Vial adapter for closure system

Abstract

A vial adapter is provided for a closure system having an elastomeric plug and a cap. The vial adapter includes: a top wall; a connector extending in a first direction from the top wall; and a cannula extending in a second direction from the top wall. The cannula includes a sharp distal tip for piercing the elastomeric stopper and provides fluid communication between the vial adapter and the vial when the vial adapter is mounted to the vial. A side plate extends from the top wall and around the cannula. The side plate includes at least one flexible retention arm having a retention latch for snap fit to an underside portion of the cap of the closure system when the vial adapter is mounted to the vial. A length of the cannula from the top wall is such that the sharp distal tip of the cannula is proximal to the retention latch.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 416,406, filed on October 14, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Technical field

[0003] The present disclosure generally relates to a drug transfer device for mixing pharmaceutical substances and, more particularly, to a vial adapter configured to facilitate attachment to a closure system of a vial. Background art

[0004] Many types of drugs are typically packaged in glass vials to provide a convenient and safe way to transport and store the drugs. Standard vials are typically closed by an elastomeric stopper that seals the opening of the vial. A metal closure (such as a metal crimp ring) is then installed over the elastomeric stopper to ensure that the elastomeric stopper remains fixed to the vial. This is accomplished by folding the bottom end of the metal crimp ring under an overhanging portion extending from the vial neck to secure the crimp ring to the vial. The edge of the folded portion of the crimp ring is typically rounded to conform to the shape of the vial's overhanging portion. Due to the ductility of aluminum, conventional crimp rings are typically made of aluminum to facilitate installation on the vial. In addition, conventional metal crimp rings typically include an opening through which the elastomeric stopper can be accessed without the user removing the crimp ring from the vial. A protective cap can also be snap - fitted over the crimp ring to cover the opening in the crimp ring for maintaining the sterility of the underlying elastomeric stopper. In use, by removing the protective cap and then piercing the elastomeric stopper with a piercing member (such as a syringe needle or a vial adapter cannula), the user is allowed access to the contents of the vial, enabling the user to withdraw a desired amount of the drug product from the vial.

[0005] From a safety perspective, using a vial adapter to access the contents of a vial is generally considered more preferable than using a syringe needle because conventional vial adapters do not require the use of a needle, thus minimizing the risk of needlestick injuries. In addition, using a vial adapter allows for a more precise positioning of the point from which the liquid is extracted from the vial, potentially reducing the amount of drug that remains in the vial and cannot be removed.

[0006] Conventional vial adapters require a large amount of force to be assembled onto a standard vial with a metal closure system. These large assembly forces have been shown to cause repetitive stress injuries, especially when assembling in a safety cabinet. Such large forces are partly due to the need to accommodate a wide variety of metal crimp rings and vial geometries. Additionally, since a typical metal crimp ring does not provide an ideal base surface for the vial adapter, increased clamping force is applied to hold the conventional vial adapter onto the vial and prevent accidental disassembly. Additionally, in cases where the pharmaceutical product is potentially toxic (e.g., chemotherapy drugs), the clamping force of the metal crimp ring on the vial is further increased in an effort to improve reliability. While a conventional closed system transfer device (CSTD) is required in such cases to maintain sterility, not all CSTDs are compatible with all vials. In some cases, due to incompatibility with the vial, the user is more likely to accidentally disassemble the CSTD, thereby exposing the user to the risk of coming into contact with the hazardous pharmaceutical product.

[0007] Accordingly, for various reasons, plastic closure systems are becoming increasingly popular compared to their metal counterparts. For example, manufacturers seeking to rapidly change flexible filler formats may face challenges with various issues, including the availability of aluminum particles in nested closures or seals. However, conventional vial adapters are incompatible with plastic closure systems. Thus, there is a distinct and substantial need for a vial adapter that is compatible with plastic closure systems, including existing plastic closure systems. Additionally, there is a need to provide a vial adapter that does not require large assembly forces to be secured to a plastic closure system. Similarly, there is a need to provide a vial adapter that provides increased clamping force for a plastic closure system. SUMMARY OF THE INVENTION

[0008] The vial adapter of the present disclosure meets the foregoing needs. According to one aspect of the present disclosure, the vial adapter includes: a top wall configured to cover a top portion of a closure system when the vial adapter is installed onto a vial; a connector extending from the top wall in a first direction, the connector being configured to connect to a drug transfer device; an intubation extending from the top wall in a second direction, the intubation including a sharp distal tip operable to pierce an elastomeric stopper of the closure system and provide fluid communication between the vial adapter and the vial when the vial adapter is installed onto the vial; and a skirt extending from the top wall and surrounding the intubation, the skirt defining an opening configured to at least partially receive the closure system, the skirt including at least one flexible retaining arm having a retaining latch configured to snap-fit onto a lower side portion of a lid of the closure system when the vial adapter is installed onto the vial, wherein a length of the intubation from the top wall is such that the sharp distal tip of the intubation is proximal to the retaining latch.

[0009] According to another aspect of the present disclosure, the flexible retaining arm further includes a locking tongue that projects into the opening defined by the side plate, and the locking tongue is configured to snap-fit correspondingly into an annular recess formed along the circumferential periphery of the lid of the closure system when the retaining latch snap-fits into the lower side portion of the lid.

[0010] According to another aspect of the present disclosure, the retaining latch is a reverse tooth having a leading face and a trailing face, the leading face being configured to facilitate attachment of the side plate above the top portion of the closure system, and the trailing face being configured to lock the side plate to the lower side portion of the closure system.

[0011] According to another aspect of the present disclosure, an elastomeric band surrounds the side plate and is operable to prevent the flexible retaining arm from deflecting away from the longitudinal axis of the vial adapter.

[0012] According to another aspect of the present disclosure, the elastomeric band is a rubber ring.

[0013] According to another aspect of the present disclosure, the outer surface of the side plate includes a lip that projects away from the longitudinal axis of the vial adapter, and the lip is configured to prevent the elastomeric band from slipping off the side plate when the flexible retaining arm is not deflected.

[0014] According to another aspect of the present disclosure, the side plate includes a plurality of flexible retaining arms.

[0015] According to another aspect of the present disclosure, the side plate further includes at least one slit that separates adjacent flexible retaining arms.

[0016] According to another aspect of the present disclosure, the side plate further includes at least one connecting bridge that is disposed within a corresponding at least one slit and interconnects adjacent flexible retaining arms.

[0017] According to another aspect of the present disclosure, the side plate further includes an outer surface having an annular groove that is configured to provide controlled bending of each flexible retaining arm.

[0018] According to another aspect of the present disclosure, the annular groove forms a corresponding section of reduced thickness in each flexible retaining arm.

[0019] According to another aspect of the present disclosure, each flexible retaining arm further includes a first flexible finger and a second flexible finger.

[0020] According to another aspect of the present disclosure, the first flexible finger and the second flexible finger of each flexible retaining arm are separated by a cutout portion.

[0021] According to another aspect of the present disclosure, the cannula extends along a longitudinal axis of the vial adapter that is perpendicular to the top wall.

[0022] According to another aspect of the present disclosure, a first direction in which the connector extends from the top wall is opposite to a second direction in which the cannula extends from the top wall.

[0023] According to another aspect of the present disclosure, the connector extends along a longitudinal axis of the vial adapter that is substantially perpendicular to the top wall.

[0024] According to another aspect of the present disclosure, the connector is a luer connector.

[0025] According to another aspect of the present disclosure, a method of using a vial adapter to access the contents of a vial sealed by a closure system having an elastomeric stopper and a cap is provided. The method includes: aligning the vial adapter to be substantially concentric with the closure system; pushing the vial adapter over the closure system such that when the cap is received within the opening of the side plate, the at least one flexible retaining arm deflects away from the longitudinal axis of the vial adapter and until the retaining latch snap-fits to a lower side portion of the cap; and connecting a drug delivery device to the connector of the vial adapter to establish fluid communication between the vial and the drug delivery device.

[0026] According to another aspect of the present disclosure, after the at least one flexible retaining arm deflects away from the longitudinal axis of the vial adapter and before the retaining latch snap-fits to the lower side portion of the cap of the closure system, a sharp distal tip of the cannula pierces the elastomeric stopper of the closure system.

[0027] According to another aspect of the present disclosure, the retaining latch is a barb having a leading face and a trailing face, the leading face being configured to facilitate attachment of the side plate over a top portion of the closure system, and the trailing face being configured to lock the side plate to the lower side portion of the closure system.

[0028] Accordingly, certain embodiments of the present disclosure have been outlined so that the detailed description thereof herein may be better understood and so that the contribution of the present disclosure to the art may be better appreciated. Additional embodiments of the present disclosure will be described below and these embodiments form the subject matter of the appended claims.

[0029] In this regard, before explaining in detail at least one aspect of the present disclosure, it should be understood that the application of the vial adapter discussed herein is not limited to the details of the construction and the arrangement of components set forth in the following description or shown in the drawings. The vial adapter can have aspects other than those described and can be practiced and carried out in various ways. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] To facilitate an understanding of the present disclosure, aspects of the vial adapter are shown by way of example in the drawings, in which like parts are referred to by like reference numerals throughout.

[0031] Figure 1 A top perspective view of a vial adapter in accordance with the present disclosure is shown.

[0032] Figure 2 A bottom perspective view of the vial adapter without the elastomeric band is shown. Figure 1 of the vial adapter is shown.

[0033] Figure 3 A cross-sectional side view of the vial adapter is shown. Figure 1 of the vial adapter is shown.

[0034] Figure 4 A cross-sectional perspective view of the vial adapter without the elastomeric band is shown. Figure 1 of the vial adapter is shown.

[0035] Figure 5 A cross-sectional side view of the vial adapter aligned with a syringe is shown. Figure 1 of the vial adapter is shown.

[0036] Figure 6 A side view of the vial adapter connected to a syringe and a vial is shown. Figure 1 of the vial adapter is shown.

[0037] Figure 7 A top perspective view of a vial adapter according to another embodiment of the present disclosure is shown.

[0038] Figure 8 A bottom perspective view of the vial adapter is shown. Figure 7 of the vial adapter is shown.

[0039] Figure 9 A cross-sectional side view of the vial adapter is shown. Figure 7 of the vial adapter is shown.

[0040] Figure 10 A cross-sectional perspective view of the vial adapter is shown. Figure 7 of the vial adapter is shown. DETAILED DESCRIPTION

[0041] The present disclosure describes a new drug transfer device (such as a vial adapter) that is configured to be mounted on a vial sealed by a plastic closure system. Specifically, Figures 1 to 4There is shown a vial adapter 10 that is operable to gain access to the contents of a vial sealed by a plastic closure system. A typical plastic closure system includes an elastomeric stopper and a plastic cap. The elastomeric stopper (such as a rubber stopper) fits within a hole in the generally cylindrical head portion of a conventional vial to seal the contents of the vial. The plastic cap fits over and is secured to the head portion of the vial, for example via a snap-fit connection, eliminating the need for a metal crimp ring. In some cases, the plastic cap may be generally cylindrical. One such example of a plastic closure system is Daikyo which provides a one-step assembly for a conventional vial with an integrated stopper and plastic cap, which helps ensure flexibility, allows for smaller batch sizes, and reduces the risks associated with aluminum seals. West The cap is another example of a plastic closure system that helps protect and maintain the vacuum pressure within the vial while simplifying the capping process. The cap is made of medical-grade polypropylene and allows for lyophilization and crimping in one step, providing an immediate seal. Some plastic closure systems may also include additional securing features (such as annular locking recesses provided on the plastic cap) that can be used to enhance the attachment of the vial adapter 10 thereto, as will be discussed in detail below.

[0042] Reference Figure 1 and Figure 2 , the vial adapter 10 of the present disclosure includes a top wall 20 and a connector 22 extending from the top wall in a first direction. In some embodiments, the connector 22 may be a male Luer lock connector, while in other embodiments, the connector 22 may be a female Luer lock connector. In other embodiments, the connector 22 may be a connector other than a Luer lock (such as another type of universal quick connector, or a custom or proprietary connector), such that connection to the vial adapter 10 may be limited to other devices 60 that share complementary custom or proprietary connectors.

[0043] Side plates 30 may be connected to the top wall 20 and may extend in a second direction opposite to the first direction in which the connector extends. The side plates 30 may be elastically deformable and generally cylindrical. The side plates 30 define an opening sized and shaped to at least partially receive a plastic closure system attached to the vial. The side plates 30 are configured to releasably engage the plastic closure system. Thus, the side plates 30 are configured to connect to the plastic closure system such that the vial adapter 10 is correspondingly interconnected with the vial, as Figure 5 shown.

[0044] Returning to Figure 1 and Figure 2, the side plate 30 includes at least one flexible retaining arm 32. According to some aspects, the side plate may include a plurality of flexible retaining arms circumferentially spaced apart by respective slits 33. Each flexible retaining arm 32 is elastically attached to the top wall 20. Thus, slits 33 are provided between adjacent flexible retaining arms 32 to provide each flexible retaining arm with a sufficient degree of flexibility to fit over the plastic closure system. More specifically, at least one flexible retaining arm 32 allows the side plate 30 to snap securely over a plastic cap attached to the head portion of a vial. Although the vial adapter 10 shown herein includes six flexible retaining arms 32, more or fewer flexible retaining arms may be provided depending on the desired flexibility of the side plate 30. In some aspects, the side plate of the vial adapter may be integrally formed of injection molded plastic (such as polypropylene, etc.).

[0045] Reference Figure 3 and Figure 4 , the piercing cannula 24 (which may be hollow) extends from the top wall in a second direction along the longitudinal axis 12 of the vial adapter 10, the second direction being opposite to the first direction in which the extension connector 22 extends. The piercing cannula 24 projects into the side plate 30, which is configured to releasably secure to a plastic closure system attached to a vial. Additionally, the sharp distal tip 24a of the piercing cannula 24 includes a flow orifice 25 that is in fluid communication with the outlet 23 of the connector 22. Thus, when the vial adapter 10 is attached to a vial via the plastic closure system, the piercing cannula 24 pierces the elastomeric stopper, thereby allowing fluid communication between the vial and the connector 22.

[0046] The distal region of each flexible retaining arm 32 includes a first flexible finger 34 and a second flexible finger 35. The first flexible finger 34 and the second flexible finger 35 are spaced apart by a cutout portion 36. In some aspects, the first flexible finger 34 may be larger than the second flexible finger 35 such that the stiffness of the first flexible finger is greater than the stiffness of the second flexible finger (or in other words, the flexibility of the second flexible finger is greater than the flexibility of the first flexible finger). In other embodiments, the first flexible finger 34 and the second flexible finger 35 may be the same size such that the stiffness of the first flexible finger 34 and the second flexible finger 35 is the same (or in other words, the flexibility of the first flexible finger 34 and the second flexible finger 35 is the same). The first flexible finger 34 and the second flexible finger 35 are configured to removably engage the bottom portion of the plastic closure system via a snap-fit connection.

[0047] In an embodiment, each first flexible finger 34 includes a respective inner surface having a first retaining latch 37 (such as a ridge or barb) extending therefrom into an opening defined by the side plate 30. The first retaining latch 37 has a leading face 37a that is inclined relative to the inner surface of the first flexible finger 34 to facilitate sliding movement over the upper end of the plastic closure system. The first retaining latch 37 also has a trailing face 37b that is substantially perpendicular to the inner surface of the first flexible finger 34 for firmly gripping the bottom end of the plastic closure system. In an embodiment, the first retaining latch 37 may be integrally formed with the respective first flexible finger 34. Alternatively, the first retaining latch 37 may be different from the respective first flexible finger 34 and may be made of the same or different material as the respective first flexible finger 34.

[0048] Similarly, in an embodiment, each second flexible finger 35 includes a respective inner surface having a second retaining latch 38 (such as a ridge or barb) extending therefrom. The second retaining latch 38 has a leading face 38a that is inclined relative to the inner surface of the second flexible finger 35 to facilitate sliding movement over the upper end of the plastic closure system. The second retaining latch 38 also has a trailing face 38b that is substantially perpendicular to the inner surface of the second flexible finger 35 for firmly gripping the bottom end of the plastic closure system. In an embodiment, the second retaining latch 38 may be integrally formed with the respective second flexible finger 35. Alternatively, the second retaining latch 38 may be different from the respective second flexible finger 35 and may be made of the same or different material as the respective second flexible finger 35.

[0049] Accordingly, the first retaining latch 37 and the second retaining latch 38 (used alone or together) provide a latching mechanism for engaging the vial adapter 10 to a plastic closure system attached to a vial.

[0050] In an embodiment, only some of the first flexible fingers 34 (including only one first flexible finger 34) in the first flexible fingers 34 may include the first retaining latch 37, and the other first flexible fingers 34 may be arranged to not have the first retaining latch 37. Similarly, in an embodiment, only some of the second flexible fingers 35 (including only one second flexible finger 35) in the second flexible fingers 35 may include the second retaining latch 38, and the other second flexible fingers 35 may be arranged to not have the second retaining latch 38. Additionally or alternatively, at least one first retaining latch 37 of the first flexible fingers 34 may have a different size (e.g., may be smaller, larger, different in shape, etc.) from at least one other first retaining latch 37 of another first flexible finger 34. Additionally or alternatively, at least one second retaining latch 38 of the second flexible fingers 35 may have a different size (e.g., may be smaller, larger, different in shape, etc.) from at least one other second retaining latch 38 of another second flexible finger 35. Such configurations can both allow for easier initial positioning of the vial adapter 10 above the plastic closure system and help maintain the longitudinal axis 12 of the vial adapter 10 concentric with the longitudinal axis of the plastic closure system, which can reduce the risk of damage and / or leakage that may be caused by a non-concentric engagement between the vial adapter 10 and the plastic closure system.

[0051] In addition, an intermediate region of one, each, or some of the flexible retaining arms 32 may include a corresponding locking tongue 39 that extends from the inner surface of the flexible retaining arm and into an opening defined by the side plate 30. The locking tongue 39 may be positioned proximal to the first flexible fingers 34 and the second flexible fingers 35. The locking tongue 39 may be operable to mate with a corresponding annular recess provided along the circumferential perimeter of the plastic cap of the plastic closure system via a snap-fit connection. Thus, the locking tongue 39 thus provides a locking mechanism for further securing the vial adapter to the plastic closure system attached to the vial. In some embodiments, the locking tongue 39 may be a ridge, pit, rib, flange, or the like. In an embodiment, the locking tongue 39 may be integrally formed with the flexible retaining arm 32. Alternatively, the locking tongue 39 may be different from the flexible retaining arm 32 and may be made of the same or different material as the flexible retaining arm 32. Additionally, in some embodiments, the annular recess formed in the plastic cap may include a groove, thread, slot, notch, or recess, etc. In other embodiments, at least one vertical channel may be formed in the cylindrical cap for guiding at least one flexible retaining arm.

[0052] In some embodiments, the vial adapter 10 may include an elastomeric band 40. The elastomeric band 40 may be removably disposed on the outer surface of the side plate 30. The elastomeric band 40 can operably compress at least one flexible retaining arm 32 of the side plate 30 inwardly in a uniform manner to ensure a sufficient snap-fit connection with the plastic closure system. In addition, the compressive force applied by the elastomeric band 40 on at least one flexible retaining arm 32 is maintained to prevent the user from inadvertently pulling the side plate away from the plastic cap and thus prevent the vial adapter from accidentally detaching from the plastic closure system. A lip 42 may be provided on the outer surface of the side plate to prevent the elastomeric band 40 from slipping off the side plate 30 during use. The lip 42 may be annular. For example, each flexible retaining arm 32 may include a distal region having an outer surface from which the lip 42 projects outwardly. According to some aspects, the lip 42 may be provided on the outer surface of one or both of the first flexible finger 34 and the second flexible finger 35 to prevent the elastomeric band 40 from inadvertently slipping off the distal region of the side plate. In an embodiment, the elastomeric band 40 may be a rubber ring, but other materials, including combinations of materials having different hardnesses and elasticities, are also possible. The elastomeric band 40 may be adapted to a variety of different geometries to accommodate the compressive forces required for a variety of different applications. For example, the cross-sectional geometry (e.g., height, thickness, etc.) may be adapted to provide the compressive force required for a particular application.

[0053] When attaching the vial adapter 10 to a plastic closure system (which is attached to a vial), the user first aligns the vial adapter to be generally concentric with the plastic closure system such that the piercing cannula 24 is aligned with the elastomeric stopper of the vial. The first flexible finger 34 and the second flexible finger 35 of each flexible retaining arm 32 extend downwardly beyond the sharp distal tip 24a of the piercing cannula 24 such that the respective retaining latches 37, 38 of each first flexible finger 34 and second flexible finger 35 are operable to contact the plastic closure system simultaneously before the piercing cannula contacts the elastomeric stopper. This allows at least one flexible retaining arm 32 to guide the vial adapter into generally concentric alignment with the vial aperture as the user pushes the vial adapter over the plastic closure system, thus ensuring that the sharp distal tip of the cannula is sufficiently aligned to pierce the elastomeric stopper.

[0054] For example, initially pressing the vial adapter 10 towards the vial causes at least one flexible retaining arm 32 (including corresponding first and second flexible fingers 34 and 35) to bend slightly outward as they travel along the peripheral surface of the plastic closure system, while the sharp distal tip 24a of the piercing cannula 24 approaches the elastomeric stopper of the vial. Continuing to press the vial adapter 10 towards the vial causes at least one flexible retaining arm 32 to slide over the peripheral surface of the plastic closure system until the corresponding first and second flexible fingers 34 and 35 snap over the bottom edge of the plastic closure system, and the flow orifice 25 of the piercing cannula is positioned within the vial to permit flow communication with the outlet 23 of the connector 22.

[0055] Additionally, continuing to press the vial adapter 10 towards the vial causes at least one flexible retaining arm 32 to slide over the peripheral surface of the plastic closure system until the corresponding locking tongue 39 snaps into a corresponding annular locking recess provided along the periphery of the plastic cap of the plastic closure system to provide a locking mechanism, thereby further securing the vial adapter to the plastic closure system attached to the vial. According to some aspects, when at least one flexible retaining arm 32 bends outward while pressing the vial adapter over the plastic closure system, the elastomeric band 40 provides an additional compressive force to the at least one flexible retaining arm. This compressive force applied by the elastomeric band 40 helps to push the at least one flexible retaining arm inwardly towards the plastic closure system in order to assist in ensuring that the corresponding retaining latch and locking tongue snap into engagement with the corresponding sections of the plastic closure system.

[0056] The vial adapter 10 is also configured to connect to another drug delivery device, such as a syringe 50 (e.g., a needleless syringe), as Figure 5 and Figure 6 shown. Specifically, the connector 22 of the vial adapter 10 can be configured to threadedly mate with a corresponding syringe connector 52. According to some aspects, the connector 22 of the vial adapter can be a male Luer fitting, and the syringe connector 52 can be a corresponding female Luer fitting, but as discussed above, other connection types are possible. Once the vial 60 is connected to the syringe 50 via the vial adapter 10, the syringe 50 can be used in a conventional manner to draw the drug 62 contained within the vial 60 into the syringe 50 such that the drug can be delivered to a patient.

[0057] In some embodiments, the vial adapter 10 is configured to connect to another drug transfer device (such as another vial adapter). For example, a pair of vial adapters 10 can be used to transfer and mix a first substance and a second substance contained in a first vial and a second vial to form a mixture that can be delivered to a patient. For example, a first vial containing a powder or lyophilized substance can be connected to a second vial containing a diluent via a closed system transfer device that includes a first vial adapter and a second vial adapter. In such a closed system transfer device, each vial adapter can be attached to a corresponding plastic closed system that is connected to the corresponding vial. Additionally, as described above, the first vial adapter and the second vial adapter are generally identical to each other except for their respective connectors. For example, the connector of the first vial adapter can be a male Luer connector, and the connector of the second vial adapter can be a corresponding female Luer connector. Thus, the first vial adapter is configured to be threadedly connected to the second vial adapter for fluidly connecting the corresponding first vial and second vial to each other.

[0058] Next turning to Figure 7 and Figure 8 , another embodiment of a vial adapter 110 for a plastic closed system is shown. The vial adapter 110 can include any of the features described above with reference to the vial adapter 10, and vice versa. For example, the vial adapter 110 can include a top wall 120 and a connector 122 that extends from the top wall in a first direction. According to some aspects, the connector 122 can be a male Luer lock connector, while in other aspects, the connector 122 can be a female Luer lock connector. The connector 122 can take the form of any of the other connectors previously described with reference to connector 22. Side plates 130 can be connected to the top wall 120 and can extend in a second direction opposite to the first direction in which the connector 122 extends. The side plates 130 can be elastically deformable and can be generally cylindrical. The side plates 130 define an opening that is sized and shaped to at least partially receive and releasably engage a plastic closed system attached to a vial. Thus, the side plates 130 are configured to connect to the plastic closed system such that the vial adapter 110 is correspondingly interconnected with the vial.

[0059] The side plate 130 includes at least one flexible retaining arm. According to some aspects, the side plate may include a plurality of flexible retaining arms 132 circumferentially spaced apart by respective slits 133. Each flexible retaining arm 132 is elastically attached to the top wall 120. Slits 133 are provided between adjacent flexible retaining arms 132 to provide a degree of flexibility to each flexible retaining arm to fit over a plastic closure system. Thereby, at least one flexible retaining arm 132 allows the side plate 130 to snap firmly over a plastic cap attached to the head portion of a vial. Although the vial adapter 110 shown herein includes six flexible retaining arms 132, more or fewer flexible retaining arms may be provided depending on the desired flexibility of the side plate 130. The thickness of the side plate 130 may vary along the longitudinal axis 12 of the vial adapter 10. For example, the side plate 130 (having one or more annular grooves or recesses 129) may provide a thin-walled section of each flexible retaining arm 132 to allow controlled, predictable bending of each flexible retaining arm during installation of the side plate on the plastic closure system. In some aspects, the annular groove or recess 129 may also provide a base for an elastomeric band around the side plate. In an embodiment, the cross-sectional thickness of an area of the side plate 130 may be greater than the cross-sectional thickness of other areas of the side plate 130. According to such a configuration, the relatively thick area may define an indexing feature that may assist in locking the vial adapter 10 relative to the plastic closure system and may prevent or limit rotation of the vial adapter 10 relative to the plastic closure system.

[0060] As Figure 9 and Figure 10 shown, the piercing cannula 124 extends from the top wall 120 in a second direction opposite to the first direction in which the extension connector 122 extends. The piercing cannula 124 projects into the side plate 130, and the sharp distal tip 124a of the piercing cannula 124 includes a flow hole 125 that is in fluid communication with the outlet 123 of the connector 122. When the vial adapter 10 is attached to a vial via a plastic closure system, the piercing cannula 124 pierces the elastomeric stopper, thereby allowing fluid communication between the vial and the outlet 123 of the connector 122.

[0061] The distal region of each flexible retaining arm 132 includes a first flexible finger 134, a second flexible finger 135, and a third flexible finger 136. The first flexible finger 134 is disposed between the second flexible finger 135 and the third flexible finger 136, and is spaced from the second flexible finger and the third flexible finger respectively by a cutout portion 131. In some aspects, the first flexible finger 134 may be larger than the second flexible finger 135 and the third flexible finger 136, such that the stiffness of the first flexible finger is greater than the stiffness of the other flexible fingers. In other words, the flexibility of the second flexible finger and the third flexible finger is greater than the flexibility of the first flexible finger. In other embodiments, the first flexible finger, the second flexible finger, and the third flexible finger may be of the same size, such that the stiffness of each flexible finger is the same (or in other words, the flexibility of each flexible finger is the same).

[0062] The first flexible finger 134 of each flexible retaining arm 132 is configured to removably engage the bottom portion of the plastic closure system via a snap-fit connection. Specifically, each first flexible finger 134 includes a respective inner surface having a retaining latch 137 (such as a ridge or barb) extending therefrom into the opening defined by the side plate 130. The retaining latch 137 has a leading face 137a that is inclined relative to the inner surface of the first flexible finger 134 to facilitate sliding movement over the upper end of the plastic closure system. The retaining latch 137 also has a trailing face 137b that is substantially perpendicular to the inner surface of the first flexible finger 134 for firmly gripping the bottom end of the plastic closure system. Thus, the retaining latch 137 provides a latching mechanism for attaching the vial adapter to the plastic closure system attached to the vial.

[0063] A connecting bridge 138 is disposed within each slit 133 and interconnects adjacent flexible retaining arms 132 with each other. This interconnection provides local rigidity to each flexible retaining arm 132 and thus may obviate the need for the separate elastomeric bands discussed above. The interconnection provided by the connecting bridge 138 between adjacent flexible retaining arms 132 also helps to ensure that the vial adapter is concentrically attached to the plastic closure system during installation. According to some aspects, each connecting bridge 138 interconnects the second flexible finger 135 and the third flexible finger 136 of directly adjacent flexible retaining arms 132. The connecting bridge 138 may be integrally formed with the side plate of the vial adapter by injection molding plastic (such as polypropylene, etc.).

[0064] In addition, an intermediate region of each flexible retaining arm 132 includes a respective locking tongue 139 that extends from an inner surface of the flexible retaining arm and into an opening defined by the side plate 130. The locking tongue 139 is positioned proximal to the first flexible finger, second flexible finger, and third flexible finger. The locking tongue 139 is operable to mate via a snap-fit connection with a corresponding annular recess provided along an outer periphery of a plastic cap of the plastic closure system. Thereby, the locking tongue 139 thus provides a locking mechanism for further securing the vial adapter to the plastic closure system attached to the vial. In addition, each locking tongue 139 includes a leading surface 139a that is inclined relative to the inner surface of the flexible retaining arm 132 to facilitate sliding movement over the upper end of the plastic closure system during installation. The locking tongue 139 also has a trailing surface 139b that is substantially perpendicular to the inner surface of the flexible retaining arm 132 for firmly clamping the bottom end of the plastic closure system. In some embodiments, the locking tongue may be a ridge, pit, rib, flange, or the like.

[0065] When attaching the vial adapter 110 to a plastic closure system (which is attached to a vial), the user first aligns the vial adapter to be generally concentric with the plastic closure system such that the piercing cannula 124 is aligned with the elastomeric stopper of the vial. The flexible fingers 134, 135, 136 of each flexible retaining arm 132 extend downwardly beyond the sharp distal tip 124a of the piercing cannula 124 such that a respective retaining latch 137 of each flexible retaining arm 132 is operable to contact the plastic closure system before the piercing cannula contacts the elastomeric stopper. This allows at least one flexible retaining arm 132 to guide the vial adapter into generally concentric alignment with the vial bore as the user pushes the vial adapter over the plastic closure system, thereby ensuring that the sharp distal tip of the cannula is sufficiently aligned to pierce the elastomeric stopper.

[0066] Initially pressing the vial adapter 110 toward the vial causes at least one flexible holding arm 132 (including a respective first flexible finger, second flexible finger, and third flexible finger) to bend slightly outward as they travel along the peripheral surface of the plastic closure system, while the sharp distal tip 124a of the piercing cannula 124 approaches the elastomeric stopper of the vial. Continuing to press the vial adapter 110 toward the vial causes at least one flexible holding arm 132 to slide over the peripheral surface of the plastic closure system until the respective flexible fingers snap-fit over the bottom edge of the plastic closure system and the flow aperture 125 of the piercing cannula is positioned within the vial to permit flow communication with the outlet 123 of the connector 122. Continuing to press the vial adapter 110 toward the vial causes at least one flexible holding arm 132 to slide over the peripheral surface of the plastic closure system until the respective locking tongue 139 snap-fits into a corresponding annular locking recess provided along the periphery of the plastic cap of the plastic closure system to provide a locking mechanism, thereby further securing the vial adapter to the plastic closure system attached to the vial. According to some aspects, the connecting bridge 138 provides additional rigidity to the distal ends of each flexible holding arm and, more particularly, to the second flexible finger and the third flexible finger to help ensure that the retaining latch and the locking tongue snap-fit with the corresponding sections of the plastic closure system.

[0067] Although certain embodiments of a vial adapter for a plastic closure system have been described in terms of aspects that may be considered to be specific aspects, the present disclosure is not limited to the disclosed aspects. Additional modifications and improvements to the foregoing vial adapter may be apparent to those skilled in the art. Moreover, many features and advantages of the present disclosure are apparent from the detailed description, and accordingly, the appended claims are intended to cover all such features and advantages of the present disclosure that fall within the spirit and scope of the present disclosure.

Claims

1. A vial adapter configured to be mounted to a vial, the vial being sealed by a closure system having an elastomeric stopper and a cap, the vial adapter comprising: A top wall configured to cover a top portion of the closure system when the vial adapter is mounted to the vial; A connector extending from the top wall in a first direction, the connector being configured to connect to a drug delivery device; A cannula extending from the top wall in a second direction, the cannula including a sharp distal tip operative to pierce the elastomeric stopper of the closure system and to provide fluid communication between the vial adapter and the vial when the vial adapter is mounted to the vial; And A side plate extending from the top wall and surrounding the cannula, the side plate defining an opening configured to at least partially receive the closure system, the side plate including at least one flexible retaining arm having a retaining latch configured to snap-fit to a lower side portion of the cap of the closure system when the vial adapter is mounted to the vial, Wherein a length of the cannula from the top wall is such that the sharp distal tip of the cannula is proximal to the retaining latch.

2. The vial adapter according to claim 1, wherein the flexible retaining arm further includes a locking tongue projecting into the opening defined by the side plate, the locking tongue being configured to snap-fit correspondingly into an annular recess formed along a circumferential perimeter of the cap of the closure system when the retaining latch snap-fits to the lower side portion of the cap.

3. The vial adapter according to any one of the preceding claims, wherein the retaining latch is a reverse tooth having a leading face and a trailing face, the leading face being configured to facilitate attachment of the side plate above the top portion of the closure system, and the trailing face being configured to lock the side plate to the lower side portion of the closure system.

4. The vial adapter according to any one of the preceding claims, further comprising an elastomeric band surrounding the side plate and operative to prevent deflection of the flexible retaining arm away from the cannula.

5. The vial adapter according to claim 4, wherein the elastomeric band is a rubber ring.

6. The vial adapter according to any one of claims 4 and 5, wherein an outer surface of the side plate includes a lip projecting away from the cannula, and the lip is configured to prevent the elastomeric band from slipping off the side plate when the flexible retaining arm is not deflected.

7. The vial adapter according to any one of the preceding claims, wherein the side plate includes a plurality of flexible retaining arms.

8. The vial adapter according to claim 7, wherein the side plate further includes at least one slit separating adjacent flexible retaining arms.

9. The vial adapter according to claim 8, wherein the side plate further comprises at least one connecting bridge, the at least one connecting bridge being disposed within a corresponding at least one slit and interconnecting adjacent flexible holding arms.

10. The vial adapter according to any one of the preceding claims, wherein the side plate further comprises an outer surface having an annular groove, the annular groove being configured to provide a controlled bend for each flexible holding arm.

11. The vial adapter according to claim 10, wherein the annular groove forms a corresponding section of reduced thickness in each flexible holding arm.

12. The vial adapter according to any one of the preceding claims, wherein each flexible holding arm further comprises a first flexible finger and a second flexible finger.

13. The vial adapter according to claim 12, wherein the first flexible finger and the second flexible finger of each flexible holding arm are separated by a cutout portion.

14. The vial adapter according to any one of the preceding claims, wherein the cannula extends along a longitudinal axis of the vial adapter that is perpendicular to the top wall.

15. The vial adapter according to any one of the preceding claims, wherein a first direction in which the connector extends from the top wall is opposite to a second direction in which the cannula extends from the top wall.

16. The vial adapter according to any one of the preceding claims, wherein the connector extends along a longitudinal axis of the vial adapter that is substantially perpendicular to the top wall.

17. The vial adapter according to any one of the preceding claims, wherein the connector is a Luer connector.

18. A method of using a vial adapter to access the contents of a vial sealed by a closure system having an elastomeric stopper and a cap, the vial adapter having a connector, a cannula, and a side plate, the side plate including at least one flexible holding arm having a retaining latch, the method comprising: aligning the vial adapter to be substantially concentric with the closure system; pushing the vial adapter over the closure system such that when the cap is received within an opening of the side plate, the at least one flexible holding arm deflects away from a longitudinal axis of the vial adapter and until the retaining latch snap-fits to a lower side portion of the cap; and connecting a drug delivery device to the connector of the vial adapter to establish fluid communication between the vial and the drug delivery device.

19. The method according to claim 18, wherein after the at least one flexible holding arm deflects away from the longitudinal axis of the vial adapter and before the retaining latch snap-fits to the lower side portion of the cap of the closure system, a sharp distal tip of the cannula pierces the elastomeric stopper of the closure system.

20. The method according to any one of claims 18 and 19, wherein the retaining latch is a barb having a leading face and a trailing face, the leading face being configured to facilitate attachment of the side plate above a top portion of the closure system, the trailing face being configured to lock the side plate to the lower side portion of the closure system.

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