Abstract:
A package for an orthopedic device is disclosed. The package includes inner and outer packaging and preferably allows for accessibility of the orthopedic device without direct handling by hand. Methods of utilizing such packaging are also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims the benefit of the filing date of U.S. Provisional Patent Application No. 62/050,407 filed Sep. 15, 2014, the disclosure of which is hereby incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to packaging for orthopedic implants and instrumentation, such as screws, nails or the like. 
         [0003]    Maintaining proper sterilization of implants and instruments utilized in orthopedic surgery is of the utmost importance. Implants and instruments that are improperly sterilized or maintained can lead to infections in a patient. These infections can have significant side effects, including some that may require additional surgery. As such, significant efforts are generally undertaken to sterilize and maintain sterilization of implants and instruments. 
         [0004]    In many cases, sterilized implants and/or instruments are delivered to the surgical theater in packaging designed to maintain the sterilization. The packaging must be opened to allow for access to the components. This often requires manipulation of the packaging in a manner so that the implants or instruments are not subjected to contamination. For instance, traditional plastic packaging is often opened just enough so that the components contained therein can be dumped onto a tray, i.e., without grasping by hand. This not only makes the package opening more difficult and/or time consuming, but also puts the implants and/or instruments in a precarious situation where the potential for contamination is actually increased (e.g., inadvertent dropping of the component). 
         [0005]    Therefore, there exists a need for an improved packaging construct that overcomes the shortcomings of the prior art. 
       BRIEF SUMMARY OF THE INVENTION 
       [0006]    The present invention provides a packaging suitable for housing an orthopedic implant or instrument that prevents contamination of the orthopedic device by a user. The packaging is such that the user can grasp the packaging, while utilizing a tool or the like to engage the device. This improves upon prior packaging, which generally required the user to dump or other dispose of the device onto a surgical tray or the like. The packaging also includes a double barrier to potential contamination. 
         [0007]    A first aspect of the present invention is a package for an orthopedic device having an inner packaging including first and second portions moveable from a first position to a second position and an outer packaging surrounding the inner packaging. The orthopedic device can be accessed upon removal of the outer packaging from the inner packaging and movement of the first and second portions to the second position. 
         [0008]    In certain embodiments of the foregoing aspect, the outer packaging includes two portions sealed together, with or without two tabs associated with the two portions. The packaging may also include a spacer situated within the inner packaging. The first and second portions of the inner packaging may be connected to each other at a living hinge. The orthopedic device can be accessed by a tool while the first and second portions are in the second position. An orthopedic implant may be contained within the inner packaging. The implant may be any type of implant, including, but not limited to nails, screws or the like. The packaging may also be utilized to contain orthopedic instruments or the like. 
         [0009]    Another aspect of the present invention is a method of removing an orthopedic device from a package. The method includes the steps of removing an outer packaging surrounding an inner packaging, moving a first portion of the inner packaging with respect to a second portion of the inner packaging to provide access to the orthopedic device and without directly contacting the orthopedic device by hand, removing the orthopedic device from the inner packaging. 
         [0010]    In certain embodiments of the foregoing aspect, the method further includes the step of engaging the orthopedic device with a tool. The removing the orthopedic device step may be performed with the tool and while the user grasps the inner packaging. Removing the outer packing step may include peeling two portions away from one another. Like above, the orthopedic device may be an orthopedic implant, including nails, screws or the like. The orthopedic device may also be an orthopedic instrument. 
         [0011]    Yet another aspect of the present invention is another package for an orthopedic device including an inner packaging and an outer packaging. The inner packaging includes first and second portions moveable between a first position and a second position, a spacer. The outer packaging surrounds the inner packaging, so that the orthopedic device can be accessed upon removal of the outer packaging from the inner packaging and movement of the first and second portions to the second position. 
         [0012]    Other embodiments of this additional aspect may include an outer packaging that includes two portions sealed together and two tabs associated with the two portions. The first and second portions may be connected to each other at a living hinge. The orthopedic device may be accessed by a tool while the first and second portions are in the second position. The packaging may further include an orthopedic implant contained within the inner packaging. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    A more complete appreciation of the subject matter of the present invention and of the various advantages thereof can be realized by reference of the following detailed description in which reference is made to the accompanying drawings in which: 
           [0014]      FIG. 1  is a perspective view of an implant packaging according to one embodiment of the present invention. 
           [0015]      FIG. 2  is a perspective view of the inner packaging of the implant packaging of  FIG. 1 . 
           [0016]      FIG. 3  is another perspective view of the inner packaging of  FIG. 2  in a position in which the implant can be removed therefrom. 
           [0017]      FIGS. 4A-G  are views of different outer packaging constructs that can be utilized in the packaging of  FIG. 1 . 
           [0018]      FIG. 5  is a perspective exploded view of the inner packaging and implant of  FIG. 2 . 
           [0019]      FIG. 6  is a perspective view of a spacer included in the inner packaging of  FIG. 2 . 
           [0020]      FIG. 7  is a perspective view of an implant packaging according to another embodiment of the present invention. 
           [0021]      FIG. 8  is a cross-sectional view of the implant packaging of  FIG. 7 . 
           [0022]      FIG. 9  is a perspective view of the inner packaging of the implant packaging of  FIG. 7 . 
           [0023]      FIG. 10  is a perspective view of an implant packaging according to another embodiment of the present invention. 
           [0024]      FIG. 11  is a perspective view of the inner packaging of the implant packaging of  FIG. 10 . 
           [0025]      FIG. 12  is another perspective view of the inner packaging of  FIG. 11  in a position in which the implant can be removed therefrom. 
           [0026]      FIG. 13  is a perspective view of an implant packaging according to another embodiment of the present invention. 
           [0027]      FIG. 14  is a side view of the implant packaging of  FIG. 13 . 
           [0028]      FIGS. 15A-15D  are views illustrating access of a screw from the implant packaging of  FIG. 13 . 
       
    
    
     DETAILED DESCRIPTION 
       [0029]      FIG. 1  depicts an implant packaging  10 . Although shown housing an orthopedic nail, it is to be understood that package  10  may be sized and/or shaped to house any type of orthopedic implant or instrument. For instance, it is contemplated to configure packaging  10  to house a knee implant, hip implant, spinal implant, orthopedic screw, or the like. Likewise, although shown as being constructed of a translucent material, packaging  10  may be constructed of entirely clear and/or opaque materials. As shown, package  10  includes an outer packaging  12 , an inner packaging  14 , an implant  16  and a spacer  18 . 
         [0030]      FIG. 2  depicts package  10  with outer packaging  12  having been removed therefrom. Inner packaging  14  includes a cap portion  20 , a container portion  22  and a window  24 . Cap portion  20  is connected to container portion  22  via a living hinge  26  (best shown in  FIG. 3 ). This design allows for implant  16  to be fully accessible upon rotation of cap portion  20  with respect to container portion  22 . It is contemplated that living hinge  26  could be replaced with a standard hinge or any other structure suitable to allow for the above-discussed rotation. In certain embodiments, living hinge  26  or any other structure may be designed to allow for multiple uses of inner packaging (i.e., cap portion  20  can be rotated back into the position of  FIGS. 1 and 2 ). Alternatively, living hinge  26  could be designed to allow for a single use, and in fact alert a user that such use has already occurred. 
         [0031]      FIGS. 4A-G  show several different configurations that outer packaging  12  may exhibit. Consistent with each design is the fact that outer packaging  12  is constructed of at least two different portions attached to each other along a sealed seam  28 . These portions are preferably formed of flexible materials that allow for the manipulation ultimately required for their removal from package  10  (discussed below). Preferably, sealed seam  28  extends entirely around portions of the two portions that encompass inner packaging  14 . Additionally, outer packaging  12  includes two graspable tabs  30   a  and  30   b  that allow for the two portions of the outer packaging to be peeled away from each other at seam  28 . This necessarily allows for inner packaging  14  to be accessed. As shown in  FIGS. 4A-G , the tabs may be of many different configurations, with each being facilitating the peeling step noted above. Likewise, it is to be understood that while  FIGS. 4A-G  illustrate an outer packaging  12  of a particular shape and size, such can be modified in order to accommodate differently shaped and sized inner packaging  14 . Like inner packaging  14 , outer packaging  12  is shown as being translucent, but may be constructed of entirely clear and/or opaque materials. 
         [0032]      FIG. 5  shows implant  16  (in the form of a nail) removed from inner packaging  14 . Moreover, spacer  18  is shown removed from inner packaging  14  in that same figure, as well as in further detail in  FIG. 6 . The inclusion of spacer  18  allows for inner packaging  14  to accommodate differently sized and/or shaped implants. For instance, implant (nail)  16  may be provided in various lengths for use in surgeries of patients of different sizes. By utilizing differently sized spacers  18 , several or all of the various length implants can be securely fit within inner packaging  14 . Shorter nails would require larger spacers  18 , while longer nails would require smaller spacers  18 . As is best shown in  FIG. 6 , spacer  18  is essentially a body designed to be slid into inner packaging  14  and ultimately disposed at a bottom end thereof. Although shown as being a solid construct, it is contemplated to form spacer  18  out of a plurality of individually and/or interconnected elements. This would allow for the variability of the spacer to accommodate differently sized implants. 
         [0033]    Package  10  may be utilized as follows. First, subsequent to manufacturing of implant  16 , a suitably sized and shaped inner packaging  14  may be selected along with a suitably sized spacer  18  for maintaining the implant within the packaging in a somewhat fixed manner. Implant  16  may then be sterilized utilizing any known method. Portions  20  and  22  may be oriented to allow for insertion of the implant within inner packaging  14 . Those portions may then be situated in the position shown in  FIGS. 1 and 2 . Outer packaging  12  can thereafter be placed and sealed around inner packaging  14 . This process may be achieved by any known method for sealing. 
         [0034]    Package  10  may thereafter be delivered to the surgical theater, where it must be opened in order for implant  16  to be utilized. First, tabs  30   a  and  30   b  are grasped by a user and the portions of outer packaging  12  are peeled away from one another. These portions may be discarded after removal from inner packaging  14 . Portion  20  is then rotated with respect to portion  22  to place inner packaging  14  in a position where implant  16  is accessible. The user, while only grasping inner packaging  14  may remove implant  16  therefrom, preferably with a tool or the like so that the implant is never actually directly touched by the user. Implant  16  can then be implanted in the body of the patient without ever having been subjected to potential contamination. 
         [0035]      FIGS. 7-9  depict another embodiment package  110  in accordance with the present invention. Because of the similarities of packages  10  and  110 , like reference numerals are utilized for the latter, but within the 100-series of numbers. For instance, package  110  includes outer packaging  112 , inner packaging  114  and implant  116 . Package  110  is largely utilized in the same fashion as package  10  is, but a spacer or the like is not utilized. This is largely due to the more flexible construction of inner packaging  114 , which can contain differently sized implants  116  in a somewhat fixed without the need for a spacer. 
         [0036]    Similarly, package  210  of  FIGS. 10-12  is of a similar design to packages  10  and  110 . Again, like reference numerals within the 200-series are utilized. However, unlike package  110 , package  210  does utilize a spacer  218 . This spacer is somewhat different than above-discussed spacer  18  in that it does not extend entirely to the bottom end of inner packaging  214 . Rather, spacer  218  may be affixed within inner packaging  214  at different positions depending upon the size and/or shape of implant  216 . 
         [0037]    Package  310  is shown in  FIGS. 13 and 14  as being a screw  316  holding device that, like the above packages, includes an outer packaging  312  and an inner packaging  314 . Much like inner packaging  114 , inner packaging  314  is of a flexible material that holds screw  316  without the need for a spacer or the like. While inner packaging  314  includes portions  320  and  322  and operates like the foregoing inner packaging, it also includes a member  332  that aids in the rotation of the portions with respect to one another. As shown in  FIGS. 15A-15D , packaging  310  is used in much the same way as is described above. Ultimately, a screw driver  334  is engaged with screw  316  without the screw ever having been subjected to direct contact, and potential contamination from a user. 
         [0038]    Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.