Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
2000-02-04
2002-11-12
Walczak, David J. (Department: 3751)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S086000, C604S414000, C604S415000, C215S247000
Reexamination Certificate
active
06478788
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device for connection between a closed recipient and a container, and to a ready-to-use assembly comprising, inter alia, a closed recipient and a connection device of the afore-mentioned type.
BACKGROUND OF THE INVENTION
In the domain of packaging medicines, it is known to store one component of a pharmaceutical preparation, such as for example its active ingredient, in a recipient closed by a relatively non-rigid material, for example made of elastomer. A liquid may be introduced info this recipient, after perforation of the stopper, in order to place the component contained in the recipient in solution or in suspension, so as to obtain a preparation, in particular a medicament or vaccine, in liquid form ready to be administered to the patients.
Documents WO-A-90/03536 and WO-A-97/10156 disclose connection devices, each comprising a base adapted to cover the neck of a recipient and extended by a flange or bush forming an inner bore, while a plunger is mounted to slide in this bore. The plunger is provided to be pushed towards a transfer position in which a hollow needle borne by the plunger passes through the stopper of the recipient. These known devices allow axial movements of the plunger when it has been displaced up to transfer position, which might lead to leakages and does not efficiently control the lost volume of the recipient, i.e. the quantity of liquid which cannot be drawn off therefrom.
Document WO-A-98/13006 discloses a device adapted, in particular, for connection between a recipient with a stopper which is adapted to be perforated and a syringe, in which teeth are distributed about the axis of the plunger and provided to be returned centrifugally or centrapetally in order to cooperate with a stop clement provided on a base. This device allows a locking of the plunger as long as the effort of displacement to which it is subjected is not too great. However, under certain conditions, the teeth might be deformed plastically, which might allow the plunger to tear in a direction of extraction.
It is a particular object of the present invention to overcame these drawbacks, by proposing an unproved connection device in which a particularly efficient locking of the plunger in transfer position is obtained
SUMMARY UP THE INVENTION
To that end, the invention relates to a device of the type mentioned above, in which the base is provided with at least one elastic catch for retaining the plunger in transfer position, this catch projecting from the bush towards the interior of the bore and being adapted to cooperate with an outer radial tab of the plunger.
Thanks to the invention, the elastic catch guarantees a efficient locking of the plunger in transfer position. Such locking is all the more efficient as a plurality of catches are advantageously provided, which may be regularly distributed about the central axis of the device.
According to a first advantageous aspect of the invention, the catch is provided, on an outer radial face, with a heel adapted to cooperate with a ring for locking the plunger in position of retention, this ring being adapted to slide about the bush. This ring gives the retaining catch a sufficient rigidity to efficiently resist an effort of displacement of the plunger from the transfer position. This ring is advantageously provided with an outer radial flange for locking in translation in a position of cooperation with the catch.
According to another advantageous aspect of the invention, the device comprises means for locking in rotation the plunger and/or the locking ring. These means advantageously comprise longitudinal ribs made on the inner face and/or the outer face of the bash and adapted to cooperate with corresponding elements in relief provided on the outer radial surface of the plunger and/or on the inner radial surface of the ring.
According to another advantageous aspect of the invention, in disengaged position with respect to the stopper, the plunger is fast with the bush by at least one breakable tongue. In addition, the base and the plunger are advantageously formed in one piece by injection of plastics material. This facilitates positioning of the plunger with respect to the base, insofar as this positioning results directly from the method of manufacture and as it is not necessary to provide an assembly step corresponding to the insertion of the plunger in the base. Moreover, the one-piece nature of the base and plunger guarantees that the plunger dues not risk sliding in the bore, particularly under the effect of vibrations or sudden accelerations during transport of the device. In this way, the tip of a needle borne by the plunger is held for certain inside the bare, with the result that it does not risk projecting beyond the base to the point of marking or perforating a stopper when the device is positioned on the recipient. With the known devices, such a risk could not be completely eliminated, including when using beads for holding the plunger.
According to another advantageous aspect of the invention, a cap for protecting the bore and the plunger is provided, on an inner face, with a member for transmission of a thrust effort for the displacement of the plunger from the first position towards the second position. In this way, the protecting cap serves as member for maneuvering the plunger.
According to another advantageous aspect of the invention, the bush comprises, near its free edge, means for blocking the container by cooperation of shapes, in particular bayonet-type locking slots adapted to cooperate with at least one tab of the container.
According to another advantageous aspect, the base comprises a cylindrical surface defining a skirt which extends around the neck of the recipient and bears hooking teeth, this skirt comprising at least one opening far access to the catch and/or to certain hooking teeth from the outside. These openings are particularly useful for efficiently moulding the catch or catches and the corresponding teeth.
The invention also relates to a ready-to-use assembly comprising a closed recipient containing a product, in particular a pharmaceutical preparation, this recipient being provided with a neck whose opening is obdurated by a stopper, and a connection device as described hereinabove, mounted on the recipient. Such an assembly enables a component of a medicine or a vaccine, in particular its active ingredient, to be kept sterile and to be prepared when necessary by mixture with a liquid, while its plunger is efficiently held in position.
REFERENCES:
patent: 3977555 (1976-08-01), Larson
patent: 5879345 (1999-03-01), Aneas
patent: 6070623 (2000-06-01), Aneas
patent: 6090093 (2000-07-01), Thibault et al.
patent: WO 90/03536 (1990-04-01), None
patent: WO 97/10156 (1997-03-01), None
patent: WO 98/13006 (1998-04-01), None
patent: WO 98/32411 (1998-07-01), None
Biodome
Nguyen Tuan
Oliff & Berridg,e PLC
Walczak David J.
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