Connector for connecting a medical injection device and a container and assembly comprising said connector and a medical injection device

Abstract

The invention relates to a connector for connecting a medical injection device (40) having a distal tip (42), a needle (47) extending from the distal tip and a sleeve (44) extending around the needle, the sleeve (44) comprising an internally threaded portion (45), to a container (60) comprising a cannula (62) closed by a pierceable septum (63), said connector (2) comprising: - a proximal portion (10) configured to be in sealing engagement with the tip (42) of the injection device (40) so as to at least enclose a portion of the needle (47), the proximal portion (10) comprising an externally threaded portion (13) configured to be detachably screwed to the internally threaded portion (45) of the sleeve; - a distal portion (20) configured to be connected to the container (60) comprising a skirt (22) configured to extend around the needle when the connector (2) is connected to the injection device (40), the skirt (22) being adapted to at least enclose the cannula (62) of the container (60) when connected to said container; - a needle shield (50) configured to be mounted on the needle (47) so as to at least sealingly enclose the tip of the needle, the needle shield (50) extending through the skirt (22) comprising a closed distal portion (52) and a proximal portion (53) comprising an opening (54), the needle shield (50) being configured to be pierced by the needle inserted through the opening (54) so as to sealingly enclose said needle.

Description

Technical Field

[0001] This invention relates to a connector for connecting a medical injection device and a container. The invention also relates to an assembly including the connector and the medical injection device, and a method for filling the container with a component contained within the medical injection device by connecting the medical injection device to the container using the connector. Background Technology

[0002] In the field of pharmaceutical packaging, it is known to store drug contents (e.g., in the form of lyophilized drugs, potent drugs, or the active substance of a drug) in medical containers commonly referred to as "vials." Vials are typically made of glass and sealed with an elastomeric diaphragm clamped by an aluminum cap. A portion of the elastomeric core at the diaphragm's center is covered by a plastic or aluminum portion that can be removed by a healthcare professional before a reassembly step, allowing access to the central portion of the rubber that can be pierced by the needle of an injection device such as a syringe.

[0003] To reconstitute medication, users typically use a disposable plastic syringe to transfer the diluent from ampoules or vials to vials containing lyophilized or potent medications. When the diluent is already stored in a pre-filled syringe, usually made of glass, healthcare professionals transfer it directly from the syringe to the vial containing the lyophilized or potent medication. This transfer is performed by puncturing the rubber septum of the vial with a needle.

[0004] However, this process involves quite a few steps.

[0005] Furthermore, the tip of the needle may be damaged during the procedure due to the removal of the needle guard, insertion of the septum into the vial, and / or misalignment during needle insertion. A damaged or bent needle may cause injury to the patient during medication administration.

[0006] Another major drawback of the known procedure is that the syringe needle is free and unprotected during the recombination process. This poses a high risk of accidents to the user, the patient, or anyone in the vicinity who may come into contact with the needle, and could result in needlestick injuries.

[0007] Furthermore, when a user extracts the recombinant drug from the vial using a needle, the length of the needle inserted into the vial needs to be adjusted as the amount of drug in the vial decreases. In practice, the user needs to slowly withdraw the needle from the container by pulling the syringe away from the vial, ensuring that the opening of the needle remains in contact with the drug; in other words, keeping the opening of the needle below the surface of the drug.

[0008] Not only is this operation difficult to perform, but the movement of the needle within the vial can also lead to the loss of a significant amount of medication remaining in the vial.

[0009] Document WO2012 / 168235 describes a connection device comprising a subassembly including a plug for connection to a medical container, a needle extending from the plug, a sealing sleeve surrounding the needle, and a base with a penetrating element. The base defines an internal volume configured to accommodate the subassembly. The penetrating element is configured to pierce a septum of a vial, defines an internal volume suitable for accommodating the needle, and includes an opening for transferring an ingredient from the medical container connected to the needle into the vial to reconstitute a drug contained in the vial.

[0010] However, this connector cannot be connected to a pre-filled syringe filled with diluent for long-term storage; it is only designed for temporary storage as a disposable device. In fact, the needle is not sealed when the connector is connected to the syringe. Therefore, the sterility of the contents of the syringe cannot be guaranteed.

[0011] Furthermore, the penetrating element is exposed, posing a risk of injury to the user or anyone around the device.

[0012] Other examples of connecting devices are given in WO2006 / 099441, EP0499481, WO2017 / 009822 and EP3067037. Summary of the Invention

[0013] The object of this invention is to provide a connector that overcomes the disadvantages detailed above. In this regard, the object of this invention is to provide a connector for connecting pre-filled medical injection devices (such as syringes or similar devices) to containers (such as vials or similar devices) that is more intuitive to use and set up, includes a reduced number of components, and reduces the total number of steps involved in transferring recombinant drugs.

[0014] Therefore, one object of the present invention is a connector for connecting a medical injection device having a distal end, a needle extending from the distal end, and a sleeve (including an internally threaded portion) extending around the distal end to a container comprising a cannula closed by an insertable septum, said connector comprising:

[0015] - A proximal portion, configured to seal into the end of the medical injection device to surround at least a portion of the needle, the proximal portion including an externally threaded portion configured to be removably screwed into an internally threaded portion of the sleeve;

[0016] - A distal portion, configured to connect to the container, the distal portion including a skirt configured to extend around the needle when the connector is connected to the medical injection device, the skirt being adapted to at least surround the cannula of the container when connected to the container, and

[0017] - A needle guard, configured to be mounted on the needle to at least seal around the end of the needle, the needle guard extending through the skirt and including a closed distal portion and a proximal portion including an opening, the needle guard being configured to be inserted through the opening to seal around the needle.

[0018] The threaded portion of the sleeve and the proximal portion of the connector ensure a tight, reliable, and sealed connection between the injection unit and the connector, preventing any leakage of flowing components between the injection unit and the connector. This is particularly important for pre-filled syringes stored for extended periods. Furthermore, screwing the connector onto and off the injection unit is easy and quick, and requires no physical force, for example, compared to snap-fit ​​connections.

[0019] Other optional features of the device according to the invention,

[0020] The needle extends at most half the length of the skirt, preferably at most one-third of the skirt length. Since only a small portion of the needle is accessible, the risk of damaging or bending the needle when it pierces the diaphragm of the container is limited. Because the skirt completely covers the needle, especially the tip, the risk of pricking the user, patient, or anyone nearby is also limited.

[0021] - The skirt includes at least one radially inwardly extending edge, which is configured to engage with a recess in the sleeve of the container when the skirt is connected to the container;

[0022] - When connected to a container, the skirt is adapted to deflect radially outward;

[0023] - The skirt is provided with a plurality of flexible tabs spaced apart by grooves, which are configured to deflect radially outward when the skirt is connected to the container;

[0024] - The needle guard protrudes from the skirt to the far side;

[0025] - The skirt includes a flange, and the proximal portion of the needle shield is configured to be sealed and at least partially inserted into a groove provided in the flange, such that the proximal portion of the needle shield abuts the inner surface of the groove in the radial direction.

[0026] - The needle guard also includes a ring that projects radially outward from the body of the needle guard, the ring being configured to abut against the skirt when the needle guard is mounted on the needle to secure the needle guard to the needle;

[0027] - The ring is configured to abut against the edge of the skirt when the needle guard is mounted on the needle;

[0028] - The ring and needle guard are integrated;

[0029] - The distal portion of the needle guard includes a grip portion configured to protrude distally away from the skirt when the needle guard is mounted on the needle, and configured to be manipulated by a user to mount or remove the needle guard from the needle.

[0030] - The gripping part includes a stem protruding from the skirt and a flange that is substantially perpendicular to the stem, which serves as a handle and is configured to be gripped by the user's fingers to manipulate the needle guard.

[0031] - The proximal and distal portions of the connector are formed as a single piece.

[0032] Another object of the present invention is a component comprising:

[0033] - A medical injection device, the medical injection device comprising a barrel, a distal end extending from the barrel, and a sleeve extending around the distal end, the sleeve having an internally threaded portion, and

[0034] -The aforementioned connector,

[0035] The proximal portion of the connector is threadedly engaged with the internal thread portion of the sleeve and is sealed to the end of the medical injection device.

[0036] According to a preferred embodiment of the component, the cylinder, the end, and the sleeve are integrally formed as a single piece.

[0037] The present invention also relates to a method for transferring an ingredient from a container sealed by a puncture-resistant septum to a medical injection device, the method comprising the following steps:

[0038] - Provide a pre-filled medical injection device having an end and a sleeve extending around the end, the sleeve including a threaded portion, and provide a connector as described above, the connector being screwed to the end through the threaded portion of the sleeve;

[0039] Remove the needle guard from the needle to expose the needle;

[0040] - The connector is connected to the container by engaging the distal portion of the connector with the container, thereby inserting the needle into the diaphragm of the container;

[0041] - The first component contained in the medical injection device is transferred to the container via the needle;

[0042] - Mix the first component with the second component contained in the container;

[0043] - Draw the mixed ingredients back from the container into the medical injection device, and unscrew the medical injection device from the connector. Attached Figure Description

[0044] Further features and advantages of the invention will become apparent from the detailed description following with reference to the accompanying drawings, in which:

[0045] Figure 1A This is a side sectional view of an embodiment of the connector of the present invention, without a pin guard.

[0046] Figure 1B yes Figure 1A Overall 3D view of the connector.

[0047] Figure 2 This is a side sectional view of a needle guard configured to be mounted on a needle of a connector for sealingly enclosing at least the end of the needle.

[0048] Figure 3 This is a side perspective view of a component of the present invention, which is obtained by connecting a connector to a medical injection device, wherein the medical injection device has an end with a needle attached thereto, and the medical injection device also has a sleeve extending around the end, wherein a needle guard is aligned with and maintains a certain distance from the needle.

[0049] Figure 4 yes Figure 3 A 3D view of the components.

[0050] Figure 5 This is a side perspective view of the component, in which a needle guard is mounted on the needle of a medical container.

[0051] Figure 6 yes Figure 5 A 3D view of the components.

[0052] Figure 7 yes Figure 5 A side sectional view of the component.

[0053] Figure 8 This is a side view of the assembly after the needle shield has been removed, showing the injection device connected to a container via a connector to transfer a first component contained within the injection device.

[0054] Figure 9 This is a side sectional view of the component connected to the medical container.

[0055] Figure 10 This is a side view of the injection device and connector, where the injection device is removed from the connector after the component is extracted, while the connector remains connected to the container.

[0056] Figure 11This is a side view of the injection device and connector, with the injection device completely removed from the connector.

[0057] Figure 12 This is a side view of a component of the present invention. Detailed Implementation

[0058] The first object of the present invention is a connector for connecting a medical injection device to a container sealed by an insertable septum. Figure 1A and 1B This describes the implementation scheme of the connector.

[0059] The connector and injection device are connected to each other to form a component. Figures 3 to 7 The implementation schemes of this component are presented from different perspectives.

[0060] Connector 2 connects to injection device 40, which is equipped with needle 47. The needle 47 is configured to pierce the septum 63 of the container when the distal portion 20 is connected to the container. The injection device is preferably a pre-filled syringe.

[0061] Reference Figure 1A and 1B Up to 7, connector 2 extends along longitudinal axis A. Connector 2 includes: a proximal portion 10 configured to connect to end 42 of injection device 40; a distal portion 20 configured to connect to container 60; and a needle guard 50 configured to be mounted on needle 47 to sealably surround at least the end of needle. Container 60 is preferably a vial.

[0062] The end 42 of the injection device extends distally from the cylinder 41, and is preferably cylindrical or truncated conical.

[0063] The sleeve 44 surrounds the end in the radial direction and maintains a certain distance from the end, thereby defining the housing 46 between the end and the sleeve.

[0064] The sleeve 44 includes an inner surface with a threaded portion 45 facing the outer surface 43 at the end.

[0065] This combination of end cap and sleeve can be called a Luer lock. TM Connection, although the invention is not limited to the connection sold under this name.

[0066] According to one embodiment, the cylinder, end, and sleeve are manufactured as a single component by plastic injection molding. According to another embodiment, the cylinder is made of glass, while the end and sleeve are made of plastic.

[0067] The proximal portion 10 of the connector includes a body 11 that surrounds a hollow internal volume 12. The outer surface of the body is provided with a threaded portion 13 configured to screw into a corresponding threaded portion 45 of the inner surface of the sleeve 44. The inner surface of the body has a shape complementary to the outer surface of the end to ensure a tight connection with the end.

[0068] The connector 2 is connected to the injection device 40 by inserting the connector body 11 into the housing 46 between the end and the sleeve, and by screwing the threaded portions 13 and 45 of the body 11 and the sleeve 44. At the same time, the end 42 of the injection device is inserted into the internal volume 12 of the proximal portion, up to the distal region 14 of the proximal portion.

[0069] Screwing the proximal portion 10 of the connector onto the sleeve 44 of the injection device ensures a tight and sealed connection between the connector 2 and the injection device 40, preventing any movement between the connector and the injection device and preventing any leakage from component 1 to the outside of the component.

[0070] The distal portion 20 of the connector includes a flange 21 extending radially outward from the distal region 14 of the proximal portion 10, and a skirt 22 extending distally from the flange.

[0071] The skirt 22 is adapted to connect with the sleeve 62 of the container. For this purpose, the skirt has a basic cylindrical shape that matches the shape of the sleeve. Therefore, when connected to the container, the skirt surrounds the sleeve of the container. The skirt 22 may include at least one radially inwardly extending edge 25. When the skirt 22 is connected to the container, such an edge 25 is configured to abut against a recess 64 of the sleeve 62 of the container 60, thereby preventing the connector 2 from being pulled away from the container 60 in the proximal direction. In particular, such an edge prevents the connector from being accidentally removed during storage.

[0072] According to a preferred embodiment, the skirt 22 includes a plurality of flexible tabs 24 spaced apart by grooves 23, the tabs being adapted to deflect radially outward for connecting the skirt to the container. Thus, the skirt further conforms to the dimensions of the sleeve, facilitating easier connection between the skirt and the container.

[0073] The tab 24 has a radially inwardly extending edge 25 at its distal end. When the skirt 22 is connected to the container 60, the tab 24 abuts against the recess 64 of the sleeve, thereby preventing the connector 2 from being pulled away from the container 60 in the proximal direction. In particular, such an edge prevents the connector from being accidentally removed during storage.

[0074] According to a preferred embodiment, the tab 24 includes a hollow portion 26. The presence of the hollow portion facilitates demolding of the connector during manufacturing and further improves the deformability of the tab. Additionally, it reduces the weight of the connector.

[0075] According to a preferred embodiment, the connector includes a nozzle 30, which in particular Figure 1A and 1B As shown in the image.

[0076] The nozzle 30 has a cylindrical shape defined by an outer surface 37 and extends distally along axis A within the hollow internal volume 12 of the proximal portion 10 of the connector, to the flange 21. The internal volume 32 of the nozzle is in fluid communication with the internal volume 12 of the proximal portion of the connector and extends to an opening 34 in the distal end 35 of the nozzle. The opening 34 forms a fluid connection therebetween when the medical injection device 40 is connected to the container 60.

[0077] The nozzle 30 is configured to receive the distal portion of the needle, aligned along axis A with the proximal portion of the needle connected to the end 42 of the injection device 40. Thus, the needle extends through opening 34 within the internal volume of the nozzle 30 and protrudes from said opening within the skirt 22.

[0078] The nozzle is configured to be inserted into the needle guard together with the needle, so that the end of the needle (including its outlet 49) is sealed within the needle guard.

[0079] When the connector is connected to the injection device, the needle 47 is completely covered by the skirt 22. Therefore, the skirt acts as a rigid cover, reducing the risk of the user pricking themselves or anyone around them if the needle is not covered. Furthermore, the skirt allows the needle 47 to automatically center relative to the septum 63, thereby mitigating puncture wounds to the septum 63.

[0080] Preferably, the needle 47 extends at most half the length of the skirt 22 within the skirt 22, and more preferably at most one-third the length of the skirt 22. This reduces the risk of injury, and the needle is optimally self-centered before piercing the septum 63 of the container.

[0081] According to a preferred embodiment, the nozzle 30 includes a tapered tube 33 that tapers from the proximal portion of the connector and a straight tube 31 that extends further distally to the distal end 35 of the nozzle.

[0082] Connector 2 is advantageously made as a single piece. In other words, the proximal portion 10, the distal portion 20, and the nozzle 30 are formed in a single piece of material, such as a plastic material. An example of a suitable material is polypropylene.

[0083] Regarding needle shield 50 Figures 2 to 7 The document describes an implementation plan.

[0084] The needle shield 50 includes a body having a closed distal portion 52, a proximal portion 53 having an opening 54, and a cavity 51 extending from the opening toward the distal portion in the body.

[0085] The shape of cavity 51 matches the shape of nozzle 30 to allow insertion of the nozzle into the cavity. Figure 2 As shown, cavity 51 has a cylindrical shape that tapers distally to match the distal end of the nozzle and facilitate needle insertion.

[0086] Before connecting connector 2 to container 60, particularly during connector storage, needle guard 50 is positioned on needle 47. When mounted on the needle, the needle pierces the body of needle guard, and at least the tip of the needle is thus sealed within needle guard. This needle guard thus prevents any injury to persons near the assembly. For the same purpose, needle guard is preferably made of a flexible material, such as an elastic material, for example rubber or thermoplastic elastomer. This material also allows the body of needle guard to be pierced by the needle.

[0087] In addition, the needle shield 50 prevents the needle from being contaminated by the external environment during storage.

[0088] The nozzle 30 is inserted into the cavity 51. This allows the needle guard to be better secured in place on the needle.

[0089] Especially in Figure 7 As can be seen, the proximal portion 53 of the needle guard is preferably configured to be sealed into the flange 21 of the connector 2. In particular, the proximal end 55 of the needle guard is inserted into a groove 16 provided in the flange 21 around the base 38 of the nozzle 30. In this way, the proximal end 55 of the needle guard is clamped in the groove 16 and abuts against the flange 21 in the radial direction.

[0090] To provide a larger contact surface, flange 21 may include an edge 15 that extends distally from the flange around the base 38 of the nozzle. This contact holds the proximal portion 53 of the needle guard onto the nozzle 30 and ensures an optimal seal between the nozzle and the needle. This contact is particularly useful when the needle guard is made of a flexible material, in which the proximal end 55 of the needle guard readily extends radially outward due to the nature of the material.

[0091] Therefore, the optimal seal of nozzle 30 is achieved by the contact between the following:

[0092] - Between the inner surface 56 of the needle guard and the outer surface 37 of the nozzle, along the nozzle 30 from its base 38 to its distal end 35, and / or

[0093] - Between the outer surface 57 of the needle guard and the inner surface of the groove 16 or edge 15, at the base 38 of the nozzle.

[0094] Preferably, the needle guard 30 further includes a ring 58 that projects radially from and surrounds the needle guard. The ring 58 is preferably integral with the needle guard. The ring 58 and the needle guard are preferably made of the same material. When the needle guard 50 is mounted on the needle 47, the ring 58 is configured to abut against the edge 25 of the skirt 22. This abutment prevents the needle guard from being pulled down during sterilization, manipulation, and / or transport of the connector.

[0095] Advantageously, the distal portion 52 of the needle guard 50 includes a grip portion 80 configured to project distally away from the skirt when the needle guard 50 is mounted on the needle 47. The grip portion 80 is preferably integral with the needle guard. The grip portion 80 and the needle guard are preferably made of the same material. The grip portion 80 is configured to be manipulated by a user to mount or remove the needle guard 50 from the needle.

[0096] The grip portion 80 preferably includes a stem 81 that extends distally parallel to the longitudinal axis A from the remainder of the needle guard. The stem 81 extends distally from the loop and protrudes sufficiently from the skirt to be gripped by the user without the user's fingers touching the skirt 22, thereby preventing contamination of the skirt by the user.

[0097] The outer surface 82 of the stem may advantageously be provided with grip markings, which improve the user's grip on the surface 82, thereby facilitating the positioning and removal of the needle guard. The grip portion 80 also includes a flange 83 substantially perpendicular to the stem 81. The flange 83 serves as a handle, which the user can grip to easily manipulate the needle guard. In particular, when manipulating the needle guard 50, the user's thumb can abut against the distal surface 84 of the flange 83, while the user's index and middle fingers can abut against the proximal surface 85 of the flange. This helps to facilitate the removal of the needle guard by helping the user overcome the resistance created by the abutment of the ring 58 against the edge 25 of the skirt 22.

[0098] according to Figure 12 In the preferred embodiment shown, the needle guard 50 may be provided with an umbrella-shaped portion 86, preferably substantially circular, extending radially outward from the stem 81 of the grip portion 80. The umbrella-shaped portion 86 includes a proximal side 87 facing the skirt portion 22 and a distal side 88 opposite to the proximal side.

[0099] The umbrella-shaped element 86 is preferably configured to abut against the skirt 22 when the needle guard is pushed toward the skirt 22 in a proximal direction. For this purpose, the diameter of the umbrella-shaped element 86 is advantageously substantially equal to or greater than the diameter of the skirt 22, so as to cover the skirt when the connector is viewed from the distal side 88 of the umbrella-shaped element 86.

[0100] When the needle guard 50 is removed from the needle 47, the umbrella-shaped structure prevents the user's fingers from touching the skirt 22, thereby preventing the user from contaminating the skirt.

[0101] The following will refer to Figures 7 to 11 This describes a method for transferring an ingredient from a container sealed by a punctureable septum to a medical injection device.

[0102] Optionally, the connector and injection device are connected to form a component to be stored before use.

[0103] Connector 2 is connected to injection device 40 by screwing the proximal portion of the connector to the end 42 of the injection device. For this purpose, the body 11 of the proximal portion is inserted into housing 46 and rotated to ensure the engagement of the threaded portions 13, 45 of the connector and injection device, respectively. The end 42 of the injection device is inserted into the internal volume of the proximal portion, and needle 47 (if present) extends through nozzle 30. A needle guard 50 is then mounted on needle 47 to sealably surround the needle. The resulting assembly 1... Figure 7 The Chinese side indicated that...

[0104] To use this component, remove the needle guard 50 from the needle 47.

[0105] The distal portion of the needle is exposed and extends from the nozzle 30 within the skirt 22.

[0106] Reference Figure 8 Connector 2 is then attached to container 60. The distal portion 20 of the connector engages with container 60, and the distal end of the needle pierces the diaphragm 63 of the container.

[0107] In this configuration, the connector's skirt 22 is securely attached to and surrounds the container's sleeve 62.

[0108] like Figure 9 As shown, a portion of the needle (including its outlet 49) penetrates into the container 60. The flange 21 of the distal portion 20 abuts against the sleeve 62 of the container, thus preventing the needle 47 from advancing further distally into the container. Therefore, the portion 48 of the needle is located within the container. The length of this portion 48 of the needle depends on the length of the needle itself and the structure of the connector, and can be adjusted when designing the connector.

[0109] The skirt 22 contacts the container, and the tab 24 covers the sleeve 62. The tab 24 can be advantageously deflected radially outward to facilitate connection. The edge 25 of the tab abuts against the recess 64 of the sleeve, thereby preventing the connector 2 from separating from the container. Thus, the container 60 is held in a fixed position relative to the connector 2.

[0110] Because the needle 47 extends along axis A within the inner space 27 of the skirt, and the skirt surrounds the sleeve of the container, the needle 47 is centered relative to the top surface 65 of the diaphragm 63 of the container. This allows the needle to be inserted at the center of the top surface 65 of the diaphragm, penetrating the central portion 66 of the diaphragm, which is typically made of elastomer and not covered by aluminum. Due to the small diameter of the needle, the insertion force is quite low, and only a small portion of the needle extends within the skirt of the connector, so the deformation of the needle 47 is negligible.

[0111] Because the skirt 22 extends further distally than the needle 47, the skirt 22 begins to engage with the sleeve 62 of the container when the needle is proximal to the diaphragm. Thus, due to the presence of the skirt, the needle is centered relative to the top surface 65 of the diaphragm 63 and guided to the central portion 66 of the diaphragm until the connector is fully engaged with the container.

[0112] The first component contained in the injection device is then transferred to a container pre-filled with the second component. To do this, the user pushes the plunger rod of the injection device (not shown) in a distal direction.

[0113] The ingredients flow along needle 47, through nozzle, and out of needle through outlet 49 and are transferred into container 60.

[0114] Then, the first component is mixed with the second component. To do this, the user can manipulate both component 1 and container 60 and gently shake them to allow mixing to occur.

[0115] The mixed components are then drawn back into the injection device.

[0116] To this end, component 1 and container 60 are inverted, and the user pulls the plunger of the injection device, thereby creating a suction effect through the needle. In this position, regardless of the amount of remaining component in the container, the needle outlet 49 remains submerged in the mixed component. Therefore, complete extraction can be achieved without adjusting the length of the needle insertion portion 48 into the container. In other words, during extraction, the user does not need to move the needle relative to the container to keep it submerged in the mixed component, as is done in the prior art. This eliminates the need for complex and imprecise operations by the user to adjust the length of the needle insertion portion into the container, and makes the transfer between the injection device and the container faster and easier.

[0117] The mixed components flow from container 60 into needle 47 through needle outlet 49, and are then transferred to the cylinder 61 of the injection device.

[0118] During extraction, the connection between the proximal portion of the connector and the end of the injection device and the sleeve ensures the sealing of the assembly and prevents any leakage from the assembly to the outside of the assembly.

[0119] Reference Figure 10 and Figure 11 The injection device 40 is then separated from the connector 2. To do this, the body 11 of the proximal portion is rotated so that the threaded portions 13, 45 of the connector and the injection device are unscrewed. The end 42 of the injection device disengages from the internal volume of the proximal portion, and the needle 47 is removed from the nozzle 30. The connector 2 remains connected to the container 60 and can be further disposed of.

[0120] Then, the injection device containing the mixed ingredients is ready to be used.

[0121] According to a preferred embodiment, the above method relates to the recombination of a drug, wherein the first component is a diluent and the second component is a drug component, such as a lyophilized drug or an active substance of a drug.

Claims

1. A connector for connecting a medical injection device (40) to a container (60), the container comprising a collar (62) closed by a penetrable septum (63), the medical injection device (40) having a distal tip (42), a needle (47) extending from the distal tip, and a sleeve (44) extending around the distal tip, the sleeve (44) comprising an internally threaded portion (45), the connector (2) comprising: - a proximal portion (10) configured to be in sealing engagement with the distal tip (42) of the medical injection device (40) so as to enclose at least a portion of the needle (47), the proximal portion (10) comprising an externally threaded portion (13) configured to be detachably screwed to the internally threaded portion (45) of the sleeve, - a distal portion (20) configured to be connected to the container (60), the distal portion (20) comprising a skirt (22) configured to extend around the needle when the connector (2) is connected to the medical injection device (40), the skirt (22) being configured to enclose at least the collar (62) of the container when connected to the container (60), and - the connector being characterized in that it further comprises a needle shield (50) removably disposed in the distal portion (20) of the connector (2) and configured to be mounted on the needle (47) so as to at least sealingly enclose the tip of the needle, the needle shield (50) extending through the skirt (22) and comprising a closed distal portion (52) and a proximal portion (53) comprising an opening (54) through which the needle is configured to be inserted so as to sealingly enclose the needle, wherein the needle shield further comprises a ring (58) protruding radially outwardly from a main body (51) of the needle shield (50), the ring (58) being configured to abut against the skirt (22) when the needle shield (50) is mounted on the needle (47) so as to retain the needle shield (50) on the needle (47), wherein the skirt (22) comprises at least one radially inwardly extending edge (25) configured to engage a recess (64) of the collar (62) of the container (60) when the skirt (22) is connected to the container (60); and wherein the ring (58) is configured to abut against the edge (25) of the skirt (22) when the needle shield (50) is mounted on the needle (47).

2. The connector of claim 1, wherein, The needle (47) extends at most half the length of the skirt (22) within the skirt (22).

3. The connector of claim 1, wherein, The needle (47) extends at most one third the length of the skirt (22) within the skirt (22).

4. The connector of claim 1 or claim 2, wherein, The skirt (22) is configured to be deflected radially outwardly when connected to the container (60).

5. The connector of claim 1 or claim 2, wherein, The skirt (22) has a plurality of flexible tabs (24) separated from each other by grooves (23), the flexible tabs (24) being configured to deflect radially outward when the skirt (22) is connected to the container (60).

6. The connector of claim 1 or claim 2, wherein, The needle shield (50) projects distally from the skirt (22).

7. The connector of claim 1 or claim 2, wherein, The skirt (22) comprises a flange (21) and a proximal portion (53) of the needle shield (50) is configured to be sealingly and at least partially inserted into a recess (16) provided in the flange (21), so that the proximal portion (53) of the needle shield is in abutment radially with an inner surface of the recess (16).

8. The connector of claim 1, wherein, The ring (58) is integral with the needle shield (50).

9. The connector of claim 1 or claim 2, wherein, A distal portion (52) of the needle shield (50) comprises a gripping portion (80) configured to project distally away from the skirt (22) when the needle shield (50) is mounted on the needle (47) and configured to be manipulated by a user to mount the needle shield (50) on the needle (47) or to remove the needle shield from the needle.

10. The connector of claim 9, wherein, The gripping portion (80) comprises a stem (81) projecting from the skirt (22) and a flange (83) substantially perpendicular to the stem (81), the flange acting as a handle configured to be pinched between the fingers of a user to manipulate the needle shield.

11. The connector of claim 1 or claim 2, wherein, The proximal portion (10) and the distal portion (20) of the connector are formed as a single piece.

12. An assembly (1) comprising: - a medical injection device (40) comprising a barrel (41), a tip (42) extending distally from the barrel, and a sleeve (44) extending around the tip, the sleeve (44) being provided with an internally threaded portion, and - a connector (2) according to any one of claims 1 to 11, wherein the proximal portion (10) of the connector (2) is threadedly engaged with the internally threaded portion (45) of the sleeve (44) and sealingly engaged with the tip (42) of the medical injection device (40).

13. The assembly of claim 12, wherein, The barrel (41), the tip (42) and the sleeve (44) are integrally formed as a single piece.

14. A method of transferring a composition from a container (60) sealed by a pierceable septum (63) to a medical injection device (40), the method comprising the steps of: - providing a pre-filled medical injection device (40) having a tip (42) and a sleeve (44) extending around the tip, the sleeve (44) comprising a threaded portion (45), and providing a connector (2) according to any one of claims 1 to 11, the connector being screwed to the tip (42) by the threaded portion (45) of the sleeve (44); - removing a needle shield (50) from a needle (47) to expose the needle (47); - connecting the connector (2) to the container (60) by engaging the distal portion (20) of the connector with the container, thereby piercing the septum (63) of the container (60) with the needle (47); - connecting the connector (2) to the container (60) by engaging the distal portion (20) of the connector with the container, thereby piercing the septum (63) of the container (60) with the needle (47); - connecting the connector (2) to the container (60) by engaging the distal portion (20) of the connector with the container, thereby piercing the septum (63) of the container (60) with the needle (47); - transferring a first component contained in the medical injection device (40) into the container (60) by means of the needle (47); - mixing the first component with a second component contained in the container (60); - withdrawing the mixed components from the container (60) into the medical injection device (40), and - unscrewing the medical injection device (40) from the connector (2).

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