with projections (27) to engage an annular seat (26) provided in the form of a circular groove around the wall of the container (11) to prevent it from accidentally moving from said first operative position.

8. Device as claimed in claim 5 characterised in that means are provided for locking said support (17) in said second position, such as a collar or a rib or teeth provided on the inner wall of the container (11) or on the base of the support itself, to prevent it moving from said second operative position.

9. Device as claimed in claim 1 characterised in that said spongy material (18) is supplied with a proper suitably dosed bacteriostat.

10. Device as claimed in claim 1 characterised in being provided with a cap (23) for closing the container (11) at its lower end (13).

11. Device as claimed in claim 9 characterised in that said cap (23) achieves a sealed closure by the effect of a perimetral seat (24) able to receive by interference the circular edge of the end (13).

12. Device as claimed in claim 1 characterised in being wrapped in an easily removable sheath of material impermeable to liquids.

13. Device as claimed in claim 2 characterised in that from the body of said cap (14) a rod (15) rigidly extends terminating with a loop (16), the dimensions of said rod being such that when the cap closes the end (12), the rod extends inside the container (11) for about two thirds of its length, so that the loop (16) is situated inside the container at a distance from the lower end (13) of about a third of the length of the container itself.

14. Device as claimed in claim 5 characterised in that the lower end (13) of the container (11) container has an enlarged diameter compared to that of the container 11.