Bottles and jars – Closures – Self-sealing – piercable-type closure
Reexamination Certificate
1999-07-01
2001-01-16
Cronin, Stephen K. (Department: 3727)
Bottles and jars
Closures
Self-sealing, piercable-type closure
C215S047000, C215SDIG003, C215S308000
Reexamination Certificate
active
06173852
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to containers and an particular to containers for sterile preparations for example for medical use.
2. Related Art
A well-known method of manufacturing containers for sterile preparations is the blow-fill-seal method in which a container is blow moulded from thermoplastics, filled with the desired preparation, which cools the thermoplastics, and then sealed. This is a convenient and inexpensive method of manufacturing such containers which has the particular advantage that the entire process may be carried out in a sterile or aseptic environment such that sterility of the container contents can be guaranteed.
A container manufactured by this method is described in EP-A-0 088 056. According to this document, the neck of the container is formed with a sealing upper section and a lower section, the two sections being connected by a frangible connection When the upper section is removed, by rupturing the frangible connection, the lower section is left in the form of a female Luer cone and may be connected to a standard male Luer connector, as commonly used in medical applications.
However, the blow moulding process used to form the container disclosed in EP-A-0 088 056 suffers from the major disadvantage that the thickness of the moulded thermoplastic cannot be consistently guaranteed. Thus, the Luer cone formed on the container cannot be guaranteed to be accurately formed, and this is an essential requirement for a Luer connection, as such a connection must form an entirely reliable seal.
WO 91/08729 discloses a similar container wherein the lower section of the neck forms a Luer lock connector. This container suffers from similar disadvantages to that of EP-A-0 088 056.
In an attempt to provide accurate connectors as part of a standard blow-fill-seal container, there have been suggested a number of containers including an insert, separately moulded from the container proper and inserted in the container before it is sealed. One such insert is disclosed in EP-A-0 685 400. An insert has the advantage that it may be moulded separately from, and therefore more accurately than, the rest of the container.
However, such inserts are generally undesirable as they complicate the manufacture of the blow-fill-seal container and in addition an insert located inside the sealed container with sterile contents must itself be sterile and this can be difficult to achieve with complete reliability.
EP-A-0 510 854 discloses a blow-fill-seal container and a cap which fits over the neck of the container. The cap has an internal needle which pierces the container as, or immediately before, the cap is placed over the container neck. The needle has a central duct which terminates externally in a receptor suitable for connection to a syringe.
U.S. Pat,. No. 5,427,275 discloses a blow-fill-seal container with a cap. The cap has an internal conical piercer which pierces the closure of the container when the cap is screwed onto the container neck. The piercer has channels formed therein which allow communication of the contents of the container with a section of the cap in the form of an external dropper, after piercing
BRIEF SUMMARY OF THE INVENTION
According to the present invention, there is provided a container comprising a container body with an integral closure portion, and a cap provided over the closure portion and having an internal spike arranged to penetrate the closure portion of the container body when the cap is moved towards the container body, the internal spike being provided with a passage for communicating the interior of the container body with the outside of the cap, the cap further having means for the connection of a syringe or similar medical device for communication with the passage, wherein the cap is removably fittable to the container body with the internal spike in a position not penetrating the closure portion, whereby the cap may be moved towards the container body to cause the internal spike to penetrate the closure portion or the cap may be removed from the container body to allow penetration of the closure portion by alternative means.
The provision of the cap enables different methods of access to the contents of the container to be provided, whilst the design of the container body can be relatively simple so that it is capable of being made by preferred methods, such as blow-fill-seal or form-fill-seal. The container is preferably supplied with the cap pre-fitted, for example to maintain a sterile region under the cap.
Thus, according to another aspect of the present invention there is provided a container comprising a container body with an integral closure portion, and a cap provided over the closure portion to maintain a sterile region under the cap.
The cap may be manufactured by a separate process, such as injection moulding, which can advantageously be a more accurate process in terms of tolerances than the process used to make the container body.
The cap is removable to expose the closure portion, for example to allow the closure portion to be penetrated by a needle or spike of a giving set or the like. Preferably, the cap is adapted to be refitted to the container body after removal, so that any remaining contents of the bottle are protected from the environment, most preferably vented to the outside via a sterile filter.
The cap may be provided with a self-sealing or resealing pierceable portion for penetration by a needle or spike, for example a thermoplastic elastomer in the external surface of the cap. A needle or spike may penetrate this portion to pierce the closure portion of the container body and access the contents of the container. When the needle or spike is removed, the resilience of the self-resealable portion closes the needle hole to reseal the container. Thus, this is one of the methods of access to the contents of the container which may be provided with an appropriately designed cap.
Alternatively, the closure portion may itself be covered by a self-sealing or resealing pierceable portion for penetration by a needle or spike. Again, this can reseal after removal of the needle or spike.
The cap is provided with a passage from its external surface to the inside of the cap, and the passage may be closed by a cover such that contamination of the closure portion by the environment is prevented.
The internal spike may be maintained sterile until it is used to penetrate the closure portion, such that there is no danger of contamination of the container contents on penetration by the spike. The walls of the passage inside the cap may form such a spike, which may be integral with the cap. The use of a penetrating spike provided on the cap gives another method of access, to the contents of the container.
The passage may be provided from the region of the tip of the spike to the outside of the cap.
The connection means may comprise a female Luer connector or a male Luer connector, or both, either of which connectors may be a Luer lock connector and/or may be vented.
The cap may be provided with separate means for the sterile venting of the container, for example a separate sterile filter, which may be provided with its own spike for penetration of the closure portion.
The cap may be provided with a branched passage communicating with the spike, or with a plurality of passages and spikes, to allow the provision of more than one connector on the same cap. Thus, a single container may allow access to its contents via plural connectors on its cap.
The cap and container body are preferably connected such that rotation of the cap results in movement of the cap towards or away from the container body. The cap may be provided with an internal screw thread or other camming means. The container body may be provided with at least one lug which cooperates with the internal screw thread or other camming means to effect the movement. Alternatively the container body may be provided with a screw thread, although this may be difficult to mould in a process such as blow-fill-seal. In the p
Bacon & Thomas PLLC
Cronin Stephen K.
Hylton Robin A.
Nycomed Imaging A/S
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