EP3554451B1 - Vorrichtung zur entnahme einer probe aus einer in einem behälter enthaltenen flüssigkeit, zugehöriger behälter und verwendung dieses behälters - Google Patents

Vorrichtung zur entnahme einer probe aus einer in einem behälter enthaltenen flüssigkeit, zugehöriger behälter und verwendung dieses behälters Download PDF

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Publication number
EP3554451B1
EP3554451B1 EP17825480.1A EP17825480A EP3554451B1 EP 3554451 B1 EP3554451 B1 EP 3554451B1 EP 17825480 A EP17825480 A EP 17825480A EP 3554451 B1 EP3554451 B1 EP 3554451B1
Authority
EP
European Patent Office
Prior art keywords
container
housing
channel
component
distal end
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.)
Active
Application number
EP17825480.1A
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English (en)
French (fr)
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EP3554451A1 (de
Inventor
Laurie LABROC
Michel Robin
Daniel ANEAS
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.)
Virbac SA
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Virbac SA
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Publication date
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Priority to SI201730512T priority Critical patent/SI3554451T1/sl
Publication of EP3554451A1 publication Critical patent/EP3554451A1/de
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Publication of EP3554451B1 publication Critical patent/EP3554451B1/de
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    • 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
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • 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
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • 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
    • A61J1/202—Separating means
    • A61J1/2031—Separating means having openings brought into alignment
    • 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
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve 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
    • A61J1/14—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
    • A61J1/202—Separating means
    • A61J1/2044—Separating means having slits
    • 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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents

Definitions

  • the invention relates to a device for sampling (or transferring) a liquid contained in a container.
  • the invention is mainly aimed at an application to the sampling of a liquid with medicinal scope, in particular intended for the treatment of animals.
  • This type of device enables liquid to be taken while also ensuring a seal.
  • a device for taking liquid from a container, comprising a valve which allows a user, by turning this valve, to close or open a passage between the internal volume of the container and the outside. of this container.
  • the valve is closed and the upper part of the passage between the external volume and the internal volume of the container remains in contact with the external medium.
  • This upper part of the passage can therefore be loaded with pollutants and in particular load with pollutants the liquid residues coming from inside the container.
  • pollutants can then enter the interior of the container. Such pollutants can also be introduced into the container when the tap is open.
  • an alternative solution to the use of a valve is the use of an elastic valve generally produced with an elastomer.
  • the advantage of the elastic valve compared to a tap, lies mainly in the absence of a passage zone for the liquid contained in the container in contact with the outside.
  • the invention also relates to a container comprising a liquid and an opening, said container being characterized in that it comprises, at its opening, a device for collecting liquid according to the invention.
  • the container may include a dip tube in connection with the distal end of the body.
  • the invention also relates to a use of a container in accordance with the invention, as packaging for a liquid consisting of a sterile pharmaceutical composition.
  • the figure 1 represents a first embodiment of the invention.
  • the device 100 for taking a liquid from a container comprises a housing 10, a component 20 located in the housing 10, an elastic valve 30 and a cap 40 removably mounted on the housing 10. All these components are shown in the general view, taken from a cut perspective, of the figure 1 (a) .
  • the housing 10 comprises a first base 11 intended to be mounted on the outside of the container and a second base 12 intended to be mounted on the inside of the container.
  • the first base 11 is shown in a sectional view on the figure 1 (b) and the second base 12 is shown in a sectional view on the figure 1 (c) .
  • the bases 11 and 12 are mounted one on top of the other, in a preferably non-removable assembly and without any relative movement being possible between them.
  • a more detailed view of a fixing zone of the two bases 11, 12 between them and on a receptacle R is shown in the sectional view of the figure 1 (d) .
  • elements 111 of the hook type of the first base are for example used to cooperate with an annular edge 122 of the second base 12.
  • the assembly is carried out to ensure a very good seal between the two bases 11, 12 so that the risks of liquid leakage or the introduction of pollutants (such as liquids, dust or even pollutants such as bacteria) between the two bases are limited.
  • the second base 12 furthermore comprises a central orifice 123 which makes it possible to accommodate a part of the component 20 and an upper wall 12SUP on which the component 20 bears.
  • the first base 11 it is hollow so as to be able to accommodate on the one hand the component 20 and on the other hand, in its lower part the second base 12.
  • mounting on the container R requires an axial compressive force F less than or equal to 300 N.
  • connection between the sampling device according to the invention and the receptacle R can advantageously be removed manually.
  • the component 20 is mounted to rotate relative to the housing 10, that is to say both with respect to the first base 11 and the second base 12, taking into account the fixing of the two bases 11, 12 one by one. compared to each other.
  • This rotation takes place between a so-called closed position and a so-called open position.
  • This rotation takes place around the longitudinal axis AL of the housing 10.
  • Component 20 is shown more precisely on the figure 1 (e) . This component 20 is also shown in its closed position on the figure 1 (a) .
  • Component 20 comprises a body 26 provided with at least one channel 21 with a proximal end 21p and a distal end 21d.
  • the channel 21 passes through the body 26 of the component 20.
  • the distal end 21d of said at least one channel 21 is closed by the housing 10 and more precisely by an internal wall 12PI of the second base 12, the internal wall which delimits the central channel 123 of this second base 12.
  • the distal end 21d of said at least one channel 21 is able to establish fluid communication with the container. More precisely, when turning, from the position of closure, the component 20 around the longitudinal axis AL of the housing 10, for example by 180 °, the distal end 21d of said at least one channel 21 then arrives opposite a passage 120 of the second base 12 opening out, in this case towards the inside of a container when the device 100 is mounted on such a container R as shown in FIG. figure 1 (d) .
  • the open position corresponds to this situation where the liquid can pass from the container to the channel 21 of the component 20, through the passage 120 of the second base 12.
  • the component 20 also comprises a receptacle 24 located in the extension of the proximal end 21p of said at least one channel 21.
  • This receptacle 24 is fixed relative to the body 26, and more precisely mounted fixed on the body 26.
  • a circumferential groove 260 can be provided, located at the level of the upper wall 26SUP of the body 26, and capable of receiving, for example by snap-fastening, a corresponding wall of the receptacle 24.
  • the receptacle 24 is fixed relative to the body 26, to provide that the receptacle 24 and the body 26 are in one piece. This will not however prevent the mounting of the elastic valve 30.
  • the elastic valve 30 can be housed inside the part formed by the receptacle 24 and the body 26, via the port 240 of receptacle 24.
  • the receptacle 24 makes it possible to house the elastic valve 30 within the component 20. More precisely, the elastic valve 30 is held between the body 26 and the walls of the receptacle 24.
  • the elastic valve 30 is complementary in shape to the internal wall of the receptacle 24. It also rests against the body 26.
  • This elastic valve 30 is advantageously made of elastomer, for example of silicone elastomer.
  • the central orifice 31 also has a proximal end 31p which is in the form of a plug 33 provided with a slot 34.
  • the slot 34 can be simple (straight) or complex (in the form of a circular arc or d 'star for example).
  • the elastic valve 30 is not requested by an external action (syringe of Luer type or the like)
  • the slot 34 is closed and a seal is provided between the outside of the component 20 and the inside of the component 20.
  • C ' is what is represented on the figures 1 (a) , 1 (e) and 1 (f) .
  • the resilient valve 30 is urged by an external action, the latter deforms axially, namely along the longitudinal axis AL of the housing 10. This is what is shown in FIG. figure 1 (g) . It is therefore understood that the elastic valve 30 is not fixed to the internal wall of the receptacle 24.
  • a Luer L is introduced into component 20, which has the effect ( figure 1 (g) ) compress the elastic valve 30 axially and open the slot 34 of the stopper 33 at the proximal end 31d of the central channel 31 of the elastic valve 30. It is therefore understood that the elastic valve is not attached to the inner wall of receptacle 24.
  • the user turns the Luer L in the other direction, still around the longitudinal axis AL of the housing 10, to go from the open position to the closed position of the component 20. Once the closed position has been reached, the user can remove the Luer L from component 20.
  • the elastic valve 30, which then no longer undergoes any action. exterior returns to its initial shape, namely that of the figure 1 (a) , thus closing the slot 34 of the plug 33 in a sealed manner.
  • the device 100 provides a double seal on the liquid sampling path.
  • the first seal is produced by a valve-type system, in this case here between the component 20 and the second base 20.
  • the second seal is produced by an elastic valve 30 located above the valve-type system.
  • the elastic valve 30 limits or prevents any introduction of pollutants into the upper part of the component 20, during before or after use. Furthermore, the presence of a valve-type system between the container and the elastic valve 30 limits the stress on the latter and also limits the presence of liquid in the channels 21 and 31.
  • the system in the closed valve position remains sealed and no leakage of the composition contained in the container n 'is visible even at high temperature, typically 40 ° C.
  • the fact of housing the elastic valve 30 in the component 20 makes it possible to implement a valve-type system with which the rotation of the component 20 relative to the housing 10 takes place around the longitudinal axis AL of the housing 10.
  • the component 20 can therefore rotate in the housing 10, without a large space being present between the component and the housing 10, which makes it possible to limit the bulk, in particular radial, of the device is therefore particularly well suited for a container.
  • the Luer L can remain in the longitudinal axis of the housing 10, and therefore of the component 20 intended to rotate, without being hampered by the container R.
  • the rotation of the Luer L around this axis longitudinal to achieve the opening or closing of the component 20 also drives the elastic valve 30 in rotation. The latter therefore does not undergo any other stresses than the axial deformation imparted by the Luer L.
  • the connection with the receptacle is advantageously made once the connection between the sampling device and the Luer L has been ensured.
  • the force for assembling the Luer L on the sampling device according to the invention must be less than 27.5 N
  • the opening of the channel 21 then takes place once the Luer link L is effective, the opening torque then being advantageously less than 0.35 N.m.
  • Closing the channel 21 advantageously requires a torque of less than 0.35 N.m.
  • the force for disassembling the Luer L must be less than 27.5 N (for 5 sec) with a torque necessary to remove the Luer L less than 0.1 N.m.
  • the cap 40 has a shape complementarity with the housing 10 and more precisely with the first base 11, for example to be able to be screwed or unscrewed (the elements 110 of the figure 1 (b) represent the threads of the first base 11).
  • the fitting torque of the cap 40 must be sufficient to ensure the closing of the liquid sampling device.
  • a normally constituted adult person can provide a tightening torque on the cap 40 of about 1.1 N.m.
  • the cap 40 is closed for a torque of less than 1.1 N.m.
  • an opening torque on the cap of approximately 1.1 N.m. can be applied by a normally constituted adult person and the cap is advantageously removed for a torque of less than 1.1 N.m.
  • the cap 40 can advantageously provide at least one tamper-evident indicator 41 of the cap 40 relative to the housing 10.
  • the tamper-evident indicator 41 may be in the form of an annular strip connected by frangible bridges (not visible on the figure 1 ) to the first base 11 of housing 10. The bridges are broken when the cap 40 is opened for the first time.
  • the effort required to tear the frangible bridges when the cap is first opened must be such that the system can be used by a person of normal constitution.
  • the first opening torque of the system C is advantageously less than 1.2 N.m
  • the figure 2 represents a second embodiment of the invention.
  • This second embodiment uses the characteristics of the first embodiment. Also, compared to figures 1 (a) to 1 (g) , the same elements bear the same references.
  • this second embodiment includes additional features.
  • the body 26 of the component 20 is modified and comprises a second channel 22 and a housing 27 into which the second channel 22 opens. More precisely, the distal end 22d of the second channel 22 is able to establish fluid communication with the container and the proximal end 22p of this second channel 22 opens into the housing 27, the latter comprising an air filter 50 in fluid communication. with outside air.
  • the air intake avoids this type of problem.
  • the air filter 50 makes it possible to filter the air taken from the outside to prevent the latter from polluting the liquid contained in the container, for example by the addition of dust or other contaminants liable to pollute the contents of the container, such as bacteria.
  • this air intake does not modify, compared to the first embodiment, the size of the sampling device 100 '.
  • the air filter 50 which is located in the housing 27 defined in the body 26 of the component 20' accompanies the rotational movement.
  • the air filter 50 is hydrophobic. This helps prevent water uptake in the container, thus protecting the contents from hydration.
  • the air filter 50 can have different porosities and advantageously a porosity which allows the absorption of sterile air, when the pores (orifices) of the filter have a greater dimension less than or equal to 0.22 ⁇ m. In this way the sterility of the composition contained in the container R can be maintained.
  • the air filter 50 can advantageously be hydrophobic and lipophobic (oleophobic). In this case, it makes it possible to limit or prevent the penetration and / or the escape of both water and nonpolar solvents such as lipids (fatty substances).
  • the figure 3 represents a third embodiment of the invention.
  • This third embodiment incorporates the characteristics of the second embodiment. Also, compared to figures 1 (a) to 1 (g) and to figures 2 (a) and 2 (b) , the same elements bear the same references.
  • figure 3 (a) shows in a sectional view a device 100 "for taking liquid from a container, when the component 20 is in its closed position.
  • figure 3 (b) shows in a sectional view, the same device 100 ", but when the component 20 is in its open position.
  • figure 3 (c) is a partial sectional view taken at the level of the air filters 50, 51.
  • the figure 3 (d) shows, in a perspective view, the component 20 ".
  • the body 26 of component 20 "is modified and comprises a third channel 23 as well as another housing 28 into which the third channel opens.
  • the third channel 23 allows an additional air intake. between the outside of the container towards the inside of the container through another air filter 51 which is housed in the housing 28.
  • the proximal end 23p of this third channel 22 opens into the housing 28 comprising the other air filter 51 and the distal end 23d of this third channel 23, capable of establishing fluid communication with the container, opens into the housing 27 of the air filter 50.
  • the outside air entering through the air filter 51 passes through the third channel 23, then through the second channel 22 before arriving in the container.
  • This design avoids making a third channel 23 identical to that of the second channel 22 and therefore makes it possible to make the best use of the space available in the body 26 of the component 20 ".
  • a third channel 23 could be provided which is completely independent of the second channel 22.
  • This additional air intake improves the speed with which the pressure is balanced when liquid is withdrawn from the container, in particular for rigid containers, without impacting the overall size of the device 100 ".
  • the air filter 51 is hydrophobic. This helps prevent water uptake in the container, thus protecting the contents from hydration.
  • the air filter 51 may have different porosities and advantageously a porosity which allows the uptake of sterile air, when the pores (orifices) of the filter have a larger dimension less than or equal to 0.22 ⁇ m. In this way the sterility of the composition contained in the container R can be maintained.
  • the other air filter 51 can advantageously be hydrophobic and lipophobic (oleophobic). In this case, it makes it possible to limit or prevent the penetration and / or the escape of both water and nonpolar solvents such as lipids (fatty substances).
  • An additional feature provided in the third embodiment concerns the addition of an air intake channel shutter 121 on the housing and more specifically on the second base 12 of this housing 10.
  • the second base 12 comprises a shutter 121 for the second channel 22.
  • the second channel 22 is closed by this obturator 121, at its distal end 22d.
  • the distal end 21d of the channel 21 intended for taking liquid is also closed by the internal wall 12PI of the second base 12.
  • the second channel 22 is open at its distal end 22d.
  • the distal end 21d of the channel 21 then opens into the passage 120 of the second base 12, which passage opens into the interior of the container R.
  • stopper 121 offers additional security when the component 20 "is in its closed position. Indeed, if the receptacle R is overturned, the liquid which cannot enter the closed channel 21 will not be able to. either enter the second channel 22.
  • a skirt 25 for example cylindrical, surrounding the receptacle 24.
  • This skirt 25 can be made with the same material as the body 26 and therefore be molded at the same time. time that the body 26.
  • This skirt allows, as can be seen on the figure 3 (b) to provide guidance for a Luer L.
  • the Luer L can thus be guided in the space defined between the receptacle 24 and the skirt 25. This facilitates the action of the user in particular by preventing misuse which would consist of applying the Luer L laterally, that is to say at an angle to the longitudinal axis (AL).
  • this skirt 25 can allow a user to perform an action of opening or closing the component 20 manually and directly, namely without the intermediary of a syringe of the type. Luer or other, by manipulating the skirt 25 without touching the receptacle 24 or the stopper 33. Therefore, this actuation can be carried out without the user touching the elements likely to be in contact with the liquid contained in the container. This ensures the cleanliness and / or sterility of the stopper 33.
  • the invention in fact covers other embodiments.
  • skirt 25 of the component 20 "surrounding the housing 24 for the elastic valve 30, discussed in support of the third embodiment, can be added to the embodiment shown in FIG. figure 1 or to the one shown on the figure 2 . Indeed, the function fulfilled by the skirt 25 is also of interest in these cases.
  • the arrangement of the housing 10 making it possible to close concomitantly on the one hand, the channel 21 of the component 20 ′′, provided for the flow of the liquid contained in the receptacle and on the other hand, the channel 22 for the intake.
  • air from component 20 "through a shutter, as discussed in support of the third embodiment, may also be provided for a modified embodiment of the figure 2 .
  • the presence of a shutter 121 provides a benefit when an air intake is envisaged.
  • an indicator of the state of the component 20, 20 ', 20 "open or closed.
  • figure 4 represents the closed position of component 20, 20 ', 20 "(visual indicator TV red for example) and the figure 4 (b) its open position (visual green TV indicator for example).
  • the first base 11 of the housing 10 may be made of Acrilonitrile Butadiene Styrene (ABS), of polycarbonate (PC) or of poly (butylene terephthalate) (PBT).
  • the second base 12 of the housing 10 and the elastic valve 30 may be made of thermoplastic elastomer (TPE), vulcanized thermoplastic elastomer (TPV), urethane elastomer thermoplastic (TPU), silicone, fluorosilicone, n chlorobutyl, bromobutyl, nitrile, fluoroelastomer (FKM) or ethylene-propylene-diene monomer (EPDM).
  • these elastomers can be coated with a protective film.
  • the component 20, 20 ', 20 "(therefore the body 26, the receptacle 24 and, where appropriate, the skirt 25) can be made of poly (butylene terephthalate) (PBT), of Polypropylene (PP) or of Polyethylene Terephthalate (PET).
  • PBT poly (butylene terephthalate)
  • PP Polypropylene
  • PET Polyethylene Terephthalate
  • the cap 40 may in particular be made of polypropylene (PP).
  • These materials can be sterilized by conventional means.
  • they can be irradiated or autoclaved.
  • the housing 10 is presented as being formed of two bases 11, 12 mounted one on the other.
  • the device 100, 100 ', 100 "for taking liquid according to the invention is not removable in order to 'to ensure the safety of children vis-à-vis the composition contained in container R or to ensure that the contents have not been modified.
  • the invention also relates to a container R comprising a liquid (solution or suspension) and an opening, said container R comprising, at its opening, a device 100, 100 ', 100 "for taking liquid according to the invention.
  • the receptacle R comprises a plunger tube TP, flexible or rigid, in connection with the distal end 21d of the body 26.
  • the plunger tube TP has a length corresponding to the height of the receptacle R, which allows sampling of the composition contained in receptacle R, head up.
  • the TP dip tube is for example shown in the figure 5 . This figure 5 actually corresponds to the figure 3 (a) , on which the TP dip tube has been added. Of course, such a dip tube can be envisioned regardless of the embodiment considered.
  • the container R can be a bottle, a vial or a bag.
  • the receptacle R can be flexible or rigid.
  • the material in which the container R is made can advantageously be glass or plastic (different types of plastics can be envisaged).
  • the invention also relates to the use of a container R comprising a liquid and provided with an opening and comprising, at its opening, a device 100, 100 ', 100 "for taking liquid according to invention as a liquid packaging consisting of a sterile pharmaceutical composition.
  • the invention also relates to the use, in the context of a curative or preventive therapeutic treatment, of a pharmaceutical composition contained in a container R comprising said pharmaceutical composition and an opening, said container R comprising, at its opening , a device 100, 100 ', 100 "for collecting liquid according to the invention.
  • said use takes place in the veterinary field for administering a sterile pharmaceutical composition to an animal.

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Claims (17)

  1. Vorrichtung (100, 100', 100") zur Entnahme einer Flüssigkeit in einem Behälter, dadurch gekennzeichnet, dass sie Folgendes umfasst:
    - eine Aufnahme (10), die eine Längsachse (AL) aufweist;
    - eine Komponente (20, 20', 20"), umfassend:
    • einen Körper (26), der mit mindestens einem Kanal (21) mit einem proximalen Ende (21p) und einem distalen Ende (21d) versehen ist;
    • einen Aufnahmebehälter (24), der in Bezug auf den Körper (26) fixiert und sich in der Verlängerung des proximalen Endes (21p) des mindestens einen Kanals (21) befindet, wobei die Komponente (20, 20', 20") in Bezug auf die Aufnahme (10) um die Längsachse dieser Aufnahme (10) zwischen einer Schließstellung, in der das distale Ende (21d) des mindestens einen Kanals (21) durch die Aufnahme (10) verschlossen ist, und einer Öffnungsstellung, in der das distale Ende (21d) des mindestens einen Kanals (21) in der Lage ist, eine Fluidkommunikation mit dem Behälter herzustellen, drehbar angebracht ist; und
    - ein elastisches Ventil (30), das in dem Aufnahmebehälter (24) untergebracht ist.
  2. Vorrichtung (100, 100', 100") nach Anspruch 1, dadurch gekennzeichnet, dass das elastische Ventil (30) eine zentrale Öffnung (31) umfasst, von der ein distales Ende (31d) in Fluidkommunikation mit dem proximalen Ende (21d) des mindestens einen Kanals (21) der Komponente (20) steht und von der ein proximales Ende (31p) in Form eines Stopfens (33) vorliegt, der mit mindestens einem Schlitz (34) versehen ist.
  3. Vorrichtung (100, 100', 100") nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass das elastische Ventil (30) aus Elastomer, z.B. aus Silikonelastomer, hergestellt ist.
  4. Vorrichtung (100, 100', 100") nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass die Komponente (20) eine Schürze (25), beispielsweise eine zylindrische Schürze, umfasst, die den Aufnahmebehälter (24) umgibt.
  5. Vorrichtung (100, 100', 100") nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass der Körper (26) der Komponente (20', 20") eine Aufnahme (27) sowie mindestens einen zweiten Kanal (22) umfasst, von dem ein proximales Ende (22p) in die Aufnahme (27) mündet, welche Aufnahme (27) einen Luftfilter (50) in Fluidkommunikation mit der Außenseite umfasst, und von dem ein distales Ende (22d) in der Lage ist, eine Fluidkommunikation mit dem Behälter herzustellen.
  6. Vorrichtung (100, 100', 100") nach Anspruch 5, dadurch gekennzeichnet, dass die Komponente (20") eine weitere Aufnahme (28) sowie mindestens einen dritten Kanal (23) umfasst, von dem ein proximales Ende (23p) in diese weitere Aufnahme (28) mündet, welche weitere Aufnahme (28) einen weiteren Luftfilter (51) in Fluidkommunikation mit der Außenseite umfasst, und von dem ein distales Ende (23d) in der Lage ist, eine Fluidkommunikation mit dem Behälter herzustellen.
  7. Vorrichtung (100, 100', 100") nach dem vorstehenden Anspruch, dadurch gekennzeichnet, dass das distale Ende (23d) des mindestens einen dritten Kanals (23) in die Aufnahme (27) mündet.
  8. Vorrichtung (100, 100', 100") nach einem der Ansprüche 5 bis 7, dadurch gekennzeichnet, dass der oder jeder Luftfilter (50, 51) hydrophob und vorteilhafterweise lipophob ist.
  9. Vorrichtung (100, 100', 100") nach einem der Ansprüche 5 bis 8, dadurch gekennzeichnet, dass der oder jeder Luftfilter (50, 51) Öffnungen aufweist, deren größte Abmessung kleiner oder gleich 0,22 µm ist.
  10. Vorrichtung (100, 100', 100") nach einem der Ansprüche 5 bis 9, dadurch gekennzeichnet, dass die Aufnahme (10) einen Verschluss (121) zum Verschließen des distalen Endes (22d, 23d) des mindestens einen zweiten Kanals (22) und/oder des mindestens einen dritten Kanals (23) umfasst, wenn sich die Komponente (20) in ihrer Schließstellung befindet.
  11. Vorrichtung (100, 100', 100") nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass sie eine Kontrollvorrichtung (T) der Schließ- oder Öffnungsstellung der Komponente (20) umfasst.
  12. Vorrichtung (100, 100', 100") nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass sie weiter eine Kappe (40) umfasst, die abnehmbar auf der Aufnahme (10) angebracht ist.
  13. Vorrichtung (100, 100', 100") nach dem vorstehenden Anspruch, dadurch gekennzeichnet, dass sie eine Originalitätssicherung (41) der Kappe (40) in Bezug auf die Aufnahme (10) umfasst.
  14. Vorrichtung (100, 100', 100") nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass die Aufnahme (10) Folgendes umfasst
    - eine erste Basis (11), die zur Anbringung an der Außenseite des Behälters vorgesehen ist; und
    - eine zweite Basis (12), die zur Anbringung an der Innenseite des Behälters vorgesehen ist, wobei die zweite Basis (12), die einstückig ist oder mit der ersten Basis (11) zusammenwirkt, den Teil der Aufnahme (10) bildet, mit dem die Komponente (20) zusammenwirkt, um von ihrer Schließstellung in ihre Öffnungsstellung und umgekehrt überzugehen.
  15. Behälter (R), der eine Flüssigkeit und eine Öffnung umfasst, wobei der Behälter dadurch gekennzeichnet ist, dass er auf Höhe seiner Öffnung eine Vorrichtung (100, 100', 100") zur Entnahme von Flüssigkeit nach einem der vorstehenden Ansprüche umfasst.
  16. Behälter (R) nach Anspruch 15, wobei der Behälter ein Tauchrohr in Verbindung mit dem distalen Ende (21d) des Körpers (26) umfasst.
  17. Verwendung eines Behälters (R) nach einem der Ansprüche 15 oder 16 als Verpackung für eine Flüssigkeit, die aus einer sterilen pharmazeutischen Zusammensetzung besteht.
EP17825480.1A 2016-12-16 2017-12-15 Vorrichtung zur entnahme einer probe aus einer in einem behälter enthaltenen flüssigkeit, zugehöriger behälter und verwendung dieses behälters Active EP3554451B1 (de)

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FR1662671A FR3060305B1 (fr) 2016-12-16 2016-12-16 Dispositif de prelevement d'un liquide contenu dans un recipient, recipient lie et utilisation de ce recipient.
PCT/EP2017/083162 WO2018109215A1 (fr) 2016-12-16 2017-12-15 Dispositif de prelevement d'un liquide contenu dans recipient, recipient lie et utlisation de ce recipient

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AU (1) AU2017378199B2 (de)
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Publication number Publication date
AU2017378199B2 (en) 2023-01-12
ES2835298T3 (es) 2021-06-22
WO2018109215A1 (fr) 2018-06-21
FR3060305A1 (fr) 2018-06-22
KR20190002569U (ko) 2019-10-14
US11364175B2 (en) 2022-06-21
US20200038290A1 (en) 2020-02-06
KR200496877Y1 (ko) 2023-05-16
JP2020514194A (ja) 2020-05-21
CN110446481B (zh) 2022-01-11
JP7169974B2 (ja) 2022-11-11
FR3060305B1 (fr) 2019-05-24
AU2017378199A1 (en) 2019-07-18
EP3554451A1 (de) 2019-10-23
CN110446481A (zh) 2019-11-12
SI3554451T1 (sl) 2021-08-31

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