Liquid sampler for rapid capture of initial volume of liquid flow

Abstract

A liquid sampling device and a kit of parts for assembling the liquid sampling device are disclosed. The device includes a housing having a fluid inlet fluidly connected to a sample outlet and a fluid outlet. A head portion of an elongate closure member slidably supported in the housing is configured to block liquid flow through the fluid outlet when the closure member slides into a sampling position, a lower guide rod portion of the closure member is configured to block the flow of liquid through the sample outlet when the closure member is slid into the diverted position. An upper portion of the guide rod includes a longitudinal slit that extends across the sample outlet when the closure member is slid into the sampling position. The lifting element is adapted to move the closure member from the sampling position to the diverting position while an initial volume of the liquid flow is being collected.

Description

Technical Field

[0001] The present invention relates to the field of liquid collecting devices, and in particular to liquid sampling devices for capturing a predetermined volume of an initial portion of a liquid flow, such as a first-void urine sample for diagnostic purposes. Background Art

[0002] With the development of highly sensitive nucleic acid amplification tests for pathogenic nucleic acids, self-collected first-pass urine has become a valuable non-invasive sample for diagnostic purposes, for example for the detection of urogenital infections such as Chlamydia trachomatis, and other sexually transmitted infections. However, the results of this test method are conclusive only if the sampled urine portion is not diluted or contaminated by subsequent mid-stream urine. Furthermore, even within the first-pass urine volume, there is a variation in the microbial load in the urine sample, which depends on the exact initial volume sampled, for example, only a small portion of the first-pass urine.

[0003] Sampling only a small volume portion of urine can be challenging in practice, especially if the urine is collected into a small container, the urine flow is rapid, or if the urine flow must be interrupted for proper sampling. This often causes discomfort to the user and often leads to unsanitary conditions while taking a urine sample. The average donor's urination rate is about 16 mL / second, making it difficult to collect a small initial volume - for example, once urination begins, the initial 1-3 mL of the first urine passage is collected in a very short period of time (a few milliseconds).

[0004] Therefore, there is a need for a liquid sampling device that allows accurate sampling of an initial volume of a liquid flow, such as urine, and whose use is hygienic and comfortable.

[0005] WO2014 / 037152 relates to a liquid sampling device for capturing a first portion of a liquid flow. The device comprises an inlet, an outlet and a guide having a displaceable element, which in a first position captures a first portion of a liquid flow, such as a first-pass urine, into a reservoir, and in a second position blocks access to the reservoir and instead passes subsequent liquid to the outlet. The displaceable element moves in a direction transverse to the liquid flow and has a lifting member. Although suitable for sampling first-pass urine, it is still challenging for this device to limit the amount of first-pass urine sampled to its small initial volume fraction (e.g., 1-3 mL).

[0006] WO2021 / 069454 discloses a liquid sampling device for a small initial volume, wherein a closure member is displaced relative to a valve housing while sampling the initial volume of a liquid flow through a sample outlet. The displacement of the closure member is driven by the buoyancy applied to a lifting member of the liquid sampling device. The gate of the closure member is lifted during the collection of the initial volume, thereby establishing a fluid path for the subsequent volume of the liquid flow between the inlet and outlet conduits. At the same time, the guide rod of the closure member blocks any additional liquid flow from passing through the sample outlet. The surface of the gate facing the inlet conduit is grooved. The groove extends downward from the gate to the guide rod, and redirects the liquid flow from the inlet conduit toward the sample outlet and through the sample outlet during the collection of the initial volume of the flow.

[0007] There is a need for a liquid sampling device that allows for the capture of a small initial volume of urine under sanitary conditions and is further designed for rapid capture of the initial volume of the liquid stream. Rapid capture is desirable for the user on the one hand and for higher quality first-pass urine samples on the other hand. In particular, with available liquid sampling devices, collecting very small volumes of first-pass urine samples, e.g., less than about 3 mL, proves challenging due to their limited capture speed.

[0008] There is therefore a need to further improve existing liquid sampling devices so that faster capture of the initial volume of the liquid flow to be sampled can be achieved. Summary of the invention

[0009] It is an object of embodiments of the present invention to capture an initial volume of a liquid stream at a relatively high velocity. This object is achieved by a liquid sampling device and kit of parts according to the present invention.

[0010] The present invention relates to a device for rapid sampling of an initial volume of a liquid flow. The device comprises a housing having a fluid inlet for receiving the liquid flow, a sample outlet for discharging the initial volume of the liquid flow, and a fluid outlet for discharging a subsequent volume of the liquid flow. A passage extends between the fluid inlet and the fluid outlet inside the housing and provides fluid communication between the fluid inlet and the fluid outlet and further between the fluid inlet and the sample outlet. The device also comprises an elongated closure member slidably supported in the housing. The closure member has a head portion and a guide rod, and a lifting element connected to the guide rod or formed in the guide rod. The lifting element is a float suitable for moving the closure member from a sampling position to a diverting position while the initial volume of the liquid flow is being collected in a container, which can be connected to the sample outlet of the housing. The head portion is configured to block the liquid flow through the fluid outlet when the closure member slides into the sampling position, thereby preventing the initial volume of the liquid flow from being transferred to the fluid outlet. The lower portion of the guide rod remote from the head portion is configured to block the liquid flow through the sample outlet when the closure member slides into the diverting position, thereby ensuring that a subsequent volume of the liquid flow is transferred to the fluid outlet. The head portion is positioned in the passage when the closure member slides into the sampling position, and the lower portion of the guide rod extends through and at least partially enters the passage when the closure member slides into the diverting position. In addition, the upper portion of the guide rod close to the head portion includes at least one longitudinal slit, which extends across the sample outlet when the closure member slides into the sampling position, thereby allowing an initial volume of the liquid flow to leave the sample outlet via the at least one slit.

[0011] The one or more slits in the upper guide rod part of the closure provide a guide rod with a slotted open center structure, which fluidically connects the front side of the guide rod facing the fluid inlet in the housing to the rear side of the guide rod facing the fluid outlet in the housing. This open structure allows a significant reduction in the weight of the closure, thereby improving its buoyancy and achieving faster collection of the initial liquid volume. In addition, the fluid path between the front side and the rear side of the guide rod allows the initial volume to be discharged on both sides of the lower guide rod part and enter a collection container. This has the beneficial effect of doubling the volumetric flow rate of liquid during the collection of the initial volume, which increases the capture speed again.

[0012] The present invention also relates to a kit of parts for assembling a liquid sampling device. The kit contains a housing, the housing including a fluid inlet for receiving a liquid flow, a sample outlet for discharging an initial volume of the liquid flow, a fluid outlet for discharging a subsequent volume of the liquid flow, and a passage for providing fluid communication between the fluid inlet and the fluid outlet and between the fluid inlet and the sample outlet. The kit further includes an inlet conduit connectable to the fluid inlet, an outlet conduit connectable to the fluid outlet, an elongated closure member slidably received by the housing, and a lifting member. The closure member has a head portion and a guide rod. The lifting member is a float connectable to the guide rod or formed in the guide rod and is suitable for moving the closure member from a sampling position to a diverting position while the initial volume of the liquid flow is being collected in a container, the container being connectable to the sample outlet of the housing. The head portion is suitable for blocking the liquid flow through the fluid outlet when the closure member slides into the sampling position. A lower portion of the guide rod distal to the head portion is adapted to block the flow of liquid through the sample outlet without blocking the flow of liquid through the fluid outlet when the closure member slides into the diverting position. An upper portion of the guide rod proximal to the head portion includes at least one longitudinal slit extending across the sample outlet when the closure member slides into the sampling position, thereby allowing an initial volume of the liquid flow to leave the sample outlet via the at least one slit.

[0013] The kit may also include a collection container and a top cover for closing the collection container. The collection container may be a collector tube. The container may be connected to a sample connector of a liquid sampling device, the sample connector protruding outwardly from the base of the housing. The connection between the sample connector and the container is preferably a threaded connection, wherein, for example, the container includes an external thread and the sample connector includes a matching internal thread. Those skilled in the art will appreciate that other connections may also be used, such as push-fit and snap-fit ​​connections. Instructions for use may be included in the kit.

[0014] According to an embodiment of the present invention, the sample connector of the housing is provided with an internal thread to engage an externally threaded collection container, such as a collection tube, with a threaded connection. This has the additional advantage that the full opening diameter of the collection container can be used to receive the guide rod of the closure member, which improves the range of movement of the closure member relative to the container and allows a larger space between the inner wall of the collection container and the closure member guide rod. As a result, friction is reduced, and the risk of adhesion and blockage caused by the accumulation of discharged liquid during the capture process of the initial volume is also reduced. In the turned position of the closure member relative to the housing, the subsequent volume of liquid can flow freely to the fluid outlet of the device through the slit in the upper guide rod part. This reduces the possibility of subsequent volume parts, such as mid-stream urine, mixing with the collected initial volume parts, such as first-stream urine.

[0015] Embodiments of the present invention allow for the collection of a small portion of the first urine in a standardized and volumetric manner without interrupting the urine flow. The first urine, generally considered to be the first 20 mL to 50 mL of the urine flow, contains higher concentrations of analytes associated with human papillomavirus (HPV) and Chlamydia trachomatis (CT) DNA than subsequent portions. In addition, first urine sampling is important for identifying cancer biomarkers such as prostate cancer.

[0016] The liquid sampling device according to embodiments of the present invention is a user-friendly and highly hygienic device that brings additional accuracy to urine-based tests in diagnostic applications.

[0017] Embodiments of the present invention allow first-pass urine samples to be obtained as valid non-invasive samples through a self-sampling method that is sufficient for use in all age groups and genders.

[0018] Another advantage of the present invention is the fact that a narrow collection tube with a very small sample volume can be connected to a liquid sampling device and used for first-stage urine capture. The improved buoyancy of the closure member and the significantly faster capture of the initial volume of the liquid stream enable the collection of as little as 3mL or even less first-stage urine, such as between 1mL and 3mL, such as between 1.0mL and 1.5mL, in the collection tube. Such small and narrow tubes can be used directly in liquid handling robots for automated sampling, such as in automated high-throughput analyzers. This helps to simplify the pre-analysis process, shorten turnaround time, minimize errors, and reduce costs. In addition, the collector tube can be prefilled with a preservative for different urine analytes, thereby improving the transportation and storage of urine at room temperature.

[0019] Particular and preferred aspects of the invention are set out in the accompanying independent and dependent claims. Where appropriate, features from the dependent claims may be combined with features of the independent claims and features of other dependent claims, rather than just as explicitly set out in a claim.

[0020] For the purpose of summarizing the present invention and the advantages achieved over the prior art, certain objects and advantages of the present invention are described above. Of course, it should be understood that not all such objects or advantages may be achieved according to any particular embodiment of the present invention. Thus, for example, those skilled in the art will recognize that the present invention may be embodied or implemented in a manner that achieves or optimizes an advantage or a set of advantages as taught herein but does not necessarily achieve other objects or advantages as may be taught or suggested herein. The above and other aspects of the present invention will become apparent from the embodiments described below and will be described with reference to the embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present invention will now be further described by way of example with reference to the accompanying drawings, in which:

[0022] Figure 1 is a perspective view of an apparatus for sampling an initial volume of a liquid flow according to an embodiment of the present invention.

[0023] Figure 2 and Figure 3 They are Figure 1 Cross-sectional view of the liquid sampling device shown in FIG. 1 without a collecting tube and with a connected collecting tube.

[0024] Figures 4 to 6 are rear, side and front elevation views of a closure member that may be used in embodiments of the present invention.

[0025] Figure 7 and Figure 8 yes Figure 4 A perspective view of a closure component is shown in FIG.

[0026] Fig. 9 and Fig.10 The diagrams respectively show the closing part of the device sliding to the sampling position and the turning position. Figure 3 The fluid path of the device.

[0027] Fig.11 is an exploded view of a kit of parts for assembling a liquid sampling device according to the present invention.

[0028] In the accompanying drawings, the size of some elements may be exaggerated for illustrative purposes and are not drawn to scale. The sizes and relative sizes do not necessarily correspond to actual reductions in practicing the invention. Any reference numerals in the claims should not be interpreted as limiting the scope. In different figures, the same reference numerals refer to the same or similar elements. DETAILED DESCRIPTION

[0029] The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims.

[0030] The terms first, second, and the like in this specification and claims are used to distinguish similar elements and are not necessarily used to describe a sequence in time, space, hierarchical, or in any other manner. It should be understood that the terms so used are interchangeable under appropriate circumstances, and that the embodiments of the invention described herein are capable of operating in sequences other than those described or illustrated herein.

[0031] It should be noted that the term "comprising" used in the claims should not be interpreted as being limited to the subsequently listed components; it does not exclude other elements or steps. It is therefore interpreted as specifying the presence of the stated features, integers, steps or components mentioned, but does not exclude the presence or addition of one or more other features, integers, steps or components or groups thereof. Therefore, the scope of the expression "a device comprising components A and B" should not be limited to devices consisting only of components A and B. This means that with respect to the present invention, the only relevant components of the device are A and B.

[0032] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular characteristic, structure, or feature described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in different places throughout this specification are not necessarily all referring to the same embodiment, but may refer to the same embodiment. Furthermore, it will be apparent to those skilled in the art from this disclosure that, in one or more embodiments, the particular features, structures, or characteristics may be combined in any suitable manner.

[0033] Similarly, it should be understood that in the description of exemplary embodiments of the present invention, various features of the present invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of simplifying the present disclosure and helping to understand one or more of the various inventive aspects. However, the disclosed method should not be interpreted as reflecting that the claimed invention requires more features than those explicitly described in each claim. On the contrary, as reflected in the following claims, the inventive aspects are less than all the features of a single aforementioned disclosed embodiment. Therefore, the claims accompanying the specific embodiment are hereby expressly incorporated into this specific embodiment, wherein each claim independently serves as a separate embodiment of the present invention.

[0034] Furthermore, although some embodiments described herein include other features that are not included in other embodiments, the combination of features of different embodiments is meant to be within the scope of the present invention and to form different embodiments, as will be understood by one skilled in the art.

[0035] It should be noted that the use of a particular term when describing certain features or aspects of the present invention should not be taken as implying that the term is redefined herein to be limited to encompass any specific characteristics of the feature or aspect of the invention associated with that term.

[0036] In the description provided herein, many specific details are set forth. However, it should be understood that embodiments of the present invention can be practiced without these specific details. In other cases, well-known methods, structures, and techniques are not shown in detail to avoid obscuring the understanding of this description.

[0037] In the context of the present invention, the liquid to be sampled typically relates to urine. However, the liquid sampling device according to the present invention is suitable for sampling liquids in general, including other body fluids, water and the like.

[0038] When referring to the first urine volume in the embodiments of the present invention, this generally refers to the first 20 mL to 50 mL of the initial urine flow. In this regard, a small volume refers to a volume (e.g., the first urine volume) of less than 20 mL, such as less than 10 mL, such as less than 5 mL, such as 4 mL. A very small volume refers to a volume (e.g., the first urine) of less than or equal to 3 mL, such as between 1 mL and 3 mL, such as between 1.5 mL and 3 mL, such as between 2 mL and 3 mL, such as between 2.5 mL and 3.0 mL, such as between 2.6 mL and 2.9 mL.

[0039] With reference to the attached drawings Figures 1 to 3 Now, a device for sampling the initial volume of a liquid flow according to an embodiment of the present invention is described. Figure 1 The sampling device 10 shown in the perspective view in comprises an inlet conduit 12, an outlet conduit 11, a housing 13 and an elongated closure member 17 which is removably insertable into the housing via an open-ended guide structure 13e in the housing, such as a guide tube, a channel or a shaft.

[0040] The closure member 17 is supported in the housing in a slidable manner and can be axially displaced relative to the housing along the longitudinal extension direction 'z' of the closure member. The guide structure 13e limits the movement of the closure member 17 to sliding only along the vertical axis 'z'. An elastic protrusion 13d is formed on the inner surface of the guide structure 13e and acts as a stop element, for example, to limit the movement of the closure member when the closure member slides upward in the housing. The base section 13f of the housing 13 limits the axial displacement of the closure member 17 when the closure member slides downward in the housing. The protrusion 13d and the base 13f respectively define the sampling position and the turning position of the closure member relative to the housing. When inserted into the housing 13, the guide rod 15 of the closure member 17 extends vertically through the opening in the base 13f. The circumferential edge of the guide rod 15 and the opening in the base have corresponding shapes, so that the opening helps the sliding movement of the closure member relative to the housing and stabilizes the sliding movement. At least one longitudinally extending slit 20 ( Figure 1 The at least one slit extends across the opening in the base 13f and leads to the interior of the housing when the closure member is moved into the sampling position. Figures 4 to 8 The closure member is further described.

[0041] The inlet duct 12 is adapted to receive a flow of liquid, such as urine, at a distal opening 12a and direct it towards the housing 13, and the outlet duct 11 is adapted to discharge a subsequent volume of the flow of liquid, such as urine, away from the housing 13 and out of the device 10 at the distal opening 11a. Although the inlet duct 12 and the opening 12a can be shaped in many ways, for the purpose of effectively collecting liquid without spillage, an inlet duct 12 forming a funnel is preferred. A funnel-shaped inlet duct 12 with a widened receiving lip as the opening 12a is particularly advantageous for sampling urine, as it provides a more hygienic and more comfortable use of the device 10 for the user. Furthermore, the inlet duct 12 and the outlet duct 11 are preferably arranged in an inclined position relative to the vertical z-axis, along which the elongated closure member 17 is typically aligned during operation of the device 10, for example at an angle in the range between 20° and 70°, such as about 45°. This has the advantage that the liquid flow entering the device 10 at the opening 12a at a low flow rate is forced forward without delay, thereby achieving a faster sampling of its initial volume while preventing contamination and adhesion of the liquid to the walls of the inlet duct 12. Similarly, the removal of the subsequent volume of the liquid flow received from the housing 13 is accelerated by the inclined outlet duct 11, thereby reducing the risk of contamination of the sampled initial volume by remnants of the subsequent volume remaining in the housing 13.

[0042] The outlet conduit 11 may be suitable for connection to a further container for capturing a subsequent volume, or may be suitable for connection to a further liquid sampling device, for example a second sampling device according to the embodiments described above (and a suitable outlet to the inlet connector) for sampling a portion of the subsequent volume of the liquid flow, such as a portion of midstream urine.

[0043] Now turn to Figure 2 , further illustrated in a cross-sectional view Figure 1 The interior of the sampling device 10. The cutting plane is taken as the mirror plane of the device perpendicular to the x-axis (yz plane).

[0044] like Figure 213, the housing 13 comprises one or more protruding side walls (in the z direction), the lower side of which is supported by a flat base 13f. The protruding side walls define a hollow interior, such as a channel or a pipe, which serves as a guide structure 13e for a closure member 17. The inner surface of the channel is shaped to receive and slidably support the head portion 14 of the closure member, which is wider than the guide rod 15. More specifically, the end section or top cover 16 of the head portion 14 has an outer edge or edge that is adapted to the inner surface shape of the channel. In other words, the guide structure 13e acts as a sliding bearing relative to the wider head portion 14, which is an extension of the thinner guide rod of the closure member. The inner surface or surface of the guide structure 13e, such as the inner surface of a vertical channel or a pipe formed inside the housing 13, corresponds to a slide, i.e., a surface on which the head portion 14 of the closure member is supported and slides.

[0045] exist Figure 2 In the insertion configuration shown in , the wider head portion 14 is held at its bottom side by the base 13f of the housing 13. The inward face of the base 13f is a bearing surface relative to the head portion 14. When the closure member slides, for example, from a sampling position in which the head portion 14 rests on the inner face of the base 13f to a turning position in which the top cover 16 docks on the protrusion 13d, the head portion 14 remains closed by the protruding side wall of the housing, while the upper part 15a of the guide rod is retracted into the housing 13 via an opening in the base 13f. This opening also serves as a sample outlet 13c, through which the initial volume of the liquid flow is collected: the sample outlet 13c, for example a circular opening, is formed through the base of the housing 13 and reaches into the passage 22, which extends between the fluid inlet 13a and the fluid outlet 13b and through the hollow interior of the housing 13. Depending on whether the closure member 17 is moved into the sampling position or the turning position, only the sample outlet 13c or only the fluid outlet 13b is selected to be in fluid communication with the fluid inlet 13a. The selection mechanism and the corresponding liquid sampling process are further explained below.

[0046] The clearance between the sample outlet 13c and the lower part 15b of the guide rod 15 is small enough to establish a liquid seal when the closure member slides into the diverted position and the lower guide rod part 15b blocks the sample outlet 13c, but still allows good mechanical sliding of the guide rod relative to the sample outlet. A fluid seal is required to prevent mixing and contamination between the initial volume collected and the subsequent volume of the liquid flow diverted by the fluid outlet 13b. Preferably, a minimum friction between the guide rod and the sample outlet is preferred to achieve rapid lifting of the closure member while collecting the initial volume of the liquid flow.

[0047] In addition to the sample outlet 13c, the fluid inlet 13a and the fluid outlet 13b are also formed as openings in the protruding side wall of the housing 13. The inlet conduit 12 and the outlet conduit 11 are connected to the fluid inlet 13a and the fluid outlet 13b, respectively. The end faces of the inlet conduit 12 and the outlet conduit 11 close to the housing 13 may have shapes and sizes equal to the fluid inlet 13a and the outlet 13b, respectively, or may be different shapes and / or different sizes. In this particular embodiment, for example, by providing the conduits 11, 12 as an integral part of the housing 13, permanent alignment of the inlet conduit 12, the outlet conduit 11 and the fluid inlet and outlet of the housing 13 has been achieved. In other words, the conduits 11, 12 and the housing 13 constitute a single integrally formed unit, wherein each conduit 11, 12 is directly connected to the protruding side wall of the housing. This way of connecting the conduits 11, 12 to the housing 13 is not limiting; alternative ways for connecting the conduits to the housing may be provided instead. For example, a snap-fit ​​connection may be made between plastic sheets, a threaded connection or a push-in or compression fitting may be used to connect the housing 13 to soft or hard tubing for the conduits 11, 12.

[0048] For the presently described embodiment, the sliding axial movement of the closure member 17 corresponds to a linear movement along a vertical direction (e.g., z-axis), which is transverse to the direction of the liquid flow through the passage between the fluid inlet 13a and the fluid outlet 13b, for example, in a direction substantially perpendicular to the flow direction through the passage (e.g., y-axis). Although a 90° angle is preferably provided between the axial movement of the closure member 17 and the flow direction through the passage, for example, as defined by the inclination angle of the flat base of the housing relative to the z-axis, embodiments of the present invention are not limited to an angle of 90° or an angle close to 90°. For example, the flow direction for an up-tilted base may be inclined, and the resulting angle between the flow direction through the passage and the axial movement of the closure member 17 may take a value in the range from 65° to 90°.

[0049] The sampling device further comprises a lifting component, which is suitable for moving the closure component 17 from the sampling position to the turning position while the initial volume of the liquid flow is being collected in a container such as a base that can be connected to the housing by the sample outlet 13c. The lifting component is shown as a float formed inside or attached to the lower guide rod part 15b. While the initial volume is collected in the container of the closed float, the buoyancy acts on the float. In an embodiment of the present invention, the float corresponds to the elongated gas-filled cavity (e.g., air bag) 15d in the lower part 15b of the guide rod 15. The gas-filled cavity has an orifice at the bottom side of the guide rod 15 and extends longitudinally into the lower guide rod part 15b. However, different embodiments of the present invention can be provided with different lifting components with floating capacity, such as a block connected to the end portion of the guide rod or a block fastened to the guide rod and surrounding the guide rod, the block comprising one or more air bags, gas-filled cavity, or comprising porous material, such as foam (e.g., extruded polystyrene foam).

[0050] Figure 3 Corresponds to Figure 2 , further showing a collection tube 19 in a connected state relative to the housing. The collection tube is a specific example of a container for collecting the initial volume of a liquid flow. A connector 18 with a downwardly protruding wall is arranged on the outward side of the base 13f of the housing 13 so that the connector wall surrounds the sample outlet 13c. The connector wall includes an internal thread, which engages the corresponding external thread on the collection tube 19 to form a threaded connection and the collection tube is releasably fastened to the housing. For example, compared with a collection tube that is pushed to fit on a sample connector, the benefit of using an externally threaded collection tube or container is that the closed component guide rod can utilize the complete opening of the tube because the inner diameter of the tube can be fully used to receive the guide rod and will not be reduced due to the internal thread on the tube. This allows a larger gap, such as 1mm or larger, and a reduced flow contraction in the zone between the lower guide rod portion and the inner wall of the collection tube. The surface tension effect and capillary action in this region that slow down the lifting of the closed component are also alleviated. Therefore, the improved flow properties of the resulting liquid contribute to the accelerated capture of the initial volume and reduce the risk of mixing between the initial volume to be collected and the subsequent volume of the liquid flow.

[0051] Reference now Figures 4 to 8 A closure member that can be used in a liquid sampling device according to the present invention is described in more detail, wherein Figure 4 The closure member is shown in rear elevation, Figure 5 The closure member is shown in side elevation, and Figure 6 The closure part is shown in front elevation. Figure 7 and Figure 81 is a corresponding perspective view of the closure member. Here, the front side of the closure member refers to the side facing the fluid inlet 13a when the closure member is inserted into the housing. Similarly, the back side of the closure member is defined as the side facing the fluid outlet 13b when the closure member is inserted into the housing. Many details presented relative to the closure member help to clarify its role in selectively blocking the flow of liquid through the fluid outlet or sample outlet.

[0052] The head portion 14 of the closure member 17 is configured to block the flow of liquid through the fluid outlet 13b when the initial volume of the liquid to be sampled flows from the fluid inlet 13a to the sample outlet 13c and into a container that can be connected to the housing, i.e. when the closure member is moved into a sampling position relative to the housing. The inclined barrier wall of the head portion 14, which is preferably composed of two flat and differently inclined wall segments 14a and 14b, achieves this blocking effect. In the sampling position of the closure member, the head portion 14 is positioned inside the passage 22, and the bottom edge of the barrier wall, such as the bottom edge of the second wall segment 14b, rests on the inward face of the housing base 13f in a region that does not overlap with the sample outlet 13c. In this case, the edge of the base 13f surrounding the sample outlet 13c serves as a support for the inclined barrier wall of the head portion. Further downward movement of the closure member 17 relative to the stationary housing 13 is thereby prevented.

[0053] In addition, the lateral edges of the first flat wall segment 14a and the second flat wall segment 14b are adapted relative to the inner surface shape of the guide structure 13e so that the passage 22 is sealed and the initial volume of the liquid flow is prevented from leaving the passage through the fluid outlet. Therefore, the flat wall segments 14a, 14b of the head portion behave like gates similar to valves that can move in and out of the passage. The bottom edge of the second wall segment 14b extends smoothly and uninterruptedly in the lateral direction (e.g., x-direction) and spans a distance that is wider than the guide rod 15 and wider than the sample outlet 13c in the base 13f of the housing 13. The profile of the inclined barrier wall is continuous and uninterrupted and can take the form of the blade of a spade having curved side edges and a straight edge at its top, for example, where the top cover 16 is connected to the first wall segment 14a. Preferably, when projected onto a frontal plane, the profile of the inclined barrier wall encompasses the profile of the fluid inlet 13a when projected onto the same frontal plane.

[0054] The front side of the first wall segment 14a close to the bottom edge of the first wall segment 14a and away from the second wall segment 14b and the upper part of the second wall segment 14b can be divided by a thin vertical wall 14c, which contacts and supports the top cover 16. The advantage of this additional vertical wall 14c is to increase the structural integrity of the closure member 17, in particular the structural integrity of the top cover 16 during its sliding contact with the housing. The first flat wall segment 14a and the second flat wall segment 14b are continuous with each other and form an extension of the guide rod 15. The transition between the first flat wall segment 14a and the second flat wall segment 14b is located midway along the guide rod diameter (e.g., in the y direction). Therefore, the first wall segment 14a rises upward on the front side of the guide rod, while the second wall segment 14b tilts downward on the rear side. The inclination angle of the second wall segment 14b is steeper than the inclination angle of the first wall segment 14a, wherein the inclination angle of the flat wall segments 14a, 14b is measured relative to the longitudinal axis (e.g., z-axis) of the elongated closure member. The inclined wall segments have the advantage that they effectively redirect the initial volume of liquid to flow in a substantially vertical direction, but the original flow direction of the liquid entering the passage through the fluid inlet is substantially horizontal. Another advantage of the inclined wall segments 14a, 14b is given by the fact that the initial volume of the received liquid flow exerts a (dynamic) pressure on the wall segments 14a, 14b. This pressure has a component parallel to the flow direction and an upward component parallel to the z-axis. Therefore, in addition to the buoyancy applied to the lifting member, the inclined wall segments 14a, 14b can also be used to further enhance the upwardly directed lifting force, which results in an even faster sliding of the closure member from the sampling position to the diverting position. Providing an inclined barrier wall as a composite wall comprising flat wall segments 14a, 14b inclined in different ways has been demonstrated to obtain better flow redirection capabilities and improved auxiliary lifting forces. The angled wings of the second flat wall segment on the redesigned float allow better guided flow towards the collection tube / container and produce additional lifting effects.

[0055] In the case of small sampling initial volume, such as the first urine of less than 4mL, such as between 2mL and 3mL, the auxiliary lifting force is more obvious, wherein the volume of the lifting part immersed in the liquid that has been sampled and collected is usually small. For example, the extremely small volume collection tube between 2mL and 3mL is particularly affected by the reduced buoyancy. The narrowing of the diameter of these tubes is problematic because the capillary adhesion will become decisive in the contraction flow area between the guide rod and the edge of the sample outlet. Adhesion may delay and hinder the collection process of the initial volume, and the risk of contamination of the initial volume and subsequent volumes increases, for example, the earlier part of the first urine is contaminated by the later part of the first urine or mid-stream urine. The auxiliary lifting force can alleviate this effect to a certain extent.

[0056] In some embodiments of the present invention, similar to Figure 7In the embodiment shown in, one or more ribs 14d can be arranged on the front side of the second flat wall segment 14b. Rib 14d connects the second flat wall segment 14b to the circumference of the upper guide rod part 15a and structurally strengthens the flat wall segment 14b. Rib 14d can specifically reduce the vibration and / or damage risk of the second wall segment 14b. In such embodiments, when the closure member moves into the sampling position, rib 14d enters the physical contact with the inner face of the base 13f of the housing 13. In order to reduce the gap between the bottom edge of the second wall segment 14b and the inner face of the base 13f of the housing 13 in the sampling position, it is preferred to have a rib 14d with a minimum height at the bottom edge of the second wall segment 14b. The presence of ribs reduces the contact surface between the base of the head portion and the housing when the closure member is in the sampling position. This has the advantage that the risk of the head portion sticking to the base is reduced, thereby allowing the rapid lifting of the head portion and the guide rod once the collection of the initial volume of the liquid stream begins. Manufacturability is another advantage of rib 14d. If the rib 14d was not present, the mold, for example a steel mold, would have to have very sharp edges in order to be able to mold the second wall segment 14b. This could lead to weakening and rapid wear of the mold. In addition, without the rib 14d, the part cannot be demoulded adequately. Therefore, the rib 14d ensures that the injection mold has a long service life.

[0057] The end of the head portion of the closure member has a flat top section or top cover 16. The advantage of an embodiment of the present invention is that the cross section of the top cover 16 (in a plan view perpendicular to the z-axis) can be adapted to the inner boundary of the guide channel 13e in the housing 13 in shape and size, so that the sliding axial movement of the closure member relative to the stationary housing is assisted by the top cover 16. The top cover 16 is supported on the inner surface of the guide channel 13e in a slidable manner, and the inner surface serves as a sliding bearing for the top cover 16 and the lateral edge of the inclined barrier wall. The top cover 16 can be provided as an asymmetric disk, such as a circular disk originally, and a certain segment thereof has been removed along the chord. The top cover 16 of the asymmetric shape adapted to the cross-sectional shape of the guide channel 13e (for example, in the xy plane) has the advantage of preventing the rotation of the head portion and the closure member as a whole around the vertical displacement axis. Other shapes for the top cover and the guide channel can be selected to produce the same effect, such as, elliptical shape, polygonal shape, etc.

[0058] It should be noted that by adapting the circumference of the guide rod 15 in the xy plane to the inner edge of the sample outlet 13c, another sliding bearing for the guide rod 15 of the closure member is thus produced, and the guiding aspect can be further improved. Due to the improved guiding of the closure member 17 at two different height levels (for example, different positions in the z direction), the tilting of the closure member 17 can be prevented. In addition, the top cover 16 so adapted provides an enhanced sealing of the passage 22 relative to the portion of the guide structure 13e located above the top cover. Therefore, the initial and subsequent volumes of the receiving liquid flow, such as urine, can be prevented from splashing or overflowing outside the upper opening of the guide structure. A person skilled in the art can know how to select the appropriate gap between the top cover and the inner surface of the guide structure, between the profile of the inclined barrier wall and the inner surface of the guide structure, and between the guide rod and the sample outlet through design routines or repeated trials, so that the guiding is performed without significant friction and is suitable for sealing the passage. The technician also knows that a small gap may be required and allowed to move the closure member 17 back to the sampling position after the liquid flow has stopped and the initial volume of sampling is safely removed.

[0059] The guide rod 15 of closure member 17 comprises lower guide rod part 15b and upper guide rod part 15a.Lower guide rod part 15b is continuously connected to upper guide rod part 15a, for example, the transition between the outer surface of two guide rod parts is smooth and does not have the change (that is, same circumference) of shape or size.Pneumatic chamber 15d is provided in the center of lower guide rod part 15b inside, so that the orifice of chamber 15d is located on the bottom surface of guide rod 15.Therefore, lower guide rod part 15b can take the form of semi-open hollow cylinder.The plenum chamber 15d inside guide rod 15 acts as a float relative to the initial volume of the liquid collected in the container, so that lower guide rod part 15b is at least partially immersed.

[0060] During the use of the sampling device, the liquid flow related to the initial volume is sampled through the sample outlet 13c and a liquid column is generated in a container previously connected to the device, for example, to the sampling connector 18. Preferably, the shape and depth of the container are selected to cooperate with a float formed inside or connected to the lower guide rod portion 15b, because the formation of the liquid column in the container is accompanied by the rapid immersion of the float. The float in the form of an air-filled cavity 15d arranged in the hollow interior of the lower part of the guide rod has the additional advantage that the material weight and cost associated with forming the elongated guide rod are conveniently saved by providing cheap low-density fluid air. This also allows the use of a smaller diameter connectable container, which effectively increases the submerged volume of the float, thereby increasing the buoyancy. However, embodiments of the present invention are not limited thereto, and other floating structures and / or materials may be used in place of the air cavity in the lower part of the guide rod or in addition thereto, such as a foam block to which the lower end portion of the guide rod extends. Due to the buoyancy acting on the lifting member as a float, the closing member is lifted and forced upward as the height of the sample liquid column continues to rise. Once the turning position is adopted, the buoyancy-driven vertical displacement stops and prevents further raising of the closing member.

[0061] The upper guide rod portion 15a is provided as an open structure and comprises at least one longitudinal slit, e.g. Figure 4 Two longitudinal slits 20a, 20b are shown. The longitudinal slits create a fluid path extending in diameter through the upper guide portion 15a, meaning that opposite sides of the guide 15 are fluidically connected through the orifices in the upper guide portion 15a. In the context of the present invention, wide slits are preferred to avoid capillary forces and adhesion effects. Therefore, the slits can also be called slots. Figure 4 , Figure 5 and Figure 6It can be understood that the elongated slits 20a, 20b establish fluid communication between the front and rear sides of the guide rod 15. The longitudinal slits divide the upper guide rod portion 15a into a plurality of vertical support sections or vertical support columns 21a-21c, which contact the flat wall segments 14a, 14b at their tops. The upwardly raised vertical support section 21b of the center strengthens the upper guide rod portion 15a structurally and minimizes the risk of breaking or bending the guide rod. The vertical support sections 21a, 21b, 21c reduce surface tension and may even minimize surface tension. Since the vertical support sections 21a-21c of the upper guide rod portion 15a directly dock on the front sides of the first wall segment 14a and the second wall segment 14b, the upper side of the slits 20a, 20b is defined by the front side of the inclined barrier wall. In the area where the slits 20a, 20b contact the front side of the wall sections 14a, 14b, a gradually narrowing flow channel 14e is formed, along which the redirected liquid is discharged toward the slits and the sample outlet. At their lower side, the slits 20a, 20b are bounded by a flat surface 15c, which is a partially exposed surface at the interface between the lower and upper parts of the guide rod and also helps to reduce surface tension.

[0062] The slit extends downward in the longitudinal direction of the enclosed part. Its minimum longitudinal dimension is greater than the thickness (e.g., length in the z direction) of the sample outlet 13c of the base 13f passing through the housing, so that each slit stretches across the sample outlet when the enclosed part moves into the sampling position. Therefore, when the enclosed part is in the sampling position relative to the housing, the elongated slit also provides the fluid connection between the outer surface of the passage 22 and the lower guide rod part 15b. Therefore, the initial volume of the liquid stream can enter the passage through the fluid inlet, and leave the passage through the elongated slit in the upper guide rod part. Gravity accelerates it when the redirected liquid falls downward in the slit.

[0063] During use of the sampling device, a container for collecting the initial volume is connected to the housing so that the lower guide rod portion reaches the container. The gap between the wall of the container and the outer surface of the lower guide rod portion 15b allows the initial volume of the liquid flow to reach the bottom of the container. Figure 6 The inlet area of ​​the slit in the front view of is significant, for example larger than the area associated with the vertical support section in the same front view, so that the discharge and collection process of the initial volume into the container can be carried out extremely quickly. In other words, the total width of the slit in the y direction can be made almost as large as the diameter of the guide rod, so that high flow rates of liquid through the slit and into the container are feasible. The inclined first flat wall segment 14a and the second flat wall segment 14b cooperate with the slit so that the received liquid flow is redirected from a horizontal or almost horizontal flow direction to a substantially vertical flow direction as long as the initial volume is collected.

[0064] Compared with the open structure of upper guide rod part 15a, lower guide rod part 15b has closed structure, and it does not have the orifice that liquid can flow through.When closing part moves to the turning position, lower guide rod part 15b extends through sample outlet 13c, and upper guide rod part 15a is positioned in passage 22 inside.The circumferential shape of lower guide rod part is adapted to the shape of sample outlet, and lower guide rod part effectively provides the plug of sealing sample outlet.Therefore, prevent the subsequent volume of liquid flow from leaving passage by sample outlet.Because the head part of closing part has been lifted from the base of housing when closing part moves to the turning position, and upper guide rod part is thinner than the inclined barrier wall of head part and also contains slit, so the subsequent volume of liquid flow can cross passage and arrive fluid outlet without major obstacle.Therefore, when closing part moves to the turning position, the subsequent volume of liquid flow turns by fluid outlet.

[0065] Compared with the closure member described in the prior art reference WO 2021 / 069454A2, which teaches a closed central structure in the form of a half-tube, the closure member according to an embodiment of the present invention has an open structure in the upper guide rod portion. The slit in the upper guide rod portion reaches and fluidically connects the front side of the guide rod with its rear side through the guide rod. This has two benefits: weight reduction and improved flow guidance. In fact, the open structure requires less material, such as less plastic material in the injection molding process, which contributes to the more efficient and cheaper manufacture of the liquid sampling device. The lightweight closure member will also be lifted more quickly by the float, which ensures faster capture of the initial volume. Especially for the first urine of a very small volume, such as less than 3mL, rapid capture is advantageous in terms of the accuracy of the sampling volume and the quality of the captured sample (e.g., less risk of being contaminated by mid-section urine). Weight reduction also helps to achieve device miniaturization, for example, for the purpose of capturing only a very small volume. It can be observed that the weight reduction of the state-of-the-art closure component in WO 2021 / 069454 A2 through a reduction in wall thickness is extremely limited, since the injection molding process strictly requires a minimum wall thickness of, for example, 0.5 mm.

[0066] In addition, the tapered area of ​​the inclined transition segment of the closure part replacing the current state of the art by flat surface 15c brings further weight reduction.The open structure of closure part of the present invention allows a larger volume flow rate, and is convenient to remove the liquid on the front side and the rear side of the lower guide rod part.This means that the inclined transition segment will only have little influence or no influence on the capture process of initial volume, and can be eliminated.In addition, the longitudinal slit can be designed to be long enough to avoid being projected back in the housing through the liquid redirected.

[0067] With regard to the improved flow guiding properties of the grooved upper portion of the guide rod, it should be noted that the presence of the open center structure greatly reduces the lateral forces exerted by the liquid flow on the upper guide rod portion. These lateral forces are particularly evident if the sampling device is used by a person with a high urination rate, such as 40 mL / sec or more. The removal of the closed center structure (grooved upper guide rod portion) in the closed part of the current state of the art reduces the area on which the lateral forces can act. It also results in a more efficient operation of the device, since excessive lateral forces have the potential to slow down or block the movement of the float due to friction.

[0068] In addition, the subsequent volume of liquid (e.g., mid-stream urine) is free to pass to the fluid outlet of the device and also flows through the slit in the upper guide portion. This increase in the available cross-sectional flow area (e.g., in the xz plane) inside the passage 22 reduces the likelihood that the subsequent volume of liquid will mix with the initial volume (e.g., first-stream urine) that has been collected.

[0069] In the application of only collecting very small volume of liquid (for example, 2-3mL) therein, for example when using a small volume collecting tube in subsequent diagnosis, there is only a small amount of available liquid that can generate buoyancy. Under the average urination rate of 16mL / second, the time that the closure part slides to the turning position from the sampling position is also very few, to ensure that only the initial volume of the liquid stream is sampled. The open center structure of the closure part of the present invention allows liquid to flow downwards along the two sides of the lower guide rod part during the capture step of the initial volume. This makes the speed of collecting samples in a collecting tube or a container increase, for example, doubled.

[0070] The absence of a closed central structure in the closure of the present invention allows the first flat wall segment 14a and the second flat wall segment 14b to cover a large surface area that receives the liquid flow and interacts with the liquid flow. The shape of the first flat wall segment 14a and the second flat wall segment 14b provides a reduced weight of the closure so as to enhance its buoyancy. The front surface of the first flat wall segment 14a and the second flat wall segment 14b can be uninterrupted, for example, fully formed and stretched across the entire width (for example, in the x direction) of the head portion of the passage inside the housing. As a result, the auxiliary lifting force can be greatly increased, thereby improving the floating capacity of the closure as a whole and reducing the time for the closure to slide from the sampling position to the steering position. In addition, providing continuous widening wall segments 14a, 14b for the head portion brings better control of the flow properties of the liquid inside the passage of the housing.

[0071] The following describes the best mode of operating the apparatus for sampling the initial volume of a liquid flow according to an embodiment of the present invention. Fig. 9 and Fig.10, which depicts the path of a liquid, such as urine, as it flows through the liquid sampling device when the closure member of the liquid sampling device is moved into the sampling position and the diverting position, respectively.

[0072] For the detection of sexually transmitted infections in urine samples, it is recommended to take a sample from a first small portion of the first urine passage, for example the initial 4 mL thereof; this improves the reliability of the results obtained by urinalysis. Collecting even smaller volumes of first urine passage, for example less than the initial 4 mL, for example less than 3 mL, for example between 2 mL and 3 mL, for example between 2.6 and 2.9 mL, has the additional advantage of improving the quality of the sample for diagnostic purposes. Therefore, care must be taken not to spill or lose any of the initial volume during the process of taking the sample. This should not be at the expense of lower handling comfort and hygiene when using the sampling device. Before sampling the initial volume of a liquid, for example urine, a user of the sampling device verifies that the closure member is positioned in the sampling position relative to the housing of the device. To do this, the user can visually inspect the guide rods of the closure member to check that the lower part of the elongated slit is positioned outside the housing, for example as shown in FIG. Figure 1 As shown in. Next, the user connects a suitable container such as a collection tube to the housing, or if the container has been previously connected to the valve housing, it can be checked that it is connected in a safe manner, for example, so that it cannot be subsequently loosened and dropped. Preferably, the container is fastened to the sample connector of the housing by means of a threaded connection, for example, by screwing the externally threaded collection tube into the internally threaded sample connector. Alternatively, the connection can be established by snap-fitting or pushing the container onto the sample connector. In the case where the sampling device is delivered to the user as a kit of parts optionally including other parts such as an expandable funnel, the user is prompted to assemble these parts as described above. A buffer solution or a preservative can be added to the bottom of the container. The user then positions the distal opening 12a of the inlet conduit 12 on the urethral orifice, wherein the wide funnel-shaped opening 12a is adapted to the anatomical shape around the urethral orifice, to prevent overflow or loss during the time when the user's body is excreting urine and urine is received by the inlet conduit 12. At the same time, the user positions the distal opening 11a of the outlet conduit 11 above or in another receiver, for example, in a larger container or toilet. Next, the user verifies that the sampling device is oriented nearly vertically and begins the urination process.

[0073] The initial volume of the first urine 30 enters the sampling device via the inlet conduit 12, passes through the fluid inlet 13a, and encounters the inclined barrier wall of the head portion that blocks the fluid outlet 13b. The inclined barrier wall turns the flow of the first urine to the vertical direction, and the diverted flow passes through the longitudinal slit extending across the sampling outlet 13c, so it leaves the housing. Finally, the initial volume of the first urine 30 flows through the gap between the outer wall of the lower guide rod part and the inner wall of the container, and is collected at the bottom of the container. It is worth noting that the slit allows the initial volume of the liquid flow to enter and pass through this gap on both sides of the lower guide rod part, such as on the front and rear sides. This has the advantageous effect that the volume flow rate can be doubled compared with the unilateral collection mechanism. The float therefore reacts much faster, and the extremely small initial volume of the first urine, such as less than 3mL, such as about 2mL, can be accurately collected and not contaminated by subsequent volumes.

[0074] While receiving the initial volume of the liquid stream, the lifting member (i.e., the float) forces the closure member upwards until the top cover 16 pushes against the projection or stop element 13d. At this moment, the closure member has slid into the turning position, and the collection of the initial volume of urine has been completed. The sample outlet 13c is now blocked by the lower part of the guide rod. However, the thinner diameter of the guide rod compared with the head portion and the slit passing through the upper guide rod portion allow the subsequent volume 31 of urine to flow through the passage in the housing 13, flow outside the fluid outlet 13b and flow toward the distal opening of the outlet conduit 11, and be discharged from the sampling device at the distal opening. Once urination is completed and no more urine enters the inlet conduit 12, the user just releases the container with the initial volume of sampling. The closure cover can be firmly screwed or snapped onto the container for the safe delivery of urine samples to the laboratory responsible for urine analysis and pathogen detection. The user may further dispose of the sampling device, such as flushing a biodegradable device in a toilet, or may clean or rinse and sterilize the sampling device for the next use (optionally replacing accessories, such as a funnel).

[0075] The components of the device for sampling an initial volume of a liquid flow as described above and the attachable accessories may be provided separately in a kit of parts. Fig.11 , showing an exploded view of the kit 60. The kit of parts 60 is for Figure 1 The kit 60 is an assembly kit for a sampling device having a plurality of components and further containing a sample collection tube 19 threadably fastened to a sample connector 18 of the housing 13. An advantage of the kit 60 is that the parts can be manufactured individually and then delivered to the user as a complete kit in a compact box (e.g., less than, for example, 380 mm x 265 mm x 32 mm and shipped by regular mail) or as replacement parts for a previously purchased kit, and the user assembles the sampling device according to the instructions.

[0076] The kit of parts 60 comprises a closure member 17, an inlet conduit 12, an outlet conduit 11, a housing 13, and an optional container such as a collection tube 19. Preferably, the housing 13 and the inlet conduits 12 and outlet conduits 11 are integral parts of a single integrally formed unit 61, such that both conduits 11, 12 are permanently connected to the housing 13, and the openings of the conduits proximal to the housing coincide with the fluid inlet and fluid outlet of the housing. The container 19 (preferably with a closure cap) is connectable to the sample connector 18 of the housing 13 and has a collection volume equal to or greater than the initial volume of the liquid flow to be sampled, such as less than the first 12 mL of first-pass urine, such as less than or equal to 4 mL of first-pass urine, such as less than or equal to 3 mL of first-pass urine, such as between 2.6 mL and 2.9 mL of first-pass urine.

[0077] A layer of soluble material of a preservative or buffer solution may be applied to the bottom of the container 19 prior to sampling of the initial volume. This allows the initial volume of the sample to be preserved during the time required to send the closed container to the laboratory responsible for the urine analysis. Suitable materials for the components of the sampling device include (but are not limited to) polypropylene, biodegradable polymers or formed bagasse, and are resistant to urine at body temperature, such as at least 40 degrees Celsius. The plastic components of the sampling device can be mass-produced by injection molding. Preferably, the materials used for the components of the sampling device are also easily compressed or folded so that they can be sent to the user as a kit or as individual parts by mail (e.g., when less than 28 mm thick), and the user then expands or unfolds the components for assembly.

[0078] In an embodiment of the present invention, where the inlet conduit 12 is not formed as a funnel 62, this inlet conduit can be adapted to receive and secure a separate funnel at the distal opening, for example, the funnel support can include a V-shaped groove for placing and aligning the funnel and a clip for securing and maintaining the open configuration of the funnel. The accessory funnel can be part of the kit 60 and can be delivered in a compact form, for example folded or collapsed, and then unfolded or expanded before use. The separate funnel has the advantage that in addition to fitting to the anatomical structure of a specific gender, such as male or female, it can also be provided as a disposable funnel made of a biodegradable polymer and is suitable for direct flushing. It should be noted that the closure member 17, which is one of the components of the kit 60, can be removably inserted into the valve housing 13 at the opening at the top of the valve housing. In this case, when the closure member 17 is inserted into the guide structure of the housing, the previously mentioned elastic protrusion 13d (e.g., a stop element) is flexed under the pressure of the top cover 16. Once the top cover 16 has passed the elastic projection 13d, the top cover snaps back to its original position, thus limiting the axial movement of the inserted closure member 17 to the interior of the housing 13 and preventing the closure member from accidentally falling out of the housing. In order to facilitate insertion during assembly, the elastic projection 13d may have an upper side that is inclined downwards.

[0079] In the above-described embodiments, the use of extremely narrow, small-volume collection tubes is supported. The liquid sampling device is designed to obtain an increased collection speed so that extremely small initial volumes can also be accurately captured in correspondingly small collection tubes, such as commercially available tubes such as Becton Dickinson 3 mL tubes, or even smaller tubes, such as tubes in the volume range of 1.0 mL-1.5 mL. These small and narrow tubes are advantageous because they can be used directly in liquid handling robots for automated sampling, such as in high-throughput analyzer instruments.

[0080] Although the present invention has been described and illustrated in detail in the drawings and the above description, such description and description should be regarded as illustrative or exemplary rather than restrictive. The foregoing description details certain embodiments of the present invention. However, it should be understood that no matter how detailed the foregoing is in words, the present invention can also be practiced in a variety of ways. Other variations of the disclosed embodiments can be understood and implemented by those skilled in the art from the study of the drawings, the disclosure and the appended claims by practicing the claimed invention. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "one" or "an" does not exclude multiple. The mere fact that certain measures are described in mutually different dependent claims does not indicate that the combination of these measures cannot be used to obtain advantages.

Claims

1. A device for sampling an initial volume of a liquid flow, comprising: a housing comprising a fluid inlet for receiving the liquid flow, a sample outlet for discharging the initial volume of the liquid flow, a fluid outlet for discharging a subsequent volume of the liquid flow, and a passageway for providing fluid communication between the fluid inlet and the fluid outlet and between the fluid inlet and the sample outlet, an elongated closure member slidably supported in the housing, the closure member comprising a head portion and a guide rod, and a lifting element connected to the guide rod or formed in the guide rod, wherein the head portion is configured to block the flow of liquid through the fluid outlet when the closure member is slid into the sampling position, thereby preventing the initial volume of the liquid flow from being transferred to the fluid outlet, wherein a lower portion of the guide rod remote from the head portion is configured to block the liquid flow through the sample outlet when the closure member is slid into the diverted position, thereby ensuring that the subsequent volume of the liquid flow is transferred to the fluid outlet, wherein an upper portion of the guide rod proximal to the head portion comprises at least one longitudinal slit, the at least one slit extending across the sample outlet when the closure member is slid into the sampling position, thereby allowing the initial volume of the liquid flow to leave the sample outlet via the at least one slit, Wherein the lifting element is a float adapted to move the closure member from the sampling position to the diverting position while the initial volume of the liquid flow is being collected in a container connectable to the sample outlet of the housing.

2. The device of claim 1 , wherein the head portion is positioned in the passage when the closure member slides into the sampling position, and wherein the lower portion of the guide rod extends through and at least partially into the passage when the closure member slides into the diverting position.

3. The device of claim 1, wherein the lifting element is an air cavity formed in the lower portion of the guide rod.

4. The device of claim 1, wherein the head portion comprises an inclined barrier wall having an edge that lies flush with a corresponding inner surface of the passageway inside the housing when the closure member is slid into the sampling position.

5. The device according to claim 4, wherein the inclined barrier wall comprises a first flat wall segment close to the fluid inlet and a second flat wall segment away from the fluid inlet, the inclination of the second flat wall segment relative to the longitudinal axis of the closure member being steeper than the inclination of the first flat wall segment.

6. The device of claim 4, wherein the upper portion of the guide rod abuts on a front side of the barrier wall, the front side facing the fluid inlet and defining the at least one slit at a top.

7. The device of claim 1, wherein a lateral side surface of the at least one slit is a planar surface perpendicular to a longitudinal axis of the closure member.

8. The device of claim 7, wherein the upper portion of the guide rod comprises at least two longitudinal slits.

9. The device of claim 1, wherein the at least one slit is defined by a flat surface at a bottom.

10. The device of claim 1, wherein when the closure member slides into the diverted position, an outer surface of the guide rod of the closure member lies flush with an inner surface of the sample outlet.

11. The device of claim 1, wherein the lower portion of the guide rod is directly and continuously connected to the upper portion of the guide rod.

12. The device according to claim 11, wherein the guide rod has a cylindrical shape.

13. The device of claim 1, wherein the sample outlet is formed as a through hole in a base of the housing, and the housing further comprises a connector protruding outwardly from the base, the connector being adapted to engage a container for collecting the initial volume of the liquid flow.

14. The device of claim 13, wherein the connector has internal threads for threadably engaging the container.

15. The device of claim 1, wherein the head portion of the closure member terminates with a cap whose outer edge lies flush with the inner surface of the housing, whereby the closure member is constrained to slide along the longitudinal axis of the closure member.

16. The device of claim 15, wherein the outer edge of the top cover is non-circular.

17. The device of claim 1, wherein the housing includes a resilient protrusion on an inner surface of the housing for limiting further movement of the closure member slid into the diverted position.

18. The device of claim 1, further comprising an inlet conduit connected to the fluid inlet and an outlet conduit connected to the fluid outlet.

19. The device of claim 18, wherein the housing, the inlet conduit and the outlet conduit are integrally formed as a single piece.

20. The device of claim 18, wherein the inlet conduit comprises a funnel.

21. A kit of parts for assembling the device of claim 1, comprising: a housing comprising a fluid inlet for receiving the liquid flow, a sample outlet for discharging the initial volume of the liquid flow, a fluid outlet for discharging a subsequent volume of the liquid flow, and a passageway for providing fluid communication between the fluid inlet and the fluid outlet and between the fluid inlet and the sample outlet, an inlet conduit connectable to said fluid inlet, an outlet conduit connectable to said fluid outlet, an elongated closure member slidably receivable by the housing, the closure member comprising a head portion and a guide rod, and a lifting member which can be connected to the guide rod or formed in the guide rod, wherein the head portion is adapted to block the flow of liquid through the fluid outlet when the closure member is slid into the sampling position, wherein a lower portion of the guide rod remote from the head portion is adapted to block the flow of the liquid through the sample outlet without blocking the flow of the liquid through the fluid outlet when the closure member slides into the diverted position, wherein an upper portion of the guide rod proximal to the head portion comprises at least one longitudinal slit, the at least one slit extending across the sample outlet when the closure member is slid into the sampling position, thereby allowing an initial volume of the liquid flow to leave the sample outlet via the at least one slit, Wherein the lifting element is a float adapted to move the closure member from the sampling position to the diverting position while the initial volume of the liquid flow is being collected in a container connectable to the sample outlet of the housing.

22. A kit according to claim 21, wherein the inlet conduit, the outlet conduit and the housing are provided as a single integrally formed piece.

23. The kit of claim 21, wherein the lifting member and the closure member are provided as a single integrally formed piece.

24. The kit of claim 23, wherein the lifting member comprises an air cavity formed in the lower portion of the guide rod.

25. The kit according to claim 21, wherein the shell includes a guide channel for guiding the head portion, the guide channel having an inner surface shape that cooperates with the outer edge of the head portion to support the sliding movement of the closing component in the shell.

26. The kit of claim 25, wherein the housing includes a resilient protrusion on an inner surface of the housing for limiting further movement of the closure member slid into the diverted position.

27. The kit of claim 21, further comprising a container having a volume ranging between 1 mL and 50 mL, the container connectable to a sampling connector protruding outwardly from a base of the housing.

28. The kit of claim 27, wherein an outer surface of the container includes a threaded portion for engaging corresponding internal threads of the sampling connector.

29. The kit of claim 27, wherein the container is a collection tube, and / or wherein the container contains a preservation solution or a nucleic acid (eg, DNA) stabilizer.

30. The kit of claim 21, further comprising a funnel connectable to the inlet conduit, the inlet conduit adapted to receive and secure the funnel.

31. The kit of claim 21, wherein the inlet conduit has a flexible shape.

32. The kit of claim 21, wherein one or more components of the kit are made from a biodegradable polymer material.

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