EP1694269B1 - Cap for safely packaging a medical bottle - Google Patents

Cap for safely packaging a medical bottle Download PDF

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Publication number
EP1694269B1
EP1694269B1 EP20040805636 EP04805636A EP1694269B1 EP 1694269 B1 EP1694269 B1 EP 1694269B1 EP 20040805636 EP20040805636 EP 20040805636 EP 04805636 A EP04805636 A EP 04805636A EP 1694269 B1 EP1694269 B1 EP 1694269B1
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EP
European Patent Office
Prior art keywords
cap
needle
bottle
injection site
seal
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.)
Not-in-force
Application number
EP20040805636
Other languages
German (de)
French (fr)
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EP1694269A1 (en
Inventor
Farid Hamedi-Sangsari
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MAPTECH
Original Assignee
MAPTECH
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Publication date
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Publication of EP1694269A1 publication Critical patent/EP1694269A1/en
Application granted granted Critical
Publication of EP1694269B1 publication Critical patent/EP1694269B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61J1/14—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 present invention relates to a pierceable cap pre-mounted on the needle of a safety packaging device for a vial for medical use.
  • This cap is mounted sealingly and sliding so as to avoid the "aerosol" phenomenon during the perforation of the bottle cap or, for example, the injection site of an infusion bag.
  • the present invention is an improvement of the patent application FR2828803 the same depositor.
  • This application describes a safety packaging device for a medical vial. It is a one-piece cylindrical plastic body consisting of two parts: a lower part intended to completely cover the glass bottle and optionally comprising at its base means for stabilizing the device in vertical position and a top part of more small 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.
  • the purpose of the device described in this application is to offer 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 substances contained in this type of bottle are potentially dangerous substances for users or the environment (anticancer, antibiotics, etc.). It is therefore very important to avoid contact with these substances.
  • the distribution / capping operation is carried out in a clean room at a pressure slightly higher than the atmospheric pressure of the geographical location and at a controlled ambient temperature at approximately 20 ° C.
  • the pressure inside the bottle becomes positive relative to the ambient air, which generates a projection of powder outside in the form of an aerosol, during the perforation of the bottle cap.
  • overpressures in the bottle up to 100 mb. The same phenomenon occurs when the air contained in the bottle is hotter than at the origin (law of expansion of the gases).
  • the patent GB2359754 discloses a sheath which sealingly covers the needle of a hypodermic syringe and which can perforate the rubber stopper of a bulb.
  • the publication WO0126718 discloses a device for reconstituting a preparation using a hollow transfer element such as a needle.
  • the device avoids any risk of nebulization or accidental throwing of the product at the time of its connection with the injection needle.
  • the present invention solves the problem mentioned above by adding to an existing transfer device, a single piece not causing significant additional cost for all.
  • This piece is a pierceable cap according to claim 1, on one end of the bi-tip needle of a medical vial security packaging device, sealingly and slidably.
  • the tightening is designed to ensure that the cap is held in place, the leaktight end of the needle is sealed with respect to the environment and the possibility of the cap sliding on the body of the needle.
  • the friction / sealing functions can be provided for example by an annular bead.
  • the figure 1 represents the cap (L) according to the present invention mounted on the end (D) of a needle.
  • the cap (L) of generally cylindrical shape comprises a bottom (A) and an open end for mounting it on a needle.
  • the bottom (A) of the cap (L) has a sufficiently thin thickness to be easily perforated by the tip (D) of the needle.
  • the bottom (A) of the cap (L) is recessed (H) relative to the end of the cap (L), so as to create one or more sealing ring (s) (G) for ) to improve the sealing of the cap / injection site contact of the infusion bag.
  • the open end of the cap has a centering cone (C) to facilitate its establishment on the tip of the needle and a flange (C) to facilitate the distribution of the part in automatic assembly.
  • the cap comprises sealing means allowing the cap to slide on the body of the needle.
  • These sealing means may be one or more annular beads (E) placed (s) above the centering cone (F).
  • the figure 2 represents the system used in the invention as a whole: safety packaging device (O) provided with the cap (L) and infusion bag (I) with its injection site (J).
  • the safety packaging device (O) comprises a two-point needle with two ends (D, M), it completely covers the bottle (P) closed by a pierceable stopper (N) and containing a powder (S) of substance active.
  • the amount of powder (S) is such that there is a volume of free air (R) in the bottle (P).
  • the figure 3 represents a view of the system after percussion of the cap (N) of the bottle (P) by the lower tip (M) of the two-point needle.
  • the difference between the conditions present inside the bottle and in the external environment (pressure and / or temperature) causes the projection of a part of the powder (S) through the needle in the cap ( L). This powder remains trapped tightly in the cap.
  • the figure 4 represents a view of the system at the time of the beginning of the perforation of the bottom of the cap (A) and the injection site (J) by the tip (D) of the two-point needle.
  • the injection site (J) of the infusion bag (I) is introduced into the safety conditioning device (O)
  • the end (D) of the two-needle needle pierces first.
  • the bottom of the cap (A) then the injection site (J).
  • the sealing ring (G) of the cap (L) abuts on the elastomer pellet of the injection site (J).
  • the figure 5 represents a view of the system after complete perforation of the site (J) and sliding of the cap (L).
  • the cap (L) slides along the body of the needle until the end of the two-point needle has completely perforated the injection site, for example until the collar (C) the cap (L) comes up against the wall with the two-point needle.
  • the end (D) of the needle passes entirely through the injection site (J) so as to put in communication the contents of the pocket (I) and the bottle (P).
  • the projection of powder (S) ("aerosol" effect) will occur inside the pocket and therefore will not pollute the external environment.
  • the figure 6 represents a view of the system after use. Since the elastomer seal of the injection site (J) has a self-sealing effect, the contents of the bag (I) remain in a closed environment after removal of the needle.
  • the cap (L) of the present invention is preferably of flexible or semi-rigid plastic (polyethylene, polypropylene, elastomer, etc.).
  • the cap is mounted on the end (D) of the bi-tip needle, which will communicate with the infusion bag (J).
  • it can be mounted on the other end (M) of the needle.
  • it is first necessary to directly perforate the injection site (J) of the infusion bag (I) and then simultaneously perforate the bottom (A) of the cap (L) and the stopper (N) of the bottle ( P).
  • the lower part of the bi-tip needle that is to say the portion of the needle which enters the free volume (R) of the bottle (P) is sufficiently long to allow the positioning of the cap (L) and its sliding along the body of the needle.
  • a cap (L) can be provided on both ends (D, M) of the needle.

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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)
  • Closures For Containers (AREA)

Abstract

The safety cap (L), made from a supple or semi-rigid plastic or elastomer material, seals one tip (D) of a double-ended needle and has a closed end (A) that is easily perforated when slid along the needle by the pressure applied against a flask stopper or the seal on a perfusion pouch, for example. The safety cap is sealed against the lateral surface of the needle by one or more rings (E), and its perforable end (A) is recessed inside the cap to form a ring (G) that provides a reliable seal when it is inserted into a flask stopper or pouch seal.

Description

La présente invention a pour objet un capuchon perforable pré-monté sur l'aiguille d'un dispositif de conditionnement de sécurité pour flacon à usage médical. Ce capuchon est monté de manière étanche et coulissante de manière à éviter le phénomène "aérosol" lors de la perforation du bouchon du flacon ou, par exemple, du site d'injection d'une poche de perfusion.The present invention relates to a pierceable cap pre-mounted on the needle of a safety packaging device for a vial for medical use. This cap is mounted sealingly and sliding so as to avoid the "aerosol" phenomenon during the perforation of the bottle cap or, for example, the injection site of an infusion bag.

La présente invention est un perfectionnement de la demande de brevet FR2828803 du même déposant. Cette demande décrit un dispositif de conditionnement de sécurité pour flacon à usage médical. Il s'agit d'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. Le but du dispositif décrit dans cette demande est d'offrir 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 present invention is an improvement of the patent application FR2828803 the same depositor. This application describes a safety packaging device for a medical vial. It is a one-piece cylindrical plastic body consisting of two parts: a lower part intended to completely cover the glass bottle and optionally comprising at its base means for stabilizing the device in vertical position and a top part of more small 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. The purpose of the device described in this application is to offer 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.

Les substances contenues dans ce type de flacon sont des substances potentiellement dangereuses pour les utilisateurs ou l'environnement (anticancéreux, antibiotiques, etc.). Il est donc très important d'éviter tout contact avec ces substances.The substances contained in this type of bottle are potentially dangerous substances for users or the environment (anticancer, antibiotics, etc.). It is therefore very important to avoid contact with these substances.

Lors de la manipulation de flacons à usage médical contenant une poudre de substance active, on a pu constater un phénomène "aérosol" dû au fait que le flacon de médicament sous forme de poudre contient un certain volume d'air emprisonné par l'herméticité du bouchage.When handling vials for medical use containing a powder of active substance, an "aerosol" phenomenon has been observed due to the fact that the drug vial in the form of a powder contains a certain volume of air trapped by the hermeticity of the clogging.

L'opération de répartition/bouchage est effectuée en salle blanche à une pression légèrement supérieure à la pression atmosphérique du lieu géographique et à une température ambiante régulée à environ 20°C.The distribution / capping operation is carried out in a clean room at a pressure slightly higher than the atmospheric pressure of the geographical location and at a controlled ambient temperature at approximately 20 ° C.

Lorsque le dispositif est utilisé sur un lieu géographique présentant une pression atmosphérique inférieure à celle présente lors du bouchage du flacon (différence d'altitude par exemple), la pression à l'intérieur du flacon devient positive par rapport à l'air ambiant, ce qui génère une projection de poudre à l'extérieur sous forme d'aérosol, lors de la perforation du bouchon du flacon. Nous avons mesuré des surpressions dans le flacon allant jusqu'à 100 mb. Le même phénomène se produit lorsque l'air contenu dans le flacon est plus chaud qu'à l'origine (loi de dilatation des gaz).When the device is used on a geographical location having a lower atmospheric pressure than that present during the capping of the bottle (altitude difference for example), the pressure inside the bottle becomes positive relative to the ambient air, which generates a projection of powder outside in the form of an aerosol, during the perforation of the bottle cap. We measured overpressures in the bottle up to 100 mb. The same phenomenon occurs when the air contained in the bottle is hotter than at the origin (law of expansion of the gases).

La projection de ces poudres, souvent allergisantes, voire toxiques (antibiotiques, anticancéreux) dans le proche environnement du personnel soignant et du malade, peut être hautement préjudiciable à leur santé et donc tout à fait inacceptable.The projection of these powders, often allergenic, even toxic (antibiotics, anticancer) in the immediate environment of the nursing staff and the patient, can be highly detrimental to their health and therefore completely unacceptable.

Il n'existe pas de solution technique simple pour résoudre ce problème. Un certain nombre de documents de brevet décrivent des systèmes permettant de protéger l'extrémité d'une aiguille ou de faciliter le transfert du contenu d'une seringue.There is no simple technical solution to solve this problem. A number of patent documents describe systems for protecting the tip of a needle or facilitating the transfer of the contents of a syringe.

Le brevet GB2359754 décrit une gaine qui recouvre de manière étanche l'aiguille d'une seringue hypodermique et qui peut perforer le bouchon en caoutchouc d'une ampoule.The patent GB2359754 discloses a sheath which sealingly covers the needle of a hypodermic syringe and which can perforate the rubber stopper of a bulb.

La publication WO0126718 décrit un dispositif pour reconstituer une préparation à l'aide d'un élément de transfert creux tel qu'une aiguille. Le dispositif évite tout risque de nébulisation ou de jet accidentel du produit au moment de sa connexion avec l'aiguille d'injection.The publication WO0126718 discloses a device for reconstituting a preparation using a hollow transfer element such as a needle. The device avoids any risk of nebulization or accidental throwing of the product at the time of its connection with the injection needle.

Cependant, aucun brevet ne décrit un système analogue à celui de l'invention permettant d'éviter le phénomène "aérosol" se produisant lors de la mise en communication d'un récipient contenant un produit pulvérulent avec un autre contenant, par exemple une poche pour perfusion.However, no patent describes a system similar to that of the invention making it possible to avoid the "aerosol" phenomenon occurring when placing a container containing a powdery product in communication with another container, for example an infusion bag.

La présente invention permet de résoudre le problème mentionné ci-dessus par adjonction à un dispositif de transfert existant, d'une pièce simple n'entraînant pas de surcoût significatif pour l'ensemble.The present invention solves the problem mentioned above by adding to an existing transfer device, a single piece not causing significant additional cost for all.

Cette pièce est un capuchon perforable conforme à la revendication 1, sur l'une des extrémités de l'aiguille bi-pointe d'un dispositif de conditionnement de sécurité pour flacon à usage médical, de manière étanche et coulissante. Le serrage est étudié pour garantir la tenue en place du capuchon, l'étanchéité de l'extrémité débouchante de l'aiguille par rapport à l'environnement et la possibilité de coulissement du capuchon sur le corps de l'aiguille. Les fonctions friction/étanchéité peuvent être assurées par exemple par un bourrelet annulaire.This piece is a pierceable cap according to claim 1, on one end of the bi-tip needle of a medical vial security packaging device, sealingly and slidably. The tightening is designed to ensure that the cap is held in place, the leaktight end of the needle is sealed with respect to the environment and the possibility of the cap sliding on the body of the needle. The friction / sealing functions can be provided for example by an annular bead.

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

  • La figure 1 est une vue en coupe longitudinale du capuchon de l'invention, monté sur une des extrémités (D) d'une aiguille bi-pointe.
  • La figure 2 est une vue en coupe longitudinale du dispositif de conditionnement de sécurité (O) équipé du capuchon de l'invention (L) avec une vue partielle en coupe de la poche de perfusion (I) munie de son site d'injection (J), avant utilisation.
  • La figure 3 est une vue partielle en coupe du système après percussion du bouchon (N) du flacon (P) par la pointe (M) de l'aiguille bi-pointe.
  • La figure 4 est une vue partielle en coupe du système au début de la perforation du fond du capuchon (A) et du site d'injection (J) par la pointe (D) de l'aiguille bi-pointe.
  • La figure 5 est une vue partielle en coupe du système après perforation complète du site (J) et coulissement du capuchon (L) sur une longueur suffisante pour mettre en communication les contenus de la poche (I) et du flacon (P).
  • La figure 6 est une vue partielle en coupe du système après désolidarisation du dispositif (O) et de la poche (I) en fin d'utilisation.
The accompanying drawings will illustrate the present invention in more detail.
  • The figure 1 is a longitudinal sectional view of the cap of the invention mounted on one end (D) of a two-point needle.
  • The figure 2 is a longitudinal sectional view of the safety packaging device (O) equipped with the cap of the invention (L) with a partial sectional view of the infusion bag (I) provided with its injection site (J), before use.
  • The figure 3 is a partial sectional view of the system after percussion cap (N) of the bottle (P) by the tip (M) of the needle bi-tip.
  • The figure 4 is a partial sectional view of the system at the beginning of the perforation of the bottom of the cap (A) and the injection site (J) by the tip (D) of the bi-tip needle.
  • The figure 5 is a partial sectional view of the system after complete perforation of the site (J) and sliding the cap (L) for a length sufficient to communicate the contents of the bag (I) and the bottle (P).
  • The figure 6 is a partial sectional view of the system after disconnection of the device (O) and the pocket (I) at the end of use.

La figure 1 représente le capuchon (L) selon la présente invention monté sur l'extrémité (D) d'une aiguille. Le capuchon (L) de forme généralement cylindrique comprend un fond (A) et une extrémité ouverte permettant de le monter sur une aiguille. Le fond (A) du capuchon (L) présente une épaisseur suffisamment fine pour pouvoir être facilement perforé par la pointe (D) de l'aiguille. De préférence le fond (A) du capuchon (L) est en retrait (H) par rapport à l'extrémité du capuchon (L), de manière à créer un ou plusieurs anneau(x) d'étanchéité (G) destiné(s) à améliorer l'étanchéité du contact capuchon/site d'injection de la poche de perfusion. L'extrémité ouverte du capuchon comporte un cône de centrage (C) destiné à faciliter sa mise en place sur la pointe de l'aiguille ainsi qu'une collerette (C) pour faciliter la distribution de la pièce en assemblage automatique. De préférence, le capuchon comporte des moyens d'étanchéité permettant le coulissement du capuchon sur le corps de l'aiguille. Ces moyens d'étanchéité peuvent être un ou plusieurs bourrelets annulaires (E) placé(s) au-dessus du cône de centrage (F).The figure 1 represents the cap (L) according to the present invention mounted on the end (D) of a needle. The cap (L) of generally cylindrical shape comprises a bottom (A) and an open end for mounting it on a needle. The bottom (A) of the cap (L) has a sufficiently thin thickness to be easily perforated by the tip (D) of the needle. Preferably the bottom (A) of the cap (L) is recessed (H) relative to the end of the cap (L), so as to create one or more sealing ring (s) (G) for ) to improve the sealing of the cap / injection site contact of the infusion bag. The open end of the cap has a centering cone (C) to facilitate its establishment on the tip of the needle and a flange (C) to facilitate the distribution of the part in automatic assembly. Preferably, the cap comprises sealing means allowing the cap to slide on the body of the needle. These sealing means may be one or more annular beads (E) placed (s) above the centering cone (F).

La figure 2 représente le système utilisé dans l'invention dans son ensemble : dispositif de conditionnement de sécurité (O) muni du capuchon (L) et poche de perfusion (I) avec son site d'injection (J). Le dispositif de conditionnement de sécurité (O) comporte une aiguille bi-pointe avec deux extrémités (D, M), il recouvre totalement le flacon (P) fermé par un bouchon perforable (N) et contenant une poudre (S) de substance active. La quantité de poudre (S) est telle qu'il existe un volume d'air libre (R) dans le flacon (P).The figure 2 represents the system used in the invention as a whole: safety packaging device (O) provided with the cap (L) and infusion bag (I) with its injection site (J). The safety packaging device (O) comprises a two-point needle with two ends (D, M), it completely covers the bottle (P) closed by a pierceable stopper (N) and containing a powder (S) of substance active. The amount of powder (S) is such that there is a volume of free air (R) in the bottle (P).

La figure 3 représente une vue du système après percussion du bouchon (N) du flacon (P) par la pointe inférieure (M) de l'aiguille bi-pointe. La différence entre les conditions présentes à l'intérieur du flacon et dans l'environnement extérieur (pression et/ou température) entraîne la projection d'une partie de la poudre (S) par l'intermédiaire de l'aiguille dans le capuchon (L). Cette poudre reste emprisonnée de manière étanche dans le capuchon.The figure 3 represents a view of the system after percussion of the cap (N) of the bottle (P) by the lower tip (M) of the two-point needle. The difference between the conditions present inside the bottle and in the external environment (pressure and / or temperature) causes the projection of a part of the powder (S) through the needle in the cap ( L). This powder remains trapped tightly in the cap.

La figure 4 représente une vue du système au moment du début de la perforation du fond du capuchon (A) et du site d'injection (J) par la pointe (D) de l'aiguille bi-pointe. Lorsque l'on introduit le site d'injection (J) de la poche de perfusion (I) dans le dispositif de conditionnement de sécurité (O), l'extrémité (D) de l'aiguille bi-pointe perce tout d'abord le fond du capuchon (A), puis le site d'injection (J). L'anneau d'étanchéité (G) du capuchon (L) vient en appui sur la pastille en élastomère du site d'injection (J). L'étanchéité de la zone perforée est garantie par la force d'appui, nécessaire à la double perforation du fond du capuchon et du site d'injection, appliquée à l'anneau d'étanchéité (G) du capuchon contre le joint en élastomère du site d'injection (J). Il ne se produira donc pas de phénomène "aérosol" vers l'extérieur.The figure 4 represents a view of the system at the time of the beginning of the perforation of the bottom of the cap (A) and the injection site (J) by the tip (D) of the two-point needle. When the injection site (J) of the infusion bag (I) is introduced into the safety conditioning device (O), the end (D) of the two-needle needle pierces first. the bottom of the cap (A), then the injection site (J). The sealing ring (G) of the cap (L) abuts on the elastomer pellet of the injection site (J). The tightness of the perforated area is guaranteed by the support force necessary for the double perforation of the bottom of the cap and the injection site, applied to the sealing ring (G) of the cap against the elastomer seal injection site (J). There will therefore be no "aerosol" phenomenon to the outside.

La figure 5 représente une vue du système après perforation complète du site (J) et coulissement du capuchon (L). Le capuchon (L) coulisse le long du corps de l'aiguille jusqu'à ce que l'extrémité de l'aiguille bi-pointe ait totalement perforé le site d'injection, par exemple jusqu'à ce que la collerette (C) du capuchon (L) vienne buter contre la cloison portant l'aiguille bi-pointe. L'extrémité (D) de l'aiguille traverse entièrement le site d'injection (J) de manière à mettre en communication les contenus de la poche (I) et du flacon (P). La projection de poudre (S) (effet "aérosol") se produira à l'intérieur de la poche et ne polluera donc pas l'environnement extérieur.The figure 5 represents a view of the system after complete perforation of the site (J) and sliding of the cap (L). The cap (L) slides along the body of the needle until the end of the two-point needle has completely perforated the injection site, for example until the collar (C) the cap (L) comes up against the wall with the two-point needle. The end (D) of the needle passes entirely through the injection site (J) so as to put in communication the contents of the pocket (I) and the bottle (P). The projection of powder (S) ("aerosol" effect) will occur inside the pocket and therefore will not pollute the external environment.

La figure 6 représente une vue du système après utilisation. Etant donné que le joint élastomère du site d'injection (J) a un effet auto-obturant ("self-sealing"), le contenu de la poche (I) reste en milieu clos après retrait de l'aiguille.The figure 6 represents a view of the system after use. Since the elastomer seal of the injection site (J) has a self-sealing effect, the contents of the bag (I) remain in a closed environment after removal of the needle.

Le capuchon (L) de la présente invention est de préférence en matière plastique souple ou semi-rigide (polyéthylène, polypropylène, élastomère, etc.).The cap (L) of the present invention is preferably of flexible or semi-rigid plastic (polyethylene, polypropylene, elastomer, etc.).

Dans le mode de réalisation illustré sur les figures, le capuchon est monté sur l'extrémité (D) de l'aiguille bi-pointe, qui entrera en communication avec la poche de perfusion (J). En variante, celui-ci peut être monté sur l'autre extrémité (M) de l'aiguille. Dans ce cas, il faut tout d'abord perforer directement le site d'injection (J) de la poche de perfusion (I) puis perforer simultanément le fond (A) du capuchon (L) et le bouchon (N) du flacon (P). Dans ce mode de réalisation, il est nécessaire que la partie inférieure de l'aiguille bi-pointe, c'est-à-dire la portion de l'aiguille qui pénètre dans le volume libre (R) du flacon (P) soit suffisamment longue pour permettre le positionnement du capuchon (L) et son coulissement le long du corps de l'aiguille. Dans une autre variante, on peut prévoir un capuchon (L) sur les deux extrémités (D, M) de l'aiguille.In the embodiment illustrated in the figures, the cap is mounted on the end (D) of the bi-tip needle, which will communicate with the infusion bag (J). Alternatively, it can be mounted on the other end (M) of the needle. In this case, it is first necessary to directly perforate the injection site (J) of the infusion bag (I) and then simultaneously perforate the bottom (A) of the cap (L) and the stopper (N) of the bottle ( P). In this embodiment, it is necessary that the lower part of the bi-tip needle, that is to say the portion of the needle which enters the free volume (R) of the bottle (P) is sufficiently long to allow the positioning of the cap (L) and its sliding along the body of the needle. In another variant, a cap (L) can be provided on both ends (D, M) of the needle.

La description et les figures sont une illustration de différents modes de réalisation de la présente invention. L'invention n'est cependant pas limitée aux modes de réalisation décrits et représentésThe description and figures are an illustration of various embodiments of the present invention. The invention is however not limited to the embodiments described and represented

Claims (6)

  1. Device which is mounted on at least one of the ends (D, M) of a double-tipped needle of a safety packaging (O) for a bottle for medical use, for directly transferring the contents of a bottle (P) into a container, such as a perfusion bag (I), characterized in that it consists of a generally cylindrical cap (L)
    - comprising
    • an end wall (A) that is thin enough to be easily perforated by one of the ends (D, M) of said double-tipped needle,
    • an open end for premounting it on one of the ends (D, M) of said double-tipped needle and
    • sealing means allowing the cap to slide in a sealed manner on the body of said needle,
    - the end wall (A) of which is perforated by the bearing force applied either to the seal of the injection site (J) or to the stopper (N) of the bottle (P), by causing the cap (L) to slide on the needle body.
  2. Device according to Claim 1, characterized in that the sealing means consist of one or more annular bulges (E).
  3. Device according to Claim 1 or 2, characterized in that the perforable end wall (A) of the cap (L) is set back (H) from the end of the cap, so as to create a sealing ring (G) for improving the seal at the point of contact between the cap and the injection site (I) of the perfusion bag (I) and/or at the point of contact between the cap and the stopper (N) of the bottle (P).
  4. Device according to one of Claims 1 to 3, characterized in that the open end of the cap (L) comprises a centering cone (F) designed to facilitate its fitting on the tip of the needle.
  5. Device according to one of Claims 1 to 4, characterized in that the open end of the cap (L) comprises a collar (C).
  6. Device according to one of Claims 1 to 5, characterized in that the cap (L) is made of a flexible or semi-rigid plastic or elastomer.
EP20040805636 2003-12-05 2004-12-03 Cap for safely packaging a medical bottle Not-in-force EP1694269B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0314295A FR2863161B1 (en) 2003-12-05 2003-12-05 CAP FOR SAFETY PACKAGING FOR BOTTLES FOR MEDICAL USE
PCT/FR2004/003117 WO2005055917A1 (en) 2003-12-05 2004-12-03 Cap for safely packaging a medical bottle

Publications (2)

Publication Number Publication Date
EP1694269A1 EP1694269A1 (en) 2006-08-30
EP1694269B1 true EP1694269B1 (en) 2012-02-08

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EP20040805636 Not-in-force EP1694269B1 (en) 2003-12-05 2004-12-03 Cap for safely packaging a medical bottle

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US (1) US20070112324A1 (en)
EP (1) EP1694269B1 (en)
AT (1) ATE544439T1 (en)
FR (1) FR2863161B1 (en)
WO (1) WO2005055917A1 (en)

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Also Published As

Publication number Publication date
FR2863161B1 (en) 2006-09-01
FR2863161A1 (en) 2005-06-10
EP1694269A1 (en) 2006-08-30
ATE544439T1 (en) 2012-02-15
US20070112324A1 (en) 2007-05-17
WO2005055917A1 (en) 2005-06-23

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