Medical or pharmaceutical stopper for sealing a container volume and method for manufacturing same

Abstract

The invention relates to a medical or pharmaceutical stopper (11) used to seal a container volume of a container for holding a fluid for medical, pharmaceutical or analytical use. The stopper has a stopper pre-moulding body (17) made of a pre-moulding material and at least one stopper injection-moulding body (20) made of an injection-moulding material. The stopper also has at least one barrier laminate (21) made of a laminate material and laminated onto the stopper pre-moulding body (17) and at least partially overmoulded by the stopper pre-moulding body (17) and the stopper injection-moulding body (20). The barrier laminate (21) is arranged between the stopper pre-moulding body (17) and the stopper injection-moulding body (20). The barrier laminate (21) covers at least 30% of a sealing cross-section (Q) of the stopper. During the production of the stopper, the barrier laminate (21) is positioned by placing it on the stopper pre-moulding body (17) and the stopper injection-moulding body (20) is moulded onto the stopper pre-moulding body (17) in such a way that the barrier laminate (21) is at least partially overmoulded by the stopper pre-moulding body (17) and the stopper injection-moulding body (20) during injection moulding. The result is a medical stopper with improved practical value.

Description

[0001] Medical or pharmaceutical stopper for sealing a

[0002] Container volume and manufacturing processes

[0003] The invention relates to a medical or pharmaceutical stopper for sealing a container volume for containing a liquid for medical, pharmaceutical, or analytical use. Furthermore, the invention relates to a manufacturing method therefor.

[0004] A medical plug of the type mentioned above, designed as a closure plug, is known from EP 2 985 015 B1. Medical plugs in the form of syringe plungers are also known.

[0005] It is an object of the invention to further develop a medical or pharmaceutical stopper of the type mentioned at the outset in such a way that its utility value is improved.

[0006] This object is achieved according to the invention by a medical or pharmaceutical stopper having the features specified in claim 1.

[0007] According to the invention, it was recognized that a barrier laminate at least partially overmolded within the plug makes it possible, on the one hand, to achieve a high gas barrier and / or liquid barrier and / or solid barrier of the plug via the laminate, while, on the other hand, the pre-injection material and / or the injection material do not necessarily have to be optimized for high gas, liquid, or solid barriers. This expands the range of materials that can be used for the pre-injection material and / or the injection material. The barrier properties of the barrier laminate can be gas barrier properties, liquid barrier properties, or even solid barrier properties, for example, the suitability of a barrier for powder material.The overmolding material and also the base material of the medical plug can then have lower barrier properties, which further simplifies the material selection for these materials or facilitates other functional optimizations.

[0008] The medical stopper can be designed as a syringe plunger, i.e., as a stopper that can be moved relative to the inner wall of a container, or as a stationary closure stopper that at least partially seals a container. A pharmaceutical or blood thinner, a liquid for medical, pharmaceutical, or analytical use, can be contained in the container volume to be sealed.

[0009] The barrier laminate can be designed as a film. The barrier laminate can cover at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% of the sealing cross-section of the plug. The sealing cross-section of the plug is defined by the plug cross-section that can be applied to the inner wall of the container to form a seal.

[0010] The barrier laminate may be partially exposed, particularly on the side of the medical stopper facing away from the liquid.

[0011] Silicone as pre-injection material or as injection material after

[0012] Claim 2 is biocompatible and has good sealing and sliding properties. Additional material treatment or wetting to achieve correspondingly good sealing and sliding properties is therefore not necessary.

[0013] Laminate materials according to claim 3 provide a good barrier and can be used in a manner tailored to the respective application.

[0014] At least one opening in the barrier laminate according to claim 4 allows, for example, a component to penetrate the barrier laminate without undesirably entraining parts or fragments of the laminate upon penetration. The opening in the barrier laminate can be centrally located. Multiple openings can also be provided in the barrier laminate. Such an opening can also improve the adhesion of the plug pre-injection body to the plug injection body. Alternatively, the barrier laminate can also be designed without openings.

[0015] A complementary shape of the plug pre-injection body to the barrier laminate according to claim 5 can facilitate positioning of the laminate relative to the plug pre-injection body before the plug injection body is molded. Such a complementary shape can be achieved, for example, by raising the plug pre-injection body at the location of a laminate opening.

[0016] Connections between the plug base body and the plug overmolded section according to claims 6 and 7, respectively, have proven successful in practice. A mechanical connection between the plug base body and the plug overmolded section can be achieved via a positive fit, in particular an undercut and / or a locking mechanism. A chemical connection between the plug base body and the plug overmolded section can be achieved via adhesion.

[0017] A receptacle for the plug base body according to claim 8 improves its function when the medical plug is designed as a syringe plunger. The receptacle for an end section of the plunger rod can be designed as a simple opening, a conical receptacle, or even a threaded receptacle.

[0018] An embodiment of the plug with a plug base body and a plug overmolding section according to claim 9 also enables independent selection of the base body material on the one hand and the overmolding material on the other, which offers additional advantages. The base body material can be selected with regard to, for example, its stability and its manufacturing properties. The overmolding material can be selected with regard to its sealing or sliding properties. The plug base body and the plug overmolding section can be mechanically and / or chemically bonded to one another. The base body material can be a thermoplastic, in particular one of the following materials: PC, PMMA, PBT, PA, PEEK. The base body material can alternatively be silicone. The overmolding material can also be silicone.

[0019] The advantages of a manufacturing method according to claim 10 correspond to those already explained above in connection with the medical plug, in particular according to claim 9. When completely overmolding the barrier laminate according to claim 11, it can also be made of less biocompatible materials, which in turn facilitates the selection of the laminate material.

[0020] Tempering according to claim 12 enables any necessary crosslinking of at least one plug material or outgassing of at least one plug material.

[0021] In particular, the result can be a durable medical plug. The plug can be designed to be highly biocompatible. The plug can be sterilized using at least one common sterilization method, for example, sterilization via gamma or X-ray radiation, electron beams, autoclaving, or treatment with ethylene oxide.

[0022] The entire plug can be manufactured using an injection molding process. The resulting plug can exhibit very good barrier properties.

[0023] Embodiments of the invention are explained in more detail below with reference to the drawings, in which:

[0024] Fig. 1 shows, in cross section, a medical plug for sealing a container volume for holding a liquid for medical, pharmaceutical, or analytical use, wherein the plug is designed as a movable plug in the shape of a syringe plunger; Fig. 2 shows, partially in cross section, another embodiment of a medical plug for sealing a container volume for holding a liquid for medical, pharmaceutical, or analytical use, wherein the plug is designed as a closure plug for a liquid container;

[0025] Fig. 3 to 5 show, in a representation similar to Fig. 2, further embodiments of a medical stopper with, compared to the embodiment according to Fig. 2, different variants of arrangements of at least one overmolded barrier laminate;

[0026] Fig. 6 shows, in a representation similar to Fig. 1, a further embodiment of the medical stopper in the form of a syringe plunger;

[0027] Fig. 7 shows in perspective the medical plug according to Fig. 6;

[0028] Fig. 8 is a perspective view of the plug according to Fig. 7, seen from the opposite direction to Fig. 7;

[0029] Fig. 9 to 11 in a representation similar to Fig. 6 the syringe plunger with further variants of an arrangement of at least one overmolded barrier laminate;

[0030] Fig. 12 and 13 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug; Fig. 14 and 15 in a representation similar to Fig. 7 and 8, a further

[0031] Execution of a medical plug;

[0032] Fig. 16 and 17 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0033] Fig. 18 and 19 show a further embodiment of a medical plug in a representation similar to Fig. 7 and 8;

[0034] Fig. 20 and 21 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0035] Fig. 22 and 23 in a representation similar to Fig. 7 and 8 a further

[0036] Execution of a medical plug;

[0037] Fig. 24 and 25 in a representation similar to Fig. 7 and 8 a further

[0038] Execution of a medical plug;

[0039] Fig. 26 and 27 in a representation similar to Fig. 7 and 8 a further embodiment of a medical plug;

[0040] Fig. 28 and 29 show a further embodiment of a medical plug in a representation similar to Fig. 7 and 8;

[0041] Fig. 30 and 31 in a representation similar to Fig. 7 and 8 a further

[0042] Design of a medical plug; Figs. 32 and 33 show a further design of a medical plug in a representation similar to Figs. 7 and 8;

[0043] Fig. 34 and 35 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0044] Fig. 36 and 37 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0045] Fig. 38 and 39 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0046] Fig. 40 and 41 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0047] Fig. 42 and 43 in a representation similar to Fig. 7 and 8, a further embodiment of a medical plug;

[0048] Fig. 44 is a side view of the plug according to Figs. 42 and 43;

[0049] Fig. 45 to 47 in a representation similar to Fig. 42 to 44, a further embodiment of a medical plug;

[0050] Fig. 48 and 49 show a further embodiment of a medical stopper in a representation similar to Fig. 7 and 8;

[0051] Fig. 50 and 51 show a further embodiment of a medical plug in a representation similar to Fig. 7 and 8; and Fig. 52 and 53 show a further embodiment of a medical plug in a representation similar to Fig. 7 and 8.

[0052] Fig. 1 shows, in an axial longitudinal section, a section of a prefilled syringe 1 for storing and later dispensing a liquid for medical, pharmaceutical, or analytical use. The syringe 1 has a syringe barrel 2 as a container for the liquid, in which a medical stopper in the form of a piston 3 is movably guided. The piston 3 is connected to a piston rod 4 of the syringe 1, whereby the piston rod 4 is only indicated in Fig. 1. Depending on the design of the piston 3, such a piston rod may also be omitted.

[0053] The piston 3 serves to seal the syringe barrel 2, i.e., to seal a container volume for holding the liquid, indicated at 5 in Fig. 1. The liquid 5 can be a blood thinner or a pharmaceutical.

[0054] The piston 3 has a plug base body 6 made of a base material and a plug overmolding section 7 made of an overmolding material. The plug base body 6 has a receptacle 6a for a section of the piston rod 4. This receptacle 6a can be designed as a simple opening, in the form of a thread, or even conically, for example.

[0055] The piston 3 is an injection-molded part manufactured using a 2K process. Via the plug-overmolding section 7, the piston 3 forms a sealing contact with an inner wall 8 of the piston cylinder 2. For this purpose, the plug-overmolding section 7 has several sealing lips 9 made of the overmolding material, in this case three, which are axially spaced apart from one another and are located on the inner wall 8. Depending on the design of the piston 3, two sealing lips, four sealing lips, or even more sealing lips can be provided. A design with exactly one sealing lip is also possible.

[0056] When using the piston 3, the sealing lips 9 slide relative to the inner wall 8.

[0057] The base material of the plug base body 6 is a thermoplastic, and in particular at least one of the following materials: PC (polycarbonate), PMMA (polymethyl methacrylate), PBT (polybutylene terephthalate), PA (polyamide), or PEEK (polyetheretherketone). The base material can be optimized, in particular, for a barrier function and can have a gas permeability that is lower than that of natural rubber, for example, 90%, 75%, 60%, 50%, 40%, 30%, 20%, 10% of the gas permeability of natural rubber, or even an even lower gas permeability compared to natural rubber.

[0058] As an alternative to a thermoplastic, the base material of the plug base body 6 can also be a silicone.

[0059] The overmolding material of the plug overmolding section 7 is a silicone material, in particular LSR (liquid silicon rubber), HCR (high consistency rubber) silicone, i.e. solid silicone rubber, and / or high-temperature crosslinking silicone rubber (HTV).

[0060] The overmolding material can be optimized for good sliding properties.

[0061] In a sliding property measurement according to the ISO 7886 / 1 standard, the overmold material has a sliding friction and / or a breakaway force that is improved by at least 10%, at least 20% and in particular by at least 25% compared to standard test specimens, in particular made of pharmaceutical rubber, with the same geometry and the same dimensions.

[0062] Depending on the material pairing of the base material of the plug base body 6 and the overmolding material of the plug overmolding section 7, these two components 6, 7 are mechanically and / or chemically bonded to one another, i.e., in particular, by adhesion. A mechanical connection can be achieved via an undercut 10, for which, for the piston 3, a circumferential collar is shown as an example. This collar is molded onto the plug base body 6 from the base material and around which the overmolding material of the plug overmolding section 7 is molded.

[0063] The plug overmolding section 7 surrounds the plug base body 6 radially, i.e., toward the inner wall 8 of the syringe barrel 2, and also axially upwards in Fig. 1, i.e., toward the liquid 5. Thus, the plug base body 6 does not come into contact with the liquid 5 at any point during use of the piston 3. During injection molding of the piston 3, the plug base body 6 is first molded. This is then overmolded by the plug overmolding section 7.

[0064] With reference to Fig. 2, a further embodiment of a medical plug in the form of a closure plug 11 for sealing a container volume for holding a liquid for medical, pharmaceutical or analytical use is described below.

[0065] Fig. 2 shows the closure plug 11 inserted into a container neck 12 of a container (not shown) for storing the liquid. The closure plug 11 has a radially projecting collar portion 13, which rests on an end wall 14 of the container neck 12, and a plug portion 15, which, like a wine cork, is inserted into the container neck 12 from the end wall and seals radially against an inner wall 16 of the container neck 12. The plug portion 15 merges into the collar portion 13 via a circumferential step.

[0066] The closure plug 11 has a plug pre-molded body 17 in the form of a plug disk with an axial extension A between a free end face 18 of the closure plug 11 and a connecting plane 19. The plug pre-molded body 17 represents an axial section of the plug section 15. A plug injection body 20 is molded onto the plug pre-molded body 17. The plug injection body 20 comprises the remaining plug section 15 and the collar section 13 of the closure plug 11. The plug pre-molded body 17 is made of a pre-mold material. The plug injection body 20 is made of a injection material. Depending on the design of the closure plug 11, the pre-mold material and the injection material can be the same or different materials.

[0067] A barrier laminate 21 made of a laminate material is laminated onto the plug pre-molded body 17 in the area of ​​the connecting plane 19. The barrier laminate 21 can be a film. The barrier laminate 21 is arranged between the plug pre-molded body 17 and the plug injection body 20 and is completely overmolded by the plug pre-molded body 17 and the plug injection body 20.

[0068] The laminate material of the barrier laminate 21 has barrier properties with respect to at least one gas and / or with respect to at least one liquid and / or with respect to at least one solid material, in particular in powder form. The barrier laminate 21 accordingly serves as a barrier for the corresponding gas and / or the corresponding liquid and / or the corresponding solid.

[0069] The barrier laminate 21 covers at least 30% of a sealing cross-section Q of the closure plug 11, which corresponds to the inner diameter of the container neck 12 in the region of the plug section 15. An outer diameter of the plug section 15 is slightly larger than the inner diameter of the container neck 12 in the force-free case, i.e., when the closure plug 11 has not yet been inserted into the container 12. The pre-injection material of the plug pre-injection body 17 and the injection material of the plug injection body 20 can be silicone, in particular LSR, HCR, or HTV.

[0070] The laminate material of the barrier laminate 21 can be a metal and / or a metal alloy and / or a glass and / or a plastic material, in particular a thermoplastic and / or a natural material, for example, hemp, an algae material, or spider silk. The laminate material can be a fabric, for example, a textile fabric. If the laminate material is a fabric, this fabric can be produced, for example, by injection molding. The fabric can be a coated or uncoated fabric. The barrier laminate 21 can also be manufactured from a powder and / or sintered material.

[0071] Examples of materials for the plastic material can be those given above in connection with the base material of the plug base body 6 of the piston 3 according to Fig. 1. One example of a metal is aluminum. Another example of a plastic material is PE (polyethylene).

[0072] The barrier laminate 21 can have at least one opening through which the plug pre-injection body 17 directly rests against the plug injection body 20. Fig. 2 shows two such openings 22, which are arranged off-center in the barrier laminate 21. Alternatively, the opening in the barrier laminate 21 can also be a central opening. Depending on the design of the barrier laminate, it can also be designed without an opening. The plug pre-injection body 17 can be shaped complementarily to the barrier laminate 21, at least in sections. This complementary shape of the plug pre-injection body 17 can be used to facilitate positioning of the barrier laminate 21 relative to the plug pre-injection body 17 before the plug injection body 20 is injected.Such a complementary shape of the plug pre-molded body 17 to the barrier laminate 21 can be realized by raising the plug pre-molded body 17 at the location of at least one of the laminate openings 22. When positioning the barrier laminate 21, it is then placed onto the pre-molded plug pre-molded body 17 in such a way that the respective elevation of the plug pre-molded body 17 engages the respective laminate opening 22.

[0073] The plug pre-injection body 17 and the plug injection body 20 can be mechanically and / or chemically connected to one another. The same applies as described above regarding the connection between the plug base body 6 and the plug overmolding section 7 of the piston 3 embodiment shown in Fig. 1.

[0074] Such a mechanical connection can generally be realized by a positive connection and, for example, also by an undercut or by a locking mechanism.

[0075] When manufacturing the closure plug 11, the plug pre-molded body 17 is first produced by injection molding, pressing, casting, gluing, or joining. The barrier laminate is also produced and can, for example, be punched out of a flat material. The barrier laminate 21 is then positioned by being placed against the plug pre-molded body 17. Subsequently, the plug injection-molded body 20 is injection-molded onto the plug pre-molded body 17 such that the barrier laminate 21 is completely overmolded by the plug pre-molded body 17 and the plug injection-molded body 20 during injection molding.

[0076] The pre-injection of the plug pre-injection body 17 and the injection of the plug injection body 20 onto the plug pre-injection body 17 can take place in the same injection mold and can in particular take place in different injection cavities of the injection mold.

[0077] The spraying process can be followed by a tempering step to crosslink the spray material and / or outgas the spray material.

[0078] During the production of the closure plug 11, a robot can be used to punch out the barrier laminate 21 and / or to load the at least one mold cavity and / or to remove the finished injection-molded closure plug 11. The finished injection-molded closure plug 11 can be temporarily packaged before tempering, for which purpose a PE bag can be used. After the tempering step and a final inspection, the finished closure plug 11 can then be packaged according to customer specifications.

[0079] When using a particularly central passage opening in the barrier laminate 21, this can in particular be designed such that a tip section 23 of a syringe 24 penetrates this central passage opening 22 when the liquid is withdrawn from the container with the container neck 12, without parts of the barrier laminate 21 being taken along by the tip section 23 in such a way that these parts are undesirably released from the rest of the barrier laminate 21.

[0080] Depending on the manufacturing process, the plug pre-injection body and the plug injection body may also be interchanged. Thus, body 20 may represent the plug pre-injection body and body 17 the plug injection body.

[0081] Further arrangement variants for the barrier laminate 21 are described below with reference to Figs. 3 to 5. Components and functions correspond to those described above with reference to Figs.

[0082] 1 and 2 have already been explained, have the same reference numbers and will not be discussed in detail again.

[0083] In the plug 11 according to Fig. 3, in addition to the barrier laminate 11 in the region of the plug section 15, there is also a further barrier laminate 21a in the collar section 13. In addition to the pre-injected body 17 and a first injection-molded body 20 between the two barrier laminates 21, 21a, the plug 11 according to Fig. 3 has a further injection-molded body 20a, which, together with the injection-molded body 20, encloses the barrier laminate 21a. The laminate arrangement according to Fig. 3 can be understood as a two-layer barrier laminate 21, 21a, which further improves the barrier properties of the plug according to Fig. 3 or reduces the requirements for the barrier properties of the individual barrier laminates 21 or 21a.

[0084] In the plug 11 according to Fig. 4, the barrier laminate 21 is accommodated in the collar section 13. The pre-injection body 17 is then formed by the entire plug section 15 as well as a lower region of the collar section 13 in Fig. 4. The remaining section of the plug section 15 is formed by the injection body 20, which, together with the pre-injection body 17, overmolds the barrier laminate.

[0085] In the piston 11 shown in Fig. 5, two barrier laminates 21, 21a are arranged one above the other in the collar section 13 of the plug section. The two barrier laminates 21, 21a can either be laminated directly to one another or can accommodate an injection molding body similar to the injection molding body 20 of the piston shown in Fig. 3 between them.

[0086] A further embodiment of a medical stopper, again in the form of a syringe plunger 25, is described below with reference to Figs. 6 to 8. Components and functions corresponding to those already explained above with reference to Figs. 1 and 2 bear the same reference numerals and will not be discussed in detail again.

[0087] A basic structure of the piston 25 can be understood as a synthesis of the plug base body 6 and the plug overmolding section 7 of the piston 3, wherein a receptacle 26 for a piston rod in the manner of the piston rod 4 in the piston 25 is designed with an undercut collar 26a.

[0088] The piston 25 does not have an overmolded base body made of a base material, but rather a base body of the piston 25 is formed - analogous to the design of the closure plug 11 according to Fig. 2 - from a plug pre-injection body 27, to which a plug injection body 28 is connected beyond a connecting plane 19. The plug injection body 28 forms a volume corresponding to the volume of the liquid 5 (see Fig.

[0089] 1) facing cap of piston 25.

[0090] Between the plug pre-injection body 27 and the plug injection body 28, a barrier laminate 29 is arranged in the region of the connecting plane 19. With regard to the plug pre-injection body 27, the plug injection body 28, and the barrier laminate 29 of the piston 25, the above statements regarding the plug pre-injection body 17, the plug injection body 20, and the barrier laminate 21 of the closure piston 11 apply accordingly.

[0091] During the production of the piston 25, the plug pre-molded body 27 is pre-molded, and the barrier laminate 29 is produced, for example, by punching from a flat material. Subsequently, the barrier laminate 29 is positioned by placing it on the plug pre-molded body 27, and the plug injection-molded body 28 is injection-molded onto the plug pre-molded body 27 such that the barrier laminate 29 is completely overmolded by the plug pre-molded body 27 and the plug injection-molded body 28 during injection. The same applies here as explained with regard to the production of the closure plug 11 according to Fig. 2.

[0092] The plug pre-molded body 27 is made of a pre-molded material, and the plug injection-molded body 28 is made of an injection-molded material. What was already explained above in connection with the closure plug 11 applies to these materials. The pre-molded material and / or the injection-molded material can, in particular, be silicone, in particular LSR and / or HCR silicone and / or HTV silicone.

[0093] The barrier laminate 29 in turn covers at least 30% of a sealing cross section Q of the piston 25.

[0094] In an embodiment not shown, the piston 25 can also have, in addition to the plug pre-injection body 27 and the plug injection body 28, which then together form a plug over-injection section, a plug base body made of a base body material, as explained above in connection with Fig. 1.

[0095] Fig. 9 to 11 show further arrangement variants for the barrier laminate 29. Components and functions which correspond to those already explained above with reference to Fig. 6 to 8 have the same reference numerals and will not be discussed again in detail.

[0096] In the piston 25 according to Fig. 9, the barrier laminate 29 is drawn radially into a radially outer circumferential section up to the uppermost sealing lip 9 in Fig. 9. In the arrangement according to Fig. 9, the barrier laminate 29 thus has an extension that corresponds practically to the entire outer diameter of the piston 25. To adapt to an outer contour of the pre-injection body 27 and the injection body 28, a radially outer section of the barrier laminate 29 is angled in the manner of a truncated cone section.

[0097] In the piston 25 according to Fig. 10, similar to the arrangement according to Fig. 5, two superimposed barrier laminates 29 are present in the end-face piston section of the piston 25. The barrier laminate 29a located below the barrier laminate 29 in Fig. 10 has such a large radial extent that it extends into the uppermost sealing lip 9 of the piston 25 according to Fig. 10.

[0098] Fig. 11 shows the piston 25 with an arrangement of two barrier laminates 29, 29a lying one above the other in the manner of Fig. 10, which are each angled in a frustoconical shape on the circumference in the manner of Fig. 9.

[0099] Both the radial enlargement of the barrier laminate in the arrangements according to Figs. 9 to 11 and the use of several superimposed barrier laminates 29, 29a in the arrangements according to Figs. 10 and 11 either improves the respective barrier property of the piston 25 or reduces the requirements for the barrier property of an individual barrier laminate 29 or 29a.

[0100] Figs. 12 and 13 show a further embodiment of a piston 30 with an integrated residual discharge pin 30a. Functions and components corresponding to those already explained above with reference to Figs. 1 to 11 bear the same reference numerals and will not be discussed in detail again.

[0101] The piston 30 can in turn be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 30 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11. Two examples of the connecting plane 19 are shown in Fig. 6. Other positions of the connecting plane 19 between the plug pre-injection body and the plug injection body are also possible with a corresponding design of the piston 30.

[0102] The piston 30 has two sealing lips 9.

[0103] Fig. 14 and 15 show a further embodiment of a piston 31. Functions and components which correspond to those already explained above with reference to Figs. 1 to 13 have the same reference numerals and will not be discussed again in detail.

[0104] The piston 31 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 31 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0105] The piston 31 is again designed as a syringe piston and has three sealing lips 9. Figs. 16 and 17 show a further embodiment of a piston 32. Functions and components which correspond to those already explained above with reference to Figs. 1 to 15 have the same reference numerals and will not be discussed again in detail.

[0106] The piston 32 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 32 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0107] The piston 32 is again designed as a syringe piston and has two sealing lips 9.

[0108] Fig. 18 and 19 show a further embodiment of a piston 33. Functions and components which correspond to those already explained above with reference to Figs. 1 to 17 have the same reference numerals and will not be discussed again in detail.

[0109] The piston 33 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 33 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0110] The piston 33 is again designed as a syringe piston and has two sealing lips 9.

[0111] Fig. 20 and 21 show a further embodiment of a piston 35. Functions and components which correspond to those already explained above with reference to Figs. 1 to 19 have the same reference numerals and will not be discussed again in detail.

[0112] The piston 35 can in turn be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 35 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11. Two examples of the connecting plane 19 are shown in Fig. 20. Other positions of the connecting plane 19 between the plug pre-injection body and the plug injection body are also possible with a corresponding design of the piston 35.

[0113] The piston 35 is again designed as a syringe piston and has three sealing lips 9. Figs. 22 and 23 show a further embodiment of a piston 36. Functions and components which correspond to those already explained above with reference to Figs. 1 to 21 have the same reference numerals and will not be discussed again in detail.

[0114] The piston 36 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 36 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0115] The piston 36 is again designed as a syringe piston and has three sealing lips 9.

[0116] Fig. 24 and 25 show a further embodiment of a piston 37. Functions and components which correspond to those already explained above with reference to Figs. 1 to 23 have the same reference numerals and will not be discussed again in detail.

[0117] The piston 37 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 37 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0118] The piston 37 is again designed as a syringe piston and has two sealing lips 9.

[0119] Fig. 26 and 27 show a further embodiment of a piston 39. Functions and components which correspond to those already explained above with reference to Figs. 1 to 25 have the same reference numerals and will not be discussed again in detail.

[0120] The piston 39 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 39 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0121] The piston 39 is again designed as a syringe piston and has three sealing lips 9.

[0122] Fig. 28 and 29 show a further embodiment of a piston 40. Functions and components which correspond to those already explained above with reference to Figs. 1 to 27 have the same reference numerals and will not be discussed in detail again. The piston 40 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 40 can be a design with a plug pre-injection body made of a pre-injection material, with a plug over-injection body made of an over-injection material and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0123] The piston 40 is again designed as a syringe piston and has two sealing lips 9.

[0124] Fig. 30 and 31 show a further embodiment of a piston 41. Functions and components which correspond to those already explained above with reference to Figs. 1 to 29 have the same reference numerals and will not be discussed again in detail.

[0125] The piston 41 can again be a design with a plug base body made of a base material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 41 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11. The piston 41 is again designed as a syringe piston and has two sealing lips 9.

[0126] In addition, the piston 41 has, formed on its end face facing the liquid 5, a pin section 41a which, when the piston 41 is fully extended, engages a tip-side end of a syringe volume for emptying the remaining liquid.

[0127] Fig. 32 and 33 show a further embodiment of a piston 42. Functions and components which correspond to those already explained above with reference to Figs. 1 to 31 have the same reference numerals and will not be discussed again in detail.

[0128] The piston 42 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 42 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0129] The piston 42 is again designed as a syringe piston and has three sealing lips 9.

[0130] Fig. 34 and 35 show a further embodiment of a piston 43. Functions and components which correspond to those already explained above with reference to Figs. 1 to 33 have the same reference numerals and will not be discussed again in detail.

[0131] The piston 43 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 43 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0132] The piston 43 is again designed as a syringe piston and has three sealing lips 9.

[0133] In the case of the piston 43, a residual emptying pin 30a is again an integral part of the piston, similar to the design according to Figs. 12 and 13.

[0134] Fig. 36 and 37 show a further embodiment of a piston 45. Functions and components which correspond to those already explained above with reference to Figs. 1 to 35 have the same reference numerals and will not be discussed again in detail.

[0135] The piston 45 can again be a design with a plug base body made of a base material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 45 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 5.

[0136] A receptacle 45a of the type of receptacles 6a or 26 is designed in the piston 45 as a thread formed in the plug base body or in the plug pre-injection body or the plug injection body.

[0137] The piston 45 is again designed as a syringe piston and has three sealing lips 9.

[0138] Fig. 38 and 39 show a further embodiment of a piston 49. Functions and components which correspond to those already explained above with reference to Figs. 1 to 37 have the same reference numerals and will not be discussed again in detail.

[0139] The piston 49 can again be a design with a plug base body made of a base material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 49 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11. The piston 49 is again designed as a closure plug and has two sealing lips 9.

[0140] Fig. 40 and 41 show a further embodiment of a piston 50. Functions and components which correspond to those already explained above with reference to Figs. 1 to 39 have the same reference numerals and will not be discussed again in detail.

[0141] The piston 50 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 50 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0142] The piston 50 is again designed as a sealing plug and has two sealing lips 9.

[0143] Fig. 42 to 44 and Fig. 45 to 47 show two further designs of the piston 50 according to Fig. 40 and 41 with different profile cross-sections of the sealing lips 9. This sealing lip profile cross-section is approximately semicircular in the design of the piston 50 according to Fig. 40 and 41.

[0144] In the piston 50 according to Figs. 42 to 44, the profile cross-section is asymmetrical with an axially outer conical section 9a and a convexly rounded axially inner profile section 9b (compare the side view according to Fig. 44).

[0145] In the piston 50 according to Figs. 45 to 47, the radial projection of the sealing lips 9 over a cylindrical base body of the piston 50 is somewhat smaller than in the embodiment according to Figs. 42 to 44. In addition, the two sealing lips 9 are axially further apart from one another in the embodiment according to Figs. 45 to 47 than in the embodiment according to Figs. 42 to 44.

[0146] Fig. 48 and 49 show a further embodiment of a piston 51. Functions and components which correspond to those already explained above with reference to Figs. 1 to 47 have the same reference numerals and will not be discussed again in detail.

[0147] The piston 51 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 51 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0148] The piston 51 is again designed as a syringe piston and has three sealing lips 9. Figs. 50 and 51 show a further embodiment of a piston 52. Functions and components which correspond to those already explained above with reference to Figs. 1 to 49 have the same reference numerals and will not be discussed again in detail.

[0149] The piston 52 can again be a design with a plug base body made of a base material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 52 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11.

[0150] The piston 52 is again designed as a syringe piston and has two sealing lips 9.

[0151] Fig. 52 and 53 show a further embodiment of a piston 53. Functions and components which correspond to those already explained above with reference to Figs. 1 to 51 have the same reference numerals and will not be discussed again in detail.

[0152] The piston 53 can again be a design with a plug base body made of a base body material and a plug overmolding section made of an overmolding material, corresponding to what was explained above in connection with Fig. 1. Alternatively or additionally, the piston 53 can be a design with a plug pre-injection body made of a pre-injection material, with a plug injection body made of an injection material, and an intermediate barrier laminate, corresponding to what was already explained above with reference to Figs. 2 to 11. The piston 53 is again designed as a syringe piston and has two sealing lips 9.

[0153] With regard to the manufacturing process for the pistons 30 to 53, the same applies as has already been explained above in connection with the pistons 3, 11 and 25.

Claims

Patent claims 1. Medical or pharmaceutical stopper (11; 25; 30 to 53) for sealing a container volume of a container for holding a liquid (5) for medical, pharmaceutical or analytical use, with a stopper pre-injection body (17; 27) made of a pre-injection material, with at least one stopper injection-molded body (20; 28) made of an injection-molded material, with at least one barrier laminate (21; 29) made of a laminate material laminated onto the stopper pre-injection body (17; 27) and at least partially over-molded by the stopper pre-injection body (17; 27) and the stopper injection-molded body (20; 28), arranged between the stopper pre-injection body (17; 27) and the stopper injection-molded body (20; 28), wherein the barrier laminate (21; 29) has at least 0% of a sealing cross-section (Q) of the plug.

2. Medical plug according to claim 1, characterized in that the pre-injection material and / or the injection material is silicone.

3. Medical plug according to claim 1 or 2, characterized in that the laminate material is at least one of the following materials: a metal, a metal alloy, a glass, PE, PC, PMMA, PBT, PA, PEEK.

4. Medical plug according to one of claims 1 to 3, characterized in that the barrier laminate (21; 29) has at least one Opening (22) through which the plug pre-injection body (17; 27) lies directly on the plug injection body (20; 28).

5. Medical plug according to one of claims 1 to 4, characterized in that the plug pre-injection body (17; 27) is shaped at least in sections complementary to the barrier laminate (21; 29).

6. Medical plug according to one of claims 1 to 5, characterized in that the plug pre-injection body (17; 27) and the plug injection body (20; 28) are mechanically connected to one another.

7. Medical plug according to one of claims 1 to 6, characterized in that the plug pre-injection body (17; 27) and the plug injection body (20; 28) are chemically bonded to one another.

8. Medical plug according to one of claims 1 to 7, characterized in that the plug pre-injection body (17; 27) and / or the plug injection body (20; 28) has a receptacle (6a; 26) for a piston rod (4).

9. Medical plug according to one of claims 1 to 8, characterized in that the plug pre-injection body (27) and / or the plug injection body (28) is a plug over-injection body made of at least one over-injection material, wherein the plug further comprises a plug base body made of a base body material, which is over-injected by the plug over-injection section wherein the plug is in sealing contact with an inner wall (8) of the container via the plug-overmolding section.

10. A method for producing a medical plug (11; 25; 30 to 53) according to one of claims 1 to 9, comprising the following steps: Producing the plug pre-molded body (17; 27), Producing the barrier laminate (21; 29), Positioning the barrier laminate (21; 29) by placing it on the plug pre-injection body (17; 27), Injection molding of the plug injection body (20; 28) onto the plug pre-injection body (17; 27) such that the barrier laminate (21; 29) is at least partially overmolded during injection molding by the plug pre-injection body (17; 27) and the plug injection body (20; 28).

11. Method according to claim 10, characterized by a complete overmolding of the barrier laminate (21; 29) when the plug injection-molded body (20; 28) is injected onto the plug pre-molded body (17; 27).

12. The method according to claim 10 or 11, characterized by tempering the medical plug after injection molding.

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