EP1799174A2 - Storage assembly for contrast media - Google Patents

Storage assembly for contrast media

Info

Publication number
EP1799174A2
EP1799174A2 EP05792129A EP05792129A EP1799174A2 EP 1799174 A2 EP1799174 A2 EP 1799174A2 EP 05792129 A EP05792129 A EP 05792129A EP 05792129 A EP05792129 A EP 05792129A EP 1799174 A2 EP1799174 A2 EP 1799174A2
Authority
EP
European Patent Office
Prior art keywords
packaging
connector
container
storage assembly
sheets
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
EP05792129A
Other languages
German (de)
French (fr)
Other versions
EP1799174B9 (en
EP1799174B1 (en
Inventor
François Bemer
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.)
Guerbet SA
Original Assignee
Guerbet 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 Guerbet SA filed Critical Guerbet SA
Publication of EP1799174A2 publication Critical patent/EP1799174A2/en
Application granted granted Critical
Publication of EP1799174B1 publication Critical patent/EP1799174B1/en
Publication of EP1799174B9 publication Critical patent/EP1799174B9/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D73/00—Packages comprising articles attached to cards, sheets or webs

Definitions

  • the present invention relates to a storage assembly comprising a pocket designated container for containing an aqueous solution (more especially a contrast medium), a connector for connecting the bag to a device such as a syringe, and a packaging for packaging the bag. pocket so as to protect the aqueous solution contained in the pocket against damage.
  • the invention also relates to the associated storage method. More particularly, the invention relates to a diagnostic product storage assembly for medical imaging (contrast medium) and liquid pharmaceutical formulation in which, even if the medical fluid is stored for a long time, it will not be subjected to no deterioration such as water loss, and also relates to the associated storage process
  • this type of container filled with parenteral fluid must have sufficient heat resistance to allow the hot sterilization of their contents (sterilization temperature above 100 ° C).
  • this type of container is preferably made of a transparent material so that their contents can be monitored from the outside.
  • the medical fluid contained in such a container comprises a component subject to deterioration - for example a component sensitive to light and oxidation - it is known to package said container in a packaging material having good properties.
  • gas barrier for example a material comprising a layer of polyvinyl chloride
  • ultraviolet light for example a material comprising an opaque layer of aluminum.
  • the product administered to the patient has a high price, which implies having to limit as much as possible the product losses.
  • An object of the present invention is to provide a storage assembly for bearing at least one of the disadvantages mentioned above.
  • the invention aims to solve other technical problems related to the clinical use of contrast products. It is desired that the bag can be connected to various types of connection and device injectors, such as manual or automatic syringe injectors, or automatic bag injectors.
  • the invention relates to a dual-package storage container for aqueous medical solution - especially for contrast medium - comprising a packaging packaging in which is packaged and hermetically sealed at least one flexible packaging container filled with an aqueous solution and sealed by means of a connector provided with a cap, a storage assembly in which: the packaging packaging comprises two superposed sheets of flexible or semi-rigid polymeric materials, the first sheet being transparent over its entire surface and the second sheet being opaque over its entire surface, the packaging container comprises two superposed sheets of polymeric material and an access member at the distal end of which is located the connector and the cap, the connector for sealing the conditioning container after filling the container. with the aqueous solution.
  • the connector and the cap are made of polycarbonate
  • the connector comprises a cylindrical body whose internal diameter is substantially equal to the external diameter of the access member so that a portion of the cylindrical body encircles and comes into contact with a portion of the access member when the connector is engaged with the access member,
  • the connector has an outer surface in the form of a portion of a truncated cone, the diameter of the cone-shaped outer surface decreases from the proximal end to the distal end of the cylindrical body,
  • the connector is of the female luer type
  • the connector comprises a frangible section provided with fins extending radially outwards
  • the sheets of the packaging packaging are composed of laminated films chosen from polypropylene, polyamide and polyethylene,
  • the second sheet of the packaging packaging comprises an opaque film of metallized polyester type
  • the second sheet of the packaging packaging comprises an opaque aluminum film
  • the sheets of the packaging container are composed of laminated polypropylene films
  • the first sheet comprises an area comprising identification markings such as the name of the product, the name of the manufacturer, the quantity of product contained in the container,
  • the sheets superimposed and sealed at their periphery define an inner container
  • the upper part of the packaging container comprising a central sector where the sheets are sealed together and form an elliptically shaped hole, and two ovoid sectors symmetrically placed extending externally from the hole and sealed at their periphery to make the upper part less flexible than the polymer sheets that form the inner tank,
  • the invention also relates to a method for storing an aqueous medical solution in a dual-package storage package, the method comprising the steps of: filling a conditioning container with the aqueous medical solution by an access member of the container packaging, seal the packaging container by means of a connector, place a cap on the end of the connector, place the packaging container whose access member is sealed by the connector in a packaging package comprising a transparent face and an opaque face, sealing the packaging so as to hermetically enclose the container whose access member is sealed by the connector provided with the cap.
  • (placing a cap on the end of the connector may be performed before or after the step of sealing the conditioning container by means of the connector.
  • the step of sealing the packaging container by means of a connector consists of sealing the container by means of a female luer-type connector ,
  • the method further comprises, prior to the step of placing the container in the packaging packaging, the step of sterilizing the assembly comprising the conditioning container, the connector and the connector cap, preferably by autoclave at a temperature between 100 and 150 ° for a period of between 10 and 40 minutes, the method further comprises, prior to the step of placing the container in the packaging packaging, the step of sterilizing the assembly comprising the conditioning container, the connector and the cap by autoclave at a temperature substantially equal to 121 ° for a period substantially equal to 20 minutes,
  • the invention also relates to a packaging packaging comprising two superposed sheets of flexible or semi-rigid polymeric materials, the first sheet being transparent over its entire surface and the second sheet being opaque over its entire surface for a storage assembly as described herein. -above.
  • the invention also relates to a packaging container comprising two superposed sheets of polymer material and an access member at the distal end of which is located the connector and the cap for a storage assembly as described above.
  • Figure 1 illustrates a front view of a storage assembly according to the present invention
  • FIG. 2 illustrates a side view of the storage assembly according to the present invention
  • FIG. 3 illustrates a view from above of the storage assembly according to the present invention
  • Figure 4 is a bottom view of the storage assembly according to the present invention
  • Figure 5 is a front view of a medical bag according to the present invention
  • Figure 6 is an axial sectional view of a female luer according to the present invention
  • Figure 7 is an axial sectional view of a cap according to the present invention
  • Figure 8 is a perspective view of the cap of Figure 7;
  • Figure 9 is another axial sectional view of the cap of Figures 7 and 8;
  • Figures 10 and 11 are illustrations of various embodiments of the female luer in accordance with the invention.
  • the storage assembly includes an overpouch containing a medical pocket.
  • This medical bag comprises an access member on which is placed in force a female luer after filling said bag with a parenteral solution.
  • the female luer has a hood.
  • Figures 1, 2, 3 and 4 illustrate in front view, in profile, from above and from below a medical bag 3 contained in an overpocket 4.
  • This overpouch 4 has a general shape in a rectangle. It can be peelable or tearable. Overpouch 4 comprises two sheets 1, 2 superimposed of appropriate length and width.
  • the first and second sheets 1, 2 are made of flexible polymer materials or semi-rigid, transparent. These sheets 1, 2 are for example polyamide, polyethylene, polypropylene, polyethylene-polypropylene copolymer. Each of the superposed transparent sheets 1, 2 is preferably composed of laminated films at least one of which is impermeable to gases, moisture and atmospheric bacteria.
  • the first sheet 1 is left transparent over its entire surface so as to allow observation of the quantity of the contents of the medical bag 3 contained in the overpouch 4. It also allows the reading of identification markings on an area 6 of the medical bag 3, such as the name of the product contained in the medical bag, the volume of product contained in the medical bag, the name of the manufacturer and the number of the manufacturing batch to which the medical fluid belongs.
  • the second sheet 2 further comprises an opaque laminate film having ultraviolet barrier and water barrier properties, such as a metal film preferably of aluminum (for example a metallized polyester film), heat-sealed and covering the entire surface of the second sheet 2. This second sheet 2 protects the integrity of the light-sensitive medical fluids contained in the medical bag 3.
  • a CT contrast product such as Xenetix® (Guerbet) typically contains 60 to 80 g of active ingredient according to the concentration used.
  • the first and second superposed sheets 1, 2 are joined together along marginal sectors 10, 11, 12, and 13.
  • the use of the overpouch 4 allows a very significant increase in the storage time of the aqueous solution contained in the medical bag 3, which allows compliance with the European Pharmacopoeia that the water loss must be less than 5 % after three months of storage at 40 ° C.
  • the overpouch 4 will have different sealing characteristics.
  • overpockets 4 are sufficiently watertight to prevent loss of water, but sufficiently permeable to avoid unwanted condensation within said overpockets.
  • the composition and thickness of the packaging packaging and the packaging container are such that the water permeability is sufficiently low that the contrast medium is not altered despite sterilization and storage over a long period of time.
  • an overpouch will be chosen whose sheets 1, 2 have a thickness of between 50 ⁇ m and 100 ⁇ m, preferably between 60 ⁇ m and 75 ⁇ m, more preferably between 62 ⁇ m and 71 ⁇ m. This thickness makes it possible to have a flexible and pleasant product of handling.
  • the pocket is :
  • the medical bag 3 has two superposed sheets 7, 8 of appropriate length and width and an access member 30.
  • the sheets 7, 8 are made of flexible or flexible materials, such as polymeric materials including polyethylene, polypropylene, and preferably thermoplastic materials.
  • the superimposed sheets 7, 8 forming the medical bag 3 are made of transparent or at least translucent materials to allow observation of the amount of its contents during the storage and administration of the product to the patient.
  • Each of the superimposed transparent sheets 7, 8 is preferably made of several layers of laminated thin films, at least one of which constitutes a barrier which is impermeable to gases, moisture and atmospheric bacteria.
  • the film in contact with the aqueous solution (or parenteral solution) is preferably chemically inert and impermeable to gases.
  • the film in contact with the parenteral solution must not contain toxic agents that could spread in the parenteral solution.
  • the sheets 7, 8 forming the medical bag 3 may comprise a stack of polypropylene film (multilayer polypropylene).
  • the sheets 7, 8 forming the medical bag 3 may comprise a polyvinyl chloride film interposed between two polyvinyl acetate or polyethylene films.
  • the polyvinyl chloride film constitutes the impermeable barrier.
  • the pocket wall material is of multilayer structure with at least 80 to 90% ethylene polypropylene.
  • the bag is formed of three outer, intermediate, inner layers from: polypropylene homopolymer, propylene / ethylene / butylene copolymer, styrene / ethylene copolymer, copolymer of ethylene carboxylic esters.
  • the superimposed sheets 7, 8 are preferably flat welded together to form a pocket 3 whose volume is zero before it is filled with parenteral solution.
  • the medical bag 3 When the medical bag 3 is filled or partially filled, it has the shape of a cushion
  • the internal volume capacity of the bag 3 may be 100, 150, 200 or 500 milliliters (ml).
  • the volume can be lowered, for example to 30 or 50 ml
  • the superimposed sheets 7, 8 forming the medical bag 3 are sealed at their lateral peripheries 20 and 21 for form a pocket 3 of general external appearance rectangular.
  • the medical bag 3 further comprises a non-folding upper portion 22 and a non-folding lower portion 23.
  • the first sheet 7 comprises the zone 6 comprising the identification markings (name, volume, manufacturer, lot number).
  • the upper part 22 of the medical bag 3 comprises: a central sector where the polymer sheets are sealed together and form a hole 24 of elliptical appearance to suspend the medical bag 3 during the administration to the patient of its contents, two ovoid sectors symmetrically 25 and 26 extending externally of the hole 24 and sealed at their periphery to make the upper portion 22 less flexible than the polymer sheets which form the inner tank 27.
  • the rounded shape of the upper portion 22 is particularly advantageous for a use of the pocket in an automatic injector as described in EP 852 152, as it facilitates the complete evacuation of the product to the outside of the pocket.
  • the lower part 23 of the medical bag 3 (where the access member 30 is located) has two symmetrically placed sectors 28 and 29 extending externally from the center of the medical bag 3 and sealed at their periphery to make the lower part 14 less flexible than the polymeric sheets which form the tank 27.
  • the inner reservoir 27 of the medical bag 3 ends, at its lower part, with two segments 32, 33.
  • the angle between the segment 32 (respectively 33) and the axis of symmetry AA ' forms an angle of between 10 ° and 85 °, preferably between 60 ° and 80 ° and more preferably between 67 ° and 68 °. This angle makes it possible to direct and facilitate the flow of the fluid contained in the medial pocket 3 towards the access member 30.
  • the dimensions of the medical bag 3 are typically as follows: for a bag with a capacity of 100 ml, there is: o width of a sheet of between 80 and 120 millimeters (mm), preferably between 97 and 103 mm; o length of a sheet of between 100 and 200 mm, preferably between 136 and 196 mm; o width of the zone 6 comprising the identification inscriptions between 35 and 95 mm, preferably substantially equal to 65 mm; o length of the zone 6 comprising the identification markings between 60 and 120 mm, preferably equal to 90 mm; for a pouch with a capacity of 150 ml, one has; o width of a sheet between 80 and 120 mm, preferably between 97 and 103 mm; o length of a sheet of between 90 and 290 mm, preferably between 160 and 220 mm; o width of the zone 6 comprising the identification inscriptions between 35 and 95 mm, preferably substantially equal to 65 mm; o length of the zone 6 comprising the identification inscription
  • This access member 30 is a tube which may be of multilayer structure, that is, that is to say comprising a stack of films.
  • the composition of the outer film of the access member 30 is compatible with the inner film of the sheets forming the medical bag 3 to ensure good weldability with the pouch sheets.
  • the composition of the inner film of the access member 30 is such that it allows good adhesion to various materials including polycarbonate materials.
  • the single or multilayer tube comprises a polypropylene / ethylene / polyethylene / vinyl acetate / styrene blend.
  • the access member 30 serves to fill the bag 3 with the parenteral fluid and to administer to the patient this fluid. It is very advantageous if the proximal end 31 of the access member 30 coming into contact with the medical liquid is flush or just below a horizontal plane. crossing the center of the lower portion of the inner tank so that all liquid contents can be dispensed from the medical bag 3. However, it is possible to introduce a depression tolerance of the tube, thus allowing the tube to protrude.
  • the dimensions of the access member 30 are typically as follows: length of the access member between 30 and 70 mm, preferably between 53 and 61 mm; inner diameter between 5.8 and 6.4 mm, preferably substantially equal to 6.1 mm; outer diameter between 7.8 and 8.4 mm, preferably equal to 8.1 mm.
  • the luer (or “luer-lock”):
  • the access member 30 is sealed with a frangible female luer 45 (in polycarbonate) on which is placed a cap 39.
  • This luer 45 and this cap 39 are for example polycarbonate Bisphenol A
  • the cap 39 comprises a cylindrical body 40 extended at one of its ends by a ferrule 41.
  • the cylindrical body 40 comprises a non-through opening at its end farthest from the shell 41.
  • a coaxial tubular portion 42 projecting slightly out of the shell 41.
  • the tubular portion 42 and the cylindrical body 40 are separated by a circular wall 43 orthogonal to the axis of symmetry B-B 'of the cap 39.
  • the female luer connector 45 comprises a cylindrical body 46 extended at one end by a frangible section 49.
  • the frangible portion 49 is located at I inside the access member.
  • the frangible section 49 comprises four fins 47, 48 extending radially outwardly so that when the female luer 45 is engaged with the access member 30, the ends of the fins 47, 48 are in contact with the limb. These fins allow an easier separation by the user of the breakable section 49.
  • the four fins 47, 48 are arranged so that a fin is perpendicular to the two fins which are close to it
  • the cylindrical body 46 has a central passage 50 ending, on the frangible section side 49, in the vicinity of a thin bridging rupture 51. At its other end, the passage 50 is open and its diameter corresponds to the outer diameter of the tubular portion 42 of the cap 39. Indeed, the female luer 45 is capable of engaging in the shell 41 of the cap 39, the tubular portion 42 of the cap 39 engaging in the passage 50.
  • the cylindrical body 46 is provided externally opposite the frangible section 49, with two opposite threaded sections 52, 53 cooperating with the thread 54 of the shell 41 of the cap 39, in order to screwably couple the cap 39 and the luer. 45.
  • Each threaded section 52, 53 comprises two lugs extending radially outwardly and forming between them an angle substantially equal to 50 °.
  • the outer wall of the tubular portion 42 is slightly conical in order to seal the connection.
  • the female luer 45 used to seal the medical bag 3 has the advantage of being a connector directly adaptable to a syringe, and therefore very easy to use.
  • the female luer 45 is engaged with the access member 30, the frangible section 49 being inside the access member 30 whose distal end 34 (distal to the pocket 3), forcibly engaged on the cylindrical body 46. abuts against two projections 54, 55.
  • the seal between the female luer 45 and the access member 30 is thanks to the polycarbonate of bisphenol A which constitutes the female luer 45. In fact, the polycarbonate of bisphenol A sticks on the access member 30 during the sterilization phase of the medical bag 3
  • the dimensions of the female luer 45 are typically as follows. diameter of the central passage 50 between 3.5 mm and 4.1 mm, preferably substantially equal to 38 mm; outer diameter of the cylindrical body 46 between 6 mm and 7 mm, preferably substantially equal to 6.5 mm; distance between the ends of the projections 54, 55 substantially equal to 10 mm, length of the female luer 45 (with breakable section 49) of between 30 mm and 50 mm, preferably between 36 mm and 37.4 mm, length of the frangible section 49 included between 14 mm and 17 mm, preferably equal to 15.8 mm
  • the cylindrical body 46 of the connector 45 has an outer diameter substantially equal to the internal diameter of the access member
  • the cylindrical body 46 of the connector 45 has an internal diameter substantially equal to the outer diameter of the access member 30, so that a portion 888 of the cylindrical body 46 encircles and comes into contact with a portion 887. the access member 30 when the connector 45 is engaged with the access member 30
  • the cylindrical body 46 of the connector 45 defines an interior space capable of receiving a portion 887 of the access member 30 when the connector 45 is engaged with the access member 30
  • This embodiment is particularly adapted for use with an automatic injector (which will be described in more detail later in the present application) Indeed, this embodiment (access member encircling the connector) avoids leakage likely to occur under the effect of the pressure at the level of the connection between the connector 45 and the access member 30.
  • the cylindrical body 46 of the connector 45 has a frustoconical portion-shaped outer surface whose diameter decreases from the proximal end 886 to the distal end 885 of the cylindrical body 46. facilitate insertion of the access member into the interior space of the cylindrical body.
  • proximal end refers to the end closest to the access member when the connector and the access member are engaged with each other.
  • the assembly allowing the storage of a parenteral solution comprises an overpouch 4, a medical bag 3, a female luer 45 and a cap 39
  • the female variant luer described is not limiting, other structures may be appropriate .
  • the present storage method makes it possible to obtain an efficient and easy-to-use storage assembly enabling the user to easily administer the parenteral solution contained in the patient to a patient. storage set.
  • the first step of the method consists of manufacturing the pocket 3, and the overpouch 4.
  • the bag 3 is placed between two laminated sheets 7, 8 of the type previously described the access member 30 and welded the two laminated sheets 7, 8 and the access member 30 together. In a second time. zone 6 is printed with the identification markings of the parenteral solution. The bag 3 is then ready for the filling operation.
  • the first sheet 1 is left transparent and the second sheet 2 comprises an opaque laminate film.
  • Three of the four marginal edges 11, 12, 13 of the superimposed sheets 1, 2 are then typically thermally welded.
  • Overpouch 4 is then ready to receive the medical bag 3.
  • the second step of the process (which can of course be remote in the time of the first step of the process, the bags being stored empty) consists of filling the bag 3 with the parenteral solution, to stop it with the female luer 45 and cap 39, and to sterilize the medical bag 3.
  • the access member 30 (tube) is used. Once the amount of parenteral solution introduced into the overpot 4 is sufficient, the female luer 45 is forced into the access member 30, the frangible portion 49 inwardly of the access member 30, so that close it. Then, the cap 39 is screwed onto the female luer 45. Finally, the device consisting of the bag 3 containing the parenteral solution, the access member 30, the female luer 45 and the cap 39 is placed in an autoclave at approximately 121 ° C. ° C for about 20 minutes to sterilize said device. During this sterilization phase, the female luer 45 and the access member 30 stick to each other due to heat. The thermally sealed junction can also be made before sterilization.
  • the device is ready to be placed in the overpot 4.
  • the last step of the method consists in placing in the overpouch 4, the bag 3 containing the parenteral solution and comprising the access member 30 on which is placed the female luer 45 provided with the cap 39.
  • This medical bag 3 is placed in the overpocket 4 so that the zone 6 comprising the identification inscriptions is in contact with the inner face of the first slip 1 left transparent.
  • the medical bag 3 placed in the overpouch 4 it welds the last edge of the overpocket 4.
  • the luer is mounted already clogged and not clogged after placing the luer on the pocket.
  • the storage assembly 5 according to the invention is then ready for use.
  • the storage assembly 5 according to the invention comprising the overpocket 4, the pocket 3, the access member 30 the female luer 45 and the cap 39 are not sterilized again.
  • the storage assembly thus obtained can then be stored in secondary packaging type carton.
  • the user will be opaque to the opaque storage side of the packaging assembly so that the translucent side of the overpouch receives a minimum of light.
  • a connector comprising a flexible connector having at one end a male portion intended to cooperate with the female luer of the pocket, and at the other end a male or female portion may to be connected in particular to: - a injection syringe with manual injection or an inlet of an automatic syringe injector to an outlet tube of an automatic injection for pockets: the contrast product is thus evacuated from the pocket automatically by programming of the injector, by the connection, to a device for administration to the patient).
  • the injector is in one piece, and encloses an enclosure as described in EP 852 152.
  • an injector will be preferred allowing a substantially complete evacuation of the contrast product to limit product losses.
  • a solid sleeve comes under the effect of a pressurized fluid applied against the sheets of the bag whose content is then discharged to the patient.
  • the evacuation rate is controlled: about 5 ml / second for a product in X-ray or MRI solution, 10 to 100 times less for a suspension contrast product of iron oxide particles.
  • the large capacities, for example of 500 ml, make it possible to treat several patients "in series".
  • the injector can receive several pockets according to the needs of clinical use, for example an injector can receive several pockets of the same content or different content (contrast medium, physiological saline ). It is also possible to combine in an injector a pouch of low volume contrast product (20 ml for example) with a 100 ml bag, for example.
  • the pockets within the same injector can be connected to a different discharge conduit with a possibly different administration sequence between the products, or to a common evacuation with a Y system.
  • the bag contains an outlet tube offset from the axis of symmetry, and at least one reclosable injection tube into the pocket.
  • a compound such as an additive or a dilution or stabilization buffer.
  • This can be useful especially for products that would give rise to possible problems of crystallization.
  • It may also provide reinforcement means, if necessary adjust the shape of the overpocket, so that the set of conditioning stands without falling.
  • the described storage method is adaptable for pockets whose structure is different from that of packaging containers of another form and / or having different means of evacuation.

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Abstract

The invention relates to a doubly packaged storage assembly (5) for an aqueous medical solution, more especially a contrast agent, comprising an overpackage (4) in which at least one flexible packaging container (3) is packaged and hermetically sealed, said container (3) being filled with an aqueous solution and sealed by means of a connector provided with a cap, in which storage assembly (5): the overpackage (4) comprises two superposed foils made of flexible or semi-rigid polymer materials, the first foil being transparent over its entire area and the second foil being opaque over its entire area; and the packaging container (3) comprises two superposed sheets made of polymer material and an access member at the distal end of which the connector and the cap are placed, the connector allowing the packaging container to be sealed after it has been filled with the aqueous solution.

Description

ENSEMBLE DE STOCKAGE POUR PRODUITS DE CONTRASTE STORAGE ASSEMBLY FOR CONTRAST PRODUCTS
La présente invention est relative à un ensemble de stockage comprenant un récipient désigné poche pour contenir une solution aqueuse (plus spécialement un produit de contraste), un connecteur pour raccorder la poche à un périphérique tel qu'une seringue, et un emballage pour empaqueter la poche de manière à protéger la solution aqueuse contenue dans la poche contre des détériorations. L'invention concerne également le procédé de stockage associé. Plus particulièrement, l'invention concerne un ensemble de stockage de produit de diagnostique pour l'imagerie médicale (produit de contraste) et de formulation pharmaceutique liquide dans lequel, même si le fluide médical est stocké pendant une longue période, celui-ci ne subira pas de détériorations telles que des déperditions d'eau, et concerne également le procédé de stockage associéThe present invention relates to a storage assembly comprising a pocket designated container for containing an aqueous solution (more especially a contrast medium), a connector for connecting the bag to a device such as a syringe, and a packaging for packaging the bag. pocket so as to protect the aqueous solution contained in the pocket against damage. The invention also relates to the associated storage method. More particularly, the invention relates to a diagnostic product storage assembly for medical imaging (contrast medium) and liquid pharmaceutical formulation in which, even if the medical fluid is stored for a long time, it will not be subjected to no deterioration such as water loss, and also relates to the associated storage process
Dans la suite, on qualifiera le récipient de « poche », le connecteur de « luer », et l'emballage de « surpoche »In the following, we will qualify the container of "pocket", the connector of "luer", and the packaging of "overpoche"
PRESENTATION GENERALE DE L' ART ANTERIEURGENERAL PRESENTATION OF THE PRIOR ART
Dans le domaine du traitement médical, les bouteilles de verre et les ampoules de verre ont été remplacées par des récipients en plastique flexibles pour les produits sanguins. Toutefois dans le cas des produits de contraste, les conditionnements de type poches en matériau plastique flexibles sont jusqu'à présent peu utilisées, le verre étant largement dominant. On connaît des poches en PVC mais elles posent des problèmes notamment liés à l'environnement. Des poches en matériau de type polypropylène sont décrites mais leur utilisation n'est pas développée, vraisemblablement en raison de problèmes réglementaires et/ou de problèmes de stockage de ces conditionnements.In the field of medical treatment, glass bottles and glass ampoules have been replaced by flexible plastic containers for blood products. However, in the case of contrast media, pouches of flexible plastic material have so far been little used, glass being largely dominant. PVC bags are known, but they pose problems particularly related to the environment. Bags of polypropylene material are described but their use is not developed, presumably because of regulatory problems and / or storage problems of these packages.
En effet, ce type de récipient rempli de fluide parentéral doit avoir une résistance thermique suffisante pour permettre la stérilisation à chaud de leur contenu (température de stérilisation supérieure à 100°C). Par ailleurs, ce type de récipients est de préférence constitué d'un matériel transparent de sorte que leur contenu puisse être surveillé de l'extérieur.Indeed, this type of container filled with parenteral fluid must have sufficient heat resistance to allow the hot sterilization of their contents (sterilization temperature above 100 ° C). Moreover, this type of container is preferably made of a transparent material so that their contents can be monitored from the outside.
Lorsque le fluide médical contenu dans un tel récipient comprend un composant sujet à une détérioration - par exemple un composant sensible à la lumière et à l'oxydation - il est connu d'empaqueter ledit récipient dans un matériau d'emballage ayant de bonnes propnétés de barrière au gaz, par exemple un matériau comprenant une couche de chlorure de polyvinyle, et aux rayons ultraviolets, par exemple un matériau comprenant une couche opaque d'aluminium. Cependant, avec ces ensembles, pour que l'utilisateur puisse vérifier le contenu du récipient flexible et lire les inscriptions d'identification imprimées sur celui-ci, il est nécessaire d'ôter le matériau d'emballage, ce qui diminue la durée limite de stockage de l'ensemble de stockage.When the medical fluid contained in such a container comprises a component subject to deterioration - for example a component sensitive to light and oxidation - it is known to package said container in a packaging material having good properties. gas barrier, for example a material comprising a layer of polyvinyl chloride, and ultraviolet light, for example a material comprising an opaque layer of aluminum. However, with these assemblies, in order for the user to check the contents of the flexible container and read the identification markings printed on it, it is necessary to remove the packaging material, which reduces the time limit for storing the storage set.
Pour résoudre cet inconvénient, il est connu de laisser une face du matériau d'emballage transparente. Le récipient plastique est alors placé dans le matériau d'emballage de sorte que la face dudit récipient comprenant les inscriptions d'identification soit en contact avec la face transparente du matériau d'emballage. L'ensemble de stockage ainsi obtenu est ensuite placé dans une autoclave pour permettre la stérilisation de la solution aqueuse à une température supérieure à 100°C.To overcome this disadvantage, it is known to leave one side of the packaging material transparent. The plastic container is then placed in the packaging material so that the face of said container including the identification indicia is in contact with the transparent face of the packaging material. The storage assembly thus obtained is then placed in an autoclave to allow the sterilization of the aqueous solution at a temperature above 100 ° C.
Cependant ces ensembles présentent l'inconvénient majeur suivant. Lorsque l'ensemble de stockage est placé à haute température pour stériliser la solution contenue dans le récipient plastique, la perméabilité du matériau composant ledit récipient augmente, induisant une déperdition d'eau qui provoque une condensation indésirable sur la face interne du matériau d'emballage, ce qui rend difficile la lecture des inscriptions d'identification imprimées sur le récipient en plastique flexible, et entraîne une perte de produit de la poche par un effet d'aspiration du produit par l'air sec entre ia poche et la surpoche lors de l'autoclavage Pour éviter cette condensation, une stérilisation sous vide a été tentée dans l'art antérieur, mais la poche vient alors se coller à la surpoche, ce qui n est pas acceptable du point de vue de la présentation du produit De plus, la mise sous vide entraîne un thermoformage, contrainte physique qui altère les propriétés physiques de la surpoche et sa perméabilité et peut diminuer une perte de stabilité.However, these sets have the following major disadvantage. When the storage assembly is placed at high temperature to sterilize the solution contained in the plastic container, the permeability of the material composing said container increases, inducing a loss of water which causes undesirable condensation on the inner side of the packaging material, which makes it difficult to read the identification markings printed on the flexible plastic container, and causes loss of product from the bag by a suction effect of the product by dry air between the pocket and the overpouch during autoclaving To avoid this condensation, a vacuum sterilization was attempted in the prior art, but the pocket then sticks to the overpouch, which is not In addition, vacuuming results in thermoforming, a physical stress that alters the physical properties of the overpouch and its permeability and may decrease a loss of stability.
En outre, plus spécialement dans le cas des produits de contraste (par exemple pour scanner aux rayons X ou pour Imagerie par Résonance Magnétique), le produit administré au patient a un prix élevé, ce qui implique de devoir limiter au maximum les pertes de produit De plus, il est très difficile dans le cas où le matériau d'emballage est stérilisé à une température supérieure à 100°C, de réaliser avec celui-ci un revêtement pelable de bonne qualité.In addition, especially in the case of contrast media (for example X-ray scanner or Magnetic Resonance Imaging), the product administered to the patient has a high price, which implies having to limit as much as possible the product losses. In addition, it is very difficult in the case where the packaging material is sterilized at a temperature above 100 ° C, to achieve with it a peelable coating of good quality.
Enfin, les éléments permettant de sceller l'accès à l'intérieur de la poche des ensembles de stockage de l'art antérieur sont peu pratiques pour un utilisateurFinally, the elements making it possible to seal the access inside the pocket of the storage assemblies of the prior art are impractical for a user
Certains fabricants ont d'ailleurs développé des solutions techniques très différentes, pour éviter ces différents problèmes, telles que des flacons (et non plus des poches) en matériau plastique rigide.Some manufacturers have also developed very different technical solutions, to avoid these various problems, such as bottles (and no longer pockets) of rigid plastic material.
Un but de la présente invention est de fournir un ensemble de stockage permettant de palier au moins l'un des inconvénients cités ci-dessus.An object of the present invention is to provide a storage assembly for bearing at least one of the disadvantages mentioned above.
Par ailleurs, l'invention vise à résoudre d'autres problèmes techniques liés à l'utilisation clinique des produits de contraste. On souhaite en effet que la poche puisse être raccordée à des types variés de raccord et de dispositif d'injection, tels que des injecteurs à seringues manuels ou automatiques, ou des injecteurs automatiques pour poches.Furthermore, the invention aims to solve other technical problems related to the clinical use of contrast products. It is desired that the bag can be connected to various types of connection and device injectors, such as manual or automatic syringe injectors, or automatic bag injectors.
PRESENTATION DE L'INVENTIONPRESENTATION OF THE INVENTION
L'invention concerne un ensemble de stockage à double conditionnement pour solution médicale aqueuse - plus spécialement pour produit de contraste - comprenant un empaquetage de conditionnement dans lequel est emballé et hermétiquement enfermé au moins un récipient de conditionnement souple rempli d'une solution aqueuse et scellé au moyen d'un connecteur muni d'un capuchon, ensemble de stockage dans lequel : l'empaquetage de conditionnement comprend deux feuillets superposés en matériaux polymères flexibles ou semi-rigides, le premier feuillet étant transparent sur toute sa surface et le second feuillet étant opaque sur toute sa surface, le récipient de conditionnement comprend deux feuilles superposées en matériau polymère et un membre d'accès à l'extrémité distale duquel est situé le connecteur et le capuchon, le connecteur permettant de sceller le récipient de conditionnement après remplissage de celui-ci avec la solution aqueuse.The invention relates to a dual-package storage container for aqueous medical solution - especially for contrast medium - comprising a packaging packaging in which is packaged and hermetically sealed at least one flexible packaging container filled with an aqueous solution and sealed by means of a connector provided with a cap, a storage assembly in which: the packaging packaging comprises two superposed sheets of flexible or semi-rigid polymeric materials, the first sheet being transparent over its entire surface and the second sheet being opaque over its entire surface, the packaging container comprises two superposed sheets of polymeric material and an access member at the distal end of which is located the connector and the cap, the connector for sealing the conditioning container after filling the container. with the aqueous solution.
Des aspects préférés mais non limitatifs de l'ensemble de stockage selon l'invention sont les suivants :Preferred but non-limiting aspects of the storage assembly according to the invention are the following:
- Ie connecteur et le capuchon sont en polycarbonate,- The connector and the cap are made of polycarbonate,
- le connecteur comprend un corps cylindrique dont un diamètre interne est sensiblement égal au diamètre externe du membre d'accès de sorte qu'une portion du corps cylindrique encercle et vient en contact avec une portion du membre d'accès lorsque le connecteur est engagé avec le membre d'accès,the connector comprises a cylindrical body whose internal diameter is substantially equal to the external diameter of the access member so that a portion of the cylindrical body encircles and comes into contact with a portion of the access member when the connector is engaged with the access member,
- le connecteur présente une surface extérieure en forme de partie de tronc de cône, - le diamètre de la surface extérieure en forme de tronc de cône diminue de l'extrémité proximale vers l'extrémité distale du corps cylindrique,the connector has an outer surface in the form of a portion of a truncated cone, the diameter of the cone-shaped outer surface decreases from the proximal end to the distal end of the cylindrical body,
- le connecteur est de type luer femelle,the connector is of the female luer type,
- le connecteur comprend une section frangible munie d'ailettes s'étendant radialement vers l'extérieur,the connector comprises a frangible section provided with fins extending radially outwards,
- les feuillets de l'empaquetage de conditionnement sont composés de films stratifiés choisis parmi le polypropylène, le polyamide, le polyéthylène,the sheets of the packaging packaging are composed of laminated films chosen from polypropylene, polyamide and polyethylene,
- le second feuillet de l'empaquetage de conditionnement comprend un film opaque de type polyester métallisé, - le second feuillet de l'empaquetage de conditionnement comprend un film opaque en aluminium,the second sheet of the packaging packaging comprises an opaque film of metallized polyester type, the second sheet of the packaging packaging comprises an opaque aluminum film,
- les feuilles du récipient de conditionnement sont composées de films stratifiés en polypropylène,the sheets of the packaging container are composed of laminated polypropylene films,
- la première feuille comprend une zone comportant des inscriptions d'identification telles que le nom du produit, le nom du fabricant, la quantité de produit contenue dans le récipient,the first sheet comprises an area comprising identification markings such as the name of the product, the name of the manufacturer, the quantity of product contained in the container,
- les feuilles superposées et scellées à leur périphérie définissent un réservoir intérieur, la partie supérieure du récipient de conditionnement comprenant un secteur central où les feuilles sont scellées ensemble et forment un trou d'aspect elliptique, et deux secteurs ovoïdes symétriquement placés se prolongeant extérieurement du trou et scellés à leur périphérie pour rendre la partie supérieure moins flexible que les feuilles polymères qui forment le réservoir intérieur,the sheets superimposed and sealed at their periphery define an inner container, the upper part of the packaging container comprising a central sector where the sheets are sealed together and form an elliptically shaped hole, and two ovoid sectors symmetrically placed extending externally from the hole and sealed at their periphery to make the upper part less flexible than the polymer sheets that form the inner tank,
- les feuilles superposées et scellées à leur périphérie définissent un réservoir intérieur, la partie inférieure du récipient de conditionnement comprenant deux secteurs ovoïdes symétriquement placés se prolongeant extérieurement du trou et scellés à leur périphérie pour rendre la partie inférieure moins flexible que les feuilles polymères qui forment le réservoir intérieur, L'invention concerne également un procédé de stockage d'une solution médicale aqueuse dans un ensemble de stockage à double conditionnement, le procédé comprenant les étapes consistant à : remplir un récipient de conditionnement avec la solution médicale aqueuse par un membre d'accès du récipient de conditionnement, sceller le récipient de conditionnement au moyen d'un connecteur, placer un capuchon sur l'extrémité du connecteur, placer le récipient de conditionnement dont le membre d'accès est scellé par le connecteur dans un empaquetage de conditionnement comprenant une face transparente et une face opaque, sceller l'empaquetage de conditionnement de manière à enfermer hermétiquement le récipient dont le membre d'accès est scellé par ie connecteur muni du capuchon.the sheets superimposed and sealed at their periphery define an inner reservoir, the lower part of the packaging container comprising two symmetrically placed ovoid sectors extending outside the hole and sealed at their periphery to make the lower part less flexible than the polymeric sheets which form the inner tank, The invention also relates to a method for storing an aqueous medical solution in a dual-package storage package, the method comprising the steps of: filling a conditioning container with the aqueous medical solution by an access member of the container packaging, seal the packaging container by means of a connector, place a cap on the end of the connector, place the packaging container whose access member is sealed by the connector in a packaging package comprising a transparent face and an opaque face, sealing the packaging packaging so as to hermetically enclose the container whose access member is sealed by the connector provided with the cap.
Il est à noter que dans le cadre de la présente invention, ( étape consistant à placer un capuchon sur l'extrémité du connecteur peut être réalisée avant ou après l'étape consistant à sceller le récipient de conditionnement au moyen du connecteur.It should be noted that in the context of the present invention, (placing a cap on the end of the connector may be performed before or after the step of sealing the conditioning container by means of the connector.
Des aspects préférés mais non limitatifs du procédé de stockage selon l'invention sont les suivants : - l'étape consistant à sceller le récipient de conditionnement au moyen d'un connecteur consiste à sceller le récipient au moyen d'un connecteur de type luer femelle,Preferred but non-limiting aspects of the storage method according to the invention are the following: the step of sealing the packaging container by means of a connector consists of sealing the container by means of a female luer-type connector ,
- le procédé comprend en outre, préalablement à l'étape consistant à placer le récipient dans l'empaquetage de conditionnement, l'étape consistant à stériliser l'ensemble comprenant le récipient de conditionnement, le connecteur et le capuchon du connecteur, de préférence par autoclave à une température comprise entre 100 et 150° pendant une durée comprise entre 10 et 40 minutes, - le procédé comprend en outre, préalablement à l'étape consistant à placer le récipient dans l'empaquetage de conditionnement, l'étape consistant à stériliser l'ensemble comprenant le récipient de conditionnement, le connecteur et le capuchon par autoclave à une température sensiblement égale à 121° pendant une durée sensiblement égale à 20 minutes,the method further comprises, prior to the step of placing the container in the packaging packaging, the step of sterilizing the assembly comprising the conditioning container, the connector and the connector cap, preferably by autoclave at a temperature between 100 and 150 ° for a period of between 10 and 40 minutes, the method further comprises, prior to the step of placing the container in the packaging packaging, the step of sterilizing the assembly comprising the conditioning container, the connector and the cap by autoclave at a temperature substantially equal to 121 ° for a period substantially equal to 20 minutes,
L'invention concerne également un empaquetage de conditionnement comprenant deux feuillets superposés en matériaux polymères flexibles ou semi-rigides, le premier feuillet étant transparent sur toute sa surface et le second feuillet étant opaque sur toute sa surface pour un ensemble de stockage tel que décrit ci-dessus.The invention also relates to a packaging packaging comprising two superposed sheets of flexible or semi-rigid polymeric materials, the first sheet being transparent over its entire surface and the second sheet being opaque over its entire surface for a storage assembly as described herein. -above.
L'invention concerne également un récipient de conditionnement comprenant deux feuilles superposées en matériau polymère et un membre d'accès à l'extrémité distale duquel est situé le connecteur et le capuchon pour un ensemble dθ stockage tel que décrit ci -dessusThe invention also relates to a packaging container comprising two superposed sheets of polymer material and an access member at the distal end of which is located the connector and the cap for a storage assembly as described above.
PRESENTATION DES FIGURESPRESENTATION OF FIGURES
D'autres caractéristiques et avantages de l'invention ressortiront encore de la description qui suit, laquelle est purement illustrative et non limitative et doit être lue en regard des dessins annexés, sur lesquels :Other features and advantages of the invention will become apparent from the description which follows, which is purely illustrative and nonlimiting and should be read with reference to the accompanying drawings, in which:
La figure 1 illustre une vue de face d'un ensemble de stockage selon la présente invention ;Figure 1 illustrates a front view of a storage assembly according to the present invention;
La figure 2 illustre une vue de profil de l'ensemble de stockage selon la présente invention ; - La figure 3 illustre une vue de dessus de l'ensemble de stockage selon la présente invention ;Figure 2 illustrates a side view of the storage assembly according to the present invention; FIG. 3 illustrates a view from above of the storage assembly according to the present invention;
La figure 4 est une vue de dessous de l'ensemble de stockage selon la présente invention ; La figure 5 est une vue de face d'une poche médicale selon la présente invention ;Figure 4 is a bottom view of the storage assembly according to the present invention; Figure 5 is a front view of a medical bag according to the present invention;
La figure 6 est une vue en coupe axiale d'un luer femelle selon la présente invention ; - La figure 7 est une vue en coupe axiale d'un capuchon selon la présente invention ;Figure 6 is an axial sectional view of a female luer according to the present invention; - Figure 7 is an axial sectional view of a cap according to the present invention;
La figure 8 est une vue en perspective du capuchon de la figure 7 ; La figure 9 est une autre vue en coupe axiale du capuchon des figures 7 et 8, - Les figures 10 et 11 sont des illustrations de différents modes de réalisation du luer femelle selon lïnvention.Figure 8 is a perspective view of the cap of Figure 7; Figure 9 is another axial sectional view of the cap of Figures 7 and 8; Figures 10 and 11 are illustrations of various embodiments of the female luer in accordance with the invention.
DESCRIPTION D'UN MODES DE REALISATION DE L'INVENTIONDESCRIPTION OF A MODES FOR CARRYING OUT THE INVENTION
L'ensemble de stockage selon la présente invention, permettant le stockage d'une solution aqueuse telle qu'un produit de contraste ou qu'une formulation pharmaceutique liquide, va maintenant être détaillé en référence aux figures 1 à 9. Les éléments équivalents représentés dans les différentes figures porteront les mêmes références numériques. L'ensemble de stockage comprend une surpoche contenant une poche médicale. Cette poche médicale comprend un membre d'accès sur lequel est placé en force un luer femelle après le remplissage de ladite poche avec une solution parentérale. Le luer femelle est muni d'un capuchon.The storage assembly according to the present invention, allowing the storage of an aqueous solution such as a contrast medium or a liquid pharmaceutical formulation, will now be detailed with reference to FIGS. 1 to 9. The equivalent elements represented in FIG. the different figures will bear the same numerical references. The storage assembly includes an overpouch containing a medical pocket. This medical bag comprises an access member on which is placed in force a female luer after filling said bag with a parenteral solution. The female luer has a hood.
Dans la suite, la description sera faite en considérant un utilisateur se trouvant face à l'ensemble de stockage, le membre d'accès de la poche médicale se trouvant vers le bas.In the following, the description will be made by considering a user facing the storage assembly, the access member of the medical pocket lying down.
La surpoche : Les figures 1 , 2, 3 et 4 illustrent en vue de face, de profil, de dessus et de dessous une poche médicale 3 contenue dans une surpoche 4.The overpocket: Figures 1, 2, 3 and 4 illustrate in front view, in profile, from above and from below a medical bag 3 contained in an overpocket 4.
Cette surpoche 4 a une forme générale en rectangle. Elle peut être soit pelable soit déchirable. La surpoche 4 comprend deux feuillets 1, 2 superposés de longueur et de largeur appropriées.This overpouch 4 has a general shape in a rectangle. It can be peelable or tearable. Overpouch 4 comprises two sheets 1, 2 superimposed of appropriate length and width.
Les premier et deuxième feuillets 1 , 2 sont faits de matériaux polymères flexibles ou semi-rigides, transparents. Ces feuillets 1 , 2 sont par exemple en polyamide, en polyéthylène, en polypropylène, en copolymère polyéthylène- polypropylène. Chacun des feuillets transparents superposés 1 , 2 est de préférence constitué de films stratifiés dont au moins un est imperméable aux gaz, à l'humidité et aux bactéries atmosphériques.The first and second sheets 1, 2 are made of flexible polymer materials or semi-rigid, transparent. These sheets 1, 2 are for example polyamide, polyethylene, polypropylene, polyethylene-polypropylene copolymer. Each of the superposed transparent sheets 1, 2 is preferably composed of laminated films at least one of which is impermeable to gases, moisture and atmospheric bacteria.
Le premier feuillet 1 est laissé transparent sur toute sa surface de manière à permettre l'observation de la quantité du contenu de la poche médicale 3 contenue dans la surpoche 4. Il permet également la lecture d'inscriptions d'identification sur une zone 6 de la poche médicale 3, telle que le nom du produit contenu dans la poche médicale, le volume de produit contenu dans la poche médicale, le nom du fabricant et numéro du lot de fabrication auquel appartient le fluide médical. Le deuxième feuillet 2 comporte en outre un film en stratifié opaque ayant des propriétés de barrière aux rayons ultraviolets, et de barrière à l'eau, tel qu'un film métallique de préférence en aluminium (par exemple un film en polyester métallisé), thermoscellé et couvrant toute la surface du deuxième feuillet 2. Ce deuxième feuillet 2 protège l'intégrité des fluides médicaux sensibles à la lumière contenus dans la poche médicale 3. Un produit de contraste pour scanner tel que le Xenetix@ (Guerbet) contient typiquement 60 à 80 g de principe actif selon la concentration utilisée.The first sheet 1 is left transparent over its entire surface so as to allow observation of the quantity of the contents of the medical bag 3 contained in the overpouch 4. It also allows the reading of identification markings on an area 6 of the medical bag 3, such as the name of the product contained in the medical bag, the volume of product contained in the medical bag, the name of the manufacturer and the number of the manufacturing batch to which the medical fluid belongs. The second sheet 2 further comprises an opaque laminate film having ultraviolet barrier and water barrier properties, such as a metal film preferably of aluminum (for example a metallized polyester film), heat-sealed and covering the entire surface of the second sheet 2. This second sheet 2 protects the integrity of the light-sensitive medical fluids contained in the medical bag 3. A CT contrast product such as Xenetix® (Guerbet) typically contains 60 to 80 g of active ingredient according to the concentration used.
Les premier et deuxième feuillets superposés 1, 2 sont joints ensemble le long de secteurs marginaux 10, 11, 12, et 13. L'utilisation de la surpoche 4 permet un allongement très significatif de la durée limite de stockage de la solution aqueuse contenue dans la poche médicale 3, ce qui permet le respect de la Pharmacopée Européenne selon laquelle la perte d'eau doit être inférieure à 5% après trois mois de stockage à 4O°C.The first and second superposed sheets 1, 2 are joined together along marginal sectors 10, 11, 12, and 13. The use of the overpouch 4 allows a very significant increase in the storage time of the aqueous solution contained in the medical bag 3, which allows compliance with the European Pharmacopoeia that the water loss must be less than 5 % after three months of storage at 40 ° C.
En effet, le demandeur a découvert que sans surpoche 4, à six mois de conservation, la perte en eau due à la perméabilité du matériau polypropylène utilisé pour réaliser la poche médicale 3 était trop importante, alors qu'en présence de la surpoche 4 présentée ci-dessus, cette eau était nettement mieux retenue. Le stockage approprié avec une perte de l'ordre de 1% est obtenu sur de longues durées, jusque de l'ordre de 36 mois.Indeed, the applicant has discovered that without overpouch 4, at six months of storage, the loss of water due to the permeability of the polypropylene material used to make the medical bag 3 was too important, while in the presence of the overpouch 4 presented above, this water was much better retained. The appropriate storage with a loss of the order of 1% is obtained over long periods, up to about 36 months.
Le tableau suivant présente les résultats obtenus en utilisant un premier mode de réalisation, et un second mode de réalisation de la surpσche 4 selon l'invention :The following table presents the results obtained using a first embodiment, and a second embodiment of the overpatch 4 according to the invention:
Ainsi, on constate que suivant son épaisseur et son grammage, la surpoche 4 présentera des caractéristiques d'étanchéité différentes. Plus le grammage et l'épaisseur de la surpoche 4 sont importants, plus l'étanchéité de la surpoche 4 à l'eau, au gaz carbonique, à Toxygène et à l'azote sera importante. Thus, it is found that according to its thickness and its weight, the overpouch 4 will have different sealing characteristics. The higher the weight and the thickness of the overpouch 4, the greater the watertightness of the overpouch 4 to water, carbon dioxide, oxygen and nitrogen will be important.
Un des avantages des surpoches 4 dont les résultats d'étanchéité sont présentés dans le tableau ci-dessus est qu'elles sont suffisamment étanches pour éviter la perte d'eau, mais suffisamment perméables pour éviter une condensation non souhaitée à l'intérieur desdites surpoches. La composition et l'épaisseur de l'empaquetage de conditionnement et du récipient de conditionnement sont tels que la perméabilité à l 'eau est suffisamment faible pour que le produit de contraste ne soit pas altéré malgré la stérilisation et le stockage sur une longue période. Selon l'invention, on choisira une surpoche dont les feuillets 1 , 2 présentent une épaisseur comprise entre 50 μm et 100 μm, préférentiellement entre 60 μm et 75 μm, encore préférentiellement entre 62 μm et 71 μm. Cette épaisseur permet d'avoir un produit souple et agréable de prise en main.One of the advantages of overpockets 4 whose sealing results are shown in the table above is that they are sufficiently watertight to prevent loss of water, but sufficiently permeable to avoid unwanted condensation within said overpockets. . The composition and thickness of the packaging packaging and the packaging container are such that the water permeability is sufficiently low that the contrast medium is not altered despite sterilization and storage over a long period of time. According to the invention, an overpouch will be chosen whose sheets 1, 2 have a thickness of between 50 μm and 100 μm, preferably between 60 μm and 75 μm, more preferably between 62 μm and 71 μm. This thickness makes it possible to have a flexible and pleasant product of handling.
La poche :The pocket :
La poche médicale 3 comporte deux feuilles superposées 7, 8 de longueur et de largeur appropriées ainsi qu'un membre d'accès 30.The medical bag 3 has two superposed sheets 7, 8 of appropriate length and width and an access member 30.
Les feuilles 7, 8 sont faites de matériaux flexibles ou souples, tels que les matériaux polymères comprenant le polyéthylène, le polypropylène, et des matériaux de préférence thermoplastiques. Les feuilles superposées 7, 8 formant la poche médicale 3 sont faites de matériaux transparents ou au moins translucides afin de permettre l'observation de la quantité de son contenu pendant les opérations de stockage et d'administration du produit au patient. Chacune des feuilles transparentes superposées 7, 8 est de préférence constituée de plusieurs couches de films minces stratifiées dont au moins un constitue une barrière qui est imperméable aux gaz, à l'humidité et aux bactéries atmosphériques. Par ailleurs, le film en contact avec la solution aqueuse {ou solution parentérale) est de préférence chimiquement inerte et imperméable aux gaz. En outre, le film en contact avec la solution parentérale ne doit pas contenir d'agents toxiques qui pourraient se répandre dans la solution parentérale. Par exemple, les feuilles 7, 8 formant la poche médicale 3 peuvent comprendre un empilement de film en polypropylène (polypropylène multicouche). Dans un autre exemple, les feuilles 7, 8 formant la poche médicale 3 peuvent comprendre un ftlm de chlorure de polyvinyle intercalé entre deux films de polyvinylacétate ou de polyéthyiène. Dans cet exemple, le film de chlorure de polyvinyle constitue la barrière imperméable. Selon une réalisation préférée, ie matériau de paroi de la poche est de structure multicouches avec au moins 80 à 90 % de polypropylène éthylène.The sheets 7, 8 are made of flexible or flexible materials, such as polymeric materials including polyethylene, polypropylene, and preferably thermoplastic materials. The superimposed sheets 7, 8 forming the medical bag 3 are made of transparent or at least translucent materials to allow observation of the amount of its contents during the storage and administration of the product to the patient. Each of the superimposed transparent sheets 7, 8 is preferably made of several layers of laminated thin films, at least one of which constitutes a barrier which is impermeable to gases, moisture and atmospheric bacteria. On the other hand, the film in contact with the aqueous solution (or parenteral solution) is preferably chemically inert and impermeable to gases. In addition, the film in contact with the parenteral solution must not contain toxic agents that could spread in the parenteral solution. For example, the sheets 7, 8 forming the medical bag 3 may comprise a stack of polypropylene film (multilayer polypropylene). In another example, the sheets 7, 8 forming the medical bag 3 may comprise a polyvinyl chloride film interposed between two polyvinyl acetate or polyethylene films. In this example, the polyvinyl chloride film constitutes the impermeable barrier. In a preferred embodiment, the pocket wall material is of multilayer structure with at least 80 to 90% ethylene polypropylene.
Par exemple la poche est formée de trois couches externe, intermédiaire, interne à partir de : homopolymère polypropylène, copolymère propylène / éthylène / butylène, copolymère styrène / éthylène, copolymère d'esters éthylène carboxyliques. Les feuilles superposées 7, 8 sont de préférence soudées plates entre elles afin de former une poche 3 dont le volume est nul avant qu'elle ne soit remplie de solution parentérale. Quand la poche médicale 3 est remplie ou partiellement remplie, elle présente la forme d'un coussinFor example the bag is formed of three outer, intermediate, inner layers from: polypropylene homopolymer, propylene / ethylene / butylene copolymer, styrene / ethylene copolymer, copolymer of ethylene carboxylic esters. The superimposed sheets 7, 8 are preferably flat welded together to form a pocket 3 whose volume is zero before it is filled with parenteral solution. When the medical bag 3 is filled or partially filled, it has the shape of a cushion
Selon le volume destiné à être administré au patient la capacité interne en volume de la poche 3 peut être de 100, 150, 200 ou 500 millilitres (ml). Pour des produits pour IRM, le volume peut être abaissé, par exemple à 30 ou 50 mlDepending on the volume to be administered to the patient the internal volume capacity of the bag 3 may be 100, 150, 200 or 500 milliliters (ml). For MRI products, the volume can be lowered, for example to 30 or 50 ml
Comme illustré à la figure 5, les feuilles superposées 7, 8 formant la poche médicale 3 sont scellées à leurs périphéries latérales 20 et 21 pour former une poche 3 d'aspect général extérieur rectangulaire. La poche médicale 3 comporte en outre une partie supérieure non pliante 22 et une partie inférieure non pliante 23. Enfin, la première feuille 7 comprend la zone 6 comportant les inscriptions d'identification (nom, volume, fabricant, numéro de lot).As illustrated in FIG. 5, the superimposed sheets 7, 8 forming the medical bag 3 are sealed at their lateral peripheries 20 and 21 for form a pocket 3 of general external appearance rectangular. The medical bag 3 further comprises a non-folding upper portion 22 and a non-folding lower portion 23. Finally, the first sheet 7 comprises the zone 6 comprising the identification markings (name, volume, manufacturer, lot number).
La partie supérieure 22 de la poche médicale 3 comporte : un secteur central où les feuilles polymères sont scellées ensemble et forment un trou 24 d'aspect elliptique pour suspendre la poche médicale 3 pendant l'administration au patient de son contenu, deux secteurs ovoïdes symétriquement piacés 25 et 26 se prolongeant extérieurement du trou 24 et scellés à leur périphérie pour rendre la partie supérieure 22 moins flexible que les feuilles polymères qui forment le réservoir intérieur 27. La forme arrondie de la partie supérieure 22 est avantageuse notamment pour une utilisation de la poche dans un injecteur automatique tel que décrit dans le document EP 852 152, car elle facilite l'évacuation complète du produit vers l'extérieur de la poche.The upper part 22 of the medical bag 3 comprises: a central sector where the polymer sheets are sealed together and form a hole 24 of elliptical appearance to suspend the medical bag 3 during the administration to the patient of its contents, two ovoid sectors symmetrically 25 and 26 extending externally of the hole 24 and sealed at their periphery to make the upper portion 22 less flexible than the polymer sheets which form the inner tank 27. The rounded shape of the upper portion 22 is particularly advantageous for a use of the pocket in an automatic injector as described in EP 852 152, as it facilitates the complete evacuation of the product to the outside of the pocket.
La partie inférieure 23 de la poche médicale 3 (où le membre d'accès 30 est situé) comporte deux secteurs symétriquement placés 28 et 29 se prolongeant extérieurement du centre de la poche médicale 3 et scellés à leur périphérie pour rendre la partie inférieure 14 moins flexible que les feuilles polymères qui forment le réservoir tntéπeur 27.The lower part 23 of the medical bag 3 (where the access member 30 is located) has two symmetrically placed sectors 28 and 29 extending externally from the center of the medical bag 3 and sealed at their periphery to make the lower part 14 less flexible than the polymeric sheets which form the tank 27.
Le réservoir intérieur 27 de la poche médicale 3 se termine, en sa partie inférieure, par deux segments 32, 33. En considérant l'axe de symétrie A-A' de la poche médicale 3 passant par le centre du membre d'accès 30, l'angle entre le segment 32 (respectivement 33) et l'axe de symétrie A-A' forme un angle compris entre 10° et 85°, de préférence entre 60° et 80° et mieux entre 67° et 68°. Cet angle permet de diriger et de faciliter l'écoulement du fluide contenu dans la poche médiale 3 vers le membre d'accès 30.The inner reservoir 27 of the medical bag 3 ends, at its lower part, with two segments 32, 33. Considering the axis of symmetry AA 'of the medical bag 3 passing through the center of the access member 30, The angle between the segment 32 (respectively 33) and the axis of symmetry AA 'forms an angle of between 10 ° and 85 °, preferably between 60 ° and 80 ° and more preferably between 67 ° and 68 °. This angle makes it possible to direct and facilitate the flow of the fluid contained in the medial pocket 3 towards the access member 30.
Les dimensions de la poche médicale 3 sont typiquement les suivantes : pour une poche d'une contenance de 100 ml, on a : o largeur d'une feuille comprise entre 80 et 120 millimètres (mm), préférentiellement comprise entre 97 et 103 mm ; o longueur d'une feuille comprise entre 100 et 200 mm , préférentiellement comprise entre 136 et 196 mm ; o largeur de la zone 6 comprenant les inscriptions d'identification comprise entre 35 et 95 mm, préférentiellement sensiblement égale à 65 mm ; o longueur de la zone 6 comprenant les inscriptions d'identification comprise entre 60 et 120 mm, préférentiellement égale à 90 mm ; pour une poche d'une contenance de 150 ml, on a ; o largeur d'une feuille comprise entre 80 et 120 mm, préférentiellement comprise entre 97 et 103 mm ; o longueur d'une feuille comprise entre 90 et 290 mm, préférentiellement comprise entre 160 et 220 mm ; o largeur de la zone 6 comprenant les inscriptions d'identification comprise entre 35 et 95 mm, préférentiellement sensiblement égale à 65 mm ; o longueur de la zone 6 comprenant les inscriptions d'identification comprise entre 85 et 145 mm, préférentiellement égale à 115 mm ; pour une poche d'une contenance de 200 ml, on a : o largeur d'une feuille comprise entre 80 et 120 mm, préférentiellement comprise entre 97 et 103 mm ; o longueur d'une feuille comprise entre 100 et 340 mm, préférentiellement comprise entre 190 et 250 mm ; o largeur de la zone 6 comprenant les inscriptions d'identification comprise entre 35 et 95 mm, préférentiellement sensiblement égale à 65 mm ; o longueur de la zone 6 comprenant les inscriptions d'identification comprise entre 80 et 200 mm, préférentiellement égaie à 140 mm ; pour une poche d'une contenance de 500 ml, on a : o largeur d'une feuille comprise entre 100 et 160 mm, préférentiellement comprise entre 129 et 135 mm ; o longueur d'une feuille comprise entre 150 et 310 mm, préférentiellement comprise entre 210 et 270 mm ; o largeur de la zone 6 comprenant les inscriptions d'identification comprise entre 60 et 140 mm, préférentiellement sensiblement égale à 97 mm ; o longueur de la zone 6 comprenant les inscriptions d'identification comprise entre 100 et 200 mm, préférentiellement égale à 150 mm ; Le membre d'accès 30 est situé au centre de la partie inférieure de la poche médicale 3 et est scellé entre les feuilles superposées 7, 8. Ce membre d'accès 30 est un tube qui peut être de structure multicouche, c'est-à-dire comprenant un empilement de films. La composition du film extérieur du membre d'accès 30 est compatible avec le film intérieur des feuilles formant la poche médicale 3 afin d'assurer de bonnes qualités de soudabilité avec les feuilles formant poche. La composition du film intérieur du membre d'accès 30 est telle qu'elle permet une bonne adhérence sur divers matériaux dont les matériaux polycarbonates. Par exemple le tube en mono ou multicouches comprend un mélange polypropylène éthylène / polyéthylène - vinyl acétate / styrène.The dimensions of the medical bag 3 are typically as follows: for a bag with a capacity of 100 ml, there is: o width of a sheet of between 80 and 120 millimeters (mm), preferably between 97 and 103 mm; o length of a sheet of between 100 and 200 mm, preferably between 136 and 196 mm; o width of the zone 6 comprising the identification inscriptions between 35 and 95 mm, preferably substantially equal to 65 mm; o length of the zone 6 comprising the identification markings between 60 and 120 mm, preferably equal to 90 mm; for a pouch with a capacity of 150 ml, one has; o width of a sheet between 80 and 120 mm, preferably between 97 and 103 mm; o length of a sheet of between 90 and 290 mm, preferably between 160 and 220 mm; o width of the zone 6 comprising the identification inscriptions between 35 and 95 mm, preferably substantially equal to 65 mm; o length of the zone 6 comprising the identification inscriptions between 85 and 145 mm, preferably equal to 115 mm; for a bag with a capacity of 200 ml, there is: o width of a sheet between 80 and 120 mm, preferably between 97 and 103 mm; o length of a sheet of between 100 and 340 mm, preferably between 190 and 250 mm; o width of the zone 6 comprising the identification inscriptions between 35 and 95 mm, preferably substantially equal to 65 mm; o length of the zone 6 comprising the identification inscriptions between 80 and 200 mm, preferably equal to 140 mm; for a bag with a capacity of 500 ml, there is: o width of a sheet of between 100 and 160 mm, preferably between 129 and 135 mm; o length of a sheet of between 150 and 310 mm, preferably between 210 and 270 mm; o width of the zone 6 comprising the identification inscriptions between 60 and 140 mm, preferably substantially equal to 97 mm; o length of the zone 6 comprising the identification inscriptions between 100 and 200 mm, preferably equal to 150 mm; The access member 30 is located in the center of the lower portion of the medical bag 3 and is sealed between the superimposed sheets 7, 8. This access member 30 is a tube which may be of multilayer structure, that is, that is to say comprising a stack of films. The composition of the outer film of the access member 30 is compatible with the inner film of the sheets forming the medical bag 3 to ensure good weldability with the pouch sheets. The composition of the inner film of the access member 30 is such that it allows good adhesion to various materials including polycarbonate materials. For example, the single or multilayer tube comprises a polypropylene / ethylene / polyethylene / vinyl acetate / styrene blend.
Le membre d'accès 30 sert au remplissage de la poche 3 avec le fluide parentéral et à l'administration au patient de ce fluide. Il est très avantageux que l'extrémité proxirnale 31 du membre d'accès 30 entrant en contact avec le liquide médical soit à affleurement ou juste au-dessous d'un plan horizontal croisant le centre de la partie inférieure du réservoir intérieur de sorte que tout le contenu liquide puisse être écoulé de la poche médicale 3. L'on peut toutefois introduire une tolérance d'enfoncement du tube, permettant ainsi que le tube dépasse. Les dimensions du membre d'accès 30 sont typiquement les suivantes : longueur du membre d'accès comprise entre 30 et 70 mm, préférentiellement comprise entre 53 et 61 mm ; diamètre intérieur compris entre 5.8 et 6.4 mm, préférentiellement sensiblement égale à 6.1 mm ; - diamètre extérieur compris entre 7.8 et 8.4 mm, préférentiellement égale à 8.1 mm.The access member 30 serves to fill the bag 3 with the parenteral fluid and to administer to the patient this fluid. It is very advantageous if the proximal end 31 of the access member 30 coming into contact with the medical liquid is flush or just below a horizontal plane. crossing the center of the lower portion of the inner tank so that all liquid contents can be dispensed from the medical bag 3. However, it is possible to introduce a depression tolerance of the tube, thus allowing the tube to protrude. The dimensions of the access member 30 are typically as follows: length of the access member between 30 and 70 mm, preferably between 53 and 61 mm; inner diameter between 5.8 and 6.4 mm, preferably substantially equal to 6.1 mm; outer diameter between 7.8 and 8.4 mm, preferably equal to 8.1 mm.
Le luer (ou « luer-lock ») :The luer (or "luer-lock"):
Après le remplissage de la poche 3 avec la solution parentérale, le membre d'accès 30 est scellé avec un luer femelle 45 frangible (en polycarbonate) sur lequel est placé un capuchon 39. Ce luer 45 et ce capuchon 39 sont par exemple en polycarbonate de bisphénol AAfter the filling of the bag 3 with the parenteral solution, the access member 30 is sealed with a frangible female luer 45 (in polycarbonate) on which is placed a cap 39. This luer 45 and this cap 39 are for example polycarbonate Bisphenol A
Le capuchon 39 comprend un corps cylindrique 40 prolongé à l'une de ses extrémités par une virole 41.The cap 39 comprises a cylindrical body 40 extended at one of its ends by a ferrule 41.
Le corps cylindrique 40 comprend une ouverture non traversante à son extrémité la plus éloignée de la virole 41. Au centre de la virole 41 se trouve une partie tubulaire coaxiale 42 faisant légèrement saillie hors de la virole 41.The cylindrical body 40 comprises a non-through opening at its end farthest from the shell 41. In the center of the shell 41 is a coaxial tubular portion 42 projecting slightly out of the shell 41.
La partie tubulaire 42 et le corps cylindrique 40 sont séparés par une paroi circulaire 43 orthogonale à l'axe de symétrie B-B' du capuchon 39.The tubular portion 42 and the cylindrical body 40 are separated by a circular wall 43 orthogonal to the axis of symmetry B-B 'of the cap 39.
Le connecteur luer femelle 45 comprend un corps cylindrique 46 prolongé, à une extrémité, par une section frangible 49. Lorsque le connecteur luer femelle 45 est engagé avec le membre d'accès 30 de la poche médicale 3. la partie frangible 49 se trouve à I intérieur du membre d'accès. La section frangible 49 comprend quatre ailettes 47, 48 s'étendant radialement vers l'extérieur de sorte que lorsque le luer femelle 45 est engagé avec le membre d'accès 30, les extrémités des ailettes 47, 48 sont en contact avec le membre d'accès 30 Ces ailettes permettent une séparation plus aisée par l'utilisateur de la section frangible 49. Les quatre ailettes 47, 48 sont disposées de sorte qu'une ailette soit perpendiculaire aux deux ailettes qui lui sont voisinesThe female luer connector 45 comprises a cylindrical body 46 extended at one end by a frangible section 49. When the female luer connector 45 is engaged with the access member 30 of the medical bag 3. the frangible portion 49 is located at I inside the access member. The frangible section 49 comprises four fins 47, 48 extending radially outwardly so that when the female luer 45 is engaged with the access member 30, the ends of the fins 47, 48 are in contact with the limb. These fins allow an easier separation by the user of the breakable section 49. The four fins 47, 48 are arranged so that a fin is perpendicular to the two fins which are close to it
Le corps cylindrique 46 présente un passage central 50 se terminant, côté section frangible 49, au voisinage d'un pontage mince de rupture 51. A son autre extrémité, le passage 50 est débouchant et son diamètre correspond au diamètre externe de la partie tubulaire 42 du capuchon 39. En effet, le luer femelle 45 est susceptible de s'engager dans la virole 41 du capuchon 39, la partie tubulaire 42 du capuchon 39 s'engageant dans le passage 50.The cylindrical body 46 has a central passage 50 ending, on the frangible section side 49, in the vicinity of a thin bridging rupture 51. At its other end, the passage 50 is open and its diameter corresponds to the outer diameter of the tubular portion 42 of the cap 39. Indeed, the female luer 45 is capable of engaging in the shell 41 of the cap 39, the tubular portion 42 of the cap 39 engaging in the passage 50.
Le corps cylindrique 46 est muni extérieurement à l'opposé de la section frangible 49, de deux sections filetées opposées 52, 53 coopérant avec le filetage 54 de la virole 41 du capuchon 39, afin d'accoupler par vissage le capuchon 39 et le luer femelle 45. Chaque section filetées 52, 53 comprend deux ergots s'étendant radialement vers l'extérieur et formant entre eux un angle sensiblement égale à 50°. Avantageusement, la paroi externe de la partie tubulaire 42 est légèrement conique afin d'assurer l'étanchéité de la liaison.The cylindrical body 46 is provided externally opposite the frangible section 49, with two opposite threaded sections 52, 53 cooperating with the thread 54 of the shell 41 of the cap 39, in order to screwably couple the cap 39 and the luer. 45. Each threaded section 52, 53 comprises two lugs extending radially outwardly and forming between them an angle substantially equal to 50 °. Advantageously, the outer wall of the tubular portion 42 is slightly conical in order to seal the connection.
Le luer femelle 45 utilisé pour sceller la poche médicale 3 présente l'intérêt d'être une connectique directement adaptable sur une seringue, et donc très simple d'utilisation. Après le remplissage de la poche 3, le luer femelle 45 est engagé avec le membre d'accès 30, la section frangible 49 étant à l'intérieur du membre d'accès 30 dont l'extrémité distale 34 (distale par rapport à la poche 3), engagée à force sur le corps cylindrique 46. vient en butée contre deux saillies 54, 55. L'étanchéité entre le luer femelle 45 et le membre d'accès 30 se fait grâce au polycarbonate de bisphénol A qui constitue le luer femelle 45. En effet, le polycarbonate de bisphénol A colle sur le membre d'accès 30 lors de la phase de stérilisation de la poche médicale 3The female luer 45 used to seal the medical bag 3 has the advantage of being a connector directly adaptable to a syringe, and therefore very easy to use. After the filling of the bag 3, the female luer 45 is engaged with the access member 30, the frangible section 49 being inside the access member 30 whose distal end 34 (distal to the pocket 3), forcibly engaged on the cylindrical body 46. abuts against two projections 54, 55. The seal between the female luer 45 and the access member 30 is thanks to the polycarbonate of bisphenol A which constitutes the female luer 45. In fact, the polycarbonate of bisphenol A sticks on the access member 30 during the sterilization phase of the medical bag 3
Les dimensions du luer femelle 45 sont typiquement les suivantes . - diamètre du passage central 50 compris entre 3.5 mm et 4.1 mm, préférentiel lement sensiblement égale 3 8 mm ; diamètre externe du corps cylindrique 46 compris entre 6 mm et 7 mm, préférentiel lement sensiblement égale à 6.5 mm ; distance entre les extrémités des saillies 54, 55 sensiblement égale à 10 mm , longueur du luer femelle 45 (avec section frangible 49) comprise entre 30 mm et 50 mm, préférentiellement comprise entre 36 mm et 37.4 mm , longueur de la section frangible 49 comprise entre 14 mm et 17 mm, préférentiellement égale à 15.8 mmThe dimensions of the female luer 45 are typically as follows. diameter of the central passage 50 between 3.5 mm and 4.1 mm, preferably substantially equal to 38 mm; outer diameter of the cylindrical body 46 between 6 mm and 7 mm, preferably substantially equal to 6.5 mm; distance between the ends of the projections 54, 55 substantially equal to 10 mm, length of the female luer 45 (with breakable section 49) of between 30 mm and 50 mm, preferably between 36 mm and 37.4 mm, length of the frangible section 49 included between 14 mm and 17 mm, preferably equal to 15.8 mm
Dans un mode de réalisation, le corps cylindrique 46 du connecteur 45 a un diamètre externe sensiblement égal au diamètre interne du membre d'accèsIn one embodiment, the cylindrical body 46 of the connector 45 has an outer diameter substantially equal to the internal diameter of the access member
30 de sorte qu'une portion du membre d'accès 30 encercle et vient en contact avec une portion du corps cylindrique 40 lorsque le connecteur est engage avec le membre d'accès 3030 so that a portion of the access member 30 encircles and contacts a portion of the cylindrical body 40 when the connector is engaged with the access member 30
Dans un autre mode de réalisation, le corps cylindrique 46 du connecteur 45 présente un diamètre interne sensiblement égal au diamètre externe du membre d'accès 30, de sorte qu'une portion 888 du corps cylindrique 46 encercle et vient en contact avec une portion 887 du membre d'accès 30 lorsque le connecteur 45 est engagé avec le membre d'accès 30In another embodiment, the cylindrical body 46 of the connector 45 has an internal diameter substantially equal to the outer diameter of the access member 30, so that a portion 888 of the cylindrical body 46 encircles and comes into contact with a portion 887. the access member 30 when the connector 45 is engaged with the access member 30
En d'autres termes, le corps cylindrique 46 du connecteur 45 définit un espace intérieur apte à recevoir une portion 887 du membre d accès 30 lorsque le connecteur 45 est engagé avec le membre d'accès 30 Ce mode de réalisation (membre d'accès encerclant le connecteur) est particulièrement adapté à l'utilisation avec un injecteur automatique (qui sera décrit plus en détail dans la suite de la présente demande) En effet, ce mode de réalisation (membre d'accès encerclant le connecteur) permet d'éviter les fuites susceptibles de se produire sous l'effet de la pression au niveau de la liaison entre le connecteur 45 et le membre d'accès 30.In other words, the cylindrical body 46 of the connector 45 defines an interior space capable of receiving a portion 887 of the access member 30 when the connector 45 is engaged with the access member 30 This embodiment (access member encircling the connector) is particularly adapted for use with an automatic injector (which will be described in more detail later in the present application) Indeed, this embodiment (access member encircling the connector) avoids leakage likely to occur under the effect of the pressure at the level of the connection between the connector 45 and the access member 30.
Dans un autre mode de réalisation, le corps cylindrique 46 du connecteur 45 présente une surface extérieure en forme de partie de tronc de cône dont le diamètre diminue de l'extrémité proximale 886 vers l'extrémité distale 885 du corps cylindrique 46. Cela permet de faciliter l'insertion du membre d'accès dans l'espace intérieur du corps cylindrique.In another embodiment, the cylindrical body 46 of the connector 45 has a frustoconical portion-shaped outer surface whose diameter decreases from the proximal end 886 to the distal end 885 of the cylindrical body 46. facilitate insertion of the access member into the interior space of the cylindrical body.
On entend, dans le cadre de la présente invention, par extrémité proximale, l'extrémité la plus proche du membre d'accès lorsque le connecteur et le membre d'accès sont engagés l'un avec l'autre.In the context of the present invention, the term "proximal end" refers to the end closest to the access member when the connector and the access member are engaged with each other.
Ainsi, l'ensemble permettant le stockage d'une solution parentérale comprend une surpoche 4, une poche médicale 3, un luer femelle 45 et un capuchon 39 La variante de luer femelle décrite n'est pas limitative, d'autres structures pouvant être appropriées.Thus, the assembly allowing the storage of a parenteral solution comprises an overpouch 4, a medical bag 3, a female luer 45 and a cap 39 The female variant luer described is not limiting, other structures may be appropriate .
On va maintenant décrire un procédé permettant le stockage de la solution parentérale. Contrairement aux systèmes et aux procédés de l'art antérieur, le présent procédé de stockage permet d'obtenir un ensemble de stockage performant et aisé d'utilisation permettant à l'utilisateur d'administrer aisément à un patient la solution parentérale contenu dans l'ensemble de stockage.We will now describe a method for storing the parenteral solution. Unlike the systems and methods of the prior art, the present storage method makes it possible to obtain an efficient and easy-to-use storage assembly enabling the user to easily administer the parenteral solution contained in the patient to a patient. storage set.
La première étape du procédé consiste à fabriquer la poche 3, et la surpoche 4.The first step of the method consists of manufacturing the pocket 3, and the overpouch 4.
Pour fabriquer la poche 3, on place entre deux feuilles stratifiées 7, 8 du type décrit précédemment le membre d'accès 30 et on soude les deux feuilles stratifiées 7, 8 et le membre d'accès 30 ensemble. Dans un deuxième temps. on imprime sur la zone 6 les inscriptions d'identification de la solution parentérale. La poche 3 est alors prête pour l'opération de remplissage.To manufacture the bag 3, is placed between two laminated sheets 7, 8 of the type previously described the access member 30 and welded the two laminated sheets 7, 8 and the access member 30 together. In a second time. zone 6 is printed with the identification markings of the parenteral solution. The bag 3 is then ready for the filling operation.
Pour fabriquer la surpoche 4, on superpose le premier feuillet 1 laissé transparent et le deuxième feuillet 2 comportant un film en stratifié opaque. Trois des quatre bords marginaux 11 , 12, 13 des feuillets superposés 1 , 2 sont ensuite soudés typiquement thermiquement. La surpoche 4 est alors prête à recevoir la poche médicale 3.To manufacture the overpouch 4, the first sheet 1 is left transparent and the second sheet 2 comprises an opaque laminate film. Three of the four marginal edges 11, 12, 13 of the superimposed sheets 1, 2 are then typically thermally welded. Overpouch 4 is then ready to receive the medical bag 3.
La deuxième étape du procédé (qui peut être bien entendu éloignée dans le temps de la première étape du procédé, les poches étant stockées vides) consiste à remplir la poche 3 avec la solution parentérale, à la boucher avec le luer femelle 45 et !e capuchon 39, et à stériliser la poche médicale 3.The second step of the process (which can of course be remote in the time of the first step of the process, the bags being stored empty) consists of filling the bag 3 with the parenteral solution, to stop it with the female luer 45 and cap 39, and to sterilize the medical bag 3.
Pour remplir la poche médicale 3, on utilise le membre d'accès 30 (tube). Une fois que la quantité de solution parentérale introduite dans la surpoche 4 est suffisante, on place en force le luer femelle 45 au niveau du membre d'accès 30, partie frangible 49 vers l'intérieur du membre d'accès 30, de manière à le fermer. Puis, on visse le capuchon 39 sur le luer femelle 45. Enfin, on place le dispositif composé de la poche 3 contenant la solution parentérale, du membre d'accès 30, du luer femelle 45 et du capuchon 39 dans une autoclave à environ 121 °C pendant environ 20 minutes afin de stériliser ledit dispositif. Durant cette phase de stérilisation, le luer femelle 45 et le membre d'accès 30 collent l'un à l'autre du fait de la chaleur. On peut aussi réaliser la jonction étanche thermiquement avant la stérilisation. Ceci permet d'éviter tout risque de fuite au niveau du luer femelle 45. Une fois la sténlisation terminée, le dispositif est prêt à être placé dans la surpoche 4. La dernière étape du procédé consiste à placer dans la surpoche 4, la poche 3 contenant la solution parentérale et comprenant le membre d'accès 30 sur lequel est placé le luer femelle 45 muni du capuchon 39. Cette poche médicale 3 est placée dans la surpoche 4 de sorte que la zone 6 comprenant les inscriptions d'identification soit en contact avec la face intérieure du premier feuillet 1 laissé transparent. Une fois la poche médicale 3 placée dans la surpoche 4, on soude le dernier bord de la surpoche 4. Selon une réalisation, le luer est monté déjà bouché et non bouché après la mise en place du luer sur la poche. L'ensemble de stockage 5 selon l'invention est alors prêt à l'utilisation.To fill the medical bag 3, the access member 30 (tube) is used. Once the amount of parenteral solution introduced into the overpot 4 is sufficient, the female luer 45 is forced into the access member 30, the frangible portion 49 inwardly of the access member 30, so that close it. Then, the cap 39 is screwed onto the female luer 45. Finally, the device consisting of the bag 3 containing the parenteral solution, the access member 30, the female luer 45 and the cap 39 is placed in an autoclave at approximately 121 ° C. ° C for about 20 minutes to sterilize said device. During this sterilization phase, the female luer 45 and the access member 30 stick to each other due to heat. The thermally sealed junction can also be made before sterilization. This makes it possible to avoid any risk of leakage at the level of the female luer 45. Once the stenlisation is complete, the device is ready to be placed in the overpot 4. The last step of the method consists in placing in the overpouch 4, the bag 3 containing the parenteral solution and comprising the access member 30 on which is placed the female luer 45 provided with the cap 39. This medical bag 3 is placed in the overpocket 4 so that the zone 6 comprising the identification inscriptions is in contact with the inner face of the first slip 1 left transparent. Once the medical bag 3 placed in the overpouch 4, it welds the last edge of the overpocket 4. In one embodiment, the luer is mounted already clogged and not clogged after placing the luer on the pocket. The storage assembly 5 according to the invention is then ready for use.
Il est à noter que contrairement aux procédés de l'art antérieur, une fois la poche 3 placée dans la surpoche 4, l'ensemble de stockage 5 selon l'invention comprenant la surpoche 4, la poche 3, le membre d'accès 30, le luer femelle 45 et le capuchon 39 ne sont pas stérilisés à nouveau. L'ensemble de stockage ainsi obtenu peut ensuite être stocké, en conditionnement secondaire de type carton d'emballage. On préconisera de préférence à l'utilisateur en clinique un stockage face opaque vers le haut de l'ensemble de conditionnement, de sorte que la face translucide de la surpoche reçoive un minimum de lumière. On comprend de la description les avantages et la facilité d'utilisation de l'ensemble de stockage. Par exemple, une fois la poche retirée de la surpoche, on utilisera une connectique comprenant un raccord flexible comportant à une extrémité une partie mâle destinée à coopérer avec le luer femelle de la poche, et à l'autre extrémité une partie mâle ou femelle pouvant être reliée notamment : - à une seringue d'injection à injection manuelle ou à une entrée d'un injecteur automatique à seringue à un tube de sortie d'un injecteυr automatique pour poches : le produit de contraste est ainsi évacué de la poche automatiquement par programmation de l'injecteur, par le raccord, jusqu'à un dispositif d'administration au patient).It should be noted that contrary to the methods of the prior art, once the pocket 3 placed in the overpouch 4, the storage assembly 5 according to the invention comprising the overpocket 4, the pocket 3, the access member 30 the female luer 45 and the cap 39 are not sterilized again. The storage assembly thus obtained can then be stored in secondary packaging type carton. Preferably, the user will be opaque to the opaque storage side of the packaging assembly so that the translucent side of the overpouch receives a minimum of light. The description of the advantages and usability of the storage assembly is understandable. For example, once the pocket removed from the overpouch, use a connector comprising a flexible connector having at one end a male portion intended to cooperate with the female luer of the pocket, and at the other end a male or female portion may to be connected in particular to: - a injection syringe with manual injection or an inlet of an automatic syringe injector to an outlet tube of an automatic injection for pockets: the contrast product is thus evacuated from the pocket automatically by programming of the injector, by the connection, to a device for administration to the patient).
Selon une réalisation très avantageuse, l'injecteur est monobloc, et enferme une enceinte telle que décrite dans le document EP 852 152. On préférera en particulier un injecteur permettant une évacuation sensiblement complète du produit de contraste pour limiter les pertes de produit. Un manchon solide vient sous l'effet d'un fluide sous pression s'appliquer contre les feuillets de la poche dont le contenu est alors évacué vers le patient. De préférence, on contrôle de la vitesse d'évacuation : environ 5 ml/seconde pour un produit en solution pour rayons X ou IRM, 10 à 100 fois moins pour un produit de contraste en suspension de particules d'oxydes de fer. Les grandes capacités, par exemple de 500 ml, permettent de traiter plusieurs patients « en série ». L'injecteur peut recevoir plusieurs poches selon les besoins d'utilisation clinique, par exemple un injecteur peut recevoir plusieurs poches de même contenu ou de contenu différent (produit de contraste, sérum physiologique ...). On peut aussi associer dans un injecteur une poche de produit de contraste de volume faible (20 ml par exemple) avec une poche de 100 ml par exemple. Les poches au sein d'un même injecteur peuvent être reliées à un conduit d'évacuation différent avec une séquence d'administration éventuellement différente entre les produits, ou à une évacuation commune avec un système en Y.According to a very advantageous embodiment, the injector is in one piece, and encloses an enclosure as described in EP 852 152. In particular, an injector will be preferred allowing a substantially complete evacuation of the contrast product to limit product losses. A solid sleeve comes under the effect of a pressurized fluid applied against the sheets of the bag whose content is then discharged to the patient. Preferably, the evacuation rate is controlled: about 5 ml / second for a product in X-ray or MRI solution, 10 to 100 times less for a suspension contrast product of iron oxide particles. The large capacities, for example of 500 ml, make it possible to treat several patients "in series". The injector can receive several pockets according to the needs of clinical use, for example an injector can receive several pockets of the same content or different content (contrast medium, physiological saline ...). It is also possible to combine in an injector a pouch of low volume contrast product (20 ml for example) with a 100 ml bag, for example. The pockets within the same injector can be connected to a different discharge conduit with a possibly different administration sequence between the products, or to a common evacuation with a Y system.
De plus on peut prévoir une poche comprenant plusieurs accès. Par exemple, la poche contient un tube de sortie décalé par rapport à l'axe de symétrie, et au moins un tube refermable d'injection dans la poche. Ainsi on peut ajuster la composition du contenu d'une poche partiellement vidée dans laquelle on souhaite réintroduire un composé tel qu'un additif ou un tampon de dilution ou de stabilisation. Cela peut être utile notamment pour des produits qui donneraient lieu à d'éventuels problèmes de cristallisation. On peut également prévoir des moyens de renfort, le cas échéant ajuster la forme de la surpoche, pour que l'ensemble de conditionnement tienne debout sans tomber.In addition one can provide a pocket with several accesses. For example, the bag contains an outlet tube offset from the axis of symmetry, and at least one reclosable injection tube into the pocket. Thus, it is possible to adjust the content composition of a partially emptied bag in which it is desired to reintroduce a compound such as an additive or a dilution or stabilization buffer. This can be useful especially for products that would give rise to possible problems of crystallization. It may also provide reinforcement means, if necessary adjust the shape of the overpocket, so that the set of conditioning stands without falling.
Le lecteur aura compris que de nombreuses modifications peuvent être apportées sans sortir matériellement des nouveaux enseignements et des avantages décrits ici. Par conséquent, toutes les modifications de ce type sont destinées à être incorporées à l'intérieur de la portée du système et du procédé de visualisation de régions d'intérêt tels qu'ils sont définis dans les revendications jointes. Par exemple, le procédé de stockage décrit est adaptable pour des poches dont la structure est différente de celle de récipients de conditionnement d'une autre forme et/ou présentant des moyens d'évacuation différents. The reader will understand that many changes can be made without materially escaping the new lessons and benefits described here. Therefore, all modifications of this type are intended to be incorporated within the scope of the system and process. viewing regions of interest as defined in the appended claims. For example, the described storage method is adaptable for pockets whose structure is different from that of packaging containers of another form and / or having different means of evacuation.

Claims

REVENDICATIONS
1. Ensemble de stockage (5) à double conditionnement pour solution médicale aqueuse - plus spécialement pour produit de contraste - comprenant un empaquetage de conditionnement (4) dans lequel est emballé et hermétiquement enfermé au moins un récipient de conditionnement (3) souple rempli d'une solution aqueuse et scellé au moyen d'un connecteurA dual-package storage container (5) for aqueous medical solution - especially for contrast medium - comprising a packaging package (4) in which is packaged and hermetically sealed at least one flexible packaging container (3) filled with an aqueous solution and sealed by means of a connector
(45) muni d'un capuchon (39), caractérisé en ce que :(45) with a cap (39), characterized in that:
- l'empaquetage de conditionnement (4) comprend deux feuillets (1, 2) superposés en matériaux polymères flexibles ou semi-rigides, le premier feuillet (1) étant transparent sur toute sa surface et le second feuillet (2) étant opaque sur toute sa surface, - le récipient de conditionnement (3) comprend deux feuilles superposéesthe packaging packaging (4) comprises two layers (1, 2) superimposed in flexible or semi-rigid polymer materials, the first sheet (1) being transparent over its entire surface and the second sheet (2) being opaque to all its surface, - the conditioning container (3) comprises two superposed sheets
(7, 8) en matériau polymère et un membre d'accès (30) à l'extrémité distale (34) duquel est situé le connecteur (45) et le capuchon (39), le connecteur (45) permettant de sceller le récipient de conditionnement après remplissage de celui-ci avec la solution aqueuse.(7, 8) of polymeric material and an access member (30) at the distal end (34) of which the connector (45) and the cap (39) are located, the connector (45) for sealing the container conditioning after filling thereof with the aqueous solution.
2. Ensemble de stockage selon la revendication 1 , caractérisé en ce que le connecteur (45) et le capuchon (39) sont en polycarbonate.2. Storage assembly according to claim 1, characterized in that the connector (45) and the cap (39) are made of polycarbonate.
3. Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que le connecteur (45) comprend un corps cylindrique3. Storage assembly according to one of the preceding claims, characterized in that the connector (45) comprises a cylindrical body
(46) dont un diamètre interne est sensiblement égal au diamètre externe du membre d'accès (30) de sorte qu'une portion (888) du corps cylindrique (46) encercle et vient en contact avec une portion (887) du membre d'accès (30) lorsque le connecteur (45) est engagé avec le membre d'accès (30). (46) having an inner diameter substantially equal to the outer diameter of the access member (30) such that a portion (888) of the cylindrical body (46) encircles and contacts a portion (887) of the limb access (30) when the connector (45) is engaged with the access member (30).
4 Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que le connecteur (45) présente une surface extérieure en forme de partie de tronc de cône4 storage assembly according to one of the preceding claims, characterized in that the connector (45) has an outer surface in the form of a truncated cone portion
5 Ensemble de stockage selon la revendication précédente, caractérisé en ce que le diamètre de la surface extérieure en forme de tronc de cône diminue de l'extrémité proximale (886) vers l'extrémité distale (885) du corps cylindrique (46)Storage assembly according to the preceding claim, characterized in that the diameter of the cone-shaped outer surface decreases from the proximal end (886) to the distal end (885) of the cylindrical body (46)
6. Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que le connecteur (45) est de type luer femelleStorage unit according to one of the preceding claims, characterized in that the connector (45) is of the female luer type.
7 Ensemble de stockage selon l'une des revendication précédentes, caractérisé en ce que le connecteur (45) comprend une section frangibleStorage unit according to one of the preceding claims, characterized in that the connector (45) comprises a frangible section.
(49) munie d'ailettes (47, 48) s' étendant radialement vers l'extérieur(49) provided with fins (47, 48) extending radially outwardly
8 Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que les feuillets (1, 2) de l'empaquetage de conditionnement (4) sont composés de films stratifiés choisis parmi le polypropylene, le polyamide, le polyéthylèπe8 storage unit according to one of the preceding claims, characterized in that the sheets (1, 2) of the packaging packaging (4) are composed of laminated films selected from polypropylene, polyamide, polyethylèπe
9 Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que le second feuillet (2) de I empaquetage de conditionnement (4) comprend un film opaque de type polyester métallisé9 storage assembly according to one of the preceding claims, characterized in that the second sheet (2) packaging packaging (4) comprises an opaque film metallized polyester type
10. Ensemble de stockage selon l'une des revendications 1 à 9, caractérisé en ce que le second feuillet (2) de l'empaquetage de conditionnement (4) comprend un film opaque en aluminium Storage assembly according to one of claims 1 to 9, characterized in that the second sheet (2) of the packaging packaging (4) comprises an opaque aluminum foil
11. Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que les feuilles (7, 8) du récipient de conditionnement (3) sont composées de films stratifiés en polypropylène.Storage unit according to one of the preceding claims, characterized in that the sheets (7, 8) of the conditioning container (3) are made of laminated polypropylene films.
12 Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que la première feuille comprend une zone (6) comportant des inscriptions d'identification telles que le nom du produit, le nom du fabricant, la quantité de produit contenue dans le récipient12 storage assembly according to one of the preceding claims, characterized in that the first sheet comprises a zone (6) comprising identification markings such as the name of the product, the name of the manufacturer, the amount of product contained in the container
13 Ensemble de stockage selon l'une des revendications précédentes, caractérisé en ce que les feuilles (7, 8) superposées et scellées a leur périphérie définissent un réservoir intérieur, la partie supérieure (22) du récipient de conditionnement (3) comprenant un secteur central où les feuilles sont scellées ensemble et forment un trou (24) d'aspect elliptique, et deux secteurs ovoïdes symétriquement placés (25, 26) se prolongeant extérieurement du trou (24) et scelles à leur périphérie pour rendre la partie supérieure (22) moins flexible que les feuilles polymères qui forment le réservoir intérieur (27)13 storage assembly according to one of the preceding claims, characterized in that the sheets (7, 8) superimposed and sealed at their periphery define an inner reservoir, the upper part (22) of the packaging container (3) comprising a sector where the sheets are sealed together and form a hole (24) of elliptical appearance, and two ovoid symmetrically placed sectors (25, 26) extending outwardly from the hole (24) and sealed at their periphery to make the upper portion (22) ) less flexible than the polymer sheets that form the inner tank (27)
14. Ensemble de stockage selon l'une des revendications précédentes, caractéπsé en ce que les feuilles (7, 8) superposées et scellées à leur périphérie définissent un réservoir intérieur, la partie inférieure (23) du récipient de conditionnement (3) comprenant deux secteurs ovoïdes symétriquement placés (25, 26) se prolongeant extérieurement du trou (24) et scellés à ieur périphérie pour rendre la partie inférieure (23) moins flexible que les feuilles polymères qui forment le réservoir intérieur (27) 14. Storage assembly according to one of the preceding claims, caractéπsé in that the sheets (7, 8) superimposed and sealed at their periphery define an inner reservoir, the lower portion (23) of the packaging container (3) comprising two symmetrically placed ovoid sectors (25, 26) extending outwardly of the hole (24) and sealed at their periphery to make the lower portion (23) less flexible than the polymer sheets which form the inner reservoir (27)
15. Procédé de stockage d'une solution médicale aqueuse dans un ensemble de stockage à double conditionnement, caractérisé en ce qu'il comprend les étapes consistant à : remplir un récipient de conditionnement (3) avec la solution médicale aqueuse par un membre d'accès (30) du récipient de conditionnementA method of storing an aqueous medical solution in a dual-package storage assembly, characterized in that it comprises the steps of: filling a conditioning container (3) with the aqueous medical solution with a member of access (30) of the packaging container
(3), sceller le récipient de conditionnement (3) au moyen d'un connecteur(3), seal the conditioning container (3) by means of a connector
(45), placer un capuchon (39) sur l'extrémité du connecteur (45), - placer le récipient de conditionnement (3) dont le membre d'accès (30) est scellé par le connecteur (45) dans un empaquetage de conditionnement (4) comprenant une face transparente et une face opaque, sceller l'empaquetage de conditionnement (4) de manière à enfermer hermétiquement le récipient (3) dont le membre d'accès (30) est scellé par le connecteur (45) muni du capuchon (39).(45), place a cap (39) on the end of the connector (45), - place the conditioning container (3) whose access member (30) is sealed by the connector (45) in a packaging of packaging (4) comprising a transparent face and an opaque face, sealing the packaging packaging (4) so as to hermetically enclose the container (3) whose access member (30) is sealed by the connector (45) provided with cap (39).
16. Procédé de stockage selon la revendication 12, caractérisé en ce l'étape consistant à sceller le récipient de conditionnement au moyen d'un connecteur consiste à sceller le récipient au moyen d'un connecteur de type luer femelle.The method of storage as claimed in claim 12, characterized in that the step of sealing the packaging container by means of a connector comprises sealing the container by means of a female luer type connector.
17. Procédé de stockage selon la revendication 12, caractérisé en ce qu'il comprend en outre, préalablement à l'étape consistant à placer le récipient dans l'empaquetage de conditionnement, l'étape consistant à • stériliser l'ensemble comprenant le récipient de conditionnement, le connecteur et le capuchon du connecteur, de préférence par autoclave à une température comprise entre 100 et 150° pendant une durée comprise entre 10 et 40 minutes. The method of storage as claimed in claim 12, characterized in that it further comprises, prior to the step of placing the container in the packaging packaging, the step of: • sterilizing the assembly comprising the container the connector and the cap of the connector, preferably by autoclave at a temperature between 100 and 150 ° for a period of between 10 and 40 minutes.
18. Procédé de stockage selon la revendication 12, caractérisé en ce qu'il comprend en outre, préalablement à l'étape consistant à placer le récipient dans l'empaquetage de conditionnement, l'étape consistant à : - stériliser l'ensemble comprenant le récipient de conditionnement, le connecteur et le capuchon par autoclave à une température sensiblement égale à 121° pendant une durée sensiblement égale à 20 minutes,18. A method of storage according to claim 12, characterized in that it further comprises, prior to the step of placing the container in the packaging packaging, the step of: - sterilize the assembly comprising the packaging container, the connector and the cap by autoclave at a temperature substantially equal to 121 ° for a period substantially equal to 20 minutes,
19. Empaquetage de conditionnement (4) comprenant deux feuillets (1 , 2) superposés en matériaux polymères flexibles ou semi-rigides, le premier feuillet (1) étant transparent sur toute sa surface et le second feuillet (2) étant opaque sur toute sa surface pour un ensemble de stockage selon les revendications 1 à 11.Packaging packaging (4) comprising two superposed sheets (1, 2) of flexible or semi-rigid polymeric materials, the first sheet (1) being transparent over its entire surface and the second sheet (2) being opaque over its entire surface. surface for a storage assembly according to claims 1 to 11.
20. Récipient de conditionnement (3) comprenant deux feuilles superposées (7, 8) en matériau polymère et un membre d'accès (30) à l'extrémité distale (34) duquel est situé le connecteur (45) et le capuchon (39) pour un ensemble de stockage selon les revendications 1 à 11. 20. A packaging container (3) comprising two superposed sheets (7, 8) of polymeric material and an access member (30) at the distal end (34) of which the connector (45) and the cap (39) are located. ) for a storage assembly according to claims 1 to 11.
EP05792129A 2004-09-08 2005-09-08 Storage assembly for contrast media Active EP1799174B9 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0409505A FR2874816B1 (en) 2004-09-08 2004-09-08 STORAGE ASSEMBLY FOR CONTRAST PRODUCTS
PCT/EP2005/054471 WO2006029989A2 (en) 2004-09-08 2005-09-08 Storage assembly for contrast media

Publications (3)

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EP1799174A2 true EP1799174A2 (en) 2007-06-27
EP1799174B1 EP1799174B1 (en) 2009-08-12
EP1799174B9 EP1799174B9 (en) 2010-07-21

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EP (1) EP1799174B9 (en)
JP (1) JP2008512160A (en)
AT (1) ATE439113T1 (en)
DE (1) DE602005015993D1 (en)
DK (1) DK1799174T3 (en)
ES (1) ES2331012T3 (en)
FR (1) FR2874816B1 (en)
PT (1) PT1799174E (en)
WO (1) WO2006029989A2 (en)

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PT1799174E (en) 2009-11-17
FR2874816B1 (en) 2006-12-08
US20080065043A1 (en) 2008-03-13
WO2006029989A3 (en) 2006-05-11
FR2874816A1 (en) 2006-03-10
WO2006029989A2 (en) 2006-03-23
EP1799174B9 (en) 2010-07-21
JP2008512160A (en) 2008-04-24
DK1799174T3 (en) 2009-12-14
EP1799174B1 (en) 2009-08-12
US9078806B2 (en) 2015-07-14
ES2331012T3 (en) 2009-12-18
DE602005015993D1 (en) 2009-09-24
ATE439113T1 (en) 2009-08-15

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