EP2001430B1 - System for preparing and making available a flowable medium formed by mixing a dry substance with a fluid - Google Patents

Abstract

A system for preparing and making available a flowable medium (43) that is formed by mixing a dry substance (39) with a fluid (41), in particular a medium for therapeutic purposes includes a) a first container (1) receiving the fluid (41) and has a wall part (3) able to deform counter to a restoring force to change the container volume, b) a second container (35) receiving the dry substance (39), and c) a transfer device (21) for producing a fluid communication between the first container (1) and the second container (35).

Description

The invention relates to a system for preparing and providing a flowable medium formed by mixing a dry substance with a fluid, in particular a medium for therapeutic purposes, with the system components: a first, the fluid receiving container with a deformable volume change against a restoring force wall part ; a second, the dry substance receiving container; and a transfer device for establishing a fluid connection between the first and second containers; wherein the first container for its connection to the transfer device has at one end a head part on which first latching means are provided for forming a latching with second latching means provided on an associated connection device of the transfer device, and wherein the head part has a central, projecting spigot whose end is normally closed by a removable closure member.

Such a system is off DE 31 52 033 A1 known. The known system comprises a container for the sterile storage of medicaments or the like in a particular designed as a bellows Applicator, wherein the container has a pierceable from Appliziergerätstückstückrohr foil wall and below the foil wall a displaceable in the container in the direction of the medicament chamber piston is arranged, which has on its side facing the film wall a recess for sealing entry of Mundstückrohrendes and on the opposite side a Spout protrudes. In the area of a recess defining the spout, a latching shoulder is provided for use in a latching throat in the end region of the mouthpiece tube. When passing through the film wall, the mouthpiece tube penetrates into the recess and locked there.

In many cases, liquid media, which are provided for example for therapeutic purposes or for other purposes, must be freshly prepared in time proximity to the actual use case, because only the components forming the medium are sufficiently stable and / or storable for themselves, but not the ready-made Medium. In practice, therefore, there is often the need to keep a dry substance and a fluid separately from each other until the application of the medium formed from a mixture of dry matter and fluid is pending.

Usually, in this case, the procedure is such that the fluid, for example a solvent, is taken up by means of an injection syringe and injected into a container containing the dry substance. Thereafter, the resulting solution is removed with a new syringe to be applied or administered in the desired manner, which can be done in therapeutic applications such as by injecting, the introduction as an additive in an infusion container or the like.

Such handling operations, which use hypodermic needles, involve the risk of injury. This situation is particularly problematic when working in an environment where HI viruses are likely to be present.

In view of this, the object of the invention is to provide a system for preparing and providing a flowable medium formed by mixing a dry substance with a fluid, which is distinguished by improved handling safety.

This object is achieved by a system having the features of claim 1 in its entirety. According to the characterizing part of patent claim 1, the first latching means of the head part are integrally formed with this, forming a gap along the outer side of the nozzle extending arms, at the free end portions locking bodies are formed, which protrude in the direction of the nozzle.

Due to the fact that a transfer device is present as an additional system component, the fluid exchange between the participating containers required for the preparation and the provision of the medium takes place in a closed functional sequence, ie without a separate handling of the individual containers per se and the mounting of a syringe from the container a container and the injection of the drawn up fluid in the other container would be required. The fact that the fluid receiving the first container has a wall portion which is deformable against a restoring force, the fluid from the first container via the transfer device in which the dry substance receiving Press second container into it, so that takes place in this container mixing the dry matter with the fluid. When this has taken place, the deformable wall part of the first container is released, so that its volume increases again due to the effective force on the first container and thus the prepared medium is sucked into the first container via the transfer device, in which now the finished prepared medium is ready for use. The system according to the invention not only allows safe handling without risk of injury, but also offers due to the closed functional sequence and a special protection against contamination.

Preferably, the deformable against restoring force wall portion of the first container is formed by a an inherent restoring force against deformation having bellows, wherein the head part is preferably integrally formed on the bellows. With such a container is preferably an ampoule-like plastic container which is produced by the known bottelpack ^® molding method, and filled with the respective fluid and provide the wall with folds and is such bellows designed that it can be compressed in axial direction to the expressing contained fluid. A bellows made of suitable plastic material returns to its original shape after removal of the compressive force acting on it, in which the volume of the container is returned to its original size.

In this case, the arrangement may advantageously be such that the head part has a Luer connection in its end region assigned to the connection piece. Further, it is advantageous if a closure piece integral with the neck is provided as a closure part.

In such a design of the head part and the locking means of the first container associated with this container connection device of the transfer device may have a hollow connecting pin, which has an end extension as a seat for receiving the nozzle to form a plug connection with the neck of the first container itself extends with its outer wall surface in the space between the locking means of the head forming arms. In a particularly simple manner, when the plug-in connection is formed by receiving the neck of the first container in the seat of the hollow connecting pin of the transfer device, a fluid-tight connection results, with simultaneous mechanical connection by the cooperating latching means.

The first locking means of the head part may have recessed notches on the locking bodies. As provided on the connection device of the transfer device second locking means in this case locking lugs may be provided which are integrally formed on the outer wall surface of the connecting pin and with the notches interact with the arms of the headboard and secure the formed connector.

In advantageous embodiments, the transfer device in extension of the connecting pin on a through-channel, the end portion is formed as part of the provided for the second container connection means of the transfer device by a projecting cannula, on the same time the fluid connection with the dry substance containing second container is produced, if this has a penetrable by the cannula closure. Such containers, preferably in the form of small-volume glass bottles, are commercially available.

In particularly advantageous embodiments, an auxiliary device may be provided as an additional system component, which facilitates and simplifies the merging of the transfer device and the second container in the positional relationship provided for the penetration of the closure through the cannula. For this purpose, a sleeve body may be provided which is open at one end and at the other end an end plate having a central passage opening for the cannula of the transfer device, wherein the sleeve body is designed so that it forms a guide for the second container, which in the Sleeve body from the open end in the direction of the cannula is inserted. For the implementation of the connection process, therefore, the second container, for example in the form of a small-volume glass bottle of commercial nature, only needs to be inserted into the sleeve body, after the transfer device has been previously inserted through the central passage opening of the end plate in the sleeve body. This ensures that when inserting the container into the sleeve body, the cannula the central area, ie penetrates the penetrable area, the closure of the second container.

In such a design of the sleeve body, this simultaneously forms a protective coating of the inserted cannula. Although such a cannula, in contrast to conventional hypodermic needles, does not constitute a serious risk of injury, the sheathing results in an additional improvement in handling safety.

The invention also provides a container which is provided for use in the system according to the invention and characterized by the features specified in claim 12.

According to claim 16, another object of the present invention relates to the use of a system according to any one of claims 1 to 11 and a container according to any one of claims 12 to 15 for preparing and providing a flowable medium.

• Fig. 1 eine annähernd in natürlicher Größe gezeichnete Seitenansicht einer als erstes Behältnis des Systemes vorgesehenen Faltenbalg-Ampulle;
• Fig. 2 eine abgebrochen gezeichnete Ansicht nur des ihrem Kopfteil benachbarten Bereiches der Ampulle von Fig. 1, demgegenüber um 90° um die Ampullenlängsachse verdreht;
• Fig. 3 eine gegenüber Fig. 1 und 2 stark vergrößert und abgebrochen gezeichnete Teilansicht nur des in Fig. 1 mit Pfeil III bezeichneten Bereiches des mit einem Luer-Anschluss versehenen Stutzens am Kopfteil der Faltenbalg-Ampulle;
• Fig. 4 eine im Längsschnitt gezeichnete Darstellung eines Ausführungsbeispieles des erfindungsgemäßen Systemes, wobei die Systembestandteile wie Faltenbalg-Ampulle von Fig. 1 als ein erstes Behältnis, eine Transfervorrichtung sowie eine Glasflasche als zweites Behältnis in auseinander gezogenen Positionen dargestellt sind;
• Fig. 5 eine der Fig. 4 entsprechende Darstellung, wobei jedoch die Systembestandteile in zusammengesetzter Position und in einem einem ersten Arbeitsschritt des Funktionsablaufes entsprechenden Zustand dargestellt sind;
• Fig. 6 einen gegenüber Fig. 5 stark vergrößert und abgebrochen gezeichneten Teillängsschnitt lediglich des in Fig. 5 mit VI bezeichneten Bereiches;
• Fig. 7A, 7B und 7C der Fig. 5 ähnliche Darstellungen des Systemes, wobei einem zweiten, einem dritten bzw. einem vierten Schritt des Funktionsablaufes entsprechende Betriebszustände dargestellt sind;
• Fig. 8 eine gegenüber einer praktischen Ausführungsform leicht vergrößert gezeichnete Seitenansicht, in der das zweite Behältnis, ein als Anschluss-Hilfsmittel dienender Hülsenkörper sowie lediglich der dem zweiten Behältnis benachbarte Endabschnitt der Transfervorrichtung gezeigt sind, und
• Fig. 9 eine der Fig. 8 entsprechende Ansicht in um 90° demgegenüber gedrehter Darstellung.

The invention is explained in detail below with reference to the drawing. Show it:

• Fig. 1 an approximately natural sized side view of a designated as the first container of the system bellows ampule;
• Fig. 2 a broken drawn view only of the headboard adjacent area of the ampoule of Fig. 1 in contrast, rotated by 90 ° about the ampoule longitudinal axis;
• Fig. 3 one opposite Fig. 1 and 2 strongly enlarged and broken drawn partial view only of in Fig. 1 Area indicated by arrow III the luer fitting on the head portion of the bellows ampule;
• Fig. 4 a drawn in longitudinal section representation of an embodiment of the system according to the invention, wherein the system components such as bellows ampoule of Fig. 1 as a first container, a transfer device and a glass bottle as a second container are shown in exploded positions;
• Fig. 5 one of the Fig. 4 corresponding representation, however, the system components are shown in the composite position and in a corresponding to a first step of the functional sequence state;
• Fig. 6 one opposite Fig. 5 strongly enlarged and broken drawn partial longitudinal section only of in Fig. 5 VI area;
• Figs. 7A, 7B and 7C of the Fig. 5 similar representations of the system, wherein a second, a third and a fourth step of the functional sequence corresponding operating states are shown;
• Fig. 8 a slightly enlarged compared to a practical embodiment side view, in which the second container, serving as a connection aid sleeve body and only the second container adjacent end portion of the transfer device are shown, and
• Fig. 9 one of the Fig. 8 corresponding view in contrast rotated by 90 ° representation.

Fig. 1 shows a designated as a whole with 1 bellows ampoule in the closed state, which forms the first container part of the system according to the invention to be described here. The ampoule 1 is together with the bellows forming its actual receiving space 3, an adjoining as a final part thereto head part 5 and with its outlet opening 9 (FIG. Fig. 3 ) Closing twist knob 7 made in one piece by the known bottelpack ^® method of plastic and filled with a fluid. The plastic material used for the production has a certain elasticity property, so that when the twisting knob 7 is removed, the bellows 3 can be compressed in the axial direction, so that by the corresponding reduction of the volume of the contained fluid from the opening 9 (FIG. Fig. 3 ) can be expressed at the nozzle 11. If the bellows 3 is released, it returns through the given due to its elasticity restoring force in the Fig. 1 shown back home shape, the interior of the bellows 3 again has the initial volume.

Fig. 3 shows the outer shape of the neck 11 of the head part 5, wherein it can be seen that there is a Luer connection 13 at the end region located at the opening 9. As can also be seen from the figures, 11 arms 15 are formed on the head part 5 on both sides of the nozzle, which extend at a distance from the outside of the nozzle 11 in the axial direction. In the vicinity of the end edges of these arms 15 are recessed notches 17 which are provided for locking with a locking rib 19 which is located on a serving as another part of the system transfer device 21. The locking comes off when, starting from the in Fig. 4 shown operating state, the calibration knob 7 of the bellows ampoule 1 is removed and as the next step of the functional sequence, a plug connection with the transfer device 21 is made, as shown in Fig. 5 is shown. Further details of the connector produced with the transfer device 21 are in Fig. 6 on a larger scale clarifies the in Fig. 5 area indicated by VI. As can be seen, this is the nozzle 11 on the head part. 5 within an enlarged seat 23 in a hollow connecting pin 25 of the transfer device 21, wherein the socket 11 in the seat 23 fits, that is, under seal, is added. Like also out Fig. 6 Most clearly seen is the locking rib 19 on the outside of the pin 25 in the vicinity of the free end. The detent notches 17 having arms 15 extending from the head portion 5, starting on the outside of the pin 25 to over the locking rib 19 which snaps into the notches 17.

Figs. 5, 7A, 7B and 7C illustrate the further functional sequence when using the system according to the invention. As can be seen, the transfer device 21 in extension of the seat 23 of the connecting pin 25 on an axial passageway 29, which extends through a thickening 31 which a stop shoulder 32 (FIG. Fig. 4 ) and extends therethrough and ends in an axially protruding cannula 33. A glass bottle 35 functioning as a second container of the system with a closure 37 which can be penetrated through the cannula 33 can be placed against the stop shoulder 32 so that the end of the cannula 33 extends into the interior of the bottle 35. If this is the case, and produced plug connection between bellows ampoule 1 and transfer device 21, now by squeezing the bellows 3, the fluid contained in the ampoule 1 can be expressed and pressed into the bottle 35 via the transfer device 21. This contains for the preparation of the medium to be produced in the initial state, in Fig. 4 is shown, for example, a dry substance 39, to which the fluid, for example a solvent 41, see Fig. 5 , will be added.

Fig. 7A shows as the next step the operating state in which after the mixing of the dry matter 35 with the solvent 41 is the finished medium 43 is located in the bottle 35. In order to return the finished medium from the bottle 35 via the transfer device 21 into the bellows ampoule 1, so that the finished medium is provided therein, can, as in Fig. 7B is presented, so that the system is reversed, whereupon, as in Fig. 7C shown, the compressed bellows 3 is now released, so that the medium 43 is sucked out of the bottle 35 in the bellows ampoule 1 by its increase in volume, see Fig. 7C , After releasing the plug-in connection with the transfer device 21, the finished medium is now provided in the ampoule 1.

8 and 9 show a variant of the system, wherein a connecting means is provided to bring the second container forming bottle 35 easily and conveniently in defined alignment with the transfer device 21. A special feature of the aid is that it simultaneously forms a protective casing for the cannula 33 of the transfer device 21 and thus also a casing for the bottle 35, as is apparent from 8 and 9 can be seen. These figures show that the bottle 35 with inserted cannula is surrounded by a sleeve body 45 in the form of a hollow cylinder which is open at the end facing away from the transfer device 21, so that the bottle in the axial direction in the sleeve body 45 from the open end can be inserted and placed in a position in which the cannula 33 enters the bottle 35. The sleeve body 45 has, at the end lying on the stop shoulder 32 of the transfer device 21, an end plate 44 surrounding a central passage opening for the cannula 33.

As 8 and 9 also show, 45 notches 59 are cut freely in the wall of the sleeve body, which resiliently into the interior of the Sheath 45 extend. When inserting the bottle 35 into the sleeve body 45 snap this wall parts on the bottleneck behind the bottle top 61, so that the inserted into the sleeve body 45 bottle 35 is secured in position. The sleeve body 45 is preferably formed of a transparent plastic material so that, in use of the system, the process of mixing fluid 41 and dry matter 39 can be visually observed.

Claims (16)

1. A system for preparing and making available a flowable medium (43) formed by mixing a dry substance (39) with a fluid (41), in particular a medium for therapeutic purposes, comprising the system components:

   - a first container (1) which holds the fluid (41) having a wall part (3) which can be deformed against a restoring force to change the volume;

   - a second container (35) which holds the dry substance (39); and

   - a transfer device (21) for producing a fluid connection between the first (1) and the second container (35);

   - the first container (1) having for its connection to the transfer device (21) a head part (5) at one end on which catch means (15, 17) are provided for forming locking with second catch means (19) which are present on an assigned connection device (23, 25) of the transfer device (21), and

   - the head part (5) having a central, projecting connection piece (11) the end of which is normally closed by a detachable closure part (7),

   - characterised in that the first catch means of the head part (5) are formed by arms (15) which are integral with the head part and which extend along the outside of the connection piece (11) with the formation of an intermediate space, on the free end regions of the arms catch bodies being moulded which project in the direction of the connection piece (11).
2. The system according to Claim 1, characterised in that the wall part of the first container (1) which can be deformed against a restoring force is formed by a bellows (3) having an inherent restoring force against deformation.
3. The system according to Claim 1 or 2, characterised in that the head part (5) has a Luer connection (13) in the end region assigned to the connection piece (11).
4. The system according to any of the preceding claims, characterised in that a twist-off toggle (7) integral with the connection piece (11) is provided as a closure part.
5. The system according to any of the preceding claims, characterised in that the connection device of the transfer device (21) assigned to the first container (1) has a hollow connecting shank (25) which, in order to form a plug connection with the connection piece (11) of the first container (1) has an end-side widening (23) as a seat for holding the connection piece (11), the connecting shank (25) extending with its outside wall surface into the intermediate space between the arms (15) forming the first catch means (17) of the head part (5).
6. The system according to any of the preceding claims, characterised in that recessed catch notches (17) are provided on the catch bodies moulded onto the arms (15).
7. The system according to Claims 5 and 6, characterised in that a catch rib (19) is provided as a catch means of the transfer device interacting with the catch notches (17) of the arms (15) of the head part (5) on the outside wall surface of the connecting shank (25).
8. The system according to any of Claims 5 to 7, characterised in that the transfer device (21) in an extension of the connecting shank (25) has a through channel (29) the end section of which as a component of the connection device of the transfer device (21) provided for the second container (35) is formed by a projecting cannula (33).
9. The system according to Claim 8, characterised in that the second container (35) has a closure (37) which can be penetrated by the cannula (33).
10. The system according to Claim 9, characterised by an aid (44, 45) for joining the transfer device (21) and the second container (35) in the positional relationship provided for penetration of the closure (37) by the cannula (33).
11. The system according to Claim 10, characterised in that the aid has a sleeve body (45) which is open on one end and on the other end has an end plate (44) with a central through opening for the cannula (33) of the transfer device (21), and that the sleeve body (45) forms a guide for the container (35) which can be inserted into the sleeve body (45) from the open end in the direction of the cannula (33).
12. A container (1) for a system according to any of Claims 1 to 11, characterised in that it has a wall part which can be deformed against restoring force and which is formed by a bellows (3) having an inherent restoring force against deformation.
13. The container according to Claim 12, characterised in that the container (1) has for its connection to the transfer device (21) on one end of the bellows (3) a head part (5) on which there are catch means (15, 17) for forming locking with catch means (19) which are present on an assigned connection device (23, 25) of the transfer device (21).
14. The container according to Claim 13, characterised in that the head part (5) has a central, projecting connection piece (11) the end of which is normally closed by a detachable closure part, preferably a twist-off toggle (7) integral with the connection piece (11).
15. The container according to Claim 14, characterised in that the catch means of the head part (5) are formed by arms (15) which are integral with the head part and which respectively extend along the outside of the connection piece (11) with the formation of an intermediate space, on the free end regions of the arms catch bodies are moulded which project in the direction of the connection piece (11) and on which there are recessed catch notches (17).
16. The use of a system according to any of Claims 1 to 11 and of a container according to any of Claims 12 to 15 for preparing and making available a flowable medium (43), in particular a medium for therapeutic purposes, by applying a compressive force to the deformable wall part (3) of the first container (1) its volume being reduced and the fluid (41) thus being forced into the second container (35) by means of the transfer device (21), and after mixing the fluid (41) with the dry substance (39) located in the second container (35) the application of the compressive force to the deformable wall part (3) being ended so that due to the increase in volume which is caused by the restoring force of the wall part (3) the medium (43) is sucked into the first container (1) and is made available in the latter for use.

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