EP1345566B1 - Reconstitution device in particular for mixing substances in the medical field - Google Patents

Reconstitution device in particular for mixing substances in the medical field Download PDF

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Publication number
EP1345566B1
EP1345566B1 EP01999342A EP01999342A EP1345566B1 EP 1345566 B1 EP1345566 B1 EP 1345566B1 EP 01999342 A EP01999342 A EP 01999342A EP 01999342 A EP01999342 A EP 01999342A EP 1345566 B1 EP1345566 B1 EP 1345566B1
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EP
European Patent Office
Prior art keywords
socket
needle
end piece
holding
flask
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.)
Expired - Lifetime
Application number
EP01999342A
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German (de)
French (fr)
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EP1345566A1 (en
Inventor
Jean Curutcharry
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Technoflex SA
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Technoflex SA
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Publication of EP1345566A1 publication Critical patent/EP1345566A1/en
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Publication of EP1345566B1 publication Critical patent/EP1345566B1/en
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    • 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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61J1/1475—Inlet or outlet ports
    • 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
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends

Definitions

  • the present invention relates to the mixing of one substance with another, particularly in the medical field for example for the reconstitution of a drug with a diluent.
  • the invention relates to the device, commonly called reconstitution device, intended to operate such a mixture.
  • a diluent which may be for example a dextrose solution, a saline solution or even water.
  • these medicaments must be mixed with a diluent contained in a flexible pouch provided for this purpose with an injection tubing comprising a tip made of a material, such as latex for example, which can be pierced by a needle, the passage formed by the latter closing of itself from the withdrawal of the needle.
  • a diluent contained in a flexible pouch provided for this purpose with an injection tubing comprising a tip made of a material, such as latex for example, which can be pierced by a needle, the passage formed by the latter closing of itself from the withdrawal of the needle.
  • the communication between the medicine vial and the flexible bag is provided by means of a reconstitution device consisting of a hollow needle pointed at its two ends and projecting into two open cylindrical sockets arranged head to tail and shaped to receive, one, the mouth of the vial with its latex cap for example and the other, the tip of the injection tubing of the flexible bag.
  • the reconstitution device is taken out of its sterile package, the needle, on the vial side, of the device is fully engaged through the stopper, then the other needle is also inserted fully into the container. end of the flexible bag, the communication between the latter and the vial thus being provided via the reconstitution device.
  • EP-A-1,034,772 discloses such a reconstitution device according to the preamble of claim 1.
  • Such a system has the disadvantage of the need to separately store soft bags, vials and reconstitution devices.
  • the purpose of the present invention is to simplify this system and make it more economical by combining the reconstitution device and the flexible bag as soon as it is manufactured by pre-positioning said device, and packaging the device + bag assembly in a package unique sterile.
  • the subject of the invention is a reconstitution device, in particular for the mixture of substances in the medical field, according to claim 1.
  • the device comprises a hollow needle, pointed at its two ends and fixed on a support defining two coaxial sleeves enveloping each end of the needle and loaded to receive, one, the plug mouth of a vial and the other, the tip of an injection port of a pocket flexible, so that, by perforation of said cap and tip, communicating the vial and the flexible bag via said needle, characterized in that said sleeve, flexible bag side, comprises positioning and retaining means giving a first stable position wherein the device is secured to the bag without the needle is in contact with the tip and a second stable position, corresponding to piercing of the tip by the needle.
  • the flask face of the device may be conventional and include a conventional socket for receiving a conventional flask.
  • the invention also relates to the assembly consisting of a flexible bag provided with at least one nozzle injection nozzle prepositioned in said first retaining position in the bushing of the reconstitution device.
  • the device of the invention therefore has substantial advantages, particularly in terms of ease of management and use.
  • the reconstitution device shown at 1 in Figure 1 comprises a hollow needle 2 passing through a circular support 3 extended towards each pointed end of the needle, a cylindrical sleeve.
  • One of the sleeves (4) is intended to accommodate (FIGS. 2 and 3) the end piece 5 of an injection tubing 6 of a flexible bag 7.
  • the other sleeve 8 arranged head to tail relative to the sleeve 4, has a larger diameter to receive the mouth provided with a plug 9 ( Figure 3) of a vial 10 of drug for example.
  • the sleeve 8 has an internal diameter adapted to the vial 10 and is closed during non-use by a plug B for security purposes.
  • the length of the bushing 8 is slightly greater than that of the projecting part of the needle 2.
  • the sleeve 4 is very substantially longer than the protruding part of the needle 2 in order to receive (FIG. 2) the entire endpiece 5 in an area remote from the pointed end of said needle.
  • the internal diameter of the bushing 4 corresponds to the external diameter of the nozzle 5, the wall of which is made of elastic material.
  • the tip 5 is of conventional structure of a material such as latex allowing its piercing through the needle 2, the passage hole closing itself after removal of the needle, as well as the material of the plug 9.
  • the sleeve 4 is internally provided with a slight annular bead 11, discontinuous as shown or not, however, at a distance from this bead 11 corresponding to the length of the nozzle 5 are provided one or several small internal projections, for example two protrusions 12 diametrically opposite, shaped at the end of two tongues 13 cut in the wall of the sleeve 4.
  • the device 1 is monobloc and made for example by molding a suitable plastic material.
  • FIG. 2 shows the device 1 pre-positioned on the injection tubing 6, in the standby position.
  • the device 1 is in its first stable position, the tip 5 having been engaged in the sleeve 4 by force to overcome, thanks to the elasticity of the tip, the inlet bead 11, the tip 5 being introduced completely and being stopped in this first position by the two abutment projections 12.
  • the tip of the needle 2 is kept at a distance from the tip 5 and the device 1 is integral with the flexible pouch 7.
  • the assembly can therefore be handled, packaged in a sterile flexible packaging , stored and managed as a single object.
  • the pocket 7 When using the pocket 7, that is to say when it is desired to mix the contents of the vial 10, with a dilution liquid for example contained in the pocket.
  • the device 1 is first placed on the tubing 6 in the position of Figure 2 (standby position). Then, the vial 10 is introduced through its plug 9 into the sleeve 8 so as to pierce the plug. Finally, the device 1-vial assembly 10 is pressed towards the pocket 7 in order to pierce the tip 5 by the needle.
  • the two containers 7 and 10 are then in communication via the needle 2 and the tubing 6.
  • the device of the invention has the advantage of allowing the removal of the entire device 1-vial 10 of the nozzle 5 after the reconstitution operation.
  • the operator is faced with a pocket 7 in which he can, via the tubing 6, make an additional injection if necessary.
  • the separation between the pocket 7 and the set 1-10 is desirable for optimized treatment of hospital waste.
  • the invention is obviously not limited to the embodiment shown and described above but covers all variants, particularly with regard to the means 11, 12 of positioning-locking of the tip 5 in his first position.
  • the bush 8 may optionally be provided internally in the known manner with one or more projections, three for example, as shown at 15 in the figures, for resiliently retain in the correct insertion position the plug 9 of the vial, and externally also in the known manner, one or more projections, three for example, as shown at 16 to retain the plug B.

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  • 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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Mixers Of The Rotary Stirring Type (AREA)

Abstract

A re-forming device in particular for mixing substances in the medical field, includes a hollow needle pointed at its two tips and fixed on a support defining two coaxial sleeves enclosing each end of the needle and designed to receive, one, the plug opening of a vial, the other, the hub of an injection tube of a flexible bag, so as to communicate, by perforating the plug and hub, the vial and the flexible bag via the needle. The sleeve, on the side of the flexible bag, is dimensioned and designed to be engaged on the hub in a first stable position wherein the device is secured to the bag without the needle being in contact with the hub and the sleeve is mounted sliding on the hub so as to pass, through simple depression of the device on the hub, from the first position into a second position, corresponding to the perforation of the hub by the needle.

Description

La présente invention a trait au mélange d'une substance avec une autre, notamment dans le domaine médical en vue par exemple de la reconstitution d'un médicament au moyen d'un diluant.The present invention relates to the mixing of one substance with another, particularly in the medical field for example for the reconstitution of a drug with a diluent.

Plus précisément, l'invention vise le dispositif, dénommé communément dispositif de reconstitution, destiné à opérer un tel mélange.More specifically, the invention relates to the device, commonly called reconstitution device, intended to operate such a mixture.

Divers médicaments devant être injectés par voie intraveineuse à un patient doivent être auparavant mélangés à un diluant qui peut être par exemple une solution de dextrose, une solution saline ou même de l'eau.Various drugs to be injected intravenously to a patient must be previously mixed with a diluent which may be for example a dextrose solution, a saline solution or even water.

Bon nombre de ces médicaments sont stockés dans des fioles en verre sous forme de poudre ou à l'état liquide.Many of these drugs are stored in glass vials in powder form or in liquid form.

Au moment de leur administration, ces médicaments doivent être mélangés à un diluant contenu dans une poche souple munie à cet effet d'une tubulure d'injection comportant un embout en un matériau, tel que du latex par exemple, susceptible d'être percé par une aiguille, le passage formé par cette dernière se refermant de lui-même dès le retrait de l'aiguille.At the time of their administration, these medicaments must be mixed with a diluent contained in a flexible pouch provided for this purpose with an injection tubing comprising a tip made of a material, such as latex for example, which can be pierced by a needle, the passage formed by the latter closing of itself from the withdrawal of the needle.

Habituellement, la communication entre la fiole de médicament et la poche souple est assurée à l'aide d'un dispositif de reconstitution constitué d'une aiguille creuse pointue à ses deux extrémités et faisant saillie dans deux douilles cylindriques ouvertes disposées tête-bêche et conformées pour recevoir, l'une, l'embouchure de la fiole avec son bouchon en latex par exemple et, l'autre, l'embout de la tubulure d'injection de la poche souple.Usually, the communication between the medicine vial and the flexible bag is provided by means of a reconstitution device consisting of a hollow needle pointed at its two ends and projecting into two open cylindrical sockets arranged head to tail and shaped to receive, one, the mouth of the vial with its latex cap for example and the other, the tip of the injection tubing of the flexible bag.

Au moment de l'utilisation du médicament, le dispositif de reconstitution est sorti de son emballage stérile, l'aiguille, côté fiole, du dispositif est engagée à fond au travers du bouchon, puis l'autre aiguille est introduite également à fond dans l'embout de la poche souple, la communication entre cette dernière et la fiole étant ainsi assurée via le dispositif de reconstitution.At the time of use of the drug, the reconstitution device is taken out of its sterile package, the needle, on the vial side, of the device is fully engaged through the stopper, then the other needle is also inserted fully into the container. end of the flexible bag, the communication between the latter and the vial thus being provided via the reconstitution device.

Le document EP-A-1 034 772 décrit un tel dispositif de reconstitution conforme au préambule de la revendication 1.EP-A-1,034,772 discloses such a reconstitution device according to the preamble of claim 1.

Un tel système présente l'inconvénient de la nécessité de stocker séparément les poches souples, les fioles et les dispositifs de reconstitution.Such a system has the disadvantage of the need to separately store soft bags, vials and reconstitution devices.

Le but de la présente invention est de simplifier ce système et de le rendre plus économique en associant dispositif de reconstitution et poche souple dès la fabrication de cette dernière par pré-positionnement dudit dispositif, et en conditionnant l'ensemble dispositif + poche dans un emballage stérile unique.The purpose of the present invention is to simplify this system and make it more economical by combining the reconstitution device and the flexible bag as soon as it is manufactured by pre-positioning said device, and packaging the device + bag assembly in a package unique sterile.

A cet effet, l'invention a pour objet un dispositif de reconstitution notamment pour le mélange de substances dans le domaine médical, conforme à la revendication 1. En particulier, le dispositif comprend une aiguille creuse, pointue à ses deux extrémités et fixée sur un support définissant deux douilles coaxiales enveloppant chaque extrémité de l'aiguille et chargée de recevoir, l'une, l'embouchure à bouchon d'une fiole et, l'autre, l'embout d'une tubulure d'injection d'une poche souple, en sorte, par perforation desdits bouchon et embout, de mettre en communication la fiole et la poche souple via ladite aiguille, caractérisé en ce que ladite douille, côté poche souple, comporte des moyens de positionnement et de retenue donnant une première position stable dans laquelle le dispositif est solidarisé à la poche sans que l'aiguille soit en contact avec l'embout et une seconde position, stable, correspondant au transpercement de l'embout par l'aiguille.For this purpose, the subject of the invention is a reconstitution device, in particular for the mixture of substances in the medical field, according to claim 1. In particular, the device comprises a hollow needle, pointed at its two ends and fixed on a support defining two coaxial sleeves enveloping each end of the needle and loaded to receive, one, the plug mouth of a vial and the other, the tip of an injection port of a pocket flexible, so that, by perforation of said cap and tip, communicating the vial and the flexible bag via said needle, characterized in that said sleeve, flexible bag side, comprises positioning and retaining means giving a first stable position wherein the device is secured to the bag without the needle is in contact with the tip and a second stable position, corresponding to piercing of the tip by the needle.

Il est ainsi possible de stocker notamment sous emballage stérile, l'association poche souple-dispositif de reconstitution qui forme un ensemble unitaire prêt à être utilisé puisque le dispositif de reconstitution est déjà en place, sans toutefois que l'aiguille soit insérée dans l'embout de la poche dont le contenu peut demeurer ainsi totalement isolé de l'extérieur. Un seul ensemble est ainsi à gérer, à stocker et à manipuler.It is thus possible to store, in particular in sterile packaging, the flexible bag-reconstitution device combination which forms a unitary unit ready to be used since the reconstitution device is already in place, without the needle being inserted into the device. tip of the pocket of which the contents can remain totally isolated from the outside. Only one set is thus to manage, store and manipulate.

Au moment de l'utilisation de la poche, il suffit d'enlever l'emballage stérile s'il y en a un, d'engager le bouchon d'une fiole dans la douille du dispositif afin de transpercer le bouchon, puis d'enfoncer l'ensemble fiole-dispositif de reconstitution sur l'embout jusqu'au transpercement de ce dernier et son engagement complet dans la douille réceptrice pour que le dispositif de reconstitution soit opérationnel.At the time of use of the bag, it is sufficient to remove the sterile package if there is one, to engage the cap of a vial in the socket of the device to pierce the cap, then to press the vial-reconstitution device assembly onto the tip until piercing of the latter and its complete engagement in the receptacle socket for the reconstitution device to be operational.

La face fiole du dispositif peut être conventionnelle et comporter une douille classique pour la réception d'une fiole également classique.The flask face of the device may be conventional and include a conventional socket for receiving a conventional flask.

L'invention a également pour objet l'ensemble constitué d'une poche souple munie d'au moins une tubulure d'injection à embout prépositionné dans ladite première position de retenue dans la douille concernée du dispositif de reconstitution.The invention also relates to the assembly consisting of a flexible bag provided with at least one nozzle injection nozzle prepositioned in said first retaining position in the bushing of the reconstitution device.

Le dispositif de l'invention présente donc des avantages substantiels notamment au niveau de la facilité de gestion et d'utilisation.The device of the invention therefore has substantial advantages, particularly in terms of ease of management and use.

D'autres caractéristiques et avantages ressortiront de la description qui va suivre d'un mode de réalisation du dispositif de l'invention, description donnée à titre d'exemple uniquement et en regard du dessin annexé sur lequel:

  • Figure 1 est une vue en coupe axiale d'un dispositif de reconstitution selon l'invention ;
  • Figure 2 illustre le dispositif de la figure 1 en place en position d'attente sur l'extrémité d'une tubulure d'injection d'une poche souple et,
  • Figure 3 représente le dispositif de la figure 2 dans la seconde position, opérationnelle.
Other characteristics and advantages will emerge from the following description of an embodiment of the device of the invention, a description given by way of example only and with reference to the appended drawing in which:
  • Figure 1 is an axial sectional view of a reconstitution device according to the invention;
  • Figure 2 illustrates the device of Figure 1 in place in the waiting position on the end of an injection pipe of a flexible bag and,
  • Figure 3 shows the device of Figure 2 in the second position, operational.

Le dispositif de reconstitution représenté en 1 sur la figure 1 comprend une aiguille creuse 2 traversant un support circulaire 3 prolongé vers chaque extrémité pointue de l'aiguille, d'une douille cylindrique.The reconstitution device shown at 1 in Figure 1 comprises a hollow needle 2 passing through a circular support 3 extended towards each pointed end of the needle, a cylindrical sleeve.

L'une des douilles (4) est destinée à accueillir (figures 2 et 3) l'embout 5 d'une tubulure d'injection 6 d'une poche souple 7.One of the sleeves (4) is intended to accommodate (FIGS. 2 and 3) the end piece 5 of an injection tubing 6 of a flexible bag 7.

L'autre douille 8, disposée tête-bêche par rapport à la douille 4, présente un diamètre plus large pour recevoir l'embouchure munie d'un bouchon 9 (figure 3) d'une fiole 10 de médicament par exemple. La douille 8 présente un diamètre interne adapté à la fiole 10 et est obturée en période de non utilisation par un bouchon B à des fins de sécurité. La longueur de la douille 8 est légèrement supérieure à celle de la partie saillante de l'aiguille 2.The other sleeve 8, arranged head to tail relative to the sleeve 4, has a larger diameter to receive the mouth provided with a plug 9 (Figure 3) of a vial 10 of drug for example. The sleeve 8 has an internal diameter adapted to the vial 10 and is closed during non-use by a plug B for security purposes. The length of the bushing 8 is slightly greater than that of the projecting part of the needle 2.

La douille 4 est très sensiblement plus longue que la partie saillante de l'aiguille 2 afin de recevoir (figure 2) la totalité de l'embout 5 dans une zone à distance de l'extrémité pointue de ladite aiguille.The sleeve 4 is very substantially longer than the protruding part of the needle 2 in order to receive (FIG. 2) the entire endpiece 5 in an area remote from the pointed end of said needle.

Le diamètre interne de la douille 4 correspond au diamètre externe de l'embout 5 dont la paroi est en matériau élastique.The internal diameter of the bushing 4 corresponds to the external diameter of the nozzle 5, the wall of which is made of elastic material.

L'embout 5 est de structure conventionnelle en un matériau tel que du latex permettant son transpercement par l'aiguille 2, le trou de passage se refermant de lui-même après retrait de l'aiguille, de même que le matériau du bouchon 9.The tip 5 is of conventional structure of a material such as latex allowing its piercing through the needle 2, the passage hole closing itself after removal of the needle, as well as the material of the plug 9.

A son orifice d'entrée, la douille 4 est munie intérieurement d'un léger bourrelet annulaire 11, discontinu comme représenté ou non, cependant qu'à une distance de ce bourrelet 11 correspondant à la longueur de l'embout 5 sont ménagées une ou plusieurs petites saillies internes, par exemple deux saillies 12 diamétralement opposées, conformées à l'extrémité de deux languettes 13 découpées dans la paroi de la douille 4.At its inlet, the sleeve 4 is internally provided with a slight annular bead 11, discontinuous as shown or not, however, at a distance from this bead 11 corresponding to the length of the nozzle 5 are provided one or several small internal projections, for example two protrusions 12 diametrically opposite, shaped at the end of two tongues 13 cut in the wall of the sleeve 4.

Le dispositif 1 est monobloc et réalisé par exemple par moulage d'une matière plastique appropriée.The device 1 is monobloc and made for example by molding a suitable plastic material.

La figure 2 représente le dispositif 1 pré-positionné sur la tubulure d'injection 6, en position d'attente. Le dispositif 1 se trouve dans sa première position stable, l'embout 5 ayant été engagé dans la douille 4 à force pour vaincre, grâce à l'élasticité de l'embout, le bourrelet d'entrée 11, l'embout 5 étant introduit complètement et étant arrêté dans cette première position par les deux saillies butées 12.FIG. 2 shows the device 1 pre-positioned on the injection tubing 6, in the standby position. The device 1 is in its first stable position, the tip 5 having been engaged in the sleeve 4 by force to overcome, thanks to the elasticity of the tip, the inlet bead 11, the tip 5 being introduced completely and being stopped in this first position by the two abutment projections 12.

Dans cette position stable d'attente, la pointe de l'aiguille 2 est maintenue à distance de l'embout 5 et le dispositif 1 fait corps avec la poche souple 7. L'ensemble peut donc être manipulé, conditionné dans un emballage souple stérile, stocké et géré comme un objet unique.In this stable waiting position, the tip of the needle 2 is kept at a distance from the tip 5 and the device 1 is integral with the flexible pouch 7. The assembly can therefore be handled, packaged in a sterile flexible packaging , stored and managed as a single object.

Lors de l'utilisation de la poche 7, c'est à dire lorsque l'on veut mélanger le contenu de la fiole 10, avec un liquide de dilution par exemple contenu dans la poche. Le dispositif 1 est d'abord placé sur la tubulure 6 dans la position de la figure 2 (position d'attente). Puis, la fiole 10 est introduite par son bouchon 9 dans la douille 8 en sorte de transpercer le bouchon. Enfin, l'ensemble dispositif 1-fiole 10 est pressé en direction de la poche 7 afin de faire transpercer l'embout 5 par l'aiguille.When using the pocket 7, that is to say when it is desired to mix the contents of the vial 10, with a dilution liquid for example contained in the pocket. The device 1 is first placed on the tubing 6 in the position of Figure 2 (standby position). Then, the vial 10 is introduced through its plug 9 into the sleeve 8 so as to pierce the plug. Finally, the device 1-vial assembly 10 is pressed towards the pocket 7 in order to pierce the tip 5 by the needle.

Au début de ce mouvement, il faut vaincre la légère résistance élastique des saillies 12 qui s'escamotent pour laisser passer l'embout, puis la totalité de l'embout 5 est transpercée par l'aiguille 2 et enfin, l'embout vient en butée dans la seconde position stable du dispositif 1 contre un cône 14 ménagé dans le fond de la douille 4.At the beginning of this movement, it is necessary to overcome the slight elastic resistance of the projections 12 which retract to let the tip, then the whole of the tip 5 is pierced by the needle 2 and finally, the tip comes into stop in the second stable position of the device 1 against a cone 14 formed in the bottom of the sleeve 4.

Les deux récipients 7 et 10 sont alors en communication via l'aiguille 2 et la tubulure 6.The two containers 7 and 10 are then in communication via the needle 2 and the tubing 6.

Il est possible bien entendu de réaliser cette communication en engageant d'abord le bouchon 9 de la fiole 10 dans la douille 8 pour transpercer le bouchon, puis en engageant l'ensemble dispositif 1-fiole 10 sur l'embout 5 pour, enfin, transpercer l'embout 5 et amener l'ensemble dans la position de la figure 3.It is of course possible to achieve this communication by first engaging the plug 9 of the vial 10 in the sleeve 8 to pierce the plug, then engaging the device 1-vial assembly 10 on the tip 5 for, finally, piercing the tip 5 and bring the assembly into the position of Figure 3.

Le dispositif de l'invention présente l'avantage de permettre le retrait de l'ensemble dispositif 1-fiole 10 de l'embout 5 après l'opération de reconstitution. Ainsi, l'opérateur se retrouve face à une poche 7 dans laquelle il pourra, via la tubulure 6, faire une injection additionnelle si nécessaire. Suivant un autre avantage, la séparation entre la poche 7 et l'ensemble 1-10 est souhaitable pour un traitement optimisé des déchets hospitaliers.The device of the invention has the advantage of allowing the removal of the entire device 1-vial 10 of the nozzle 5 after the reconstitution operation. Thus, the operator is faced with a pocket 7 in which he can, via the tubing 6, make an additional injection if necessary. According to another advantage, the separation between the pocket 7 and the set 1-10 is desirable for optimized treatment of hospital waste.

Enfin, l'invention n'est évidemment pas limitée au mode de réalisation représenté et décrit ci-dessus mais en couvre au contraire toutes les variantes, notamment en ce qui concerne les moyens 11, 12 de positionnement-blocage de l'embout 5 dans sa première position. Il est à noter que la douille 8 peut éventuellement être munie intérieurement à la manière connue d'une ou plusieurs saillies, trois par exemple, telles que représentées en 15 sur les figures, pour retenir élastiquement en position d'enfoncement correct le bouchon 9 de la fiole, et extérieurement également à la manière connue, d'une ou plusieurs saillies, trois par exemple, telles que représentées en 16 pour retenir le bouchon B.Finally, the invention is obviously not limited to the embodiment shown and described above but covers all variants, particularly with regard to the means 11, 12 of positioning-locking of the tip 5 in his first position. It should be noted that the bush 8 may optionally be provided internally in the known manner with one or more projections, three for example, as shown at 15 in the figures, for resiliently retain in the correct insertion position the plug 9 of the vial, and externally also in the known manner, one or more projections, three for example, as shown at 16 to retain the plug B.

Claims (5)

  1. A reconstitution device, in particular for mixing substances in the medical field, of the type comprising a hollow needle (2), pointed at both ends and fixed to a support (3) defining two coaxial sockets enveloping each end of the needle and responsible for receiving in the one case (8) the outlet of a flask (10) with a stopper (9) and in the other case (4) the end piece (5) of an injection nozzle (6) of a flexible pouch (7), so as, by perforation of said stopper (9) and end piece (5), to put the flask (10) and flexible pouch (7) in communication via said needle (2), said device being in a single piece with said socket (4), on the flexible pouch (7) side, having means of positioning and holding said socket on the end piece, said means comprising a rim (11), continuous or not, projecting internally in the vicinity of the inlet orifice of said socket (4), said device being characterised in that said positioning and holding means comprise in addition one or more elastically retractable projections (12), formed on the inside of said socket (4), said projections (12) being situated at a distance from the inlet orifice of the socket (4) corresponding to the length of the end piece (5), and in that
    - said means allow the engagement of the end piece (5) of said socket (4) at a first stable position in which the device (1) is fixed to the pouch (7) without the needle (2) being in contact with the end piece (5) and said socket (4) is mounted slideably on the end piece (5) so as to pass, by a simple pushing in of the device (1) on the end piece (5), from said first position into a second stable position corresponding to the piercing of the end piece (5) by the needle (2).
  2. A device according to claim 1, characterised in that it comprises means (11, 12) of positioning and holding said socket (4) on the end piece (5) in said second position.
  3. An arrangement according to claim 2, characterised in that the socket (8), on the flask (10) side, is provided internally with one or more projections (15) for elastically holding the stopper (9) of said flask elastically in the correct pushed-in position.
  4. A device according to claim 2 or 3, characterised in that the socket (8), on the flask (10) side, is provided externally with one or more projections (16) for holding a stopper (B) for safety purposes.
  5. An assembly consisting of a flexible pouch (7) provided with at least one injection nozzle (6) with an end piece (5) pre-positioned between the means (11, 12) of positioning and holding the socket (4) of the device according to one of claims 1 to 4.
EP01999342A 2000-12-06 2001-12-06 Reconstitution device in particular for mixing substances in the medical field Expired - Lifetime EP1345566B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0015823 2000-12-06
FR0015823A FR2817465B1 (en) 2000-12-06 2000-12-06 RECONSTRUCTION DEVICE, PARTICULARLY FOR MIXING SUBSTANCES IN THE MEDICAL FIELD
PCT/FR2001/003853 WO2002045649A1 (en) 2000-12-06 2001-12-06 Re-forming device in particular for mixing substances in the medical field

Publications (2)

Publication Number Publication Date
EP1345566A1 EP1345566A1 (en) 2003-09-24
EP1345566B1 true EP1345566B1 (en) 2006-06-07

Family

ID=8857302

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01999342A Expired - Lifetime EP1345566B1 (en) 2000-12-06 2001-12-06 Reconstitution device in particular for mixing substances in the medical field

Country Status (7)

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US (1) US7442189B2 (en)
EP (1) EP1345566B1 (en)
AT (1) ATE328567T1 (en)
AU (1) AU2002216186A1 (en)
DE (1) DE60120475T2 (en)
FR (1) FR2817465B1 (en)
WO (1) WO2002045649A1 (en)

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FR2819418B1 (en) * 2001-01-17 2003-03-14 Technoflex Sa TRANSFER SET, ESPECIALLY FOR THE ADMINISTRATION OF A MIXTURE OF LIQUIDS FOR MEDICAL PURPOSES
EP1454609B1 (en) 2003-03-05 2012-10-24 CSL Behring GmbH Transfer device
DE502004005171D1 (en) 2003-03-06 2007-11-22 Csl Behring Gmbh Transfer device, in particular for medical fluids
DE502006005333D1 (en) * 2006-02-16 2009-12-24 Roche Diagnostics Gmbh System and device for withdrawing pharmaceuticals
JP5506681B2 (en) 2007-08-21 2014-05-28 ユーコン・メディカル，リミテッド・ライアビリティ・カンパニー Vial access and injection system
JP5685522B2 (en) 2008-04-01 2015-03-18 ユーコン・メディカル，リミテッド・ライアビリティ・カンパニー Duplex container fluid transfer device
USD655017S1 (en) 2010-06-17 2012-02-28 Yukon Medical, Llc Shroud
USD681230S1 (en) 2011-09-08 2013-04-30 Yukon Medical, Llc Shroud
CA2877506A1 (en) * 2012-02-13 2013-08-22 Chongqing Lummy Pharmaceutical Co., Ltd. Doser having two needles
USD769444S1 (en) 2012-06-28 2016-10-18 Yukon Medical, Llc Adapter device
GB201318315D0 (en) * 2013-10-16 2013-11-27 Sab Miller Plc Dispensing apparatus
CN104385568B (en) * 2014-09-17 2016-08-10 长沙市中一制药机械有限公司 A kind of method and apparatus of orthoscopic Batch assemblage medical drugs packaging material
CN105342850B (en) * 2015-11-13 2019-10-18 重庆莱美药业股份有限公司 Single needle medicine mixer, hard double nip and transfusion flexible bag
WO2017096238A1 (en) 2015-12-03 2017-06-08 Drexel University Medical fluid delivery system

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US5653698A (en) * 1995-01-13 1997-08-05 Sanofi Winthrop, Inc. Coupling systems for saftey cannula
US6022339A (en) * 1998-09-15 2000-02-08 Baxter International Inc. Sliding reconstitution device for a diluent container
FR2790749B1 (en) * 1999-03-10 2001-05-18 Maco Pharma Sa DEVICE FOR TRANSFERRING A SUBSTANCE CONTAINED IN A BOTTLE INTO A POUCH OF SOLUTE

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US3872867A (en) * 1971-06-02 1975-03-25 Upjohn Co Wet-dry additive assembly

Also Published As

Publication number Publication date
US7442189B2 (en) 2008-10-28
AU2002216186A1 (en) 2002-06-18
EP1345566A1 (en) 2003-09-24
DE60120475T2 (en) 2007-01-04
FR2817465A1 (en) 2002-06-07
FR2817465B1 (en) 2003-04-25
US20040015148A1 (en) 2004-01-22
ATE328567T1 (en) 2006-06-15
WO2002045649A1 (en) 2002-06-13
DE60120475D1 (en) 2006-07-20

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