The present application is a national phase entry under 35 U.S.C. ยง371 of International Application No. PCT/EP2012/003762 filed Sep. 7, 2012, which claims priority from German Patent Application No. 10 2011 112 516.0 filed Sep. 7, 2011, the disclosures of which are hereby incorporated herein by reference.
The invention relates to a container for containing a liquid, a container filled with liquid, as well as a package comprising a container filled with liquid and a liquid withdrawal device.
For appropriately conserving liquid medicines, glass ampoules are used, wherein for withdrawing liquid, the ampoule head has to be broken off whereupon the content can be withdrawn by means of an injection syringe. Opening the glass ampoules is not without problems, which is the reason why containers have already been used, the cover of which consists of an elastomeric material, for example silicone or isobutyl rubber, and which is secured by means of a metallic crimp cap. Withdrawing the liquid is carried out via a hollow needle by means of which the cover wall can be pierced.
In the case of such containers with covers, there is the danger that volatile constituents can escape along the sealing surfaces or through the material itself, or that the useful liquid dissolves material constituents out of the elastomeric materials, which material constituents are undesirable in the useful liquid. Specifically in the case of medicines, all constituents of the container, even during prolonged storage, have to prove to be compatible with the liquid medicine. If substances are dissolved out of the container, they have to be toxicologically examined. The examination efforts required for this are significant.
EP 0694498 A1 and EP 0919215 A1 describe the withdrawal of a liquid from a closed glass ampoule by means of a blunt hard object, for example a thick-walled cannula. The bottom of the glass ampoule the shaft region connected thereto can be enclosed by an elastomeric part so as to retain glass splinters occurring in the ampoule region. While in the case of EP 0694498 A1, no predetermined breaking point is provided in the bottom of the glass ampoule, the bottom in the case of EP 0919215 A1, due to its shape and/or a coating, has a defined predetermined breaking point region which can be destroyed with little expenditure of force. In detail, the bottom of the ampoule has a recessed region with a point-like ceramic coating that serves as point of engagement for the opening tool of the ampoule.
It is an object of the invention to provide a liquid container that securely seals the contained liquid and avoids the danger of separating constituents from the sealing material. In comparison with glass ampoules, safe and injury-free withdrawal of liquid shall be enabled.
In order to achieve the given object, the container comprises a hollow body and an elastomer septum. Said hollow body comprises an inner wall from a single material that is compatible with the liquid. A predetermined breaking point that can be pierced with a hollow needle is provided on the hollow body. The predetermined breaking point is covered by an elastomer septum that is fixedly connected to the hollow body. In this configuration of the container, the point of the hollow needle is guided through the elastomer septum and is stabilized when piercing the predetermined breaking point. When piercing the elastomer septum, the material thereof is laterally displaced resulting in good sealing at the circumference of the hollow needle. The liquid can then be suctioned out of the container interior or can be withdrawn by generating overpressure.
The preferred material for the septum comprises silicone, isobutyl rubber and neoprene. Provided that the liquid is not in direct contact with the septum during storage, particularly inexpensive, commercially available materials can be used for the septum.
The thickness of the septum is selected in dependence on the desired degree of sealing to the hollow needle. If a very good sealing effect between the septum and the hollow needle is required, a septum thickness in the range of 3 mm is advantageous. However, if the demands on the sealing effect are lower, a thickness in the range of 1 mm can already be reasonable.
As a material for the inner wall of the hollow body, plastics or also glass can be considered.
For example, plastics from the class of polyamides, in particular PA 6.6 or PA 12, or from the class of cyclic olefin copolymers (COC), have proved to be particularly suitable for use as material for the inner wall.
Furthermore, preferably used plastics comprise the group polypropylene or polyethylene. The plastics polypropylene and polyethylene can advantageously be used for an aqueous, unproblematic liquid. Here, polypropylene is characterized, for example, by its low production costs as well as its low density and its good general material resistance with respect to various liquids.
As a glass, preferably such glass materials are used which are produced as hollow glass bodies and are suitable for pharmaceutics. Such glasses can be categorized according to their hydrolytic resistance according to ISO 719. According to this classification, glasses of the hydrolytic class 1 such as, for example, borosilicate glasses are particularly preferably used for the inner wall.
The predetermined breaking point is formed from a thickness-reduced spot of the wall of the hollow body. This thickness-reduced wall spot can be formed as a wall indentation.
The hollow body can be produced based on a jar and a cover which, after filling the container, are welded or fused together so that a gapless inner wall from a single material is formed. The use of additional filler materials and sealants can be completely dispensed with.
For withdrawing liquid, a standard needle can be used which, at its end opposite the needle point, has a customary connector to which an injection syringe for extracting the liquid can be attached. It is also possible to use a hollow needle that is supplied together with the liquid-filled container and together with the same represents a package. It is also conceivable to press the liquid out of the container by means of gas pressure.
Exemplary embodiments of the invention are described with reference to the drawings.
In the figures:
Apart from that,
Another embodiment is shown in
Handling during withdrawal of the liquid takes place as follows:
If it is intended to withdraw the liquid with a set of injection instruments, the hollow needle is placed onto the marked point 30 of the septum 3, pierces therethrough and breaks through the predetermined breaking point 4 so as to reach the interior 10 of the container. Subsequently, as much liquid as needed is suctioned from the content of the container. Further liquid can be suctioned via the usual connector for standard needles.
It is also possible to work with special liquid withdrawal devices 5 as they have been described above.
The liquid withdrawal device 5 according to
It is also possible to feed gas pressure through the transverse opening 53 in order to push liquid out of the interior of the container. Gas supply can take place through a cannula into the interior 50 of the hollow needle 51 so as to provide for a clear separation of the flows within the hollow needle (not illustrated).
In the embodiments according to the
In the case of hollow bodies 10 made from glass or other brittle materials, splinters can form when the point of the hollow needle breaks through the predetermined breaking point 4, which splinters can be caught by filter material. A filter fleece can be used in the channel 50, or the channel 50 is connected to a filter unit via which the liquid is delivered to the intended location.
In the above description, diverse measures and features of different embodiments of the container have been described. It is understood that these measures and features can also be used in combinations other than those described here so as to obtain further embodiments of the invention.
Number | Date | Country | Kind |
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10 2011 112 516 | Sep 2011 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2012/003762 | 9/7/2012 | WO | 00 | 3/7/2014 |
Publishing Document | Publishing Date | Country | Kind |
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WO2013/034302 | 3/14/2013 | WO | A |
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Entry |
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