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:
FIELD OF THE INVENTION 
     The present invention relates to a system for preparing and making available a flowable medium formed by mixing a dry substance with a fluid, in particular a medium for therapeutic purposes. 
     BACKGROUND OF THE INVENTION 
     Fluid media intended, for example, for therapeutic purposes or other purposes must often be freshly prepared close to the time they are actually to be used, because only the components forming the medium are inherently stable and/or storable enough. The ultimately prepared medium may not be inherently stable or storable enough. In practical applications, it is often necessary to store a dry substance and a fluid separately from one another until the use of the medium formed from a mixture of the dry substance and the fluid is imminent. 
     Generally the procedure followed involves taking the fluid, for example, a solvent, by a hypodermic needle and injecting it into a container containing the dry substance. Afterwards the resulting solution is removed with a new syringe to be applied or administered in the desired manner. In therapeutic applications, this administration can take place, for example, by injection, placement as an additive in an infusion container or the like. 
     Such application processes, in which injection needles are used, entail the risk that injuries can occur. This circumstance is extremely problematical when working in an environment in which the presence of HIV viruses can be expected. 
     SUMMARY OF THE INVENTION 
     An object of the present invention is to provide a system for preparing and making available a flowable medium formed by mixing a dry substance with a fluid, where the system has improved handling safety. 
     This object is basically achieved by a system, according to the present invention, including a transfer device as the additional system component. The fluid exchange between the containers involved necessary for preparing and making available the medium takes place in a closed operating process, i.e., without separate handling of the individual containers themselves and drawing up a syringe from one container and injection of the withdrawn fluid into the other container having been necessary. Because the first container holding the fluid has a wall part which can be deformed against a restoring force, the fluid from the first container can be forced by the transfer device into the second container holding the dry substance. In the latter container, the dry substance is then mixed with the fluid. When this mixing has taken place, the deformable wall part of the first container is released. As a result of the restoring force acting on the first container, its volume increases again and thus the prepared medium is intaken via the transfer device into the first container in which now the completely prepared medium is ready for use. The system according to the present invention enables safe handling without the risk of injury, and as a result of the closed operating process offers special protection against contamination. 
     Preferably, the wall part which can be deformed against the restoring force is formed by a bellows having an inherent restoring force against deformation. This container is preferably an ampule-like plastic container produced using the known Bottelpack® molding process and filled with the pertinent fluid. The container wall is provided with folds and is designed bellows-like such that it can be compressed in the axial direction to express the enclosed fluid. Such bellows formed from a suitable plastic material, after the compressive force acting on it is removed, returns to its original shape in which the volume of the container is returned to its original size. 
     Preferably, the first container for its connection to the transfer device on one end of the bellows can have a head part molded onto the bellows in one piece. On the head part, a catch is provided for engaging the catch present on a connecting means of the transfer device. 
     Preferably, a central, projecting connection piece has an end normally closed by a removable closure part, preferably a twist-off toggle integral with the connection piece. 
     The catch of the head part can be formed by arms integral with the head part and extending along the outside of the connection piece with the formation of an intermediate space. On the free end regions of the arms, catch bodies are molded which project in the direction to the connection piece and on which there are recessed catch notches. 
     In such configuration of the head part and of the catch means of the first container, the connecting means of the transfer device assigned to this container can have a hollow connecting shank. In order to form a plug connection with the connection piece of the first container, the connecting shank has an end-side widening as a seat for holding the connection piece extending with its outside wall surface into the intermediate space between the arms forming the catch of the head. In an especially simple manner, when the plug connection is formed by the holder of the connection piece of the first container in the seat of the hollow connecting shank of the transfer device, a fluid-tight connection is formed with simultaneous mechanical connection by the interacting catch means. 
     As catch means provided on the connecting means of the transfer device, catch projections can be molded onto the outer wall surface of the connecting shank and can interact with the catch notches on the arms of the head part to ensure that the plug connection has been formed in this way. 
     In advantageous embodiments, the transfer device in an extension of the connecting shank has a through channel. A channel end section is a component of the connecting means of the transfer device intended for the second container. The channel end section is formed by a projecting cannula. At the same time a fluid connection can be produced with the second container containing the dry substance, the second container closure can be penetrated by the cannula. Containers such as these, preferably in the form of small-volume glass bottles, are standard. 
     In especially advantageous embodiments, an additional system component can be a device which facilitates and simplifies joining the transfer device and the second container in the positional relationship provided for penetration of the closure by the cannula. For this purpose, a sleeve body is open on one end and on the other end has an end plate with a central through opening for the cannula of the transfer device. The sleeve body is designed such that it forms a guide for the second container which can be inserted into the sleeve body from the open end in the direction to the cannula. To implement the connection process, the second container, for example, in the form of a small-volume glass bottle of the conventional type, need simply be pushed into the sleeve body after the transfer device has been inserted beforehand into the sleeve body through the central through opening of the end plate. This arrangement ensures that when the container is pushed into the sleeve body the cannula penetrates the central region, i.e., the region of the closure of the second container which can be penetrated. 
     In this configuration of the sleeve body, at the same time it forms a protective jacket of the inserted cannula. Although this cannula, in contrast to conventional injection needles, does not pose a significant injury risk, an additional improvement of handling safety is achieved by the jacketing. 
     The present invention is also a container intended for use in the system according to the present invention. 
     This invention also relates to the use of a system and a container for preparing and making available a flowable medium. 
     Other objects, advantages and salient features of the present invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses a preferred embodiment of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Referring to the drawings which form a part of this disclosure: 
         FIG. 1  is a front elevational view of a bellows ampule intended as the first container of the system, shown approximately in natural size, according to an exemplary embodiment of the present invention; 
         FIG. 2  is a partial side elevational view of only the region of the ampule from  FIG. 1  adjacent to its head part, turned 90° around the longitudinal axis of the ampule; 
         FIG. 3  is a partial front elevational view solely of the region of the connecting piece provided with a Luer connection on the head part of the bellows ampule, which region is identified with arrow III in  FIG. 1 , and which view is shown detached and greatly enlarged relative to  FIGS. 1 and 2 ; 
         FIG. 4  is an exploded side elevational view, partially in section, of one embodiment of the system according to the present invention including the bellows ampule of  FIG. 1  as a first container, a transfer device and a glass bottle as the second container; 
         FIG. 5  is a side elevational view, partially in section, of the system of  FIG. 4  in the assembled position and in a state corresponding to a first working step of the operating sequence; 
         FIG. 6  is a partial elevational view in section of the region designated as VI in  FIG. 5 , greatly enlarged compared to  FIG. 5 ; 
         FIGS. 7A ,  7 B and  7 C are side elevational views partially in section of the system which are similar to  FIG. 5  in the operating states corresponding to second, third and fourth steps of the operating sequence, respectively; 
         FIG. 8  is a side elevational view slightly enlarged relative to a practical embodiment, in which the second container, a sleeve body used as a connecting device, and only the end section of the transfer device adjacent to the second container are shown, and 
         FIG. 9  is a front elevational view corresponding to  FIG. 8  and turned 90° relative thereto. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  shows a bellows ampule  1  in a closed state forming a component of the system according to the present invention and described here as the first container. The ampule  1  includes bellows  3  forming its actual receiving space, a head part  5  adjoining bellows  3  as a closure part, and a twist-off toggle  7  closing its outlet opening  9  ( FIG. 3 ), is produced using the known Bottelpack® process from plastic in one piece, and is filled with a fluid. The plastic material used for production has a certain elastic property so that when the twist-off toggle  7  is removed, the bellows  3 , forming a deformable wall part of the container, can be compressed in the axial direction so that by a respective reduction of the volume the contained fluid can be expressed from the opening  9  ( FIG. 3 ) on the connection piece or hollow central projection  11 . If the bellows  3  is released, due to the restoring force dictated by its elasticity it returns to the original shape shown in  FIG. 1 , with the interior of the bellows  3  again having the initial volume. 
       FIG. 3  shows the outside shape of the connection piece  11  of the head part  5 . On the end region having the opening  9 , there is a Luer connection  13 . Arms  15  with catch bodies are molded onto the head part  5  on both sides of the connection piece  11  and extend in the axial direction at a distance from the outside of the connection piece  11 . In the vicinity of the end edges of these arms  14 , there are recessed catch notches  17  intended for locking with a catch rib  19  located on a transfer device  21  used as another component of the system. Locking occurs when, proceeding from the operating state shown in  FIG. 4 , the twist-off toggle  7  of the bellows ampule  1  is removed and as the next step of the operating sequence a plug connection to the transfer device  21  is established, as is shown in  FIG. 5 . Details of the plug connection produced with the transfer device  21  are illustrated in  FIG. 6  on a larger scale showing the region VI in  FIG. 5 . The connection piece  11  is located on the head part  5  within a widened seat  23  in a hollow connection shank  25  of the transfer device  21 , and is suitably held in the seat  23 , i.e., sealed. As most clearly shown in  FIG. 6 , the catch rib  19  is located on the outside of the shank  25  in the vicinity of its free end. The arms  15  having the catch notches  17  extend from the head part  5  over the outside of the shank  25  to above the catch rib  19  which snaps into the notches  17 . 
       FIGS. 5 ,  7 A,  7 B, and  7 C illustrate the continuing operating sequence in the use of the system according to the present invention. As is apparent, the transfer device  21  in an extension of the seat  23  of the connecting shank  25  has an axial through channel  29  extending through a thickened region  31  forming a stop shoulder  32  ( FIG. 4 ), and ends in an axially projecting cannula  33 . A glass bottle  35  acting as the second container of the system has a closure  37  which can be penetrated by a cannula  33 , and can be placed on the stop shoulder  32  so that the end of the cannula  33  extends into the interior of the bottle  35 . When this is the case, and when a plug connection has been established between the bellows ampule  1  and the transfer device  21 , by compressing the bellows  3  the fluid in the ampule  1  is expressed and forced into the bottle  35  via the transfer device  21 . For preparing the medium to be produced, in the initial state shown in  FIG. 4  the bottle contains, for example, a dry substance  39  to which the fluid, for example, a solvent  41 , see  FIG. 5 , is added. 
       FIG. 7A  shows as the next step the operating state in which after mixing the dry substance  35  with the solvent  41  the prepared medium  43  is in the bottle  35 . To return the prepared medium from the bottle  35  via the transfer device  21  to the bellows ampule  1  so that the prepared medium is made available in it, as is shown in  FIG. 7B , the system is turned around, whereupon, as is shown in  FIG. 7C , the compressed bellows  3  is now released so that due to the increase of its volume the medium  43  is sucked back out of the bottle  35  into the bellows ampule  1 , see  FIG. 7C . After releasing the plug connection with the transfer device  21  the prepared medium is now made available in the ampule  1 . 
       FIGS. 8 and 9  show a version of the system with a connection device to bring the bottle  35  forming the second container easily and comfortably into defined alignment with the transfer device  21 . One particular feature of the device is that at the same time it forms a protective jacket for the cannula  33  of the transfer device  35 , as is apparent from  FIGS. 8 and 9 . These figures show that the bottle  35  with the cannula inserted is surrounded by the sleeve body  45  in the form of a hollow cylinder which is open on the end facing away from the transfer device  21 , so that the bottle can be pushed into the sleeve body  45  in the axial direction from the open end and can be moved into a position in which the cannula  33  enters the bottle  35 . The sleeve body  45  on the end lying on the stop shoulder  32  of the transfer device  21  has an end plate  44  surrounding the central through opening for the cannula  33 . 
     As  FIGS. 8 and 9  moreover show, in the wall of the sleeve body  45  notches  59  are cut out extending elastically into the interior of the jacket  45 . When the bottle  35  is pushed into the sleeve body  45 , these wall parts on the bottle neck snap in behind the top part of the bottle  61 . The bottle  35  which has been pushed into the sleeve body  45  is then secured in position. The sleeve body  45  is preferably molded from a transparent plastic material so that when the system is being used the process of mixing of the fluid  41  and the dry substance can be visually observed. 
     While one embodiment has been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the appended claims.