FILLING AID

Description

[0001] The invention relates to a filling aid for filling a cylindrical ampoule and a method for filling a cylindrical ampoule using such a filling aid.

[0002] In various medical applications, it is necessary to transfer a medical or pharmaceutical liquid from a container into a cylindrical ampoule, also known as a carpule. This is particularly the case when the liquid must first be dissolved from a dry, especially powdered, medical or pharmaceutical substance by adding a liquid solvent, such as saline solution or water for injection.

[0003] These cartridges are used particularly in so-called "pen systems" or cartridge syringes, which can also be intended for home use. Such pen systems are especially well-known for insulin, but can also be used for other medical or pharmaceutical agents, for example, hormone preparations for children and adolescents. These are usually in powder form and must first be dissolved as described above and then transferred into a cartridge before being inserted into the cartridge syringe or pen system. This is not entirely straightforward, especially for someone without medical training. Maintaining the necessary sterility during these procedures is particularly challenging.

[0004] EP 1 757 320 A1 discloses a device for filling a pen system for administering a liquid medication. The device is suitable for mixing a powdered medication with a liquid and then dispensing it in a metered dose into the pen system. For this purpose, the device incorporates a complex mechanism. Furthermore, it includes replaceable cassettes, each containing a container with the powdered medication, a container with the liquid, and a receptacle for used syringes. This results in a relatively large and expensive overall design for the device.

[0005] WO 2011 / 109915 A1 discloses a modular filling device for an applicator, in which various containers and syringes are connected to the applicator body via an applicator holder for filling. This requires the correct connection of various components, which poses a risk of incorrect operation for a layperson.

[0006] US 4,434,820 discloses a device for filling syringes, comprising a holder in which two containers for liquids are arranged. Furthermore, a holder for a syringe is provided for filling it from the containers, with limiting levers for limiting the syringe's plunger stroke to establish a defined dosage.

[0007] US 4,338,980, WO 2005 / 011781 A1 and US 4,475,915 disclose holders in which a container with a liquid and a syringe can be held to transfer the liquid from the container into the syringe. These devices are not specifically designed to dissolve powdered drugs or pharmaceuticals and transfer them into a cartridge or caplet.

[0008] With regard to this problem, the object of the invention is to provide a filling aid for filling a cylindrical ampoule, which makes it possible to easily transfer a medical or pharmaceutical liquid from a container into a cylindrical ampoule or cartridge.

[0009] This problem is solved by a filling aid having the features specified in claim 1 and by a method having the features specified in claim 15. Preferred embodiments are described in the dependent claims, the following description, and the accompanying figures.

[0010] The filling aid according to the invention serves to transfer a medical or pharmaceutical liquid from a container in which this liquid is provided or mixed, into a cylindrical ampoule. This filling aid can be used for a wide variety of medical or pharmaceutical liquids.

[0011] The filling aid according to the invention has as an essential element at least one holding aid. This holding aid has a housing in which a first receptacle is formed. This first receptacle is designed to receive the cylindrical ampoule to be filled. This means that the receptacle is dimensioned and shaped such that a cylindrical ampoule to be filled, preferably a cylindrical ampoule for conventional cartridge syringes, can be received. Such cylindrical ampoules are known on the market under the name "carpule." Furthermore, a second receptacle is provided in the housing, which is designed to receive a container in which the medical or pharmaceutical liquid is provided. This means that the second receptacle is dimensioned and shaped such that a conventional container for holding a medical or pharmaceutical substance can be inserted into and received in it.This container is, in particular, a standard vial. Instead of providing the medical or pharmaceutical liquid in ready-to-use form, the container can also contain a medical or pharmaceutical substance that must first be dissolved with an added solvent, such as saline solution or water, to produce the medical or pharmaceutical liquid. This dissolving preferably takes place in the filling aid, i.e., in a state where the container is received in the second recording.

[0012] The first receptacle has a first access opening. This opening is positioned and designed so that it faces the opening of a cylindrical ampoule when the ampoule is inserted into the first receptacle. That is, the opening, or a septum closing this opening, of an inserted cylindrical ampoule is accessible from the outside through the first access opening, allowing the cylindrical ampoule, which is located in the housing of the filling aid, to be filled through this opening. Furthermore, the housing has a second access opening, which is located on the second receptacle. This second access opening is designed and positioned so that it faces the opening, or a closure, of a container when the container is inserted into the second receptacle. That is, the opening or closure (e.g.,(a septum) of the container, when inserted into the second receptacle, is accessible through the second access opening, so that, for example, a solvent for dissolving a powder can be introduced into the container through the second access opening and / or the contents of the container can be removed from it.

[0013] This embodiment of the filling aid according to the invention has the advantage that the two elements between which the medical or pharmaceutical liquid is to be transferred can be securely held in a single component, namely the holding aid. Thus, the filling aid can simultaneously hold the container in which the liquid is mixed or prepared and the cylindrical ampoule to be filled. This simplifies handling, as the transfer of the liquid from the container to the cylindrical ampoule can then be carried out, for example, using a syringe, which is first inserted into the second access opening to draw the contents of the container into the syringe. The syringe can then be moved from the second access opening to the first access opening, and the contents can then be transferred from the syringe into the cylindrical ampoule. The filling aid, or rather,The holding aid secures the cartridge and container, ensuring that their openings are protected and contamination is prevented. After the liquid is transferred into the cartridge, it can be removed from the initial holder and inserted into a cartridge syringe or a conventional pen system for use. This design is advantageous not only for self-administration by the patient but also for use in clinics, doctors' offices, and laboratories.

[0014] The housing of the filling aid according to the invention is preferably made of plastic and is further preferably designed as a one-piece, and in particular a single-piece, plastic component. In particular, the housing can be manufactured as an injection-molded part from plastic, which enables cost-effective production.

[0015] The first receptacle preferably contains fixing elements designed and intended to detachably fix a cylindrical ampoule within it. These fixing elements are preferably designed to hold a standard, i.e., conventional, cylindrical ampoule or cartridge. The fixing elements are designed and arranged such that they hold the cylindrical ampoule in the receptacle when a syringe is inserted through the first access opening to fill the cartridge. However, the fixing elements are also designed to allow the cylindrical ampoule to be removed from the receptacle. This is achieved by grasping the cartridge and applying a force that exceeds the holding force of the fixing elements. The direction in which the cylindrical ampoule can be removed from the first receptacle preferably extends along the length of the cartridge.This is also preferably the insertion direction in which a syringe can be inserted into the first access opening to make contact with the opening of the cylindrical ampoule and introduce a liquid from the syringe into the cylindrical ampoule. The fixing means are preferably designed as force-locking and / or form-locking fixing elements, which preferably grip the cylindrical ampoule at its front end, i.e., the end adjacent to the opening. More preferably, the fixing means can be designed as locking hooks or locking tongues. In particular, the locking hooks or locking tongues can engage around or behind a collar surrounding the opening. The locking hooks or locking tongues are preferably arranged such that, upon application of a sufficiently large force in the longitudinal direction of the cylindrical ampoule, they are deflected from their locking position and release the cylindrical ampoule. Such locking tongues or locking hooks are preferably one-piece, furthermore...formed integrally with at least part of the housing, preferably with the entire housing. Particularly when the housing is manufactured from plastic, such locking hooks or locking tongues can be easily incorporated.

[0016] According to a particularly preferred embodiment, the filling aid is designed such that a cylindrical ampoule is pre-assembled in the first receptacle with the fixing means and is detachably fixed, and can be removed from the first receptacle. The filling aid is thus delivered to the user in this pre-assembled state, so that the user no longer needs to insert the cylindrical ampoule into the filling aid. This has the advantage of further simplifying handling and ensuring that the cylindrical ampoule is securely and safely fixed in the filling aid.

[0017] According to a further preferred embodiment, fixing means are arranged in the second receptacle, which are designed and intended to preferably releasably fix a container holding a medical or pharmaceutical substance within the receptacle. Such a container can be a vial commonly used in the medical field. That is, the fixing means are preferably dimensioned and designed to be able to fix such a vial. The fixation by the fixing means is preferably releasable in such a way that the container can be removed from the receptacle by applying sufficient force and releasing the fixation. The removal direction is preferably such that it corresponds to the longitudinal or central axis of the container, which preferably also corresponds to the insertion direction of a syringe into the second access opening.The fixing means are preferably designed as locking hooks or locking tongues that engage the container at a collar. Such a collar is present on conventional containers at the axial end where the opening is located and surrounds and / or holds the container's closure. The locking tongues or locking hooks are preferably formed integrally with at least part of the housing, preferably with the entire housing. This allows these locking hooks to be manufactured cost-effectively by injection molding together with the housing. The locking hooks or locking tongues are preferably designed such that, when sufficiently large a force is applied to the container, they move from their locked position to a released position, allowing the container to be removed from the receptacle.It is still preferred, but also possible, to supply the container with the medical or pharmaceutical substance or liquid separately, so that the user must first insert it into the second receptacle and preferably lock and / or clamp it there using the fixing elements. After the medical or pharmaceutical liquid has been removed from the container in the manner described above, the container can remain in the receptacle, as it is no longer needed. Alternatively, it can also be removed from the receptacle by the user for separate disposal, provided that the fixing elements in the second receptacle are designed to allow for releasable fixation.

[0018] According to a further preferred embodiment, a cannula element is detachably held in the second receptacle. This cannula element comprises a cannula and a Luer connector. The cannula element is arranged in the second receptacle such that the Luer connector of the cannula faces the second access opening and the cannula is oriented to penetrate a container inserted into the second receptacle. The cannula element serves to penetrate the opening of the container with its cannula and, in particular, to pierce a seal, for example, a septum, in the opening of the container.

[0019] Preferably, the cannula element in the second receptacle is arranged in a linear guide, which allows movement of the cannula element in its longitudinal direction, i.e., along the length of the cannula. The cannula element is movable in the linear guide between a first and a second position, with the cannula element being closer to the second access opening in the first position than in its second position. The second position is such that the cannula penetrates the container in this position, i.e., in particular, pierces a septum of the container. In the initial position, i.e., in the delivery state of the filling aid, the cannula element is preferably located in the first position, in which the cannula does not penetrate the part of the receiving space in which the container is received. Preferably, a locking mechanism that can be overcome by force is provided.A clamping mechanism is provided for the cannula element in the first position. During use, a syringe with a Luer connector is inserted into the second access opening so that the Luer connector engages with the Luer connection of the cannula. As the syringe is further inserted into the second access opening, the cannula element is moved from its first position to its second position, preferably overcoming any existing locking or clamping mechanism. In this way, the cannula element with the cannula is inserted into the container.

[0020] Preferably, at least one retaining element is arranged in the second receptacle, which releasably fixes the cannula element. This retaining element preferably generates a holding force in the longitudinal direction of the cannula that is less than the force, i.e., the tensile force, that can be transmitted longitudinally by the Luer connector. The retaining element can simultaneously perform the function of the locking or clamping mechanism described above. The retaining element prevents the cannula element from falling out of the second access opening. During use, after the liquid has been transferred from the container into an inserted syringe, the cannula element, together with the syringe, is pulled out of the second access opening using the cannula element, thereby overcoming the holding force of the retaining element. This means that the connection between the Luer cone and the Luer connector must remain intact so that a tensile force can be transmitted to overcome the holding force of the retaining element.

[0021] The second access opening is preferably dimensioned such that the cannula element can be removed through it. For this purpose, the cannula element is preferably pulled out of the second access opening together with a syringe attached to the cannula element.

[0022] In the next step, the syringe with the cannula element can preferably be inserted into the first access opening, and the cannula can then penetrate the opening of the cartridge, which is held or fixed in the first receptacle. The cannula preferably pierces a closure, in particular a septum of the cartridge. The first access opening and the first receptacle are preferably designed and arranged such that the cannula element is guided linearly within the first receptacle to precisely pierce a septum of the cartridge. A guide is further preferably provided that directs the cannula element so that the cannula penetrates the septum outside its center. This has the advantage that where the septum is later pierced in a pen system, it has not already been pierced by the cannula during filling, thus ensuring a good seal in this area.

[0023] According to a preferred embodiment of the invention, the filling aid includes a syringe with a Luer cone, separate from the housing. This syringe is designed such that the Luer cone can engage with the Luer connection of the previously described cannula element. The syringe can either be provided empty or pre-filled with a liquid for dissolving a medical or pharmaceutical substance in the container, for example, a saline solution or water for injection. This syringe is then used in the manner described above to transfer a medical or pharmaceutical liquid from a container into a cartridge. Optionally, the liquid contained in the syringe can first be injected into the container to dissolve a dry substance and produce the desired liquid.After sufficient mixing, the liquid is preferably drawn out of the container using the same syringe, and then the syringe with the cannula element is removed from the second access opening in the manner described above and inserted into the first access opening in order to transfer the liquid into the cylinder ampoule held in the first opening.

[0024] According to a particular embodiment of the invention, a third receptacle can be formed in the housing, which is designed to receive and secure a syringe. This third receptacle makes it possible to insert the syringe into it after use and then dispose of it together with the filling aid. Preferably, the third receptacle is designed only to receive and secure the syringe; the cannula element preferably remains in or attached to the first access opening after use, as described below.

[0025] Preferably, the first access opening is dimensioned such that a cannula element, and preferably the cannula element described above, can be inserted into the first receptacle through the first access opening. This makes it possible to insert the syringe with the cannula element, after it has been removed from the second access opening, into the first access opening in order to insert or pierce the cannula of the cannula element into the cylinder ampoule to be filled.

[0026] In the first version, at least one locking device is preferably arranged at the first access opening. This device is designed to secure a cannula element inserted through the first access opening, preferably in a way that prevents its removal. This allows the syringe to be removed from the first access opening after the liquid has been introduced into the cartridge, while the cannula element remains secured there for safe disposal. The locking device is therefore preferably designed so that it can be overcome in one direction during insertion and locks in the opposite direction. This can be achieved, for example, by elastic locking tabs or locking protrusions, which are preferably integrally formed with at least one housing part.This could be, for example, the housing described above, or a component connected to the housing, such as the locking element described below.

[0027] According to the invention, the filling aid further comprises a locking element movable between a first and a second position. In the first position, this element closes the first access opening and releases the second access opening, and in its second position, it closes the second access opening and releases the first access opening. The locking element ensures safe handling, as it releases only one access opening at a time in the correct sequence for use. That is, in the delivered state, the locking element is preferably in its first position, so that a syringe can initially be inserted into the second access opening.After the syringe has preferably been removed from the second access opening, the closure element can be moved to its second position, thus releasing the first access opening and allowing the syringe, preferably with the attached cannula element, to be inserted into the first access opening. The closure element is preferably also manufactured as an injection-molded plastic part and is movably connected to the housing described above. This connection can be achieved, for example, by a snap-fit ​​mechanism. In this way, it is possible to manufacture the housing and the closure element from just two components, with all the housing components described above, in particular the retaining elements, securing elements, fixing elements, detents, and / or clamps, preferably being formed integrally with the housing.

[0028] The previously described securing device for the cannula element at the first access opening can preferably be formed by locking hooks or locking tongues on the closure element, so that the cannula element is fixed between the closure element and the housing after insertion into the first access opening.

[0029] More preferably, the locking element has at least one releasable lock that releasably secures the locking element in its first and / or second position, the lock preferably being releasable with one hand. Such a lock prevents the locking element from being unintentionally moved from the first to the second position. This lock can, for example, be formed by a projection on the housing arranged on a spring-loaded tongue, which, when the locking element is in its first position, is located in front of an edge, in particular a leading edge of the locking element in the direction of movement. Thus, the projection blocks the movement of the locking element. To move the locking element, the projection must then be disengaged from the edge via the spring-loaded detent tongue, allowing the locking element to then be moved, in particular to be shifted.The locking mechanism can preferably be designed such that it also engages with the locking element in a suitable manner in the second position to secure the locking element in that position. For this purpose, the locking element can preferably have a recess or opening into which the projection of the spring-loaded detent engages. Such a locking mechanism could also be arranged in reverse, such that the projection engages in a recess of the locking element in the first position and, in the second position, is located on a rear edge of the locking element (in the direction of movement) or in a second recess. Particularly preferred are two such locking mechanisms located on opposite sides of the housing, which must be pressed together by the fingers to move the locking element.

[0030] Preferably, the closure element is slidably guided in a guide within the housing. The guide is preferably straight and extends transversely to the insertion directions of the syringe into the first and second access openings. Particularly preferably, the guide and the direction of movement defined by it do not extend perpendicular to the insertion direction, but rather obliquely. This causes the closure element, when moved from the first to the second position, to move not only transversely to the insertion directions, but also to a certain extent in the direction of the insertion directions. An opening may be provided in the closure element which, in the second position, covers the first access opening. This opening also serves to guide the syringe.If the closure element is also moved axially in the insertion direction when it is shifted from the first to the second position, the guide formed by the opening is thus moved into a different axial position. This is advantageous because the cylindrical ampoule to be filled is usually longer in the axial direction than the container, especially a vial. In this way, it is possible to design the filling aid to be particularly compact, especially in its delivered state, in which the closure element is in the first position, which is intended for inserting the syringe into the container. The axial length of the filling aid required to guide the syringe for insertion into the cylindrical ampoule is then only created by shifting the closure element into its second position, thereby lengthening the filling aid in the axial direction.

[0031] The first and second access openings are preferably located on the same side of the housing. This simplifies handling, as it is not necessary to rotate the housing; the syringe can simply be moved from the first to the second access opening on the same side.

[0032] The first receptacle with the first access opening and the second receptacle with the second access opening are preferably arranged and designed such that the insertion directions of the first and second access openings, along which a cannula element and / or a syringe can be inserted into or removed from the access openings, run parallel to each other. This also simplifies handling, as the angular position of the housing does not need to be changed when the syringe is pulled out and inserted.

[0033] The invention further relates to a method for filling a cylindrical ampoule with a medical or pharmaceutical liquid using a filling aid as described above. The essential process steps are described below. Further details of the process sequence have already been described above in connection with the design of the filling aid. Reference is made to these descriptions with regard to the method.

[0034] According to the procedure, a container with the medical or pharmaceutical liquid to be transferred into the cartridge is first provided. This container is inserted into the second receptacle of the filling aid housing or is already inserted there upon delivery. In the next step, a syringe is inserted into the second access opening of the second receptacle in the housing and brought into fluid-conducting contact with the interior of the container. This is preferably done by inserting a cannula of a cannula element, which is already pre-assembled and held in the second receptacle, into the opening of the container, as described above. In the next step, the medical or pharmaceutical liquid is transferred from the container into the syringe. This can be done, in particular, by aspiration using the syringe.Alternatively, a container with a piston can be provided, allowing the transfer to be effected by pressing the piston within the container. After the liquid has been transferred into the syringe, the syringe is removed from the second access opening, preferably also removing a cannula element attached to the syringe. The syringe is then inserted into the first access opening, optionally after a closure element has been moved. If present, the cannula is inserted into the opening of the cartridge. The medical or pharmaceutical liquid is then dispensed from the syringe into a cartridge located in the first receptacle. The cartridge is preferably pre-assembled and held in the first receptacle, so the filling aid is supplied with the cartridge already mounted.After the liquid has been transferred from the syringe into the cartridge, the cartridge can then be removed from the first receptacle and inserted into a caplet syringe or pen system in a known manner. The syringe can then be removed from the first access port as described above, preferably leaving a cannula element in the receptacle. If necessary, the syringe can then be inserted into a third receptacle as described above.

[0035] According to a particular embodiment of the method, the container may initially contain a powdered, for example freeze-dried, medical or pharmaceutical substance, which is dissolved by the addition of a liquid to produce the aforementioned medical or pharmaceutical liquid within the container. For this purpose, a solvent, for example saline solution or water for injection, is preferably injected into the container using a syringe inserted into the second access opening, whereupon the substance in the container is dissolved by the liquid. This can optionally be done with shaking. After thorough mixing or dissolution, the medical or pharmaceutical liquid thus produced is then preferably transferred back into the same syringe as described above.Then the syringe is removed from the second access opening as described and inserted into the first access opening.

[0036] An advantage of the method according to the invention is that the medical or pharmaceutical liquid is forced from the syringe into the cartridge vial and is not drawn in by movement of the movable stopper in the cartridge vial, as is usual with conventional filling of cartridge vials. This is advantageous because it prevents undesirable foaming of the liquid. To prevent this also during the transfer from the container to the syringe, the container can also be designed to have a movable piston which is pressed to force the liquid from the container into an attached syringe.

[0037] The invention is described below by way of example with reference to the accompanying figures. These show: Fig. 1 shows the essential parts of a filling aid according to the invention, including a container for a medical or pharmaceutical liquid and a cylindrical ampoule. Fig. 2 shows a perspective view of the housing of the filling aid with the attached closure element. Fig. 3 shows a side view of the housing according to the invention. Fig. 2 , Fig. 4 a top view of the housing according to Fig. 3 Fig. 5 shows a side view of the housing without the locking element, Fig. 6 shows a side view of the housing according to Fig. 5 Looking at one of the end faces, Fig. 7 shows a sectional view through the housing according to Fig. 5 along line VII in Fig. 6 , Fig. 8 a perspective view of the closure element, Fig. 9 a perspective view of the filling aid with inserted cylinder ampoule and inserted container, Figs. 10 - 20 step by step the use of the filling aid according to the invention and Fig. 21 a perspective view of the filling aid after filling the cylinder ampoule.

[0038] The filling aid shown here as an example has two essential components: firstly, a holding device 2, which consists of a housing 4 with a closure element 6 attached to it, and secondly, a syringe 8. The holding device 2 serves to hold a cylindrical ampoule 7 to be filled. The syringe 8 is formed in the usual way from a cylinder 10 with a piston 11 movable therein via a piston rod 12. The syringe 8 has a Luer cone 14 at its end, on which the in Fig. 1 The example shown shows a cap 16 is placed on top.

[0039] The filling aid according to the invention serves to transfer a medical or pharmaceutical liquid from a container 18 into the cylindrical ampoule 7. The container 18 shown here is a conventional vial or injection bottle, which is closed at its top by a stopper or septum 20. A collar 22 is formed on the container 18 surrounding the septum 20. The housing 4 has a first receptacle 24 and a second receptacle 26, the first receptacle being designed to receive the cylindrical ampoule 7 and the second receptacle 26 being designed to receive the container 18, i.e., shaped and dimensioned accordingly. The first receptacle 24 and the second receptacle 26 are open towards the same side of the housing 4 and have insertion directions E1 and E2 parallel to each other, along which the cylindrical ampoule 7 and the container 18 are inserted into the first receptacle 24 and the second receptacle 26 respectively.The first receptacle 24 has a first access opening 28, which opens towards an end face of the housing 4 opposite to the insertion direction E1. The second receptacle 26 accordingly has a second access opening 30, which opens towards the same side as the first access opening 28.

[0040] In the first receptacle 24, spring-loaded locking tongues 32, integrally formed with the housing 4, are arranged near the first access opening 28. These locking tongues 32 are arranged and designed such that they can engage a collar 34, which surrounds a stopper or septum of the cylindrical ampoule 7, in order to detachably fix the cylindrical ampoule 7 in the receptacle 24. When the cylindrical ampoule 7 is fixed in the receptacle 24 in this manner, the opening of the cylindrical ampoule 7, closed by the septum, is opposite the first access opening 28.

[0041] The locking tongues 32, which form fixing means, are arranged and designed such that, under sufficiently large force, they deform radially outwards away from the first access opening 28 in the insertion direction E1, so that the collar 34 can pass the locking tongues 32 and the cylindrical ampoule can be removed from the first receptacle 24.

[0042] In the second receptacle 26, locking elements in the form of locking tongues 36 are arranged, which are dimensioned and positioned such that they can engage behind the collar 22 of the container 18 in order to secure the container 18 in the second receptacle 26. The locking tongues 36 can be designed with their projections such that the container 18 cannot be removed from the second receptacle 26 again; that is, the locking tongues 36 only expand once when the container is inserted into the second receptacle 26 and are not intended to release the container 18. Alternatively, however, the locking tongues 36 can also be designed similarly to the locking tongues 32 in such a way that it is possible to remove the container 18 again.

[0043] In the second recess 26, a retaining element 38 in the form of a clamp is formed between the locking tongues 36 and the second access opening 30. The retaining element 38 serves to receive and fix a cannula element 40. The cannula element 40 is guided axially displaceably by the retaining elements 38 in the direction of insertion E2. The cannula element 40 has a Luer connector 42 at its end facing the second access opening 30 and a cannula 44 at its opposite end. The cannula element 40 is positioned in the direction of insertion E2 between a first position, which is located in the cutout A1 in Fig. 12 shown, and a second position, which is shown in section A2 in Fig. 12 As shown, it is movable. In the second position, the cannula 44 penetrates the septum 20 of the container 18, as shown, for example, in Fig. 9 The second access opening 30 is dimensioned such that the cannula element 40 can be removed from the second access opening 30.

[0044] The locking element 6 is designed as a slider that is slidable on the housing 4 and overlaps the housing 4 on two sides. That is, the locking element 6 has a U-shaped cross-section and overlaps the housing 4 on two opposite side surfaces. The direction of movement or displacement S of the locking element 6 extends transversely to the insertion directions E1 and E2. The displacement direction S is not normal, but oblique to the insertion directions E1 and E2. For this purpose, the housing 4 has a guide groove 46 on each of its two opposite side surfaces, which extends in the displacement direction S. The locking element 6 has a projection 48 on each of its two facing inner surfaces. Fig. 8 only one visible) which engage in the guide grooves 46.

[0045] The locking element 6 is designed such that it is in a first position in the Figuren 2 bis 4 and 9In the position shown, the first access opening 28 is closed and the second access opening 30 is opened. In this position, the locking element 6 is secured against unintentional movement by a lock. This lock is formed by two spring-loaded tongues 50 on two opposing side surfaces of the housing 4. The tongues 50 each have outwardly projecting projections 52 at their free ends. In the first position of the slide, these projections 52 engage in an opening 54 on the locking element 6. To move the locking element 6 into its second position, it is necessary to compress the two projections 52 from the outside so that they disengage from the openings 54. In the second position, the tongues 50 then spring back outwards, and the projections 52 come to rest against a side edge 56, as shown, for example, in Fig. 1 As shown, the closure element 6 is secured in its second position. In this second position, an opening 58, formed on the end face of the closure element 6, is located opposite the first access opening 28. The opening 58 has spring tongues 60 around its circumference, which form a locking means for holding the cannula element 40. The opening 58 and the spring tongues 60 are dimensioned such that the cannula element 40 can pass through the opening 58 with radial expansion of the spring tongues 60. Once the cannula element 40 has passed through the opening 58, the spring tongues 60 spring back radially inward, preventing the cannula element 40 from moving backward.

[0046] The functioning of the filling aid according to the invention will now be explained using the Figuren 10 bis 20 explained. In this embodiment, the container 18 is pre-filled with a powdered medical or pharmaceutical substance. The holding device 2 is, as in Fig. 10 The product is shown in a state in which the locking element is in its first position. Furthermore, the cylinder ampoule 7 is pre-assembled in the housing 4 in the first receptacle 24. It is held there by the locking tongues 32 as described above. In this state, a movable piston 62 is located in the Fig. 1 shown position, i.e., near the opening or septum of the cylindrical ampoule 7, which is held by the collar 34. Furthermore, the cannula element 40 is pre-assembled in the housing 4, initially in its first position, in the cutout A1 in Fig. 12 The container 18 is in the position shown, i.e., in a position facing one of the second access openings 30. In this state, the container 18 is inserted into the second receptacle 26 in the second insertion direction E2, with the locking tongues 36 expanding radially so that the collar 22 can pass over the projections of the locking tongues 36 and is subsequently engaged by the projections of the locking tongues 36, thus fixing the container 18 in the second receptacle 26.

[0047] In the next step, after removing cap 16, the syringe 8 is inserted as shown in Fig. 11 As shown, the syringe 8 is inserted into the second access opening 30. The Luer cone 14 of the syringe 8 engages with the Luer connector 42 of the cannula element 40. In this example, the syringe 8 is pre-filled with a liquid for dissolving the medical or pharmaceutical substance, for example, a saline solution or water for injection.

[0048] When the syringe 8 with its Luer cone 14 has engaged with the cannula element 40, as in Fig. 12 As shown, the syringe 8 is advanced further in the insertion direction E2, so that, as in excerpt A2 in Fig. 12 As shown, the cannula element 40 is moved into its second position, further away from the second access opening 30. In this position, the cannula 44 penetrates the septum 20 of the container 18. In the next step, as shown in Fig. 13 As shown, the piston rod 12 of the syringe 8 is moved, thus emptying the contents of the syringe 8 through the cannula element 40 into the container 18. The substance is thereby dissolved in the container 18, and the holding device 2, i.e., the housing 4, can be shaken if necessary. In the next step, as shown in Fig. 14 The holding device 2 with the inserted syringe 8 is shown reversed so that the piston rod 12 points downwards. In this state, the syringe 8 is drawn up so that the contents of the container 18, which is now a medical or pharmaceutical liquid, are drawn into the syringe 8.

[0049] In the next step, as in Fig. 15 As shown, the holding device 2 is reversed and the syringe 8 is withdrawn from the second access opening together with the cannula element 40 in the insertion direction E2, whereby the cannula 44 is withdrawn from the septum 20. For this to occur, the holding force in the holding means 38 must be less than the clamping force between the Luer cone 14 and the Luer connector 42.

[0050] In the next step, as in Fig. 16a und Fig. 16b As shown, the locking element 6 is moved along the displacement direction S on the housing 4. For this purpose, first, as shown in Fig. 16a shown, the projections 52 (in Fig. 16a (Only the projection located on the front is visible; a second, identically shaped projection 52 is located on the rear) is compressed so that the projections 52 disengage from the openings 54. Subsequently, as in Fig. 16 b As shown, the locking element 6 can be moved in the direction of movement S. One-handed operation is possible. That is, the compression of the projections 52 and the movement of the locking element 6 can be done with one hand without repositioning the grip, since the locking element 6 can be held in the area of ​​the openings 54 while moving it. Thus, the locking element 6 comes into its position in Fig. 17 shown second position. In this position, the projections 52 on the tongues 50 spring back outwards, so that they come into contact with the side edges 56 of the locking element 6 and secure it in the second position shown.

[0051] In this position, the syringe 8, with the cannula element 40 and the cannula 44 leading, is inserted in the insertion direction E1 first into the opening 58 on the closure element 6 and subsequently into the first access opening 28 of the housing 4 located below it. The cannula element 40 passes the spring tongues 60 on the opening 58 as described above. Simultaneously, the cannula 44 enters the cartridge 7 through the closure or septum. In this state, the following procedure is then carried out, as described in Fig. 18 As shown, the piston rod 12 of the syringe 8 is moved in the insertion direction E2, and the contents of the syringe 8 are pushed or transferred into the cylinder ampoule 7. During this process, the piston 62 in the cylinder ampoule 7 moves towards the end furthest from its opening. In the next step, as shown in Fig. 19 As shown, the cylindrical ampoule 7 is withdrawn from the first receptacle 24 in the insertion direction E1. The locking tabs 32 then expand radially, allowing the collar 34 of the cylindrical ampoule 7 to pass over the projections of the locking tabs 32. The syringe 8 initially remains in the first access opening 28.

[0052] The first access opening 28 has a guide 68 for the cannula element 40, which guides the cannula element 40 such that the cannula 44 enters the closure or septum of the cartridge 7 at a defined position. The guide is preferably selected such that the cannula 44 enters the septum of the cartridge 7 at its outer center. That is, the guide 68 is offset radially slightly with its longitudinal or central axis relative to the central axis of the first receptacle 24. This causes the septum of the cartridge 7 to be pierced at a different location than it will be later in a pen system when the cartridge 7 is used.

[0053] Following this, as in Fig. 20 As shown, the syringe 8 is removed from the opening 58, whereby the Luer cone 14 of the syringe 8 detaches from the Luer connector 42 of the cannula element 40, since the cannula element 40 is held in place by the spring tongues 60, as described above. The syringe 8 can then be inserted into a third receptacle 64 (see Fig. 7 The syringe 8 is inserted into the housing 4. A clamping element 66 is formed in the third receptacle 64, its shape adapted to the Luer cone 14 such that the latter is clamped in the clamping element 66. In this state, the syringe 8 is fixed in the housing 4. Simultaneously, the cannula element 40 is fixed between the closure element 6 and the housing 4 as described, and the emptied container 18 is further secured in the second receptacle 26. In this state, the holding device 2, together with the cannula element 40 of the syringe 8 and the container 18, can then be disposed of. Bezugszeichen

[0054] 2 Holding device 4 Housing 6 Closure element 7 Cylindrical ampoule 8 Syringe 10 Cylinder 11 Piston 12 Piston rod 14 Luer cone 16 Cap 18 Container 20 Septum 22 Collar 24 First receptacle 26 Second receptacle 28 First access opening 30 Second access opening 32 Detent points 34 Collar 36 Detent points 38 Retaining element 40 Cannula element 42 Luer connector 44 Cannula 46 Guide grooves 48 Projection 50 Tongues 52 Projections 54 Openings 56 Side edges 58 Opening 60 Spring tongues 62 Piston 64 Third receptacle 66 Clamping element E1, E2 insertion directions S displacement direction

Claims

1. A filling aid for filling a cylinder ampoule (7) with a medical or pharmaceutical liquid, wherein the filling aid in a common housing (4) has a first receptacle (24), which is designed to hold the cylinder ampoule (7) to be filled, and a second receptacle (26), which is designed to hold a container (18) containing a medical or pharmaceutical substance, fixing means (32) are arranged in the first receptacle (24), which are designed and provided for detachably fixing a cylinder ampoule (7) in the first receptacle (24), fixing means (36) are arranged in the second receptacle (26), which are designed and provided for fixing a container (18) containing a medical or pharmaceutical substance in the second receptacle (26), a first access opening (28) is formed at the first receptacle (24), and arranged in such a way that it lies opposite an opening of a cylinder ampoule (7) when it has been placed in the first receptacle (24), and that the opening of the cylinder ampoule (7) is accessible from outside through the first access opening (28), and the housing (4) has a second access opening (30), which is formed on the second receptacle (26) and arranged in such a way that it lies opposite an opening of a container (18) when it has been placed in the second receptacle (26), and that an opening of the container is accessible through the second access opening (30), characterized in that the filling aid has a closure element (6) that can be moved between a first and a second position, which in the first position closes the first access opening (28) and releases the second access opening (30), and in its second position closes the second access opening (30) and releases the first access opening (28).

2. The filling aid according to claim 1, in which a cylinder ampoule (7) is preassembled and detachably fixed in the first receptacle (24) with the fixing means (32), and can also be removed from the first receptacle (24).

3. The filling aid according to claim 1 or 2, in which the fixing means (36) arranged in the second receptacle (26) are designed and provided for detachably fixing a container (18) containing a medical or pharmaceutical substance in the form of a vial in the second receptacle (26).

4. The filling aid according to one of the preceding claims, in which a canula element (40) having a canula (44) and a Luer connection (42) is detachably held in the second receptacle (26), wherein the Luer connection (42) of the canula element (40) faces the second access opening (30) and the canula (44) is directed in such a way as to penetrate into a container (18) placed in the second receptacle (26).

5. The filling aid according to claim 4, in which the second access opening (30) is dimensioned in such a way that the canula element (40) can be removed through the second access opening (30).

6. The filling aid according to one of the preceding claims, in which at least one holding means (38) is arranged in the second receptacle, and detachably fixes the canula element (40), wherein the holding means (38) preferably generates a holding force in the longitudinal direction of the canula (44) that is less than a force transmissible by the Luer connection (42) in the longitudinal direction.

7. The filling aid according to one of the preceding claims, which has a syringe that is separate from the housing (4) and has a Luer cone (14), which can be engaged with the Luer connection (42) of the canula element (40).

8. The filling aid according to one of the preceding claims, in which the housing (4) has a third receptacle (64), which is designed for holding and fixing a syringe (8).

9. The filling aid according to one of the preceding claims, in which the first access opening (28) is dimensioned in such a way that a canula element (40), and preferably the canula element (40) defined in claims 4 to 8, can be inserted in the first receptacle (24) through the first access opening (28).

10. The filling aid according to claim 9, in which at least one safeguard (60) is arranged in the first receptacle (24) at the first access opening (28), and designed in such a way as to fix a canula element (40) inserted through the first access opening (28), preferably so that it cannot be removed again.

11. The filling aid according to claim 10, in which the at least one safeguard is designed as a latching element, and in particular as a latching tongue (60).

12. The filling aid according to one of the preceding claims, in which the closure element (6) has at least one detachable lock (50, 52), which detachably fixes the closure element (6) in its first and / or its second position, wherein the lock (50, 52) can preferably be detached onehandedly.

13. The filling aid according to one of the preceding claims, in which the first (28) and the second (30) access opening are arranged on the same side of the housing (4).

14. The filling aid according to one of the preceding claims, in which the first receptacle (24) with the first access opening (28) and the second receptacle (26) with the second access opening (30) are designed in such a way that the insertion directions (E1, E2) of the first and the second access opening (28, 30), along which a canula element (40) and / or a syringe (8) can be inserted into the access openings (28, 30), run parallel to each other.

15. A method for filling a cylinder ampoule (7) with a medical or pharmaceutical liquid using a filling aid according to one of the preceding claims, in which, sequentially, a container (18) with the medical or pharmaceutical liquid to be introduced into the cylinder ampoule (7) has been or is inserted into the second receptacle (26), a syringe (8) is inserted into the second access opening (30), the medical or pharmaceutical liquid is siphoned out of the container (18) into the syringe (8), the syringe (8) is removed from the second access opening (30) and inserted into the first access opening (28), and the medical or pharmaceutical liquid is transferred from the syringe (8) into a cylinder ampoule (7) arranged in the first receptacle (24).

16. The method according to claim 15, in which a powdery medical or pharmaceutical substance is initially contained in the container (18), and dissolved by adding a liquid, so as to generate the medical or pharmaceutical liquid in the container (18) in this way.

17. The method according to claim 16, in which a powdery medical or pharmaceutical substance is initially contained in the container (18), the syringe (8) is filled with a liquid for dissolving the substance prior to insertion into the second access opening (30), the liquid is transferred from the syringe (8) into the container (18) after insertion of the syringe (8) into the second access opening (30), so as to dissolve the powdery substance and thereby form the medical or pharmaceutical liquid, after which the liquid is preferably siphoned into the same syringe (8) again in order to transfer it into the cylinder ampoule (7).