Patent Grant
12071279
A vial closure assembly including a shell configured to be connected to a vial for holding a stopper in place relative to the vial, in order to ensure adequate isolation of the contents of the vial and stopper from the outside and surrounding environment is provided. Another embodiment relates to a container equipped with such a vial closure assembly.
In the field of containers for medication, a glass bottle can be used to store an active ingredient in freeze-dried form, in powder form, or in the form of a liquid solution. Such a bottle must be closed off in a leak-tight manner, so as to maintain its contents in a satisfactory state of preservation, until the date on which it is used. In order to close a bottle hermetically, a vial closure assembly can be used that comprises an elastomer stopper that has the function of being totally sealed against gas, liquids, and bacteria. Such a device further comprises a locking cover that can be made of a plastic material, and that is designed to be held in place around the stopper so as to isolate the stopper from the outside and so as to oppose removal of the stopper.
When the cover needs to be moved so as to be locked around the neck of the corresponding container, friction creates resistance to this movement, the magnitude of which varies as a function firstly of the manufacturing tolerances of the component parts of the cover, and secondly of the pre-positioning of the parts when they are installed on the neck of the container. Thus, when a presser plate is used to lock the covers on a large number of corresponding containers, certain covers are not locked correctly in view of the manufacturing tolerances of the component parts of the covers and in view of the operating clearances of the presser plate. Also, the dimensional variations in the containers themselves and in the stoppers that are used further complicate the closure of a batch of containers. Furthermore, rotational movement of the cover and stopper relative to the vial, particularly for plastic closure assemblies, may cause breaches in the desired isolation of the contents of the vial.
Therefore, it is desirable to use a stopper device which provides for secure and stable positioning of the cover on a vial stopper and is configured so as to minimize the chances of the cover and stopper rotating relative to the vial. More particularly, it would be desirable to provide a vial closure assembly which is configured such that it would be difficult for an individual to rotate the stopper relative to the vial.
According to one aspect, a vial closure assembly comprises a ring, a cover, a cap, and a shell. The ring comprises a first top wall and a skirt extending downwardly from the first top wall, and the first top wall defines a first central through-opening. The skirt comprises a plurality of locking tabs. The cover comprises a second top wall, a sidewall extending downwardly from the second top wall and an interior cavity defined by the second top wall and the sidewall. The second top wall defines a second central through-opening generally aligned with the first central through-opening of the ring. The cap comprises a plurality of tabs configured to engage the second top wall of the cover. The shell comprises a barrel-shaped body having an inwardly radially extending upper lip and an inwardly radially extending lower lip, such that the shell is configured to captivate the cover. The upper lip includes at least one rail for sliding contact with a top surface of the second top wall.
According to another aspect, a vial closure assembly comprises a ring, a cap, and a shell. The ring comprises a top wall and a skirt extending downwardly from the top wall. The first top wall defines a first central through-opening, and the skirt comprises a plurality of locking tabs. The cap comprises a plurality of tabs configured to engage the top wall of the ring. The shell comprises a barrel-shaped body having an inwardly radially extending upper lip and an inwardly radially extending lower lip, such that the shell is configured to captivate the ring. The upper lip includes at least one rail for sliding contact with a top surface of the top wall.
These and other aspects of the various embodiments disclosed herein will be apparent in view of the following description.
The foregoing summary, as well as the following detailed description will be better understood when read in conjunction with the appended drawings. There are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities shown. In the drawings:
Referring generally to the figures, the various embodiments disclosed herein relate to a vial closure assembly to be positioned on a container for closure of the vial in a leak-tight and secure manner. The vial closure assembly includes a ring, a cover, a shell, and a stopper assembled thereto. The stopper is configured to be positioned at least partially in the container. Preferably, the stopper is an elastomeric stopper. The stopper is substantially T-shaped in cross-section, and has a cylindrical body and a head. The cylindrical body is designed to be positioned within the neck of the container. The head defines a peripheral flange for abutting against the top surface of the rim of the container.
The ring, cover, and shell have a substantially cylindrical shape, a first end and an opposing second end. Once the stopper is inserted within the interior of the ring, the assembly can be press fit onto the crown of a vial until the stopper flange is compressed against the vial crown at a stopper/vial interface surface. The vial closure assembly, specifically the shell, is configured to hinder rotation of the stopper relative to the vial.
In one embodiment, the ring may include a plurality of locking tabs which are elastically deformable, and more particularly radially deformable (inwardly or outwardly) relative to a central longitudinal axis X of the tubular sidewall. The locking tabs are preferably configured to engage the rim of the vial when the vial closure assembly is in the sealed position. The ring may further include a tongue or prong configured to engage the stopper for securing the stopper within the interior cavity of the ring. The tongue or prongs are preferably cantilevered and inclined with respect to the interior surface of the respective leg. Each tongue is also biased at such an incline toward the interior cavity of the shell. Alternatively and/or in addition, the stopper may be retained within the ring by other means, such as by an interference fit.
In another embodiment, the vial closure assembly device includes an optional inner cover configured to surround and engage the ring.
It will be understood that the various embodiments disclosed herein are not limited to the aforementioned components of the vial closure assembly and need not include all of the aforementioned elements.
The vial closure assembly further includes an outer shell that surrounds the ring (and the inner cover if present). The outer shell is preferably the outermost portion of the vial closure assembly and therefore, the portion that a user is most likely to grip and apply a rotational torque. The outer shell is configured in such a way that it cannot be removed from the shell, but also such that it does not transfer external torque applied to the outer shell to the inner components of the vial closure assembly. The outer shell is designed to rotate freely with minimal friction between the internal surface of the outer shell and the external surface of the ring (or inner cover if present). The vial closure assembly therefore reduces the chances of rotation of the stopper (and ring) relative to the vial, and therefore reduces the chances of breaching an adequate sealing surface between the stopper and vial opening (i.e., the sealing surface at the stopper/vial interface). Because the outer shell covers all or almost all of the ring (or the inner cover if present), the vial closure assembly makes it more difficult for an individual to gain direct access to the stopper to twist or rotate the stopper relative to the vial.
In one embodiment, the outer cover is produced from a polymer material by an injection molding process.
Now, referring specifically to
The vial closure assembly 10 shown in
The vial closure assembly 10 is configured to cover the rim 20 and neck 18 of the container 12 and preferably with at least a portion of the stopper 14 positioned therein. The vial closure assembly 10, and more particularly each component of the vial closure assembly 10 as described in detail herein, is preferably made of a plastic material, and more preferably a thermoplastic material such as, but not limited to, PE, PET, PETG, PEHD, polypropylene (PP) or acrylonitrile butadiene styrene (ABS). More preferably, the vial closure assembly 10 is made of a pharma grade polypropylene material, and more particularly a pharma grade polypropylene material that is free of contaminants or critical substances (e.g., bisphenol A or formaldehyde).
According to one embodiment, the vial closure assembly 10 comprises a ring 28, a cover 30, a cap or sealing button 32, and a shell 70.
Referring to
The skirt 36 preferably comprises a plurality of locking tabs configured to capture the rim 20 of the vial 12 when the vial closure assembly 10 is in the sealed condition. In one embodiment, the plurality of locking tabs comprise a plurality of spaced-apart first walls or legs 40 and a plurality of spaced-apart second walls or legs 42. In a preferred embodiment, the plurality of spaced-apart first legs 40 includes three first legs 40 and the plurality of spaced-apart second legs 42 includes three second legs 42, meaning a total of six, preferably alternating, spaced-apart first and second legs 40, 42 form the skirt 36. Each first leg 40 and each second leg 42 has a first or proximal end 40a, 42a integrally formed with or attached to the top wall 34 and an opposing second or distal end 40b, 42b which is a free end. The first and second legs 40, 42 are elastically deformable, and more particularly radially deformable (inwardly or outwardly) relative to a central longitudinal axis X of the skirt 36. The central longitudinal axis X of the skirt 36 also defines a central longitudinal axis of the overall vial closure assembly 10. The first and second legs 40, 42 are preferably arranged in an alternating fashion relative to each other, meaning that each first leg 40 is positioned between two of the second legs 42 and, similarly, each second leg 42 is positioned between two of the first legs 40. As such, the skirt 36 is formed of alternating first legs 40 and second legs 42.
An interior surface of each first leg 40 includes a rib or ledge 44 protruding inwardly toward the interior cavity 37 of the ring 28. Each ledge 44 defines a catch designed to engage the rim 20 of the container 12, for example, before and during final closure and sealing of the container 12, as described in more detail herein. The ledge 44 is preferably provided at an intermediate position between the first and second ends 40a, 40b of each first leg 40 (i.e., each ledge 44 is distal from both the first and second ends 40a, 40b of the respective first leg 40). The ledges 44 of the first legs 40 are referred to hereinafter as upper ledges 44. An exterior surface of each first leg 40 includes a ledge 46 protruding outwardly away from the interior cavity 37 of the ring 28. Preferably, the ledge 46 of each first leg 40 is provided at a corresponding position to the upper ledge 44 of the respective first leg 40. Such an outwardly protruding ledge 46 may also be provided on the exterior surface of each second leg 42 at the same position and orientation, such that the plurality of outwardly protruding ledges 46 collectively define an annular outwardly protruding ledge.
The first legs 40 and second legs 42 are different from each other. More particularly, the second legs 42 do not include the same type of intermediately-positioned ledge 44 as the first legs 40. Rather, at or proximate the second end 42b of each second leg 42, each second leg 42 includes or is formed as a rib or ledge 48 which protrudes inwardly toward the interior cavity 37 of the ring 28. As such, the ledge 48 of each second leg 42 defines another catch designed to engage the rim 20 of the container 12, for example, during a treatment process, as described in more detail herein. The ledges 48 of the second legs 42 are referred to hereinafter as lower ledges 48. The distance between the upper ledges 44 of the first legs 40 and the lower ledges 48 of the second legs 42 is generally equal to or at least slightly larger than the height of the rim 20 of the container 12.
The interior surface of each second leg 42 further comprises a tongue 50 (alternatively may be referred to as a tab, prong, tooth and the like), and more particularly a flexible tongue 50, and a corresponding recess 52 configured to receive the tongue 50 when the tongue 50 is in a retracted configuration. Each tongue 50 is cantilevered and is inclined with respect to the interior surface of the respective second leg 42. Each tongue 50 is biased at such an incline toward the interior cavity 37 of the ring 28. The tongue 50 is provided at an intermediate position between the first and second ends 42a, 42b of each second leg 42. More particularly, the distance between the top wall 34 (i.e., the first ends 42a of the second legs 42) and the flexible tongues 50 is generally equal to or at least slightly larger than a height of the flanged head 26 of the stopper 14.
Referring to
An interior surface of the skirt 56 of the cover 30 preferably includes a rib or ledge 60 which protrudes inwardly toward the interior cavity 57 of the cover 30. More particularly, the ledge 60 is an annular ledge. The ledge 60 defines a catch designed to prevent separation of the cover 30 from the ring 28 by engaging the peripheral rim 38 of the top wall 34 of the ring 28 in a first position (for example, during a treatment process, such as lyophilization or sterlization) and by engaging the outwardly protruding ledges 46 of the first legs 40 and/or second legs 42 in a second position (for example, in a closed or sealed position), as described in more detail herein. The inwardly protruding ledge 60 is preferably provided closer to the open second end 30b of the cover 30 than to the first end 30a.
The various embodiments of the vial closure assemblies are not limited to the specific configuration of the ring and cover described above. For example, the ring and cover of the assemblies may alternatively be configured to not include an intermediate position and have differently configured locking tabs for securing the assembly to the collar of the vial, such as the components described in U.S. Pat. No. 8,714,384, the content of which is incorporated by reference herein in its entirety. As previously noted, the cover component is optional, and the vial closure assemblies disclosed herein may exclude the cover and include, for example, a cap and ring component that is configured similar to the cap and cover of the device described in U.S. Pat. No. 9,260,227, which is also incorporated by reference herein in its entirety.
Referring to
In one embodiment, the cap 32 includes an elastically deformable connecting web in the area between the peripheral rim 62 and the central depressed region 64, such that the peripheral rim 62 may be configured to move axially under drive from an axial pressure or force. Thus, the peripheral rim 62 may be configured to move between a raised position and a lowered position. In one embodiment, the peripheral rim 62 is also be biased to the raised position, such that the peripheral rim 62 automatically returns to the raised position when a pressure or force ceases to be applied to it.
The cap 32 functions as a spring element, and more particularly a flexible spring element, which provides for at least partial compensation of the heights of the stacked components of the assembly. More particularly, the cap 32 allows for the partial compensation of different heights of the various stacked components (e.g., the container 12, the stopper 14 and the vial closure assembly 10) of the assembly, and therefore reduces the risk of breakage of the container 12 during a treatment process. This benefit is particularly advantageous in the context of glass containers 12 being used in a lyophilization process.
Referring to
In order to limit the frictional contact between the shell 70 and the cover 30, the free end of the cantilevered upper lip 72 may be provided with at least one axially extending rail 76 for sliding contact on the top surface of the top wall 54 of the cover 30. The rail 76 extends in a direction that is generally parallel to the barrel 71 of the shell 70 and is preferably tapered to a narrow tip. The tip of the rail 76 rests on the top surface of the top wall 54 of the cover 30, thereby, providing the contact area between the cover 30 and the shell 70. The rail 76 may be configured in a single continuous circular shape or in order to further reduce the frictional contact between the cover 30 and the shell 70, the rail 76 may include gaps, such that the rail 76 is configured as a plurality of arcuate sections.
The barrel 71 of the shell 70 is preferably made from a hard material (e.g., a strong resilient plastic, such as acrylonitrile butadiene styrene (ABS)), such that the shell 70 will resist radial pinching forces that may cause contact between the barrel 71 and the skirt 56 of the cover 30. Maintaining an axial gap between the shell 70 and the cover 30 and reducing the frictional contact between the two components, thereby prevents the transfer of torque from the shell 70 to the cover 30 and reduces the likelihood of further transfer of torsional forces to the inner stopper 14 that may cause a leak if the flanged head 26 of the stopper 14 were to separate from the rim 20 of the container 12.
It will also be understood by those skilled in the art that the vial closure assembly 10 of the present invention may be utilized on a container made of any type of material and may be used in conjunction with a container for any type of treatment process (e.g., sterilization process, filling process and the like), and is in no way limited to glass containers and a lyophilization (freeze-drying) process.
When the cap 32 is removed by a user, a part of the upper (or exterior) surface 26b of the head 26 of the stopper 14 is exposed through the openings 58 and 29. The stopper 14 may thus be pierced, for example, by a needle of a syringe (not shown) for introducing a liquid solvent or diluent into the container 12 and/or drawing out a liquid drug product from the container 12, for example.
A description of one of the methods for assembling the vial closure assembly 10 follows. The successive steps which may be utilized for joining the vial closure assembly 10 (including the stopper 14 pre-assembled therewith) together with the container 12 (e.g., for pre-assembly or for a treatment process, in a first position) and, finally, for closing the container 12 in a sealed manner by the vial closure assembly 10 (i.e., a second position) are also described.
During assembly of the vial closure device 10, the stopper 14 is positioned within the ring 28, as shown in
In a separate step and if present, the cover 30 is captivated within the shell 70. This may be accomplished by providing a shell 70 that lacks either an upper lip 72 or a lower lip 74, inserting the cover 30, and then providing the shell 70 with either the upper lip 72 or lower lip 74. In one embodiment, the cover 30 is inserted into the shell 70 through the end lacking a lip, and after insertion, a press or similar tool may be used to inwardly flare the end of the shell to form the upper lip 72 or lower lip 74. Preferably, the lower lip 74 is the lip that is formed by the flaring step after inserting the cover 30 due to the complexity of the shape of the upper lip 72 and the associated rail 76. In a less preferred embodiment, the upper and/or lower lip may be provided as a separate ring or washer that is bonded to the end of the shell 70 after the cover 30 is inserted into the barrel 71 of the shell 70.
Next, the ring 28, with the stopper 14 secured therein, is partially inserted into the interior cavity 57 of the cover 30 through the open second end 30b. In one embodiment, prior to the partial insertion of the assembled ring 28 and stopper 14 into the interior cavity 57 of the cover 30, the cap 32 has already been coupled to the cover 30, as described above, such that the spaced-apart tabs 66 of the cap 32 are engaged with the underside of the top wall 54 of the cover 30. As previously noted, if the cover 30 is absent, the ring 28 may be inserted into the shell 70 lacking an upper lip 72 or lower lip 74, as described above, followed by the steps of providing a upper or lower lip and finally, attachment of the cap 32.
The process of partially inserting the assembled ring 28 and stopper 14 into the interior cavity 57 of the cover 30 will now be described. Specifically, starting with the top wall 34, the assembled ring 28 and stopper 14 pass through the open second end 30b of the cover 30 and are pushed in an upward direction toward the top wall 54 of the cover 30 (or vice versa the cover 30 is pushed in a downward direction toward the top wall 34 of the ring 28). This insertion motion continues until the peripheral flange 38 of the top wall 34 of the ring 28 passes over and then comes to rest on the inwardly protruding ledge 60 of the cover 30. During the insertion motion, the skirt 36 of the ring 28, and more particularly the first and second legs 40, 42, may deform at least slightly radially inwardly. In an assembled position, the peripheral flange 38 of the top wall 34 of the ring 28 is positioned above and on the inwardly protruding ledge 60 of the cover 30, such that ledge 60 of the cover 30 abuts and directly contacts the lower surface or underside 38a of the peripheral flange 38. As such, a portion of the assembled ring 28 and stopper 14 is received within the interior cavity 57 of the cover 30, while the remaining portion of the assembled ring 28 and stopper 14 is positioned outside of the cover 30, as shown in
At this stage, the closure device 10 is in its assembled position or state. The assembled closure device 10 may then be subjected to a preliminary treatment process, such as a sterilization process.
Next, the assembled closure device 10 is positioned on the container 12 in a first position, as shown in
As such, in the first position, the assembled closure device 10 and container 12 joined thereto may be subjected to one or more of a variety of treatment processes. As a non-limiting example, the assembled closure device 10 and container 12 joined thereto, in the first position, may be subjected to a lyophilization (i.e., freeze-drying) process. Because the cylindrical body 24 or the tapered end 24a of the stopper 14 is not yet inserted within the opening 22 of the container 12, water vapor released during the lyophilization process is able to escape from the container 12.
After the treatment process or processes are complete, the container 12 can be finally closed and sealed by the vial closure assembly 10 (i.e., placed into the second position). It will be understood by those skilled in the art that the processes described herein may be simultaneously carried out on multiple containers 12 and vial closure assemblies 10, providing for bulk assembly, treatment and closure.
To effect complete closure and sealing of the container 12, after the treatment process is complete, pressure or force (e.g., by a pressing plate) may be exerted in a downward direction on the cap 32, and this pressure or force then translates through the vial closure assembly 10. Alternatively, pressure or force may be exerted in an upward direction on the container 12, which in turn exerts pressure or force in an upward direction on the vial closure assembly 10. The following discussion regarding closure of the container 12 relates to the embodiment wherein force is exerted in the downward direction on the cap 32, but it will be understood by those skilled in the art that the relative movement of the vial closure assembly 10 and container 12 should be the same regardless of the direction of application of pressure or force.
For example, when pressure or force is applied in the downward direction on the cap 32, the pressure/force causes the container rim 20 to come out of the annular seat defined by the upper ledges 44 of the first legs 40 and the lower ledges 48 of the second legs 42 of the ring 28, and moves in an upward direction toward the top wall 34 of the ring 28 and past the upper ledges 44 of the first legs 40 and the flexible tongues 50 of the second legs 42. During this upward motion, the cylindrical body 24 of the stopper 14 simultaneously moves into the opening 22 of the container 12, and the container rim 20 comes into contact with the surfaces of the flexible tongues 50, thus causing the tongues 50 to again retract inside the respective recesses 52. This motion continues until the cylindrical body 24 of the stopper 14 is fully received within the opening 22 of the container 12, and until the container rim 20 rests against the underside 26a of the head 26 of the stopper 14 and is secured within the area between the underside 26a of the head 26 of the stopper 14 and the upper ledges 44 of the first legs 40. In parallel to movement of the stopper 14, the first legs 40 deform or bend radially outwardly until the inner diameter of the upper ledges 44 equals the outer diameter of the container rim 20 of the container 12. The first legs 40 will deform or bend radially inwardly again, once the stopper 14 is pushed into the opening 22 of the container 12, such that the upper ledges 44 of the first legs 44 engage the underside of the container rim 20 for final container fixation, as illustrated in
To help prevent particles of the plastic material of the closure device 10 from entering the container 12, the relative movement between the cover 30 and the ring 28 may start once the stopper 14 is completely pushed into the opening 22 of the container 12. This pressure/force also causes the inwardly protruding ledge 60 of the cover 30 and the peripheral flange 38 of the ring 28 to come out of engagement with each other, and the cover 30 to move in a downward direction toward the container 12 until the inwardly protruding ledge 60 engages and abuts against the outwardly protruding ledges 46 of the ring 28, and until the top wall 34 of the ring 28 is proximate (or abuts) the top wall 54 of the cover 30.
At this stage, the vial closure assembly 10 is securely locked to the container 12, such that the container 12 is closed and sealed in a secure and leak-tight manner. Furthermore, the provision of the outer shell 70 reduces the likelihood that the achieved seal may be lost as a result of the application of torque to the vial closure assembly 10.
Certain terminology is used in the following description for convenience only and is not limiting. The words “proximal,” “distal,” “upward,” “downward,” “bottom” and “top” designate directions in the drawings to which reference is made. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, a geometric center of the closure device and container and/or designated parts thereof, in accordance with the present invention. Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element, but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
This application is a National Stage of International Patent Application No. PCT/US2020/043031, filed on Jul. 22, 2020, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/877,473, titled “Vial Closure Assembly,” filed on Jul. 23, 2019, the entire contents of which are incorporated herein by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/043031 | 7/22/2020 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2021/016328 | 1/28/2021 | WO | A |
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| Number | Date | Country | |
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| 20220250803 A1 | Aug 2022 | US |
| Number | Date | Country | |
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| 62877473 | Jul 2019 | US |
