EP2351643B1 - Method for manufacturing a flexible container for medical use - Google Patents

Method for manufacturing a flexible container for medical use Download PDF

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Publication number
EP2351643B1
EP2351643B1 EP10196326.2A EP10196326A EP2351643B1 EP 2351643 B1 EP2351643 B1 EP 2351643B1 EP 10196326 A EP10196326 A EP 10196326A EP 2351643 B1 EP2351643 B1 EP 2351643B1
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EP
European Patent Office
Prior art keywords
vessel
curved portion
internal volume
sheet
sheet portions
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
EP10196326.2A
Other languages
German (de)
French (fr)
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EP2351643A1 (en
Inventor
François CAPITAINE
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Technoflex SA
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Technoflex SA
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2155/00—Flexible containers made from webs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2155/00—Flexible containers made from webs
    • B31B2155/001—Flexible containers made from webs by folding webs longitudinally
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2155/00—Flexible containers made from webs
    • B31B2155/001—Flexible containers made from webs by folding webs longitudinally
    • B31B2155/0014—Flexible containers made from webs by folding webs longitudinally having their openings facing transversally to the direction of movement
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2160/00—Shape of flexible containers
    • B31B2160/10—Shape of flexible containers rectangular and flat, i.e. without structural provision for thickness of contents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B50/00—Making rigid or semi-rigid containers, e.g. boxes or cartons
    • B31B50/26—Folding sheets, blanks or webs
    • B31B50/36—Folding sheets, blanks or webs by continuously feeding the sheets, blanks or webs to stationary members, e.g. plates, ploughs or cores
    • B31B50/38—Folding sheets, blanks or webs by continuously feeding the sheets, blanks or webs to stationary members, e.g. plates, ploughs or cores the members being forming-tubes
    • B31B50/40—Folding sheets, blanks or webs by continuously feeding the sheets, blanks or webs to stationary members, e.g. plates, ploughs or cores the members being forming-tubes acting internally
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/26—Folding sheets, blanks or webs
    • B31B70/262—Folding sheets, blanks or webs involving longitudinally folding, i.e. along a line parallel to the direction of movement
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/74—Auxiliary operations
    • B31B70/81—Forming or attaching accessories, e.g. opening devices, closures or tear strings
    • B31B70/84—Forming or attaching means for filling or dispensing contents, e.g. valves or spouts
    • B31B70/844—Applying rigid valves, spouts, or filling tubes

Definitions

  • the present invention relates to a method of manufacturing a flexible container for medical use. It also relates to an administration set comprising such a flexible container, in particular for the administration for medical purposes of a liquid contained in this container.
  • stem cells For example, to preserve stem cells by placing them in a storage bag with a cryoprotectant and then freezing this bag at a very low temperature, typically at -190 ° C. When the contents of the bag are required by a patient, the corresponding storage bag is released. The stem cells are then delivered to the patient by intravenous route.
  • This mortality is caused in the first place by the existence of stress zones in the storage pocket. These stress zones result from the assembly at their periphery of flat sheets of plastic to form the internal volume of the pocket.
  • This mortality is also the consequence of a non-uniform freezing / thawing rate over the entire internal volume of the storage bag.
  • the stressed cells die and therefore, it can not be guaranteed that a sufficient amount of live cells will be delivered to the patient.
  • So-called three-dimensional pockets formed of two flat sheets of plastic material are known which are connected on their periphery to define an internal volume, the walls being deformed during the assembling step of these walls to define a uniform and increased internal volume. on a large part of the storage pocket. This ensures a uniform freezing rate in this internal volume and, consequently, a decrease in the mortality of living cells.
  • the storage pockets of the state of the art are generally made of plasticized polyvinyl chloride (S-PVC) or ethylene-vinyl acetate or EVA. These materials have the advantage of offering some elasticity to ensure optimal filling of the internal volume of the pocket.
  • S-PVC plasticized polyvinyl chloride
  • EVA ethylene-vinyl acetate
  • these flexible S-PVC or EVA storage pockets include additives known as plasticisers, which can migrate into the liquid contained in the internal volume of these bags.
  • the objective of the present invention is therefore to propose a storage bag which is simple in its design and in its operating mode, economic and inert, offering an optimization of the storage volume for a given bulk without weakening thereof, this which results in the formation of a volume storage pocket.
  • the invention relates to a method according to claim 1 for forming at least one flexible container for medical use having a sealed internal volume for receiving a liquid.
  • this internal volume is closed by assembling the still free ends of the two plate portions at least partially placed one above the other, while maintaining a path or channel of access to this internal volume to allow access to the content.
  • This can be achieved, for example, by inserting between the plate portions of an access member to said internal volume of said container, and then assembling these portions and the access member. This assembly can be achieved by welding.
  • the access element may be, for illustrative purposes, a chimney.
  • flexible plate a single flexible sheet of an inert material or on the contrary, a superposition of several sheets, at least one designed to define the inner wall of the container is inert material, this assembly being flexible.
  • defect means a scratch, a fold, a stitch or a stretch constituting a weakening of the flexible container and likely to lead to cryogenization of this container to a rupture thereof.
  • step a) an edge of the plate is folded on the opposite edge thereof so as to duplicate this plate without generating a fold.
  • step c) the plate parts are assembled by welding.
  • the applicant has developed an experimental method for determining the minimum radius of curvature Rc.
  • a flexible plate identical to that used to manufacture the flexible containers is first taken. This flexible plate is folded on itself without generating a fold to form two superposed plate parts and possibly placed edge to edge.
  • a rod is placed on the outer surface of the upper plate portion. The rod is moved from its free end to the other end having the curved portion until the appearance of a fold on this curved portion. From the appearance of this fold, the operator knows that the minimum radius of curvature of the curved portion has been exceeded. The position of the end of the rod relative to the curved portion allows the operator to determine the value of this minimum radius of curvature Rc.
  • the conformation piece is placed perpendicularly or substantially perpendicular to the direction of travel of the flexible plate folded on itself.
  • the conformation piece is inserted between the plate portions so that the end of this conformation piece is placed at a distance from this curved portion.
  • this line of weakness is a pre-cut line consisting of perforations.
  • the invention also relates to an administration set according to claim 12 comprising a container obtained by the manufacturing method as described above and a transfer set connected to an access element to said internal volume of said container.
  • the Figure 1 shows one of the steps of manufacturing a flexible container according to a particular embodiment of the invention. Take a single sheet of inert material such as a polyolefin film or EVA or EVA derivatives in accordance with the prescriptions of the pharmacopoeia. One edge of this sheet is folded on the opposite edge thereof so as to duplicate this sheet. Care is taken during this step not to generate folds that could lead to embrittlement of the container and therefore a subsequent tear of the container during cryopreservation. This sheet being initially rectangular, it forms a band after folding.
  • inert material such as a polyolefin film or EVA or EVA derivatives
  • this conformation piece 4 is inserted so that its end 5 is placed at a distance, here about one quarter of the height of the internal volume, the end of the internal volume defined by the top of the curved portion 3 so as not to weaken this curved portion during assembly of the sheet portions 1, 2.
  • the sheet thus folded is advanced relative to the shaping piece 4, then a new junction line is formed to define the internal volume of another container.
  • the Figures 2 and 3 show a flexible and flexible container obtained by the method of manufacturing a flexible container as described above.
  • This container therefore comprises a single sheet of an inert material whose edge has been folded on the opposite edge of this sheet so as to duplicate it.
  • the superposed parts of this sheet thus folded were welded to define the side edges 6, 7 of the flexible container thus delimiting the internal volume.
  • This internal volume which is intended to receive a liquid, the medical solution, is therefore delimited by an upper portion 8, a lower portion 3 and side edges 6, 7.
  • the upper portion 8 and the side edges 6, 7 are not adapted to receive a liquid and are, in this sense, distinct from the internal volume. They each have a part in contact with the internal volume delimiting the upper end and the lateral edges of the latter.
  • the upper part 8 of the container comprises a port 9 allowing access to the internal volume of the container.
  • This access port 9 is, in known manner, taken between the thus connected walls of the container. It is here placed in the upper portion 8 of the flexible container.
  • This access port 9 comprises a lower orifice 10 intended to be placed in contact with the medical solution contained in the internal volume of the container and an upper portion 11 protruding from the container and intended to allow the attachment temporarily or permanently a coupling member of a transfer set or an intravenous line.
  • the shaping part used was a 2 mm thick U-shaped sheet with a diverging U-bar.
  • the length of the inserted portion of this sheet between the plate portions was 2/3 of the depth of the pocket produced.
  • the soft pouch material was 18% EVA manufactured by Renolit.

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  • 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)

Description

La présente invention concerne un procédé de fabrication d'un récipient souple à usage médical. Elle concerne également un ensemble d'administration comprenant un tel récipient souple, notamment pour l'administration à des fins médicales d'un liquide contenu dans ce récipient.The present invention relates to a method of manufacturing a flexible container for medical use. It also relates to an administration set comprising such a flexible container, in particular for the administration for medical purposes of a liquid contained in this container.

On connaît des systèmes de stockage à long terme de matériels biologiques. De tels systèmes sont utilisés dans le stockage, par exemple, de globules rouges extraits du sang ou encore de cellules souches conservées dans des biobanques.Long-term storage systems for biological materials are known. Such systems are used in storage, for example, red blood cells extracted from blood or stem cells stored in biobanks.

Il est connu, par exemple, d'assurer la conservation de cellules souches en plaçant celles-ci dans une poche de stockage avec un cryoprotecteur, puis en congelant cette poche à très basse température, typiquement à -190°C. Lorsque le contenu de la poche est requis par un patient, la poche de stockage correspondante est libérée. Les cellules souches sont ensuite délivrées au patient par simple voie intraveineuse.It is known, for example, to preserve stem cells by placing them in a storage bag with a cryoprotectant and then freezing this bag at a very low temperature, typically at -190 ° C. When the contents of the bag are required by a patient, the corresponding storage bag is released. The stem cells are then delivered to the patient by intravenous route.

Or, on observe après décongélation du contenu de la poche de stockage, une mortalité importante des cellules vivantes ainsi conservées.Now, after defrosting the contents of the storage bag, a significant mortality of the living cells thus conserved is observed.

Cette mortalité est causée en premier lieu par l'existence de zones de contrainte dans la poche de stockage. Ces zones de contraintes résultent de l'assemblage à leur périphérie de feuilles plates de matière plastique pour constituer le volume interne de la poche.This mortality is caused in the first place by the existence of stress zones in the storage pocket. These stress zones result from the assembly at their periphery of flat sheets of plastic to form the internal volume of the pocket.

Cette mortalité est la conséquence également d'une vitesse de congélation/décongélation non homogène sur l'ensemble du volume interne de la poche de stockage.This mortality is also the consequence of a non-uniform freezing / thawing rate over the entire internal volume of the storage bag.

Lors de la congélation, les cellules stressées meurent et en conséquence, on ne peut garantir l'administration d'une quantité suffisante de cellules vivantes au patient.During freezing, the stressed cells die and therefore, it can not be guaranteed that a sufficient amount of live cells will be delivered to the patient.

Il est donc rapidement apparu nécessaire d'augmenter le volume de stockage de la poche pour un encombrement donné afin de s'assurer d'une quantité suffisante de cellules vivantes après décongélation.It therefore quickly became necessary to increase the storage volume of the bag for a given size to ensure a sufficient amount of live cells after thawing.

On connaît ainsi des poches dites tridimensionnelles formées de deux feuilles plates de matière plastique qui sont reliées sur leur périphérie pour définir un volume interne, les parois étant déformées lors de l'étape d'assemblage de ces parois pour définir un volume interne uniforme et accru sur une grande partie de la poche de stockage. On s'assure ainsi d'une vitesse de congélation uniforme dans ce volume interne et, par conséquent, d'une baisse de la mortalité des cellules vivantes.So-called three-dimensional pockets formed of two flat sheets of plastic material are known which are connected on their periphery to define an internal volume, the walls being deformed during the assembling step of these walls to define a uniform and increased internal volume. on a large part of the storage pocket. This ensures a uniform freezing rate in this internal volume and, consequently, a decrease in the mortality of living cells.

On a cependant constaté que ces poches dites tridimensionnelles étaient fragilisées par la déformation provoquée aux parois de la poche délimitant le volume interne de stockage.However, it has been found that these so-called three-dimensional pockets are weakened by the deformation caused to the walls of the pocket delimiting the internal storage volume.

Ces parois qui présentent, en effet, des arêtes, peuvent présenter des déchirures lors de la cryogénisation de la poche de stockage, lesquelles entraîneront des fuites après décongélation de cette poche.These walls, which in fact have ridges, may have tears during cryopreservation of the storage bag, which will cause leaks after thawing of this bag.

Par ailleurs, les poches de stockage de l'état de l'art sont généralement réalisées en chlorure de polyvinyle plastifié (S-PVC) ou en éthylène-acétate de vinyle ou EVA. Ces matériaux présentent l'avantage d'offrir une certaine élasticité pour assurer un remplissage optimal du volume interne de la poche.In addition, the storage pockets of the state of the art are generally made of plasticized polyvinyl chloride (S-PVC) or ethylene-vinyl acetate or EVA. These materials have the advantage of offering some elasticity to ensure optimal filling of the internal volume of the pocket.

Toutefois, ces poches de stockage souples en S-PVC ou EVA comportent des additifs connus sous le nom de plastifiants, lesquels peuvent migrer dans le liquide contenu dans le volume interne de ces poches.However, these flexible S-PVC or EVA storage pockets include additives known as plasticisers, which can migrate into the liquid contained in the internal volume of these bags.

Or, il n'est pas désirable que ces éléments chimiques passent dans le sang du patient lors de l'administration du contenu de la poche de stockage car certains d'entre eux sont listés comme cancérigènes.However, it is not desirable that these chemical elements pass into the blood of the patient during the administration of the contents of the storage bag because some of them are listed as carcinogenic.

Il serait donc important de répondre à ces divers inconvénients en proposant une poche de stockage dont la conception originale permette de résoudre les problèmes techniques posés par les poches de stockage de l'art antérieur, comme le document FR 2528801 .It would therefore be important to address these various drawbacks by providing a storage pocket whose original design makes it possible to solve the technical problems posed by the storage pockets of the prior art, such as the document FR 2528801 .

L'objectif de la présente invention est donc de proposer une poche de stockage qui soit simple dans sa conception et dans son mode opératoire, économique et inerte, offrant une optimisation du volume de stockage pour un encombrement donné sans fragilisation de celle-ci, ce qui se traduit par la formation d'une poche de stockage volumique.The objective of the present invention is therefore to propose a storage bag which is simple in its design and in its operating mode, economic and inert, offering an optimization of the storage volume for a given bulk without weakening thereof, this which results in the formation of a volume storage pocket.

A cet effet, l'invention concerne un procédé selon la revendication 1 pour la formation d'au moins un récipient souple à usage médical comportant un volume interne étanche destiné à recevoir un liquide.For this purpose, the invention relates to a method according to claim 1 for forming at least one flexible container for medical use having a sealed internal volume for receiving a liquid.

Selon l'invention, on réalise au moins les étapes suivantes :

  1. a) on rabat une plaque souple unique sur elle-même sans générer de pliure pour former deux parties de plaque au moins partiellement placées l'une au dessus de l'autre, lesdites parties de plaque étant reliées entre elles par une portion courbe destinée à former une extrémité dudit volume interne,
  2. b) on assure un rayon de courbure Rc minimal de ladite portion courbe lors de l'assemblage desdites parties de plaque empêchant l'apparition d'un défaut au niveau de ladite portion courbe,
  3. c) on assemble lesdites parties de plaque le long d'au moins deux lignes de jonction, lesdites lignes de jonction étant espacées les unes des autres, au moins deux desdites lignes de jonction délimitant latéralement le volume interne dudit récipient passant par ladite portion courbe pour former les bords dudit récipient.
According to the invention, at least the following steps are carried out:
  1. a) a single flexible plate is folded onto itself without generating folds to form two plate portions at least partially placed one above the other, said plate portions being interconnected by a curved portion for forming an end of said internal volume,
  2. b) a minimum radius of curvature Rc of said curved portion is ensured during the assembly of said plate portions preventing the occurrence of a defect at said curved portion,
  3. c) assembling said plate portions along at least two connecting lines, said connecting lines being spaced from each other, at least two of said junction lines laterally delimiting the internal volume of said container passing through said curved portion to forming the edges of said container.

De préférence, après formation du volume interne de la poche, on ferme ce volume interne en assemblant les extrémités encore libres des deux parties de plaque au moins partiellement placées l'une au dessus de l'autre, tout en conservant un chemin ou canal d'accès à ce volume interne pour permettre d'accéder au contenu. Ceci peut être obtenu, par exemple, par l'insertion entre les parties de plaque d'un élément d'accès audit volume interne dudit récipient, puis à l'assemblage de ces parties et de l'élément d'accès. Cet assemblage peut être réalisé par soudure. L'élément d'accès peut être, à titre illustratif, une cheminée.Preferably, after formation of the internal volume of the pocket, this internal volume is closed by assembling the still free ends of the two plate portions at least partially placed one above the other, while maintaining a path or channel of access to this internal volume to allow access to the content. This can be achieved, for example, by inserting between the plate portions of an access member to said internal volume of said container, and then assembling these portions and the access member. This assembly can be achieved by welding. The access element may be, for illustrative purposes, a chimney.

On entend par "plaque souple", une unique feuille souple d'un matériau inerte ou au contraire, une superposition de plusieurs feuilles dont au moins celle destinée à définir la paroi interne du récipient est en matériau inerte, cet ensemble étant souple.The term "flexible plate", a single flexible sheet of an inert material or on the contrary, a superposition of several sheets, at least one designed to define the inner wall of the container is inert material, this assembly being flexible.

On entend par "défaut", une rayure, une pliure, une piqure ou un étirement constituant une fragilisation du récipient souple et susceptible de conduire lors de la cryogénisation de ce récipient à une rupture de celui-ci.The term "defect" means a scratch, a fold, a stitch or a stretch constituting a weakening of the flexible container and likely to lead to cryogenization of this container to a rupture thereof.

De préférence, à l'étape a), on rabat un bord de la plaque sur le bord opposé de celle-ci de manière à mettre en double cette plaque sans générer de pliure.Preferably, in step a), an edge of the plate is folded on the opposite edge thereof so as to duplicate this plate without generating a fold.

Avantageusement, à l'étape c), on assemble les parties de plaque par soudure.Advantageously, in step c), the plate parts are assembled by welding.

Le demandeur a développé une méthode expérimentale pour déterminer le rayon de courbure Rc minimal. Selon ce test, on prend préalablement une plaque souple identique à celle mise en oeuvre pour fabriquer les récipients souples. On rabat cette plaque souple sur elle-même sans générer de pliure pour former deux parties de plaque superposées et placées éventuellement bord à bord. On place une tige sur la surface externe de la partie de plaque supérieure. On déplace ladite tige en partant de son extrémité libre vers l'autre extrémité comportant la portion courbe jusqu'à observer l'apparition d'une pliure sur cette portion courbe. Dés l'apparition de cette pliure, l'opérateur sait que le rayon de courbure minimal de la portion courbe a été dépassé. La position de l'extrémité de la tige par rapport à la portion courbe permet à l'opérateur de déterminer la valeur de ce rayon de courbure Rc minimal.The applicant has developed an experimental method for determining the minimum radius of curvature Rc. According to this test, a flexible plate identical to that used to manufacture the flexible containers is first taken. This flexible plate is folded on itself without generating a fold to form two superposed plate parts and possibly placed edge to edge. A rod is placed on the outer surface of the upper plate portion. The rod is moved from its free end to the other end having the curved portion until the appearance of a fold on this curved portion. From the appearance of this fold, the operator knows that the minimum radius of curvature of the curved portion has been exceeded. The position of the end of the rod relative to the curved portion allows the operator to determine the value of this minimum radius of curvature Rc.

Dans différents modes de réalisation particuliers de ce procédé de fabrication, chacun ayant ses avantages particuliers et susceptibles de nombreuses combinaisons techniques possibles:

  • à l'étape b), on insère entre lesdites parties de plaque une pièce de conformation destinée à garantir un rayon de courbure Rc minimal de ladite portion courbe lors de l'assemblage,
In various particular embodiments of this manufacturing method, each having its particular advantages and susceptible to many possible technical combinations:
  • in step b), there is inserted between said plate portions a shaping piece intended to guarantee a minimum radius of curvature Rc of said curved portion during assembly,

De préférence, la pièce de conformation est placée perpendiculairement ou sensiblement perpendiculairement au sens de défilement de la plaque souple rabattue sur elle-même.Preferably, the conformation piece is placed perpendicularly or substantially perpendicular to the direction of travel of the flexible plate folded on itself.

De préférence, on insère la pièce de conformation entre les parties de plaque de sorte que l'extrémité de cette pièce de conformation soit placée à distance de cette portion courbe.Preferably, the conformation piece is inserted between the plate portions so that the end of this conformation piece is placed at a distance from this curved portion.

Cette distance est, par exemple, de l'ordre de 1/4 de la hauteur du volume interne du récipient souple. On cherche en effet, à éviter l'apparition de rayures susceptibles de fragiliser le récipient souple, la zone sensible étant constituée par le fond ou portion courbe de ce récipient.

  • ladite pièce de conformation est une feuille rigide ou une portion rigide en forme de U dont les branches s'écartent l'une de l'autre en s'éloignant du fond du U,
  • à l'étape b), on insère entre lesdites parties de plaque un ballonnet gonflable, ledit ballonnet étant dans son état gonflé destiné à garantir ledit rayon de courbure Rc minimal,
  • à l'étape b), on introduit un fluide sous pression entre lesdites parties de plaque pour garantir ledit rayon de courbure Rc minimal,
  • avant l'étape c), on s'assure du positionnement bord à bord desdites parties de plaque,
This distance is, for example, of the order of 1/4 of the height of the internal volume of the flexible container. In fact, it is sought to avoid the appearance of scratches likely to weaken the flexible container, the sensitive area being constituted by the bottom or curved portion of this container.
  • said conformation piece is a rigid sheet or a U-shaped rigid portion whose branches deviate from each other while moving away from the bottom of the U,
  • in step b), there is inserted between said plate portions an inflatable balloon, said balloon being in its inflated state for guaranteeing said minimum radius of curvature Rc,
  • in step b), a pressurized fluid is introduced between said plate portions to guarantee said minimum radius of curvature Rc,
  • before step c), it ensures the positioning edge of said plate portions,

On cherche à s'assurer du parallélisme des parties superposées de plaque souple ainsi rabattue en vue de leur assemblage de manière à fabriquer des récipients souples dont les dimensions sont régulières.It is sought to ensure the parallelism of the superimposed portions of flexible plate thus folded for assembly so as to produce flexible containers whose dimensions are regular.

Pour cela, la pièce de conformation pourra comporter des butées destinées à assurer le parallélisme desdites parties de plaque. De préférence, ces parties de plaque sont placées bord à bord après l'étape a).

  • après l'étape c), on retire ladite pièce de conformation, ou ledit ballonnet gonflable, du volume interne ainsi défini, puis on introduit de nouveau ladite pièce de conformation, ou ledit ballonnet gonflable, entre lesdites parties de plaque mais à l'extérieur dudit volume interne précédemment formé et on assemble lesdites parties de plaque le long d'au moins une nouvelle ligne de jonction passant par ladite portion courbe pour délimiter une portion de volume interne d'un autre récipient,
For this, the conformation piece may include stops for ensuring the parallelism of said plate portions. Preferably, these plate portions are placed edge to edge after step a).
  • after step c), said conformation piece, or said inflatable balloon, is removed from the internal volume thus defined, and then said conformation piece, or said inflatable balloon, is introduced again between said plate portions but outside said previously formed internal volume and joining said plate portions along at least one new junction line passing through said curved portion to delimit an internal volume portion of another container,

On répète éventuellement ces étapes pour former autant de volumes internes, et par conséquent de récipients, que nécessaires.

  • ladite pièce de conformation, ou ledit ballonnet gonflable, étant fixe, on applique une tension sur un bord de ladite plaque ainsi rabattue pour maintenir le rayon de courbure Rc d'au moins la portion de la plaque ainsi rabattue comprise entre ladite pièce de conformation, ou ledit ballonnet gonflable, et ledit bord,
  • on guide la plaque ainsi rabattue avec des moyens de guidage pour maintenir les extrémités rabattues de la plaque,
  • à l'étape c), on réalise au moins une ligne de jonction supplémentaire pour fractionner ledit volume interne,
  • on réalise sur au moins une desdites lignes de jonction, une ligne d'affaiblissement.
These steps are optionally repeated to form as many internal volumes, and therefore containers, as necessary.
  • said conformation piece, or said inflatable balloon, being fixed, a tension is applied on an edge of said plate thus folded to maintain the radius of curvature Rc of at least the portion of the plate thus folded between said conformation piece, or said inflatable balloon, and said edge,
  • the plate thus folded is guided with guiding means to hold the folded ends of the plate,
  • in step c), at least one additional junction line is made to split said internal volume,
  • at least one of said connecting lines is provided with a weakening line.

A titre d'exemple, cette ligne d'affaiblissement est une ligne de prédécoupe constituée de perforations.By way of example, this line of weakness is a pre-cut line consisting of perforations.

>>

L'invention concerne encore un ensemble d'administration selon la revendication 12 comprenant un récipient obtenu par le procédé de fabrication tel que décrit précédemment et un set de transfert relié à un élément d'accès audit volume interne dudit récipient.The invention also relates to an administration set according to claim 12 comprising a container obtained by the manufacturing method as described above and a transfer set connected to an access element to said internal volume of said container.

L'invention sera décrite plus en détail en référence aux dessins annexés dans lesquels:

  • la figure 1 montre de manière schématique une feuille rabattue sur elle-même, une pièce de conformation étant insérée entre les parties de la feuille ainsi rabattues selon un mode de réalisation de l'invention;
  • la figure 2 représente schématiquement un récipient souple selon un mode de réalisation préférée de l'invention;
  • la figure 3 est une vue en coupe selon l'axe A-A du récipient souple de la figure 2;
The invention will be described in more detail with reference to the accompanying drawings in which:
  • the figure 1 shows schematically a folded sheet on itself, a conformation piece being inserted between the parts of the sheet thus folded according to one embodiment of the invention;
  • the figure 2 schematically represents a flexible container according to a preferred embodiment of the invention;
  • the figure 3 is a sectional view along the axis AA of the flexible container of the figure 2 ;

La Figure 1 montre une des étapes de fabrication d'un récipient souple selon un mode de réalisation particulier de l'invention. On prend une feuille unique en matériau inerte tel qu'un film de polyoléfines ou en EVA ou dérivés d'EVA conforme aux prescriptions de la pharmacopée. On rabat un bord de cette feuille sur le bord opposé de celle-ci de manière à mettre en double cette feuille. On prend bien soin lors de cette étape de ne pas générer de pliures qui pourraient entraîner une fragilisation du récipient et par conséquent une déchirure ultérieure de ce récipient lors de la cryogénisation. Cette feuille étant initialement rectangulaire, elle forme une bande après rabattement.The Figure 1 shows one of the steps of manufacturing a flexible container according to a particular embodiment of the invention. Take a single sheet of inert material such as a polyolefin film or EVA or EVA derivatives in accordance with the prescriptions of the pharmacopoeia. One edge of this sheet is folded on the opposite edge thereof so as to duplicate this sheet. Care is taken during this step not to generate folds that could lead to embrittlement of the container and therefore a subsequent tear of the container during cryopreservation. This sheet being initially rectangular, it forms a band after folding.

On obtient ainsi deux parties de feuille 1, 2 placées l'une au dessus de l'autre, ces parties étant reliées entre elles par une portion courbe 3.Thus, two sheet portions 1, 2 are placed one above the other, these parts being interconnected by a curved portion 3.

Puis, on insère entre ces parties de feuille 1, 2, une pièce de conformation 4 destinée à garantir un rayon de courbure Rc minimal de la portion courbe 3 lors de l'assemblage de ces parties de feuille 1, 2 afin d'empêcher l'apparition d'un défaut.Then, there is inserted between these parts of sheet 1, 2, a conformation piece 4 intended to guarantee a minimum radius of curvature Rc of the curved portion 3 during the assembly of these parts of sheet 1, 2 in order to prevent the appearance of a defect.

Comme le montre la Figure 1, cette pièce de conformation 4 est insérée de sorte que son extrémité 5 soit placée à distance, ici environ un quart de la hauteur du volume interne, de l'extrémité du volume interne définie par le sommet de la portion courbe 3 de manière à ne pas fragiliser cette portion courbe lors de l'assemblage des parties de feuille 1, 2.As shown in Figure 1 this conformation piece 4 is inserted so that its end 5 is placed at a distance, here about one quarter of the height of the internal volume, the end of the internal volume defined by the top of the curved portion 3 so as not to weaken this curved portion during assembly of the sheet portions 1, 2.

Un bord de la feuille ainsi rabattue est inséré entre deux axes d'entrainement permettant de faire défiler cette feuille par rapport à la pièce de conformation 4 dont la position est fixée. Ces axes d'entrainement qui sont ici des rouleaux, permettent également d'exercer une tension sur ce bord de la feuille pour maintenir le rayon de courbure Rc de la portion de la feuille ainsi rabattue comprise entre la pièce de conformation 4 et ce bord.An edge of the sheet thus folded is inserted between two drive shafts to scroll this sheet relative to the shaping piece 4 whose position is fixed. These drive axes which are here rollers, also allow to exert tension on this edge of the sheet to maintain the radius of curvature Rc of the portion of the sheet thus folded between the shaping piece 4 and this edge.

On soude ces parties de feuille le long de deux lignes de jonction 6, 7 passant par la portion courbe 3, ces lignes de jonction étant espacées les unes des autres pour définir les bords délimitant latéralement le volume interne du récipient. Eventuellement et à titre purement illustratif, une ligne de jonction supplémentaire est réalisée pour diviser ce volume interne. Toutefois, cette ligne de jonction supplémentaire ne passe pas par la portion courbe 3. Le liquide reçu dans le volume interne du récipient peut donc passer d'un compartiment à l'autre du volume interne ainsi divisé. Cette ligne de jonction supplémentaire séparera le volume interne en deux compartiments distincts par une soudure réalisée ultérieurement au remplissage du récipient souple.These sheet portions are welded along two connecting lines 6, 7 passing through the curved portion 3, these connecting lines being spaced from each other to define the edges laterally delimiting the internal volume of the container. Optionally and purely for illustrative purposes, an additional junction line is made to divide this internal volume. However, this additional junction line does not pass through the curved portion 3. The liquid received in the internal volume of the container can therefore pass from one compartment to another of the internal volume thus divided. This additional junction line will separate the internal volume into two separate compartments by a weld subsequently made to fill the flexible container.

Après formation de ce volume interne initial, on fait avancer la feuille ainsi rabattue par rapport à la pièce de conformation 4, puis on forme une nouvelle ligne de jonction pour définir le volume interne d'un autre récipient.After forming this initial internal volume, the sheet thus folded is advanced relative to the shaping piece 4, then a new junction line is formed to define the internal volume of another container.

On répète ces étapes pour former autant de récipients souples que nécessaires.These steps are repeated to form as many flexible containers as necessary.

Les Figures 2 et 3 montrent un récipient souple et flexible obtenu par le procédé de fabrication d'un récipient souple tel que décrit précédemment.The Figures 2 and 3 show a flexible and flexible container obtained by the method of manufacturing a flexible container as described above.

Ce récipient comporte donc une unique feuille d'un matériau inerte dont un bord a été rabattu sur le bord opposé de cette feuille de manière à mettre en double celle-ci. Les parties superposées de cette feuille ainsi rabattue ont été soudés pour définir les bords latéraux 6, 7 du récipient souple délimitant ainsi le volume interne.This container therefore comprises a single sheet of an inert material whose edge has been folded on the opposite edge of this sheet so as to duplicate it. The superposed parts of this sheet thus folded were welded to define the side edges 6, 7 of the flexible container thus delimiting the internal volume.

Ce volume interne qui est destiné à recevoir un liquide, la solution médicale, est donc délimité par une portion supérieure 8, une portion inférieure 3 et des bords latéraux 6, 7.This internal volume which is intended to receive a liquid, the medical solution, is therefore delimited by an upper portion 8, a lower portion 3 and side edges 6, 7.

Alors que la portion inférieure 3 peut recevoir un liquide, la portion supérieure 8 et les bords latéraux 6, 7 ne sont pas aptes à recevoir un liquide et sont, en ce sens, distincts du volume interne. Ils ont toutefois chacun une partie en contact avec le volume interne délimitant l'extrémité supérieure et les bords latéraux de ce dernier.While the lower portion 3 can receive a liquid, the upper portion 8 and the side edges 6, 7 are not adapted to receive a liquid and are, in this sense, distinct from the internal volume. They each have a part in contact with the internal volume delimiting the upper end and the lateral edges of the latter.

La partie supérieure 8 du récipient comprend un port 9 permettant l'accès au volume interne du récipient. Ce port d'accès 9 est, de manière connue, pris entre les parois ainsi reliées du récipient. Il est ici placé dans la portion supérieure 8 du récipient souple. Ce port d'accès 9 comporte un orifice inférieur 10 destiné à être placé en contact avec la solution médicale contenue dans le volume interne du récipient et une partie supérieure 11 formant saillie du récipient et destinée à permettre l'attachement de manière temporaire ou définitive d'un organe de couplage d'un set de transfert ou d'une ligne intraveineuse.The upper part 8 of the container comprises a port 9 allowing access to the internal volume of the container. This access port 9 is, in known manner, taken between the thus connected walls of the container. It is here placed in the upper portion 8 of the flexible container. This access port 9 comprises a lower orifice 10 intended to be placed in contact with the medical solution contained in the internal volume of the container and an upper portion 11 protruding from the container and intended to allow the attachment temporarily or permanently a coupling member of a transfer set or an intravenous line.

A titre purement illustratif et dans un mode de mise en oeuvre particulier de la présente invention, des poches souples ayant une soudure de coté de 90 mm de longueur avec une largeur de soudure de 3 mm ont été réalisées. Le compartiment ainsi formé présentait une largeur de 90 mm intérieur définissant ainsi le volume intérieur de la poche souple.For purely illustrative purposes and in a particular embodiment of the present invention, flexible bags having a side weld of 90 mm in length with a weld width of 3 mm were made. The compartment thus formed had a width of 90 mm inside thus defining the interior volume of the flexible pouch.

La pièce de conformation utilisée était une tôle de 2 mm d'épaisseur en forme de U avec barre de U divergente. La longueur de la partie insérée de cette tôle entre les parties de plaque était de 2/3 de la profondeur de la poche produite.The shaping part used was a 2 mm thick U-shaped sheet with a diverging U-bar. The length of the inserted portion of this sheet between the plate portions was 2/3 of the depth of the pocket produced.

La matière de la poche souple était de l'EVA 18% fabriqué par la société Renolit.The soft pouch material was 18% EVA manufactured by Renolit.

Claims (12)

  1. Method for forming one or more flexible vessels for medical use, each comprising an impermeable internal volume designed to receive a liquid, characterized in that at least the following steps are performed:
    a) a single flexible sheet is folded over onto itself without generating fold marks so as to form two sheet portions positioned at least in part one above the other, said sheet portions being connected to each other by a curved portion (3) designed to form one extremity of said internal volume, said curved portion (3) being solely formed from a portion of said flexible sheet,
    b) a minimum radius of curvature Rc for said curved portion (3) is ensured during the assembly of said sheet portions preventing the occurrence of a defect at the location of said curved portion (3) designed to form the bottom of said vessel or vessels,
    c) said sheet portions are assembled along at least two joining lines, said joining lines being spaced apart from each other, at least two said joining lines (6, 7) delimiting laterally the internal volume of a vessel, passing via said curved portion (3) to form the edges of said vessel, and in that
    - the extremity of said vessel comprising said curved portion being solely formed from said curved portion (3) and of the joining lines (6, 7) delimiting laterally said vessel's internal volume, said curved portion (3) having no defects weakening this vessel and consequently likely to lead to a breach of this vessel when it is subjected to cryogenic temperatures.
  2. Method according to claim 1, characterized in that at step b), a conformation member (4) is inserted between said sheet portions designed to guarantee a minimum radius of curvature Rc for said curved portion (3) during assembly.
  3. Method according to claim 2, characterized in that said conformation member (4) is inserted between said sheet portions such that the extremity of said conformation member (4) is positioned away from said curved portion (3).
  4. Method according to claim 2 or 3, characterized in that said conformation member (4) is a U-shaped rigid sheet or rigid portion whose branches get further apart the further they are from the bottom of the U.
  5. Method according to claim 1, characterized in that at step b), an inflatable bag is inserted between said sheet portions, said bag being in its inflated state designed to guarantee said minimum radius of curvature Rc.
  6. Method according to any one of claims 1 to 5, characterized in that before step c), the edge-to-edge positioning of said sheet portions is verified.
  7. Method according to any one of claims 2 to 4 and to claim 6, characterized in that said conformation member (4) comprises stops to ensure the parallelism of said sheet portions.
  8. Method according to any one of claims 2 to 4 or 5, characterized in that after step c), said conformation member (4) or said inflatable bag is removed from the internal volume thus defined, then said conformation member (4) or said inflatable bag is again inserted between said sheet portions, but on the outside of said previously defined internal volume and in that said sheet portions are assembled along at least one new joining line passing via said curved portion (3) to delimit a portion of another vessel's internal volume.
  9. Method according to any one of claims 1 to 4 or 5, characterized in that with said conformation member (4) or said inflatable bag being fixed in place, tension is applied onto an edge of said sheet thus folded over so as to maintain the radius of curvature Rc of at least the portion of the sheet thus folded over included between said conformation member (4) or said inflatable bag and said edge.
  10. Method according to any one of claims 1 to 9, characterized in that at step c), at least one additional joining line is realized so as to split said internal volume.
  11. Method according to any one of claims 1 to 10, characterized in that a weakening line is realized on at least one of said joining lines.
  12. Administration set comprising a vessel obtained by the manufacturing method according to any one of claims 1 to 11 and a transfer set, one of said vessel's extremities being solely formed from joining lines delimiting the internal volume of this vessel laterally and of a curved portion (3) having no defects weakening this vessel and consequently likely to lead to a breach of this vessel when it is subjected to cryogenic temperatures.
EP10196326.2A 2009-12-24 2010-12-21 Method for manufacturing a flexible container for medical use Not-in-force EP2351643B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR0959592A FR2954694B1 (en) 2009-12-24 2009-12-24 PROCESS FOR MANUFACTURING A FLEXIBLE CONTAINER FOR MEDICAL USE

Publications (2)

Publication Number Publication Date
EP2351643A1 EP2351643A1 (en) 2011-08-03
EP2351643B1 true EP2351643B1 (en) 2013-12-11

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Application Number Title Priority Date Filing Date
EP10196326.2A Not-in-force EP2351643B1 (en) 2009-12-24 2010-12-21 Method for manufacturing a flexible container for medical use

Country Status (3)

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EP (1) EP2351643B1 (en)
DK (1) DK2351643T3 (en)
FR (1) FR2954694B1 (en)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2528801B1 (en) * 1982-06-22 1986-10-17 Etude Applic Indle Brevets FLEXIBLE BAG FOR THE SLOW FLOW OF A LIQUID MEDIUM, METHOD AND MACHINE FOR MAKING SAME
DE4234957C2 (en) * 1992-10-16 1996-12-12 Fresenius Ag Flexible plastic bag for medical solutions

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EP2351643A1 (en) 2011-08-03
FR2954694A1 (en) 2011-07-01
DK2351643T3 (en) 2014-03-17
FR2954694B1 (en) 2013-02-15

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