EP3203972A1

EP3203972A1 - System and method for providing an injection

Info

Publication number: EP3203972A1
Application number: EP15774926.8A
Authority: EP
Inventors: Tilman Roedle
Original assignee: Vetter Pharma Fertigung GmbH and Co KG
Current assignee: Vetter Pharma Fertigung GmbH and Co KG
Priority date: 2014-10-08
Filing date: 2015-10-06
Publication date: 2017-08-16
Also published as: RU2704016C2; RU2017115841A; RU2017115841A3; WO2016055445A1; BR112017007299A2; CA2963449A1; MX2017004511A; JP2017530804A; US20170304525A1; DE102014220365A1

Abstract

The invention relates to a system (1) for providing an injection, comprising a first container (3), which is formed with a first cavity (5) and has a rigid outer wall (7) and two ends. A movable plug (11) is provided on one side of the first cavity (5), said plug sealingly closing the first cavity and being movable within the first container (3). The system also comprises a second container (21) which encloses a second cavity (23). One container contains a first substance, and the other container contains a second substance. The invention is characterized in that the second container (21) comprises a wall (35) which is elastic in at least some regions, and the second container thus encloses a variable volume; the second container (21) is designed such that a pressure can be built up in the interior of the second container (21) by means of the wall which is elastic in at least some regions; and the second container (21) is a tube.

Description

System and method for preparing an injection Description

The invention relates to a system for preparing an injection according to the preamble of claim 1, moreover a combination of a syringe or carpule with a tube according to claim 12 and a method for preparing an injection according to the preamble of claim 13.

Systems and methods of the type discussed here are known. They have a first container which is designed as a cylindrical body with a first cavity and, for example, represents a syringe or carpule. In this powdery substance, in particular a lyophilisate is present, which is a medicinal substance. This is used to inject a patient. For this it is necessary to dissolve the powdery substance. It is known to provide the first container with an injection cannula to aspirate a liquid from a second container having a second cavity and thus to dissolve the powdery substance present in the first cavity of the cylindrical body of the first container. The generated solution can then be administered to a patient. In conventional systems, the second container is made of glass or a solid clear plastic material. He is, as usually the first container, not completely filled and contains a volume of air. This makes it possible to transfer the solvent, also referred to as diluent, from the cavity of one container into the cavity of the other container in order to dissolve the powdery substance. It has been shown that when the powdery substance is difficult to dissolve, the solution process is time consuming. It can also happen that the powdery substance does not dissolve completely, which can lead to problems in the application or injection. Such systems are also known, which have a first and a second container, but, in contrast to the above, both containers have a liquid. To prepare for an injection, these two fluids must be mixed together. It is essential that the mixing of these liquids is complete, so that the constituents of both liquids are virtually homogeneously distributed before the mixture is applied. For some medicinal fluids, it has been found that their complete and homogeneous mixing is difficult to achieve. This is the case in particular with vaczines and vitamin preparations, for example. The object of the invention is therefore to provide a system which avoids this disadvantage.

To solve this problem, a system for preparing an injection is proposed, which has the features of claim 1. It comprises a first container enclosing a first cavity, which has a rigid outer wall and two ends, wherein on one side of the first cavity a movable plug is provided, which closes off this seal and is displaceable within the container. The system has a second container enclosing a second cavity. The system is characterized by a coupling device which has a first first coupling element provided on the first container and a second coupling element provided on the second container, and in that the two containers can be connected to one another by means of the coupling elements such that their cavities in fluid communication with each other. The system is further characterized in that the second container comprises a variable volume. By the fluid communication between the two cavities in the first and second containers, it is possible to mix the solid substance with the liquid. In this case, the variable volume of the second container contributes to the thorough mixing can take place very intensively.

The system proposed here is characterized in that the second container has an at least partially elastic wall, so that it comprises a variable volume. In this way, the system is set up so that the second container is expanded by introducing a gas and / or liquid volume, so that the wall addressed here is stretched elastically at least in some areas. Due to the inherent elasticity of the wall, the interior of the second container is under an internal pressure in such a way that a substance provided here can be discharged under pressure and thereby reaches the first container.

For mixing the two substances, the liquid substance present in the second container is transferred to the first container. It can flow completely into the first container, because the elastic outer wall of the second container is einwölbbar, so that the volume of the enclosed space in the second container can be reduced. If, therefore, the volume in the second container increases during the introduction of a liquid by widening of the partially elastic outer wall, this can, as stated, also become smaller. This results in a much better mixing of the two substances, as is the case with conventional systems. As a result, thorough mixing of the second substance expelled in the second container and from there with the first substance in the first container takes place. This applies both to the fact that a liquid or pulverulent substance is present in the first container, onto which the second substance from the second container impacts due to the overpressure built up by the at least one elastic wall region. So even if a powder is present in the second container, it is transferred by the overpressure into the first container and blown into a liquid.

The system explained here, in which the second container is designed as a tube, is characterized in that a cost-effective implementation is given. With tube here an element is addressed, which has a hollow, in particular tubular Grundkör- per, which is closed at one end. When realizing the tube made of a plastic material, the main body can be welded shut, be it by heat, frictional heat or by means of ultrasonic welding. Other materials and sealing methods can easily be used here.

The opposite other end of the base body is formed as a preferably integral lid thereof and has a closable opening, which is preferably surrounded by a preferably cylindrical approach. Preferably, the lid is somewhat more stable than the side walls of the main body. The cylindrical projection can preferably be provided with an external thread on which a screw cap with an internal thread is applied. Also conceivable are plug or squeeze closures. It is crucial that the production of tubes with today's known methods is simple and extremely cost-effective to implement, even if the outer wall of the tube is at least partially elastic and preferably realized opaque or transparent.

When configuring the cylindrical projection in the region of the cover with an external thread, it is very easily possible to couple the tube to the first container, for example by a threaded connection, and to realize a fluid connection between the inner chambers of the first container and the tube. In this case, the external thread of the tube can also be adapted to an internal thread of a Luer connection, so that the tube can readily be used with conventional syringes or the like.

A preferred embodiment of the system is characterized in that the first substance is a lyophilisate and the second substance is a diluent solvent for the lyophilisate. The fact that in this system the lyophilisate and the solvent are housed in separate cavities, results in a very good shelf life of the lyophilisate. Another embodiment of the system is characterized in that lyophilisate is contained in the first container and a solvent for the lyophilisate in the second container.

In a particularly preferred embodiment of the system it is provided that it is set up and designed such that, for an amount of a first substance in the first container, an amount of a second substance in the second container is provided to an amount of an injection solution for injection provide. It is thus possible to match the containers with the substances to be provided for an injection, so that the system is very easy to handle.

In particular, the volume of the first container is matched to the quantity of the first substance and / or the volume of the second container is matched to the quantity of the second substance. This results in the advantage that the system is very compact.

Particularly preferred is an embodiment of the system in which a number of containers are provided with different amounts of a substance. These containers may be combined with other containers containing different amounts of another substance, with a first container having a first substance and a second container being fluidly contacted with a second substance to mix the two substances together. Characteristic of this system is that the amount of the second substance is exactly matched to the amount of the first substance to provide an injection solution for injection. For example, liquids are provided in the two containers, wherein the amount in the first container is adapted to the amount in the second container such that exactly a certain mixing ratio of the two liquids is achieved. On the one hand, this is relevant in order to provide an injection solution of a specific concentration for an injection. On the other hand, this aspect is relevant to the fact that, for example, two liquids are mixed together, in which the proportions must be coordinated with each other for complete mixing. It is also possible to provide a certain amount of a first substance in a first container and to combine it with different containers in order to realize an injection solution with different concentrations. For example, in the first container may be a lyophilisate. In the second container at least as much liquid is provided as is required for dissolving or activating the lyophilisate. Moreover, when combining the first container with a second container of a larger amount of solvent, an injection solution of a different concentration can be produced from one amount of a lyophilisate.

The system designed in this way is also characterized in that lyophilisates of various types, ie first substances, are provided in a number of first containers, which differ in that they require different amounts of diluents, ie solvents, for complete dissolution. It is easily possible in the system described here to combine second containers with different quantities of diluents or solvents with the first containers with different lyophilizates. In this case, a second container with a certain amount of a diluent can be made available to a first container with a first lyophilisate in order to provide an injection solution. A container with a second lyophilisate may be supplied with a different amount of solvent by combining another second container with a larger or smaller amount of solvent.

The system defined here can thus be adapted in a simple manner to different cases of use, be it the use of different substances for administration to one Patients or to use injection solutions with different concentrations of the ingredients. In other words, a modular system of two containers is provided here so that the two containers have different substances and / or different volumes for receiving substances in order to provide a solution for injection in a simple and optimal manner.

The system described here is thus characterized by a flexible use possibility.

A particularly preferred embodiment of the system is characterized in that the first container is a syringe or carpule and the second container is a tube. This has an at least partially elastic outer wall, so that it can be expanded and contracted when mixing the two substances in the first and second cavity, so that reduces their internal volume. The system defined here is characterized in that a conventional one-chamber syringe or a one-chamber cartridge with a lyophilisate can be coupled in a simple manner with the second container in order to dissolve the lyophilisate.

Further exemplary embodiments emerge from the associated subclaims.

The object of the invention is also to provide a combination of a syringe or cartridge and a tube, which avoids this disadvantage.

To solve this problem, a combination of a syringe or carpule and at least one regionally elastic Created wall containing tube. This is characterized by the fact that given in the syringe or carpule volume and the volume given in the tube are coordinated so that the syringe can take a defined amount of a first substance and the tube a defined amount of a second substance. Due to the at least partially elastic wall, it is possible to press from the syringe or carpule at least a partial volume in the tube, and thus widen the wall against their given by the elasticity restoring forces. This results in the at least partially elastic wall contracting again after the introduction of a partial volume from the first container and introducing the second substance in the tube under pressure into the first container. As a result, a liquid encounters a powder or a liquid in the first container at high speed and with energy, so that the mixing of the substances to produce a solution for injection takes place optimally. By optimal is meant here a state in which a lyophilisate is dissolved completely and without residue by a solvent or that two liquids are mixed together so that the concentration of the two liquids in the entire volume of the resulting injection solution is the same. Here again it should be noted that from the tube also a powder can be sprayed into a liquid that is in the syringe or carpule. The object of the invention is also to provide a method which avoids this disadvantage.

To solve the problem, a method for preparing an injection by means of a system of the type described here is also proposed. It comprises the features of claim 13 and the following The first step involves first connecting the two containers via the coupling device in such a way that a fluid connection is realized. Then, the liquid substance is transferred to the solid, preferably powdery substance. This transfer process is very effective because it contains the liquid substance in the container, which has an at least partially elastic outer wall. For transferring the liquid substance into the cavity with the solid substance, the elastic outer wall area can be widened or drawn in, so that as much as possible of the liquid substance reaches the solid. In a further step, the substances in the containers are mixed by shaking and / or moving a plug provided in the one container. During the movement of the plug, it has a particularly advantageous effect that the second container comprises an outer wall that is at least partially elastic. By the elastic outer wall ensures that the movement of the plug in the second container no significant back pressure is built up, which could hinder the movement of the plug.

Particularly preferred is an embodiment of the method, which is characterized in that the fluid-tight coupling of the two containers, a Luer connector is used as a first coupling element which receives an external thread of a second coupling element.

Further preferred embodiments of the method emerge from the associated subclaims.

The invention will be explained in more detail below with reference to the drawing. Show it: Figure 1 shows a system for preparing an injection with a first and second container;

Figure 2 shows the system of claim 1 with coupled

Containers in a first functional position; Figures 3 to 5, the system in further functional positions.

FIG. 1 shows a system 1 for preparing an injection with a first container 3, which encloses a first cavity 5 and comprises a rigid outer wall 7. The first container 3 has two ends, wherein at a first end an opening 9 is provided, via which a movable in the first cavity 5 plug 1 1 is inserted. Via a piston rod 13, which is coupled to the plug 1 1, the plug 1 1 can be displaced in the interior of the first container along its longitudinal axis perpendicular thereto. The plug 1 1 is formed so that it bears sealingly against the inner surface of the outer wall 7, so that the cavity 5 is sealed off relative to the opening 9. At the opposite end of the opening 9 of the first container 3, a first coupling element 15 is attached. At this end, the first container 3 has a projection 16 on which the coupling element 15 is placed. The first container 3 is a syringe. In another exemplary embodiment of the container, a projection may be formed at the end present here with a cap which seals the cavity 5 of the container. The container can thus also be designed as a carpule, whereby a puncturable plug can be present at the end addressed here, but in particular it is also possible to connect a further container via a coupling element in order to obtain a fluid. idverbindung establish between this and the cavity 5 in the container. This will be discussed in more detail below.

The first container 3 contains a first substance, which is accommodated in the cavity 5. For example, the first substance is a powder, in particular a lyophilisate 17, ie a freeze-dried substance which is in powder form. Above the lyophilisate 17 is an air volume 19. However, the first substance may also be a liquid.

The system 1 shown here comprises a second container 21, which encloses a cavity 23. In this there is a second substance, for example a powder, if the first substance is a liquid, a liquid serving as a diluent, if the first substance is a powder, in particular a solvent 25, if the first substance is a lyophil - lisat is. Basically, it should be noted that in the two containers 3 and 21 different substances are present, preferably on the one hand a lyophilisate and on the other hand a solvent called diluent. In the exemplary embodiment of the system 1 shown here, it is assumed that the lyophilisate 17 is in the first container 3 and the solvent 25 is in the second container 21. But it is also possible to accommodate the lyophilisate 17 in the second container 21 and the solvent in the first container 3.

The second container 21 has at one, in this case the upper end, a closure 27 which seals the cavity 23 of the second container 21. At the end of the container 3 at the top in FIG. 1, a cap K is provided, which is held by the coupling element 15 and serves to seal the cavity 5 of the first container 3 tightly. In this way it is ensured that the substance accommodated in the hollow space 5, in this case the lyophilisate 17, is safely enclosed and a high storage life without contamination is ensured. The cap K is, as is known, preferably designed as a tamper-evident closure, so that manipulation of the cap for a user of the first container 3 is readily apparent.

In FIG. 1, therefore, the two containers 3 and 21 of the system 1 are separated from one another and sealed in each case, so that the substances introduced into the associated cavities 5 and 23 of the containers 3 and 21 are securely enclosed. If a substance enclosed in the containers 3 and 21, in this case the lyophilisate 17 in the first container 3, is to be administered to a patient, the lyophilisate 17 must be dissolved in preparation for an injection. This is done by the solvent 25 accommodated in the second container 21. In order to be able to dissolve the lyophilizate 17, the two containers s and 21 must be brought into fluid communication with one another. To make this possible, on the one hand the cap K must be removed from the first container 3 and the closure 27 from the second container 21. By removing the cap K, the first coupling element 15 on the first container 3 is accessible. This is preferably a Luer connection, which is placed on the projection 16 or molded onto the container 3 and has an internal thread. If the closure 27 is removed from the second container 21, a second coupling element, which can interact with the first coupling element 15 on the first container 3, is accessible at the end of the second container 21 associated with the closure 27. In the event that the first coupling element 15 is designed as a Luer connection, the second coupling element 29 is formed on the second container 21 as a cylindrical projection with an external thread, which cooperates with the internal thread in the Luer approach. This makes it possible to screw the second container 21 onto the first container 3, the first coupling element 15 receiving the second coupling element in a sealing manner. The two coupling elements thus form a coupling device 31, which ensures a tight fluid connection between the cavity 5 in the first container 3 and the cavity 23 of the second container 21. The end of the second container 21 may also be closed by means of a membrane, which is covered by the closure 27. This has the advantage that the contents of the second container immediately after removal of the closure 27, which may be formed, for example, as a screw, not yet freely accessible. Through the membrane protection against contamination of the contents or even against an unwanted escape of the same is guaranteed. After removing the closure 27, the membrane can be pierced and torn open, for example by the projection 16 at the end of the first container 3. In this way, a fluid connection between the two containers 3 and 21 is then realized.

FIG. 2 shows the system 1 with the two coupling devices 31 comprising the two coupling elements 15 and 29 with containers 3 and 21 coupled to one another in a first functional position. development. The same parts are provided with the same reference numerals, so that reference is made to the description of Figure 1 in order to avoid repetition.

The first functional position of the system 1 reproduced in FIG. 2 is characterized in that a fluid connection is established via the coupling device 31 between the cavity 5 in the first container 3 and the cavity 23 in the second container 21 shown here in longitudinal section, wherein the stopper 1 1 is in its initial position shown in Figure 1 in the first container 3. The plug 1 1 inside the first container is still in its initial position.

FIG. 3 shows the system 1 with the two containers 3 and 21 in a second functional position. The same parts are provided with the same reference numbers, so that reference is made to the preceding description.

In the second functional position according to FIG. 3, the plug 1 1 has been displaced upward from the position shown in FIGS. 1 and 2 according to the arrow 33 in the direction of the coupling device 31. Since the two containers 3 and 21 are in fluid communication, in an upward movement of the plug 1 1 apparent in Figures 1 and 2 air volume 19 is displaced in the first cavity 5 and enters the second cavity 23 of the second container 21st It is possible that air is in the second cavity 23 before use of the second container 21, as shown in Figure 2, but this is not absolutely necessary.

The second container 21 has a variable volume: It can be seen that the wall 35 of the second container 21 at least can expand in regions as soon as an overpressure in the second cavity 23 is established by the introduced air volume 19. FIG. 3 shows the second container 21 in the expanded state. Here, as can also be seen from FIGS. 1 and 2, the second container 21 is preferably designed as a tube which consists of an elastic, in particular opaque or transparent material, so that the substance present in the cavity 23, here the solvent 25, is visible. The material of the second container 21 is preferably designed so that its cavity 23 is protected from UV light. The wall 25 consists of a material which does not change during storage of the system 1 and which in particular does not change the substance 25 present in the cavity 23 during storage. It is preferably provided that the wall 35 is coated on its inner surface facing the cavity 23. It is also possible to realize the wall two- or multi-layered in order, inter alia, to reduce its permeability. Particularly preferred is an embodiment of the wall, in which the inner, the cavity 23 facing layer is resistant to the substance present in the cavity 23. The remaining material or the remaining layers of the wall 35 can / may then optionally consist of cheaper materials. Multi-layered walls can be realized by coating and also by multi-layer extrusion. In the functional position shown in FIG. 3, therefore, the volume of air 19 present in the cavity 5 has been displaced upwards in the direction of the coupling device 31 into the cavity 23 of the second container 21 by displacement of the plug 11, so that this expands and has a larger internal volume than is the case in the first functional position shown in FIG.

FIG. 4 shows a third functional position of the system 1. The same parts are provided with the same reference numerals, so that reference is made to the preceding description.

The illustration according to FIG. 4 shows that the plug 1 1 has been displaced downwards from its position shown in FIG. 3 by means of the piston rod 13 in the direction of the arrow 37, so that the solvent 25 present in the cavity 23 in the second container 21 is preferred completely enters the cavity 5 of the first container 3 and can mix with the existing there lyophilisate 17. Thus, a defined volume of liquid is supplied to the lyophilisate. In this way, a liquid present in the first container 3 can also be supplied to a second liquid present in the second container 21.

By the introduction of the volume of air 19, as stated, the second container 21 was widened, whereby its wall 35 was stretched. There was therefore an overpressure in the second container 21. If the plug 1 1 is now pulled downward in the direction of the arrow 37, a negative pressure is created in the cavity 5 in the first container 3, which draws the solvent 25 out of the second container 21. This encounters the lyophilisate 17 at high speed, because it is additionally injected by the positive pressure in the interior of the second container 21 into the first container 3. This leads to a very good mixing of the diluent with the powdery lyophilisate 17, or the two liquids, which may be present in the containers 3 and 21. The plug 1 1 is pulled from the position shown in Figure 4 preferably further down, but so that it is not pulled out of the first container 3. As a result, the substances given in the cavity 5 remain sealed, ie, safe from contamination.

Due to the further displacement of the plug 1 1 in the direction of arrow 37 down, so beyond the reproduced in Figure 4 position addition, air is sucked in from the second container 21, so that the lyophilisate 17 by shaking the two containers 3 and 21 easily in the first Cavity 5 can be resolved. It is also possible to displace the plug very slightly upwards, because the second container 21 has a variable volume and thus does not offer much resistance when the plug 1 1 is displaced in the direction of the coupling element 31. This ensures that optimum mixing of the substances, in particular therefore of the lyophilisate 17 and of the solvent 25, can take place in the first cavity 5 of the first container 3. A good mixing is also given, by the way, even if in the two containers 3 and 21 liquids are present, which are basically relatively difficult to dissolve. This is often the case with vaczines and vitamin supplements, for example.

Finally, FIG. 5 shows the first container 3 of the system 1 in a further functional position. The same parts are provided with the same reference numbers, so that reference is made to the preceding description.

From Figure 5 it can be seen that the second container 21 removed from the first container, so here is unscrewed. With the first th coupling element 15 is an injection needle 39 is connected, which is screwed via a known, having an external thread approach in the form here as Luer connection coupling element 15. The plug 1 1 is here in a position in which all air components are expelled from the cavity 5 and also preferably from the injection needle 39. So here's an injection ready for injection.

In the figures, it was assumed, as stated above, that the second container 3 is a syringe which can be coupled via a coupling element 15 to an injection needle 39.

It should be pointed out again, however, that the first container 3 can also be formed as a carpule, which can be coupled via a coupling device with a second container 21 to dissolve a present in or in the second container of the carpule lyophilisate by means of a solvent, which is in the other container. The carpule can then be used for example in an injection system called a pen or in an infusion device. After all, it is essential that the second container 21 at least partially has an elastic wall. It can ultimately be arbitrarily shaped, so for example, cylindrical. It is therefore not absolutely necessary to provide a container designed as a tube here. It is also important that the coupling device 31 must be designed so that a tight fluid connection between the two cavities is created in the containers. As is widespread, is absolutely prefer a Luer system, so a Luer connection as a first coupling element 15 and a second container with an externally threaded approach, which serves as a second coupling element 29. Regarding the function of the injection preparation system and the procedure for preparing an injection, the following should be noted:

It can be seen from the explanations to FIGS. 1 to 5 that in carrying out the method for preparing an injection, the two containers 3 and 21 of a system 1 which contain various substances, in particular a lyophilisate and a solvent, are initially connected to one another must be that a tight fluid connection between the enclosed by the containers 3 and 21 cavities 5 and 23 is provided. This is done by means of the coupling device 31, which has a first coupling element 15 on the first container 3 and second coupling element 29 on the second container 21. After the coupling of the containers and the realization of a fluid connection, the liquid medium, the solvent, the powdered medium, the lyophilisate, fed. In the embodiment of the system set forth here, a solvent 25 is introduced from the second container 21 into the cavity 5 of the first container 3, in which the lyophilisate 17 is located. The transfer of the solvent 25 into the first container 3 is promoted by having second container 21 a variable volume, preferably a wall 35 which is at least partially elastic, and that the second container 21 by an air volume 19 from the first container 3 is first expanded. It has been explained in connection with FIGS. 3 and 4 that initially the stopper 1 1 within the first container 3 is moved upwards in the direction of the arrow 33 in order to generate an overpressure in the second container 21. Due to the overpressure and by the displacement of the plug 1 1 within the first container 3 in the direction of the arrow 37 (see Figure 4), the solvent 25 is transferred from the second container 21 into the cavity 5 of the first container 3.

But it is also possible, starting from the situation shown in Figure 2, the plug 1 1 within the first container 3 in the direction of the arrow 37, as shown in Figure 4, to shift down and present in the second container 21 solvent 25th to be transferred to the first container 3. In this case, the volume inside the second container 21 decreases, as a comparison of Figures 2 and 4 shows.

By moving and / or shaking the first container 3 containing the lyophilisate 17 and the solvent 25, the lyophilisate 17 is dissolved. The dissolution of the lyophilisate 17 and also the mixing of the substances can be promoted by moving the plug 11 up and down in the interior of the first container 3 in the direction of its longitudinal axis. The plug 1 1 can be moved up and down so far that the substances to be mixed flow through the coupling region between the two containers 3 and 29. Since there is usually a relatively small flow cross section, there is a particularly good mixing of the two substances. Also, a solution of a lyophilisate in a diluent is promoted in this way. During an upward movement of the plug 1 1 in the direction of the arrow 33 (FIG 3), the volume in the second container 21 increases, so that, as Figure 3 shows, is widened.

The movement of the plug 1 1 is facilitated by the fact that the second container 21 has a variable volume and thus at most opposes a slight back pressure of an upward movement of the plug 1 1.

It is known to couple two containers together for the preparation of an injection solution and, for example, to aspirate a liquid from one container into the other container in order to mix the liquid there with a lyophilisate or with another liquid. In the system described herein, a liquid flows through a coupling area between two containers to contact, for example, another liquid or lyophilizate. The resulting solution can be forced to mix the two liquids or the dissolved lyophilisate through the coupling point in the container in which initially was the sucked liquid. In the multiple up and down movement of a plug 1 1 in the interior of the first container 3 in the direction of its longitudinal axis, the substances to be mixed pass through the coupling region repeatedly to flow between the two containers 3 and 29. In this case, a liquid from the first container passes into the second container, which originally contained the serving as a solvent or diluent liquid. Since it is preferably provided here that the quantities of the substances in the two containers are exactly matched to produce an injection solution, the solution can be forced out of the first into the second container, which can be prevented by the latter at least one elastic wall area is easily possible. This is a distinguishing feature over other systems where a large amount of liquid is provided in a container, which is drawn into a different container for multiple injections. In these known systems it is important that the medium present in the container, which is sucked into different syringes or cartridges, is in no way contaminated, so that even when the container is used several times, the injection solution to be produced is not contaminated. The first container 3 is preferably a one-chamber syringe containing the lyophilisate. Such syringes and cartridges are known. The lyophilizate can be easily dissolved by means of a solvent by the syringe or carpule is coupled to a second container 21 via a coupling device 31, wherein a fluid connection is created. The second container 21 has a variable volume, which is realized in particular by an at least partially elastic wall 35. Particularly preferably, the second container 21 is formed as a tube, which can be coupled in a simple manner with the first container, so the syringe or carpule. In this case, this tube can replace conventional containers, which usually contain a solvent and are coupled to the syringe or carpule. It is thus very easily possible to exploit the advantages of the second container 21 having a variable volume in order to dissolve a lyophilizate in conventional syringes and cartridges or to mix two different liquids with one another.

From the explanations it can be seen that an essential aspect of the invention is the at least one partially elastic Wall of a container, in particular a tube, is. The wall is widened to provide an injection solution, so that so the at least one partially elastic wall is stretched. As a result of the restoring forces of this wall, a medium present in the second container is expelled under pressure from the container into the first container, so that this medium mixes optimally with that in the first container. For example, a liquid jet from the second vessel hits a powdery substance in the first vessel at high speed and energy, so that it optimally mixes with the liquid. Naturally, this phenomenon also occurs when the liquid leaving the second container at high energy and speed encounters another liquid in the first container.

Moreover, it is possible in a simple manner to allow the media present in the containers to pass through a fluid connection between the containers by displacing the stopper 11 in the first container 3 in the direction of the second container and in the opposite direction. In a reciprocating movement of the plug, a liquid with a powder to be mixed or with a further liquid to be mixed flows back and forth through the fluid connection. Since this has a smaller cross-section than the two containers, the substances pass through the fluid connection at high speed, which causes optimum mixing of the substances, in particular a good solution of a lyophilisate by means of a solvent or diluent.

In this case, the at least partially elastic wall is of great advantage because it can expand and contract during a reciprocating movement of the plug and thus prevent the mixture of substances promotes. In doing so, it sets comparatively little resistance to a widening of the second container.

After all, it is found that for the volumes of the first and second container, in particular a syringe or cartridge and a tube, preferably a maximum of 100 ml are selected. Volumes of from 1 ml to 50 ml, in particular from 1 ml to 10 ml or 15 ml, have proven particularly useful.

The last-mentioned volumes of the first container or of the syringe or carpule and of the second container or tube result in particularly compact designs for the system for preparing an injection or a combination of syringe or carpule on the one hand and tube on the other hand. This embodiment is thus characterized by a particularly good handling, which is also very manageable for patients.

Claims

claims

1 . System (1) for the preparation of an injection, with

- A first container (3), the

- Is formed with a first cavity (5), and - has a rigid outer wall (7), and two ends, wherein

- On one side of the first cavity (5), a movable plug (1 1) is provided, which closes this sealingly and within the first container (3) is displaceable, and with

- A second container (21) enclosing a second cavity (23), wherein

a container contains a first substance and the other container contains a second substance, characterized in that

the first container (3) and the second container (21) are connectable to one another in such a way that their cavities (5, 23) are in fluid communication with one another,

- The second container (21) an at least partially elastic wall (35) and in this way comprises a variable volume, that the second container (21) is designed such that by means of at least partially resilient wall, a pressure in the interior of the second container ( 21) is buildable, and that - The second container (21) is a tube.

2. System according to claim 1, characterized in that one of the substances is solid and the other substance is liquid.

3. System according to claim 1, characterized in that one of the substances is liquid and the other substance is also liquid.

4. System according to claim 2, characterized in that the first substance is lyophilisate (17) and the second substance is a solvent (25) for the lyophilisate (17).

5. System according to claim 4, characterized in that in the first container (3) lyophilisate (17) and in the second container (21) the solvent (25) for the lyophilisate (17) is contained.

6. System according to any one of the preceding claims, characterized in that the first container (3) is a syringe or a carpule.

7. System according to any one of the preceding claims, characterized in that in the first container (3) in addition an air volume (19) is included.

8. System according to any one of the preceding claims, characterized in that the coupling device (31) realizes a screw connection, preferably a luer system, wherein the coupling device (31) has a first coupling element (13) attached to the first container (3) ) and a second on the second container (21) provided second coupling element (29).

9. System according to claim 8, characterized in that the first coupling element (15) on the first container is a Luer connection and the second coupling element (29) has an external thread screwed into the Luer connection.

A system according to any one of the preceding claims, characterized in that it is arranged and arranged for a quantity of a first substance in the first container (3) to be provided with a quantity of a second substance in the second container (21) Provide an injection solution for injection, wherein the volume of the first container (3) on the amount of the first substance and / or the volume of the second container (21) is adjusted to the amount of the second substance.

1 1. A system according to any one of the preceding claims, characterized in that it is arranged and arranged to provide a number of containers with different quantities of substance to be combined with a number of containers with different quantities of a second substance, a first one Container (3) is brought into fluid communication with a first substance having a second container (21) with a second substance in which the amount of the second substance is exactly matched to the amount of the first substance in the first container (3) to an injection solution to provide for an injection.

12. Combination of a syringe or carpule and a tube having at least one partially elastic wall (35), characterized in that this combination is chosen such that the volume given in the syringe and the volume given in the tube are matched to one another in such a way, that the syringe a defined amount of a first substance and the tube can receive a defined amount of a second substance, and that from the syringe or carpule at least a partial volume can be introduced into the tube to build up an overpressure in the tube and the at least one partially elastic wall (35) expand.

13. A method for preparing an injection, in particular by means of a system according to one of claims 1 to 9, comprising the following steps:

- coupling a first container (3) and a variable volume having second container (21) for realizing a fluid connection, and

- Mixing of substances contained in the containers (3,21) by shaking and / or repeated moving a provided in the first container (3) plug (1 1); characterized in that

- For mixing the substances, the variable volume in the second container (21) is used.

14. The method according to claim 13, characterized in that from the first container (3) by means of the there provided plug (1 1) a partial volume in the second container (21) is urged so that the at least one partially elastic wall (35) of the second container (21) is widened against its elastic restoring force.

15. The method according to claim 13 or 14, marked thereby, that in the second container (21) existing substance upon retraction of the plug (1 1) in the container (3) due to the at least partially elastic wall (35) of the second container (21) and the restoring force constructed pressure at high speed and / or energy enters the first container (3) ,

16. The method according to any one of claims 13 to 15, characterized in that a first of the in the containers (3,21) existing substances and a second is liquid.

17. The method according to any one of claims 13 to 16, character- ized in that both in the containers (3,21) existing

Substances are liquid.

18. The method according to any one of the preceding claims 13 to 17, characterized in that the coupling takes place by screwing a Luer system.