Sample collection device

Abstract

The invention relates to a sample collection device (10) for the sterile collection of a clinical sample, having: a swab (20) comprising a tubular, hollow swab stick (22) which has a sample uptake means (24) at its front end; a substantially cylindrical swab tube (30), which is provided for the swab (20) and is closed at its front end (32) and open at its rear end (34); and a swab head (40), which can be fitted onto the swab (20) and has a main part (50) with a removal fitting (54) and also a closure element (60) for sealed covering of the fitting. Once the swab head (40) has been connected to the swab (20), the removal fitting (54) is fluidically connected to the hollow swab stick (22), and the swab head (40) forms a grip, which is provided for the swab (20) and closes the open end (34) of the swab tube (30) with an exact fit. The sample collection device has a first sealing device (80) and a different, second sealing device (82), and the two sealing devices (80, 82) each form an opening indicator, which undergoes an irreversible, recognizable change when the sealing device (80, 82) is opened for the first time. The first sealing device (80) seals the connection between the swab tube (30) and the swab head (40) such that opening of the first sealing device (80) indicates a removal of the swab head with the swab. The second sealing device (82) seals the connection of the main part (50) of the swab head to the closure element (60) of the swab head such that opening of the second sealing device (82) indicates the opening of the closure element (44) towards the fitting (54). According to the invention, the removal fitting is a Luer removal fitting, and the second sealing device is formed by a retaining ring comprising a plurality of narrow breaking projections, which connect a grip cap of the closure element to a locking ring fixed to the main part.

Description

[0001] Sampling device

[0002] The invention relates to a sampling device for taking a clinical sample and in particular to a sampling device with a swab having a tubular, hollow swab stick which has a sample receiving means at its front end, a substantially cylindrical swab sheath for the swab which is closed at its front end and open at its rear end, and with a swab head which can be attached to the swab, the swab head having a base body with a sampling port and a sealing element for tightly covering the port, wherein after connection of the swab head with the swab, the sampling port is in fluid communication with the hollow swab stick, and the swab head forms a handle for the swab which closes the open end of the swab sheath precisely.

[0003] A variety of different swabs are used in the prior art for taking clinical samples. These swabs often have a plastic or wooden stem with a head made of absorbent material such as cotton attached to the end. To improve sample uptake and release, various materials and structures have been introduced, including synthetic fibers, foams, and microfiber-based heads. Some swabs have special coatings to facilitate the binding of specific molecules. In addition, designs with snap-off stems have been developed to allow for the safe transfer of the sample into transport containers.

[0004] A swab system is known from publication WO 2013 / 071920 A 1. After sampling, the handle of the swab stick in this system can be sealed with a cap for contamination-free transport of the sample. However, with such a system, a user cannot tell whether the swab stick has already been removed and reinserted. Furthermore, contaminants may have entered the sample tube through a previous opening of the cap without this being apparent to the user.

[0005] German patent application DE 102009015724 A 1 discloses a sampling device according to the preamble of claim 1. The sampling device has a first and a different second sail assembly, wherein the two sail assemblies each form an opening indicator which undergoes an irreversible, recognizable change when the sail assembly is opened for the first time.

[0006] The first sail assembly seals the connection between the swab cover and the swab head, so that opening the first sail assembly indicates that the swab head has been removed along with the swab.

[0007] The second sail assembly seals the connection between the base body of the swab head and the closure element of the swab head, so that opening the second sail assembly indicates the opening of the closure element towards the connection.

[0008] Based on this, the invention aims to provide a generic sampling device that overcomes the disadvantages of existing technology and, in particular, enables a user to perform safe, sterile sample collection. This objective is achieved by the features of the independent claims. Further developments of the invention are the subject of the dependent claims.

[0009] According to the invention, in a sampling device of the type mentioned in DE 102009015724 A 1, the sampling connection is a Luer sampling connection, and the second sail device is formed by a shear ring made of a plurality of narrow fracture webs, which connect a handle cap of the closure element with a locking ring fixed to the base body.

[0010] In an advantageous embodiment, the first sail arrangement is formed by a band, preferably a perforated band.

[0011] The second sail device is formed by a shear ring consisting of a plurality of narrow fracture bars, which connect a handle cap of the locking element with a locking ring fixed to the base body.

[0012] When the swab head is opened, the handle cap is twisted against the fixed locking ring, causing the break tabs to tear off, thus indicating the opening irreversibly and clearly.

[0013] In an advantageous embodiment, the base body has at least one recess and the locking ring of the closure element has at least one corresponding locking pin which, in the sealed state, engages in the at least one recess and thereby fixes the locking ring to the base body. Advantageously, two or three recesses and two or three corresponding locking pins may be provided. In another, equally advantageous embodiment, the base body has at least one protruding pin and the locking ring of the closure element has at least one corresponding recess or opening into which the at least one protruding pin engages in the sealed state and thereby fixes the locking ring to the base body. Advantageously, two or three protruding pins and two or three corresponding recesses or openings may be provided.

[0014] The locking element is advantageously made of a rigid material, preferably a hard plastic, in particular high-density polyethylene (HDPE). The rigidity of the locking element ensures that the breakaway ribs of the safety ring are destroyed when the locking element is opened, thus irreversibly indicating that the locking element has been opened.

[0015] According to an advantageous embodiment of the invention, the swab casing has a circumferential casing wall which is thickened in a receiving area at the front, closed end of the swab casing in order to reduce the internal volume of the swab casing in the receiving area.

[0016] The casing wall in the receiving area advantageously has a wall thickness that is thicker than the normal area outside the receiving area by a factor of between 1.5 and 8, preferably by a factor of between 2 and 4, and in particular by a factor of about 2.5.

[0017] The advantages of the invention and further embodiments are explained below with reference to the figures, which are not drawn to scale or proportion to the actual product to enhance clarity. They show:

[0018] Fig. 1 schematically shows a sampling device for the sterile removal of a clinical sample.

[0019] Fig. 2 shows the swab head of the sampling device of Fig. 1, wherein (a) shows the swab head with the base body and the closure element in a perspective view, (b) shows only the base body after removal of the closure element, and (c) shows the swab head of (a) in a sectional view.

[0020] Fig. 3 shows the swab casing of a sampling device according to an embodiment of the invention, in which the casing wall is thickened in a receiving area, and

[0021] Fig. 4 shows the swab head of a sampling device according to another embodiment of the invention.

[0022] Figure 1 schematically shows a sampling device 10 for the sterile collection of a clinical sample. The sampling device comprises a sterile swab 20, a cylindrical swab sleeve 30, and a swab head 40.

[0023] The swab 20 contains a tubular, hollow swab stick 22, which has a viscose pad 24 at its front end to serve as a sample receiving medium. The swab 20 is held in the cylindrical swab sleeve 30, which is closed at its front end 32 and open at its rear end 34 (Fig. 3).

[0024] The swab head 40 can be attached to the swab 20, with Fig. 1 showing the swab head in the attached state. In the exemplary embodiment, the swab head 40 is a two-component component and consists of a base body 50 with a Luer extraction port (Fig. 2(b)) and a sealing element 60, in particular for tightly covering the Luer port (see Fig. 2(c)).

[0025] If the swab head 40 is connected to the swab 20, as shown in Fig. 1, the Luer extraction port 54 is in fluid contact with the hollow interior of the swab stick 22. The swab head 40 also forms a handle for the swab 20, which, when inserted, precisely closes the open end 34 of the swab sheath 30.

[0026] As a special feature, the sampling device 10 has two different sail arrangements 80, 82, which independently of each other each form an opening indicator which undergoes an irreversible, recognizable change when the sail arrangement is opened for the first time, so that the undamaged state of the sail arrangements 80, 82 indicates the suitability of the sampling device 10 for sterile sampling.

[0027] In the exemplary embodiment, the first sail assembly 80 consists of a perforated band that seals the connection between the swab sleeve 30 and the swab head 40. When the swab head 40 is removed with the sample swab 20 for sampling, the band 80 tears along the perforation and is thereby destroyed. The removal or tearing of the band 80 clearly indicates to the user that the swab head 40 has already been removed or the sample swab taken out.

[0028] The second sail assembly 82 seals the connection between the base body 50 of the swab head and the locking element 60 of the swab head. In the exemplary embodiment, it is formed by a shear ring 70 consisting of a plurality of narrow breakable ribs 72, which connect the handle cap 62 of the locking element 60 to a locking ring 64 and which break off when subjected to a rotational stress during the opening of the swab head. The breaking off of the ribs is detectable both visually and tactilely, since the broken ribs subsequently no longer resist rotation of the handle cap.

[0029] For further explanation, Fig. 2 shows the swab head 40 in more detail. Fig. 2(a) shows the swab head with the base body 50 and closure element 60 in a perspective view. Fig. 2(c) shows the swab head of Fig. 2(a) in a sectional view, and Fig. 2(b) shows only the base body 50 without the closure element 60.

[0030] As can best be seen in Fig. 2(b), the base body 50 of the swab head 40 has a Luer dispensing port 54 in the form of a Luer lock on its upper side. On its underside, the base body 50 is provided with a snap-in recess 52 for receiving and securely holding the swab stick 22. The base body 50 also contains two opposing recesses 56 into which the locking pins 68 of the locking element 60 engage after the swab head has been assembled. With reference to Fig. 2(a) and 2(c), the closure element 60 of the swab head, made of hard polyethylene (HDPE), comprises two sub-elements, namely a ribbed round handle cap 62 and a locking ring 64 with two rigid ribs 66, each of which carries on its rear side a locking pin 68 engaging in the corresponding recess 56 of the base body 50.The handle cap 62 and the locking ring 64 are connected by a safety ring 70, which consists of a plurality of narrow breaking bars 72 arranged along the circumference (Fig. 2(c)).

[0031] In the sealed state, the locking pins 68 of the rigid ribs 66 engage in the recesses 56 of the base body 50, thereby fixing the locking ring 64 to the base body 50. If a user turns the handle cap 62 of the closure element 60 against the base body 50 to open the swab head, the narrow breaking ribs 72 of the safety ring break off and irreversibly separate the handle cap 62 from the locking ring 64. The opening of the swab head is easily recognizable by the breakage of the breaking ribs 72 of the second sealing device 82. After unscrewing, the handle cap 62 of the closure element 60 can be removed to expose the Luer dispensing port 54. The locking ring 64 remains fixed to the base body 50 because of the locking pins 68 engaging in the recesses 56.

[0032] Due to their design, the two different sealing devices 80, 82 of the sampling device 10 can be opened independently of each other, with each opening resulting in an irreversible, recognizable change to the sealing device and allowing a quick visual check of the swab head's opening status. The perforated band 80 indicates the opening status of the swab head and thus that the sample has already been taken. The sealing device 82 indicates the opening status of the closure element and thus that the Luer-An connector has already been accessed.

[0033] In an undamaged state, the two sail devices 80, 82 therefore guarantee to the user that the swab 20 has not already been removed and that the closure element 44 is still unopened, so that a sterile taking of a clinical sample can be carried out with the sampling device 10.

[0034] Figure 4 shows a swab head 40 according to another embodiment of the invention, which differs from the embodiment of Fig. 2 in the design of the second sail assembly 82. In the embodiment of Fig. 4, the base body 50 has two opposing protruding pins 94, which, in the sealed state, are each received and fixed in an opening 96 in the rigid sail 66 of the closure element 60.

[0035] In this embodiment as well, the narrow breaking tabs 72 of the safety ring 70 break off and separate the handle cap 62 from the locking ring 64 as soon as a user unscrews the handle cap 62 of the locking element 60 against the base body 50 to open the swab head. The opening of the swab head is easily recognizable by the irreversible breakage of the breaking tabs 72 of the second sail assembly 82. After unscrewing, the handle cap 62 of the locking element 60 can be removed to expose access to the Luer sampling port 54, while the locking ring 64 remains fixed to the base body 50 due to the pins 94 received in the openings 96. Figure 3 illustrates an advantageous feature of a further development of the sample collection device 10.The swab casing 30, shown in cross-section in the figure, has a circumferential casing wall 36 which, in a receiving area 35 at the front, closed end 32 of the swab casing, is provided with a thickening 38 that reduces the internal volume of the swab casing in the receiving area 35. For example, the casing wall in the receiving area can be thickened by a factor of 2.5 compared to the normal area.

[0036] Due to the thickening 38 and the reduced internal volume, a smaller amount of liquid is required in the sampling area 35 for subsequent analysis. Furthermore, the thickening 38 increases the stability of the swab casing when exposed to heat and / or ultrasound, as is typically required for the denaturation or inactivation of inhibitors, or for the lysis of an analyte. The thickening 38 therefore facilitates subsequent analysis of the extracted sample.

[0037] In practice, the assembly of the sampling device 10 can proceed as follows, for example. The three components – swab 20, swab sleeve 30, and swab head 40 – may initially be separate, for example, after delivery. However, the base body 50 and the closure element 60 are usually already connected at the factory, and the second sail assembly 82 is closed or sealed.

[0038] The swab 22 is first inserted into the locking receptacle 52 of the swab head 40. A click confirms that the swab 22 is correctly locked into place. The swab 20, with the swab head 40 attached, is then inserted into the swab sleeve 30 without touching the inner or outer edges of the sleeve 30. With slight pressure, the swab head 40 is attached to the sleeve, sealing the open end 34 of the sleeve 30 precisely. The correct, gap-free insertion of the swab head 40 is visually inspected and confirmed.

[0039] Finally, the perforated banderole 80 is applied to seal the connection between swab sleeve 30 and swab head 40.

[0040] The three components are assembled in an environment that is as germ-free as possible. The assembled sampling device is then sterilized.

[0041] During a subsequent sampling, the swab head 40 is removed from the swab casing 30 with the swab 20, thereby destroying the perforated banderole and thus the first sail assembly 80.

[0042] After sampling and inserting the swab 20 into the swab sleeve, the Luer extraction port 54 can be exposed by unscrewing the locking element 44, allowing the sample to be taken without contamination via the Luer connection. For this purpose, a solubilizing solution can be introduced into the receiving area 35 of the swab sleeve 30 using a syringe with a suitable Luer connector, and the sample can then be analyzed in an analyzer, optionally with the application of heat and / or ultrasound. When the Luer extraction port 54 is exposed by opening the swab head, the break tabs 72 of the safety ring 70, and thus the second sealing device 82, are destroyed.

Claims

Godparent Sayings 1. Sampling device (10) for sterile sampling of a clinical sample, with - a swab (20) with a tubular, hollow swab stick (22) which has a sample receiving means (24) at its front end, - an essentially cylindrical swab casing (30) for the swab, which is closed at its front end (32) and open at its rear end (34), and a swab head (40) that can be attached to the swab (20), which has a base body (50) with a sampling port (54) and a sealing element (60) for tightly covering the port, - wherein, after connecting the swab head (40) with the swab (20), the sampling port (54) is in fluid connection with the hollow swab stick (22), and the swab head (40) forms a handle for the swab (20), which closes the open end (34) of the swab sheath (30) precisely, - wherein the sampling device has a first (80) and a different second (82) sail assembly, wherein the two sail assemblies (80, 82) each form an opening indicator which undergoes an irreversible, detectable change when the sail assembly (80, 82) is opened for the first time, - wherein the first sail device (80) seals the connection between the swab sheath (30) and the swab head (40), so that opening the first sail device (80) indicates that the swab head has been removed with the swab, - and wherein the second sail device (82) seals the connection between the base body (50) of the swab head and the closure element (60) of the swab head, such that an opening of the second sail device (82) indicates the opening of the closure element (44) towards the connection (54), characterized in that - the extraction port is a Luer extraction port (54), and the second sail device (82) is formed by a shear ring (70) made of a plurality of narrow fracture webs (72) which connect a handle cap (62) of the locking element (60) with a locking ring (64) fixed to the base body.

2. Sample collection device according to claim 1, characterized in that the first sail arrangement (80) is formed by a banderole, preferably a perforated banderole.

3. Sample collection device according to claim 1 or 2, characterized in that the base body (50) has at least one recess (56) and the locking ring (64) of the closure element (60) has at least one corresponding locking pin (68) which, in the sealed state, engages in the at least one recess (56) and thereby fixes the locking ring (64) to the base body (50).

4. Sample collection device according to claim 1 or 2, characterized in that the base body (50) has at least one protruding pin (94) and the locking ring (64) of the closure element (60) has at least one corresponding recess or opening (96) into which the at least one protruding pin (94) engages in the sealed state and thereby fixes the locking ring (64) to the base body (50). - 15- 5. Sample collection device according to at least one of claims 1 to 4, characterized in that the closure element (60) is made of a rigid material, preferably of a hard plastic, in particular of hard polyethylene (HDPE).

6. Sample collection device according to at least one of claims 1 to 5, characterized in that the swab casing (30) has a circumferential casing wall (36) which is thickened (38) in a receiving area (35) at the front, closed end of the swab casing in order to reduce the internal volume of the swab casing in the receiving area.

7. Sample collection device according to claim 6, characterized in that the casing wall (36) in the receiving area (35) has a wall thickness which is thickened by a factor of between 1.5 and 8, preferably by a factor of between 2 and 4, in particular by a factor of about 2.5, compared to the normal area outside the receiving area (35).

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