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CONNECTOR ASSEMBLY FOR A VIAL
HAVING A FLEXIBLE COLLAR
FIELD OF THE INVENTION
The invention relates to a connector assembly for a vial, 5 and more particularly, to a connector assembly for a vial which minimizes the number of components in the connector assembly and which reduces the number of microbial barriers necessary to safeguard sterility of the system. ^
BACKGROUND
In the art, it is generally known that to reduce inventory space or to increase the shelf life of certain drugs, or both, it is advantageous to reduce these drugs to a dry or powdered 15 form. These dry or powdered drugs are normally stored in a sealed container such as a vial, and reconstituted into liquid form with an appropriate diluent or solvent solution prior to administration to a patient. The vials, typically formed of glass or plastic materials, include an elastomeric stopper 20 sealing the open end of the vial. The stopper includes a portion inserted into the neck of the vial as well as a planar portion which rests on top of the vial, against the vial rim. The planar portion is normally tightly affixed to the vial rim with an aluminum crimp cap. Owing to the malleable nature 25 of aluminum, the crimp cap readily adapts itself any differing dimension or tolerances which may exist between the stopper and the vial. The result is that the crimp cap evenly distributes sealing forces between the stopper and the vial. Thus, it has been generally recognized in the art that the 30 vial/stopper/aluminum crimp cap solution safeguards the sterility of the drug contained within the vial over suitably long storage periods and prescribed conditions. The sizes and dimensions of the various vials and stopper components may be configured to given standards, such as given ISO 35 standards.
One way to reconstitute the drug stored in the vial is to introduce the solvent or diluent from a syringe by piercing the stopper sealing the vial. Owing to various considerations, such as the convenience of the healthcare 40 worker charged with reconstituting the drug, the art has recognized ways to transform the standard sealed vial into a system suitable for permitting safe, effective reconstitution of the drug contained within the vial. In these systems, typically, a fluid transfer assembly is connected to the neck 45 of the vial. The fluid transfer system includes structure for connecting the vial to a source of diluent, such as diluent held in bottles, bags or syringes. The transfer assembly is thereafter activated to permit the flow of fluid into the vial to form the source of diluent, thereby reconstituting the 50 drug.
In some configurations, the systems are such that standard vial stopper is eliminated in favor of fluid transfer assembly having a rubber stopper which is inserted into the neck of the vial, without the need for a planar portion which rests 55 against the rim of the vial. This stopper remains within the neck until such time as reconstitution of the drug is desired. When the transfer assembly is activated, the stopper is urged towards the interior of the vial to open the neck, thereby permitting fluid to flow through the transfer assembly and 60 into the vial body. Examples of such approaches include the MONO VIAL® line of drug delivery devices manufactured and sold by Becton Dickinson Pharmaceutical Systems of Le Pont de Claix, France and exemplified, for instance, by U.S. Pat. No. 5,358,501. While forming an excellent drug 65 reconstitution system displaying superior properties, particularly convenience of use and sterility maintenance of the
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drug held in the vial, as typically configured these systems are useful for vial applications where the vial is of a relatively large size, typically 12 milliliters ("ml") or more. Accordingly, some pharmaceutical companies have expressed the desire for a reconstitution approach where the vial is of a size smaller than the sizes for which the aforementioned system is normally configured.
In response to the aforementioned concerns, then, one logical way around the dilemma would be to convert, as exactly as possible, the characteristics associated with vial components already in use by the pharmaceutical companies, such as ISO standard via/stopper/aluminum crimp cap components, and to implement a reconstitution system around these components for use by the healthcare worker. The prior art has considered some attempts in that regard. For instance, as exemplified by PCT Patent Application No. WO 97/10156 to Biodome, SA of Issoire Cedex, France, the aluminum crimp cap which would normally hermetically affix the planar portion of the standard stopper to the vial rim is replaced by a rubber-piercing fluid transfer assembly affixed around the neck of the vial. This rubber piercing fluid transfer assembly is activated by an end user when it is desired to reconstitute the drug held in the vial. The transfer assembly disclosed in this patent application features a fairly rigid, outermost plastic locking ring which, in theory, should lock the plastic transfer assembly firmly against the planar portion of the stopper and, hence, sealing this portion stopper against the vial rim. As has been pointed out, though, in practice, there may be significant variance between the dimensional tolerances of the glass components (the vial), the rubber components (the stopper) and the plastic components (the fluid transfer assembly) forming the system. The malleable nature of the aluminum crimp cap takes into account differences in tolerances. However, owing to the rigid characteristics of the sealing ring, with this approach, there may be the possibility that given a particular vial, stopper, or transfer assembly, the sealing forces realized by the outside sealing ring against the stopper and the vial may not be sufficient or otherwise uniform. Accordingly, the potential contamination of the drug, given the environmental stresses to which the vial may be subject to during manufacture, shipping, or storage, presents a concern.
Accordingly, there is a need for a safe and effective drug reconstitution system, wherein a fluid transfer assembly is affixed to a standard vial and stopper arrangement in a manner such that the sealing forces achievable by an aluminum crimp cap are effectively replicated. Such a drug reconstitution system is disclosed herein.
SUMMARY OF THE INVENTION
The present invention addresses the aforementioned concerns in a convenient and cost-efficient manner. A connector assembly in accordance with the present invention is designed to be employed with a standard vial and stopper so as to be able to be processed by a pharmaceutical manufacturer with standard processing equipment. The connector assembly is fully able to account for dimensional variances or tolerance variances in the vial or stopper components or in the components forming the connector assembly itself, so as to ensure good microbiological barrier characteristics.
The connector assembly features a protective cap for covering the open end of the vial neck. The cap includes an open proximal end, a closed distal end, and a shield wall formed therebetween. A collar is provided adjacent the open proximal end of the cap. The collar can be molded with the cap, or it can be separately manufactured and thereafter
affixed to the cap. The collar features a proximal end, a distal end, and a sidewall therebetween. One or more rib elements are provided on an interior portion of the collar adjacent the distal end, and the ribs designed to form a tight seal against the stopper as the collar is positioned against the stopper. Interior portions of the collar can be configured to mate with a vial access device provided to pierce the stopper.
A defining aspect of the collar is the provision of a flexible skirt adjacent the proximal end of the collar. The skirt is foldable about the rim of the vial when the collar is positioned against the stopper so as to engage the underside portion of the rim. The skirt can be formed on the collar in a variety of ways.
A crimp cap fixes the collar to the vial rim. As the collar is locked to the rim of the vial by the crimp cap, the crimp cap exerts a force against the distal end of the collar and against the skirt that has been folded against the underside portion of the rim. The collar is thus tightly thrust against the stopper, thereby ensuring a proper seal of the stopper to the vial. Additionally, the ribs provided in the internal portion of the collar form an additional microbiological barrier against the ambient environment. The crimp cap can be preaffixed to the collar in an uncrimped condition, with the crimping operation occurring after the collar is placed around the vial rim. Alternately, the crimp cap can be affixed about the collar after the collar is placed onto the vial rim.
The connector assembly can be shipped to a pharmaceutical manufacturer, either with the crimp cap preaffixed or not. In the cleanroom environment where the vial is filled with a medicament and the stopper is placed against the rim, the connector assembly can be attached to the vial. The connector assembly is transferred from a first position, whereby the collar is placed around the rim and the distal end of the collar spaced from the stopper, to a second position, whereby the flexible skirt of the collar is projected beyond the underside portion of the rim. By this action also, the ribs provided in the interior of the collar are thrust into sealing relation with the stopper. Thereafter, the crimp cap is positioned in crimped relation about the collar and the vial rim to secure the collar the vial rim. The crimp cap will exert a force against the flexible skirt, folding it against the underside portion of the rim into secured relation with it. The flexibility imparted by the skirt allows the collar to compensate for any dimensional or tolerance variations present in the vial, the stopper, or in the connector assembly itself If the crimp cap is supplied to the customer pre-attached to the collar but in an uncrimped state, the connector assembly itself is secured to the vial in sealing relation with the stopper within the cleanroom environment, and the crimping operation itself need only occur outside of the cleanroom.
If desired, the cap and collar can be manufactured in such a manner such that the cap is removable from the collar by a twisting action, permitting a user a convenient way to engage the vial access device held by the connector assembly. In one configuration, the cap can be formed with the collar with a frangible connection formed from a material— such as a thermoplastic elastomer—that is different from the material forming the cap and collar itself, such as polypropylene or polyethylene. The user may simply twist the cap such that the frangible connection shears, allowing the user to remove the cap from the collar to expose the vial access device. One way to achieve this construction is through a co-injection process. All in all, the minimization of the number of components forming the connector assembly results in a concomitant reduction in the number of biological barriers necessary to safeguard the sterility of the vial access device as well as the medicament contained within the vial.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will now be described in detail by way of reference to the appended drawings, wherein:
FIG. 1 is an exploded view of a first embodiment of the connector assembly in accordance with the present invention;
FIG. 2 is a cross-sectional view of FIG. 1;
FIG. 3 is a cross-sectional view depicting placement of the connector assembly against the vial in a first position, wherein the collar is placed around the rim and the flexible skirt urged beyond the underside portion of the rim;
FIG. 4 is a cross-sectional view depicting the crimp cap applied to the connector assembly such that the skirt is folded against the underside portion of the rim; and
FIGS. 5A and 5B depict two manners of configuring a frangible section between the cap and the collar to permit removal of the cap from the collar to expose the vial access device.
DETAILED DESCRIPTION OF THE
PREFERRED EMBODIMENTS
A convention used throughout this application is that the term "proximal" denotes a distance closest to rim 14 of vial 10, while the term "distal" denotes a distance furthest from the rim of the vial.
Turning to the drawings, wherein like numerals denote like components, FIGS. 1 and 2 illustrate a first embodiment 30 of a connector assembly for a vial 10 in accordance with the present invention. Vial IO is characterized by a bottom wall 11, a sidewall 13, a neck 12 and an annular rim 14. Annular rim 14 includes an underside portion 18, a side portion 20, and a top surface 16. A stopper 22 is typically employed to obturate an open end 17 associated with the vial. Stopper 22 features a planar portion 24 covering top surface 16 of the rim, and a plug portion 21 obturating the inside surface 19 of neck 12. Vial 10 is typically filled with a desired medicament, such as a dry drug or a lyophilized drug, and thereafter affixed with stopper 22, in a cleanroom environment. For the purposes of this invention, it will be realized that the dimensions and characteristics of vial 10 and stopper 22 can be conformed to various accepted standards, such as ISO standards, governing vials and stoppers intended for medicamental use.
As previously explained, a drawback in the art is ensuring that proper sealing forces exist between stopper 22 and vial 10. It would also be advantageous to incorporate a solution to this problem in a vial connector assembly that is easily processed by the pharmaceutical manufacturer and which, desirably, can be fully processed in the cleanroom environment where medicaments are processed, introduced into the vial, and stoppered within the vial.
With the foregoing in mind then, a first embodiment 30 of the connector assembly of the present invention is provided. Connector assembly 30 is formed of three principal components, namely, a cap 32, a collar 42, and a crimp cap 60.
Cap 32 is characterized by a closed distal end 34, an open proximal end 36, and a shield wall 38 therebetween. Cap 32 is provided adjacent collar 42. Cap 32 and collar 42 can be formed together, such as by a co-injection process, or they can be separately formed and joined together by mechanical means, welding, or the like. In a preferred construction, cap 32 and collar 42 are formed together and connected by a frangible section 100, as will be hereinafter discussed.
Collar 42 is designed to mate with rim 14 of the vial. Collar 42 is located adjacent open proximal end 36. Collar
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