Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-02-08
2001-02-13
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S192000, C604S198000, C604S263000
Reexamination Certificate
active
06186980
ABSTRACT:
The invention relates to a single-use device for injection, which is designed to be pre-filled with a dose of fluid to be injected.
The single-use devices for injection which are conventionally used at present consist of pre-filled syringes, which are provided with a cap which is designed to protect the needle before use, then is removed so that the injection can take place, and is finally put back into position after the injection has taken place, in order to prevent further risks of being pricked by the contaminated needle.
However, it has been found that a design of this type has a major disadvantage, which is derived from the fact that when the needle is capped once more, the cap must be presented opposite the end of this needle. This requirement has in fact been found to be the cause of accidents, consisting of pricking which occurs relatively frequently, with all the risks involved in being pricked in this manner by a contaminated needle. Furthermore, syringes of this type do not have any safety device which is designed to prevent them from being re-used, and particular care must therefore be taken to destroy them.
In order to eliminate these disadvantages, the conventional technique consists of providing the device for injection with a protective sheath which can slide along the body of the syringe, or inside which the syringe can be retracted, such as to obtain either a position for injection, in which the injection needle is released, or a position for protection after use, in which this injection needle is accommodated and protected inside the protective sheath.
According to this principle, a conventional solution consists of providing devices for injection which have resilient means interposed between the syringe body and the protective sheath, which are designed to be kept compressed, and to assure positioning of the protective sheath and the syringe in their position for injection, before and during injection, and to relax and give rise automatically to sliding of the said protective sheath or the said syringe towards their position for protection after use, when injection is completed.
This solution makes it possible to produce devices for injection as described in the international patent applications WO-91.13634, WO-93.23089, WO-93.25254, and European patent applications EP-446.551 and EP-307.367, which firstly prevent any risk of being pricked accidentally before and after the injection takes place, in particular since the protective sheath or the syringe are made to slide automatically by means of release of the resilient means, after the injection has taken place, and secondly prevent the syringe from being re-used.
However, these devices for injection require production of specific syringes, which therefore have a substantially higher cost than that of conventional syringes, such as the glass syringes which are produced at present in very large numbers at a very low cost.
In fact, no solution has been found to the problem which consists of obtaining a device for injection of this type, which is non-re-usable after injection, and is equipped with a conventional syringe.
The present devices of this type for injection also have another disadvantage, derived from the fact that when release takes place of the resilient means, which are controlled by unlocking means disposed in the piston rod, there is no guarantee that the syringe has been completely emptied, owing to the tolerances accepted concerning the length of the syringes when the latter are manufactured. Since devices of this type for injection are designed to be used for the purpose of injection of very small quantities of fluids (of approximately one cubic millimeter), the quantity administered of which must be respected rigorously, this technical solution is unsuitable for fulfilling the requirements applicable.
The object of the present invention is to eliminate these disadvantages, and its substantial objective is to provide a device for injection which is easy to manufacture, which comprises a conventional syringe, and cannot be reused after injection has taken place.
A further objective of the invention is to provide a device for injection which guarantees injection of all of the dose of fluid.
For this purpose, the invention relates to a single-use device for injection, comprising a syringe which is provided with a front nose which supports an injection needle, and with a rear collar, the said syringe delimiting a chamber which is filled with a dose of fluid to be injected, and is sealed by a piston which is rendered integral with one of the ends of a piston rod, which is provided with a thruster at its opposite end.
According to the invention, this device for injection comprises a device for protection after the syringe has been used, comprising:
a protective sheath, consisting of two tubular bodies, which are known as the front body and the rear body, and are provided with assembly means which make it possible to render the bodies integral one in the extension of the other, the front body having a diameter which is conjugated relative to that of the syringe, and a length which is designed to accommodate the said syringe partially, and the rear body having a diameter which is larger than that of the collar of the said syringe, and comprising finger-support units;
a ring which is disposed in the rear body, which comprises means for locking the collar of the syringe, and can make it possible to introduce the said syringe, by presenting the needle opposite the rear body of the protective sheath;
the ring and the rear body comprising:
first means for relative locking in translation, which can make it possible to introduce the said ring in the said rear body, by presenting the ring opposite the surface of assembly of the latter with the front body, and defining a first locking position, known as the position for injection, which allows the injection to take place when the device for injection has been assembled;
second means for relative locking in translation, which define a second locking position, known as the position for protection after use, which is obtained after rearward sliding of the ring inside the rear body, in which the injection needle is accommodated in the front body;
the ring and the front body being provided with stop means, which can keep resilient means compressed in the first locking position, for injection; and
the ring or the rear body comprising a rear portion which is deformable radially, and supporting the first locking means in translation, which portion is designed to be deformed by the thruster of the piston rod at the end of the path of the latter, such as to release the said first locking units, and to permit displacement of the ring towards its second locking position, for protection after use.
The device according to the invention, for protection of syringes, thus comprises four main elements (ring, front and rear body of the protective sheath, and resilient means), which are designed to be assembled such as to constitute a pre-assembled assembly in which a conventional syringe is then inserted, and which then provides protection of the needle after use, and prevents any re-use.
In addition, the device for protection is produced in a very simple manner, by means of steps which can easily be automated. In fact, this assembly is carried out in accordance with the following steps:
introduction of the ring into the rear body of the protective sheath, until it is positioned in the first locking position;
putting into place resilient means which are not compressed in the ring; and
assembly of the rear and front bodies, leading to compression of the resilient means by the stop means of the said front body and of the ring.
This pre-assembled assembly makes it possible to put into place subsequently a conventional pre-filled syringe, which is locked when it is put into place in this manner, at its collar, in its position for injection, and then, after injection has taken place, it is brought into a position for protection, which prevents any re-use.
According to a preferred
Sanofi-Synthelabo
Yasko John D.
Young & Thompson
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