Bottles and jars – Closures – Self-sealing – piercable-type closure
Reexamination Certificate
2001-01-23
2003-12-09
Newhouse, Nathan J. (Department: 3727)
Bottles and jars
Closures
Self-sealing, piercable-type closure
C215S251000, C215S254000
Reexamination Certificate
active
06659296
ABSTRACT:
BACKGROUND OF INVENTION
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 commonly supplied in bottles made of glass, which are chemically inert and highly unlikely to contaminate or otherwise adulterate the sterile fluid.
The 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infusion spike of an infusion set, a spike of an autoinjector, or the like, to allow the contents of the bottle to be withdrawn.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, or to be sucked up using a quill or straw of an autoinjector.
In order to hold the stopper in place, one approach has been to provide a cap made of aluminium or similar thin sheet metal which 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 sheet metal cap is either partially or totally torn away.
However, packages incorporating aluminium caps have a number of disadvantages. For example, 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 countries, waste must be sorted by nature or type 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. However, 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 pierceable 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.
Further types of closures, manufactured by Stelmi of France, are marketed under the name of “Monobloc”™ and “Duobloc”™. Corresponding patent publications are FR 2745793 and EP 0794129. The “Monobloc” comprises a plastics cap which fits over the neck and stopper of a traditional glass bottle. A removable portion may be torn away to allow 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.
In the case of such plastics caps, the removable portion is integrally moulded with the rest of the cap. A line of weakness is normally provided around the removable portion to allow the removable portion to be torn away to gain access to the stopper. The stopper can then be pierced by a needle or infusion spike or the like. An engageable member in the form of a pull-ring is integrally moulded with the removable portion and when it is desired to gain access to the top surface of the stopper a force is applied to the pull-ring to remove the removable portion.
There is however a disadvantage of such plastics caps provided with pull-rings. In order for the pull-rings provided on the caps to be accessible they generally project from the cap. However, during shipping and storage, there is a risk that the pull-rings will snag on something and accidentally be operated to cause the line of weakness to be torn. This may result in the complete removal of the removable portion and thus result in the scrapping of the package and its contents. Alternatively, the tear may only be very small and, although not sufficient to cause the removable portion to be removed, allow contamination of the stopper. Such accidental partial opening of the cap may only be detected upon close inspection of the cap. In certain cases adequate inspection of the integrity of the cap seal may not be performed before it is opened and, consequently, the package may be used when in fact the top surface of stopper has become contaminated. This is clearly undesirable.
A proposed solution to the problem of accidental opening of packages incorporating a cap with a removable portion has been to surround the pull-ring with a raised section in the form of an annular wall. In such a proposal, shown in FIG. 7 of EP 0480196, a two piece injection moulded cap is provided, to be welded to a plastics bottle. In this proposal a first moulding defines the portion of the cap to be attached to the bottle and a hole is formed in the upper surface thereof for receiving a cannula. The hole may be covered by a membrane. An annular wall is formed which extends about the periphery of the upper surface. A second moulding is made up of a ring, which fits inside the annular wall of the first moulding, and a pull-ring attached to a removable portion which in turn is attached to the ring by a circumferential weakened region. The two mouldings are formed separately and then ultrasonically welded to form a sealing bond between the upper surface of the first moulding and the ring of the second moulding. The cap is then permanently attached to the plastic bottle. When it is desired to gain access to the contents of the bottle the pull-ring is removed by tearing along the weakened region and a cannula may be introduced into the bottle through the hole formed in the first moulding.
However, with such a cap the sterility of the upper surface of the first moulding is dependent on the quality of the ultrasound weld, so that any defect in the weld will create the potential for contamination of the upper surface.
Another proposal for a cap having a protective annular wall for a pull-ring for removing a removable portion is described in EP 0079676. This cap is for a plastic bottle and is made up of a plug member and three plastic injection mouldings. The first moulding consists of the pull-ring, the removable portion connected to the rest of the moulding by a frangible region, and an annular wall which extends around the pull-ring. The plug member is positioned in a cavity, formed by a portion of the annular wall projecting below the removable portion, and sealed in place by the second moulding which is formed around the lower part of the first moulding. The cap is completed by a third moulding which is formed around the external surfaces of the first and second mouldings. The cap is then heat-welded along its lower edge to the neck of a plastic bottle. In order to gain access to the contents of the bottle the removable portion is removed by pulling on the pull-ring and causing the weakened region to tear. A syringe, cannula or other such device may then be introduced through the plug member and a wall of the second moulding.
The arrangement of EP 0079676 avoids the problem mentioned above concerning EP 0480196, of relying on a single ultrasonic weld to maintain the sterility of a region to be pierced after tearing away the removable portion. It is however a relatively complicated arrangement in that it consists of four separat
Amersham Health AS
Chisholm Robert F.
Newhouse Nathan J.
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