The present invention relates to the field of container caps. More specifically, the present invention is directed to a tamper-evident container cap assembly.
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 containers made of plastic or glass, which is chemically inert and highly unlikely to contaminate or otherwise adulterate the sterile fluid.
The containers are normally closed by a rubber stopper inserted into the mouth of the container. 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a hypodermic syringe, an infusion spike of an infusion set, or the like, to allow the contents of the container to be withdrawn. The stopper may also be removed to allow the contents of the bottle to be poured out.
In order to hold the stopper in place, a cap assembly is often threaded over the stopper and the neck of the bottle. In order to gain access to the stopper, either to pierce it or remove it, the cap is either partially torn away or totally removed from the container neck. The art has seen various designs for a container cap assembly which may be secured to a container neck and thereby prevent exposure of the stopper until use of the fluid.
The cap 12 of
The art therefor lacks a cap assembly which provides high bridge integrity as well as easy visual verification of bridge integrity.
In view of the needs of the art, the present invention provides a container cap assembly with improved tamper-evident features.
In one aspect, the present invention provides an improved tamper-evident bridge extending between a cap and a tamper-evident ring.
In another aspect, the present invention provides radially-extending cooperative links between the cap and the tamper-evident ring which prevent destructive deflection of the bridges as the cap assembly is secured to a container neck while still allowing the bridges to take the full force when removing the cap from the container and tamper-evident ring.
In yet another aspect of the invention, there is provided a package comprising a container with a neck defining a mouth, a stopper inserted into or over the mouth, and a cap of the present invention overlying the stopper and neck of the container.
Desirably, the container and the cap have complementary helical threads to provide a simple and effective way to help secure 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 still yet another embodiment, the cap includes a removable portion which can provide access to the stopper while the remainder of the cap is maintained on the container.
Preferred embodiments of the invention will now be described by way of example only and with reference to the accompanying drawings, in which:
Referring to
Annular rim 120 defines a cap aperture 122 formed to extend in overlying registry with a stopper (not shown) placed in or across the open neck of the container which cap assembly 110 is attached. Cap 112 includes an inner cylindrical surface 124 supporting an internally-extending helical thread 126 for screwing onto a mating thread on the neck of a container. As shown, cap assembly 110 may include a removable top 130 which spans across the second end 118 of the cap 112, although the manner of protecting the aperture in registry with the container stopper is not essential to the present invention. For example, it is also contemplated that cap 112 may, instead of removable top 130, include a removable lid 18 frangibly connected to the annular rim 120 as depicted for the cap assembly 10 of
Cap assembly 110 is also provided with a tamper-evident ring 140 which is designed to remain with the container after cap 112 has been removed. Ring 140 includes a ring body 141 which defines a number of lug apertures 142 which allow a snap-fit to cooperating projecting lugs on the neck of the container. The projecting lugs of the container ensure that ring 140 remains in place as cap 112 is rotated off of the container and separated from ring 140.
Cap assembly 110 includes first and second elongate frangible bridge elements 150 and 160 extending from cap 112 to ring 140. Desirably, bridge elements 150 and 160 are diametrically opposed across cap 112 from each other. While the present invention contemplates that only a single frangible element of the design of bridge element 150 or 160 may be employed in the cap assembly 110, also contemplated is providing at least two such bridge elements will provide a more tamper-evident cap assembly 110. Cap assembly 110 further includes first radially-extending cap link 170 and second radially-extending cap link (not shown, opposite) while ring 140 includes first radially-extending ring link 172 and second radially-extending ring link (not shown, opposite). Cap link 170 and ring link 172 are positioned in close proximity and in facing opposition across a gap 174. Similarly, on the opposite side, the second cap link (not shown, opposite) and second ring link (not shown, opposite) are positioned in close proximity and in facing opposition across a radially-spaced gap (not shown, opposite). Desirably, the first cap link 170 and second cap link (not shown, opposite) are diametrically opposed across cap 112 from each other while the first ring link 172 and second ring link (not shown, opposite) are diametrically opposed across ring 140 from each other. The first ring link 172 and the second ring link (not shown, opposite) are positioned to be radially-outward of first end 116 of cap wall 114 so that cap wall 114 will pass clear radially-inward of first ring link portion 172 and second ring link (not shown, opposite) as cap 112 is removed from ring 140.
Bridge elements 150 and 160 are shown having desirably identical designs, so bridge element 150 will be described in further detail. As shown in
With particular reference to
It will be appreciated that the shaping of bridge body 206 additionally provides more strength at the edge portions of the bridge which experience tension as cap assembly 110 is threaded, or rotated, onto the neck of a container, until ring 140 deflects over the lugs of the container and the lugs extend through the lug apertures 142, allowing ring 140 to relax against the container neck.
Additionally, the length and shape of bridge body 206 allows for vertical movement during application of cap assembly 110 to a container without failing. As shown in
Cap 112 and ring 140 are desirably formed from a polymer, such as polypropylene, by injection molding. When moulding the cap assembly 110 the plastic flows where the cross section is largest (designated along arrow D in
The design of the bridges of the present invention provide easy visual confirmation of their integrity. When broken, after cap 112 removal, these relatively wide and thin bridges will have been stretched to failure, making them very difficult to make look intact again.
An alternative embodiment of the present invention also provides bridges 250 which are uniformly long, flat and thin, as depicted in
While bridges 250 of
The radially extending first cap link 170 and second cap link (not shown, opposite) and first ring link 172 and second ring link (not shown, opposite) cooperate to prevent a failure load being applied to the bridges while attaching or connecting the cap 112 to a container. In an undeflected orientation, first cap link 170 and second cap link (not shown, opposite) of cap 112 and first ring link 172 and second ring link (not shown, opposite) of ring 140 are spaced apart less than the maximum deflection allowed by bridges 150 and 160 before tearing of the bridges begins. The spacing of the cap links from the ring links is further contemplated to also take into account any deformation at the links which could allow further deflection of the bridges, all to ensure that the bridges do not fail during application of the cap assembly to a container. As shown in
With particular reference to
With a cap assembly of the present invention, the container to which it is connected may be opened in a number of ways. The removable portion of cap assembly 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 112 may be removed (which will stress the bridges connecting the cap to the tamper-evident ring to failure), which then allows complete access to the entire stopper. Complete access to the stopper may be useful if, for example, an infusion spike which is wider than the removable portion of the cap is to be used. As a further alternative, the entire cap 112 and the stopper can be removed, to enable pouring out the contents or the insertion of a quill or straw to load an autoinjector.
While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.
This application is a filing under 35 U.S.C. 371 of international application number PCT/US2013/077909, filed Dec. 27, 2013, which claims priority to U.S. application No. 61/746,204, filed Dec. 27, 2012, the entire disclosures of each of which are hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2013/077909 | 12/27/2013 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2014/106002 | 7/3/2014 | WO | A |
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Number | Date | Country | |
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20150298869 A1 | Oct 2015 | US |
Number | Date | Country | |
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61746204 | Dec 2012 | US |