EP3554451B1 - Device for collecting a sample of a liquid contained in a container, associated container, and use of this container - Google Patents
Device for collecting a sample of a liquid contained in a container, associated container, and use of this container Download PDFInfo
- 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.)
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Links
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—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
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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
- A61J1/1475—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
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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
- A61J1/202—Separating means
- A61J1/2031—Separating means having openings brought into alignment
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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
- A61J1/202—Separating means
- A61J1/2037—Separating means having valve means
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- A—HUMAN NECESSITIES
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- 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
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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
- A61J1/2068—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.
Landscapes
- 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)
- Sampling And Sample Adjustment (AREA)
- Closures For Containers (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
L'invention concerne un dispositif de prélèvement (ou de transfert) d'un liquide contenu dans un récipient.The invention relates to a device for sampling (or transferring) a liquid contained in a container.
Elle concerne également un récipient muni d'un tel dispositif de prélèvement.It also relates to a container provided with such a sampling device.
Elle concerne encore une utilisation de ce récipient.It also relates to a use of this container.
L'invention vise principalement une application au prélèvement d'un liquide à portée médicamenteuse, en particulier destiné au traitement des animaux.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.
Ce type de dispositif permet le prélèvement de liquide tout en assurant, par ailleurs, une étanchéité.This type of device enables liquid to be taken while also ensuring a seal.
A cet effet, on a déjà proposé un dispositif de prélèvement de liquide dans un récipient, comportant un robinet qui permet à un utilisateur, en tournant ce robinet, de fermer ou d'ouvrir un passage entre le volume interne du récipient et l'extérieur de ce récipient.For this purpose, a device has already been proposed 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.
Lorsque ce passage est fermé, le liquide contenu dans le récipient ne peut pas sortir de celui-ci. Toute fuite de liquide depuis l'intérieur vers l'extérieur du récipient est alors empêchée et on évite l'introduction de toute pollution externe (fluide non désiré ou poussières, par exemple) à l'intérieur du récipient.When this passage is closed, the liquid contained in the container cannot leave it. Any leakage of liquid from the interior to the exterior of the container is then prevented and the introduction of any external pollution (unwanted fluid or dust, for example) inside the container is avoided.
Lorsque ce passage est ouvert, un prélèvement du liquide contenu dans le récipient peut être effectué.When this passage is open, a sample of the liquid contained in the container can be performed.
Une telle solution est par exemple proposée dans le document
Cependant, cette solution n'est pas parfaite.However, this solution is not perfect.
En effet, après une première utilisation, le robinet est fermé et la partie supérieure du passage entre le volume externe et le volume interne du récipient reste en contact avec le milieu externe. Cette partie supérieure du passage peut donc se charger en polluants et notamment charger en polluants les résidus de liquide provenant de l'intérieur du récipient. Aussi, lors d'une ouverture ultérieure du dispositif de prélèvement, des polluants peuvent alors entrer à l'intérieur du récipient. De tels polluants peuvent aussi être introduits dans le récipient lorsque le robinet est ouvert.Indeed, after a first use, 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. Also, during a subsequent opening of the sampling device, pollutants can then enter the interior of the container. Such pollutants can also be introduced into the container when the tap is open.
A cet effet également, une solution alternative à l'utilisation d'un robinet est l'emploi d'une valve élastique généralement réalisée avec un élastomère.Also for this purpose, an alternative solution to the use of a valve is the use of an elastic valve generally produced with an elastomer.
C'est par exemple ce qui est proposé dans le document
L'intérêt de la valve élastique, par rapport à un robinet, réside principalement en l'absence d'une zone de passage du liquide contenu dans le récipient en contact avec l'extérieur.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.
Cependant, une telle valve élastique est sollicitée fortement et fréquemment si bien que sa longévité peut en être altérée, notamment par rapport à celle d'un robinet.However, such an elastic valve is stressed strongly and frequently so that its longevity may be impaired, in particular compared to that of a valve.
Par ailleurs, avec cette solution, maintenir une étanchéité dans tous les cas est délicat. Ainsi et par exemple, si le récipient est renversé, le liquide qu'il contient applique une pression sur la valve élastique et des fuites peuvent alors être constatées.Moreover, with this solution, maintaining a seal in all cases is difficult. Thus, for example, if the container is overturned, the liquid it contains applies pressure on the elastic valve and leaks can then be observed.
Il existe donc un besoin pour un dispositif de prélèvement d'un liquide dans un récipient amélioré.There is therefore a need for a device for withdrawing a liquid from an improved container.
A cet effet, l'invention propose un dispositif de prélèvement d'un liquide dans un récipient, caractérisé en ce qu'il comporte :
- un logement présentant un axe longitudinal ;
- un composant comprenant :
- un corps muni d'au moins un canal avec une extrémité proximale et une extrémité distale ;
- un réceptacle, fixe par rapport au corps, et situé dans le prolongement de l'extrémité proximale dudit au moins un canal,
- une valve élastique logée dans le réceptacle.
- a housing having a longitudinal axis;
- a component comprising:
- a body provided with at least one channel with a proximal end and a distal end;
- a receptacle, fixed relative to the body, and located in the extension of the proximal end of said at least one channel,
- an elastic valve housed in the receptacle.
Le dispositif selon l'invention pourra également comprendre les caractéristiques suivantes, prises seules ou en combinaison :
- la valve élastique comporte un orifice central dont une extrémité distale est en communication fluidique avec l'extrémité proximale dudit au moins un canal du composant et dont une extrémité proximale se présente sous la forme d'un bouchon muni d'au moins une fente ;
- la valve élastique est réalisée en élastomère, par exemple en élastomère silicone ;
- le composant comporte une jupe, par exemple une jupe cylindrique, entourant le réceptacle ;
- le corps du composant comprend un logement ainsi qu'au moins un deuxième canal dont une extrémité proximale débouche dans le logement, lequel logement comporte un filtre à air en communication fluidique avec l'extérieur, et dont une extrémité distale est apte à établir une communication fluidique avec le récipient ;
- le composant comprend un autre logement ainsi qu'au moins un troisième canal dont une extrémité proximale débouche dans cet autre logement, lequel autre logement comporte un autre filtre à air en communication fluidique avec l'extérieur, et dont une extrémité distale est apte à établir une communication fluidique avec le récipient ;
- l'extrémité distale dudit au moins un troisième canal débouche dans le logement ;
- le ou chaque filtre à air est hydrophobe et avantageusement lipophobe ;
- le ou chaque filtre à air présente des orifices dont la plus grande dimension est inférieure ou égale à 0,22 µm ;
- le logement comprend un obturateur pour fermer l'extrémité distale dudit au moins un deuxième canal et/ou dudit au moins un troisième canal lorsque le composant est dans sa position de fermeture ;
- le dispositif comprend un témoin de la position de fermeture ou d'ouverture du composant ;
- le dispositif comprend, en outre, un capuchon monté de façon amovible sur le logement ;
- le dispositif comprend un témoin d'effraction du capuchon par rapport au logement ;
- le logement comporte une première embase destinée à être montée sur l'extérieur du récipient ; et une deuxième embase destinée à être montée sur l'intérieur du récipient, ladite deuxième embase, venue de matière ou coopérant avec la première embase, formant la partie du logement avec laquelle le composant coopère pour passer de sa position de fermeture à sa position d'ouverture et inversement.
- the elastic valve comprises a central orifice, a distal end of which is in fluid communication with the proximal end of said at least one channel of the component and of which a proximal end is in the form of a plug provided with at least one slot;
- the elastic valve is made of elastomer, for example of silicone elastomer;
- the component comprises a skirt, for example a cylindrical skirt, surrounding the receptacle;
- the body of the component comprises a housing as well as at least one second channel, a proximal end of which opens into the housing, which housing comprises an air filter in fluid communication with the outside, and of which a distal end is able to establish communication fluidics with the container;
- the component comprises another housing as well as at least a third channel, one proximal end of which opens into this other housing, which other housing comprises another air filter in fluid communication with the outside, and of which a distal end is able to establish fluid communication with the container;
- the distal end of said at least one third channel opens into the housing;
- the or each air filter is hydrophobic and advantageously lipophobic;
- the or each air filter has orifices the largest dimension of which is less than or equal to 0.22 μm;
- the housing comprises an obturator for closing the distal end of said at least one second channel and / or of said at least one third channel when the component is in its closed position;
- the device comprises an indicator of the closed or open position of the component;
- the device further comprises a cap removably mounted on the housing;
- the device comprises a tamper-evident indicator of the cap relative to the housing;
- the housing comprises a first base intended to be mounted on the outside of the container; and a second base intended to be mounted on the inside of the container, said second base, integrally formed or cooperating with the first base, forming the part of the housing with which the component cooperates to move from its closed position to its position of 'opening and vice versa.
L'invention concerne également un récipient comportant un liquide et une ouverture, ledit récipient étant caractérisé en ce qu'il comprend, au niveau de son ouverture, un dispositif de prélèvement de liquide selon l'invention.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.
Le récipient pourra comprendre un tube plongeur en connexion avec l'extrémité distale du corps.The container may include a dip tube in connection with the distal end of the body.
Enfin, l'invention concerne aussi une utilisation d'un récipient conforme à l'invention, en tant que conditionnement pour un liquide consistant en une composition pharmaceutique stérile.Finally, 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.
L'invention sera décrite plus précisément en référence aux figures annexées, données à titre non limitatif :
- la
figure 1 , qui comprend lesfigures 1(a) à 1(g) , représente un premier mode de réalisation d'un dispositif selon l'invention; - la
figure 2 , qui comprend lesfigures 2(a) et 2(b) , représente un deuxième mode de réalisation de l'invention ; - la
figure 3 , qui comprend lesfigures 3(a) à 3(d) , représente un troisième mode de réalisation de l'invention ; - la
figure 4 , qui comprend lesfigures 4(a) et 4(b) , représente une réalisation possible pour un témoin d'état d'ouverture/fermeture du dispositif selon l'invention ; - la
figure 5 est une variante de réalisation dans laquelle un tube plongeur est représenté.
- the
figure 1 , which includesfigures 1 (a) to 1 (g) , shows a first embodiment of a device according to the invention; - the
figure 2 , which includesfigures 2 (a) and 2 (b) , represents a second embodiment of the invention; - the
figure 3 , which includesfigures 3 (a) to 3 (d) , represents a third embodiment of the invention; - the
figure 4 , which includesfigures 4 (a) and 4 (b) , represents a possible embodiment for an opening / closing status indicator of the device according to the invention; - the
figure 5 is an alternative embodiment in which a dip tube is shown.
La
De manière générale, le dispositif 100 de prélèvement d'un liquide dans un récipient selon l'invention comporte un logement 10, un composant 20 situé dans le logement 10, une valve élastique 30 et un capuchon 40 monté de façon amovible sur le logement 10. Tous ces composants sont représentés sur la vue générale, réalisée selon une perspective coupée, de la
Le logement 10 comprend une première embase 11 destinée à être montée sur l'extérieur du récipient et une deuxième embase 12 destinée à être montée sur l'intérieur du récipient. La première embase 11 est représentée selon une vue en coupe sur la
Avantageusement, le montage sur le récipient R requiert un effort de compression axiale F inférieur ou égal à 300 N.Advantageously, mounting on the container R requires an axial compressive force F less than or equal to 300 N.
Par ailleurs, la liaison entre le dispositif de prélèvement selon l'invention et le récipient R est avantageusement indémontable manuellement.Moreover, the connection between the sampling device according to the invention and the receptacle R can advantageously be removed manually.
Le composant 20 est monté à rotation par rapport au logement 10, c'est-à-dire à la fois par rapport à la première embase 11 et la deuxième embase 12 compte tenu de la fixation des deux embases 11, 12 l'une par rapport à l'autre. Cette rotation s'effectue entre une position dite de fermeture et une position dite d'ouverture. Cette rotation s'effectue autour de l'axe longitudinal AL du logement 10. En pratique, il est alors avantageux de prévoir une rotation, entre la position de fermeture et la position d'ouverture, autour de cet axe longitudinal AL de 180°.The
Le composant 20 est représenté de manière plus précise sur la
Le composant 20 comprend un corps 26 muni d'au moins un canal 21 avec une extrémité proximale 21p et une extrémité distale 21d. Le canal 21 traverse le corps 26 du composant 20.
Dans la position de fermeture (
Dans la position d'ouverture (non représentée), l'extrémité distale 21d dudit au moins un canal 21 est apte à établir une communication fluidique avec le récipient. Plus précisément, lorsque l'on tourne, à partir de la position de fermeture, le composant 20 autour de l'axe longitudinal AL du logement 10, par exemple de 180°, l'extrémité distale 21d dudit au moins un canal 21 arrive alors en vis-à-vis d'un passage 120 de la deuxième embase 12 débouchant, en l'occurrence vers l'intérieur d'un récipient lorsque le dispositif 100 est monté sur un tel récipient R comme représenté sur la
Le composant 20 comprend également un réceptacle 24 situé dans le prolongement de l'extrémité proximale 21p dudit au moins un canal 21. Ce réceptacle 24 est fixe par rapport au corps 26, et plus précisément monté fixe sur le corps 26. Par exemple, pour monter fixement le réceptacle 24 sur le corps 26, on peut prévoir une rainure circonférentielle 260, située au niveau de la paroi supérieure 26SUP du corps 26, et apte à recevoir, par exemple par encliquetage, une paroi correspondante du réceptacle 24.The
Un autre type de montage entre le corps 26 et le réceptacle 24 peut être envisagé, l'essentiel étant que ce montage, amovible ou non, permette une fixation interdisant tout mouvement relatif entre le corps 26 et le réceptacle 24.Another type of assembly between the
A cet égard, il est donc possible, en variante, et pour que le réceptacle 24 soit fixe par rapport au corps 26, de prévoir que le réceptacle 24 et le corps 26 soient d'une seule pièce. Cela n'empêchera pas pour autant le montage de la valve élastique 30. En effet, du fait de son élasticité, la valve élastique 30 peut être logée à l'intérieur de la pièce formée par le réceptacle 24 et le corps 26, via l'orifice 240 du réceptacle 24.In this regard, it is therefore possible, as a variant, and so that the
Ainsi, le réceptacle 24 permet de loger la valve élastique 30 au sein du composant 20. Plus précisément, la valve élastique 30 est maintenue entre le corps 26 et les parois du réceptacle 24.Thus, the
La valve élastique 30 est en complémentarité de forme avec la paroi interne du réceptacle 24. Elle s'appuie par ailleurs contre le corps 26.The
Cette valve élastique 30 est avantageusement réalisée en élastomère, par exemple en élastomère silicone.This
Elle comporte un orifice central 31 dont une extrémité distale 31d est en communication fluidique avec l'extrémité proximale 21d dudit au moins un canal 21 du composant 20. Cette communication fluidique entre le canal 21 et l'orifice central 31 est présente quelle que soit la position angulaire du composant 20 par rapport au logement 10.It comprises a
L'orifice central 31 comporte également une extrémité proximale 31p qui se présente sous la forme d'un bouchon 33 muni d'une fente 34. La fente 34 peut être simple (droite) ou complexe (en forme d'arc de cercle ou d'étoile par exemple). Lorsque la valve élastique 30 n'est pas sollicitée par une action extérieure (seringue de type Luer ou autre), la fente 34 est fermée et une étanchéité est assurée entre l'extérieur du composant 20 et l'intérieur du composant 20. C'est ce qui est représenté sur les
D'ailleurs, lorsque l'on souhaite prélever un liquide dans un récipient muni d'un dispositif tel que représenté sur la
Un Luer L est introduit dans le composant 20, ce qui a pour effet (
Puis, à l'aide du Luer L, on effectue une rotation du composant 20 et de la valve élastique 30, tous deux alors en prise avec le Luer L. Cette rotation s'effectue autour de l'axe longitudinal AL du logement 10. L'axe longitudinal AL du logement 10 se confond alors avec l'axe longitudinal du Luer L comme avec celui du canal central 31 de la valve élastique 30. Le composant 20 passe alors de sa position de fermeture à sa position d'ouverture. En pratique, le composant 20 et plus précisément la paroi 261NF du corps 26 glisse alors contre la paroi supérieure 12SUP de la deuxième embase 12 du logement 10. En position d'ouverture, un passage existe alors entre le volume intérieur du récipient et le Luer L. Le liquide contenu dans le récipient peut alors être prélevé par le Luer L.Then, using the Luer L, one performs a rotation of the
Une fois le prélèvement de liquide dans le récipient terminé, l'utilisateur tourne le Luer L dans l'autre sens, toujours autour de l'axe longitudinal AL du logement 10, pour aller de la position d'ouverture à la position de fermeture du composant 20. Une fois la position de fermeture atteinte, l'utilisateur peut retirer le Luer L du composant 20. La valve élastique 30, qui ne subit alors plus d'action extérieure reprend sa forme initiale, à savoir celle de la
Le dispositif 100 selon l'invention prévoit une double étanchéité sur le chemin de prélèvement de liquide.The
La première étanchéité est réalisée par un système de type robinet, en l'occurrence ici entre le composant 20 et la deuxième embase 20. La deuxième étanchéité est réalisée par une valve élastique 30 située au-dessus du système de type robinet.The first seal is produced by a valve-type system, in this case here between the
La valve élastique 30 limite ou empêche toute introduction de polluants dans la partie supérieure du composant 20, pendant avant ou après utilisation. Par ailleurs, la présence d'un système de type robinet entre le récipient et la valve élastique 30 limite la sollicitation de celle-ci et limite aussi la présence de liquide dans les canaux 21 et 31.The
Par ailleurs, lors d'un stockage à l'envers d'un récipient R comportant le dispositif de prélèvement d'un liquide selon l'invention, le système en position robinet fermé reste étanche et aucune fuite de la composition contenue dans le récipient n'est visible et ce même à température élevée, typiquement 40°C.Moreover, during storage upside down of a container R comprising the device for sampling a liquid according to the invention, 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.
De plus, le fait de loger la valve élastique 30 dans le composant 20 permet de mettre en œuvre un système de type robinet avec lequel la rotation du composant 20 par rapport au logement 10 s'effectue autour de l'axe longitudinal AL du logement 10. Le composant 20 peut donc tourner dans le logement 10, sans qu'un espace important ne soit présent entre le composant et le logement 10, ce qui permet de limiter l'encombrement, notamment radial, du dispositif est donc particulièrement bien adapté pour un récipient. Par ailleurs, avec cette conception, le Luer L peut rester dans l'axe longitudinal du logement 10, et donc du composant 20 destiné à tourner, sans être gêné par le récipient R. De plus, la rotation du Luer L autour de cet axe longitudinal pour réaliser l'ouverture ou la fermeture du composant 20 entraîne également en rotation la valve élastique 30. Celle-ci ne subit donc pas d'autres contraintes que la déformation axiale imprimée par le Luer L.In addition, the fact of housing the
En utilisation, il convient néanmoins de fournir un certain couple afin d'ouvrir le canal 21 et ainsi de connecter un système de ponction ou de collecte avec le contenu du récipient. Cette opération doit être aisée, tout en donnant la sensation de connexion à l'utilisateur. Afin d'éviter le risque de contamination, la connexion avec le récipient est avantageusement effectuée une fois la liaison entre le dispositif de prélèvement et le Luer L assurée. Avantageusement, l'effort d'assemblage du Luer L sur le dispositif de prélèvement selon l'invention doit être inférieur à 27,5 NIn use, it is nevertheless necessary to provide a certain torque in order to open the
(pendant 5 sec) avec un couple d'insertion inférieur à 0,1 N.m. L'ouverture du canal 21 s'effectue alors une fois la liaison Luer L effective, le couple d'ouverture étant alors avantageusement inférieur à 0.35 N.m. La fermeture du canal 21 requiert avantageusement un couple inférieur à 0,35 N.m. Avantageusement l'effort de désassemblage du Luer L doit être inférieur à 27,5 N (pendant 5 sec) avec un couple nécessaire pour retirer le Luer L inférieur à 0,1 N.m.(for 5 sec) with an insertion torque less than 0.1 N.m. The opening of the
Le capuchon 40 présente une complémentarité de forme avec le logement 10 et plus précisément avec la première embase 11, par exemple pour pouvoir être vissée ou dévissée (les éléments 110 de la
Le couple de mise en place du capuchon 40 doit être suffisant pour assurer la fermeture du dispositif de prélèvement de liquide. Une personne adulte normalement constituée peut fournir un couple de serrage sur le capuchon 40 d'environ 1,1 N.m. Ainsi et avantageusement, la fermeture du capuchon 40 est effectuée pour un couple inférieur à 1,1 N.m. Pareillement, un couple d'ouverture sur le capuchon d'environ 1,1 N.m. peut être appliqué par une personne adulte normalement constituée et avantageusement le retrait du capuchon est réalisé pou un couple inférieur à 1,1 N.m.The fitting torque of the
Le capuchon 40 peut avantageusement prévoir au moins un témoin d'effraction 41 du capuchon 40 par rapport au logement 10. Le témoin d'effraction 41 peut se présenter sous la forme d'une bande annulaire reliée par des ponts frangibles (non visibles sur la
Avantageusement, l'effort nécessaire pour déchirer les ponts frangibles lors de la première ouverture du capuchon, doit être telle que le système puisse être utilisé par une personne normalement constituée. Par exemple, pour un diamètre d'ouverture du récipient R de 20 mm, le couple de première ouverture du système C est avantageusement inférieur à 1,2 N.mAdvantageously, 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. For example, for an opening diameter of the receptacle R of 20 mm, the first opening torque of the system C is advantageously less than 1.2 N.m
Il convient de noter que s'il est avantageux de prévoir un capuchon 40, sa présence n'est pas obligatoire.It should be noted that while it is advantageous to provide a
La
Ce deuxième mode de réalisation reprend les caractéristiques du premier mode de réalisation. Aussi, par rapport aux
Cependant, ce deuxième mode de réalisation comprend des caractéristiques supplémentaires.However, this second embodiment includes additional features.
En effet, dans ce deuxième mode de réalisation, le corps 26 du composant 20' est modifié et comporte un deuxième canal 22 et un logement 27 dans lequel le deuxième canal 22 débouche. Plus précisément, l'extrémité distale 22d du deuxième canal 22 est apte à établir une communication fluidique avec le récipient et l'extrémité proximale 22p de ce deuxième canal 22 débouche dans le logement 27, ce dernier comportant un filtre à air 50 en communication fluidique avec l'air extérieur.Indeed, in this second embodiment, the
Ceci permet de pouvoir équilibrer les pressions entre le volume interne du récipient et l'extérieur, en particulier lors d'un prélèvement de liquide dans le récipient. En effet, en prélevant du liquide dans le récipient, et en l'absence d'une prise d'air sur l'extérieur, on crée petit à petit un vide qui rend le prélèvement de liquide supplémentaire un peu plus difficile pour l'utilisateur. Ceci se rencontre principalement lorsque le récipient est rigide.This makes it possible to be able to balance the pressures between the internal volume of the container and the outside, in particular when liquid is withdrawn from the container. In fact, by taking liquid from the container, and in the absence of an air intake on the outside, a vacuum is gradually created which makes the additional liquid withdrawal a little more difficult for the user. . This is mainly encountered when the container is rigid.
La prise d'air permet d'éviter ce type de problème.The air intake avoids this type of problem.
Par ailleurs, le filtre à air 50 permet de filtrer l'air pris de l'extérieur pour éviter que celui-ci ne vienne polluer le liquide contenu dans le récipient, par exemple par l'apport de poussières ou autres contaminants susceptibles de polluer le contenu du récipient, tels que des bactéries.Moreover, the
Par ailleurs, il convient de noter que l'ajout de cette prise d'air, intégrant un filtre à air 50, ne modifie pas, par rapport au premier mode de réalisation, l'encombrement du dispositif de prélèvement 100'.Furthermore, it should be noted that the addition of this air intake, incorporating an
Et lorsque le composant 20' est mis en rotation, le filtre à air 50 qui est situé dans le logement 27 défini dans le corps 26 du composant 20' accompagne le mouvement de rotation.And when the component 20 'is rotated, the
Selon un mode de réalisation particulièrement avantageux, le filtre à air 50 est hydrophobe. Cela permet d'éviter la prise en eau dans le récipient, protégeant ainsi le contenu de l'hydratation. Le filtre à air 50 peut avoir différentes porosités et avantageusement une porosité qui permet la reprise en air stérile, lorsque les pores (orifices) du filtre présentent une plus grande dimension inférieure ou égale à 0,22 µm. De cette manière la stérilité de la composition contenue dans le récipient R peut être conservée. Le filtre à air 50 peut avantageusement être hydrophobe et lipophobe (oléophobe). Dans ce cas, il permet de limiter ou d'empêcher la pénétration et/ou l'échappement à la fois d'eau et des solvants apolaires comme les lipides (corps gras).According to a particularly advantageous embodiment, the
La
Ce troisième mode de réalisation reprend les caractéristiques du deuxième mode de réalisation. Aussi, par rapport aux
La
Cependant, il comprend des caractéristiques supplémentaires.However, it includes additional features.
En effet, dans ce troisième mode de réalisation, le corps 26 du composant 20" est modifié et comporte un troisième canal 23 ainsi qu'un autre logement 28 dans lequel le troisième canal débouche. Le troisième canal 23 permet une prise d'air additionnelle entre l'extérieur du récipient vers l'intérieur du récipient à travers un autre filtre à air 51 qui est logé dans le logement 28.In fact, in this third embodiment, the
Avantageusement, l'extrémité proximale 23p de ce troisième canal 22 débouche dans le logement 28 comportant l'autre filtre à air 51 et l'extrémité distale 23d de ce troisième canal 23, apte à établir une communication fluidique avec le récipient, débouche dans le logement 27 du filtre à air 50. Par ce biais, l'air extérieur entrant par le filtre à air 51 passe par le troisième canal 23, puis par le deuxième canal 22 avant d'arriver dans le récipient. Cette conception évite de réaliser un troisième canal 23 de façon identique à celui du deuxième canal 22 et permet donc de mettre à profit au mieux l'espace disponible dans le corps 26 du composant 20".Advantageously, the
En variante, on pourrait cependant prévoir un troisième canal 23 totalement indépendant du deuxième canal 22.As a variant, however, a
Là également, l'autre filtre à air 51 du fait de son insertion dans un logement 28 du composant 20", suit le mouvement de rotation de ce composant 20".Here too, the
Cette prise d'air supplémentaire améliore la rapidité de l'équilibrage de pression lors d'un prélèvement de liquide dans le récipient, en particulier pour des récipients rigides, sans impacter l'encombrement global du dispositif 100".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
Selon un mode de réalisation particulièrement avantageux, le filtre à air 51 est hydrophobe. Cela permet d'éviter la prise en eau dans le récipient, protégeant ainsi le contenu de l'hydratation. Le filtre à air 51 peut avoir différentes porosités et avantageusement une porosité qui permet la reprise en air stérile, lorsque les pores (orifices) du filtre présentent une plus grande dimension inférieure ou égale à 0,22 µm. De cette manière la stérilité de la composition contenue dans le récipient R peut être conservée. L'autre filtre à air 51 peut avantageusement être hydrophobe et lipophobe (oléophobe). Dans ce cas, il permet de limiter ou d'empêcher la pénétration et/ou l'échappement à la fois d'eau et des solvants apolaires comme les lipides (corps gras).According to a particularly advantageous embodiment, the
Une caractéristique additionnelle prévue dans le troisième mode de réalisation concerne l'ajout d'un obturateur 121 de canal de prise d'air sur le logement et plus précisément sur la deuxième embase 12 de ce logement 10.An additional feature provided in the third embodiment concerns the addition of an air
En effet, la deuxième embase 12 comporte un obturateur 121 pour le deuxième canal 22. Ainsi, lorsque le composant 20" est dans sa position de fermeture (
L'utilisation d'un obturateur 121 offre une sécurité supplémentaire lorsque le composant 20" est dans sa position de fermeture. En effet, si le récipient R est renversé, le liquide qui ne peut entrer dans le canal 21, fermé, ne pourra pas non plus entrer dans le deuxième canal 22.The use of a
Un autre caractéristique additionnelle prévue dans le troisième mode de réalisation concerne l'ajout d'une jupe 25, par exemple cylindrique, entourant le réceptacle 24. Cette jupe 25 peut être réalisée avec le même matériau que le corps 26 et donc être moulée en même temps que le corps 26. Cette jupe permet, comme on peut le constater sur la
Par ailleurs, la présence de cette jupe 25 peut permettre à un utilisateur d'assurer une action d'ouverture ou de fermeture du composant 20 manuellement et directement, à savoir sans l'intermédiaire d'une seringue de type Luer ou autre, en manipulant la jupe 25 sans toucher le réceptacle 24 ou le bouchon 33. De ce fait, cet actionnement peut s'effectuer sans que l'utilisateur ne touche les éléments susceptibles d'être en contact avec le liquide contenu dans le récipient. Ceci permet d'assurer la propreté et/ou la stérilité du bouchon 33.Furthermore, the presence of this
Il convient de noter que l'invention n'est pas limitée au trois modes de réalisation représentés sur les figures annexées.It should be noted that the invention is not limited to the three embodiments shown in the appended figures.
L'invention couvre en effet d'autres modes de réalisation.The invention in fact covers other embodiments.
Ainsi, la jupe 25 du composant 20" entourant le logement 24 pour la valve élastique 30, discutée à l'appui du troisième mode de réalisation, peut être ajoutée à la réalisation représentée sur la
Ainsi également, l'agencement du logement 10 permettant de fermer concomitamment d'une part, le canal 21 du composant 20", prévu pour l'écoulement du liquide contenu dans le récipient et d'autre part, le canal 22 de prise d'air du composant 20" par un obturateur, comme discuté à l'appui du troisième mode de réalisation, peut également être prévu pour une réalisation modifiée de la
Quel que soit le mode de réalisation envisagé, on peut prévoir un témoin de l'état du composant 20, 20', 20" ouvert ou fermé. Pour cela, il suffit de prévoir au moins une ouverture O sur la première embase 11 permettant de voir, à travers cette ouverture, une partie du composant 20 comportant un témoin visuel TV de son état.Whatever the embodiment envisaged, it is possible to provide an indicator of the state of the
C'est ce qui est représenté sur la
Cela apporte une sécurité supplémentaire à l'utilisateur.This provides additional security for the user.
Il est avantageux de prévoir aussi, sur la première embase 11, au moins une barbacane ou une ouverture, latéralement par rapport à l'ouverture O, afin de permettre l'évacuation de liquides éventuellement recueillis derrière la première embase 11. En effet, il a été constaté que lorsque du liquide est emprisonné derrière la première embase 11, son évaporation peut apporter, au contact du ou des filtres, des résidus susceptibles de diminuer l'efficacité des filtres pour l'équilibrage des pressions entre l'intérieur et l'extérieur du récipient R. L'évacuation de liquides est augmentée grâce à la présence de barbacanes et le risque de dégradation de la qualité des filtres est diminué.It is advantageous to also provide, on the
Différents matériaux sont envisageables pour réaliser les différents éléments du dispositif 100, 100', 100" selon l'invention.Different materials can be envisaged for making the different elements of the
La première embase 11 du logement 10 pourra être réalisée en Acrilonitrile Butadiène Styrène (ABS), en polycarbonate (PC) ou en poly(téréphtalate de butylène) (PBT). La deuxième embase 12 du logement 10 et la valve élastique 30 pourront être réalisées en thermoplastique élastomère (TPE), thermoplastique élastomère vulcanisé (TPV), en thermoplastique élastomère uréthane (TPU), en silicone, en fluorosilicone, n chlorobutyle, en bromobutyle, en nitrile, fluoroélastomère (FKM) ou en éthylène-propylène-diène monomère (EPDM). Avantageusement, ces élastomères peuvent être revêtus d'un film protecteur.The
Le composant 20, 20', 20" (donc le corps 26, le réceptacle 24 et, le cas échéant, la jupe 25) pourra être réalisé en poly(téréphtalate de butylène) (PBT), en Polypropylène (PP) ou en Polyéthylène Téréphtalate (PET).The
Le capuchon 40 pourra notamment être réalisé en polypropylène (PP).The
Ces matériaux sont stérilisables par voie classique. Avantageusement, ils peuvent être irradiés ou autoclavés.These materials can be sterilized by conventional means. Advantageously, they can be irradiated or autoclaved.
Il convient de noter que dans la description qui précède, le logement 10 est présenté comme étant formé de deux embases 11, 12 montées l'une sur l'autre. Dans le cadre de l'invention, on pourrait prévoir que le logement 10 soit réalisé d'une seule pièce, une première partie remplissant la fonction de la première embase 11 et une deuxième partie remplissant la fonction de la deuxième embase 12. On peut, à titre d'exemple, envisager l'utilisation d'une capsule sertie, clipsée ou vissée sur l'ouverture du récipient R. Avantageusement, le dispositif 100, 100', 100" de prélèvement de liquide selon l'invention est indémontable afin d'assurer la sécurité des enfants vis-à-vis de la composition contenue dans le récipient R ou de garantir que le contenu n'a pas été modifié.It should be noted that in the foregoing description, the
L'invention porte aussi sur un récipient R comportant un liquide (solution ou suspension) et une ouverture, ledit récipient R comprenant, au niveau de son ouverture, un dispositif 100, 100', 100" de prélèvement de liquide selon l'invention. Selon un mode de réalisation, le récipient R comprend un tube plongeur TP, souple ou rigide, en connexion avec l'extrémité distale 21d du corps 26. Avantageusement le tube plongeur TP présente une longueur correspondant à la hauteur du récipient R, ce qui permet le prélèvement de la composition contenue dans le récipient R, tête en haut. Le tube plongeur TP est par exemple représenté sur la
Le récipient R peut être une bouteille, un flacon ou une poche.The container R can be a bottle, a vial or a bag.
Le récipient R peut être souple ou rigide. Le matériau dans lequel est constitué le récipient R peut être avantageusement du verre ou du plastique (différents types de plastiques peuvent être envisagés).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).
Enfin, l'invention porte également sur l'utilisation d'un récipient R comprenant un liquide et muni d'une ouverture et comprenant, au niveau de son ouverture, un dispositif 100, 100', 100" de prélèvement de liquide selon l'invention en tant que conditionnement d'un liquide consistant en une composition pharmaceutique stérile.Finally, 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
L'invention porte aussi sur l'utilisation, dans le cadre d'un traitement thérapeutique curatif ou préventif, d'une composition pharmaceutique contenue dans un récipient R comportant ladite composition pharmaceutique et une ouverture, ledit récipient R comprenant, au niveau de son ouverture, un dispositif 100, 100', 100" de prélèvement de liquide selon l'invention. Selon un mode particulièrement préféré de l'invention, ladite utilisation a lieu dans le domaine vétérinaire pour administrer à un animal une composition pharmaceutique stérile.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
Claims (17)
- Device (100, 100', 100") for taking a liquid in a container, characterised in that it comprises:- a housing (10) having a longitudinal axis (AL);- a component (20, 20', 20") comprising:• a body (26) equipped with at least one channel (21) with a proximal end (21p) and a distal end (21d);• a receptacle (24), attached with respect to the body (26), and situated in the extension of the proximal end (21p) of said at least one channel (21),said component (20, 20' 20") being rotatably mounted with respect to the housing (10) about the longitudinal axis of this housing (10) between a closed position wherein the distal end (21d) of said at least one channel (21) is closed by the housing (10) and an open position wherein the distal end (21d) of said at least one channel (21) is capable of establishing a fluid communication with the container; and- an elastic valve (30) housed in the receptacle (24).
- Device (100, 100', 100") according to claim 1, characterised in that the elastic valve (30) comprises a central orifice (31) of which a distal end (31d) is in fluid communication with the proximal end (21d) of said at least one channel (21) of the component (20) and of which a proximal end (31p) is presented in the form of a plug (33) equipped with at least one slot (34).
- Device (100, 100', 100") according to one of the preceding claims, characterised in that the elastic valve (30) is made of elastomeric material, for example of elastomeric silicon.
- Device (100, 100', 100") according to one of the preceding claims, characterised in that the component (20) comprises a sleeve (25), for example a cylindrical sleeve, surrounding the receptacle (24).
- Device (100, 100', 100") according to one of the preceding claims, characterised in that the body (26) of the component (20', 20") comprises a housing (27) as well as at least one second channel (22) of which a proximal end (22p) opens into the housing (27), which housing (27) comprises an air filter (50) in fluid communication with the exterior, and of which a distal end (22d) is capable of establishing a fluid communication with the container.
- Device (100, 100', 100") according to claim 5, characterised in that the component (20") comprises another housing (28) as well as at least one third channel (23) of which a proximal end (23p) opens into this other housing (28), which other housing (28) comprises another air filter (51) in fluid communication with the exterior, and of which a distal end (23d) is capable of establishing a fluid communication with the container.
- Device (100, 100', 100") according to the preceding claim, characterised in that the distal end (23d) of said at least a third channel (23) opens into the housing (27).
- Device (100, 100', 100") according to one of claims 5 to 7, characterised in that the, or each, air filter (50, 51) is hydrophobic and advantageously lipophobic.
- Device (100, 100', 100") according to one of claims 5 to 8, characterised in that the, or each, air filter (50, 51) has orifices of which the largest dimension is less than or equal to 0.22µm.
- Device (100, 100', 100") according to one of claims 5 to 9, characterised in that the housing (10) comprises a valve (121) to close the distal end (22d, 23d) of said at least one second channel (22) and/or said at least a third channel (23) when the component (20) is in its closed position.
- Device (100, 100', 100") according to one of the preceding claims, characterised in that it comprises a closed or open position indicator (T) for the component (20).
- Device (100, 100', 100") according to one of the preceding claims, characterised in that it comprises, in addition, a cap (40) mounted in a detachable manner on the housing (10).
- Device (100, 100', 100") according to the preceding claim, characterised in that it comprises a breakage indicator (41) for the cap (40) with respect to the housing (10).
- Device (100, 100', 100") according to one of the preceding claims, characterised in that 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, said second base (12), integral or engaging with the first base (11), forming the part of the housing (10) with which the component (20) engages to pass from its closed position to its open position, and vice versa.
- Container (R) comprising a liquid and an opening, said container being characterised in that it comprises, at the level of its opening, a liquid taking device (100, 100', 100") according to one of the preceding claims.
- Container (R) according to claim 15, said container comprising a dip tube in connection with the distal end (21d) of the body (26).
- Use of a container (R) according to one of claims 15 or 16, as packaging for a liquid consisting of a sterile pharmaceutical composition.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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SI201730512T SI3554451T1 (en) | 2016-12-16 | 2017-12-15 | Device for collecting a sample of a liquid contained in a container, associated container, and use of this container |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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FR1662671A FR3060305B1 (en) | 2016-12-16 | 2016-12-16 | DEVICE FOR COLLECTING A LIQUID CONTAINED IN A CONTAINER, CONTAINER AND USE THEREOF. |
PCT/EP2017/083162 WO2018109215A1 (en) | 2016-12-16 | 2017-12-15 | Device for collecting a sample of a liquid contained in a container, associated container, and use of this container |
Publications (2)
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EP3554451A1 EP3554451A1 (en) | 2019-10-23 |
EP3554451B1 true EP3554451B1 (en) | 2020-11-11 |
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EP17825480.1A Active EP3554451B1 (en) | 2016-12-16 | 2017-12-15 | Device for collecting a sample of a liquid contained in a container, associated container, and use of this container |
Country Status (10)
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US (1) | US11364175B2 (en) |
EP (1) | EP3554451B1 (en) |
JP (1) | JP7169974B2 (en) |
KR (1) | KR200496877Y1 (en) |
CN (1) | CN110446481B (en) |
AU (1) | AU2017378199B2 (en) |
ES (1) | ES2835298T3 (en) |
FR (1) | FR3060305B1 (en) |
SI (1) | SI3554451T1 (en) |
WO (1) | WO2018109215A1 (en) |
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FR3080368B1 (en) | 2018-04-20 | 2021-04-23 | Virbac | SHOCK PROTECTION DEVICE SUITABLE TO EQUIP A BOTTLE |
EP4076334A1 (en) * | 2019-12-17 | 2022-10-26 | Fresenius Kabi Deutschland GmbH | Connector and connection system for a medical packaging, and method for providing a liquid for a medical packaging |
WO2021129782A1 (en) * | 2019-12-26 | 2021-07-01 | 常熟大吉医用塑料制品有限公司 | Liquid taking device, medicine bottle assembly having the liquid taking device, and liquid taking method |
EP3912709B1 (en) * | 2020-05-19 | 2024-02-14 | Heraeus Medical GmbH | Method and device for mixing liquids |
JP2024518674A (en) * | 2021-03-03 | 2024-05-02 | エクアシールド メディカル リミテッド | Valve arrangement for tamper-resistant luer lock connectors and adapters |
IT202100013283A1 (en) * | 2021-05-21 | 2022-11-21 | Bios Health Diagnostics S R L | CONTAINER LID AND CORRESPONDING INJECTOR FOR FILLING A CONTAINER |
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2016
- 2016-12-16 FR FR1662671A patent/FR3060305B1/en active Active
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2017
- 2017-12-15 ES ES17825480T patent/ES2835298T3/en active Active
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US11364175B2 (en) | 2022-06-21 |
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FR3060305A1 (en) | 2018-06-22 |
FR3060305B1 (en) | 2019-05-24 |
EP3554451A1 (en) | 2019-10-23 |
JP7169974B2 (en) | 2022-11-11 |
ES2835298T3 (en) | 2021-06-22 |
WO2018109215A1 (en) | 2018-06-21 |
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