Patent Application
20210186814
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.
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.
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:
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:
Another object of the invention is an assembly comprising:
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:
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:
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 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:
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:
Another object of the invention is an assembly comprising:
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:
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:
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:
Further features and advantages of the invention will become apparent from the detailed description to follow, with reference to the appended drawings, in which:
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
The connector and the injection device connected to each other form an assembly, a first and a second embodiment of which are represented in
According to the first embodiment represented in
According to the second embodiment represented in
Both the first and second embodiments will be described in parallel in the following.
In reference to
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.
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
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
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
According to the second embodiment illustrated in
As such, optimal sealing of the hollow spike 30 is achieved by the contact between:
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
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
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
First, as illustrated in
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
In reference to
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
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
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
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 18305609.2 | May 2018 | EP | regional |
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.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2019/061102 | 4/30/2019 | WO | 00 |
