DE4400510A1 - Container, in particular drug container - Google Patents

Abstract

The invention relates to a container, preferably to a drug container, for the sterile mixing of drugs consisting of two or more components. The container is designed such that further containers are located inside the container, the further containers housing the different components separately. Using an injection cannula which is initially introduced into the outer container and then consecutively into the inner containers (ampoules), the mixing procedure principally takes place by the conventional method and the drug is subsequently drawn into the syringe. The opening of the outer container through which the cannula is introduced is filled by a type of silicone plug which ensures that the interior of the outer container remains sterile even after introduction and removal of the injection cannula. Since handling is practical, the time expenditure is in no way higher than before, and in fact it is rather less, and the risk of injury to the user is likewise less, while storage of an open ampoule in the container is unproblematical because the interior is sterile and - and this is probably the most significant advantage - infectious diseases caused by non-sterile medicaments can thus be avoided. Various embodiments of the container according to the invention permit its application in many medical fields. <IMAGE>

Description

Substances are known which consist of two or more components. You need z. B. in ampoules, bottles, tubes or pillow-like, elastic plastic containers stored separately are and are only closed shortly before the substance is used mix.

Unpacking the tubes (e.g. ampoules) from their outer packaging, the currently used mixing of the components represents one Process that is cumbersome and time consuming and beyond does not meet the sterile requirements in medicine.

Is z. B. a medical component (K1) like Aquarest from one Ampule A drawn onto a syringe to a second component (K2), e.g. B. in the form of a pulverized mass, so add the cannula must be pulled out of the first ampoule A, gets contact with the air and is already in that moment non-sterile, is placed on the second ampoule B, the wound up Aquarest (K1) is divided into the powdered component (K2) filled ampoule B and both components are now mixed together by shaking.

During this process, the syringe cannula must remain in the ampoule B, so that it is not exposed to the air again. Hold the syringe and ampoule in one hand while shaking is very cumbersome and difficult especially when difficult to solve components should be mixed together.

Mixing can also be caused by the air contact between the cannula and the opened ampoule is not carried out under sterile conditions become.  

The outer packaging elements as well as broken ampoule heads or Bottle caps, the latter pose an additional risk of injury at the user (doctor or nursing staff), make increased attention necessary and thereby take additional handling time.

Too many different actions are necessary, if in particular under time pressure a patient a certain medication to be administered. And this is not what is desirable Work processes in hospitals, medical practices and at mobile use in aircraft and ambulances or outdoors, e.g. B. in traffic accidents or disasters.

There is already a comprehensive one to solve this problem Potential for ideas, as can be seen from the numerous patent documents is. That none of these ideas has yet been realized on the market, may be because the inventions are too complex and the Manufacturing costs are too high or due to the lack technical feasibility.

The object of the present invention is to take precautions meet, the sterile mixing of two or more components to ensure and simplify according to handling criteria, in accordance with the economic and technical Requirements, e.g. B. to avoid injury to the user or to save packaging.

This object is achieved in that two or several ampoules, bottles or similar shock-absorbing in a container a sterile closable opening are stored so that a Spray cannula without problems when piercing this opening one after the other into which ampoules or bottles can be inserted, where at least part of the container interior is sterile is fulfilled and hermetically sealed.

In variant A (drawing 1) z. B. the container ( Fig. 1) is provided with two diagonally extending troughs 4 of preferably shock-absorbing material 3 , in each of which an ampoule 5 a and 5 b is to be inserted so that the closures indicate the cannula inlet. On the front 15 of the housing 1 there is an opening with a z. B. rubber-like plug 2 , (preferably made of silicone) is filled, through which the syringe 17 after removal of the protective film 14 , which keeps the closure sterile, is pushed. Because the silicone is airtight around the cannula, the best possible sterility is guaranteed.

Due to the diagonal position of the two ampoules and their foil closures 16 (plastic or thin metal foil, whereby rubber plugs are also conceivable), which can only be pierced, the cannula can be inserted into the first ampoule 5 a from the container opening 2 without any problems.

The drug component 6 is drawn onto the syringe ( FIG. 2), the cannula leaves the first ampoule 5 a, but not the sterile container ( FIG. 1), is introduced into the second ampoule 5 b with the second component 7 , the syringe ( Fig. 2), which contains the first drug component 6 , is emptied, both components mix by z. B. shaking the container ( Fig. 1) in the ampoule 5 b, the syringe 17 a does not leave the ampoule 5 b.

After the mixing process is complete, the mixed can now 2-component drug drawn on the syringe and be used for its purpose.

For further relief or advantages when mixing a To achieve multi-component drug is the inventive Container expandable:

The shape of the container can be freely designed in such a way that also commercially available ampoules and bottles made of glass or Plastic, tubes or z. B. also elastic plastic pillows  can be used, even in different sizes or can also be combined with one another in shape and size (e.g. tube and bottle).

In the manner according to the invention there are also more than two components miscible with each other, with more than three components an advanced technique should be used that will be explained in more detail below.

In any case, the components can be in any physical state assume: solid, liquid, gaseous.

So that shaking in the hand is not as cumbersome as before, because ampoule and syringe during the shaking process at the same time must be held, the housing is with a Equip clamp for the syringe.

It is also advantageous if the container with a rubber-like, encased ergonomically and easy to use shaped layer is that at the front of the case, where the Opening of the container is designed so that it Allows a syringe to jam during the mixing process, so that an additional holding clamp is no longer required. The inventive variant C in drawing 2 shows such a casing, which is also particularly heat-insulating.

Furthermore, the container is preferably such that it is of at least one side is transparent and thus the view on the ampoule, bottles etc. releases and that it is for the purpose of Reusability is made up of two or more parts to make it returned to the manufacturer after use, cleaned, can be disinfected and refilled.

For the manufacture of the container are preferably Materials to use glass, plastic and / or metal, where these can also be combined with one another.

It is obvious to use specially crafted and equip recyclable ampoules or bottles or that  part of the container has cavities into which the drug Components must be filled in sterile and sterile until removed be stored.

It is also possible to manufacture the container that it can also be opened by the hospital staff so that the container can be filled by him as needed, because cleaning and Disinfection devices for e.g. B. OR cutlery is in hospitals in usually present.

The usual written information on the outer packaging today or any leaflets inside the packaging omitted because the necessary information about content and Composition of the substances and / or solutions contained one side, preferably the bottom, of the container printed or, e.g. B. can be glued on with foil.

In addition, the rubber-like casing with chambers be provided in the, sterile packed in foil, one or more Spray equipment is stored so that it can be applied quickly in an emergency can be accessed.

A particularly inexpensive variant (B) is, in addition to the stable container described above, an elastic film container (drawing 1, Fig. 3).

Here the ampoules 11 a and 11 b are welded into film 8 . A sterile cavity 9 is located in front of the ampoule closures 18 .

So that the foil does not tear when the syringe ( FIG. 4) is inserted into this cavity, there is preferably also a silicone plug 10 here , through which the cannula 17 b into the cavity 9 and, one after the other, into the ampoules 11 a, 11 b is inserted without leaving the cavity 9 in between. As a result, the mixing process can be carried out step by step without the cannula being exposed to the air and thus becoming non-sterile.

A foil closure (plastic or thin metal foil, 18 ) is also sufficient here so that there are no problems when the cannula penetrates the ampoules. To maintain sterility, it is advantageous if the silicone plug 10 is also provided with a removable protective layer.

Further details emerge from the drawing 1, in which Fig. 1 denotes a stable container according to the invention, with 1 the housing wall, with 2 the rubber-like plug at the cannula entrance, with 3 the housing interior (preferably equipped with insulating material), with 4 the Ampoule wells, with 5 a and 5 b the ampoules, with 6 a liquid medicinal component, with 7 a powdered component, with 14 the removable film, with 15 the front and with 16 the film-like ampoule closures. Fig. 2 shows a syringe, 17 a its cannula.

Fig. 3 shows an elastic film container according to the invention, 11 a and 11 b denoting the welded ampoules, 12 a liquid drug component, 13 a powdered, 8 the film, 9 a sterile cavity in front of the ampoule closures 18 and with 10 a silicone-like closure for introducing the cannula 17 b. Fig. 4 shows the syringe belonging to the cannula.

If a multi-component drug comes e.g. B. in disaster areas or used in accidents, it is especially unprofitable in terms of time, one each equipped for only one mixing process To use containers.

To z. B. a two-component drug within a short To repeatedly use the time interval contains a container according to the invention a movable magazine that with Chambers is equipped in which miscible with each other Components are stored separately, in ampoules, Bottles, tubes, elastic plastic containers or similar  

Such a container variant (C) is shown in the illustrations in Drawing 2.

Between the opening 39/40 of the container ( Fig. 5) and the magazine 19 is a stable channel 22 for the insertable syringe 44 , at the inner end, near the magazine, there is an ampoule opening device in the manner of a sharp folding bolt 24 , which is then is put into operation if the z. B. filled with ampoules by rotating the rotary switch 36 on this device.

Here, the ampoule closure moves with its predetermined breaking point 42 onto the sharp edge of the bolt, the closure 34 of the ampoule 30 breaking off and access to the contents of the ampoule being free for a syringe cannula 44 .

With a further slight rotary movement, the magazine 19 can be moved further and engages with the opened ampoule 30 at the point where it stops, where the already mentioned inner cannula channel 22 ends.

On the outer wall of the container there is an openable closure with a sterile, removable film 39 , which is equipped in such a way that the cannula 44 of a syringe ( FIG. 7) first pierces a silicone-like plug 40 , then is guided through the cannula channel 22 , through another silicone-like plug 41 and opens into the open ampoule 30 in order to pull up the first medical component (K1) (see FIG. 1).

After this operation, the cannula 22 is pulled back a little, out of the now empty ampoule 31 , but remaining in the cannula channel 23 (see FIG. 2).

By a further rotation of the magazine, which in this case slips out of the anchoring, the next ampoule 38 with the second component (K2) is decapitated at its predetermined breaking point by the folding bolt 25 and, after a further slight rotary movement, engages again at the end of the cannula channel 23 .

The injection cannula 45 is then inserted deeper again so that it opens into the second ampoule 38 . The contents 46 of the syringe ( FIG. 8) are then injected into this second ampoule, so that both components can mix with one another, preferably by shaking the container ( FIG. 6).

In order to facilitate the shaking process in the hand, the housing is encased with an ergonomically shaped, rubber-like layer 21 , as described above, which is shaped on the head part in such a way that it functions as a syringe holder 27 .

After mixing, the finished medication can now be taken from the ampoule be drawn onto the syringe. So that no residual liquid from the empty ampoules through the Housing is running, it is advantageous if after inserting the Ampoules in the magazine create a vacuum inside the container becomes.

Now that the syringe is filled with the medication, the cannula is pulled out of the container, the cannula channel automatically closing again, since at the beginning and preferably also at the end of the channel there are the silicone plugs 40 and 41 through which the cannula is located pushes through and which after leaving the needle 44, 45 contract so that they become tight and airtight.

Even with an inventive magazine-containing You have different ways of using the container e.g. T. can be combined with each other:

The magazine is equipped in such a way that standard ampoules, Bottles, tubes and other containers, e.g. B. elastic  Plastic pillows can be used, whereby for bottles, Tubes and elastic plastic containers other opening devices are to be created as for ampoules with z. B. Predetermined breaking points.

Bottles can e.g. B. for use according to the invention sealing plugs and tubes only sealed with a film be pierced with the syringe. Elastic plastic cushions can be pierced directly from the cannula become.

In these cases, folding bolts are not absolutely necessary. she but must be present when z. B. ampoules with predetermined breaking points and bottles with foil closures combined in the magazine should be used.

Since the density of the components to be mixed, depending on the type of medicament, can be of different heights and, if appropriate, the use of different ampoule or bottle sizes, particularly in the case of the commercially available ones, is advantageous, the chambers 28 of the magazine are the same or as required manufactured in different shapes and sizes, either specifically for certain types of medication or universally applicable. The size of the container also depends on the size of the magazine.

Ampoules 29 , bottles etc. specially made for the magazine, which are fitted into the storage or chambers 28 provided for this purpose, e.g. B. are also provided with notches or the like and have their counterpart in the warehouse of the magazine so that they do not slip in it.

So that the opened ampoule does not during the work process slips or the inadvertent turning of the magazine is prevented, is located below the magazine under one chamber and / or between the chambers Holding device.  

In addition, all others apply to this container Extensions to the container described above as variant A. has been.

The drawing 2 shows in Fig. 1 a container according to the invention ( Fig. 5) with magazine 19. With 21 the rubber-like layer that encases the housing is designated, with 27 the designed part of this layer, which serves as a syringe holder, with 39 the removable protective film and with 40 the silicone-like plug, each at the cannula entrance, with 22 the cannula channel, with 41 the silicone-like plug at the outlet of the cannula channel, with 35 the axis of the rotary switch 36 , with 28 the magazine chamber for the storage of the ampoules, with 29 die closed ampoules containing a liquid pharmaceutical component, with 32 and 33 the closed ampoules containing a pulverized component and with 30 an ampoule filled with liquid component, which was already opened by the folding bolt 24 at its predetermined breaking point 42 .

With 34 the broken-off ampoule head is designated, with 26 a cavity filled with insulating material, which stores the broken-off ampoule heads 34 . The interior 20 of the housing is filled with fibrous materials or other insulating materials 43 for additional shock protection.

FIG. 7 shows a syringe cannula 44 inserted into the opened ampoule 30 , which is intended to draw up the liquid content of the ampoule.

Fig. 2 shows the next step with the container according to the invention ( Fig. 6):

FIG. 6 shows the syringe now drawn up with the liquid component 46 , the cannula 45 of which has been drawn back out of the emptied ampoule 31 into the cannula channel 23 .

The ampoule 38 has just been opened by the folding bolt 25 by turning the rotary switch 37 in order to be rotated further into the correct position so that the cannula can be inserted into the second ampoule 38 .

In the previous embodiment, the magazine that As required, all around with eight ampoule chambers for four Use with a 2-component drug.

The use of a rotating magazine container is u. U. also advantageous for the multiple use of one-component drugs, e.g. B. also in disaster relief.

But also for the simple use of 2- or multi-component The container according to the invention is not only medicinal according to Variants A and B, but also with magazine according to variant C usable.

Is there a drug e.g. B. from three components, it is possible to manufacture the magazine so that the ampoules are parallel to each other trending chambers are used and the magazine z. B. not rotated, but for the change from right to left or to be reversed, preferably also here z. B. the Notches or similar are provided on the underside of the container housing, so that the magazine engages so that the ampoule openings opposite the cannula channel exit and do not slip can.

If a medicine consists of z. B. five components, so here is again a rotary magazine with 5 or standardized 6 chambers advantageous.

An extended variant (D) is shown in drawing 3:

The container according to the invention consists of two elements, the element with the sterile interior ( Fig. 10/12) being compatible with other, different container elements ( Fig. 11 and Fig. 13).

The sterile element has its cannula inlet (opening) on the front 47 , which is also provided here with rubber plugs and sterile pull-off film 48 .

On the three rear sides 53 a to 53 c there are arrangements 54 a to 54 c for piercing the cannula, which are preferably also provided with rubber plugs, so that the sterile element (FIGS . 10, 12) assumes the function of the cannula channel of version C.

The sterile element ( Fig. 10) in Fig. 1 is put together by means of holding clamps 60 or the like with an element ( Fig. 11) which contains three different medicament containers 55 a to 55 c. The injection cannula leads here through the rubber-like stopper 48 , through the interior and through the stopper 54 c on the side 53 c opposite on the side into the bottle 55 c.

The second example in Fig. 2 shows an element ( Fig. 13) that is intended for only two pharmaceutical vials 55 d and 55 e.

58 and 59 denote the housing walls and 49 and 50 the insulating materials in the interior of the housing in FIGS . 11 and 13, with 52, 56 and 57 the glass plates, which are located on all three housing elements.

A manufacturing company is able to because of Versatility of the subject matter of the invention an extensive and to build future-oriented product line that Mixing two or more drug components is an optimum of global, time-saving and safety-related application options as well as the best possible sterility at Application offers.

In addition, this system is also outside of the system if required medical field applicable, - in areas in which with more than one component is being worked on.

Claims (41)

1. Container for sterile mixing of two or more components, characterized in that in the interior of the container ( Fig. 1) at least two smaller containers, in particular drug containers ( 5 a and 5 b, drawing 1) such as. B. ampoules that are shockproof embedded in preferably insulating materials ( 3 ) and / or integrated in a movable magazine ( 19 , drawing 2) that the container interior or part of its interior is sterile and hermetically sealed and that the container is preferably a has a sterile closable opening ( 2, 14 , line 1, 39, 40 , drawing 2). 2. Container according to claim 1, characterized in that the opening is preferably on the front ( 15 ) or top (see FIG. 3, drawing 1) of the container and preferably with a rubber (silicone) -like plug ( 2, 40 ) and is sealed with a sterile, removable protective film ( 14, 39, 48 ). 3. Container according to claim 1 or 2, characterized in that the medicament containers ( 5 a, 5 b) are arranged in a star shape / diagonally, with the openings or closures ( 16 ) pointing inwards, so that they face each other and / or located diagonally opposite the container opening ( 2/14 ). 4. Container according to one of claims 1 to 3, characterized in that the materials in which the medicament containers are embedded, have troughs ( 4 ), chambers or the like, which preferably form the medicament container ( 5 a / 5 b) and size adjusted and which may be provided with notches, small wedges or the like. 5. Container according to one of claims 1 to 4, characterized in that the smaller medicament containers ( 5 a / 5 b) located in the container contain multi-component medicaments and that these containers are preferably commercially available ampoules, bottles or Tubes made of plastic, glass or metal or elastic plastic cushions are available, which are available in different shapes and sizes and which can also be combined with one another and used in the container. 6. Container according to one of claims 1 to 5, characterized, that the size and shape of the container varies according to the size and shape the smaller drug container and / or the portable one Magazine. 7. Container according to one of claims 1 to 6, characterized, that the drug containers containing the components specifically manufactured and recyclable for the container according to the invention are and / or closable cavities within the container are to be filled with component medicines. 8. Container according to one of claims 1 to 7, characterized in that the container is recyclable and consists of one or more assembled elements that are to be assembled or put together ( Fig. 10 to 13). 9. Container according to one of claims 1 to 8, characterized, that the container housing made of the materials plastic, glass and / or metal, with at least the part of the top of the housing, which is above the smaller medicine containers, transparent is. 10. Container according to one of claims 1 to 9, characterized in that the sterile housing element ( Fig. 10, 12, drawing 3) can be used in a compatible manner with different, variable elements equipped with medicament containers ( Fig. 11 and Fig. 13, Drawing 3). 11. Container according to one of claims 1 to 10, characterized in that that the container is designed so that it is only from the Manufacturer can be reprocessed or that it can be or practice staff to clean themselves with the help of appropriate equipment, is to be sterilized and refilled. 12. Container according to one of claims 1 to 11, characterized in that the housing is equipped with a holder for the syringe is. 13. Container according to one of claims 1 to 12, characterized in that the housing is partially covered by a rubber-like, preferably ergonomically shaped layer ( 21 ) which is shaped in the opening region of the housing in particular so that it serves as a syringe holder ( 27 ) . 14. Container according to claim 13, characterized in that the housing casing is equipped with a chamber in the, preferably sterile packed in foil, a cutlery stores. 15. Container according to claim 13 and 14, characterized in that the layer encasing the housing has a heat-insulating effect. 16. Container according to one of claims 1 to 15, characterized in that that written information about the medication and / or the Instructions for use etc. on the container, preferably on its Underside, printed or, e.g. B. are glued on with foil. 17. Container according to one of claims 1 to 16, characterized in that instead of the stable container, a film container ( Fig. 3, drawing 1) comes into play, in which the medicament containers are welded or a rigid plastic film the medicament container (such as an outer packaging) encloses. 18. Container according to one of claims 1 to 17, characterized in that in front of the closures of the smaller drug containers a sterile cavity is located. 19. Container according to one of claims 1 to 18, characterized in that that there is a rubber-like plug on the film, which with a removable, e.g. B. metal foil is kept sterile.   20. Container according to one of claims 1 to 19, characterized in that the smaller drug containers within the larger one Container through plastic films or metal foils or through rubber-like stoppers are closed. 21. Container according to one of claims 1 to 20, characterized in that the film container is shaped so that instead of the smaller one Drug containers the components are filled directly. 22. Container according to one of claims 1, 2, 4 to 16 and 20, characterized in that a movable magazine located in the container is equipped with chambers ( 28 , drawing 2) in which medicament containers are stored, the chambers being one or have several unit sizes or are specially tailored to the size and shape of certain pharmaceutical containers. 23. Container according to one of claims 1, 2, 4 to 16, 20 and 22, characterized in that the magazine is rotatably equipped with a rotary switch ( 36 ) which the star-shaped drug container, with the closures to the outside, by rotating movements in brings the opposite position of the container opening. 24. Container according to one of claims 1, 2, 4 to 16, 20, 22 and 23, characterized, that the chambers of the magazine position parallel to each other, the magazine with z. B. a lever back and forth and thereby the medicine container alternately in the opposite position of the container opening.   25. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 24, characterized in that there is a stable cannula channel ( 22, 23 , drawing 2) between the magazine and the container opening, at the entrance and / or exit there is preferably in each case a rubber-like plug ( 40, 41 ) which has the property of contracting again after piercing a cannula in such a way that it regains its original shape. 26. Container according to one of claims 1 to 25, characterized, that instead of rubber-like stoppers, air-tight valves or other commercially available, airtight closures than Serve cannula inlet. 27. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 26, characterized in that commercially available ampoules with z. B. predetermined breaking points ( 42 ), also in combination with other commercially available pharmaceutical containers, and / or especially for the magazines, suitable, reusable ampoules or bottles, which are preferably provided with notches or the like, whose matching counterparts are in the chambers of the magazine. 28. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 27, characterized in that an ampoule opening device, preferably a folding bolt ( 24 , drawing 2) is located between the cannula channel and the magazine. 29. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 28, characterized, that the magazine is constructed so that due to z. B. Notches or small wedges or the like below or to the side of the magazine Snap it into place or anchor it to the desired one Places. 30. Container according to one of claims 1 to 29, characterized, that a valve is present in the housing wall through which With the help of an appropriate device, the container housing Oxygen is withdrawn and a (sterile) vacuum is created. 31. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 30, characterized in that the interior, between the housing wall and the magazine, shock-absorbing materials ( 20 ), for. B. contains fibrous materials. 32. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 31, characterized in that there is a separate cavity ( 26 , drawing 2) next to the folding bolt, which catches the cut ampoule heads ( 34 ) and due additional insulation materials prevents the ampoule heads from falling apart. 33. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 32, characterized, that the container with magazine for one or more times Use is usable.   34. Container according to one of claims 1, 2, 4 to 16, 20, 22 to 33, characterized, that the container with magazine is also suitable for repeated use Use of a one-component drug is suitable. 35. Container according to one of claims 1 to 34, characterized, that different chambers or different housing elements are optically highlighted, e.g. B. by coloring. 36. Container according to one of claims 1 to 35, characterized, that the container is constructed so that it is in the container drugs are stored safely, e.g. B. by a lead sheath. 37. Container according to one of claims 1 to 36, characterized, that the container is heat and cold resistant. 38. Container according to one of claims 1 to 37, characterized, that the container has devices that cooling or Heating of the components, with or without appropriate auxiliary devices, enable short term or over a longer period.   39. Container according to one of claims 1 to 38, characterized, that the housing wall of the container is double-walled. 40. Container according to one of claims 1 to 39, characterized, that the container system also applies to other multi-component areas is transferable. 41. Container according to one of claims 1 to 40, characterized, that the container according to the invention except for multi-component drugs also for others, especially organic and inorganic Substances that are sterile to mix, e.g. B. in the applied Genetic engineering, suitable and to be used.