EP0102302B1 - Beutel für medizinischen Gebrauch, insbesondere bestimmt für parenterale Ernährung - Google Patents

Beutel für medizinischen Gebrauch, insbesondere bestimmt für parenterale Ernährung Download PDF

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Publication number
EP0102302B1
EP0102302B1 EP83401732A EP83401732A EP0102302B1 EP 0102302 B1 EP0102302 B1 EP 0102302B1 EP 83401732 A EP83401732 A EP 83401732A EP 83401732 A EP83401732 A EP 83401732A EP 0102302 B1 EP0102302 B1 EP 0102302B1
Authority
EP
European Patent Office
Prior art keywords
bag
frame
sheets
pocket
flat
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP83401732A
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English (en)
French (fr)
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EP0102302A2 (de
EP0102302A3 (en
Inventor
Etienne Porges
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.)
Synthelabo SA
Original Assignee
Synthelabo 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 Synthelabo SA filed Critical Synthelabo SA
Priority to AT83401732T priority Critical patent/ATE21028T1/de
Publication of EP0102302A2 publication Critical patent/EP0102302A2/de
Publication of EP0102302A3 publication Critical patent/EP0102302A3/fr
Application granted granted Critical
Publication of EP0102302B1 publication Critical patent/EP0102302B1/de
Expired legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00—Bottles and jars
    • Y10S215/90—Collapsible wall structure

Definitions

  • the present invention relates to bags for medical use, and more specifically relates to bags intended for parenteral feeding.
  • Parenteral feeding is an artificial mode of nutrition which consists in bringing intravenously to a patient, who can no longer eat totally or partially using the physiological digestive tract, all the elements necessary for his nutrition.
  • parenteral nutrition must be total, it is desirable to rationally combine the three types of nutrients: carbohydrates, in the form of glucose most often, proteins, in the form of balanced mixtures of amino acids, lipids, as well as additives such as electrolytes, trace elements, and vitamins, which are in the form of emulsions, solutes, and suspensions in water, which are injectable.
  • the industrial association of glucose and amino acids within the same aqueous medium is difficult because of the Maillard reaction.
  • the combination of reducing sugars with amino acids leads to the formation of new organic compounds whose coloring ranges from yellow to dark brown, and this reaction has other drawbacks, in particular the appearance of active or non-metabolizable compounds , even toxic, and above all a modification of the nutritional value of the mixture.
  • the nutritive mixture is generally prepared extemporaneously, or in the 24 hours which precede the administration to the patient.
  • a set has long been used comprising a small glass vial filled with amino acids and capped under vacuum, a larger volume vial partially filled with glucose and capped under vacuum, as well as a tube provided with a end of a perforator and a built-in air intake, and at the other end of a perforation needle.
  • this tubing and its perforators the operator transfers the amino acids from the small bottle into the glucose contained in the large bottle, thanks to the vacuum in the latter.
  • handling errors are relatively frequent, that handling of the vials is not carried out under good aseptic conditions, and that a non-negligible part of the amino acids does not transfer into glucose. so that it is necessary to add an air intake to the bottle to be emptied.
  • these glass bottles have the disadvantages of being awkward to store and delicate to transport.
  • Reusable bags made of silicone elastomer, which were initially replaced by glass bottles, have recently been replaced by disposable plastic bags, most often polyvinyl chloride, or polyethylene polyvinylacetate, inspired by the production of bags of liquids usually used in infusion.
  • Such a pocket is most often made up of two rectangular sheets of plastic material welded flat one on the other on four sides, so as to delimit between the two sheets and the four welded sides, a tank whose volume is zero until it is filled under pressure.
  • a reinforcing element also made of plastic, is inserted between the two opposite faces of the two sheets and welded to the latter, and this reinforcing element has perforations through which it is possible to hang or hang the pocket.
  • one or more tubes are introduced between the two sheets and welded to the latter in a sealed manner to allow the filling or emptying of the pocket, as well as the extemporaneous addition of additional medication to the nutritious mixture possibly contained in this pocket.
  • a pocket of this type is described. in U.S. patents 3,788,369 and FR. 2,431,289, and pockets of neighboring structure are described in U.S. Patents 3,740,770 and 3,342,326.
  • plastic sheets used have a relatively large thickness, which is generally between 300 and 400 microns.
  • the production of these pockets therefore results in a significant consumption of plastic materials, and, in their application to parenteral nutrition, the nutritive mixtures must be prepared in these pockets, extemporaneously or shortly before administration to the patient, because, as has already been specified, and unlike fluids usually used in infusion, parenteral feeding mixtures are fragile and the amino acids they include are easily oxidizable by oxygen in the air.
  • these bags in their application to parenteral nutrition, are used as a means of administration of a nutritive mixture prepared extemporaneously, and not as a means of storing a ready-to-use nutritive mixture, prepared industrially and also carried in his pocket.
  • the invention aims to provide a bag having a vacuum of practically zero volume, therefore easy to store, which can be filled without the need to exercise significant pressure on its faces, and therefore on the welds, so that the bag is less fragile to transport when filled.
  • Another object of the invention is also a pocket which has sufficient mechanical strength, although the plastic sheets used for the production of these faces are much less thick than in the prior art.
  • Another object of the invention is to produce a bag having no sealing problem at the level of the passages of the pipes.
  • the object of the invention is to produce ready-to-use bags, prepared and filled on an industrial scale with nutritive mixtures intended for parenteral nutrition, and in which it is possible to store and transport these mixtures, these bags can finally also be used as a means of administration.
  • a bag according to the invention intended to contain injectable products, and which has two faces each consisting of a flexible sheet comprising at least one layer of plastic material, is characterized in that it comprises a frame of semi-rigid plastic frame with flat faces, and in that the two sheets, each of which is shaped and rounded, for example by thermoforming, and has substantially the shape of at least one bowl with a flat bottom, are secured in a sealed manner, for example by press welding, by parts of sheets which surround the concave part of each bowl, on either side of the frame, each on one of the two flat faces of the latter, so that the sheets are nested one inside the other at rest, on the same side of the plane of symmetry passing through the thickness of the frame, in order to delimit, between the two sheets and in at least one opening of the frame, a variable volume chamber, and the volume is practically zero when the pocket is at rest.
  • the latter which open on the one hand outside the pocket and, on the other hand, inside the pocket between the two sheets of the latter, pass through the thickness of one side of the frame and preferably extend towards the outside of the frame by end caps.
  • the frame of a pocket according to the invention is advantageously produced in one piece by injection molding under press.
  • the two sheets of a pocket each have at least one part which extends beyond at least one side of the frame crossed by at least one tube, and which delimits with the corresponding part of the other sheet , and to which it is preferably secured, an annex pocket for protecting the pipes, and possibly the ends of the latter. It is thus essential to open the additional protective pocket, either by tearing it, possibly at a part of less resistance provided for this purpose, or by cutting it, in order to access the pipes.
  • the bag according to the invention comprises at least two tubes, one of which is definitively closed after filling the bag,
  • one of the sides of the frame which is not crossed by pipes has at least one hooking and / or hanging pocket opening and / or at least one 'hooking member and / or hanging from the pocket.
  • each sheet of the pouch consists of a complex film of materials in thin layers, comprising at least one layer which constitutes a barrier impermeable to atmospheric gases and to water vapor, for example made of polyvinylidene chloride, sandwiched between at least two layers, at least one of which, located towards the inside of the pocket, is made of a compatible material with the contents of the bag, and does not contain harmful, toxic or plasticizing elements which are extractable by this content, for example made of polyethylene polyvinylacetate.
  • the assembly formed by these three layers can itself be sandwiched between two layers of a plastic material, for example polyethylene.
  • each complex film constituting one of the sheets of the pocket comprises at least one thin metallic layer, for example aluminum.
  • the latter is preferably made of the same plastic material as the layer of the complex film with which it comes into contact through its flat faces.
  • the pocket shown in Figures 1 and 2 comprises two transparent sheets 1, each consisting of a complex film of thin layers of plastic.
  • This complex film which always comprises at least one layer constituting a tight barrier to atmospheric gases and water vapor, comprises in a first embodiment, a central layer of polyvinylidene chloride sandwiched between two layers of polyethylene polyvinylacetate .
  • This set of three layers, in which the central layer of polyvinylidene chloride constitutes the waterproof barrier can itself be sandwiched between two layers of another plastic material, for example polyethylene, or any other plastic material compatible with the contents of the bag, and containing no plasticizing elements such as polyvinyl chloride, nor harmful or toxic ingredients which can be extracted by the contents of the bag.
  • the complex films in which the sheets 1 are cut do not necessarily have a symmetrical structure, and this structure can not only comprise a greater or lesser number of plastics in thin layers but also a thin metallic layer, for example a layer of aluminum, which will not be placed on one side of the film.
  • the two flexible sheets 1 which constitute the faces of the pocket each have an initial planar and rectangular shape. On most of their surfaces, each of these two sheets 1 is shaped and curved by thermoforming, so that it has substantially the shape of a dish with a flat bottom 1 ', surrounded by a flat rim, and adjacent along a part of this rim to the flat, undeformed part 1 "of the sheet 1.
  • the depth of the flat-bottomed bowl 1 ′ is limited to a few centimeters and chosen according to the final volume of the pocket that the 'we wish to obtain.
  • the pocket also includes a semi-rigid frame frame 2, the two lateral faces of which are flat, and which has a single central opening, the shape of which in plan corresponds substantially to that of the dished portion in a flat-bottomed bowl 1 'of each sheet 1.
  • the width of the flat edges of the frame 2 which surround its central opening is substantially equal to that of the flat rim of each sheet 1 which surrounds the part of the latter shaped as a flat-bottomed bowl 1' , except at an enlarged side 3 of the frame 2.
  • This enlarged side 3 has two circular lateral perforations 4, intended to allow the suspension and the attachment of the frame 2 to a bracket or the passage of suspension members and d hooking the frame 2 to a bracket, as well as an elongated central perforation 5 which delimits a grip and transport handle for the user and which has a central notch 6 on the side opposite to the opening of the frame, in order to allow also t the attachment and suspension of the frame 2 either directly or using an attachment member.
  • the frame 2 has on its side 7 opposite to the enlarged side 3 two tubes made up of tubular end pieces 8 projecting relative to the side 7 towards the outside of the frame 2, in the direction opposite to the central opening of the latter, and the axial passage conduits of the end pieces 8 extend in the thickness of the side 7 and open into the central opening of the frame 2.
  • the frame 2 is produced by injection under press of a plastic material which is that of the surface layers of the complex films of the sheets 1 against which the frame 2 comes into contact, during assembly of the bag.
  • This assembly is carried out by press welding of the flat rim of each of the sheets 1 "which surrounds the part in the form of a flat-bottomed bowl 1 'against one of the flat faces of the frame 2, around the central opening of the latter. so that the two sheets 1 are tightly joined to the frame 2 on either side of the latter 2.
  • the sheets 1 are welded to the frame 2 asymmetrically, being arranged so that the two concave parts substantially in the form of a flat-bottomed bowl 1 ′ are nested one inside the other, as is clearly shown in FIG. 2.
  • the sheets 1 Facing the opening of the frame 2, the sheets 1 are therefore not arranged symmetrically l 'vis-à-vis the other relative to the plane of symmetry which passes through the thickness of the frame 2, but on the same side of this plane of symmetry, and the pocket at rest therefore has a volume practically no.
  • the bag has a large volume, of the order of 40% of its maximum volume, which can be filled without exerting pressure and without any notable stress is applied to the sheets 1 and therefore to the welds.
  • This notably reduces the risks of rupture of the sheets 1 and of the welds of these sheets on the frame 2.
  • the filling of the pocket can then be completed to its maximum volume by stretching the sheets, but at equal maximum volume, a pocket thus produced is considerably less stressed at the welds and the films of the faces than a pocket of the prior art, so that the risks of permanent deformation and rupture are reduced.
  • the hanging or hanging devices of the pocket are only connected to the frame 2 by its enlarged side 3, the mechanical resistance of the pocket is improved, because all the pressure stresses are transmitted by the frame 2 to the members hanging.
  • the thickness of the films used to make the sheets 1 can be limited to 100 microns, while it often reaches 400 microns in the pockets of the prior art.
  • a pocket according to FIGS. 1 and 2 offers a volume much greater than that of the pockets of the state of the art with the same surface in plan. At equal maximum volume, the surface of the frame can therefore be reduced, and this also constitutes an advantage insofar as the consumption of plastic film is reduced.
  • the flat parts 1 "of the sheets 1, which extend beyond the side 7 of the frame 2 through which the pipes 8 pass, are welded to each other along their edge and envelop the pipes 8 in an annex protection pocket, whose closure guarantees inviolability.
  • a flap 9, delimited in one of the parts 1 "by a line of least resistance, allows, by tearing, to open this annex pocket and access at least one of the pipes 8, for example that which is not permanently blocked after filling the bag, if the latter is sold ready to use.
  • the bags according to the invention can advantageously be used as parenteral feeding bags, filled on an industrial scale, then stored and transported and finally distributed ready for use for administration to a patient.
  • the reinforcing frame has several openings, it is possible to produce multiple pockets if the sheets of complex film are welded to the frame so that they delimit with the frame several chambers with variable volume.
  • these bags can also be used as bags for blood, for bladder irrigation, infusion, transfusion, etc.

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Bag Frames (AREA)

Claims (11)

1. Beutel für Injektionsmittel, welcher zwei Flächen aufweist, von denen jede aus einer weichen Folie (1) besteht und mindestens eine Schicht aus Plastik enthält, dadurch gekennzeichnet, daß der Beutel einen halbstarren Bewehrungsrahmen (2) aus Plastik mit ebenen Oberflächen aufweist und daß die Folien (1), von denen jede z. B. durch Warmverformung ausgeformt bzw. gewölbt ist und im wesentlichen die Form einer Mulde mit flachem Boden (1') aufweist, in dichtender Weise, z. B. durch Druckschweißen, angebracht sind, und zwar über Abschnitte der Folien (1), welche den konkaven Bereich jeder Mulde (1') zu beiden Seiten des Rahmens (2) umgeben, wobei jeder Folienabschnitt an eine der beiden ebenen Oberflächen des Rahmens auf solche Weise angebracht ist, daß die Folien (1) im Ruhezustand in derselben Symmetrieebene, welche in die Dicke einer Kante (7) des Rahmens (2) eintritt, ineinander verschachtelt sind, um zwischen den beiden Folien (1) und in zumindest einer Öffnung des Rahmens (2) eine Kammer mit veränderbarem Volumen zu schaffen, deren Volumen in der Praxis gleich Null ist, wenn sich der Beutel im Ruhezustand befindet.
2. Beutel nach Anspruch 1, gekennzeichnet durch mindestens eine Rohrleitung (8), welche an einer Seite an die Außenseite und an der anderen Seite zwischen den beiden Folien (1) in den Innenraum des Beutels mündet und die in die Dicke einer Seite (7) des Rahmens (2) eintritt und sich vorzugsweise durch einen Tiefzug zur Außenseite verlängert.
3. Beutel nach einem der Ansprüche 1 bis 2, dadurch gekennzeichnet, daß der Rahmen (2) mit den ebenen Öberflächen, welcher eventuell die Rohrleitungen (8) und die entsprechenden Tiefzüge aufweist, durch Druckeinspritzung einstückig ausgebildet ist.
4. Beutel nach einem der Ansprüche 2 oder 3, dadurch gekennzeichnet, daß die beiden Folien (1) jeweils zumindest einen Abschnitt (1") besitzen, welcher sich jenseits von zumindest einer Kante (7) des Rahmens (2) erstreckt und von zumindest einer Rohrleitung (8) durchquert wird und mit dem entsprechenden Abschnitt (1") der anderen Folie (1) abschließt und an den vorzugsweise eine Zusatztasche zum Schutz der Rohrleitungen (8) und möglicherweise deren Tiefzüge angebracht ist.
5. Beutel nach einem der Ansprüche 2 bis 4 zur Verwendung als Beutel für die Speicherung, den Transport und die Verabreichung einer Injektionsmischung, dadurch gekennzeichnet, daß der Beutel mindestens zwei Rohrleitungen (8) aufweist, von denen eine nach dem Anfüllen des Beutels endgültig abgeschlossen wird.
6. Beutel nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß eine der Seiten des Rahmens (2), welche vorzugsweise nicht von einer Rohrleitung (8) durchquert wird, mindestens eine Öffnung (4, 5) zum Anbringen und/oder Aufhängen des Beutels und/oder zumindest ein Organ zum Anbringen und/oder Aufhängen des Beutels aufweist.
7. Beutel nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß jede Folie (1) aus einem aus Dünnschichtmaterialien zusammengesetzten Film besteht, welcher zumindest eine Schicht aufweist, die eine dichte Barriere in bezug auf die atmosphärischen Gase und den Wasserdampf bildet und beispielsweise aus Polyvinylchlorid besteht und sandwichartig zwischen mindestens zwei Schichten aufgenommen ist, von denen zumindest jene Schicht, die zum Innenraum des Beutels gerichtet ist, aus einem mit dem Inhalt des Beutels verträglichem Material, beispielsweise aus Polyäthylen-Polyvinylazetat besteht und keine schädlichen, toxischen oder weichmachenden Materialien enthält, die vom Inhalt des Beutels ausgedehnt werden können.
8. Beutel nach Anspruch 7, dadurch gekennzeichnet, daß die aus der die dichtende Barriere bildenden und sandwichartig zwischen zwei Schichten eingeschlossenen Schicht bestehende Einheit ihrerseits sandwichartig zwischen zwei Schichten aus Plastikmaterial, beispielsweise Polyäthylen, eingeschlossen ist.
9. Beutel nach Anspruch 7 oder 8, dadurch gekennzeichnet, daß jeder zusammengesetzte Film zumindest eine dünne metallische Schicht aufweist, welche beispielsweise aus Aluminium besteht.
10. Beutel nach einem der Ansprüche 7 bis 9, dadurch gekennzeichnet, daß der starre Rahmen (2) aus dem selben Plastikmaterial wie jene Schicht des zusammengesetzten Films besteht, mit welcher er über seine ebenen Oberflächen in Kontakt tritt.
11. Beutel nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß der Rahmen (2) mehrere Öffnungen aufweist, mit denen die Folien (1) mehrere Kammern mit veränderbarem Volumen abgrenzen und so einen vielschichtigen Beutel schaffen.
EP83401732A 1982-09-02 1983-09-01 Beutel für medizinischen Gebrauch, insbesondere bestimmt für parenterale Ernährung Expired EP0102302B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT83401732T ATE21028T1 (de) 1982-09-02 1983-09-01 Beutel fuer medizinischen gebrauch, insbesondere bestimmt fuer parenterale ernaehrung.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8215008A FR2532550B1 (fr) 1982-09-02 1982-09-02 Poches a usage medical, et en particulier destinees a l'alimentation parenterale
FR8215008 1982-09-02

Publications (3)

Publication Number Publication Date
EP0102302A2 EP0102302A2 (de) 1984-03-07
EP0102302A3 EP0102302A3 (en) 1984-04-04
EP0102302B1 true EP0102302B1 (de) 1986-07-30

Family

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Application Number Title Priority Date Filing Date
EP83401732A Expired EP0102302B1 (de) 1982-09-02 1983-09-01 Beutel für medizinischen Gebrauch, insbesondere bestimmt für parenterale Ernährung

Country Status (7)

Country Link
US (1) US4559053A (de)
EP (1) EP0102302B1 (de)
JP (1) JPS5964060A (de)
AT (1) ATE21028T1 (de)
CA (1) CA1192867A (de)
DE (1) DE3364955D1 (de)
FR (1) FR2532550B1 (de)

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Also Published As

Publication number Publication date
US4559053A (en) 1985-12-17
CA1192867A (en) 1985-09-03
DE3364955D1 (en) 1986-09-04
JPS5964060A (ja) 1984-04-11
ATE21028T1 (de) 1986-08-15
FR2532550A1 (fr) 1984-03-09
EP0102302A2 (de) 1984-03-07
FR2532550B1 (fr) 1986-01-17
EP0102302A3 (en) 1984-04-04

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