Special receptacle or package – Combined or convertible – Packaged assemblage or kit
Reexamination Certificate
2000-11-21
2002-06-04
Foster, Jim (Department: 3728)
Special receptacle or package
Combined or convertible
Packaged assemblage or kit
C206S365000, C604S192000
Reexamination Certificate
active
06398031
ABSTRACT:
A vial for packaging a liquid for medical use is a small reservoir, the volume of which varies from a few milliliters to a few tens of milliliters, and which is intended to contain in a sealed and sterile manner an active principle or a solvent (0.9% NaCl, 5% glucose). The reservoir is made of a material which is biocompatible with its content and of pharmaceutical grade. The material of which the reservoir is made may be glass or synthetic material. Glass vials are intended to be gradually phased out and replaced with vials made of synthetic material which are more practical to use.
The content of a vial is generally used to dilute active principles or to reconstitute powdered medicinal products.
The way in which a vial is used in the context of reconstitution is as follows:
the operator disinfects the zone of the opening of the vial, then breaks the tearable element to gain access to the content thereof;
the operator removes a sterile hypodermic needle from its packaging, attaches the needle to a syringe, and withdraws the rigid sheath that forms a needle protector;
the operator sucks out a given volume of liquid from inside the vial, it being possible for this volume to be checked using the graduations on the syringe;
once the liquid has been taken up into the syringe, the operator transfers this liquid into a bottle containing the powder or lyophilisate that is to be diluted. The bottle is sealed closed by an elastomer stopper that the syringe needle can perforate;
after homogenization, the solution is drawn back up by the syringe;
the product thus prepared is stored in the syringe fitted with its needle, can then be transferred to a drip bag or bottle, still using the needle by puncturing a sealed membrane provided for this purpose on the drip bag or bottle;
after use, the needle is put back inside the needle protector to be discarded without the risk of needle stick injury.
This technique entails a great many elements for using the content of a vial: Needle housed inside a protector and packaged in sterile packaging, syringe, and vial containing the liquid. The number of operations to-be performed is high. The needle packaging has to be opened, the needle attached to the syringe, the needle protector removed, the vial disinfected, the vial broken with the risk of generating particles which may drop into the liquid contained therein, and the needle has to be introduced into a small-diameter hole.
This results in costs which are high both as regards the device itself and as regards its use.
The object of the invention is to provide a vial for packaging a liquid for medical use which is of an economical price, the use of which is simple, reliable and quick for the user.
To this end, the vial to which it relates comprises a tubular body made of synthetic material exhibiting two chambers which are isolated in a sealed manner by a puncturable membrane or a removable or tearable wall, one of which chambers contains the liquid and the other of which chambers contains a hypodermic needle, the pointed part of which points towards the puncturable membrane or removable or tearable wall, and the other end of which is fitted with means of connection to a syringe body.
Advantageously, the chamber containing the needle comprises a tube forming a needle holder closed by the membrane or the removable or tearable wall and exhibiting, at its end opening into the chamber containing the needle, an annular sealing bead. The needle is therefore packaged in the chamber provided for this purpose, the part forming the actual needle proper being inside the tube, and the end equipped with means of connection to a syringe body being outside the tube. In practice, the operator opens the chamber containing the needle, attaches the body of a syringe to it, and pushes down on the needle to puncture the membrane to gain communication with the chamber containing the liquid, or breaks the tearable wall corresponding to this membrane. The annular sealing bead seals the chamber containing the liquid closed. The operator can then use the syringe to draw up the desired amount of liquid, which is made easier by the fact that the tubular body made of synthetic material is deformable. After the contents of the syringe have been used in a conventional way, the operator can put the needle back inside the tube that forms the needle holder, which protects this needle while it is taken away to be destroyed.
According to one feature of the invention, the length of the tube intended to house the needle is at least equal to that of the needle, the membrane or the removable or tearable wall being located near to that end of the tube which faces towards the chamber containing the liquid and the bead located near the other end of the tube being intended to provide sealing around the means of connecting the needle to a syringe body.
Furthermore, the distance between the free end of the tube and the membrane or the removable or tearable wall is at least equal to the travel of the needle between a storage position and a position for withdrawing the liquid, in which position the pointed end of the needle passes through the membrane or the removable or tearable wall and the means of connecting the needle are gripped in the sealing bead. Under these conditions, the needle does not protrude from the end of the tube after the membrane has been punctured or the removable wall torn, which means that the risk of the wall of the vial being punctured accidentally by the point of the needle is eliminated. The translational movement of the needle is limited by a shoulder that this needle has in the zone of connection between the hypodermic needle itself and the means of connection of the needle, for example of the female Luer type, to the body of the syringe.
Advantageously, the tube comprises, near the sealing bead, means for preventing the needle from rotating, such as ribs or bosses intended to collaborate with complementary means borne by the needle. This feature makes the needle easier to attach to the syringe body by preventing the needle from turning at the same time as the syringe.
According to a preferred embodiment of this vial, the tube intended to house the needle is secured to a transverse wall, the periphery of which is secured to the interior wall of the tubular body. The tube advantageously forms a single piece with the interior wall of the tubular body.
According to a first embodiment of this vial, the tubular body, the wall separating the two chambers and the needle holder are made as one piece of synthetic material obtained by moulding.
In this case, for example, the chamber containing the liquid is closed off by a thermal weld after the body has been filled with the liquid and flattened, and the chamber containing the needle, the edge of which is delimited by a flange, is closed by a film seal, such as a vapour-permeable film, fixed by hot welding or by a stopper made of synthetic material sealed on by screw-fastening or snap-fastening. Closure using a vapour-permeable film allows the chamber containing the needle to be sterilized.
According to one other feature of the invention, on the one hand, the wall separating the two chambers and the needle holder are made as one piece of synthetic material obtained by moulding and, on the other hand, the tubular body consists of a tube of synthetic material which is extruded or made from two films of possibly thermoformed synthetic material, fixed by welding to the wall separating the two chambers, and the two ends of which are closed by thermal welds after the two chambers have been formed, the chamber containing the liquid has been filled, and the needle has been placed in the other chamber.
In such a case it is possible to make the tubular body from a material that is far more flexible than the wall separating the two chambers and the needle holder, and for the ends of the two chambers, and particularly the end of the chamber containing the liquid, to be given a shape, for example, in the form of a V which makes it possible to limit the residual volume of liquid inside this
Foster Jim
Oliff & Berridge PLC.
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