Stool sampling device for processing in autosampler systems

Abstract

A stool sampling device (10) is described consisting of a sample lance (30) and a container (40, 60). The lance (30) has a male double thread (32) and the container (40, 60) has a female double thread (61) for secure assembly. For a sealing of the top opening, the sample lance (30) comprises elongated retainer tabs (38) disposed longitudinally towards the lower end of the assembled sampling device (10)), and the container (40, 60) includes resilient engagement hooks (46) arranged in longitudinal direction towards the lower end of the device (10) with respect to the female double thread (61). The retainer tabs (38) and the resilient engagement hooks (46) are engageable in a transport position (100) by a screwing movement directed by the male and the female double thread (31, 61). The stool sampling device is designed for use with automated clinical chemistry analyzer systems including a decapper module.

Description

STOOL SAMPLING DEVICE FOR PROCESSING IN AUTOSAMPLER SYSTEMSFIELD OF THE INVENTION

[0001] The invention relates to a stool sampling device for collecting a sample of fecal material for analysis in a clinical laboratory. In particular, the invention relates to a stool sampling device suitable for use in an automated high-throughput analyzer.BACKGROUND OF THE INVENTION

[0002] There are numerous devices for sampling pasty fecal material, such as spatulas, scoops, ladles, spoons, slot samplers, lancer samplers, or dippers. Sampling systems for occult blood testing typically consist of a screw cap attached to a grooved stick with molded recesses and a tube prefilled with a preservative buffer. To collect a fecal sample, the stick is pierced into the fecal material and then inserted through a fitting hole into the chamber containing the extraction and preservative buffer (see e.g., EP 1 384 442, US 5,246,669, US 5,514,341 , US 7,780,915, DE 10 2008 057866, DE 10 2012 109457, EP 3 629 017, US 11 ,293,839).

[0003] EP 1 366 715 discloses a sampling device comprising a buffer-filled tubular container that is open at the top end and wherein a top closure member is provided with a threaded rod, and when the closure is fitted into the top end, the rod projects in the axial direction into the interior of the tubular container. The tubular container has a partition at an intermediate position which divides the container into a proximal compartment and a distal chamber. The partition is provided with an aperture that allows an axial passage of the threaded rod and any sample contained in its recesses but retains any excess stool in the said upper chamber. The bottom opening of the tubular container is provided with a lower closure member so that said device can be used as a sampling tube and placed into a sample holding plate of an automatic analyzer unit. For automated processing purposes, the bottom closure member may have a blind hole, e.g., having a hexagonal shape so that it can be removed automatically from the tube.

[0004] A disadvantage of this collection system is that the top cap on the collection stick must be screwed on manually with two hands, and that it cannot be given to patients to collect a sample of their own feces. There would always be an increased risk of an incorrect sample size. A fraction of the patients would simply do the same collection twice or more to "adjust" or "correct" the sample in their minds. In addition, modern automated clinical chemistry and immunochemistry analyzers for high-throughput testing include modules for sorting, reading, decapping, aliquoting and recapping of sample tubes. This increases the risk of accidental loosening or removal of the cap and fecal contamination ofthe analyzer. Therefore, such a conventional fecal sampling tube or device cannot be used with high throughput analysers.

[0005] WO 2013 / 107893 discloses a tube for mixing, diluting, and preserving a sample, comprising a transport pin and a hollow first container with a through-hole for the transport pin. The transport pin is movable between an initial position in which a recess is positioned at least partially on the outer side of the first container, and an end position, in which the recess is positioned at least partially on the inner side of the first container. The transport pin and / or the through-hole comprises a latch that prohibits unforced movement of the transport pin in its initial position and / or its end position. In particular, in the end position, the latch may lock the movement of the pin completely, i.e., also against a higher pushing force. This secures the tube against accidental leaking of the diluted sample or introduction of unwanted particles. However, while the latches protect against accidental opening of the tube, intentional opening remains possible.

[0006] DE 10 2012 109457 discloses an odour-proof stool sampling device. However, the user may easily remove the sample lance after collection of a stool sample and insertion into the device. This situation may occur, for example, if the user wrongly considers that an insufficient amount of sample has been introduced into the reagent vessel and proceeds to repeat the procedure of sample collection.

[0007] There is a need for a stool sample collection device that is suitable for use in a high-throughput analyzer and can avoid repeated sampling by the user, which leads to subsequent erroneous determinations and measurements, and which essentially allows one-handed collection and transfer of stool samples into the tube. The state of the art represents a problem.SHORT DESCRIPTION OF THE INVENTION

[0008] The present invention is defined in the appended claims.

[0009] In particular, the present invention is embodied by a stool sampling device 10 comprising a sample lance 30 and a container portion 40, 60, the sample lance 30 defining an upper end of the stool sampling device 10 and the container portion 40, 60 defining a lower end of the stool sampling device, wherein the sample lance 30 includes a male double thread 32 and the container portion comprises a top access opening and a female double thread 61 at a first end, the female double thread 61 corresponding to the said male double thread 32 for secure assembly of the sample lance 30 to the container portion 40,60, sealing the top access opening. Following the present invention, the sample lance 30 further comprises a set of at least two elongated retaining tabs 38 disposed in a longitudinal direction towards the lower end of the assembled stool sampling device for themale double thread 32. The container portion 40, 60 further includes a set of at least two resilient engagement hooks 46 arranged in a longitudinal direction towards the lower end of the assembled stool sampling device with respect to the female double thread 61 , and the elongate retaining tabs 38. The said resilient engagement hooks 46 are engaged in a transport position by a closing screwing movement directed by the said male double thread and the female double thread.

[0010] According to the present invention, the stool sampling device is inevitably locked in a transport position 100, in which the device cannot be reopened unless excessive force is employed to damage the device structurally. According to the invention, the device allows the user or patient to collect a stool sample using the sample lance 30 and store it safely and hygienically within the container portion 40, 60 of the stool sampling device 10. Once the stool sample is safely collected and stored and by connection of the sample lance with the container portion, the corresponding elongated retainer tabs 38 (mounted on the sample lance) and resilient engagement hooks 46 (mounted on the container portion) form a locking connection, which may not be reopened either on purpose or accidentally. Therefore, the present invention allows the safe collection and storage of a stool sample, and is convenient and easy to use without medical or technical professional supervision.

[0011] According to one embodiment of the present invention, the container portion 60 may further comprise a lesser sealing bead 43 arranged towards the upper end with respect to the resilient engagement hooks and the sample lance 30 may further comprise a taper sealing ring 33, 34 arranged towards the upper end with respect to the said retainer tabs 38, wherein the lesser sealing bead 43 and the said taper sealing ring 44 may be releasably engaged into a sales position 200.

[0012] According to this aspect of the invention, the stool sampling device may be set in a sales position 200 in addition to the above-described transport position 100. The stool sample device may be offered for sale and / or provided to the user in its sales position. In the sales position, the sample lance 30 and the container portion 40, 60 are connected via double thread and set in a position maintained by the lesser sealing bead 43 on the container portion and the taper sealing ring 43 on the sample lance. The lesser sealing bead 43 and the taper sealing ring 33 are adapted to hold the sample lance 30 and the container portion 60 in their respective positions for the sales position 200 so that they are easily disconnected by the user intending to take a stool sample.

[0013] According to one embodiment of the present invention, the container portion 40, 60 may further comprise a greater sealing bead 44 arranged between the lesser sealing bead 43 and the said resilient engagement hooks 46, and this greater sealing bead 44 and the said taper sealing ring 34 may be engaged in the transport position 100.

[0014] The presence of the greater sealing bead 44, which is preferably broader and / or thicker than the lesser sealing bead 43, protects the device from accidentally being pushed into its transport position 100 from its sales position 200. When the stool sample device is in its sales position 200, it may be moved into its transport position 100 by overcoming the mechanical resistance engendered by the resilient engagement hooks 46. This may occur by exerting the necessary force onto the sample lance 30 and / or the container portion 40, 60. The presence of a greater sealing bead requires a larger force to be exerted in order to move the stool sample holder into its transport position, since an additional resistance needs to be overcome to engage the greater sealing bead of the container portion with the taper ring of the sample lance.

[0015] According to one embodiment, engagement of the greater sealing bead 44 with the taper sealing ring may induce an audible noise. An audible noise may be induced upon locking the stool sampling device into its transport position, alerting the user that the device is now locked and the sample is safely stored within it.

[0016] According to one embodiment, the sample lance may include a knurled holding portion 36 at the upper end of the stool sampling device and / or a set of sample chambers 39 for collecting a stool sample at its lower end. The knurled holding portion 36 allows the user to handle and grip the sample lance 30 better when collecting and storing a stool sample and when engaging the stool sampling device in its transport position 100 after sample collection. The sample chambers 39 for collecting a stool sample allow for a defined stool volume collection by simply dipping the sample lance into the stool. This makes sample collection by the user particularly simple, convenient and hygienic, in particular given the private nature of the act of sample collection.

[0017] According to one embodiment, the stool sampling device may further comprise a screw cap 20 including a female double thread, and the container portion may further include at a second end opposite the first end a male double thread for secure assembly of the screw cap to the container portion. The presence of the screw cap allows the opening and closing of the container portion at its end opposite the end on which the sample lance may be secured. However, if the stool sampling device is locked in its transport position, upon opening of the container portion using the screw cap, it is not possible to remove the sample lance 30 from the assembled stool sampling device 10. Therefore, it becomes possible to open the container portion of the assembled stool sampling device 10 according to the present invention without removing the sample lance 30. The presence of the screw cap 20 and the possibility of opening the container portion 40, 60 is necessary for accessing the stool sample and / or an extraction medium or solvent present within the container portion after sample collection. In particular, if the stool sampling device 10 is to be opened and analysed using an automated analyzer, the screwcap 20 can be removed automatically by a decapper module to allow the collection of a portion of the sample, or an extraction medium or solution from the container portion to pass the collected portion to analysis.

[0018] According to one embodiment, the container portion of the stool sampling device may comprise a hollow central tube 40 and a threaded upper portion 60, the female double thread 61 being arranged at the upper end inside the threaded upper portion 60 and the resilient engagement hooks 46 being arranged at the upper end of the hollow central tube 40, wherein the hollow central tube and the threaded upper portion 60 may be assembled to form the container portion by secure locking.

[0019] In this embodiment, the container portion is assembled from two constituent parts 40,60. It has been found that such an assembly from constituent parts 20,40 makes production of the device according to the invention easier, and the constituent parts may be formed from different materials, such as for example a transparent material and an opaque material. As the faeces sampling device 10 is typically distributed pre-filled with a predetermined amount of liquid reagent for stabilizing the sample and / or extracting one or more analytes from the faeces, preferred embodiments thereof are made with two or more sealing beads, 43 and 44, near the opening edge on the inner wall of the threaded upper portion 60, i.e. the portion forming with the central transparent tube 40 the container portion. It is preferred that the sealing beads 43, 44 are formed at some distance from each other so that they can cooperate with one or more sealing rings 33, 34 on the conical portion of the sample lance 30. In order to achieve an airtight and liquid-tight seal, at least double sealing beads are provided on the inner wall in the vicinity of the opening edge, which cooperate with one or more respective sealing rings 33, 34 on the conical portion of the sample lance 30 with the screw cap. The wall of the threaded upper portion 60 and the central tube 40, are preferably made of a rigid material. In order to achieve maximum tightness, the insertion cone of the sample lance 30 with the upper and lower sealing rings 33, 34 is preferably made of a softer, elastic material. A double seal is necessary because the sampling device 10 is often subjected to shear and torsional forces act during handling and to air pressure differences during transport, which would lead to small leakages with a single seal only. In the case of faecal sampling tubes intended for automated handling, any form of leakage will result in an unpleasant odour which will be a nuisance to laboratory staff. In addition, any spillage in the clinical chemistry analyzer system would result in a complicated cleaning task and a complete rejection of the sampling device.

[0020] The hollow central tube forming part of the container portion of the stool sampling device may comprise a hollow elongated portion and a connection portion which includes the set of engagement hooks 46 as described above as well as a set of guiding male portions 48 along its outside surface for positioning the threaded upper portion 60relative to the hollow central tube 40 upon connection of the two. In embodiments including a screw cap, the male double thread for secure assembly of the screw cap to the container portion will be positioned at the hollow central tube 40, at an end opposite the end comprising the set of engagement hooks 46.

[0021] The threaded upper portion 60 forming part of the container portion of the stool sampling device may be embodied by a hollow open tube and comprise the female double thread of the container portion, for secure connection with male double thread of the sample lance. It may also comprise a set of guides on its interior surface for positioning the hollow central tube relative to the threaded upper portion 60 upon connection of the two. Upon connection of the hollow central tube and the threaded upper portion 60 for forming the container portion, the each guide of the set of guides of the threaded upper portion 60 will engage with each guiding male portion of the set of guiding male portions of the hollow central tube. The engagement may be a sliding engagement along the guiding male portions and guides which are arranged in a longitudinal direction on the respective surface of the respective portion. Assembly of the container portion from the hollow central tube and the threaded upper portion 60 may be helped and secured by using a commonly known mechanical locking mechanism such as a latch or a taper. In any case, it is not intended that the user disassembles the container portion by separating the hollow central tube from the threaded upper portion 60.

[0022] According to one embodiment of the present invention, the hollow central tube 40 may be formed at least partially of a transparent material. This may allow the user to see the contents of the container portion, including the sample chambers of the sample lance, both in the sales and transport positions 100, 200. According to the invention, this may ease the correct use of the sampling device, as the user may feel better able to correctly carry out sample collection using the sample lance and introduce the loaded sample lance into the container portion 40, 60. This will also allow the user to verify that sample material is present in the sample chambers 39 of the lance before locking the stool sampling device into its transport position 100.

[0023] According to one embodiment of the present invention, the threaded upper portion 60 of the container portion may have an exterior surface suitable for affixing a label, such as a label carrying information concerning a patient and / or a sample contained within the stool sampling device, or a QR code granting access to a database including such information. For example, the surface may be roughened to allow the affixing of an adhesive label.

[0024] According to one embodiment of the present invention, the stool sampling device 10 according to the invention may be prefilled with a reagent for extraction andstabilisation of analytes from a stool sample. If the stool sampling device is prefilled with such a reagent, a stool sample charged into the device may be immediately extracted and stabilised.SHORT DESCRIPTION OF THE FIGURES

[0025] The invention is illustrated with reference to the accompanying figures:Fig. 1 - A schematic drawing showcasing the stool sampling device in tis assembled state according to the invention.Figs. 2A and 2B - Close-up views offering detailed perspectives of the holding and locking portions of the sample lance.Fig. 3a An exterior view presenting the upper portion of the stool sampling device.Fig. 3b An interior view revealing the upper portion of the stool sampling device.Fig. 4 A side view of the reagent vessel of the stool sampling device.Fig. 5 An oblique perspective providing a detailed view of the reagent vessel of the stool sampling device.Fig. 6 A sectional representation through the upper part of the reagent vessel of the stool sampling device.Fig. 7A A side view showcasing the fully assembled stool sampling device without screw cap, positioned in the dispense mode.Fig. 7B A detailed side view accentuating the locking mechanism created by the sample lance and the reagent vessel, in the dispense position.Fig. 7C A detailed perspective view of the locking mechanism formed by the sample lance and the reagent vessel, in the dispense position.Fig. 8A A detailed perspective view of the locking mechanism formed by the sample lance and the reagent vessel, in the transport position.Fig. 8B A detailed side view of the locking mechanism formed by the sample lance and the reagent vessel, in the transport position.Fig. 9A A side view illustrating the fully assembled stool sampling device without the screw cap, in the transport position.Fig. 9B A detailed side view of the locking mechanism formed by the sample lance and the reagent vessel, in the transport position.Fig. 9C A detailed perspective view illustrating the locking mechanism formed by the sample lance and the reagent vessel, in the transport position.Figs. 10A to 10D - Various views depicting the screw cap.

[0026] It is to be understood that the ensuing description and references to the figures pertain to exemplary embodiments of the present invention and are not intended to restrict the scope of the invention as defined by the claims.DETAILED DESCRIPTION OF THE INVENTION

[0027] The present invention, as defined in the appended claims, introduces a stool sampling device 10 comprising a sample lance 30 and a container portion 40, 60. For clarity, the sample lance 30 constitutes the upper end of the stool sampling device 10 in its assembled state, while the container portion 40, 60 forms the lower end.

[0028] In accordance with the present invention, the sample lance 30 and the container portion 40, 60 incorporate corresponding engagement and sealing features, enabling the stool sampling device 10 to be configured in a transport position 100 and optionally in a sales position 200.

[0029] Fig. 1 provides an illustration of an embodiment of the stool sampling device 10 in three different perspectives. The stool sampling device 10 comprises a sample lance 30 and a container position 40, 60. The container portion 40, 60 is constructed from a central tube 40 and an upper threaded portion 60. The sample lance is affixed to one end of the container portion 40, 60 and defines the upper end of the stool sampling device 10. The sample lance 30 includes sample chambers 39, which are visible within the container portion 40, 60 when it is at least partially transparent, as shown in Fig. 1. A sample lance channel 45 within the container allows the sample chambers 39 to pass through when the stool sampling device 10 is assembled by connecting the sample lance 30 and the container portion 40, 60. As will be readily apparent from Fig. 1 , in an assembled position of the stool sampling device 10, the container portion 40, 60 encloses a void space including the sample chambers 39, whereby if liquid medium, such as a reagent for extraction and stabilisation of analytes, is present within the container portion 40, 60, this medium may submerge or partially submerge sample present within the sample chambers 39. The stool sampling device 10 must therefore be adapted to seal its contents tightly without leakage.

[0030] As shown in Fig. 1 , the stool sampling device 10 may further optionally comprise at its lower end a screw cap 20, which, if present, may be used to seal the end ofthe central tube 40 which is directed away from the sampling lance 30. If no screw cap 20 is used, the central tube 40 is closed at its end opposite the sample lance 30.

[0031] The surface of component 60 is completely round. For aesthetic reasons, component 60 is preferably provided with a fine longitudinal knurl, as is common on many screw caps in the pharmaceutical sector. Such knurling hides possible sink marks and shiny spots caused by different wall thicknesses on the component 60. This also results in an improved grip when closing the tube.

[0032] According to Figure 1 , the stool sampling device 10 is closed at the other end by a screw cap 20. In some embodiments, the device may be closed at the other end by a sealing foil instead of the screw cap 20. The use of a sealing foil allows liquid to be withdrawn by means of a piercing needle.

[0033] As shown in Fig. 2A and 2B, the sample lance 30 comprises, from top to bottom end, (i) a knurled holding portio n 36, (ii) a male double thread 32 for engagement with a corresponding female double thread 61 of the container portion 40, 60, (iii) optionally a tapered sealing ring 34 for engagement with lesser and greater sealing beads 43 and 44 optionally present on the container portion 40, 60, (iv) a set of elongated retaining tabs 38 for locking engagement with corresponding resilient engagement hooks 46 present on the container portion 40, 60, and (v) the actual lance comprising sample chambers 39 near its lower end (only shown in Fig. 1). The functions of the various components of the sampling lance 30 are described in more detail below.Container portion 40, 60

[0034] Various aspects of the container portion 40, 60 are shown in detail in Figs. 3A, 3B, 4, 5 and 6. The container portion 40, 60 may be an integral part or it may be formed by permanent connection of separate parts, the central tube 40 and the threaded upper portion 60. The overall structure of the container portion 40, 60 does not differ in those cases where it is an integral part or formed by permanent connection of separate portions. The container portion 40, 60 will therefore be first described as an integral part, and subsequently additional features resulting from it being formed by permanent connection of separate portions will be additionally described.

[0035] The container portion 40, 60 comprises, from top to bottom end, (i) a female double thread 61 on its interior surface (see Fig. 3A and 3B) for engagement with the male double thread 32 of the sample lance 30, (ii) optionally lesser and greater sealing beads 43, 44 (see Fig. 6) for engagement with conical sealing ring 34 of the sample lance 30, (iii) a set of resilient engagement hooks 46 (Fig. 4, 5 and 6) for locking engagement with corresponding elongate retainer tabs 38 of the sample lance 30, (iv) optionally a maledouble thread 42 (Fig. 4) for a screw cap 20 at its lower end. If the container portion 40, 60 does not include a male double thread 42 for a screw cap 20, the container portion 40, 60 is sealed at its lower end.

[0036] As previously stated, the stool sample device 10 typically contains a predetermined amount of liquid reagent (not shown) for preparing and stabilizing the faecal sample or extracting one or more analytes from the stool sample. Therefore, it is preferable that two or more sealing beads, 43 and 44, be formed in proximity to the opening edges on the inner wall of the threaded upper portion 60, which forms with the central transparent tube 40 the container portion. It is preferable that the sealing beads 43, 44 be formed at some distance from each other. They cooperate with one or more sealing rings 33, 34 on the conical portion of the sample lance 30. In order to achieve an airtight and liquid-tight seal, at least double sealing beads are provided on the inner wall in the vicinity of the opening edge, which cooperate with one or more respective sealing rings on the conical portion of the sample lance 30 with the screw cap. The wall of the threaded upper portion 60 and the central tube 40, are preferably made of a rigid material, preferably transparent polypropylene or transparent polystyrene. In order to achieve maximum tightness, the insertion cone 30 with the (upper and lower sealing rings 33, 34 is preferably made of a soft, elastic material. A double seal is necessary as shear and torsional forces act on the stool sampling device 10 during handling and due to air pressure differences during transport, which would lead to small leakages with a single seal only. It is difficult to eliminate pressure differences and shear forces. However, in the case of faecal sample tubes intended for automated handling, any form of leakage or spilling of the apparatus will result in an unpleasant odour that will be a nuisance to laboratory staff. In addition, any spillage in the clinical chemistry analyzer system will result in a complicated cleaning task and a rejection of the sampling device.

[0037] In the case the container portion 40, 60 is formed by permanent connection of the central tube 40 and the threaded upper portion 60, these two elements may be brought into the correct position with respect to each other by a set of elongate guides 65 positioned in a longitudinal direction along the exterior surface of the threaded upper portion 60 and corresponding elongate guide male portions 48 positioned in a longitudinal direction along the interior surface of the central tube 40. Both portions may be usefully connected and secured together by means known those skilled in the art, such as a latch or a taper.

[0038] The container portion 40, 60 includes a main internal cavity formed towards the bottom of the container portion 40, 60 for securely receiving the stool sample and optionally a liquid extraction reagent. Where the container portion 40, 60 is provided with a thread 42 for a screw cap 20, the screw cap 20 will usefully remain connected to the container portion 40, 60 to prevent leakage or escape of the sample and / or any extractionreagent. It is not envisaged that the user will open the screw cap 20 as this is only required at the stage of sample analysis. If the container portion 40, 60 is not provided with a thread 42 for a screw cap 20, the container portion is sealed at its lower end to safely store stool sample and / or extraction reagent.

[0039] The main internal cavity of the container portion 40, 60 is bounded on its upper end by the sample lance channel 45. In an assembled position of the stool sampling device 10, the main inner void is therefore essentially sealed by the presence of the sample lance 30 protruding through the sample lance channel 45. The additional structural features of the container portion 40, 60 which are located above the main inner void beyond the sample lance channel 45 serve mainly to lock the stool sampling device 10 into its transport position 100 and / or its optional sales position 200 and will be described in more detail below.

[0040] According to the present invention, the various components for assembling the stool sampling device 10 comprise special structural features, which allow the stool sampling device 10 to be placed in a transport position 100 and optionally in a sales position 200. The transport and sales positions 100, 200 and the special structural features relating to the setting of these positions will be discussed below, with reference to Figs. 2A, 2B, 3A, 3B, 4, 5, 6, 7A, 7B, 7C, 8A and 8B.Transport Position

[0041] When set in the transport position 100, the sample lance 30 and the container portion 40, 60 of the stool sampling device 10 according to the present invention are tightly locked together. The transport position may be usefully engaged after sample collection, thereby locking and permanently storing the sample within the stool sampling device 10. According to the present invention, it is not possible to release the sample lance 30 and the container portion 40, 60 from the transport position without the use of tools, unless structural damage is inflicted on the stool sampling device 10. The engagement and sealing features of the sample lance 30 and the container portion 40, 60 are arranged and shaped such that once the transport position 100 is engaged, they cannot be released under normal circumstances to separate the sample lance 30 from the container portion 40, 60.

[0042] In accordance with the present invention and as shown in Figs. 2A and 2B, the sample lance 30 includes a male double thread 32 and at least two longitudinal retainer tabs 38. The longitudinal retainer tabs 38 are located towards the lower end of the stoolsample tube 10 with respect to the male double thread 32. The longitudinal retainer tabs 38 are therefore located between the male double thread 32 and the lower end position of the sample lance 30 which includes the sample chambers 39.

[0043] Further according to the present invention, the container portion 40, 60 includes a female double thread 61 as shown in Figs. 3A and 3B and at least two engagement hooks 46 as shown in Figs. 4, 5 and 6. The engagement hooks 46 are located towards the lower end of the stool sampling device 10 with respect to the female double thread 61 .

[0044] Further according to the present invention, the male double thread 32 and the female double thread 61 are designed to cooperate with each other upon assembly of the sample lance 30 with the container portion 40, 60. The elongate retainer tabs 38 are designed and positioned to engage with the engagement hooks 46 upon assembly of the sample lance 30 with the container portion 40, 60 by screwing motion of the male double thread 32 against the female double thread 61. Accordingly, the number of elongated retainer tabs 38 should be equal to the number of engagement hooks 46. The elongate retainer tabs 38 may be formed as protrusions with an elongated shape, directed in the longitudinal direction of the sample lance 30, and extending from the rotational axis of the sample lance 30 defined by the rotating direction directed by the male double thread 32 (See Figs. 2A and 2B). Accordingly, the engagement hooks may be formed as resilient flanges extending from the interior wall of the container portion 40, 60 towards the rotational axis of the container portion 40, 60 defined by the rotating direction directed by the female double thread 61 (see Figs. 5 and 6).

[0045] The described arrangement of the male and female double threads 32, 61 , the elongate retainer tabs 38 and the resilient engagement hooks 46 allows for the stool sampling device 10 to be locked in the transport position 100 by the following process. Fig. 7C shows a schematic view of the retainer tabs 38 and the resilient engagement hooks 46 when not engaged in a transport position. Upon rotation of the sample lance 30 in a clockwise direction as depicted in Fig. 7C around the axis defined by the male and female double threads 32, 61 (not shown), the elongated portions 38 will push against the resilient engagement hooks 46 and move them away from the central axis. Upon further rotation, the elongated portions 38 will move beyond the resilient engagement hooks 46, causing them to snap back into their original position and engage the sample lance 30 in the transport position 100 (Figs. 8A and 8B). In this position, the sample lance 30 may no longer be rotated back in the opposite direction to release the threaded connection between the sample lance 30 and the container 40, 60, due to a snap-fit engagement between the elongate retainer tabs 38 and the resilient engagement hooks 46. The stool sampling device 10 is locked in its transport position 100.

[0046] According to an embodiment of the present invention, the container portion 40, 60 may further comprise a larger sealing bead 44, disposed circumferentially on its inner surface between the resilient engagement hooks 46 and the female double thread 61 (see Fig. 6). The sample lance may correspondingly comprise a conical sealing ring 34, arranged between the elongate retaining hooks 38 and the male double thread 32. Upon engagement of the transport position 100, the larger sealing bead 44 and the taper sealing ring 34 will be engaged, providing resistance to engagement of the transport position 100, thereby preventing inadvertent engagement of the transport position 100. In accordance with an embodiment of the present invention, the larger sealing bead 44 and the taper sealing ring 34 may be configured such that an audible sound is produced by their engagement, indicating to a user that the transport position 100 has been engaged. Further illustrative representations of the stool sampling device 10 in its transport position 100 are shown in Figs. 9A, 9B and 9C.Safes or dispense position

[0047] According to certain embodiments of the present invention, the stool sampling device 10 may further be set in a sales position 200. It is intended that the stool sampling device 10 is initially assembled in the sales position 200. In the sales position 200, the sample lance 30 is releasably fixed in position with the container portion 40, 60 by cooperation of a lesser sealing bead 43 located on the circumference of the sample lance 30 with the taper sealing ring 34 located within the container portion 40, 60 between the elongated retaining hooks 38 and the male double thread 32. When assembled in the sales position 200, the stool sampling device may easily be disassembled and reassembled, either into the sales position 200, or into the locked transport position 100.

[0048] According to these embodiments of the present invention, the stool sampling device 10, when set in the sales position 200, appears as shown in Figs. 7A to 7C. It can be seen in Fig. 7A that in the sales position, the sample lance 30 is not tightly connected to the container portion 40, 60, leaving a portion of the male double thread 32 visible on the assembled stool sampling device 10. The male double thread 32 may be partially engaged into the female double thread 61 , but not to the extent that the transport position is engaged as described above. As seen in Figs. 6 and 7B, for engagement into the sales position 200, the container portion 40, 60 incudes a lesser sealing bead 43, which is arranged between the greater sealing bead 44 and the female double thread (not shown). In the sales position 200, the taper sealing ring 34 of the sample lance 30 is releasably engaged in the lesser sealing bead 43. In order to engage the taper sealing ring 34 with the lesser sealing bead 43, the sample lance 30 is screwed onto the container portion 40, 60,as directed by the male and female double threads 32, 61 , without however fully engaging the double thread mechanism in order to avoid engagement in the locked transport position.

[0049] When the stool sampling device 10 of the present invention is provided to a user, it is advantageously set in its sales position 200. Alternatively, it may be in a disassembled state. In case the stool sampling device 10 were provided in its transport position 100, it could not be used to collect a stool sample and would therefore be unusable.Sample collection by user

[0050] Provision of the stool sampling device 10 in its sales position 200 or in a disassembled state allows the user to take the sample lance 30, if required release it from the container portion 40, 60 by simply pulling, and take a stool sample by dipping the sample chambers in a stool. The sample lance 30 may be safely and easily handled by holding onto its knurled holding portion 36. As is known to the skilled person in the art, the stool sample is easily collected with the sample chambers 39, and the amount of stool is defined by their internal shape and contours. The sample chambers 39 are suitable for collection of samples with varying consistencies from liquid to near solid. Also as known to the skilled person in the art, when a stool sample is collected using the sample lance 30 and introduced into the container portion 40, 60, the sample lance channel 45 present within the container portion 40, 60 may serve to remove any portions of stool sample that may protrude from the sample chambers 39, and prevent excess sample mass from entering the interior of the container portion by withholding any excess on the edges of the sample lance channel 45. In this way, the amount of stool introduced into the container portion 40, 60 may be controlled.

[0051] After sample collection, the stool sampling device 10 is preferably locked by the user into its transport position 100. The transport position 100 is engaged by screwing the sample lance 30 onto the container portion 40, 60 using the male double thread 32 of the sample lance and the corresponding female double thread 61 of the container portion 40, 60, and pressing the sample lance 30 against the container portion 40, 60 to engage the locking mechanism of the retainer tabs 38 with the engagement hooks 46, thereby locking the stool sampling device 10 into its transport position 100. In some embodiments, the container portion is equipped with a greater sealing bead 44 and the sample lance 30 is equipped with a taper sealing ring 34, which is positioned such that an additional resistance beyond the resilient force of the engagement hooks 46 may be overcome when engaging the greater sealing bead 44 with the sealing ring 34, and optionally an audible noise may be induced, for example by the friction between the greatersealing bead 44 and the sealing ring 34, which serves as an indicator to the user that the locked transport position 100 has been engaged.

[0052] Once the transport position 100 has been engaged, the stool sample is securely maintained in the sampling chambers 39, which in turn are stored within the interior of the container portion 40, 60 of the stool sampling device 10. Any excess sample which may have been present on or around the sampling chambers 39 would have remained outside the main void formed by the container portion 40, 60, as not having fir through the sample lance channel 45. In this way, the amount of stool sampled may be controlled. In the transport position 100, the sample lance 30 and the container portion 40, 60 may no longer be physically separated under normal conditions, and the sample is therefore securely maintained within the stool sampling device 10, without risk of escape or leakage.

[0053] In embodiments in which a reagent for extraction and stabilisation of analytes from a stool sample has been prefilled within the container portion of the stool sampling device 10, the reagent is now in contact with the stool sample, and extraction of analytes may be induced by simple shaking of the stool sampling device 10 locked in its transport position 100. Alternatively, the stool sampling device 10 may simply be left without additional shaking, which may be deferred to a later time.

[0054] If no reagent forextraction and stabilisation of analytes from a stool sample is present within the container portion 40, 60, the stool sampling device 10 locked in its transport position 100 may simply be transferred to the next stage for analysis of the stool sample, without extraction at this time.

[0055] As described above, sample collection by the user is simple, hygienic and safe. The user is merely required to dip the sampling lance 30 in a stool and then secure it with the container portion 40, 60 into the locked transport position 100. After engagement of the transport position 100, no sample or extraction reagent may leak or escape from the locked stool sampling device 10, and any excess stool sample which may have been collected by dipping the sample lance 30 into the stool does not reach the main void of the container portion 40, 60, while it is still stored safely within the stool sampling device 10. However, any excess stool sample is not forwarded to analysis by being entered into the main void of the container portion 40, 60. There is merely the need to ensure that no reagent is spilled from the container portion 40, 60 in case this has been prefilled into it.Sample analysis

[0056] The various embodiments of the present invention flexibly allow different ways of analysing collected stool samples.

[0057] In embodiments which do not include a screw cap 20, the container portion 40, 60 is sealed at its bottom end, and the collected sample cannot easily be accessed once the device is locked into its transport position 100. In this case, it is possible to access the collected sample by either releasing the sample lance 30 from its locked transport position by employing correspondingly shaped tools that may unlock the resilient engagement hooks 46 from the elongate retainer tabs 38. Although this is possible in theory, it is unlikely that such a course of action may be routinely taken, since it is cumbersome and requires individual treatment of each stool sampling device 10 in its transport position 100 by a human handler.

[0058] Alternatively, the container portion may be destructively opened to access the collected stool sample by cutting or breaking. In such cases it may be advantageous for the container portion 40, 60 to be at least partially transparent to allow the handler to better see the location of the sample lance 30 and the sample chambers 39 within the container portion 40, 60 prior to its destructive opening to avoid damaging the collected sample. It is conceivable that this process could be automated on a high-throughput analyzer. In this case, the stool sampling devices 10 in their locked transport positions 100 are sorted into racks with their upper ends downwards (in other words, the holding portion 36 of the sample lance 30 is entered into a holding rack first with the lower end of the container portion facing upwards). It is therefore advantageous for the holding portion 36 of the sample lance 30 to have a rounded upper end, which can centre itself on the rack, where a flat bottom would be more likely to crash. The sealed lower end of the container portion 40, 60 faces upwards. The sorted stool sample devices 10 can then be transported to a suitable cutting or breaking device, which can destructively remove the lower end of the container portion 40, 60, for example, by cutting or breaking. If the container portion 40, 60 contains prefilled extraction reagent, this can then be partially removed automatically by pipette, aliquoted and passed to analysis. If the container portion 40, 60 did not contain a prefilled extraction reagent, the stool sample container within the sample chambers 39 can then be accessed for further analysis.

[0059] Embodiments which do include a screw cap 20, connected to the lower end of the container portion 40, 60, are much more suitable for automated analysis using high throughput analysers. In this case, stool sampling devices 10 in their locked transport positions 100 are sorted into racks with their upper ends down (in other words, the holding portion 36 of the sample lance 30 is entered first into a holding rack, and the lower end of the container portion 40, 60 points upwards). It is therefore advantageous for the holding portion 36 of the sample lance 30 to have a rounded upper end, so that the device centres itself on the rack. Incidentally, a flat bottom or top would be more likely to crash. The sealed bottom end of the container portion 40, 60 with the screwed-on screw cap 20 facesupwards. It is advantageous that the screw cap is opaque for a camera of the high- throughput analyzer to easily identify the screw cap, which may then be removed by robotic action.

[0060] Once the screw cap has been removed, the main void of the container portion 40, 60 is easily accessible. In case the container portion 40, 60 included a prefilled extraction reagent, it can then be automatically removed by pipette aliquoting and passing to analysis. In case the container portion 40, 60 did not include a prefilled extraction reagent, the stool sample container within the sample chambers 39 may then be accessed for further analysis.

[0061] The presence of a male thread 42 for a screw cap 20 therefore gives the additional advantage of making the stool sampling device 10, according to the present invention, better suitable for analysis using high-throughput analysers. Advantageous features of the screw cap 20, including the presence of a holding rod 22 for better robotic handling and unscrewing, are shown in Figs. 10A to 10D.

[0062] In a most preferred embodiment of the invention, the stool sampling device 10 is specifically designed for advanced and modular high throughput analyzer systems, particularly those used for immunoassays and photometric analysis. Examples of such systems include the Cobas® series by Roche Diagnostics, the Architect® series by Abbott, or the Atellica® solution by Siemens Healthcare. These fully automated analysers are equipped with various modules for tasks such as sample tube recognition and reading, software-controlled random access, device sorting, and decapping and recapping. Although this last task may seem simple, removing caps from hundreds or thousands of fecal sample tubes can cause fatigue and lead to chronic symptoms such as Carpel T unnel syndrome. Aerosol spraying during cap removal can be a health hazard and infection risk to employees and can lead to contamination of the samples and machine environment, even cross-contamination. If tubes are left open for long periods, there is an even greater risk of sample alteration, odour contamination, oxidation and evaporation. Transporting open tubes around the laboratory is also detrimental to sample integrity. These problems have been minimised with the autosampler tubes as claimed in the present invention which have been designed for automatic decapping as close to the analysers as possible. At the same time, potential health and sample problems are reduced and the quality of the process is noticeably improved. In the context of such a fully automated system, the prefilled stool sample tube 10 with a bottom screw cap 20 is carefully dimensioned in width and length to allow for the central tube 40 to be pre-filled with approximately 3 ml extraction liquid for the extraction of the sampled fecal specimen. When positioned for decapping and subsequent analysis - the assembled device 10 is turned around so that the rounded top of the sample lance is centred on the rack - it ensures that there is no spillage during decapping and anyfurther processing or movement of the sample tube. The strategic orientation is to leave approximately 15 mm between the liquid's surface and the tube's upper end. This free space is critical to prevent accidental spillage with the opened tube device is transported and automatically manipulated within the system. The design of the feces collection device has been tailored to integrate seamlessly with these advanced analyzer systems, ensuring automated spill-free handling throughout the analysis process. To this end, the tube design has also been smoothed to prevent it from catching on any other surfaces or supports, and the length and width of the collection tube has also been designed to conform to known standards, so that it can be easily labelled and recognised.

[0063] It should be noted that the present invention may comprise any combination of the features and limitations discussed herein except for mutually exclusive combinations. The preceding description focuses on specific embodiments to illustrate the invention, but modifications and variations are possible within the scope of the appended claims.LIST OF REFERENCE NUMBERS10 Assembled stool sampling device20 Screw cap22 Holding rod30 Sample lance32 Male double thread34a Upper taper sealing ring34b Lower taper sealing ring36 Knurled holding portion38 Retainer tabs39 Sample chambers40 Central tube42 Male double thread for screw cap43 Lesser (upper) sealing bead44 Greater (lower) sealing bead45 Sample lance channel46 Engagement hooks48 Guiding male portion60 Upper thread portion61 Female double thread65 Guide100 Transport position200 Sales / dispense position

Claims

C L A I M S1. Stool sampling device (10) comprising a sample lance (30) and a container portion (40, 60), the sample lance (30) defining an upper end of the stool sampling device (10) and the container portion (40, 60) defining a lower end of the stool sampling device (10), wherein the said sample lance (30) includes a male double thread (32) and the container portion (40, 60) includes a top access opening and a female double thread (61) at a first end, the female double thread (61) corresponding to the said male double thread (32) for secure assembly of the sample lance (30) to the container portion (40, 60), sealing the top access opening, characterised in that the sample lance (30) comprises a set of at least two elongated retainer tabs (38) disposed in a longitudinal direction towards the lower end of the assembled stool sampling device (10) with respect to the male double thread (32), and in that the said container portion (40, 60) further includes a set of at least two resilient engagement hooks (46) arranged in a longitudinal direction towards the lower end of the assembled stool sampling device (10) with respect to the female double thread (61), and in that the said elongated retainer tabs (38) and the said resilient engagement hooks (46) are engageable in a transport position (100) by a screwing movement directed by the said male double thread (32) and the said female double thread (61).

2. The stool sampling device (10) according to claim 1 , wherein the said container portion (40, 60) further comprises a lesser sealing bead (43) disposed towards the upper end with respect to the said resilient engagement hooks (46), and the said sample lance (30) further comprises a tapered sealing ring (34) disposed towards the upper end with respect to the said retainer tabs (38), wherein the lesser sealing bead (43) and the tapered sealing ring (34) are releasably engageable in a dispense position (200).

3. The stool sampling device (10) according to claim 2, wherein the said container portion (40, 60) further comprises a greater sealing bead (44) arranged between the said lesser sealing bead (43) and the said resilient engagement hooks (46),wherein the greater sealing bead (44) and the tapered sealing ring (34) are engageable into the transport position (100).

4. The stool sampling device (10) according to claim 3, wherein engagement of the said greater sealing bead (44) with the said taper sealing ring (34) induces an audible noise.

5. The stool sampling device (10) according to any one of the preceding claims, wherein the greater lower sealing bead (44) and the lesser upper sealing bead (43) on the inner wall of the upper thread portion (60) cooperate respectively with the lower taper sealing ring (34) and the upper taper sealing ring (33) on the exterior of the sample lance (30) to provide double sealing against leakage of any liquid contained in the central tube when the assembled stool sampling device (10) is in either the sales position (200) or the dispense position (100).

6. The stool sampling device (10) according to any one of the preceding claims, wherein the sample lance (30) further comprises a knurled retaining portion (36) at the upper end of the stool sampling device (10) and / or a set of sample chambers (39) for collecting a stool sample at its lower end.

7. The stool sampling device (10) according to any one of the preceding claims, further comprising a screw cap (20), wherein the said screw cap (20) includes a female double thread, and the container portion (40, 60) further includes at a second end opposite the said first end a male double thread (42) for secure assembly of the screw cap (20) to the container portion (40, 60).

8. The stool sampling device (10) according to any one of the preceding claims, wherein the said container portion (40, 60) comprises a hollow central tube (40) and a threaded upper portion (60), the said female double thread (61) being arranged at the upper end inside the threaded upper portion (60) and the said resilient engagement hooks (46) being arranged at the upper end of the hollow central tube (40), wherein the said hollow central tube (40) and the said threaded upper portion (60) may be assembled to form the container portion (40, 60) by secure locking.

9. The stool sampling device (10) according to claim 8, wherein the said hollow central tube (40) is formed at least partially of a transparent material.

10. The stool sampling device (10) according to claim 8 or 9, wherein the said threaded upper portion (60) comprises a roughened exterior surface.

11. The stool sampling device (10) according to any one of the preceding claims, wherein the said stool sampling device (10) has been prefilled with a reagent for extraction and stabilisation of analytes from a stool sample.

12. Use of the stool sample (10) according to any one of the previous claims in an automated clinical analyzer system comprising a decapper module.

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