Ampoule with tamper-proof closure and closure cap for such an ampoule

Abstract

The invention relates to an ampoule (2) with a tamper-proof closure for a medical syringe (1), with an ampoule body (4, 4') having a connection piece (8) at its distal end (6) for attaching a hollow needle or the like, which is intended to reliably enable a high degree of leak-tightness with simple handling and favourable manufacture. According to the invention, a closure cap (30, 30', 30'') is provided for the connection piece (8), wherein the closure cap (30, 30', 30'') comprises a sealing cap (42, 42') of a comparatively soft plastic material arranged in an outer cap (40, 70) and provided with an inner channel (50) adapted to the connection piece (8) and pushed onto the connection piece (8) with the latter, wherein the outer cap (40, 70) is formed from a comparatively hard plastic material and has a contact ring (52, 52') that abuts against the ampoule body (4, 4') and is adapted in its outer cross-section to that of the ampoule body (4, 4'), and with an adhesive label (62) that, in order to form the tamper-proof closure, is connected in a materially bonded manner all round, both to the outer surface (58) of the contact ring (52, 52') and, in a mouth region neighbouring the distal end (6) of the ampoule body (4, 4'), to the outer surface of the ampoule body (4, 4').

Description

[0001] Description

[0002] Ampoule with tamper-evident closure and cap for such an ampoule

[0003] The invention relates to an ampoule with a tamper-evident closure, comprising an ampoule body having a connecting piece at its distal end for attaching a hollow needle or the like, and comprising a closure cap for the connecting piece. It further relates to a closure cap for such a syringe.

[0004] Medications, particularly for treatment in highly specialized or complex therapies, are usually provided in active ingredient or medication containers, also known as containers or vials. Alternatively, medications can also be provided in prefilled syringes or ampoules. Such prefilled ampoules, which usually significantly simplify subsequent handling by staff, particularly when administering the active ingredient, usually comprise the actual ampoule body filled with the active ingredient, to which the syringe needle is attached, for example screwed or plugged on, for the purpose of administration immediately before the syringe is used. To attach the pointed or hollow needle to the ampoule body, the ampoule body usually has a suitable connection piece, for example as part of a LUER connection.

[0005] It is generally desirable to design the systems or components used in the administration of medications for particularly low material or active ingredient losses throughout the entire handling chain. For containers in which medications are stored for a short period of time, especially for prefilled syringes or prefilled ampoules, a highly leak-tight closure system is therefore desirable. For this purpose, the connection piece of such a prefilled ampoule is usually sealed with a cap, which is removed from the connection piece immediately before the ampoule is used, i.e., immediately before the syringe or hollow needle is attached.

[0006] Such prefilled syringes or ampoules are typically provided with a so-called tamper-evident seal, which, like a seal, must be broken upon first use of the ampoule. For example, by tearing off connecting bars of the cap with an element remaining on the ampoule body, such as a tear-off ring or the like. Such a tamper-evident seal can ensure, among other things, that the ampoule was not already opened during use and could therefore potentially be contaminated, and also that no unauthorized tampering with the contents, i.e., the active ingredient contained in the ampoule body, has occurred.

[0007] Given the high volumes in which such prefilled ampoules are used, there is a general need to enable particularly simple and reliable handling and particularly cost-effective production with a high level of reliability and tightness of the closure system.

[0008] The invention is therefore based on the object of providing an ampoule with a tamper-evident closure of the type described above, which reliably achieves a high level of tightness while being easy to handle and inexpensive to manufacture. Furthermore, a closure cap for such a syringe is to be provided.

[0009] With regard to the ampoule, this object is achieved according to the invention in that the closure cap comprises a sealing cap made of a comparatively soft plastic material, arranged in an outer cap, provided with an inner channel adapted to the connecting piece, and pushed onto the connecting piece with this inner channel, wherein the outer cap is formed from a comparatively hard plastic material and has a contact ring which abuts the ampoule body and whose outer cross-section is adapted to that of the ampoule body, and with an adhesive label which, in order to form the tamper-evident seal, is materially bonded all the way around both to the outer surface of the contact ring and, in a mouth region adjacent to the distal end of the ampoule body, to the outer surface of the ampoule body.

[0010] Advantageous embodiments of the invention are the subject of the subclaims.

[0011] The invention is based on the idea that the closure cap for the connection piece should be designed as a multi-component cap in the interests of high reliability and good handling, in order to particularly well meet the various requirements. On the one hand, the sealing cap, which is made of a comparatively soft and thus easily deformable plastic, is specifically designed for a high sealing effect, which is particularly promoted by the shape of the sealing cap with the integrated inner channel, the shape and geometry of which is adapted to the connection piece and thus suitable for surface contact. On the other hand, the mechanical stability and thus robustness is provided by the outer cap surrounding the sealing cap, which is accordingly made of a comparatively hard plastic.

[0012] In order to ensure the usual requirements regarding storage stability and robustness during handling with such a two-component or 2K design of the closure cap, sufficient strength of the connection between the closure cap and the ampoule body must be ensured. This can be achieved in a particularly simple manner and thus with minimal manufacturing effort and cost by, on the one hand, ensuring that the sealing cap contributes to the strength of the connection through appropriate shape, dimensioning, and material selection. To this end, the sealing cap with its inner channel should be suitably adapted to the connection piece so that the pushed-on sealing cap already provides a certain degree of strength to the connection.In addition, the tamper-evident seal should be designed in such a way that, in a dual function, it provides the desired indication of whether the ampoule is unaltered and untampered with. On the other hand, it should also contribute to the strength of the connection between the closure cap and the ampoule body.

[0013] To make this possible, one aspect of the invention provides for the tamper-evident seal to be implemented by means of an adhesive label that is attached to a distal end region of the ampoule body in such a materially bonded manner (i.e., in particular, adhesively bonded) that it encompasses both an edge region of the outer cap of the closure cap and an end region of the outer shell of the ampoule body. According to this aspect, which is considered inventive, the adhesive label can thus have a triple benefit: firstly, it serves in a completely conventional manner as an information element on which important information characteristic of the ampoule or the active ingredients contained therein, such as contents or shelf life, is displayed. secondly, it serves as a tamper-evident seal, as it is destroyed when the closure cap is removed from the ampoule body.Thirdly, it complements the strength and stability of the connection between the closure cap and the ampoule body, as it can, among other things, contribute to the transfer of holding forces between the cap and ampoule. Accordingly, without compromising the performance of the connection system between the closure cap and ampoule body, the other components of the connection system, such as the combination of the sealing cap and connecting piece, can be designed in a correspondingly simpler and thus more cost-effective manner.

[0014] To create a particularly preferred, continuous and adapted connection between the outer cap and the ampoule body, the outer cap, according to one aspect of the invention, has a contact ring at its end, which abuts the ampoule body and whose outer cross-section is adapted to the ampoule body in such a way that a continuous surface transition results. In particular, both the contact ring and the ampoule body can have a cylindrical basic shape and thus a circular outer cross-section, wherein, according to one aspect of the invention, the diameter of the contact ring is equal to the diameter of the ampoule body.

[0015] In a particularly advantageous embodiment, the adhesive label arranged in the transition area between the contact ring and the ampoule body completely surrounds the outer circumference of the contact ring and ampoule body, thus creating a continuous and complete connection around the central axis of the ampoule body. Such an arrangement allows for effective reinforcement of the stability of the entire assembly to be achieved in a particularly simple manner and with simple means.

[0016] According to one aspect of the invention, the closure cap can be designed as a "true" two-component or 2K cap and comprise only the sealing cap and the outer cap as components. In such an embodiment, the sealing cap is then positioned directly in the outer cap and supported and stabilized by it; for example, it could be inserted or snapped into it. According to an alternative aspect of the invention, however, the sealing cap can also be arranged in a carrier cap, which in turn is held in the outer cap. Such a multi- or three-component design can be particularly preferred and advantageous for comparatively thick or large-sized systems.According to one aspect of the invention, the outer cap is designed to be well adapted to the outer dimensions of the ampoule body, so that in the contact area between the outer cap and the ampoule body, a common base or ground surface is formed by the contact ring of the outer cap provided in this area, on the one hand, and the mouth-side end area of ​​the outer shell of the ampoule body, on the other hand, to which the adhesive label can be applied. This ensures that the adhesive label reliably forms a materially bonded connection with both the contact ring of the outer cap and the ampoule body.

[0017] This can be achieved, with a suitable geometry of the aforementioned components, particularly with comparatively "narrow" ampoule bodies, by a system in which the sealing cap is arranged directly in the outer cap. However, with larger outer diameters, it may be advantageous to provide an additional outer cap in the manner of an adapter piece, using the preferably standardized sealing cap and the original outer cap designed for "narrow" systems. This additional outer cap receives and supports the "original" outer cap and then, in turn, provides the contact ring for connection to the ampoule body. In this embodiment, the "original" outer cap thus serves as a carrier cap for the sealing cap.Such an overall system has the particular advantage that, even with differently dimensioned ampoule bodies, standardized components, namely the sealing cap and the “original” outer cap, can be used, so that particularly large quantities can be used.

[0018] The sealing cap is preferably made of TPE or rubber. In an alternative or additional advantageous embodiment, the carrier and / or outer cap is made of polypropylene (PP), a polyolefin, cycloolefin copolymer (COC), cycloolefin polymer (COP), or polycarbonate.

[0019] According to an aspect of the invention considered to be independently inventive, the connecting piece of the ampoule is tapered towards its free end, preferably conical, particularly preferably as a LUER cone, and the inner channel of the sealing cap is adapted to widen towards its free end, preferably in the manner of an inverted cone. Due to the self-locking nature of a conical connection, especially in combination with the material properties in the connection area, also taking into account the properties of the deformable, soft plastic material of the sealing cap, this design according to one aspect of the invention already allows for a comparatively high degree of stability and strength of the connection.

[0020] The carrier or outer cap carrying the sealing cap can be shaft-like in an area enclosing the inner channel of the sealing cap, wherein a thread can be arranged on the outside of this shaft. According to one aspect of the invention, this can be screwed into a corresponding internal thread on the connection piece of the ampoule, for example if the connection area of ​​the ampoule is designed in the manner of a Luer connection with a Luer thread. In such a design, the strength and stability of the connection can be essentially ensured by this screw connection. According to one aspect of the invention and in a particularly advantageous design, the carrier or outer cap holding the sealing cap is designed to be thread-free in an area enclosing the inner channel of the sealing cap.On the one hand, this makes production particularly simple, and on the other hand, such a system can then be easily combined with a wide variety of connection piece designs.

[0021] According to one aspect of the invention, the ampoule is prefilled with a medicament or medicinal agent.

[0022] With regard to the closure cap, in particular for an ampoule of the type described above, the stated object is achieved by a sealing cap made of a comparatively soft plastic material arranged in an outer cap, wherein the outer cap is formed from a comparatively hard plastic material and has a contact ring forming a circumferential adhesive surface in the region of its free end. By means of such a configuration, when the closure cap is attached to the ampoule body, a common base or ground surface can be reliably formed in the contact area between the outer cap and ampoule body by the contact ring of the outer cap provided in this area on the one hand and the mouth-side end area of ​​the outer casing of the ampoule body on the other hand, to which the adhesive label provided according to one aspect of the invention can be applied.This ensures that the adhesive label can reliably form a material-tight connection with both the contact ring of the outer cap and the ampoule body.

[0023] The advantages achieved by the invention lie in particular in the fact that the multi-component design of the closure cap allows a number of competing design objectives, such as high tightness, high reliability, mechanical strength, and / or good handling, to be achieved equally. By designing the tamper-evident seal as an adhesive label, it can also fulfill the aforementioned triple benefit: firstly, as an information element; secondly, as a tamper-evident seal, since it is destroyed when the closure cap is removed from the ampoule body; and thirdly, as a supplement to the strength and stability of the connection between the closure cap and the ampoule body.Accordingly, without compromising the performance of the connection system between the closure cap and the ampoule body, the other components of the connection system, such as the combination of sealing cap and connector, can be designed to be simpler and thus more cost-effective. The closure cap ensures the integrity of the ampoule and tamper protection, yet can still be easily opened. It also offers a seamless fit for prefilled glass or polymer syringes. Container closure integrity is a general concern in the pharmaceutical industry. This is achieved, as is the equally important user-friendliness.

[0024] An embodiment of the invention is explained in more detail with reference to a drawing. In the drawing:

[0025] FIG. 1 a medical syringe in side view, still without tamper-evident closure,

[0026] FIG. 2 shows the medical syringe according to FIG. 1 in longitudinal section in two different cutting planes,

[0027] FIG. 3 shows an ampoule of the syringe according to FIG. 1 in a perspective view in an exploded view,

[0028] FIG. 4 shows the ampoule according to FIG. 3 in longitudinal section in exploded view, FIG. 5 shows the closure cap attached to the distal end of the ampoule according to FIG. 3 in longitudinal section,

[0029] FIG. 6 shows the closure cap according to FIG. 5 in a side view,

[0030] FIG. 7 shows an alternative embodiment of a closure cap attached to the distal end of the ampoule according to FIG. 3 in longitudinal section,

[0031] FIG. 8 shows the closure cap according to FIG. 7 in a side view,

[0032] FIG. 9 the syringe according to FIG. 1 with the tamper-evident closure attached,

[0033] FIG. 10 the syringe according to FIG. 9 with the closure cap removed, and

[0034] FIG.11 shows a further alternative embodiment of a closure cap attached to the distal end of the ampoule according to FIG.3 in longitudinal section.

[0035] Identical parts are provided with the same reference numerals in all figures.

[0036] The syringe 1 according to FIGS. 1, 2 is intended for dispensing a medicinal active ingredient. It essentially comprises two assemblies, namely an ampoule 2 (also referred to as a carpule or cartridge) forming an active ingredient container with an ampoule body 4, which has a connecting piece 8 at its distal end 6 for attaching a hollow needle or the like, and which is connected to an actuating element 12 at its proximal end 10. In the overall view in FIG. 1 and also in the longitudinal section views in FIG. 2 (FIGS. 2a and 2b, each in different sectional planes), the syringe 1 is shown with an actuating element 12, which is designed as a conventional push-button system with an actuating plunger 14. The actuating plunger 14 is provided with a push-button plate 16 and is attached to the ampoule 2 via a base plate 18.The actuating plunger 14 extends through the base plate 18 and is connected to a plug 20 arranged in the ampoule 2. Alternatively, other configurations of the actuating element 12 are also conceivable; for example, it could be designed as an automated actuating element 12 with an automated plug drive in the manner of an auto-injector or as a pre-dosable element to form a so-called pen injector. The ampoule 2 is provided at its proximal end 10 with a circumferential fastening collar 22, which can be inserted into a fastening slot 24 formed on the base plate 18 of the ampoule to fasten the actuating element 12. According to an aspect considered to be independently inventive, the ampoule 2 is thus arbitrarily designed in the manner of a platform system and can be combined with different types of actuating element 12 depending on the intended use.

[0037] The ampoule 2 comprises, in accordance with a conventional design, a cylindrical or tubular hollow body 26 forming the ampoule body 4, which is intended to hold the medicinal active ingredient. The plug 20 is guided within this hollow body 26 within the syringe channel 28 forming the actual active ingredient chamber, sealing the interior of the hollow body 26 to its proximal end 10. Furthermore, a closure cap 30 is attached to the distal end 6 of the hollow body 26, sealing the interior of the hollow body 26. The ampoule 2 is thus designed as a sealed container in which the medicinal active ingredient can be stored and kept for a certain storage period. In particular, the ampoule 2 can thus be designed as a prefilled active ingredient container.

[0038] With regard to the choice of material for the ampoule 2 and the hollow body 26 forming it, which is considered to be inventive in its own right, particular account is taken of the high demands placed on reliable temporary storage of the active ingredient, particularly in the event of necessary storage in a deep-frozen state, along with particularly high safety in handling the components. The cylindrical hollow body 26 can be made of COC, PC, or PP, but in the illustrated embodiment, in a design considered to be inventive, it is made of the high-performance plastic cyclo-olefin polymer (COP). This material is characterized by high fracture strength and glass-like transparency. Furthermore, it does not release alkali ions, thus eliminating the risk of a pH shift in the stored active ingredient.

[0039] The ampoule 2, which is considered to be independently inventive, is shown with its two-sided closure elements, namely the closure cap 30 on the one hand and the plug 20 on the other, in FIG. 3 in a perspective view and in FIG. 4 in longitudinal section, each in an exploded view. The ampoule body 4 is provided with the fastening collar 22 at its proximal end 10 to enable connection to the actuating element 12. Alternatively, other concepts for fastening the actuating element 12, for example a screw or snap connection, can of course also be provided. The plug 20 can be inserted into the proximal end 10 and, when inserted, seals the ampoule body 4 towards its proximal end 10.

[0040] The plug 20 can be moved within the ampoule body 14 via the actuating element 12 arranged at the proximal end 10 of the ampoule body 4, so that, for example, the active ingredient stored in the ampoule body 4 can be dispensed and thus applied via a hollow needle attached to the connecting piece 8. The plug 20 is dimensioned such that it lies tightly against the inner wall of the ampoule body 4; in the longitudinal region of the interior of the ampoule body 4 between the distal end 6 and the plug 20, the reservoir for the active ingredient is thus formed, in which the active ingredient can be stored. When a hollow needle is attached to the connecting piece 8, the hollow needle is connected to this reservoir volume on the media side. The plug 20 can be moved within the ampoule body 4 towards the distal end 6, so that the active ingredient is pressed out of the interior by the hollow needle.This can be done in particular in a silicone-free design.

[0041] In order to satisfy even the highest demands with regard to tightness on the one hand and sliding properties within the ampoule body 4 on the other, the stopper 20 is designed as a multi-component, in particular two-component, configuration considered to be independently inventive. The stopper 20 is designed as described in the unpublished European patent application No. 22213561.8; the disclosure of this is expressly incorporated into the present disclosure with regard to the design and functioning of the stopper 20 ("incorporation by reference"). In particular, the stopper 20 comprises, as a first component, a central stopper body 32 made of a comparatively hard plastic such as PP, COC or COP, which is arranged in an outer sealing jacket 34 made of a comparatively softer material such as TPE, provided as a second component.

[0042] The closure cap 30 attached to the ampoule body 4 comprises, as can be seen in the enlarged longitudinal section in FIG. 5 and in a side view in FIG. 6, as essential components, on the one hand, a rigid outer cap 40 and, on the other hand, a sealing cap 42 made of a softer and more deformable material than the outer cap 40, namely rubber in the case shown here. The outer cap 40 is formed by a base body 44, which in the exemplary embodiment is made of a plastic, in particular polypropylene (PP), a polyolefin, cycloolefin copolymer (COC), cycloolefin polymer (COP) or polycarbonate, each in particular of the “medical grade” quality level. An inner channel 48 extending in the longitudinal direction indicated by the longitudinal axis 46 is incorporated into this base body 44 and is provided for receiving the sealing cap 42.

[0043] The base body 44 of the outer cap 40 could be provided with an external thread in a "lower" area intended for establishing the connection to the connecting piece 8 of the ampoule 2—preferably designed as a Luer thread, particularly with regard to common connection systems in the field of medical devices. In the illustrated embodiment, however, this area is designed without a thread.

[0044] The outer contour of the sealing cap 42, in terms of its dimensions and geometry, is adapted to the inner channel 48 in the base body 44 of the outer cap 40, so that it can be inserted into it and fixed there. On the inside, however, it has an inner channel 50 into which the mouth contour of the connecting piece 8 of the ampoule 2 can be inserted. According to one aspect of the invention, the connecting piece 8 of the ampoule body 4 tapers towards its free end, conical in the exemplary embodiment, in particular designed as a LUER cone. Adapted thereto, the inner channel 50 of the sealing cap 42 widens towards its free end, preferably in the manner of an inverted cone.Due to the material selected for the sealing cap 42—in this case, rubber with correspondingly soft, elastic properties—and the geometrical alignment of the components, the connecting piece 8 of the ampoule body 4 can be sealed tightly. The conical design in the connection area synergistically complements the self-locking properties of a conical connection, providing additional reinforcement and strength to the connection.

[0045] The closure cap 30 thus comprises as essential components the sealing cap 42 made of a comparatively soft plastic material arranged in the outer cap 40, provided with the inner channel 50 adapted to the connecting piece 8, and pushed onto the connecting piece 8 with this, wherein the outer cap 40 is formed from a comparatively hard plastic material.

[0046] The closure cap 30, which is considered to be independently inventive, is also specifically designed to be able to form a tamper-evident closure for the ampoule 2 of the type described below. For this purpose, the outer cap 40 has a molded-on contact ring 52 in the manner of a distal apron that abuts the ampoule body 4 or is at least immediately adjacent to it. This contact ring can abut directly against the ampoule body 4 to form a butt ring 54 or can be slightly spaced from it to form a circumferential annular gap 56. The outer cross-section of the contact ring 52 is adapted to that of the ampoule body 4 and thus, with its outward-facing annular surface 58, together with the end region of the outer jacket of the ampoule body 4, forms a cylindrical jacket-shaped, circumferential adhesive surface 60.

[0047] This adhesive surface 60, formed by the contact ring 52 of the outer cap 40 provided in this area on the one hand and the mouth-side end region of the outer casing of the ampoule body 4 on the other hand, forms a common base or ground surface to which the adhesive label 62 provided according to one aspect of the invention to form the tamper-evident seal can be applied in a materially bonded manner. This ensures that the adhesive label can reliably form a materially bonded connection both with the contact ring of the outer cap and with the ampoule body. The adhesive label 62 covers the butt ring 54 or annular gap 56 between the outer cap 40 and the outer casing of the ampoule body 4, as can be clearly seen in the longitudinal section in FIG. 5, for example. In order to open the ampoule body 4 closed in this way, the adhesive label 62 must therefore either be removed or applied in the area of ​​the butt ring 54 orannular gap 56 is destroyed so that it is clearly recognizable that the ampoule 2 has already been opened.

[0048] An alternative embodiment of a closure cap 30' attached to the ampoule body 4 is shown in the enlarged view in FIG. 7 in longitudinal section and in FIG. 8 in lateral view. In this variant, with otherwise identical functionality of the components, the sealing cap 42' is made of TPE with an adapted geometry.

[0049] In the above-described FIG. 1, the syringe 1 is still shown without the tamper-evident seal for the sake of clarity. In contrast, FIG. 9 shows the syringe 1 with the ampoule 2 with the tamper-evident seal attached. Clearly visible is the adhesive label 62, which in the case shown here covers the contact ring 52 of the outer cap 40 on the one hand and the entire outer shell of the ampoule body 4 on the other. To facilitate removal of the label and thus opening of the ampoule 2, the adhesive label 62 is provided with an opening perforation 64 in the manner of a predetermined breaking point in the area overlapping the impact ring 54 or annular gap 56 between the outer cap 40 and the ampoule body 4.

[0050] To open the ampoule 2, the adhesive label 62 is separated, for example by twisting the outer cap 40 relative to the ampoule body 4, tearing open, for example, in the area of ​​the opening perforation 64. As a result, the adhesive label 62 no longer connects the outer cap 40 to the ampoule body 4, and the closure cap 30 can be removed. This is illustrated in FIG. 10. It is clearly visible that the connection piece 8 of the ampoule 2 is exposed and made accessible, allowing a needle head or the like to be attached.

[0051] A further variant of a closure cap 30" attached to the distal end 6 of an ampoule 2' is shown in longitudinal section in FIG. 11. This is an ampoule 2' with, in the manner of an enlarged container, an increased filling volume compared to the variants described above and thus an increased outer diameter of the ampoule body 4'. The components provided for the connection of further components such as the syringe needle, in particular the connecting piece 8, are designed identically to the connecting piece 8 described above with regard to standard-compatible design, including its dimensions.In order to be able to continue to use the above-described components, in particular the sealing cap 42, 42' and the outer cap 40, unchanged across all systems, even for such containers in the sense of producing large quantities, the closure cap 30" is designed in three components (instead of the previous two) according to an aspect of the invention that is considered to be independently inventive.

[0052] The sealing cap 42, 42' is arranged unchanged in the outer cap 40, which in this variant, however, serves merely as a carrier cap 40. This carrier cap 40 is in turn held in an outer cap 70 in this variant. The outer cap 70, in turn, has the contact ring 52', the outer diameter of which is adapted to that of the ampoule body 4'. In accordance with the embodiments described above, the adhesive label 62 can now be materially bonded, in particular glued, to both the contact ring 52' and the outer shell of the ampoule body 4' to form the tamper-evident seal.

[0053] List of reference symbols

[0054] 1 syringe

[0055] 2 ampoules

[0056] 4, 4' ampoule body

[0057] 6 distal end

[0058] 8 connecting pieces

[0059] 10 proximal end

[0060] 12 Actuating element

[0061] 14 actuating plungers

[0062] 16 Push plate

[0063] 18 Base plate

[0064] 20 plugs

[0065] 22 mounting collars

[0066] 24 fortification backdrop

[0067] 26 hollow bodies

[0068] 28 syringe channel

[0069] 30, 30', 30" cap

[0070] 32 plug bodies

[0071] 34 Sealing jacket

[0072] 40 outer cap

[0073] 42.42' sealing cap

[0074] 44 basic bodies

[0075] 46 Longitudinal axis

[0076] 48, 50 inner channel

[0077] 52, 52 'contact ring

[0078] 54 Shock ring

[0079] 56 Annular gap

[0080] 58 ring area

[0081] 60 adhesive surface

[0082] 62 adhesive labels

[0083] 64 Opening perforation

[0084] 70 outer cap

Claims

Claims 1 . Ampoule (2) with a tamper-evident closure for a medical syringe (1), comprising an ampoule body (4, 4') which has a connecting piece (8) at its distal end (6) for attaching a hollow needle or the like, with a closure cap (30, 30', 30") for the connecting piece (8), wherein the closure cap (30, 30', 30") comprises a sealing cap (42, 42') made of a comparatively soft plastic material, arranged in an outer cap (40, 70), provided with an inner channel (50) adapted to the connecting piece (8), and pushed onto the connecting piece (8) with said inner channel, wherein the outer cap (40, 70) is formed from a comparatively hard plastic material and has a contact ring (52, 52') and with an adhesive label (62),which, to form the tamper-evident seal, is materially connected all the way around both to the outer surface (58) of the contact ring (52, 52') and, in a mouth region adjacent to the distal end (6) of the ampoule body (4, 4'), to the outer surface of the ampoule body (4, 4').

2. Ampoule (2) according to claim 1, the sealing cap (42, 42') of which is arranged in a carrier cap (40), which in turn is held in the outer cap (70).

3. Ampoule (2) according to claim 1 or 2, whose sealing cap (42, 42') is made of TPE or rubber.

4. Ampoule (2) according to one of claims 1 to 3, whose carrier and / or outer cap (40, 70) is made of polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefin polymer (COP) or polycarbonate.

5. Ampoule (2) according to one of claims 1 to 4, in which the connecting piece (8) of the ampoule body (4, 4') is tapered towards its free end, preferably conically, particularly preferably as a LUER cone, and adapted thereto the inner channel (50) of the sealing cap (42, 42') is widened towards its free end, preferably in the manner of an inverted cone.

6. Ampoule (2) according to one of claims 1 to 5, the carrier or outer cap (40, 70) holding the sealing cap (42, 42') is designed without a thread in an area surrounding the inner channel (50) of the sealing cap (42, 42').

7. Ampoule (2) pre-filled with a medication or medicinal agent.

8. Closure cap (30, 30', 30"), in particular for an ampoule (2) according to one of claims 1 to 7, with a sealing cap (42, 42') arranged in an outer cap (40, 70) made of a comparatively soft plastic material, wherein the outer cap (40, 70) is formed from a comparatively hard plastic material and has a contact ring (52, 52') forming a circumferential adhesive surface (58) in the region of its free end

Images