EP2262464B1 - Interface device for bottles designed to be perforated for the preparation of infused liquids - Google Patents

Interface device for bottles designed to be perforated for the preparation of infused liquids Download PDF

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Publication number
EP2262464B1
EP2262464B1 EP20090719854 EP09719854A EP2262464B1 EP 2262464 B1 EP2262464 B1 EP 2262464B1 EP 20090719854 EP20090719854 EP 20090719854 EP 09719854 A EP09719854 A EP 09719854A EP 2262464 B1 EP2262464 B1 EP 2262464B1
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EP
European Patent Office
Prior art keywords
interface device
connection base
syringe
bottle
needle
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Active
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EP20090719854
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German (de)
French (fr)
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EP2262464A1 (en
Inventor
Jean-Luc Carrez
Jean-Louis Coussegal
Laurent Barre
Pierrick Guyomarc'h
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Vygon SA
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Vygon SA
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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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing 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
    • A61J1/14—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
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • 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
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal venting
    • 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
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • 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
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Description

L'invention concerne un dispositif d'interfaçage destiné à mettre en liaison une seringue et un flacon à perforer contenant un médicament à fins de préparations de liquides destinés à être perfusés chez un patient. Un exemple d'un tel dispositif est décrit dans le document FR 2717086 .
En oncologie, pour le traitement des tumeurs cancéreuses, il est nécessaire de perfuser des liquides très agressifs. La préparation de ces liquides se présentant sous forme de soluté peut s'avérer être dangereuse pour le personnel soignant. Dans beaucoup de cas, le médicament qui doit être administré se présente sous la forme de poudre dans un flacon sous vide (appelé Vial). Ce flacon est obturé par un bouchon à membrane élastomérique.The invention relates to an interfacing device for connecting a syringe and a puncture bottle containing a medicament for the purpose of preparing liquids for infusion into a patient. An example of such a device is described in the document FR 2717086 .
In oncology, for the treatment of cancerous tumors, it is necessary to infuse very aggressive liquids. The preparation of these liquids in the form of a solute may prove to be dangerous for the nursing staff. In many cases, the drug to be administered is in powder form in a vacuum vial (called Vial). This bottle is closed by an elastomeric membrane stopper.

Afin de mélanger ce médicament contenu dans un tel flacon sous vide à un liquide adapté à être perfusé, il faut dans un premier temps diluer le médicament sous forme de poudre dans ce liquide à l'aide d'une seringue. Pour cela, la seringue est équipée d'une aiguille. Cette seringue contient du liquide à perfuser, tel que du sérum physiologique (eau distillée + NaCl). Le bouchon à membrane élastomérique du flacon est alors traversé avec l'aiguille, ce qui a pour effet de faire entrer de l'air brutalement dans le flacon qui était sous vide. Cet air qui entre brutalement se mélange avec le médicament sous forme de poudre et peut ressortir en partie en entrainant du médicament pur, ce qui est dangereux pour le personnel soignant chargé de la préparation. Une fois l'aiguille de la seringue mise en place à travers le bouchon à membrane élastomérique, le personnel soignant chargé de la préparation pousse à l'aide de la seringue du liquide à perfuser dans le flacon, ce qui fait ressortir, là encore, de l'air avec éventuellement des particules de médicaments non encore diluées. Le flacon est alors secoué et le mélange est aspiré à travers le bouchon à membrane élastomérique à l'aide de la seringue. En pratique, le mélange liquide à perfuser plus médicament dilué est injecté et aspiré plusieurs fois de suite hors et dans le flacon avec la seringue, à fins de bien mélanger le médicament au liquide. A chaque fois, il y a des sorties et des entrées d'air dans le flacon, ce qui implique des risques de pollution pour le personnel soignant chargé de la préparation, d'une part, et, d'autre part, pour le mélange préparé.
Enfin, l'aiguille est sortie du flacon. Il faut alors la déconnecter de la seringue sans se piquer et éviter tout contact direct du mélange ainsi réalisé avec le personnel soignant chargé de la préparation. La seringue remplie est alors connectée près du patient à une poche de perfusion reliée à celui-ci ou connectée directement au patient lui-même.In order to mix this medicament contained in such a vacuum flask with a liquid suitable for being perfused, it is first necessary to dilute the drug in the form of a powder in this liquid with the aid of a syringe. For this, the syringe is equipped with a needle. This syringe contains liquid to be infused, such as saline (distilled water + NaCl). The elastomeric membrane cap of the bottle is then crossed with the needle, which has the effect of bringing air suddenly into the vial which was under vacuum. This air, which comes in abruptly, mixes with the drug in the form of a powder and can come out in part by drawing pure medicine, which is dangerous for the health care staff in charge of the preparation. Once the needle of the syringe is put in place through the elastomeric membrane cap, the nursing staff responsible for the preparation pushes with the syringe liquid to infuse into the bottle, which again, again, air with possible drug particles not yet diluted. The vial is then shaken and the mixture is sucked through the elastomeric membrane cap using the syringe. In practice, the liquid infusion mixture plus diluted drug is injected and sucked several times in and out of the vial with the syringe, in order to thoroughly mix the drug with the liquid. Each time, there are outlets and air inlets in the bottle, which involves risks of pollution for the health care staff responsible for the preparation, on the one hand, and, on the other hand, for mixing prepare.
Finally, the needle is out of the bottle. It must then be disconnected from the syringe without stinging and avoid direct contact of the mixture thus made with the care staff responsible for the preparation. The filled syringe is then connected near the patient to an infusion bag connected thereto or connected directly to the patient himself.

Un but de l'invention telle que définie dans les revendications est de fournir un dispositif d'interfaçage situé entre le flacon à perforer contenant le médicament pur sous forme de poudre et la seringue contenant le liquide à perfuser, qui soit sécurisé tout en restant simple d'utilisation lors de la préparation du mélange entre le liquide à perfuser et le médicament pur situé dans le flacon à perforer.An object of the invention as defined in the claims is to provide an interfacing device located between the vial to be perforated containing the pure drug in powder form and the syringe containing the liquid to be infused, which is secure while remaining simple of use in preparing the mixture between the liquid to be infused and the pure drug in the flask to be perforated.

A cet effet, il est prévu selon l'invention, un dispositif d'interfaçage destiné à mettre en liaison une seringue et un flacon à perforer contenant un médicament, comprenant une embase de connexion au flacon à perforer, l'embase de connexion comportant des moyens de circulation d'air, destinés à permettre des entrées et des sorties d'air du flacon à perforer, comprenant des moyens de filtration d'air.For this purpose, there is provided according to the invention, an interface device for connecting a syringe and a bottle to be perforated containing a medicament, comprising a base for connection to the flask to be perforated, the connection base comprising air circulation means, intended to allow inflow and outflow of the vial to be perforated, comprising air filtration means.

Ainsi, l'utilisation de moyens de circulation d'air équipés de moyens de filtration de cet air imposent une circulation d'air entre le flacon et l'extérieur, passant par les moyens de filtration qui vont alors retenir, d'une part lors de sortie d'air du flacon, les particules de médicament pur non encore diluées et, d'autre part lors d'entrée d'air dans le flacon, des impuretés contenues dans l'air ambiant pénétrant dans le flacon. Ceci permet de sécuriser la manipulation et la préparation du mélange.Thus, the use of air circulation means equipped with means for filtering this air impose a flow of air between the bottle and the outside, passing through the filtering means which will then retain, on the one hand during the air outlet of the bottle, the pure drug particles not yet diluted and, secondly, when air enters the bottle, impurities contained in the ambient air entering the bottle. This helps to secure the handling and preparation of the mixture.

Avantageusement, le dispositif d'interfaçage comporte les caractéristiques suivantes:

  • o le dispositif comporte une aiguille creuse de perforation;
  • o les moyens de circulation d'air comprennent une canule destinée à s'étendre dans le flacon à perforer au niveau d'une extrémité distale de la canule;
  • o l'aiguille creuse de perforation est montée à coulissement avec un jeu fonctionnel dans la canule;
    et au moins l'une des caractéristiques suivantes :
    • o l'aiguille creuse de perforation est montée à coulissement étanche dans l'embase de connexion au niveau d'une partie proximale de ladite embase de connexion;
    • o les moyens de circulation d'air comportent un orifice débouchant sur l'extérieur;
    • o l'orifice débouchant est fermé par les moyens de filtration;
    • o les moyens de filtration comportent un filtre à particules de l'ordre d'une valeur comprise entre environ 2 µm et environ 5 µm;
    • o l'embase de connexion comporte, au niveau d'une partie distale, un bouchon clippant destiné à permettre le montage par clippage du dispositif d'interfaçage sur le flacon à perforer;
    • o le bouchon clippant est monté sur l'embase de connexion selon une liaison rotule;
    • o l'aiguille comporte, au niveau d'une extrémité distale, des moyens de retenue de l'aiguille dans la canule;
    • o les moyens de retenue comportent une déformation réalisée par écrasement;
    • o le dispositif d'interfaçage comporte une deuxième embase de connexion sur la seringue;
    • o la deuxième embase de connexion comporte des moyens de filtration d'un liquide destiné à être aspiré par la seringue depuis le flacon à perforer;
    • o la deuxième embase de connexion comporte, au niveau d'une partie proximale, un connecteur à membrane permettant la connexion directe et sécurisée de la seringue et,
    • o la deuxième embase de connexion est montée de manière étanche, au niveau d'une partie distale, sur une extrémité proximale de l'aiguille creuse de perforation.
Advantageously, the interfacing device comprises the following characteristics:
  • the device comprises a hollow perforation needle;
  • o the air circulation means comprise a cannula for extending into the flask to be perforated at a distal end of the cannula;
  • the hollow perforation needle is slidably mounted with a functional clearance in the cannula;
    and at least one of the following:
    • the hollow perforation needle is slidably mounted in the connection base at a proximal portion of said connection base;
    • o the air circulation means comprise an orifice opening on the outside;
    • o the opening opening is closed by the filtering means;
    • the filtration means comprise a particle filter of the order of a value of between about 2 μm and about 5 μm;
    • o the connection base comprises, at a distal portion, a clipper plug for allowing mounting by clipping the interfacing device on the vial to be perforated;
    • o the clipper cap is mounted on the connection base according to a ball joint connection;
    • the needle comprises, at a distal end, means for retaining the needle in the cannula;
    • o the retaining means comprise a deformation carried out by crushing;
    • o the interfacing device comprises a second connection base on the syringe;
    • o the second connection base comprises means for filtering a liquid to be sucked by the syringe from the vial to be perforated;
    • o the second connection base comprises, at a proximal portion, a membrane connector for the direct and secure connection of the syringe and,
    • the second connection base is sealingly mounted at a distal portion on a proximal end of the hollow perforation needle.

D'autres caractéristiques et avantages de l'invention apparaîtront lors de la description ci-après d'un mode préféré réalisation. Aux dessins annexés:

  • o la figure 1 est une vue de côté d'un dispositif d'interfaçage selon l'invention monté sur un flacon à perforer;
  • o la figure 2 est une vue en coupe selon II-II du dispositif de la figure 1;
  • o la figure 3 est une vue détaillée agrandie du détail III du dispositif d'interfaçage de la figure 2;
  • o la figure 4 est une vue de côté de l'embase de connexion distale du dispositif d'interfaçage de la figure 1;
  • o la figure 5 est une vue en coupe selon V-V de l'embase de connexion de la figure 4;
  • o la figure 6 est une vue tridimensionnelle du bouchon clippant du dispositif d'interfaçage de la figure 1;
  • o la figure 7 est une vue de côté du bouchon clippant de la figure 6;
  • o la figure 8 est une vue en coupe selon VIII-VIII du bouchon clippant de la figure 7;
  • o la figure 9 est une vue tridimensionnelle de l'embase de connexion proximale du dispositif d'interfaçage de la figure 1;
  • o la figure 10 est une vue de côté de l'embase de connexion de la figure 9;
  • o la figure 11 est une vue en coupe selon XI-XI de l'embase de connexion de la figure 10;
  • o la figure 12 est une vue de côté du dispositif d'interfaçage selon l'invention de la figure 1 monté sur le flacon en position basse d'utilisation;
  • o la figure 13 est une vue en coupe selon XIII-XIII du dispositif d'interfaçage lors d'une utilisation telle qu'illustrée à la figure 12;
  • o la figure 14 est une vue en coupe du dispositif d'interfaçage de la figure 12 incliné par rapport au flacon;
  • o la figure 15 est une vue tridimensionnelle de la pièce permettant le stockage et la manipulation du dispositif selon l'invention de la figure 1 avant placement sur le flacon à perforer.
Other features and advantages of the invention will become apparent from the following description of a preferred embodiment. In the accompanying drawings:
  • o the figure 1 is a side view of an interfacing device according to the invention mounted on a flask to be perforated;
  • o the figure 2 is a sectional view along II-II of the device of the figure 1 ;
  • o the figure 3 is an enlarged detailed view of the detail III of the interface device of the figure 2 ;
  • o the figure 4 is a side view of the distal connection base of the interface device of the figure 1 ;
  • o the figure 5 is a sectional view along VV of the connection base of the figure 4 ;
  • o the figure 6 is a three-dimensional view of the clip clipper of the interface device of the figure 1 ;
  • o the figure 7 is a side view of the cork clipper of the figure 6 ;
  • o the figure 8 is a sectional view according to VIII-VIII of the cork clipper of the figure 7 ;
  • o the figure 9 is a three-dimensional view of the proximal connection base of the interface device of the figure 1 ;
  • o the figure 10 is a side view of the connection socket of the figure 9 ;
  • o the figure 11 is a sectional view along XI-XI of the connection base of the figure 10 ;
  • o the figure 12 is a side view of the interfacing device according to the invention of the figure 1 mounted on the bottle in the low position of use;
  • o the figure 13 is a sectional view according to XIII-XIII of the interfacing device during a use as illustrated in FIG. figure 12 ;
  • o the figure 14 is a sectional view of the interfacing device of the figure 12 inclined with respect to the bottle;
  • o the figure 15 is a three-dimensional view of the part allowing the storage and manipulation of the device according to the invention of the figure 1 before placement on the vial to be perforated.

En référence aux figures 1 et 2, nous allons décrire les principaux éléments d'un dispositif d'interfaçage selon l'invention. Le dispositif d'interfaçage (1) est destiné à être monté sur un flacon à perforer (2), aussi appelé Vial, au niveau d'une extrémité distale du dispositif d'interfaçage (1) et sur une seringue (non représentée) au niveau d'une extrémité proximale dudit dispositif d'interfaçage (1). Le dispositif d'interfaçage (1) comporte, depuis l'extrémité distale vers l'extrémité proximale, un bouchon clippant (10) destiné à mettre en place et maintenir ledit dispositif d'interfaçage sur un flacon à perforer (2), une première embase de connexion (100), dite « distale », dans laquelle coulisse une aiguille creuse de perforation (30) à l'extrémité proximale de laquelle est montée une deuxième embase de connexion (50), dite « proximale », sur laquelle sont installés des moyens de filtration (60). Les moyens de filtration (60) peuvent être connectés directement à une seringue contenant un liquide à perfuser destiné à être mélangé avec un médicament pur contenu dans le flacon à perforer (2). Optionnellement, un connecteur à membrane (3) est positionné entre la seringue et les moyens de filtration. Un tel connecteur à membrane (3) permet une connexion directe et sécurisée de ladite seringue sur le dispositif d'interfaçage. Un tel connecteur à membrane est décrit en détail dans le document EP 0 544 581 auquel il est possible de se référer pour de plus amples informations. Le dispositif d'interfaçage (1) selon l'invention comporte en outre une membrane déformable (40) entourant l'aiguille creuse de perforation (30) et fixée à une extrémité distale sur l'embase de connexion distale (100) et à une extrémité proximale à l'embase de connexion proximale (50). Enfin, le dispositif d'interfaçage (1) selon l'invention présente un dispositif de stockage et de manipulation (20) qui permet de maintenir éloignées les deux embases de connexion (100) et (50) l'une de l'autre. En variante, le dispositif de stockage et de manipulation (20) comprend un prolongement qui permet de maintenir dans une position prédéterminée le bouchon clippant (10) monté sur l'embase de connexion distale (100).With reference to Figures 1 and 2 , we will describe the main elements of an interfacing device according to the invention. The interfacing device (1) is intended to be mounted on a perforating vial (2), also called Vial, at a distal end of the interfacing device (1) and on a syringe (not shown) at the a level of a proximal end of said interfacing device (1). The interfacing device (1) comprises, from the distal end towards the proximal end, a clipping cap (10) intended to place and hold said interfacing device on a flask to be perforated (2), a first connection base (100), called "distal", in which slides a hollow perforation needle (30) at the proximal end of which is mounted a second connection base (50), called "proximal", on which are installed filtration means (60). The filtration means (60) can be connected directly to a syringe containing a liquid for infusion to be mixed with a pure drug contained in the flask to be perforated (2). Optionally, a membrane connector (3) is positioned between the syringe and the filter means. Such a membrane connector (3) allows a direct and secure connection of said syringe on the interfacing device. Such a membrane connector is described in detail in the document EP 0 544 581 to which it is possible to refer for further information. The interfacing device (1) according to the invention further comprises a deformable membrane (40) surrounding the hollow perforation needle (30) and fixed at a distal end to the distal connection base (100) and at a distal end (40). proximal end to the proximal connection base (50). Finally, the interfacing device (1) according to the invention has a storage and handling device (20) which keeps the two connection bases (100) and (50) away from one another. Alternatively, the storage and handling device (20) includes an extension for maintaining in a predetermined position the clipping cap (10) mounted on the distal connection base (100).

En référence aux figures 2, 3, 4 et 5, nous allons maintenant décrire en détail la première embase de connexion (100), dite « distale ». L'embase de connexion distale (100) comporte un corps (104), ici monobloc issu de moulage. Le corps (104) de l'embase de connexion distale (100) comporte une chambre longitudinale (105) tubulaire s'étendant entre une extrémité proximale (114) et une extrémité distale (107) où la chambre longitudinale se termine, dans son prolongement, par un conduit (103). La chambre longitudinale (105) est, ici, de forme tronconique de révolution. Le corps (104) comporte un orifice (108) sensiblement perpendiculaire à un axe principal de la chambre longitudinale (105). L'orifice (108) débouche d'un côté dans la chambre longitudinale (105) et de l'autre côté à l'extérieur du corps (104) formant l'embase de connexion distale (100). Au niveau de l'extrémité proximale (114) de l'embase de connexion distale (100), la chambre longitudinale (105) présente une gorge circonférentielle (106) destinée à recevoir un joint d'étanchéité (120) qui est traversé de manière coulissante par l'aiguille creuse de perforation (30) du dispositif d'interfaçage (1). Au niveau du conduit (103), l'embase de connexion distale (100) comporte une canule (102) qui est introduite dans ce conduit (103) et y est fixée de manière étanche, et de sorte à légèrement s'étendre dans la chambre longitudinale (105), d'une part, et, d'autre part, à s'étendre au-delà de l'extrémité distale (107) de l'embase de connexion distale(100). L'aiguille creuse de perforation (30) est reçue de manière sensiblement coaxiale dans la canule (102) de manière à coulisser avec un jeu fonctionnel (101) selon un axe principal de la canule (102).
L'orifice (108) débouchant dans la chambre longitudinale (105) est fermé par des moyens de filtration (109). Les moyens de filtration (109) comportent, ici, un filtre à particules permettant de retenir les éventuelles particules en suspension dans l'air lorsque l'air traverse, quel qu'en soit le sens, les moyens de filtration (109). Par exemple, le filtre à particules présente une porosité de 0,2 µm environ, c'est-à-dire que le filtre retient toutes particules dont les dimensions sont supérieures à 0,2 µm.
Le corps (104) de l'embase de connexion distale (100) comporte, sur une circonférence externe, une gorge (110) adjacente à l'orifice (108) et située au-dessus de cet orifice en direction proximale. Cette gorge (110) est destinée à coopérer avec le dispositif de stockage et de manipulation (20) qui sera décrit ultérieurement. Située entre cette gorge (110) et l'extrémité proximale (114) du corps (104), l'embase de connexion distale (100) présente une série d'ondulations (113) sur un pourtour extérieur dudit corps (104). Comme cela est illustré en figure 2, cette série d'ondulations (113) est destinée à recevoir une extrémité de la membrane déformable (40) du dispositif d'interfaçage (1) selon l'invention. Afin de maintenir en place cette extrémité de la membrane déformable (40), un manchon serrant (34) entoure l'extrémité de la membrane en regard de la série d'ondulations (113) du corps (104) de l'embase de connexion distale (100).
Au niveau de l'extrémité distale (107), l'embase de connexion distale (100) comprend une gorge (115) surmontant, en direction proximale, une extrémité de forme tronconique de révolution (116). Cette extrémité tronconique de révolution (116) et cette gorge (115) sont destinées à recevoir et à former une liaison rotule avec un bouchon clippant (10) qui sera décrit ci-dessous.With reference to figures 2 , 3, 4 and 5 , we will now describe in detail the first connection base (100), called "distal". The distal connection base (100) comprises a body (104), here integrally molded. The body (104) of the base of distal connection (100) comprises a tubular longitudinal chamber (105) extending between a proximal end (114) and a distal end (107) where the longitudinal chamber terminates, in its extension, by a conduit (103). The longitudinal chamber (105) is here of frustoconical shape of revolution. The body (104) has an orifice (108) substantially perpendicular to a main axis of the longitudinal chamber (105). The orifice (108) opens on one side into the longitudinal chamber (105) and on the other side out of the body (104) forming the distal connection base (100). At the proximal end (114) of the distal connection base (100), the longitudinal chamber (105) has a circumferential groove (106) for receiving a seal (120) which is traversed so that sliding by the hollow perforation needle (30) of the interfacing device (1). At the duct (103), the distal connection base (100) has a cannula (102) which is inserted into this duct (103) and is sealingly attached thereto, and so as to extend slightly into the duct (103). longitudinal chamber (105), on the one hand, and, on the other hand, extending beyond the distal end (107) of the distal connection base (100). The hollow perforation needle (30) is substantially coaxially received in the cannula (102) so as to slide with a functional clearance (101) along a major axis of the cannula (102).
The orifice (108) opening into the longitudinal chamber (105) is closed by filtration means (109). The filtration means (109) comprise, here, a particulate filter allowing to retain any particles suspended in the air when the air crosses, in whatever sense, the filtration means (109). For example, the particulate filter has a porosity of about 0.2 μm, that is, the filter retains any particles larger than 0.2 μm in size.
The body (104) of the distal connection base (100) has, on an outer circumference, a groove (110) adjacent the orifice (108) and located above this orifice in a proximal direction. This groove (110) is intended to cooperate with the storage and handling device (20) to be described later. Located between this groove (110) and the proximal end (114) of the body (104), the distal connection base (100) has a series of corrugations (113) on an outer periphery of said body (104). As illustrated in figure 2 , this series of corrugations (113) is intended to receive an end of the deformable membrane (40) of the interfacing device (1) according to the invention. In order to hold this end of the deformable membrane (40) in place, a tightening sleeve (34) surrounds the end of the membrane opposite the series of corrugations (113) of the body (104) of the connection base. distal (100).
At the distal end (107), the distal connection hub (100) includes a groove (115) proximally surmounting a tapered end of revolution (116). This frustoconical end of revolution (116) and this groove (115) are intended to receive and form a ball joint with a clipping cap (10) which will be described below.

En référence aux figures 6 à 8, nous allons maintenant décrire le bouchon clippant (10). Ce dernier est de forme général sensiblement cylindrique de révolution. Le bouchon clippant (10) comporte un fond (17) sensiblement plan et sensiblement perpendiculaire à un axe de révolution du bouchon clippant (10). Le fond (17) comporte en son centre une ouverture traversante (11) présentant une forme tronconique (18) d'entrée puis un lamage (19). L'orifice traversant (11) est destiné à coopérer avec la gorge (115) et l'extrémité tronconique (116) de l'extrémité distale (107) de l'embase de connexion distale (100), le lamage (19) étant alors reçue dans la gorge (115). Il est à noter qu'une telle géométrie de l'orifice traversant (11) associé à la géométrie de l'extrémité distale (107) de l'embase de connexion distale (100) permet un montage avec une liaison rotule du bouchon clippant (10) sur l'embase de connexion distale (100) tout en évitant que le bouchon clippant (10) et l'embase de connexion distale (100) ne se séparent lors d'une mise en place du dispositif d'interfaçage selon l'invention sur le flacon à perforer (2). Le bouchon clippant (10) comporte une série de languettes (12) uniformément réparties sur une circonférence et s'étendant en saillies, de manière sensiblement parallèle à l'axe de révolution du bouchon clippant (10), d'une périphérie radialement externe du fond (17) dudit bouchon clippant (10). Chacune des languettes (12) comporte une première partie (15) sensiblement parallèle à l'axe de révolution du bouchon clippant (10) suivi d'une ondulation (14) orientée de manière centripète par rapport à l'axe de révolution du bouchon clippant (10) puis d'une partie s'évasant de manière tronconique (13). Chacune des languettes (12) est d'autre part déformable élastiquement pour permettre la mise en place du bouchon clippant (10) sur un goulot du flacon à perforer (2). Une fois mise en place sur le flacon à perforer (2), le bouchon clippant (10) retient prisonnier le goulot du flacon à perforer (2) au niveau de la partie (15) des languettes (12), les ondulations (14) maintenant le goulot en place alors que l'extrémité des parties (13) vient en contact avec une paroi externe du flacon à perforer (2), comme cela est illustré sur les figures 1, 2, 12 à 14.With reference to Figures 6 to 8 , we will now describe the clipping cap (10). The latter is of generally cylindrical general shape of revolution. The clipping cap (10) has a substantially plane bottom (17) and substantially perpendicular to an axis of revolution of the clipping cap (10). The bottom (17) has at its center a through opening (11) having a frustoconical shape (18) inlet and a countersink (19). The through orifice (11) is intended to cooperate with the groove (115) and the frustoconical end (116) of the distal end (107) of the distal connection base (100), the counterbore (19) being then received in the throat (115). It should be noted that such a geometry of the through orifice (11) associated with the geometry of the distal end (107) of the distal connection base (100) allows mounting with a ball joint connection of the clipping cap ( 10) on the distal connection base (100) while avoiding that the clipping cap (10) and the distal connection base (100) are separated during an implementation of the interfacing device according to the invention on the flask to be perforated (2). The clipping cap (10) comprises a series of tongues (12) uniformly distributed over a circumference and extending in projections, substantially parallel to the axis of revolution of the clipping cap (10), a radially outer periphery of the bottom (17) of said clipping cap (10). Each of the tongues (12) comprises a first portion (15) substantially parallel to the axis of revolution of the clipper stopper (10) followed by a corrugation (14) oriented centripetally with respect to the axis of revolution of the clipper cap (10) then a portion flaring frustoconically (13). Each of the tongues (12) is further elastically deformable to allow the introduction of the clipping cap (10) on a neck of the flask to be perforated (2). Once placed on the perforating vial (2), the clipper cap (10) holds the neck of the vial to be perforated (2) trapped at the portion (15) of the tongues (12), the corrugations (14). now the neck in place while the end of the parts (13) comes into contact with an outer wall of the flask to be perforated (2), as illustrated in the Figures 1, 2 , 12 to 14 .

Maintenant, en référence aux figures 9 à 11, nous allons décrire la deuxième embase de connexion (50), dite « proximale ». L'embase de connexion proximale (50) est de forme générale cylindrique de révolution. Comme l'embase de connexion distale (100), l'embase de connexion proximale (50) est, ici, monobloc issue de moulage. L'embase de connexion proximale (50) comporte une extrémité distale (51) dans laquelle est aménagé un conduit (57) débouchant dans une chambre tubulaire (56) sensiblement de forme cylindrique de révolution. Une partie centrale de l'embase de connexion proximale(50) comporte une série d'ondulations (53) dont le rôle est similaire à la série d'ondulations (113) de l'embase de connexion distale (100) qui vient d'être décrite. La série d'ondulations (53) permet de maintenir en place, en coopération avec un manchon serrant (35) similaire au manchon serrant (34) précédemment décrit, l'autre extrémité de la membrane déformable (40) du dispositif d'interfaçage (1) selon l'invention. Adjacente à cette série d'ondulations (53), l'embase de connexion proximale (50) présente une gorge (52) sur une circonférence externe de l'embase de connexion proximale (50). Cette gorge (52) a la même fonction que la gorge (110) de l'embase de connexion (100) et est donc destinée à coopérer avec le dispositif de stockage et de manipulation (20) du dispositif d'interfaçage (1) selon l'invention. Enfin, au niveau d'une extrémité proximale, l'embase de connexion (50) comporte, d'une part, un raccord femelle (54) prolongeant la chambre (56) et réalisé selon la norme Luer ou Luer-Lock, et, d'autre part, une coupelle formée de deux pétales (55) s'étendant autour du raccord femelle (54). Chacun des pétales (55) est sensiblement de forme semi-circulaire d'axe principale de l'embase de connexion proximale (50).
Etant donné que le raccord femelle (54) répond aux normes Luer ou Luer-Lock, ce dernier est apte à recevoir directement une seringue présentant un embout mâle à la norme Luer ou Luer-Lock, Les pétales (55) recevant alors la base du fût de la seringue. Dans une variante de réalisation, ici illustrée, aux différentes figures, le raccord femelle (54) reçoit un dispositif de filtration (60) que nous allons maintenant décrire en référence à la figure 2.Now, with reference to Figures 9 to 11 , we will describe the second connection base (50), called "proximal". The proximal connection base (50) is generally cylindrical in shape. Like the distal connection base (100), the proximal connection base (50) is, here, integrally molded. The proximal connection base (50) has a distal end (51) in which is arranged a conduit (57) opening into a tubular chamber (56) substantially cylindrical in shape of revolution. A central portion of the proximal connection base (50) includes a series of corrugations (53) whose role is similar to the series of corrugations (113) of the distal connection base (100) that has just to be described. The series of corrugations (53) makes it possible to hold in place, in cooperation with a clamping sleeve (35) similar to the clamping sleeve (34) previously described, the other end of the deformable membrane (40) of the interfacing device ( 1) according to the invention. Adjacent to this In a series of corrugations (53), the proximal connection base (50) has a groove (52) on an outer circumference of the proximal connection base (50). This groove (52) has the same function as the groove (110) of the connection base (100) and is therefore intended to cooperate with the storage and handling device (20) of the interfacing device (1) according to the invention. Finally, at a proximal end, the connection base (50) comprises, on the one hand, a female connector (54) extending the chamber (56) and made according to the Luer or Luer-Lock standard, and on the other hand, a cup formed of two petals (55) extending around the female connector (54). Each of the petals (55) is substantially semicircular in shape of the main axis of the proximal connection base (50).
Since the female connector (54) meets the Luer or Luer-Lock standards, the latter is able to directly receive a syringe having a male end to the standard Luer or Luer-Lock, The petals (55) then receiving the base of the barrel of the syringe. In an alternative embodiment, here illustrated, in the various figures, the female connector (54) receives a filtration device (60) which will now be described with reference to FIG. figure 2 .

Le dispositif de filtration (60) comporte un élément aval (62) comportant lui-même un raccord mâle (66) répondant à la norme Luer ou Luer-Lock et comportant un conduit (64). Le dispositif de filtration (60) comporte un élément amont (61) qui présente un raccord femelle (65) répondant à la norme Luer ou Luer-Lock. Les deux éléments amont (61) et aval (62) sont mis l'un sur l'autre, de manière tête-bêche, et délimitent ainsi une chambre (63) apte à recevoir un filtre à particules qui va permettre de retenir les particules en suspension dans le liquide à perfuser qui transitera à travers le dispositif de filtration (60). Par exemple, le filtre à particules ne laissera pas passer les particules en suspension dans le liquide à perfuser dont les dimensions sont supérieures à une valeur comprise entre environ 2 µm et environ 5 µm. Le raccord femelle Luer ou Luer-Lock (65) est destiné à recevoir directement l'embout Luer ou Luer-Lock mâle de la seringue ou bien un connecteur à membrane (3), comme cela est illustré en figure 2 par exemple.The filtration device (60) comprises a downstream element (62) which itself comprises a male connector (66) corresponding to the Luer or Luer-Lock standard and comprising a conduit (64). The filter device (60) includes an upstream member (61) having a female connector (65) complying with the Luer or Luer-Lock standard. The two elements upstream (61) and downstream (62) are placed one on the other, head to tail, and thus delimit a chamber (63) adapted to receive a particulate filter that will help retain the particles in suspension in the liquid to be infused which will pass through the filtration device (60). For example, the particulate filter will not let the particles in suspension in the liquid to be infused whose size is greater than a value between about 2 microns and about 5 microns. The Luer or Luer-Lock female connector (65) is intended to directly receive the male Luer or Luer-Lock tip of the syringe or a membrane connector (3), as illustrated in FIG. figure 2 for example.

La deuxième embase de connexion (50), dite « proximale » est montée sur une extrémité proximale (33) de l'aiguille creuse de perforation (30) de sorte que l'aiguille creuse de perforation (30) s'étende légèrement dans la chambre (56) de l'embase de connexion proximale (50). Le montage de l'embase de connexion proximale (50) sur l'aiguille (30) se fait de manière étanche au niveau du conduit (57).The second (so-called "proximal") connection base (50) is mounted on a proximal end (33) of the hollow perforation needle (30) so that the hollow perforation needle (30) extends slightly in the chamber (56) of the proximal connection base (50). Mounting of the proximal connection base (50) on the needle (30) is sealed at the conduit (57).

De nouveau en référence à la figure 3, l'aiguille creuse de perforation (30) comporte au niveau d'une extrémité distale (31) un biseau surmonté de moyens de retenue (32) dont les dimensions sont légèrement supérieures à un diamètre interne de la canule (102) dans laquelle est montée à coulissement l'aiguille creuse de perforation (30). Cela permet d'éviter que l'aiguille ne sorte complètement de la canule. Par exemple, les moyens de retenue (32) comportent une légère déformation réalisée par écrasement de l'aiguille creuse de perforation (30).Again with reference to the figure 3 , the hollow perforation needle (30) comprises at a distal end (31) a bevel surmounted by retaining means (32) whose dimensions are slightly greater than an internal diameter of the cannula (102) in which is slidably mounting the hollow perforation needle (30). This prevents the needle from coming out of the cannula completely. By for example, the retaining means (32) comprise a slight deformation produced by crushing the hollow perforation needle (30).

En référence à la figure 15, nous allons décrire le dispositif de stockage et de manipulation (20) précité. Ce dernier comporte un corps (24) sensiblement cylindrique de révolution, creux et ouvert d'un côté. Le corps (24) comporte des languettes de manipulation (21) qui s'étendent en saillies d'un côté opposé de l'ouverture, en regard l'une de l'autre, et de manière tangentielle au corps (24). Chacune des extrémités du corps (24) présente une pince (23, 22) destinée à coopérer respectivement avec la gorge (52) de l'embase de connexion proximale (50) et la gorge (110) de l'embase de connexion distale(100). En variante de réalisation, le dispositif de stockage et manipulation (20) comporte une excroissance s'étendant en saillies de l'extrémité comportant la pince (22) de manière sensiblement parallèle à un axe de révolution du corps (24). Cette excroissance est destinée à venir en contact avec le bouchon clippant (10) afin de neutraliser la liaison rotule existant entre le bouchon clippant (10) et l'embase de connexion distale (100).With reference to the figure 15 , we will describe the above storage and handling device (20). The latter comprises a substantially cylindrical body (24) of revolution, hollow and open on one side. The body (24) has manipulating tabs (21) projecting from opposite sides of the opening, facing one another, and tangentially to the body (24). Each of the ends of the body (24) has a clamp (23, 22) intended to cooperate respectively with the groove (52) of the proximal connection base (50) and the groove (110) of the distal connection base ( 100). In an alternative embodiment, the storage and handling device (20) comprises an outgrowth projecting from the end comprising the clamp (22) substantially parallel to an axis of revolution of the body (24). This protrusion is intended to come into contact with the clipper cap (10) in order to neutralize the existing ball joint connection between the clipping cap (10) and the distal connection base (100).

Maintenant, en référence aux figures 1, 2, 12 à 14, nous allons décrire une utilisation et un fonctionnement du dispositif d'interfaçage (1) selon l'invention qui vient d'être décrit.
En stockage, le dispositif d'interfaçage (1) est équipé du dispositif de stockage et de manipulation (20), comme cela est illustré en figures 1 et 2. Le personnel soignant chargé de la préparation saisit le dispositif d'interfaçage (1) par les languettes (21) du dispositif de stockage et de manipulation (20). Il vient alors clipper le bouchon clippant (10) sur le goulot du flacon à perforer contenant le médicament, ce qui a pour effet, d'une part, de solidariser le flacon et le dispositif d'interfaçage (1) selon l'invention et, d'autre part, de provoquer une perforation de la membrane (5) obturant le goulot du flacon à perforer par, dans un premier temps, l'extrémité distale (31) en biseau de l'aiguille creuse de perforation (30) puis l'extrémité distale de la canule (102). Une entrée d'air dans le flacon à perforer a alors lieu. Cette entrée d'air passe à travers les moyens de filtration (109) de l'orifice débouchant (108) puis par la chambre longitudinale (105) pour enfin s'écouler dans le jeu fonctionnel (101) entre la canule et l'aiguille creuse de perforation (30). Ainsi, si des particules de médicament ou de pollution sont poussées soit hors du flacon par l'air ou à l'intérieur dudit flacon, elles sont bloquées d'une part par le joint (120) et, d'autre part, par les moyens de filtration (109). Il est à noter que de l'air et des particules sont susceptibles d'entrer dans le flacon à travers l'aiguille creuse de perforation (30), mais, d'une part, cette circulation est bloquée par le connecteur à membrane (3) si celui-ci est présent et, d'autre part, de toutes façons, les particules sont bloquées par le filtre à particules placé dans la chambre (63) du dispositif de filtration (60).Now, with reference to Figures 1, 2 , 12 to 14 , we will describe a use and operation of the interfacing device (1) according to the invention which has just been described.
In storage, the interfacing device (1) is equipped with the storage and handling device (20), as illustrated in FIG. Figures 1 and 2 . The The caregiver prepares the interfacing device (1) by the tabs (21) of the storage and handling device (20). It then clipper clipper (10) on the neck of the flask to be drilled containing the drug, which has the effect, on the one hand, to secure the bottle and the interfacing device (1) according to the invention and on the other hand, causing a perforation of the membrane (5) closing the neck of the flask to be perforated by, at first, the distal end (31) bevel of the hollow perforation needle (30) then the distal end of the cannula (102). An air inlet into the flask to be perforated then takes place. This air inlet passes through the filtration means (109) of the opening opening (108) and then through the longitudinal chamber (105) to finally flow into the functional clearance (101) between the cannula and the needle hollow perforation (30). Thus, if particles of drug or pollution are pushed out of the bottle by the air or inside said bottle, they are blocked on the one hand by the seal (120) and on the other hand by the filtering means (109). It should be noted that air and particles are likely to enter the bottle through the hollow perforation needle (30), but, on the one hand, this circulation is blocked by the membrane connector (3). ) if it is present and, secondly, in any case, the particles are blocked by the particulate filter placed in the chamber (63) of the filter device (60).

Une fois le flacon (2) perforé, le personnel soignant chargé de la préparation connecte une seringue remplit de liquide à perfuser (sérum physiologique, par exemple) sur le connecteur à membrane (3), si celui-ci est présent, ou directement sur le raccord femelle Luer ou Luer-Lock (65) du dispositif de filtration (60). Le liquide à perfuser est alors injecté dans le flacon à perforer (2), ce qui pousse l'air contenu dans ledit flacon à l'extérieur, air qui ne peut sortir que par les moyens de filtration (109) de l'orifice traversant (108) de l'embase de connexion distale (100). Si cet air contient des particules, celles-ci sont alors bloquées par le joint (120), d'une part, et, d'autre part, les moyens de filtration (109). Le personnel soignant chargé de la préparation agite alors le flacon afin de diluer au mieux le médicament contenu dans le flacon (2) avec liquide à perfuser qui a été injecté. Ensuite, le personnel soignant retire le dispositif de stockage et de manipulation (20) en appuyant sur les deux languettes (21) l'une vers l'autre pour ouvrir les extrémités formant pince (23) et (22) afin que celles-ci puissent être retirer des gorges (52) de l'embase de connexion proximale (50) et (110) de l'embase de connexion distale (100). Une fois le dispositif de stockage et de manipulation (20) retiré, le personnel soignant peut alors descendre l'aiguille creuse de perforation au fond du flacon en faisant coulisser cette aiguille (30) dans l'embase de connexion (100) en appuyant par exemple sur l'embase de connexion (50). Une fois l'aiguille creuse de perforation (30) descendue au fond du flacon, le personnel soignant peut aspirer avec la seringue le mélange ainsi généré et le réinjecter dans le flacon à plusieurs reprises afin de mieux l'homogénéiser. Lors de ces manipulations, de l'air entre et sort du flacon (2) en passant obligatoirement par les moyens de filtration (109). D'autre part, le liquide à perfuser lorsqu'il est réaspiré dans la seringue est filtré par le dispositif de filtration (60) évitant à ce que les particules de médicament pur non encore diluées ne se retrouvent dans la seringue.Once the vial (2) perforated, the health care staff in charge of the preparation connects a syringe filled with liquid to infuse (saline, for example) on the membrane connector (3), if it is present, or directly on the female Luer or Luer-Lock connector (65) of the filter device (60). The liquid to be infused is then injected into the vial to be perforated (2), which pushes the air contained in said vial to the outside, which air can only exit through the filtration means (109) of the through orifice. (108) of the distal connection base (100). If this air contains particles, they are then blocked by the seal (120), on the one hand, and on the other hand, the filtration means (109). The health care staff responsible for the preparation then shake the bottle in order to best dilute the drug contained in the bottle (2) with infused liquid that has been injected. Thereafter, the caregiver removes the storage and handling device (20) by pressing the two tabs (21) towards each other to open the clip ends (23) and (22) so that the latter can be removed from the grooves (52) of the proximal connection base (50) and (110) of the distal connection base (100). Once the storage and handling device (20) removed, the caregiver can then lower the hollow perforation needle to the bottom of the bottle by sliding the needle (30) in the connection base (100) by pressing by example on the connection base (50). Once the perforated hollow needle (30) has been lowered into the bottom of the vial, the nursing staff can draw the mixture thus generated with the syringe and inject it back into the vial. several times in order to better homogenize it. During these manipulations, air enters and leaves the bottle (2) by passing through the filter means (109). On the other hand, the liquid to be perfused when it is sucked back into the syringe is filtered by the filtering device (60) avoiding that the pure drug particles not yet diluted are found in the syringe.

Une fois le mélange entre le liquide à perfuser et le médicament prêt, le personnel soignant chargé de la préparation l'aspire une dernière fois dans la seringue. Pour éviter de laisser de la préparation souvent très chère dans le flacon à perforer (2), le personnel soignant peut incliner le flacon à perforer (2) et faire rotuler le dispositif d'interfaçage (1) selon l'invention au niveau de la liaison entre le bouchon clippant (10) et l'extrémité distale de l'embase de connexion distale (100) afin d'atteindre avec le biseau (31) de l'aiguille creuse de perforation (30) le bord inférieur et intérieur dudit flacon à perforer (2) comme cela est illustré en figure 14. Une fois l'ensemble du mélange aspiré par la seringue, l'ensemble flacon à perforer (2) vide / dispositif d'interfaçage selon l'invention (1) est jeté en l'état, sans déconnexion du flacon du dispositif d'interfaçage (1). L'aiguille creuse de perforation (30) ne peut sortir du flacon du fait de la présence des moyens de retenue (32) au niveau de l'extrémité distale (31) de l'aiguille creuse de perforation (30). Ainsi, le personnel soignant chargé de la préparation est protégé de toute pique accidentelle avec cette aiguille creuse de perforation (30).Once the mixture between the liquid to be infused and the drug is ready, the health care worker in charge of the preparation sucks it one last time into the syringe. In order to avoid leaving the often expensive preparation in the perforating bottle (2), the nursing staff can incline the perforating bottle (2) and swivel the interfacing device (1) according to the invention at the level of the connecting the clipping cap (10) and the distal end of the distal connection base (100) to reach with the bevel (31) of the hollow perforation needle (30) the lower and inner edge of said vial to be perforated (2) as illustrated in figure 14 . Once the entire mixture has been sucked by the syringe, the empty perforating bottle (2) / interface device according to the invention (1) is discarded as it is, without disconnecting the bottle from the interfacing device. (1). The hollow perforation needle (30) can not exit the vial due to the presence of the retaining means (32) at the distal end (31) of the hollow perforation needle (30). Thus, the health care worker in charge of the preparation is protected from any accidental sting with this hollow perforation needle (30).

Il est à noter qu'à aucun moment l'aiguille n'a été touchée, donc il n'y a pas de contamination possible du personnel soignant par le mélange ou du mélange par le personnel soignant. D'autre part, la membrane du connecteur à membrane (3) est facile à nettoyer avant toute connexion de la seringue.It should be noted that at no time has the needle been touched, so there is no possible contamination of the nursing staff by mixing or mixing by the nursing staff. On the other hand, the diaphragm connector membrane (3) is easy to clean before any connection of the syringe.

Bien entendu, il est possible d'apporter à l'invention de nombreuses bonifications sans pour autant sortir du cadre de celle-ci.Of course, it is possible to provide the invention with many bonuses without departing from the scope thereof.

Claims (13)

  1. An interface device (1) designed to connect a syringe to a perforable bottle (2) containing a drug, comprising a hollow perforation needle (30) and a base (100) for connection to the perforable bottle, which connection base comprises air circulation means (101, 105, 108, 109) designed to allow air in and out of the perforable bottle, comprising air filtration means (109) and a tubule (102) designed to extend into the perforable bottle at a distal end of the tubule, characterized in that the hollow perforation needle is mounted slidingly with functional play (101) in the tubule.
  2. The interface device according to claim 1, characterized in that the hollow perforation needle is sealably slidingly mounted (120) in the connection base (100) at a proximal portion (114) of said connection base.
  3. The interface device according to one of claims 1 to 2, characterized in that the air circulation means include an orifice (108) emerging on the outside.
  4. The interface device according to claim 3, characterized in that the emerging orifice is closed by the filtration means (109).
  5. The interface device according to claim 4, characterized in that the filtration means include a filter for particles in the vicinity of a value between about 2 µm and about 5 µm.
  6. The interface device according to one of claims 1 to 5, characterized in that the connection base includes, at a distal portion (107), a clipping stopper (10) designed to allow the mounting by clipping of the interface device on the perforable bottle.
  7. The interface device according to claim 6, characterized in that the clipping stopper is mounted on the connection base according to a ball coupling.
  8. The interface device according to claim 1, characterized in that the hollow perforation needle includes, at a distal end (31), means (32) for retaining the needle in the tubule.
  9. The interface device according to claim 8, characterized in that the retaining means include a deformation produced by crushing of the hollow perforation needle.
  10. The interface device according to one of claims 1 to 9, characterized in that it includes a second connection base (50) on the syringe.
  11. The interface device according to claim 10, characterized in that the second connection base includes means (60) for filtering a liquid designed to be suctioned by the syringe from the perforable bottle.
  12. The interface device according to one of claims 10 to 11, characterized in that the second connection base includes, at a proximal portion, a membrane connector (3) allowing the direct and secured connection of the syringe.
  13. The interface device according to one of claims 10 to 12, characterized in that the second connection base (50) is sealably mounted, at a distal portion (51), on a proximal end (33) of the hollow perforation needle.
EP20090719854 2008-03-12 2009-03-11 Interface device for bottles designed to be perforated for the preparation of infused liquids Active EP2262464B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0851620A FR2928539B1 (en) 2008-03-12 2008-03-12 INTERFACING DEVICE FOR PERFORATING BOTTLES FOR THE PREPARATION OF PERFUME FLUIDS
PCT/EP2009/052882 WO2009112535A1 (en) 2008-03-12 2009-03-11 Interface device for bottles designed to be perforated for the preparation of infused liquids

Publications (2)

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EP2262464A1 EP2262464A1 (en) 2010-12-22
EP2262464B1 true EP2262464B1 (en) 2012-10-10

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EP20090719854 Active EP2262464B1 (en) 2008-03-12 2009-03-11 Interface device for bottles designed to be perforated for the preparation of infused liquids

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US (1) US20110004183A1 (en)
EP (1) EP2262464B1 (en)
JP (1) JP2011513013A (en)
KR (1) KR20100129317A (en)
CA (1) CA2717508A1 (en)
DK (1) DK2262464T3 (en)
ES (1) ES2395486T3 (en)
FR (1) FR2928539B1 (en)
PT (1) PT2262464E (en)
WO (1) WO2009112535A1 (en)

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Also Published As

Publication number Publication date
ES2395486T3 (en) 2013-02-13
FR2928539A1 (en) 2009-09-18
FR2928539B1 (en) 2012-02-24
PT2262464E (en) 2012-12-20
CA2717508A1 (en) 2009-09-17
DK2262464T3 (en) 2013-01-21
WO2009112535A1 (en) 2009-09-17
JP2011513013A (en) 2011-04-28
US20110004183A1 (en) 2011-01-06
KR20100129317A (en) 2010-12-08
EP2262464A1 (en) 2010-12-22

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