EP3383342B1 - Vorrichtung zur verbindung eines behälters und behälter und verbindungsanordnung mit solch einer vorrichtung - Google Patents

Vorrichtung zur verbindung eines behälters und behälter und verbindungsanordnung mit solch einer vorrichtung 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
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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
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English (en)
French (fr)
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EP3383342A1 (de
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
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Priority to PL16806018T priority Critical patent/PL3383342T3/pl
Publication of EP3383342A1 publication Critical patent/EP3383342A1/de
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Publication of EP3383342B1 publication Critical patent/EP3383342B1/de
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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.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Claims (15)

  1. Vorrichtung (10) zur Verbindung eines durch einen perforierbaren Stopfen (26) abgedichteten Gefäßes (20) mit einem Behälter (30), wie z. B. einem Spritzenkörper, wobei die Vorrichtung Folgendes umfasst:
    - eine Basis (14), die dazu ausgebildet ist, auf dem Gefäß befestigt zu werden, und die einen Hohlkörper (144) zum Perforieren des Stopfens umfasst, wobei der Hohlkörper mindestens eine Öffnung (146) eingrenzt, und
    - einen mit der Basis (14) lösbar verbundenen Nadelhalter (18), der zur Verbindung mit dem Behälter bereit steht und der eine Injektionsnadel (180) umfasst, deren eines (180a) ihrer Enden in das Innenvolumen (V144) des Hohlkörpers (144) mündet,
    dadurch gekennzeichnet, dass die Vorrichtung (10) des Weiteren Folgendes umfasst:
    - eine an dem Nadelhalter (18) angebrachte Schelle (16), und
    - eine Hülse (11), die mit der Schelle (16) verbunden ist und die eine Mittelachse (X11) definiert, entlang der die Hülse relativ zu der Schelle und um diese herum gegen eine durch Rückstellmittel (15) ausgeübte elastische Kraft bewegbar ist.
  2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Rückstellmittel eine axial zwischen der Schelle (16) und einem radialen Innenvorsprung der Hülse (11) angeordnete Feder (15) umfassen.
  3. Vorrichtung nach Anspruch 2, dadurch gekennzeichnet, dass die Schelle (16) mindestens einen radialen Zapfen (160) umfasst, der in eine entsprechende radiale Öffnung (110) der Hülse (11) eingreift.
  4. Vorrichtung nach Anspruch 3, dadurch gekennzeichnet, dass jede Öffnung (110) eine erste Abzweigung (110a) und eine zweite Abzweigung (110b) umfasst, die jeweils von einem axialen Verbindungsgang (110c) abzweigen, wobei die erste Abzweigung, die zweite Abzweigung und der Verbindungsgang zusammen ein "Y" bilden.
  5. Vorrichtung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Vorrichtung eine Dichtungsmuffe (13) umfasst, die von der Nadel (180) durchdrungen ist und die im Inneren der Basis (14) fixiert ist, derart, dass eine dichte Verbindung zwischen dem Innenvolumen (V144) des Hohlkörpers (144) und einem zentralen Kanal der Nadel (180) gewährleistet ist.
  6. Vorrichtung nach Anspruch 5, dadurch gekennzeichnet, dass die Nadel (180) ein abgeschrägtes Ende (180a) aufweist, welches eine Höhe (h180a) aufweist, die größer oder gleich der Höhe (h130) einer Wand (130) der von der Nadel (180) durchdrungenen Muffe (13) ist.
  7. Vorrichtung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Hülse, in einer Anordnung, in der der Nadelhalter (18) von der Basis (14) gelöst ist, zwischen einer ersten Position, in der die Hülse die Nadel (180) verdeckt, und einer zweiten Position, in der die Nadel offen herausragt, bewegbar ist, und dass die Rückstellmittel (15) dazu ausgebildet sind, die Hülse in ihre erste Position zurückzustellen.
  8. Vorrichtung nach Anspruch 7, dadurch gekennzeichnet, dass die Vorrichtung in der ersten Position Verriegelungseinrichtungen (110d) der Hülse (11) umfasst, die dazu ausgebildet sind, zu verhindern, dass die Hülse (11) in ihre zweite Position zurückkehrt.
  9. Vorrichtung nach Anspruch 7 oder 8, dadurch gekennzeichnet, dass der Nadelhalter (18) in das Innere der Schelle (16) eingeschraubt ist, und dass jede Öffnung (110) derart ausgebildet ist, dass die Hülse (11) sich in Einschraubrichtung des Nadelhalters (18) um ihre Achse (X11) dreht, wenn sie in ihre erste Position zurückgestellt wird.
  10. Vorrichtung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass der Nadelhalter (18) in das Innere der Schelle (16) eingeschraubt ist.
  11. Vorrichtung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Hülse (11) unter Druck in Richtung der Mittelachse (X11) formstabil ist.
  12. Vorrichtung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Hülse (11) entlang der Mittelachse (X11) zwei gegenüberliegende Öffnungen umfasst.
  13. Vorrichtung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass der Nadelhalter (18) eine kegelförmige Innenfläche umfasst, um einen Endabschnitt (320) des Behälters (32) aufzunehmen, und so bemessen ist, dass er um den Endabschnitt herum einpressbar ist.
  14. Verbindungsanordnung (1), umfassend ein durch einen perforierbaren Stopfen (26) abgedichtetes Gefäß (20), einen Behälter (30) und eine Verbindungsvorrichtung (10) nach einem der vorhergehenden Ansprüche.
  15. Verfahren zum Befüllen eines zur Bestückung mit einer Nadel (180) vorgesehenen Behälters (30) mit einem in einem durch einen perforierbaren Stopfen (26) abgedichteten Gefäß (20) enthaltenen Produkt, wobei das Verfahren dadurch gekennzeichnet ist, dass es die folgenden Schritte umfasst:
    a) Befestigen einer Verbindungsvorrichtung (10) nach einem der Ansprüche 1 bis 8 auf dem Gefäß (20), um den Stopfen (128) mit dem Perforationskörper (144) zu perforieren,
    b) Verbinden (F2) des Behälters (30) mit dem Nadelhalter (18),
    c) Einspritzen (F3) einer im Behälter (30) vorhandenen Flüssigkeit (L) in das Gefäß (20) über den zentralen Kanal der Nadel (180) und das Innenvolumen (V144) des Perforationskörpers (144),
    d) Anordnen (F5) des Gefäßes (20), der Verbindungsvorrichtung (10) und des Behälters (30) in einer Position, in der der Inhalt aus dem Gefäß über das Innenvolumen (V144) des Perforationskörpers (144) und den zentralen Kanal der Nadel (180) in Richtung des inneren Volumens (V32) des Behälters (30) fließt, und
    e) Trennen (F8) des Behälters (30) und des Gefäßes (20), wobei der Nadelhalter (18) dann von der Basis (14) entfernt wird und die Hülse (11) von den Rückstellmitteln (15) in einer ersten Position, in der sie die Nadel (180) verdeckt, gehalten wird oder in diese zurückgestellt wird.
EP16806018.4A 2015-11-30 2016-11-29 Vorrichtung zur verbindung eines behälters und behälter und verbindungsanordnung mit solch einer vorrichtung Active EP3383342B1 (de)

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FR1561578A FR3044218B1 (fr) 2015-11-30 2015-11-30 Dispositif de connexion entre un recipient et un contenant, ensemble de connexion comprenant un tel dispositif
PCT/EP2016/079117 WO2017093243A1 (fr) 2015-11-30 2016-11-29 Dispositif de connexion entre un récipient et un contenant et ensemble de connexion comprenant un tel dispositif

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CA (1) CA3006648C (de)
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ATE129906T1 (de) 1990-07-19 1995-11-15 Nardino Righi Sicherheitsspritze zum einmaligen gebrauch.
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RU2018119668A3 (de) 2020-03-02
BR112018010956B1 (pt) 2022-07-05
JP6949020B2 (ja) 2021-10-13
FR3044218B1 (fr) 2017-12-29
ES2790878T3 (es) 2020-10-29
CA3006648C (fr) 2023-09-19
US10912715B2 (en) 2021-02-09
PL3383342T3 (pl) 2020-09-07
FR3044218A1 (fr) 2017-06-02
BR112018010956A2 (pt) 2018-12-04
CA3006648A1 (fr) 2017-06-08
US20190175450A1 (en) 2019-06-13
CN108430428A (zh) 2018-08-21
WO2017093243A1 (fr) 2017-06-08
EP3383342A1 (de) 2018-10-10
CN108430428B (zh) 2021-05-28
RU2729640C2 (ru) 2020-08-11
AU2016361823A1 (en) 2018-06-21
AU2016361823B2 (en) 2021-02-25
JP2018537186A (ja) 2018-12-20
RU2018119668A (ru) 2019-12-04

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