STOPPER DEVICE, MEDICINE CONTAINER AND METHOD FOR MIXING TWO SUBSTANCES IN A MEDICINE CONTAINER

Abstract

A method is disclosed here for a target mobility management entity and a target mobility management entity to execute the method on a core network to communicate network function utilization (NF) information with a source mobility management entity during a mobility management entity change.The method comprises: receiving, through the target mobility management entity, at least one legacy NF identifier (ID) from the source mobility management entity that corresponds to a legacy NF entity serving a user equipment (UE); determining whether to use the at least one legacy NF ID or to use at least one new NF ID that corresponds to a new NF entity of the same NF type as the legacy NF entity; and communicating, through the target mobility management entity to the source mobility management entity, information indicating to the source mobility management entity whether the target mobility management entity uses the at least one legacy NF ID or uses the at least one new NF ID.

Description

FIELD OF INVENTION The present invention relates to a stopper device, a medicine container having such a stopper device, and a method for mixing two rheologically separate substances in such a medicine container. BACKGROUND OF THE INVENTION Stopper devices, drug containers, and methods of this type are known. Typically, two substances, stored separately rheologically, are mixed in a drug container configured as a double-chamber system. The first substance is placed in a proximal chamber, and the second substance in a distal chamber. In such a drug container, the first proximal chamber is bounded proximally by a first stopper device, in particular, an end stopper, distally by a second stopper device, in particular, a center stopper, and radially by an inner wall of the drug container. The second distal chamber is bounded proximally by the second stopper device, radially by the inner wall of the drug container, and distally by the tip of the drug container, which is preferably closed by a cap. Before initialization of the medication container, the proximal chamber is rheologically sealed from the distal chamber and the surrounding environment. Only during initialization is the second stopper moved to a mixing position, establishing a rheological connection between the two chambers via a bypass. This allows the two substances to mix while the second stopper remains in this position. The contents of the proximal chamber, i.e., the first substance, are pushed into the distal chamber by applying pressure, particularly manual pressure, through the bypass. This reduces the volume of the proximal chamber, and the second stopper remains in the mixing position until it abuts the second stopper. The initialization process therefore involves applying pressure to the first stopper in a distal direction, causing it to displace. Due to this displacement and the rheological sealing of the proximal chamber, pressure is applied to the second stopper, causing it to also displace distally to the mixing position. In the mixing position, pressure is equalized through deflection, so that the second stopper is no longer unilaterally exposed to pressure. Therefore, in such conventional drug containers, it is necessary for both stoppers to be displaced for initialization and, consequently, for the mixing of the two substances. Before initialization, i.e., the application of the known method for mixing the substances, the two substances are stored separately, which increases their safety and / or shelf life. Initialization is performed only before a planned application, particularly an injection, by moving the stopper devices in the medication container to an axial position—along the central axis of the container—where mixing is possible, specifically through a diverter. To increase the sliding capacity of the stopper devices in the medication container and to achieve a secure container that ensures aseptic storage and / or application of an active medicinal ingredient, the inner wall of the container is coated with silicone. However, this makes it impossible, or at least unsafe, to place known substances that react upon contact with the silicone-coated inner wall in such medication containers, particularly unintentionally. Filling the chambers separately in time and / or space is complicated, since the medication container must be rotated and / or closed after the first chamber is filled, and / or the filling of the second chamber must be completed before the first chamber can be filled.Mixing the two substances in such a medicine container is also not optimal, particularly because of the typically reduced dimensioning of the deviation. With such conventional stopper devices, it is not possible, or only under more difficult conditions, to form an ampoule or injection vial as a multi-chamber system, particularly as a double-chamber system, since these containers are configured open only at one end. When axially sealed stopper devices are moved in such containers, pressure fluctuations occur that hinder and ultimately limit axial movement. In particular, the second stopper device, which acts as a central stopper, cannot be moved far enough into such a container without difficulty. Furthermore, in such containers, it is not possible to move the second stopper device to the mixing position due to the pressure fluctuations this causes, or at least it is significantly more difficult and therefore impractical. BRIEF DESCRIPTION OF THE INVENTION The object of the invention is to create a stopper device, a medication container, and a method for mixing two substances in a medication container, avoiding the aforementioned disadvantages. In particular, an object of the invention is to create a medication container and a stopper device in which unstable substances, particularly powdered medications that should not come into contact with a silicone-coated inner wall, can be safely stored and mixed with a second substance. The objective is achieved by creating the objects of the independent claims. Advantageous arrangements result from the dependent claims. The objective is achieved, in particular, by creating a stopper device for sealing a medicine container in which the stopper device comprises a stopper element, the stopper element being configured to seal the medicine container in an axial direction of a central axis of the medicine container, in particular, by means of the stopper element, the stopper device being able to be at least partially inserted into the medicine container and the stopper element being displaceable in the medicine container, when correctly installed, along the central axis of the medicine container, and the stopper device, in particular, the stopper element having a retention zone with at least one retention means.The stopper device is distinguished by the fact that—in its initial functional state—a sealing element is retained in a stationary, separable manner relative to the stopper element, specifically directly within the stopper element in a retained position such that a cavity is formed between the sealing element and the stopper element. Consequently, a substance intended for mixing can be placed within this cavity of the stopper device and kept sealed from the environment without requiring a separate medication container. Filling a medication container with two substances can be easily accomplished in two separate, largely independent steps.It is also possible to safely store an unstable substance, particularly a powdered medication, in such a stopper device, as it prevents any contact with silicone, specifically with the silicone-coated inner wall of a medication container. Furthermore, this stopper device simplifies the creation of a dual-chamber system in an injection vial and / or ampoule, since no central plug is required to separate the two chambers. Herein, a substance is understood to mean, in particular, a medicinal substance, and more specifically, an active ingredient and / or a medicinal adjuvant. The stopper device, in particular the closure element and the stopper element, is configured to house such a substance, in particular a medicinal active ingredient, preferably aseptically, the cavity being rheologically airtight. The stopper device preferably comprises or consists of plastic. A stopper element is understood to mean a stopper, in particular, an end stopper for a drug container. The stopper element preferably comprises or consists of elastic material. The stopper element preferably consists of an elastomer and / or a soft plastic. In a sealing zone, the stopper element is preferably at least partially elastically shaped and / or configured to seal against the inner wall and / or an insert sleeve along a wrap-around portion of the sealing zone. This wrap-around portion is oriented in the correct assembly position within a drug container and seals against the inner wall of the drug container and / or an insert sleeve.That is, the medicine container is sealed axially, in particular, by the airtight support of the stopper element and / or the stopper device on an internal wall of the medicine container, so that at least one chamber of the medicine container configured to receive a substance is delimited axially, preferably proximally. The term "medication container" herein refers specifically to a syringe, carpule, ampoule, and / or injection vial. Such medication containers, particularly syringes and carpules, are configured as a single-chamber system or as a multi-chamber system, specifically as a double-chamber system. rorp Ln / nznz / E / Yi The stopper device and / or the stopper element, preferably, can be inserted at least partially, and more preferably, completely, into the medication container. In the inserted state, i.e., in a correctly assembled position within the medication container, the stopper element can be moved along its central axis, preferably by means of a plunger rod and / or an ejection device. The retaining element in the retention region is preferably configured as a single piece with the plug element. The retaining element preferably comprises an elastic section in the radial direction, such that the closure element—in its first functional state—is retained by radial retaining forces. The retaining element and the plug element are preferably made of an elastic material, in particular rubber and / or soft plastic. The locking element is retained in the first functional state, preferably in such a position that displacement of the plug element is not possible without simultaneous displacement of the locking element. That is, preferably there is mechanical contact between the plug element and the locking element, at least in the first functional state of the plug device. According to an improvement of the invention, in the first functional state the cavity is rheologically sealed against a wall, specifically an inner wall of the medication container. This prevents contact with a silicone-coated surface and ensures high safety for the substance stored in the cavity. The cavity is preferably delimited—in the first functional state—only by the closure element and the stopper element, and is formed by these. It is specifically provided that the cavity is formed by a notch in the stopper element and / or the closure element, and that the cavity can be closed by means of the closure element, in particular, being closed in the first functional state. That is, the closure element seals the cavity, so that a substance stored within it is rheologically sealed from the environment, specifically from the medication container. In particular, a rheological seal is created with respect to the inner wall of a medication container—with the correct assembly position in the medication container. Therefore, even without a medication container, a sealed cavity has been created for the safe storage of a substance. According to an improvement of the invention, the cavity is provided to be open in a second functional state, and the closing element is not held in the retaining position by the retaining means. It is therefore possible to open the cavity and mix a first substance stored within it with a second substance stored in a chamber of a medication container. In the correct assembly position of the stopper device in the medication container, the cavity is open in the second functional state, particularly with respect to the chamber of the medication container, and a rheological connection exists between the cavity and the chamber in which, preferably, the second substance is stored. A simple and safe mixing of two substances, in particular the first and second substances, can therefore be carried out in a medication container comprising such a stopper device. Alternatively, however, it is also possible that the plug element is not completely released by the retention means in the second functional state, but remains retained, instead of it, at least partly in the plug element, in particular, in the retention region, although the closing element then no longer obstructs the cavity, so that there is a rheological connection outside the cavity, in particular, to the chamber of the drug container. Alternatively or additionally, it is anticipated that even when not inserted into the medication container of the stopper device, the closure element in its first functional state will remain stationary relative to the stopper element. The stopper device can therefore be used flexibly, and no medication container is required for the safe storage of the first substance within the stopper device. Preferably, the stopper element of the stopper device is configured as an end stopper for a medication container, the stopper device and—at least in the first functional state—the stopper element being arranged at the end, specifically the proximal end of a chamber of the medication container. An end stopper arranged at the end is understood to mean, in particular, a stopper that seals the medication container, all substances, particularly medicinal substances, contained within the medication container, and / or all chambers configured for this purpose, arranged distally from the stopper. Proximal to the end stopper, however, no chambers or zones configured to securely store any substance, particularly any medicinal substance, are provided.Such an end plug thus separates an aseptic region provided distal to the end plug from a region provided proximal to the end plug that is subject only to minor cleaning requirements, in particular, none. According to an improvement of the invention, the closing element is configured as a mixing body, specifically as a sphere for the medication container, and / or is freely movable in the second functional state, particularly independently of the stopper element. In the second functional state, the spherical closing element is freely positioned within the medication container. This enhances the mixing of the first substance with the second substance by shaking the medication container, while the mixing body creates additional turbulence within the container. According to an improvement of the invention, the stopper element—in its first functional state—is provided to have, on the side facing the closure element, an ejection protrusion that is oriented at least partially in the direction of the closure element. The ejection protrusion may be elastically formed, at least in a longitudinal direction along a central axis when in the correct assembly position in a drug container, but it is configured to be sufficiently stable so that the closure element can be displaced by the ejection protrusion from the retention position, in which the cavity is hermetically sealed, in an axial direction, particularly in the distal direction of the drug container, overcoming the retention forces generated by the retention medium.An axial resistance force, i.e., the resistance of the ejection protrusion acting against an axial deformation of the ejection protrusion, is therefore greater than the retention force generated by the retention medium. The axial force required to release the locking element from the retained position, in particular, in the distal direction, is preferably generated by a plunger rod and manual pressure on the plunger rod. The ejection protrusion preferably extends distally. The locking element can therefore be easily displaced from the retained position, and the stopper device can then be moved to the second functional state. The cavity and the substance contained within it, and—in a correctly assembled position in a medication container—the chamber of the medication container and the second substance stored therein, are at all times rheologically sealed, in particular, sterile with respect to the environment of the medication container, in particular, sealed by means of a closing cap. It is preferable that the ejection protrusion be arranged concentrically—in the case of a correctly positioned, rotationally symmetric, and in particular, essentially cylindrical, medication container—with respect to the longitudinal axis of the medication container. The forces that must be applied distally are therefore minimal, and the seal between the stopper device and an inner wall of the medication container is particularly good thanks to the symmetry thus created. An outer wall of the stopper element is preferably offset radially inward compared to an outer wall in the sealing region, so that—in the case of correct assembly in a medication container—a circumferential clearance is formed between the stopper element and the inner wall of the medication container for the deflection of the retaining medium. This clearance simplifies the release of the closure element from the sealing region, since the stopper element material requires less compression and only deformation within the clearance space. According to an improvement of the invention, the ejection protrusion is provided to rest on the closing element—at least in the discharge state of the stopper device, but preferably also in the first functional state—with one side, one tip, and / or one front face oriented toward the closing element. The discharge state thus designates the state of the stopper device in which the closing element is still in the first functional state, but would change, with minimal force applied distally to the stopper device and pressure from the ejection protrusion on the closing element, directly to the second functional state. The discharge state is therefore the boundary state between the first and second functional states.The forces that have to be applied in the distal direction are therefore minimal, and the release of the closing element from the retention region is carried out in a particularly controlled manner. According to an improvement of the invention, it is anticipated that the closing element has at least a first locking means and that the retaining means of the stopper device has at least a second locking means, formed correspondingly to the first locking means and arranged in the retaining region on one side of the stopper element facing the closing element, and that the first locking means and the second locking means—in the first functional state—engage by locking. The closing element is thus securely retained in the stopper element. The closure element preferably has at least one locking receptacle, in particular, a circumferential annular locking groove, and the retention means of the stopper device has at least one locking lug formed corresponding to the locking receptacle, which is disposed in the retention region on one side of the stopper element that is oriented toward the stopper element, the locking lug engaging—in the first functional state—within the locking receptacle. In this case, then, the first locking means is formed as a locking receptacle and the second locking means as a locking lug. The locking receptacle is formed—in the correct assembly position of the stopper device in the drug container—circumferentially around a central axis of the drug container.The locking element is therefore held in the retained position in a particularly reliable manner. Alternatively, the first locking mechanism can be configured as a locking lug and the second locking mechanism as a locking receptacle, such that the locking mechanism has the locking receptacle and the locking element has the locking lug. In this case as well, the locking element is securely held in the locked position. According to an improvement of the invention, the stopper device comprises an insert sleeve that encloses the stopper element, particularly in the circumferential direction, and an outer side of a sleeve wall is preferably configured for a leak-proof fit against an inner wall of the drug container. The stopper element is leak-proof against an inner side of the sleeve wall opposite the outer side. The insert sleeve is preferably formed with rotational symmetry, particularly from at least cylindrical sections. The sleeve wall has a finite thickness in the radial direction, such that at the distal end of the insert sleeve, in the correct assembly position of the stopper device in the drug container, a recessed region is formed that widens radially.The retaining region of the plug device is preferably under inward radial preload when inserted into the insert sleeve, as the retaining region is radially compressed by the insert sleeve. After the retaining region moves to this recoil region, it is under a lower, preferably relaxed, preload. The retaining region thus widens in the radial direction, and the closing element is no longer retained. In particular, the locking lug is released in this displacement position of the plug element and the retaining region from the locking receptacle, thereby eliminating the positive locking effect formed on the plug element.This creates a particularly simple actuation release mechanism for the closing element, with the help of which two substances can be mixed, in particular also in a medicine container formed with cylindrical symmetry without deviation, only requiring that the stopper element be moved distally. The insert sleeve of the stopper device preferably has a wedge-shaped configuration at its distal end, particularly in the recoil region, and includes a sliding bevel for the stopper element, so that the radial expansion in the recoil region is smooth and uniform. This simplifies the production of the stopper device, in which the closing element is moved to a first functional position associated with the first functional state. This also improves safety, particularly regarding the sealing of the cavity and / or chamber of the medication container, as well as the handling during mixing and / or dispensing of the mixed substances. According to an improvement of the invention, the insert sleeve is configured as a finger support and has at its proximal end at least one radially projecting finger plate, configured to be accessible from the rear for a finger. The finger plate is preferably configured to completely surround a central axis or is divided into at least two individual, opposing plates. Importantly, the finger plate projects radially, particularly from an outer wall of a medication container in which the stopper device is disposed, so that it is accessible from the rear and thus simplifies handling of the medication container. According to an improvement of the invention, the insert sleeve has a fixing structure for securing it to a medication container. This fixing structure preferably includes a receptacle for the medication container, into which the container can be inserted by latching and / or tightening its proximal end, particularly by radial lubrication of the proximal end of the medication container. The fixing structure preferably consists of a notch extending axially around the central axis, open distally, into which the proximal end of the medication container can be inserted and secured by latching and / or tightening. The stopper device can thus be easily and quickly attached to a medication container. The stopper element, in particular the retaining means, is disposed in the retention region, preferably in the correct assembly position within a medication container, at a distance from an inner wall of the medication container and / or an inner side of the insert sleeve. It is therefore possible for the retaining means to separate radially, particularly under the effect of a force on the stopper element, thereby releasing the closure element. The objective is achieved, in particular, also because a drug container is created with a basic body, preferably cylindrical, consisting, in particular, of glass, and having a stopper device according to one of the preceding claims, and because the stopper device is arranged offset within the drug container such that the stopper element seals a proximal end of the drug container with respect to a chamber of the basic body, in particular, in a leak-proof manner, and because the chamber is delimited radially by an inner wall of the basic body and distally by a closable discharge opening of the basic body and / or by a closing cap. The chamber is also preferably configured with rotational symmetry, essentially in a cylindrical shape.The chamber is provided in a distal direction of the drug container, viewed from the stopper device, and is designed for the reception of a medicinal substance, in particular, a medicinal active ingredient and / or adjuvant, with a very particular preference, a solvent for a powdered drug. A closed, sterile volume is preferably formed by the chamber for receiving the second substance. In the second functional state of the stopper device, the closing element is loosely arranged within this chamber. The closing element is preferably larger than the discharge opening of the main body, so that it cannot be displaced out of the chamber through the discharge opening. In other words, the closing element is configured as a mixing body. rorp Ln / nznz / E / Yi According to an improvement of the invention, the discharge opening of the basic body is provided to have a geometry, at least on its side facing the chamber, in particular, a cross-section, which differs in such a way from the side facing the discharge opening, in particular, from each side of the closing element, that a rheologically airtight closure of the discharge opening by the closing element is prevented. The closing element here is preferably round, in particular, spherical. This prevents the discharge opening from being blocked by the closing element in the second functional state. The closing element is unsuitable, in particular, for rheologically sealing the discharge opening, such that the closing element cannot prevent the discharge of the first and / or second substance from the medication container, particularly in the second functional state. A radial expansion of the non-round geometry is preferably larger than a radial extension of one side of the closure element suitable for support at the discharge opening. The closure element alternatively or additionally has on its outer surface a curvature that differs from a curvature of the floor wall of the medication container that includes the discharge opening. If the locking element comprises latching receptacles, the locking element is round, except for these latching recesses, and in particular, spherical. Specifically, the annular latching groove is arranged at the equator of the spherical locking element, with an upper hemispherical section of the locking element separated by the latching groove from a lower hemispherical section. The closing cap is preferably positioned distally on the main body to seal the discharge opening. Here, a closing cap is understood to be an element that seals the chamber, and in particular, a closed injection device. In the cavity of the stopper device, a first substance is disposed here, a second substance being disposed in the chamber of the medicine container, both substances being intended for mixing and the time of mixing being selectable by a user, since the two substances are disposed in volumes rheologically sealed to each other, namely, in the chamber of the medicine container and in the cavity of the stopper device, the seal between the chamber and the cavity being removable by the user by applying pressure to the stopper device. The medication container preferably has a finger rest which, during the dispensing of the active substances from the container, is capable of generating sufficient force on an ejection device, in particular, a plunger rod. The finger rest is formed as a single piece with the main body or—if the stopper device is arranged in an insert sleeve that has the finger rest—separately from the main body. In both cases, however, the finger rest is fixedly attached to the main body, so that the dispensing is carried out in the same manner in both embodiments, in particular, the dispensing of one or both substances from the medication container. According to an improvement of the invention, an ejection device, in particular a plunger rod, is provided, with a convex protrusion, particularly spherical, conical, and / or conical, at the distal end of the ejection device. The distal end here refers to the end of the ejection device facing the stopper device, which acts directly on the end, particularly the proximal end, of the stopper device when dispensing the substances from the medication container. The protrusion is preferably centered with respect to the central axis of the medication container, such that the ejection device applies maximum force to the stopper device in its central region when acting upon it. According to an improvement of the invention, the plug element is configured elastically, deformable by means of the ejection device's protrusion through the application of pressure, particularly manual pressure applied distally to the ejection device. The ejection protrusion of the plug element has axial resistance greater than that required to release the closure element. This axial resistance is determined by the plug element's structural configuration and / or material. The ejection protrusion is configured for this purpose, specifically in a conical shape. This allows for easy release of the closure element from the retention region. Here, strength refers specifically to mechanical resistance that prevents elastic and / or plastic material failure. This strength can preferably be quantified as mechanical stress, specifically as pressure or force, and can preferably be calculated as a pressure. In this case, the axial strength is preferably greater than the pressure required to release the locking element. The strength of the ejection protrusion thus prevents, in particular, elastic and / or plastic deformation of the ejection protrusion. The objective is achieved, in particular, also because a method is created for mixing two substances, stored rheologically separate from each other in a drug container, in particular, according to one of the embodiments described above, with a stopper device, in particular, according to one of the embodiments described above, wherein the first of the two substances is disposed in the cavity of the stopper device and a second of the two substances in the chamber of the base body, wherein the stopper device is loaded in the distal direction with a force, the rheological separation of the two substances from each other is eliminated, the stopper device, in particular, the stopper element is deformed in the retention region due to the application of a distal force at least partially sufficient, in particular, in the radial direction.so that the closing element moves out of its retained position. It is particularly advantageous in this respect that the application of force and the resulting deformation and / or displacement are sufficient to remove the rheological barrier between the first and second substances, allowing the two substances to be mixed easily and safely. Furthermore, the advantages already mentioned in relation to the examples of the medicine container and the stopper device are obtained. In particular, a method is created for mixing two substances stored rheologically separated from each other in a drug container, specifically according to one of the embodiments described above, using a stopper device, wherein the first of the two substances is disposed in the cavity of the stopper device and the second of the two substances in the chamber of the base body, wherein the stopper device is loaded distally with pressure, specifically a finger pressure, eliminating the rheological separation of the two substances, and the stopper device, specifically the stopper element, is deformed in the retention region due to the application of distal pressure, at least partially sufficient, specifically in the radial direction.so that the closing element moves out of its retained position. A particularly advantageous feature here is that displacement of the stopper device and / or the stopper element to open the cavity, and thus to mix the substance, is neither necessary nor, in fact, required. Simply applying pressure and the resulting deformation is sufficient to eliminate the rheological seal between the first and second substances. In this way, mixing can be easily performed in a medication container, particularly in a syringe or carpule with a closed dispensing opening, but also in an injection vial or ampoule with a similar stopper device, thus avoiding large pressure fluctuations within the containers. The plug element then deforms, preferably at its proximal end, particularly due to the action of the ejection device's protrusion on the plug. Thanks to the elastic deformation and the conical, or conical, shape of the protrusion, the retention region of the plug element widens radially, releasing the closure element held by the retention mechanism. To allow the retention region to widen sufficiently in the radial direction, it is preferable that the stopper device—in its correct assembly position within the medication container—does not rest directly against an inner wall of the container. Instead, a gap is provided between the inner wall of the medication container and an outer wall of the stopper element within the retention region. The stopper element, particularly the retention mechanism, is pushed into this gap to release the closure element. As already explained in the context of the medicine container, the closing element in the retained position closes the cavity and the cavity is sealed, in particular, with respect to the chamber of the medicine container. In particular, a method is created for mixing two substances, stored rheologically separate from each other in a drug container, in particular, according to one of the embodiments described above, with a stopper device, in particular, according to one of the embodiments described above, wherein the first of the two substances is disposed in the cavity of the stopper device and a second of the two substances in the chamber of the base body, wherein the stopper device is displaced in the distal direction, the rheological separation of the two substances from each other is eliminated, the retention region is radially relaxed during the distal displacement of the stopper device and the retention of the closing element in the retention position is released.The retention region of the plug device, in particular the plug element, is preferably under radial preload by being compressed in the retention region relative to a relaxed position. In a relaxation region, specifically the recoil region at the distal end of the insert sleeve, which has an enlarged internal radius relative to the insert sleeve—after the plug element has moved into this region—the retention region relaxes. The closing element can thus be easily displaced from the retention region, and the cavity can be opened in this way. Relaxation, in particular, is understood to mean a widening deformation of the plug device under preload, particularly of the plug element in the retention region. It is anticipated, in particular, that in a method according to one of the modalities described above, the medication container will be shaken after opening the cavity, that is, after moving the stopper device to the second functional state. This improves the mixing of the two substances. According to an improvement of the invention, the stopper device is displaced, using one of the methods described above, within the medication container for the complete discharge of the first and / or second substance, particularly a medication, to a distal final position. The closure element is preferably housed in this final position entirely within the cavity, and / or the cavity is completely filled by the closure element. A distal final position is understood here to mean, in particular, a position of the stopper element at the distal end of the chamber of the basic body, with the stopper element resting, in particular, on the discharge opening. In this way, the dead volume is minimized when using a medication container of the type described herein, particularly when performing the method described herein. The descriptions of the method, the stopper device, and the drug container should be understood as complementary. In particular, the characteristics of the stopper device and / or the drug container that are explicitly or implicitly described in the context of the method are, preferably individually or in combination, characteristics of the stopper device and / or the drug container. The stopper device and / or the drug container are preferably configured for the execution of at least one step of the method described in the context of the method. The steps of the method that are explicitly or implicitly described in the context of the stopper device and the drug container are steps of a preferred modality of the method, preferably individually or in combination.The method, in particular, preferably includes at least one step resulting from at least one feature of the stopper device and / or the medicine container. It is shown, in general, that the mixing of two substances in a medication container is improved by the stopper device, the medication container, and the method described herein. Handling is also improved, particularly during a production process, since filling the cavity with the first substance can be carried out independently of filling the medication container with the second substance. In particular, the cavity of the stopper device is rheologically sealed even without a medication container, so that a substance stored in it is, on the one hand, securely stored even without a medication container and, on the other hand—in the correct assembly position of the stopper device in the medication container—cannot come into contact with a silicone-coated inner wall of the medication container.This enables, in particular, the aseptic packaging of powder in a double-chamber system using the described stopper device, the described drug container, and the described method, even in a previously silicone-coated drug container, ensuring the safety and chemical stability of the packaged powder. Furthermore, the shelf life of the substances is increased in the described stopper device, drug container, and method. BRIEF DESCRIPTION OF THE FIGURES The invention is explained in more detail below with reference to the figures. These show: Figure 1: A longitudinal section of a plug device according to a first embodiment, Figure 2 shows a longitudinal section of a plug device according to a second embodiment, Figure 3 shows a longitudinal section of a medicine container according to a first embodiment with a stopper device according to the second embodiment. Figure 4 shows a longitudinal section of a plug device according to a third embodiment, Figure 5 shows a longitudinal section of a medicine container according to a second embodiment with a stopper device according to the third embodiment in a first functional state. Figure 6 shows a longitudinal section of a medicine container according to a second embodiment with a stopper device according to the third embodiment in a second functional state, and Figure 7 shows a longitudinal section of a medicine container according to a second embodiment with a stopper device according to the third embodiment in a final position of the stopper device in the medicine container. DETAILED DESCRIPTION OF THE INVENTION Figure 1 shows a stopper device 1 in a longitudinal sectional representation, having a stopper element 3, a retaining means 5, and a closing element 7. The stopper element 3 has a sealing region 9, where an envelope 11 of the stopper element 3 is configured to seal. In the sealing region 9, the stopper element 3 is supported in a particularly tight manner against an inner side 13 of an insert sleeve 15, such that, after assembly of the stopper device 1 in a drug container (not shown here), the drug container is axially sealed. The stopper device 1 shown here is configured with rotational symmetry about a rotation axis A. In a correctly assembled position in a drug container, the rotation axis coincides with a central axis of the drug container.The insert sleeve 15 then envelops the plug element 3 in the circumferential direction about the rotation axis A and is supported radially in a watertight manner by the plug element 3. The insert sleeve 15 has at its proximal end, upper in Figure 1, a finger plate 19 surrounding a proximal opening 17. With the help of this finger plate 19, the stopper device 1 and / or a drug container can be used, in particular, to apply a force in the distal direction on the stopper element 3. At its distal end, lower in Figure 1, the insert sleeve 15 has a recoil region 21, and the ends of the insert sleeve 15 are configured in a wedge shape in the longitudinal section through the stopper device 1 shown here, in particular, as a sliding bevel. The retaining means 5 is provided, presently, in a retaining region 23 of the rorp Ln / nznz / E / Yi plug device 1, the retaining region 23 being formed in the axial section, lower in figure 1, of the plug element 3. In this retaining region 23 the elastically configured plug element 3 is compressed from a relaxed position, so that the retaining means 5 is under radial preload. The stopper element 3 is displaceable along the axis of rotation - i.e., up and / or down in Figure 1 - in the insertion sleeve 15. After inserting the stopper device 1 into the drug container not shown here, the stopper element 3 can be displaced, in particular down, in a distal direction, and the drug container is sealed in all axial displacement positions by means of the stopper device 1, in particular, the stopper element 3 and the insertion sleeve 15. The plug device 1 is shown in Figure 1 in a first functional state, and the closing element 7 is detachably retained by the retaining means 5 in a stationary position relative to the plug element 3 in a retained position. In the embodiment shown herein, the closing element 7 is retained by force, and the retaining means 5 applies a radially inward force K to the closing element 7, specifically from all sides, due to its rotationally symmetric configuration. The closing element 7, which is currently configured as a sphere 25, is then pressed into a lower opening 27 distal to the plug element 3. The lower opening 27, distal to the stopper element 3, is rheologically sealed by the closure element 7. A cavity 29 is thus formed between the closure element 7 and the stopper element 3, in which a first substance 31, specifically a powdered medicament, has been placed. This creates a rheologically sealed cavity 29 where the first substance 31 can be safely stored without requiring a separate medicament container to achieve the rheological seal. As shown in Figure 1, the locking element 7 does not project beyond a lower, distal end of the insert sleeve 15, so that the locking element 7 is protected against unintentional displacement, in particular in the direction of the cavity 29, or against any other disruptive displacement that could compromise the tightness of the cavity 29. The first substance 31 can therefore be safely stored in this stopper device 1 and can be mounted at a later arbitrary time in a drug container. Figure 2 shows a plug device 1 in a side-section representation according to a second embodiment. The plug device 1 is shown here, in particular, in a second functional state in which the closing element 7 is not held in the retaining position by the retaining means 5. Identical parts or parts having the same function are provided with the same reference symbols, so that reference is made to the description of the preceding figures. Unlike the embodiment shown in Figure 1, cavity 29 is open in Figure 2. The closing element 7 is not held in the retaining position by the retaining means 5. The first substance 31 disposed in cavity 29 can therefore escape from cavity 29. The plug element 3 here has—as in Figure 1—the obturation region 9 and the retention region 23. It is also foreseen in Figure 2 that the retention region 23, in the first functional state, which is not shown here, is under radial preload inwards, so that the closing element 7 is pressed into the lower opening 27, distal to the plug element 3. By displacing the plug element 3 to the second functional state, shown here, a part of the plug element 3, in particular the retention region 23, has been displaced outwards from the insert sleeve 15, so that the plug element 3 can relax radially outwards in the retention region 23, and with it also the retention means 5. Thanks to the radial relaxation, the retention forces K on the closing element 7 decrease, and the closing element 7 is no longer retained in the retention position. In addition to the retention mechanism described above, which is implemented exactly as in the first embodiment shown in Figure 1, Figure 2 provides a latching receptacle 33 in the locking element 7. This latching receptacle 33 is formed, in particular, by an equatorially circumferential latching groove 35. Corresponding to this latching groove 35, the retention means 5 is provided to have a latching projection 37 that extends around the lower, distal opening 27 and engages—in the first functional state—in a positive connection with the latching groove 35. This creates an additional locking mechanism to retain the locking element 7 in the locked position. In order to release the locking element 7 from the retaining position, in the second embodiment of the plug device 1, shown in Figure 2, it is necessary that the retaining region 23 be compressed in the first functional state by at least the same distance as the length of the locking lug 37. The length of the locking lug here refers, in particular, to the radial extension of the locking lug. This ensures that the restoring force resulting from the preload radially expands the retaining element 5, in particular the locking lug 37, at least sufficiently so that the locking lug 37 is no longer engaged in the locking groove 35. Preferably, the wall thickness 39 of the insert sleeve 15 is also provided to be equal to or thicker than the length of the locking lug 37.This ensures that the retention region 23 - in a correct assembly position in a medicine container with a cylindrical interior - can be relaxed sufficiently to dissolve the positive bond between the interlocking groove 35 and the interlocking shoulder 37. Figure 2 also shows that the insert sleeve 15 has a fixing structure 41 for securing the insert sleeve 15 to a medication container. This fixing structure 41 has a receptacle 43 for a medication container, into which the medication container can be inserted by snapping and / or tightening its proximal end. The stopper device 1 can therefore be easily attached to the medication container, in particular, by snapping it into place. The stopper device 1 can be alternatively or additionally connected to the medication container by means of the fixing structure 41; in particular, it can be glued and / or welded onto or into the medication container, thus ensuring particularly reliable sterility inside the medication container. The receptacle 43 shown in Figure 2 extends in the direction of the central axis only over a small section of the insert sleeve 15. In an alternative embodiment, not shown here, the receptacle 43 preferably extends over the entire axial length of the insert sleeve 15. This is achieved in the alternative embodiment, not shown here, preferably such that an outer wall 44 of the receptacle 43 extends, in particular, parallel to the inner side 13 of the insert sleeve 15 over the entire axial length of the insert sleeve 15. The outer wall 44 of the receptacle 43 preferably extends—in the first functional state—over the entire axial length of the locking element 7, preferably beyond it in the distal direction.An additional seal can thus be established, in particular, between the outer wall 44 of the receptacle 43 and an external wall of the medicine container, thereby increasing the sterility and safety of the medicine container. Figure 3 shows a medicine container 45 with a stopper device 1 according to the embodiment described in Figure 2. The medicine container 45 has a cylindrical body 47 and a proximal end 49. A chamber 51 of the medicine container 45, configured for receiving a medicinal substance, is delimited by an inner wall 53, in particular coated with silicone, of the body 47, the stopper device 1, and—in the distal direction—by a distal discharge opening 55. The distal discharge opening 55 is closed, as shown in Figure 3, by means of a closing cap 57. A second substance 59, in particular a solvent for the powdered medicine, is disposed in the chamber 51. With the stopper device 1 correctly installed in the medicine container 45, the rotation axis A of the stopper device 1 coincides with a central axis M of the medicine container 45, the stopper element 3 being displaceable along the central axis A, in particular, in the distal direction. For the sake of clarity, the interlocking structures shown in Figure 2, namely the interlocking groove 35 and the interlocking shoulder 37, are not shown here in Figure 3; however, they are provided for. The retention forces K are also provided for here, but are not indicated either for the sake of clarity. The stopper device 1 is here in its first functional state, such that cavity 29 is hermetically sealed. The first substance 31, disposed in cavity 29, is rheologically isolated from chamber 51, from the second substance 59 disposed in it, and also from the inner wall 53, in particular the silicone-coated wall, of the drug container 45. A reaction between the silicone and the first substance 31 is therefore prevented. The discharge opening 55 of the basic body 47 has, on the side facing the chamber 51, a geometry that differs from the shape of the closing element 7. This geometry is achieved here, in particular, by a non-round cross-section 60, so that the spherical closing element 7—except for the latching groove 35—cannot bear against the discharge opening 55 with a sealing effect, and the discharge opening 55 therefore remains open from the inside on its side facing the chamber 51. The cross-section 60 is preferably configured, at least in part, in the shape of a cross. Figure 4 shows a plug device 1 in a side sectional representation according to a third embodiment. Identical parts or parts having the same function are provided with the same reference symbols, so that reference is made to the preceding figure description. The plug device 1 depicted here does not have any insertion sleeve 19, unlike the first and second embodiments of the plug device 1. Similar to the embodiments of the stopper device 1 described above, the third embodiment of the stopper device 1 shown in Figure 4 also has a stopper element 3 configured to seal a drug container 45 in an axial direction. The stopper device 1 shown here can be inserted, in particular, completely into a drug container 45, with the stopper element 3, in this case the complete stopper device 1, being configured to be movable along the central axis M within the drug container 45. The stopper device 1 comprises a retention region 23 with a retention means 5 and a sealing region 9 comprising a plurality of envelopes 11 of the stopper element 3. Each of the plurality of envelopes 11 is preferably configured to rest - in a correct assembly position of the stopper device 1 in the drug container 45 - with a sealing effect on an inner wall 53 of the drug container 45. The retaining means 5 retains a closing element 7 in a retained position. The closing element 7, which is formed as a sphere 25, is retained directly in the plug element 3. Between the closing element 7 and the plug element 3 a cavity 29 is formed which, in figure 4, appears to be bipartite because of the side sectional representation, but which is a contiguous annular cavity 29, given the rotational symmetry about the rotation axis A. The retention means 5 holds the closing element 7 in the retained position, specifically under force, since retention forces K originating from the retention region 23 of the plug element 3 act radially inwards and thereby press the closing element 7 into a lower, distal opening 27. This also ensures, in the retention region 23, the tight fit of the plug element 3 against the closing element 7 and thus the sealing of the cavity 29. In addition to this clamping effect of the retaining means 5, it is provided in the embodiment of the plug device 1, represented in Figure 4, that the retaining region 23 of the plug element 3 - in the first functional state represented herein - extends at least partially beyond an equator 61 of the sphere 25 in a distal direction and that the retaining region 23 rests on the closing element 7, so that the closing element 7 is held in the distal direction by the retaining means 5. The closing element is therefore also retained in a positive connection. By an equator 61 is meant in particular, a circumferential line closed around the closing element 7 enclosing a surface that is perpendicular to the rotation axis A and having a radius that corresponds to the radius of the closing element 7, the radius with respect to the longitudinal extension of the central axis being maximum at least locally, preferably globally. The plug element 3 has -unlike the two embodiments described above in figures 1, 2 and 3- on its side facing the closing element 7 an ejection protrusion 63 oriented at least partially in the direction of the closing element 7. This ejection protrusion 63 projects in the form of a cone -in particular in the form of a truncated cone- from the plug element 3 and abuts a front face 65, in figure 4 below, of the release protrusion 63 with the closing element 7. The plug device 1 is therefore in an ejection state in which a minor deformation, in particular an axial action of the ejection protrusion 63 on the closing element 7, can cause the closing element 7 to be ejected from the retention position. Figures 5 to 7 show a medicine container 45 with a stopper device 1 according to the embodiment described in Figure 4, in which the stopper device 1 is arranged—in different functional states—in a correct assembly position in the medicine container. A method for mixing two substances, stored rheologically separate, namely a first substance 31 and a second substance 59, in the medicine container 45 is explained with reference to these figures. In Figure 5, the first substance 31 is rheologically sealed in the cavity 29 of the stopper device by the stopper element 3 and the closing element 7. The stopper device 1 shown in Figure 5 is therefore in the first functional state. To release the locking element 7 and thereby open the cavity 29, pressure is applied distally to the plug element 3, as shown in Figure 6. Due to the resulting deformation, particularly in the proximal region of the plug element 3, a distal end opens, and consequently, the lower opening 27, distal to the plug element 3, opens radially outward. This removes, on the one hand, the forceful connection caused by the retaining means 5 and, on the other hand, the positive connection caused by clamping beyond the equator 61 of the locking element 7. Consequently, the locking element 7 is no longer held in the retaining position and is displaced from the retaining position by gravity and / or a jerking motion. The cavity 29 is now open, and the first substance 31 mixes with the second substance 59 as a result of the rheological opening of the cavity 29.The closing element 7 is configured here, in particular, as a mixing body that produces additional turbulence in the chamber 51 of the drug container 45 by shaking the drug container 45, which accelerates and / or improves mixing. It should be emphasized here that a displacement of the plug element 3 is not necessarily required to open cavity 29. Rather, the application of pressure in a distal direction is sufficient to cause an appropriate deformation of the plug element 3. The deformation of the stopper element 3 is caused in particular by an ejection device 67 configured as a plunger rod 69. A convex, spherically shaped protrusion 73 is provided at a distal end 71 of the ejection device 67. This protrusion 73 is configured with rotational symmetry about a central axis M of the drug container 45. The protrusion 73 is at its maximum at the center with respect to the central axis M. When pressure is applied to the stopper element 3 by means of the ejection device 67, the deformation is maximum in a central region in the immediate vicinity of the central axis M, such that the retaining means M opens in the retaining region 23 in a lever-like manner in at least two radial directions, preferably opposite each other, and particularly preferably ubiquitously in all radial directions. Figure 7 shows the medicine container 45 in a final position where the closure element 7 is almost entirely within the cavity 29, such that the cavity 29 is in turn almost completely filled by the closure element 7. A minimal amount of the first and / or second substance remains in chamber 51 of the medicine container 45. To this end, the stopper element 3, in particular the ejection protrusion 63, is elastically shaped, deforming in the final position so that the remaining volume 75 of cavity 29 is minimal. The ejection protrusion 63, however, has sufficient strength to displace the closing element 7 - as depicted in Figures 5 and 6 - against the retention forces K of the retention position, preferably reducing the retention forces K by a deformation of the plug element 3. It is shown in general terms that by means of such a stopper device 1 and such a drug container 45, a first substance 31, in particular unstable, is rheologically sealed, safely and without reaction, previously packaged in the stopper device 1, and that it can be mixed in the drug container 45, in particular, by means of such a method, with a second substance 59, the risk of a reaction, in particular, of an unintentional reaction with a silicone-coated inner wall 53 of the drug container 45 being minimal. Handling is also improved compared to conventional stopper devices 1 and / or drug containers 45, since the stopper device 1 can be pre-filled with the substance 31, independently of the drug container 45, and can eventually be packaged without requiring any drug container 45.Furthermore, in such a medicine container 45, the dead volume is minimized, that is, the remaining volume of the first substance 31 and / or the second substance 59 in chamber 51.

Claims

1. A stopper device for sealing a drug container, having a stopper element, the stopper device being configured to seal the drug container in an axial direction about a central axis of the drug container, the stopper device being at least partially insertable into the drug container, and the stopper element being configured to be displaceable along the central axis of the drug container in a correct assembly position in the drug container, characterized in that the stopper device comprises a retention region with at least one retention means, a closing element—in a first functional state of the stopper device—being retained separably, stationarily with respect to the stopper element, in particular, on the stopper element in a retention position,by means of the retaining means in such a way that a cavity is formed between the closing element, on the one hand, and the plug element, on the other hand.

2. The stopper device according to claim 1, further characterized in that in the first functional state the cavity is rheologically sealed with respect to a wall, in particular, an inner wall of the medicine container.

3. The plug device according to one of the preceding claims, further characterized in that the cavity is open in a second functional state, the closing element not being retained by the retention means in the retention position.

4. The stopper device according to one of the preceding claims, further characterized in that the closing element is configured as a mixing body for the medicine container and / or in that it is arranged - in the second functional state - freely movable in the medicine container.

5. The plug device according to one of the preceding claims, further characterized in that the plug element has - in the first functional state - on its side facing the closing element an ejection protrusion oriented at least partly in the direction of the closing element.

6. The plug device according to one of the preceding claims, further characterized in that the ejection protrusion - at least in an ejection state of the plug device - rests with a side and / or tip oriented towards the closing element on the closing element.

7. The stopper device according to one of the preceding claims, further characterized in that the closing element comprises at least a first locking means, the retaining means of the stopper device having at least a second locking means formed correspondingly to the first locking means, the second locking means being disposed in the retaining region on one side of the stopper element facing the closing element, the first locking means and the second locking means - in the first functional state - being mutually locked.

8. The stopper device according to one of the preceding claims, further characterized in that the stopper device comprises an insert sleeve enclosing the stopper element, an outer side of the sleeve wall being preferably configured for leak-proof support on an inner wall of the medicine container.

9. The plug device according to one of the preceding claims, further characterized in that the insert sleeve is configured as a finger support and comprises at a proximal end at least one radially projecting finger plate, which is formed accessible from behind for a finger.

10. The stopper device according to one of the preceding claims, further characterized in that the insertion sleeve comprises a fixing structure for fixing the insertion sleeve to the medicine container, the fixing structure preferably comprising a receptacle for the medicine container in which the medicine container can be housed with its proximal end by latching and / or tightening.

11. A medicine container having a basic body and a stopper device according to one of the preceding claims, the stopper device being arranged so that it can be moved within the medicine container such that the stopper element seals a proximal end of the medicine container relative to a chamber of the basic body, the chamber being bounded radially by an inner wall of the basic body and distally by a discharge opening of the basic body and / or by a closing cap.

12. The medicine container according to claim 11, further characterized in that the discharge opening of the basic body has at least on its side facing the chamber a geometry, in particular a cross-section in the shape of a cross, that differs from a side of the closing element facing the discharge opening in such a way as to prevent a rheologically airtight closure of the discharge opening by the closing element.

13. The medicine container according to claim 11 or 12, further characterized in that an ejection device is provided, a protrusion being provided at a distal end of the ejection device.

14. The medicine container according to any one of claims 11 to 13, further characterized in that the stopper element is configured in an elastic form, being deformable by means of the projection of the ejection device by applying pressure, in particular, manually in a distal direction on the ejection device, the ejection projection of the stopper element having a resistance in the axial direction that is greater than that corresponding to the pressure required for the ejection of the closure element.

15. A method for mixing two substances stored rheologically separated from each other in a medicament container according to any one of claims 11 to 14 with a stopper device according to any one of claims 1 to 10, the first of the two substances being disposed in the cavity of the stopper device and a second of the two substances in the chamber of the base body, the stopper element being loaded with a force in the distal direction, removing the rheological separation of the two substances, characterized in that the stopper device, in particular the stopper element, is deformed so much as, due to the application of distal force, at least in part, that the closing element is displaced from the retaining position.

16. The method according to claim 15, further characterized in that the plug element Ln / nznz / E / Yi is displaced in the distal direction, removing the rheological separation of the two substances, the retention region being radially relaxed during the distal displacement of the plug device and the retention of the closing element being released in the retention position.

17. The method according to claim 15 or 16, further characterized in that the medicine container 5 is shaken after the cavity is opened.

18. The method according to any one of claims 15 to 17, further characterized in that the stopper device is displaced to a final position for the complete discharge of the two substances into the medicine container, the closing element being housed in the final position in the cavity and the cavity being completely filled by the closing element.

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