Medical packaging sleeve with tamper-evident closure and assembly lock for sterile use

Abstract

Medical packaging sleeve (1) with tamper-evident closure (20) for sterile use, consisting of an approximately cylindrical sleeve body (2) which is open on one side and whose opening can be tightly closed by a closure plug (5), wherein the closure plug (5) is provided with a sealed threaded screw connection (9, 10;16, 17) can be screwed into the opening of the sleeve body (2) and the position of the closure plug (5) can be fixed by means of a tamper-evident closure (20, 30) which overlaps the closure plug (5) and is approximately sleeve-shaped, wherein the tamper-evident closure (20, 30) can be snapped onto the sleeve body (2) and the tamper-evident closure (20, 30) is connected to the closure plug (5) in a rotationally fixed manner and can only be snapped into the sleeve body (2) in the sealed rotational position of the closure plug (5), wherein an optical visual inspection (13, 14, 44) is provided for checking the sealed rotational position between the closure plug (5) and the sleeve body (2);

Description

[0001] The subject matter of the invention is a medical packaging sleeve according to the preamble of patent claim 1.

[0002] A medical packaging sleeve of a general type has become known, for example, from the subject matter of EP 1 055 609 B1, in which a closure cap provided with an internal thread is screwed onto the external thread of a packaging sleeve or packaging bottle and a strip which can be separated from the cap by a thin section is formed on the underside of the cap and which, in conjunction with a tear-off tab, enables the cap to be twisted off the packaging sleeve or packaging bottle when the tear-off tab is torn open.

[0003] The disadvantage of such a known medical sleeve packaging is that the sealing connection between the lid, which is secured by a tamper-evident closure, and the packaging sleeve does not seal reliably because there is no appropriate pre-tension of the sealing ring.

[0004] A further disadvantage of the conventional sleeve packaging is that there is no control of the sealing connection between the screw-on lid and the sleeve body of the packaging sleeve. Consequently, it is not possible to verify whether the screw cap is properly and firmly screwed onto the packaging body.

[0005] A further disadvantage is that the sealing surface is only arranged axially on the inside of the closure cap and therefore cannot be visually inspected. A radial arrangement of such a sealing surface is not indicated in this publication.

[0006] However, the arrangement of a radial sealing surface would have the advantage that, during a seal test using at least partially transparent materials, the failure of the respective seal could be demonstrated, which is not possible in the subject matter of EP 1 055 609 B1 due to the arrangement of the seal used.

[0007] A further disadvantage of the known arrangement is that the tamper-evident closure forms a single, integral part with the lid and that, therefore, the functions of the lid and its sealing closure in conjunction with the tamper-evident closure are not separated.

[0008] Thus, it is not possible to screw or slide a cap tightly onto a closure body and check the sealing effect in a first check, and only then, in a second step, apply a tamper-evident closure that establishes and permanently maintains this sealed rotational position of the cap. None of these features are evident from the aforementioned publication.

[0009] The subject matter of WO 2009 / 109312 A1 discloses another medical sleeve packaging with assembly security. The packaging body is first sealed with a rubber stopper, and the rubber stopper, which is placed sealingly on the packaging body, is secured with a sleeve-like tamper-evident closure. The tamper-evident closure serves to sterilely close a syringe barrel. The syringe barrel has a lockable conical connection in the form of an outer cone with a snap-in internal thread adapter. The outer cone is sealed with a rubber stopper. The tamper-evident closure is placed over the rubber stopper and a security cap.

[0010] It is a two-part tamper-evident closure in which an upper sleeve part can be separated from a lower sleeve part, whereby the connection between the two sleeve parts is not formed by a circumferential tear strip, but by connecting knobs with a reduced cross-section.

[0011] The cited document therefore concerns a tamper-evident closure for a container or syringe with a lockable cone adapter, which is sterilely closed by means of a rubber stopper and secured by a safety sleeve, wherein the safety sleeve, which is permanently pushed onto the cone adapter lock, consists of a holding part, a break-off part and a break-off zone located between these parts.

[0012] The disadvantage is that the sealing position and sealing function of the rubber stopper used in the closure sleeve cannot be controlled. Furthermore, it is not a screw seal, but a plug-in seal, so the rubber stopper, with its external sealing ribs, should rest against the inner surface of a neck-shaped projection in the closure sleeve.

[0013] Furthermore, it is known from this document that the two-part tamper-evident closure with a locking collar located at the bottom can be snapped onto an associated locking edge on the packaging sleeve at its lower open end, which simultaneously also controls the displacement position of the rubber stopper in the packaging sleeve.

[0014] The sealing position of the rubber stopper used can therefore only be checked by snapping the two-part tamper-evident seal into place. There is no provision for a special visual inspection or mechanical positional security between the sealing stopper and the packaging sleeve.

[0015] A mechanical position securing of the sealing plug with a control of this position on the packaging sleeve cannot be inferred from this publication.

[0016] It may therefore happen that the desired sealing effect is not achieved with deformed sealing plugs and that an improved sealing effect in medical sleeve packaging should in any case be achieved by means of threaded connections that can be screwed into one another and that a shear seal connection is therefore not sufficiently secure, especially if a medical sleeve packaging is to be designed to be double-sterile.

[0017] Furthermore, there is the further disadvantage that the medical sleeve packaging mentioned is only functional if the tamper-evident closure is also used, because only this enables the positional securing of the push-in or plug-in stopper.

[0018] The removal of the tamper-evident seal would render the packaging unusable.

[0019] Furthermore, the above-mentioned document is not able to transfer a specific rotational, plug-in or sealing position of the closure plug or a specific closure position to the tamper-evident seal and, from there, to provide a positional assurance that the tamper-evident seal is connected to the plug in the correct position and securely.

[0020] The invention is therefore based on the object of WO 2009 / 109312 A1 to further develop a medical sleeve packaging with a tamper-evident closure in such a way that an assembly lock is additionally provided to secure and check the sealing effect.

[0021] A preferred feature of the invention is therefore that, with the technical features of independent claim 1, it is now possible to visually and / or mechanically check whether the closure plug is mounted in the packaging sleeve in a positionally secured and sealed manner by arranging a tamper-evident closure.

[0022] According to a further preferred feature, it can be checked mechanically and / or optically whether the rotational position, in particular the sealing position of the closure plug, is in the correct position and sealed with the packaging sleeve.

[0023] Thus, in a preferred embodiment, the invention provides that a tamper-evident closure is connected to the closure plug in a rotationally fixed manner in order to be able to control the rotational and sealing position of the closure plug.

[0024] According to a first embodiment of the present invention, it is therefore provided that the closure plug is screwed into the packaging sleeve as a threaded sealing connection and forms a first sealing surface there.

[0025] It is preferred if the arrangement of this sealing surface is controllable; for this purpose, the invention provides the necessary design features.

[0026] In a preferred embodiment, there is a sequential control chain, wherein the rotational position between the closure plug and the packaging sleeve is preferably provided by a visual seal check, so that—regardless of the arrangement of a tamper-evident seal—it can be checked whether the closure plug, which is provided with a threaded seal, is screwed onto the packaging sleeve in the correct position and sealed. The aforementioned visual inspection thus checks the first sealing surface between the closure plug and the packaging sleeve.

[0027] In a further development of the invention, it can be provided that the end position between the sealing plug and the packaging sleeve can be additionally checked by a mechanical, tactile detent, which, however, only needs to be present in special cases. In other cases, this mechanical detent can be omitted, so that a tactile reaching of the end position between the sealing plug and the packaging sleeve can also be omitted.

[0028] Due to the first-mentioned optical and / or mechanical control of the rotational position between the closure plug and the packaging sleeve, according to a feature of the invention, the controlled sealing rotational position of the closure plug with the packaging sleeve is now transferred to the tamper-evident closure which can be applied separately.

[0029] According to a preferred feature, it is therefore provided that the closure plug is connected to the tamper-evident closure in a rotationally fixed manner, which can be achieved, for example, by a manually operable toggle being attached to the closure plug, which engages in a rotationally fixed manner in an associated receiving opening on the inside of the tamper-evident closure or in a slotted opening, in order to thus provide a rotationally fixed connection between the tamper-evident closure and the closure plug.

[0030] This provides the advantage that, due to the aforementioned control function, the position-secured closure position of the closure plug is now transferred to the tamper-evident seal, initially through the optical and / or mechanical control of the rotational and sealing position between the closure plug and the packaging sleeve. A further development of the invention provides that the tamper-evident seal can now only be pushed onto the packaging sleeve and locked into place once the aforementioned secured rotational connection between the packaging sleeve and the closure plug has been achieved. If this is not achieved, the tamper-evident seal, as a sleeve part, cannot be locked onto the packaging sleeve either.

[0031] According to a further preferred feature, this is achieved in that at least one axially projecting centering lug is arranged on the lower sleeve part of the tamper-evident closure, which can be brought into alignment with an associated locking groove arranged on the circumference of the packaging sleeve and open towards the top.

[0032] Only when at least one centering lug on the lower edge of the tamper-evident seal engages in the locking groove arranged on the circumference of the packaging sleeve can the tamper-evident seal be snapped onto the packaging sleeve.

[0033] It is therefore a rotationally coded key connection between the packaging sleeve and the tamper-evident seal, which ensures that the tamper-evident seal can only be snapped onto the packaging sleeve in a specific rotational position in relation to the latter.

[0034] Instead of such a key position with a centering lug, which is arranged on the tamper-evident closure and which can be snapped into an associated locking groove on the outer circumference of the packaging sleeve, there are also other key assignments.

[0035] In another embodiment, which is designed as a kinematic reversal of the first-mentioned embodiment, it can be provided that such a centering lug is arranged on the outer circumference of the packaging sleeve, which cooperates with an associated locking groove on the outer circumference of the tamper-evident closure.

[0036] Likewise, in another embodiment, it is possible for inwardly directed radial knobs to be formed, for example, on the inner circumference of the annular collar of the sleeve part, which each engage in an associated locking groove on the outer circumference of the packaging sleeve.

[0037] Instead of radially protruding nubs, it is also possible to arrange axially protruding nubs either on the sleeve part of the tamper-evident closure or on the ring collar of the packaging sleeve, which interact with associated locking grooves on the opposite part.

[0038] It is therefore a key-rotary connection which ensures that the tamper-evident closure can only be pushed onto the packaging sleeve and locked into place in a specific rotational position, whereby according to a preferred feature the rotational position of the closure plug is transferred to the tamper-evident closure so that the tamper-evident closure can only be pushed onto the packaging sleeve if the closure plug is connected to the packaging sleeve in its verified sealing position.

[0039] As mentioned above, this involves a multiple seal between the closure plug and the packaging sleeve. More specifically, there is a first end-face sealing surface between the upper end face of the packaging sleeve and the closure plug. A preferred embodiment provides for the sealing surface to be formed as an additional, soft sealing ring, which is integrally bonded to the remaining plastic material of the closure plug using a two-component process.

[0040] The sealing insert creates a flexible, elastomeric sealing surface on the front side, which provides an initial sterile barrier.

[0041] Two additional sterile barriers are axially connected and act radially. They are each formed by spaced-apart sealing lips that radially engage the inside of the sealing collar of the packaging sleeve, forming two consecutive sealing surfaces separated from each other in the axial direction, which serve as two additional sterile barriers. Thus, the aforementioned medical sleeve packaging is designed to reliably ensure sterility while maintaining sterile conditions over the long term.

[0042] Because the tamper-evident seal according to the invention can only be pushed onto the packaging sleeve in a specific rotational position, and this rotational position is also mechanically locked and controllable, a sliding assembly is preferred. Therefore, the sleeve-like tamper-evident seal is designed to be pushed onto the packaging sleeve and lockable to it only in a specific rotational position, i.e., a sliding assembly.

[0043] The specific sealed rotational position is controlled by the previously mentioned mechanical position control between the centering lug, which preferably protrudes on the lower ring circumference of the sleeve part of the tamper-evident closure and which can be brought into engagement with an associated, upwardly open groove on the outer circumference of the packaging sleeve.

[0044] Alternative versions of this position-locked key connection have already been described above.

[0045] According to a preferred feature of the invention, a total of two designs of a tamper-evident seal are proposed. However, the invention is not limited to these.

[0046] In a first embodiment, the closure plug is connected to a toggle that protrudes axially from the upper cover surface of the closure plug. It is preferred if the toggle and the material of the closure plug are made of a single piece. The toggle is thus connected to the closure plug in a single piece and is rotationally fixed.

[0047] In other embodiments, however, it may be provided that the toggle is separated from the cover surface of the sealing plug and is connected to it by an adhesive connection or by a plug-in or snap-in connection.

[0048] The following assumes a rotationally fixed, one-piece material connection between the toggle and the closure plug. According to a further feature, the toggle forms the positional securing element on the tamper-evident closure. Therefore, in a first embodiment, a tamper-evident closure is provided that has a slotted opening in its upper cover surface through which the toggle engages, thus providing rotationally fixed positional securing between the closure plug and the tamper-evident closure.

[0049] The advantage of having a toggle protruding from the tamper-evident seal is that if the toggle is deliberately twisted, it will be evident that the finished and sterilized packaging has been tampered with, and this is a sign that the packaging is unusable.

[0050] According to one feature of the invention, it is provided that the respective tamper-evident closure consists of two sleeve parts separated from one another by separating joints and the two sleeve parts are connected to one another in one piece via an annular groove with a reduced cross-section and can be separated by a tear-off tab, so that when the tear-off tab is separated, the upper sleeve part can be separated from the lower one.

[0051] However, if the toggle protrudes from the upper part of the sleeve and is accidentally turned, the separating joints will tear and tampering with the packaging sleeve will be evident.

[0052] According to another embodiment of the invention, it is provided that the tamper-evident closure with its upper sleeve part forms a self-contained sleeve which covers the toggle of the closure plug, wherein in this case the toggle of the closure plug is held in an associated receiving opening which is separated from one another by two ribs, in a positionally secured and rotationally fixed manner, but not visible from the outside.

[0053] In both cases, tamper-evident closures are proposed which transfer the rotational position of the closure plug and thus its sealing position to the tamper-evident closure, and the tamper-evident closure itself can only be snapped onto the packaging sleeve in a specific rotational position.

[0054] This means that, on the one hand, the packaging sleeve can also be used without a tamper-evident closure and the triple sterile sealing surfaces are retained, and, on the other hand, it means that the tamper-evident closure in its various designs can be used as an additional part with the packaging sleeve according to the invention and thus an additional control function is provided with regard to the maintenance of the preferably three separately formed sealing surfaces.

[0055] Particularly if the packaging sleeve is made of a transparent plastic, leak tests in the vacuum chamber can be used to check whether the three sealing surfaces mentioned are functioning properly or whether there are any leaks.

[0056] The tamper-evident closure is preferably made of a polyethylene or polypropylene material, which ensures that a tear tab can be arranged with separating joints of thinned cross-section in between.

[0057] The subject matter of the present invention arises not only from the subject matter of the individual patent claims, but also from the combination of the individual patent claims with one another.

[0058] All information and features disclosed in the documents, including the abstract, in particular the spatial configuration depicted in the drawings, could be claimed as essential to the invention, insofar as they are novel, individually or in combination, compared to the prior art. The use of the terms "essential" or "according to the invention" or "essential to the invention" is subjective and does not imply that the features so named must necessarily be part of one or more patent claims.

[0059] The invention is explained in more detail below with reference to drawings illustrating only one embodiment. Further essential features and advantages of the invention will become apparent from the drawings and their description.

[0060] They show: Fig. 1: Perspective view of a packaging sleeve without tamper-evident closure in the sealing position of the sealing plug Fig. 2: a sealing plug according to Fig. 1 in side view Fig. 3: a perspective view of the sealing plug according to Fig. 2 Fig. 4: the representation of the packaging sleeve according to Fig. 1 without sealing plug Fig. 5: the representation of the packaging sleeve with sealing plug and a tamper-evident closure in a first version Fig. 6: the same representation as Fig. 5 with a tamper-evident closure in a second version Fig. 7: a section through the tamper-evident seal after Fig. 6 Fig. 8: a section through the tamper-evident seal after Fig. 5 Fig. 9: a section through the packaging sleeve without tamper-evident closure according to Fig. 1 Fig. 10: an enlarged section after Fig. 9 Fig. 11: a cut after Fig. 10 with a partially applied tamper-evident seal in the non-secured position Fig. 12: the same representation as Fig. 11 with the other embodiment of the tamper-evident seal in the non-secured position Fig. 13: the perspective side view of the packaging sleeve according to Fig. 1 without tamper-evident closure with illustration of the securing position between the sealing plug and the packaging sleeve Fig. 14: the partial securing position of the mechanical security between a first embodiment of the tamper-evident closure, whereby the rotationally fixed connection has not yet been established Fig. 15: the same representation as Fig. 14 with the tamper-evident closure in the second version Fig. 16: the representation of the incorrect rotational position between the sealing plug and the packaging sleeve Fig. 17: the representation of an incorrect twisting position between the first embodiment of the tamper-evident closure and the packaging sleeve Fig. 18: the representation of the incorrect rotational position between the second embodiment of the tamper-evident closure and the packaging sleeve Fig. 19: the securing position of the packaging sleeve with a fully snapped-on tamper-evident closure in the second version Fig. 20: the completed securing position of the packaging sleeve with the tamper-evident closure in the first version Fig. 21: schematically shows the serial arrangement of a control chain with different control measures Fig. 22: the representation according to Fig. 21 showing the sequence of the various control chains associated with each other when connecting the mentioned parts

[0061] The packaging sleeve 1 according to Fig. 1 essentially consists of a hollow cylindrical sleeve body 2, preferably made of a transparent plastic. The type of packaging sleeve and its function are, for example, the subject of the older patent application DE 10 2015 012 898 A1.

[0062] Reference is made to the description therein with regard to the following description.

[0063] The sleeve body 2 is generally round-cylindrical. However, it can also be oval, provided that the upper and lower end faces of the sleeve body, including the flanges attached there, are cylindrical.

[0064] The bottom of the sleeve body 2 is formed by a conical shoulder 3 which is closed at the bottom.

[0065] In the area of ​​the conical shoulder 3 or above it, tab-shaped shoulders 4 are provided, which project radially beyond the outer circumference of the sleeve body 2 and form a rolling lock for the sleeve body 2. Therefore, the sleeve body 2 should not roll on a support surface. This is prevented by the shoulders 4.

[0066] In Fig. 2, the packaging sleeve 1 is shown without the closure plug 5. It essentially consists of an upper sealing collar 7, on whose upper annular edge 38 a first sealing surface 39 is formed in relation to the closure plug 5, which will be explained later.

[0067] A visually recognizable marking symbol 13 is also arranged in the area of ​​the sealing collar 7.

[0068] The sealing collar 7 is followed by an annular collar 8 of enlarged diameter, on the outer circumference of which at least one, but preferably two separate locking grooves 12 are provided.

[0069] The annular collar 8 is followed in the axial direction by a threaded area 9 of reduced diameter in which a thread 10 with associated thread turns is formed.

[0070] In the threaded area 9 there is also an upwardly open locking groove 11 which is formed as a recessed area on the circumference of the threaded area 9.

[0071] The sealing plug 5 to be inserted into the sleeve body 2 is in the Fig. 2 and Fig. 3. It consists of an upper toggle 6, which serves as a handle for rotating the closure plug 5 and is integrally connected to the plastic material in the area of ​​a ring attachment 19.

[0072] In the area of ​​the ring shoulder 19, an optically recognizable marking symbol 14 is arranged, which is to be aligned with the marking symbol 13 on the sleeve body side.

[0073] Adjoining the ring shoulder 19 is a region of reduced diameter, which is formed by sealing lips 15 arranged at a distance from one another and parallel to one another, which, in conjunction with the associated inner surfaces of the sleeve body 2, form the sealing surfaces 36a, 36b to be described later.

[0074] In this double sealing area with respect to the sealing surfaces 36a, 36b, a sealing ring 35 of reduced diameter is connected, which merges into a threaded shoulder 16 in which a thread is formed, of which a thread turn 17 is visible.

[0075] In the area of ​​the thread 17, a locking recess 43 is formed, which interacts with an associated locking groove 11 on the outer circumference of the sleeve body 2 in the thread area 9.

[0076] Only when the thread 17 of the closure plug 5 is inserted into the corresponding thread 10 of the sleeve body 2 in the correct position does the locking recess 43 engage in the locking groove 11, and thus the operator is haptically informed that the end stop for the intermeshing threads 10, 17 has been reached during a rotational movement.

[0077] This allows the rotational position of the sealing plug 5 in the sleeve body 2 of the packaging sleeve 1 to be checked haptically during assembly.

[0078] However, such a haptic control can also be dispensed with, as it is only intended as an additional measure to the optical control that is provided in Fig. 1 is shown.

[0079] If the correct rotational position between the sealing plug 5 and the sleeve body 2 is reached, then - according to Fig. 1 - the marking symbol 14 arranged on the closure plug opposite the marking symbol 13 arranged on the sleeve body 2.

[0080] This position-locked rotational position between the sealing plug 5 and the sleeve body 2 simultaneously ensures that the sealing surfaces 36a, 36b (see Fig. 3) on the inner circumference of the sealing collar 7 are in operation.

[0081] The rotational position thus set, which can be achieved on the one hand by the correspondence of the marking symbols 14, 15 and (additionally optionally) on the other hand by the haptic engagement of the locking recess 43 in the locking groove 11, the securing position can be checked and secured in both embodiments of tamper-evident closures 20, 30.

[0082] It should also be noted that the closure plug 5 is hollow, and the plug end 18 does not form a closure. The closure of the closure plug 5 occurs in the area of ​​the ring extension 19.

[0083] Coming back to the Fig. 5 and Fig. 6 it is stated that the first embodiment of the tamper-evident closure 20 consists of two separable sleeve parts 21, 22 which are integrally formed in the plastic material and can be separated from one another by separating joints 24, 25 which are thinner in cross-section, wherein the two separating joints 24, 25 are connected to one another by a tear-open tab 23 when the tear-open tab 23 has not yet been actuated.

[0084] The difference between the tamper-evident seal 20 according to Fig. 5 and the tamper-evident seal 30 according to Fig. 6 is that the tamper-evident seal 20 is Fig. 5 according to Fig. 8 in the upper lid area there is a slotted opening 27 through which the toggle 6 engages the sealing plug 5 in a rotationally secured manner, as is also the case, for example, in Fig. 12 is shown in section.

[0085] With the tamper-evident seal 30 after Fig. 6, however, the upper sleeve part 31 is formed by a self-contained closure cap, which accommodates the toggle 6 of the closure plug 5 in its interior in a rotationally secured manner, as shown in Fig. 7 is shown.

[0086] The Fig. 7 shows that the toggle is received in a receiving opening 33 on the inside of the upper sleeve part 31, the receiving opening being formed by two spaced-apart, axially inwardly directed ribs 32.

[0087] It can also be seen that in both tamper-evident closures 20, 30, at least one axially projecting centering lug 26 is provided on the lower sleeve part 22, which interacts with the previously described locking groove 12 on the outer circumference of the sleeve body 2.

[0088] Furthermore, the sectional images of the Fig. 7 and Fig. 8 that the lower sleeve part 22 of the tamper-evident closure 20, 30 is designed as a locking collar 28, which has inclined entry bevels 29, so that both tamper-evident closures 20, 30 can be pushed together - see the Fig. 11 and Fig. 12 - are pushed onto the sleeve body and connected to each other in the correct position, as shown in the Fig. 14 and Fig. 15 is shown.

[0089] In the securing position (end position), the respective at least one centering lug 26 of the lower sleeve part 22 of the tamper-evident closure 20, 30 engages in the associated, upwardly open locking groove 12 of the sleeve body 2.

[0090] The Fig. 9 and Fig. 10 shows the completed sealing position of the sealing plug 5 with control of the rotational position, where it can be seen that the sealing plug 5 is designed as a two-part part, but was manufactured in a single plastic injection molding process. On the outer circumference of the sealing plug 5, according to Fig. 9 and Fig. 10 a ring extension 19b of different material is formed, which forms a one-piece part with the upper ring extension 19a, which, however, is of different material.

[0091] Thus, according to Fig. 10 a first sealing surface 39 is formed between the ring edge 38 of the sleeve body 2 and the associated edge of the softer ring shoulder 19b.

[0092] This is followed in the axial direction by two further separate sealing surfaces 36a, 36b.

[0093] Each of the sealing surfaces is formed by a circumferential sealing lip 15, wherein the sealing lips are formed parallel to one another and spaced apart from one another in the softer material annular shoulder 19b. They therefore form the aforementioned axially separated sealing surfaces 36a, 36b on the inner circumference of the sleeve body 2.

[0094] An annular collar 8 with an enlarged circumference forms an annular groove 37, which, however, is only present for manufacturing reasons.

[0095] Below the annular groove 37, the threaded screw area of ​​the intermeshing threads is arranged between the thread 10 of the sleeve body 2 and the threads 17 of the sealing plug 5.

[0096] The Fig. 11 and Fig. 12 shows an operating position of the two tamper-evident closures 20, 30, wherein the securing connection with the sleeve body 2 of the packaging sleeve 1 has not yet been established. It can thus be seen that the locking collar 28 is still seated on the upper side of the annular collar 8 and has not yet been brought into engagement with the locking edge 47 on the lower side of the annular collar 8.

[0097] The Fig. 11 and Fig. 12 therefore show both tamper-evident closures 20, 30 in an intermediate position before reaching their position-secured locking position.

[0098] As assembly progresses, the respective tamper-evident closure 20, 30 is pressed downwards in the direction of arrow 40, and the locking collar 28 thus expands radially and passes over the annular collar 8. The inlet bevel 29 slides over the upper surfaces of the annular collar 8 and then brings the lower locking collar 28 to the position-secured engagement of the locking edge 47 of the annular collar 8.

[0099] The Fig. 13 shows the optically controllable rotational position lock between the closure plug 5 and the sleeve body 2 of the packaging sleeve 1, because it can be seen that the closure plug 5 with its marking symbol 14 must be brought into opposition to the marking symbol 13 of the sleeve body 2.

[0100] If this rotational position is not achieved, the two marking symbols 13, 14 deviate from each other, then this results in an optically controllable incorrect position, as shown in Fig. 16 is shown.

[0101] The optically identifiable misalignment according to Fig. 16 continues in the representation after Fig. 17 and Fig. 18, because it is evident that if the respective tamper-evident seal 20, 30 is in the wrong position according to Fig. 16 is placed on the sealing plug 5, the axially projecting centering lug 26 does not engage with the locking groove 12 on the sleeve body side, as in the Fig. 17 and Fig. 18 is shown.

[0102] Incorrect assembly is thus excluded,

[0103] The reason for this security measure is that the toggle 6 of the sealing plug 5 is connected to the respective tamper-evident closure 20, 30 in a rotationally fixed manner and in this “wrong” rotational position according to Fig. 16 cannot be brought into engagement with its centering lug 26 into the locking groove 12 on the sleeve body side.

[0104] The two fully constructed safety positions are shown in section in the Fig. 19 and Fig. 20. Here is Fig. 19 the tamper-evident closure 30 is shown in its fully secured position, whereby it is now ensured that the secured position can only be established when the closure plug 5 is fully screwed in and sealed in the sleeve body 2 and only then can the lower locking collar 28 of the tamper-evident closure 30 be brought into engagement with the associated locking edge 47 of the annular collar 8 of the sleeve body 2.

[0105] Likewise, the Fig. 20 the position-secured locking position of the tamper-evident seal 20.

[0106] If the sealing plug 5 is not completely screwed onto the sleeve body 2, this is shown on the one hand by the missing juxtaposition of the two markings 13 and 14 and on the other hand a gap 42 is formed according to Fig. 16 between the sleeve body 2 and the closure plug 5.

[0107] The Fig. Figure 21 shows schematically the sequence of the various control mechanisms of the invention.

[0108] In the first inspection stage, the visual inspection 44 checks the alignment of the marking symbols 13, 14 between the closure plug 5 and the sleeve body 2.

[0109] In the second control stage, the mechanical position control 45, the position assignment between the closure plug 5 and the sleeve body 2 is additionally controlled by a haptic feedback in that the locking recess 43 arranged on the closure plug 5 engages haptically in the associated locking groove 11 on the outer circumference of the sleeve body 2.

[0110] In the third control stage, a further position control 46 is formed, which ensures a secure rotational position and closure position between the tamper-evident closure 20, 30 and the sleeve body 2, in that the one or more centering lugs 26 arranged on the tamper-evident closure 20, 30 can only be brought into engagement with the locking grooves 12 on the sleeve body side when the correct rotational position between the closure plug 5 and the sleeve body 2 has been established.

[0111] According to Fig. 22 by a chain of control stages, whereby in addition to the first optical visual control 44, a haptic position control between the closure plug and the sleeve body 2 can be present, but can also be omitted.

[0112] Here, the mechanical position control 46 between the tamper-evident closure and the sleeve body 2 is crucial, whereby this position control is only successful if the closure plug 5 is covered by the tamper-evident closure 20, 30 in the correct rotational position. Drawing legend 1 packaging sleeve 2 sleeve bodies 3 cone attachment 4 Approach 5 sealing plugs 6 gags 7 Sealing collar (of 1) 8 ring bundle (of 1) 9 Thread range 10 threads 11 Locking groove (for 5) 12 locking groove (for 20) 13 Marking symbol (of 1) 14 Marking symbol (of 5) 15 sealing lips (of 5) 16 threaded neck 17 threads (out of 5) 18 Plug end 19 Ring attachment a, b 20 tamper-evident seal 21 Sleeve part (top) 22 Sleeve part (bottom) 23 Tear tab 24 Separation joint above 25 Parting line below 26 Centering nose 27 Slotted opening (for 6) 28 locking collar 29 Inlet slope 30 tamper-evident seal 31 Sleeve part (top) 32 ribs 33 mounting opening (for 6) 34 Opening 35 sealing ring (of 5) 36 Sealing surface a, b 37 Ring groove 38 ring rim (of 1) 39 sealing surface (of 38) 40 Arrow direction 41 stop surface (of 1) 42 gap 43 locking recess (from 5 to 11) 44 Visual inspection (between 1 & 5) 45 Position control (between 1 & 5) 46 Position Control (between 20, 30 & 1) 47 locking edges (of 8)

Claims

[1] Medical packaging sleeve (1) with tamper-evident closure (20) for sterile use, consisting of an approximately cylindrical sleeve body (2) which is open on one side and whose opening can be tightly closed by a closure plug (5), the closure plug (5) being provided with a sealed threaded screw connection (9, 10;16, 17) can be screwed into the opening of the sleeve body (2) and the position of the closure plug (5) can be fixed by means of a tamper-evident closure (20, 30) which overlaps the closure plug (5) and is approximately sleeve-shaped, wherein the tamper-evident closure (20, 30) can be snapped onto the sleeve body (2) and the tamper-evident closure (20, 30) is connected to the closure plug (5) in a rotationally fixed manner and can only be snapped into the sleeve body (2) in the sealed rotational position of the closure plug (5), wherein an optical visual inspection (13, 14, 44) is provided for checking the sealed rotational position between the closure plug (5) and the sleeve body (2); [2] Packaging sleeve according to claim 1, characterized by that a first sealing surface (36a, 36b) between the closure plug (5) and the sleeve body (2) of the packaging sleeve (1) can be checked with the optical visual inspection (13, 14, 44). [3] Packaging sleeve according to claim 1 or 2, characterized by that the sealed end position between the sealing plug (5) and the packaging sleeve (1) can additionally be checked by a haptic locking position (45). [4] Packaging sleeve according to one of claims 1 to 3, characterized by that the rotationally fixed connection between the closure plug (5) and the tamper-evident closure (20, 30) consists of a manually operable toggle (6) connected to the closure plug (5) which engages in a shaped opening (27, 32) on the end face of the tamper-evident closure (20, 30). [5] Packaging sleeve according to one of claims 1 to 4, characterized by that at least one axially projecting centering lug (26) is arranged on the lower sleeve part (22) of the tamper-evident closure (20, 30), which can be brought into alignment with an associated, upwardly open locking groove (12) arranged on the circumference of the packaging sleeve (1). [6] Packaging sleeve according to one of claims 1 to 5, characterized by that the rotational position of the closure plug (5) can be transferred to the tamper-evident closure (20, 30) by means of the rotationally fixed connection, and that the tamper-evident closure (20, 30) can only be pushed onto the sleeve body (2) if the closure plug (5) is sealed in its checked sealing position with the sleeve body. [7] Packaging sleeve according to one of claims 1 to 6, characterized by that a multiple seal (35, 36a, 36b) is present between the closure plug (5) and the sleeve body (2) of the packaging sleeve (1). [8] Packaging sleeve according to one of claims 1 to 7, characterized bythat the tamper-evident closure (20, 30) consists of two sleeve parts (21, 22) separated from one another by separating joints (24, 25), which are connected to one another in one piece via an annular groove with a reduced cross-section and can be separated by a tear-off tab (23). [9] Packaging sleeve according to one of claims 1 to 8, characterized by that the lower sleeve part (22) of the tamper-evident closure (20, 30) is designed as a radially elastically expandable locking collar (28) which has inclined inlet bevels (29). [10] Packaging sleeve according to claim 9, characterized by that the locking collar (28) can be snapped onto the annular collar (8) of the sleeve body (2) in a radially expandable manner.

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