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EP1005429A1 - Mixing flask contacting two isolated constituents before they are drawn and injected into a syringe - Google Patents

Mixing flask contacting two isolated constituents before they are drawn and injected into a syringe

Info

Publication number
EP1005429A1
EP1005429A1 EP98942758A EP98942758A EP1005429A1 EP 1005429 A1 EP1005429 A1 EP 1005429A1 EP 98942758 A EP98942758 A EP 98942758A EP 98942758 A EP98942758 A EP 98942758A EP 1005429 A1 EP1005429 A1 EP 1005429A1
Authority
EP
European Patent Office
Prior art keywords
bottle
mixing
seal
neck
syringe
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP98942758A
Other languages
German (de)
French (fr)
Inventor
Dominique Mounier
Jean De Chaumont
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1005429A1 publication Critical patent/EP1005429A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/04—Partitions
    • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
    • B65D25/085—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is dislodged by means of a plunger rod or the like pushing the plug down
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2041—Separating means having removable plugs

Definitions

  • the subject of the invention is a system which makes it possible to ensure the mixing of two isolated components, in particular a solvent and a lyophilisate, before their removal and then their injection using a syringe, of any type and more precisely, it relates to a mixing bottle with a double pull-out compartment which makes it possible to carry out the mixing by manual action, without having to use the syringe as a means of transfer.
  • a product such as the mixture of a solvent and a lyophilisate into the body of a patient is a normal operation which is carried out most of the time using a syringe.
  • the products must first be mixed with each other just before injection, and this under optimal conditions of sterility and safety.
  • the injection of the product is done from a disposable syringe sold empty in a sterilized packaging, and from a vial or a vial pre-filled with the product to be injected which is aspirated in the syringe before the injection.
  • This system is suitable for the injection of simple single-dose product but is not suitable for mixing a solvent and a lyophilisate which should only be brought into contact at the last moment.
  • the two components are usually each contained in an independent bottle and their mixing is ensured using a disposable syringe itself which may be made of plastic.
  • a disposable syringe itself which may be made of plastic.
  • the liquid is drawn from a first bottle using the syringe, then it is transferred to the other bottle which is then shaken to obtain a homogeneous mixture, the needle being able to remain stuck in the stopper during this last operation. . It remains to aspirate the mixture obtained using the syringe before proceeding with the injection. It can therefore be seen that this operating mode requires two bottles and two successive manipulations, thereby increasing the risks of untimely bite.
  • the solution which consists in using a syringe pre-filled with one of the components for example the solvent and to have only one bottle for the lyophilisate. This reduces the number of manipulations, but in return it is necessary that the pre-filled syringe is made of a material capable of responding to the constraints related to interactions content-containing, for example glass, more expensive material which excludes the use of a simple standard disposable syringe made from standard or convenience plastics.
  • the objective is therefore to have a device which makes it possible to respond to the injection modes usually encountered and as described above, in combination with a safety syringe.
  • the main object of the invention is therefore a mixing bottle making it possible to ensure the mixing of two components before their removal, a bottle which has two nesting compartments, one of which consists of the bottle itself and the other of a profiled seal. in the form of a cup capable of moving inside said bottle to bring the two compartments into contact, under the action of a perforable stopper which can be moved in the neck of the bottle against the force of a elastic restraint.
  • the neck has a narrower section than that of the main flared body of the bottle, the lower part of which constitutes a compartment for one component and the seal delimiting the other compartment for the other component is maintained. inside said neck to separate one from the other, in a leaktight manner, the two compartments.
  • the seal consists of a circular base on which are reported diametrically opposite vertical sides, externally shaped to match the circular outline of the neck of the bottle, openings being formed between the sides.
  • the lower part of the stopper is supported on the sides of the seal, the stopper and the seal being joined together, or else the stopper and the seal form a single piece.
  • the elastic retaining member is a crimping sleeve covering the head of the stopper, a sleeve whose side walls are in the form of an accordion and whose
  • a needle is integrated in the stopper, its tapered end flush with the lower part of the stopper.
  • Figure 1 a sectional view of a mixing bottle.
  • Figure 2 a schematic perspective view of the seal included in the bottle.
  • Figure 3 a schematic sectional view partially showing the attachment of the seal to the plug.
  • Figure 4 a sectional view of the bottle according to Figure 1, in the mixing position.
  • Figure 5 a schematic perspective view of an alternative embodiment of the seal.
  • Figure 6 a sectional view of a bottle with needle integrated in the cap.
  • FIG. 7 a partial sectional view on a larger scale of the stopper according to FIG. 6.
  • the mixing bottle 1 illustrated in FIG. 1 has a neck 2 of narrower section than that, flared, of the main body which contains the solvent 3, the neck further forming an annular rim 7 on the outside of the bottle.
  • This is formed of a circular base 5 whose outer edge forms sealing lips 6.
  • On the base 5 are reported two diametrically opposite vertical sides 8 which are profiled externally to conform to the circular outline of the neck.
  • the sides and the circular base of the joint 4 form a cup delimiting a compartment which serves as a housing for a pellet 9 of lyophilis t, however leaving openings 12 between the sides 8 for the passage of liquid.
  • a cylindrical plug 10 also made of elastomer, the cylindrical part of which slides freely in the neck 2 of the bottle, the seal being also provided for example by lips. 11.
  • This stopper closes the bottle 1 ensuring the tightness of the compartment containing the lyophilisate 9.
  • this elastomer stopper 10 is hollow to allow the passage of the needle of a syringe during the aspiration phase. of the mixture to be injected.
  • the cap is not fully inserted into the neck of the bottle. Its head 13 is capped with a crimping sleeve 14 whose side walls 15 are in the form of an "accordion" and whose lower end is hooked by construction to the annular rim 7 of the bottle.
  • a retractable capsule is provided on the top of the crimping sleeve, so as to be able to introduce the needle into the head of the stopper without detaching its crimping which must be maintained during the entire operation.
  • the seal 4 and the lower part of the plug 10 are made integral by a connection of the tenon-mortise type known per se, visible in FIG. 3.
  • FIG. 1 therefore shows a mixing bottle as obtained in manufacturing, in which the solvent and the lyophilisate are each located in their respective compartment, without the possibility of untimely mixing, whatever the transport and shocks undergone by the bottle, due to the fact that the crimping sleeve 14 strictly maintains the plug in its position, as well as the seal 4 which is associated with it.
  • the bottle 1 being kept inverted, the neck 2 being oriented downwards, it is easy to aspirate the dose to be injected using a syringe by pricking the head 13 of the stopper 10 in its middle after removal of the retractable capsule, the needle easily passing through the hollow body of the stopper.
  • the plug 10 and the seal 4 are not connected to each other, the seal remaining in place by the simple pressure exerted by the elastomer on the walls of the neck. When the cap is pushed in, the seal falls into the bottom of the bottle and mixing is done automatically.
  • the plug and the seal form a single piece whose manufacture by molding is thus simplified.
  • the vertical sides 8 of the seal 4 merge with the wall of the plug 10.
  • the seal is formed of a circular base on which abuts a ring which delimits the edge of the cup.
  • the end of the needle 16 is flush with the base of the stopper 10 and its tapered end is protected from lyophilisate by a protective cup 17 mounted at the center of a cross 18 inserted between said stopper and the seal 4.
  • the head 13 of the plug is for this purpose hollowed out of a cell 19 into which the needle 16 opens and in which is arranged a profiled needle holder 20 capable of receiving the end of a syringe, the needle holder being closed at its upper part by a small shutter 21.
  • a locking system with clips or notches is provided in the needle holder to avoid disassembly needle-syringe.
  • the shutter may be of any other type, for example with a removable tab, etc.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)

Abstract

The invention concerns a mixing flask for mixing two isolated constituents before they are drawn, comprising two tiered compartments one of which consists of the flask (1) itself, and the other is limited by joint (4) with a profile shaped like a base cup mobile inside the flask neck (2), of smaller cross-section than the main body, for contacting the two compartments, by the action of a plug capable of being pierced (10) mobile in said neck countering the force of an elastic crimping sleeve (14). The invention is useful for mixing solvent and lyophilizate before it is injected with a syringe.

Description

Flacon mélangeur mettant en contact deux composants isolés avant leur prélèvement et leur injection à l'aide d'une seringue.Mixing bottle bringing two isolated components into contact before they are withdrawn and injected using a syringe.
L'invention a pour objet un système qui permet d'assurer le mélange de deux composants isolés, notamment un solvant et un lyophilisât, avant leur prélèvement puis leur injection à l'aide d'une seringue, de quelque type qu'elle soit et elle concerne plus précisément un flacon mélangeur à double compartiment gigogne qui permet de réaliser le mélange par action manuelle, sans avoir à utiliser la seringue comme moyen de transfert.The subject of the invention is a system which makes it possible to ensure the mixing of two isolated components, in particular a solvent and a lyophilisate, before their removal and then their injection using a syringe, of any type and more precisely, it relates to a mixing bottle with a double pull-out compartment which makes it possible to carry out the mixing by manual action, without having to use the syringe as a means of transfer.
L'injection d'un produit tel que le mélange d'un solvant et d'un lyophilisât dans le corps d'un patient, est une opération normale qui s'effectue la plupart du temps à l'aide d'une seringue. Mais il faut auparavant que les produits soient mélangés entre eux juste avant l'injection, et cela dans les conditions optimales de stérilité et de sécurité.The injection of a product such as the mixture of a solvent and a lyophilisate into the body of a patient is a normal operation which is carried out most of the time using a syringe. However, the products must first be mixed with each other just before injection, and this under optimal conditions of sterility and safety.
Il existe plusieurs techniques pour aboutir à ce résultat. Tout d'abord l'injection du produit se fait à partir d'une seringue jetable vendue vide dans un emballage stérilisé, et d'une ampoule ou un flacon prérempli du produit à injecter que l'on aspire dans la seringue avant l'injection. Ce système convient pour l'injection de produit simple à dose unique mais ne se prête pas au mélange d'un solvant et d'un lyophilisât qui ne doivent être mis au contact qu ' au dernier moment .There are several techniques to achieve this result. First of all, the injection of the product is done from a disposable syringe sold empty in a sterilized packaging, and from a vial or a vial pre-filled with the product to be injected which is aspirated in the syringe before the injection. . This system is suitable for the injection of simple single-dose product but is not suitable for mixing a solvent and a lyophilisate which should only be brought into contact at the last moment.
Dans ce cas particulier, les deux composants sont habituellement chacun contenus dans un flacon indépendant et leur mélange est assuré à l'aide d'une seringue jetable elle-même qui peut-être en matière plastique. Ainsi on aspire le liquide d'un premier flacon à l'aide de la seringue, puis on le transfère dans l'autre flacon qui est ensuite agité pour obtenir un mélange homogène, l'aiguille pouvant rester piquée dans le bouchon pendant cette dernière opération. Il reste à aspirer le mélange obtenu à l'aide de la seringue avant de procéder à l'injection. On constate donc que ce mode opératoire nécessite deux flacons et deux manipulations successives, augmentant ainsi les risques de piqûre intempestive.In this particular case, the two components are usually each contained in an independent bottle and their mixing is ensured using a disposable syringe itself which may be made of plastic. Thus the liquid is drawn from a first bottle using the syringe, then it is transferred to the other bottle which is then shaken to obtain a homogeneous mixture, the needle being able to remain stuck in the stopper during this last operation. . It remains to aspirate the mixture obtained using the syringe before proceeding with the injection. It can therefore be seen that this operating mode requires two bottles and two successive manipulations, thereby increasing the risks of untimely bite.
Pour s'éviter cela, on connait la solution qui consiste à utiliser une seringue préremplie de l'un des composants par exemple le solvant et de n'avoir qu'un flacon pour le lyophilisât. On réduit ainsi le nombre de manipulations, mais en contrepartie il faut que la seringue préremplie soit réalisée dans un matériau susceptible de répondre aux contraintes liées aux interactions contenu- contenant, par exemple le verre, matériau plus coûteux qui exclut l'usage d'une simple seringue standard et jetable fabriquée à partir de matières plastiques standard ou de commodité .To avoid this, we know the solution which consists in using a syringe pre-filled with one of the components for example the solvent and to have only one bottle for the lyophilisate. This reduces the number of manipulations, but in return it is necessary that the pre-filled syringe is made of a material capable of responding to the constraints related to interactions content-containing, for example glass, more expensive material which excludes the use of a simple standard disposable syringe made from standard or convenience plastics.
Dans la continuité de ce mode opératoire on a pensé aussi à préremplir la seringue en verre ou en tout autre matériau d'un produit prêt à l'emploi, c'est à dire d'un mélange de produit actif et de solvant. Mais l'utilisation d'un produit prêt à l'emploi nécessite la plupart du temps pour des questions de durée de stockage ou de péremption, la présence dans le mélange de stabilisants qui apportent un surcoût à l'ensemble et qui requièrent des tests d'acceptabilité longs et coûteux.As a continuation of this operating mode, it has also been thought to pre-fill the syringe in glass or in any other material with a ready-to-use product, that is to say a mixture of active product and of solvent. But the use of a ready-to-use product requires most of the time for questions of storage time or expiration, the presence in the mixture of stabilizers which bring an additional cost to the whole and which require tests of 'long and costly acceptability.
Les risques de contamination et toutes les conséquences qui en découlent vont conduire irrémédiablement à l'obligation de réduire les opérations à risque et d'utiliser du matériel de sécurité, notamment des seringues de sécurité qui ne sont utilisables qu'une seule fois et ce, quel que soit le mode d'utilisation.The risks of contamination and all the consequences which ensue from it will irreparably lead to the obligation to reduce risky operations and to use safety equipment, in particular safety syringes which can be used only once, whatever the mode of use.
L'objectif est donc d'avoir un dispositif qui permette de répondre aux modes d'injection habituellement rencontrés et tels que décrits plus haut, en association avec une seringue de sécurité.The objective is therefore to have a device which makes it possible to respond to the injection modes usually encountered and as described above, in combination with a safety syringe.
Comme il a été vu lors de la description des modes d'injection, certain cas demandent le recours à la seringue pour préparer le mélange. On voit qu'alors, il n'est pas possible d'utiliser une seringue de sécurité à usage unique. En effet, si la seringue ne peut véritablement servir qu'une seule fois, il est logique qu'il ne soit pas possible d'y avoir recours pour préparer le mélange solvant-lyophilisat .As has been seen during the description of the injection methods, certain cases require the use of the syringe to prepare the mixture. We see that then, it is not possible to use a disposable safety syringe. If the syringe can only be used once, it It is logical that it cannot be used to prepare the solvent-lyophilisate mixture.
Ces inconvénients ont conduit le Demandeur à imaginer un dispositif qui permet de réaliser le mélange des deux composants au sein d'un même flacon sans avoir recours à une autre pièce extérieure, notamment une seringue celle- ci étant exclusivement réservée à l'opération d'injection. Ainsi la nouvelle technique proposée évite tout risque de piqûres lors de la manipulation du flacon ; elle permet l'utilisation d'une seringue de sécurité lors de l'injection ultérieure, et enfin elle est particulièrement avantageuse sur le plan économique puisqu'elle ne nécessite qu'un seul flacon de conception simple, et une seringue standard jetable, en matière plastique, pour l'injection. L'invention a donc pour objet principal un flacon mélangeur permettant d'assurer le mélange de deux composants avant leur prélèvement, flacon qui comporte deux compartiments gigognes dont l'un est constitué du flacon lui-même et l'autre d'un joint profilé en forme de coupelle apte à se déplacer à l'intérieur dudit flacon pour mettre en contact les deux compartimen s, sous l'action d'un bouchon perforable déplaçable dans le col du flacon à 1 ' encontre de la force d'un organe de retenue élastique.These drawbacks have led the Applicant to imagine a device which makes it possible to mix the two components within the same bottle without having to use another external part, in particular a syringe, the latter being exclusively reserved for the operation of injection. Thus the new proposed technique avoids any risk of punctures when handling the bottle; it allows the use of a safety syringe during the subsequent injection, and finally it is particularly advantageous from the economic point of view since it requires only a single vial of simple design, and a standard disposable syringe, in material plastic, for injection. The main object of the invention is therefore a mixing bottle making it possible to ensure the mixing of two components before their removal, a bottle which has two nesting compartments, one of which consists of the bottle itself and the other of a profiled seal. in the form of a cup capable of moving inside said bottle to bring the two compartments into contact, under the action of a perforable stopper which can be moved in the neck of the bottle against the force of a elastic restraint.
Selon une autre caractéristique principale de l'invention, le col a une section plus étroite que celle du corps principal évasé du flacon dont la partie inférieure constitue un compartiment pour un composant et le joint délimitant l'autre compartiment pour l'autre composant est maintenu à l'intérieur dudit col pour séparer l'un de l'autre, de façon étanche, les deux compartiments.According to another main characteristic of the invention, the neck has a narrower section than that of the main flared body of the bottle, the lower part of which constitutes a compartment for one component and the seal delimiting the other compartment for the other component is maintained. inside said neck to separate one from the other, in a leaktight manner, the two compartments.
Plus précisément le joint est constitué d'une base circulaire sur laquelle sont rapportés des flancs verticaux diamétralement opposés, profilés extérieurement pour épouser le contour circulaire du col du flacon, des ouvertures étant ménagées entre les flancs. La partie inférieure du bouchon est en appui sur les flancs du joint, le bouchon et le joint étant solidarisés entre eux, ou encore le bouchon et le joint forment une seule et même pièce.More specifically, the seal consists of a circular base on which are reported diametrically opposite vertical sides, externally shaped to match the circular outline of the neck of the bottle, openings being formed between the sides. The lower part of the stopper is supported on the sides of the seal, the stopper and the seal being joined together, or else the stopper and the seal form a single piece.
Selon une caractéristique particulière de l'invention, l'organe de retenue élastique est un manchon de sertissage coiffant la tête du bouchon, manchon dont les parois latérales sont en forme d'accordéon et dontAccording to a particular characteristic of the invention, the elastic retaining member is a crimping sleeve covering the head of the stopper, a sleeve whose side walls are in the form of an accordion and whose
1 ' extrémité inférieure est accrochée à un rebord annulaire extérieur au col du flacon.1 lower end is attached to an annular rim outside the neck of the bottle.
Enfin selon une variante préférentielle de l'invention, une aiguille est intégrée dans le bouchon, son extrémité effilée affleurant à la partie inférieure du bouchon.Finally according to a preferred variant of the invention, a needle is integrated in the stopper, its tapered end flush with the lower part of the stopper.
D'autres caractéristiques particulières et avantages de l'invention ressortiront de la description qui va suivre d'exemples non limitatifs de réalisation dans lesquels il est fait référence aux dessins annexés qui représentent :Other particular characteristics and advantages of the invention will emerge from the description which follows of nonlimiting exemplary embodiments in which reference is made to the appended drawings which represent:
Figure 1, une vue en coupe d'un flacon mélangeur.Figure 1, a sectional view of a mixing bottle.
Figure 2, une vue schématique en perspective du joint inclus dans le flacon. Figure 3 , une vue schématique en coupe montrant partiellement l'accrochage du joint au bouchon.Figure 2, a schematic perspective view of the seal included in the bottle. Figure 3, a schematic sectional view partially showing the attachment of the seal to the plug.
Figure 4, une vue en coupe du flacon selon la figure 1, en position de mélange.Figure 4, a sectional view of the bottle according to Figure 1, in the mixing position.
Figure 5, une vue schématique en perspective d'une variante de réalisation du joint.Figure 5, a schematic perspective view of an alternative embodiment of the seal.
Figure 6, une vue en coupe d'un flacon avec aiguille intégrée dans le bouchon.Figure 6, a sectional view of a bottle with needle integrated in the cap.
Figure 7, une vue partielle en coupe à plus grande échelle du bouchon selon la figure 6. Le flacon mélangeur 1 illustré à la figure 1 présente un col 2 de section plus étroite que celle, évasée, du corps principal qui contient le solvant 3, le col formant en outre un rebord annulaire 7 à l'extérieur du flacon.FIG. 7, a partial sectional view on a larger scale of the stopper according to FIG. 6. The mixing bottle 1 illustrated in FIG. 1 has a neck 2 of narrower section than that, flared, of the main body which contains the solvent 3, the neck further forming an annular rim 7 on the outside of the bottle.
Dans le col 2 est positionné un joint creux 4 représenté plus en détail à la figure 2. Celui-ci est formé d'une base circulaire 5 dont la bordure extérieure forme des lèvres d'étanchéïté 6. Sur la base 5 sont rapportés deux flancs verticaux 8 diamétralement opposés qui sont profilés extérieurement pour épouser le contour circulaire du col.In the neck 2 is positioned a hollow seal 4 shown in more detail in Figure 2. This is formed of a circular base 5 whose outer edge forms sealing lips 6. On the base 5 are reported two diametrically opposite vertical sides 8 which are profiled externally to conform to the circular outline of the neck.
Les flancs et la base circulaire du joint 4 forment une coupelle délimitant un compartiment qui sert de logement à une pastille 9 de lyophilis t, laissant toutefois des ouvertures 12, entre les flancs 8 pour le passage de liquide. Au dessus de ce joint avantageusement réalisé en élastomère ou toute matière souple ou élastique vient s'appuyer un bouchon cylindrique 10 également en élastomère dont la partie cylindrique coulisse librement dans le col 2 du flacon, 1 ' étanchéïté étant également assurée par exemple par des lèvres extérieures 11. Ainsi ce bouchon ferme le flacon 1 en assurant l'étanchéité du compartiment contenant le lyophilisât 9. En outre ce bouchon en élastomère 10 est creux pour permettre le passage de l'aiguille d'une seringue lors de la phase d'aspiration du mélange à injecter. On voit à la figure 1 que le bouchon est incomplètement enfoncé dans le col du flacon. Sa tête 13 est coiffée d'un manchon de sertissage 14 dont les parois latérales 15 sont en forme "d'accordéon" et dont l'extrémité inférieure est accrochée par construction au rebord annulaire 7 du flacon. Une capsule escamotable est prévue sur le dessus du manchon de sertissage, de façon à pouvoir introduire l'aiguille dans la tête du bouchon sans désolidariser son sertissage qui doit être maintenu pendant toute l'opération.The sides and the circular base of the joint 4 form a cup delimiting a compartment which serves as a housing for a pellet 9 of lyophilis t, however leaving openings 12 between the sides 8 for the passage of liquid. Above this seal advantageously made of elastomer or any flexible or elastic material comes to bear a cylindrical plug 10 also made of elastomer, the cylindrical part of which slides freely in the neck 2 of the bottle, the seal being also provided for example by lips. 11. This stopper closes the bottle 1 ensuring the tightness of the compartment containing the lyophilisate 9. In addition, this elastomer stopper 10 is hollow to allow the passage of the needle of a syringe during the aspiration phase. of the mixture to be injected. We see in Figure 1 that the cap is not fully inserted into the neck of the bottle. Its head 13 is capped with a crimping sleeve 14 whose side walls 15 are in the form of an "accordion" and whose lower end is hooked by construction to the annular rim 7 of the bottle. A retractable capsule is provided on the top of the crimping sleeve, so as to be able to introduce the needle into the head of the stopper without detaching its crimping which must be maintained during the entire operation.
Le joint 4 et la partie inférieure du bouchon 10 sont rendus solidaires par une liaison du type tenon- mortaise connu en soi, visible à la figure 3.The seal 4 and the lower part of the plug 10 are made integral by a connection of the tenon-mortise type known per se, visible in FIG. 3.
La figure 1 montre donc un flacon mélangeur tel qu'obtenu en fabrication, dans lequel le solvant et le lyophilisât sont localisés chacun dans leur compartiment respectifs, sans possibilité de mélange intempestif, quels que soient les transports et chocs subis par le flacon, du fait que le manchon de sertissage 14 maintient rigoureusement le bouchon dans sa position, ainsi que le joint 4 qui lui est associé.FIG. 1 therefore shows a mixing bottle as obtained in manufacturing, in which the solvent and the lyophilisate are each located in their respective compartment, without the possibility of untimely mixing, whatever the transport and shocks undergone by the bottle, due to the fact that the crimping sleeve 14 strictly maintains the plug in its position, as well as the seal 4 which is associated with it.
Lorsqu'un utilisateur veut effectuer le mélange des deux composants, il lui suffit d'enfoncer le bouchon 10 dans le col 2 du flacon, à 1 ' encontre de la force de retenue du manchon de sertissage 14 dont les parois latérales 15 se trouvent alors comprimées comme on le voit à la figure 4. Ce mouvement de descente du bouchon 10 dans le col 2 entraine également la descente du joint 4 vers le fond du flacon, dans une zone moins étroite de celui-ci. De ce fait les ouvertures 12 se trouvent apparentes au niveau de la partie évasée du flacon, permettant ainsi de mettre en communication le compartiment contenant le lyophilisât avec le solvant. En retournant et/ou en agitant le flacon, le solvant 3 dissout le lyophilisât 9.When a user wants to mix of the two components, it suffices to push the stopper 10 into the neck 2 of the bottle, against the retaining force of the crimping sleeve 14 whose side walls 15 are then compressed as seen in the figure 4. This movement of descent of the stopper 10 into the neck 2 also causes the descent of the seal 4 towards the bottom of the bottle, in a narrower area of the latter. As a result, the openings 12 are visible at the flared part of the bottle, thus allowing the compartment containing the lyophilisate to be placed in communication with the solvent. By inverting and / or shaking the bottle, the solvent 3 dissolves the lyophilisate 9.
Une fois le mélange homogène obtenu, le flacon 1 étant maintenu retourné, le col 2 étant orienté vers le bas, il est aisé d'aspirer la dose à injecter à l'aide d'une seringue en piquant la tête 13 du bouchon 10 en son milieu après retrait de la capsule escamotable, l'aiguille traversant facilement le corps creux du bouchon.Once the homogeneous mixture has been obtained, the bottle 1 being kept inverted, the neck 2 being oriented downwards, it is easy to aspirate the dose to be injected using a syringe by pricking the head 13 of the stopper 10 in its middle after removal of the retractable capsule, the needle easily passing through the hollow body of the stopper.
On a ainsi supprimé certaines manipulations, allant dans le sens de la simplification et de la sécurité de toute opération d'injection à l'aide d'une seringue. On a aussi réalisé une économie substantielle sur la nature des matériaux et le nombre de pièces comme par exemple un flacon. Hormis le gain de temps obtenu, ce système permet le maintien du matériel stérile le plus longtemps possible avant l'injection. Enfin on préserve la qualité de l'aiguille, dont le biseau pourrait s ' émousser et l'orifice de l'aiguille se boucher au cours des manipulations, ceci dans le cas où une seule aiguille est utilisée. Dans le cas où deux aiguilles sont nécessaires (l'une pour transférer, l'autre pour réaliser l'injection) ce système permet l'économie d'une aiguille.We thus eliminated certain manipulations, going in the direction of simplification and safety of any injection operation using a syringe. We also made a substantial saving on the nature of the materials and the number of parts such as a bottle. Apart from the time saved, this system allows sterile equipment to be kept as long as possible before injection. Finally, the quality of the needle is preserved, the bevel of which could dull and the orifice of the needle become blocked during handling, this in the case where only one needle is used. In the case where two needles are necessary (one to transfer, the other to carry out the injection) this system saves one needle.
En variante de réalisation non représentée, le bouchon 10 et le joint 4 ne sont pas raccordés l'un à l'autre, le joint restant en place par la simple pression qu'exerce l' élastomère sur les parois du col. Lors de l'enfoncement du bouchon, le joint tombe dans le fond du flacon et le mélange se fait automatiquement.In an alternative embodiment not shown, the plug 10 and the seal 4 are not connected to each other, the seal remaining in place by the simple pressure exerted by the elastomer on the walls of the neck. When the cap is pushed in, the seal falls into the bottom of the bottle and mixing is done automatically.
Selon une autre variante de réalisation montrée à la figure 5, au contraire de la réalisation précédente, le bouchon et le joint forment une seule et même pièce dont la fabrication par moulage est ainsi simplifiée. Dans ce cas les flancs verticaux 8 du joint 4 se confondent avec la paroi du bouchon 10.According to another alternative embodiment shown in Figure 5, unlike the previous embodiment, the plug and the seal form a single piece whose manufacture by molding is thus simplified. In this case, the vertical sides 8 of the seal 4 merge with the wall of the plug 10.
Selon encore une autre variante de réalisation non représentée, le joint est formé d'une base circulaire sur laquelle vient en appui une bague qui délimite la bordure de la coupelle.According to yet another alternative embodiment not shown, the seal is formed of a circular base on which abuts a ring which delimits the edge of the cup.
Pour éviter la manipulation qui consiste à enfoncer une aiguille dans le bouchon 10 pour y aspirer la dose à injecter, on peut aussi intégrer dans le bouchon une aiguille 16 comme on le voit plus précisément aux figures 6 et 7. Cette opération se fait au moment de l'assemblage des pièces lors de la fabrication.To avoid the manipulation which consists in pushing a needle into the stopper 10 in order to aspirate the dose to be injected therein, one can also integrate into the stopper a needle 16 as can be seen more precisely in FIGS. 6 and 7. This operation is done at the time of the assembly of parts during manufacture.
L'extrémité de l'aiguille 16 affleure la base du bouchon 10 et son extrémité effilée est protégée du lyophilisât par une coupelle de protection 17 montée au centre d'un croisillon 18 intercalé entre le dit bouchon et le joint 4. Lorsque le mélange est réalisé, il ne reste plus qu'à présenter le corps de la seringue au-dessus de la têteThe end of the needle 16 is flush with the base of the stopper 10 and its tapered end is protected from lyophilisate by a protective cup 17 mounted at the center of a cross 18 inserted between said stopper and the seal 4. When the mixture is done, all that remains is to present the body of the syringe above the head
13 du bouchon 10, et retirer l'aiguille 16 après avoir rempli la seringue du mélange à injecter. La tête 13 du bouchon est à cet effet creusée d'une alvéole 19 dans laquelle débouche l'aiguille 16 et dans laquelle est disposé un porte-aiguille profilé 20 pouvant recevoir l'extrémité d'une seringue, le porte-aiguille étant fermé à sa partie supérieure par un petit obturateur 21. Un système de blocage à clips ou à cran est prévu dans le porte-aiguille pour éviter le désassemblage aiguille-seringue. En variante de réalisation et selon l'usage du flacon mélangeur, l'obturateur peut-être de tout autre type, par exemple à languette arrachable etc...13 of the plug 10, and withdraw the needle 16 after filling the syringe with the mixture to be injected. The head 13 of the plug is for this purpose hollowed out of a cell 19 into which the needle 16 opens and in which is arranged a profiled needle holder 20 capable of receiving the end of a syringe, the needle holder being closed at its upper part by a small shutter 21. A locking system with clips or notches is provided in the needle holder to avoid disassembly needle-syringe. In an alternative embodiment and according to the use of the mixing bottle, the shutter may be of any other type, for example with a removable tab, etc.
Quand le mélange est effectué lors de l'enfoncement du bouchon 10, une légère surpression va s'établir dans le flacon 1, surpression qui disparaîtra au moment du retrait de l'obturateur 21, avant le verrouillage de la seringue sur le porte-aiguille, la mise à l'air se faisant par l'intermédiaire de l'aiguille. Des variantes de réalisation notamment dans la forme ou la nature des éléments constitutifs du flacon mélangeur, tels que le joint, le bouchon, le manchon de sertissage et le flacon lui-même, ainsi que leurs modes d'accrochage, peuvent être réalisés sans sortir du cadre de l'invention. When mixing is carried out when the plug 10 is pressed, a slight overpressure will settle in the bottle 1, overpressure which will disappear when the obturator 21 is withdrawn, before the syringe is locked on the needle holder, the venting being done by means of the needle. Variant embodiments in particular in the shape or nature of the constituent elements of the mixing bottle, such as the seal, the stopper, the crimping sleeve and the bottle itself, as well as their methods of attachment, can be produced without leaving of the scope of the invention.

Claims

REVENDICATIONS 1 - Flacon mélangeur permettant d'assurer le mélange de deux composants isolés avant leur prélèvement comportant deux compartiments gigognes dont l'un est constitué du flacon lui-même dont la partie inférieure constitue un compartiment pour un composant et dont l'autre est formé d'une coupelle délimitant l'autre compartiment pour l'autre composant, la coupelle étant apte à se déplacer à 1 ' intérieur dudit flacon pour mettre en contact les deux compartiments, caractérisé en ce que la coupelle est constituée par un joint profilé (4) maintenu à l'intérieur du col (2) du flacon (1) par un bouchon perforable (10) déplaçable dans ledit col du flacon à 1 ' encontre de la force d'un organe de retenue élastique (14) . 2 - Flacon mélangeur selon la revendication 1 caractérisé en ce que le joint (4) est constitué d'une base circulaire (5) sur laquelle sont rapportés des flancs verticaux (8) diamétralement opposés, profilés extérieurement pour épouser le contour circulaire du col (2) du flacon, des ouvertures (12) étant ménagées entre les flancs (8) .CLAIMS 1 - Mixing bottle making it possible to ensure the mixing of two isolated components before their sampling comprising two nesting compartments, one of which consists of the bottle itself, the lower part of which constitutes a compartment for one component and the other of which is formed a cup delimiting the other compartment for the other component, the cup being able to move inside one of said bottle to bring the two compartments into contact, characterized in that the cup is constituted by a profiled seal (4 ) held inside the neck (2) of the bottle (1) by a perforable stopper (10) movable in said neck of the bottle against the force of an elastic retaining member (14). 2 - Mixing bottle according to claim 1 characterized in that the seal (4) consists of a circular base (5) on which are reported vertical sides (8) diametrically opposite, profiled externally to match the circular outline of the neck ( 2) of the bottle, openings (12) being formed between the sides (8).
3 - Flacon mélangeur selon les revendications 1 et 2 caractérisé en ce que la partie inférieure du bouchon (10) est en appui sur les flancs (8) du joint (4) , le bouchon et le joint étant solidarisés entre eux.3 - Mixing bottle according to claims 1 and 2 characterized in that the lower part of the plug (10) is supported on the sides (8) of the seal (4), the plug and the seal being secured together.
4 - Flacon mélangeur selon les revendications 1 et 2 caractérisé en ce que le bouchon (10) et le joint (4) forment une seule et même pièce.4 - Mixing bottle according to claims 1 and 2 characterized in that the plug (10) and the seal (4) form a single piece.
5 - Flacon mélangeur selon la revendication 1 caractérisé en ce que l'organe de retenue élastique est un manchon de sertissage (14) coiffant la tête (13) du bouchon (10) , manchon dont les parois latérales (15) sont en forme d'accordéon et dont l'extrémité inférieure est accrochée à un rebord annulaire (7) extérieur au col (2) du flacon. 6 - Flacon mélangeur selon la revendication 1 caractérisé en ce que une aiguille (16) est intégrée dans le bouchon (10), son extrémité effilée affleurant à la partie intérieure du bouchon.5 - Mixing bottle according to claim 1 characterized in that the elastic retaining member is a crimping sleeve (14) covering the head (13) of the stopper (10), sleeve whose side walls (15) are d-shaped accordion and the lower end of which is attached to an annular rim (7) outside the neck (2) of the bottle. 6 - Mixing bottle according to claim 1 characterized in that a needle (16) is integrated in the stopper (10), its tapered end flush with the part inside the cap.
7 - Flacon mélangeur selon la revendication 1 caractérisé en ce que la tête (13) du bouchon (10) est creusée d'une alvéole (19) dans laquelle débouche l'aiguille (16) et dans laquelle s'adapte l'extrémité d'une seringue. 7 - Mixing bottle according to claim 1 characterized in that the head (13) of the plug (10) is hollowed out of a cell (19) into which the needle (16) opens and in which the end d 'a needle.
EP98942758A 1997-08-22 1998-08-20 Mixing flask contacting two isolated constituents before they are drawn and injected into a syringe Withdrawn EP1005429A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9710573 1997-08-22
FR9710573A FR2767514B1 (en) 1997-08-22 1997-08-22 MIXER BOTTLE COMBINING TWO INSULATED COMPONENTS BEFORE THEY ARE COLLECTED AND INJECTED WITH A SYRINGE
PCT/FR1998/001825 WO1999010245A1 (en) 1997-08-22 1998-08-20 Mixing flask contacting two isolated constituents before they are drawn and injected into a syringe

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EP1005429A1 true EP1005429A1 (en) 2000-06-07

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JP (1) JP2001514029A (en)
CN (1) CN1071242C (en)
BR (1) BR9815583A (en)
CA (1) CA2301727A1 (en)
FR (1) FR2767514B1 (en)
WO (1) WO1999010245A1 (en)

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WO2001022913A1 (en) * 1999-09-30 2001-04-05 Fujisawa Pharmaceutical Co., Ltd. Infusion container and method of storing freeze-dried medicine
JP4617552B2 (en) * 1999-09-30 2011-01-26 アステラス製薬株式会社 Infusion container and lyophilized drug storage method
FR2811640B1 (en) 2000-07-17 2002-12-27 Oreal PACKAGING AND DELIVERY DEVICE FOR DELIVERING A VARIABLE DOSE
FR2811639B1 (en) * 2000-07-17 2002-10-04 Oreal DEVICE FOR PACKAGING AND DISPENSING A PRODUCT, ESPECIALLY A HAIR PRODUCT
US7131784B2 (en) * 2004-03-11 2006-11-07 3M Innovative Properties Company Unit dose delivery system
JP4608301B2 (en) * 2004-12-14 2011-01-12 大成化工株式会社 Dissolving eye dropper kit
WO2009096803A1 (en) * 2008-01-29 2009-08-06 Skvortsov, Igor Victorovich 'expromt' bottle
JP6378621B2 (en) * 2014-12-03 2018-08-22 大成化工株式会社 Dissolving type eye drop container kit and eye drop nozzle used therefor
CN106560096A (en) * 2015-09-30 2017-04-12 李和伟 Delivery and dissolving device of lyophilized excipient preparation
CN105923276B (en) * 2016-06-19 2018-04-06 承德市中心医院 A kind of Pathologic specimen stores translator
JP7315536B2 (en) 2017-09-28 2023-07-26 エフ． ホフマン－ラ ロシュ アーゲー Vial stoppers for lyophilization vials and closure methods for closing lyophilization vials
EP3695823A4 (en) * 2017-10-10 2021-10-13 Seikagaku Corporation DRUG STORAGE CONTAINER, LOCKING ELEMENT, METHOD FOR MANUFACTURING A DRUG STORAGE CONTAINER, METHOD FOR INSPECTING MICRO-ORGANISMS AND CONTAMINATION AND FIXING PREPARATION FOR BUFFERLING

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FR2767514B1 (en) 1999-11-05
FR2767514A1 (en) 1999-02-26
BR9815583A (en) 2002-01-15
JP2001514029A (en) 2001-09-11
CA2301727A1 (en) 1999-03-04
WO1999010245A1 (en) 1999-03-04
CN1275113A (en) 2000-11-29

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