Sampling device

Abstract

The invention relates to a sampling device (10) for the sterile taking of a clinical sample, comprising a swab (20) with a tubular, hollow swab stick (22) which has a sample receiving means (24) at its front end, with a substantially cylindrical swab sheath (30) for the swab (20) which is closed at its front end (32) and open at its rear end (34), and with a swab head (40) which can be attached to the swab (20) and which has a base body (50) with a Luer extraction connection (54) and a sealing element (60) for tightly covering the Luer connection. After connecting the swab head (40) with the swab (20), the Luer extraction port (54) is in fluid contact 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.According to the invention, the sampling device comprises a first (80) and a different second (82) sealing device, each of which forms an opening indicator that undergoes an irreversible, detectable change upon the first opening of the sealing device (80, 82). The first sealing device (80) seals the connection between the swab sleeve (30) and the swab head (40), so that opening the first sealing device (80) indicates that the swab head has been removed along with the sample. The second sealing device (82) seals the connection between the base body (50) of the swab head and the closure element (60) of the swab head, so that opening the second sealing device (82) indicates that the closure element (40) has been opened towards the Luer connector (54).

Description

[0001] The invention relates to a sampling device for taking a clinical sample and relates 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 Luer extraction connection and a sealing element for tightly covering the Luer connection, wherein after connection of the swab head with the swab, the Luer extraction connection 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.

[0002] A variety of swabs are currently used for collecting clinical samples. These swabs often have a plastic or wooden stem with a head made of absorbent material such as cotton. 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. Furthermore, designs with snap-off stems have been developed to allow for the safe transfer of samples into transport containers.

[0003] A swab system according to the preamble of claim 1 is known from publication WO 2013 / 071920 A1. After sampling, the handle of the swab can be sealed with a cap for contamination-free transport of the sample. However, with such a swab system, a user cannot tell whether the swab 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.

[0004] Based on this, the invention aims to provide a generic sampling device that overcomes the disadvantages of the prior art and, in particular, enables a user to perform safe sterile sampling.

[0005] This problem is solved by the features of the independent claims. Further developments of the invention are the subject of the dependent claims.

[0006] According to the invention, a sampling device of the type mentioned at the outset is provided to have a first and a different second sealing device, wherein the two sealing devices each form an opening indicator which undergoes an irreversible, recognizable change when the sealing device is opened for the first time.

[0007] The first sealing device seals the connection between the swab casing and the swab head, so that opening the first sealing device indicates that the swab head has been removed along with the swab.

[0008] The second sealing device seals the connection between the base body of the swab head and the closure element of the swab head, so that opening the second sealing device indicates the opening of the closure element towards the Luer connector.

[0009] In an advantageous embodiment, the first sealing device is formed by a band, preferably a perforated band.

[0010] The second sealing device is advantageously formed by a safety ring consisting of a plurality of narrow breakable segments that connect a handle cap of the closure element to a locking ring fixed to the base body. When the swab head is opened, the handle cap is twisted against the fixed locking ring, causing the breakable segments to tear off, thus indicating the opening irreversibly and clearly.

[0011] 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 can be provided.

[0012] 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, thereby fixing the locking ring to the base body. Advantageously, two or three protruding pins and two or three corresponding recesses or openings can be provided.

[0013] 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.

[0014] 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.

[0015] The shell 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.

[0016] Advantages of the invention and further embodiments are explained below with reference to the figures, in the representation of which a scale and proportion-accurate reproduction has been omitted in order to increase clarity.

[0017] They show: Fig. 1. Schematic representation of a sampling device for the sterile removal of a clinical sample. Fig. 2 the swab head of the sampling device of the 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 the removal of the closure element, and (c) shows the swab head of (a) in a sectional view, Fig. 3 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 Fig. 4 the swab head of a sampling device according to another embodiment of the invention.

[0018] Fig. 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.

[0019] The swab 20 contains a tubular, hollow swab stick 22, which has a viscose pad 24 at its front end as a sample-receiving medium. The swab 20 is contained in the cylindrical swab casing 30, which is closed at its front end 32 and at its rear end 34 ( Fig. 3) is open.

[0020] The swab head 40 can be attached to the swab 20, whereby Fig. Figure 1 shows 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 connection ( Fig. 2(b)) and a sealing element 60, in particular for tightly covering the Luer connector (see Fig. 2(c)).

[0021] Is the swab head 40, as in Fig. 1, connected to the swab 20, 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 sleeve 30.

[0022] As a special feature, the sampling device 10 has two different sealing devices 80, 82, which independently each form an opening indicator which undergoes an irreversible, recognizable change when the sealing device is opened for the first time, so that the undamaged state of the sealing devices 80, 82 indicates the suitability of the sampling device 10 for sterile sampling.

[0023] In the exemplary embodiment, the first sealing device 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.

[0024] The second sealing device 82 seals the connection between the base body 50 of the swab head and the closure element 60 of the swab head. In the exemplary embodiment, it is formed by a safety ring 70 consisting of a plurality of narrow breakable tabs 72, which connect the handle cap 62 of the closure element 60 to a locking ring 64 and which break off when the swab head is opened due to a rotational stress. The breaking off of the breakable tabs is detectable both visually and tactilely, since the broken-off tabs subsequently no longer resist rotation of the handle cap.

[0025] To explain in more detail, Fig. 2. The swab head 40 is examined more closely. This shows Fig. 2(a) the swab head with the base body 50 and closure element 60 in a perspective view. Fig. 2(c) shows the swab head of the Fig. 2(a) in a sectional view and Fig. 2(b) shows only the basic body 50 without the locking element 60.

[0026] How best to Fig. As can be seen in Figure 2(b), the base body 50 of the swab head 40 has a Luer dispensing connection 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 receptacle 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 closure element 60 engage after the swab head has been assembled.

[0027] With reference to Fig. 2(a) and Fig. 2(c) The closure element 60 of the swab head, made of high-density polyethylene (HDPE), comprises two sub-elements: a ribbed round handle cap 62 and a locking ring 64 with two rigid ribs 66, each of which carries a locking pin 68 on its rear side that engages 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 ribs 72 arranged along the circumference ( Fig. 2(c)) exists.

[0028] 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.

[0029] Due to their design, the two different sealing devices 80 and 82 of the sampling device 10 can be opened independently of each other. Each opening results in an irreversible, recognizable change to the sealing device and allows for 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 connector has already been accessed.

[0030] In an undamaged state, the two sealing 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.

[0031] Fig. Figure 4 shows a swab head 40 according to another embodiment of the invention, which differs in the design of the second sealing device 82 from the embodiment of the Fig. 2 differs. In the exemplary embodiment of the 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 webs 66 of the closure element 60.

[0032] In this configuration 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 sealing device 82. After unscrewing, the handle cap 62 of the locking element 60 can be removed to expose access to the Luer dispensing port 54, while the locking ring 64 remains fixed to the base body 50 due to the pins 94 received in the openings 96.

[0033] Fig.Figure 3 illustrates an advantageous feature of a further development of the sampling device 10. The swab sheath 30, shown in cross-section in the figure, has a circumferential sheath wall 36 which, in a receiving area 35 at the front, closed end 32 of the swab sheath, is provided with a thickening 38 that reduces the internal volume of the swab sheath in the receiving area 35. For example, the sheath wall in the receiving area can be thickened by a factor of 2.5 compared to the normal area.

[0034] Due to the thickening 38 and the reduced internal volume, a smaller amount of liquid is required in the receiving 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.

[0035] 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 sealing device 82 is closed or sealed.

[0036] The swab stick 22 is then first inserted into the locking receptacle 52 of the swab head 40. A click confirms that the swab stick 22 has correctly locked into place.

[0037] The swab 20 with the swab head 40 is then inserted into the swab sleeve 30 without touching the inner and outer edges of the swab sleeve 30. With slight pressure, the swab head 40 is attached to the swab sleeve, sealing the open end 34 of the swab sleeve 30 precisely. The correct, gap-free fit of the swab head 40 is visually inspected and confirmed.

[0038] Finally, the perforated banderole 80 is applied to seal the connection between swab sleeve 30 and swab head 40.

[0039] The three components are assembled in an environment that is as germ-free as possible. The assembled sampling device is then sterilized.

[0040] During a subsequent sampling, the swab head 40 is removed from the swab sleeve 30 with the swab 20, thereby destroying the perforated banderole and thus the first sealing device 80.

[0041] 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 after applying heat and / or ultrasound.

[0042] When the Luer extraction port 54 is exposed by opening the swab head, the breaking ribs 72 of the safety ring 70 and thus the second sealing device 82 are destroyed. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2013 / 071920 A1

[0003]

Claims

[1] Sampling device for the sterile collection of a clinical sample, with - a swab with a tubular, hollow swab stick that has a sample collection device at its front end, - an essentially cylindrical swab casing for the swab, which is closed at its front end and open at its rear end, and - a swab head that can be attached to the swab, which has a base body with a Luer extraction port and a sealing element for tightly covering the Luer port, - wherein, after connecting the swab head to the swab, the Luer extraction port is in fluid contact with the hollow swab stick, and the swab head forms a handle for the swab, which precisely seals the open end of the swab casing, characterized by , that - the sampling device has a first and a different second sealing device, wherein the two sealing devices each form an opening indicator which undergoes an irreversible, recognizable change when the sealing device is opened for the first time, - wherein the first sealing device seals the connection between the swab casing and the swab head, so that opening the first sealing device indicates that the swab head has been removed with the swab, - and wherein the second sealing device seals the connection between the base body of the swab head and the closure element of the swab head, such that an opening of the second sealing device indicates the opening of the closure element towards the Luer connector. [2] Sampling device according to claim 1, characterized by that the first sealing device is formed by a band, preferably a perforated band. [3] Sampling device according to claim 1 or 2, characterized by , that the second sealing device is formed by a safety ring consisting of a plurality of narrow breaking bars, which connect a handle cap of the locking element to a locking ring fixed to the base body. [4] Sampling device according to claim 3, characterized by that the base body has at least one recess and the locking ring of the locking element has at least one corresponding locking pin which, in a sealed state, engages in the at least one recess and thereby fixes the locking ring to the base body. [5] Sampling device according to claim 3, characterized by that the base body has at least one protruding pin and the locking ring of the locking 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. [6] Sampling device according to at least one of claims 1 to 5, characterized by that the closure element is made of a rigid material, preferably a hard plastic, in particular high-density polyethylene (HDPE). [7] Sampling device according to at least one of claims 1 to 6, characterized by that 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. [8] Sampling device according to claim 7, characterized by that the shell wall in the recording area has a wall thickness which is thicker than the normal area outside the recording area 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.

Images