Abstract:
A universal sterile packaging assembly for an orthopedic device includes an outer blister having a first recessed central region and an inner blister having a second recessed central region. The second recessed central region includes a protrusion configured for securement of a medical part thereto. The inner blister is sized to fit within the first recessed central region. The assembly also includes a first lid securable to the inner blister and a second lid securable to the outer blister so as to enclose the inner blister within the outer blister.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 62/267,022, filed Dec. 14, 2015, the disclosure of which is hereby incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Maintaining proper sterilization of medical implants or parts utilized in orthopedic surgery is of paramount importance. Implants or parts 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 medical implants and parts. 
         [0003]    In many instances, sterilized implants and/or parts are delivered to the surgical theater in packaging designed to maintain the sterilization. These packages are often in the form of a sealed blister. Typically, the parts are loose or are contained in a smaller package within the sealed blister. In instances where packages are used, however, the packages are not secured to the sealed blister in a manner that ensures the parts remain secured when the package is opened or even during repeated handling. Examples of such packages include those described in U.S. Pat. Nos. 6,889,839, 8,096,420, 8,113,348 and 8,584,853, the disclosures of which are hereby incorporated by reference herein. Such configurations can lead to problems including torn packages and parts falling from the packages when opened. Moreover, because existing sealed blisters do not minimize the risk of parts falling from the package when the seal is removed, existing blisters cannot ensure that parts will not be contaminated. Existing packages also require users to directly contact any parts therein, which can expose them to any sharp edges of the parts when parts are retrieved. 
         [0004]    Thus, there exists a need for an improved packaging construct that enhances the safety of handling medical implants or parts. 
       BRIEF SUMMARY OF THE INVENTION 
       [0005]    A first aspect of the present invention is a universal sterile packaging assembly for an orthopedic device. The assembly includes an inner blister having a recessed central region where the recessed central region includes a protrusion adapted to facilitate the securitization of medical parts thereto. A first lid is secured onto the inner blister. The assembly further includes an outer blister that surrounds the inner blister. A second lid is secured onto the outer blister so that both the outer and inner blister are enclosed within. 
         [0006]    In another embodiment, the protrusion is two pins adapted to allow a medical part to be hooked onto the pins. In yet another embodiment, the recessed central portion further includes an elevated portion defined by a curved surface, where the protrusion is located on the elevated portion. 
         [0007]    In yet another embodiment, the medical part is a plate. The assembly with the plate can further include a separation member adapted to be placed between the plate and the recessed central portion of the inner blister. 
         [0008]    In another embodiment, the medical part is a screw. The assembly with the screw can also include a pouch that is configured to store the screw. The pouch is further configured to be attached to the protrusion on the recessed central portion of the inner blister. The pouch can also be adapted to fold in a manner similar to a matchbook. 
         [0009]    In a second aspect, the invention relates to an inner blister of a universal sterile packaging assembly for storing and transporting an orthopedic device. The inner blister includes a perimeter region that has a surface with a width extending around an entire perimeter of the inner blister. The inner blister also has an inner region that is central to the perimeter region. The inner region is recessed relative to the perimeter region. On a surface of the inner region, two pins extend in a direction transverse to the surface. 
         [0010]    In another embodiment, the inner region further comprises an elevated portion that is located in a middle portion of the inner region. The elevated portion has a convex curved surface relative to the adjacent portions of the inner region surface. 
         [0011]    In a third aspect, the invention relates to a method of using a universal sterile packaging assembly. The method includes the steps of opening a first lid attached to an outer blister of the assembly. This is followed by removing an inner blister from the outer blister and transferring the inner blister to a sterile field. Opening a second lid attached to the inner blister follows, and then removing an object secured onto pins of the inner blister. 
         [0012]    In another embodiment, the object removed from the pins is a plate and it is removed using a medical instrument. The removal of the pins can be performed by placing clamping prongs of the medical instrument on opposite sides of the object following the opening of the second lid attached to the inner blister. 
         [0013]    In yet another embodiment, the object removed from the pins is a pouch and it is removed manually, by hand. Where the pouch is stored in a folded configuration, it can be opened following its removal from the pins in the inner blister. The pouch of this embodiment is foldable in a manner similar to a matchbook. 
         [0014]    In another aspect, the invention relates to a universal sterile packaging assembly for an orthopedic device. In one embodiment, the packaging assembly includes an outer blister having a first recessed central region and an inner blister having a second recessed central region including a protrusion configured for securement of a medical part thereto. The inner blister is sized to fit within the first recessed central region. The packaging assembly also includes a first lid securable to the inner blister and a second lid securable to the outer blister so as to enclose the inner blister within the outer blister. 
         [0015]    In another embodiment, the protrusion is two pins, and at least one of the pins includes a hook configured so that a medical part is securable thereto. In yet another embodiment, the second recessed central region of the inner blister includes an elevated portion defined by a curved surface. In this embodiment the elevated portion is positioned so that the protrusion extends from the elevated portion. In a variant, the elevated portion is shaped so that the curved surface extends in a convex manner from a surface of the recessed central region external to the elevated portion toward the protrusion. 
         [0016]    In one embodiment, the medical part is a plate. In a variant of this embodiment, the assembly includes a separation member configured to be placed between the plate and a surface of the second recessed central region. In another embodiment, the medical part is a screw. 
         [0017]    In yet another aspect, the invention relates to a universal sterile packaging assembly for an orthopedic device that includes an inner blister and a pouch. In one embodiment, the assembly includes an inner blister having a perimeter region and an inner region. The perimeter region includes a surface extending around an entire perimeter of the inner blister and the inner region is central to the perimeter region and is recessed relative to the perimeter region. The inner region is partially defined by an inner surface and includes a pin extending in a transverse direction relative to the inner surface of the inner region. The assembly also includes a pouch with an opening corresponding to the pin such that the pouch is releasably securable to the inner blister. In addition, the pouch is configured for the placement of a medical part therein. 
         [0018]    In another embodiment, the pouch includes a pocket configured to store the medical part. In a variant, the inner region of the inner blister includes a pin sized and positioned for placement of one or more plates in the inner blister and a pin sized and positioned for placement of one or more pouches in the inner blister. 
         [0019]    In yet another embodiment, the pouch is foldable in a manner similar to a matchbook. In a variant, the pouch includes one pocket on each side of the pouch opening so that when the pouch is moved from an open position into a folded position, the respective pockets become closer to one another. 
         [0020]    In another aspect, the invention relates to a method of using a universal sterile packaging assembly. In one embodiment, the method includes steps as follows: opening a first lid attached to an outer blister of the assembly; removing an inner blister from the outer blister; transferring the inner blister to a sterile field; opening a second lid attached to the inner blister; and removing an object secured onto a protrusion of the inner blister. 
         [0021]    In one embodiment, the object is a plate and removing the plate includes using a medical instrument to remove the plate from the protrusion. In a variant, the method includes an additional step of clamping prongs of the medical instrument to opposite sides of the plate following the opening of the second lid. 
         [0022]    In another embodiment, the object is a pouch that includes two parts foldable onto one another. In a variant, removing the pouch includes gripping the pouch and then removing the pouch from its secured position on the inner blister. In another variant, the method includes an additional step of opening the pouch following removal of the pouch from the protrusion. In this step, the opening of the pouch is completed without making any contact with the object disposed within the pouch. In yet another variant, the method includes an additional step of removing the object from within the pouch without making any contact with the object. In another variant, the opening the pouch includes separating the two parts of the pouch so that each part no longer faces the other. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    The present invention will be better understood on reading the following detailed description of non-limiting embodiments thereof, and on examining the accompanying drawings, in which: 
           [0024]      FIG. 1  is a perspective view of a medical device sterile packaging assembly housing a plate, according to one embodiment of the present invention. 
           [0025]      FIG. 2  is an exploded perspective view of the medical device sterile packaging assembly of  FIG. 1 . 
           [0026]      FIG. 3  is a perspective view of the medical device sterile packaging assembly housing a pouch, according to another embodiment of the present invention. 
           [0027]      FIG. 4  is an exploded perspective view of the medical device sterile packaging assembly of  FIG. 3 . 
           [0028]      FIGS. 5A, 5B and 5C  are a plan view and elevation views of both sides of the inner blister of the medical device sterile packaging assembly of  FIG. 1 , respectively. 
           [0029]      FIG. 6  is another embodiment of the inner blister with four pins. 
           [0030]      FIG. 7  is yet another embodiment of the inner blister with six pins. 
           [0031]      FIG. 8  is one embodiment of the inner blister with two pins. 
           [0032]      FIG. 9  is a perspective view of the pouch of  FIG. 3  in an open configuration. 
           [0033]      FIG. 10  is a perspective view of another embodiment of the pouch. 
           [0034]      FIG. 11  illustrates a plate being removed from the inner blister of the medical device sterile packaging assembly of  FIG. 1 . 
           [0035]      FIG. 12  illustrates a screw being removed from one embodiment of the pouch in the open configuration. 
       
    
    
     DETAILED DESCRIPTION 
       [0036]    The present invention is directed to a universal sterile packaging assembly for use in safely storing and transporting medical implants or parts, such as screws and plates. Specifically, the present invention provides two layers of protection against contamination, and thus maintains sterility of medical parts housed thereon in situations such as when the packaging assembly is dropped. In addition, the assembly improves handling, usability and cleanliness. In some variants, the assembly also prevents exposure to the medical parts by a user handling the assembly. In this regard, the assembly is designed to allow access to the medical part without direct touching of same. 
         [0037]    Turning now to the various embodiments of the invention,  FIG. 1  depicts a universal sterile packaging assembly  10  with a plate secured to an inner blister. In its protected state, the packaging assembly  10  is sealed by a tyvek lid (not shown). Of course, other seals may be utilized, such as a heat activated lid.  FIG. 2  depicts the same assembly, but shows the various elements separated from one another. An outer blister  20  is the largest component, and includes a recess  22  for placement of inner blister  30 . Inner blister  30  also includes a recessed central portion  32  that provides space for a separation member  40  to be placed therein and a plate  42  secured over the separation member to the pins of the inner blister  30 . As illustrated in  FIG. 1 , the separation member is shaped to suit a size of the inner blister and the medical parts held within it and is comprised of a material suitable for performance as a barrier between elements that it separates. In addition to the lid on the outer blister, a second lid is sealed onto the inner blister (not shown). In some embodiments, no separation member is included when placing a plate onto the pins of the inner blister. In addition, a separation member can be included in some variants of the other embodiments described herein. 
         [0038]      FIGS. 3 and 4  illustrate the same assembly as  FIGS. 1 and 2 , however, instead of a plate, the inner blister  30  houses a pouch  50 . In the embodiment shown, the pouch has the appearance of a matchbook. The pouch includes pockets at each end sized for the storage of screws  52 . Each pocket includes a slit for access into the pouch from a central portion of the pouch. In  FIG. 3 , the pouch is shown in a closed configuration while in  FIG. 4  it is in an open configuration. In a variant, the pockets can be sized to accommodate other medical parts such as spacers or rods. In a further variant, the pouch can include a plurality of pockets at each end or pockets at both ends of the pouch. Alternatively, the pouch can include other combinations of pouch size, pocket quantity, pocket size, and other characteristics. 
         [0039]      FIG. 5A  shows a top down view of the inner blister  30 . A perimeter region  31  of the inner blister is characterized by a generally planar surface that extends around a perimeter of the inner blister. Central to the perimeter is an inner region of the inner blister  30  having a cavity  32 . Outer walls  33  of the cavity are tapered inward toward a bottom surface of the cavity and the edges between the walls and both the perimeter region and bottom surface are curved. A central portion of the cavity  32  includes an elevated portion  34 . The elevated portion  34  is defined by curved surfaces  35 ,  36  along both a longitudinal axis of the inner blister  30  and an axis transverse to it (best shown in  FIGS. 5B and 5C , respectively). On the surface of the elevated portion  34  at approximately a midway point of a length of the inner blister  30  are two pins  38 . The pins extend in a direction away from the surface of the inner blister  30  and have circular cross sections. Medical parts can be secured to the pins through features on the pins that allow implants or parts to hook onto them. Of course, the pins may exhibit any shape suitable for holding a medical part. For instance, in another embodiment, the pins can be of an oblong cross-sectional shape. In yet another embodiment, protrusions extend from the surface of the inner region of the inner blister and provide an attachment point between medical parts and the inner blister. As with the pins described above, the protrusions may exhibit any shape suitable for holding a medical part. The top of the protrusions or pins are also part of the seal created by the second lid as movement of the pins is restricted by the lid. This prevents a component of a plate or pouch hooked onto the pins from moving and thus prevents contact between the plate and/or pouch and the second lid in the event that the inner blister is shaken or otherwise transported. 
         [0040]    In still further embodiments, three or more pins can extend from the surface of the inner blister. In the same way, a plurality of protrusions can also be incorporated. The pins can be positioned at various locations on the inner blister. For example,  FIG. 6  illustrates a central portion of a cavity  132  of an inner blister with four pins  138  and  FIG. 7  illustrates a cavity  232  of an inner blister with six pins  238 . In any of the above embodiments, multiple elevated portions can be included to accommodate the placement of pins and/or pouches within the inner blister. In such configurations, multiple pouches can be included. The example of  FIG. 6  illustrates the inner blister housing two pouches  150  each holding screws. The pouches shown have the appearance of a matchbook.  FIG. 7  illustrates the inner blister housing a cervical plate  242 , a pouch holding a PEEK interbody spacer  255 , and a pouch holding screws  250 . The pouches in  FIG. 7  fold in a manner similar to those of  FIG. 6  and thus are also like a matchbook. The pouch can also be adapted to hold a variety of medical parts. For example,  FIG. 8  illustrates a cavity of an inner blister  332  with two pins  338  housing one pouch  350  containing two rods for pedicle screw fixation and four pedicle screws. 
         [0041]    In the embodiment shown in  FIGS. 1 and 2 , the plate  42  includes at least two openings suitable for placement over pins  38  to secure plate  42  to inner blister  30 . Plates of varying size can be used with the assembly. Alternatively, the plate can be placed in or on the separation member, and the separation member itself secured to the pins. In another embodiment, the inner blister, and the separation member where applicable, are shaped to accommodate plates that have curved surfaces. 
         [0042]    In the embodiment shown in  FIGS. 3, 4 and 9 , the pouch  50  is designed for use with the assembly  10 . The pouch includes a flap that is unfolded in a manner similar to a matchbook to change the pouch from a closed to an open configuration. The pouch in the open configuration is shown in  FIG. 9 , where it can be seen that the pouch includes pockets  54  at each end with slits for placement of medical parts. In another embodiment shown in  FIG. 10 , the pouch  450  can house at least three screws  452  on one side of the pouch with a two-fold configuration. The pouch of this embodiment also has the appearance of a matchbook. In a variant, the pouch can hold one or two screws, although any number is contemplated. In yet another variant, parts other than screws can be held. Openings  453  are accessible on the closed pouch to hook or otherwise secure the pouch to pins of inner blister. A closed pouch secured to inner blister is shown in  FIG. 3 . The pouch  50  is opened to retrieve screws  52  or other medical parts. In some embodiments, the pouch is made from a thermoplastic polyurethane material. In other embodiments, the pouch includes a structure that remains in an open configuration when placed in the inner blister and is not folded in any way. 
         [0043]    The present invention has numerous advantages. The pin feature within the inner blister ensures that medical parts do not move within the assembly during transport from one location to another. This mitigates any possibility of contamination or alteration to the medical parts. For the same reasons, the risk of a tear in the lid or any other aspect of the assembly during transport is minimized, as is the risk that parts drop or fall out of the inner blister when the assembly is opened to access the parts. Because pins or protrusions are used to secure parts to the assembly and the assembly is sealed, there are at least two levels of protection to ensure safe and sterile transport and handling of medical parts. 
         [0044]    Additional advantages include a lower risk of contamination when parts are stored within a pouch. For example, when a pouch is removed from the inner blister, the parts remain within the pouch, thus minimizing the amount of time the parts are exposed to open air prior to use. In addition, the pouch includes a holding area for gripping to ease retrieval of parts from within the pouch when desired, thus reducing the likelihood that a user would need to touch any part. Other advantages of not having to touch any part within a pouch include prevention of incidents where a glove of a user tears. Any tearing of the glove could affect sterility and safety of the user of the parts and/or a patient. 
         [0045]    In another aspect, the present invention involves a method of using the universal sterile packaging assembly for storage and transport of medical parts. When all components, including those shown in  FIG. 2 or 4 , are enclosed and sealed within a tyvek lid, the assembly is in a secure state. A user intent on use of a medical part in a particular sealed assembly will first pick up the assembly by hand. Once the user has reached the location of desired use of the medical part(s), the tyvek lid is removed. With the lid removed, the user transfers the inner blister to a sterile field and then opens it. As indicated above, other lids may be utilized, such as a heat activated lid. 
         [0046]    Where the medical part is a plate, the user then obtains a plate holder instrument  60  to remove the plate  42  from the inner blister  30 , as shown in  FIG. 11 . The plate  42  is then ready for use in a desired application. Where the medical part is a screw, the individual first removes the pouch from the inner blister and then opens the pouch  50  placing it in a configuration as shown in  FIG. 9 . Once the pouch is removed from the inner blister and opened, the user holds the pouch and applies a screw instrument  62  to the screw  52  to remove it from the pouch without making any bodily contact as shown in  FIG. 12 . The screw is then ready for use in a desired application. In a variant, the user retrieving a pouch does not need to open the pouch as it is stored in an open configuration within the inner blister. 
         [0047]    Advantages of the method of the present invention include that the position of the plate or pouch within the inner blister provides easy access and retrieval as it allows a user holding an instrument to reach in to retrieve the part when the assembly is opened. This also ensures that a user will not be required to touch or handle any part(s), and thus the cleanliness and sterility of the part(s) are maintained. Moreover, the user is not exposed to the risk of making contact with any sharp surfaces on the part(s). 
         [0048]    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.