Abstract:
A closure system includes a container and a closure. The container including a rim extending perpendicular to the side wall, the rim including a locking lug extending from an upper surface of the rim and a break disposed in the rim adjacent to the locking tab, the break operable to form a deflectable locking portion of the rim. The closure including a side wall, a flange extending perpendicular to the side wall, and a locking lug disposed within the flange for engaging the corresponding locking lug of the container. The flange substantially covers the upper surface of the rim of the container and includes a gap portion disposed adjacent to the locking lug for allowing a user to deflect the deflectable locking portion of the container through the gap portion in the flange to disengage the locking lug of the container from the locking lug of the closure.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority to co-pending U.S. Provisional Application Ser. No. 62/082,256 filed Nov. 20, 2014, entitled “Child Resistant Closure System,” the entire contents of which is incorporated herein in its entirety. 
     
    
     FIELD 
       [0002]    This disclosure relates to a child resistant closure system. More particularly, this disclosure relates to a child resistant closure system for pharmaceutical containers requiring interaction from the user with a discrete locking system in order to remove the closure from the container. 
       BACKGROUND 
       [0003]    Many child-resistant closure systems require the user to deflect a tab extending from the container in order to remove the closure when it is installed on the container in a child resistant position. For example, U.S. Pat. No. 5,899,348 describes a closure having a bottom peripheral skirt/flange with a locking lug disposed underneath the skirt, while the container of the &#39;348 Patent has a deflectable release element disposed at an interruption of a neck ring/rim/radial skirt/flange extending from the outer circumference of the container. The release element includes a locking lug axially aligned with the peripheral skirt of the closure when the closure is being installed onto the container such that the locking lug of the closure is operable to engage the locking lug of the container. Engagement of the corresponding locking lugs prevents the closure from being turned in the counter-clockwise direction, and thus prevents the closure from being removed from the container. In order to disengage the locking lugs and remove the closure, the user pushes down on a portion of the deflectable release element that extends out from the skirt/flange of the closure and the neck ring of the container. 
         [0004]    Similarly, U.S. Pat. No. 6,508,373 describes a closure having a pair of diametrically opposed internal lugs beneath the closure thread that engage a stop log disposed on a deflectable tab of a container. It is noted that the tab of the container disclosed in the &#39;373 Patent extends tangentially from the container&#39;s neck ring in order to provide a portion that extends from the container so that the user can access and deflect the tab when the closure is installed on the container. In order for the tab to deflect, the tab is separated from the external surface of the container and the opposing edge of the neck ring by a tangential slot as best shown in FIG. 7 of the &#39;373 Patent. 
         [0005]    One advantage touted by the &#39;373 Patent is that its design can be fabricated by injection blow molding. However, while this may be true, the tangentially spaced tab separated from the container by the tangential slot renders the neck ring asymmetrical, which renders the container of the &#39;373 Patent impossible to manufacture using a more efficient/desirable two-stage injection stretch blow molding method. In this regard, the plastic in a two-stage injection blow molding process is (1) molded into a preform and then ejected from the ejection mold during the injection cycle; and (2) fed after cooling via the container&#39;s neck through a reheat stretch blow molding machine during the blowing cycle. Once ejected from the original ejection mold, the “orientation” of the container during the fabrication process is lost. Thus, in order for the container to be properly handled and fed through the stretch blow molding machine during the second stage of the process, the neck of the container must be symmetrical to prevent any mishandling of the preforms by the machine. Similarly, other containers with a deflectable tab extending from the neck ring of the container, such as the container in the &#39;348 Patent described above which is formed by injection molding, result in an assymetrical neck ring that prevents these types of containers from being used in two-stage injection stretch blow molding machines. The asymetrical neck ring also prevents the containers from being used in automated dispensing machines due to the machines&#39; trouble feeding containers with a tab element extending from one side. 
         [0006]    Assignee of the present disclosure also describes a reversible closure system having yet another similar child resistant locking system as that of the &#39;348 Patent and &#39;373 Patent in U.S. Pat. Nos. 8,662,331 and 8,881,988, the entire contents of which are both incorporated herein by reference. With respect to the locking system described in the &#39;331 Patent and &#39;988 Patent and referring to  FIGS. 1-5  of the present application, the reversible child-resistant closure system  10  includes an injection molded container  12  and a reversible child resistant closure  40 . 
         [0007]    As shown in  FIG. 2 , the container  12  generally includes a body  13  and a neck  14 . The neck  14  includes a container engaging structure  18  disposed on an exterior of the neck  14 , a container opening edge  20  defining a container opening  22 , and a bottom edge  25  opposite the container opening edge  20  preferably defined by a neck ring or rim  24 . The engaging structure  18  is operable to interact with a corresponding engaging structure  56  on the non-child resistant portion or engaging structure  58  on the child resistant portion of the reversible child resistant closure  40  to secure the closure  40  to the container  12 . Disposed adjacent the rim  24  of the neck  14  is a deflectable locking structure  26  preferably disposed at an interruption of space in the rim  24 . A locking lug  30  extends from a top surface  28  of the locking structure  26  towards the opening edge  20  of the container  12  for releasably engaging a corresponding locking lug  64  of the reversible child resistant closure  40  when the closure  40  is installed on the container  12  in a child-resistant configuration. For clarification purposes, the locking lug  30  of the container  12  is referred to herein as a locking tab, and the corresponding locking lug  64  of the closure  40  is referred to as a locking projection. In preferred embodiments, the locking tab  30  of container  12  includes a ramp or inclined surface  31  and a locking edge  33 . 
         [0008]    Referring to  FIGS. 3A-3D , the corresponding closure  40  includes a first section  42  having a first edge  44  and a second section  46  having a second edge defined by flange  60 . The first section  42  and second section  46  are separated by a solid divider  50  which prevents pharmaceuticals or other materials from exiting the opening  22  of the container  12  whether the one piece closure  40  is used in a child resistant configuration or a non-child resistant configuration. A circumferential sidewall  52  extends around the outer circumference of the closure  40  extending from the first edge  44  of the first section  42  to the flange  60  of the second section  46 . The solid divider  50  and sidewall  52  forms a first section cavity  43  extending between the first edge  44  and the divider  50  and a second section cavity  47  extending from the bottom of flange  60  to the divider  50 . Thus, the closure  40  provides a one-piece cap that can be lined on both sides as described more particularly in the &#39;988 Patent. 
         [0009]    The exterior surface  53  of the sidewall  52  preferably includes a gripping structure such as a plurality of knurls  55  for assisting a user to grip and rotate the closure  40  relative to the container  12 . The first and second section  42 ,  46  includes respective engaging structures  56 ,  58  preferably disposed on the interior surface  54  of sidewall  52  that are operable to interact for rotatable engagement with the complementary engaging structure or structures  18  on the container  12  to secure the closure  40  to the container  12 . In this regard, when the closure  40  is applied to the container  12  in the child resistant configuration, engaging structure  58  of the closure  40  interacts with the engaging structure  18  of the container  12 . On the other hand, when the closure  40  is inverted and applied to the container in the non-child resistant configuration, engaging structure  56  of the closure  40  interacts with the engaging structure  18  of the container  12 . As shown in the Figures, the engaging structures  56  and  58  are preferably solid or segmented threads. However, other suitable engaging structures  56 ,  58  may be used as long as they are operable to interact with a corresponding engaging structure  18  of the container  12 . 
         [0010]    As shown best in the inverted view of  FIG. 4 , the flange  60  of the second section  46  is a peripheral skirt extending radially from the sidewall  52 . The locking projection  64  extends radially inward from the inner surface  62  of the flange  60  and is operable to engage the locking tab  30  of the container  12  for preventing the closure  40  from rotating with respect to the container  12  when the closure is installed on the container  12  in the child resistant configuration. In this regard, the locking projection  64  of closure  40  preferably includes a ramp or inclined surface  66  and a locking edge  68 . In operation, the closure  40 , when applied to the container  12  in the child resistant configuration, is rotated in a closing direction, preferably clockwise, about the neck  14  of container  12  until the locking projection ramp  66  traverses the locking tab ramp  31 . In order to remove the closure  40  from the container  12 , a user must deflect the locking structure  26  so that the locking projection  64  disengages the locking tab  30 . Referring to  FIG. 1 , a user preferably deflects the locking structure  26  downward to disengage the locking tab  30  of the container  12  from the locking projection  64  of the closure  40 . 
         [0011]    Thus, in order for the locking tab  30  to releasably engage the corresponding locking projection  64  of the closure  40 , the locking structure  26  of this system  10 , as well as many other child resistant systems known in the art, is yieldable or deflectable relative to the rim  24  of the container  12 . Further, in order to deflect the locking tab  30 , the locking structure  26  includes a push down tab  34  extending radially outward with respect to the flange  60  of the closure  40  and rim  24  of the container  12  (when the rim  24  is axially aligned with the flange  60 ) such that the locking structure is accessible to the user&#39;s fingers when the closure  40  is installed in the child resistant configuration. As noted above, the &#39;348 and &#39;373 Patents include similar deflectable tab structures extending from the container neck and the outer circumference of the closure flange in order to disengage their respective locking mechanisms. Many of these designs even include specific instructions, such as the indicia HOLD on the push down tab  34  of the locking structure  26  as shown in  FIGS. 1-2 , explicitly telling the user how to operate the child resistant closure. 
         [0012]    While these types of closures systems are generally very effective in preventing a child from opening the closure, it is not impossible for children to open them (hence the name “child resistant”). In particular, a child playing with this type of closure system is likely to be drawn to the tab element extending from the container which, in some instances, may result in the child unintentionally pushing down on the tab element and removing the closure from the container. Also, the child may even figure out how to open the container, such as by watching their parents or even reading instructions displayed on the deflectable tab element, and then be able to do so on their own. What is needed therefore is a more discrete locking system that makes it more difficult for a child to recognize or understand how to open the closure system or otherwise prevents attracting child actions that result in the child unintentionally opening the container. 
         [0013]    In another aspect, the ability to more efficiently manufacture a blow molded container incorporating a deflectable tab structure is needed. 
       SUMMARY 
       [0014]    A closure system according to one embodiment of the disclosure includes a container and a closure. The container includes neck portion having a circumferential side wall and a rim extending perpendicular to the side wall, the rim including a locking lug extending from an upper surface of the rim and a break disposed in the rim adjacent to the locking tab, the break operable to form a deflectable locking portion of the rim. The closure is dimensioned and configured to be secured to the neck portion of the container and includes a circumferential side wall, a flange extending perpendicular to the side wall, and a locking lug disposed within the flange for engaging the corresponding locking lug of the container when the closure is installed on the container in a child resistant configuration. The flange is dimensioned and configured to substantially cover the upper surface of the rim of the container and includes a gap portion disposed adjacent to the locking lug for allowing a user to deflect the deflectable locking portion of the container through the gap portion in the flange to disengage the locking lug of the container from the locking lug of the closure. 
         [0015]    According to certain embodiments, the gap portion of the flange of the closure is dimensioned and configured to require a foreign object to be inserted through the gap portion to deflect the deflectable locking portion of the container. 
         [0016]    According to some embodiments, the rim is circumferentially shaped and the break in the rim is substantially symmetrically aligned with the rim. According to this embodiment, the closure system is preferably manufactured in a stretch blow molding process, and most preferably a two-stage stretch blow molding process. Also, the break in the rim of the container preferably includes a curved slot disposed between the rim and the circumferential side wall of the container. 
         [0017]    According to another embodiment of the disclosure, a closure system includes a container having a deflectable container locking mechanism disposed adjacent a rim of the container and a closure dimensioned and configured for being secured to the container. The closure includes a closure locking mechanism operable to engage the container locking mechanism to lock the container in an engaged position and a flange dimensioned and configured to cover the deflectable container locking mechanism of the container when the closure is installed on the container in a child resistant configuration. The flange includes an aperture dimensioned and configured to receive an unlocking tool through the aperture operable to deflect the container locking mechanism to an unengaged position. 
         [0018]    According to yet another embodiment of the disclosure, a closure system includes a container and a closure. The container includes a neck portion having a circumferential side wall and a circumferential rim extending perpendicular to the side wall, the rim including a locking lug extending from an upper surface of the rim and a break disposed in the rim adjacent to the locking tab, the break being substantially symmetrically aligned with the rim and including a curved slot disposed between the rim and the circumferential side wall of the container operable to form a deflectable locking portion of the rim. The closure is dimensioned and configured to be secured to the neck portion of the container, and includes a circumferential side wall, a flange extending perpendicular to the side wall, and a locking lug disposed within the flange for engaging the corresponding locking lug of the container when the closure is installed on the container in a child resistant configuration. The deflectable locking portion of the rim is operable to be deflected to disengage the locking lugs of the container and the closure to uninstall the closure from the child resistant configuration. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    Further advantages of the disclosure are apparent by reference to the detailed description when considered in conjunction with the figures, which are not to scale so as to more clearly show the details, wherein like reference numbers indicate like elements throughout the several views, and wherein: 
           [0020]      FIG. 1  is a side perspective view of a prior art closure system with a closure installed in a child resistant configuration and a locking structure of a container being deflected downward to remove the closure from the container; 
           [0021]      FIG. 2  is a side perspective view of the prior art container of  FIG. 1 ; 
           [0022]      FIGS. 3A-3B  are overhead side perspective views of the top section of the prior art closure of  FIG. 1 ; 
           [0023]      FIGS. 3C-3D  are underneath side perspective views of the bottom section of the prior art closure of  FIG. 1 ; 
           [0024]      FIG. 4  is an overhead perspective view of the bottom section/child resistant portion of the prior art closure of  FIGS. 3A-3D ; 
           [0025]      FIG. 5  is a cross sectional view of the closure of  FIGS. 3A-3D ; 
           [0026]      FIG. 6  is a side perspective view of a container according to one embodiment of the disclosure; 
           [0027]      FIG. 7  is an overhead perspective view of the container of  FIG. 6 ; 
           [0028]      FIG. 8  is a top view of a bottom section/child resistant portion of a closure according to one embodiment of the disclosure; 
           [0029]      FIG. 9  is a side view of the closure of  FIG. 8 ; 
           [0030]      FIG. 10  is an overhead perspective view of the closure of  FIGS. 8-9  installed on the container of  FIGS. 7-8  in a child resistant configuration; 
           [0031]      FIG. 11  is a top view of the closure of  FIGS. 8-9  installed on the container of  FIGS. 7-8  in a child resistant configuration; 
           [0032]      FIG. 12  is a bottom view of a container according to another embodiment of the disclosure; 
           [0033]      FIG. 13  is a cross-sectional view of the container of  FIG. 12 ; 
           [0034]      FIG. 14  is a side view of the container of  FIG. 12 ; and 
           [0035]      FIG. 15  is a top view of a child resistant portion of a closure according to one embodiment of the disclosure; 
           [0036]      FIG. 16  is a side perspective view of the closure of  FIG. 15  installed on the container of  FIGS. 12-14  according to one embodiment of the disclosure; 
           [0037]      FIG. 17  is an overhead perspective view of the closure system of  FIG. 16 ; and 
           [0038]      FIG. 18  is a side view of a key for the closure system of  FIGS. 16-17  according to one embodiment of the disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0039]    The disclosure relates to a child resistant closure system in which an exposed deflectable push down tab element of a locking structure of a container is removed and access is provided to deflect the locking structure through a small gap provided in a peripheral skirt/flange of the closure. The closure system of the present disclosure is primarily directed for use with containers intended to store and dispense pharmaceutical products, and particularly prescription pharmaceuticals. However, the system may also be used with other types of containers in which a child resistant closure is desired. 
         [0040]    It should be noted that, while the child resistant closure system  100  described below is similar to the closure system  10  of the &#39;331 and &#39;988 Patents described above and shown in  FIGS. 1-5  herein with the primary exception being the manner in which a user is able to access the locking structure  26  of the container  12 , the features of this disclosure can be implemented into any other child resistant closure systems utilizing similar deflectable tab elements. 
         [0041]    Referring to  FIGS. 6-11 , closure system  100  includes a container  112  and closure  140  similar to the container  12  and closure  40  substantially as described above with the exception of the locking structure  126  and access provided thereto. In this regard, instead of including a container portion extending radially outward with respect to the rim  24  of the container  12  and flange  60  of the closure  40 , the outermost portion of the locking structure  126  of container  112  is preferably radially aligned with the rim  124  such that it at least would be covered by flange  160 . In other words, the push down tab  34  of the container  12  described above has been removed such that no portion of the locking structure  126  extends radially outward with respect to the flange  160  of the closure  140 . Accordingly, when the closure  140  is installed on the container  112  in a child resistant configuration as shown best in  FIG. 10 , the manner in which to unlock the closure system  100  is discretely hidden from a user or is otherwise not readily apparent. 
         [0042]    In preferred embodiments and as shown  FIGS. 6-7 , the locking structure  126  is simply a locking tab  130  extending from a top surface of a symmetrical rim  124 . The rim is referred to as “symmetrical” because the outermost width of the rim  124  in relation to the sidewall of the container  112  is consistent around the entire circumference of the container neck. To form the deflectable portion, a break  128  in the rim  124  is provided adjacent the locking tab  130 . Break  128  includes a gap  127  in the rim  124  and a curved slot  129  extending from the gap  127  along the side of the container  112  to at least the tab  130  (i.e., at least a small amount of space is provided between the rim  124  and the side of the container from the gap  127  to the tab  130 ), which allows for the portion of the rim  124  between the tab  130  and the gap  127  to be deflected slightly downward to disengage the locking tab  130  from the locking projection  164  of the closure  140  when the closure  140  is installed on the container  112  in the child resistant configuration. For purposes of the present application, the break  128  is referred to herein as being substantially symmetrically aligned with the rim  124  due to the rim  124  and break  128  being configured together to provide the substantially symmetrical shape of the rim  124 . 
         [0043]    Unlike the neck rings described above with respect to the prior art containers having a deflectable tab portion extending from their neck rings, providing container  112  of the present disclosure with a substantially symmetrical rim/neck ring  124  allows the container  112  to be able to be easily and consistently picked up and handled by two stage injection blow mold machines during fabrication or automated dispensing machines during dispensing of medications in the containers  112 . Additionally, because there is no longer a projection extending from the rim  124  of the container  112  (i.e., the rim  124  is an entirely symmetrical bead with simply a hinged tab created by the break  128  in the rim  124 ), it should be understood that container  112  can be manufactured using either a one-stage or the more efficient two-stage injection stretch blow molding fabrication process. In this regard, the curved slot  129  for forming the deflectable portion of rim  124  is able to formed using stretch blow molding techniques because the mold is able to move in both the “X-direction” and one of the “Y-direction” or “Z-direction” in stretch blow molding machines. On the other hand, the curved slot  129  cannot be formed using the injection blow molding method contemplated in the &#39;373 Patent due to the mold in injection blow molding machines only being able to move in the “Y-direction” (the &#39;373 Patent refers to this method as “injection blow molding processes using standard neck ring technology in which the container finish can be formed by straight pull from the neck rings . . . ”). 
         [0044]    In view of the advantages described above of having a substantially symmetrical rim on containers, alternate embodiments of the present disclosure may include a substantially symmetrical rim that extends out from the container side wall a sufficient distance such that it is not entirely covered by the flange of the closure. In other words, in an alternate embodiment, the present disclosure provides a child resistant closure system in which the rim is symmetrical such that it can be molded in two-stage blow molding fabrication methods and can be easily handled in automated dispensing systems while also providing a more discernible push down portion if desired by extending the width of the symmetrical rim past the flange of the closure intended to be secured to the container. 
         [0045]    Referring to  FIGS. 8-11 , in embodiments where the rim  124  does not extend out from the flange  160 , closure  140  of closure system  100  includes a small gap  161  disposed in its flange  160  for providing access to the locking structure  126  of container  112 . In operation, the closure  140  is installed onto the container  112  by rotating the closure  140  until the locking projection  164  of the closure  140  engages the locking tab  130  of the container  112 . At this point, the gap  161  of closure  140  is vertically aligned with at least a portion of the deflectable portion of the rim  124  of container  112  disposed between the gap  127  and the locking tab  130 . To remove the closure  140  from the container  112 , the user inserts the tip of one of their fingers into the gap  161  in the rim  160  of closure  140  and pushes down on the portion of the rim  124  of the container  112  adjacent to the gap  127  in the rim  124  to disengage the locking tab  130  from the locking projection  164  of closure  140 . 
         [0046]    In alternate embodiments, the gap  161  in the flange  160  of the closure  140  is reduced to a size in which a user cannot access or otherwise push down on the deflectable portion of rim  124  of the container  112  with a user&#39;s finger. Instead, the user is required to use a small tool such as a paper clip or the side of a credit card to traverse the gap  161  and deflect the rim  124 . In yet a further embodiment, the gap  161  is formed of an aperture of a particular shape such that a specialized key is needed to be inserted into the aperture to push down on the deflectable portion of rim  124 . 
         [0047]    For example, referring to the alternate embodiment of  FIGS. 12-18 , closure system  200  includes a container  212  and closure  240  similar to container  12  and closure  40  of container system  10  except the outermost portion of the locking structure  226  of container  212  does not extend out from the container  212  any further than the flange  260  of closure  240  when the closure  240  is installed on the container  212  in the child resistant configuration. Thus, a user is unable to disengage the locking structure  226  of the container  212  from the locking projection  264  of the closure  240  by simply pushing down on the locking structure  226  with one&#39;s finger. 
         [0048]    Accordingly, in order to remove the closure  240  from the container  212  when the closure  240  is installed in the child resistant configuration, closure  240  includes a small aperture  261  (such as a thin slot as depicted) disposed in flange  260  adjacent to the locking edge  268  of the locking projection  264 . In preferred embodiments, the aperture  261  is small enough (0.040 inches or less) such that readily available household items such as coins cannot be inserted into the aperture  261 . In most preferred embodiments, aperture  261  is so thin that it is generally not discernible when viewing the closure  240 , at least to a child or unless a user knows where to look for it on the closure  240 . Accordingly, referring to  FIGS. 16-18 , disengagement of the locking projection  264  of the closure  240  from the locking structure  226  of the container  212  is permitted only with a separate unlocking tool  280  having a thin key portion  282  that is dimensioned and configured to fit through the aperture  261  and deflect locking structure  226 . 
         [0049]    In other aspects, the unlocking tool  280  preferably includes a handle portion  284  to assist in gripping the tool  280  and driving the key portion  282  in an appropriate direction (i.e., downward in this embodiment) to deflect the locking structure  226 . The handle portion  284  preferably includes a key aperture  286  such that the unlocking tool  280  may be secured to a user&#39;s key ring to prevent loss of the unlocking tool  280 . The unlocking tool  280  may also include a top lip portion  288  and/or bottom lip portion  290  dimensioned and configured to ensure that the key portion  282  is only inserted into the aperture  261  to a depth sufficient to disengage the corresponding locking structures of the closure  240  and container  212 . For example, bottom lip portion  290  may include a thicker portion of tool  280  adjacent to the key portion  282  that does not fit into aperture  261  and contacts the flange  260  once the key portion  282  is inserted a sufficient depth into aperture  261 . On the other hand, top lip portion  288  is a portion of tool  280  that extends outward from the main body opposite the handle portion  284  such that the top lip portion  288  contacts the top edge  244  of the closure  240  once the key portion  282  is inserted into aperture  261  to a sufficient depth. Lip portions  288 ,  290  prevent the user from applying too much pressure to the unlocking tool  280 , which in turn prevents the user from breaking the key portion  282  of tool  280  and/or the locking structure  226  of the container  212 . 
         [0050]    In yet another aspect of the disclosure, the aperture  261  is preferably disposed in the flange  260  directly against the sidewall  252  of closure  240 . Thus, in order to locate the aperture  261 , the user may position the bottom of key portion  282  against the corner of the sidewall  252  and flange  260  and rotate the closure  240  or unlocking tool  280  until the key portion  282  drops into the aperture  261 . 
         [0051]    The foregoing description of preferred embodiments for this disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments are chosen and described in an effort to provide the best illustrations of the principles of the disclosure and its practical application, and to thereby enable one of ordinary skill in the art to utilize the disclosure in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the disclosure as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.