WO2005089840A1 - Tamper-proof device for syringe and syringe comprising one such device - Google Patents

Tamper-proof device for syringe and syringe comprising one such device Download PDF

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Publication number
WO2005089840A1
WO2005089840A1 PCT/FR2005/000426 FR2005000426W WO2005089840A1 WO 2005089840 A1 WO2005089840 A1 WO 2005089840A1 FR 2005000426 W FR2005000426 W FR 2005000426W WO 2005089840 A1 WO2005089840 A1 WO 2005089840A1
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WO
WIPO (PCT)
Prior art keywords
tamper
syringe
evident
evident device
cylindrical cavity
Prior art date
Application number
PCT/FR2005/000426
Other languages
French (fr)
Inventor
Pascal Claude Henri Magnan
Original Assignee
Biocorp Recherche Et Developpement
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biocorp Recherche Et Developpement filed Critical Biocorp Recherche Et Developpement
Publication of WO2005089840A1 publication Critical patent/WO2005089840A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • A61M2005/3139—Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M5/31505—Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit

Definitions

  • the present invention relates to a tamper-evident device for a syringe and to a syringe equipped with such a device.
  • a syringe conventionally comprises a body, in a cylindrical cavity of which is mounted with a seal a piston actuated by a plunger.
  • the piston and the body jointly delimit a chamber of variable volume intended to contain a liquid or pasty product to be injected.
  • Such a liquid or pasty product must not be able to escape from the chamber of variable volume passing between the body and the piston, for which the latter generally comprises a seal.
  • Such a syringe can be sold empty, in which case the user must fill it himself.
  • a syringe can also be sold full.
  • the invention therefore at least aims to increase the reliability of the content of a pre-filled syringe.
  • the invention relates to a tamper-evident device for a syringe, characterized in that it delimits a through hole for the passage of a plunger of the syringe and comprises means for its mounting on a body of the syringe, so as to be inseparable from this body with less damage, in a configuration where said device closes a cylindrical cavity of this body, except at the level of the through hole.
  • this tamper-evident device comprises two parts, each of which defines a half-collar of a collar for mounting the tamper-evident device on one end of the body of the syringe, as well as a part from the edge of the through hole, the internal surface of at least one of the two half-collars delimiting at least one recess for receiving a portion of the body intended to retain the tamper-evident device;
  • the two parts of the tamper-evident device carry additional means for their snap-on assembly; - a hinge that comes in with the two parts of the tamper-evident device connects these two parts to each other; the complementary assembly means ensure an irreversible snap-fastening of the two parts of the tamper-evident device and are located opposite the hinge.
  • a subject of the invention is also a syringe comprising: - a body delimiting a cylindrical cavity, - a piston mounted in the cylindrical cavity so as to delimit with the body a chamber of variable volume having an outlet, and a plunger penetrating into the cavity cylindrical by one end of this cylindrical cavity and capable of sliding the piston in the body, characterized in that it includes tamper-evident means which are inseparable from the body unless damaged and close the cylindrical cavity behind the piston except at the level a through hole for the passage of the pusher, the pusher having, at least at the level of the hole crossing, a section. transverse substantially complementary to the shape of this through hole.
  • the piston has a portion which is located inside the cylindrical cavity and for which the tamper-evident means form an impassable stop;
  • the tamper-evident means are defined by an added tamper-evident device as defined above; outside the body, a portion of the added tamper-evident device defines at least one bearing surface for the fingers of a user, this bearing surface being substantially turned in the direction in which the pusher can push the piston .
  • FIG. 1 is a perspective view, partially broken away, d 'A syringe equipped with a device according to the invention
  • - Figure 2 is a partially exploded perspective view of the syringe shown in Figure 1
  • - Figure 3 is a section along plane III of Figure 1.
  • a syringe which has a body 1 provided with a tip 2 and a tamper-evident device 3.
  • a piston 4 is slidably mounted and with a seal in a cylindrical cavity 5 delimited by the body 1. This piston 4 is fixed to one end of a pusher 7.
  • the reference 8 designates the end of the cylindrical cavity 5 by which the pusher 7 enters this cavity 5.
  • the body 1 and the piston 4 jointly define a variable volume chamber 9 which contains a liquid or pasty product, not shown.
  • the piston 4 consists of an elastomeric sealing member which prevents the liquid or pasty product from escaping from the variable volume chamber 9 passing between it and the body 1.
  • the body 1 comprises a tube 1A on which the end piece is mounted 2. In known manner, this tube 1A delimits an outlet by which the liquid or pasty product is expelled from the chamber of variable volume, when the pusher 7 slides the piston 4 in the direction opposite to the end 8.
  • each of the parts 10A and 10B defines a half-collar 12A or 12B, as well as a closure wall 13A or 13B.
  • additional means of irreversible assembly by snap-fastening of the half-collars 12A and 12B comprise a finger 14 and a perforated wall 15.
  • the half-collar 12B carries the finger 14, whose head 16 is generally in the form of a harpoon.
  • the half-collar 12A defines the wall 15, through the hole 17 from which the head 16 of the finger 14 can only pass in one direction, namely that which leads to the assembly of the half-collars 12A and 12B to the opposite of the hinge 11.
  • Each of the half-collars 12A and 12B defines one of two internal and identical grooves 18, only one of which is visible in FIG. 2.
  • the body 1 is provided with a collar 20 for retaining the tamper-evident device 3. In FIGS. 1 and 3, this tamper-evident device 3 is permanently mounted on the body 1.
  • the parts 10A and 10B are assembled by snap-fastening of the head 16 of the finger 14 in the perforated wall 15, so that the half-collars 12A and 12B form a mounting collar which surrounds the end 20 of the body 1.
  • the grooves 18 of these half-collars 12A and 12B jointly form an internal annular groove in the which penetrates the retaining flange 20.
  • the edges of the walls 13A and 13B define a through hole 21 for the passage of the pusher 7 through the tamper-evident device 3.
  • the hole 21 has a passage section complementary to the cross section which the pusher 7 has between its two ends.
  • the walls 13A and 13B close the passages extending between the pusher 7 and the internal surface of the body 5 and thus prevent reaching the piston 4 passing through the end 8 of the cavity 5. From thereby, in accordance with the object of the invention, it is not possible to alter the content of the variable volume chamber 9 by injecting any substance into the latter, in particular using a needle piercing the piston 4.
  • the tamper-evident device 3 prevents the piston 4 from leaving the body 1. It also prevents from leaving from this body 1 an end portion 22 which comprises the pusher 7 and which does not pass through the hole 21.
  • the tamper-evident device 3 projects laterally from the body 1 so as to define an external support surface for the fingers of a user. This bearing surface, which is referenced 23 in FIG. 2, is turned in the direction in which the pusher 7 can push the piston 4.
  • the device 3 cannot be opened without being damaged, which is immediately detected by a potential user syringe.
  • the device 3 guarantees the inviolability of the syringe when it is intact.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to a tamper-proof device for a syringe and to a syringe comprising one such device. The inventive device defines a through hole (21) for the passage of a syringe plunger (7) and comprises means (12A, 12B) for mounting same to the barrel (1) of the syringe in a manner such that the device cannot be removed therefrom without causing damage and such the device seals a cylindrical cavity (5) in the barrel (1) except at the through hole. In this way, any syringe equipped with said device is protected against unauthorised handling.

Description

DISPOSITIF D'INVIOLABILITE POUR SERINGUE ET SERINGUE EQUIPEE D'UN TEL DISPOSITIF La présente- invention concerne un dispositif d' inviolabilité pour une seringue et une seringue équipée d'un tel dispositif. Une seringue comporte classiquement un corps, dans une cavité cylindrique duquel est monté à joint étanche un piston actionné par un poussoir. Le piston et le corps délimitent conjointement une chambre de volume variable destinée à contenir un produit liquide ou pâteux à injecter. Un tel produit liquide ou pâteux ne doit pas pouvoir s'échapper de la chambre de volume variable en passant entre le corps et le piston, ce pour quoi ce dernier comprend généralement un joint d' étanchéité . Une telle seringue peut être vendue vide, auquel cas son utilisateur doit la remplir lui-même. Une seringue peut également être vendue pleine. Lorsque tel est le cas, son utilisateur doit pouvoir avoir le plus possible confiance dans le contenu de la seringue pré-remplie, lequel contenu peut par exemple être une dose d'un médicament ou d'un vaccin. L'invention a donc au moins pour but d'augmenter la fiabilité du contenu d'une seringue pré-remplie. A cet effet, l'invention a pour objet un dispositif d'inviolabilité pour une seringue, caractérisé en ce qu'il délimite un trou traversant pour le passage d'un poussoir de la seringue et comprend des moyens pour son montage sur un corps de la seringue, de manière à être indissociable de ce corps à moins de dommages, dans une configuration où ledit dispositif ferme une cavité cylindrique de ce corps, sauf au niveau du trou traversant. Selon d' autres caractéristiques avantageuses de ce dispositif d' inviolabilité : - il comporte deux parties dont chacune définit un demi-collier d'un collier de montage du dispositif d'inviolabilité sur une extrémité du corps de la seringue, ainsi qu'une partie du bord du trou traversant, la surface interne de l'un au moins des deux demi-colliers délimitant au moins un creux de réception d'une portion du corps destinée à retenir le dispositif d'inviolabilité ; - les deux parties du dispositif d'inviolabilité portent des moyens complémentaires pour leur assemblage par encliquetage ; - une charnière venue de manière avec les deux parties du dispositif d'inviolabilité relie ces deux parties l'une à l'autre ; les moyens complémentaires d'assemblage assurent un encliquetage irréversible des deux parties du dispositif d'inviolabilité et se trouvent à l'opposé de la charnière . L'invention a également pour objet une seringue comportant : - un corps délimitant une cavité cylindrique, - un piston monté dans la cavité cylindrique de manière à délimiter avec le corps une chambre de volume variable ayant une sortie, et un poussoir pénétrant dans la cavité cylindrique par une extrémité de cette cavité cylindrique et pouvant faire coulisser le piston dans le corps, caractérisée en ce qu'elle comprend des moyens d'inviolabilité qui sont indissociables du corps à moins de dommages et ferment la cavité cylindrique derrière le piston sauf au niveau d'un trou traversant pour le passage du poussoir, le poussoir ayant, au moins au niveau du trou traversant, une section . transversale sensiblement complémentaire de la forme de ce trou traversant. Selon d'autres caractéristiques avantageuses de cette seringue : - le piston comporte une portion qui est située à l'intérieur de la cavité cylindrique et pour laquelle les moyens d'inviolabilité forment une butée infranchissable ; - les moyens d'inviolabilité sont définis par un dispositif d'inviolabilité rapporté tel que défini ci- dessus ; à l'extérieur du corps, une portion du dispositif d'inviolabilité rapporté définit au moins une surface d'appui pour les doigts d'un utilisateur, cette surface d' appui étant sensiblement tournée dans la direction dans laquelle le poussoir peut pousser le piston. L'invention sera bien comprise à la lecture de la description qui va suivre, donnée uniquement à titre d'exemple et faite en se référant aux dessins annexés, sur lesquels : - la figure 1 est une vue en perspective, avec arrachement partiel, d'une seringue équipée d'un dispositif conforme à l'invention ; - la figure 2 est une vue partiellement éclatée, en perspective, de la seringue représentée à la figure 1 ; - la figure 3 est une coupe selon le plan III de la figure 1. Sur les figures 1 et 2 est représentée une seringue qui comporte un corps 1 muni d'un embout 2 et d'un dispositif d'inviolabilité 3. Un piston 4 est monté à coulissement et à joint étanche dans une cavité cylindrique 5 que délimite le corps 1. Ce piston 4 est fixé à une extrémité d'un poussoir 7. La référence 8 désigne l'extrémité de la cavité cylindrique 5 par laquelle le poussoir 7 pénètre dans cette cavité 5. Le corps 1 et le piston 4 délimitent conjointement une chambre de volume variable 9 qui contient un produit liquide ou pâteux non représenté. Le piston 4 est constitué d' un organe d' étanchéité en élastomère qui empêche le produit liquide ou pâteux de s'échapper de la chambre de volume variable 9 en passant entre lui et le corps 1. A l'opposé de l'extrémité 8, le corps 1 comporte une tubulure 1A sur laquelle est monté l'embout 2. De manière connue, cette tubulure 1A délimite une sortie par laquelle le produit liquide ou pâteux est expulsé de la chambre de volume variable, lorsque le poussoir 7 fait coulisser le piston 4 dans la direction opposée à l'extrémité 8. Jusqu'à l'utilisation de la seringue, cette sortie de la chambre de volume variable est obturée par un opercule scellé, que masque l'embout 2 sur les figures 1 et 2. Avant d'utiliser la seringue, il convient de retirer cet opercule, qui participe à l'inviolabilité de la seringue puisque son absence ou sa détérioration peut être le signe d'une intrusion dans la chambre de volume variable 9. Dans le présent texte et dans les revendications annexées, les termes « derrière » et « devant », ainsi que les termes analogues, se réfèrent au sens dans lequel coulisse le piston 4 lorsqu'il est poussé par le poussoir 7 dans la direction opposée à l'extrémité 8. Le dispositif d'inviolabilité 3 est une pièce d'un seul tenant, moulée en un polymère. Il comporte deux parties 10A et 10B, ainsi qu'une charnière 11 que forme deux languettes articulant ces deux parties 10A et 10B l'une à l'autre. Chacune des parties 10A et 10B définit un demi-collier 12A ou 12B, ainsi qu'une paroi de fermeture 13A ou 13B. A l'opposé de la charnière 11, des moyens complémentaires d'assemblage irréversible par encliquetage des demi-colliers 12A et 12B comportent un doigt 14 et une paroi trouée 15. Le demi-collier 12B porte le doigt 14, dont la tête 16 est globalement en forme de harpon. Le demi-collier 12A définit la paroi 15, dans le trou 17 de laquelle la tête 16 du doigt 14 ne peut passer que dans un seul sens, à savoir celui qui mène à l'assemblage des demi- colliers 12A et 12B à l'opposé de la charnière 11. Chacun des demi-colliers 12A et 12B délimite l'une de deux gorges internes et identiques 18, dont une seule est visible à la figure 2. A son extrémité 19 correspondant à l'extrémité 8 de la cavité 5, le corps 1 est pourvu d'une collerette 20 de retenue du dispositif d'inviolabilité 3. Sur les figures 1 et 3, ce dispositif d'inviolabilité 3 est monté de manière définitive sur le corps 1. A l'opposé de la charnière 11, les parties 10A et 10B sont assemblées par encliquetage de la tête 16 du doigt 14 dans la paroi trouée 15, de sorte que les demi-colliers 12A et 12B forment un collier de montage qui entoure l'extrémité 20 du corps 1. Les gorges 18 de ces demi-colliers 12A et 12B forment conjointement une gorge annulaire interne dans laquelle pénètre la collerette de retenue 20. A moins d'un dommage, tel que la rupture de la charnière 11 ou du doigt 14, le dispositif d'inviolabilité 3 ne peut pas être dissocié du corps 1. Toujours sur les figures 1 et 3, les bords des parois 13A et 13B délimitent un trou traversant 21 pour le passage du poussoir 7 à travers le dispositif d'inviolabilité 3. Sauf au niveau de ce trou 21, les parois 13A et 13B ferment la cavité cylindrique 5. Le trou 21 a une section de passage complémentaire de la section transversale en croix que possède le poussoir 7 entre ses deux extrémités. En d'autres termes, les parois 13A et 13B ferment les passages s' étendant entre le poussoir 7 et la surface interne du corps 5 et empêchent ainsi d' atteindre le piston 4 en passant par l'extrémité 8 de la cavité 5. De ce fait, conformément au but de l'invention, il n'est pas possible d'altérer le contenu de la chambre de volume variable 9 en injectant dans cette dernière une quelconque substance, notamment à l'aide d'une aiguille transperçant le piston 4. Le dispositif d' inviolabilité 3 empêche de sortir le piston 4 du corps 1. Il empêche également de sortir de ce corps 1 une portion d'extrémité 22 que comporte le poussoir 7 et qui ne passe pas dans le trou 21. En d'autres termes, le poussoir 7 ne peut pas être retiré du trou 21 pour désobstruer ce dernier. Le dispositif d'inviolabilité 3 dépasse latéralement du corps 1 de manière à définir une surface extérieure d'appui pour les doigts d'un utilisateur. Cette surface d'appui, qui est référencée 23 à la figure 2, est tournée dans la direction dans laquelle le poussoir 7 peut pousser le piston 4. Le dispositif 3 ne peut pas être ouvert sans être endommagé, ce que détecte immédiatement un utilisateur potentiel de la seringue. Ainsi, le dispositif 3 est garant de l'inviolabilité de la seringue lorsqu'il est intact. The present invention relates to a tamper-evident device for a syringe and to a syringe equipped with such a device. A syringe conventionally comprises a body, in a cylindrical cavity of which is mounted with a seal a piston actuated by a plunger. The piston and the body jointly delimit a chamber of variable volume intended to contain a liquid or pasty product to be injected. Such a liquid or pasty product must not be able to escape from the chamber of variable volume passing between the body and the piston, for which the latter generally comprises a seal. Such a syringe can be sold empty, in which case the user must fill it himself. A syringe can also be sold full. When this is the case, its user must be able to have as much confidence as possible in the content of the pre-filled syringe, which content may for example be a dose of a drug or a vaccine. The invention therefore at least aims to increase the reliability of the content of a pre-filled syringe. To this end, the invention relates to a tamper-evident device for a syringe, characterized in that it delimits a through hole for the passage of a plunger of the syringe and comprises means for its mounting on a body of the syringe, so as to be inseparable from this body with less damage, in a configuration where said device closes a cylindrical cavity of this body, except at the level of the through hole. According to other advantageous characteristics of this tamper-evident device: - it comprises two parts, each of which defines a half-collar of a collar for mounting the tamper-evident device on one end of the body of the syringe, as well as a part from the edge of the through hole, the internal surface of at least one of the two half-collars delimiting at least one recess for receiving a portion of the body intended to retain the tamper-evident device; - The two parts of the tamper-evident device carry additional means for their snap-on assembly; - a hinge that comes in with the two parts of the tamper-evident device connects these two parts to each other; the complementary assembly means ensure an irreversible snap-fastening of the two parts of the tamper-evident device and are located opposite the hinge. A subject of the invention is also a syringe comprising: - a body delimiting a cylindrical cavity, - a piston mounted in the cylindrical cavity so as to delimit with the body a chamber of variable volume having an outlet, and a plunger penetrating into the cavity cylindrical by one end of this cylindrical cavity and capable of sliding the piston in the body, characterized in that it includes tamper-evident means which are inseparable from the body unless damaged and close the cylindrical cavity behind the piston except at the level a through hole for the passage of the pusher, the pusher having, at least at the level of the hole crossing, a section. transverse substantially complementary to the shape of this through hole. According to other advantageous characteristics of this syringe: - the piston has a portion which is located inside the cylindrical cavity and for which the tamper-evident means form an impassable stop; - the tamper-evident means are defined by an added tamper-evident device as defined above; outside the body, a portion of the added tamper-evident device defines at least one bearing surface for the fingers of a user, this bearing surface being substantially turned in the direction in which the pusher can push the piston . The invention will be clearly understood on reading the description which follows, given solely by way of example and made with reference to the accompanying drawings, in which: - Figure 1 is a perspective view, partially broken away, d 'A syringe equipped with a device according to the invention; - Figure 2 is a partially exploded perspective view of the syringe shown in Figure 1; - Figure 3 is a section along plane III of Figure 1. In Figures 1 and 2 is shown a syringe which has a body 1 provided with a tip 2 and a tamper-evident device 3. A piston 4 is slidably mounted and with a seal in a cylindrical cavity 5 delimited by the body 1. This piston 4 is fixed to one end of a pusher 7. The reference 8 designates the end of the cylindrical cavity 5 by which the pusher 7 enters this cavity 5. The body 1 and the piston 4 jointly define a variable volume chamber 9 which contains a liquid or pasty product, not shown. The piston 4 consists of an elastomeric sealing member which prevents the liquid or pasty product from escaping from the variable volume chamber 9 passing between it and the body 1. Opposite the end 8 , the body 1 comprises a tube 1A on which the end piece is mounted 2. In known manner, this tube 1A delimits an outlet by which the liquid or pasty product is expelled from the chamber of variable volume, when the pusher 7 slides the piston 4 in the direction opposite to the end 8. Until the syringe is used, this outlet from the variable volume chamber is closed by a sealed cap, which the end piece 2 masks in FIGS. 1 and 2. Before using the syringe, it is advisable to remove this cover, which contributes to the inviolability of the syringe since its absence or its deterioration can be the sign of an intrusion into the chamber of variable volume 9. In the present text and in the claims s appended, the terms “behind” and “in front”, as well as similar terms, refer to the direction in which the piston 4 slides when it is pushed by the pusher 7 in the direction opposite to the end 8. The device tamper evident 3 is a single piece, molded from a polymer. It has two parts 10A and 10B, as well as a hinge 11 formed by two tongues hinging these two parts 10A and 10B to one another. Each of the parts 10A and 10B defines a half-collar 12A or 12B, as well as a closure wall 13A or 13B. Opposite the hinge 11, additional means of irreversible assembly by snap-fastening of the half-collars 12A and 12B comprise a finger 14 and a perforated wall 15. The half-collar 12B carries the finger 14, whose head 16 is generally in the form of a harpoon. The half-collar 12A defines the wall 15, through the hole 17 from which the head 16 of the finger 14 can only pass in one direction, namely that which leads to the assembly of the half-collars 12A and 12B to the opposite of the hinge 11. Each of the half-collars 12A and 12B defines one of two internal and identical grooves 18, only one of which is visible in FIG. 2. At its end 19 corresponding to the end 8 of the cavity 5 , the body 1 is provided with a collar 20 for retaining the tamper-evident device 3. In FIGS. 1 and 3, this tamper-evident device 3 is permanently mounted on the body 1. Opposite the hinge 11, the parts 10A and 10B are assembled by snap-fastening of the head 16 of the finger 14 in the perforated wall 15, so that the half-collars 12A and 12B form a mounting collar which surrounds the end 20 of the body 1. The grooves 18 of these half-collars 12A and 12B jointly form an internal annular groove in the which penetrates the retaining flange 20. Unless there is damage, such as rupture of the hinge 11 or of the finger 14, the tamper-evident device 3 cannot be dissociated from the body 1. Still in FIGS. 1 and 3 , the edges of the walls 13A and 13B define a through hole 21 for the passage of the pusher 7 through the tamper-evident device 3. Except at the level of this hole 21, the walls 13A and 13B close the cylindrical cavity 5. The hole 21 has a passage section complementary to the cross section which the pusher 7 has between its two ends. In other words, the walls 13A and 13B close the passages extending between the pusher 7 and the internal surface of the body 5 and thus prevent reaching the piston 4 passing through the end 8 of the cavity 5. From thereby, in accordance with the object of the invention, it is not possible to alter the content of the variable volume chamber 9 by injecting any substance into the latter, in particular using a needle piercing the piston 4. The tamper-evident device 3 prevents the piston 4 from leaving the body 1. It also prevents from leaving from this body 1 an end portion 22 which comprises the pusher 7 and which does not pass through the hole 21. In other words , the pusher 7 cannot be removed from the hole 21 to unblock the latter. The tamper-evident device 3 projects laterally from the body 1 so as to define an external support surface for the fingers of a user. This bearing surface, which is referenced 23 in FIG. 2, is turned in the direction in which the pusher 7 can push the piston 4. The device 3 cannot be opened without being damaged, which is immediately detected by a potential user syringe. Thus, the device 3 guarantees the inviolability of the syringe when it is intact.

Claims

REVENDICATIONS
1. Dispositif d'inviolabilité pour une seringue, caractérisé en ce qu'il délimite un trou traversant (21) pour le passage d'un poussoir (7) de la seringue et comprend des moyens (12A, 12B, 14, 15, 18) pour son montage sur un corps (1) de la seringue, de manière à être indissociable de ce corps (1) à moins de dommages, dans une configuration où ledit dispositif ferme une cavité cylindrique (5) de ce corps (1), sauf au niveau du trou traversant (21) . 1. Tamper-evident device for a syringe, characterized in that it delimits a through hole (21) for the passage of a plunger (7) of the syringe and comprises means (12A, 12B, 14, 15, 18 ) for its mounting on a body (1) of the syringe, so as to be inseparable from this body (1) with less damage, in a configuration where said device closes a cylindrical cavity (5) of this body (1), except at the level of the through hole (21).
2. Dispositif d'inviolabilité selon la revendication2. Tamper-evident device according to claim
1, caractérisé en ce qu'il comporte deux parties (10A, 10B) dont chacune définit un demi-collier (12A, 12B) d'un collier de montage du dispositif d'inviolabilité sur une extrémité (19) du corps (20) de la seringue, ainsi qu'une partie du bord du trou traversant (21), la surface interne de l'un au moins des deux demi-colliers (12A, 12B) délimitant au moins un creux (18) de réception d'une portion (20) du corps (1) destinée à retenir le dispositif d' inviolabilité. 1, characterized in that it comprises two parts (10A, 10B) each of which defines a half-collar (12A, 12B) of a collar for mounting the tamper-evident device on one end (19) of the body (20) of the syringe, as well as part of the edge of the through hole (21), the internal surface of at least one of the two half-collars (12A, 12B) delimiting at least one recess (18) for receiving a portion (20) of the body (1) intended to retain the tamper - evident device.
3. Dispositif d'inviolabilité selon la revendication3. Tamper-evident device according to claim
2, caractérisé en ce que les deux parties (10A, 10B) du dispositif d'inviolabilité portent des moyens complémentaires (14, 15) pour leur assemblage par encliquetage . 2, characterized in that the two parts (10A, 10B) of the tamper-evident device carry complementary means (14, 15) for their snap-on assembly.
4. Dispositif d'inviolabilité selon la revendication 2 ou 3, caractérisé en ce qu'une charnière venue de manière avec les deux parties (10A, 10B) du dispositif d'inviolabilité relie ces deux parties (10A, 10B) l'une à 1' autre . 4. Tamper-evident device according to claim 2 or 3, characterized in that a hinge provided so with the two parts (10A, 10B) of the tamper-evident device connects these two parts (10A, 10B) one to The other.
5. Dispositif d'inviolabilité selon les revendications 3 et 4, caractérisé en ce que lesdits moyens complémentaires d'assemblage (14, 15) assurent un encliquetage irréversible des deux parties (10A, 10B) du dispositif d'inviolabilité et se trouvent à l'opposé de la charnière (11) . 5. Tamper-evident device according to claims 3 and 4, characterized in that said means complementary assemblies (14, 15) ensure an irreversible snap-fastening of the two parts (10A, 10B) of the tamper-evident device and are located opposite the hinge (11).
6. Seringue comportant : - un corps (1) délimitant une cavité cylindrique (5), - un piston (4) monté dans la cavité cylindrique (5) de manière à délimiter avec le corps (1) une chambre de volume variable ayant une sortie, et un poussoir (7) pénétrant dans la cavité cylindrique (5) par une extrémité (8) de cette cavité cylindrique (5) et pouvant faire coulisser le piston (4) dans le corps (1) , caractérisée en ce qu'elle comprend des moyens d'inviolabilité (3) qui sont indissociables du corps (1) à moins de dommages et ferment la cavité cylindrique (5) derrière le piston (4) sauf au niveau d'un trou traversant (21) pour le passage du poussoir (7), le poussoir (7) ayant, au moins au niveau du trou traversant (21) , une section transversale sensiblement complémentaire de la forme dudit trou traversant (21) . 6. Syringe comprising: - a body (1) delimiting a cylindrical cavity (5), - a piston (4) mounted in the cylindrical cavity (5) so as to delimit with the body (1) a chamber of variable volume having a outlet, and a pusher (7) penetrating into the cylindrical cavity (5) through one end (8) of this cylindrical cavity (5) and capable of sliding the piston (4) in the body (1), characterized in that it includes tamper-evident means (3) which are inseparable from the body (1) with less damage and close the cylindrical cavity (5) behind the piston (4) except at the level of a through hole (21) for passage of the pusher (7), the pusher (7) having, at least at the level of the through hole (21), a cross section substantially complementary to the shape of said through hole (21).
7. Seringue selon la revendication 6, caractérisée en ce que le piston (4) comporte une portion (22) qui est située à l'intérieur de la cavité cylindrique (5) et pour laquelle les moyens d'inviolabilité (3) forment une butée infranchissable (13A, 13B) . 7. Syringe according to claim 6, characterized in that the piston (4) has a portion (22) which is located inside the cylindrical cavity (5) and for which the tamper-evident means (3) form a impassable stop (13A, 13B).
8. Seringue selon l'une des revendications 6 ou 7, caractérisée en ce que les moyens d' inviolabilité sont définis par un dispositif d'inviolabilité rapporté (3) qui est selon l'une quelconque des revendications 1 à 5. 8. Syringe according to one of claims 6 or 7, characterized in that the tamper-evident means are defined by an added tamper-evident device (3) which is according to any one of claims 1 to 5.
9. Seringue selon la revendication 8, caractérisée en ce qu'à l'extérieur du corps (1), une portion du dispositif d'inviolabilité rapporté (3) définit au moins une surface d'appui- (23) pour les doigts- d'un utilisateur, cette surface d'appui (23) étant sensiblement tournée dans la direction dans laquelle le poussoir (7) peut pousser le piston (4) . 9. Syringe according to claim 8, characterized in that outside the body (1), a portion of the added tamper-evident device (3) defines at least one surface support (23) for the fingers of a user, this support surface (23) being substantially rotated in the direction in which the pusher (7) can push the piston (4).
PCT/FR2005/000426 2004-02-24 2005-02-23 Tamper-proof device for syringe and syringe comprising one such device WO2005089840A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0401836A FR2866573B1 (en) 2004-02-24 2004-02-24 INVIOLABILITY DEVICE FOR SYRINGE AND SYRINGE EQUIPPED WITH SUCH A DEVICE
FR0401836 2004-02-24

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WO2005089840A1 true WO2005089840A1 (en) 2005-09-29

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WO (1) WO2005089840A1 (en)

Cited By (6)

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EP2130561A1 (en) * 2008-06-06 2009-12-09 Aesculap AG Medical syringe with piston blocking means
JP2012519044A (en) * 2009-03-02 2012-08-23 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Drug delivery device with foldable finger pad
WO2013009387A1 (en) * 2011-07-11 2013-01-17 Bristol-Myers Squibb Company Flange extender for use with an injection device and method of assembly
JP2014128383A (en) * 2012-12-28 2014-07-10 Nipro Corp Syringe
EP3479857A1 (en) * 2017-11-03 2019-05-08 Fagron B.V. Seal for locking a syringe
US10537683B2 (en) 2016-11-03 2020-01-21 Johnson & Johnson Surgical Vision, Inc. Syringe finger grip

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110046559A1 (en) * 2009-08-21 2011-02-24 Becton Dickinson France S.A.S. Syringe Assembly Having a Flexible or Slidable Flange

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US4592746A (en) * 1985-06-10 1986-06-03 Sherwood Medical Company Syringe and locking device and method of assembling same
US5344407A (en) * 1993-05-04 1994-09-06 Ryan Dana W Safety holder for pre-filled disposable syringe cartridge
US5925032A (en) * 1998-02-17 1999-07-20 Alcon Laboratories, Inc. Syringe cannula holder
WO2002087670A1 (en) * 2001-04-28 2002-11-07 Owen Mumford Limited Improvements relating to syringe holders
JP2002360692A (en) * 2001-06-06 2002-12-17 Arute:Kk Auxiliary grip of syringe also serving as vessel

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Publication number Priority date Publication date Assignee Title
US4592746A (en) * 1985-06-10 1986-06-03 Sherwood Medical Company Syringe and locking device and method of assembling same
US5344407A (en) * 1993-05-04 1994-09-06 Ryan Dana W Safety holder for pre-filled disposable syringe cartridge
US5925032A (en) * 1998-02-17 1999-07-20 Alcon Laboratories, Inc. Syringe cannula holder
WO2002087670A1 (en) * 2001-04-28 2002-11-07 Owen Mumford Limited Improvements relating to syringe holders
JP2002360692A (en) * 2001-06-06 2002-12-17 Arute:Kk Auxiliary grip of syringe also serving as vessel

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2130561A1 (en) * 2008-06-06 2009-12-09 Aesculap AG Medical syringe with piston blocking means
JP2012519044A (en) * 2009-03-02 2012-08-23 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Drug delivery device with foldable finger pad
WO2013009387A1 (en) * 2011-07-11 2013-01-17 Bristol-Myers Squibb Company Flange extender for use with an injection device and method of assembly
JP2014520627A (en) * 2011-07-11 2014-08-25 ブリストル−マイヤーズ スクイブ カンパニー Flange expansion device and assembly method for use in an injection device
USD793552S1 (en) 2011-07-11 2017-08-01 Bristol-Myers Squibb Company Flange extender
JP2014128383A (en) * 2012-12-28 2014-07-10 Nipro Corp Syringe
US10537683B2 (en) 2016-11-03 2020-01-21 Johnson & Johnson Surgical Vision, Inc. Syringe finger grip
EP3479857A1 (en) * 2017-11-03 2019-05-08 Fagron B.V. Seal for locking a syringe
WO2019086590A1 (en) 2017-11-03 2019-05-09 Fagron B.V. Seal for locking a syringe

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FR2866573B1 (en) 2006-06-23

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