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Title:
ADAPTER FOR A CONTAINER WITH A NECK
Document Type and Number:
WIPO Patent Application WO/2023/062425
Kind Code:
A1
Abstract:
A cap (10) for a container comprising a neck terminated by a flange, comprising a body (12) comprising an axial opening (14) for engaging the neck, two clamping blades (16) adapted to cooperate with the neck to retain the flange. The cap accommodates at least two different flange diameters. Each blade extends radially from the edge of the axial opening towards the interior of the cap, thus presenting a base anchored to the edge of the axial opening in an embedding zone and a free inner end. Each blade comprises along its length at least a first portion P of curvature radius R and has, along its length, a width decreasing towards its free end and is elastically deformable.

Inventors:
MONNIN EMMANUEL (FR)
RIVOIRA DIDIER (FR)
AKLE MAHUTIN (FR)
DEHAN CHRISTOPHE (FR)
Application Number:
PCT/IB2022/000588
Publication Date:
April 20, 2023
Filing Date:
October 12, 2022
Export Citation:
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Assignee:
EVEON (FR)
International Classes:
A61M39/10; B01L3/00; B65D41/34
Domestic Patent References:
WO2011144569A22011-11-24
Foreign References:
US20100179506A12010-07-15
AU2006293821A22008-04-17
US5090581A1992-02-25
US20190344938A12019-11-14
KR102096586B12020-04-02
US6875205B22005-04-05
Attorney, Agent or Firm:
ICOSA (FR)
Download PDF:
Claims:
CLAIMS Cap (10) for a container (100) comprising a neck (101) terminated by a flange (111), the cap (10) comprising: a body (12) extending along an axis of revolution and comprising an axial opening (14) for engaging the neck (101) of the container (100), at least two clamping blades (16) adapted to cooperate with the neck (101) of the container (100) to retain the flange (111) against disengagement of the neck (101), the cap (10) being configured to accommodate at least two different flange diameters (d), and the cap (10) being characterized in that: each clamping blade (16) extends radially from the edge of the axial opening (14) towards the interior of the cap (10), thus presenting a base (22) anchored to the edge of the axial opening (14) in an embedding zone (22) and a free inner end (24), each clamping blade (16) comprises along its length at least a first portion P of curvature radius R, each blade (16) has, along its length, a width decreasing towards its free end (24), each clamping blade (16) is elastically deformable, allowing the cap (10) to move from a spread configuration to a clamping configuration, the spread configuration allowing the passage of the flange (111), and the clamping configuration being configured so that at least one portion Q bears against the neck (101) of the container (100). Cap (10) according to claim 1, wherein the cap (10) comprises three clamping blades (16) extending radially from the edge of the axial opening (14) towards the interior of the cap (10), the three clamping blades (16) being anchored at regular intervals on the edge of the axial opening (14). Cap (10) according to any one of the preceding claims, wherein all the clamping blades (16) are identical. Cap (10) according to any one of the preceding claims, wherein each clamping blade (16) comprises successively along its length, from its embedded base (22) towards its free inner end (24), at least a first portion (Pi) of curvature radius (Ri) and a second portion P2 of curvature radius (R2), the two curvature radii (Ri) and (R2) being different from each other and both being greater than or equal to zero. Cap (10) according to any one of the preceding claims, wherein the first and second portions (Pi, P2) of each clamping blade (16) have a curvature radius (Ri, R2) strictly greater than zero, so as to be curved. Cap (10) according to the preceding claim, wherein the first portion (Pi) has a curvature radius (Ri) greater than the curvature radius (R2) of the second portion (P2). Cap (10) according to any one of claims 1 to 4, wherein the first and second portions (Pi, P2) of each clamping blade (16) are straight, the first portion (Pi) being inclined at an angle Asi with regards to a diameter Do of the axial opening passing through the base and the free inner end (24) of the clamping blade (16), and the second portion (P2) being inclined at an angle Ap2 formed between the same diameter Do and the free inner end (24) of the clamping blade (16), the angle Asi being smaller than the angle Ap2. Cap (10) according to any one of claims 1 to 4, wherein at least one portion (Pi, P2) of each clamping blade (16) is straight and the second is curved. Cap (10) according to any one of the preceding claims, wherein each clamping blade (16) comprises, at its embedded base (22), a chamfer (32) defining an angle of less than or equal to 45° between the axis of revolution (X) and the clamping blade (16), in order to center the flange (111) with respect to the axial opening (14) prior to engagement of the neck (101) of the container (100). Cap (10) according to any one of claims 1 to 8, wherein each clamping blade (16) comprises, at its embedded base (22), a chamfer (32) defining an angle of less than or equal to 30° between the axis of revolution (X) and the clamping blade (16), in order to center the flange (111) with respect to the axial opening (14) prior to engagement of the neck (101) of the container (100).
Description:
ADAPTER FOR A CONTAINER WITH A NECK

FIELD OF INVENTION

[0001] The present invention relates to an adaptor or connecting means referred to, in the present invention, as a cap, for attachment to a container having a neck terminated by a flange, configured to accommodate a range of at least two different flange diameters.

BACKGROUND OF INVENTION

[0002] Pharmaceutical products intended to be injected into a patient classically comprise different components stored separately and are thus generally packaged in two types of flanged glass vials (or containers), each characterised by its own flange diameter: a first type of vial having a flange of 13 mm diameter; the second, a flange of 20 mm diameter as example. The dimensions of such vials are standardised, for example, by the NF EN ISO 8362-1 standard. The invention thus enables the fixation of different neck vial diameter ranging from 13 to 32 mm as commonly used in the industry.

[0003] Figures 1A, IB and 1C show respectively a partial cross-sectional view of flanged vials as defined by NF EN ISO 8362-1 type 2R and 10R, as well as the range of vial profiles existing under this standard.

[0004] In a conventional manner and well known per se, each vial (or container) comprises a body intended to contain the pharmaceutical product, extended by a neck with a narrower cross-section than the body. The neck is connected to the body by a shoulder, and has a flange at its end opposite to the shoulder, the external diameter of said flange being greater than the diameter of the neck. The vial generally presents a revolution shape around an axis X.

[0005] The neck circumscribes an axial opening which is generally sealed by a plug or septum (not shown) through which fluid can be introduced or removed from the vial by means of a needle or spike piercing the stopper substantially along the X axis. [0006] A ring-shaped metal cap ("crimp") is usually crimped onto the flange to hold the plug/septum in the neck while allowing the needle or cannula to pass through.

[0007] The NF EN ISO 8362-1 standard governs the geometric and dimensional characteristics of the flange. These vials are intended to contain pharmaceutical products in different forms, notably lyophilised (powder) or liquid. The reconstitution of the final pharmaceutical product to be given to the patient, or its extraction from the vial, is done with a syringe by piercing the septum. Although good practice allows safe handling for both patient and practitioner, there are frequent concerns about product contamination or sharp-injuries. To reduce these risks, intermediate connection means, classically called "vial adapters", are used to connect the vial to another device. The vial can be connected to another device, for example another container, an injection device such as a syringe, a fluid cassette, etc. via an adapter. The vial may be connected to another device, for example another container, an injection device such as a syringe, a fluidic cassette, etc. via an adapter (referred to as a cap in this application). Depending on the case, the adapter may be integrated into the device or form a separate part connectable to the device.

[0008] Given the differences in the dimensions of the flanges of the various vials, it is common practice to use a specific adapter for each flange format. However, this solution has disadvantages in terms of stock management, since it requires the management of as many adapter references as there are bottle/device pairs to be connected.

[0009] To overcome this drawback, multi-vial adapters have been designed to accommodate at least two different flange sizes. For example, US 6,875,205 discloses an adapter suitable for flanges of 13mm and 20mm diameter. This adapter is provided with an axial opening adapted to engage the neck of the bottle, and two sets of arms of different lengths alternating around the periphery of the opening. The arms of a first series are relatively shorter than those of the second series and configured to cooperate with the neck of a 20mm vial, the arms of the second series being then plastically deformed to fit along the opening; the arms of the second series are longer than those of the first series and configured to cooperate with the neck of a 13mm vial, without the arms of the first series interfering with said vial. [0010] However, this design is relatively cumbersome in the axial direction. In addition, the manufacture of such an adapter by injection moulding of a plastic material requires the use of a mould comprising removable blocks involving a large number of parting lines. In addition to the fact that such a mould is relatively complex to manufacture and develop, the adapter is subject to the presence of burrs at the parting lines, which may impair the operation of the adapter.

[0011] Such a device must also be single-use in order to preserve patient safety and health. However, systems that only have a means of clipping by a single axial movement do not guarantee the inviolability of the system, and therefore do not protect against accidental or intentional reuse. The devices marketed by QOSINA and WESTPHARMA are characterised by the absence of a clip (fixing only when the bottle is pierced), or by the use of axial clips of the "tulip" type which do not allow constraints to be applied to prevent the clip from spreading.

[0012] Such a device must also be adapted to different type of standard drug containers such as cartridges. Those containers which display a volume that can vary from 1.5, 2, 3, 5 or 20ml, present different sizes regarding cylinder diameters and heights. However, they present common dimensions regarding their flanges which can vary from 7,15mm to 13mm diameter with same neck height.

SUMMARY

[0013] One aim of the invention is therefore to design an adapter, more generally referred to as a "cap" in the present application, compatible with two diameters of vial necks, more generally referred to as "containers" in the present application, which are very widely used in the pharmaceutical industry, namely 13mm and 20mm diameter necks. More broadly, this solution has the advantage of being able to attach containers whose templates differ in the diameter of the neck and whose minimum diameter that can be attached corresponds to 35% of the maximum diameter of the range. Another aim of the invention is to provide a connection solution, which is simpler, less bulky than known adapters (or caps) and economical with regard to the means of manufacture. Such an adaptor (or cap) should advantageously be tamper-proof to allow for a non-removable connection to the container. Preferably, such a capsule should also allow pre-centering of the container so as to improve the use of the health professionals or patients. Finally, such a cap should preserve these advantages while reducing the effort required to insert the container so as to improve the use of hospital practitioners.

[0014] This invention thus relates to a cap for a container comprising a neck terminated by a flange, the cap comprising: a body extending along an axis of revolution and comprising an axial opening for engaging the neck of the container, at least two blades adapted to cooperate with the neck of the container to retain the flange against disengagement of the neck, the cap being configured to accommodate at least two different flange diameters, and the cap being characterized in that: each blade extends radially from the edge of the axial opening towards the interior of the cap, thus presenting a base anchored to the edge of the axial opening in an embedding zone and a free inner end, each blade comprises along its length at least a first portion of curvature radius R, each blade has, along its length, a width decreasing towards its free end, each blade is elastically deformable, allowing the cap to move from a spread configuration to a clamping configuration, the spread configuration allowing the passage of the flange, and the clamping configuration being configured so that at least one portion Q bears against the neck of the container.

[0015] In a preferred embodiment, the cap comprises three clamping blades extending radially from the edge of the axial opening towards the interior of the cap, the three clamping blades being anchored at regular intervals on the edge of the axial opening.

[0016] Preferably, all the clamping blades are identical in order to equilibrate the container. [0017] Advantageously, each clamping blade comprises successively along its length, from its embedded base towards its free inner end, at least a first portion of curvature radius Ri and a second portion of curvature radius, the two curvature radii Ri and R2 being different from each other and both being greater than or equal to zero. These portions make it possible to delimit different zones of mechanical stress and deformation on the blade, so as to obtain a zone with a mainly axial movement while the other will have a mainly radial movement.

[0018] Preferably, the first and second portions of each clamping blade have a curvature radius strictly greater than zero, so as to be curved and adopt a shape the closest possible to the curvature of the container.

[0019] Also preferably, the first portion has a curvature radius Ri greater than the curvature radius R2 of the second portion, in order to concentrate the deformation force on the peripheral parts of the blades, which are configured to follow the curvature of the container. Moreover, this configuration limits the accessibility of the container, making it more difficult to be disconnected from the container.

[0020] In an alternative embodiment, the first and second portions of each clamping blade are straight, the first portion being inclined at an angle Asi with regards to a diameter Do of the axial opening passing through the base and the free inner end of the clamping blade, and the second portion being inclined at an angle Ap2 formed between the same diameter Do and the free inner end of the clamping blade, the angle Asi being smaller than the angle Ap2. This embodiment enables an easier manufacturing process.

[0021] In a second alternative embodiment, at least one portion of each clamping blade is straight and the second is curved. This embodiment alternates simplicity of manufacture with a technically more efficient portion for movement and development of the circle for fixing the bottle.

[0022] Advantageously, each clamping blade comprises, at its embedded base, a chamfer defining an angle of less than or equal to 45° between the axis of revolution and the clamping blade, in order to center the flange with respect to the axial opening prior to engagement of the neck of the container. The chamfer maximizes the guidance and centering of the container in the capsule.

[0023] Preferably, each clamping blade comprises, at its embedded base, a chamfer defining an angle of less than or equal to 30° between the axis of revolution and the clamping blade, in order to center the flange with respect to the axial opening prior to engagement of the neck of the container. Such an angle limits the resulting radial forces and enhances the guidance of the container in the axis of the cap.

[0024] Preferably, the height of each blade varies continuously from its base to its free end so as to provide the necessary flexibility at the ends to fit between the flange and the neck of the container.

[0025] In an alternative mode, the cap is characterized by the fact that the height of each blade varies in steps from its embedded base to its free end. This configuration allows the introduction of positioning stops to improve the guidance of the container as it is introduced into the cap.

[0026] Advantageously, each blade of the cap has a contact face intended to be in contact with the flange when the neck of the container is engaged in the axial opening, each contact face extending in a plane. The contact face interfering with the container allows clamping forces to be applied.

[0027] A particular embodiment of the cap involves each blade having a notch near its base, so as to enhance axial movements.

[0028] A second particular embodiment of the cap involves each blade having at least one or more recesses at its base, so as to enhance axial movements.

[0029] A particular embodiment of the cap involves the blades having at their embedded base, between the embedded base and the mobile part, a fin to reduce radial movements of the first portion of the blade.

[0030] Advantageously, the cap is characterized in that the body has, opposite to the axial opening, a bottom intended to cooperate with the free end of the container neck. This cooperation makes it possible to adapt to the small variations in the height of the collars that can be identified on the various models of container and thus to promote contact with the blade.

[0031] More preferably, the cap is characterized by a base having a surface S which is convex in shape when the cap is in its spread configuration, the surface S being capable of axial deformation upon insertion of the container into the axial opening. This shape allows pressure to be applied between the inner face of the flange and the outer face so as to exert sufficient pressure to stabilize small containers, a configuration in which deformation is minimal. In a configuration with a container of maximum flange diameter the deformation is maximum and clamping forces are also applied.

[0032] More advantageously, the cap is characterized in that the surface S of the body has a homogeneous thickness for greater manufacturing simplicity.

[0033] In an alternative mode, the cap is characterized in that the surface S has a decreasing thickness from its periphery towards its center to concentrate the flexibility at the area under its center which might comprise a cannula.

[0034] In another alternative mode, the cap is characterized in that the surface S has an increasing thickness from its periphery towards its center to distribute the flexibility of the entire base while maintaining a central rigidity.

[0035] Preferably, the cap is characterized in that the bottom has a rear opening allowing the establishment of a fluidic connection with the interior of the container. This external connection allows interfacing with different means such as another adapter, a syringe, a medical device or laboratory equipment.

[0036] The cap can also be characterized in that it comprises a hollow connection element extending axially from the bottom in the direction opposite the axial opening, this hollow connection element being able to receive an extraction means, allowing fluid communication between the inside of the container and the said extraction means. This connection allows in particular the use of handling devices without needles in order to limit the risk of injury to the user. [0037] Advantageously, the cap further comprises a hollow cannula extending axially, from the bottom of the cap body, into the axial opening, said cannula being adapted to perforate a septum arranged in the neck of the container. This cannula replaces needles and protects the user from the risk of needlestick injuries.

[0038] More preferably, the cap is characterized in that the hollow cannula is made in one piece with the capsule body for the design of a single-use element

[0039] Advantageously, the cap comprises an external attachment element, configured to attach the cap to a support. This external attachment element may comprise a screwing or press-fit means so as to meet industry standards.

[0040] More particularly, the capsule is characterized in that the external attachment element allows attachment of the cap to a second container. To allow needleless transfer by pressure differential.

[0041] The capsule according to the present invention may be characterized in that the external attachment element allows a fluid connection between the two containers.

[0042] The invention also includes for an object a fluidic cassette forming a shell and comprising at least one cap as described above.

[0043] A third object of the present invention is an infusion device comprising at least one cap as described above. This device allows for universal use with the various containers used for the packaging of medicines.

[0044] This device for transferring fluids between two containers may comprise at least one cap according to any of the above technical features. This allows the connection of containers with heterogeneous flange diameters. DEFINITIONS

[0045] In the present invention, the terms below are defined as follows:

"Cap" refers to an engaging means as claimed. Different devices may require the incorporation of such a cap,

"Container" refers to, but is not limited to, vials as described in the standard NF EN ISO 8362-1. The containers must be defined by the presence of a flange, "Involute" refers to the shape given to the clamping blades enabling them to extend radially from the periphery towards the center of the cap. The involutes can be circular, elliptical, or segmental (straight portion radius of curvature), Do: Blade anchoring diameter, axial opening of the cap, Ro: Radius of anchorage of the blades,

Di: Diameter of curvature of the Pi portion of the blades,

Ri: Radius of curvature of the Pi portion of the blades,

Li: Distance between the centers of diameters Do and Di, D2: Diameter of curvature of the P2 portion of the blades, R2: Radius of curvature of the P2 portion of the blades, L2: Distance between the centers of diameters Do and D2,

Ai: Angle of separation between the curvature radii Ri and R2 defined by the measure of the angle defined by the center of D2, the intersection of Ri with R2 with the center of Do. If the blade forms an ellipse, Ai is no longer an angle but the first point of contact between the blade and a 20mm vial,

A2: Angle of limitation the shape of the blade anchorage defines the intersection between Ro passing through the anchorage end and the diameter Do perpendicular to the blade end,

A3: Angle of the chamfer for docking the bottles,

- Epi: minimum thickness of the first portion of the blade,

Ep2: minimum thickness of the second portion of the blade,

Api: Slope angle 1,

Ap2: Slope angle 2,

Asi: Angle of separation of slopes 1 and 2; similar to Ai in the case where the two portions of the slats are straight lines. BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1A, IB and 1C illustrate the different types of containers concerned by the NF EN ISO 8362-1 standard, a) size of a type 2R vial, b) size of a type 10R vial and c) overview of standard vials with 13 and 20mm flange diameters, Figures 2A and 2B shows a first and a second embodiment of the cap, more precisely an adapter cap, according to the present invention,

Figure 3A and 3B displays a cap according to the embodiment of figure 2B, first in a vial presentation phase, and second once the vial is engaged inside the cap, Figures 4A, 4B and 4C illustrate a further embodiment of the cap according to the present invention, a shell cap, configured for fitting a microfluidic cassette, respectively in a cross-section view of the vial presentation phase, in vial presentation phase side view, with the vial engaged bottom view.

Figures 5A and 5B shows an adapter cap respectively in top view and in rear view.

Figure 6A and 6B are schematic diagram illustrating the phenomenon of cooperation of the bottom of the cap body with a container,

Figures 8A and 8B illustrates a cross-sectional view of the position of the clamping blades respectively before and after insertion of a flanged container, as well as the clamping portions in dynamic view on the blades according to a 1 OR (b) or 2R (c) vial.

Figure 9 shows the key dimensional elements for the definition of a blade with two radii of curvature according to the positions of the diameter of curvature, Figure 10 shows the key dimensional elements for the definition of a blade with two radii of curvature according to an angle of separation,

Figure 11 shows the key dimensional elements for the definition of a blade with two radii of curvature according to the angle of inking limitation,

Figure 12 shows the key dimensional elements for defining a blade with two straight portions, DETAILED DESCRIPTION

[0046] The following description will be better understood by reference to the drawings listed above. For the purpose of illustration, the cap is shown in various embodiments. It should be understood, however, that the present application is not limited to the precise arrangements, structures, features, embodiments, and appearances shown on said drawings. The drawings are not drawn to scale and are not intended to limit the scope of the claims to the embodiments shown therein. According to one embodiment.

[0047] Therefore, it should be understood that, when features which are mentioned in the claims are followed by references, such references are included solely for the purpose of enhancing the understanding of the claims and do not limit the scope of the claims in any way.

[0048] As already mentioned in the introduction, Figure 1C shows the great variability of vials 100 meeting the NF EN ISO 8362-1 standard. Any other classically used standards in any part of the world is considered, in this application, to also be relevant. These vials 100 all classically comprise a flange 111 displaying a diameter d. The vials 100 of figure 1C differ in one key dimensional element which is the diameter d of their flanges 111, as shown in Figures 1A and IB. Other elements may vary by a few millimetres but remain substantially of the same order of magnitude, namely the height of the neck between 3.71mm and 4.4mm into which the container clamping means generally fit. As can be seen on figures 3 A and 4B, a cap 10 according to the present invention can present distinct forms: Figures 3 A, 4B thus show two particular ways of shaping the cap in a shell form and in a vial adapter form. The cap 10 according to the present invention can thus display, for example, an adapter form (figure 3A) and a shell form (figure 4B).

[0049] As can be seen on the figures, the present the cap 10, regardless of its configuration, is configured to cooperate with the neck 101 of a container 100 comprising a neck 101 terminated by a flange 111 (for example following the NF EN ISO 8362-1 standard), as already mentioned. The cap 10 is configured to cooperate by clamping (friction or pression) with the container 100. Therefore, according to the definition given above, the cap 10 allows the attachment of containers 100 comprising a neck 101 terminated by a flange 111.

[0050] More particularly, each cap 10 comprises: a body 12 extending along a revolution axis X and comprising an axial opening 14 for engaging the neck 101 of the container 100, at least two clamping blades 16 adapted to cooperate, by friction and/or pression and/or clamping, with the neck 101 of the container 100 and further configured to retain the flange 111 in order to avoid the disengagement of the neck 101.

[0051] In order to be answering the technical problem, each cap 10 according to the present invention is configured to accommodate at least two different flange 111 diameters d.

[0052] The cap 10 is thus suitable for retaining containers 100 which present a variation in their flange diameters up to 60%, for example ranging from 13mm (minimum diameter d) is up to 32mm (maximum diameter d). In a preferred embodiment, the cap 10 is configured to retain containers 100 presenting a variation in their flange diameters d up to 54%, for example ranging from 13mm (minimum diameter d) up to 28mm (maximum diameter d). In a more preferred embodiment, the cap 10 is configured to retain containers 100 presenting a variation in their flange diameters d up to 48%, for example ranging from 20mm (minimum diameter d) up to 32mm (maximum diameter d), or ranging from 7.15mm (minimum d diameter) up to 13mm (maximum diameter). In an advantageous embodiment, the cap 10 is configured to retain containers 100 presenting a variation in their flange diameters d up to 35%, for example ranging from 13mm (minimum diameter d) up to 20mm (maximum diameter d). In a more advantageous embodiment, the cap 10 is configured to retain containers 100 presenting a variation in their flange diameters d up to 38%, for example ranging from 20mm (minimum diameter d) up to 32mm (maximum diameter d). In a further embodiment, the cap 10 is configured to retain containers 100 presenting a variation in their flange diameters d up to 28%, for example ranging from 20mm (minimum diameter d) up to 28mm (maximum diameter d). In a last embodiment, the cap 10 is configured to retain containers 100 presenting a variation in their flange diameters d up to 28%, for example ranging from 20mm (minimum diameter d) up to 28mm (maximum diameter d).

[0053] As can be seen on the figures, the body 12 of the cap 10 presents a bottom 18 and an external wall 20 extending along the revolution axis X. In some embodiments, the bottom 18 presents a surface S. In the case of the shell form of figures 4A, 4B and 4C, the external wall 20 is part of a shell which will be described further below, as being part of a “fluidic cassette”.

[0054] As shown in Figures 1A and IB, the different vials 100 present several types which all present small variations of less than 2mm in neck 101 and flange 111 heights. While these variations are negligible, they can still influence the correct positioning, sealing, stability and tamper evidence of each container 100 inside the cap 10. This necessitates the cap 10 to be adaptable to different variation in size. In the case of figures 6A and 6B, an example of a cap 10 is shown with a convex bottom 18 which is able to deform in response to the stresses applied to it when the container 100 is inserted. Figure 6A shows the absence of deformation of the convex bottom 18 at rest while a 13mm container 100 will induce a median deformation of the surface S (Figure 6 B) and a maximum deformation for a 20mm (or a 32mm) diameter container. The docking of the container 100 results in the complete compression of the convex bottom 18, which applies an opposing force so as to keep the blades 16 of the cap 10 in contact with the container 100 shoulder. A convex bottom 18 can thus adapt to any container size. The cap 10 can thus respond accordingly to the different stresses exerted by containers 100 presenting variable sizes and secure all safely and strongly. This bottom surface S can have a variable thickness between 1mm and 2mm.

[0055] The body 12 of the cap 10 thus presents preferably at least two distinct deformable elements: the bottom 18 and the blades 16. Those deformable elements 16, 18 form an embedding area. By positioning the blades 16 inside the body 12, with regards to the bottom 18, , no movement of the docketed container 100 is allowed, thus improving the tamper evidence of the system (cap 10 + docketed container 100). [0056] Opposite to the bottom 18, the cap 10 presents the axial opening 14 enabling it to receive the container 100 it has to cooperate with (see figures 3B and 4B). The body 12 presents a width (along the revolution axis X) ranging from 3 to 6,5cm, preferably from 3 to 6cm, or alternatively from 1 to 3,5cm.

[0057] As can be seen on figures 2A, 2B, 5 A and 5B each clamping blade 16 extends radially, in a resting configuration, from the edge of the axial opening 14 of the cap 10 towards the interior of the cap 10. More particularly, each clamping blade 16 extends from one point of the circumference of the external wall 20 towards another point of the circumference of the external wall 20. Each clamping blade 16 thus presents a base 22 anchored to the edge of the axial opening 14, on the external wall 20. More precisely, each clamping blade 16 presents an external embedded base 22 and a free inner end 24. Each clamping blade 16 thus presents a given length L between its external embedded base 22 and its free inner end 24.

[0058] Each blade 16 comprises along its length at least a portion P of curvature radius R defining its involute. Each blade 16 has, along its length, a width decreasing towards its free end 24, in order to improve its deformability and reduce its breaking risks without risking to detach it from the external wall 20 of the body 12.

[0059] Figures 2A and 2B show two embodiments of caps 10 in which the blades 16 have an involute with different curvature radii R.

[0060] Figures 5 A, 8 A and 8B show an embodiment in which the blades 16 present an involute defined by a first portion Pi of curvature radius Ri and a second portion P2 of curvature radius R2.

[0061] As mentioned above, it is possible to apply different curvature radii defining the shape of the clamping blades 16. For example, in figure 2A, one can see a cap 10 with blades 16 presenting a single curvature radius RA defining a circular blade characterised in that the blades 16 are designed with a single portion P of curvature radius RA. Figure 2B presents another embodiment with blades 16 presenting a single curvature radius RB. Figures 5 A and 5B illustrates an involute with two curvature radii Ri, R2 so as to limit the part (contact area Q, see figure 4C) of the blade 16 to which an axial force is applied and thus the risk of breaking. Each blade 16 of the embodiment of figures 5A and 5B thus presents curvature radius Ri defined for the blade portion Pi and a curvature radius R2 of the clamping blade portion P2.

[0062] In some alternative embodiment, the first and second portions Pi, P2, of each blade 16 are straight. The first portion Pi is inclined at an angle Asi with regards to a diameter Do of the axial opening 14 passing through the base 22 and the free end 24 of the blade 16, and the second portion P2 is inclined at an angle Ap2 formed between the same diameter Do and the free end 24 of the blade 16. The angle Asi is smaller than the angle Ap2. The first portion Pi presents preferably a curvature radius Ri close to the curvature of the external wall 20 of the body 12 in order to maximize stability. The second portion P2 presents preferably a curvature radius R2 which is smaller in order to maximize stability and/or the “hook effect” of the clamping blades 16 (see figures 8A and 8B).

[0063] More particularly, in some embodiments, the clamping blades 16 can thus present an ellipsoidal shape defined by two curvatures radii Ri, R2. A first curvature radius Ri virtually extends from the free end 24 of the clamping blade 16 to the last internal contact point between the clamping blade 16 and the docketed container 100. A second radius R2 virtually extends from the same last internal contact point to the embedded base 22 of the clamping blade 16.

[0064] In order to better adapt to the neck 101 and the flange 111 of the container 100, and in order to increase the cooperation between the neck 101 and the blades 16, each clamping blade 16 is elastically deformable, allowing the cap 10 to move from a spread configuration to a clamping configuration. The spread configuration allows the passage of the flange 111 of the container 100, and the clamping configuration is configured so that at least one contact area Q (see figure 4C) of each blade 16 bears against the neck lOlof the container 100. The clamping configuration thus retains the flange 111 and clamps the neck 101, preventing the container 100 from disengagement and retaining it.

[0065] Finally, the cap 10 can comprises some physical deformation control means and this leads to fact that the blades of the cap 10 can be characterised by the positioning of notches 26 near their embedded base 22, so as to improve their spacing. These notches 26 are preferably positioned in the portion Pi of each clamping blade 16. As the embedding base 22 is the part with the most material and therefore potentially the most rigid part of the cap 10, some notches can also be present in the external wall 20 in order to bring back some flexibility and reduce the risks of breaking. In figure 2A, one can see the presence of notches 26 at the level of the embedded base 22and on the blades 16. Figures 2B and 10 B show the presence of notches 26 in the embedded base 22. These physical deformation control means are used according to the desired mechanical properties or tribology of the materials used for each particular cap 10.

[0066] Figures 2A and 2B show the body 12 of the cap 10 with its clamping blades 16 extending radially towards the centre of the cap 10 from the embedded base 22. When a container 100 is presented as in figure 3 A or 4B, the fact of bringing the container 100 into contact with the clamping blades 16, allows both an axial and a radial movement of each blade 16 in order to bring the cap 10 into its spread configuration: an axial movement along the revolution axis X, which leads each blade 16 to bend, at least partially, towards the bottom 18 of the body 12 and protects the blades 16 from any risk of breaking, and a radial movement in a plane sensibly parallel to the bottom 18 of the body 12, which leads each blade 16 to be elastically pushed towards the periphery/the external wall 20 of the cap 10.

[0067] The fact that the clamping blades 16 are configured to be deformed radially and axially (along the revolution axis X) allows a strong technical compromise between a spreading torque and a clamping torque which lowers the breaking risk.

[0068] The insertion of the container 100 induces a spacing of the blades 16 according to the diameter d of the flange 111 of the presented container 100. The elasticity of the blades 16 allows the containers 100 of variable flange 111 diameters d to be inserted.

[0069] The insertion of the container 100 happens along the revolution axis X.

[0070] When the neck 101 is definitively passed and the flange 111 is in contact with the bottom 18, the clamping blades 16 tend to return to their resting configuration and the cap is put in its clamping configuration. The presence of the container 100 inside (see figures 3B and 4A) the cap 10 does not allow the blades 16 to regain their resting configuration so that they apply a clamping force to the contact area Q between each blade 16 and the container 100. In a shell-like form as shown in Figures 4A, 4B and 4C, a container 100 of classified shape 2R can be seen in axial section (see Figure 4A), in side view (see Figure 4B) and in bottom view (see Figure 4C). In this embodiment, the bottom 18 is defined by the shell and can present a circular lumen (or aperture) at the centre of the body 12 to enable a fluidic connection between the container 100 and any device connected to the shell, for example a microfluidic cassette. A microfluidic cassette can be defined as a planar plastic member containing fluidic channels of a section varying from few micrometres to hundreds of micrometres as example. Another type of (micro)fluidic cassette can be constituted by flexible plastic tubing enabling fluidic connection between at least two components. The bottom view (Figure 4C) shows the positioning of the cap 10 as part of a cover of a fluidic cassette and its action on the second portion of the blades during insertion.

[0071] In some embodiments (for example on Figure 2) the cap 10 comprises a hollow cannula 28 extending axially from the bottom 18 of the cap 10 into the axial opening 14. The cannula 28 is adapted to perforate a septum arranged in the neck 101 of the container 100. The cannula 28 is attached to the cap body 12 by the surface S of the bottom 18.

[0072] Figure 5B shows a rear opening 30 for the connection of an extraction element (not shown). As the connection can be made according to the various “Glow” standards, it is possible to connect to the rear opening 30, for example, a syringe for introducing a liquid or extracting a liquid without using a needle.

[0073] The cap 10 may also be provided with a fin 32 (see figure 7) for each of the clamping blades 16 at their embedded bases 22 to reduce their radial movement. The fins 32, as shown in Figure 10, act as a stop to reduce the amplitude of the spaced position of the blades 16 when the container 100 is inserted inside the cap 10.

[0074] The cap 10 also has a container 100 positioning and guiding function to aid insertion of the container 100 into its centre. A centring system is configured to assure this positioning and guiding function. Figures 14 A and 14 B illustrate respectively two possible strategies for this, namely: the presence of a chamfer 34 on each clamping blade 16 (see figure 2B) which forms an angle with its extension with the revolution axis X of the cap 10, which has a value less than or equal to 45°. Preferably a value of less than 30° so that the resulting radial forces during insertion of the container remain minimal. The chamfer 34, combined with the tribology of the clamping blade 16 materials, thus encourages the container 100 to slide towards the centre of the cap 10. the presence of positioning stops 36 (see figure 5B) on the upper edge of the clamping blades 16. These positioning stops 36 are placed on the clamping blades 16 in such a way as to delimit the moments of contact between the clamping blades 16 and the flange 111 of the container 100 by forming decreasing steps from the embedded base 22 towards the centre of the bottom 18.

[0075] Thus placed, there is an optimal position reserved for the pre-positioning of 20mm diameter containers and 13mm diameter containers.

[0076] A preferred embodiment of the invention presents an embedded base 22 capable of adjusting to each inserted container 100 and thus systematically offering optimal positioning of the clamping blades 16 in the area between the flange 111 and the shoulder of the container 100 (meaning the neck 101).

[0077] Figure 6 provides a better understanding of the relationship between the different geometric points of the cap 10. It should be noted that the anchoring diameter DO is defined as the minimum diameter that can accommodate all the vials 100 in the range of vials as shown in figure 1C. This anchoring diameter Do refers to the axial opening 20 of the cap 10. This anchoring diameter Do must be greater than 25mm, preferably greater than or equal to 28mm. In this configuration, the anchorage radius (Do/2) of the clamping blades 16 is therefore greater than 12.5mm, preferably greater than or equal to 14mm. In a configuration with one curvature radius Ri, the diameter Di of curvature of the first portion Pi is respectively between 19 and 13mm, preferably between 18.5mm and 14mm and even more preferably between 16.5 and 14.5mm. The distance Li between these two diameters Do and Di is therefore between 6 and 3mm, preferably between 3.8 and 5.2mm. [0078] In the case of an involute with two curvature radii Ri, R2, the definition of this radius is done by the diameters D2 being between 25mm and 40mm. The distance between the centres of the diameters Di and Do is between 8mm and 15mm. The two curvature radii Ri, R2 are arranged at a separation angle of between 27 and 42° (see figures 7A and 7B).

[0079] The embedded base 22 can be defined according to the angle A2 of limitation of the resting configuration. This angle is greater than 30° so that the involute of each clamping blade 16 follows the periphery of the cap 10 body 12 as closely as possible and works according to two axial and radial deformation components. The cap embedding area may have at least one or more recesses in the clamping blade 16, so as to improve the axial movements. By way of example, the said recesses may be recesses in the outer part of the cap body as shown in figure 11.