The present application is a national phase entry of International Application No. PCT/EP2017/083162, filed Dec. 15, 2017, which claims priority to French Application No. 1662671, filed Dec. 16, 2016, the contents of which are incorporated herein by reference in their entirety.
The invention concerns a device for sampling (or transferring) a liquid contained in a container.
It also concerns a container equipped with such a sampling device.
It also concerns the use of this container.
The invention is mainly intended for use in the sampling of a liquid exerting medicinal effects, in particular intended for the treatment of animals.
This type of device allows the sampling of a liquid while ensuring, in addition, a tightness.
For this purpose, a device for sampling a liquid from a container has already been proposed, including 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.
When this passage is closed, the liquid contained in the container cannot escape from it. Any leakage of liquid from the inside to the outside of the container is then prevented and the introduction of any external pollution (e. g. unwanted fluid or dust) into the inside of the container is avoided.
When this passage is open, a sampling of the liquid contained in the container can be carried out.
Such a solution is proposed, for example, in document WO 2012/057843 (D1).
However, this solution is not perfect.
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 the liquid residues coming from inside the container. Also, when the sampling device is opened later, pollutants may enter the interior of the container. Such pollutants can also be introduced into the container when the valve is open.
Also for this purpose, an alternative solution to the use of a valve is the use of an elastic valve, usually made of an elastomer.
This is for example what is proposed in document U.S. Pat. No. 5,425,465 (D2).
The interest of the elastic valve, in relation to a valve, lies mainly in the absence of a passage zone for the liquid contained in the container in contact with the outside.
However, such an elastic valve is subjected to high and frequent stress, so its service life can be impaired, especially compared to that of a valve.
In addition, with this solution, maintaining a tightness in all cases is complicated. Thus, for example, if the container is spilled, the liquid it contains applies pressure to the elastic valve and leaks can then be detected.
There is therefore a need for an improved device for sampling a liquid from an container.
For this purpose, the invention proposes a device for sampling a liquid from a container, characterized in that it includes:
said component being mounted in rotation with respect to the housing about the longitudinal axis of this housing between a closing position in which the distal end of said at least one channel is closed by the housing and an opening position in which the distal end of said at least one channel is capable of establishing a fluid communication with the container; and
The device according to the invention may also include the following characteristics, taken alone or in combination:
The invention also concerns a container including a liquid and an opening, said container being characterized in that it includes, at its opening, a device for sampling a liquid according to the invention.
The container may include a dip tube in connection with the distal end of the body.
Finally, the invention also concerns the use of a container according to the invention, as a packaging for a liquid consisting of a sterile pharmaceutical composition.
The invention shall be described more precisely with reference to the attached figures, given in non-restrictive way.
Generally, the device 100 for sampling a liquid from a container according to the invention includes a housing 10, a component 20 located in the housing 10, an elastic valve 30 and a cap 40 detachably mounted on the housing 10. All these components are represented in the general perspective and sectional view, in
The housing 10 includes 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 cross-sectional view in
Advantageously, the assembly on the container R requires an axial compressive force F less than or equal to 300 N.
In addition, the connection between the sampling device according to the invention and the container R is advantageously non-detachable manually.
The component 20 is mounted in rotation with respect to the housing 10, i.e. with respect to both the first base 11 and second base 12, considering the fixing of the two bases 11, 12 one with respect to the other. This rotation is carried out between a closing position and an opening position. This rotation is carried out around the longitudinal axis AL of the housing 10. In practice, it is then advantageous to provide a rotation, between the closing position and the opening position, of 180° around this longitudinal axis AL.
The component 20 is more accurately represented in
The component 20 includes a body 26 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.
In the closing position (
In the opening position (not shown), the distal end 21d of said at least one channel 21 is able to establish a fluid communication with the container. More precisely, when turning the component 20 about the longitudinal axis AL of the housing 10, from the closing position, for example by 180° C., the distal end 21d of said at least one channel 21 then arrives facing a passage 120 of the second base 12 opening, in this case towards the inside of a container when the device 100 is mounted on such a container R as shown in
The component 20 also includes a receptacle 24 located in the extension of the proximal end 21p of said at least one channel 21. This receptacle 24 is fixed with respect to the body 26, and more precisely mounted fixed on the body 26. For example, to securely mount the receptacle 24 to the body 26, a circumferential groove 260 can be provided, located at the upper wall 26SUP of the body 26, and suitable for receiving, for example by snap-in, a corresponding wall of the receptacle 24.
Another type of assembly between the body 26 and the receptacle 24 can be considered, the essential being that this assembly, removable or not, allows a fixing preventing any relative movement between the body 26 and the receptacle 24.
In this respect, it is therefore possible, as an alternative, and for the receptacle 24 to be fixed with respect to the body 26, to provide that the receptacle 24 and the body 26 are of a single piece. This will not prevent the assembly of the elastic valve 30. Indeed, due to its elasticity, the elastic valve 30 can be accommodated inside the part formed by the receptacle 24 and the body 26, via the opening 240 of the receptacle 24.
Thus, the receptacle 24 allows the elastic valve 30 to be housed 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 in shape complementarity with the inner wall of the receptacle 24. It also leans against the body 26.
This elastic valve 30 is advantageously made of elastomer, for example silicone elastomer.
It has a central orifice 31, a distal end 31d of which is in fluid communication with the proximal end 21d of said at least one channel 21 of the component 20. This fluid communication between the channel 21 and the central orifice 31 is present regardless of the angular position of the component 20 with respect to the housing 10.
The central orifice 31 also includes 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 (e. g. in the shape of an arc or star). When the elastic valve 30 is not stressed by an external action (Luer syringe or other), the slot 34 is closed and a seal is provided between the outside of the component 20 and the inside of the component 20. This is what is shown in
Moreover, when you wish to sample a liquid from a container equipped with a device as shown in
A Luer L is introduced into the component 20, which has the effect (
Then, using the Luer L, the component 20 and elastic valve 30 are rotated, both in engagement with the Luer L. This rotation is done around the longitudinal axis AL of the housing 10. The longitudinal axis AL of the housing 10 then merges with the longitudinal axis of the Luer Las well as with that of the central channel 31 of the elastic valve 30. The component 20 then moves from its closing position to its opening position. In practice, the component 20 and more precisely the wall 261NF of the body 26 then slides against the upper wall 12SUP of the second base 12 of the housing 10. In the opening position, a passage then exists between the internal volume of the container and the Luer L. The liquid contained in the container can then be removed by the Luer L.
Once the liquid sampling from the container is complete, the user turns the Luer L in the opposite direction, always around the longitudinal axis AL of the housing 10, from the opening position to the closing position of the component 20. Once the closing position is reached, the user can remove the Luer L from the component 20. The elastic valve 30, which then no longer undergoes any external action, returns to its original shape, i.e. that of
The device 100 according to the invention provides a double sealing on the liquid sampling path.
The first sealing is carried out by a valve type system, in this case between the component 20 and the second base 20. The second sealing is achieved 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. In addition, the presence of a valve-type system between the container and the elastic valve 30 limits the stress on the latter and limits also the presence of liquid in channels 21 and 31.
In addition, when storing on the reverse side of a container R including 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 is visible, even at high temperature, typically 40° C.
In addition, 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 with respect to the housing 10 is carried out 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 limits the sizes, particularly radial, of the device and is therefore particularly well suited for a container. In addition, with this design, the Luer L can remain in the longitudinal axis of the housing 10, and therefore of the component 20 intended to rotate, without being obstructed by the container R. In addition, the rotation of the Luer L around this longitudinal axis to open or close the component 20 also causes the elastic valve 30 to rotate. This one therefore does not undergo any other stresses than the axial deformation printed by the Luer L.
In use, however, it is necessary to provide a certain torque to open the channel 21 and thus connect a puncture or collection system with the contents of the container. This operation must be easy, while giving the user the feeling of connection. In order to avoid the risk of contamination, the connection with the container is advantageously made once the connection between the sampling device and the Luer L is ensured. Advantageously, the assembly force of the Luer L on the sampling device according to the invention must be less than 27.5 N (during 5 sec) with an insertion torque of less than 0.1 N·m. The channel 21 is then opened once the Luer L link is effective, the opening torque being advantageously lower than 0.35 N·m. The closing channel 21 requires advantageously a torque lower than 0.35 N·m. Advantageously the disassembly force of the Luer L must be less than 27.5 N (during 5 sec) with a torque required to remove the Luer L lower than 0.1 N·m.
The cap 40 has a complementary shape with the housing 10 and more precisely the first base 11, for example to be screwed or unscrewed (elements 110 in
The implementation torque of the cap 40 must be enough to ensure the closure 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. Thus, and advantageously, the closure of the cap 40 is carried out for a torque lower than 1.1 N·m. Similarly, an opening torque on the cap of about 1.1 N·m. can be applied by a normally constituted adult person and advantageously the removal of the cap is achieved for a torque lower than 1.1 N·m.
The cap 40 can advantageously provide at least one tamper indicator 41 of the cap 40 compared to the housing 10. The tamper indicator 41 can take the form of an annular strip connected by frangible bridges (not visible in
Advantageously, the force required to tear the frangible bridges when the cap is first opened must be such that the system can be used by a normally constituted person. For example, for an opening diameter of the container R of 20 mm, the first opening torque of the system C is advantageously lower to 1.2 N·m.
It should be noted that while it is advantageous to provide a cap 40, its presence is not mandatory.
This second embodiment takes the characteristics of the first embodiment. Also, compared to
However, this second embodiment includes additional characteristics.
Indeed, in this second embodiment, the body 26 of the component 20′ is modified and includes a second channel 22 and a housing 27 in which the second channel 22 opens. More precisely, the distal end 22d of the second channel 22 can establish fluid communication with the container and the proximal end 22p of this second channel 22 opens into the housing 27, the latter including an air filter 50 in fluid communication with the outside air.
This allows the pressures to be balanced between the internal volume of the container and the outside, especially when sampling a liquid from the container. Indeed, by sampling a liquid from the container, and in the absence of an air intake on the outside, a vacuum is gradually created which makes it a little more difficult for the user to sample additional liquid. This occurs mainly when the container is rigid.
The air intake prevents this type of problem.
In addition, the air filter 50 filters the air taken from the outside to prevent it from polluting the liquid contained in the container, for example by adding dust or other contaminants that may pollute the contents of the container, such as bacteria.
In addition, it should be noted that the addition of this air intake, incorporating an air filter 50, does not change the size of the sampling 100′ device compared to the first embodiment.
And when the component 20′ is rotated, the air filter 50 which is located in the housing 27 defined in the body 26 of the component 20′ accompanies the rotation movement.
According to a particularly advantageous embodiment, the air filter 50 is hydrophobic. This prevents intake of water in the container, thus protecting the contents from hydration. The air filter 50 can have different porosities and advantageously a porosity that allows the return of sterile air, when the pores (orifices) of the filter have a largest dimension less than or equal to 0.22 μm. In this way the sterility of the composition contained in the container R can be preserved. The air filter 50 can advantageously be hydrophobic and lipophobic (oleophobic). In this case, it limits or prevents the penetration and/or escape of both water and non-polar solvents such as lipids (fats).
This third embodiment takes the characteristics of the second embodiment. Also, compared to
However, it includes additional characteristics.
Indeed, in this third embodiment, the body 26 of the component 20″ is modified and includes a third channel 23 as well as another housing 28 in which the third channel opens. The third channel 23 allows an additional air intake between the outside of the container and the inside of the container through another air filter 51 which is housed in the housing 28.
Advantageously, the proximal end 23p of this third channel 22 opens into the housing 28 including the other air filter 51 and the distal end 23d of this third channel 23, able to establish a fluid communication with the container, opens into the housing 27 of the air filter 50. In this way, the outside air entering through the air filter 51 passes through the third channel 23, then through the second channel 22 before reaching the container. This design avoids the need for a third channel 23 identical to that of the second channel 22 and therefore makes the best use of the space available in the body 26 of the component 20″.
Alternatively, however, a third channel 23 could be provided that is totally independent of the second channel 22.
Also, here, the other air filter 51, because of its insertion into a housing 28 of the component 20″, follows the rotational movement of this component 20″.
This additional air intake improves the speed of pressure balancing when sampling a liquid from the container, in particular for rigid containers, without impacting the overall sizes of the device 100″.
According to a particularly advantageous embodiment, the air filter 51 is hydrophobic. This prevents intake of water in the container, thus protecting the contents from hydration. The air filter 51 can have different porosities and advantageously a porosity that allows the return of sterile air, when the pores (orifices) of the filter have a largest dimension less than or equal to 0.22 μm. In this way the sterility of the composition contained in the container R can be preserved. The other air filter 51 can advantageously be hydrophobic and lipophobic (oleophobic). In this case, it limits or prevents the penetration and/or escape of both water and non-polar solvents such as lipids (fats).
An additional characteristic provided for in the third embodiment concerns the addition of an air intake channel shutter 121 on the housing and more precisely on the second base 12 of this housing 10.
Indeed, the second base 12 has a shutter 121 for the second channel 22. Thus, when the component 20″ is in its closing position (
The use of a shutter 121 provides additional safety when the component 20″ is in its closing position. Indeed, if the container R is spilled, the liquid that cannot enter the closed channel 21 will also not be able to enter the second channel 22.
Another additional characteristic provided for in the third embodiment concerns the addition of 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 as the body 26. This skirt allows, as can be seen in
In addition, the presence of this skirt 25 can allow a user to ensure an opening or closing action of the component 20 manually and directly, i.e. without the use of a syringe of the Luer type or other, by handling the skirt 25 without touching the receptacle 24 or the plug 33. As a result, this actuation can be carried out without the user touching the elements likely to contact the liquid contained in the container. This ensures the cleanliness and/or sterility of the plug 33.
It should be noted that the invention is not limited to the three embodiment represented in the annexed figures.
Indeed, the invention covers other embodiments.
Thus, the skirt 25 of the component 20″ surrounding the housing 24 for the elastic valve 30, discussed with the support of the third embodiment, can be added to the embodiment shown in
Thus, the arrangement of the housing 10 allowing to close simultaneously, on the one hand, the channel 21 of the component 20″, intended for the flow of the liquid contained in the container and, on the other hand, the channel 22 of air intake of the component 20″ by a shutter, as discussed with the support of the third embodiment, can also be provided for a modified embodiment of
Regardless of the embodiment envisaged, an open or closed component status indicator 20, 20′, 20″ can be provided. To do this, it is enough to provide at least one opening O on the first base 11 allowing to see, through this opening, a part of the component 20 with a TV visual indicator of its status.
This is shown in
This provides additional security for the user.
It is advantageous to also provide, on the first base 11, at least one barbican or opening, laterally with respect to the opening O, in order to allow the evacuation of any liquids collected behind the first base 11. Indeed, it has been found that when liquid is trapped behind the first base 11, its evaporation can bring, in contact with the filter(s), residues likely to reduce the effectiveness of the filters for balancing pressures between the inside and outside of the container R. The evacuation of liquids is increased by the presence of barbicans and the risk of filter quality degradation is reduced.
Different materials are possible to make the different elements of the device 100, 100′, 100″ according to the invention.
The first base 11 of the housing 10 can be realized in Acrylonitrile Butadiene Styrene (ABS), polycarbonate (PC) or poly(butylene terephthalate) (PBT). The second base 12 of the housing 10 and the elastic valve 30 can be made of thermoplastic elastomer (TPE), thermoplastic elastomer vulcanized (TPV), thermoplastic elastomer urethane (TPU), silicone, fluorosilicone, chlorobutyl, bromobutyl, nitrile, fluoroelastomer (FKM) or ethylene-propylene-diene monomer (EPDM). Advantageously, these elastomers can be coated with a protective film.
The component 20, 20′, 20″ (i.e. the body 26, receptacle 24 and, if applicable, skirt 25) can be made of poly(butylene terephthalate) (PBT), Polypropylene (PP) or Polyethylene Terephthalate (PET).
The cap 40 can be made in particular of polypropylene (PP).
These materials can be sterilized by conventional means. Advantageously, they can be irradiated or autoclaved.
It should be noted that in the above description, the housing 10 is presented as consisting of two bases 11, 12 mounted one on the other. As part of the invention, the housing 10 could be made of a single piece, a first part fulfilling the function of the first base 11 and a second part fulfilling the function of the second base 12. For example, it is possible to consider using a capsule that is crimped, clipped or screwed onto the opening of the container R. Advantageously, a device 100, 100′, 100″ for sampling a liquid according to the invention is non-dismountable in order to ensure the safety of children with respect to the composition contained in the container R or to ensure that the contents have not been modified.
The invention also concerns a container R having a liquid (solution or suspension) and an opening, said container R including, at its opening, a device 100, 100′, 100″ for sampling a liquid according to the invention. According an embodiment, the container R includes a flexible or rigid dip tube TP in connection with the distal end 21d of the body 26. Advantageously, the dip tube TP has a length corresponding to the height of the container R, which allows the composition contained in the container R to be sampled, with its head at the top. For example, the dip tube TP is shown in
The container R can be a bottle, a flask or a pouch.
The container R can be flexible or rigid. The material in which the container R is made can be glass or plastic (different types of plastics can be considered).
Finally, the invention also concerns the use of a container R including a liquid and provided with an opening and including, at its opening, a device 100, 100′, 100″ for sampling a liquid according to the invention as a packaging for a liquid consisting of a sterile pharmaceutical composition.
The invention also concerns the use, in the context of a curative or preventive therapeutic treatment, of a pharmaceutical composition contained in a container R including said pharmaceutical composition and an opening, said container R including, at its opening, a device 100, 100′, 100″ for sampling a liquid according to the invention. According to a particularly preferred embodiment of the invention, said use takes place in the veterinary field to administer a sterile pharmaceutical composition to an animal.
Number | Date | Country | Kind |
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1662671 | Dec 2016 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2017/083162 | 12/15/2017 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2018/109215 | 6/21/2018 | WO | A |
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Entry |
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Asamura Patent Office, Notice of Reasons for Refusal, Japanese Patent Application No. 2019-532026, dated Aug. 25, 2021. (Year: 2021). |
English Translation of Asamura Patent Office, Notice of Reasons for Refusal, Japanese Patent Application No. 2019-532026, dated Aug. 25, 2021. (Year: 2021). |
International Search Report and Written Opinion for Application No. PCT/EP2017/083162 dated Apr. 3, 2018, 9 pages. |
Number | Date | Country | |
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20200038290 A1 | Feb 2020 | US |