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EP1435893B1 - Safety packaging for a bottle for medical use - Google Patents

Safety packaging for a bottle for medical use Download PDF

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Publication number
EP1435893B1
EP1435893B1 EP20020796303 EP02796303A EP1435893B1 EP 1435893 B1 EP1435893 B1 EP 1435893B1 EP 20020796303 EP20020796303 EP 20020796303 EP 02796303 A EP02796303 A EP 02796303A EP 1435893 B1 EP1435893 B1 EP 1435893B1
Authority
EP
European Patent Office
Prior art keywords
bottle
packaging device
tube
storage position
partition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP20020796303
Other languages
German (de)
French (fr)
Other versions
EP1435893A1 (en
Inventor
Farid Hamedi-Sangsari
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.)
MAPTECH
Original Assignee
MAPTECH
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 MAPTECH filed Critical MAPTECH
Publication of EP1435893A1 publication Critical patent/EP1435893A1/en
Application granted granted Critical
Publication of EP1435893B1 publication Critical patent/EP1435893B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/2065—Connecting means having aligning and guiding means

Definitions

  • the subject of the present invention is a safety packaging device for a bottle for medical use, in particular for a bottle containing substances that are potentially dangerous for users or the environment (anticancer drugs, antibiotics, etc.).
  • These medicinal substances are generally packaged in glass vials capped by a pierceable elastomeric stopper, itself fixed inviolably on the vial by crimping an aluminum cap.
  • These drugs can be in the form of a liquid, a powder or a lyophilisate. They are intended to be transferred to an infusion bag containing an infusion fluid (NaCl, glucose, etc.) and then injected to the patient. Drugs stored in the vial as a liquid can be directly transferred to the infusion bag, those in the form of a powder or lyophilizate must first be reconstituted by dissolution in a solvent.
  • the object of the present invention is therefore to provide a device offering the best guarantees of safety with regard to both the risk of breakage of the bottle, the risk of accidental puncture and the risk of leakage.
  • the patent FR1380706 describes a device for transferring a container into another consisting of a plate traversed by two hollow needles pointed at both ends.
  • the patent FR1545963 discloses a transfer device constituted by a hollow cylinder provided with a stop diaphragm traversed by a perforated needle having two tips.
  • the patent FR2302134 discloses a device for transferring the liquid contents of a container through the stopper or lid of motivation-ci into a second container comprising a tubular body covering the necks of the two containers, a hollow needle having two pointed ends of a length sufficient to cross the caps or lids of the containers and another hollow needle, one end of which passes through the plug or cap of one of the containers and the other end remains in communication with the atmosphere.
  • Licences EP0192661 and EP0195018 describe devices for reconstituting drugs for connecting a powder vial and an infusion bag with a bi-tip needle and including means to prevent accidental separation of the elements.
  • the FR2780878 discloses a transfer cap for the passage of a medicament between a vial and a solute bag comprising a tubular monoblock body and a needle, characterized by particular detent means.
  • connection devices between a closed container and a container in particular form of ready-to-use assemblies.
  • a device for the preparation of a liquid drug solution reconstituted from two components comprising at least one element carrying a cannula for communicating the two containers when they are arranged head to tail and a conduit arranged to open through a first port in the container containing the active substance and to terminate, through a second port, to a transfer tip of the reconstituted liquid drug substance.
  • the present invention is defined in claim 1 and provides a cheap transfer device, easy to manufacture and meeting both the objectives of personnel safety and protection against breakage.
  • the device may be a one-piece cylindrical plastic body consisting of two parts: a lower part intended to completely cover the glass bottle and possibly comprising at its base means of stabilization of the device in vertical position and a lower part of smaller diameter constituted by a cylindrical chamber containing means, for example a bi-tip needle, for transferring the contents of the vial into a container, such as an infusion bag.
  • FIG. 1 represents a standard glass bottle (1) closed by an elastomer stopper (2) fixed on the bottle by an aluminum capsule (3).
  • the vial contains a drug in the form of a powder or lyophilizate (4). But it can be a sterile liquid.
  • Figure 2 shows a standard infusion bag (6) provided with an injection site (5) for transferring the drug.
  • FIG. 3 represents a device constituted by a tubular monobloc body comprising a partition (12), perpendicular to the axis of the tubular body, which delimits two open chambers (A) and (B).
  • the partition (12) which constitutes the base of the chamber (A) is provided with means for holding in place a two-point needle (10, 11).
  • the height of the cylindrical chamber (A) is chosen so as to completely protect the tip (10) of the needle.
  • the inside diameter of the chamber (A) is less than that of the chamber (B) but sufficient to accept the passage of the injection sites (5) equipping the infusion bags.
  • the two-point needle (10, 11) can be held in the partition (12) by any appropriate means, such as gluing, welding, overmolding.
  • the chamber (B) in which opens the other end (11) of the bi-tip needle is constituted by a tube (13).
  • This chamber (B) is intended to cover the bottle (1).
  • the diameter of the tube (13) is therefore chosen so as to insert the bottle (1) into the tube.
  • the diameter of the tube (13) is slightly greater than the diameter of the body of the bottle (1).
  • the tube (13) is narrowed at its upper end forming a tube (13a) of smaller diameter than that of the tube (13), the diameter of the tube (13a) being slightly greater than the diameter of the lid (3). ) of the bottle.
  • the diameters are chosen so as to allow the insertion of bottles of slightly different dimensions.
  • the height of the tube (13a) is chosen as a function of the height h plug (2) - operculum (3) of the bottle (1).
  • This embodiment comprising a tube (13) and a tube (13a) makes it possible to match the shape of the bottle (1) by improving the connection between the bottle (1) and the tip (11).
  • the wall of the tube (13) covering the bottle may be full or have recesses over part or all of the height.
  • the bottle is held in the storage position by means of retaining means (8) intended to prevent the bottle from leaving the chamber (B) and retaining means (7) intended to prevent drilling. inadvertent plug.
  • the retaining means (8) are sufficiently elastic to allow the force introduction of the bottle into the device.
  • a continuous annular bead can be used.
  • these retaining means are constituted by axial ribs formed inside the tube (13) which provide a frictional force on the body of the bottle.
  • the device can be used for bottles having slightly different diameters.
  • the retaining means (8) can be replaced by a perforable seal by the thumb (film or welded paper) or by a captive plug.
  • the retaining means (7) may be formed by any means capable of providing an elastic stop function, for example a continuous annular bead or no.
  • the tube (13) comprises at its base means for increasing the stability of the device in vertical position.
  • This is for example a flange (9), optionally comprising additional means, for example flats, to prevent the device from rolling when in the horizontal position.
  • the tubular monobloc body is made of a shockproof plastic material, to avoid the risk of breakage, and preferably transparent to allow reading of the information mentioned on the body of the bottle and the monitoring of its contents. Any plastic material having such properties as polypropylene, polycarbonate or K resin may be used.
  • the contents of the bottle (1) are placed in communication with the contents of the infusion bag (6) after perforation of the stopper (2) by the tip (11) and the injection site (5) by the tip (10).
  • the bottle (1) slides in the chamber (B) under the action of a thrust exerted on the bottom (14) of the bottle.
  • the bottle moves until it abuts on the partition (12), which allows the tip (11) to pierce the stopper (2).
  • it is pushed on the bottom (14) of the bottle with the thumb.
  • the retaining means (7) make it possible to keep the bottle in the use position and to avoid the axial displacement of the bottle downwards.
  • the injection site (5) of the infusion bag (6) is pierced in a conventional manner by force introduction of the site in the chamber (A).
  • FIG. 5 represents a particular embodiment of the abutment means (7) preventing the inadvertent piercing of the plug.
  • the elastic retaining means consist of tabs (15, 16) whose free ends are oriented towards the inside of the tube (13a).
  • the thrust exerted on the bottom of the bottle separates the tabs (15, 16) which, after drilling the stopper (2), prevent the bottle from falling back to the bottom of the device.
  • the elastic means (8) may also consist of tongues such as tongues (15, 16).
  • FIG. 6 represents a particular embodiment of the base of the device.
  • the base of the tube (13) has one or more openings (17) to facilitate the thrust on the bottom of the bottle. Systems with a single opening are preferred to avoid the risk of the bottle being pulled out.
  • the figures illustrate an embodiment in which a vial (1) and an infusion bag (6) are placed in communication.
  • the system can be used to port a vial to another type of container.
  • the exemplified embodiments relate to a device with a two-point needle, but a device with a bottle-side needle and a pouch-side luer site can also be used.
  • the device is a one-piece plastic body. It is therefore easy to produce using the conventional processes of the plastics industry.
  • the device is sterilized with ethylene oxide, steam or radiation.
  • the device is placed in advance on the bottle (1).
  • the device / vial assembly is pre-assembled, placed in a blister and sterilized as above.
  • the device may be provided with a removable cap sealingly sealing the chamber A, then after mounting the bottle in the chamber B the bottom of the chamber B may be sealed with a "heat sealable" paper, allowing sterilization from the assembly to ethylene oxide or steam.
  • a "heat sealable” paper allowing sterilization from the assembly to ethylene oxide or steam.
  • the device is placed on the bottle (1) at the time of its use. Just remove the cap (3) and forcefully insert the vial into the tube (13).

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Buffer Packaging (AREA)
  • Closures For Containers (AREA)

Abstract

The invention relates to an economical packaging device that is intended for a bottle for medical use. The inventive packaging device is easy to produce and meets objectives both in terms of safety of personnel and protection against breakage. Said device comprises a one-piece cylindrical plastic body consisting of two parts which are separated by a partition (12), said partition being disposed perpendicularly to the axis of the tubular body. The lower part (B), which is intended to cover the glass bottle (1) completely, may comprise means (9) on the base thereof for stabilising the device in the vertical position. The second upper part is provided with a smaller diameter and consists of a cylindrical chamber (A) containing means, e.g. a double-pointed needle (10, 11), for transferring the contents of the bottle (1) into a container, such as an infusion bag (6).

Description

La présente invention a pour objet un dispositif de conditionnement de sécurité pour flacon à usage médical, notamment pour flacon contenant des substances potentiellement dangereuses pour les utilisateurs ou l'environnement (anticancéreux, antibiotiques, etc.).The subject of the present invention is a safety packaging device for a bottle for medical use, in particular for a bottle containing substances that are potentially dangerous for users or the environment (anticancer drugs, antibiotics, etc.).

Ces substances médicamenteuses sont généralement conditionnées dans des flacons en verre operculés par un bouchon en élastomère perforable, lui-même fixé de manière inviolable sur.le flacon par sertissage d'une capsule en aluminium. Ces médicaments peuvent être sous la forme d'un liquide, d'une poudre ou d'un lyophilisat. Ils sont destinés à être transférés dans une poche de perfusion contenant un liquide de perfusion (NaCl, glucose, etc.) puis à être injectés au patient. Les médicaments stockés dans le flacon sous la forme d'un liquide peuvent être directement transférés dans la poche de perfusion, ceux sous la forme d'une poudre ou d'un lyophilisat doivent au préalable être reconstitués par dissolution dans un solvant.These medicinal substances are generally packaged in glass vials capped by a pierceable elastomeric stopper, itself fixed inviolably on the vial by crimping an aluminum cap. These drugs can be in the form of a liquid, a powder or a lyophilisate. They are intended to be transferred to an infusion bag containing an infusion fluid (NaCl, glucose, etc.) and then injected to the patient. Drugs stored in the vial as a liquid can be directly transferred to the infusion bag, those in the form of a powder or lyophilizate must first be reconstituted by dissolution in a solvent.

Les risques liés à la manipulation quotidienne de ces médicaments en flacon en verre sont de trois ordres pour le personnel soignant:

  • risque de piqûre accidentelle lors des opérations de transfert ou de reconstitution à l'aide d'une seringue munie d'une aiguille non protégée,
  • risque de brisure des flacons en verre lors de leur manipulation ou de leur transport.
  • Risque de fuite du médicament lors de la reconstitution.
The risks associated with the daily handling of these medicines in glass bottles are threefold for the caregiver:
  • risk of accidental puncture during transfer or reconstitution with a syringe equipped with an unprotected needle,
  • risk of breaking glass vials during handling or transport.
  • Risk of drug leakage during reconstitution.

Dans le cas de la brisure accidentelle d'un flacon contenant un anticancéreux, ou de fuite du médicament, la procédure de décontamination mise en place est extrêmement lourde et coûteuse, surtout dans le cas où une femme enceinte a été en contact avec le médicament répandu (répercussions sur la croissance du foetus).In the case of accidental breakage of a vial containing an anticancer drug, or leakage of the drug, the decontamination procedure put in place is extremely cumbersome and expensive, especially in the case where a pregnant woman has been in contact with the drug. widespread drug (impact on fetal growth).

Pour un certain nombre de substances actives, il n'est pas possible d'utiliser des flacons en matière plastique et le risque de brisure du flacon est un problème majeur.For a number of active substances, it is not possible to use plastic bottles and the risk of breakage of the bottle is a major problem.

Le but de la présente invention est donc de fournir un dispositif offrant les meilleures garanties de sécurité en ce qui concerne à la fois le risque de brisure du flacon, le risque de piqûre accidentelle et les risques de fuite.The object of the present invention is therefore to provide a device offering the best guarantees of safety with regard to both the risk of breakage of the bottle, the risk of accidental puncture and the risk of leakage.

On connaît déjà des dispositifs réduisant le risque de piqûre accidentelle.Devices that reduce the risk of accidental puncture are already known.

Le brevet FR1380706 décrit un dispositif de transvasement d'un récipient dans un autre constitué d'une platine traversée par deux aiguilles creuses pointues à leurs deux extrémités.The patent FR1380706 describes a device for transferring a container into another consisting of a plate traversed by two hollow needles pointed at both ends.

Le brevet FR1545963 décrit un dispositif de transvasement constitué par un cylindre creux muni d'un diaphragme d'arrêt traversé par une aiguille perforée comportant deux pointes.The patent FR1545963 discloses a transfer device constituted by a hollow cylinder provided with a stop diaphragm traversed by a perforated needle having two tips.

Le brevet FR2302134 décrit un dispositif pour transférer le contenu liquide d'un récipient à travers le bouchon ou l'opercule de célui-ci dans un second récipient comprenant un corps tubulaire coiffant les cols des deux récipients, une aiguille creuse comportant deux extrémités pointues d'une longueur suffisante pour traverser les bouchons ou opercules des récipients et une autre aiguille creuse dont l'une des extrémités traverse le bouchon ou opercule de l'un des récipients et l'autre extrémité reste en communication avec l'atmosphère.The patent FR2302134 discloses a device for transferring the liquid contents of a container through the stopper or lid of celui-ci into a second container comprising a tubular body covering the necks of the two containers, a hollow needle having two pointed ends of a length sufficient to cross the caps or lids of the containers and another hollow needle, one end of which passes through the plug or cap of one of the containers and the other end remains in communication with the atmosphere.

Les brevets EP0192661 et EP0195018 décrivent des dispositifs pour la reconstitution de médicaments permettant de relier un flacon de poudre et une poche de perfusion à l'aide d'une aiguille bi-pointe et comportant des moyens pour empêcher la séparation accidentelle des éléments.Licences EP0192661 and EP0195018 describe devices for reconstituting drugs for connecting a powder vial and an infusion bag with a bi-tip needle and including means to prevent accidental separation of the elements.

Le brevet FR2780878 décrit un capuchon de transfert pour le passage d'un médicament entre un flacon et une poche à soluté comprenant un corps monobloc tubulaire et une aiguille, caractérisé par des moyens d'encliquetage particuliers.The FR2780878 discloses a transfer cap for the passage of a medicament between a vial and a solute bag comprising a tubular monoblock body and a needle, characterized by particular detent means.

Les documents EP0850178 , EP1006981 , WO0016730 et FR2789369 décrivent des dispositifs de connexion entre un récipient fermé et un contenant sous forme notamment d'ensembles prêts à l'emploi.The documents EP0850178 , EP1006981 , WO0016730 and FR2789369 describe connection devices between a closed container and a container in particular form of ready-to-use assemblies.

Ces différents dispositifs soit sont pré-montés par clipsage sur le goulot du flacon, soit sont livrés séparément, de préférence sous blister stérile, et clipsés sur le flacon par le personnel soignant.These various devices are pre-mounted by clipping on the neck of the bottle, or are delivered separately, preferably in sterile blister, and clipped on the bottle by the caregiver.

On connaît d'après le document WO97/20536-A , état de la technique le plus proche, un dispositif pour la préparation d'une solution médicamenteuse liquide reconstituée à partir de deux composants, comportant au moins un élément portant une canule pour mettre en communication les deux conteneurs lorsqu'ils sont disposés tête-bêche et un conduit agencé pour déboucher par un premier orifice dans le conteneur contenant la substance active et pour aboutir, par un second orifice, à un embout de transfert de la substance médicamenteuse liquide reconstituée.We know from the document WO97 / 20536-A , the closest state of the art, a device for the preparation of a liquid drug solution reconstituted from two components, comprising at least one element carrying a cannula for communicating the two containers when they are arranged head to tail and a conduit arranged to open through a first port in the container containing the active substance and to terminate, through a second port, to a transfer tip of the reconstituted liquid drug substance.

On connaît d'après le document EP-1034772-A un dispositif de transfert d'une substance médicamenteuse contenue dans un flacon vers une poche de soluté comprenant un premier guide cylindrique apte à recevoir le col et la partie supérieure du corps du flacon, ce premier guide comprenant des moyens aptes à empêcher le retrait total du flacon, un second guide cylindrique apte à recevoir l'orifice d'entrée de la poche de soluté et un moyen de perçage des moyens de fermeture du flacon et de la poche de soluté. Cependant, ce dispositif ne protège que la partie supérieure du corps du flacon.We know from the document EP-1034772-A a device for transferring a medicinal substance contained in a bottle to a bag of solute comprising a first cylindrical guide adapted to receive the neck and the upper part of the body of the bottle, this first guide comprising means capable of preventing the total withdrawal of the vial, a second cylindrical guide adapted to receive the inlet of the solute bag and a means for piercing the closure means of the bottle and the solute bag. However, this device only protects the upper part of the body of the bottle.

Les systèmes prêts à l'emploi sont plus simples à manipuler et ils évitent le risque de contamination lors du clipsage sur le flacon ; cependant, ils sont coûteux et ne résolvent pas le problème de brisure des flacons en verre.Ready-to-use systems are easier to handle and avoid the risk of contamination when clipping onto the bottle; however, they are expensive and do not solve the problem of breaking glass vials.

La présente invention est définie dans la revendication 1 et permet d'obtenir un dispositif de tranvasement bon marché, facile à fabriquer et répondant à la fois aux objectifs de sécurité du personnel et protection contre la casse.The present invention is defined in claim 1 and provides a cheap transfer device, easy to manufacture and meeting both the objectives of personnel safety and protection against breakage.

Le dispositif peut être un corps monobloc cylindrique en matière plastique constitué de deux parties : une partie inférieure destinée à recouvrir totalement le flacon en verre et comportant éventuellement à sa base des moyens de stabilisation du dispositif en position verticale et une partie supérieure de plus faible diamètre constituée par une chambre cylindrique contenant des moyens, par exemple une aiguille bi-pointe, permettant le transfert du contenu du flacon dans un contenant, tel qu'une poche de perfusion.The device may be a one-piece cylindrical plastic body consisting of two parts: a lower part intended to completely cover the glass bottle and possibly comprising at its base means of stabilization of the device in vertical position and a lower part of smaller diameter constituted by a cylindrical chamber containing means, for example a bi-tip needle, for transferring the contents of the vial into a container, such as an infusion bag.

Les dessins annexés permettront d'illustrer plus en détail la présente invention.

  • La figure 1 est une vue en coupe d'un flacon standard contenant un médicament en poudre.
  • La figure 2 est une vue d'une poche de perfusion standard remplie de solution injectable.
  • La figure 3 est une vue en coupe axiale du dispositif de conditionnement selon la présente invention avec un flacon en position "stockage".
  • La figure 4 est une vue en coupe axiale du dispositif de conditionnement selon la présente invention avec un flacon en position "utilisation".
  • La figure 5 est une vue partielle en coupe d'un mode de réalisation particulier des moyens de butée empêchant le perçage intempestif du bouchon.
  • La figure 6 est une vue d'un mode de réalisation particulier de l'embase du dispositif.
The accompanying drawings will illustrate the present invention in more detail.
  • Figure 1 is a sectional view of a standard vial containing powdered medicine.
  • Figure 2 is a view of a standard infusion bag filled with injectable solution.
  • Figure 3 is an axial sectional view of the packaging device according to the present invention with a bottle in the "storage" position.
  • Figure 4 is an axial sectional view of the packaging device according to the present invention with a bottle in the "use" position.
  • Figure 5 is a partial sectional view of a particular embodiment of the abutment means preventing the inadvertent drilling of the plug.
  • Figure 6 is a view of a particular embodiment of the base of the device.

La figure 1 représente un flacon standard en verre (1) fermé par un bouchon (2) en élastomère fixé sur le flacon par une capsule (3) en aluminium. Le flacon contient un médicament sous forme d'une poudre ou d'un lyophilisat (4). Mais il peut s'agir d'un liquide stérile.FIG. 1 represents a standard glass bottle (1) closed by an elastomer stopper (2) fixed on the bottle by an aluminum capsule (3). The vial contains a drug in the form of a powder or lyophilizate (4). But it can be a sterile liquid.

La figure 2 représente une poche de perfusion standard (6) pourvue d'un site d'injection (5), destiné au transfert du médicament.Figure 2 shows a standard infusion bag (6) provided with an injection site (5) for transferring the drug.

La figure 3 représente un dispositif constitué par un corps monobloc tubulaire comportant une cloison (12), perpendiculaire à l'axe du corps tubulaire, qui délimite deux chambres (A) et (B) ouvertes.FIG. 3 represents a device constituted by a tubular monobloc body comprising a partition (12), perpendicular to the axis of the tubular body, which delimits two open chambers (A) and (B).

La cloison (12) qui constitue la base de la chambre (A) est munie de moyens pour maintenir en place une aiguille bi-pointe (10, 11). La hauteur de la chambre cylindrique (A) est choisie de manière à protéger complètement la pointe (10) de l'aiguille. Le diamètre intérieur de la chambre (A) est inférieur à celui de la chambre (B) mais suffisant pour accepter le passage des sites d'injection (5) équipant les poches de perfusion.The partition (12) which constitutes the base of the chamber (A) is provided with means for holding in place a two-point needle (10, 11). The height of the cylindrical chamber (A) is chosen so as to completely protect the tip (10) of the needle. The inside diameter of the chamber (A) is less than that of the chamber (B) but sufficient to accept the passage of the injection sites (5) equipping the infusion bags.

L'aiguille bi-pointe (10, 11) peut être maintenue dans la cloison (12) par tout moyen approprié, tel que collage, soudure, surmoulage.The two-point needle (10, 11) can be held in the partition (12) by any appropriate means, such as gluing, welding, overmolding.

La chambre (B) dans laquelle débouche l'autre extrémité (11) de l'aiguille bi-pointe est constituée par un tube (13). Cette chambre (B) est destinée à recouvrir le flacon (1). Le diamètre du tube (13) est donc choisi de manière à pouvoir insérer le flacon (1) dans le tube. Ainsi, le diamètre du tube (13) est légèrement supérieur au diamètre du corps du flacon (1). De préférence, le tube (13) est rétréci à son extrémité supérieure en formant un tube (13a) de diamètre inférieur à celui du tube (13), le diamètre du tube (13a) étant légèrement supérieur au diamètre de l'opercule (3) du flacon. Les diamètres sont choisis de manière à permettre l'insertion de flacons de dimensions légèrement différentes. La hauteur du tube (13a) est choisie en fonction de la hauteur h bouchon (2) - opercule (3) du flacon (1).The chamber (B) in which opens the other end (11) of the bi-tip needle is constituted by a tube (13). This chamber (B) is intended to cover the bottle (1). The diameter of the tube (13) is therefore chosen so as to insert the bottle (1) into the tube. Thus, the diameter of the tube (13) is slightly greater than the diameter of the body of the bottle (1). Preferably, the tube (13) is narrowed at its upper end forming a tube (13a) of smaller diameter than that of the tube (13), the diameter of the tube (13a) being slightly greater than the diameter of the lid (3). ) of the bottle. The diameters are chosen so as to allow the insertion of bottles of slightly different dimensions. The height of the tube (13a) is chosen as a function of the height h plug (2) - operculum (3) of the bottle (1).

Ce mode de réalisation comportant un tube (13) et un tube (13a) permet d'épouser la forme du flacon (1) en améliorant la liaison entre le flacon (1) et la pointe (11).This embodiment comprising a tube (13) and a tube (13a) makes it possible to match the shape of the bottle (1) by improving the connection between the bottle (1) and the tip (11).

Cette meilleure liaison assure un positionnement optimal du dispositif sur le flacon, permettant ainsi à l'aiguille de perforer le bouchon (2) du flacon dans les meilleures conditions, ce qui évite les fuites à ce niveau. Ce problème de fuite est assez fréquent avec les dispositifs vendus séparément. En effet, lorsque l'infirmière connecte l'ensemble poche-dispositif-flacon, elle secoue fortement l'ensemble afin d'accélérer la dissolution du médicament, ainsi si le flacon n'est pas parfaitement solidaire du dispositif il se produit un phénomène de cisaillement qui favorise la survenue de fuite.This better connection ensures optimal positioning of the device on the bottle, thus allowing the needle to perforate the cap (2) of the bottle in the best conditions, which prevents leaks at this level. This leakage problem is quite common with devices sold separately. Indeed, when the nurse connects the bag-device-vial assembly, it shakes strongly all to accelerate the dissolution of the drug, so if the bottle is not perfectly attached to the device there a shear phenomenon occurs which favors the occurrence of leakage.

La paroi du tube (13) recouvrant le flacon peut être pleine ou comporter des évidements sur une partie ou la totalité de la hauteur.The wall of the tube (13) covering the bottle may be full or have recesses over part or all of the height.

Sur la figure 3, le flacon est maintenu en position de stockage à l'aide de moyens de retenue (8) destinés à empêcher le flacon de sortir de la chambre (B) et de moyens de retenue (7) destinés à empêcher le perçage intempestif du bouchon.In FIG. 3, the bottle is held in the storage position by means of retaining means (8) intended to prevent the bottle from leaving the chamber (B) and retaining means (7) intended to prevent drilling. inadvertent plug.

Les moyens de retenue (8) sont suffisamment élastiques pour permettre l'introduction en force du flacon dans le dispositif. On peut utiliser par exemple un bourrelet annulaire continu on non. Dans une variante non exemplifiée, non couverte par les revendications, ces moyens de retenue sont constitués par des nervures axiales ménagées à l'intérieur du tube (13) qui assurent une force de friction sur le corps du flacon. De plus, en jouant sur l'épaisseur de ces nervures le dispositif peut être utilisé pour des flacons ayant des diamètres légèrement différents. En variante, non couverte par les revendications, les moyens de retenue (8) peuvent être remplacés par un opercule perforable par le pouce (film ou papier soudé) ou par un bouchon prisonnier.The retaining means (8) are sufficiently elastic to allow the force introduction of the bottle into the device. For example, a continuous annular bead can be used. In a non-exemplified variant, not covered by the claims, these retaining means are constituted by axial ribs formed inside the tube (13) which provide a frictional force on the body of the bottle. In addition, by varying the thickness of these ribs, the device can be used for bottles having slightly different diameters. Alternatively, not covered by the claims, the retaining means (8) can be replaced by a perforable seal by the thumb (film or welded paper) or by a captive plug.

Les moyens de retenue (7) peuvent être formés par tout moyen susceptible d'assurer une fonction de butée élastique, par exemple un bourrelet annulaire continu on non.The retaining means (7) may be formed by any means capable of providing an elastic stop function, for example a continuous annular bead or no.

De préférence, le tube (13) comporte à sa base des moyens destinés à augmenter la stabilité du dispositif en position verticale. Il s'agit par exemple d'une collerette (9), comportant éventuellement des moyens supplémentaires, par exemple des méplats, pour éviter que le dispositif ne roule lorsqu'il est en position horizontale.Preferably, the tube (13) comprises at its base means for increasing the stability of the device in vertical position. This is for example a flange (9), optionally comprising additional means, for example flats, to prevent the device from rolling when in the horizontal position.

Le corps monobloc tubulaire est réalisé en une matière plastique antichoc, pour éviter les risques de brisure, et de préférence transparente pour permettre la lecture des informations mentionnées sur le corps du flacon et la surveillance de son contenu. On peut utiliser toute matière plastique présentant de telles propriétés, telles que polypropylène, polycarbonate ou résine K.The tubular monobloc body is made of a shockproof plastic material, to avoid the risk of breakage, and preferably transparent to allow reading of the information mentioned on the body of the bottle and the monitoring of its contents. Any plastic material having such properties as polypropylene, polycarbonate or K resin may be used.

Sur la figure 4, le contenu du flacon (1) est mis en communication avec le contenu de la poche de perfusion (6) après perforation du bouchon (2) par la pointe (11) et du site d'injection (5) par la pointe (10).In FIG. 4, the contents of the bottle (1) are placed in communication with the contents of the infusion bag (6) after perforation of the stopper (2) by the tip (11) and the injection site (5) by the tip (10).

Le flacon (1) coulisse dans la chambre (B) sous l'action d'une poussée exercée sur le fond (14) du flacon. Le flacon se déplace jusqu'à venir buter sur la cloison (12), ce qui permet à la pointe (11) de percer le bouchon (2). De préférence, on exerce une poussée sur le fond (14) du flacon à l'aide du pouce.The bottle (1) slides in the chamber (B) under the action of a thrust exerted on the bottom (14) of the bottle. The bottle moves until it abuts on the partition (12), which allows the tip (11) to pierce the stopper (2). Preferably, it is pushed on the bottom (14) of the bottle with the thumb.

Les moyens de retenue (7) permettent de maintenir le flacon en position utilisation et d'éviter le déplacement axial du flacon vers le bas.The retaining means (7) make it possible to keep the bottle in the use position and to avoid the axial displacement of the bottle downwards.

Le site d'injection (5) de la poche de perfusion (6) est percé d'une manière classique par introduction en force du site dans la chambre (A).The injection site (5) of the infusion bag (6) is pierced in a conventional manner by force introduction of the site in the chamber (A).

La figure 5 représente un mode de réalisation particulier des moyens de butée (7) empêchant le perçage intempestif du bouchon. Dans ce mode de réalisation, les moyens de retenue élastiques sont constitués par des languettes (15, 16) dont les extrémités libres sont orientées vers l'intérieur du tube (13a). Ainsi, la poussée exercée sur le fond du flacon écarte les languettes (15, 16) qui, après le perçage du bouchon (2), empêchent le flacon de retomber vers le fond du dispositif.FIG. 5 represents a particular embodiment of the abutment means (7) preventing the inadvertent piercing of the plug. In this embodiment, the elastic retaining means consist of tabs (15, 16) whose free ends are oriented towards the inside of the tube (13a). Thus, the thrust exerted on the bottom of the bottle separates the tabs (15, 16) which, after drilling the stopper (2), prevent the bottle from falling back to the bottom of the device.

Les moyens élastiques (8) peuvent également être constitués de languettes telles que les languettes (15, 16).The elastic means (8) may also consist of tongues such as tongues (15, 16).

La figure 6 représente un mode de réalisation particulier de l'embase du dispositif. Dans ce mode de réalisation, l'embase du tube (13) comporte une ou plusieurs ouvertures (17) destinées à faciliter la poussée sur le fond du flacon. On préfère les systèmes avec une seule ouverture pour éviter le risque de sortie du flacon par traction.FIG. 6 represents a particular embodiment of the base of the device. In this embodiment, the base of the tube (13) has one or more openings (17) to facilitate the thrust on the bottom of the bottle. Systems with a single opening are preferred to avoid the risk of the bottle being pulled out.

Les figures illustrent un mode de réalisation dans lequel on met en communication un flacon (1) et une poche de perfusion (6). Cependant, le système peut être utilisé pour mettre en communication un flacon avec un autre type de contenant.The figures illustrate an embodiment in which a vial (1) and an infusion bag (6) are placed in communication. However, the system can be used to port a vial to another type of container.

Les modes de réalisation exemplifiés concernent un dispositif avec une aiguille bi-pointe, mais on peut utiliser également un dispositif avec une aiguille côté flacon et un site Luer côté poche.The exemplified embodiments relate to a device with a two-point needle, but a device with a bottle-side needle and a pouch-side luer site can also be used.

Le dispositif est un corps monobloc en matière plastique. Il est donc facile à produire en mettant en oeuvre les procédés classiques de l'industrie des matières plastiques.The device is a one-piece plastic body. It is therefore easy to produce using the conventional processes of the plastics industry.

De plus, afin d'assurer, un mode de mise en oeuvre stérile, le dispositif est stérilisé à l'oxyde d'éthylène, à la vapeur ou par rayonnement.In addition, to ensure a sterile mode of implementation, the device is sterilized with ethylene oxide, steam or radiation.

De préférence, le dispositif est placé à l'avance sur le flacon (1). L'ensemble dispositif/flacon est pré-assemblé, placé dans un blister et stérilisé comme ci-dessus.Preferably, the device is placed in advance on the bottle (1). The device / vial assembly is pre-assembled, placed in a blister and sterilized as above.

En variante 1, le dispositif peut être muni d'un bouchon amovible obturant de manière étanche la chambre A, puis après montage du flacon dans la chambre B le fond de la chambre B peut être operculé par un papier "thermosoudable", permettant la stérilisation de l'ensemble à l'oxyde d'éthylène ou à la vapeur. Cette variante permet d'éviter la mise sous blister de l'ensemble dispositif-flacon. Lors de l'utilisation, l'infirmière retire le bouchon, puis pousse le flacon à travers le papier, qui va se déchirer sans effort.Alternatively, the device may be provided with a removable cap sealingly sealing the chamber A, then after mounting the bottle in the chamber B the bottom of the chamber B may be sealed with a "heat sealable" paper, allowing sterilization from the assembly to ethylene oxide or steam. This variant avoids the blistering of the device-bottle assembly. In use, the nurse removes the cap, then pushes the vial through the paper, which will tear without effort.

Selon une autre variante, le dispositif est placé sur le flacon (1) au moment de son utilisation. Il suffit de retirer l'opercule (3) et d'insérer en force le flacon dans le tube (13).According to another variant, the device is placed on the bottle (1) at the time of its use. Just remove the cap (3) and forcefully insert the vial into the tube (13).

La description et les figures sont une illustration de différents modes de réalisation de la présente invention.The description and figures are an illustration of various embodiments of the present invention.

Claims (11)

  1. Safety packaging device for a bottle (1) for medical use, allowing the contents of the bottle (1) to be transferred directly into a container, such as an infusion bag (6), comprising:
    - a cylindrical tubular body covering the lateral walls of the bottle (1) over the full height of the latter, both in the storage position and in the position of use of the bottle,
    - a partition (12) perpendicular to the axis of the tubular body
    ✔ the partition defining a first open chamber (A) and a second open chamber (B), the second chamber (B) being formed by a tube (13) with first retention means (7) placed above the bottle (1) in the storage position and second retention means (8) placed under the bottle (1) in the storage position,
    ■ the first retention means (7) being designed to prevent accidental piercing of the stopper of the bottle (1) in the storage position, and to prevent downward axial displacement of said bottle in the position of use, and being sufficiently elastic to permit the axial displacement of said bottle towards the transfer means under the action of a thrust exerted on the bottom (14) of said bottle, and
    ■ the second retention means (8) being designed to prevent the bottle (1) from escaping from the second chamber (B) in the storage position, and being sufficiently elastic to permit the introduction of said bottle into the device,
    ✔ the partition being provided with means by which the means for transferring the contents of the bottle (1) into the container are held in place.
  2. Packaging device according to Claim 1, characterized in that the transfer means are formed by a double-pointed needle (10, 11).
  3. Packaging device according to Claim 1, characterized in that the transfer means are formed by a needle in the direction of the bottle (1) and a male or female luer site in the direction of the container.
  4. Packaging device according to one of Claims 1 to 3, characterized in that the tube (13) is narrowed at its upper end to form a tube (13a) with a diameter slightly smaller than that of the tube (13).
  5. Packaging device according to one of Claims 1 to 4, characterized in that the elastic retention means (7, 8) are formed by a continuous or non-continuous annular bead.
  6. Packaging device according to one of Claims 1 to 5, characterized in that the elastic retention means (7, 8) are formed by tongues (15, 16) whose free ends are oriented towards the inside of the tube (13).
  7. Packaging device according to one of Claims 1 to 6, characterized in that the base of the tube (13) is equipped with a collar (9), optionally provided with means for preventing the device from rolling in a horizontal position.
  8. Packaging device according to one of Claims 1 to 7, characterized in that the base of the tube comprises one or more openings (17) designed to facilitate the thrust exerted on the bottom of the bottle.
  9. Packaging device according to one of Claims 1 to 8, characterized in that the tubular body is made of impact-resistant and transparent plastic.
  10. Packaging device according to one of Claims 1 to 9, characterized in that the device is sterilized in its packaging using ethylene oxide, steam or radiation.
  11. Packaging device according to one of Claims 1 to 10, characterized in that the device is packaged in a blister pack.
EP20020796303 2001-08-22 2002-08-22 Safety packaging for a bottle for medical use Expired - Lifetime EP1435893B1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
FR0110982A FR2828802A1 (en) 2001-08-22 2001-08-22 Safety package for flask for medical use, e.g. for perfusion fluid, comprising cylindrical tubular body with partition and holder for transfer element
FR0110982 2001-08-22
FR0116379 2001-12-18
FR0116379A FR2828803B1 (en) 2001-08-22 2001-12-18 SAFETY PACKAGING FOR MEDICAL BOTTLE
PCT/FR2002/002920 WO2003017916A1 (en) 2001-08-22 2002-08-22 Safety packaging for a bottle for medical use

Publications (2)

Publication Number Publication Date
EP1435893A1 EP1435893A1 (en) 2004-07-14
EP1435893B1 true EP1435893B1 (en) 2008-02-06

Family

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Application Number Title Priority Date Filing Date
EP20020796303 Expired - Lifetime EP1435893B1 (en) 2001-08-22 2002-08-22 Safety packaging for a bottle for medical use

Country Status (8)

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EP (1) EP1435893B1 (en)
AT (1) ATE385418T1 (en)
DE (1) DE60224940T2 (en)
DK (1) DK1435893T3 (en)
ES (1) ES2300504T3 (en)
FR (2) FR2828802A1 (en)
PT (1) PT1435893E (en)
WO (1) WO2003017916A1 (en)

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Publication number Priority date Publication date Assignee Title
FR2863161B1 (en) 2003-12-05 2006-09-01 Map France CAP FOR SAFETY PACKAGING FOR BOTTLES FOR MEDICAL USE
US7615041B2 (en) 2004-07-29 2009-11-10 Boston Scientific Scimed, Inc. Vial adaptor
FR2878737B1 (en) * 2004-12-07 2007-03-16 Maptech Soc Par Actions Simpli SAFETY DEVICE FOR A BOTTLE FOR MEDICAL USE
ES2458417T3 (en) * 2009-09-14 2014-05-05 Nestec S.A. Container with aluminum seals and penetration media
US20160039546A1 (en) * 2014-08-07 2016-02-11 Greg Gardner Condiment transfer device and method
ITUB20153260A1 (en) * 2015-08-27 2017-02-27 Paolo Gobbi Frattini S R L Hermetic closure cap for a sterile sealed bottle containing medicinal or nutritional active substances, suitable for sterile connection with a container of liquid diluent solution, and a sterile connection system using said closure cap.
WO2020167910A1 (en) * 2019-02-12 2020-08-20 Amgen Inc. Systems and approaches for drug delivery device reconstitution
CH716516A1 (en) * 2019-08-22 2021-02-26 Mpi Int Sa Method for preparing at least one solution for injection in a pocket, unit for preparing said solution for injection and pocket containing said solution for injection.
CH716733A1 (en) * 2019-10-29 2021-04-30 Mpi Int Sa Process for preparing at least one injectable solution in an ampoule, unit for preparing said injectable solution and ampoule containing said injectable solution.

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FR1380706A (en) 1963-10-23 1964-12-04 Device for transferring a fluid from one container to another
FR1545963A (en) 1967-11-07 1968-11-15 Abc Ist Biolog Chem Spa Packaging of two separate and miscible substances, at least one of which is liquid, with transfer device
FR2302134A1 (en) 1975-02-28 1976-09-24 Merieux Inst Appts. to transfer liq. from one closed container to another - esp. for feeding solvent to vaccine doses aseptically
US4607671A (en) 1984-08-21 1986-08-26 Baxter Travenol Laboratories, Inc. Reconstitution device
US4759756A (en) 1984-09-14 1988-07-26 Baxter Travenol Laboratories, Inc. Reconstitution device
CA1302837C (en) * 1987-04-02 1992-06-09 David Scarrow Apparatus for contacting material such as a drug with a fluid
DE19513666C1 (en) * 1995-04-11 1996-11-28 Behringwerke Ag Device for bringing together a first liquid and a second solid or liquid component by means of negative pressure under sterile conditions
FR2738550B1 (en) 1995-09-11 1997-11-07 Biodome DEVICE FOR SEALING A CONTAINER ITSELF CLOSED, ASSEMBLY FOR PROVIDING A PRODUCT COMPRISING SUCH A CONTAINER AND SUCH A SEALING DEVICE
WO1997020536A1 (en) * 1995-12-06 1997-06-12 Gabriel Meyer Device for preparing a medicinal solution reconstituted from two components
FR2753624B1 (en) 1996-09-25 1999-04-16 Biodome CONNECTION DEVICE, PARTICULARLY BETWEEN A CONTAINER WITH PERFORABLE CAP AND A SYRINGE
FR2780878B1 (en) 1998-07-10 2000-09-29 Frederic Senaux SNAP-ON TRANSFER CAP
FR2790749B1 (en) * 1999-03-10 2001-05-18 Maco Pharma Sa DEVICE FOR TRANSFERRING A SUBSTANCE CONTAINED IN A BOTTLE INTO A POUCH OF SOLUTE

Also Published As

Publication number Publication date
ES2300504T3 (en) 2008-06-16
FR2828802A1 (en) 2003-02-28
WO2003017916A1 (en) 2003-03-06
FR2828803B1 (en) 2004-10-22
ATE385418T1 (en) 2008-02-15
DE60224940D1 (en) 2008-03-20
FR2828803A1 (en) 2003-02-28
PT1435893E (en) 2008-05-09
DK1435893T3 (en) 2008-06-09
EP1435893A1 (en) 2004-07-14
DE60224940T2 (en) 2008-08-21

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