EP1034772A1 - Device for transfering a substance contained in a vial to a pouch containing a solute - Google Patents

Device for transfering a substance contained in a vial to a pouch containing a solute Download PDF

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Publication number
EP1034772A1
EP1034772A1 EP00400612A EP00400612A EP1034772A1 EP 1034772 A1 EP1034772 A1 EP 1034772A1 EP 00400612 A EP00400612 A EP 00400612A EP 00400612 A EP00400612 A EP 00400612A EP 1034772 A1 EP1034772 A1 EP 1034772A1
Authority
EP
European Patent Office
Prior art keywords
guide
bottle
needle
solute
bag
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.)
Granted
Application number
EP00400612A
Other languages
German (de)
French (fr)
Other versions
EP1034772B1 (en
Inventor
Thierry Verpoort
Francis Goudaliez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Maco Pharma SAS
Original Assignee
Maco Pharma SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Maco Pharma SAS filed Critical Maco Pharma SAS
Publication of EP1034772A1 publication Critical patent/EP1034772A1/en
Application granted granted Critical
Publication of EP1034772B1 publication Critical patent/EP1034772B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/2013Piercing means having two piercing ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2065Connecting means having aligning and guiding means

Definitions

  • the invention relates to a device for transferring a substance, for example medication, inside a pocket.
  • the contents of the solution bag for example glucose to which the drug, is then administered to the patient continuously, by example using a conventional infusion device.
  • a transfer device comprising a first part, intended to be mounted on the inlet opening of a pocket, and a second part, intended to receive the end of a bottle.
  • the first and second parts are provided with a coaxial hollow needle allowing on the one hand to pierce the cap of the bottle, generally in rubber, as well as the pocket inlet, then transfer the contents from the bottle in the pocket on the other hand.
  • the first part of the device is mounted on the inlet port of the solute bag by piercing the inlet port of the bag, the needle is found in the airlock of the injection site, then the vial is mounted on the second part of the device, the needle also piercing the stopper rubber of the bottle.
  • the vial and the transfer device are usually removed from the pocket.
  • the solution pouch containing the drug can then be administered to the sick.
  • medication transfers can be made to the bedside, and hospital staff must assemble the solute bags, transfer devices and vials.
  • the invention aims to remedy these drawbacks by proposing a device for transfer which makes it possible to control the nature of the product transferred and the correct completion of this transfer.
  • the device for transferring, in a bag of solute, a substance, for example medicinal, contained in a container, such as a bottle comprises a first guide, of generally substantially cylindrical shape, open at one end and closed at its other end opposite the end opened.
  • the first guide is able to receive at least the neck and the upper part of the body of the bottle, the bottle being capable of sliding at least partially in the first guide.
  • the first guide also includes means capable of preventing withdrawal total of the bottle out of the first guide after its introduction therein, said means being arranged so as to allow at least partial sliding of said bottle in the first guide.
  • the device according to the invention further comprises a second guide, in the form generally substantially cylindrical, extending the first guide on the side of the closed end thereof and mounted coaxially with the first guide.
  • the end of the second guide opposite the first guide is open and suitable for receive the inlet port of the solute bag.
  • the device according to the invention also comprises a means for piercing the means for closing the bottle and the solute bag respectively, and transfer of the substance contained in the vial into the solution bag, the drilling means being arranged coaxially with the first and second guides.
  • the means preventing the withdrawal of the bottle comprise at least one tab elastic formed on the internal face of the first guide, for example at the level from the open end of the first guide.
  • the tab projects from one of its ends towards the inside of the first guide being directed towards the closed end of the first guide.
  • the internal face of the first guide may have three legs elastic arranged substantially evenly therebetween and substantially at the same level on the internal face of the first guide.
  • the means preventing the withdrawal of the bottle include at least one elastic annular lip disposed on the face internal of the first guide, for example at the open end of the first guide.
  • the annular lip is arranged projecting inward from the first guide, substantially perpendicular to the longitudinal axis of the first guide.
  • the second guide can be rigidly fixed on the first guide.
  • the second guide is slidably mounted on the first guide.
  • the second guide comprises an additional region small external diameter, located towards the end of the second guide opposite to the open end of the second guide and intended to slide in a opening of corresponding diameter made in the closed end of the first guide.
  • the terminal portion of the smaller diameter region located on the side of the first guide is provided with an annular lip forming a bearing surface against the closed end of the first guide, inside of it, so as to block the sliding of the second guide in the first guide.
  • the means for piercing the means for closing the bottle and the orifice pocket entry points include a hollow needle over its entire length, coaxial with the first and second guides.
  • the two ends of the needle are in the form of bevelled points, in opening for one in the first guide and for the other in the second guide.
  • the needle is held in place at the closed end of the first guide.
  • the needle is held in place at the region of smaller diameter of the second guide.
  • the tip of the needle opening into the first guide and / or the tip of the needle opening into the second guide is protected by a flexible envelope, for example latex.
  • the transfer device according to the invention can be independent of the storage bag. solution and bottle, the various elements being assembled before transfer.
  • the second guide may include means capable of prevent total withdrawal of the inlet port of the solute bag from the second guide after its introduction in this one.
  • said means have a structure identical to those laid out in the first guide and are arranged to allow at least partial sliding of the orifice entry into the second guide.
  • the transfer device according to the invention can be integrated, so permanent and not detachable, with a solution pocket.
  • the transfer device of the invention can be mounted so fixed on the inlet opening of a solution bag, at the open end from the second guide.
  • the user only has to introduce the bottle into the first guide, before proceeding with the transfer.
  • the tip of the needle located on the side of the solution bag does not need to be protected by a flexible envelope, since it is no longer in contact with the outside.
  • the tip of the needle located on the side of the solution bag did not need to be beveled, since it no longer pierces the inlet opening of the pocket of solute.
  • the transfer device mounted on the solute bag can be protected, in addition to the flexible envelope covering the needle on the side of the first guide, by a cover resting on the longitudinal walls of the first guide.
  • FIG. 1 represents a schematic view, in longitudinal section, of a mode for producing the transfer device of the invention.
  • Figure 2 shows a schematic view, in longitudinal section, of another embodiment of the transfer device of the invention.
  • Figures 3, 4, 5 and 6 show schematic views, in section of the operation of the transfer device shown in the figure 2.
  • the transfer device 1 comprises a first guide 2 capable of receiving, at least partially, a bottle 3.
  • the first guide 2 is generally cylindrical in shape, the shape of the first guide depending on that of the bottle.
  • the first guide can be of a shape other than cylindrical, for example parallelepiped, to adapt to bottles of a corresponding shape.
  • the first guide 2 comprises a longitudinal wall 4 open to one of its ends 6 and closed at its opposite end 5.
  • the first guide 2 is provided with means preventing the withdrawal of the bottle 3 from the first guide 2. These means also allow at least partial sliding of the bottle 3 in the first guide 2.
  • the means preventing the removal include two elastic tabs 7 disposed on the inner face 8 of the longitudinal wall 4 of the first guide 2.
  • the two tabs 7 are arranged so as to allow the introduction of the bottle 3 in the first guide 2 and to prevent its total withdrawal out of it while allowing said bottle 3 to slide in the first guide 2.
  • the legs 7 deviate towards the face internal 8 of the first guide 2 under the action exerted by the neck 9 of the bottle 3.
  • the neck 9 of the bottle 3 can then be introduced into the first guide 2.
  • the legs 7 return to their initial position, the bottle 3 being partially introduced into the first guide 2, the neck 10 of the bottle 3 located at the legs 7.
  • the legs 7 can then again move towards the internal face 8 of the first guide 2, to allow the sliding of said bottle so as to pass the body 11 of the bottle 3.
  • the legs 7 are fixed to the internal face 8 of the first guide 2 by one of their ends 12, the other free end 13 of the legs 7 being directed towards the closed end of the first guide 2, so as to block the withdrawal of the bottle 3 outside the first guide 2, at the neck 10 of the bottle 3.
  • the number of legs 7 may vary depending in particular on the resistance to withdrawal that one wishes to give to the transfer device 1 of the invention.
  • the transfer device 1 comprises three legs 7 arranged substantially at the same level of the internal face 8 of the first guide 2 and spaced substantially evenly therebetween.
  • the first guide 2 is extended on the side of the closed end 5 by a second guide 14.
  • the second guide 14 is fixedly and coaxially arranged with respect to the median longitudinal axis X of the device 1, with the first guide 2.
  • the second guide 14 is hollow and intended to receive the inlet orifice 15 of a solution bag 16.
  • the inlet 15 includes an elastomer sleeve 28 passable by the needle 17 and self-concealing which is U-shaped and which is closed by a cover 23.
  • the needle 17 passes through first the cover 23 to be in the airlock 29 formed inside the U then additional sliding brings the needle 17 into contact with the bottom 30 of the U so that it can pass through it and thus bring the interior of the solution bag with the outside.
  • the second guide comprises means preventing total withdrawal of the inlet 15 outside the second guide 14 after its introduction into this one.
  • the means preventing the total withdrawal have a structure identical to that of the means preventing the withdrawal of the bottle 3 and therefore comprise two elastic tabs 25 arranged on the internal face of the longitudinal wall of the second guide 14.
  • the tabs 25 deviate towards the face internal of the second guide 14 under the action exerted. Blocking the withdrawal of the inlet 15 is then made between the free end 26 of the legs 25 and a circular flat 27 made on said orifice.
  • the assembly formed by the pocket of solute 16 and the device 1 is then in a first position (see figure 2) in which although associated with one another, the needle 17 has not passed through the cover 23. Under the action of an additional force, the inlet 15 can then slide so that the needle is in the airlock 29 (second position shown in particular in Figure 1) then crosses the bottom 30 to put the inside of the solution bag 16 in contact with the inside of the bottle 3 (third position shown in particular in Figure 6).
  • the second guide 14 comprises a hollow needle 17, substantially parallel to the median longitudinal axis X.
  • the needle 17 is provided with two ends forming bevelled points 18, intended to pierce the inlet orifice 15 of the solute bag 16 on the one hand and the bottle cap 3 on the other hand.
  • the needle 17 is held in place at the closed end 5 of the first guide 2, the two points 18 of the needle 17 opening for one in the first guide 2 and for the other in the second guide 14.
  • the base region 19 makes it possible to prevent the needle 17 from becoming twists when piercing the bottle cap 3 or the inlet orifice 15 of the solution bag 16.
  • the transfer device 1 can be made of an injectable plastic.
  • the plastic used must also be able to withstand the conditions of sterilization.
  • the transfer device can be made of a polymer based polyethylene, polycarbonate, polypropylene, polystyrene, as well as derivatives and / or mixtures of these products.
  • the transfer device shown in Figure 1 is manufactured by injection, starting from the raw materials indicated above, the first and second guides being formed in one piece and the needle molded.
  • FIG. 1 Another embodiment of the transfer device 1 is shown in the figure 2.
  • the transfer device 1 comprises a first guide 2 and a second guide 14 into which open the points 18 of a needle 17.
  • the second guide 14 is slidably mounted on the first guide 2.
  • the second guide 14 comprises a region of smaller diameter external 20, located at the end of the second guide 14 located on the side of the first guide 2.
  • This region of smaller external diameter 20 is slidably mounted in a corresponding opening made on the closed end 5 of the first guide 2.
  • a more or less easy sliding of the second guide 14 can be obtained by depending on the choice of plastic materials used for the first and second guides and the external diameter of region 20 relative to the opening made on the closed end 5 of the first guide 2.
  • Sliding can be further facilitated by depositing a silicone material on the region with the smallest external diameter 20.
  • the sliding of the second guide 14 is limited in one direction by a lip annular 21 forming a bearing surface against the closed end 5 of the first guide 2, inside the first guide 2.
  • the sliding of the second guide 14 is limited in the other direction by the return of the second guide 14 at its normal diameter, at region 22.
  • the embodiment of the transfer device 1 according to the invention as illustrated in Figure 2 involves the separate manufacture of two corresponding parts to the first and second guides.
  • FIGS 3, 4, 5 and 6 illustrate the operation of the transfer device according to the invention.
  • FIGS. 3 to 6 the same reference numerals designate the same elements as in Figures 1 and 2.
  • a transfer device 1 according to the invention is mounted, via the second guide 14, on the orifice inlet 15 of a solute bag 16 so as to make the device 1 integral and the solute bag 16.
  • the other point 18 of the needle 17 located on the side of the first guide 2 is protected by a flexible self-sealing envelope 24, for example made of latex, for the purpose to guarantee the sterility of the transfer device 1.
  • Such an envelope 24 can also be provided on the side of the point 18 of the needle 17 located on the side of the second guide 14.
  • a bottle 3 containing for example a drug is introduced into the first guide 2 (figures 4 and 5).
  • the bottle 3 is associated with the solute bag 16 by via the transfer device 1 to form a unitary assembly in which the interior of the bottle 3 and the interior of the pocket 16 are not communication.
  • the solute bag 16, the device 1 and the bottle 3 are irreversibly associated with each other.
  • unitary assembly is understood to mean in particular that it can be stored, sold, handled and used together.
  • the stopper of the bottle 3 then comes into contact with the point 18 of the needle 17 protected by the casing 24.
  • the operator can then exert a force on the solute bag 16 and on the bottle 3 so as to simultaneously cause on the one hand a sliding additional bottle 3 which leads to piercing the cap and the casing 24 by the needle 17 and on the other hand an additional sliding of the inlet orifice 15 which leads to the drilling of the bottom 30 by the other end 18 of needle 17.
  • This action connects the interior of the bottle 3 with the interior of the solute bag 16, via the hollow needle 17 ( Figure 6).
  • the solute bag 16 is positioned with the inlet port 15 facing the down to introduce, by exerting manual pressure on the solution bag 16, a small amount of solute inside the bottle 3 to dissolve the medicine it contains. After dissolution, the whole solution bag 16 and bottle 3 is inverted in order to transfer the contents of bottle 3 to the solution 16, the sterile air in the solution bag 16 replacing the contained liquid in bottle 3.
  • the bottle 3 remains on the device 1 according to the invention, its withdrawal being prevented by the tabs 7 which block the passage of the neck 9 outside the first guide 2.

Abstract

A connector made from an injection-mouldable and sterilisable plastic, comprising a first basically cylindrical guide (2), open at one end (6) and closed at the other (5), and a second guide (14) extending coaxially from the closed end of the first guide, and having an open end for the inlet (15) of a solute pouch (16), is new. A connector made from an injection-mouldable and sterilisable plastic, comprising a first basically cylindrical guide (2), open at one end (6) and closed at the other (5), and a second guide (14) extending coaxially from the closed end of the first guide, and having an open end for the inlet (15) of a solute pouch (16), is new. A hollow needle (17) for piercing the flask and pouch caps simultaneously is located coaxially inside the connector and passes through the closed end. The first guide (2) is shaped so that it receives not only the neck but the body end of the flask as well, and has a retainer with elastic lugs (7) that allow the flask to slide inside it and hold it in place.

Description

L'invention se rapporte à un dispositif de transfert d'une substance, par exemple un médicament, à l'intérieur d'une poche.The invention relates to a device for transferring a substance, for example medication, inside a pocket.

Les soins prodigués en milieu hospitalier nécessitent fréquemment de faire passer un médicament sous forme liquide ou solide, contenu dans un flacon, dans une poche de soluté.Hospital care frequently requires doing pass a drug in liquid or solid form, contained in a bottle, in a solution pocket.

Le contenu de la poche de soluté, par exemple du glucose auquel est ajouté le médicament, est ensuite administré au malade d'une façon continue, par exemple en utilisant un dispositif de perfusion conventionnel.The contents of the solution bag, for example glucose to which the drug, is then administered to the patient continuously, by example using a conventional infusion device.

On connaít ainsi un dispositif de transfert comprenant une première partie, destinée à être montée sur l'orifice d'entrée d'une poche, et une seconde partie, destinée à recevoir l'extrémité d'un flacon.There is thus known a transfer device comprising a first part, intended to be mounted on the inlet opening of a pocket, and a second part, intended to receive the end of a bottle.

Les première et seconde parties sont munies d'une aiguille creuse coaxiale permettant d'une part de percer le bouchon du flacon, généralement en caoutchouc, ainsi que l'orifice d'entrée de la poche, puis de transférer le contenu du flacon dans la poche d'autre part.The first and second parts are provided with a coaxial hollow needle allowing on the one hand to pierce the cap of the bottle, generally in rubber, as well as the pocket inlet, then transfer the contents from the bottle in the pocket on the other hand.

Pour réaliser un tel transfert, la première partie du dispositif est montée sur l'orifice d'entrée de la poche de soluté en perçant l'orifice d'entrée de la poche, l'aiguille se retrouve dans le sas du site d'injection, puis le flacon est monté sur la seconde partie du dispositif, l'aiguille perçant également le bouchon en caoutchouc du flacon.To carry out such a transfer, the first part of the device is mounted on the inlet port of the solute bag by piercing the inlet port of the bag, the needle is found in the airlock of the injection site, then the vial is mounted on the second part of the device, the needle also piercing the stopper rubber of the bottle.

Lorsque le flacon et la poche sont ainsi montés sur le dispositif, l'intérieur du flacon et l'intérieur de la poche sont en communication.When the bottle and the bag are thus mounted on the device, the interior of the bottle and the inside of the pocket are in communication.

En comprimant et en relâchant ensuite la poche de soluté, une dépression s'établit, permettant le passage du médicament du flacon vers la poche de soluté. By compressing and then releasing the solute bag, a vacuum is established, allowing the passage of the drug from the bottle to the bag of solute.

Une fois le médicament transféré, le flacon et le dispositif de transfert sont généralement retirés de la poche.Once the medicine is transferred, the vial and the transfer device are usually removed from the pocket.

La poche de soluté contenant le médicament peut alors être administrée au malade.The solution pouch containing the drug can then be administered to the sick.

Ce système présente cependant des inconvénients.This system has drawbacks, however.

Tant sur le plan de la sécurité pour le malade que sur le plan pratique pour le personnel soignant hospitalier.Both in terms of safety for the patient and in practical terms for the hospital nursing staff.

Sur le plan de la sécurité, il n'existe en effet pas de moyen de contrôle, après le transfert effectué et le dispositif de transfert ôté de la poche, que celle-ci contient effectivement le médicament transféré d'une part, et qu'il s'agit bien du médicament prescrit d'autre part.In terms of security, there is indeed no means of control, after the transfer made and the transfer device removed from the pocket, that the latter contains the transferred medicine on the one hand, and that it is the medication prescribed on the other hand.

En outre, les transferts de médicaments peuvent être effectués au lit du malade, et le personnel hospitalier doit assembler sur place les poches de soluté, les dispositifs de transfert et les flacons.In addition, medication transfers can be made to the bedside, and hospital staff must assemble the solute bags, transfer devices and vials.

Il en résulte ainsi de possibles erreurs dans la manipulation des dispositifs, ainsi que la nécessité de véhiculer tout au long de la journée, l'ensemble des éléments nécessaires aux soins.This results in possible errors in the handling of the devices, as well that the need to convey throughout the day, all of the elements necessary for care.

Il en résulte donc également une perte de temps pour le personnel soignant hospitalier, lors de la préparation des transferts de médicaments.This also results in a loss of time for the nursing staff hospital, when preparing medication transfers.

L'invention vise à remédier à ces inconvénients, en proposant un dispositif de transfert qui permette de contrôler la nature du produit transféré et la bonne réalisation de ce transfert. The invention aims to remedy these drawbacks by proposing a device for transfer which makes it possible to control the nature of the product transferred and the correct completion of this transfer.

Et qui permette également d'opérer les transferts de médicaments à la pharmacie centrale de l'hôpital, le personnel soignant n'ayant plus, au lit du malade, qu'à opérer l'administration du médicament, sans avoir à assembler les différents éléments entre eux, et ce en toute sécurité.And which also makes it possible to operate the transfers of drugs to the central pharmacy of the hospital, the nursing staff no longer having in bed patient, to operate the drug, without having to assemble the different elements between them, and this in complete safety.

A cet effet, le dispositif de transfert, dans une poche de soluté, d'une substance, par exemple médicamenteuse, contenue dans un récipient, tel qu'un flacon, comprend un premier guide, de forme générale sensiblement cylindrique, ouvert à l'une de ses extrémités et fermé à son autre extrémité opposée à l'extrémité ouverte.To this end, the device for transferring, in a bag of solute, a substance, for example medicinal, contained in a container, such as a bottle, comprises a first guide, of generally substantially cylindrical shape, open at one end and closed at its other end opposite the end opened.

Le premier guide est apte à recevoir au moins le col et la partie supérieure du corps du flacon, le flacon étant susceptible de coulisser au moins partiellement dans le premier guide.The first guide is able to receive at least the neck and the upper part of the body of the bottle, the bottle being capable of sliding at least partially in the first guide.

Le premier guide comprend de plus des moyens aptes à empêcher le retrait total du flacon hors du premier guide après son introduction dans celui-ci, lesdits moyens étant agencés de sorte à permettre le coulissement au moins partiel dudit flacon dans le premier guide.The first guide also includes means capable of preventing withdrawal total of the bottle out of the first guide after its introduction therein, said means being arranged so as to allow at least partial sliding of said bottle in the first guide.

Le dispositif selon l'invention comprend de plus un second guide, de forme générale sensiblement cylindrique, prolongeant le premier guide du côté de l'extrémité fermée de celui-ci et monté de façon coaxiale avec le premier guide.The device according to the invention further comprises a second guide, in the form generally substantially cylindrical, extending the first guide on the side of the closed end thereof and mounted coaxially with the first guide.

L'extrémité du second guide opposée au premier guide est ouverte et apte à recevoir l'orifice d'entrée de la poche de soluté.The end of the second guide opposite the first guide is open and suitable for receive the inlet port of the solute bag.

Le dispositif selon l'invention comprend également un moyen de perçage des moyens de fermeture du flacon et de la poche de soluté respectivement, et de transfert de la substance contenue dans le flacon dans la poche de soluté, les moyens de perçage étant disposés de façon coaxiale avec les premier et second guides. The device according to the invention also comprises a means for piercing the means for closing the bottle and the solute bag respectively, and transfer of the substance contained in the vial into the solution bag, the drilling means being arranged coaxially with the first and second guides.

Selon d'autres caractéristiques et un mode d'exécution particulier de l'invention, les moyens empêchant le retrait du flacon comprennent au moins une patte élastique ménagée sur la face interne du premier guide, par exemple au niveau de l'extrémité ouverte du premier guide.According to other characteristics and a particular embodiment of the invention, the means preventing the withdrawal of the bottle comprise at least one tab elastic formed on the internal face of the first guide, for example at the level from the open end of the first guide.

La patte fait saillie par l'une de ses extrémités vers l'intérieur du premier guide en étant dirigée vers l'extrémité fermée du premier guide.The tab projects from one of its ends towards the inside of the first guide being directed towards the closed end of the first guide.

Par exemple, la face interne du premier guide peut comporter trois pattes élastiques disposées de façon sensiblement régulière entre elles et sensiblement au même niveau sur la face interne du premier guide.For example, the internal face of the first guide may have three legs elastic arranged substantially evenly therebetween and substantially at the same level on the internal face of the first guide.

Selon un autre mode d'exécution, les moyens empêchant le retrait du flacon comprennent au moins une lèvre annulaire élastique disposée sur la face interne du premier guide, par exemple au niveau de l'extrémité ouverte du premier guide.According to another embodiment, the means preventing the withdrawal of the bottle include at least one elastic annular lip disposed on the face internal of the first guide, for example at the open end of the first guide.

La lèvre annulaire est disposée en faisant saillie vers l'intérieur du premier guide, de façon sensiblement perpendiculaire à l'axe longitudinal du premier guide.The annular lip is arranged projecting inward from the first guide, substantially perpendicular to the longitudinal axis of the first guide.

Selon l'invention, le second guide peut être fixé rigidement sur le premier guide.According to the invention, the second guide can be rigidly fixed on the first guide.

En variante, le second guide est monté de façon coulissante sur le premier guide.As a variant, the second guide is slidably mounted on the first guide.

Selon cette seconde variante, le second guide comprend une région de plus petit diamètre externe, située vers l'extrémité du second guide opposée à l'extrémité ouverte du second guide et destinée à venir coulisser dans une ouverture de diamètre correspondant ménagée dans l'extrémité fermée du premier guide. According to this second variant, the second guide comprises an additional region small external diameter, located towards the end of the second guide opposite to the open end of the second guide and intended to slide in a opening of corresponding diameter made in the closed end of the first guide.

La partie terminale de la région de plus petit diamètre située du côté du premier guide est munie d'une lèvre annulaire formant une surface d'appui contre l'extrémité fermée du premier guide, à l'intérieur de celui-ci, de façon à bloquer le coulissement du second guide dans le premier guide.The terminal portion of the smaller diameter region located on the side of the first guide is provided with an annular lip forming a bearing surface against the closed end of the first guide, inside of it, so as to block the sliding of the second guide in the first guide.

Les moyens de perçage des moyens de fermeture du flacon et de l'orifice d'entrée de la poche comprennent une aiguille creuse sur toute sa longueur, coaxiale avec les premier et second guides.The means for piercing the means for closing the bottle and the orifice pocket entry points include a hollow needle over its entire length, coaxial with the first and second guides.

Les deux extrémités de l'aiguille sont en forme de pointes biseautées, en débouchant pour l'une dans le premier guide et pour l'autre dans le second guide.The two ends of the needle are in the form of bevelled points, in opening for one in the first guide and for the other in the second guide.

Dans la variante de réalisation selon laquelle le second guide est monté de façon fixe, l'aiguille est maintenue en place au niveau de l'extrémité fermée du premier guide.In the alternative embodiment according to which the second guide is mounted fixedly, the needle is held in place at the closed end of the first guide.

Dans la variante de réalisation selon laquelle le second guide est monté de façon coulissante, l'aiguille est maintenue en place au niveau de la région de plus faible diamètre du second guide.In the alternative embodiment according to which the second guide is mounted sliding way, the needle is held in place at the region of smaller diameter of the second guide.

Selon un mode d'exécution de l'invention, la pointe de l'aiguille débouchant dans le premier guide et/ou la pointe de l'aiguille débouchant dans le second guide est protégée par une enveloppe souple, par exemple en latex.According to one embodiment of the invention, the tip of the needle opening into the first guide and / or the tip of the needle opening into the second guide is protected by a flexible envelope, for example latex.

Le dispositif de transfert selon l'invention peut être indépendant de la poche de soluté et du flacon, les différents éléments étant assemblés avant le transfert.The transfer device according to the invention can be independent of the storage bag. solution and bottle, the various elements being assembled before transfer.

Dans cette variante, le second guide peut comprendre des moyens aptes à empêcher le retrait total de l'orifice d'entrée de la poche de soluté hors du second guide après son introduction dans celui-ci. Par exemple, lesdits moyens ont une structure identique à ceux disposés dans le premier guide et sont agencés de sorte à permettre un coulissement au moins partiel de l'orifice d'entrée dans le second guide.In this variant, the second guide may include means capable of prevent total withdrawal of the inlet port of the solute bag from the second guide after its introduction in this one. For example, said means have a structure identical to those laid out in the first guide and are arranged to allow at least partial sliding of the orifice entry into the second guide.

En variante, le dispositif de transfert selon l'invention peut être intégré, de façon permanente et non détachable, à une poche de soluté.Alternatively, the transfer device according to the invention can be integrated, so permanent and not detachable, with a solution pocket.

Par exemple, le dispositif de transfert de l'invention peut être monté de façon fixe sur l'orifice d'entrée d'une poche de soluté, au niveau de l'extrémité ouverte du second guide.For example, the transfer device of the invention can be mounted so fixed on the inlet opening of a solution bag, at the open end from the second guide.

Dans ce cas, l'utilisateur n'a plus qu'à introduire le flacon dans le premier guide, avant de procéder au transfert.In this case, the user only has to introduce the bottle into the first guide, before proceeding with the transfer.

Selon cette variante, la pointe de l'aiguille située du côté de la poche de soluté n'a pas besoin d'être protégée par une enveloppe souple, puisqu'elle n'est plus en contact avec l'extérieur.According to this variant, the tip of the needle located on the side of the solution bag does not need to be protected by a flexible envelope, since it is no longer in contact with the outside.

De même, la pointe de l'aiguille située du côté de la poche de soluté n'a pas besoin d'être biseautée, puisqu'elle ne perce plus l'orifice d'entrée de la poche de soluté.Likewise, the tip of the needle located on the side of the solution bag did not need to be beveled, since it no longer pierces the inlet opening of the pocket of solute.

Selon cette variante, le dispositif de transfert monté sur la poche de soluté peut être protégé, en plus de l'enveloppe souple recouvrant l'aiguille du côté du premier guide, par un opercule reposant sur les parois longitudinales du premier guide.According to this variant, the transfer device mounted on the solute bag can be protected, in addition to the flexible envelope covering the needle on the side of the first guide, by a cover resting on the longitudinal walls of the first guide.

L'invention sera mieux comprise dans la description qui suit, faite en référence aux figures annexées.The invention will be better understood in the description which follows, given with reference to the appended figures.

La figure 1 représente une vue schématique, en coupe longitudinale, d'un mode de réalisation du dispositif de transfert de l'invention. FIG. 1 represents a schematic view, in longitudinal section, of a mode for producing the transfer device of the invention.

La figure 2 représente une vue schématique, en coupe longitudinale, d'un autre mode de réalisation du dispositif de transfert de l'invention.Figure 2 shows a schematic view, in longitudinal section, of another embodiment of the transfer device of the invention.

Les figures 3, 4, 5 et 6 représentent des vues schématiques, en coupes longitudinales, du fonctionnement du dispositif de transfert représenté sur la figure 2.Figures 3, 4, 5 and 6 show schematic views, in section of the operation of the transfer device shown in the figure 2.

En se référant maintenant à la figure 1, le dispositif de transfert 1 selon l'invention comprend un premier guide 2 apte à recevoir, au moins partiellement, un flacon 3.Referring now to FIG. 1, the transfer device 1 according to the invention comprises a first guide 2 capable of receiving, at least partially, a bottle 3.

Le premier guide 2 est de forme généralement cylindrique, la forme du premier guide dépendant de celle du flacon.The first guide 2 is generally cylindrical in shape, the shape of the first guide depending on that of the bottle.

Ainsi, le premier guide peut être d'une forme autre que cylindrique, par exemple parallélépipédique, pour s'adapter à des flacons d'une forme correspondante.Thus, the first guide can be of a shape other than cylindrical, for example parallelepiped, to adapt to bottles of a corresponding shape.

Le premier guide 2 comprend une paroi longitudinale 4 ouverte à l'une de ses extrémités 6 et fermée à son extrémité opposée 5.The first guide 2 comprises a longitudinal wall 4 open to one of its ends 6 and closed at its opposite end 5.

Au niveau de son extrémité ouverte 6, le premier guide 2 est muni de moyens empêchant le retrait du flacon 3 hors du premier guide 2. Ces moyens permettent également le coulissement au moins partiel du flacon 3 dans le premier guide 2.At its open end 6, the first guide 2 is provided with means preventing the withdrawal of the bottle 3 from the first guide 2. These means also allow at least partial sliding of the bottle 3 in the first guide 2.

Selon la forme d'exécution représentée sur la figure 1, les moyens empêchant le retrait comprennent deux pattes 7 élastiques disposées sur la face interne 8 de la paroi longitudinale 4 du premier guide 2.According to the embodiment shown in Figure 1, the means preventing the removal include two elastic tabs 7 disposed on the inner face 8 of the longitudinal wall 4 of the first guide 2.

Les deux pattes 7 sont disposées de façon à permettre l'introduction du flacon 3 dans le premier guide 2 et à empêcher son retrait total hors de celui-ci tout en permettant le coulissement dudit flacon 3 dans le premier guide 2. The two tabs 7 are arranged so as to allow the introduction of the bottle 3 in the first guide 2 and to prevent its total withdrawal out of it while allowing said bottle 3 to slide in the first guide 2.

Selon la forme d'exécution représentée, les pattes 7 s'écartent vers la face interne 8 du premier guide 2 sous l'action exercée par le goulot 9 du flacon 3.According to the embodiment shown, the legs 7 deviate towards the face internal 8 of the first guide 2 under the action exerted by the neck 9 of the bottle 3.

Le goulot 9 du flacon 3 peut alors être introduit dans le premier guide 2.The neck 9 of the bottle 3 can then be introduced into the first guide 2.

Après le passage du goulot 9, les pattes 7 reviennent dans leur position initiale, le flacon 3 étant partiellement introduit dans le premier guide 2, le col 10 du flacon 3 se situant au niveau des pattes 7.After the neck 9 has passed, the legs 7 return to their initial position, the bottle 3 being partially introduced into the first guide 2, the neck 10 of the bottle 3 located at the legs 7.

Sous l'action d'une force supplémentaire, les pattes 7 peuvent ensuite de nouveau s'écarter vers la face interne 8 du premier guide 2, pour permettre le coulissement dudit flacon de sorte à réaliser le passage du corps 11 du flacon 3.Under the action of an additional force, the legs 7 can then again move towards the internal face 8 of the first guide 2, to allow the sliding of said bottle so as to pass the body 11 of the bottle 3.

Les pattes 7 sont fixées à la face interne 8 du premier guide 2 par l'une de leurs extrémités 12, l'autre extrémité libre 13 des pattes 7 étant dirigée vers l'extrémité fermée du premier guide 2, de façon à bloquer le retrait du flacon 3 hors du premier guide 2, au niveau du col 10 du flacon 3.The legs 7 are fixed to the internal face 8 of the first guide 2 by one of their ends 12, the other free end 13 of the legs 7 being directed towards the closed end of the first guide 2, so as to block the withdrawal of the bottle 3 outside the first guide 2, at the neck 10 of the bottle 3.

Le nombre de pattes 7 peut varier en fonction notamment de la résistance au retrait que l'on souhaite conférer au dispositif de transfert 1 de l'invention.The number of legs 7 may vary depending in particular on the resistance to withdrawal that one wishes to give to the transfer device 1 of the invention.

Selon une forme de réalisation, le dispositif de transfert 1 comprend trois pattes 7 disposées sensiblement au même niveau de la face interne 8 du premier guide 2 et espacées de façon sensiblement régulière entre elles.According to one embodiment, the transfer device 1 comprises three legs 7 arranged substantially at the same level of the internal face 8 of the first guide 2 and spaced substantially evenly therebetween.

Le premier guide 2 est prolongé du côté de l'extrémité fermée 5 par un second guide 14.The first guide 2 is extended on the side of the closed end 5 by a second guide 14.

Selon le mode d'exécution représenté sur la figure 1, le second guide 14 est disposé de façon fixe et coaxiale, par rapport à l'axe longitudinal médian X du dispositif 1, avec le premier guide 2. According to the embodiment shown in Figure 1, the second guide 14 is fixedly and coaxially arranged with respect to the median longitudinal axis X of the device 1, with the first guide 2.

Le second guide 14 est creux et destiné à recevoir l'orifice d'entrée 15 d'une poche de soluté 16.The second guide 14 is hollow and intended to receive the inlet orifice 15 of a solution bag 16.

Dans les modes de réalisation représentés sur les figures, l'orifice d'entrée 15 comprend une douille 28 en élastomère traversable par l'aiguille 17 et autorecelant qui se présente en forme de U et qui est refermée par un opercule 23. Lors de l'introduction de l'aiguille 17 dans l'orifice d'entrée, celle-ci traverse d'abord l'opercule 23 pour se trouver dans le sas 29 formé à l'intérieur du U puis un coulissement supplémentaire amène l'aiguille 17 en contact avec le fond 30 du U de sorte qu'elle puisse le traverser et ainsi mettre en contact l'intérieur de la poche de soluté avec l'extérieur.In the embodiments shown in the figures, the inlet 15 includes an elastomer sleeve 28 passable by the needle 17 and self-concealing which is U-shaped and which is closed by a cover 23. When the needle 17 is introduced into the inlet orifice, the latter passes through first the cover 23 to be in the airlock 29 formed inside the U then additional sliding brings the needle 17 into contact with the bottom 30 of the U so that it can pass through it and thus bring the interior of the solution bag with the outside.

En variante, le second guide comprend des moyens empêchant le retrait total de l'orifice d'entrée 15 hors du second guide 14 après son introduction dans celui-ci.As a variant, the second guide comprises means preventing total withdrawal of the inlet 15 outside the second guide 14 after its introduction into this one.

Selon une forme d'exécution représentée sur les figures, les moyens empêchant le retrait total ont une structure identique à celle des moyens empêchant le retrait du flacon 3 et comprennent donc deux pattes 25 élastiques disposées sur la face interne de la paroi longitudinale du second guide 14.According to an embodiment shown in the figures, the means preventing the total withdrawal have a structure identical to that of the means preventing the withdrawal of the bottle 3 and therefore comprise two elastic tabs 25 arranged on the internal face of the longitudinal wall of the second guide 14.

Lors de l'introduction de l'orifice d'entrée 15, les pattes 25 s'écartent vers la face interne du second guide 14 sous l'action exercée. Le blocage du retrait de l'orifice d'entrée 15 est alors réalisé entre l'extrémité libre 26 des pattes 25 et un méplat circulaire 27 réalisé sur ledit orifice. L'ensemble formé par la poche de soluté 16 et le dispositif 1 se trouve alors dans une première position (voir figure 2) dans laquelle bien qu'associés l'un à l'autre, l'aiguille 17 n'a pas traversé l'opercule 23. Sous l'action d'une force supplémentaire, l'orifice d'entrée 15 peut alors coulisser de sorte que l'aiguille se trouve dans le sas 29 (deuxième position représentée notamment sur la figure 1) puis traverse le fond 30 pour mettre en contact l'intérieur de la poche de soluté 16 avec l'intérieur du flacon 3 (troisième position représentée notamment sur la figure 6). During the introduction of the inlet orifice 15, the tabs 25 deviate towards the face internal of the second guide 14 under the action exerted. Blocking the withdrawal of the inlet 15 is then made between the free end 26 of the legs 25 and a circular flat 27 made on said orifice. The assembly formed by the pocket of solute 16 and the device 1 is then in a first position (see figure 2) in which although associated with one another, the needle 17 has not passed through the cover 23. Under the action of an additional force, the inlet 15 can then slide so that the needle is in the airlock 29 (second position shown in particular in Figure 1) then crosses the bottom 30 to put the inside of the solution bag 16 in contact with the inside of the bottle 3 (third position shown in particular in Figure 6).

Le second guide 14 comprend une aiguille creuse 17, sensiblement parallèle à l'axe longitudinal médian X.The second guide 14 comprises a hollow needle 17, substantially parallel to the median longitudinal axis X.

L'aiguille 17 est munie de deux extrémités formant des pointes biseautées 18, destinées à percer l'orifice d'entrée 15 de la poche de soluté 16 d'une part et le bouchon du flacon 3 d'autre part.The needle 17 is provided with two ends forming bevelled points 18, intended to pierce the inlet orifice 15 of the solute bag 16 on the one hand and the bottle cap 3 on the other hand.

L'aiguille 17 est maintenue en place au niveau de l'extrémité fermée 5 du premier guide 2, les deux pointes 18 de l'aiguille 17 débouchant pour l'une dans le premier guide 2 et pour l'autre dans le second guide 14.The needle 17 is held in place at the closed end 5 of the first guide 2, the two points 18 of the needle 17 opening for one in the first guide 2 and for the other in the second guide 14.

On peut prévoir une région 19 formant socle du côté de l'extrémité fermée 5 du premier guide 2 (ou, alternativement, du côté du second guide 14) pour renforcer la rigidité de l'aiguille 17.One can provide a region 19 forming a base on the side of the closed end 5 of the first guide 2 (or, alternatively, on the side of the second guide 14) for strengthen the rigidity of the needle 17.

En particulier, la région formant socle 19 permet d'éviter que l'aiguille 17 ne se torde lors du percement du bouchon du flacon 3 ou de l'orifice d'entrée 15 de la poche de soluté 16.In particular, the base region 19 makes it possible to prevent the needle 17 from becoming twists when piercing the bottle cap 3 or the inlet orifice 15 of the solution bag 16.

Le dispositif de transfert 1 peut être réalisé en une matière plastique injectable.The transfer device 1 can be made of an injectable plastic.

La matière plastique utilisée doit de plus pouvoir supporter les conditions de stérilisation.The plastic used must also be able to withstand the conditions of sterilization.

Par exemple, le dispositif de transfert peut être réalisé en un polymère à base de polyéthylène, polycarbonate, polypropylène, polystyrène, ainsi que les dérivés et/ou mélanges de ces produits.For example, the transfer device can be made of a polymer based polyethylene, polycarbonate, polypropylene, polystyrene, as well as derivatives and / or mixtures of these products.

Le dispositif de transfert représenté sur la figure 1 est fabriqué par injection, à partir des matières premières indiquées ci-dessus, les premier et second guides étant formés en une seule pièce et l'aiguille sur-moulée. The transfer device shown in Figure 1 is manufactured by injection, starting from the raw materials indicated above, the first and second guides being formed in one piece and the needle molded.

Un autre mode de réalisation du dispositif de transfert 1 est représenté sur la figure 2.Another embodiment of the transfer device 1 is shown in the figure 2.

Sur la figure 2, les mêmes références numériques correspondent aux mêmes éléments que ceux décrits en relation avec la figure 1 et ne seront donc pas repris en détail dans ce qui suit.In FIG. 2, the same reference numbers correspond to the same elements as those described in relation to Figure 1 and therefore will not detailed in the following.

En se référant maintenant au mode de réalisation représenté sur la figure 2, le dispositif de transfert 1 comprend un premier guide 2 et un second guide 14 dans lesquels débouchent les pointes 18 d'une aiguille 17.Referring now to the embodiment shown in Figure 2, the transfer device 1 comprises a first guide 2 and a second guide 14 into which open the points 18 of a needle 17.

Selon ce mode d'exécution, le second guide 14 est monté coulissant sur le premier guide 2.According to this embodiment, the second guide 14 is slidably mounted on the first guide 2.

Ceci pour faciliter le montage et le transfert d'un médicament contenu dans un flacon.This is to facilitate the assembly and transfer of a drug contained in a bottle.

Pour ce faire, le second guide 14 comprend une région de plus faible diamètre externe 20, localisée à l'extrémité du second guide 14 située du côté du premier guide 2.To do this, the second guide 14 comprises a region of smaller diameter external 20, located at the end of the second guide 14 located on the side of the first guide 2.

Cette région de plus faible diamètre externe 20 est montée coulissante dans une ouverture correspondante ménagée sur l'extrémité fermée 5 du premier guide 2.This region of smaller external diameter 20 is slidably mounted in a corresponding opening made on the closed end 5 of the first guide 2.

Un coulissement plus ou moins aisé du second guide 14 peut être obtenu en fonction du choix des matériaux plastiques utilisés pour les premier et second guides et du diamètre externe de la région 20 par rapport à l'ouverture ménagée sur l'extrémité fermée 5 du premier guide 2.A more or less easy sliding of the second guide 14 can be obtained by depending on the choice of plastic materials used for the first and second guides and the external diameter of region 20 relative to the opening made on the closed end 5 of the first guide 2.

Le coulissement peut encore être facilité par le dépôt d'une matière siliconée sur la région de plus faible diamètre externe 20. Sliding can be further facilitated by depositing a silicone material on the region with the smallest external diameter 20.

Le coulissement du second guide 14 est limité dans un sens par une lèvre annulaire 21 formant une surface d'appui contre l'extrémité fermée 5 du premier guide 2, à l'intérieur du premier guide 2.The sliding of the second guide 14 is limited in one direction by a lip annular 21 forming a bearing surface against the closed end 5 of the first guide 2, inside the first guide 2.

Le coulissement du second guide 14 est limité dans l'autre sens par le retour du second guide 14 à son diamètre normal, au niveau de la région 22.The sliding of the second guide 14 is limited in the other direction by the return of the second guide 14 at its normal diameter, at region 22.

Le mode de réalisation du dispositif de transfert 1 selon l'invention tel qu'illustré sur la figure 2 implique la fabrication séparée de deux pièces correspondantes au premier et second guides.The embodiment of the transfer device 1 according to the invention as illustrated in Figure 2 involves the separate manufacture of two corresponding parts to the first and second guides.

Les figures 3, 4, 5 et 6 illustrent le fonctionnement du dispositif de transfert selon l'invention.Figures 3, 4, 5 and 6 illustrate the operation of the transfer device according to the invention.

Sur les figures 3 à 6, les mêmes références numériques désignent les mêmes éléments que sur les figures 1 et 2.In FIGS. 3 to 6, the same reference numerals designate the same elements as in Figures 1 and 2.

En se référant maintenant à ces figures, un dispositif de transfert 1 selon l'invention est monté, par l'intermédiaire du second guide 14, sur l'orifice d'entrée 15 d'une poche de soluté 16 de sorte à rendre solidaire le dispositif 1 et la poche de soluté 16.Referring now to these figures, a transfer device 1 according to the invention is mounted, via the second guide 14, on the orifice inlet 15 of a solute bag 16 so as to make the device 1 integral and the solute bag 16.

Sous l'action sur force supplémentaire exercée suivant la direction X, la pointe 18 de l'aiguille 17 située du côté du second guide 14 perce l'opercule 23 fermant l'orifice d'entrée 15 de la poche 16 de sorte que la pointe 18 soit disposée dans le sas 29 (figure 3).Under the action on additional force exerted in direction X, the point 18 of needle 17 located on the side of the second guide 14 pierces the seal 23 closing the inlet 15 of the pocket 16 so that the tip 18 is disposed in the airlock 29 (figure 3).

L'autre pointe 18 de l'aiguille 17 située du côté du premier guide 2 est protégée par une enveloppe souple autorescellante 24, par exemple en latex, dans le but de garantir la stérilité du dispositif de transfert 1.The other point 18 of the needle 17 located on the side of the first guide 2 is protected by a flexible self-sealing envelope 24, for example made of latex, for the purpose to guarantee the sterility of the transfer device 1.

Une telle enveloppe 24 peut également être prévue du côté de la pointe 18 de l'aiguille 17 située du côté du second guide 14. Such an envelope 24 can also be provided on the side of the point 18 of the needle 17 located on the side of the second guide 14.

Après mise en place du dispositif de transfert 1 sur la poche de soluté 16, un flacon 3 contenant par exemple un médicament est introduit dans le premier guide 2 (figures 4 et 5).After installation of the transfer device 1 on the solute bag 16, a bottle 3 containing for example a drug is introduced into the first guide 2 (figures 4 and 5).

Sous l'action d'un effort exercé sur le flacon 3 suivant la direction X, les pattes élastiques 7 s'écartent contre la face interne 8 du premier guide 2 pour permettre le passage du goulot 9 du flacon 3, puis reviennent à leur position initiale lors du passage du col 9 du flacon 3 (figure 4).Under the action of a force exerted on the bottle 3 in the direction X, the legs elastics 7 move apart against the internal face 8 of the first guide 2 to allow the passage of the neck 9 of the bottle 3, then return to their position initial when passing the neck 9 of the bottle 3 (Figure 4).

Dans cette configuration, le flacon 3 est associé à la poche de soluté 16 par l'intermédiaire du dispositif 1 de transfert pour former un ensemble unitaire dans lequel l'intérieur du flacon 3 et l'intérieur de la poche 16 ne sont pas en communication. En particulier, la poche de soluté 16, le dispositif 1 et le flacon 3 sont associés l'un à l'autre de façon irréversible.In this configuration, the bottle 3 is associated with the solute bag 16 by via the transfer device 1 to form a unitary assembly in which the interior of the bottle 3 and the interior of the pocket 16 are not communication. In particular, the solute bag 16, the device 1 and the bottle 3 are irreversibly associated with each other.

Par ensemble unitaire, on entend notamment qu'il peut être stocké, vendu, manipulé et utilisé ensemble.The term “unitary assembly” is understood to mean in particular that it can be stored, sold, handled and used together.

Sous l'action d'un deuxième effort exercé sur le flacon 3 suivant la direction X, les pattes 7 peuvent s'écartent de nouveau pour permettre le coulissement du flacon 3 et donc le passage du corps 11 du flacon 3 (figure 5).Under the action of a second force exerted on the bottle 3 in the direction X, the tabs 7 can move apart again to allow the sliding of the bottle 3 and therefore the passage of the body 11 of the bottle 3 (Figure 5).

Le bouchon du flacon 3 arrive alors au contact de la pointe 18 de l'aiguille 17 protégée par l'enveloppe 24.The stopper of the bottle 3 then comes into contact with the point 18 of the needle 17 protected by the casing 24.

L'opérateur peut alors exercer un effort sur la poche de soluté 16 et sur le flacon 3 de sorte à provoquer simultanément d'une part un coulissement supplémentaire du flacon 3 qui conduit au perçage du bouchon et de l'enveloppe 24 par l'aiguille 17 et d'autre part un coulissement supplémentaire de l'orifice d'entrée 15 qui conduit au perçage du fond 30 par l'autre extrémité 18 de l'aiguille 17. Cette action met en communication l'intérieur du flacon 3 avec l'intérieur de la poche de soluté 16, par l'intermédiaire de l'aiguille creuse 17 (figure 6).The operator can then exert a force on the solute bag 16 and on the bottle 3 so as to simultaneously cause on the one hand a sliding additional bottle 3 which leads to piercing the cap and the casing 24 by the needle 17 and on the other hand an additional sliding of the inlet orifice 15 which leads to the drilling of the bottom 30 by the other end 18 of needle 17. This action connects the interior of the bottle 3 with the interior of the solute bag 16, via the hollow needle 17 (Figure 6).

La poche de soluté 16 est positionnée avec l'orifice d'entrée 15 dirigé vers le bas afin d'introduire, en exerçant une pression manuelle sur la poche de soluté 16, une petite quantité de soluté à l'intérieur du flacon 3 pour dissoudre le médicament qu'il contient. Après dissolution, l'ensemble poche de soluté 16 et flacon 3 est retourné afin de transférer le contenu du flacon 3 dans la poche de soluté 16, l'air stérile de la poche de soluté 16 remplaçant le liquide contenu dans le flacon 3.The solute bag 16 is positioned with the inlet port 15 facing the down to introduce, by exerting manual pressure on the solution bag 16, a small amount of solute inside the bottle 3 to dissolve the medicine it contains. After dissolution, the whole solution bag 16 and bottle 3 is inverted in order to transfer the contents of bottle 3 to the solution 16, the sterile air in the solution bag 16 replacing the contained liquid in bottle 3.

Une fois le transfert achevé, le flacon 3 reste sur le dispositif 1 selon l'invention, son retrait étant empêché par les pattes 7 qui bloquent le passage du goulot 9 hors du premier guide 2.Once the transfer is complete, the bottle 3 remains on the device 1 according to the invention, its withdrawal being prevented by the tabs 7 which block the passage of the neck 9 outside the first guide 2.

Claims (24)

Dispositif (1) de transfert, dans une poche de soluté (16), d'une substance, par exemple médicamenteuse, contenue dans un récipient, tel qu'un flacon (3), comprenant : un premier guide (2), de forme générale sensiblement cylindrique, ouvert à l'une de ses extrémités (6) et fermé à son autre extrémité (5) opposée à l'extrémité ouverte (6), ledit premier guide (2) comprenant des moyens aptes à empêcher le retrait total du flacon (3) hors du premier guide (2) après son introduction dans celui-ci; un second guide (14), de forme générale sensiblement cylindrique, prolongeant le premier guide (2) du côté de l'extrémité fermée (5) de celui-ci et monté de façon coaxiale avec le premier guide (2), l'extrémité du second guide (14) opposée au premier guide (2) étant ouverte et apte à recevoir l'orifice d'entrée (15) de la poche de soluté (16); un moyen de perçage des moyens de fermeture du flacon (3) et de la poche de soluté (16) respectivement, et de transfert de la substance contenue dans le flacon (3) dans la poche de soluté (16), les moyens de perçage étant disposés de façon coaxiale avec les premier (2) et second (14) guides ; caractérisé en ce que le premier guide (2) est apte à recevoir non seulement le col (10) mais également la partie supérieure du corps (11) du flacon (3), et en ce que les moyens aptes à empêcher le retrait total du flacon (3) sont agencés de sorte à permettre le coulissement au moins partiel dudit flacon (3) dans le premier guide (2).Device (1) for transferring a substance, for example a medicinal substance, contained in a container, such as a bottle (3), into a solute bag (16), comprising: a first guide (2), of generally substantially cylindrical shape, open at one of its ends (6) and closed at its other end (5) opposite the open end (6), said first guide (2) comprising means capable of preventing the total withdrawal of the bottle (3) from the first guide (2) after its introduction therein; a second guide (14), of generally substantially cylindrical shape, extending the first guide (2) on the side of the closed end (5) thereof and mounted coaxially with the first guide (2), the end the second guide (14) opposite the first guide (2) being open and capable of receiving the inlet orifice (15) of the solute bag (16); means for piercing the means for closing the bottle (3) and the solute bag (16) respectively, and for transferring the substance contained in the bottle (3) into the solute bag (16), the piercing means being arranged coaxially with the first (2) and second (14) guides; characterized in that the first guide (2) is capable of receiving not only the neck (10) but also the upper part of the body (11) of the bottle (3), and in that the means capable of preventing the total withdrawal of the bottle (3) are arranged so as to allow at least partial sliding of said bottle (3) in the first guide (2). Dispositif selon la revendication 1, caractérisé en ce que les moyens empêchant le retrait du flacon (3) comprennent au moins une patte élastique (7) ménagée sur la face interne (8) du premier guide (2), par exemple au niveau de l'extrémité ouverte (6) du premier guide (2), la patte (7) faisant saillie vers l'intérieur du premier guide (2) par l'une de ses extrémités (13) en étant dirigée vers l'extrémité fermée (5) du premier guide (2). Device according to claim 1, characterized in that the means preventing the withdrawal of the bottle (3) comprise at least one elastic tab (7) formed on the internal face (8) of the first guide (2), for example at the open end (6) of the first guide (2), the tab (7) projecting towards the inside of the first guide (2) by one of its ends (13) being directed towards the closed end (5) of the first guide (2). Dispositif selon la revendication 2, caractérisé en ce que les pattes (7) sont fixées à la face interne (8) du premier guide (2) par l'une de leurs extrémités (12), l'autre extrémité (13) des pattes (7) étant dirigée vers l'extrémité fermée (5) du premier guide (2).Device according to claim 2, characterized in that the tabs (7) are fixed to the internal face (8) of the first guide (2) by one of their ends (12), the other end (13) of the tabs (7) being directed towards the closed end (5) of the first guide (2). Dispositif selon la revendication 2 ou 3, caractérisé en ce qu'il comporte trois pattes élastiques (7) disposées de façon sensiblement régulière entre elles et sensiblement au même niveau sur la face interne (8) du premier guide (2).Device according to claim 2 or 3, characterized in that it comprises three elastic tabs (7) arranged in a substantially regular manner between them and substantially at the same level on the internal face (8) of the first guide (2). Dispositif selon la revendication 1, caractérisé en ce que les moyens empêchant le retrait du flacon (3) comprennent au moins une lèvre annulaire élastique disposée sur la face interne (8) du premier guide (2), par exemple au niveau de l'extrémité ouverte (6) du premier guide (2), en faisant saillie vers l'intérieur du premier guide (2), de façon sensiblement perpendiculaire à l'axe longitudinal (X) du premier guide (2).Device according to claim 1, characterized in that the means preventing the withdrawal of the bottle (3) include at least one annular lip elastic disposed on the internal face (8) of the first guide (2), for example at level of the open end (6) of the first guide (2), projecting towards the interior of the first guide (2), substantially perpendicular to the axis longitudinal (X) of the first guide (2). Dispositif selon l'une quelconque des revendications 1 à 5, caractérisé en ce que le second guide (14) est fixé rigidement sur le premier guide (2).Device according to any one of Claims 1 to 5, characterized in that that the second guide (14) is rigidly fixed on the first guide (2). Dispositif selon l'une quelconque des revendications 1 à 5, caractérisé en ce que le second guide (14) est monté de façon coulissante sur le premier guide (2).Device according to any one of Claims 1 to 5, characterized in that that the second guide (14) is slidably mounted on the first guide (2). Dispositif selon la revendication 7, caractérisé en ce que le second guide (14) comprend une région de plus petit diamètre externe (20), située vers l'extrémité du second guide (14) opposée à l'extrémité ouverte du second guide (14) et destinée à venir coulisser dans une ouverture de diamètre correspondant ménagée dans l'extrémité fermée (5) du premier guide (2).Device according to claim 7, characterized in that the second guide (14) includes a region of smaller external diameter (20), located towards the end of the second guide (14) opposite the open end of the second guide (14) and intended to slide in an opening of corresponding diameter formed in the closed end (5) of the first guide (2). Dispositif selon la revendication 8, caractérisé en ce que la partie terminale de la région de plus petit diamètre (20) située du côté du premier guide (2) est munie d'une lèvre annulaire (21) formant une surface d'appui contre l'extrémité fermée (5) du premier guide (2), à l'intérieur de celui-ci, de façon à bloquer le coulissement du second guide (14) dans le premier guide (2).Device according to claim 8, characterized in that the end part of the region of smaller diameter (20) located on the side of the first guide (2) is provided with an annular lip (21) forming a bearing surface against the end closed (5) of the first guide (2), inside thereof, so as to block the sliding of the second guide (14) in the first guide (2). Dispositif selon la revendication 8 ou 9, caractérisé en ce que la région de plus petit diamètre (20) est revêtue d'une matière siliconée.Device according to claim 8 or 9, characterized in that the region of smaller diameter (20) is coated with a silicone material. Dispositif selon l'une quelconque des revendications 1 à 10, caractérisé en ce que les moyens de perçage des moyens de fermeture du flacon (3) et de l'orifice d'entrée (15) de la poche (16) comprennent une aiguille (17) creuse sur toute sa longueur, coaxiale avec les premier (2) et second (14) guides, les deux extrémités de l'aiguille (17) étant en forme de pointes (18) biseautées, en débouchant pour l'une dans le premier guide (2) et pour l'autre dans le second guide (14).Device according to any one of Claims 1 to 10, characterized in what the means for piercing the means for closing the bottle (3) and for the inlet orifice (15) of the pocket (16) include a needle (17) hollow on its entire length, coaxial with the first (2) and second (14) guides, both the ends of the needle (17) being in the form of bevelled points (18), opening for one in the first guide (2) and for the other in the second guide (14). Dispositif selon la revendication 11, caractérisé en ce que l'aiguille (17) est maintenue en place au niveau de l'extrémité fermée (5) du premier guide (2).Device according to claim 11, characterized in that the needle (17) is held in place at the closed end (5) of the first guide (2). Dispositif selon la revendication 12, caractérisé en ce qu'il comprend une région formant socle (19) du côté de l'extrémité fermée (5) du premier guide (2) ou, alternativement, du côté du second guide (14), pour renforcer la rigidité de l'aiguille (17).Device according to claim 12, characterized in that it comprises a base region (19) on the side of the closed end (5) of the first guide (2) or, alternatively, on the side of the second guide (14), to reinforce the rigidity of the needle (17). Dispositif selon la revendication 11, caractérisé en ce que l'aiguille (17) est maintenue en place au niveau de la région de plus faible diamètre (20) du second guide (14).Device according to claim 11, characterized in that the needle (17) is held in place at the region of smaller diameter (20) of the second guide (14). Dispositif selon l'une quelconque des revendications 11 à 14, caractérisé en ce que la pointe (18) de l'aiguille (17) débouchant dans le premier guide (2) est protégée par une enveloppe souple (24), par exemple en latex.Device according to any one of Claims 11 to 14, characterized in that the point (18) of the needle (17) opening into the first guide (2) is protected by a flexible envelope (24), for example made of latex. Dispositif selon l'une quelconque des revendications 11 à 15, caractérisé en ce que la pointe (18) de l'aiguille (17) débouchant dans le second guide (14) est protégée par une enveloppe souple auto rescellante (24), par exemple en latex. Device according to any one of claims 11 to 15, characterized in that the point (18) of the needle (17) opening into the second guide (14) is protected by a flexible self-resealing envelope (24), for example made of latex. Dispositif selon l'une quelconque des revendications 1 à 16, caractérisé en ce qu'il est indépendant de la poche de soluté (16) et du flacon (3).Device according to any one of claims 1 to 16, characterized in which is independent of the solute bag (16) and the bottle (3). Dispositif selon la revendication 17, caractérisé en ce que le second guide (14) comprend des moyens aptes à empêcher le retrait total de l'orifice d'entrée (15) de la poche de soluté (16) hors du second guide (14) après son introduction dans celui-ci.Device according to claim 17, characterized in that the second guide (14) includes means capable of preventing total withdrawal of the inlet orifice (15) of the solute bag (16) out of the second guide (14) after its introduction In this one. Dispositif selon la revendication 18, caractérisé en ce que les moyens empêchant le retrait de l'orifice d'entrée (15) ont une structure identique à celle des moyens empêchant le retrait du flacon (3) du premier guide (2) et sont agencés de sorte à permettre le coulissement au moins partiel dudit orifice d'entrée (15) dans le second guide (14).Device according to claim 18, characterized in that the means preventing the withdrawal of the inlet orifice (15) have a structure identical to that means preventing the withdrawal of the bottle (3) from the first guide (2) and are arranged to allow at least partial sliding of said orifice entry (15) in the second guide (14). Dispositif selon l'une quelconque des revendications 1 à 16, caractérisé en ce qu'il est intégré de façon permanente et non détachable à la poche de soluté (16).Device according to any one of claims 1 to 16, characterized in that it is permanently integrated and not detachable in the solution bag (16). Dispositif selon la revendication 20, caractérisé en ce qu'il est monté de façon fixe sur l'orifice d'entrée (15) de la poche de soluté (16), au niveau de l'extrémité ouverte du second guide (14).Device according to claim 20, characterized in that it is mounted fixedly on the inlet (15) of the solute bag (16), at the open end of the second guide (14). Dispositif selon la revendication 20 ou 21, caractérisé en ce qu'il est protégé de plus par un opercule reposant sur les parois longitudinales (4) du premier guide (2).Device according to claim 20 or 21, characterized in that it is protected in addition by a cover resting on the longitudinal walls (4) of the first guide (2). Dispositif selon l'une quelconque des revendications 1 à 22, caractérisé en ce qu'il est réalisé en une matière plastique injectable et stérilisable.Device according to any one of claims 1 to 22, characterized in what it is made of injectable and sterilizable plastic. Dispositif selon la revendication 23, caractérisé en ce qu'il est réalisé à partir d'un polymère à base de polyéthylène, polycarbonate, polypropylène, polystyrène ainsi que les dérivés et/ou mélanges de ces produits.Device according to claim 23, characterized in that it is produced from of a polymer based on polyethylene, polycarbonate, polypropylene, polystyrene as well as the derivatives and / or mixtures of these products.
EP20000400612 1999-03-10 2000-03-07 Device for transfering a substance contained in a vial to a pouch containing a solute Expired - Lifetime EP1034772B1 (en)

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FR9902963A FR2790749B1 (en) 1999-03-10 1999-03-10 DEVICE FOR TRANSFERRING A SUBSTANCE CONTAINED IN A BOTTLE INTO A POUCH OF SOLUTE
FR9902963 1999-03-10

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EP1917988A1 (en) 2006-10-31 2008-05-07 Maco Pharma Container equipped with an aseptic transfer system
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EP1797857A1 (en) * 2002-02-08 2007-06-20 Cardinal Health 303, Inc. Vial adapter having a needle-free valve for use with vial closures of different sizes
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AU2003217342B8 (en) * 2002-02-08 2009-07-23 Carefusion 303, Inc. Vial Adapter for Use with Vial Closures of Different Sizes
EP2255773A1 (en) * 2002-02-08 2010-12-01 CareFusion 303, Inc. Vial adapter having a needle-free valve for use with vial closures of different sizes having a set of rigid claws
WO2003066152A3 (en) * 2002-02-08 2004-03-18 Alaris Medical Syst Inc Vial adapter having a needle-free valve for use with vial closures of different sizes
FR2863161A1 (en) * 2003-12-05 2005-06-10 Map France Safety cap for one tip of double-ended hollow needle used to transfer medical fluid from flask has closed end that is easily perforated by pressure on flask cap or adjoining component
WO2005055917A1 (en) * 2003-12-05 2005-06-23 M.A.P. France Cap for safely packaging a medical bottle
EP1917988A1 (en) 2006-10-31 2008-05-07 Maco Pharma Container equipped with an aseptic transfer system
US7621298B2 (en) 2006-10-31 2009-11-24 Maco Pharma, S.A. Recipient equipped with an aseptic transfer system
JP2013523292A (en) * 2010-04-09 2013-06-17 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Coded connecting element with bendable locking element for drug reservoir
US9844630B2 (en) 2010-04-09 2017-12-19 Sanofi-Aventis Deutschland Gmbh Coded drug reservoir connection element with hinged flange
CN102917740A (en) * 2010-04-09 2013-02-06 赛诺菲-安万特德国有限公司 Coded drug reservoir connection element with hinged flange
JP2013523293A (en) * 2010-04-09 2013-06-17 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Encoded drug reservoir connection element with hinged flange
WO2011124632A1 (en) * 2010-04-09 2011-10-13 Sanofi-Aventis Deutschland Gmbh Coded drug reservoir connection element with hinged flange
US20130253432A1 (en) * 2010-04-09 2013-09-26 Sanofi-Aventis Deutschland Gmbh Coded drug reservoir connection element with hinged flange
US9061110B2 (en) 2010-04-09 2015-06-23 Sanofi-Aventis Deutschland Gmbh Coded drug reservoir connection element with bendable locking elements
WO2011124631A1 (en) * 2010-04-09 2011-10-13 Sanofi-Aventis Deutschland Gmbh Coded drug reservoir connection element with bendable locking elements
CN102917740B (en) * 2010-04-09 2017-02-08 赛诺菲-安万特德国有限公司 Coded drug reservoir connection element with hinged flange
US9549873B2 (en) 2012-02-02 2017-01-24 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US9668939B2 (en) 2012-02-02 2017-06-06 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling with a medical container
US9180070B2 (en) 2012-02-02 2015-11-10 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US10532005B2 (en) 2012-02-02 2020-01-14 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US10751252B2 (en) 2012-02-02 2020-08-25 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling with a medical container
US10966903B2 (en) 2012-02-02 2021-04-06 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US9713574B2 (en) 2012-08-03 2017-07-25 Becton Dickinson France Dose counting device for coupling with a medical container
US10195112B2 (en) 2012-11-26 2019-02-05 Becton Dickinson France Adaptor for multidose medical container
CN111474375A (en) * 2013-07-26 2020-07-31 积水医疗株式会社 Reagent supply device
USD747650S1 (en) 2013-08-05 2016-01-19 Becton Dickinson France Blocking closure for container
WO2024039713A1 (en) * 2022-08-16 2024-02-22 Oyster Point Pharma, Inc. Drug transfer system configured for aseptic transfer of liquid product

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Publication number Publication date
EP1034772B1 (en) 2007-01-24
FR2790749B1 (en) 2001-05-18
FR2790749A1 (en) 2000-09-15
ATE352274T1 (en) 2007-02-15
DE60033074D1 (en) 2007-03-15

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