FR2699146A1 - Commonly packed infusion throw-away set for infusion of medicinal soln in body of patient - Google Patents

Commonly packed infusion throw-away set for infusion of medicinal soln in body of patient Download PDF

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Publication number
FR2699146A1
FR2699146A1 FR9315120A FR9315120A FR2699146A1 FR 2699146 A1 FR2699146 A1 FR 2699146A1 FR 9315120 A FR9315120 A FR 9315120A FR 9315120 A FR9315120 A FR 9315120A FR 2699146 A1 FR2699146 A1 FR 2699146A1
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France
Prior art keywords
bag
infusion
assembly
packaging according
fluid
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Granted
Application number
FR9315120A
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French (fr)
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FR2699146B3 (en
Inventor
Farina Italia
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SIFRA
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SIFRA
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Publication of FR2699146B3 publication Critical patent/FR2699146B3/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Packages (AREA)

Abstract

The set (5) is enclosed in a flexible plastic bag (17), which permits sterilisation of set within bag. The bag has opening (22) closed by a strip (23) or semipermeable material, impassable for bacteria but passable to sterilising fluid. The opening is arranged in wall (19) of bag and extends over complete length of wall.The set, after the bag has been closed with the strip, is sterilised by immersion of complete packing in ambience with gas. The strip is of medical paper, and the sterilising gas is ethylene oxide.

Description

La présente invention concerne un emballage pour ensemble à usage unique de perfusion d'un fluide médical dans le corps d'un patient. The present invention relates to a packaging for a disposable assembly for infusing a medical fluid into the body of a patient.

Il est nécessaire pour les perfusions médicales, de disposer d'un récipient pour le fluide, d'un dispositif de perfusion comprenant une aiguille de perfusion courante; d'un régulateur de débit goutte-à-goutte et, au moins, d'un tube de raccordement, reliant ladite aiguille au récipient. Cet ensemble ou kit de composants est ordinairement livré dans des emballages distincts ou dans un emballage unique dans lequel les composants sont séparés. It is necessary for medical infusions, to have a container for the fluid, an infusion device comprising a common infusion needle; a drip flow regulator and, at least, a connecting tube, connecting said needle to the container. This set or kit of components is usually delivered in separate packages or in a single package in which the components are separated.

Pour pouvoir réduire les frais de lavage des éléments et le risque de contagion, il est récemment devenu d'un usage courant de n'utiliser tous les éléments qu'une seule fois, y compris l'aiguille de perfusion. Toutefois, le groupage des éléments avant l'utilisation nécessite qu'ils soient manipulés avec des précautions particulières et, en cas de besoin, les éléments ainsi manipulés doivent être stérilisés. In order to reduce the cost of washing the elements and the risk of contagion, it has recently become common practice to use all the elements only once, including the infusion needle. However, the grouping of the elements before use requires that they be handled with special precautions and, if necessary, the elements thus handled must be sterilized.

L'invention a pour objet de fournir un emballage pour un ensemble de perfusion de fluide médical à usage unique et, cet ensemble doit être aussi simple que possible tout en supprimant les inconvénients cités plus haut, rencontrés dans l'art antérieur. The object of the invention is to provide a packaging for a disposable medical fluid infusion set and, this set must be as simple as possible while eliminating the abovementioned drawbacks encountered in the prior art.

Cet but est atteint au moyen d'un emballage pour ensemble à usage unique selon l'invention, comprenant un récipient pour ledit fluide, ledit récipient étant relié, par l'intermédiaire d'un régulateur goutte-à-goutte, à un dispositif de perfusion par l'intermédiaire d'un tube de distribution muni d'une aiguille et est caractérisé en ce que ledit ensemble est enfermé dans un sac de matière plastique souple permettant la stérilisation dudit ensemble à l'intérieur du sac. This object is achieved by means of a packaging for a disposable assembly according to the invention, comprising a container for said fluid, said container being connected, by means of a drip regulator, to a device for infusion by means of a dispensing tube fitted with a needle and is characterized in that said assembly is enclosed in a bag of flexible plastic material allowing the sterilization of said assembly inside the bag.

D'autres buts, avantages et caractéristiques apparaîtront à la lecture de la description d'un mode d féalisation de l'invention, faite à titre non limitatif et en regard des dessins annexés, où:
Fig.l est une vue de face en élévation et en coupe partielle d'un emballage pour un ensemble à usage unique selon l'invention;
Fig.2 est une vue en coupe prise suivant la ligne Il-Il de la Fig.l.Other objects, advantages and characteristics will appear on reading the description of a mode of realization of the invention, given without limitation and with reference to the appended drawings, where:
Fig.l is a front view in elevation and in partial section of a package for a disposable assembly according to the invention;
Fig.2 is a sectional view taken along the line Il-Il of Fig.l.

En se référant à la Fig.l, le chiffre 4 désigne d'une manière générale un emballage pour un ensemble à usage unique de perfusion d'un fluide médical 5. L'ensemble 5 comprend un récipient en forme de poche 6, réalisé en matériau plastique souple et transparent, tel que du PVC. La poche 6 est pourvue d'un raccord d'entrée 7 disposé, soit à la partie supérieure, soit à la partie inférieure, permettant de remplir la poche d'une quantité prédéterminé de fluide de perfusion médicale. Referring to Fig.l, the number 4 generally designates a package for a disposable set for infusion of a medical fluid 5. The set 5 comprises a pocket-shaped container 6, made of flexible and transparent plastic material, such as PVC. The bag 6 is provided with an inlet connector 7 arranged either at the top or at the bottom, making it possible to fill the bag with a predetermined quantity of medical infusion fluid.

Le raccord 7 est fermé ensuite de façon connue, en ménageant sur celui-ci le cône de rupture habituel, et est pourvu également d'un bouchon 8 ou, en variante, peut être aussi soudé.The connector 7 is then closed in a known manner, leaving the usual rupture cone thereon, and is also provided with a plug 8 or, as a variant, can also be welded.

La poche 6 comprend également une patte 9 munie d'un trou permettant de la suspendre à un crochet au cours de la perfusion. Enfin, la poche 6 comprend un raccord formant régulateur goutte-à-goutte 10 à sa sortie, sur lequel on peut raccorder un tube de distribution 11, enroulé hélicoidalement autour d'un support de protection 12. Le tube 11 est, pour sa part, relié à un dispositif de perfusion 13 qui comprend une aiguille de perfusion courante. Cette aiguille est fixée sur un corps 14 pour pouvoir être maintenue dans la main et est ordinairement logée dans le corps, dans un siège 16 faisant partie du support 12, de manière à pouvoir l'extraire au moment de son utilisation. The bag 6 also includes a tab 9 provided with a hole allowing it to be suspended from a hook during the infusion. Finally, the bag 6 comprises a connector forming a drip regulator 10 at its outlet, onto which a distribution tube 11 can be connected, helically wound around a protective support 12. The tube 11 is, for its part , connected to an infusion device 13 which includes a common infusion needle. This needle is fixed on a body 14 so that it can be held in the hand and is usually housed in the body, in a seat 16 forming part of the support 12, so that it can be extracted at the time of its use.

L'ensemble 5 est formé par la poche 6, le tube 11, le dispositif 13 et le support 12, l'ensemble assemblé, prêt pour l'emploi, comme décrit plus haut, est ensuite conditionné sous vide dans un second sac en matière plastique 17, de préférence souple lui aussi.  The assembly 5 is formed by the pocket 6, the tube 11, the device 13 and the support 12, the assembled assembly, ready for use, as described above, is then vacuum-packed in a second material bag. plastic 17, preferably flexible too.

Avantageusement, le remplissage du liquide de perfusion peut être effectué, soit par l'utilisateur, soit par le fabricant. Advantageously, the filling of the perfusion liquid can be carried out either by the user or by the manufacturer.

Dans le premier cas, le sac 17 est en forme d'enveloppe composée de deux parois 18 et 19, réunies ensemble tout autour du périmètre 21. La paroi 19 comporte une grande ouverture 22 s'étendant approximativement sur toute sa longueur, à travers laquelle l'ensemble 5 peut être facilement introduit à l'intérieur du sac 17. In the first case, the bag 17 is in the form of an envelope composed of two walls 18 and 19, joined together all around the perimeter 21. The wall 19 has a large opening 22 extending approximately over its entire length, through which the assembly 5 can be easily introduced inside the bag 17.

Après l'introduction, l'ouverture 22 est scellée en collant sur la paroi 19 une bande 23 constituée par une feuille en matériau semi-perméable, éventuellement autocollant. Ce matériau semi-perméable, de préférence en papier à usage médical, est imperméable aux bactéries mais perméable aux gaz. After the introduction, the opening 22 is sealed by sticking to the wall 19 a strip 23 consisting of a sheet of semi-permeable material, possibly self-adhesive. This semi-permeable material, preferably paper for medical use, is impermeable to bacteria but permeable to gases.

L'ensemble 4 ainsi scellé est ensuite stérilisé en l'immergeant pendant un temps prédéterminé dans un environnement saturé de gaz stérilisant, par exemple de l'oxyde d'éthylène. Au cours de la stérilisation, cet environnement est maintenu à la température et à la pression adéquates pour permettre au gaz de migrer à travers la bande 23 et de stériliser l'ensemble 5. The assembly 4 thus sealed is then sterilized by immersing it for a predetermined time in an environment saturated with sterilizing gas, for example ethylene oxide. During sterilization, this environment is maintained at the appropriate temperature and pressure to allow the gas to migrate through the strip 23 and to sterilize the assembly 5.

Comme la bande 23 est imperméable aux bactéries, l'ensemble 5 reste stérilisé jusqu'au moment de l'ouverture de l'emballage 4. Lors de l'ouverture de l'emballage 4, au moment de l'utilisation, l'ensemble 5 est donc prêt pour le traitement du patient, sans nécessiter de stérilisation supplémentaire. As the strip 23 is impermeable to bacteria, the assembly 5 remains sterilized until the opening of the packaging 4. When the packaging 4 is opened, at the time of use, the assembly 5 is therefore ready for the treatment of the patient, without requiring additional sterilization.

Si le remplissage doit être effectué par le fabricant, la matière plastique servant à la fabrication du sac 17 doit être changée pour pouvoir effectuer la stérilisation dans de la vapeur saturée; dans ce cas, le liquide de perfusion contenu dans le sac sera directement injectable. If the filling must be carried out by the manufacturer, the plastic material used to manufacture the bag 17 must be changed in order to be able to carry out sterilization in saturated steam; in this case, the infusion liquid contained in the bag will be directly injectable.

Comparativement aux ensembles de l'art antérieur, les avantages de l'ensemble à usage unique 5, conditionné selon l'invention, apparaîtront clairement de la description qui précède. Ainsi, les différents éléments de l'ensemble 5 sont, à la fois, assemblés et stérilisés par le fabricant de manière appropriée et au prix le plus avantageux, ce qui évite les opérations et manipulations conteuses de l'ensemble 5 dans l'infirmerie ou la salle de soins. Compared to the assemblies of the prior art, the advantages of the disposable assembly 5, packaged according to the invention, will become clear from the description above. Thus, the various elements of the assembly 5 are both assembled and sterilized by the manufacturer in an appropriate manner and at the most advantageous price, which avoids the storytelling operations and manipulations of the assembly 5 in the infirmary or the treatment room.

Il est entendu que l'ensemble décrit peut être modifié et perfectionné sans que l'on ne sorte du cadre de l'invention. It is understood that the assembly described can be modified and improved without departing from the scope of the invention.

Par exemple, le tube 11, le support 12, peuvent être omis et la poche 6 peut être réalisée sous forme d'un récipient rigide ou semi-rigide. De plus, la stérilisation peut être effectuée par tout autre gaz ayant des propriétés de stérilisation équivalentes. For example, the tube 11, the support 12, can be omitted and the pocket 6 can be made in the form of a rigid or semi-rigid container. In addition, sterilization can be carried out by any other gas having equivalent sterilization properties.

Claims (7)

REVENDICATIONS 1. Emballage pour un ensemble à usage unique de perfusion d'un fluide médical dans le corps d'un patient, comprenant un récipient (6) pour ledit fluide, ledit récipient étant relié, au moyen d'un régulateur goutte-à-goutte, à un dispositif de perfusion (13) par l'intermédiaire d'un tube de distribution (11) muni d'une aiguille, caractérisé en ce que ledit ensemble (5) est enfermé dans un sac en matière plastique souple (17) permettant la stérilisation dudit ensemble (5) dans ledit sac (17). 1. Package for a disposable set for infusing a medical fluid into the body of a patient, comprising a container (6) for said fluid, said container being connected, by means of a drip regulator , to an infusion device (13) via a dispensing tube (11) provided with a needle, characterized in that said assembly (5) is enclosed in a flexible plastic bag (17) allowing sterilizing said assembly (5) in said bag (17). 2. Emballage selon la revendication 1, caractérisé en ce que ledit sac (17) comprend une ouverture (22) fermée par une feuille (23) en un matériau semi-perméable, imperméable aux bactéries mais perméable à un fluide de stérilisation. 2. Packaging according to claim 1, characterized in that said bag (17) comprises an opening (22) closed by a sheet (23) of a semi-permeable material, impermeable to bacteria but permeable to a sterilizing fluid. 3. Emballage selon la revendication 2, caractérisé en ce que ladite ouverture (22) est située dans une paroi (19) dudit sac et s'étend sur toute la longueur de ladite paroi (19). 3. Packaging according to claim 2, characterized in that said opening (22) is located in a wall (19) of said bag and extends over the entire length of said wall (19). 4. Emballage selon la revendication 2 ou 3, caractérisé en ce que ledit ensemble (5) est stérilisé après que ledit sac (17) a été scellé avec ladite feuille (23), par immersion de l'ensemble complet dans un environnement contenant ledit gaz. 4. Packaging according to claim 2 or 3, characterized in that said assembly (5) is sterilized after said bag (17) has been sealed with said sheet (23), by immersion of the complete assembly in an environment containing said gas. 5. Emballage selon la revendication 2, caractérisé en ce que ladite feuille (23) est constituée par un papier à usage médical et que ledit gaz de stérilisation est de l'oxyde d'éthylène. 5. Packaging according to claim 2, characterized in that said sheet (23) consists of a paper for medical use and that said sterilization gas is ethylene oxide. 6. Emballage selon la revendication 4 ou 5, caractérisé en ce que ledit sac (17) est maintenu dans ledit environnement pendant, au moins, une période de temps pré-déterminée au cours de laquelle ledit environnement est maintenu dans des conditions de température et de pression prédéterminées. 6. Packaging according to claim 4 or 5, characterized in that said bag (17) is maintained in said environment for at least a predetermined period of time during which said environment is maintained in temperature conditions and predetermined pressure. 7. Emballage selon la revendication 1 ou 2, caractérisé en ce que lorsque ledit récipient est rempli de liquide de perfusion, ledit fluide de stérilisation est de la vapeur sous pression.  7. Packaging according to claim 1 or 2, characterized in that when said container is filled with perfusion liquid, said sterilization fluid is steam under pressure.
FR9315120A 1992-12-16 1993-12-15 PACKAGE FOR A SINGLE-USE ASSEMBLY FOR PERFUSION OF A MEDICAL FLUID INTO THE BODY OF A PATIENT. Expired - Fee Related FR2699146B3 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ITFI920293 1992-12-16

Publications (2)

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FR2699146A1 true FR2699146A1 (en) 1994-06-17
FR2699146B3 FR2699146B3 (en) 1996-03-08

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FR9315120A Expired - Fee Related FR2699146B3 (en) 1992-12-16 1993-12-15 PACKAGE FOR A SINGLE-USE ASSEMBLY FOR PERFUSION OF A MEDICAL FLUID INTO THE BODY OF A PATIENT.

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2743300A1 (en) * 1996-01-04 1997-07-11 Maco Pharma Sa Medical perfusion apparatus
WO2001097882A1 (en) * 2000-06-19 2001-12-27 Angelo Giovanni D Intravenous infusion drip bag kit
EP1308146A1 (en) * 2001-10-31 2003-05-07 Gallini S.r.l. Sterilisable device for draining urine
DE102007028733A1 (en) * 2007-06-21 2008-12-24 Fresenius Kabi Deutschland Gmbh Container for use in enteral nutrition
FR3080021A1 (en) * 2018-04-16 2019-10-18 Technoflex POCKET TRAY FOR MEDICAL USE, TUBULES AND ACCESSORIES, FOR STERILIZATION

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2743300A1 (en) * 1996-01-04 1997-07-11 Maco Pharma Sa Medical perfusion apparatus
WO2001097882A1 (en) * 2000-06-19 2001-12-27 Angelo Giovanni D Intravenous infusion drip bag kit
EP1308146A1 (en) * 2001-10-31 2003-05-07 Gallini S.r.l. Sterilisable device for draining urine
DE102007028733A1 (en) * 2007-06-21 2008-12-24 Fresenius Kabi Deutschland Gmbh Container for use in enteral nutrition
FR3080021A1 (en) * 2018-04-16 2019-10-18 Technoflex POCKET TRAY FOR MEDICAL USE, TUBULES AND ACCESSORIES, FOR STERILIZATION
WO2019201776A1 (en) * 2018-04-16 2019-10-24 Technoflex Tray for bag for medical use, tubes and accessories, intended for sterilisation
CN112672712A (en) * 2018-04-16 2021-04-16 泰科诺富莱克斯公司 Tray for medical bags, tubes and accessories intended for sterilization
JP2021521905A (en) * 2018-04-16 2021-08-30 テクノフレックス Tray for medical bags, tubes, and accessories intended for sterilization
US11399911B2 (en) 2018-04-16 2022-08-02 Technoflex Tray for bag for medical use, tubes and accessories, intended for sterilisation

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