Patent Publication Number: US-2015078961-A1

Title: Sterile barrier packaging system

Description:
BACKGROUND OF THE INVENTION 
     This application claims priority to U.S. Provisional Patent Application 61/525,427 filed Aug. 19, 2011, which is incorporated by reference in its entirety herein. 
     1. Field 
     This application relates generally to sterilization packaging and more particularly to sterilization packaging configured to allow sterilization prior to sealing of a product having a removable cap. 
     2. Description of Related Art 
     Sharp instruments to be packaged for sterilization may present particular technical challenges. Generally, such instruments are shipped with protective coverings or caps over the sharp portion in order to reduce damage to the products and/or package during shipping. The cap, however, tends to impede exposure of sterliant compositions during exposure. Similarly, in sterilization of pre-filled syringes, needles should be sterilized prior to capping with protective coverings. Cap materials may be selected such that they are permeable to sterilant gas, however this may tend to place limitations on both cap material and sterilant. For example, rubber caps are sufficiently permeable to ethylene oxide to allow for sterilization with the cap in place. 
     BRIEF SUMMARY OF THE INVENTION 
     A sterile barrier packaging system includes a container configured to hold at least one object to be sterilized, and a respective mating component for the object. The container is configurable in an expanded configuration, wherein the object and the mating component are held spaced apart in mutual registration. The container is further configurable in a compressed configuration, wherein the object and mating component are mated. A method of sterilizing an object includes sterilizing the object in a container holding the object and a mating component spaced apart in mutual registration and subsequently compressing the container to mate the component with the object. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a figure illustrating a typical package containing several syringes; 
         FIG. 2  is a cross sectional side view of a tub in accordance with an embodiment of the present invention in an expanded configuration; and 
         FIG. 3  is a cross sectional side view of a tub in accordance with an embodiment of the present invention in a compressed configuration. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to  FIG. 1 , an example of a product or object to be sterilized is shown. A container, or tub,  10  is arranged to hold a tray supporting multiple prefillable syringes  12 . In a typical example, the tub may hold 100 syringes that are ready to be filled. The syringes are supported by a plate  14  that includes holes configured to allow a barrel of each syringe to pass through while being supported at an upper end. The plate may be, for example, polypropylene, and the tub may be polystyrene. The tub may include a barrier layer (such as, e.g., Tyvek®) that permits gases to enter and exit the package through this barrier layer and serves as a barrier to microbes and dirt, protecting the tub contents. Similarly, the tub may be sealed with a barrier lid, not shown. Each tub may be placed in a pouch to further protect the tub and syringes. 
     In a sterilization method in accordance with an embodiment, the tub  10  and the syringes  12  contained therein are sterilized after the syringes are loaded into the tub and the tub is sealed. The sterilization method may make use of NO 2 , ethylene oxide, hydrogen peroxide, or another sterilant gas. 
     As described above, the complexity or orientation of product components may hinder easy sterilization of the product while the seal is in place. In this case, it may be useful to allow for manipulation of the products after sterilization, without removing them from their sterile barrier packaging system, in order to place them in the proper orientation for shipping and use. 
     An embodiment of a package  10 ′ that addresses this concern is illustrated in  FIGS. 2 and 3 . The package  10 ′ includes the plate  14  that supports the barrels  16  of the syringes  12 . A lower plate  18  supports the respective caps  20  for each syringe  12 . A needle portion  22  of the syringe  12  is shown suspended above the cap  20  in  FIG. 2 . A portion  24  of the side of the package  10 ′ is formed in an accordion shape, allowing the package  10 ′ to be compressible. 
     As will be appreciated, compressibility does not depend on the existence of an accordion shape, and alternate compressible structures may be employed. For example, slidably mated telescoping wall portions may be used, though such an arrangement may tend to be more difficult to seal. Similarly, a flexible material may be used, allowing relative motion between a top and a bottom without use of either telescoping or accordion folding. In any of these embodiments, guide pins or other aligning structure may be used, extending generally between the plate  14  and the lower plate  18  to reduce lateral motion of the package during compression. External alignment structure may similarly be employed. 
     The package  10 ′ is shown in  FIG. 2  in an expanded configuration. In this configuration, the needle  22  is suspended above the cap  20 , allowing sterilant to flow around the needle and inside the cap. As shown in the Figure, the cap may be separated from the syringe by a relatively small distance, as long as gas flow is possible. Where the distance is relatively small, it is possible to pulse sterilant gas and to use vacuum purging to ensure that sterilant contacts all relevant surfaces. The two plates ensure proper registration between the syringes and respective caps. 
       FIG. 3  illustrates a collapsed configuration, wherein the accordion portion  24  is compressed. As a result, the needle  22  becomes firmly engaged with the cap  20 . 
     In an embodiment, the package remains collapsed once the caps are attached. In an alternate approach, the package resiliently returns to its expanded configuration. In this second approach, it will be appreciated that the caps should be sufficiently engaged with the syringes that they do not disengage on expansion. 
     In alternate approaches, the caps may release from the lower support plate  18  after being mated to the syringes, or they might stay engaged with the lower plate. 
     In an embodiment, caps that are intended to mate to a threaded luer hub may be designed so that the caps may be applied to the fluid path without twisting (pressed into place with a linear motion), but are then removed with a twisting motion. 
     While many of the concepts are described for syringes, these concepts can be applied to many applications including, but not limited to surgical tools such as drill bits, saw and/or knife blades, medical implants, and the like. 
     Although the invention has been described in detail for the purpose of illustration based on what are currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the inventions are not limited to the disclosed embodiments, but, on the contrary, are intended to cover modifications and equivalent arrangements that are within the spirit and scope of the described embodiments. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.