EP3283043A1 - Sealing device for making it possible to collect a composition, packaging assembly comprising such a sealing device, collection and packaging methods - Google Patents

Sealing device for making it possible to collect a composition, packaging assembly comprising such a sealing device, collection and packaging methods

Info

Publication number
EP3283043A1
EP3283043A1 EP16719282.2A EP16719282A EP3283043A1 EP 3283043 A1 EP3283043 A1 EP 3283043A1 EP 16719282 A EP16719282 A EP 16719282A EP 3283043 A1 EP3283043 A1 EP 3283043A1
Authority
EP
European Patent Office
Prior art keywords
container
composition
closure
closing device
sampling
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
EP16719282.2A
Other languages
German (de)
French (fr)
Other versions
EP3283043B1 (en
Inventor
Jean-Marc DUBAELE
Thierry GUILLEMAUT
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.)
Centre Hospitalier Universitaire D'amiens - Picardie
Original Assignee
Centre Hospitalier Universitaire D'amiens - Picardie
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 Centre Hospitalier Universitaire D'amiens - Picardie filed Critical Centre Hospitalier Universitaire D'amiens - Picardie
Priority to PL16719282T priority Critical patent/PL3283043T3/en
Publication of EP3283043A1 publication Critical patent/EP3283043A1/en
Application granted granted Critical
Publication of EP3283043B1 publication Critical patent/EP3283043B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • 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
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • 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
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
    • B65D47/12—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages having removable closures
    • B65D47/14—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages having removable closures and closure-retaining means
    • 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
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1425—Snap-fit type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit

Definitions

  • Clogging device for sampling a packaging composition comprising such a closure device, sampling and packaging methods
  • the present invention relates to a closure device for sampling for administration, enterally or nasally, or for external use of compositions in the pharmaceutical, cosmetic and food.
  • the invention also relates to a packaging assembly comprising such a closure device as well as methods for packaging and sampling compositions.
  • Syrups or oral solutions packaged in multi-dose vials with screw caps are known. As soon as the bottle is opened, the outside air enters the container and contaminates the contents.
  • antimicrobial preservatives be added to the liquid solutions thus conditioned.
  • the main antimicrobial preservatives validated and used for liquid forms are alcohol, benzoic acid and parabens. Alcohol and benzoic acid can not be used in all liquid formulations, especially in pediatric preparations or for the treatment of persons with hepatic disease. There remains the parabens, already largely added to pharmaceuticals, cosmetics and food. However, a potential accumulation of these parabens in the body, could lead to hormonal disturbances. The use of parabens is so far controversial. The current trend is the elimination of preservatives in all products, especially those intended for children or those with contraindications to preservatives. However, for lack of validated alternative, the use of these antimicrobial preservatives remains valid.
  • EP 0 960 616 discloses an elastomeric stopper for insertion into the neck of a vial and having a sealing membrane capable of self-sealing.
  • No. 4,614,515 describes a device for capping a vial, in particular allowing the content to be removed by means of a needle syringe for parenteral administration.
  • FR 2 928 539 discloses an interfacing device for connecting a parenteral needle syringe and a drug-containing perforating bottle.
  • FR 2 993 174 relates to a device for securing the distribution of a liquid contained in a bottle, comprising a section reducer having a first orifice capable of receiving a syringe, an intermediate piece having a second orifice and intended to cap the reducer of section so that said first and second holes are facing each other and a closing means of the first and / or second orifices.
  • EP 2,266,523 discloses a vial adapter comprising a valve that can occupy an open position allowing communication between a syringe and the interior of the vial to allow the introduction of a liquid into the vial or the collection of liquid. out of the bottle, and a closed position preventing any fluid communication.
  • WO 2012/061353 discloses a system for filling a fluid in bottles and distributing the fluid from the bottles, comprising two different valves, each being adapted for one of these two functions.
  • WO 2011/027207 relates to a connection device between different medical accessories to allow and control the transfer of fluid from one accessory to another.
  • EP 2,601,987 discloses a device comprising two non-return valves for connecting a bottle, a syringe and a catheter.
  • the present invention provides a closure device for taking a composition intended for enteral or nasal administration, or for external use, contained in a container, characterized in that 'it comprises :
  • a nozzle defining an internal passage opening onto an opening, configured to allow a connection to a sampling member such as an enteral syringe,
  • a non-return valve associated with said nozzle, configured to open when the contents of the container are taken with the aid of the sampling member
  • the contamination of the composition contained in the container is avoided, which makes it possible to avoid or reduce the use of preservatives in the compositions, especially those intended for children or persons with a pathology such as hepatic or allergic pathology.
  • composition is meant any liquid solution, emulsion, semi-liquid solution, colloidal solution, or semi-pasty product, especially a gel, for (e) pharmaceutical, food or cosmetic use.
  • the air intake port allows the entry of air into the container, in particular simultaneously with a sample of composition in the container.
  • the tip may have at least partially a substantially conical shape, in particular with a conicity of about 6%, being preferably of the "lockable standard cone” or “luer lock cone” type.
  • the tip advantageously constitutes a secure and sealed connection member for a composition removal member for enteral administration or external use.
  • the sampling member can be screwed onto the end piece so as to secure and seal the connection clogging.
  • the tip comprises means for fixing, in particular the screwing of the sampling member, for example a thread, outer or inner. Compatibility with only the organs of sampling and administration enterally or externally, avoids the risk of sampling oral solution or not compulsorily sterile with a syringe for parenteral route.
  • the non-return valve may include a seat and a sealing membrane resting on said seat and may have an annular shape. It may comprise an annular constriction on the waterproofing membrane to facilitate its deformation.
  • the waterproofing membrane may be made of a polymeric material, especially a flexible material, used in the manufacture of devices for medical, food or cosmetic use, for example an elastomeric or silicone material.
  • the filter may be made of a hydrophobic material intended to reduce bacterial contamination, for example having an average pore diameter of less than 0.3 ⁇ , for example equal to 0.22 ⁇ .
  • the closure device according to the invention may comprise a plate intended to be in contact with the interior of the container and having at least one aperture for the passage of air and at least one aperture for the passage of liquid.
  • the filter can then cover said at least one aperture for the passage of air, which can be fixed, in particular by gluing or welding, to said plate.
  • the non-return valve can be positioned on the plate so as to close off said at least one aperture for the passage of liquid.
  • the closure device according to the invention may comprise fixing means on the container.
  • These fixing means may comprise a fixing skirt, in particular internally threaded, arranged to attach to a neck of the container, by screwing and / or latching.
  • the fastening means may comprise a tamper evident relief configured to prevent the closure device from being removed from the container once it is secured to the container.
  • the fixing means advantageously comprise a sealing skirt arranged to come into sealed internal contact with the neck of the container.
  • the closure device according to the invention may comprise a closure member, the closure member being preferably connected to the rest of the device of the invention. capping by a flexible link, such as a film hinge.
  • the closure member which can form a cover, makes it possible to close the closure device and in particular to close the end piece and the air intake opening or ports.
  • the closure member may be provided with a tamper-evident means (tamper-evident means), proof that the device and therefore the composition has never been used.
  • tamper-evident means proof that the device and therefore the composition has never been used.
  • the closure device according to the invention may comprise an upper part and a lower part assembled together, in particular by snapping, said upper and lower parts together defining when assembled, an area for the passage of air, an intermediate zone for the maintaining the non-return valve, and an area for the passage of liquid.
  • the upper part may comprise the nozzle and said at least one air intake port. It may comprise, on an internal face, a sealing lip intended to bear against the non-return valve, in particular on said annular shrinkage of the non-return valve.
  • the upper part makes it possible to fix the sampling member.
  • the lower part may include the tray. It is preferably in at least partial contact with the composition and can be attached to the bottle, comprising the means for attachment to the container.
  • the entire closure device is advantageously made of thermoplastic material, by injection molding, the lower part and the closure member can be made in one piece.
  • a packaging assembly for a composition intended for enteral administration or for external use comprising a container for packaging said composition, secured to a device for capping as defined above.
  • Such an assembly may further comprise at least one sampling member, which is advantageously configured to allow enteral or external administration.
  • This set can be packaged in an individual package totally or partially sterile or not, the container being filled with the composition to be dispensed.
  • the invention makes it possible to reduce manufacturing costs compared to single-dose vials.
  • the invention also makes it possible to increase the shelf life, after first opening of the container, of the composition.
  • the concentration of preservatives in the composition can thus be reduced or even reduced to zero.
  • the subject of the present invention is also, in combination with the foregoing, a process for taking a composition using a sampling device such as an enteral syringe in a container provided with a closure device such as defined above, including the following steps:
  • the method may comprise the steps of opening the closure member before securing the sampling member to the tip and closing the closure member after removal of the sampling organ.
  • the subject of the invention is also, in combination with the foregoing, a method of packaging in a container a composition intended for enteral administration or for external use, comprising the following steps:
  • This packaging method may comprise the steps of associating with said container at least one sampling member such as a syringe and optionally to dispose the whole in an individual package, sterile or otherwise.
  • FIG. 1 schematically and in perspective shows an example of a closure device according to the invention
  • FIG. 2 represents, in axial section, schematic and partial, the closure device of FIG. 1,
  • FIG. 3 is a diagrammatic view from below of the closure device of FIG. 1,
  • FIG. 4 is a diagrammatic plan view of the closure device of FIG. 1, the upper part removed,
  • FIG. 5 represents in axial section, schematically and partially, the closure device of FIG. 1, closed and fixed on the neck of a container
  • FIG. 6 is a diagrammatic perspective view of the container provided with capping device of Figure 1, closed
  • FIG. 7 schematically represents a packaging assembly comprising the container of FIG. 6 and a suitable sampling device
  • FIGS. 8 and 9 schematically represent two steps of a method for packaging a composition in a closed container by a closure device according to the invention.
  • Figures 10 to 13 illustrate, schematically, steps of a method of sampling a composition using the closure device according to the invention.
  • the closure device 1, shown in Figures 1 to 5, is intended to be attached to a container 10, visible in particular in Figure 5 or 6.
  • This container 10 contains a composition to be administered enterally or externally, of which the rate of preservatives is reduced or even zero.
  • the closure device 1 comprises a dispensing nozzle 2 defining an internal passage 3 extending along a longitudinal axis X.
  • the internal passage 3 opens onto an opening 4 forming the free end of the nozzle 2.
  • the latter is configured to allow a connection to a sampling member such as an enteral syringe 20, visible in Figure 7.
  • the closure device 1 further comprises a non-return valve 5 associated with the nozzle 2, configured to open when the contents of the container are taken with the aid of the sampling member, visible in particular in the figures 2, 4 and 5.
  • the anti- return 5 prevents any return of liquid inside the container, and also prevents the entry of air in the absence of sampling member.
  • the closure device 1 also comprises at least one air intake port 6, of which there are nine in this example. At least one antibacterial filter, aimed at reducing bacterial contamination, is associated with the orifices 6. Such a filter 7 systematically filters the air entering the container through the orifices 6, preventing contamination of the composition contained in the container.
  • a filter 7 systematically filters the air entering the container through the orifices 6, preventing contamination of the composition contained in the container.
  • the orifices 6 are for example each of circular shape.
  • the tip 2 has at least partially a substantially conical shape about the longitudinal axis X, being slightly flared outwardly towards its opening 4, as can be seen in FIG. to be around 6%.
  • the tip 2 may be a tip called “lockable standardized cone” or “cone luer lock”, the latter form with collar 8 locking further allowing a locking of the sampling member in the tip 2, of known way in itself.
  • the non-return valve 5 is composed of a sealing membrane 27, made of a flexible polymer material, for example elastomer or silicone, having an annular shape around the X axis, as can be seen in particular in FIG.
  • An annular necking 9 facilitates its deformation in the X axis of the container.
  • the filter 7 is advantageously made of a hydrophobic material, so as to prevent the liquid from leaving the orifices 6.
  • the filter 7 has, for example, an average pore diameter of less than 0.3 ⁇ .
  • the closure device 1 illustrated has, as more particularly visible in Figure 3 or 5, a plate 11 intended to be in contact with the interior 73 of the container and having at least one aperture 12 for the passage of air and at least one aperture 13 for the passage of liquid.
  • the openings 12 and 13 are distributed annularly around the central axis X, the openings 12 forming ring portions. located radially outwardly relative to the openings 13, also arranged in a ring portion about the longitudinal axis X.
  • the number of openings 13 is six, this number can be reduced or increased without leaving the scope of the invention in particular be between three and six, so as to allow the passage of air without having to exert excessive traction on the syringe during sampling.
  • the number of openings 12 is three, each opening 12 having separations 14 which can participate in maintaining the filter 7 underlying.
  • the filter 7, or the filters 7, cover (s) the openings 12 for the passage of air and are fixed in particular by gluing or welding to the plate 11.
  • a filter 7 is shown in FIG. 7 may be unique and have an annular shape of diameter and dimensions such that it covers all the openings 12 for the passage of air.
  • the filters may be three in number as in this example, but only one filter 7 is shown in FIG. 4. Each filter 7 covers an aperture 12 for the passage of air.
  • the angular extent of the air passage openings 12 is sufficient for the openings to overlap at least partially with at least a portion of the orifices 6.
  • the upper and lower portions delimit between them an annular chamber where the air can circulate between the orifices 6 and the openings 12, when the air intake.
  • the sealing membrane 27 is positioned in this example on the plate 11 so as to seal at rest, as can be seen in FIG. 4, the openings 13.
  • the central, disc-shaped portion of the plate 11 thus forms the seat of the non-return valve 5.
  • the sealing membrane is advantageously bonded, in particular by ultrasound.
  • the closure device 1 further comprises fixing means 15 on the container.
  • the fastening means 15 may comprise, as illustrated, a fastening skirt 16 having an internal thread 17 arranged to attach to a threaded collar externally of the container, as can be seen in FIG. 5.
  • the fastening means 15 advantageously comprise a tamper evident relief 18, visible in FIGS. 2 and 5, configured to prevent the closure device 1 from being removed from the receptacle 10, once it is secured to the receptacle.
  • this inviolability relief may be in the form of an annular groove, and the receptacle 10 may in turn comprise a fastening bead 21 complementary inviolability relief 18, on which the groove snaps to the end of the screwing of the fastening means.
  • the fastening means 15 also comprise a sealing skirt 19 adapted to come into sealed internal contact with the neck of the container, as can be seen in particular in FIG. 5.
  • the closure device 1 also comprises a closure member 25 whose role is to seal the opening 4 of the nozzle 2.
  • the closure member 25 consists of a cover connected by a flexible link 26, such as a film hinge, at the base 100 of the closure device.
  • the closure member 25 comprises a sealing lip 35 adapted to form the seal around the opening 4 of the nozzle 2, to prevent leakage when the closure device 1 is closed.
  • a tamper-proof guarantee system before the first use is also provided.
  • the cover has at its periphery, on its inner surface, an annular bead 31 adapted to snap into a corresponding groove 30 of the base 100, formed on a post protruding around the openings 6 of air intake.
  • the base 100 comprises an upper part 50 and a lower part 60 assembled together, in this example by snap-fitting with complementary snap-on reliefs 51 and 52, respectively formed on the upper parts 50 and lower 60, in a form circular in a peripheral region thereof.
  • the top 50 and bottom 60 together define when assembled three distinct areas.
  • a first outer zone 61 defines the aforementioned annular chamber which allows the passage of air.
  • a second zone 62 intermediate annular also allows the maintenance of the non-return valve 5 and a third zone 63, substantially cylindrical, allows the passage of liquid.
  • the intermediate zone 62 prevents any communication between the zones 61 and 63.
  • the upper part 50 of the closure device comprises the nozzle 2 and the air intake orifices 6.
  • the upper part 50 has on an internal face 54 a sealing lip 55 bearing against the sealing membrane 27 of the non-return valve 5, on the annular necking 9. a depression is exerted, only the radially inner portion 4 to the annular necking of the membrane 27 is deformed.
  • the dimensions of the upper part can be optimized so as to avoid stagnation of the liquid and avoid contamination during the next sampling.
  • the lower part 60 comprises the plate 1 1 as well as the fixing means
  • FIGS. 6 and 7 show an example of a packaging assembly 70, according to the invention.
  • the container 10 consists of a glass bottle having a screw neck, for example of diameter 27 mm.
  • the container or neck may be different without departing from the scope of the invention.
  • the packaging assembly 70 comprises, in the example illustrated in FIG. 7, a sampling member 20 consisting of a luer lock type enteral syringe and an individual package 71 for packaging the assembly.
  • the packaging 71 comprises in particular a plurality of sampling members 20.
  • FIG. 8 illustrates steps of a packaging method according to the invention.
  • the step illustrated in FIG. 8 consists in introducing the composition L into the container 10.
  • the packaging method then comprises the step illustrated in FIG. 9, of fixing the closure device 1, in particular in this example by screwing on the neck 72 of the container 10.
  • the packaging process may further comprise the step of associating with the container 10 provided with the closure device 1 at least one sampling member 20 and optionally disposing the whole in an individual package 71, totally or partially sterile or not as illustrated on Figure 7.
  • FIGS. 10 to 13 show a method of taking the composition L with the aid of a sampling member.
  • the closing member 25 of the closure device 1 is first opened, as illustrated in FIG. 10, and then the sampling member 20 is secured to the end piece 2, in this example by screwing, as illustrated in FIG. 11. Then, by returning the container, the desired amount of composition L with the sampling member 20, by pulling on the piston of the sampling member, as illustrated in Figure 12.
  • the container may be equipped with a dip tube and / or be flexible elastic wall.
  • An additional non-return valve can be positioned near the tip.
  • Such an additional non-return valve for dry contact may be provided with a lockable standardized screwable cone specific for enteral administration.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • Ceramic Engineering (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The present invention relates to a sealing device (1) for making it possible to collect a composition that is intended for enteral or nasal administration or for topical use and is contained in a container. The sealing device is characterized in that it comprises: - a tip (2) that defines an internal passage (3) leading to an opening (4) and is designed to allow connection to a collection member such as an enteral syringe, - a non-return valve (5) that is associated with said tip (2) and is designed to open during collection of the contents of the container using the collection member, - at least one air-return port (6), and - an antibacterial filter (7) associated with said at least one port (6).

Description

Dispositif de bouchage pour permettre un prélèvement d'une composition ensemble de conditionnement comprenant un tel dispositif de bouchage, procédés de prélèvement et de conditionnement  Clogging device for sampling a packaging composition comprising such a closure device, sampling and packaging methods
La présente invention concerne un dispositif de bouchage permettant le prélèvement en vue de l'administration, par voie entérale ou nasale, ou pour un usage externe de compositions dans les domaines pharmaceutique, cosmétique et alimentaire. L'invention concerne également un ensemble de conditionnement comportant un tel dispositif de bouchage ainsi que des procédés de conditionnement et de prélèvement de compositions. The present invention relates to a closure device for sampling for administration, enterally or nasally, or for external use of compositions in the pharmaceutical, cosmetic and food. The invention also relates to a packaging assembly comprising such a closure device as well as methods for packaging and sampling compositions.
Des sirops ou solutions buvables conditionnés dans des flacons multi-doses à bouchon vissé sont connus. Dès l'ouverture du flacon, l'air extérieur pénètre le contenant et contamine le contenu.  Syrups or oral solutions packaged in multi-dose vials with screw caps are known. As soon as the bottle is opened, the outside air enters the container and contaminates the contents.
Il est donc nécessaire que des conservateurs antimicrobiens soient additionnés aux solutions liquides ainsi conditionnées. Les principaux conservateurs antimicrobiens validés et utilisés pour les formes liquides sont l'alcool, l'acide benzoïque et les parabènes. L'alcool et l'acide benzoïque ne peuvent pas être utilisés dans toutes les formulations liquides, notamment dans les préparations pédiatriques ou pour le traitement de personnes porteuses d'une pathologie hépatique. Il reste donc les parabènes, déjà largement additionnés aux produits pharmaceutiques, cosmétiques et alimentaires. Or, une potentielle accumulation de ces parabènes dans l'organisme, pourrait entraîner des perturbations hormonales. L'utilisation des parabènes est à ce jour controversée. La tendance actuelle est ainsi l'élimination des conservateurs dans tous les produits, notamment ceux destinés aux enfants ou aux personnes présentant une contre-indication aux conservateurs. Toutefois, faute d'alternative validée, l'utilisation de ces conservateurs antimicrobiens reste d'actualité.  It is therefore necessary that antimicrobial preservatives be added to the liquid solutions thus conditioned. The main antimicrobial preservatives validated and used for liquid forms are alcohol, benzoic acid and parabens. Alcohol and benzoic acid can not be used in all liquid formulations, especially in pediatric preparations or for the treatment of persons with hepatic disease. There remains the parabens, already largely added to pharmaceuticals, cosmetics and food. However, a potential accumulation of these parabens in the body, could lead to hormonal disturbances. The use of parabens is so far controversial. The current trend is the elimination of preservatives in all products, especially those intended for children or those with contraindications to preservatives. However, for lack of validated alternative, the use of these antimicrobial preservatives remains valid.
Il existe ainsi un besoin de retirer ou de diminuer le ou les conservateurs des compositions dans les domaines pharmaceutique, alimentaire et cosmétique.  There is thus a need to remove or reduce the preservative (s) of the compositions in the pharmaceutical, food and cosmetic fields.
Pour ce faire, il est connu de réaliser des récipients unidoses pour la distribution de compositions. Cependant, cette solution génère davantage de déchets, et nécessite plus de main d'œuvre et d'emballage. La demande internationale WO2004/043326 décrit un manchon pour col de flacon dimensionné de manière à être fixé de manière étanche dans le col du flacon et comprenant un manchon définissant une cheminée permettant la solidarisation avec un embout de seringue afin de réaliser un prélèvement. Néanmoins, l'entrée d'air ambiant potentiellement contaminé n'est pas empêchée par un tel dispositif de bouchage. De plus, il est toujours possible d'injecter dans le flacon un liquide qui peut être contaminé. To do this, it is known to produce single-dose containers for dispensing compositions. However, this solution generates more waste, and requires more manpower and packaging. The international application WO2004 / 043326 discloses a bottle neck sleeve dimensioned to be sealingly attached in the neck of the bottle and comprising a sleeve defining a chimney for securing with a syringe tip to perform a sampling. Nevertheless, the entry of potentially contaminated ambient air is not prevented by such a closure device. In addition, it is always possible to inject into the flask a liquid that can be contaminated.
EP 0 960 616 décrit un bouchon en élastomère destiné à être inséré dans le col d'un flacon et comportant une membrane de scellement capable d'auto-scellement.  EP 0 960 616 discloses an elastomeric stopper for insertion into the neck of a vial and having a sealing membrane capable of self-sealing.
FR 2 870 827décrit un organe de distribution placé dans l'embouchure d'un flacon, comportant une cheminée munie d'un orifice permettant l'introduction d'une seringue dans la cheminée, le prélèvement de solution contenue dans le flacon au travers de l'orifice puis le retrait de la seringue.  FR 2 870 827describes a dispensing member placed in the mouth of a bottle, having a chimney provided with an orifice allowing the introduction of a syringe into the chimney, the removal of solution contained in the bottle through the orifice and withdrawal of the syringe.
US 4 614 515 décrit un dispositif de bouchage d'un flacon permettant notamment le prélèvement du contenu à l'aide d'une seringue à aiguille pour administration parentérale.  No. 4,614,515 describes a device for capping a vial, in particular allowing the content to be removed by means of a needle syringe for parenteral administration.
FR 2 928 539 décrit un dispositif d'interfaçage destiné à mettre en liaison une seringue à aiguille pour administration parentérale et un flacon à perforer contenant un médicament.  FR 2 928 539 discloses an interfacing device for connecting a parenteral needle syringe and a drug-containing perforating bottle.
FR 2 993 174 concerne un dispositif pour sécuriser la distribution d'un liquide contenu dans un flacon, comprenant un réducteur de section présentant un premier orifice susceptible de recevoir une seringue, une pièce intermédiaire présentant un second orifice et destinée à venir coiffer le réducteur de section de sorte à ce que lesdits premier et second orifices se trouvent en regard l'un de l'autre et un moyen de fermeture des premier et/ou second orifices.  FR 2 993 174 relates to a device for securing the distribution of a liquid contained in a bottle, comprising a section reducer having a first orifice capable of receiving a syringe, an intermediate piece having a second orifice and intended to cap the reducer of section so that said first and second holes are facing each other and a closing means of the first and / or second orifices.
EP 2 266 523 décrit un adaptateur pour flacon comprenant une valve pouvant occuper une position ouverte permettant la communication entre une seringue et l'intérieur du flacon afin de permettre l'introduction d'un liquide à l'intérieur du flacon ou le prélèvement de liquide hors du flacon, et une position fermée empêchant toute communication fluidique.  EP 2,266,523 discloses a vial adapter comprising a valve that can occupy an open position allowing communication between a syringe and the interior of the vial to allow the introduction of a liquid into the vial or the collection of liquid. out of the bottle, and a closed position preventing any fluid communication.
WO 2012/061353 décrit un système de remplissage d'un fluide dans des flacons et de distribution du fluide depuis les flacons, comprenant deux valves différentes, chacune étant adaptée pour l'une de ces deux fonctions. WO 2011/027207 concerne un dispositif de connexion entre différents accessoires médicaux afin de permettre et contrôler le transfert de fluide d'un accessoire à l'autre. WO 2012/061353 discloses a system for filling a fluid in bottles and distributing the fluid from the bottles, comprising two different valves, each being adapted for one of these two functions. WO 2011/027207 relates to a connection device between different medical accessories to allow and control the transfer of fluid from one accessory to another.
EP 2 601 987 divulgue un dispositif comprenant deux valves anti-retour permettant de relier un flacon, une seringue et un cathéter.  EP 2,601,987 discloses a device comprising two non-return valves for connecting a bottle, a syringe and a catheter.
Pour répondre à tout ou partie des besoins précités, la présente invention propose un dispositif de bouchage permettant un prélèvement d'une composition destinée à l'administration entérale ou nasale, ou à un usage externe, contenue dans un récipient, caractérisé par le fait qu'il comporte :  To meet all or part of the aforementioned needs, the present invention provides a closure device for taking a composition intended for enteral or nasal administration, or for external use, contained in a container, characterized in that 'it comprises :
- un embout définissant un passage interne débouchant sur une ouverture, configuré pour permettre une connexion à un organe de prélèvement tel qu'une seringue entérale,  a nozzle defining an internal passage opening onto an opening, configured to allow a connection to a sampling member such as an enteral syringe,
une valve anti-retour associée audit embout, configurée pour s'ouvrir lors du prélèvement du contenu du récipient à l'aide de l'organe de prélèvement,  a non-return valve associated with said nozzle, configured to open when the contents of the container are taken with the aid of the sampling member,
- au moins un orifice de reprise d'air, et  at least one air intake port, and
un filtre antibactérien associé audit orifice de reprise d'air  an antibacterial filter associated with said air intake port
Grâce à l'invention, la contamination de la composition contenue dans le récipient est évitée, ce qui permet d'éviter ou de diminuer l'utilisation de conservateurs dans les compositions, notamment celles destinées aux enfants ou aux personnes présentant une pathologie telle qu'une pathologie hépathique ou de type allergique.  Thanks to the invention, the contamination of the composition contained in the container is avoided, which makes it possible to avoid or reduce the use of preservatives in the compositions, especially those intended for children or persons with a pathology such as hepatic or allergic pathology.
Par « composition », on entend toute solution liquide, émulsion, solution semi- liquide, solution colloïdale, ou produit semi-pâteux, notamment un gel, destiné(e) à un usage pharmaceutique, alimentaire ou cosmétique.  By "composition" is meant any liquid solution, emulsion, semi-liquid solution, colloidal solution, or semi-pasty product, especially a gel, for (e) pharmaceutical, food or cosmetic use.
L'orifice de reprise d'air permet l'entrée d'air dans le récipient, notamment simultanément à un prélèvement de composition dans le récipient.  The air intake port allows the entry of air into the container, in particular simultaneously with a sample of composition in the container.
L'embout peut présenter au moins partiellement une forme sensiblement conique, notamment de conicité de 6% environ, étant de préférence de type "cône normalisé verrouillable'Ou "cône luer lock".  The tip may have at least partially a substantially conical shape, in particular with a conicity of about 6%, being preferably of the "lockable standard cone" or "luer lock cone" type.
L'embout constitue avantageusement un organe de connexion sécurisé et étanche pour un organe de prélèvement de composition destinée à une administration entérale ou à usage externe. L'organe de prélèvement peut être vissé sur l'embout, de manière à sécuriser et étanchéifîer la connexion organe de prélèvement - dispositif de bouchage. Dans ce cas, l'embout comporte des moyens permettant la fixation, notamment le vissage de l'organe de prélèvement, par exemple un filetage, extérieur ou intérieur. La compatibilité avec les seuls organes de prélèvement et d'administration par voie entérale ou à usage externe, permet d'éviter le risque de prélèvement de solution buvable ou non obligatoirement stérile à l'aide d'une seringue pour voie parentérale. The tip advantageously constitutes a secure and sealed connection member for a composition removal member for enteral administration or external use. The sampling member can be screwed onto the end piece so as to secure and seal the connection clogging. In this case, the tip comprises means for fixing, in particular the screwing of the sampling member, for example a thread, outer or inner. Compatibility with only the organs of sampling and administration enterally or externally, avoids the risk of sampling oral solution or not compulsorily sterile with a syringe for parenteral route.
La valve anti-retour peut comporter un siège et une membrane d'étanchéité reposant sur ledit siège et pouvant présenter une forme annulaire. Elle peut comporter un rétreint annulaire, sur la membrane d'étanchéité, pour faciliter sa déformation. La membrane d'étanchéité peut être réalisée dans un matériau polymère, notamment souple, utilisé dans la fabrication de dispositifs à usage médical, alimentaire ou cosmétique, par exemple un matériau élastomère ou silicone. Lorsqu'une dépression est exercée sur la valve anti-retour, par exemple par un piston de l'organe de prélèvement lorsque solidarisé à l'embout, la membrane d'étanchéité s'écarte du siège et permet le passage de liquide.  The non-return valve may include a seat and a sealing membrane resting on said seat and may have an annular shape. It may comprise an annular constriction on the waterproofing membrane to facilitate its deformation. The waterproofing membrane may be made of a polymeric material, especially a flexible material, used in the manufacture of devices for medical, food or cosmetic use, for example an elastomeric or silicone material. When a depression is exerted on the non-return valve, for example by a piston of the sampling member when secured to the nozzle, the sealing membrane moves away from the seat and allows the passage of liquid.
Le filtre peut être réalisé dans un matériau hydrophobe visant à diminuer la contamination bactérienne, présentant par exemple un diamètre moyen des pores inférieur à 0.3μιη, par exemple égal à 0.22μιη.  The filter may be made of a hydrophobic material intended to reduce bacterial contamination, for example having an average pore diameter of less than 0.3μιη, for example equal to 0.22μιη.
Le dispositif de bouchage selon l'invention peut comporter un plateau destiné à être en contact avec l'intérieur du récipient et présentant au moins un ajour pour le passage d'air et au moins un ajour pour le passage de liquide.  The closure device according to the invention may comprise a plate intended to be in contact with the interior of the container and having at least one aperture for the passage of air and at least one aperture for the passage of liquid.
Le filtre peut alors recouvrir ledit au moins un ajour pour le passage d'air, pouvant être fixé, notamment par collage ou soudage, audit plateau. La valve anti-retour peut être positionnée sur le plateau de manière à venir obturer ledit au moins un ajour pour le passage de liquide.  The filter can then cover said at least one aperture for the passage of air, which can be fixed, in particular by gluing or welding, to said plate. The non-return valve can be positioned on the plate so as to close off said at least one aperture for the passage of liquid.
Le dispositif de bouchage selon l'invention peut comporter des moyens de fixation sur le récipient. Ces moyens de fixation peuvent comporter une jupe de fixation, notamment filetée intérieurement, agencée pour se fixer à un col du récipient, par vissage et/ou encliquetage. Les moyens de fixation peuvent comporter un relief d'inviolabilité configuré pour empêcher de retirer le dispositif de bouchage du récipient, une fois celui-ci solidarisé au récipient. Les moyens de fixation comportent avantageusement une jupe d'étanchéité agencée pour venir en contact intérieur étanche avec le col du récipient.  The closure device according to the invention may comprise fixing means on the container. These fixing means may comprise a fixing skirt, in particular internally threaded, arranged to attach to a neck of the container, by screwing and / or latching. The fastening means may comprise a tamper evident relief configured to prevent the closure device from being removed from the container once it is secured to the container. The fixing means advantageously comprise a sealing skirt arranged to come into sealed internal contact with the neck of the container.
Le dispositif de bouchage selon l'invention peut comporter un organe de fermeture, l'organe de fermeture étant de préférence relié au reste du dispositif de bouchage par un lien flexible, tel qu'une charnière film. L'organe de fermeture, pouvant former un capot, permet de fermer le dispositif de bouchage et notamment de fermer l'embout et le ou les orifices de reprise d'air. The closure device according to the invention may comprise a closure member, the closure member being preferably connected to the rest of the device of the invention. capping by a flexible link, such as a film hinge. The closure member, which can form a cover, makes it possible to close the closure device and in particular to close the end piece and the air intake opening or ports.
L'organe de fermeture peut être muni d'un système de garantie d'inviolabilité avant une première ouverture (en anglais « tamper-evident means »), preuve que le dispositif et donc la composition n'a jamais servi.  The closure member may be provided with a tamper-evident means (tamper-evident means), proof that the device and therefore the composition has never been used.
Le dispositif de bouchage selon l'invention peut comporter une partie supérieure et une partie inférieure assemblées entre elles, notamment par encliquetage, lesdites parties supérieure et inférieure définissant ensemble lorsqu' assemblées, une zone pour le passage d'air, une zone intermédiaire pour le maintien de la valve anti-retour, et une zone pour le passage de liquide.  The closure device according to the invention may comprise an upper part and a lower part assembled together, in particular by snapping, said upper and lower parts together defining when assembled, an area for the passage of air, an intermediate zone for the maintaining the non-return valve, and an area for the passage of liquid.
La partie supérieure peut comporter l'embout et ledit au moins un orifice de reprise d'air. Elle peut comporter, sur une face interne, une lèvre d'étanchéité destinée à venir en appui sur la valve anti-retour, notamment sur ledit rétreint annulaire de la valve anti-retour. La partie supérieure permet de fixer l'organe de prélèvement.  The upper part may comprise the nozzle and said at least one air intake port. It may comprise, on an internal face, a sealing lip intended to bear against the non-return valve, in particular on said annular shrinkage of the non-return valve. The upper part makes it possible to fix the sampling member.
La partie inférieure peut comporter le plateau. Elle est de préférence en contact au moins partiel avec la composition et peut être fixée sur le flacon, comprenant les moyens de fixation au récipient.  The lower part may include the tray. It is preferably in at least partial contact with the composition and can be attached to the bottle, comprising the means for attachment to the container.
L'ensemble du dispositif de bouchage est avantageusement réalisé en matériau thermoplastique, par moulage par injection, la partie inférieure et l'organe de fermeture pouvant être réalisés d'une seule pièce.  The entire closure device is advantageously made of thermoplastic material, by injection molding, the lower part and the closure member can be made in one piece.
La présente invention a également pour objet, en combinaison avec ce qui précède, un ensemble de conditionnement d'une composition destinée à l'administration entérale ou à un usage externe, comportant un récipient pour le conditionnement de ladite composition, solidarisé avec un dispositif de bouchage tel que défini plus haut. Un tel ensemble peut comporter en outre au moins un organe de prélèvement, lequel est avantageusement configuré pour permettre l'administration par voie entérale ou externe. Cet ensemble peut être conditionné dans un emballage individuel totalement ou partiellement stérile ou non, le récipient étant rempli par la composition à distribuer.  The subject of the present invention is also, in combination with the foregoing, a packaging assembly for a composition intended for enteral administration or for external use, comprising a container for packaging said composition, secured to a device for capping as defined above. Such an assembly may further comprise at least one sampling member, which is advantageously configured to allow enteral or external administration. This set can be packaged in an individual package totally or partially sterile or not, the container being filled with the composition to be dispensed.
L'invention permet de réduire les coûts de fabrication par rapport à des flacons unidoses. L'invention permet également d'augmenter la durée de conservation, après première ouverture du récipient, de la composition. La concentration en conservateurs dans la composition peut ainsi être diminuée, voire réduite à zéro. The invention makes it possible to reduce manufacturing costs compared to single-dose vials. The invention also makes it possible to increase the shelf life, after first opening of the container, of the composition. The concentration of preservatives in the composition can thus be reduced or even reduced to zero.
Grâce à l'étanchéité réalisée à plusieurs niveaux, à savoir dans la liaison entre le dispositif de bouchage et le récipient d'une part, au sein du dispositif de bouchage lui- même et dans l'interface entre l'organe de prélèvement et le dispositif de bouchage, les fuites de liquide hors du récipient lors du prélèvement peuvent être évitées, ce qui améliore l'hygiène lors de l'utilisation.  Thanks to the sealing performed at several levels, namely in the connection between the closure device and the container on the one hand, within the closure device itself and in the interface between the sampling member and the capping device, leaks of liquid out of the container during sampling can be avoided, which improves hygiene during use.
La présente invention a encore pour objet, en combinaison avec ce qui précède, un procédé de prélèvement d'une composition à l'aide d'un organe de prélèvement tel qu'une seringue entérale dans un récipient muni d'un dispositif de bouchage tel que défini plus haut, comportant les étapes suivantes :  The subject of the present invention is also, in combination with the foregoing, a process for taking a composition using a sampling device such as an enteral syringe in a container provided with a closure device such as defined above, including the following steps:
solidariser l'organe de prélèvement à l'embout, prélever la quantité souhaitée de composition avec l'organe de prélèvement, notamment à l'aide d'un piston d'une seringue,  fasten the sampling member to the tip, take the desired amount of composition with the sampling member, in particular with the aid of a piston of a syringe,
- retirer l'organe de prélèvement de l'embout,  - remove the sampling member from the tip,
répéter les étapes précédentes, si nécessaire, et autant de fois que nécessaire.  repeat the previous steps, if necessary, and as many times as necessary.
Lorsque le dispositif de bouchage comporte un organe de fermeture, le procédé peut comporter les étapes consistant à ouvrir l'organe de fermeture avant de solidariser l'organe de prélèvement à l'embout et à fermer l'organe de fermeture après retrait de l'organe de prélèvement.  When the closure device comprises a closure member, the method may comprise the steps of opening the closure member before securing the sampling member to the tip and closing the closure member after removal of the sampling organ.
L'invention a également pour objet, en combinaison avec ce qui précède, un procédé de conditionnement dans un récipient d'une composition destinée à l'administration entérale ou à un usage externe, comportant les étapes suivantes :  The subject of the invention is also, in combination with the foregoing, a method of packaging in a container a composition intended for enteral administration or for external use, comprising the following steps:
- introduire ladite composition dans le récipient,  introducing said composition into the container,
fixer un dispositif de bouchage tel que défini plus haut au récipient. Ce procédé de conditionnement peut comporter les étapes consistant à associer audit récipient au moins un organe de prélèvement tel qu'une seringue et éventuellement à disposer le tout dans un emballage individuel, stérile ou non.  fix a closure device as defined above to the container. This packaging method may comprise the steps of associating with said container at least one sampling member such as a syringe and optionally to dispose the whole in an individual package, sterile or otherwise.
L'invention pourra être mieux comprise à la lecture de la description détaillée qui va suivre, d'un exemple de mise en œuvre non limitatif de celle-ci, et à l'examen du dessin annexé, sur lequel : la figure 1 représente de manière schématique et en perspective un exemple de dispositif de bouchage conforme à l'invention, The invention will be better understood on reading the following detailed description of an example of non-limiting implementation thereof, and on examining the appended drawing, in which: FIG. 1 schematically and in perspective shows an example of a closure device according to the invention,
la figure 2 représente en coupe axiale, schématique et partielle, le dispositif de bouchage de la figure 1 ,  FIG. 2 represents, in axial section, schematic and partial, the closure device of FIG. 1,
- la figure 3 représente de manière schématique en vue de dessous le dispositif de bouchage de la figure 1 ,  FIG. 3 is a diagrammatic view from below of the closure device of FIG. 1,
la figure 4 représente de manière schématique en vue de dessus le dispositif de bouchage de la figure 1 , la partie supérieure enlevée,  FIG. 4 is a diagrammatic plan view of the closure device of FIG. 1, the upper part removed,
la figure 5 représente en coupe axiale, de manière schématique et partielle, le dispositif de bouchage de la figure 1, fermé et fixé sur le col d'un récipient, la figure 6 représente, de manière schématique et en perspective, le récipient muni du dispositif de bouchage de la figure 1 , fermé,  FIG. 5 represents in axial section, schematically and partially, the closure device of FIG. 1, closed and fixed on the neck of a container, FIG. 6 is a diagrammatic perspective view of the container provided with capping device of Figure 1, closed,
la figure 7 représente de manière schématique un ensemble de conditionnement comportant le récipient de la figure 6 et un organe de prélèvement adapté,  FIG. 7 schematically represents a packaging assembly comprising the container of FIG. 6 and a suitable sampling device;
- les figures 8 et 9 représentent de manière schématique deux étapes d'un procédé de conditionnement d'une composition dans un récipient fermé par un dispositif de bouchage conforme à l'invention, et  FIGS. 8 and 9 schematically represent two steps of a method for packaging a composition in a closed container by a closure device according to the invention, and
les figures 10 à 13 illustrent, de manière schématique, des étapes d'un procédé de prélèvement d'une composition à l'aide du dispositif de bouchage selon l'invention.  Figures 10 to 13 illustrate, schematically, steps of a method of sampling a composition using the closure device according to the invention.
Le dispositif de bouchage 1, représenté sur les figures 1 à 5, est destiné à être fixé à un récipient 10, visible notamment sur la figure 5 ou 6. Ce récipient 10 contient une composition à administrer par voie entérale ou à usage externe, dont le taux de conservateurs est réduit, voire nul.  The closure device 1, shown in Figures 1 to 5, is intended to be attached to a container 10, visible in particular in Figure 5 or 6. This container 10 contains a composition to be administered enterally or externally, of which the rate of preservatives is reduced or even zero.
Le dispositif de bouchage 1 comporte un embout de distribution 2 définissant un passage interne 3 s 'étendant selon un axe longitudinal X. Le passage interne 3 débouche sur une ouverture 4 formant l'extrémité libre de l'embout 2. Ce dernier est configuré pour permettre une connexion à un organe de prélèvement tel qu'une seringue entérale 20, visible sur la figure 7.  The closure device 1 comprises a dispensing nozzle 2 defining an internal passage 3 extending along a longitudinal axis X. The internal passage 3 opens onto an opening 4 forming the free end of the nozzle 2. The latter is configured to allow a connection to a sampling member such as an enteral syringe 20, visible in Figure 7.
Le dispositif de bouchage 1 comporte en outre une valve anti-retour 5 associée à l'embout 2, configurée pour s'ouvrir lors du prélèvement du contenu du récipient à l'aide de l'organe de prélèvement, visible en particulier sur les figures 2, 4 et 5. La valve anti- retour 5 empêche tout retour de liquide à l'intérieur du récipient, et empêche également l'entrée d'air en l'absence d'organe de prélèvement. The closure device 1 further comprises a non-return valve 5 associated with the nozzle 2, configured to open when the contents of the container are taken with the aid of the sampling member, visible in particular in the figures 2, 4 and 5. The anti- return 5 prevents any return of liquid inside the container, and also prevents the entry of air in the absence of sampling member.
Le dispositif de bouchage 1 comprend également au moins un orifice 6 de reprise d'air, au nombre de neuf dans cet exemple. Au moins un fîltre7 antibactérien, visant à réduire la contamination bactérienne, est associé aux orifices 6. Un tel filtre 7 permet de filtrer systématiquement l'air entrant dans le récipient par les orifices 6, empêchant la contamination de la composition contenue dans le récipient. Ainsi, grâce à l'invention, il est possible de faire un prélèvement multidose ou de multiples prélèvements d'une composition contenue dans un récipient via le dispositif de bouchage 1 sans contaminer la composition restant dans le récipient, en empêchant le retour de composition à l'intérieur du récipient, potentiellement contaminée, et grâce à la filtration de tout air entrant dans le récipient en raison de la dépression créée lors du prélèvement de la solution.  The closure device 1 also comprises at least one air intake port 6, of which there are nine in this example. At least one antibacterial filter, aimed at reducing bacterial contamination, is associated with the orifices 6. Such a filter 7 systematically filters the air entering the container through the orifices 6, preventing contamination of the composition contained in the container. Thus, thanks to the invention, it is possible to make a multidose sampling or multiple samples of a composition contained in a container via the closure device 1 without contaminating the composition remaining in the container, preventing the return of composition to inside the container, potentially contaminated, and through the filtration of any air entering the container due to the depression created during the removal of the solution.
Les orifices 6 sont par exemple chacun de forme circulaire.  The orifices 6 are for example each of circular shape.
Dans l'exemple illustré, l'embout 2 présente au moins partiellement une forme sensiblement conique autour de l'axe longitudinal X, étant légèrement évasé vers l'extérieur en rapprochement de son ouverture 4, comme visible sur la figure 2. La conicité peut être d'environ 6%. En particulier, l'embout 2 peut être un embout dit « cône normalisé verrouillable » ou « cône luer lock », cette dernière forme avec collerette 8 de verrouillage permettant en outre un verrouillage de l'organe de prélèvement dans l'embout 2, de façon connue en soi.  In the example shown, the tip 2 has at least partially a substantially conical shape about the longitudinal axis X, being slightly flared outwardly towards its opening 4, as can be seen in FIG. to be around 6%. In particular, the tip 2 may be a tip called "lockable standardized cone" or "cone luer lock", the latter form with collar 8 locking further allowing a locking of the sampling member in the tip 2, of known way in itself.
La valve anti-retour 5 est composée d'une membrane d'étanchéité 27, réalisée en un matériau polymère souple, par exemple en élastomère ou en silicone, présentant une forme annulaire autour de l'axe X, comme visible notamment sur la figure 4. Un rétreint annulaire 9 facilite sa déformation dans l'axe X du récipient.  The non-return valve 5 is composed of a sealing membrane 27, made of a flexible polymer material, for example elastomer or silicone, having an annular shape around the X axis, as can be seen in particular in FIG. An annular necking 9 facilitates its deformation in the X axis of the container.
Le filtre 7 est réalisé avantageusement dans un matériau hydrophobe, de manière à empêcher la sortie de liquide par les orifices 6. Le filtre 7 présente par exemple un diamètre moyen de pores inférieur à 0,3 μιη.  The filter 7 is advantageously made of a hydrophobic material, so as to prevent the liquid from leaving the orifices 6. The filter 7 has, for example, an average pore diameter of less than 0.3 μιη.
Dans le dispositif de bouchage 1 illustré, celui-ci comporte, comme visible plus particulièrement sur la figure 3 ou 5, un plateau 11 destiné à être en contact avec l'intérieur 73 du récipient et présentant au moins un ajour 12 pour le passage d'air et au moins un ajour 13 pour le passage de liquide. Dans l'exemple illustré, les ajours 12 et 13 sont répartis de manière annulaire autour de l'axe X central, les ajours 12 formant des portions d'anneau situées radialement à l'extérieur par rapport aux ajours 13, disposés également en portion d'anneau autour de l'axe longitudinal X. Dans cet exemple, le nombre d'ajours 13 est de six, ce nombre pouvant être réduit ou augmenté sans sortir du cadre de l'invention notamment être compris entre trois et six, de manière à permettre le passage d'air sans avoir à exercer une traction trop importante sur la seringue lors du prélèvement. Le nombre d'ajours 12 est de trois, chaque ajour 12 présentant des séparations 14 qui peuvent participer au maintien du filtre 7 sous jacent. In the closure device 1 illustrated, it has, as more particularly visible in Figure 3 or 5, a plate 11 intended to be in contact with the interior 73 of the container and having at least one aperture 12 for the passage of air and at least one aperture 13 for the passage of liquid. In the example shown, the openings 12 and 13 are distributed annularly around the central axis X, the openings 12 forming ring portions. located radially outwardly relative to the openings 13, also arranged in a ring portion about the longitudinal axis X. In this example, the number of openings 13 is six, this number can be reduced or increased without leaving the scope of the invention in particular be between three and six, so as to allow the passage of air without having to exert excessive traction on the syringe during sampling. The number of openings 12 is three, each opening 12 having separations 14 which can participate in maintaining the filter 7 underlying.
Dans cet exemple, le filtre 7, ou les filtres 7, recouvre(nt) les ajours 12 pour le passage d'air et sont fixés notamment par collage ou soudage au plateau 11. Un filtre 7 est représenté sur la figure 4. Le filtre 7 peut être unique et présenter une forme annulaire de diamètre et des dimensions telles qu'il recouvre l'ensemble des ajours 12 pour le passage d'air. En variante, les filtres peuvent être au nombre de trois comme dans cet exemple, un seul filtre 7 étant toutefois représenté sur la figure 4. Chaque filtre 7 recouvre un ajour 12 pour le passage d'air.  In this example, the filter 7, or the filters 7, cover (s) the openings 12 for the passage of air and are fixed in particular by gluing or welding to the plate 11. A filter 7 is shown in FIG. 7 may be unique and have an annular shape of diameter and dimensions such that it covers all the openings 12 for the passage of air. In a variant, the filters may be three in number as in this example, but only one filter 7 is shown in FIG. 4. Each filter 7 covers an aperture 12 for the passage of air.
L'étendue angulaire des ajours de passage d'air 12 est suffisante pour que les ajours se superposent au moins partiellement à au moins une partie des orifices 6.  The angular extent of the air passage openings 12 is sufficient for the openings to overlap at least partially with at least a portion of the orifices 6.
Les parties supérieure et inférieure délimitent entre elles une chambre annulaire où l'air peut circuler entre les orifices 6 et les ajours 12, lors de la reprise d'air.  The upper and lower portions delimit between them an annular chamber where the air can circulate between the orifices 6 and the openings 12, when the air intake.
La membrane d'étanchéité 27 est positionnée dans cet exemple sur le plateau 11 de manière à venir obturer au repos, comme visible sur la figure 4, les ajours 13. La portion centrale, de forme discoïde, du plateau 11 forme ainsi le siège de la valve antiretour 5. La membrane d'étanchéité est avantageusement collée, notamment par ultrasons.  The sealing membrane 27 is positioned in this example on the plate 11 so as to seal at rest, as can be seen in FIG. 4, the openings 13. The central, disc-shaped portion of the plate 11 thus forms the seat of the non-return valve 5. The sealing membrane is advantageously bonded, in particular by ultrasound.
Dans l'exemple illustré, le dispositif de bouchage 1 comporte en outre des moyens de fixation 15 sur le récipient. Les moyens de fixation 15 peuvent comporter comme illustré une jupe de fixation 16 présentant un filetage intérieur 17 agencé pour se fixer à un col fileté extérieurement du récipient, comme visible sur la figure 5.  In the illustrated example, the closure device 1 further comprises fixing means 15 on the container. The fastening means 15 may comprise, as illustrated, a fastening skirt 16 having an internal thread 17 arranged to attach to a threaded collar externally of the container, as can be seen in FIG. 5.
Les moyens de fixation 15 comportent avantageusement un relief d'inviolabilité 18, visible sur les figures 2 et 5, configuré pour empêcher de retirer le dispositif de bouchage 1 du récipient 10, une fois celui-ci solidarisé au récipient. Comme visible sur la figure 5, ce relief d'inviolabilité peut se présenter sous la forme d'une gorge annulaire, et le récipient 10 peut comporter quant à lui un bourrelet d'accrochage 21 complémentaire du relief d'inviolabilité 18, sur lequel la gorge s'encliquète au terme du vissage des moyens de fixation. The fastening means 15 advantageously comprise a tamper evident relief 18, visible in FIGS. 2 and 5, configured to prevent the closure device 1 from being removed from the receptacle 10, once it is secured to the receptacle. As can be seen in FIG. 5, this inviolability relief may be in the form of an annular groove, and the receptacle 10 may in turn comprise a fastening bead 21 complementary inviolability relief 18, on which the groove snaps to the end of the screwing of the fastening means.
Les moyens de fixation 15 comportent encore une jupe d'étanchéité 19 apte à venir en contact interne étanche avec le col du récipient, comme visible en particulier sur la figure 5.  The fastening means 15 also comprise a sealing skirt 19 adapted to come into sealed internal contact with the neck of the container, as can be seen in particular in FIG. 5.
Le dispositif de bouchage 1 selon l'invention comporte également un organe de fermeture 25 dont le rôle est de fermer de manière étanche l'ouverture 4 de l'embout 2. Dans l'exemple illustré, l'organe de fermeture 25 consiste en un capot relié par un lien flexible 26, tel qu'une charnière film, à la base 100 du dispositif de bouchage. L'organe de fermeture 25 comporte une lèvre d'étanchéité 35 apte à former l'étanchéité autour de l'ouverture 4 de l'embout 2, afin d'empêcher toute fuite lorsque le dispositif de bouchage 1 est fermé. Un système de garantie d'inviolabilité avant la première utilisation, non visible sur les figures dans un souci de clarté du dessin, est également prévu.  The closure device 1 according to the invention also comprises a closure member 25 whose role is to seal the opening 4 of the nozzle 2. In the example shown, the closure member 25 consists of a cover connected by a flexible link 26, such as a film hinge, at the base 100 of the closure device. The closure member 25 comprises a sealing lip 35 adapted to form the seal around the opening 4 of the nozzle 2, to prevent leakage when the closure device 1 is closed. A tamper-proof guarantee system before the first use, not visible in the figures for the sake of clarity of the drawing, is also provided.
Le capot présente à sa périphérie, sur sa surface intérieure, un bourrelet annulaire 31 apte à s'encliqueter dans une gorge correspondante 30 de la base 100, ménagée sur un montant formant saillie autour des orifices 6 de reprise d'air.  The cover has at its periphery, on its inner surface, an annular bead 31 adapted to snap into a corresponding groove 30 of the base 100, formed on a post protruding around the openings 6 of air intake.
La base 100 comporte une partie supérieure 50 et une partie inférieure 60 assemblées entre elles, dans cet exemple par encliquetage à l'aide de reliefs d'encliquetage complémentaires 51 et 52, respectivement formés sur les parties supérieure 50 et inférieure 60, sous une forme circulaire dans une région périphérique de celles-ci. Les parties supérieure 50 et inférieure 60 définissent ensemble lorsqu' assemblées trois zones distinctes. Une première zone extérieure 61, définit la chambre annulaire précitée qui permet le passage d'air. Une deuxième zone 62 intermédiaire, annulaire également, permet le maintien de la valve anti-retour 5 et une troisième zone 63, sensiblement cylindrique, permet le passage de liquide. La zone intermédiaire 62 empêche toute communication entre les zones 61 et 63.  The base 100 comprises an upper part 50 and a lower part 60 assembled together, in this example by snap-fitting with complementary snap-on reliefs 51 and 52, respectively formed on the upper parts 50 and lower 60, in a form circular in a peripheral region thereof. The top 50 and bottom 60 together define when assembled three distinct areas. A first outer zone 61 defines the aforementioned annular chamber which allows the passage of air. A second zone 62 intermediate annular also allows the maintenance of the non-return valve 5 and a third zone 63, substantially cylindrical, allows the passage of liquid. The intermediate zone 62 prevents any communication between the zones 61 and 63.
Dans cet exemple, la partie supérieure 50 du dispositif de bouchage comporte l'embout 2 et les orifices 6 de reprise d'air. Comme visible notamment sur la figure 2, la partie supérieure 50 comporte sur une face interne 54 une lèvre d'étanchéité 55 venant en appui sur la membrane d'étanchéité 27 de la valve anti-retour 5, sur le rétreint annulaire 9. Lorsqu'une dépression est exercée, seule la partie radialement intérieure 4 à ce rétreint annulaire de la membrane 27 se déforme. Les dimensions de la partie supérieure peuvent être optimisées de manière à éviter la stagnation de liquide et éviter la contamination lors du prélèvement suivant. In this example, the upper part 50 of the closure device comprises the nozzle 2 and the air intake orifices 6. As can be seen in particular in FIG. 2, the upper part 50 has on an internal face 54 a sealing lip 55 bearing against the sealing membrane 27 of the non-return valve 5, on the annular necking 9. a depression is exerted, only the radially inner portion 4 to the annular necking of the membrane 27 is deformed. The dimensions of the upper part can be optimized so as to avoid stagnation of the liquid and avoid contamination during the next sampling.
La partie inférieure 60 comporte le plateau 1 1 ainsi que les moyens de fixation The lower part 60 comprises the plate 1 1 as well as the fixing means
15 au récipient. 15 to the container.
Sur la figure 5, on voit le col 72 du récipient 10 présentant un filetage 73 extérieur, ce qui lui permet de coopérer avec le filetage intérieur 17 de la jupe de fixation In Figure 5, we see the neck 72 of the container 10 having an external thread 73, which allows it to cooperate with the internal thread 17 of the fixing skirt
16 du dispositif de bouchage 1. 16 of the closure device 1.
On a représenté sur les figures 6 et 7 un exemple d'ensemble de conditionnement 70, conforme à l'invention.  FIGS. 6 and 7 show an example of a packaging assembly 70, according to the invention.
Dans l'exemple illustré, le récipient 10 consiste en un flacon en verre ayant un col à vis, par exemple de diamètre 27mm.  In the illustrated example, the container 10 consists of a glass bottle having a screw neck, for example of diameter 27 mm.
Le récipient ou le col peut être différent sans sortir du cadre de l'invention. L'ensemble de conditionnement 70 comporte, dans l'exemple illustré sur la figure 7, un organe de prélèvement 20 consistant en une seringue entérale de type luer lock ainsi qu'un emballage individuel 71 pour conditionner l'ensemble.  The container or neck may be different without departing from the scope of the invention. The packaging assembly 70 comprises, in the example illustrated in FIG. 7, a sampling member 20 consisting of a luer lock type enteral syringe and an individual package 71 for packaging the assembly.
On ne sort pas du cadre de l'invention si l'emballage 71 comprend notamment une pluralité d'organes de prélèvement 20.  It is not beyond the scope of the invention if the packaging 71 comprises in particular a plurality of sampling members 20.
Les figures 8 et 9 illustrent des étapes d'un procédé de conditionnement, selon l'invention. L'étape illustrée sur la figure 8 consiste à introduire la composition L dans le récipient 10. Le procédé de conditionnement comprend ensuite l'étape illustrée sur la figure 9, consistant à fixer le dispositif de bouchage 1, notamment dans cet exemple par vissage sur le col 72 du récipient 10.  Figures 8 and 9 illustrate steps of a packaging method according to the invention. The step illustrated in FIG. 8 consists in introducing the composition L into the container 10. The packaging method then comprises the step illustrated in FIG. 9, of fixing the closure device 1, in particular in this example by screwing on the neck 72 of the container 10.
Le procédé de conditionnement peut encore comprendre l'étape consistant à associer au récipient 10 muni du dispositif de bouchage 1 au moins un organe de prélèvement 20 et à disposer éventuellement le tout dans un emballage individuel 71 , totalement ou partiellement stérile ou non comme illustré sur la figure 7.  The packaging process may further comprise the step of associating with the container 10 provided with the closure device 1 at least one sampling member 20 and optionally disposing the whole in an individual package 71, totally or partially sterile or not as illustrated on Figure 7.
On a représenté sur les figures 10 à 13 un procédé de prélèvement de la composition L à l'aide d'un organe de prélèvement.  FIGS. 10 to 13 show a method of taking the composition L with the aid of a sampling member.
On ouvre d'abord l'organe de fermeture 25 du dispositif de bouchage 1, comme illustré sur la figure 10, puis on solidarise l'organe de prélèvement 20 à l'embout 2, dans cet exemple par vissage, comme illustré sur la figure 11. Puis on prélève, en retournant le récipient, la quantité souhaitée de composition L avec l'organe de prélèvement 20, en tirant sur le piston de l'organe de prélèvement, comme illustré sur la figure 12. The closing member 25 of the closure device 1 is first opened, as illustrated in FIG. 10, and then the sampling member 20 is secured to the end piece 2, in this example by screwing, as illustrated in FIG. 11. Then, by returning the container, the desired amount of composition L with the sampling member 20, by pulling on the piston of the sampling member, as illustrated in Figure 12.
Lors du prélèvement, une dépression est créée au sein du récipient et la membrane d'étanchéité 27 se déforme de son siège. Simultanément, de l'air pénètre dans le récipient 10 par les orifices 6, filtré par le filtre 7. Enfin, on retire l'organe de prélèvement 20 et, comme illustré sur la figure 13, on referme l'organe de fermeture 25, la quantité de composition contenue dans le récipient 10 ayant diminué de la quantité prélevée et étant disponible pour une ou plusieurs utilisations ultérieures, sans contamination de la composition L.  During sampling, a vacuum is created within the container and the sealing membrane 27 deforms its seat. Simultaneously, air enters the container 10 through the orifices 6, filtered by the filter 7. Finally, the sampling member 20 is removed and, as shown in FIG. 13, the closing member 25 is closed again, the amount of composition contained in the container 10 having decreased in the amount withdrawn and being available for one or more subsequent uses, without contamination of the composition L.
Bien entendu, l'invention n'est pas limitée à l'exemple qui vient d'être décrit. Of course, the invention is not limited to the example just described.
En particulier, le récipient peut être équipé d'un tube plongeur et/ou être à paroi souple élastique. Une valve anti-retour additionnelle peut être positionnée à proximité de l'embout. Une telle valve anti-retour additionnelle pour contact sec pourra être munie d'un cône vissable normalisé verrouillable spécifique à l'administration pour voie entérale. In particular, the container may be equipped with a dip tube and / or be flexible elastic wall. An additional non-return valve can be positioned near the tip. Such an additional non-return valve for dry contact may be provided with a lockable standardized screwable cone specific for enteral administration.
Dans toute la description, l'expression « comportant un » doit être comprise comme étant synonyme de « comprenant au moins un », sauf si le contraire est spécifié.  Throughout the description, the phrase "having one" should be understood as being synonymous with "comprising at least one", unless the opposite is specified.

Claims

REVENDICATIONS
1. Dispositif de bouchage (1) pour permettre un prélèvement d'une composition destinée à l'administration entérale ou nasale ou à un usage externe, contenue dans un récipient, caractérisé par le fait qu'il comporte : 1. Closing device (1) for allowing a collection of a composition intended for enteral or nasal administration or for external use, contained in a container, characterized in that it comprises:
- un embout (2) définissant un passage interne (3) débouchant sur une ouverture (4), configuré pour permettre une connexion à un organe de prélèvement tel qu'une seringue destinée à la voie entérale,  a tip (2) defining an internal passage (3) opening onto an opening (4), configured to allow connection to a sampling member such as a syringe intended for the enteral route,
- une valve anti-retour (5) associée audit embout (2), configurée pour s'ouvrir lors du prélèvement du contenu du récipient à l'aide de l'organe de prélèvement,  a non-return valve (5) associated with said nozzle (2), configured to open when the contents of the container are taken with the aid of the sampling member,
- au moins un orifice (6) de reprise d'air, et  at least one air intake opening (6), and
- un filtre (7) antibactérien associé audit au moins un orifice (6). an antibacterial filter (7) associated with said at least one orifice (6).
2. Dispositif de bouchage (1) selon la revendication 1, dans lequel l'embout (2) présente au moins partiellement une forme sensiblement conique, notamment de conicité de 6% environ, notamment de type « cône vissable normalisée verrouillable » ou « cône luer lock ». 2. Closing device (1) according to claim 1, wherein the tip (2) has at least partially a substantially conical shape, including conicity of about 6%, especially of the type "lockable standard screwable cone" or "cone luer lock ".
3. Dispositif de bouchage (1) selon l'une quelconque des revendications précédentes, dans lequel la valve anti-retour (5) comporte une membrane d'étanchéité de forme annulaire, et comporte de préférence un rétreint annulaire (9) pour permettre sa déformation.  3. Closing device (1) according to any one of the preceding claims, wherein the non-return valve (5) comprises an annular sealing membrane, and preferably comprises an annular necking (9) to allow its deformation.
4. Dispositif de bouchage (1) selon l'une quelconque des revendications précédentes, dans lequel le filtre (7) est réalisé dans un matériau hydrophobe, présentant un diamètre moyen des pores inférieur à 0.3μιη, notamment égal à 0.22μιη.  4. Closing device (1) according to any one of the preceding claims, wherein the filter (7) is made of a hydrophobic material having an average pore diameter less than 0.3μιη, in particular equal to 0.22μιη.
5. Dispositif de bouchage (1) selon l'une quelconque des revendications précédentes, comportant un plateau (11) destiné à être en contact avec l'intérieur du récipient et présentant au moins un ajour (12) pour le passage d'air et au moins un ajour (13) pour le passage de liquide.  5. Closing device (1) according to any one of the preceding claims, comprising a plate (11) intended to be in contact with the interior of the container and having at least one aperture (12) for the passage of air and at least one aperture (13) for the passage of liquid.
6. Dispositif de bouchage (1) selon la revendication 5, le filtre (7) recouvrant ledit au moins un ajour (12) pour le passage d'air et étant fixé, notamment par collage, audit plateau (11).  6. Closing device (1) according to claim 5, the filter (7) covering said at least one aperture (12) for the passage of air and being fixed, in particular by gluing, said plate (11).
7. Dispositif de bouchage (1) selon la revendication 5 ou 6, ladite membrane d'étanchéité (27) étant positionnée sur le plateau (11) formant le siège de la valve anti- retour (5) de manière à venir obturer ledit au moins un ajour (13) pour le passage de liquide. 7. Closing device (1) according to claim 5 or 6, said sealing membrane (27) being positioned on the plate (11) forming the seat of the anti-blocking valve. return (5) so as to close off said at least one aperture (13) for the passage of liquid.
8. Dispositif de bouchage (1) selon l'une quelconque des revendications précédentes, comprenant des moyens de fixation (15) sur le récipient, les moyens de fixation (15) comportant de préférence une jupe de fixation (16), notamment filetée intérieurement, agencée pour se fixer à un col du récipient.  8. Closing device (1) according to any one of the preceding claims, comprising fixing means (15) on the container, the fixing means (15) preferably comprising a fixing skirt (16), in particular internally threaded. arranged to attach to a neck of the container.
9. Dispositif de bouchage (1) selon la revendication 8, dans lequel les moyens de fixation (15) comportent un relief d'inviolabilité (18) configuré pour empêcher de retirer le dispositif de bouchage (1) du récipient, une fois celui-ci solidarisé au récipient.  9. A closure device (1) according to claim 8, wherein the fastening means (15) comprise a tamper evident relief (18) configured to prevent removal of the closure device (1) from the container, once the ci secured to the container.
10. Dispositif de bouchage (1) selon l'une quelconque des revendications précédentes, comportant un organe de fermeture (25), de préférence relié au reste du dispositif de bouchage (1) par un lien flexible (26), l'organe de fermeture pouvant être muni d'un système de garantie d'inviolabilité avant une première ouverture.  10. Closing device (1) according to any preceding claim, comprising a closure member (25), preferably connected to the rest of the closure device (1) by a flexible link (26), the organ of closure that can be provided with a tamper-proof guarantee system before a first opening.
11. Dispositif de bouchage (1) selon l'une quelconque des revendications précédentes, comportant une base (100) comportant une partie supérieure (50) et une partie inférieure (60) assemblées entre elles.  11. Closing device (1) according to any one of the preceding claims, comprising a base (100) having an upper portion (50) and a lower portion (60) assembled together.
12. Dispositif de bouchage (1) selon les revendications 5 et 11, dans lequel la partie supérieure (50) comporte l'embout (2) et ledit au moins un orifice (6) et dans lequel la partie inférieure (60) comporte ledit plateau (11).  12. Closing device (1) according to claims 5 and 11, wherein the upper portion (50) comprises the tip (2) and said at least one orifice (6) and wherein the lower portion (60) comprises said tray (11).
13. Dispositif de bouchage (1) selon les revendications 1 1 et éventuellement 3, dans lequel la partie supérieure (50) comporte, sur une face interne, une jupe d'étanchéité (55) destinée à venir en appui sur la valve anti-retour (5), notamment sur ledit rétreint annulaire (9).  13. A closure device (1) according to claims 1 1 and optionally 3, wherein the upper portion (50) comprises, on an inner face, a sealing skirt (55) intended to bear against the anti-blocking valve. return (5), in particular on said annular narrowing (9).
14. Ensemble (70) de conditionnement d'une composition (L) destinée à l'administration entérale ou à un usage externe permettant son prélèvement, comportant un récipient (10) pour le conditionnement de ladite composition (L), solidarisé avec un dispositif de bouchage (1) selon l'une quelconque des revendications 1 à 13.  14. A set (70) for packaging a composition (L) intended for enteral administration or for external use making it possible to take it out, comprising a container (10) for conditioning said composition (L), secured to a device capping device (1) according to any one of claims 1 to 13.
15. Ensemble (70) selon la revendication 14, comportant en outre au moins un organe de prélèvement (20).  15. Assembly (70) according to claim 14, further comprising at least one sampling member (20).
16. Ensemble (70) selon l'une quelconque des revendications 14 et 15, conditionné dans un emballage individuel (71), stérile ou non. 16. The assembly (70) according to any one of claims 14 and 15, packaged in an individual package (71), sterile or otherwise.
17. Procédé de prélèvement d'une composition (L) à l'aide d'un organe de prélèvement (20) tel qu'une seringue entérale dans un récipient (10) muni d'un dispositif de bouchage (1) selon l'une quelconque des revendications 1 à 13, comportant les étapes suivantes : 17. A method of sampling a composition (L) using a sampling member (20) such as an enteral syringe in a container (10) provided with a closure device (1) according to the invention. any one of claims 1 to 13, comprising the steps of:
- solidariser l'organe de prélèvement (20) à l'embout (2),  - secure the sampling member (20) to the tip (2),
- prélever une quantité souhaitée de composition (L) avec l'organe de prélèvement (20), notamment à l'aide d'un piston,  - Take a desired amount of composition (L) with the sampling member (20), in particular with the aid of a piston,
- retirer l'organe de prélèvement (20) de l'embout (2),  - remove the sampling member (20) from the tip (2),
- répéter les étapes précédentes si nécessaire et autant que nécessaire.  - repeat the previous steps if necessary and as necessary.
18. Procédé selon la revendication 17, le dispositif de bouchage (1) comportant un organe de fermeture (25), comportant les étapes consistant à ouvrir l'organe de fermeture (25) avant de solidariser l'organe de prélèvement (20) à l'embout (2) et à fermer l'organe de fermeture (25) après retrait de l'organe de prélèvement (20).  18. The method of claim 17, the closure device (1) comprising a closure member (25), comprising the steps of opening the closure member (25) before securing the sampling member (20) to the tip (2) and closing the closure member (25) after removal of the sampling member (20).
19. Procédé de conditionnement d'une composition (L) destinée à l'administration entérale ou à un usage externe dans un récipient (10), comportant les étapes suivantes :  19. Process for packaging a composition (L) intended for enteral administration or for external use in a container (10), comprising the following steps:
- introduire ladite composition (L) dans le récipient (10),  introducing said composition (L) into the container (10),
- fixer un dispositif de bouchage (1) selon l'une quelconque des revendications 1 à 13 audit récipient (10).  - Fixing a closure device (1) according to any one of claims 1 to 13 said container (10).
20. Procédé selon la revendication 19, comprenant les étapes consistant à associer audit récipient (1), au moins un organe de prélèvement (20) et à disposer le tout dans un emballage individuel (71), stérile ou non.  20. The method of claim 19, comprising the steps of associating with said container (1), at least one sampling member (20) and arrange the whole in a single package (71), sterile or not.
EP16719282.2A 2015-04-17 2016-04-14 Sealing device for making it possible to collect a composition, packaging assembly comprising such a sealing device, collection and packaging methods Active EP3283043B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL16719282T PL3283043T3 (en) 2015-04-17 2016-04-14 Sealing device for making it possible to collect a composition, packaging assembly comprising such a sealing device, collection and packaging methods

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1553442A FR3035080B1 (en) 2015-04-17 2015-04-17 CLOSURE DEVICE FOR PERMITTING A SAMPLE OF A PACKAGING ASSEMBLY COMPOSITION COMPRISING SUCH A CLOGGING DEVICE, METHODS FOR COLLECTING AND PACKAGING
PCT/EP2016/058194 WO2016166197A1 (en) 2015-04-17 2016-04-14 Sealing device for making it possible to collect a composition, packaging assembly comprising such a sealing device, collection and packaging methods

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EP3283043A1 true EP3283043A1 (en) 2018-02-21
EP3283043B1 EP3283043B1 (en) 2019-06-12

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US (1) US11090226B2 (en)
EP (1) EP3283043B1 (en)
JP (2) JP2018512990A (en)
KR (1) KR20180008501A (en)
CN (1) CN107750225B (en)
CA (1) CA2982935A1 (en)
ES (1) ES2745278T3 (en)
FR (1) FR3035080B1 (en)
HK (2) HK1246256A1 (en)
IL (1) IL255082A0 (en)
MX (1) MX2017013325A (en)
PL (1) PL3283043T3 (en)
PT (1) PT3283043T (en)
RU (1) RU2710242C2 (en)
WO (1) WO2016166197A1 (en)

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Publication number Publication date
KR20180008501A (en) 2018-01-24
HK1246256A1 (en) 2018-09-07
US20180104150A1 (en) 2018-04-19
JP2018512990A (en) 2018-05-24
PT3283043T (en) 2019-09-26
JP2021184862A (en) 2021-12-09
CA2982935A1 (en) 2016-10-20
MX2017013325A (en) 2018-06-22
RU2017136441A (en) 2019-05-17
PL3283043T3 (en) 2020-03-31
ES2745278T3 (en) 2020-02-28
IL255082A0 (en) 2017-12-31
HK1249006A1 (en) 2018-10-26
FR3035080A1 (en) 2016-10-21
RU2710242C2 (en) 2019-12-25
WO2016166197A1 (en) 2016-10-20
EP3283043B1 (en) 2019-06-12
FR3035080B1 (en) 2019-08-09
US11090226B2 (en) 2021-08-17
RU2017136441A3 (en) 2019-07-29
CN107750225A (en) 2018-03-02
CN107750225B (en) 2019-10-11

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