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EP1458326A2 - Administration tip for a flexible bag for medical use - Google Patents

Administration tip for a flexible bag for medical use

Info

Publication number
EP1458326A2
EP1458326A2 EP02802536A EP02802536A EP1458326A2 EP 1458326 A2 EP1458326 A2 EP 1458326A2 EP 02802536 A EP02802536 A EP 02802536A EP 02802536 A EP02802536 A EP 02802536A EP 1458326 A2 EP1458326 A2 EP 1458326A2
Authority
EP
European Patent Office
Prior art keywords
chimney
upstream
flexible
downstream
infusion
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.)
Withdrawn
Application number
EP02802536A
Other languages
German (de)
French (fr)
Inventor
Jean Curutcharry
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.)
Technoflex SA
Original Assignee
Technoflex SA
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 Technoflex SA filed Critical Technoflex SA
Publication of EP1458326A2 publication Critical patent/EP1458326A2/en
Withdrawn legal-status Critical Current

Links

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
    • A61J1/05—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

Definitions

  • the present invention relates to containers with sterile content and more particularly to flexible bags for medical use and relates to a nozzle more specifically intended for the sites of infusion of such flexible bags.
  • Soft bags for medical use are made from various materials, in particular from polyolefins such as, for example, materials from the polypropylene family.
  • the invention particularly relates to flexible bags using polyolefins as a constituent material.
  • the infusion site usually consists of a chimney, part of which is sandwiched between the two faces of the plastic sheath from which the flexible bag is made, the chimney thus being welded to the pocket in a sealing strip closing the pocket.
  • the chimney is separated internally by a thin perforable partition delimiting an upstream chamber in permanent communication with the inside of the pocket and a downstream chamber accessible from the external orifice of the chimney, an orifice which is advantageously closed by a removable element preserving sterility from the chimney until it is used at the site of administration, for example an infusion.
  • Such a device is known and illustrated for example by patent FR 2,665,633 in the name of the present Applicant.
  • the present invention aims to improve this type of infusion site by proposing a more practical infusion nozzle, adaptable to different communication structures between the inside and the outside of flexible bags, in particular polyolefins, and this, under optimal conditions. tightness to the right of the junction zone between the nozzle and the flexible pouch thus equipped.
  • the subject of the invention is a perfusion nozzle for a flexible bag for medical use, of the type comprising a chimney formed by two coaxial tubular parts separated by a transverse transverse membrane, characterized in that said chimney is provided on its external periphery of an annular projection, continuous or not, delimiting a part of upstream nozzle intended to be introduced and fixed by welding in a part integral with the flexible bag to be equipped and a part of downstream nozzle capable of receiving an infusion line and in that it further comprises, on the one hand, a ring engaged inside said upstream part and able, due to its hardness, to act as a mandrel during the execution of said welding between the periphery of the upstream part and the pocket part into which this upstream part has been introduced and, on the other hand, a cap coming to cap said downstream part and capable of ensuring the preservation of the sterility of the chimney while allowing access to the latter
  • the tubular end of the downstream part of the chimney has a diameter and a thickness which tapers
  • the cap covering the downstream part also advantageously consists of a tubular part surrounding said downstream part extended by a part connected to said tubular part by a zone of least resistance, which can be broken to give access to the chimney of the 'tip
  • the tip according to the invention is adaptable to different types of flexible pockets Thus it can be directly welded to the pocket during its manufacture, the ring inserted in the upstream part of the chimney serving as a rigid mandrel when welding said upstream part between the two walls of the sealed sheath to constitute one of the pocket closure bands.
  • the end piece can also, in another context, be force-fitted inside an outlet tube forming an integral part of the flexible bag and welded to this tube in excellent sealing conditions thanks to the presence of said mandrel ring
  • - Figure 1 is a coaxial sectional view of a perfusion nozzle according to the invention
  • - Figure 2 is an axial sectional view of the single chimney
  • FIG. 3 is a coaxial sectional view of the single ring acting as a mandrel
  • - Figure 4 is an axial sectional view of the cap's cap alone
  • - Figure 5 illustrates the integration of the tip of Figure 1 on a conventional flexible bag
  • the complete end piece 1 shown in FIG. 1 comprises a tubular chimney 2 partly capped by a cap 3 and internally provided in its part opposite to that receiving the cap 3, with an annular ring 4
  • the chimney 2 constitutes the percutable element the tip, that is to say capable of being pierced when the time comes, when using the flexible pocket (not shown) equipped with the tip 1, using a trocar (not represents) of an infusion line
  • the chimney 2 is, in known manner, formed of a tubular conduit with a relatively thin wall, provided with a transverse separating membrane 5 substantially in its median zone.
  • the membrane 5 has a thickness in the order of a few tenths of millimeters and divides the interior of the chimney into an upstream space 6 in communication with the interior of the flexible bag and a downstream space 7.
  • the part of the latter delimiting the downstream space 7 has a wall thickness which tapers towards the downstream orifice 8 of the chimney.
  • the conical profile and thinned thickness of the downstream part of the chimney gives a certain elasticity to the end of the chimney 2 and ensures a good seal on the trocar of the perfusion line introduced to pierce the membrane 5.
  • the part of the chimney delimiting the upstream space 6 has a constant wall thickness for example of the order of a millimeter, the end of the chimney, at the height of the orifice 8, having for comparison a wall thickness of the order of half a millimeter.
  • the chimney 2 is provided on its external periphery, substantially in its median zone and opposite the upstream space 6 in the embodiment illustrated by the drawings, a continuous projection in the form of annular bead 9 of rectangular section, delimiting in the chimney 2 an upstream part 1 0 intended to be introduced into a tubular part integral with the flexible bag.
  • This tubular part can be for example a tubular section 1 1 ( Figure 5) formed during the production of a flexible bag 1 2, more precisely during the execution of the welding strip 1 3 closing one of the ends of the plastic sheath from which the pocket is made.
  • the chimney 2 of the nozzle is shown with its upstream part 1 0 completely inserted into said tubular section 1 1 formed by pressing the walls of the sheath around said part 1 0.
  • the bead 9 abuts against the extreme edge of the weld strip 1 3.
  • the end piece 1 can also be introduced through its part 1 0 into a pocket outlet tube, itself welded to the body of the latter.
  • the part 2 is preferably produced by molding from a grade of flexible polypropylene for reasons of compatibility with the material of the bags and their tubes.
  • the downstream part 1 4 of the chimney 2 is capable of being capped by the cap 3 which is of generally frustoconical shape with a first part covering the part 1 4 of the chimney and extended by a part 1 5 of reduced diameter, with a wall thinner, the annular zone 1 6 of connection between these two parts constituting a zone of less resistance which one can break to give access to the orifice 8 of the chimney 2.
  • the cap 3 which is of generally frustoconical shape with a first part covering the part 1 4 of the chimney and extended by a part 1 5 of reduced diameter, with a wall thinner, the annular zone 1 6 of connection between these two parts constituting a zone of less resistance which one can break to give access to the orifice 8 of the chimney 2.
  • step 1 7 intended to come into abutment against the bead 9 at the end of insertion of the cap on the chimney 2.
  • the cap 3 is advantageously produced by molding from a grade of rigid brittle polypropylene.
  • the purpose of the cap 3 is to protect the fragile part 1 4 of the nozzle during the sterilization phase of the bag and its solution. On the other hand, it preserves the sterility of the chimney 2 until it is used.
  • the reinforcing ring 4 is a simple cylindrical element of constant thickness of the same order as that of the part 1 0 of the chimney into which it is introduced.
  • the internal end of the ring 4 is however slightly thinned in diameter and in thickness at 1 8 to facilitate its insertion into the chimney 2, while the other end is provided with a small peripheral projection 1 9 for retaining, coming in stop (figure 1) on the end of the chimney 2.
  • the length of the ring 4 corresponds substantially to that of the upstream part 1 0 of the chimney
  • the ring 4 is preferably made of rigid polypropylene
  • the device of the invention it is possible to have a very good weld thanks to the presence of the ring 4 which acts as a rigid mandrel preventing the collapse of the chimney 2 at during welding.
  • the ring 4 which acts as a rigid mandrel preventing the collapse of the chimney 2 at during welding.
  • the end piece 1 is mounted on an outlet tube secured to a flexible pocket, it will be possible to ensure perfect sealing by welding the tube to the end piece in line with the part 1 4 of the chimney, the ring 4 then, HERE also, acting as a rigid mandrel inside said part 1 4
  • the invention is obviously not limited to the embodiment shown and described above, but on the contrary covers all its variants, in particular as regards the shapes and dimensions of the elements 2, 3 and 4 constituting the 'end piece, as well as the material which can be used for their production II should also be noted that the bead 9 can be discontinuous or replaced by any other means capable of the same effect of driving in both the cap 3 on the chimney 2 and of the latter in any receiving tubular element

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (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)
  • Bag Frames (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to an administration tip for a flexible for medical use. The inventive administration tip is of the type that comprises a chamber (2) consisting of two co-axial, tubular parts which are separated by a piercable, transverse membrane (5). The tip is characterised in that the external periphery of the chamber (2) is provided with a continuos or non-continuous annular projection (9). Said projection defines: (i) an upstream part of the tip which is intended to be inserted in, and welded to, an integral part of the flexible bag to be equipped; and (ii) a downstream part of the tip which is designed to receive a venous line. The invention is also characterised in that it comprises a ring (4) which is inserted inside the upstream part and which, owing to the hardness thereof, can act as a mandrel while the periphery of the upstream part is being welded to the flexible bag in which it has been inserted. Moreover, the invention comprises a cover (3) which is placed on the downstream part and which ensures that the chamber (2) remains sterile, while providing access thereto. The invention is suitable for flexible bags that are used for medical purposes.

Description

EMBOUT PERFUSEUR POUR POCHE SOUPLE A USAGE MEDICAL PERFUSER MOUTHPIECE FOR FLEXIBLE POCKET FOR MEDICAL USE
La présente invention se rapporte aux récipients à contenu stérile et plus particulièrement aux poches souples à usage médical et concerne un embout plus spécifiquement destiné aux sites de perfusion de telles poches souples. Les poches souples à usage médical sont fabriquées à partir de divers matériaux, notamment à partir de polyoléfines telles que par exemple des matériaux de la famille des polypropylènes. L'invention vise tout particulièrement des poches souples utilisant des polyoléfines comme matériau constituant. Dans ces poches souples, le site de perfusion est habituellement constitué d'une cheminée dont une partie est prise en sandwich entre les deux faces de la gaine de matière plastique à partir de laquelle est confectionnée la poche souple, la cheminée étant ainsi soudée à la poche dans une bande de soudure de fermeture de la poche. La cheminée est séparée intérieurement par une cloison mince perforable délimitant une chambre amont en communication permanente avec l'intérieur de la poche et une chambre aval accessible depuis l'orifice externe de la cheminée, orifice qui est avantageusement obturé par un élément amovible préservant la stérilité de la cheminée jusqu'à son usage sur le site d'administration par exemple d'une perfusion.The present invention relates to containers with sterile content and more particularly to flexible bags for medical use and relates to a nozzle more specifically intended for the sites of infusion of such flexible bags. Soft bags for medical use are made from various materials, in particular from polyolefins such as, for example, materials from the polypropylene family. The invention particularly relates to flexible bags using polyolefins as a constituent material. In these flexible bags, the infusion site usually consists of a chimney, part of which is sandwiched between the two faces of the plastic sheath from which the flexible bag is made, the chimney thus being welded to the pocket in a sealing strip closing the pocket. The chimney is separated internally by a thin perforable partition delimiting an upstream chamber in permanent communication with the inside of the pocket and a downstream chamber accessible from the external orifice of the chimney, an orifice which is advantageously closed by a removable element preserving sterility from the chimney until it is used at the site of administration, for example an infusion.
Un tel dispositif est connu et illustré par exemple par le brevet FR 2 665 633 au nom du présent Demandeur. La présente invention vise à perfectionner ce type de site de perfusion en proposant un embout perfuseur plus pratique, adaptable à différentes structures de communication entre l'intérieur et l'extérieur de poches souples notamment en polyoléfines et, ce, dans des conditions optimales d'étanchéité au droit de la zone de jonction entre l'embout et la poche souple ainsi équipée. A cet effet, l'invention a pour objet un embout perfuseur pour poche souple à usage médical, de type comprenant une cheminée formée de deux parties tubulaires coaxiales séparées par une membrane transversale transperçable, caractérisé en ce que ladite cheminée est munie sur sa périphérie externe d 'une saillie annulaire, continue ou non, délimitant une partie d'embout amont destinée à être introduite et fixée par soudage dans une partie solidaire de la poche souple à équiper et une partie d 'embout aval apte à recevoir une ligne de perfusion et en ce qu' il comporte, en outre, d'une part, une bague engagée à l'intérieur de ladite partie amont et apte, du fait de sa dureté, à faire office de mandrin lors de l'exécution dudit soudage entre la périphérie de la partie amont et la partie de poche dans laquelle cette partie amont a été introduite et, d'autre part, une cape venant coiffer ladite partie aval et apte à assurer la conservation de la stérilité de la cheminée tout en permettant l'accès à cette dernière Avantageusement, l 'extrémité tubulaire de la partie aval de la cheminée présente un diamètre et une épaisseur allant en s'amincissant de l' intérieur vers l'extérieur en sorte de donner à cette extrémité de l 'élasticité lors de la mise en place d 'une ligne de perfusion et d'assurer une bonne étanchéité au niveau du trocart de la ligne de perfusion avant et après transpercement de ladite membrane séparatriceSuch a device is known and illustrated for example by patent FR 2,665,633 in the name of the present Applicant. The present invention aims to improve this type of infusion site by proposing a more practical infusion nozzle, adaptable to different communication structures between the inside and the outside of flexible bags, in particular polyolefins, and this, under optimal conditions. tightness to the right of the junction zone between the nozzle and the flexible pouch thus equipped. To this end, the subject of the invention is a perfusion nozzle for a flexible bag for medical use, of the type comprising a chimney formed by two coaxial tubular parts separated by a transverse transverse membrane, characterized in that said chimney is provided on its external periphery of an annular projection, continuous or not, delimiting a part of upstream nozzle intended to be introduced and fixed by welding in a part integral with the flexible bag to be equipped and a part of downstream nozzle capable of receiving an infusion line and in that it further comprises, on the one hand, a ring engaged inside said upstream part and able, due to its hardness, to act as a mandrel during the execution of said welding between the periphery of the upstream part and the pocket part into which this upstream part has been introduced and, on the other hand, a cap coming to cap said downstream part and capable of ensuring the preservation of the sterility of the chimney while allowing access to the latter Advantageously, the tubular end of the downstream part of the chimney has a diameter and a thickness which tapers from the inside towards the outside so as to give this end elasticity when setting up an infusion line and ensuring a good seal at the trocar of the infusion line before and after piercing said separating membrane
La cape coiffant la partie aval est par ailleurs avantageusement constituée d 'une partie tubulaire entourant ladite partie aval prolongée par une partie reliée a ladite partie tubulaire par une zone de moindre résistance, que l'on peut rompre pour donner accès à la cheminée de l'embout L' embout selon l' invention est adaptable à différents types de poches souples C'est ainsi qu'il peut être directement soudé sur la poche lors de sa fabrication, la bague insérée dans la partie amont de la cheminée servant de mandrin rigide lors du soudage de ladite partie amont entre les deux parois de la gaine scellée pour constituer l'une des bandes de fermeture de la poche. L'embout peut également, dans un autre contexte, être emmanché à force à l'intérieur d' un tube de sortie formant partie intégrante de la poche souple et soudé à ce tube dans d'excellentes conditions d 'étanchéité grâce à la présence de ladite bague-mandrinThe cap covering the downstream part also advantageously consists of a tubular part surrounding said downstream part extended by a part connected to said tubular part by a zone of least resistance, which can be broken to give access to the chimney of the 'tip The tip according to the invention is adaptable to different types of flexible pockets Thus it can be directly welded to the pocket during its manufacture, the ring inserted in the upstream part of the chimney serving as a rigid mandrel when welding said upstream part between the two walls of the sealed sheath to constitute one of the pocket closure bands. The end piece can also, in another context, be force-fitted inside an outlet tube forming an integral part of the flexible bag and welded to this tube in excellent sealing conditions thanks to the presence of said mandrel ring
D'autres caractéristiques et avantages ressortiront de la description qui va suivre d'un mode de réalisation du dispositif de l' invention, description donnée à titre d'exemple uniquement et en regard des dessins annexés sur lesquels :Other characteristics and advantages will emerge from the description which follows of an embodiment of the device of the invention, description given by way of example only and with reference to the appended drawings in which:
- la figure 1 est une vue en coupe coaxiale d ' un embout perfuseur conforme à l'invention ; - la figure 2 est une vue en coupe axiale de la seule cheminée ;- Figure 1 is a coaxial sectional view of a perfusion nozzle according to the invention; - Figure 2 is an axial sectional view of the single chimney;
- la figure 3 est une vue en coupe coaxiale de la seule bague faisant office de mandrin ;- Figure 3 is a coaxial sectional view of the single ring acting as a mandrel;
- la figure 4 est une vue en coupe axiale de la seule cape de l'embout, et - la figure 5 illustre l'intégration de l 'embout de la figure 1 sur une poche souple conventionnelle- Figure 4 is an axial sectional view of the cap's cap alone, and - Figure 5 illustrates the integration of the tip of Figure 1 on a conventional flexible bag
L'embout complet 1 représenté sur la figure 1 comprend une cheminée tubulaire 2 coiffée pour partie par une cape 3 et munie intérieurement dans sa partie opposée à celle recevant la cape 3, d'une bague annulaire 4 La cheminée 2 constitue l'élément percutable de l'embout, c'est-a-dire susceptible d 'être transpercé le moment venu, lors de l'utilisation de la poche souple (non représentée) équipée de l'embout 1 , a l' aide d'un trocart (non représente) d 'une ligne de perfusionThe complete end piece 1 shown in FIG. 1 comprises a tubular chimney 2 partly capped by a cap 3 and internally provided in its part opposite to that receiving the cap 3, with an annular ring 4 The chimney 2 constitutes the percutable element the tip, that is to say capable of being pierced when the time comes, when using the flexible pocket (not shown) equipped with the tip 1, using a trocar (not represents) of an infusion line
A cet effet, la cheminée 2 est, a la manière connue, formée d' un conduit tubulaire a paroi relativement mince, muni d'une membrane séparatrice transversale 5 sensiblement dans sa zone médiane A titre d'exemple, la membrane 5 a une épaisseur de l'ordre de quelques diziemes de millimètres et divise l'intérieur de la cheminée en un espace amont 6 en communication avec l'intérieur de la poche souple et un espace aval 7.To this end, the chimney 2 is, in known manner, formed of a tubular conduit with a relatively thin wall, provided with a transverse separating membrane 5 substantially in its median zone. For example, the membrane 5 has a thickness in the order of a few tenths of millimeters and divides the interior of the chimney into an upstream space 6 in communication with the interior of the flexible bag and a downstream space 7.
Selon une caractéristique de la cheminée 2 de l'invention, la partie de cette dernière délimitant l'espace aval 7 présente une épaisseur de paroi qui va en s'amincissant en direction de l'orifice aval 8 de la cheminée.According to a characteristic of the chimney 2 of the invention, the part of the latter delimiting the downstream space 7 has a wall thickness which tapers towards the downstream orifice 8 of the chimney.
Le profil conique et d'épaisseur amincie de la partie aval de la cheminée confère une certaine élasticité à l'extrémité de la cheminée 2 et assure une bonne étanchéité sur le trocart de la ligne de perfusion introduit pour transpercer la membrane 5. La partie de la cheminée délimitant l'espace amont 6 présente une épaisseur de paroi constante par exemple de l'ordre du millimètre, l 'extrémité de la cheminée, à hauteur de l'orifice 8, ayant à titre de comparaison une épaisseur de paroi de l'ordre d'un demi-millimètre.The conical profile and thinned thickness of the downstream part of the chimney gives a certain elasticity to the end of the chimney 2 and ensures a good seal on the trocar of the perfusion line introduced to pierce the membrane 5. The part of the chimney delimiting the upstream space 6 has a constant wall thickness for example of the order of a millimeter, the end of the chimney, at the height of the orifice 8, having for comparison a wall thickness of the order of half a millimeter.
Suivant une autre caractéristique du dispositif de l'invention, la cheminée 2 est munie sur sa périphérie externe, sensiblement dans sa zone médiane et en regard de l 'espace amont 6 dans le mode de réalisation illustré par les dessins, une saillie continue en forme de bourrelet annulaire 9 de section rectangulaire, délimitant dans la cheminée 2 une partie amont 1 0 destinée à être introduite dans une partie tubuiaire solidaire de la poche souple.According to another characteristic of the device of the invention, the chimney 2 is provided on its external periphery, substantially in its median zone and opposite the upstream space 6 in the embodiment illustrated by the drawings, a continuous projection in the form of annular bead 9 of rectangular section, delimiting in the chimney 2 an upstream part 1 0 intended to be introduced into a tubular part integral with the flexible bag.
Cette partie tubuiaire peut être par exemple un tronçon tubuiaire 1 1 (figure 5) ménagé lors de la réalisation d 'une poche souple 1 2, plus précisément lors de l'exécution de la bande de soudage 1 3 de fermeture de l'une des extrémités de la gaine de matière plastique à partir de laquelle est confectionnée la poche.This tubular part can be for example a tubular section 1 1 (Figure 5) formed during the production of a flexible bag 1 2, more precisely during the execution of the welding strip 1 3 closing one of the ends of the plastic sheath from which the pocket is made.
Sur la figure 5 la cheminée 2 de l 'embout est représentée avec sa partie amont 1 0 complètement introduite dans ledit tronçon tubuiaire 1 1 formé par plaquage des parois de la gaine autour de ladite partie 1 0. Le bourrelet 9 vient en butée contre le bord extrême de la bande de soudure 1 3. L' embout 1 peut également être introduit par sa partie 1 0 dans un tube de sortie de poche, lui-même soudé au corps de cette dernière. La pièce 2 est de préférence réalisée par moulage à partir d'un grade de polypropylène souple pour des questions de compatibilité avec le matériau des poches et de leurs tubes.In Figure 5 the chimney 2 of the nozzle is shown with its upstream part 1 0 completely inserted into said tubular section 1 1 formed by pressing the walls of the sheath around said part 1 0. The bead 9 abuts against the extreme edge of the weld strip 1 3. The end piece 1 can also be introduced through its part 1 0 into a pocket outlet tube, itself welded to the body of the latter. The part 2 is preferably produced by molding from a grade of flexible polypropylene for reasons of compatibility with the material of the bags and their tubes.
La partie aval 1 4 de la cheminée 2 est susceptible d'être coiffée par la cape 3 qui est de forme générale tronconique avec une première partie recouvrant la partie 1 4 de la cheminée et prolongée par une partie 1 5 de diamètre réduit, à paroi plus mince, la zone annulaire 1 6 de liaison entre ces deux parties constituant une zone de moindre résistance que l 'on peut rompre pour donner accès à l'orifice 8 de la cheminée 2. Sur la face interne de l'extrémité de la cape 3 opposée au prolongementThe downstream part 1 4 of the chimney 2 is capable of being capped by the cap 3 which is of generally frustoconical shape with a first part covering the part 1 4 of the chimney and extended by a part 1 5 of reduced diameter, with a wall thinner, the annular zone 1 6 of connection between these two parts constituting a zone of less resistance which one can break to give access to the orifice 8 of the chimney 2. On the internal face of the end of the cap 3 opposed to extension
1 5, est ménagé un redan 1 7 destiné à venir en butée contre le bourrelet 9 en fin d 'enfoncement de la cape sur la cheminée 2.1 5, there is a step 1 7 intended to come into abutment against the bead 9 at the end of insertion of the cap on the chimney 2.
La cape 3 est avantageusement réalisée par moulage à partir d'un grade de polypropylène rigide cassant. La cape 3 a pour but de protéger la partie 1 4, qui est fragile, de l'embout pendant la phase de stérilisation de la poche et de sa solution. D'autre part, il préserve la stérilité de la cheminée 2 jusqu'à son usage.The cap 3 is advantageously produced by molding from a grade of rigid brittle polypropylene. The purpose of the cap 3 is to protect the fragile part 1 4 of the nozzle during the sterilization phase of the bag and its solution. On the other hand, it preserves the sterility of the chimney 2 until it is used.
Au moment de l'usage de l'embout la partie en saillie 1 5 de la cape est facilement rompue par pliage, à hauteur de la zone annulaire 1 6, libérant ainsi totalement l'orifice 8When the tip is used, the projecting part 1 5 of the cap is easily broken by folding, at the level of the annular zone 1 6, thus completely freeing the orifice 8
Enfin, la bague de renfort 4 est un simple élément cylindrique d 'épaisseur constante du même ordre que celle de la partie 1 0 de la cheminée dans laquelle il est introduit. L'extrémité interne de la bague 4 est cependant légèrement amincie en diamètre et en épaisseur en 1 8 pour faciliter son insertion dans la cheminée 2, cependant que l'autre extrémité est munie d 'une petite saillie périphérique 1 9 de retenue, venant en butée (figure 1 ) sur l'extrémité de la cheminée 2.Finally, the reinforcing ring 4 is a simple cylindrical element of constant thickness of the same order as that of the part 1 0 of the chimney into which it is introduced. The internal end of the ring 4 is however slightly thinned in diameter and in thickness at 1 8 to facilitate its insertion into the chimney 2, while the other end is provided with a small peripheral projection 1 9 for retaining, coming in stop (figure 1) on the end of the chimney 2.
La longueur de la bague 4 correspond sensiblement a celle de la partie amont 1 0 de la cheminée La bague 4 est de préférence en polypropylène rigideThe length of the ring 4 corresponds substantially to that of the upstream part 1 0 of the chimney The ring 4 is preferably made of rigid polypropylene
Elle sert avantageusement de mandrin rigide lorsque l'embout 1 est intégré à une poche souple au cours de sa fabrication (figure 5) En effet, lorsque l'on veut souder une pièce tubuiaire sur une poche, il est d'usage d'introduire un mandrin rigide à l'intérieur de la pièce tubuiaire, pendant l'opération de soudage, pour assurer une bonne pression de soudage.It advantageously serves as a rigid mandrel when the end piece 1 is integrated into a flexible pocket during its manufacture (FIG. 5) In fact, when it is desired to weld a tubular part on a pocket, it is customary to introduce a rigid mandrel inside the tubular part, during the welding operation, to ensure good welding pressure. .
En son absence, en effet, la partie tubuiaire s'affaisserait et la soudure ne serait pas bonne.In its absence, in fact, the tubular part would collapse and the weld would not be good.
Dans le cas, illustré par la figure 5, de l'embout selon l'invention, à cheminée 2 munie d'une membrane 5 qui doit rester vierge, il est impossible d'introduire un mandrin pour obtenir une bonne soudure entre la face externe de la partie amont 1 4 de la cheminée et la partie de gaine entourant cette dernière et destinée à former la bande de soudure 1 3.In the case, illustrated by FIG. 5, of the end piece according to the invention, with a chimney 2 provided with a membrane 5 which must remain blank, it is impossible to introduce a mandrel to obtain a good weld between the external face of the upstream part 1 4 of the chimney and the sheath part surrounding the latter and intended to form the weld strip 1 3.
Suivant une caractéristique et un avantage tout à fait intéressants du dispositif de l'invention, il est possible d'avoir une très bonne soudure grâce à la présence de la bague 4 qui fait office de mandrin rigide évitant l'affaissement de la cheminée 2 au cours du soudage. De même, si on monte l'embout 1 sur un tube de sortie solidaire d 'une poche souple, on pourra assurer une parfaite étanchéité en soudant le tube à l'embout au droit de la partie 1 4 de la cheminée, la bague 4 faisant alors, ICI également, office de mandrin rigide à l'intérieur de ladite partie 1 4According to a completely advantageous characteristic and advantage of the device of the invention, it is possible to have a very good weld thanks to the presence of the ring 4 which acts as a rigid mandrel preventing the collapse of the chimney 2 at during welding. Similarly, if the end piece 1 is mounted on an outlet tube secured to a flexible pocket, it will be possible to ensure perfect sealing by welding the tube to the end piece in line with the part 1 4 of the chimney, the ring 4 then, HERE also, acting as a rigid mandrel inside said part 1 4
Enfin, l'invention n'est évidemment pas limitée au mode de réalisation représenté et décrit ci-dessus, mais en couvre au contraire toutes les variantes, notamment en ce qui concerne les formes et dimensions des éléments 2, 3 et 4 constitutifs de l'embout, ainsi que le matériau utilisable pour leur réalisation II est à noter par ailleurs que le bourrelet 9 peut être discontinu ou remplacé par tout autre moyen apte au même effet de butée d'enfoncement à la fois de la cape 3 sur la cheminée 2 et de cette dernière dans tout élément tubuiaire récepteur Finally, the invention is obviously not limited to the embodiment shown and described above, but on the contrary covers all its variants, in particular as regards the shapes and dimensions of the elements 2, 3 and 4 constituting the 'end piece, as well as the material which can be used for their production II should also be noted that the bead 9 can be discontinuous or replaced by any other means capable of the same effect of driving in both the cap 3 on the chimney 2 and of the latter in any receiving tubular element

Claims

R E V E N D I C A T I O N S
1. Embout perfuseur pour poche souple à usage médical, de type comprenant une cheminée (2) formée de deux parties tubulaires coaxiales séparées par une membrane transversale transperçable (5), caractérisé en ce que ladite cheminée (2) est munie sur sa périphérie externe d'une saillie annulaire (9), continue ou non, délimitant une partie d'embout amont (10) destinée à être introduite et fixée par soudage dans une partie solidaire de la poche souple à équiper et une partie d'embout aval (14) apte à recevoir une ligne de perfusion et en ce qu'il comporte, en outre, d'une part, une bague (4) engagée à l'intérieur de ladite partie amont (10) et apte, du fait de sa dureté, à faire office de mandrin lors de l'exécution dudit soudage entre la périphérie de la partie amont et la partie de poche dans laquelle cette partie amont a été introduite et, d'autre part, une cape (3) venant coiffer ladite partie aval (14) et apte à assurer la conservation de la stérilité de la cheminée (2) tout en permettant l'accès à cette dernière.1. Perfusion nozzle for flexible bag for medical use, of the type comprising a chimney (2) formed by two coaxial tubular parts separated by a transverse transverse membrane (5), characterized in that said chimney (2) is provided on its external periphery an annular projection (9), continuous or not, delimiting an upstream end part (10) intended to be inserted and fixed by welding in a part integral with the flexible pocket to be fitted and a downstream end part (14 ) suitable for receiving an infusion line and in that it further comprises, on the one hand, a ring (4) engaged inside said upstream part (10) and suitable, due to its hardness, to act as a mandrel during the execution of said welding between the periphery of the upstream part and the pocket part into which this upstream part has been introduced and, on the other hand, a cap (3) which covers said downstream part ( 14) and capable of ensuring the preservation of sterility from the chimney (2) while allowing access to the latter.
2. Embout perfuseur selon la revendication 1, caractérisé en ce que l'extrémité tubuiaire de la partie aval (14) de la cheminée (2) présente un diamètre et une épaisseur allant en s'amincissant de l'intérieur vers l'extérieur en sorte de donner à cette extrémité de l'élasticité lors de la mise en place d'une ligne de perfusion et d'assurer une bonne étanchéité au niveau du trocart de la ligne de perfusion2. infusion nozzle according to claim 1, characterized in that the tubular end of the downstream part (14) of the chimney (2) has a diameter and a thickness which tapers from the inside to the outside in sort of giving this end elasticity when setting up an infusion line and ensuring a good seal at the trocar of the infusion line
3 Embout perfuseur selon la revendication 1 ou 2, caractérise en ce que ladite cape (3) coiffant la partie aval (14) de la cheminée (2) est constituée d'une partie tubuiaire entourant ladite partie aval (14) prolongée par une partie (15) reliée à ladite partie tubuiaire par une zone de moindre résistance (16), que l'on peut rompre pour donner accès a la cheminée3 infusion nozzle according to claim 1 or 2, characterized in that said cap (3) covering the downstream part (14) of the chimney (2) consists of a tubular part surrounding said downstream part (14) extended by a part (15) connected to said tubular part by a zone of least resistance (16), which can be broken to give access to the chimney
4 Embout perfuseur selon l'une des revendications 1 à 3, caractérisé en ce que ladite bague (4) rapportée à l'intérieur de ladite partie amont (10) de la cheminée comporte une extrémité interne (18) légèrement amincie en diamètre et en épaisseur et une extrémité opposée munie d'une saillie de retenue ( 1 9) .4 infusion nozzle according to one of claims 1 to 3, characterized in that said ring (4) attached to the inside of said upstream part (10) of the chimney has an internal end (18) slightly thinned in diameter and thickness and an opposite end provided with a retaining projection (1 9).
5. Embout perfuseur selon l'une des revendications 1 à 4, caractérisé en ce que la cheminée (2), la cape (3) et la bague (4) sont constitués à partir respectivement d'un polypropylène souple, d'un polypropylène rigide et cassant et d'un polypropylène rigide. 5. infusion nozzle according to one of claims 1 to 4, characterized in that the chimney (2), the cap (3) and the ring (4) are made respectively from a flexible polypropylene, a polypropylene rigid and brittle and of rigid polypropylene.
EP02802536A 2001-12-17 2002-12-17 Administration tip for a flexible bag for medical use Withdrawn EP1458326A2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0116299A FR2833483B1 (en) 2001-12-17 2001-12-17 PERFUSER MOUTHPIECE FOR FLEXIBLE POCKET FOR MEDICAL USE
FR0116299 2001-12-17
PCT/FR2002/004379 WO2003051270A2 (en) 2001-12-17 2002-12-17 Administration tip for a flexible bag for medical use

Publications (1)

Publication Number Publication Date
EP1458326A2 true EP1458326A2 (en) 2004-09-22

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EP02802536A Withdrawn EP1458326A2 (en) 2001-12-17 2002-12-17 Administration tip for a flexible bag for medical use

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US (1) US20050035149A1 (en)
EP (1) EP1458326A2 (en)
AU (1) AU2002364922A1 (en)
CA (1) CA2470224A1 (en)
FR (1) FR2833483B1 (en)
WO (1) WO2003051270A2 (en)

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US7581899B2 (en) * 2004-11-30 2009-09-01 James Alexander Corporation Dispenser and process
US20090093794A1 (en) * 2007-10-03 2009-04-09 Tyco Healthcare Group Lp Bolus tube assembly
FR2945750B1 (en) * 2009-05-19 2013-06-07 Technoflex CONNECTOR FOR A SOFT CONTAINER FOR CONTAINING A MEDICAL LIQUID
ES2549694B9 (en) 2014-10-23 2017-01-04 Grifols, S.A. ASEPTIC FILLING PROCEDURE OF A BAG
FR3100984B1 (en) * 2019-09-20 2021-09-03 Technoflex One-piece connector for flexible infusion bag

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Also Published As

Publication number Publication date
WO2003051270A3 (en) 2003-12-11
US20050035149A1 (en) 2005-02-17
FR2833483B1 (en) 2004-09-24
FR2833483A1 (en) 2003-06-20
WO2003051270A2 (en) 2003-06-26
AU2002364922A1 (en) 2003-06-30
CA2470224A1 (en) 2003-06-26

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