Patent Publication Number: US-2021186814-A1

Title: Connector for Connecting a Medical Injection Device to a Container

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is the United States national phase of International Application No. PCT/EP2019/061102 filed Apr. 30, 2019, and claims priority to European Patent Application No. 18305609.2 filed May 17, 2018, the disclosures of which are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Technical Field of the Invention 
     The invention relates to a connector for connecting a medical injection device to a container. The invention also relates to a method for filling a medical injection device with a composition contained in a container by connecting said injection device to the container with the connector. 
     Technical Background 
     In the field of medicament packaging, it is known to store a drug content, in the form for example of a lyophilized drug, a power drug or an active substance of a drug, in a medical container usually referred to as a “vial”. A vial is typically made of glass and is sealed by an elastomer septum that is crimped by an aluminum cap. A portion of elastomer at the center of the septum is covered by plastic part or aluminum part which can be removed by the healthcare professional prior reconstitution procedure so that the healthcare professional can access to a center portion in rubber that can be pierced by a needle of an injection device such as a syringe. 
     To reconstitute the drug, the user uses usually a disposable plastic syringe to transfer the diluent from an ampoule or a vial into the vial containing the lyophilized drug or power drug. When the diluent is already stored in a prefilled syringe, typically made of glass, the healthcare professional transfers the diluent directly from the syringe to the vial containing the lyophilized drug or power drug. The healthcare professional uses for this transfer a needle to pierce the rubber septum of the vial. 
     However this process comprises a significant number of steps. 
     Moreover, during the whole process, the needle tip may be damaged due to the removal of the needle shield, piercing of the septum of the vial, and/or misalignment during insertion of the needle. A damaged or bent needle may lead to injuries of the patient during the injection of the drug. 
     Another major drawback of the known processes is that, during the reconstitution process, the needle of the syringe is left free and unprotected. This represents a high risk of accident for the user as well as for the patient or any person around who were to come into contact with the needle, and may lead to needle stick injuries. 
     Furthermore, when the user withdraws the reconstituted drug from the vial through the needle, the user needs to adjust the length of the portion of the needle that is inserted in the vial as the amount of drug in the vial decreases. In a practical way, the user needs to slowly draw the needle back from the container by pulling the syringe away from the vial, so that the opening of the needle constantly remains in contact with the drug, in other terms, below the surface of the drug. 
     Not only this handling is hard to perform, but also such movement of the needle in the vial may lead to a loss of a significant amount of drug that remains in the vial. 
     Document WO2012/168235 describes a connection device that comprises a subassembly including a plug intended to be connected to a medical container, a needle extending from the plug, a sealing sleeve arranged around the needle, and a base with a penetrating member. The base defines an inner volume that is configured to accommodate the subassembly. The penetrating member is configured to pierce the septum of a vial, defines an inner volume adapted to accommodate the needle, and comprises an opening for transferring a composition from the medical container connected to the needle to the vial, for reconstituting a drug contained in the vial. 
     However, this connection device cannot be connected to a prefilled syringe filled with diluent for a long-term storage, only designed as a disposable device for extemporaneous storage. Indeed, the needle is not sealed when the connection device is connected to the syringe. Thus, the sterility of the content of the syringe cannot be ensured. 
     Moreover, the penetrating member is exposed, which represents a risk of injury to the user or any person around the device. 
     SUMMARY OF THE INVENTION 
     The invention aims to provide a connector that overcomes the drawbacks detailed previously. In that matter, the invention aims to provide a connector for connecting a prefilled medical injection device, such as a syringe or the like, to a container, such as a vial or the like, that is more intuitive to use and to set up, comprises a reduced number of constitutive parts and reduces the overall number of steps to transfer the reconstitute the drug. 
     To this end, one object of the invention is a connector for connecting a medical injection device having a distal tip and a sleeve extending around the tip, the sleeve being provided with an inner threaded portion, to a container closed by a pierceable septum, said connector comprising:
         a proximal part configured to sealingly engage the tip of the injection device, the proximal part comprising an outer threaded portion configured to be removably screwed to the inner threaded portion of the sleeve,   a distal part configured to be connected to the container,   a hollow spike extending distally from the proximal part, having an internal volume configured to be in fluidic connection with the injection device, the spike being configured to perforate the pierceable septum of the container when the distal part is connected to the container, the spike comprising an opening in a distal end, said opening being configured to create a fluidic connection between the medical injection device and the container.       

     The threaded portions of the sleeve and the proximal portion ensure a tight, reliable, and sealed connection between the injection device and the connector that prevents any leak of a composition flowing between the injection device and the connector, which is especially important for long term storage pre-filled syringes. Moreover, screwing and unscrewing the connector to the injection device is easy, fast, and does not require physical strength, contrary to, for example, a snap-in connection. 
     According to other optional features of the device of the invention:
         The distal part comprises a skirt extending around the hollow spike, the skirt being adapted to enclose at least the collar of the container when connected to said container. The skirt thus ensures a tight and reliable connection between the connector and the container.   The skirt comprises at least one rim that extends radially inwardly, said rim being configured to engage a recess of the collar of the container when the skirt is connected to the container. The rim prevents the connector from being pulled away in a proximal direction from the container, especially during storage.   The skirt is adapted to deflect radially outwardly when connected to the container. This allows the skirt to adapt to the dimensions of the collar of the container. Connecting the connector to the container is thus easier.   The skirt is provided with a plurality of flexible tabs separated from each other by recesses, the flexible tabs being configured to deflect radially outwardly when the skirt is connected to the container. The flexible tabs render the skirt more flexible and the skirt further fits to the collar of the container.   The skirt may extend more distally than the spike. The skirt thereby acts as a guide that facilitates the centering of the spike when piercing the septum of the container.   Alternatively, the spike may extend more distally than the skirt.   According to an embodiment, the internal volume of the hollow spike is configured to accommodate a needle of the injection device fixed to the tip of said injection device. In this way, the hollow spike covers the needle. When connecting the connector to the container, the spike pierces the septum of the container, letting the needle enclosed therein untouched. This prevents any deformation or damage to the needle.   The connector comprises a sealing cap mounted on the hollow spike so as to sealingly enclose at least the opening of the hollow spike. The sealing cap is put on the spike before use of the connector, typically during storage. In more details, the connector is connected to the injection device previously filled with a composition, and the sealing cap is put on the spike so as to cover it. The sealing cap sealingly isolates the spike, and in particular the opening of the spike, from the outside, which reduces the risk of contamination of the composition. Moreover, the sealing cap covers the pointed end of the spike, thereby preventing the user from pricking himself or any person around with the spike and the needle enclosed herein. When the connector is connected to a pre-filled syringe, the sealing cap also enables to close the spike and then the pre-filled syringe.   The skirt comprises a flange, the sealing cap comprises a closed distal part, a proximal part provided with an opening, and a hollow body that extends from the opening towards the distal part, the hollow body being configured to sealingly engage the hollow spike, and the proximal part of the sealing cap being configured to be sealingly and at least partially inserted into a groove provided in the flange so that said proximal part of the sealing cap radially abuts an inner surface of the groove. The sealing of the hollow spike is thus optimal.   The sealing cap further comprises a ring protruding radially outwardly from the hollow body, said ring being configured to abut the skirt when the sealing cap is mounted on the hollow spike so as to retain the sealing cap on the hollow spike. The combination of the ring and the skirt prevents the sealing cap from being pulled off during sterilization, handling, and/or transportation of the connector.   The ring is configured to abut the rim of the skirt when the sealing cap is mounted on the hollow spike. In that way, the skirt not only is used for connecting the connector to the container, but also said skirt prevents the sealing cap from being pulled off.   The ring is preferably integral with the sealing cap. This facilitates the manufacturing of the sealing cap. For example, the sealing cap provided with the ring is made by molding.   The distal part of the sealing cap comprises a grip portion configured to protrude distally away from the skirt when the sealing cap is mounted on the hollow spike, and configured to be handled by a user for mounting or removing the sealing cap from the hollow spike.   The grip portion comprises a stem that protrudes from the skirt, and a flange substantially perpendicular to the stem that acts as a handle configured to be gripped between a user&#39;s fingers to manipulate the sealing cap.   The connector is preferably in a single piece, apart from the sealing cap when present. In other terms, the proximal part, the distal part, and the spike of the connector are made in a single piece of material, which makes the connector readily usable with no pre-assembling requirement. The sealing cap consists of another piece configured to be mounted on the spike.       

     Another object of the invention is an assembly comprising:
         a medical injection device comprising a distal tip and a sleeve extending around the tip, and   a connector as described previously,       

     wherein the proximal part of the connector is in threaded engagement with the threaded portion of the sleeve and sealingly engages the tip of the medical injection device. 
     This assembly has the significant advantage to allow long term storage. 
     According to other optional features of the assembly of the invention:
         The medical injection device comprises a needle staked in the tip, said needle extending into the hollow spike of the connector.   The needle extends into the hollow spike up to the opening of the spike. An injection outlet of the needle and the opening of the spike face each other in an oblique or substantially radial direction. Hence, the composition passes directly from the outlet of the needle to the opening of the spike, or in other way from the opening of the spike to the outlet of the needle. This limits the contact of the composition with the inner volume of the spike and limits pressure losses.   Alternatively, the medical injection device may not comprise any staked needle, such that the needle may be assembled on the medical injection device after the reconstitution.   The medical injection device is preferably a pre-filled syringe.   The pre-filled syringe is preferably filled with a diluent intended to be mixed with a lyophilized drug or a power drug contained in the container to reconstitute a drug.   According to different embodiments, the medical injection device may comprise a barrel in plastic or in glass.   According to different embodiments, the barrel, the tip and the sleeve may be integrally formed as a single piece, or the barrel may be in glass while the tip and sleeve are in plastic.   The medical injection device is a prefilled syringe, and the connector is a connector that comprises a sealing cap as described above, the sealing cap being mounted onto the hollow spike.       

     Another object of the invention is a method for transferring a composition from a container sealed by a pierceable septum, to a medical injection device, the method comprising the following steps:
         providing a prefilled medical injection device with a tip and a sleeve extending around the tip, the sleeve being provided with a threaded portion, and a connector as described previously screwed to the tip via the threaded portion of the sleeve,   connecting the connector to the container by engaging the distal part of the connector with the container, the hollow spike thereby perforating the septum of the container,   transferring into the container a first composition contained in the injection device through the internal volume of the spike,   mixing the first composition with a second composition contained in the container,   drawing the mixed compositions from the container back to the injection device,   unscrewing the injection device from the connector.       

     Reducing the number of steps during reconstitution enables to decrease potential contamination risk and needle stick injuries risk. 
     According to other optional features of the method of the invention:
         The connector comprises a sealing cap as described above mounted onto the hollow spike.   Prior to connecting the connector to the container, the sealing cap is removed from the spike so as to expose the spike and the opening.   The first composition is a diluent and the second composition is a drug content, the transferring and mixing steps being carried out to reconstitute a drug.   The needle of the medical injection device is staked in the tip of said medical injection device.   The method further comprises removably mounting a needle on the tip of the injection device after unscrewing the injection device from the connector.   The container is preferably a vial.   The vial may be filled with a lyophilized drug or a power drug.       

     The invention also relates to a connector for connecting a medical injection device having a distal tip and a sleeve extending around the tip, to a container closed by a pierceable septum, said connector comprising:
         a proximal part configured to sealingly engage the tip of the injection device, and to be connected to the sleeve,   a distal part configured to be connected to the container,   a hollow spike extending distally from the proximal part, having an internal volume configured to be in fluidic connection with the injection device, the spike being configured to perforate the pierceable septum of the container when the distal part is connected to the container, the spike comprising an opening in a distal end, said opening being configured to create a fluidic connection between the medical injection device and the container,   a sealing cap mounted on the hollow spike so as to sealingly enclose at least the opening of the hollow spike.       

     The injection device and the connector are sealingly connected to each other, which prevents any leak of a composition flowing between the injection device and the connector. This is especially important for long term storage pre-filled syringes. 
     The sealing cap is put on the spike before use of the connector, typically during storage. In more details, the connector is connected to the injection device previously filled with a composition, and the sealing cap is put on the spike so as to cover it. The sealing cap sealingly isolates the spike, and in particular the opening of the spike, from the outside, which reduces the risk of contamination of the composition. Moreover, the sealing cap covers the pointed end of the spike, thereby preventing the user from pricking himself or any person around with the spike and the needle enclosed herein. When the connector is connected to a pre-filled syringe, the sealing cap also enables to close the spike and then the pre-filled syringe. 
     According to other optional features of the device of the invention:
         The sleeve of the medical injection device is provided with an inner threaded portion, the proximal part comprises an outer threaded portion configured to be removably screwed to the inner threaded portion of the sleeve. The threaded portions of the sleeve and the proximal portion ensure a tight, reliable, and sealed connection between the injection device and the connector that further prevents any leak of a composition flowing between the injection device and the connector. Moreover, screwing and unscrewing the connector to the injection device is easy, fast, and does not require physical strength, contrary to, for example, a snap-in connection.   The distal part comprises a skirt extending around the hollow spike, the skirt being adapted to enclose at least the collar of the container when connected to said container. The skirt thus ensures a tight and reliable connection between the connector and the container.   The skirt comprises at least one rim that extends radially inwardly, said rim being configured to engage a recess of the collar of the container when the skirt is connected to the container. The rim prevents the connector from being pulled away in a proximal direction from the container, especially during storage.   The skirt is adapted to deflect radially outwardly when connected to the container. This allows the skirt to adapt to the dimensions of the collar of the container. Connecting the connector to the container is thus easier.   The skirt is provided with a plurality of flexible tabs separated to each other by recesses, the flexible tabs being configured to deflect radially outwardly when the skirt is connected to the container. The flexible tabs render the skirt more flexible and the skirt further fits to the collar of the container.   The skirt may extend more distally that the spike. The skirt thereby acts as a guide that facilitates the centering of the spike when piercing the septum of the container.   Alternatively, the spike may extend more distally than the skirt.   According to an embodiment, the internal volume of the hollow spike is configured to accommodate a needle of the injection device fixed to the tip of said the injection device. In this way, the hollow spike covers the needle. When connecting the connector to the container, the spike pierces the septum of the container, letting the needle enclosed therein untouched. This prevents any deformation or damage to the needle.   The skirt comprises a flange, the sealing cap comprises a closed distal part, a proximal part provided with an opening, and a hollow body that extends from the opening towards the distal part, the hollow body being configured to sealingly engage the hollow spike, and the proximal part of the sealing cap being configured to be sealingly and at least partially inserted into a groove provided in the flange so that said proximal part of the sealing cap radially abuts an inner surface of the groove. The sealing of the hollow spike is thus optimal.   The sealing cap further comprises a ring protruding radially outwardly from the hollow body, said ring being configured to abut the skirt when the sealing cap is mounted on the hollow spike so as to retain the sealing cap on the hollow spike. The combination of the ring and the skirt prevents the sealing cap from being pulled off during sterilization, handling, and/or transportation of the connector.   The ring is configured to abut the rim of the skirt when the sealing cap is mounted on the hollow spike. In that way, the skirt not only is used for connecting the connector to the container, but also said skirt prevents the sealing cap from being pulled off.   The ring is preferably integral with the sealing cap. This facilitates the manufacturing of the sealing cap. For example, the sealing cap provided with the ring is made by molding.   The distal part of the sealing cap comprises a grip portion configured to protrude distally away from the skirt when the sealing cap is mounted on the hollow spike, and configured to be handled by a user for mounting or removing the sealing cap from the hollow spike.   The grip portion comprises a stem that protrudes from the skirt, and a flange substantially perpendicular to the stem that acts as a handle configured to be gripped between a user&#39;s fingers to manipulate the sealing cap.   The connector is preferably in a single piece, which does not include the sealing cap when present. In other terms, the proximal part, the distal part, and the spike of the connector are made in a single piece of material, which makes the connector readily usable with no pre-assembling requirement. The sealing cap consists of another piece configured to be mounted on the spike.       

     Another object of the invention is an assembly comprising:
         a medical injection device comprising a barrel, a tip extending distally from the barrel, and a sleeve extending around the tip and   a connector as described previously,       

     wherein the proximal part of the connector sealingly engages the tip of the medical injection device. 
     This assembly has the significant advantage to allow long term storage. 
     According to other optional features of the assembly of the invention:
         The medical injection device comprises a needle staked in the tip, said needle extending into the hollow spike of the connector.   The needle extends into the hollow spike up to the opening of the spike. An injection outlet of the needle and the opening of the spike face each other in an oblique or substantially radial direction. Hence, the composition passes directly from the outlet of the needle to the opening of the spike, or in other way from the opening of the spike to the outlet of the needle. This limits the contact of the composition with the inner volume of the spike and limits pressure losses.   Alternatively, the medical injection device may not comprise any staked needle, such that the needle may be assembled on the medical injection device after the reconstitution.   The medical injection device is preferably a pre-filled syringe.   The pre-filled syringe is preferably filled with a diluent intended to be mixed with a lyophilized drug or a power drug contained in the container to reconstitute a drug.   According to different embodiments, the medical injection device may comprise a barrel in plastic or in glass.   According to different embodiments, the barrel, the tip and the sleeve may be integrally formed as a single piece, or the barrel may be in glass while the tip and sleeve are in plastic.   The medical injection device is a prefilled syringe.       

     Another object of the invention is a method for transferring a composition from a container sealed by a pierceable septum, to a medical injection device, the method comprising the following steps:
         providing a prefilled medical injection device with a tip and a sleeve extending around the tip, and a connector as described previously connected to the sleeve,   connecting the connector to the container by engaging the distal part of the connector with the container, the hollow spike thereby perforating the septum of the container,   transferring into the container a first composition contained in the injection device through the internal volume of the spike,   mixing the first composition with a second composition contained in the container,   drawing the mixed compositions from the container back to the injection device,   separating the injection device from the connector.       

     Reducing the number of steps during reconstitution enables to decrease potential contamination risk and needle stick injuries risk. 
     According to other optional features of the method of the invention:
         Prior to connecting the connector to the container, the sealing cap is removed from the spike so as to expose the spike and the opening.   The first composition is a diluent and the second composition is a drug content, the transferring and mixing steps being carried out to reconstitute a drug.   The needle of the medical injection device is staked in the tip of said medical injection device.   The method further comprises removably mounting a needle on the tip of the injection device after separating the injection device from the connector.   The container is preferably a vial.   The vial may be filled with a lyophilized drug or a power drug.       

    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features and advantages of the invention will become apparent from the detailed description to follow, with reference to the appended drawings, in which: 
         FIG. 1  is a side view of an embodiment of a connector of the invention; 
         FIG. 2  is a side sectional view of a first embodiment of an assembly obtained by connecting the connector to a medical injection device, wherein the medical injection device is provided with a tip having a needle attached thereto, and a sleeve extending around the tip; 
         FIG. 3  is a side sectional view of a second embodiment of an assembly obtained by connecting the connector to a medical injection device, wherein the medical injection device is provided with a tip with no needle and a sleeve extending around the tip; 
         FIG. 4  is a perspective view of the connector of  FIG. 1 , wherein the connector and the injection device are put close to each other prior to being connected; 
         FIG. 5  is a side view of the connector of  FIG. 1 , wherein the connector and the injection device are connected to each other to form the assembly of  FIG. 2 ; 
         FIG. 6  is a perspective view of the assembly of  FIG. 2 , wherein a sealing cap according to a first embodiment is being removed from a hollow spike of the connector; 
         FIG. 7  is a side view of the assembly of  FIG. 2 , wherein the injection device is connected to a container via the connector, so as to transfer a first composition contained in the injection device; 
         FIG. 8  is a side sectional view of the injection device, the connector, and the container of  FIG. 7 ; 
         FIG. 9  is a side view of the injection device and connector, wherein the injection device is being removed from the connector after withdrawal of the composition, the connector remaining connected to the container; 
         FIG. 10  is a side view of the injection device and connector, wherein the injection device is completely removed from the connector, according to the first embodiment of the invention; 
         FIG. 11  is a side view of the injection device and connector, wherein the injection device is completely removed from the connector, according to the second embodiment of the invention; 
         FIG. 12  is a side view of the injection device according to the second embodiment of the invention with a disposable needle adapted to be mounted thereon; 
         FIG. 13  is a perspective view of the assembly of the invention, wherein a sealing cap according to a second embodiment is mounted onto the hollow spike of the connector; 
         FIG. 14  is a side view of the assembly of  FIG. 13 ; 
         FIG. 15  is a side sectional view of the assembly of  FIG. 13 ; and 
         FIG. 16  is another side sectional view of the assembly of  FIG. 13 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A first object of the invention is a connector for connecting a medical injection device to a container closed by a pierceable septum. An embodiment of the connector is represented in  FIG. 1 . 
     The connector and the injection device connected to each other form an assembly, a first and a second embodiment of which are represented in  FIGS. 2 and 3 . 
     According to the first embodiment represented in  FIG. 2 , the connector  2  is connected to an injection device  40  provided with a needle  47 . The injection device is preferably a pre-filled syringe. 
     According to the second embodiment represented in  FIG. 3 , the connector  2  is connected to an injection device  40  with no needle. The injection device is preferably a pre-filled syringe. A separate needle  70  is removably connected to the injection device  40  only after separating said injection device from the connector, as explained further. 
     Both the first and second embodiments will be described in parallel in the following. 
     In reference to  FIGS. 1, 2 and 3 , the connector  2  extends along a longitudinal axis A. The connector  2  comprises a proximal part  10  configured to be connected to the tip  42  of the injection device  40 , a distal part  20  configured to be connected to a container  60 , and a hollow spike  30  configured to pierce the septum  63  of the container when the distal part  20  is connected to the container. The container  60  is preferably a vial. 
     The tip  42  of the injection device extends distally from the barrel  41  and is advantageously of a cylindrical or frustoconical shape. 
     A sleeve  44  extends around and at a distance from the tip in the radial direction, thereby defining a housing  46  between the tip and the sleeve. 
     The sleeve  44  comprises an inner surface provided with a threaded portion  45  that faces the outer surface  43  of the tip. 
     Such a combination of the tip and the sleeve may be known as a Luer Lock™ connection, although the invention is not limited to a connection sold under this designation. 
     According to one embodiment, the barrel, tip and sleeve are made as a single part, by plastic injection molding. According to another embodiment, the barrel is made in glass, whereas the tip and sleeve are made in plastic. 
     The proximal part  10  of the connector comprises a body  11  that encloses a hollow inner volume  12 . The outer surface of the body is provided with a threaded portion  13  which is configured to be screwed to the 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 tip to ensure a tight connection with the tip. 
     The connector  2  is connected to the injection device  40  by inserting the body  11  of the connector in the housing  46  between the tip and the sleeve, by screwing the threaded portions  13 ,  45  of the body  11  and the sleeve  44 . At the same time, the tip  42  of the injection device is inserted in the inner volume  12  of the proximal part up to a distal region  14  of the proximal part. 
       FIG. 4  shows the alignment of the connector  2  and the injection device  40  along the axis A before connection, and a general side view of the resulting assembly  1  is represented in  FIG. 5 . 
     The screwing of the proximal part  10  of the connector to 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 of the connector and the injection device relative to each other, and preventing any leakage from the assembly  1  to the outside of said assembly. 
     The distal part  20  of the connector comprises a flange  21  which extends radially outwardly from the distal region  14  of the proximal part  10 , and a skirt  22  which extends from the flange in the distal direction. 
     The skirt  22  is adapted to be connected to the collar  62  of the container. To that end, the skirt has a substantially cylindrical shape that matches the shape of the collar. Hence, when connected to the container, the skirt encloses the collar of the container. The skirt  22  may comprise at least one rim  25  that extends radially inwardly. Such rim  25  is configured to abut against a recess  64  of the collar  62  of the container  60  when the skirt  22  is connected to the container, thereby preventing the connector  2  from being pulled away in a proximal direction from the container  60 . In particular, such rim prevents accidental removal of the connector during storage. 
     According to a preferred embodiment, the skirt  22  comprises a plurality of flexible tabs  24  separated from each other by recesses  23 , said tabs being adapted to deflect radially outwardly for connecting the skirt to the container. The skirt thereby further fits to the dimensions of the collar, making the connection of the skirt to the container easier. 
     The tabs  24  are provided at their distal end with borders  25  that extend radially inwardly. When the skirt  22  is connected to the container  60 , the tabs  24  abut against the recess  64  of the collar, thereby preventing the connector  2  from being pulled away in a proximal direction from the container  60 . In particular, such borders prevent accidental removal of the connector during storage. 
     According to a preferred embodiment, the tabs  24  comprise hollow portions  26 . The presence of the hollow portions facilitates the demolding of the connector during the manufacture, and further increase the ability of deflection of the tabs. In addition, the weight of the connector is reduced. 
     The hollow spike  30  has a cylindrical shape delimited by an outer surface  37 , and extends distally in the inner space  27  of the skirt  22  along the axis A from the flange  21 . The distal end of the hollow spike  30  is provided with a pointed end  35  configured to perforate the pierceable septum  63  of the container when the connector  2  is connected to the container  60 . The internal volume  32  of the spike is in fluidic communication with the inner volume  12  of the proximal part of the connector. 
     According to a preferred embodiment, the hollow spike  30  is completely covered by the skirt  22 . Hence, the skirt acts as a rigid cover that reduces the risk of a user pricking himself or any person around. Moreover, the skirt enables to auto-center the spike towards the pierceable septum  63  and thus eases the pricking of the pierceable septum  63  by the spike. 
     Preferably, the skirt protrudes 1 mm from the pointed end  35  of the hollow spike  30 . 
     As illustrated in  FIG. 1 , the skirt  22  extends more distally than the spike  30 . 
     According to a preferred embodiment, the spike  30  comprises a tapered pipe  33  that tapers away from said proximal part and a straight pipe  31  that extends further distally up to its pointed end  35 . 
     The spike  30  comprises an opening  34  close to the pointed end  35 . The opening  34  creates a fluidic connection between the medical injection device  40  and the container  60  when connected thereto. 
     The connector  2  is advantageously made in a single piece. In other terms, the proximal part  10 , the distal part  20 , and the hollow spike  30  are formed in a single piece of material, such as a plastic material. An example of appropriate material is polypropylene. 
     The assembly  1  further comprises a hollow sealing cap  50 . A first embodiment of the sealing cap  50  is illustrated in  FIGS. 2 to 6 , and a second embodiment is illustrated in  FIGS. 13 to 16 . 
     The sealing cap comprises a closed distal part  52 , a proximal part  53  provided with an opening  54 , and a hollow body  51  that extends from the opening towards the distal part. The sealing cap is positioned on the spike  30  before connecting the connector  2  with the container  60 , in particular during storage of the connector. When mounted on the spike, the sealing cap  50  sealingly covers the spike  30 , and in particular covers at least the opening  34  of said spike. The sealing cap  50  thus prevents any injury to a person at the vicinity of the assembly. To the same purpose, the sealing cap is preferably made in a flexible material, such as elastomeric material, for example rubber or thermoplastic elastomer. 
     Moreover, the sealing cap  50  prevents any contamination of the spike from the external environment during storage. 
     The hollow body  51  of the sealing cap has a shape that matches that of the spike so as to allow the insertion of the spike  30  in the hollow body of the sealing cap. In  FIGS. 2 and 3 , the hollow body of the sealing cap has a cylindrical shape that tapers distally so as to match the pointed end of the spike. 
     According to the second embodiment illustrated in  FIGS. 13 to 16 , the proximal part  53  of the sealing cap is configured to be sealingly inserted into the flange  21  of the connector  2 . In particular, the proximal end  55  of the sealing cap is inserted into a groove  16  provided in the flange  21  around the base  38  of the spike  30 . This is clearly visible in  FIG. 15 . In that way, the proximal end  55  of the sealing cap is griped in the groove  16  and radially abuts the flange  21  of the connector. To provide a greater abutment surface, the flange  21  may comprise a rim  15  that extends distally therefrom, around the base  38  of the spike. This abutment maintains the proximal part  53  of the sealing cap onto the spike  30 , as well as ensuring an optimal sealing of said spike. This abutment is particularly useful when the sealing cap is made in a flexible material, wherein the proximal end  55  of the sealing cap is prone to extend radially outwardly due to the nature of the material. 
     As such, optimal sealing of the hollow spike  30  is achieved by the contact between:
         the inner surface  56  of the sealing cap and the outer surface  37  of the spike, along the spike  30 , from the base  38  to the pointed end  35  of the spike, and/or   the outer surface  57  of the sealing cap and the inner surface of the groove  16  or the rim  15 , at the base  38  of the spike.       

     Advantageously, the sealing cap further preferably comprises a ring  58  that protrudes radially from and around the sealing cap  30 . The ring  58  is preferably integral with the sealing cap. The ring  58  and the sealing cap are preferably made in the same material. The ring  58  is configured to abut the rim  25  of the skirt  22  when the sealing cap  50  is mounted on the hollow spike  30 . This abutment prevents the sealing cap  30  from being pulled off during sterilization, handling, and/or transportation of the connector. 
     Advantageously, the distal part  52  of the sealing cap  50  comprises a grip portion  80  configured to protrude distally away from the skirt when the sealing cap  50  is mounted on the hollow spike  30 . The grip portion  80  is preferably integral with the sealing cap. The grip portion  80  and the sealing cap are preferably made in the same material. The grip portion  80  is configured to be handled by a user for mounting or removing the sealing cap  50  from the hollow spike  30 . 
     The grip portion  80  preferably comprises a stem  81  that extends in the distal direction, parallel to the longitudinal axis A, from the rest of the sealing cap. The stem  81  extends distally from the ring and protrudes sufficiently from the skirt to be gripped by the user without the fingers of the user contacting the skirt  22 , thereby preventing contamination of the skirt by the user. 
     The outer surface  82  of the stem may be advantageously be provided with grip marks that improve the grip of the fingers of the user onto said surface  82 , thereby facilitating the positioning and the removal of the sealing cap. The grip portion  80  further comprises a flange  83  that is substantially perpendicular to the stem  81 . The flange  83  acts as a handle the user may grip to manipulate the sealing cap easily. In particular, when handling the sealing cap  50 , the thumb of the user may abut the distal surface  84  of the flange  83  and the index and middle finger of the user may abut the proximal surface  85  of the flange, which facilitates the removal of the sealing cap by helping him overcoming the resistance caused by the abutment of the ring  58  against the rim  25  of the skirt  22 . 
     According to an embodiment illustrated in  FIG. 16 , the sealing cap  50  may be provided with an umbrella  86 , preferably substantially circular, which extends radially outwardly from the stem  81  of the grip portion  80 . The umbrella  86  comprises a proximal face  87  that faces the skirt  22 , and a distal face  88  opposite the proximal face. 
     The umbrella  86  is preferably configured to abut the skirt  22  when the sealing cap is pushed in the proximal direction toward the skirt. To that end, the diameter of the umbrella  86  is advantageously substantially equal to or greater than the diameter of the skirt  22  so as to cover said skirt when the connector is observed from the distal face  88  of the umbrella  86 . 
     When removing the sealing cap  50  from the spike  30 , the umbrella prevents the fingers of the user from contacting the skirt  22 , thereby preventing contamination of said skirt by the user when removing the sealing cap  50 . 
     Although the injection device  40  illustrated in  FIGS. 15 and 16  is provided with a needle  47 , the sealing cap  50  may of course be mounted onto an injection device with no needle. 
     A method for transferring a composition from the container sealed by a pierceable septum to the medical injection device will now be described in the following, in reference to the  FIGS. 4 to 12 . 
     First, as illustrated in  FIG. 4 , the connector  2  is connected to the injection device  40 , by screwing the proximal part of the connector to the tip  42  of the injection device. To this end, the body  11  of the proximal part is inserted in the housing  46  and rotated to ensure screwing of the respective threaded portions  13 ,  45  of the connector and the injection device. The tip  42  of the injection device is inserted in the inner volume of the proximal part and the needle  47 , when present, is enclosed in the spike  30 . The assembly  1  obtained is represented in  FIG. 5 . 
     According to the first embodiment, the spike  30  encloses a portion of the needle. The needle  47  extends along the axis A, from the tip  42  of the injection device, along the inner volume  32  of the spike, and further distally up to the distal end of the spike. The needle  47  may be staked in the tip  42 . 
     According to the first embodiment, the injection outlet  49  of the needle preferably faces the opening  34  of the spike in an oblique or substantially radial direction. 
     In the case where the spike  30  is previously covered by the sealing cap  50 , said sealing cap is removed so as to expose the spike  30  and the opening  34 , as illustrated in  FIG. 6 . 
     In reference to  FIG. 7 , the connector  2  is then connected to the container  60 . The distal part  20  of the connector engages the container  60 , and the pointed end  35  of the spike perforates the septum  63  of the container. 
     In this configuration, the skirt  22  of the connector is firmly attached to the collar  62  of the container and encloses said collar. 
     A portion of the spike, including the opening  34 , penetrates inside the container  60 . The flange  21  of the distal part  20  abuts the collar  62  of the container, so that the spike  30  cannot go further distally inside the container. Hence, a portion  36  of the spike of a determined length, including a portion  48  of the needle enclosed therein when present, is located in the container. The length of this portion  36  of spike depends on the length of the spike itself and the structure of the distal portion  20 , and may be adjusted when the connector is being designed. 
     The skirt  22  contacts the container, and the tabs  24  cover the collar  62 . The tabs  24  may advantageously deflect radially outwardly to facilitate the connection. The borders  25  of the tabs abut against the recess  64  of the collar, thereby preventing the connector  2  from being separated from the container. The container  60  is thus maintained in a fixed position to the connector  2 . 
     Since the spike  30  extends along the axis A in the inner space  27  of the skirt and said skirt encloses the collar of the container, the spike  30  is centered relative to the top surface  65  of the septum  63  of the container. This allows the insertion of the spike, and the needle enclosed herein when present, at the center of said top surface  65  of the septum, the spike  30  piercing the center portion  66  of the septum typically made of elastomer that is not covered by aluminum. Since the needle  47  is protected by the spike  30 , it does not contact the septum or the wall of the container, and any deformation of the needle  47  is thus prevented. 
     When the skirt  22  extends more distally than the spike  30 , the skirt  22  begins engaging the collar  62  of the container as the spike is proximally remote from the septum. Hence, thanks to the skirt, the spike is centered relative to the top surface  65  of the septum  63  and guided to the center portion  66  of the septum until full engagement of the connector onto the container. 
     As visible in  FIG. 8 , the connector  2  is configured so that when the spike  30  is inserted in the septum  63  of the container, the opening  34  of the spike is located slightly distally relative to the septum, in the vicinity of the septum. 
     A first composition, contained in the injection device, is then transferred into the container prefilled with a second composition. To that end, the user pushes the plunger rod (not represented) of the injection device in the distal direction. 
     According to the first embodiment, the composition flows along the needle  47 , passes through the outlet  49  of the needle, and is expelled from the spike  30  via the opening  34  and transferred into the container  60 . In the case where the outlet  49  of the needle faces the opening  34  of the spike, the first composition passes directly from the outlet of the needle to the opening of the spike, which limits the contact of said first composition with the inner volume of the spike and limits pressure losses. 
     According to the second embodiment, the composition flows along the spike  30  in contact with the inner wall of the spike, and is expelled from the spike via the opening  34  and transferred into the container  60 . 
     The first composition is then mixed with the second composition. To that end, the user may handle both the assembly  1  and the container  60 , and shake them gently so as to allow the mixing. 
     The mixed compositions are then drawn back to the injection device. 
     To that end, the assembly  1  and the container  60  are turned upside down, and the user pulls the plunger rod of the injection device, thereby creating a suction effect through the spike. In this position, the opening  34  of the spike remains immersed in the mixed compositions regardless the amount of compositions remaining in the container. Therefore, complete withdrawal can be achieved with no need to adjust the length of the portion  36  of the spike inserted in the container. In other terms, the user does not need to move the needle relative to the container as in the prior art for keeping the needle immersed in the mixed compositions as long as the withdrawal goes. This saves the user from having to perform complicated and imprecise manipulations in order to adjust the length of the portion of needle inserted in the container, and makes the transfer between the injection device and the container much faster and easier. 
     According to the first embodiment, the suction effect is also created in the needle  47 . The mixed compositions flow from the container  60  into the needle  47  via the opening  34  of the spike and the outlet  49  of the needle, and is then transferred into the barrel  61  of the injection device. 
     In the case where the outlet  49  of the needle faces the opening  34  of the spike, the mixed compositions pass directly from the opening  34  of the spike to the outlet  49  of the needle, which limits the contact of said composition with the inner wall of the spike and limits pressure losses. 
     According to the second embodiment, the mixed compositions flow from the container  60  into the inner volume  32  of the spike via the opening  34  of the spike, and is then transferred into the barrel  61  of the injection device. 
     During withdrawal, the connection between the proximal part of the connector and the tip and sleeve of the injection device ensures the sealing of the assembly and prevents any leak from the assembly to the outside of said assembly. 
     In reference to  FIGS. 9 and 10 , the injection device  40  is then separated from the connector  2 . To this end, the body  11  of the proximal part is rotated to cause unscrewing of the respective threaded portions  13 ,  45  of the connector and the injection device. The tip  42  of the injection device disengages the inner volume of the proximal part, and the needle  47 , when present, is removed from the spike  30 . The connector  2  remains connected to the container  60  and may be further disposed of. 
     According to the first embodiment, the injection device containing the mixed compositions is then ready to be used. 
     According to the second embodiment, a needle  70  is removably mounted on the tip  42  of the injection device after separating the injection device from the container, as illustrated in  FIGS. 11 and 12 . 
     The needle  70  is fixed to the injection device via its fitting  71  which is inserted in the housing  46  between the tip  42  and the sleeve  44  of the injection device, preferably by screwing onto the sleeve. 
     According to a preferred embodiment, the method described above is related to the reconstitution of a drug, wherein the first composition is a diluent and the second composition is a drug content, such as for example a lyophilized drug or an active substance of a drug. 
     The embodiments illustrated herein are mere examples of the present invention and should therefore not be construed as being limiting. Alternatives provided by a skilled person in consideration of the embodiments are likewise encompassed by the scope of protection of the present invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.