Abstract:
Storage containers for storing fluids are generally discussed herein with particular discussions on storage containers having a rubber septum for port access. Aspects of the present invention further include provisions for a gasket to displace an internal space between a cap and a nozzle of a storage container to minimize or eliminate seepage into the same space.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 60/912,881, filed Apr. 19, 2007, the disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    Storage containers for storing fluids are generally discussed herein with particular discussions on storage containers having a rubber septum for port access. 
         [0003]    Containers for dispensing fluids come in many shapes, types and sizes. A typical container includes a vial or a container body, a cap, and a seal for sealing the interface therebetween. The cap may be removable for dispensing the stored fluid or a separate channel, port, or weakened section provided for dispensing the stored fluid. 
         [0004]    For a nutritional or therapeutic container designed for intravenous use, the container further includes means for port access. This typically involves use of a rubber septum to be punctured by a spike. However, while a rubber septum is able to seal around a spike, the interface between the septum and the vial or between the cap and the vial provides crevices for the fluid to seep into, which gives the appearance of leakage. 
         [0005]    Accordingly, there is a need for a port access type container that is easy to make, fill, and seal and that, among other things, minimizes or eliminates leakage into the crevices between the cap and the vial. 
       SUMMARY 
       [0006]    The present invention may be implemented by providing a storage container comprising a vial comprising a nozzle comprising a shoulder; a cap positioned over the nozzle comprising a skirt defining an interior cavity having a stopper positioned therein; wherein the nozzle is sealed by an upper nozzle dome layer; and wherein a pliable gasket is positioned between and in contact with at least one of the upper nozzle dome layer and the stopper. 
         [0007]    Other aspects of the present invention include a storage container comprising a vial comprising a nozzle comprising a shoulder; a cap positioned over the nozzle comprising a skirt defining an interior cavity having a stopper positioned therein and a flange; wherein the nozzle is sealed by an upper nozzle dome layer and the shoulder and the flange bonded to one another; and wherein a pliable gasket is positioned between the upper nozzle dome layer and the stopper. 
         [0008]    In yet another aspect of the present invention, there is provided a method of using a gasket with a storage container to displace available space comprising: forming a container body from hot parison by forming a closed end; the container body defining a volumetric storage space; filling the storage space with a fluid; forming a nozzle comprising an open end and a shoulder and sealing the open end; providing a cap with a stopper disposed therein; placing the cap over the nozzle of the sealed open end; and providing a gasket in between the stopper and the sealed open end to displace at least some of the available space. 
         [0009]    The containers as provided above may be made from a blow-fill-seal process. 
         [0010]    In yet other aspects of the present invention, a shoulder on the container nozzle and a flange on the cap may be attached to one another by injection attachment. 
         [0011]    In accordance with still other aspects of the present invention, the gasket may be stamped and placed into the cap as a sub-assembly or injected in place with the cap over the nozzle. 
         [0012]    In one particular preferred embodiment, a method for reducing fluid flow space between a cap and a nozzle of a container is provided which includes the steps of placing a stopper in the cap; and placing a foam material between the stopper and the nozzle to displace the fluid flow space with the foam material. 
         [0013]    In still yet another aspect of the present invention, there is provided a method of using a gasket with a storage container to displace available space comprising forming a container body from hot parison by forming a closed end; the container body defining a volumetric storage space; filling the storage space with a fluid; forming a nozzle comprising an open end and a shoulder and sealing the open end by pinching the nozzle; providing a cap with a stopper disposed therein; placing the cap over the nozzle of the sealed open end; and providing a gasket in between the stopper and the sealed open end to displace at least some of the available space. 
         [0014]    Other aspects and features of the storage containers provided herein may be better appreciated as the same become better understood with reference to the specification, claims, and appended drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The appended drawings include: 
           [0016]      FIG. 1 , which is an exploded perspective view of a storage container provided in accordance with aspects of the present invention; 
           [0017]      FIG. 2 , which is a partial cross-sectional view of the storage container of  FIG. 1  in an assembled state; 
           [0018]      FIG. 3 , which is a partial cross-sectional partial perspective view of the storage container of  FIG. 2 , which shows a cut-out on a gasket in relations to two indentations on a stopper; 
           [0019]      FIG. 4 , which is a partial cross-sectional view of an alternative storage container provided in accordance with other aspects of the present invention; 
           [0020]      FIG. 5 , which is a partial cross-sectional side view of a mold for attaching the shoulder and the flange of the cap and container using injection attachment; 
           [0021]      FIG. 6 , which is a partial cross-sectional side view of multi-laminate peelable cover provided in accordance with aspects of the present invention; and 
           [0022]      FIG. 7 , which is a cross-sectional side view of a polymeric peelable layer. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of storage containers provided in accordance with aspects of the present invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the storage containers of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. Also, as denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features. 
         [0024]    Referring now to  FIG. 1 , an exploded perspective view of a storage container provided in accordance with aspects of the present invention is shown, which is generally designated  10 . In one exemplary embodiment, the storage container  10  includes a container body  12  defining a volumetric storage space and a cap  14  for capping a nozzle  16 . For simplicity, the container body  12  may be referred to herein as a vial, which represents the container body shown and more generally any volumetric storage space. 
         [0025]    In one exemplary embodiment, the vial  12  includes a hanger  18  having an opening  20  on a base  22 , opposite the end with the nozzle  16 . The vial  12  is preferably formed form a blow-fill-seal process, which is well known in the art. More particularly, the body section  24 , the base  22 , and the hanger  18  are first formed from hot parison. The formed body section  24  is then filled with a fluid and then the nozzle  16  is formed, which includes a dome  26  for sealing in the fluid, such as IV fluid therapy, drug delivery, parenteral nutrition, or other desired fluids. The dome  26  may be formed by pinching the hot parison during the nozzle formation process, which typically leaves a pinch line  27 . The vial may be made from a number of thermoplastic materials with low density polyethylene (LDPE), high density polyethylene (HDPE), and polypropylene material being more preferred and with LDPE being most preferred. Although vent ports may be incorporated, the vial  12  is pliable and collapsible to allow fluids to drain therefrom without them. 
         [0026]    In one exemplary embodiment, the nozzle  16  has a cylindrical tubular shape and incorporates a lip or bead  28  and a flange or shoulder  30  for mating with the cap  14 , as further discussed below. However, the nozzle  16 , and also the body section  24 , may be completed with different geometries, which include different sizes, different cross-sectional shapes, different lengths, different spacing between the bead  28  and the shoulder  30 , etc., without deviating from the spirit and scope of the present invention. 
         [0027]    In one exemplary embodiment, the cap  14  incorporates a receiving section  32  ( FIG. 2 ) projecting from a cap surface  34 , a skirt section  36 , and a flange  38 , which is configured to mate with the flange  30  on the nozzle  16 . Internally, a bead ( 56 ,  FIG. 2 ) is incorporated to engage with the bead  28  on the nozzle  16  for retaining the cap to the nozzle during assembly, as further discussed below. 
         [0028]    The receiving section  32  is preferably integrally formed to the skirt section  36  and projects a sufficient amount from the cap surface  34  to accommodate a stopper  40 . Although the receiving section  32  is shown with an oblong shape, it may incorporate any number of geometries, including circular, square, rectangular, polygon, etc. In one exemplary embodiment, the receiving section  32  is incorporated with two access holes or through holes  42 , although one or more than two may be incorporated. The access holes  42  permit a spike and a needle to be inserted through the receiving section without first piercing through the cap material. The cap  14  may be made from standard prior art molding techniques, such as injection molding, using a HDPE material. 
         [0029]    The stopper  40  provided in accordance with aspects of the present invention may be made from a thermoplastic elastomer material, such as KRATON®, ethylene-propylene diene monomer (EPDM), polyisoprene, SANOPRENE™, and PEBAX™. In a preferred embodiment, the stopper  40  is molded directly into the receiving section  32  of the cap. However, the stopper may also be made separately from a thermal set material and subsequently added to the cap  14 . A plurality of projections  44  may be formed to an underside of the stopper  40  to minimize surface to surface contact between the dome  26  on the nozzle  16  and the stopper  40 . 
         [0030]    In one exemplary embodiment, a gasket  46  is incorporated. The gasket  46  may be stamped from a foam, low density or HDPE, sheet and includes a cut-out  48  sized so that the perimeter of the cut-out is outside of the path of insertion of a spike. In other words, the cut-out is preferably sized so that no part of the gasket is pierced by a spike or a medication additive needle. This avoids the possibly of transferring foam fragments to the dispensed fluid. The thickness of the gasket  46  may be sufficiently thick to fill the gap or space located between the dome  26  on the nozzle  16  and the cap surface  34 , as further discussed below. 
         [0031]    A peelable cover  50  for providing sterility may be sealed to the receiving section  32 . The cover  50  may be peelable from the receiving section prior to use and preferably includes a pull tab (not shown) to facilitate gripping. As further discussed below, the peelable cover  50  may be bonded to the receiving section and may include a polymeric material or a multi-laminate layer that includes an aluminum foil layer. 
         [0032]      FIG. 2  is a partial cross-sectional side view of the storage container  10  of  FIG. 1 , which shows the flange  38  on the cap  14  placed against the flange  30  on the nozzle  16  of the vial  12 . In practice, a mold is used to clamp the two flanges  30 ,  38  and molten polymeric material injected to form a ring  52  for bonding the two flanges together in a process known as injection attachment. The resultant ring is shown as a welded flange  54  in  FIG. 2 . In one exemplary embodiment, molten polypropylene (PP) material is used to fuse the two flanges  30 ,  38  together. However, HDPE, LDPE, or other polymeric material may also be used. While the welded flange  54  is shown with stepped surfaces, any configurations, contours, and shapes may be used without deviating from the spirit and scope of the present invention. 
         [0033]    As previously discussed, a lip or bead  56  is incorporated internally of the cap  14  to engage with the lip or bead  28  on the nozzle  16 . This engagement allows the cap  14  to be temporarily secured to the nozzle  16  during the ring formation. 
         [0034]    In one exemplary embodiment, the stopper  40  includes one or more craters or indentations  58 ,  60 . The two indentations  58  subjacent the two access holes  42  on the cap are optional and when incorporated, are configured to minimize the thickness of the stopper  40  at the puncture site for a spike or needle to facilitate puncturing. The middle indentation  60  is also optional and when incorporated is configured to minimize direct surface-to-surface contact between the stopper  40  and the dome  26 . In one exemplary embodiment, the number of indentations  58 ,  60  formed in the stopper corresponds with the number of openings  42  formed on the receiving section  32  of the cap  14  ( FIG. 1 ). The indentations  58 ,  60  may have a variety of shapes and depths without deviating from the spirit and scope of the present invention. 
         [0035]    As previously indicated, when a spike (not shown) punctures through the stopper  40  and through the dome  26  of the vial  12 , the spike is sealed along its external surface by the stopper, which prevents leakage around the external periphery of the spike. However, as the space  62  between the stopper  40  and the dome surface  26  of the vial  12  is not sealed, dispensed fluid may leak into and fill the space  62  near the skirt  36 . Thus, in accordance with one aspect of the present invention, a foam gasket  46  is provided between the stopper  40  and the dome  26  on the vial  12 . The gasket  46 , which in one embodiment is formed by stamping a foam sheet, may be placed into the skirt section  36  of the cap  14  as a sub-assembly. The sub-assembly may then be placed over the nozzle  16  and the two flanges  30 ,  38  clamped and welded, as previously discussed. In one exemplary embodiment, the foam sheet may be a LDPE foam sheet. However, other pliable foam sheet material may be used without deviating from the spirit and scope of the present invention. 
         [0036]    In one exemplary embodiment, the gasket  46  is sized so that its periphery extends into the skirt section  36  of the cap and pinched between the cap surface  34  and the outer ridges  64  of the nozzle  16  and the dome  26 . During autoclave sterilization and the container&#39;s temperature is raised, the polyethylene gasket  46  approaches its softening point and may thermally bond to the dome  26  on the vial  12  and the stopper  40 . Whether the gasket  46  forms a bond with the vial and the stopper or not, the presence of the gasket acts to displace the space  62  between the cap and the nozzle to reduce or eliminate liquid flowing into the same space. 
         [0037]    In one exemplary embodiment, a lip  66  is incorporated at the top surface  67  of the receiving section  32 . The lip  66  and the top surface  67  form a recess for receiving a peelable cover  50  (not shown). However, the peelable cover  50  may be bonded directly to the top surface  67  without the lip  66 . 
         [0038]      FIG. 3  is a partial cross-sectional partial perspective view of the container  10  of  FIG. 2 . The relative position of the cut-out  48  on the gasket  46  and the two craters  58  located on the stopper  40  is shown. As is readily apparent to a person of ordinary skill in the art, the cut-out  48 , shown having an oblong shape, may incorporate a different shape, such as circular or rectangular, provided the perimeter of the cut-out is outside of a path to be taken by a spike when the same is used to puncture the stopper  40 . 
         [0039]    Referring now to  FIG. 4 , a cross-sectional side view of an alternative container  68  provided in accordance with aspects of the present invention is shown. In the present embodiment, a stopper  70  having two concave craters  72  formed along its upper surface  74  and a plurality of bumps on its lower surface  76  is used. The stopper  70  may be formed in place with the two craters  72  created by inserting two core pins (not shown) through the two openings  42  of the receiving section  32  or as a thermal set that is placed into the cap as a sub-assembly. 
         [0040]    In one exemplary embodiment, two or more injection passages  78  are formed along the cap surface  34  and/or the skirt section  36  of the cap  14 , near the flange  38 . The injection passages  78  may be used as means for injecting polyethylene foam into the space  62  between the stopper  70  and the nozzle  16 . In practice, during the injection attachment process for forming a ring around the two flanges  38 ,  30 , liquefied polyethylene foam is injected into the space  62  inside the cap  14  through the two or more injection passages  78 . Once the foam is cooled, it solidifies and displaces the space or gap between the top surface  34  of the cap and the dome  26  on the vial  12 . In another embodiment, both a stamped foam sheet and liquefied foam injection may be used to displace the gap or space between the cap and the dome and nozzle section of the vial. 
         [0041]      FIG. 5  is a partial cross-sectional side view of an alternative cap  80  positioned over a vial  12  and the flange  30  on the vial abutting the flange  82  on the cap  80 . In one exemplary embodiment, the flange  82  on the cap incorporates a tapered shoulder  84  having a first slope. As previously discussed, the two flanges  30 ,  82  may be welded together using a process known as injection attachment, which involves clamping two mold halves  86  (only one shown) around the nozzle  16  and cap  80  and injecting liquefied polymeric material through one or more injection ports  88  (only one shown) to fuse the two flanges together. The resultant flange resembles the flange  54  shown in  FIG. 2 , with a different outer contour due to a different mold design. 
         [0042]    When two mold halves  86  are clamped around the nozzle  16  and cap  80 , they move in an orthogonal direction  90  to the longitudinal axis of the vial  12 . Thus, while the two flanges  30 ,  38  are held together, they may not be axially compressed together as desired. To generate a compressive force on the two flanges  30 ,  82 , a tapered shoulder  92  having a second slope is incorporated in the mold cavity. The second slope may have a value greater than or less than the first slope  84  on the cap. When the two dissimilar slopes meet, they produce a pair of component forces having an equivalent axial force component  94  in the direction of the longitudinal axis of the vial  12 . Thus, where a stamped gasket is used to displace at least some of the space between the cap  80  and the nozzle  16 , such as the gasket  46  in  FIG. 1 , the axial force  94  is configured to compress the gasket to provide a seal between the cap surface and the nozzle to limit or eliminate leakage into the internal space section  62  of the cap. 
         [0043]    Turning now to  FIG. 6 , a partial cross-sectional view of a peelable cover  50 ′ for covering the upper surface  67  of the nozzle  16  of  FIG. 1  is shown. In one exemplary embodiment, the peelable cover  50 ′ comprises a multi-layer laminate sheet, which includes a lower polymeric layer  96 , which is preferably a polyethylene-polybutylene blend, a middle moisture impermeable foil layer  98 , and an outer polymer layer  100 , which is preferably Polyethylene Terephthalate (PET). The three layers  96 ,  98 ,  100  may be bonded to one another using known prior art bonding techniques. The lower layer  96  is configured to be attached to the cap. 
         [0044]    In one exemplary embodiment, the peelable cover  50 ′ is heat sealed to the upper surface  67  of the cap with the lower layer  96  directly facing the upper surface  67  of the cap. Because the foil layer  98  is moisture impermeable, no moisture can permeate through to the cap  14  during autoclave sterilization, which is not preferred and possibly not acceptable for autoclave sterilization. Thus, in accordance with one aspect of the present invention, pluralities of perforated holes  102 , and more preferably a plurality of micro-performed holes, are formed in the foil layer  98  for moisture permeability. In one exemplary embodiment, at least some of the micro-perforated holes are formed in a pattern directly over the two access holes  42  ( FIG. 1 ) on the cap to ensure moisture penetration through the cap. The micro-perforated holes are preferably sized sufficiently large and in quantity to ensure adequate moisture flow to satisfy autoclave sterilization but not so large in size or number so as to compromise the structural integrity of the aluminum foil layer and be susceptible to tearing. The micro-perforated holes  102  may be formed in a pattern or at random and the foil layer should be sufficiently thick so that as the peelable cover  50 ′ is bent back to expose the access holes  42  on the cap ( FIG. 1 ), the foil layer maintains the peelable layer in a folded-back state. 
         [0045]      FIG. 7  is a cross-sectional side view of an alternative peelable cover  50 ″ provided in accordance with aspects of the present invention. In the alternative peelable cover  50 ″, a single polymeric layer, such as a PET material, is used to heat seal to the upper surface  67  of the cap. The cover  50 ″ is moisture permeable and may be attached directly to the upper surface  67  of the cap. Both peelable covers  50 ′ and  50 ″ of  FIGS. 6 and 7  preferably include a pull tab to facilitate pulling and removing the cover from the container (not shown). 
         [0046]    In a further aspect of the present invention, a method is provided for displacing space between the cap  14  and the nozzle  16 . In one method, a foam material is used to displace the space. In another method, a foam material is used in combination with a compressive force to displace the space. In another method, liquefied foam material is used to inject into the space to displace the same with foam material. In yet another method, a combination of foam sheet material and liquefied foam material is used to displace the space with foam material. 
         [0047]    In yet other aspects of the present invention, a method is provided for minimizing the presence of fluid in the space between the cap  14  and the nozzle  16 . In a specific embodiment, foam is placed in the available space so that less space or zero space is available for displaced fluid to leak into said same space. 
         [0048]    Although limited embodiments of the storage containers and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the containers may be made transparent, semi-transparent, or opaque, the nozzle may include additional beads or ribs, the shape of the container may be different, and the materials used may be a composite. Accordingly, it is to be understood that the storage containers and their components constructed according to principles of this invention may be embodied other than as specifically described herein. The invention is also defined in the following claims.