EP3383342A1

EP3383342A1 - Device for connecting a vessel and a container and connection assembly including such a device

Info

Publication number: EP3383342A1
Application number: EP16806018.4A
Authority: EP
Inventors: Antoine Aneas
Original assignee: Biocorp Production SA
Current assignee: Biocorp Production SA
Priority date: 2015-11-30
Filing date: 2016-11-29
Publication date: 2018-10-10
Anticipated expiration: 2036-11-29
Also published as: US10912715B2; RU2018119668A; JP2018537186A; CA3006648A1; RU2018119668A3; US20190175450A1; WO2017093243A1; RU2729640C2; FR3044218A1; CN108430428A; EP3383342B1; ES2790878T3; FR3044218B1; AU2016361823A1; BR112018010956B1; PL3383342T3; JP6949020B2; CN108430428B; AU2016361823B2; BR112018010956A2

Abstract

The invention relates to a device (10) which makes it possible to connect a vessel, which is sealed by a perforable stopper, and a container. The device includes a base (14), which is configured to be mounted on the vessel and which includes a hollow member for perforating the stopper, said hollow member defining at least one opening, and a needle holder (18), which is awaiting connection to the container, and which comprises a needle (180) of which one of the ends leads into the inside space of the hollow member. The device (10) also comprises a collar (16), attached to the needle holder (18), and a bush (11), which is connected around the collar (16) and which defines a central axis (X11) according to which the device is movable counter to a resilient force exerted by return means.

Description

Connecting device between a container and a container and connection assembly comprising such a device

The invention relates to a connection device between a container closed by a pierceable stopper and a container, a connection assembly comprising the container, the container and the device and a method of filling the container by means of this device.

In particular, the connection device according to the invention makes it possible, on the one hand, to reconstitute a medicine inside a container, such as a syringe body, and, on the other hand, to assemble a hypodermic needle on the syringe body, so as to obtain a ready-to-use syringe, that is to say a syringe ready for a puncture. The connection device according to the invention is therefore configured for the reconstitution of a drug for a puncture.

Conversely, US-A-2010/0241088 and US-A-2008/0249479 each disclose a system wherein the syringe is a syringe needleless type ("needle-less syringe"). Once filled, the syringe is connected to a catheter via a specific adapter. In this system, the connection device therefore does not include a needle holder waiting for connection with the syringe body. This system is not suitable for reconstituting a drug for a puncture.

Also, US-A-2014/0261877 discloses a very particular system, designed for the reconstitution of an anticancer drug (oncology). This system allows to transfer a liquid, completely sealed and without pressure differential, from a sealed container with a pierceable stopper to a syringe. The system includes a connection device between the container and the syringe, which comprises, on the syringe side, a first adapter and, on the container side, a second adapter. The second adapter comprises a hollow perforation member of the plug. The first adapter comprises a cannula holder waiting for connection with the syringe and having a cannula whose one of its ends opens into the internal volume of the hollow organ (see Figure 13). The first adapter also comprises a cannula protector, which is provided in the form of an elastic sleeve and which is elastically movable around the cannula against an elastic force. When the drug is reconstituted, the cannula protector is resiliently biased back to the cannula sealing position. A separate system is then connected to the syringe to inject the drug into the patient's body. The connection device does not allow to obtain, once the reconstituted drug, a syringe with a hypodermic needle ready for use. In the field of reconstitution of medicaments, it is also known from WO-A-2012/168 235 a device for connecting a container provided with a closed neck with a pierceable stopper with a container intended to be equipped with a needle. . Typically, this container is a syringe body. The device comprises a base configured to be mounted on the container and comprising a hollow perforation member of the cap. This hollow member comprises an opening which communicates an internal volume of the hollow member with an internal volume of the container when the base is mounted on the container, that is to say when the plug is perforated. The connection device also comprises a needle holder, which is waiting for connection with the syringe body and which is detachable from the base. In particular, the needle holder is adapted to be screwed inside a nut mounted on the end portion of the syringe body. The needle holder is received inside the base so as to communicate, through the hollow needle, the internal volume of the hollow organ with the internal volume of the syringe body when the needle holder is connected to the syringe body.

The container generally contains a drug in freeze-dried form, while the syringe body contains a solvent. The drug is obtained by dissolving the lyophilizate in the solvent. To prepare an injectable solution by means of this device, it is necessary first to mount the base on the container, so as to perforate the plug with the perforating member. It is then necessary to seal the needle holder and the syringe body, and to inject into the container, the solvent present in the syringe body. Then, it is necessary to arrange the container, the connecting device and the syringe body, then assembled, in a position where the contents of the container flow towards the interior volume of the syringe body. In particular, the contents of the container pass through the internal volume of the hollow perforation member and through the central channel of the needle.

Once the drug is reconstituted, then the entire syringe body and needle holder can be disconnected from the container. This assembly forms a ready-to-use syringe, which is shown in FIG. 13 of WO-A-2012 / 168,235. As shown in this figure, the hollow needle is uncovered, which means that there is a risk of sting before and after injection. There is therefore a risk of disease transmission, such as HIV. The syringe therefore does not comply with European directives and the recommendations of the US Food and Drug Administration (FDA) for any device with a needle. It is to these drawbacks that the invention more particularly intends to remedy by proposing a connection device with which the container, then connected to the needle holder, is safer once it is disconnected from the container.

To this end, the invention relates to a connection device between a container closed by a pierceable stopper and a container, such as a syringe body, this device comprising:

a base, which is configured to be mounted on the container and which comprises a hollow perforation member of the plug, this hollow member delimiting at least one opening, and

- a needle holder, which is releasably connected to the base, which is waiting for connection with the container, and which comprises a hypodermic needle whose one end opens into the internal volume of the hollow organ,

According to the invention, the device further comprises

a collar attached to the needle holder, and

a sleeve, which is connected to the collar and which defines a central axis according to which the sleeve is movable relative to the collar and around it, against an elastic force exerted by return means.

Thanks to the invention, when the container is detached from the container, particularly when the drug is reconstituted, the sleeve and the return means together form a safety system for protecting the needle before and after use. In particular, the sleeve tends, under the action of the return means, to occupy a position where it covers the needle, which prevents accidental puncture before injection and limits the risk of breakage. During an injection, the sheath retracts in contact with the skin to discover the needle, which can then enter the epidermis to perform the injection. At the end of the injection, the sheath returns to cover the needle under the effect of the return means and then covers the needle again, which allows to protect the needle after injection and to avoid thus an accidental puncture after injection.

According to advantageous, but not compulsory, aspects of the invention, such a connection device comprises any of the following features, taken in any technically permissible combination:

- The return means comprise a spring interposed axially between the collar and an inner radial shoulder of the sleeve.

- The collar comprises at least one radial pin, which is engaged in a corresponding radial opening of the sleeve. Each opening comprises a first branch and a second branch, each extending from an axial corridor, the first branch, the second branch and the corridor together forming a "Y".

- The device comprises a sealing sleeve, which is traversed by the needle and which is immobilized inside the base so as to ensure a sealed communication between the internal volume of the hollow member and a central channel of the needle.

- The needle has a beveled end, which has a height greater than or equal to the height of a wall of the sleeve through which the needle.

- In a configuration where the needle holder is detached from the base, the sleeve is movable between a first position where it covers the needle and a second position, where the needle is uncovered and the return means are configured to recall the sheath in its first position.

- The device comprises locking means of the sleeve in the first position, configured to prevent the sheath from returning to its second position.

- The needle holder is screwed inside the collar.

Each opening is shaped so that, when the sleeve is returned to its first position, it pivots about its axis in the direction of the screwing of the needle holder.

- The sleeve is dimensionally compressive in the direction of the central axis. - The sleeve comprises two opposite ports along the central axis.

- The needle holder comprises a frustoconical inner surface for receiving an end portion of the container and is sized to be force-fitted around said end portion.

The invention also relates to a connection assembly, comprising a container closed by a pierceable stopper, a container and a connection device as defined above.

The invention finally relates to a method of filling a container intended to be equipped with a needle with a product contained in a container closed by a pierceable stopper. According to the invention, this method comprises steps of:

a) mounting a connecting device as defined above on the container to perforate the plug with the perforating member,

b) connect the container with the needle holder,

c) injecting into the container a liquid present in the container, through the central channel of the needle and the internal volume of the perforating member, d) disposing the container, the connecting device and the container in a position where the contents of the container flow towards the interior volume of the container, through the internal volume of the perforating member and the central channel of the needle , and

e) disconnecting the container and the container, the needle holder then being removed from the base and the sleeve being held or returned by the biasing means in a first position where it covers the needle.

The invention and other advantages thereof will appear more clearly in the light of the following description of an embodiment of a connection device according to its principle, made only by way of example and in reference to the drawings in which:

FIG. 1 is a perspective view showing a connection device according to the invention and a container provided with a neck closed by a perforable stopper,

FIG. 2 is a section in plane II of FIG. 1,

FIG. 3 is a view on a larger scale of the box III of FIG. 2; FIG. 4 is a section similar to FIG. 2, in which the device is mounted on the container,

FIG. 5 is a perspective view similar to FIG. 1, in which the connection device is mounted on the container in a configuration where it is waiting for connection with a container, in particular a syringe body,

FIG. 6 is a section in the plane VI of FIG. 5,

FIGS. 7 to 9 are sections similar to FIG. 6 and represent the various steps of a process for preparing a solution for injection from a drug in the form of a lyophilizate contained in the container and a solvent contained therein in the container,

FIG. 10 is a perspective view similar to FIG. 5, in which part of the connection assembly is detached, the detached part forming a syringe comprising the container, a needle holder and a security system,

- Figure 1 1 is a section in the plane XI of Figure 10,

FIG. 12 is a perspective view of the syringe of FIG. 10 in an injection configuration,

FIG. 13 is a section in the plane XIII of FIG. 12,

FIGS. 14 and 15 are figures respectively similar to FIGS. 12 and 13, in a configuration in which the syringe is removed from the patient's body, that is to say after an injection,

FIG. 16 is an exploded perspective view of the connection device of FIGS. 1 to 15, FIG. 17 is a longitudinal section of a base belonging to the connection device of FIG. 16, and

FIG. 18 is a front view of a collar belonging to the connection device of FIG. 16.

FIGS. 1 to 16 show, in different configurations, a device

The device 10 is therefore independent of the container 20 and the container 30. The device 10, the container 20 and the container 30 together form a connection assembly 1.

The container 20 shown in Figures 1 and 2 in particular is a glass bottle 22 with a geometry of revolution about an axis X22 and provided with a neck 220 closed by a pierceable stopper 26. The glass vial 22 contains an active ingredient P in the form of lyophilisate or powder. The container 20 also comprises a plastic cap 24 which covers the stopper 26 and the neck 220 of the glass vial 22. This plastic cap 24 comprises unrepresented teeth which are anchored in the upper face of the cap 26. Thus, the cap 24 is connected to the plug 26. It ensures that the plug 26 sealingly closes the neck 220 of the bottle 22.

In a variant not shown, the container 20 comprises, in place of the plastic cap 24, an aluminum ring set around the neck 220 of the bottle 22. In this case, the elastic tabs 142 of the skirt 141 are jammed in support against a lower face of the neck 220, which ensures the attachment of the base 14 of the container 20. The device 10 is compatible with the plastic cap containers, of the type shown in the figures, and the hooded containers. in aluminium.

The container 30 shown in Figures 5 and 6 in particular comprises a syringe body 32 defining an internal volume V32 filled with a liquid solvent L. The syringe body 32 defines an end portion 320. This end portion 320 defines a channel liquid flow L. The body 32 has a geometry of revolution about a central axis X32. A rod 34 is movable in translation inside the syringe body 32 and is held at one of its ends inside a piston seal 36. In the example, the rod 34 is screwed to the inside of the syringe body 32. inside of the piston seal 36, but it can also be clipped. The rod 34 comprises at the other end thereof a thrust pallet 340.

As shown in FIGS. 1 and 2, the connection device 10 is wrapped in a blister 12, which is removed after mounting the device 10 on the container 20.

As shown in Figure 17, the device 10 comprises a plastic base 14 configured to be mounted on the container 20. This base 14 generally has a geometry of revolution about an axis X14. The base 14 includes a chimney 140 centered on the axis X14 and delimiting an internal radial surface S140. V140 denotes the internal volume of the chimney 140.

As can be seen in FIG. 3, the internal radial surface S140 of the chimney 140 delimits an internal radial shoulder 140a. A skirt 141 extends in the lower part of the chimney 140 and is also centered on the axis X14. This skirt 141 defines openings, in which are provided elastic tabs 142 which project into the internal volume of the skirt 141. These elastic tabs 142 are deformed radially outwardly during assembly of the base 14 on the container 20 and then exert a radial pressure force on the plastic cap 24, which ensures the cohesion between the base 14 and the container 20.

As can be seen in FIG. 17 in particular, the base 14 also comprises a hollow member 144 for perforating the plug 26. The fact that the hollow member 144 is made of plastic material makes it possible to avoid coring during the perforation of the plug 26. This hollow member 144 extends in the center of the skirt 141 and defines three radial openings 146 distributed around the axis X14. The openings 146 place in communication an internal volume V144 of the hollow member 144 with the internal volume V22 of the container 20 when the base 14 is mounted on the container 20, that is to say when the plug 26 is perforated. The radial shoulder 140a widens the inside diameter of the chimney 140 towards the hollow member 144.

A sealing sleeve 13 made of elastomer is mounted inside the chimney

140, as shown in Figure 3. More specifically, the sealing sleeve 13 defines an axis of revolution X13 and has a U-shaped flat bottom section. It is mounted in compression inside the chimney 140 by the end opposite to the hollow member 144. During the insertion of the sealing sleeve 13, the latter is compressed radially and then returns to its original shape by elastic return when it exceeds the shoulder 140a delimited by the bore S140 of the chimney 140. The sealing sleeve 13 is then locked inside the chimney 140, in a configuration where it closes, in a sealed manner , the passage between the internal volume V144 of the hollow member 144 and the internal volume V140 of the chimney 140. In other words, the sleeve 13 seals the internal volume V144 of the hollow perforation member 144.

The sleeve 13 comprises a bottom wall 130 which is pierced by a metal needle 180. The needle 180 is a hypodermic needle intended to pass through the skin of the human body for the injection of a substance. The needle 180 has a bevelled end 180a, which has a height h180a which is greater than a thickness h130 of the bottom wall 130, the thickness h130 and the height h180a being measured parallel to the X13 axis. Thus, there is no coring of the sleeve 13 when the needle 180 passes through its bottom wall 130.

The end 180a of the needle 180 opens into the internal volume V144 of the hollow member 144. The sleeve 13 provides a sealed communication between the internal volume V144 of the hollow member 144 and the central channel of the needle 180.

As can be seen in FIG. 16 in particular, the needle 180 belongs to a needle holder 18, which is partially received inside the chimney 140. This needle holder 18 is detachably connected to the base 14. It is waiting for connection with the end portion 320 of the container 30. The needle holder 18 is a connector type "luer slip" (registered trademark). It delimits an internal surface that is frustoconical, centered on an axis X18. More precisely, the frustoconical surface converges with respect to the axis X18 in the direction of the needle 180. The needle holder 18 defines a through hole in which the hollow metal needle 180 is fixed. The needle holder 18 is intended to to be force-fitted around the end portion 320 of the container 30 visible in Figure 6 or 7 in particular. The connection between the needle holder 18 and the container 30 is then tight and difficult to dismount in tension, that is to say by pulling on the needle holder 18 in a direction opposite to the container 30.

Still referring to FIG. 16, the needle holder 18 comprises a flange 182 making it possible to fix the needle holder 18 securely to a collar 16. More specifically, the needle holder 18 is screwed inside the collar 16, which comprises a tapping 162 adapted to the outer diameter of the collar 182. The collar 16 partially surrounds the chimney 140 of the base 14 and comprises two pins 160 which project radially outwardly relative to the outer radial surface of the collar 16 and which are arranged diametrically opposite. The collar 16 is centered on an axis X16.

Each pin 160 is engaged in a corresponding opening 1 10 of a sleeve 1 1 disposed coaxially around the collar 16. Each opening 1 10 of the sleeve 1 1 has a Y shape, that is to say it comprises a first branch 1 10a and a second branch 1 10b which each extend from an axial corridor 1 10c. The sleeve 1 1 is then connected to the collar 16 by cooperation of the pins 160 with the openings 1 10.

The sleeve 1 1 has a tubular shape and defines a central axis X1 1, in which it is movable relative to the collar 16. The sleeve 1 1 therefore defines two opposite ports along the axis X1 1. The two orifices are substantially of the same size. Advantageously, the sleeve 1 1 is made of a rigid material, such as plastic. In contrast to the sealing sleeve made of elastic material disclosed in US-A-2014/0261877, the sleeve 1 1 is dimensionally compressive in the direction of the axis X1 1.

Returning means 15 make it possible to hold the sleeve 1 1 in a preliminary position, in which the sleeve 1 1 is in abutment axially against the base 14 and in which the pins 160 are at the intersection between the first branch 1 10a. and the passage 1 10c of the openings 1 10. The return means 15 comprise a spring interposed between the collar 16 and an internal radial shoulder of the sheath 11, arranged at the end.

In the assembled state of the device 10, the axes X1 1, X13, X18, X16 and X14 merge with the same axis X10 of the device 10.

The following is described, with reference to FIGS. 1 to 1 1, a process for the preparation of an injectable solution M from a drug in the form of a lyophilizate P contained in the container 20 and of the liquid solvent L contained in the container. 30. This process allows the container 30 to be filled with the solution for injection, i.e. with the reconstituted drug.

A first step represented in FIGS. 1 to 4 consists of taking the connection device 10 out of its blister pack 12 and then mounting the device 10 on the container 20. During this step, the skirt 141 of the base 14 belonging to the device The resilient tabs 142 of the base 14 then exert a radial pressure force against the outer radial wall of the cap 24, which maintains the base 14 in contact with the container 20. .

When mounting the base 14 on the container 20, the hollow member 144 pierces the stopper 26, so that the internal volume V144 of the hollow member 144 communicates with the internal volume V22 of the bottle 22 through the openings 146. In this configuration, the needle holder 18 is waiting for connection with the end portion 320 of the container 30. In addition, the axes X10 and X22 are merged.

A second step shown in FIGS. 5 to 7 consists in connecting the container 30 to the device 10. During this step, the syringe body 32 is pushed inside the sheath 11 and the end portion 320 of the syringe body. 32 is force-fitted inside the needle holder 18. The needle holder 18 and the end portion 320 of the syringe body 32 are then sealingly connected and difficult to dismount in tension. The connection assembly 1 formed by the device 10, the container 20 and the container 30 is then in the configuration of FIG. 7. In this configuration, the axes X10, X22 and X32 coincide. In addition, the metal needle 180 communicates the internal volume V144 of the hollow organ 144 and the internal volume V32 of the syringe body 32. A third step shown in FIGS. 7 and 8 consists in injecting the liquid solvent L into the interior of the container 20. To do this, the user pushes the piston rod 34 inside the syringe body 32. In other words, it presses the thrust pallet 340 of the rod 34 towards the container 20, that is to say in the direction of the arrow F3 in Figure 7, to move the piston 36 inside the syringe body 32 and thus eject the liquid solvent L contained in the internal volume V32 of the syringe body 32 to the container 22. More specifically, the liquid solvent L passes through the central channel of the end portion 320 of the syringe body 32, the volume internal of the needle holder 18, the central channel of the hollow needle 180, the internal volume V144 of the hollow perforation member 144 and finally the openings 146 to join the internal volume V22 of the bottle 22. The transfer of the liquid L between the container 30 and the container 20 is The connection assembly 1 is then in the configuration of FIG. 8, in which the drug M is reconstituted.

A fourth step shown in FIGS. 8 and 9 consists of transferring the reconstituted medicament M from the container 20 to the container 30. To do this, the user returns the connection assembly 1, as represented by the arrow F5 in FIG. the container 20 shakes to dissolve the lyophilizate P inside the solvent L and pulls on the rod 34 towards the outside of the syringe body 32, that is to say in the direction of the arrow F7 in FIG. 9. In the inverted configuration of FIG. 9, the reconstituted drug M flows, under the effect of the depression generated by the displacement of the piston seal 36 inside the body 32, towards the internal volume V32 of the body More specifically, the medicament M passes through the openings 146, the internal volume V144 of the hollow organ 144 and the central channel of the hollow needle 180 to join the internal volume of the needle holder 18, from which it can go through s the syringe body 32 through the end portion 320. The transfer of the drug M from the container 20 to the container 30 is represented by the arrow F6 in Figure 9.

When the drug M has been completely transferred from the container 20 to the container 30, the user can disconnect the container 30 and the container 20, as shown by the arrows F8 in Fig. 10. The container 30 then carries with it the needle holder. 18, the collar 16 in which is screwed the needle holder 18 and the protective sleeve 1 1, which is attached to the collar 16. In contrast, the base 14 remains attached to the container 20. Thus, the needle holder 18 is detached from the base 14. The detached part of the container 20 forms a syringe S ready for use.

After disconnection, that is to say in a configuration where the needle holder 18 is detached from the base 14, the protective sleeve 1 1 moves from the preliminary position to a first position under the biasing force exerted by the spring 15. This displacement is represented by the arrow F9 in Figure 10. During this movement, the pins 160 then join the bottom of the leg 1 10a of the openings 1 10. In the first position, the sleeve 1 1 covers the needle 180, of in order to prevent an accidental puncture before injection and to mechanically protect the needle 180 from being broken, that is to say in case of a fall of the syringe S or of collision with an object. The sleeve 1 1 and the spring 15 thus form a safety system to protect the needle 180 before injection.

During an injection, the user presses the syringe S against the epidermis of the patient, which causes the protective sheath 1 1 to move back into contact with the skin, against the elastic force of the spring 15, from its first position to a second position. This movement is represented by the arrows F10 in FIG. 12. The needle 180 is then uncovered and the spring 15 is compressed. Each pin 160 moves from the bottom of the first leg 1 10a to the bottom of the passage 1 10c of the corresponding radial opening 1 10. This has the effect of rotating the sleeve 1 1 about its axis X1 1, as shown by the arrow R10 in Figure 12. The user then presses the rod 34 of the container 30 to eject the drug M in the body of the patient.

When the injection is completed and the syringe S is removed from the body of the patient, the protective sheath 1 1 moves from its second position to its first position under the action of the spring 15. Each peg 160 then moves from the bottom from the corridor 1 10c to the bottom of the branch 1 10b of the corresponding radial opening 1 10. This has the effect of rotating the sleeve 1 1 about its axis X1 1. The syringe S is then in the configuration of FIGS. 14 and 15. The sheath 11 then protects the needle 180 after the injection, so as to prevent an accidental sting and the transmission of diseases, such as HIV.

Each opening 1 10 is shaped so that, when the sleeve 1 1 moves back from its first position to its first position and returns to its first position, it pivots about the axis X1 1 counterclockwise when viewed from the 180. Thus, the sleeve 1 1 exerts, by pivoting about its axis X1 1, a torque on the collar 16 which is directed in the counterclockwise direction. Advantageously, this torque tends to screw more the needle holder 18 inside the collar 16. Thus, the needle holder 18 is not likely to unscrew during an injection. In other words, the sleeve 1 1 rotates in the direction of the screwing of the needle holder 18.

As shown in FIGS. 14 and 15, after the injection, the sheath 11 is locked in its first position. Indeed, if one tries to move back the sleeve 1 1, each pin 160 engages in a corresponding terminal portion 1 10d extending axially towards the corridor 1 10c and defining the free end of the leg 1 10b. This end portion 1 10d thus forms a housing for receiving the pin 160. The axial movement of the sleeve 1 1 is then blocked by cooperation of the pins 160 with the bottom of the housing 1 10d. Thus, a used syringe S, that is to say having already served, can no longer be used because we can no longer discover the needle 180. The end portion 1 10d of the second leg 1 10b thus forms means of locking, configured to block the axial displacement of the sleeve 1 1 when it is returned to its first position, that is to say in the configuration of FIG. 15. In other words, the locking means are configured to prevent the sheath to return to its second position.

In the example of the figures, the preliminary position is a position halfway between the first position and the second position. The sleeve 1 1 is then shorter and less wide than if the device were arranged so that the sleeve 1 1 would be in the first position in configuration mounted on the container 20. This position halfway therefore limits the size of the device 10 in the radial and axial direction.

Alternatively not shown, another system is used to connect the needle holder 18 to the syringe body 32. For example, it may be a screw system, type "luer lock" in English (registered trademark). This system has the advantage that the needle holder 18 is easily removable.

Alternatively not shown, a container 30 other than a syringe body is used.

The features of the main embodiment and the alternatives contemplated above may be combined with one another to generate new embodiments of the invention.

Claims

1. - Device (10) for connection between a container (20) closed by a pierceable stopper (26) and a container (30), such as a syringe body, said device comprising:

a base (14), which is configured to be mounted on the container and which comprises a hollow perforation member (144) of the plug, said hollow member defining at least one opening (146), and a needle holder (18), which is detachably connected to the base (14), which is waiting for connection with the container, and which comprises a hypodermic needle (180), one of whose ends (180a) opens into the volume internal portion (V144) of the hollow member (144),

characterized in that the device (10) further comprises

a collar (16) attached to the needle holder (18), and

a sheath (1 1), which is connected to the collar (16) and which defines a central axis (X1 1) according to which the sleeve is movable relative to the collar and around it, against an elastic force exerted by return means (15).

2. - Device according to claim 1, characterized in that the biasing means comprises a spring (15) interposed axially between the collar (16) and an inner radial shoulder of the sleeve (1 1).

3.- Device according to claim 2, characterized in that the collar (16) comprises at least one radial pin (160), which is engaged in a corresponding radial opening (1 10) of the sleeve (1 1).

4. - Device according to claim 3, characterized in that each opening (1 10) comprises a first leg (1 10a) and a second leg (1 10b) which each extend from an axial corridor (1 10c ), the first branch, the second branch and the corridor together forming a "Y".

5. - Device according to one of the preceding claims, characterized in that the device comprises a sealing sleeve (13), which is traversed by the needle (180) and which is immobilized inside the base (14) so as to ensure communication sealing between the internal volume (V144) of the hollow member (144) and a central channel of the needle (180).

6. - Device according to claim 5, characterized in that the needle (180) has a beveled end (180a), which has a height (h180a) greater than or equal to the height (h130) of a wall (130) the sleeve (13) traversed by the needle (180).

7. - Device according to one of the preceding claims, characterized in that, in a configuration where the needle holder (18) is detached from the base (14), the sleeve is movable between a first position where it covers the l needle (180) and a second position, where the needle is uncovered and in that the return means (15) are configured to return the sleeve to its first position.

8.- Device according to claim 7, characterized in that the device comprises means (1 10d) for locking the sleeve (1 1) in the first position, configured to prevent the sleeve (1 1) to return to its second position.

9. - Device according to claim 7 or 8, characterized in that the needle holder (18) is screwed inside the collar (16) and in that each opening (1 10) is shaped so that when the sleeve (1 1) is returned to its first position, it pivots about its axis (X1 1) in the direction of the screwing of the needle holder (18).

10. - Device according to one of the preceding claims, characterized in that the needle holder (18) is screwed inside the collar (16).

1 1. - Device according to one of the preceding claims, characterized in that the sleeve (1 1) is dimensionally compressive in the direction of the central axis (X1 1).

12.- Device according to one of the preceding claims, characterized in that the sleeve (1 1) comprises two opposite ports along the central axis (X1 1).

13.- Device according to one of the preceding claims, characterized in that the needle holder (18) comprises a frustoconical inner surface for receiving an end portion (320) of the container (32) and is dimensioned to be sheathed in force around said end portion.

14.- Connection assembly (1), comprising a container (20) closed by a pierceable stopper (26), a container (30) and a connection device (10) according to one of the preceding claims.

15.- A method of filling a container (30) to be equipped with a needle (180) with a product contained in a container (20) closed by a pierceable stopper (26), this method being characterized in that it comprises steps of:

a) mounting a connecting device (10) according to one of claims 1 to 8 on the container (20) for perforating the plug (128) with the perforating member (144),

b) connecting (F2) the container (30) with the needle holder (18),

c) injecting (F3) into the container (20) a liquid (L) present in the container (20), through the central channel of the needle (180) and the internal volume (V144) of the perforating member (144)

d) disposing (F5) the container (20), the connecting device (10) and the container

(30) in a position where the contents of the container flow to the interior (V32) of the container (30) through the internal volume (V144) of the puncturing member (144) and the central channel of the container (30). needle (180), and

e) disconnecting (F8) the container (30) and the container (20), the needle carrier (18) being then removed from the base (14) and the sleeve (1 1) being held or recalled by the means of recall (15) in a first position where it covers the needle (180).