EP2351643A1 - Verfahren zur Herstellung eines flexiblen Behälters zum medizinischen Einsatz - Google Patents

Verfahren zur Herstellung eines flexiblen Behälters zum medizinischen Einsatz Download PDF

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Publication number
EP2351643A1
EP2351643A1 EP10196326A EP10196326A EP2351643A1 EP 2351643 A1 EP2351643 A1 EP 2351643A1 EP 10196326 A EP10196326 A EP 10196326A EP 10196326 A EP10196326 A EP 10196326A EP 2351643 A1 EP2351643 A1 EP 2351643A1
Authority
EP
European Patent Office
Prior art keywords
internal volume
plate
curved portion
container
plate 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.)
Granted
Application number
EP10196326A
Other languages
English (en)
French (fr)
Other versions
EP2351643B1 (de
Inventor
François CAPITAINE
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 EP2351643A1 publication Critical patent/EP2351643A1/de
Application granted granted Critical
Publication of EP2351643B1 publication Critical patent/EP2351643B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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 for forming at least one flexible container for medical use comprising 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 a flexible container for medical use comprising a sealed internal volume for receiving a liquid, an upper portion and a lower portion of said container, said internal volume being placed between said upper and lower portions of said container, said container comprising more than one access element to said internal volume.
  • said internal volume is delimited by a single flexible plate folded on itself and of which only the lateral edges and the upper part receiving said at least one access element are assembled at least on their periphery and in that said internal volume being filled, the lower portion has a radius of curvature greater than or equal to Rc.
  • Rc is here the minimum radius of curvature Rc of the curved portion obtained by folding a flexible plate on itself, during the assembly of the plate parts.
  • this assembly can be achieved by welding or gluing.
  • the invention also relates to an administration set 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.

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)
EP10196326.2A 2009-12-24 2010-12-21 Verfahren zur Herstellung eines flexiblen Behälters zum medizinischen Einsatz Not-in-force EP2351643B1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR0959592A FR2954694B1 (fr) 2009-12-24 2009-12-24 Procede de fabrication d'un recipient souple a usage medical

Publications (2)

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

Family

ID=42341349

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10196326.2A Not-in-force EP2351643B1 (de) 2009-12-24 2010-12-21 Verfahren zur Herstellung eines flexiblen Behälters zum medizinischen Einsatz

Country Status (3)

Country Link
EP (1) EP2351643B1 (de)
DK (1) DK2351643T3 (de)
FR (1) FR2954694B1 (de)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2528801A1 (fr) * 1982-06-22 1983-12-23 Etude Applic Indle Brevets Sachet souple pour l'ecoulement lent d'un milieu liquide, procede et machine pour le fabriquer
DE4234957A1 (de) * 1992-10-16 1994-04-21 Fresenius Ag Verpackung für medizinische Lösungen, insbesondere flexibler Kunststoffbeutel

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2528801A1 (fr) * 1982-06-22 1983-12-23 Etude Applic Indle Brevets Sachet souple pour l'ecoulement lent d'un milieu liquide, procede et machine pour le fabriquer
DE4234957A1 (de) * 1992-10-16 1994-04-21 Fresenius Ag Verpackung für medizinische Lösungen, insbesondere flexibler Kunststoffbeutel

Also Published As

Publication number Publication date
FR2954694A1 (fr) 2011-07-01
EP2351643B1 (de) 2013-12-11
DK2351643T3 (en) 2014-03-17
FR2954694B1 (fr) 2013-02-15

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