Patent Publication Number: US-10327986-B2

Title: Parenteral vial cap

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application Nos. 61/842,478, filed Jul. 3, 2013 and 61/862,204, filed Aug. 5, 2013 which are incorporated herein as if fully set forth. 
    
    
     FIELD OF INVENTION 
     The invention pertains to a cap for closing a parenteral vial. More specifically, the invention pertains to a cap for closing a parenteral vial in cooperation with a vial stopper, wherein the cap and stopper fit together as an integral unit that can be applied to the parenteral vial as a unit, which moves between a partially engaged position that allows for escape of vapor from the vial interior during lyophilization procedures, and a fully engaged position in which the stopper sealingly closes the vial. 
     BACKGROUND 
     Injectable parenteral drugs are typically packaged in parenteral vials. Packing of such parenteral drugs may include processing steps that are specific to such parenteral vials and the drugs packaged therein. Such injectable parenteral drugs may be provided to the consumer in liquid or freeze dried form. For freeze dried parenteral drugs, the vial containing the drug is closed with a lyophilization stopper, and undergoes a lyophilization step, prior to closing of the vial. The vials are then closed by standard stoppers, and a metal crimp is applied around the vial rim to retain the stopper therein. Vials containing liquid parenteral drugs are provided with a stopper that sealingly engages the vial at the filling point. Vial filling and packaging can take place via a filling line, with the vials housed in a vial tray such as that disclosed in U.S. Provisional Patent Application No. 61/767,496, which is incorporated herein by reference as if fully set forth. During application of the metal crimp, vials are typically lifted out from the tray, so that the crimp applying apparatus can adequately access the vial rim. Furthermore, in the case of freeze dried drugs, the additional step of lyophilization requires the ability of vaporized moisture removed from the parenteral drug to exit during processing. This step typically takes place outside of the tray. A need exists for a mechanism that functions similarly to the metal crimp used to close parenteral vials, while allowing escape of vapors during lyophilization. A further need exists for such a mechanism that can be applied without lifting the vial out of the processing tray, in order to simplify processing. A further need exist to standardize the stopper and cap, eliminating the need for specific caps for liquid and dried parenteral drugs. Such a mechanism would advantageously allow for simplified processing of liquid and dried parenteral drugs together. 
     SUMMARY 
     The present invention relates to a parenteral vial, stopper and cap assembly comprising a vial having a body defining an interior, and an opening leading to the interior. The assembly further comprises a stopper configured to sealingly engage the opening, and a cap configured to cover the opening and the stopper. The stopper and the cap fit together to form an integral unit configured to cap the vial. The cap moves with respect to the vial between a partially engaged position that permits gas flow out from the vial interior, and a fully engaged position in which the stopper sealingly engages the opening. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an embodiment of a cap according to the invention, in a closed position; 
         FIG. 2  is a perspective view of the cap of  FIG. 1 , in an opened position; 
         FIG. 3  is a perspective view of the cap as shown in  FIG. 1 , affixed to a parenteral vial, in the fully engaged, closed position; 
         FIG. 4  is a top plan view of the cap of  FIG. 1 , in an opened position; 
         FIG. 5  is a bottom plan view of the cap of  FIG. 1 , in an opened position; 
         FIG. 6  is a perspective view of an exemplary stopper for use with the cap of the invention; 
         FIG. 7  is a cross section taken along line  7 - 7  of  FIG. 1 ; 
         FIG. 8  is a partial cross section taken along line  8 - 8  of  FIG. 3 ; 
         FIG. 9  is a cross section such as that of  FIG. 8 , with the cap in the lyophilization position; 
         FIG. 10  is a perspective view of an exemplary vial for use with the cap of the invention; 
         FIG. 11  is a bottom perspective view of the vial cap of  FIG. 1 , in an opened position; and 
         FIG. 12  is a bottom perspective view of the vial cap of  FIG. 1 , in an opened position, with the hinge broken. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Certain terminology is used in the foregoing description for convenience and is not intended to be limiting. Words such as “front,” “back,” “top,” and “bottom” designate directions in the drawings to which reference is made. This terminology includes the words specifically noted above, derivatives thereof, and words of similar import. Additionally, the words “a” and “one” are defined as including one or more of the referenced item unless specifically noted. The phrase “at least one of” followed by a list of two or more items, such as “A, B or C,” means any individual one of A, B or C, as well as any combination thereof. 
       FIGS. 1-5 and 7-9  show an embodiment of a parenteral vial cap  10  according to the invention. As shown, the cap  10  includes a main body  20  and a cover  50 . The main body  20  is formed as a generally tubular wall  22  configured to surround the neck  82  of a parenteral vial  80 . The cover  50  fits on top of the main body  20  to cover the opening when the cap  10  is in the closed position, as shown in  FIGS. 1-3 and 6-9 . The cap  10  is configured to accommodate a stopper  100 , which is configured to sealingly fit within and close an opening  84  formed at the top of the vial neck  82  and leading to the interior  86 . The cap  10  and the stopper  100  fit together to form an integral unit, which can be used to cap the vial  80 . The cap  10  is configured to move with respect to the vial  80  between a partially engaged position that permits gas flow out from the vial interior, and a fully engaged position in which the stopper  100  sealingly engages the opening  84 . 
     Referring to  FIG. 10 , an exemplary vial  80  for use with the invention is shown. As shown, the vial  80  includes a base wall  88  and a substantially tubular side wall  90  extending upwardly from the base wall  88 , the base wall  88  and side wall  90  together defining the interior  86  of the vial  80 . A radially inwardly extending shoulder  98  is formed at an upper portion of the side wall  90  and joins the side wall  90  with the neck  82 . A rim  92  is formed at an upper edge of the neck  82  as a section of increased radial thickness with respect to the neck  82 . The rim  92  includes a top surface  94  and defines the opening  84  of the vial  80 . An outer annular groove  96  is formed on an outer surface of the rim  90  and is configured to facilitate attachment of the cap  10 , as described in detail below. An inner annular groove  97  is formed on an inner surface of the neck  82 , near the opening  84 , to facilitate attachment of the stopper  100 , as described in detail below. 
     Now referring to  FIGS. 6, 8 and 9 , an exemplary vial stopper  100  for use with the invention is shown in detail. As shown, the stopper  100  includes a substantially horizontally extending top wall  102  and a plug  104  extending downward therefrom. The top wall  102  is configured to completely or substantially completely cover the vial rim  92  and opening  84  when seated thereon. Accordingly, the top wall  102  has a diameter substantially equal to the outer diameter of the rim  92 . The top wall  102  could alternatively have an outer diameter greater than that of the rim  92 , or less than that of the rim  92 , but greater than the inner diameter of the opening  84 , such that the opening  84  is in any event covered by the top wall  102  when the stopper  100  is seated thereon. The outer edges of the top wall  102  and the rim  92  may be substantially radially aligned, such as in the illustrated embodiment in which the outer diameter of the rim  92  is slightly greater than that of the top wall. 
     The plug  104  extends downward from a bottom surface of the top wall  102  and has an outer diameter equal to or slightly greater than the inner diameter of the opening  84 . In use, the plug  104  extends into the opening  84  and forms an interference fit therewith to seal the vial  80 . The plug  104  may include a dome shaped indentation  106  at the bottom thereof, to facilitate deformation of the plug  104  during insertion into the opening  84  in order to achieve an optimum fit and seal. A first circular ridge  108  is formed on the top surface of the top wall  102 , for engagement of the stopper  100  with the cap  10 , as described in detail below. A second circular ridge  110  is formed on an outer surface of the plug  104  to facilitate engagement with the vial opening  84 , as described in detail below. 
     With reference to  FIGS. 1-5, and 7-9 , the cap  10  will now be described in detail. The cap  10  comprises a main body  20  and a cover  50 . The main body  20  is formed as a substantially tubular wall  22 . The tubular wall  22  is configured to surround the vial rim  92  and stopper top wall  102  when the cap  10  is affixed on the vial  10 . As shown, the inner diameter of the tubular wall  22  is slightly greater than the outer diameters of the rim  92  and top wall  102 . The tubular wall  22  has a sufficient length in the axial direction to permit extension from the shoulder  98  to a point above the top wall  102  of the stopper  100 , when the cap  10  is in the fully closed position on the vial  80 , as shown in  FIG. 8 . A plurality of radially inwardly extending protrusions  26  are formed on the inner surface of the tubular wall  22 . A radially inwardly extending annular ridge is 28 further formed on the inner surface of the tubular wall  22 , at an axial location above the protrusions  26 . 
     Referring now to  FIGS. 2, 4 and 5 , a top wall  30  extends across an upper portion of the tubular wall  22 . The top wall  30  extends in the horizontal or radial direction of the cap  10 , near the top edge of the tubular wall  22 . A central, circular aperture  32  is formed in the top wall. Additionally, a channel  34  extends circumferentially near the edge of the top wall  30 , about the entire circumference thereof. A valley  40 , formed as an extension of the channel  34 , extends radially outward therefrom, from an outer edge of the channel  34  to an outer edge of the top wall  30  radially aligned with and adjacent to the hinge  36 . The valley  40  terminates where the top wall  30  meets the tubular wall  22  at a radially inwardly indented region  70  thereof. The indented region  70  is located on an outer surface of the tubular wall  22 , radially aligned with the hinge  36 , and joins with an axially upper edge of the tubular wall  22 . A gap  62  is formed between an inner surface of the hinge tab  38  and the indented region  70  of the tubular wall  22 . 
     A plurality of openings  42  are formed in the top wall  30  within the channel  34 . Depressions  44  in the thickness of the tubular wall  22  are formed on the inner surface thereof, in axial alignment with the openings, as shown in  FIG. 11 . One or more annular projections  46 ,  48  may be formed in the bottom surface of the top wall  30 , radially located between the aperture  32  and the channel  34 . In the illustrated embodiment, two projections are formed, including a radially inner projection  46  and a radially outer projection  48 , though fewer or more projections could be formed as well. The projections  46 ,  48  are configured to contact and exert an even force on the stopper  100  when moving the cap  10  from the partially engaged position to the fully engaged position, as described below. 
     The hinge  36  is formed as a tab  38  that pivotally attaches an edge of the cover  50  to an upper portion of the tubular wall  22 . The hinge  36  is a double hinge, such that it includes a first pivot axis P 1  where it attaches to the tubular wall  22  and a second pivot axis P 2  where it attaches to cover  50 . The hinge  36  is preferably of the “living hinge” type, i.e., formed integrally with the remainder of the cap  10 , with the pivot axes P 1 , P 2  being formed as sections of material sufficiently thin to as to permit bending. The hinge  36  permits the cover  50  to rotate with respect to the main body  20  between an opened position, for example as shown in  FIG. 2 , and a closed position, for example as shown in  FIG. 1 . 
     The cover includes a cover base  52 , which is formed as a round wall configured to cover the top wall  30  of the main body  20  when in the closed position. An outer flange  54  extends downward from a bottom surface of the base  52  and around the entire outer perimeter of the base  52 , and is configured to be received by the channel  34 , when the cover  50  is in the closed position. Outer flange  54  does not sit perfectly within channel  34 ; rather, a small gap  58  is formed therebetween. An inner ring  56  also projects downward from the bottom surface of the base  52 , at a substantially central location thereof, and is configured to fit within the aperture  32  when the cover is in the closed position. 
     The cap  10 , when affixed to the vial  80 , moves between a partially engaged, or lyophilization position, as shown in  FIG. 9 , and a fully engaged position, as shown in  FIG. 8 . The cap  10  in the fully engaged position is located axially below the partially engaged position. Furthermore, the cover  50  moves between an initial opened position, as shown in  FIG. 2 , a closed position, as shown in  FIG. 1 , and a final opened position, as shown in  FIG. 12 , in which the hinge  36  has been broken. 
     Referring first to  FIG. 9 , the partially engaged position will be described in detail. As shown, when the cap  10  is in the partially engaged position, the cover  50  is in the closed position. Accordingly, the cover  50  sits atop the main body  20  with outer edge of the base  52  resting on the upper edges of the tubular wall  22 . The stopper  100  is positioned within the tubular wall  22  and beneath the top wall  30 . The aperture  32  and openings  42  are covered by the cover  50 . Flange  54  sits within channel  34 . Preferably, flange  54  and channel  34  are frictionally engaged, and may form an interference fit. Engagement of the flange  54  and channel  34  helps to retain the cover  50  in place on the tubular wall  22 . 
     Still referring to  FIG. 9 , ring  56  projects downward from the bottom surface of cover base  52  and fits within aperture  32  of top wall. Preferably, ring  56  and aperture  32  are frictionally engaged, and may form an interference fit. Engagement of the ring  56  and aperture  32  helps retain the cover  50  on the main body  20 , keeping the cover  50  in the closed position. 
     Ring  56  continues to project downward past aperture  32 , and reaches the top wall  102  of stopper  100 , where it receives the first ridge  108 . Preferably, the first ridge  108  and ring  56  are frictionally engaged, and may form an interference fit. Engagement of the first ridge  108  and ring  56  helps retain the stopper  100  in place beneath the top wall  30  of the cap main body  20 . 
     Still referring to  FIG. 9 , protrusions  26  of the tubular wall  22  are received within the outer annular groove  96  of vial rim  92 . Preferably, protrusions  26  and outer annular groove  96  are frictionally engaged, and may form an interference fit. Engagement of the protrusions  26  and outer annular groove  96  help retain the cap  10  in place on the vial  80  in the partially engaged, or lyophilization position. Preferably, the engagement of the protrusions  26  and the ridge  28  is strong enough so as to prevent inadvertent disengagement, for example as could be caused by bumping the cap  10 , but not so strong as to prevent disengagement to move the cap  10  downward on the vial  80 , into the fully engaged position, as described below. 
     When the cap  10  is in the partially engaged position on the vial  10 , the opening  84  of the vial  10  is substantially covered, to prevent foreign objects from entering. Additionally, the stopper  100 , while not yet directly engaged with the vial  10 , is positioned to be moved directly downward to be positioned on the vial  10 . This position permits gas flow out from the vial interior  86 . As shown in  FIG. 9 , a plurality of flow paths F are formed from the interior  86  to the exterior of the vial  10 , to allow for escape of moisture vapor during lyophilization. As shown in  FIG. 9 , several of the flow paths F 1  begin at the vial interior  86  and travel between the vial rim  92  and stopper plug  104 , outward then upward between the tubular wall  22  and outer edge of stopper top wall  102  within depressions  44 , inward between the stopper top wall  102  and cap base top wall  30 , upwards through openings  42 , then outwards through gap  58  formed between flange  54  and channel  34 . Additional flow paths F 2  begin at the vial interior  86  and travel between the vial rim  92  and stopper plug  104 , outward then upward between the tubular wall  22  and cap base top wall  102  within depressions  44 , inward between the stopper top wall  102  and cap base top wall  30 , upwards through openings  42 , through channel  34  and then through valley  40  and outward through gap  62 . 
     After lyophilization, the cap  10  is moved downwards on the vial, to the fully engaged position, as shown in  FIG. 8 . In this position, the stopper  100  and the cap  10  remain in the same position with respect to each other and retain their engagements with each other. Accordingly, the above-described engagements between the ring  56  and aperture  32  as well as the ring  56  and ridge  108 , remain in place. The cap  10  and stopper  100  together move downward as a unit with respect to the vial  80  to move the assembly into the fully engaged position. 
     As shown, in the fully engaged position, the ridge  28  of tubular wall  22  is now received by outer annular groove  96  of vial rim. Preferably, the ridge  28  and outer annular groove  96  are frictionally engaged, and may form an interference fit. Engagement of the ridge  28  and outer annular groove  96  helps retain the cap  10  in place on the vial  80  in the fully engaged position. Preferably, the engagement of the ridge  28  and groove  96  is sufficient to prevent disengagement that would allow movement of the cap  10  with respect to the vial  80 , for example removal of the cap  10  from the vial  80  using manual force. It is for this reason that a complete annular ridge  28  is provided on the inner surface of the tubular wall for this purpose, in contrast to the protrusions  26  provided for engagement with the outer annular groove  96  when in the partially engaged position, which results in a weaker engagement, so as to permit moving the cap  10  from the partially engaged position to the fully engaged position. 
     Also in the fully engaged position, the plug  104  is received within the vial opening  84 . Preferably, the plug  104  and the opening  84  are frictionally engaged and may form an interference fit. The second ridge  110  formed on the outer surface of the stopper plug  104  is received by the inner annular groove  97 . Preferably, the second ridge  110  and the inner annular groove  97  are frictionally engaged, and may form an interference fit. Engagement between the second ridge  110  and inner annular groove  97  helps retain the plug  104  within the opening  84  and in turn cap  10  in place on the vial  80  in the fully engaged position. 
     In the fully engaged position, flow path F has been closed off by closing the spaces between the stopper  100  and vial rim  92 . The stopper  100  and vial rim  92  preferably form a sealed engagement, to prevent entry of foreign objects, as well as to prevent entry and further exit of any liquid or gas matter. The assembly, including cap  10 , vial  80 , and stopper  100  is suitable for transport and distribution to consumers at this point. 
     The hinge  36  may serve as a tamper evident feature of the cap  10 . When the vial  80  and cap  10  assembly reaches a consumer, the cover  50  is to be removed from the cap  10 , giving the user access to the aperture  32  and the stopper top wall  102  located below. A tab  60  is formed as an extension of the cover base  52 . The tab  60  protrudes slightly outward from the cover base  52 , and may be located over the indented region  70  on the outer surface of tubular wall  22 , such that a user can easily access tab  60  as a source of leverage to permit removal of the cover  50  from cap base  50 . Hinge  36  connects tab  50  with a step  72  formed at the bottom of indented region  70 . In order to force the cover  50  off of main body  20  by way of tab, hinge  36  must be broken, which can be achieved easily at the fold formed by first pivot axis P 1 . The hinge  36  may optionally include a perforation  40  at the first pivot point P 1 , to facilitate breaking of the hinge in this manner. A broken hinge  36  alerts the consumer that the cover  50  has been detached from main body  20 , serving as a tamper evident mechanism.  FIG. 12  shows the cap in the final opened position, with the hinge  36  broken at the first pivot axis P 1  to alert the consumer that the cover  50  has been detached from the main body  20 . 
     Once the cover  50  is removed from main body  20  and top wall  102  of stopper is accessible, the consumer can insert a syringe through top wall  102  and retrieve a dose of the medication contained within the vial  80 . 
     The components of the assembly described above can each be made of any suitable material known in the art. Exemplary materials for forming the vial include glass and polymeric materials, such as cyclic olefin polymer and cyclic olefin copolymer. Exemplary materials for forming the cap include polymeric materials such as polypropylene. Exemplary materials for forming the stopper include elastomeric materials. 
     While the preferred embodiments of the invention have been described in detail above, the invention is not limited to the specific embodiments described, which should be considered as merely exemplary.