Bottles and jars – Closures – Self-sealing – piercable-type closure
Reexamination Certificate
2000-03-14
2001-05-01
Newhouse, Nathan J. (Department: 3727)
Bottles and jars
Closures
Self-sealing, piercable-type closure
C215S251000, C215S254000
Reexamination Certificate
active
06223918
ABSTRACT:
The present invention relates to a package, and more particularly to a package for sterile fluids.
In the medical field, sterile fluids, such as medicaments, pharmaceuticals, sterile saline solution and so on are frequently required for the treatment of patients. Such sterile fluids are normally supplied in bottles made of glass, which is chemically inert and highly unlikely to contaminate or otherwise adulterate the sterile fluid.
The glass bottles are normally closed by a rubber stopper inserted into the mouth of the bottle. The stopper is designed so that it can be pierced by a needle of a hypodermic syringe, an infusion spike of an infusion set, or the like, to allow the contents of the bottle to be withdrawn. The stopper can also be removed to allow the contents of the bottle to be poured out.
In order to hold the stopper in place, a cap made of aluminium or similar thin sheet metal is crimped over the stopper and the upper part of the bottle. In order to gain access to the stopper, either to pierce it or remove it, the cap is either partially or totally torn away.
Such a package, although in wide use, has a number of disadvantages. For example, glass bottles tend to be relatively heavy. Further, glass is a relatively fragile material, and glass bottles are prone to breakage. This is particularly true when the volume of the bottle exceeds 100 ml. In order to reduce the incidence of breakage during shipping, such glass bottles must be packed carefully, with inserts separating the bottles from each other. Since such inserts take up a certain volume, the number of bottles which can be accommodated in a given volume is reduced, and thus the cost of transporting the bottles is increased.
In addition, tearing the aluminium cap away can cause problems, as sharp edges are left where the cap is torn. These edges are sharp enough to puncture surgical gloves and human skin, which is obviously a disadvantage in the medical field in particular, where the risk of infection must be kept to a minimum.
In addition, in many European countries, waste must be sorted by nature before being disposed of. Having a metal cap and a rubber stopper on a glass bottle means that the package contains three different sorts of material (glass, metal and plastics), which must be disposed of separately.
Alternative approaches to containers for sterile fluids have also been tried, with varying degrees of success. In one known product, plastic bottles with screw caps are used, the screw caps having stoppers attached thereto. When the screw cap is removed, the stopper is also removed from the bottle. While this avoids the problems associated with the use of glass bottles, the package is not compatible with infusion procedures, and cannot be used with hypodermic needles as the standard packages can.
In another proposal, described in DE 19500460, a plastic bottle is provided with an injection moulded cap which is covered by a plastic foil. In this proposal there is no stopper in the mouth of the bottle and the primary sealing of the bottle is by an integrally moulded closure wall which is piercable by a cannula or spike but not otherwise openable. The cap fits over the closure wall. When it is desired to access the contents of the bottle the foil is removed and both the cap and the closure wall must be pierced, requiring sufficient force to penetrate both these parts and with a possible risk of the cannula or spike being plugged by the material of the closure wall, or coring that material to create particles in the contents of the bottle.
It is also known to use plastic bottles with traditional stoppers, retained by aluminium caps. These still have the problems of needing to sort the various parts of the package before they can be discarded as waste, and of leaving sharp edges when the aluminium cap is torn.
Further types of closure, manufactured by Stelmi of France, are marketed under the name of “Monobloc” and “Duobloc”. The “Monobloc” comprises a plastics cap which fits over the neck and stopper of a traditional glass bottle. A tear-off portion allows access to the stopper, and the entire cap can be removed if necessary. The “Duobloc” is similar, but has a screw-threaded insert which snaps over the neck of the glass bottle, and the remainder of the cap is threadedly engaged with the insert. However, both use glass bottles with their attendant problems, and the various parts of the package must be sorted before the package can be disposed of.
According to a first aspect of the invention, there is provided a package comprising a container with a mouth, a stopper inserted into said mouth, and a cap overlying said stopper, wherein said container and said cap are formed from plastics material.
By forming the container and cap of the package from plastics material, the problems of weight and breakage associated with glass containers are avoided. Further, there is no need to sort the container and cap parts of the package into glass, metal and plastics before it is discarded.
The stopper will generally be formed of an elastic material and is preferably also formed from plastics. The stopper may be formed from rubber.
In one preferred embodiment, the container is a bottle. This is preferable as sterile fluids are routinely supplied in glass bottles, and it is desirable to avoid any confusion on the part of the end-user by supplying material in much the same format, even if the package is formed from different materials.
Preferably, the container and the cap have complementary screw threads. This provides a simple and effective way of securing the cap on the container.
It is further preferred that the cap be provided with a tamper-evident feature, to reduce the risk of fluid being administered from a package which has been opened and then reclosed. Such opening and reclosing can result in the fluid losing its sterility, or in adulteration or contamination of the fluid in some form. One suitable form of tamper-evident feature is a member removably attached to the cap, which must be detached from the cap before the cap can be removed. The absence of the member is then a sign that the package has been opened at some time, and should not be used.
In a preferred embodiment, the cap comprises a removable portion which can be removed to gain access to the stopper.
With such a cap, the closure can be opened in a number of ways. The removable portion can be removed to gain access to the stopper, whilst leaving the stopper in place. The stopper can then be pierced by a hypodermic needle or similar. Alternatively, the entire cap can be removed (which may entail removal of a tamper-evident feature), which then allows access to the entire stopper. This may be useful if, for example, an infusion spike which is wider than the removable portion is to be used. As a further alternative, the entire cap and the stopper can be removed, to enable pouring or the insertion of a quill or straw to load an autoinjector.
Preferably, the cap has an engageable member for operation by a user to remove the removable portion. This facilitates removal of the removable portion.
In preferred arrangements the engageable member comprises a ring upwardly spaced from the removable portion. This allows the user of the package to hook a finger beneath the engageable member, and thus makes it easier to operate.
It is further preferred that the cap also comprises at least one projection which acts as a pivot for the engageable member. If a pivot is not used, then the force exerted on the engageable member by the user is simply transmitted to the removable portion. However, if a pivot point is provided, then a leverage effect can allow the force exerted on the engageable member to be amplified, thus making it easier to remove the removable portion.
In preferred embodiments the engageable member projects from the cap, and there is thus a risk that the member could snag on something and accidentally be operated to remove the removable region. Preferably, therefore, the cap is also provided with a wall which extends generally about the periphery of the engageable
Bacon & Thomas
Newhouse Nathan J.
Nycomed Imaging AS
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