Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/52—Containers specially adapted for storing or dispensing a reagent
  • B01L3/523—Containers specially adapted for storing or dispensing a reagent with means for closing or opening
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/02—Adapting objects or devices to another
  • B01L2200/023—Adapting objects or devices to another adapted for different sizes of tubes, tips or container
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/06—Fluid handling related problems
  • B01L2200/0689—Sealing
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/14—Process control and prevention of errors
  • B01L2200/141—Preventing contamination, tampering
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/16—Reagents, handling or storing thereof
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/04—Closures and closing means
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/04—Closures and closing means
  • B01L2300/041—Connecting closures to device or container
  • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/04—Closures and closing means
  • B01L2300/046—Function or devices integrated in the closure
  • B01L2300/049—Valves integrated in closure
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/12—Specific details about materials
  • B01L2300/123—Flexible; Elastomeric
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/16—Surface properties and coatings
  • B01L2300/168—Specific optical properties, e.g. reflective coatings
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/06—Valves, specific forms thereof
  • B01L2400/0605—Valves, specific forms thereof check valves
  • B01L2400/0611—Valves, specific forms thereof check valves duck bill valves
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/06—Valves, specific forms thereof
  • B01L2400/0633—Valves, specific forms thereof with moving parts
  • B01L2400/0638—Valves, specific forms thereof with moving parts membrane valves, flap valves

Definitions

• Reagent storage container including improved sealing sample passage
• the present invention falls within the technical field of containers which can be used for the storage and / or for the transport of reagents, in particular liquids, for example for the analysis of biological samples.
• the invention applies for example to a container with deformable flexible walls, for example to a container of the infusion bag type.
• the container guarantees the seal between a reagent contained in the container and the external environment, including during the insertion and extraction of a reagent sampling device.
• the reagents In the context of the transport and storage of volumes of reagents, used to carry out automated physiological measurements within the framework of the diagnosis of pathologies, the reagents must not be contaminated by the ambient air. It is therefore necessary to minimize the contact surfaces between the interior of the receptacles containing the reagents and the external environment.
• Many diagnostic devices have rigid containers with a top opening supposed to provide a seal for a liquid reagent contained therein.
• the top opening has a pre-drilled or pre-slit membrane. In the absence of a sampling device (such as a pipette), the slit remains closed, which guarantees the seal for the reagent.
• the length of the slit is necessarily greater than the outside diameter of the pipette, otherwise the pipette cannot be correctly inserted. While the pipette is inserted, the sides of the slit therefore provide space and air can flow from one side of the pre-pierced membrane to the other.
• the reagent is highly susceptible to contamination from ambient air when stored or transported in a rigid container.
• certain rigid containers of the state of the art comprise a pierceable film, which hermetically seals the container before the first sampling, and which can be pierced on the passage of a pipette.
• the film is for example made of thin metal foil.
• the piercing of the film is not reversible and the periphery of the orifice made in the film after insertion of the pipette is not stuck to the pipette. Thus, the seal is not guaranteed either during the first sample, or for subsequent samples.
• the desired container must be compatible with conventional sampling devices such as pipettes.
• sampling devices such as pipettes.
• the parts ensuring the seal must not require too great a penetrating force, nor specific shapes of the sampling device, to be passed through by the sampling device.
• the desired container is preferably simple and inexpensive to manufacture.
• a first object of the invention is a container for the storage of a reagent, the container comprising a reagent storage space and a passage having a first end opening out to the outside of the container and a second end opening. in the storage space, the passage being adapted to allow access to the storage space by a sampling device,
• the container comprising a deformable partition which closes the passage when said partition is not mechanically stressed, and which can be biased by the sampling device towards a position where the passage is open, said container being characterized in that it comprises in besides a seal arranged in the passage, said seal being adapted to ensure a seal with the walls external parts of the sampling device when said device is introduced into the passage.
• the reagent container of the invention thus comprises a passage allowing the insertion of a sampling device (for example a pipette) during a reagent sampling.
• the passage comprises, on one end, a deformable partition which constitutes a first level of sealing, preventing the entry of air from the external environment into the reagent storage space in the absence of a sampling device in the passage, both before and after collection.
• Said passage further comprises a seal.
• the walls of the sampling device cooperate with the seal so that the latter provides a seal with the external walls of the sampling device.
• the seal constitutes a second level of sealing, preventing the exchange of fluid between the external environment and the space containing the reagent while a sampling device is inserted in the passage.
• the container of the invention has several advantages.
• the combination of the two sealing levels - the deformable partition and the gasket, both arranged on the passage of the sampling device - protects the reagent from any contamination by the external environment, whether before, during or after a sampling.
• the gasket used to achieve the seal during sampling can be sized to deform under the effect of a small penetrating force exerted by the sampling device. It is not necessary to provide a specific sampling device which is compatible with this container. A standard pipette, the outer walls of which have an appropriate diameter in view of the dimensions of the seal, is suitable for sampling.
• the sampling passage of the container of the invention has a simple mechanical structure. The gasket and the deformable partition can optionally be removed and replaced independently of one another.
• the container defined above may also have, in an optional and non-limiting manner, the following characteristics, taken alone or in any one of the technically possible combinations:
• the container storage space comprises a flexible pocket.
• An advantage of this additional feature is that at least one wall of the flexible bag is able to retract during a reagent withdrawal to compensate for a drop in pressure and / or a reduction in the volume of liquid in the storage space. . Thus, it is not necessary to resort to a vent with potentially contaminated air.
• the flexible bag can be deformed to adapt to the pressure variations inside the storage space, which is particularly interesting in combination with the deformable partition and the elastically deformable seal as defined above. Indeed, this partition and this seal maintain the seal between the interior of the storage space and the outside environment, both during a sample and between samples.
• the seal comprises an elastically deformable rim defining an orifice adapted to receive a part of the sampling device, said rim being adapted to ensure a seal with the external walls of the sampling device when said device is introduced into the passage, the elastically deformable rim is configured so that the orifice remains open in the absence of a sampling device in the passage.
• the elastically deformable rim is configured so that the orifice is circular in the absence of a sampling device in the passage.
• the elastically deformable rim is configured so that the orifice has a diameter of between 0.5 millimeters and 5 millimeters, in the absence of a sampling device in the passage.
• the elastically deformable rim has an internal perimeter, said rim being configured to adhere to the external walls of the sampling device along the entire internal perimeter.
• the elastically deformable rim is configured to expand in a reversible manner by tilting in the direction of the reagent storage space, on insertion of the sampling device.
• the seal has a truncated cone body.
• the truncated cone body ends with the elastically deformable rim.
• the seal comprises an outer annular edge and comprises an inner portion located radially between the outer annular edge and the elastically deformable rim
• the deformable partition comprises a pre-split membrane comprising a slot.
• the deformable partition is adapted to deform and open the passage under the effect of a penetrating force of the sampling device of between 0.1 and 10 Newton, preferably between 1 and 3 Newton.
• the container comprises a chimney through which the passage passes, said chimney being integral with the storage space.
• the enlarged head has a plurality of ridges onto which the flexible pouch is welded.
• the chimney comprises a cap inside which an internal cavity extends, the deformable partition and the seal being arranged in the internal cavity.
• the partition has an outer annular edge of the partition and the cap has a shoulder at an inner edge of the internal cavity, the shoulder being complementary to the outer annular edge of the partition.
• a second object of the invention is an assembly for storing and withdrawing a reagent, comprising a container for storing a reagent as defined above, and comprising a collecting device, preferably a pipette, configured to be inserted at least in part into the passage of the container via the first end, and configured to deform the seal so as to ensure a seal with the external walls of the sampling device.
• the storage and sampling assembly defined above has the following characteristics taken alone or in any of the technically possible combinations:
• the seal has an elastically deformable rim which is configured to seal with the outer walls of the sampling device.
• the elastically deformable rim defines an orifice suitable for receiving part of the sampling device.
• the orifice has, at rest, a surface strictly less than a cross-sectional area of the sampling device, preferably an area less than 99% of said cross-sectional area.
• Figure 1a is a view of a reagent storage and transport container according to an exemplary embodiment of the invention, on which a chimney is seen separately from a flexible bag of the storage space.
• Figure 1b is an exploded view of the chimney of the container of Figure 1a, in which a cap and the elements it contains are shown in isolation.
• Figure 2 is a longitudinal sectional view of the lower end of the chimney of Figures 1 a and 1 b while the cap is fixed to this lower end.
• Figure 3 is a bottom perspective view of a cap of the container of Figures 1a and 1b.
• Figure 4a is a perspective view from above of a deformable partition of the container of Figures 1a and 1b.
• Figure 4b is a top view of a deformable partition according to a first variant, in a closed position.
• Figure 4c is a top view of a deformable partition according to a first variant, in an open position.
• Figure 4d is a top view of a deformable partition according to a second variant, in a closed position.
• Figure 4e is a top view of a deformable partition according to a third variant, in a closed position.
• Figure 5a is a perspective view from below of a deformable seal of the container of Figures 1a and 1b.
• Figure 5b is a side view of the seal of Figure 4a in an unstressed position.
• Figure 5c is a side view of the seal of Figure 4a in a deformed position.
• Figure 6 is a longitudinal sectional view of an assembly comprising a deformable partition and a deformable seal according to a second exemplary embodiment. Said gasket and partition can be mounted in a cap according to Figure 3.
• Figure 7a schematically shows a reagent container and a collection device at the start of insertion of the collection device.
• Figure 7b shows schematically said container and sampling device at a later stage of insertion of the sampling device.
• Figure 7c schematically shows said container and sampling device at the end of the insertion of the sampling device.
• container described below relate to a container comprising a flexible bag of the “infusion bag” type suitable for the storage and transport of a reagent, in particular a liquid reagent.
• the invention can be applied for the storage of a reagent in a container the walls of which are rigid.
• FIGS 1a and 1b illustrate a reagent storage container according to an exemplary embodiment.
• This container comprises a reagent storage space suitable for receiving a volume of reagent, for example in the liquid state, less than a predetermined volume.
• the storage space is formed by a flexible pouch 10.
• flexible is meant that at least one wall of the pouch, and advantageously all the walls of the pouch, are flexible and can be deformed. under the effect of a reagent suction inside the bag.
• the flexible bag 10 comprises flexible walls 11 between which extends a storage space. The storage space makes it possible to receive, store and transport a reagent, for example in the liquid state.
• a flexible bag for example of the infusion bag type, is particularly advantageous because it makes it possible to avoid an excessive drop in pressure within the container during a reagent sample, without it being necessary to resort to the introduction of potentially contaminating outside air.
• the walls of the flexible bag can be deformed to compensate for the drop in pressure inside the bag when withdrawing reagent (in particular liquid reagent).
• the atmosphere of the medium external to the container is preferably controlled.
• the term “controlled atmosphere” conditions will be understood to mean either an absence of air in the reagent storage space, or the presence in this space of a volume of air the quality of which is assumed to be satisfactory.
• the objective is to maintain the conditions of a controlled atmosphere, avoiding the introduction of air from another medium which could contaminate the reagent. Thanks to the seal between the reagent and the external environment guaranteed by the container of Figures 1 to 5, a user of the container filled with reagent is not required to maintain a sterile ambient medium in the room where the container is stored.
• the flexible pocket 10 comprises a central space formed between two flexible walls 11 extending one opposite the other upwardly from a bottom wall 12.
• the bottom wall 12 is preferably also flexible.
• the bottom wall 12 is preferably rounded or conical, in order to create a liquid collection basin at the bottom of the flexible bag. This reduces the “dead volume” of the container, that is to say the volume of reagent which can hardly be removed.
• the bottom wall may have a planar shape to allow the container to be placed in a vertical position on a flat surface.
• the flexible pouch 10 can be produced in a so-called “vertical” or “doypack” form by means of particular folding and welding techniques (for example in a manner similar to that disclosed in document US Pat. No. 4,837,849. ) so that a preferably rounded bottom wall 12 is obtained to create a liquid collection bowl and simultaneously allow the container to be placed in a vertical position on a flat surface.
• the flexible pocket 10 comprises, on both sides of the central space, junction portions 13.
• the flexible walls 11 providing the central space are glued together at the level of the junction portions 13, preferably along the entire length. of central space.
• the flexible walls 11 are not joined together, so that the flexible walls 11 provide an upper opening 14.
• the flexible pouch 10 is preferably made of polymer, for example of polyethylene or of polypropylene. These materials have the advantage of being chemically compatible with the majority of chemical compositions that the container can be made to contain as reagents. In addition, these materials have the advantage of being easy to heat seal, which allows forming a flexible pouch 10 by heat welding along the junction portions 13, and attaching the flexible pouch to the vertical walls 91 of the head 9 or to the chimney walls 31 by heat welding.
• the container has at least one outer surface which is at least partly covered with a protective film comprising a material suitable for filtering electromagnetic radiation harmful to the liquid reagent (for example ultraviolet radiation), and / or to reduce the porosity of the exterior gas surface.
• a protective film comprising a material suitable for filtering electromagnetic radiation harmful to the liquid reagent (for example ultraviolet radiation), and / or to reduce the porosity of the exterior gas surface.
• the outer surfaces of the two flexible walls 11 forming the central space of the flexible pouch 10 are covered with such a film.
• An aluminum film is for example used to cover the walls.
• the protective film can have an additional role of improving the mechanical performance of the walls of the pocket.
• the flexible pouch is made of a multilayer laminate film comprising different materials which should contribute to different properties.
• the inner layer facing the reagent is preferably made of a polyethylene or polypropylene film having the advantages of being chemically compatible with the majority of the reagents and being able to be heat sealed.
• the thickness of this inner polymer layer is preferably between 20 and 200 micrometers, more preferably between 50 and 150 micrometers.
• the laminate is composed of at least one layer made of a different polymer from that of the inner layer.
• This layer plays a role in improving the mechanical performance of the walls of the pocket.
• This layer is preferably chosen from a polymer material having a mechanical strength and a higher melting point than those of the polymer of the inner layer. Examples of such polymeric materials are polyethylene terephthalate (PET) or polyamide (PA).
• PET polyethylene terephthalate
• PA polyamide
• the thickness of this at least one polymer layer is preferably between 5 and 100 micrometers, more preferably between 10 and 25 micrometers.
• the laminate film may optionally contain an additional layer made of a protective material to block electromagnetic radiation (such as light) and / or reduce gas permeability.
• the protective material can be chosen, for example, from aluminum, aluminum oxide, silicon oxide or another barrier material known from the state of the art.
• the protective material can be incorporated into the laminate either in the form of a self-supporting film (e.g. by coextrusion or adhesive lamination) or in the form of a very thin coating applied to one of the polymer layers (e.g. by vapor phase coating, liquid phase coating, electrochemical coating, etc.).
• the thickness of such a coating or protective film layer can therefore range from a value less than one micrometer up to 100 micrometers, preferably less than 50 micrometers, more preferably less than 20 micrometers.
• the use of thin coatings and thin films of polymer is advantageous in reducing the stiffness of the flexible pouch 10. Low stiffness and high flexibility are important in order to facilitate its ability to retract when the reagent is withdrawn and under pressure. inside the
• said film is preferable to arrange said film on the outer surfaces so as to prevent contact between the particles of said film and the reagent contained in the container.
• contact surfaces between the flexible bag and the reagent should be used which prevent the dissemination of particles of the wall material within the reagent.
• the storage space could only comprise rigid walls and not be deformable under the effect of a drop in pressure.
• the container further comprises a sampling passage 3, having a first end 4 opening out to the outside of the container as well as a second end opening into the storage space.
• passage 3 opens into the flexible pocket via the second end.
• the passage 3 is schematically illustrated in dotted lines in the exploded view of FIG. 1b.
• the passage 3 is, in the present example, made inside a cylindrical chimney 2 which is attached to the flexible bag.
• the passage 3 is adapted to allow a sampling device (not shown in Figures 1a and 1b) inserted in the passage to access the space storage.
• a sampling device not shown in Figures 1a and 1b
• the passage is made in a chimney 2 which will be described below, the chimney 2 being integral with the flexible bag 10.
• the container has a deformable partition 7.
• the partition 7 closes the passage 3 at rest, when it is not mechanically stressed.
• the partition is here arranged inside the tubular inner wall which forms the sampling passage. The partition can be urged by a sampling device towards an opening position of the passage.
• the partition 7 ensures a hermetic closure of the storage space. Fluid communication between the reagent storage space and the external environment via passage 3 is prevented when the passage is not crossed by a sampling device - for example, when the container is awaiting collection.
• the container further comprises a seal 6 disposed in the passage.
• the seal 6 ensures the seal between the outer walls of the sampling device and the walls of the passage (here the tubular inner wall of the chimney) when a sampling device is inserted into the sampling passage, typically during a reagent sampling. .
• the seal prevents accidental communication of fluid (eg air) between the storage space and the exterior of the container during collection.
• fluid eg air
• only the volume of reagent taken by the sampling device is able to circulate between the interior of the storage space and the exterior of the container.
• the reagent thus remains stored under controlled atmosphere conditions.
• the performance of the reagents is thus preserved during their storage in the container, whatever the environmental conditions: quality of the ambient air in the laboratory, presence of contaminants in the environment outside the container, etc.
• the container described in relation to Figures 1 to 5 can therefore be used for the storage and transport of a wide variety of reagents, even with reagents which are very sensitive to interactions with the external environment. Waterproof chimney
• the gasket 6 ensuring the seal during sampling is positioned above the partition 7 ensuring the seal in the absence of sampling.
• the gasket and the partition are positioned on the lower end of the cylindrical chimney 2.
• the upper part of the chimney 2 is fixed to an upper portion of the flexible walls 11 of the pocket 10.
• the partition 7 can be positioned above the seal 6 within the passage.
• the seal 6 and the partition 7 can be placed at any longitudinal position between the first end 4 and the storage space.
• the chimney 2 is thus integral with the storage space and in particular with the flexible pocket 10.
• the chimney 2 On a lower part, the chimney 2 comprises an inner side wall 30 and an outer side wall 31 concentric extending parallel to the direction D.
• the sampling passage 3 is delimited by the inner side wall 30.
• the two walls 30 and 31 are waterproof.
• the internal side walls 30 of the chimney are inclined with respect to the direction D so that the internal diameter of the sampling passage 3 is reduced towards the lower part of the chimney approaching the position of the seal 6.
• This has the advantage of guiding the sampling device 20 (for example a pipette) towards the center of the sampling passage 3 during insertion into the chimney and of aligning the center of the sampling device with the center of the orifice 61 of the seal 6. This prevents damage to the seal 6 during the insertion of the sampling device 20 due to imprecise positioning and alignment between the sampling device 20 and the reagent container 10.
• guide structures such as corners or ledges narrowing the open space towards the lower part of the chimney. may be included on the interior side walls 30 of the chimney to achieve an equivalent alignment, or "funnel" effect, between the orifice 61 and the inserted sampling device.
• the upper part of the chimney 2 is fixed to the storage space at the level of an enlarged head 9 of the chimney.
• the head 9 is widened along a surface 90 substantially perpendicular to the direction D of extension of the passage 3 for sampling.
• the head 9 is enlarged relative to the outer side wall 31 of the chimney in all directions of the surface 90.
• the head 9 further comprises four walls 91 extending from the surface 90 towards the lower end of the chimney.
• the ratio between the longitudinal extension of the walls 91 in direction D and the total longitudinal extension of the chimney 2 is low here. This ratio is for example between 10% and 30%.
• the walls 91 form, for example, seen from below, a diamond shape.
• the enlarged head 9 comprises a plurality of ridges 92 for welding the walls of the flexible pouch.
• the striations 92 are here three in number and are hollowed out from the outside in the four walls 91 of the head 9.
• the material of the walls of the flexible bag partially engages in the ridges during the welding.
• the ridges improve the mechanical cohesion and the seal between the chimney 2 and the flexible bag 10 and guarantee the mechanical integrity of the container 1.
• the welding is carried out at the level of the walls 91, which are for example made of high density polyethylene or
• HDPE low density polyethylene
• LDPE low density polyethylene
• PP polypropylene
• the flexible pouch can also be welded directly to the outer surface of the chimney 31, just below the head surface 90. This has the advantage of requiring only a narrow top opening 14, which facilitates retraction and removal. sagging of the flexible bag 10 when the reagent is withdrawn.
• the surface 90 comprises a closing orifice 93 at the level of the upper end 4 of the passage 3.
• the orifice 93 can be blocked. during the manufacture of the container, then opened during sampling.
• the orifice 93 is for example blocked by a thin tear film.
• the tear-off film is made of a waterproof material, preferably metallic. The film is pierced by the insertion of a sampling device, or else removed manually by a user before sampling.
• the enlarged head 9 may include a removable plug for closing the upper end of the passage 3.
• the removable plug may comprise a cover mounted on a hinge.
• the head 9 further comprises a micro-orifice 94 for transferring the reagent into the storage space, during the manufacture of the container containing the reagent.
• This micro-orifice makes it possible not to stress the chimney with the seal 6 and the partition 7 from manufacture, so as not to damage these elements.
• the micro-orifice 94 can be plugged after this filling, by gluing a film or by welding or gluing a post.
• the chimney 2 through which the sampling passage 3 passes thus forms a sealed sampling interface, attached to the flexible bag 10 via the upper opening 14 during the manufacture of the container 1.
• FIG. 2 The lower end of the chimney 2 is illustrated in FIG. 2.
• the seal 6 and the partition 7 are shown here at rest, in the absence of stress from a sampling device. Passage 3 does not contain a sampling device in this figure.
• the gasket 6 and the partition 7 are fixed to the lower end of the chimney by a cap 8.
• the cap 8 has an upper edge 81 suitable for engaging in a groove 25 made at the lower end of the chimney. the chimney, in the outer side wall 31 of the chimney. Preferably, the groove is made over the entire circumference of the outer side wall 31.
• the cap 8 is generally hollow cylindrical in shape. On the upper part of the cap delimited by the upper edge 81, the thickness of the cap is small. On a middle part of the cap, the thickness of the cap is greater.
• the inner walls of the cap thus define a first cavity part having a diameter D1 and a second cavity part which is concentric with the first part.
• the second cavity part has a diameter D2 which is smaller than the diameter D1 of the first cavity part.
• the two cavity parts together form an internal cavity 80 in which the gasket 6 and the partition 7 are arranged, the latter being secured to the chimney 2.
• the cap 8 comprises, at the interface between the upper part of the cap and the middle part of the cap, an inner edge which defines a shoulder 82.
• This shoulder 82 is advantageous because it allows an outer annular edge 72 of the partition 7 to be held in position against the walls of the cap 8.
• the shape of the shoulder 82 is here complementary to the shape of the outer annular edge.
• the outer diameter of the outer annular edge 72 is equal to the diameter D1 and the partition 7 comprises a cylindrical portion 73 which extends downward from the outer annular edge 72, the cylindrical portion 73 having an outer diameter equal to diameter D2.
• the seal 6 here also has an outer annular edge 62, the diameter of which is equal to the diameter D1.
• the seal 6 can be held in position against the partition 7, while the latter is itself held in position against the shoulder 82 of the cap.
• the seal 6 and the partition 7 could be separated by a spacer. It is then necessary to ensure the sealing of the contact between the spacer and each of these two elements.
• annular edges 62 and 72 have an outer diameter greater than the diameter of the inner side wall 30 of the chimney, it is possible to maintain the seal 6 and the partition 7 on the sampling passage 3.
• An additional advantage of the cap 8 is to improve the seal between the walls of the chimney 2 on the one hand and the gasket 6 and the partition 7 on the other hand thanks to the compressive force exerted by the cap, while protecting laterally the sampling device during its insertion and its extraction.
• the cap 8 serves as a skirt to prevent the deformable walls of the flexible pouch 10 from retracting until they are very close to or in contact with the lower end of the chimney 2, when the pressure within the flexible bag drops when withdrawing the reagent.
• the lower edge of the cap 8 blocks the walls of the flexible bag and provides a reagent sampling chamber.
• the cap 8 has, on a lower part, a plurality of slits 83.
• the slits 83 extend vertically and have a herringbone shape distributed regularly around the perimeter of the cap.
• the slits 83 pass through the thickness of the cap, so that the internal cavity is accessible through the slits 83 from the outside.
• the chimney 2 is configured so that a lower end 21 of a sampling device 20 (such as a pipette) inserted in the passage 3 reaches the internal cavity of the cap during a reagent sampling.
• the internal cavity delimits the sampling chamber.
• An advantage of the slots 83 is to put the internal cavity in direct communication with the reagent storage space. If the reagent is in the liquid state and if the liquid level exceeds the level of the cap 8, the renewal of the reagent within the sampling chamber is facilitated by the slots 83.
• slots 83 Another advantage of the slots 83 is that they avoid the trapping of air and air bubbles in the cavity space under the partition 7, which could cause inaccurate withdrawal of reagent.
• the container 1 comprises a deformable partition 7.
• the partition 7 is configured to deform and allow access to a reagent contained in the storage space by a sampling device, under the effect of a low penetrating force.
• the penetration force necessary for opening the partition is preferably between 0.1 and 10 Newton, and even more preferably between 1 and 3 Newton.
• the container comprising the partition is thus compatible with a wide range of sampling devices.
• the partition 7 can be urged towards an open position by a simple pipette.
• an elastic membrane not pre-pierced - such as that used in certain blood collection tubes - in place of the partition 7 would require a significant penetrating force to allow the opening, which would restrict the scope of the sampling devices that can be used.
• FIG. 4a to 4c a partition 7 according to a first variant corresponding to the partition of Figure 2.
• This partition comprises a pre-split membrane.
• the partition 7 has the general shape of a hat. It comprises the outer annular edge 72 and the cylindrical portion 73.
• the portion 73 has the shape of a hollow cylinder, the face located on the side of the annular edge 72 being open and the opposite face being closed by the pre-slit membrane 70.
• the pre-slit waterproof membrane 70 comprises at its center a slot 71 which can be opened by a sampling device.
• This type of partition is easy to install and does not require expensive materials.
• the septum 7 may be molded directly onto the inner side walls of the cap 8 by a two-component injection molding process for making a single molded part comprising the cap 8 with the septum 7 integrated. This further facilitates assembly with the corresponding chimney 2.
• the pre-slit membrane 70 has the shape of a slightly rounded dome.
• the slot 71 is easy to open by a sampling device and requires a low penetrating force.
• the membrane 70 may have a shape of the “duckbill” or “duckbill” type according to English terminology.
• the duckbill shape of the membrane also requires a low penetrating force, while ensuring that the elastic deformation of the membrane 70 is responsive.
• “reactive” is meant that the time between a withdrawal of the sampling device and an elastic return of the membrane 70 to its form at rest is short. Still alternatively, the membrane 70 can be planar.
• the membrane is configured to allow the formation of an opening of minimum diameter greater than an outside diameter of the walls of a sampling device.
• the material of the membrane 70 is chosen to allow reversible elastic deformation of the membrane.
• the membrane is preferably made of a polymer, for example an elastomer. Possible materials, taken alone or in combination, are silicone, EPDM (for ethylene-propylene-diene monomer) or a fluoropolymer, a thermoplastic elastomer (TPE), or a thermoplastic polyurethane elastomer (TPU).
• the material of the membrane 70 is hydrophobic, in the case of aqueous reagents (generally not very wettable by the reagent medium). This limits wetting of the walls of the membrane 70 and creates capillary pressure to further prevent the passage of liquid through the slit 71, in the case of an open position during insertion, reagent aspiration, and retraction. a sampling device.
• FIG. 4d illustrates a second variant of a partition 7.
• the membrane 70 is crossed by two substantially perpendicular slits 71 ′, drawing the shape of a cross on the membrane.
• a sampling device can pass through the center of the cross.
• Figure 4e illustrates a third variant of a partition 7.
• the cross shape of the second variant is here replaced by a star shape formed of five slots. Two consecutive slits form an angle of approximately 35 ° between them.
• An advantage of this form is that the penetrating force required for a sampling device to spread the membrane and open the passage is lower.
• Another number of slots can be chosen as a function of the desired compromise between the penetrating force required for the insertion of the sampling device and performance in terms of sealing.
• the partition 7 allows a good seal before and after a sample. However, during a collection, that is, while a collection device is inserted into the container and passes through the collection passage, there is a fluid communication space between the outer walls of the collection device and them. edges of the slot 71 of the deformable partition 7. Fluids, and in particular air, can enter the storage space from the external environment and contaminate the reagent.
• the container 1 further comprises a deformable seal
• the seal 6 is disposed on the sampling passage 3.
• a function of the seal 6 is to conform to the circumference of the outer walls of a sampling device inserted in the sampling passage 3, so as to ensure a direct seal with the. sampling device 20 during the sampling phases.
• Figures 5a to 5c are close-up views of the example of seal 6 used in the container shown in Figure 2.
• Figures 5a and 5b correspond to the rest position of seal 6, while Figure 5c corresponds to a deformed position .
• the seal 6 has, at rest, a central orifice 61 visible in Figures 5a to 5c.
• the orifice 61 remains open in the absence of a sampling device in the sampling passage 3. Indeed, thanks to the partition 7, the sampling passage 3 remains blocked in the absence of a sampling device.
• the seal 6 has the general shape of a cap and comprises an external annular edge 62 which extends into a body 63 in a truncated cone inclined towards the inside of the annular edge.
• the body 63 is hollow and ends inwardly with an elastically deformable rim 64.
• the elastically deformable rim 64 defines the central orifice 61.
• the elastically deformable rim 64 can conform to the outer walls of the sampling device 20, when the latter is engaged in the sampling passage 3.
• the elastically deformable rim 64 is provided to adhere to the outer walls of the sampling device 20, along an entire inner perimeter of the elastically deformable rim 64.
• the entire perimeter of the elastically deformable rim 64 is pressed against the outer walls of the sampling device 20 and sticks to said walls, which prevents an entry or exit of air through passage 3.
• the central orifice 61 is chosen so as to present, at rest, a surface strictly less than a sectional surface of a sampling device used with the container.
• the area of the orifice 61 is preferably less than 99% of said sectional area of the sampling device, even more preferably less than 95%.
• the orifice 61 is of substantially circular shape.
• the orifice 61 is here delimited by the inside of the rim 64.
• the central orifice 61 preferably has a diameter OD of between 0.5 and 5 millimeters at rest. .
• the deformability of the rim 64 is, for example, obtained by a localized thinning of the walls of the body 63 in the vicinity of the orifice 61.
• the body 63 extends downward (i.e. towards the partition 7, when the seal 6 and the partition 7 are engaged together) by thinning inwards, that is to say by thinning up to the rim 64.
• the thickness at the level of the rim 64 in a normal direction is, for example, at least 2 times less than 1 'thickness at the level of the outer annular edge 62 in a normal direction, and preferably at least 3 times less.
• the flange 64 thus forms, in the example of Figure 5a, a second truncated cone concentric with the body 63 in the form of a truncated cone.
• the walls of the rim 64 are shown in Figure 5c in a position deformed by a sampling device (the latter not being illustrated in the figure).
• a penetrating force is exerted from top to bottom on the rim 64, said rim reversibly enlarges by tilting towards the storage space of the container, ie downward here.
• the orifice reversibly deforms to allow passage of the sampling device 20, while ensuring continuous contact with the walls of the latter.
• the rim 64 therefore functions as an O-ring.
• the central orifice 61 reversibly enlarges as the walls of the sampling device pass during its insertion.
• a sampling device is used, the outer walls of which have an outer diameter greater than the diameter OD of the orifice 61 of the seal 6 at rest.
• the rim 64 is elastically deformed and moves away.
• a sealing lip is thus created by the seal 6 over the entire circumference of the outer walls of the sampling device.
• the seal 6 thus constitutes a second level of sealing which completes the first level formed by the deformable partition 7.
• the seal 6 prevents the exchange of fluid between the external medium and the space containing the reagent, even when the partition 7 is open. , especially during a sample.
• the walls of the container comprise a flexible pocket 10, formed by the flexible walls 11 between which the space of storage.
• the flexible bag 10 can be adapted to variations in pressure inside the storage space as the samples are taken. It is therefore not necessary to “vent” the interior volume of the storage space.
• the rim 64 is preferably made of a polymer, for example an elastomer. Possible rim materials, taken alone or in combination, are silicone, EPDM (for ethylene-propylene-diene monomer) or a fluoro-polymer, a thermoplastic elastomer (TPE), or a thermoplastic polyurethane elastomer (TPU) .
• a polymer for example an elastomer.
• Possible rim materials taken alone or in combination, are silicone, EPDM (for ethylene-propylene-diene monomer) or a fluoro-polymer, a thermoplastic elastomer (TPE), or a thermoplastic polyurethane elastomer (TPU) .
• the partition 7 comprises a pre-slit membrane with a slot 71
• the latter has a length LF greater than the diameter DO of the orifice 61 of the seal 6 at rest. This configuration allows the insertion of the sampling device through the seal 6 and the partition 7 simultaneously, while allowing good adhesion of the walls of the orifice 61 against the walls of the sampling device.
• the gasket 6 can be directly attached and molded onto the lower end of the chimney 2 by a two-component injection molding process so that a single molded part is made including the chimney 2 and the gasket. 6. This further facilitates insertion and assembly with the corresponding cap 8.
• FIG. 6 There is shown in Figure 6 a deformable partition 7 and a deformable seal 6 according to an alternative example, mounted together.
• the sectional view of Figure 6 corresponds, for example, to an insertion position of the gasket 6 and the partition 7 in the cap 8.
• the general function of the seal 6 and of the partition 7 is unchanged.
• the partition 7 guarantees the seal between the inside of the container and the outside environment, before and after sampling.
• the seal 6 conforms to the circumference of the outer walls of a sampling device inserted in the passage 3 of sampling, so as to ensure a direct seal with the sampling device 20, during the sampling phases.
• the seal 6 has, here again, a deformable central orifice 61, adapted to open in a reversible manner.
• the orifice 61 ’ is defined by an elastically deformable flange 64’.
• the rim 64 ′ reversibly enlarges by tilting towards the storage space (that is to say here in the direction of the partition 7) when a sampling device 20 is inserted.
• the seal 6 has an outer annular edge 62 ', intended to be positioned against the inner walls of the cap 8 or against the inner walls of a sampling passage.
• the seal 6 has a bead 621 on the radially inner side opposite the outer annular edge 62 '.
• the gasket 6 has an extra thickness at the level of the bead 621.
• the seal 6 according to the variant of Figure 6 comprises a body 63 ′ in the form of a truncated cone, terminating in the elastically deformable rim 64 ′.
• the body 63 'in a truncated cone extends downwards (that is to say towards the partition 7, when the seal 6 and the partition 7 are engaged together) from the bead 621, that is to say say in the direction of the partition 7 when the gasket 6 and the partition 7 are engaged together.
• the body 63 has a complementary edge 631 with an interior edge of the partition 7.
• the edge 631 tilts less rapidly inward as one approaches the storage space, compared to the inclination. of the body 62 in the form of a truncated cone of the seal illustrated in Figures 5a to 5c.
• the 631 edge ends in a 65 ’rounded corner.
• the angle formed by the rounded corner 65 ", between the edge 631 and the surfaces of the flange 64" is close to a right angle. Said angle is for example between 90 ° and 120 °.
• the rounded corner 65 ′ is complementary with a shoulder formed on the inside of the partition 7.
• the central orifice 61 ′ reversibly enlarges as the external walls of the sampling device pass.
• the rim 64 ’ is, again, configured to adhere to the outer walls of the sampling device 20 along an entire interior perimeter of the rim 64’.
• the partition 7 is, like the example of partition described above, configured to deform and allow access by the sampling device 20 to a reagent contained in the storage space. , under the effect of a weak penetrating force.
• the penetrating force necessary for opening the partition 7 is preferably between 0.1 and 10 Newton, and even more preferably between 1 and 3 Newton.
• the partition 7 comprises a pre-slit membrane, having a slot 71 provided to open to the passage of the sampling device 20.
• the partition 7 has the general shape of a staircase.
• the partition 7 thus has an upper portion of large diameter, close to the diameter of the outer annular edge 62 ′ of the seal 6, and has a lower portion comprising the pre-slit membrane (by lower portion is meant the portion directed towards the partition 7 , when the gasket 6 and the partition 7 are engaged together).
• the upper portion has an annular edge 72 ’provided to press against the walls of a cap or a sampling passage.
• the upper portion and the lower portion of the partition 7 are interconnected by an intermediate portion 73 ’cylindrical.
• the outside diameter of the middle portion 73 ’ is less than the diameter of the upper portion.
• the partition 7 instead of a pre-slit membrane in the form of a dome, the partition 7 has a pre-slit membrane of generally planar shape at the level of the lower portion.
• the seal 6 shown in Figure 6 can be held in position against the partition 7 shown in Figure 6, while the latter is itself held in position. against the shoulder 82 of the cap 8 of Figure 3.
• the shoulder 82 allows the annular edge 72 'of the partition 7 to be held in position against the walls of the cap 8.
• the seal 6 and the partition 7 can be positioned. stably inside the cap 8.
• Figures 7a to 7c illustrate successive steps of a liquid reagent withdrawal using a reagent storage and withdrawal assembly.
• This latter assembly comprises a reagent storage container comprising a flexible bag 10 and a sampling passage with a seal 6 and a partition 7, for example the container described above in relation to Figures 2 to 5c.
• the sampling passage comprises a seal 6 and a partition 7 conforming to the variant described above in relation to FIG. 6.
• the reagent is here stored under a controlled atmosphere, possibly with a small volume of sterile air present in the storage space for the reagent R.
• This assembly also comprises a sampling device configured to be inserted at least in part into the passage 3 and to deform the seal 6.
• a pipette is used here as a sampling device 20.
• the seal 6 and the partition 7 form two sealing levels, so that the sealing between the reagent R contained inside the flexible bag 10 and the external environment is ensured before , during and after a sample.
• the level of reagent R exceeds the vertical position of the partition 7.
• the empty pipette is inserted via the upper end 4 of the sampling passage.
• the seal 6 is located above the partition 7 in the sampling passage.
• the partition 7 is positioned at the lower end of the sampling passage.
• the central orifice 61 has a diameter smaller than the diameter of the outer walls of the end 21 of the pipette.
• the end 21 of the pipette first passes through the seal 6.
• the walls of the orifice 61 of the seal 6 are deformed in the direction of a widening of the orifice, to allow the passage of the end 21 of the pipette.
• the rim 64 of seal 6 expands and swings downward to open to the reagent storage space, reversibly.
• the rim 64 then adheres preferentially to the external walls of the pipette along the entire internal perimeter of the rim 64.
• the insertion of the pipette up to the interior of the flexible bag 10 ends with the passage of the partition 7 through the end 21 of the pipette.
• the partition 7 comprises a membrane pre-slit by a central slot.
• the end 21 exerts a penetrating force on the edges of the slot, which has the effect of moving said edges apart and leaving an opening which allows the passage of the pipette.
• the end 21 reaches the volume occupied by the reagent R, which allows sampling.
• the pressure inside the container preferably remains substantially constant, without the need for venting the reagent.
• the withdrawal device can be withdrawn via the upper end 4 of the withdrawal passage.
• the partition 7 Since the deformation of the seal 6 and of the partition 7 during the insertion of the sampling device 20 is reversible, the partition 7 returns to its closed position after removal of the sampling device. In addition, the seal 6 returns to its rest position, in which the orifice 61 is open.
• Another sample can be taken later using the pipette or possibly using another sampling device.
• the gasket 6 and the partition 7 provide a seal between the reagent R and the external environment before, during and after this new sample.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Medicinal Chemistry (AREA)
• Analytical Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Sampling And Sample Adjustment (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)
• Closures For Containers (AREA)

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• 2019
  • 2019-07-17 FR FR1908044A patent/FR3098798B1/fr active Active
• 2020
  • 2020-07-17 EP EP20739722.5A patent/EP3999234A1/fr active Pending
  • 2020-07-17 US US17/626,178 patent/US20220274114A1/en active Pending
  • 2020-07-17 CN CN202080065401.9A patent/CN114423525A/zh active Pending
  • 2020-07-17 WO PCT/EP2020/070311 patent/WO2021009357A1/fr unknown

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