EP3383342B1 - Device for connecting a vessel and a container and connection assembly including such a device - Google Patents

Device for connecting a vessel and a container and connection assembly including such a device Download PDF

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Publication number
EP3383342B1
EP3383342B1 EP16806018.4A EP16806018A EP3383342B1 EP 3383342 B1 EP3383342 B1 EP 3383342B1 EP 16806018 A EP16806018 A EP 16806018A EP 3383342 B1 EP3383342 B1 EP 3383342B1
Authority
EP
European Patent Office
Prior art keywords
container
needle
sheath
needle holder
vessel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP16806018.4A
Other languages
German (de)
French (fr)
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EP3383342A1 (en
Inventor
Antoine Aneas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biocorp Production SA
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Biocorp Production SA
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Publication date
Application filed by Biocorp Production SA filed Critical Biocorp Production SA
Priority to PL16806018T priority Critical patent/PL3383342T3/en
Publication of EP3383342A1 publication Critical patent/EP3383342A1/en
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Publication of EP3383342B1 publication Critical patent/EP3383342B1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means

Definitions

  • the invention relates to a connection device between a container closed by a perforable plug and a container, a connection assembly comprising the container, the container and the device and a method of filling the container using this device.
  • connection device makes it possible, on the one hand, to reconstitute a medicament 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 an injection.
  • the connection device according to the invention is therefore configured for the reconstitution of a medicament for an injection.
  • US-A-2010/0241088 and US-A-2008/0249479 each discloses a system in which the syringe is a syringe of the needle-less syringe type. 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 awaiting connection with the syringe body. This system is therefore not suitable for reconstituting a drug for an injection.
  • US-A-2014/0261877 discloses a very specific system, designed for the reconstitution of an anticancer drug (oncology).
  • This system makes it possible to transfer a liquid, completely sealed and without pressure differential, from a container closed by a perforable cap 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 includes a hollow plug perforation member.
  • the first adapter includes a cannula holder awaiting connection with the syringe and comprising a cannula, one of its ends of which opens into the internal volume of the hollow member (see figure 13 ).
  • the first adapter also includes a cannula protector, which is provided in the form of an elastic sleeve and which is movable elastically around the cannula against an elastic force.
  • a cannula protector which is provided in the form of an elastic sleeve and which is movable elastically around the cannula against an elastic force.
  • the cannula guard is resiliently recalled to the sealed cover position of the cannula.
  • a separate system is then connected to the syringe to inject the drug into the patient's body.
  • the connection device therefore does not make it possible to obtain, once the drug has been reconstituted, a syringe with a hypodermic needle ready for use.
  • WO-A-2012/168 235 a device for connecting a container provided with a neck closed by a perforable plug with a container intended to be equipped with a needle.
  • this container is a syringe body.
  • the device comprises a base configured to be mounted on the container and comprising a hollow member for perforating the stopper.
  • This hollow member has 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 cap is perforated.
  • the connection device also includes a needle holder, which is awaiting connection with the syringe body and which is detachable from the base.
  • the needle holder is designed to be screwed inside a nut mounted on the end part of the syringe body.
  • the needle holder is received inside the base so as to put, through the hollow needle, the internal volume of the hollow member with the internal volume of the syringe body when the needle holder is connected to the syringe body.
  • the container usually contains a drug in the form of a lyophilisate, while the syringe body contains a solvent.
  • the drug is obtained by dissolving the lyophilisate in the solvent.
  • you must first mount the base on the container, so as to perforate the cap with the perforating member. It is then necessary to tightly connect the needle holder and the syringe body, and to inject, into the container, the solvent present in the syringe body. Then, the container, the connection device and the syringe body, then assembled, must be placed in a position where the content of the container flows towards the interior volume of the syringe body. In particular, the contents of the container pass through the internal volume of the hollow perforating member and through the central channel of the needle.
  • the syringe body and needle holder assembly can then be disconnected from the container.
  • This set forms a ready-to-use syringe, which is shown in the figure 13 of WO-A-2012/168 235 .
  • the hollow needle is exposed, which means that there is a risk of puncture before and after the injection. There is therefore a risk of transmission of diseases, such as HIV.
  • the syringe therefore does not comply with European directives and the recommendations of the American Food and Drug Products Agency (FDA) regarding any device fitted with a needle.
  • FDA American Food and Drug Products Agency
  • the invention intends to remedy more particularly by proposing a connection device with which the container, then connected to the needle holder, is safer once it is disconnected from the container.
  • the sheath and the return means together form a safety system intended to protect the needle before and after use.
  • the sheath 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.
  • the sheath moves back in contact with the skin to discover the needle, which can then penetrate the epidermis to perform the injection.
  • the sheath returns to cover the needle under the effect of the return means and then covers the needle again, which makes it possible to protect the needle after the injection and to avoid thus an accidental injection after injection.
  • connection assembly comprising a container closed by a perforable plug, a container and a connection device as defined above.
  • a device 10 for connection between a container 20 and a container 30 is shown, in different configurations, a device 10 for connection between a container 20 and a container 30.
  • 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 set 1.
  • the container 20 shown in Figures 1 and 2 in particular is a glass bottle 22 with a geometry of revolution around an axis X22 and provided with a neck 220 closed by a perforable stopper 26.
  • the glass bottle 22 contains an active principle P in the form of lyophilisate or powder.
  • the container 20 also comprises a plastic cap 24 which covers the cap 26 and the neck 220 of the glass bottle 22.
  • This plastic cap 24 includes teeth not shown which are anchored in the upper face of the cap 26. Thus, the cap 24 is linked to the cap 26. It ensures that the cap 26 seals the neck 220 of the bottle 22.
  • the container 20 comprises, in place of the plastic cap 24, an aluminum ring crimped around the neck 220 of the bottle 22.
  • the elastic tabs 142 of the skirt 141 are wedged in abutment against a lower face of the neck 220, which ensures the fixing of the base 14 on the container 20.
  • the device 10 is therefore compatible with containers with plastic caps, of the type shown in the figures, and containers with caps in aluminium.
  • the container 30 shown in Figures 5 and 6 in particular comprises a syringe body 32 delimiting an internal volume V32 filled with a liquid solvent L.
  • the syringe body 32 delimits an end part 320.
  • This end part 320 delimits a liquid flow channel L.
  • the body 32 has a geometry of revolution around 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 the piston seal 36, but it can also be clipped.
  • the rod 34 comprises at the other of its ends a thrust pallet 340.
  • connection device 10 is wrapped in a blister 12, which is removed after mounting the device 10 on the container 20.
  • 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 around an axis X14.
  • Base 14 includes a chimney 140 centered on the axis X14 and delimiting an internal radial surface S140.
  • V140 designates the internal volume of the chimney 140.
  • 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 delimits openings, in which elastic tabs 142 are provided which project into the internal volume of the skirt 141. These elastic tabs 142 are deformed radially outward when the base 14 is mounted on the container 20 and then exert a radial pressure force on the plastic cap 24, which ensures cohesion between the base 14 and the container 20.
  • the base 14 also includes a hollow member 144 for perforating the plug 26.
  • This hollow member 144 s extends to the center of the skirt 141 and delimits three radial openings 146 distributed around the axis X14.
  • the openings 146 put an internal volume V144 of the hollow member 144 into communication 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 internal diameter of the chimney 140 in the direction of the hollow member 144.
  • An elastomeric sealing sleeve 13 is mounted inside the chimney 140, as shown in FIG. figure 3 . More specifically, the sealing sleeve 13 defines an axis of revolution X13 and has a U-shaped section with a flat bottom. 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, then regains its initial 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 blocked inside the chimney 140, in a configuration where it seals, in a leaktight 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 crossed 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 beveled 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 crosses 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 ensures sealed communication between the internal volume V144 of the hollow member 144 and the central channel of the needle 180.
  • the needle 180 belongs to a needle holder 18, which is partly received inside the chimney 140.
  • This needle holder 18 is detachably linked with respect to the base 14. It is on standby for connection with the end portion 320 of the container 30.
  • the needle holder 18 is a connector of the “luer slip” type (registered trademark). It delimits an internal surface which 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 delimits a through hole in which the hollow metal needle 180 is fixed.
  • the needle holder 18 is intended to be force fitted around the end portion 320 of the container 30 visible at the figure 6 or 7 especially.
  • the connection between the needle holder 18 and the container 30 is then sealed and difficult to dismantle in traction, that is to say by pulling on the needle holder 18 in a direction opposite to the container 30.
  • the needle holder 18 comprises a collar 182 allowing the needle holder 18 to be fixedly attached to a collar 16. More specifically, the needle holder 18 is screwed inside the collar 16, which includes a thread 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 outward relative to the external 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 110 of a sheath 11 arranged coaxially around the collar 16.
  • Each opening 110 of the sheath 11 has a Y shape, that is to say that it has a first branch 110a and a second branch 110b which each extend from an axial passage 110c.
  • the sheath 11 is then linked to the collar 16 by cooperation of the pins 160 with the openings 110.
  • the sheath 11 has a tubular shape and defines a central axis X11, along which it is movable relative to the collar 16.
  • the sheath 11 therefore defines two opposite orifices along the axis X11.
  • the two orifices are substantially the same size.
  • the sheath 11 is made of a rigid material, such as plastic. Unlike the leak-proof elastic material sealing sleeve in US-A-2014/0261877 , the sleeve 11 is undeformable in compression in the direction of the axis X11.
  • Return means 15 keep the sleeve 11 in a preliminary position, in which the sleeve 11 is axially abutting against the base 14 and in which the pins 160 are at the intersection between the first branch 110a and the corridor 110c of the openings 110.
  • the return means 15 comprise a spring interposed between the collar 16 and an internal radial shoulder of the sleeve 11, arranged at the end.
  • the axes X11, X13, X18, X16 and X14 are merged with the same axis X10 of the device 10.
  • a first step represented at figures 1 to 4 consists of removing the connection device 10 from its blister packaging 12, then mounting the device 10 on the container 20.
  • the skirt 141 of the base 14 belonging to the device 10 surrounds the plastic cap 24 of the container 20.
  • the elastic tabs 142 of the base 14 then exert a radial pressure force against the external radial wall of the cap 24, which keeps the base 14 in contact with the container 20.
  • the hollow member 144 punctures the plug 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.
  • the needle holder 18 is awaiting connection with the end portion 320 of the container 30.
  • the axes X10 and X22 are merged.
  • a second stage represented at Figures 5 to 7 consists in connecting the container 30 to the device 10.
  • the syringe body 32 is pressed inside the sheath 11 and the end part 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 tightly connected and difficult to dismantle in traction.
  • the connection assembly 1 formed by the device 10, the container 20 and the container 30 is then in the configuration of the figure 7 . In this configuration, the axes X10, X22 and X32 are merged.
  • the metal needle 180 communicates the internal volume V144 of the hollow member 144 and the internal volume V32 of the syringe body 32.
  • a third stage represented at Figures 7 and 8 consists in injecting the liquid solvent L inside the container 20.
  • the user pushes the plunger rod 34 inside the syringe body 32.
  • the liquid solvent L passes through the central channel of the end portion 320 of the syringe body 32, the internal volume 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 represented by the arrows F4 at the figure 7 .
  • the connection assembly 1 is then in the configuration of the figure 8 , in which drug M is reconstituted.
  • a fourth stage represented at figures 8 and 9 consists in transferring the reconstituted medicament M from the container 20 to the container 30.
  • the user returns the connection assembly 1, as represented by the arrow F5 to the figure 8 , optionally shakes the container 20 to dissolve the lyophilisate P well 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 to the figure 9 .
  • the reconstituted medicament M flows, under the effect of the vacuum generated by the displacement of the piston seal 36 inside the body 32, towards the internal volume V32 of the syringe body 32.
  • the medicament M passes through the openings 146, the internal volume V144 of the hollow member 144 and the central channel of the hollow needle 180 to reach the internal volume of the needle holder 18, from which it can flow into the syringe body 32 by the end portion 320.
  • the transfer of the drug M from the container 20 to the container 30 is represented by the arrow F6 at the figure 9 .
  • the user can disconnect the container 30 and the container 20, as shown by the arrows F8 at the figure 10 .
  • the container 30 then takes with it the needle holder 18, the collar 16 into which the needle holder 18 is screwed and the protective sheath 11, which is attached to the collar 16.
  • the base 14 remains attached to the container 20.
  • the needle holder 18 is detached from the base 14.
  • the detached part of the container 20 forms a syringe S ready for use.
  • the protective sheath 11 moves from the preliminary position to a first position under the restoring force exerted by the spring 15. This displacement is represented by arrow F9 at the figure 10 .
  • the pins 160 then join the bottom of the branch 110a of the openings 110.
  • the sheath 11 covers the needle 180, so as to prevent an accidental puncture before injection and to mechanically protect the needle 180 of the case, that is to say in case of fall of the syringe S or collision with an object.
  • the sheath 11 and the spring 15 therefore form a safety system intended to protect the needle 180 before an injection.
  • the user presses the syringe S against the patient's epidermis, which causes the protective sheath 11 to move back in contact with the skin, against the elastic force of the spring 15, of its first position to a second position.
  • This displacement is represented by the arrows F10 at the figure 12 .
  • the needle 180 is then uncovered and the spring 15 is compressed.
  • Each pin 160 moves from the bottom of the first branch 110a to the bottom of the corridor 110c of the corresponding radial opening 110. This has the effect of rotating the sheath 11 around its axis X11, as represented by the arrow R10 at the figure 12 .
  • the user then presses on the stem 34 of the container 30 to eject the drug M into the patient's body.
  • the protective sheath 11 moves from its second position to its first position under the action of the spring 15.
  • Each pin 160 then moves from the bottom of the corridor 110c towards the bottom of the branch 110b of the corresponding radial opening 110. This has the effect of rotating the sheath 11 around its axis X11.
  • the syringe S is then in the configuration of the Figures 14 and 15 .
  • the sheath 11 then protects the needle 180 after the injection, so as to prevent an accidental injection and the transmission of diseases, such as HIV.
  • Each opening 110 is shaped so that, when the sheath 11 moves back from its first position to its first position and returns to its first position, it pivots around the axis X11 counterclockwise when looking from the side of the needle 180.
  • the sheath 11 exerts, by pivoting about its axis X11, a torque on the collar 16 which is directed counterclockwise.
  • this couple tends to screw the needle holder 18 more inside the collar 16.
  • the needle holder 18 does not risk unscrewing during an injection.
  • the sheath 11 rotates in the direction of screwing of the needle holder 18.
  • each pin 160 engages in a corresponding terminal portion 110d extending axially in the direction of the passage 110c and defining the free end of the branch 110b.
  • This terminal portion 110d therefore forms a housing for receiving the pin 160.
  • the axial movement of the sleeve 11 is then blocked by cooperation of the pins 160 with the bottom of the housings 110d.
  • the terminal portion 110d of the second branch 110b therefore forms locking means, configured to block the axial movement of the sleeve 11 when the latter is returned to its first position, that is to say in the configuration of the figure 15 .
  • the locking means are configured to prevent the sheath from returning to its second position.
  • the preliminary position is a position halfway between the first position and the second position.
  • the sheath 11 is then shorter and narrower than if the device were arranged so that the sheath 11 would be in the first position in the configuration mounted on the container 20.
  • This half-way position therefore limits the size of the device 10 in the radial and axial direction.
  • another system is used to connect the needle holder 18 to the syringe body 32.
  • it may be a screw system, of the “luer lock” type in English (registered trademark). This system has the advantage that the needle holder 18 is easily removable.
  • a container 30 other than a syringe body is used.

Description

L'invention concerne un dispositif de connexion entre un récipient obturé par un bouchon perforable et un contenant, un ensemble de connexion comprenant le récipient, le contenant et le dispositif et un procédé de remplissage du contenant au moyen de ce dispositif.The invention relates to a connection device between a container closed by a perforable plug and a container, a connection assembly comprising the container, the container and the device and a method of filling the container using this device.

En particulier, le dispositif de connexion selon l'invention permet, d'une part, de reconstituer un médicament à l'intérieur d'un contenant, tel qu'un corps de seringue, et, d'autre part, d'assembler une aiguille hypodermique sur le corps de seringue, de façon à obtenir une seringue prête à l'emploi, c'est-à-dire une seringue prête pour une piqûre. Le dispositif de connexion selon l'invention est donc configuré pour la reconstitution d'un médicament en vue d'une piqûre.In particular, the connection device according to the invention makes it possible, on the one hand, to reconstitute a medicament 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 an injection. The connection device according to the invention is therefore configured for the reconstitution of a medicament for an injection.

A l'inverse, US-A-2010/0241088 et US-A-2008/0249479 divulguent chacun un système dans lequel la seringue est une seringue du type sans aiguille (« needle-less syringe »). Une fois remplie, la seringue est connectée à un cathéter par l'intermédiaire d'un adaptateur spécifique. Dans ce système, le dispositif de connexion ne comprend donc pas de porte-aiguille en attente de connexion avec le corps de seringue. Ce système n'est donc pas adapté à la reconstitution d'un médicament en vue d'une piqûre.Conversely, US-A-2010/0241088 and US-A-2008/0249479 each discloses a system in which the syringe is a syringe of the needle-less syringe type. 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 awaiting connection with the syringe body. This system is therefore not suitable for reconstituting a drug for an injection.

Egalement, US-A-2014/0261877 divulgue un système très particulier, conçu pour la reconstitution d'un médicament anticancéreux (oncologie). Ce système permet de transférer un liquide, de manière complètement étanche et sans différentiel de pression, depuis un récipient obturé par un bouchon perforable vers une seringue. Le système inclut un dispositif de connexion entre le récipient et la seringue, lequel comprend, côté seringue, un premier adaptateur et, côté récipient, un second adaptateur. Le second adaptateur comprend un organe creux de perforation du bouchon. Le premier adaptateur comporte un porte-canule en attente de connexion avec la seringue et comportant une canule dont l'une de ses extrémités débouche dans le volume interne de l'organe creux (voir figure 13). Le premier adaptateur comporte également un protège-canule, qui est prévu sous la forme d'un manchon élastique et qui est mobile élastiquement autour de la canule à l'encontre d'un effort élastique. Lorsque le médicament est reconstitué, le protège-canule est rappelé élastiquement en position de couverture étanche de la canule. Un système séparé est alors connecté à la seringue pour injecter le médicament dans le corps du patient. Le dispositif de connexion ne permet donc pas d'obtenir, une fois le médicament reconstitué, une seringue avec une aiguille hypodermique prête à l'emploi.Also, US-A-2014/0261877 discloses a very specific system, designed for the reconstitution of an anticancer drug (oncology). This system makes it possible to transfer a liquid, completely sealed and without pressure differential, from a container closed by a perforable cap 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 includes a hollow plug perforation member. The first adapter includes a cannula holder awaiting connection with the syringe and comprising a cannula, one of its ends of which opens into the internal volume of the hollow member (see figure 13 ). The first adapter also includes a cannula protector, which is provided in the form of an elastic sleeve and which is movable elastically around the cannula against an elastic force. When the drug is reconstituted, the cannula guard is resiliently recalled to the sealed cover position of the cannula. A separate system is then connected to the syringe to inject the drug into the patient's body. The connection device therefore does not make it possible to obtain, once the drug has been reconstituted, a syringe with a hypodermic needle ready for use.

Dans le domaine de la reconstitution de médicaments, il est également connu de WO-A-2012/168 235 un dispositif permettant de connecter un récipient pourvu d'un col obturé par un bouchon perforable avec un contenant destiné à être équipé d'une aiguille. Typiquement, ce contenant est un corps de seringue. Le dispositif comprend une embase configurée pour être montée sur le récipient et comprenant un organe creux de perforation du bouchon. Cet organe creux comporte une ouverture qui met en communication un volume interne de l'organe creux avec un volume interne du récipient lorsque l'embase est montée sur le récipient, c'est-à-dire lorsque le bouchon est perforé. Le dispositif de connexion comprend également un porte-aiguille, qui est en attente de connexion avec le corps de seringue et qui est détachable de l'embase. En particulier, le porte-aiguille est prévu pour être vissé à l'intérieur d'un écrou monté sur la partie d'extrémité du corps de seringue. Le porte-aiguille est reçu à l'intérieur de l'embase de manière à mettre en communication, à travers l'aiguille creuse, le volume interne de l'organe creux avec le volume interne du corps de seringue lorsque le porte-aiguille est connecté au corps de seringue.In the field of reconstitution of drugs, it is also known to WO-A-2012/168 235 a device for connecting a container provided with a neck closed by a perforable plug 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 member for perforating the stopper. This hollow member has 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 cap is perforated. The connection device also includes a needle holder, which is awaiting connection with the syringe body and which is detachable from the base. In particular, the needle holder is designed to be screwed inside a nut mounted on the end part of the syringe body. The needle holder is received inside the base so as to put, through the hollow needle, the internal volume of the hollow member with the internal volume of the syringe body when the needle holder is connected to the syringe body.

Le récipient contient généralement un médicament sous forme de lyophilisat, alors que le corps de seringue contient un solvant. Le médicament est obtenu en dissolvant le lyophilisat dans le solvant. Pour préparer une solution injectable au moyen de ce dispositif, il faut commencer par monter l'embase sur le récipient, de manière à perforer le bouchon avec l'organe de perforation. Il convient ensuite de connecter de façon étanche le porte-aiguille et le corps de seringue, et d'injecter, dans le récipient, le solvant présent dans le corps de seringue. Puis, il faut disposer le récipient, le dispositif de connexion et le corps de seringue, alors assemblés, dans une position où le contenu du récipient s'écoule vers le volume intérieur du corps de seringue. En particulier, le contenu du récipient passe à travers le volume interne de l'organe creux de perforation et à travers le canal central de l'aiguille.The container usually contains a drug in the form of a lyophilisate, while the syringe body contains a solvent. The drug is obtained by dissolving the lyophilisate in the solvent. To prepare a solution for injection using this device, you must first mount the base on the container, so as to perforate the cap with the perforating member. It is then necessary to tightly connect the needle holder and the syringe body, and to inject, into the container, the solvent present in the syringe body. Then, the container, the connection device and the syringe body, then assembled, must be placed in a position where the content of the container flows towards the interior volume of the syringe body. In particular, the contents of the container pass through the internal volume of the hollow perforating member and through the central channel of the needle.

Une fois le médicament reconstitué, on peut alors déconnecter l'ensemble corps de seringue et porte-aiguille du récipient. Cet ensemble forme une seringue prête à l'emploi, laquelle est représentée à la figure 13 de WO-A-2012/168 235 . Comme visible sur cette figure, l'aiguille creuse est découverte, ce qui signifie qu'il y a un risque de piqûre avant et après l'injection. Il y a donc un risque de transmission de maladie, comme le VIH. La seringue n'est donc pas conforme aux directives européennes et aux recommandations de l'agence Américaine des produits alimentaires et médicamenteux (FDA) en ce qui concerne tout appareil muni d'une aiguille.Once the drug has been reconstituted, the syringe body and needle holder assembly can then be disconnected from the container. This set forms a ready-to-use syringe, which is shown in the figure 13 of WO-A-2012/168 235 . As visible in this figure, the hollow needle is exposed, which means that there is a risk of puncture before and after the injection. There is therefore a risk of transmission of diseases, such as HIV. The syringe therefore does not comply with European directives and the recommendations of the American Food and Drug Products Agency (FDA) regarding any device fitted with a needle.

C'est à ces inconvénients qu'entend plus particulièrement remédier l'invention en proposant un dispositif de connexion avec lequel le contenant, alors connecté au porte-aiguille, est plus sûr une fois qu'il est déconnecté du récipient.It is these drawbacks that the invention intends to remedy more particularly by proposing a connection device with which the container, then connected to the needle holder, is safer once it is disconnected from the container.

A cet effet, l'invention concerne un dispositif de connexion entre un récipient obturé par un bouchon perforable et un contenant, tel qu'un corps de seringue, ce dispositif comprenant :

  • une embase, qui est configurée pour être montée sur le récipient et qui comprend un organe creux de perforation du bouchon, cet organe creux délimitant au moins une ouverture, et
  • un porte-aiguille, qui est lié de manière détachable par rapport à l'embase, qui est en attente de connexion avec le contenant, et qui comporte une aiguille hypodermique dont l'une de ses extrémités débouche dans le volume interne de l'organe creux,
To this end, the invention relates to a connection device between a container closed by a perforable 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 member for perforating the stopper, this hollow member delimiting at least one opening, and
  • a needle holder, which is detachably linked with respect to the base, which is awaiting connection with the container, and which comprises a hypodermic needle of which one of its ends opens into the internal volume of the organ hollow,

Conformément à l'invention, le dispositif comprend en outre,

  • un collier attaché au porte-aiguille, et
  • un fourreau, qui est lié au collier et qui définit un axe central selon lequel le fourreau est mobile par rapport au collier et autour de celui-ci, à l'encontre d'un effort élastique exercé par des moyens de rappel.
According to the invention, the device further comprises,
  • a collar attached to the needle holder, and
  • a sheath, which is linked to the collar and which defines a central axis along which the sheath is movable relative to and around the collar, against an elastic force exerted by return means.

Grâce à l'invention, lorsque le contenant est désolidarisé du récipient, en particulier lorsque le médicament est reconstitué, le fourreau et les moyens de rappel forment ensemble un système de sécurité visant à protéger l'aiguille avant et après usage. En particulier, le fourreau tend, sous l'action des moyens de rappel, à occuper une position où il recouvre l'aiguille, ce qui empêche une piqûre accidentelle avant injection et limite le risque de casse. Lors d'une injection, le fourreau recule au contact de la peau pour découvrir l'aiguille, laquelle peut alors pénétrer dans l'épiderme pour réaliser l'injection. A la fin de l'injection, le fourreau revient en recouvrement de l'aiguille sous l'effet des moyens de rappel et recouvre alors de nouveau l'aiguille, ce qui permet de protéger l'aiguille après l'injection et d'éviter ainsi une piqûre accidentelle après injection.Thanks to the invention, when the container is detached from the container, in particular when the medicament is reconstituted, the sheath and the return means together form a safety system intended to protect the needle before and after use. In particular, the sheath 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 moves back in contact with the skin to discover the needle, which can then penetrate 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 makes it possible to protect the needle after the injection and to avoid thus an accidental injection after injection.

Selon des aspects avantageux, mais non obligatoires, de l'invention, un tel dispositif de connexion comprend l'une quelconque des caractéristiques suivantes, prises dans toute combinaison techniquement admissible :

  • Les moyens de rappel comprennent un ressort intercalé axialement entre le collier et un épaulement radial interne du fourreau.
  • Le collier comprend au moins un pion radial, qui est engagé dans une ouverture radiale correspondante du fourreau.
  • Chaque ouverture comporte une première branche et une deuxième branche qui s'étendent chacune à partir d'un couloir axial, la première branche, la deuxième branche et le couloir formant ensemble un « Y ».
  • Le dispositif comprend un manchon d'étanchéité, qui est traversé par l'aiguille et qui est immobilisé à l'intérieur de l'embase de manière à assurer une communication étanche entre le volume interne de l'organe creux et un canal central de l'aiguille.
  • L'aiguille comporte une extrémité biseautée, laquelle présente une hauteur supérieure ou égale à la hauteur d'une paroi du manchon traversée par l'aiguille.
  • Dans une configuration où le porte-aiguille est détaché de l'embase, le fourreau est mobile entre une première position où il recouvre l'aiguille et une deuxième position, où l'aiguille est découverte et les moyens de rappel sont configurés pour rappeler le fourreau dans sa première position.
  • Le dispositif comprend des moyens de verrouillage du fourreau en première position, configurés pour empêcher le fourreau de revenir vers sa deuxième position.
  • Le porte-aiguille est vissé à l'intérieur du collier.
  • Chaque ouverture est conformée de sorte que, lorsque le fourreau est rappelé dans sa première position, il pivote autour de son axe dans le sens du vissage du porte-aiguille.
  • Le fourreau est indéformable en compression dans la direction de l'axe central.
  • Le fourreau comprend deux orifices opposés selon l'axe central.
  • Le porte-aiguille comprend une surface intérieure tronconique, pour recevoir une partie d'extrémité du contenant et est dimensionné pour être emmanché en force autour de ladite partie d'extrémité.
According to advantageous, but not compulsory, aspects of the invention, such a connection device comprises any one of the following characteristics, taken in any technically admissible combination:
  • The return means comprise a spring axially interposed between the collar and an internal radial shoulder of the sheath.
  • 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 which each extend from an axial passage, 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 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 passes.
  • In a configuration where the needle holder is detached from the base, the sheath 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 scabbard in its first position.
  • The device comprises means for locking the sheath 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 screwing of the needle holder.
  • The sheath is undeformable in compression in the direction of the central axis.
  • The sheath comprises two opposite orifices along the central axis.
  • The needle holder includes a frustoconical inner surface to receive an end portion of the container and is dimensioned to be force fitted around said end portion.

L'invention concerne également un ensemble de connexion, comprenant un récipient obturé par un bouchon perforable, un contenant et un dispositif de connexion tel que défini précédemment.The invention also relates to a connection assembly, comprising a container closed by a perforable plug, a container and a connection device as defined above.

L'invention concerne enfin un procédé de remplissage d'un contenant destiné à être équipé d'une aiguille avec un produit contenu dans un récipient obturé par un bouchon perforable. Conformément à l'invention, ce procédé comprend des étapes consistant à :

  1. a) monter un dispositif de connexion tel que défini précédemment sur le récipient pour perforer le bouchon avec l'organe de perforation,
  2. b) connecter le contenant avec le porte-aiguille,
  3. c) injecter dans le récipient un liquide présent dans le contenant, à travers le canal central de l'aiguille et le volume interne de l'organe de perforation,
  4. d) disposer le récipient, le dispositif de connexion et le contenant dans une position où le contenu du récipient s'écoule vers le volume intérieur du contenant, à travers le volume interne de l'organe de perforation et le canal central de l'aiguille, et
  5. e) déconnecter le contenant et le récipient, le porte-aiguille étant alors retiré de l'embase et le fourreau étant maintenu ou rappelé par les moyens de rappel dans une première position où il recouvre l'aiguille.
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 perforable plug. According to the invention, this method comprises steps consisting in:
  1. a) mount a connection device as defined above on the container for perforating the plug with the perforating member,
  2. b) connect the container with the needle holder,
  3. c) injecting a liquid present in the container into the container, through the central channel of the needle and the internal volume of the perforating member,
  4. d) arrange the container, the connection device and the container in a position where the content of the container flows towards the interior volume of the container, through the internal volume of the perforating member and the central channel of the needle , and
  5. e) disconnecting the container and the container, the needle holder then being removed from the base and the sheath being maintained or returned by the return means in a first position where it covers the needle.

L'invention et d'autres avantages de celle-ci apparaitront plus clairement à la lumière de la description qui va suivre d'un mode de réalisation d'un dispositif de connexion conforme à son principe, faite uniquement à titre d'exemple et en référence aux dessins dans lesquels :

  • la figure 1 est une vue en perspective représentant un dispositif de connexion conforme à l'invention et un récipient pourvu d'un col obturé par un bouchon perforable,
  • la figure 2 est une coupe dans le plan II de la figure 1,
  • la figure 3 est une vue à plus grande échelle de l'encadré III de la figure 2,
  • la figure 4 est une coupe analogue à la figure 2, dans laquelle le dispositif est monté sur le récipient,
  • la figure 5 est une vue en perspective analogue à la figure 1, dans laquelle le dispositif de connexion est monté sur le récipient dans une configuration où il est en attente de connexion avec un contenant, notamment un corps de seringue,
  • la figure 6 est une coupe dans le plan VI de la figure 5,
  • les figures 7 à 9 sont des coupes analogues à la figure 6 et représentent les différentes étapes d'un procédé de préparation d'une solution injectable à partir d'un médicament sous forme de lyophilisat contenu dans le récipient et d'un solvant contenu dans le contenant,
  • la figure 10 est une vue en perspective analogue à la figure 5, dans laquelle une partie de l'ensemble de connexion est détachée, la partie détachée formant une seringue comportant le contenant, un porte-aiguille et un système de sécurité,
  • la figure 11 est une coupe dans le plan XI de la figure 10,
  • la figure 12 est une vue en perspective de la seringue de la figure 10 dans une configuration d'injection,
  • la figure 13 est une coupe dans le plan XIII de la figure 12,
  • les figures 14 et 15 sont des figures respectivement analogues aux figures 12 et 13, dans une configuration où la seringue est retirée du corps du patient, c'est-à-dire après une injection,
  • la figure 16 est une vue en perspective éclatée du dispositif de connexion des figures 1 à 15,
  • la figure 17 est une coupe longitudinale d'une embase appartenant au dispositif de connexion de la figure 16, et
  • la figure 18 est une vue de face d'un collier appartenant au dispositif de connexion de la figure 16.
The invention and other advantages thereof will appear more clearly in the light of the following description of an embodiment of a connection device in accordance with its principle, given solely by way of example and in reference to the drawings in which:
  • the figure 1 is a perspective view showing a connection device according to the invention and a container provided with a neck closed by a perforable plug,
  • the figure 2 is a section in plane II of the figure 1 ,
  • the figure 3 is an enlarged view of Box III of the figure 2 ,
  • the figure 4 is a cut similar to the figure 2 , in which the device is mounted on the container,
  • the figure 5 is a perspective view similar to the figure 1 , in which the connection device is mounted on the container in a configuration where it is awaiting connection with a container, in particular a syringe body,
  • the figure 6 is a section in plane VI of the figure 5 ,
  • the figures 7 to 9 are cuts similar to the figure 6 and represent the different steps of a process for the preparation of an injectable solution from a medicament in the form of lyophilisate contained in the container and of a solvent contained in the container,
  • the figure 10 is a perspective view similar to the figure 5 , in which a part of the connection assembly is detached, the detached part forming a syringe comprising the container, a needle holder and a safety system,
  • the figure 11 is a section in plane XI of the figure 10 ,
  • the figure 12 is a perspective view of the syringe of the figure 10 in an injection configuration,
  • the figure 13 is a section in plane XIII of the figure 12 ,
  • the Figures 14 and 15 are figures respectively analogous to figures 12 and 13 , in a configuration where the syringe is withdrawn from the patient's body, that is to say after an injection,
  • the figure 16 is an exploded perspective view of the device for connecting the Figures 1 to 15 ,
  • the figure 17 is a longitudinal section of a base belonging to the connection device of the figure 16 , and
  • the figure 18 is a front view of a collar belonging to the connection device of the figure 16 .

Sur les figures 1 à 16 est représenté, dans différentes configurations, un dispositif 10 de connexion entre un récipient 20 et un contenant 30. Le dispositif 10 est donc bien indépendant du récipient 20 et du contenant 30. Le dispositif 10, le récipient 20 et le contenant 30 forment ensemble un ensemble de connexion 1.On the Figures 1 to 16 is shown, in different configurations, a device 10 for connection between a container 20 and a container 30. 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 set 1.

Le récipient 20 représenté aux figures 1 et 2 notamment est un flacon en verre 22 à géométrie de révolution autour d'un axe X22 et pourvu d'un col 220 obturé par un bouchon perforable 26. Le flacon en verre 22 contient un principe actif P sous forme de lyophilisat ou poudre. Le récipient 20 comprend également un capuchon en matière plastique 24 qui recouvre le bouchon 26 et le col 220 du flacon en verre 22. Ce capuchon en matière plastique 24 comprend des dents non représentées qui sont ancrées dans la face supérieure du bouchon 26. Ainsi, le capuchon 24 est lié au bouchon 26. Il assure que le bouchon 26 obture de manière étanche le col 220 du flacon 22.The container 20 shown in Figures 1 and 2 in particular is a glass bottle 22 with a geometry of revolution around an axis X22 and provided with a neck 220 closed by a perforable stopper 26. The glass bottle 22 contains an active principle P in the form of lyophilisate or powder. The container 20 also comprises a plastic cap 24 which covers the cap 26 and the neck 220 of the glass bottle 22. This plastic cap 24 includes teeth not shown which are anchored in the upper face of the cap 26. Thus, the cap 24 is linked to the cap 26. It ensures that the cap 26 seals the neck 220 of the bottle 22.

En variante non représentée, le récipient 20 comprend, à la place du capuchon en matière plastique 24, une bague en aluminium sertie autour du col 220 du flacon 22. Dans ce cas, les pattes élastiques 142 de la jupe 141 viennent se coincer en appui contre une face inférieure du col 220, ce qui assure la fixation de l'embase 14 sur le récipient 20. Le dispositif 10 est donc compatible avec les récipients à capuchon plastique, du type de celui représenté sur les figures, et les récipients à capuchon en aluminium.In a variant not shown, the container 20 comprises, in place of the plastic cap 24, an aluminum ring crimped around the neck 220 of the bottle 22. In this case, the elastic tabs 142 of the skirt 141 are wedged in abutment against a lower face of the neck 220, which ensures the fixing of the base 14 on the container 20. The device 10 is therefore compatible with containers with plastic caps, of the type shown in the figures, and containers with caps in aluminium.

Le contenant 30 représenté aux figures 5 et 6 notamment comprend un corps de seringue 32 délimitant un volume interne V32 rempli par un solvant liquide L. Le corps de seringue 32 délimite une partie d'extrémité 320. Cette partie d'extrémité 320 délimite un canal d'écoulement du liquide L. Le corps 32 est à géométrie de révolution autour d'un axe central X32. Une tige 34 est mobile en translation à l'intérieur du corps de seringue 32 et est maintenue à l'une de ses extrémités à l'intérieur d'un joint de piston 36. Dans l'exemple, la tige 34 est vissée à l'intérieur du joint de piston 36, mais elle peut également être clipsée. La tige 34 comporte à l'autre de ses extrémités une palette de poussée 340.The container 30 shown in Figures 5 and 6 in particular comprises a syringe body 32 delimiting an internal volume V32 filled with a liquid solvent L. The syringe body 32 delimits an end part 320. This end part 320 delimits a liquid flow channel L. The body 32 has a geometry of revolution around 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 the piston seal 36, but it can also be clipped. The rod 34 comprises at the other of its ends a thrust pallet 340.

Comme représenté aux figures 1 et 2, le dispositif de connexion 10 est enveloppé dans un blistère 12, qui est retiré après le montage du dispositif 10 sur le récipient 20.As shown in Figures 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.

Comme visible à la figure 17, le dispositif 10 comprend une embase en matière plastique 14 configurée pour être montée sur le récipient 20. Cette embase 14 présente globalement une géométrie de révolution autour d'un axe X14. L'embase 14 comprend une cheminée 140 centrée sur l'axe X14 et délimitant une surface radiale interne S140. V140 désigne le volume interne de la cheminée 140.As visible at the 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 around an axis X14. Base 14 includes a chimney 140 centered on the axis X14 and delimiting an internal radial surface S140. V140 designates the internal volume of the chimney 140.

Comme visible à la figure 3, la surface radiale interne S140 de la cheminée 140 délimite un épaulement radial interne 140a. Une jupe 141 s'étend en partie inférieure de la cheminée 140 et est également centrée sur l'axe X14. Cette jupe 141 délimite des ouvertures, dans lesquelles sont prévues des pattes élastiques 142 qui font saillie dans le volume interne de la jupe 141. Ces pattes élastiques 142 sont déformées radialement vers l'extérieur lors du montage de l'embase 14 sur le récipient 20 et exercent alors un effort radial de pression sur le capuchon en matière plastique 24, ce qui assure la cohésion entre l'embase 14 et le récipient 20.As visible at the figure 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 delimits openings, in which elastic tabs 142 are provided which project into the internal volume of the skirt 141. These elastic tabs 142 are deformed radially outward when the base 14 is mounted on the container 20 and then exert a radial pressure force on the plastic cap 24, which ensures cohesion between the base 14 and the container 20.

Comme visible à la figure 17 notamment, l'embase 14 comporte également un organe creux 144 de perforation du bouchon 26. Le fait que l'organe creux 144 soit en matière plastique permet d'éviter le carottage lors de la perforation du bouchon 26. Cet organe creux 144 s'étend au centre de la jupe 141 et délimite trois ouvertures radiales 146 réparties autour de l'axe X14. Les ouvertures 146 mettent en communication un volume interne V144 de l'organe creux 144 avec le volume interne V22 du récipient 20 lorsque l'embase 14 est montée sur le récipient 20, c'est-à-dire lorsque le bouchon 26 est perforé. L'épaulement radial 140a élargit le diamètre intérieur de la cheminée 140 en direction de l'organe creux 144.As visible at the figure 17 in particular, the base 14 also includes a hollow member 144 for perforating the plug 26. The fact that the hollow member 144 is made of plastic makes it possible to avoid core drilling during the perforation of the plug 26. This hollow member 144 s extends to the center of the skirt 141 and delimits three radial openings 146 distributed around the axis X14. The openings 146 put an internal volume V144 of the hollow member 144 into communication 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 internal diameter of the chimney 140 in the direction of the hollow member 144.

Un manchon d'étanchéité 13 en élastomère est monté à l'intérieur de la cheminée 140, comme représenté à la figure 3. Plus précisément, le manchon d'étanchéité 13 définit un axe de révolution X13 et présente une section en U à fond plat. Il est monté en compression à l'intérieur de la cheminée 140 par l'extrémité opposée à l'organe creux 144. Lors de l'insertion du manchon d'étanchéité 13, celui-ci est comprimé radialement, puis retrouve sa forme initiale par retour élastique lorsqu'il dépasse l'épaulement 140a délimité par l'alésage S140 de la cheminée 140. Le manchon d'étanchéité 13 se trouve alors bloqué à l'intérieur de la cheminée 140, dans une configuration où il obture, de manière étanche, le passage entre le volume interne V144 de l'organe creux 144 et le volume interne V140 de la cheminée 140. Autrement dit, le manchon 13 ferme de manière étanche le volume interne V144 de l'organe creux de perforation 144.An elastomeric sealing sleeve 13 is mounted inside the chimney 140, as shown in FIG. figure 3 . More specifically, the sealing sleeve 13 defines an axis of revolution X13 and has a U-shaped section with a flat bottom. 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, then regains its initial 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 blocked inside the chimney 140, in a configuration where it seals, in a leaktight 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.

Le manchon 13 comprend une paroi de fond 130 qui est traversée par une aiguille en métal 180. L'aiguille 180 est une aiguille hypodermique destinée à traverser la peau du corps humain pour l'injection d'une substance. L'aiguille 180 comporte une extrémité biseautée 180a, laquelle présente une hauteur h180a qui est supérieure à une épaisseur h130 de la paroi de fond 130, l'épaisseur h130 et la hauteur h180a étant mesurées parallèlement à l'axe X13. Ainsi, il n'y a pas de carottage du manchon 13 lorsque l'aiguille 180 traverse sa paroi de fond 130.The sleeve 13 comprises a bottom wall 130 which is crossed 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 beveled 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 crosses its bottom wall 130.

L'extrémité 180a de l'aiguille 180 débouche dans le volume interne V144 de l'organe creux 144. Le manchon 13 assure une communication étanche entre le volume interne V144 de l'organe creux 144 et le canal central de l'aiguille 180.The end 180a of the needle 180 opens into the internal volume V144 of the hollow member 144. The sleeve 13 ensures sealed communication between the internal volume V144 of the hollow member 144 and the central channel of the needle 180.

Comme visible à la figure 16 notamment, l'aiguille 180 appartient à un porte-aiguille 18, lequel est reçu en partie à l'intérieur de la cheminée 140. Ce porte-aiguille 18 est lié de manière détachable par rapport à l'embase 14. Il est en attente de connexion avec la partie d'extrémité 320 du contenant 30. Le porte-aiguille 18 est un connecteur du type « luer slip » (marque déposée). Il délimite une surface interne qui est tronconique, centrée sur un axe X18. Plus précisément, la surface tronconique converge par rapport à l'axe X18 en direction de l'aiguille 180. Le porte-aiguille 18 délimite un trou débouchant dans lequel est fixé l'aiguille creuse en métal 180. Le porte-aiguille 18 est destiné à être emmanché en force autour de la partie d'extrémité 320 du contenant 30 visible à la figure 6 ou 7 notamment. La connexion entre le porte-aiguille 18 et le contenant 30 est alors étanche et difficilement démontable en traction, c'est-à-dire en tirant sur le porte-aiguille 18 selon une direction opposée au contenant 30.As visible at the figure 16 in particular, the needle 180 belongs to a needle holder 18, which is partly received inside the chimney 140. This needle holder 18 is detachably linked with respect to the base 14. It is on standby for connection with the end portion 320 of the container 30. The needle holder 18 is a connector of the “luer slip” type (registered trademark). It delimits an internal surface which 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 delimits a through hole in which the hollow metal needle 180 is fixed. The needle holder 18 is intended to be force fitted around the end portion 320 of the container 30 visible at the figure 6 or 7 especially. The connection between the needle holder 18 and the container 30 is then sealed and difficult to dismantle in traction, that is to say by pulling on the needle holder 18 in a direction opposite to the container 30.

Toujours en référence à la figure 16, le porte-aiguille 18 comprend une collerette 182 permettant d'attacher fixement le porte-aiguille 18 à un collier 16. Plus précisément, le porte-aiguille 18 est vissé à l'intérieur du collier 16, lequel comporte un taraudage 162 adapté au diamètre extérieur de la collerette 182. Le collier 16 entoure partiellement la cheminée 140 de l'embase 14 et comprend deux pions 160 qui font saillie radialement vers l'extérieur par rapport à la surface radiale externe du collier 16 et qui sont disposés de manière diamétralement opposée. Le collier 16 est centré sur un axe X16.Still referring to the figure 16 , the needle holder 18 comprises a collar 182 allowing the needle holder 18 to be fixedly attached to a collar 16. More specifically, the needle holder 18 is screwed inside the collar 16, which includes a thread 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 outward relative to the external radial surface of the collar 16 and which are arranged diametrically opposite. The collar 16 is centered on an axis X16.

Chaque pion 160 est engagé dans une ouverture correspondante 110 d'un fourreau 11 disposé coaxialement autour du collier 16. Chaque ouverture 110 du fourreau 11 a une forme en Y, c'est-à-dire qu'elle comporte une première branche 110a et une deuxième branche 110b qui s'étendent chacune à partir d'un couloir axial 110c. Le fourreau 11 est alors lié au collier 16 par coopération des pions 160 avec les ouvertures 110.Each pin 160 is engaged in a corresponding opening 110 of a sheath 11 arranged coaxially around the collar 16. Each opening 110 of the sheath 11 has a Y shape, that is to say that it has a first branch 110a and a second branch 110b which each extend from an axial passage 110c. The sheath 11 is then linked to the collar 16 by cooperation of the pins 160 with the openings 110.

Le fourreau 11 présente une forme tubulaire et définit un axe central X11, selon lequel il est mobile par rapport au collier 16. Le fourreau 11 définit donc deux orifices opposés selon l'axe X11. Les deux orifices sont sensiblement de même taille. Avantageusement, le fourreau 11 est fabriqué dans une matière rigide, comme de la matière plastique. A l'inverse du manchon d'étanchéité en matière élastique divulgué dans US-A-2014/0261877 , le fourreau 11 est indéformable en compression dans la direction de l'axe X11.The sheath 11 has a tubular shape and defines a central axis X11, along which it is movable relative to the collar 16. The sheath 11 therefore defines two opposite orifices along the axis X11. The two orifices are substantially the same size. Advantageously, the sheath 11 is made of a rigid material, such as plastic. Unlike the leak-proof elastic material sealing sleeve in US-A-2014/0261877 , the sleeve 11 is undeformable in compression in the direction of the axis X11.

Des moyens de rappel 15 permettent de maintenir le fourreau 11 dans une position préliminaire, dans laquelle le fourreau 11 est en butée axialement contre l'embase 14 et dans laquelle les pions 160 se trouvent à l'intersection entre la première branche 110a et le couloir 110c des ouvertures 110. Les moyens de rappel 15 comprennent un ressort intercalé entre le collier 16 et un épaulement radial interne du fourreau 11, agencé en extrémité.Return means 15 keep the sleeve 11 in a preliminary position, in which the sleeve 11 is axially abutting against the base 14 and in which the pins 160 are at the intersection between the first branch 110a and the corridor 110c of the openings 110. The return means 15 comprise a spring interposed between the collar 16 and an internal radial shoulder of the sleeve 11, arranged at the end.

A l'état assemblé du dispositif 10, les axes X11, X13, X18, X16 et X14 sont confondus avec un même axe X10 du dispositif 10.In the assembled state of the device 10, the axes X11, X13, X18, X16 and X14 are merged with the same axis X10 of the device 10.

Ci-dessous est décrit, en référence aux figures 1 à 11, un procédé de préparation d'une solution injectable M à partir d'un médicament sous forme de lyophilisat P contenu dans le récipient 20 et du solvant liquide L contenu dans le contenant 30. Ce procédé permet de remplir le contenant 30 avec la solution injectable, c'est-à-dire avec le médicament reconstitué.Below is described, with reference to Figures 1 to 11 , a method of preparing an injectable solution M from a medicament in the form of lyophilisate P contained in the container 20 and of the liquid solvent L contained in the container 30. This method makes it possible to fill the container 30 with the injectable solution , i.e. with the reconstituted drug.

Une première étape représentée aux figures 1 à 4 consiste à sortir le dispositif de connexion 10 de son emballage blistère 12, puis à monter le dispositif 10 sur le récipient 20. Lors de cette étape, la jupe 141 de l'embase 14 appartenant au dispositif 10 vient entourer le capuchon en matière plastique 24 du récipient 20. Les pattes élastiques 142 de l'embase 14 exercent alors un effort radial de pression contre la paroi radiale externe du capuchon 24, ce qui maintient l'embase 14 au contact du récipient 20.A first step represented at figures 1 to 4 consists of removing the connection device 10 from its blister packaging 12, then mounting the device 10 on the container 20. During this step, the skirt 141 of the base 14 belonging to the device 10 surrounds the plastic cap 24 of the container 20. The elastic tabs 142 of the base 14 then exert a radial pressure force against the external radial wall of the cap 24, which keeps the base 14 in contact with the container 20.

Lors du montage de l'embase 14 sur le récipient 20, l'organe creux 144 perfore le bouchon 26, de manière que le volume interne V144 de l'organe creux 144 communique avec le volume interne V22 du flacon 22 par les ouvertures 146. Dans cette configuration, le porte-aiguille 18 est attente de connexion avec la partie d'extrémité 320 du contenant 30. De plus, les axes X10 et X22 sont confondus.When the base 14 is mounted on the container 20, the hollow member 144 punctures the plug 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 awaiting connection with the end portion 320 of the container 30. In addition, the axes X10 and X22 are merged.

Une deuxième étape représentée aux figures 5 à 7 consiste à connecter le contenant 30 au dispositif 10. Lors de cette étape, le corps de seringue 32 est enfoncé à l'intérieur du fourreau 11 et la partie d'extrémité 320 du corps de seringue 32 est emmanchée en force à l'intérieur du porte-aiguille 18. Le porte-aiguille 18 et la partie d'extrémité 320 du corps de seringue 32 sont alors liés de manière étanche et difficilement démontable en traction. L'ensemble de connexion 1 formé par le dispositif 10, le récipient 20 et le contenant 30 se trouve alors dans la configuration de la figure 7. Dans cette configuration, les axes X10, X22 et X32 sont confondus. De plus, l'aiguille en métal 180 met en communication le volume interne V144 de l'organe creux 144 et le volume interne V32 du corps de seringue 32.A second stage represented at Figures 5 to 7 consists in connecting the container 30 to the device 10. During this step, the syringe body 32 is pressed inside the sheath 11 and the end part 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 tightly connected and difficult to dismantle in traction. The connection assembly 1 formed by the device 10, the container 20 and the container 30 is then in the configuration of the figure 7 . In this configuration, the axes X10, X22 and X32 are merged. In addition, the metal needle 180 communicates the internal volume V144 of the hollow member 144 and the internal volume V32 of the syringe body 32.

Une troisième étape représentée aux figures 7 et 8 consiste à injecter le solvant liquide L à l'intérieur du récipient 20. Pour ce faire, l'utilisateur pousse la tige de piston 34 à l'intérieur du corps de seringue 32. Autrement dit, il appuie sur la palette de poussée 340 de la tige 34 en direction du récipient 20, c'est-à-dire dans le sens de la flèche F3 à la figure 7, pour déplacer le piston 36 à l'intérieur du corps de seringue 32 et éjecter ainsi le solvant liquide L contenu dans le volume interne V32 du corps de seringue 32 vers le récipient 22. Plus précisément, le solvant liquide L traverse le canal central de la partie d'extrémité 320 du corps de seringue 32, le volume interne du porte-aiguille 18, le canal central de l'aiguille creuse 180, le volume interne V144 de l'organe creux de perforation 144 et enfin les ouvertures 146 pour rejoindre le volume interne V22 du flacon 22. Le transfert du liquide L entre le contenant 30 et le récipient 20 est représenté par les flèches F4 à la figure 7. L'ensemble de connexion 1 se trouve alors dans la configuration de la figure 8, dans laquelle le médicament M est reconstitué.A third stage represented at Figures 7 and 8 consists in injecting the liquid solvent L inside the container 20. To do this, the user pushes the plunger rod 34 inside the syringe body 32. In other words, he presses on the push pallet 340 of the rod 34 in the direction of the container 20, that is to say in the direction of the arrow F3 at the 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 towards the container 22. More precisely, the liquid solvent L passes through the central channel of the end portion 320 of the syringe body 32, the internal volume 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 represented by the arrows F4 at the figure 7 . The connection assembly 1 is then in the configuration of the figure 8 , in which drug M is reconstituted.

Une quatrième étape représentée aux figures 8 et 9 consiste à transférer le médicament reconstitué M du récipient 20 au contenant 30. Pour ce faire, l'utilisateur retourne l'ensemble de connexion 1, comme représenté par la flèche F5 à la figure 8, éventuellement secoue le récipient 20 pour bien dissoudre le lyophilisat P à l'intérieur du solvant L et tire sur la tige 34 vers l'extérieur du corps de seringue 32, c'est-à-dire dans le sens de la flèche F7 à la figure 9. Dans la configuration retournée de la figure 9, le médicament reconstitué M s'écoule, sous l'effet de la dépression générée par le déplacement du joint de piston 36 à l'intérieur du corps 32, vers le volume interne V32 du corps de seringue 32. Plus précisément, le médicament M traverse les ouvertures 146, le volume interne V144 de l'organe creux 144 et le canal central de l'aiguille creuse 180 pour rejoindre le volume interne du porte-aiguille 18, à partir duquel il peut s'écouler dans le corps de seringue 32 par la partie d'extrémité 320. Le transfert du médicament M du récipient 20 au contenant 30 est représenté par la flèche F6 à la figure 9.A fourth stage represented at figures 8 and 9 consists in 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 to the figure 8 , optionally shakes the container 20 to dissolve the lyophilisate P well 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 to the figure 9 . In the returned configuration of the figure 9 , the reconstituted medicament M flows, under the effect of the vacuum generated by the displacement of the piston seal 36 inside the body 32, towards the internal volume V32 of the syringe body 32. More precisely, the medicament M passes through the openings 146, the internal volume V144 of the hollow member 144 and the central channel of the hollow needle 180 to reach the internal volume of the needle holder 18, from which it can flow into the syringe body 32 by the end portion 320. The transfer of the drug M from the container 20 to the container 30 is represented by the arrow F6 at the figure 9 .

Lorsque le médicament M a été entièrement transféré du récipient 20 au contenant 30, l'utilisateur peut déconnecter le contenant 30 et le récipient 20, comme représenté par les flèches F8 à la figure 10. Le contenant 30 emmène alors avec lui le porte-aiguille 18, le collier 16 dans lequel est vissé le porte-aiguille 18 et le fourreau de protection 11, qui est attaché au collier 16. En revanche, l'embase 14 demeure attachée au récipient 20. Ainsi, le porte-aiguille 18 est détaché de l'embase 14. La partie détachée du récipient 20 forme une seringue S prête à l'emploi.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 at the figure 10 . The container 30 then takes with it the needle holder 18, the collar 16 into which the needle holder 18 is screwed and the protective sheath 11, which is attached to the collar 16. On the other hand, 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.

Après déconnexion, c'est-à-dire dans une configuration où le porte-aiguille 18 est détaché de l'embase 14, le fourreau de protection 11 se déplace de la position préliminaire vers une première position sous l'effort de rappel exercé par le ressort 15. Ce déplacement est représenté par la flèche F9 à la figure 10. Lors de ce déplacement, les pions 160 rejoignent alors le fond de la branche 110a des ouvertures 110. Dans la première position, le fourreau 11 recouvre l'aiguille 180, de manière à prévenir une piqûre accidentelle avant injection et à protéger mécaniquement l'aiguille 180 de la casse, c'est-à-dire en cas de chute de la seringue S ou de collision avec un objet. Le fourreau 11 et le ressort 15 forment donc un système de sécurité visant à protéger l'aiguille 180 avant une injection.After disconnection, that is to say in a configuration where the needle holder 18 is detached from the base 14, the protective sheath 11 moves from the preliminary position to a first position under the restoring force exerted by the spring 15. This displacement is represented by arrow F9 at the figure 10 . During this movement, the pins 160 then join the bottom of the branch 110a of the openings 110. In the first position, the sheath 11 covers the needle 180, so as to prevent an accidental puncture before injection and to mechanically protect the needle 180 of the case, that is to say in case of fall of the syringe S or collision with an object. The sheath 11 and the spring 15 therefore form a safety system intended to protect the needle 180 before an injection.

Lors d'une injection, l'utilisateur presse la seringue S contre l'épiderme du patient, ce qui fait reculer le fourreau de protection 11 au contact de la peau, à l'encontre de l'effort élastique du ressort 15, de sa première position vers une deuxième position. Ce déplacement est représenté par les flèches F10 à la figure 12. L'aiguille 180 est alors découverte et le ressort 15 est comprimé. Chaque pion 160 se déplace du fond de la première branche 110a vers le fond du couloir 110c de l'ouverture radiale 110 correspondante. Cela a pour effet de faire tourner le fourreau 11 autour de son axe X11, comme représenté par la flèche R10 à la figure 12. L'utilisateur appuie ensuite sur la tige 34 du contenant 30 pour éjecter le médicament M dans le corps du patient.During an injection, the user presses the syringe S against the patient's epidermis, which causes the protective sheath 11 to move back in contact with the skin, against the elastic force of the spring 15, of its first position to a second position. This displacement is represented by the arrows F10 at the figure 12 . The needle 180 is then uncovered and the spring 15 is compressed. Each pin 160 moves from the bottom of the first branch 110a to the bottom of the corridor 110c of the corresponding radial opening 110. This has the effect of rotating the sheath 11 around its axis X11, as represented by the arrow R10 at the figure 12 . The user then presses on the stem 34 of the container 30 to eject the drug M into the patient's body.

Lorsque l'injection est terminée et que la seringue S est retirée du corps du patient, le fourreau de protection 11 se déplace de sa deuxième position vers sa première position sous l'action du ressort 15. Chaque pion 160 se déplace alors du fond du couloir 110c vers le fond de la branche 110b de de l'ouverture radiale 110 correspondante. Cela a pour effet de faire tourner le fourreau 11 autour de son axe X11. La seringue S est alors dans la configuration des figures 14 et 15. Le fourreau 11 protège alors l'aiguille 180 après l'injection, de manière à prévenir une piqûre accidentelle et la transmission de maladies, comme le VIH.When the injection is complete and the syringe S is withdrawn from the patient's body, the protective sheath 11 moves from its second position to its first position under the action of the spring 15. Each pin 160 then moves from the bottom of the corridor 110c towards the bottom of the branch 110b of the corresponding radial opening 110. This has the effect of rotating the sheath 11 around its axis X11. The syringe S is then in the configuration of the Figures 14 and 15 . The sheath 11 then protects the needle 180 after the injection, so as to prevent an accidental injection and the transmission of diseases, such as HIV.

Chaque ouverture 110 est conformée de sorte que, lorsque le fourreau 11 recule de sa première position vers sa première position et revient dans sa première position, il pivote autour de l'axe X11 dans le sens antihoraire lorsque l'on regarde du côté de l'aiguille 180. Ainsi, le fourreau 11 exerce, en pivotant autour de son axe X11, un couple sur le collier 16 qui est dirigé dans le sens antihoraire. Avantageusement, ce couple tend à visser davantage le porte-aiguille 18 à l'intérieur du collier 16. Ainsi, le porte-aiguille 18 ne risque pas de se dévisser pendant une injection. Autrement dit, le fourreau 11 tourne dans le sens du vissage du porte-aiguille 18.Each opening 110 is shaped so that, when the sheath 11 moves back from its first position to its first position and returns to its first position, it pivots around the axis X11 counterclockwise when looking from the side of the needle 180. Thus, the sheath 11 exerts, by pivoting about its axis X11, a torque on the collar 16 which is directed counterclockwise. Advantageously, this couple tends to screw the needle holder 18 more inside the collar 16. Thus, the needle holder 18 does not risk unscrewing during an injection. In other words, the sheath 11 rotates in the direction of screwing of the needle holder 18.

Comme représenté aux figures 14 et 15, après l'injection, le fourreau 11 est verrouillé dans sa première position. En effet, si l'on tente de reculer le fourreau 11, chaque pion 160 s'engage dans une portion terminale correspondante 110d s'étendant axialement en direction du couloir 110c et définissant l'extrémité libre de la branche 110b. Cette portion terminale 110d forme donc un logement de réception du pion 160. Le mouvement axial du fourreau 11 est alors bloqué par coopération des pions 160 avec le fond des logements 110d. Ainsi, une seringue S usagée, c'est-à-dire ayant déjà servi, ne peut plus être utilisée car on ne peut plus découvrir l'aiguille 180. La portion terminale 110d de la deuxième branche 110b forme donc des moyens de verrouillage, configurés pour bloquer le déplacement axial du fourreau 11 lorsque celui-ci est rappelé dans sa première position, c'est-à-dire dans la configuration de la figure 15. Autrement dit, les moyens de verrouillage sont configurés pour empêcher le fourreau de revenir dans sa deuxième position.As shown in Figures 14 and 15 , after injection, the sleeve 11 is locked in its first position. Indeed, if an attempt is made to move the sheath 11 back, each pin 160 engages in a corresponding terminal portion 110d extending axially in the direction of the passage 110c and defining the free end of the branch 110b. This terminal portion 110d therefore forms a housing for receiving the pin 160. The axial movement of the sleeve 11 is then blocked by cooperation of the pins 160 with the bottom of the housings 110d. Thus, a used syringe S, that is to say one that has already been used, can no longer be used because the needle 180 can no longer be discovered. The terminal portion 110d of the second branch 110b therefore forms locking means, configured to block the axial movement of the sleeve 11 when the latter is returned to its first position, that is to say in the configuration of the figure 15 . In other words, the locking means are configured to prevent the sheath from returning to its second position.

Dans l'exemple des figures, la position préliminaire est une position à mi-chemin entre la première position et la deuxième position. Le fourreau 11 est alors plus court et moins large que si le dispositif était agencé de telle sorte que le fourreau 11 serait dans la première position en configuration montée sur le récipient 20. Cette position à mi-chemin limite donc l'encombrement du dispositif 10 dans le sens radial et axial.In the example of the figures, the preliminary position is a position halfway between the first position and the second position. The sheath 11 is then shorter and narrower than if the device were arranged so that the sheath 11 would be in the first position in the configuration mounted on the container 20. This half-way position therefore limits the size of the device 10 in the radial and axial direction.

En variante non représentée, un autre système est utilisé pour connecter le porte-aiguille 18 au corps de seringue 32. Par exemple, il peut s'agir d'un système vissé, du type « luer lock » en anglais (marque déposée). Ce système a pour avantage que le porte-aiguille 18 est facilement démontable.In a variant 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, of the “luer lock” type in English (registered trademark). This system has the advantage that the needle holder 18 is easily removable.

En variante non représentée, un contenant 30 autre qu'un corps de seringue est utilisé.Alternatively not shown, a container 30 other than a syringe body is used.

Les caractéristiques du mode de réalisation principal et des variantes envisagées ci-dessus peuvent être combinées entre elles pour générer de nouveaux modes de réalisation de l'invention.The characteristics of the main embodiment and of the variants envisaged above can be combined with one another to generate new embodiments of the invention.

Claims (15)

  1. A connecting device (10) between a vessel (20) closed off by a perforable stopper (26) and a container (30), such as a syringe body, this device comprising:
    - a base (14), which is configured to be mounted on the vessel and which comprises a hollow member (144) for perforating the stopper, this hollow member delimiting at least one opening (146), and
    - a needle holder (18), which is detachably connected relative to the base (14), which is waiting to be connected with the container, and which includes a hypodermic needle (180), one end (180a) of which emerges in the inner volume (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 (11), which is connected to the collar (16) and which defines a central axis (X11) along which the sheath is movable relative to the collar and around the latter, against a resilient force exerted by return means (15).
  2. The device according to claim 1, characterized in that the return means comprise a spring (15) inserted axially between the collar (16) and an inner radial shoulder of the sheath (11).
  3. The 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 (110) of the sheath (11).
  4. The device according to claim 3, characterized in that each opening (110) has a first branch (110a) and a second branch (110b) that each extend from an axial corridor (110c), the first branch, the second branch and the corridor together forming a "Y".
  5. The 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 provide sealed communication between the inner volume (V144) of the hollow member (144) and a central channel of the needle (180).
  6. The 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) of the sleeve (13) traversed by the needle (180).
  7. The device according to one of the preceding claims, characterized in that, in one configuration where the needle holder (18) is detached from the base (14), the sheath is movable between a first position where it covers the needle (180) and a second position, where the needle is exposed, and in that the return means (15) are configured to return the sheath to its first position.
  8. The device according to claim 7, characterized in that the device comprises means (110d) for locking the sheath (11) in the first position, configured to prevent the sheath (11) from returning toward its second position.
  9. The 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 (110) is configured such that, when the sheath (11) is returned to its first position, it pivots around its axis (X11) in the screwing direction of the needle holder (18).
  10. The device according to one of the preceding claims, characterized in that the needle holder (18) is screwed inside the collar (16).
  11. The device according to one of the preceding claims, characterized in that the sheath (11) cannot be deformed in compression in the direction of the central axis (X11).
  12. The device according to one of the preceding claims, characterized in that the sheath (11) comprises two opposite orifices along the central axis (X11).
  13. The device according to one of the preceding claims, characterized in that the needle holder (18) comprises a frustoconical inner surface, to receive an end part (320) of the container (32) and is sized to be fitted forcibly around said end part.
  14. A connecting assembly (1), comprising a vessel (20) closed off by a perforable stopper (26), a container (30) and a connecting device (10) according to one of the preceding claims.
  15. A method for filling a container (30) intended to be equipped with a needle (180) with a product contained in a vessel (20) closed off by a perforable stopper (26), this method being characterized in that it comprises the following steps:
    a) mounting a connecting device (10) according to one of claims 1 to 8 on the vessel (20) to perforate the stopper (128) with the perforating member (144),
    b) connecting (F2) the container (30) with the needle holder (18),
    c) injecting (F3) a liquid (L) present in the container (20) into the vessel (20), through the central channel of the needle (180) and the inner volume (V144) of the perforating member (144),
    d) arranging (F5) the vessel (20), the connecting device (10) and the container (30) in a position where the contents of the vessel flow toward the inner volume (V32) of the container (30), through the inner volume (V144) of the perforating member (144) and the central channel of the needle (180), and
    e) disconnecting (F8) the container (30) and the vessel (20), the needle holder (18) then being removed from the base (14) and the sheath (11) being maintained or returned by the return means (15) into a first position where it covers the needle (180).
EP16806018.4A 2015-11-30 2016-11-29 Device for connecting a vessel and a container and connection assembly including such a device Active EP3383342B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL16806018T PL3383342T3 (en) 2015-11-30 2016-11-29 Device for connecting a vessel and a container and connection assembly including such a device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1561578A FR3044218B1 (en) 2015-11-30 2015-11-30 DEVICE FOR CONNECTION BETWEEN A CONTAINER AND A CONTAINER, CONNECTION ASSEMBLY COMPRISING SUCH A DEVICE
PCT/EP2016/079117 WO2017093243A1 (en) 2015-11-30 2016-11-29 Device for connecting a vessel and a container and connection assembly including such a device

Publications (2)

Publication Number Publication Date
EP3383342A1 EP3383342A1 (en) 2018-10-10
EP3383342B1 true EP3383342B1 (en) 2020-03-11

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP16806018.4A Active EP3383342B1 (en) 2015-11-30 2016-11-29 Device for connecting a vessel and a container and connection assembly including such a device

Country Status (12)

Country Link
US (1) US10912715B2 (en)
EP (1) EP3383342B1 (en)
JP (1) JP6949020B2 (en)
CN (1) CN108430428B (en)
AU (1) AU2016361823B2 (en)
BR (1) BR112018010956B1 (en)
CA (1) CA3006648C (en)
ES (1) ES2790878T3 (en)
FR (1) FR3044218B1 (en)
PL (1) PL3383342T3 (en)
RU (1) RU2729640C2 (en)
WO (1) WO2017093243A1 (en)

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1173370B (en) 1984-02-24 1987-06-24 Erba Farmitalia SAFETY DEVICE TO CONNECT A SYRINGE TO THE MOUTH OF A BOTTLE CONTAINING A DRUG OR A TUBE FOR DISPENSING THE SYRINGE DRUG
ES2082052T3 (en) 1990-07-19 1996-03-16 Nardino Righi SAFETY SYRINGE, SINGLE USE.
SE517084C2 (en) * 2000-08-10 2002-04-09 Carmel Pharma Ab Procedures and devices for aseptic preparation
US8454573B2 (en) * 2008-05-06 2013-06-04 Philip Wyatt Medicament administration apparatus
EP1909735A1 (en) * 2005-08-01 2008-04-16 Medimop Medical Projects Ltd. Liquid drug delivery system
FR2930161B1 (en) * 2008-04-16 2011-05-13 Becton Dickinson France NEEDLE PROTECTIVE ARRANGEMENT HAVING A RADIALLY MOBILE LOCKING ELEMENT.
CN100563740C (en) * 2006-09-28 2009-12-02 明辰股份有限公司 Safe medicament injection apparatus for medical and be used for the push bar assembly of medical medicine injection
JP2011519700A (en) * 2008-05-06 2011-07-14 ハイポセーフ インヴェストメンツ（プロプライエタリー）リミテッド Hypodermic needle protector
US8864725B2 (en) * 2009-03-17 2014-10-21 Baxter Corporation Englewood Hazardous drug handling system, apparatus and method
CA2695265A1 (en) 2010-03-02 2011-09-02 Duoject Medical Systems Inc. Injection device
FR2975896B1 (en) * 2011-06-06 2014-06-06 Biocorp Rech Et Dev DEVICE FOR CONNECTION BETWEEN A CONTAINER AND A CONTAINER, METHOD FOR ASSEMBLING AND USING SUCH A DEVICE
US10022301B2 (en) * 2013-03-15 2018-07-17 Becton Dickinson and Company Ltd. Connection system for medical device components
US9414990B2 (en) 2013-03-15 2016-08-16 Becton Dickinson and Company Ltd. Seal system for cannula

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

Also Published As

Publication number Publication date
RU2729640C2 (en) 2020-08-11
US20190175450A1 (en) 2019-06-13
JP2018537186A (en) 2018-12-20
JP6949020B2 (en) 2021-10-13
AU2016361823B2 (en) 2021-02-25
FR3044218B1 (en) 2017-12-29
CA3006648A1 (en) 2017-06-08
RU2018119668A (en) 2019-12-04
AU2016361823A1 (en) 2018-06-21
ES2790878T3 (en) 2020-10-29
CA3006648C (en) 2023-09-19
CN108430428A (en) 2018-08-21
BR112018010956B1 (en) 2022-07-05
RU2018119668A3 (en) 2020-03-02
EP3383342A1 (en) 2018-10-10
CN108430428B (en) 2021-05-28
BR112018010956A2 (en) 2018-12-04
FR3044218A1 (en) 2017-06-02
WO2017093243A1 (en) 2017-06-08
PL3383342T3 (en) 2020-09-07
US10912715B2 (en) 2021-02-09

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