Patent Publication Number: US-2007102446-A1

Title: Blow fill sealed container with twist off top operated by overcap and method of making the same

Description:
The present invention relates to the field of containers. More particularly this invention relates to a sterile container assembly for storing fluids, including but not limited to drugs, and transferring them to a needleless syringe.  
     BACKGROUND OF THE INVENTION  
      In the past, the general practice of surgeons or other medical practitioners using hypodermic syringes has been to transfer an injection solution to a syringe from ampoules or vials holding a single dose. These ampoules have been adapted to be sealed by a non-resealable cap. The ampoule is opened by rocking the non-resealable cap, tearing the non-resealable cap from an outlet of the ampoule at an area of weakness.  
      The outlets of these ampoules are often designed to mate with the open end of a needleless syringe. The open ends of needleless syringes come in several different forms or shapes. The two most popular forms of needle fitting are the friction fit fitting (such as the luer slip fitting) and the combination of screw thread and friction engagement fitting (such as the luer lock fitting). Ampoules with outlets that are designed to mate with luer slip fittings and ampoules with outlets that are designed to mate with luer lock fittings are known.  
      It will be appreciated that this past practice has required separate sterilizing measures, as solution transfer for injecting into humans requires scrupulous sterilizing of components.  
      Prior solutions for keeping these ampoules sterile include utilization of blister packaging of the ampoules prior to sterilization. This blister packaging is both costly and difficult to remove.  
      Other types of conventional containers have a cover that the user turns to engage the cap and tear the cap from the container. None of these containers are adapted to operate with a needleless syringe. Further, none of these containers are particularly well adapted to prevent compromise or contamination of the sterile port of the container during the manual manipulation required to open the port.  
      Therefore, a principal object of this invention is to provide a container assembly that maintains a sterile attachment zone for a needleless syringe.  
      Another object of the invention is to provide a container assembly that has a guarded sterile syringe attachment zone, which is easily compromised during the manual manipulation, required to open the container assembly.  
      Another object reduces risk of contamination of its opened port by finger touches.  
      Another object of the invention is to provide a container assembly adapted for use with a needleless syringe and which includes an overcap to facilitate removal of a closure top from the container.  
      A further object of the invention is to provide an overcap with an improved detent portion for engaging the closure top of a container.  
      These and other objects will be apparent to those skilled in the art.  
     SUMMARY OF THE INVENTION  
      A container assembly includes a container body having a port adapted for use with a luer end of a needleless syringe. A first frangible seal seals the aperture to a closure top. An overcap has a cap base sealed to the container body and an upper cap connected to the cap base by a second frangible seal, providing a sterile barrier surrounding the first frangible seal. Depressing the upper cap toward the container body breaks the second frangible seal. Alternatively, the second frangible seal is a removable tear strip broken by tugging on the tear strip. The upper cap includes a detent portion frictionally securing the upper cap to the closure top when the upper cap is depressed toward the container body. The upper cap and secured closure top are removed from container body by twisting the upper cap to break the first frangible seal. After removal, the top remains frictionally retained in the upper cap by the detent portion. 
    
    
     DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a perspective view of the device of this invention;  
       FIG. 2  is a partial sectional side view of the device of this invention taken on line  2 - 2  of  FIG. 1 ;  
       FIG. 3  is a partial sectional side view similar to  FIG. 2 , but the tear strip has been removed;  
       FIG. 4  is a partial sectional side view similar to  FIG. 3 , but the upper cap has been pressed downward to retentively engage the closure top;  
       FIG. 5  is a partial sectional side view similar to  FIG. 4 , but the overcap and the closure top retained therein have been removed;  
       FIG. 6  is a partial sectional front view of a syringe and the opened container of this invention;  
       FIG. 7  is a side view of a second embodiment of the device of this invention;  
       FIG. 8  is a partial sectional side view of the device of this invention taken on line  8 - 8  of  FIG. 7 ;  
       FIG. 9  is a partial sectional side view similar to  FIG. 8 , but the second frangible seal has been broken and the upper cap has been engaged with the closure top;  
       FIG. 10  is a partial sectional side view of the device of this invention taken on line  10 - 10  of  FIG. 9 ;  
       FIG. 11  is a partial sectional side view similar to  FIG. 10 , but the overcap and closure top have been rotated to fracture the first frangible seal; and  
       FIG. 12  is a partial sectional side view similar to  FIG. 11 , but the overcap and the closure top retained therein have been removed. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
      With reference to  FIG. 1 , a container assembly  10  includes a container body  12  for containing fluid, including but not limited to drugs. An overcap  14  is sealed to the container body  12  to provide a barrier over a portion of the container body  12  to prevent contamination by touch or otherwise. The overcap  14  provides a sterile barrier once the entire container assembly  10  has been sterilized.  
      Referring to  FIG. 2 , a port  16  provides access to the contents of the container body  12  through an aperture  18 . A non-resealable closure top  20  is sealed over the aperture  18  to the container body  12  at a first frangible seal  22 . The first frangible seal  22  is a sterilized surface, where the overcap  14  is positioned over the first frangible seal  22  and sealed to the container body  12  to provide a sterile barrier or zone surrounding the first frangible seal  22 .  
      A cap base  24  of overcap  14  is sealed to a horizontally extending flange  26  on the container body  12 . The cap base  24  has a horizontally extending lip  28  with an outer end  30  and an inner end  32 . An annular skirt  34  extends downwardly from the outer end  30  and mates with an outer edge  36  of flange  26  on the-container body  12 . An annular rim  38  extends upwardly from the inner end  32  of lip  28 .  
      Referring to  FIGS. 2 and 3 , an upper cap  40  of overcap  14  is sealed to the cap base  24  by a second frangible seal  42 . A cylindrical skirt portion  44  of upper cap  40  extends downwardly from an outer portion  46  of a radial extending end  48 . The second frangible seal  42  seals the cylindrical skirt  44  to the cap base  24 .  
      A removable tear strip  50  is located between the annular rim  38  of cap base  24  and the cylindrical skirt portion  44  of upper cap  40 , forming the second frangible seal  42 . The tear strip  50  has a hold area  52  that extends horizontally from the overcap  14 . The hold area  52  permits a user to grasp and pull the hold area  52  to remove the tear strip  50 . When tear strip  50  is removed the second frangible seal  42  is broken and the cap base  24  and upper cap  40  are severed from each other.  
      Referring to  FIGS. 3 and 4 , a detent portion  54  of upper cap  40  frictionally attaches the closure top  20  to the upper cap  40  once the second frangible seal  42  (not shown) is broken. Once the second frangible seal  42  (not shown) is broken by removing the tear strip  50  (not shown), the upper cap  40  is depressed towards the container body  12 , mating the detent portion  54  to the closure top  20 .  
      The detent portion  54  includes planar finger elements  56  extending downwardly from the end  48  of upper cap  40  and around the closure top  20 . Each finger element  56  includes a finger shoulder  58  mateable with a corresponding tang shoulder  60  on the closure top  20 .  
      Some force is required to move a bottom edge  62  of the finger shoulder  58  over a leading edge  64  of the tang shoulder  60 . Once the upper cap  40  is depressed, a top edge  66  of the finger shoulder  58  contacts a trailing edge  68  of the tang shoulder  60 , preventing the closure top  20  from detaching from the detent portion  54 . Although various mating configurations are possible, preferably the finger shoulder  58  and the tang shoulder  60  both extend horizontally.  
      Referring to  FIG. 5 , a grip area  70  is located the outer surface of upper cap  40 . The grip area  70  permits a user to grasp and rotate the upper cap  40 . As the upper cap  40  is rotated, the mated detent portion  54  and closure top  20  twist relative to the container body  12 . This rotation breaks the first frangible seal  22  (not shown). Once the first frangible seal  22  (not shown) is broken, the detent portion  54  and closure top  20  remain mated, and are removed from the container body  12 . The closure top  20  is retained within the upper cap  40  once removed from the container body  12 .  
      The upper cap  40  provides a balanced application of torque resulting in a clean break of the first frangible seal  22  (not shown). This clean break minimizes the amount of plastic strands generated from the broken seal.  
      Referring to  FIG. 6 , a luer end  72  of a syringe  74  is inserted into the aperture  18  of port  16  once the closure top  20  is removed. The syringe  74  allows a user to extract fluid content from the container  12 . The luer end  72  is shown as a luer lock fitting but may be a luer slip fitting. The luer end  72  includes a male luer  76  and a female threaded surface  78 . The male luer  76  is inserted into the aperture  18  of the port  16 . The female threaded surface  78  is engaged to port threads  80  located on the port  16  to threadingly mate the luer end  72  to the port  16 .  
      Referring to  FIGS. 7 through 12 , a second embodiment of the present invention includes an upper cap  82  sealed to the cap base  24  by a second frangible seal  84 . A cylindrical skirt portion  86  extends downwardly from a rectangular detent portion  88  of upper cap  82 . The cylindrical skirt  86  is located within the cap base  24  and is sealed to the cap base  24  by the-second frangible seal  84 . The second frangible seal  84  can be broken by manually depressing the upper cap  82  toward the container body  12 , whereupon the detent portion  88  of upper cap  82  frictionally attaches to a closure top  90 . Alternatively, the user can rock the upper cap  82  back and forth until the second frangible seal  84  fractures, then push the upper cap  82  downward.  
      The detent portion  88  includes substantially planar surface elements  92  extending upwardly from cylindrical skirt portion  86  of upper cap  82  and positioned around the closure top  90 . Each substantially planar surface element  92  corresponds to a corresponding substantially planar surface portion  94  of closure top  90 . One or more optional friction enhancing elements  95  are formed in one or more of the substantially planar surface elements or portions  92 ,  94 . The friction enhancing elements  95  are shown as a pair of raised domes on the substantially planar surface portions  94 ; however, those skilled in the art will understand from the description herein that other friction enhancing elements or combinations of elements can be utilized, including but not limited to ribs, ribs and grooves, and other complementary or noncomplementary surface irregularities, without detracting from the present invention. At any rate, the substantially planar surface elements  92  and the substantially planar portions  94  are configured so that some force is required to retentively engage planar surface elements  92  to the planar surface portions  94 . Once the upper cap  82  is depressed, the planar surface elements  92  frictionally engage the planar surface portions  94 , preventing the closure top  90  from detaching from the detent portion  88 .  
      Referring to  FIGS. 7, 10  and  12 , a grip area  96  is located on the outer surface of upper cap  82  and at least forms a portion of the outer surface of detent portion  88 . The grip area  96  permits a user to grasp and rock or rotate the upper cap  82 . As the upper cap  82  is rotated, the mated detent portion  88  and closure top  90  twist relative to the container body  12 . This rotation breaks the first frangible seal  22 . Once the first frangible seal  22  is broken, the detent portion  88  and closure top  90  remain mated, and are removed from the container body  12 . The closure top  90  is retained within the upper cap  82  once removed from the container body  12 .  
      Referring to  FIGS. 2 and 8 , during formation, the container body  12  and closure top  20  or  90  are formed by a blow/fill/seal method and then sterilized. The material that forms the container body  12 , the closure top  20  or  90 , and the overcap  14  can be any material suitable for blow fill molding, and autoclave sterilization including but not limited to glass and plastic. More preferably, the material is polypropylene based or polyethylene tetrachloride-based. Most preferably, the material is a polypropylene random copolymer, such as Huntsman 23M2CS30A or Exxon Mobil 9122. The overcap  14  is fusion welded to the container  12 . The container body  12  and overcap  14  assembly are then autoclaved to sterilize the entire container assembly  10 . The overcap  14  is not fixed to the closure top  20  or  90  during autoclaving, permitting expansion at different rates and in different dimensions so as to prevent unnecessary strain on the container assembly  10 . Once the entire container assembly  10  is sterilized, the overcap  14  preserves the sterility of first frangible seal  22 . When the second frangible seal  42  or  84  is broken, a sterile uncontaminated port  16  remains until the closure top  20  or  90  is rotated by the overcap  14  and removed from the container  12 .  
      It is therefore seen that the present invention provides a container assembly that maintains a sterile barrier or zone around the port until just prior to use. The present invention further provides a container assembly adapted for use with a syringe and which includes an overcap to facilitate removal of a closure top from the container with a twisting motion rather than the usual rocking motion that can lead to spillage and contamination by touch. The present invention also provides an overcap with an improved detent portion for engaging the closure top of a container.  
      It is therefore seen that this invention will accomplish at least all of its stated objectives.