Abstract:
A package holds and stores articles such as drug delivery devices. An inner slide card ( 100 ) with a tray ( 110 ) is loaded with drug delivery devices ( 116 ) and inserted into an outer sleeve ( 200 ). Receiving slots ( 114 ) and apertures ( 118 ) secure the drug delivery devices in a tray. Elements such as catches ( 122 ) associated with the slide card cooperatively engage elements such as catches ( 240 ) associated with the outer sleeve ( 200 ). The cooperative engagement of the respective catches provides a child-resistant feature and a spill-resistant feature. A release button ( 224 ) disengages the child-resistant feature. The horizontal orientation of the injectables provides easy access for a user who has limited dexterity as well as sufficient area to apply graphics.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to co-pending U.S. Provisional Application No. 60/591,677, filed on Jul. 28, 2004, which is entirely incorporated herein by reference. The application also claims the benefit of the filing date of co-pending International Patent Application No. PCT/US05/26779 (now US Non-Provisional application Ser. No. 11/572,673), filed Jul. 28, 2005, which is also entirely incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to packaging, and more specifically to a two-piece apparatus that houses one or more drug delivery devices on an internal slide card within an outer shell. This apparatus may have one or more internal or external locks that prevent the slide card from being pulled out without triggering a related lock release. 
       BACKGROUND OF THE INVENTION 
       [0003]    Conventional pharmaceutical packaging has shortcomings with regard to injectables, which create problems for both the manufacturer and end user. For example, there is known to distribute syringes, vials, and parts thereof in packaging that incorporate foam or plastic elements to protect the product. Such conventional packaging normally holds the product in a vertical position. Where conventional packaging holds the product in a horizontal position, the products are typically stacked on top of each other. There is also known to distribute syringes, vials, and parts thereof loose-or loose, but individually wrapped-in conventional boxes without any means for holding or protecting the products. 
         [0004]    The conventional manufacturer that incorporates foam or plastic elements in its packaging to protect the product carries an increased inventory and employs a more complicated manufacturing system to produce its packaging. Further, the conventional manufacturer typically produces one kind of package to be filled by automated means and another kind to be filled by hand, which also increases inventory and the number of product lines. 
         [0005]    Conventional manufacturers of injectable holding packaging typically do not provide a child-resistant feature to prevent unauthorized access, or a stopping feature to prevent accidental spillage. Where these features do exist, they exist at the expense of easy access for the end user with limited dexterity. Neither does the known injectable packaging provide ample space to place appropriately sized graphics, such as dose compliance instructions and warnings, for the end user with limited sight. 
         [0006]    In addition, conventional manufacturers pack injectables tightly and in the most efficient manner possible-from the perspective of shipping cost savings-but, again, at the expense of the end user who has limited physical mobility, such as an end user with arthritis of the fingers. Also conventional manufacturers are known to distribute only wholly-assembled syringes together, parts of syringes together, or vials together, but not whole syringes or parts or vials mixed together. This convention requires the end user to create and maintain an inventory of injectables to fill their individual needs. 
         [0007]    End users are familiar with the disposal problems created by the use of injectables. Typically, spent vials, needles, syringes, barrels, and other injectables or parts thereof must be sealed or otherwise protected in order to be disposed of safely. While it is known to dispose of injectables in a separate device, such as a sealable plastic container, there remains a need for an injectable packaging that also serves as a safe means of disposal. 
         [0008]    It is apparent from a survey of the pharmaceutical arts that there exists a need for an apparatus that holds and protects all types of drug delivery devices and parts thereof, allows for improved manufacturing processes, includes child-resistant and spill-prevention features, stores a variety of objects in response to the end users&#39; needs, is fitted for easy access by the end user who has limited dexterity, has sufficient area to receive graphics, and provides a means for safe disposal. 
       SUMMARY OF THE INVENTION 
       [0009]    Generally speaking, the present invention fulfills the needs identified above by providing packaging embodiments comprising an outer sleeve and an inner slide card retained within the outer sleeve and with embodiments that releaseably lock the inner slide card within the outer sleeve. In lockable embodiments, the outer sleeve includes at least one panel with an inner slide card means for locking, an inner slide card means for releasing, and an optional inner slide card means for stopping. The inner slide card includes a tray and at least one panel configured to cooperatively engage the outer sleeve means for locking, means for releasing, and optional means for stopping. 
         [0010]    In exemplary embodiments the inner slide card means for locking include extension panels or tabs integral to the inner card or, optionally, attachments extending therefrom, configured to releasably engage the outer sleeve. Also the inner card means for releasing includes a catch and a release on an outer sleeve panel, or an attachment extending therefrom, configured to releasably engage said means for locking. The inner slide card means for locking or retaining comprises inner card and outer sleeve extension panels or tabs configured to engage, or attachments or catches associated with the card and sleeve that are configured to engage. Thus the present invention provides an optional child-resistant feature. 
         [0011]    In exemplary embodiments, the inner card means for stopping comprises inner card and outer sleeve extension panels or tabs configured to engage, or attachments or catches associated with the card and sleeve that are configured to engage. Thus the present invention provides an optional spill-resistant feature to prevent the user from pulling the inner card completely away from the outer sleeve, but which can be opened and closed numerous times to access the drug delivery devices. 
         [0012]    Alternative embodiments include an apparatus and method for holding and storing drug delivery devices by providing an inner tray configuration that, by way of example and not limitation, protects a plunger from inadvertent activation; shields a needle from inadvertent exposure; allows easy access to a drug-filled container for removal and replacement; and collects and stores the spent devices. Accordingly, embodiments of the present invention provide an apparatus and system that is able to safely ship drug delivery devices for transepidermal, oral, and hypodermic administration, including pre-filled syringes, needles, vials, ampoules, protective shields, and accessories, safely store the unused devices, and safely store the used devices until all can be safely disposed as a unit. 
         [0013]    Alternative embodiments include an apparatus and method for providing compliance directions or information directed to therapy management. In one embodiment, indicia such as, but not limited to, time of day, days of the week, numerical sequence, or dosage amounts are positioned adjacent to the devices. In another embodiment, compliance information or general information related to the medication or therapy is positioned on or with the inner slide card or outer sleeve in a manner easily visible by the user. 
         [0014]    Further embodiments include an apparatus for use with a high volume pick-and-pack manufacturing process. The same embodiments provide an apparatus for use with a hand pick-and-pack manufacturing process. Another embodiment includes an apparatus and method for protecting and storing spent drug delivery devices within a secure container until they can be disposed of in a controlled fashion. 
         [0015]    Embodiments according to this invention offer at least the following advantages: lightness in weight, resistance to tampering, child-resistance, ease of access, excellent durability, ease of assembly, device protection, ease of storage, ease of disposal, the ability to present devices of different and unusual shapes, and excellent economy. 
         [0016]    It is also contemplated that the present invention is not limited to pharmaceutical-related goods, but is applicable to a plethora of delicate, sensitive, or unique portable articles. Small electronic components, jewelry, foods, expensive and precious goods, and any other item which requires a safe, stable, and portable environment in which to be shipped and stored may find an application with the present invention. Other advantages of the present invention will be apparent from the following description, the accompanying drawings, and the appended claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is a plan view of an embodiment of a combined slide card and tray blank, according to the present invention. 
           [0018]      FIG. 2  is a perspective view of the completely constructed blank of  FIG. 1 . 
           [0019]      FIG. 3  is a perspective view of an alternative embodiment of a slide card and tray, according to the present invention. 
           [0020]      FIG. 4  is a plan view of an embodiment of an outer sleeve blank, according to the present invention. 
           [0021]      FIG. 5  is a perspective view of the completely constructed blank of  FIG. 4 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    As required, detailed embodiments of the present invention are disclosed herein. It will be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale, and some features may be exaggerated or minimized to show details of particular components. In other instances, well-known materials or methods have not been described in detail in order to avoid obscuring the present invention. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but as a basis for the claims and for teaching one skilled in the art to variously employ the present invention. 
         [0023]    Referring now to the drawings, wherein like numerals represent like features throughout, there are illustrated embodiments of the present invention. Turning first to  FIG. 1  and  FIG. 2 , there is shown an internal slide card blank  10  configured to form an inner tray  12  for holding articles such as drug delivery devices. Herein, the term “drug delivery devices,” whether in the singular or plural, is used broadly to refer to all apparatus and parts thereof used in conjunction with transferring solids, fluids, or gases into or out of a body. By way of example and not limitation, a drug delivery device may be in the form of an injectable device comprising a needle, plunger, and cap used by a medical professional to treat a patient with a pharmaceutical drug in liquid form. The same term is applicable herein to refer to all parts of the device as well as the vial(s) used to hold or receive the drug. For purposes of teaching and not limitation, the illustrated embodiments are directed to packaging for articles such as a drug delivery device in the form of an injectable device. 
         [0024]    As best shown in  FIG. 1 , the illustrated blank  10  includes a base panel  14 , spine panel  16 , and top panels  18 ,  20 . The top panel  20  comprises an integral spine support panel  22 , formed by cuts  23  and fold lines  24 . Blank  10  further includes extension panels  25 . 
         [0025]    An extension panel  25  comprises an outside sidewall panel  26 , top panel  28 , inside sidewall panel  30 , and securing panel  32 . Further, panel  25  comprises a plunger-receiving slot  34 , formed by cuts  23  and fold lines  24 , and a needle-receiving aperture  36 ,  38 . Alternative aperture designs are shown to illustrate a means for securing syringe ends with or without a protective cap. As understood by one skilled in the art, in certain embodiments the aperture  36  may be formed by cuts  23  in the form of an “X” while in other embodiments the aperture  38  may be formed by cuts  23  that create a void. 
         [0026]    Blank  10  further includes locking tab  40  and stopping tabs  42 . As described in detail below, locking tab  40  cooperatively engages with another element to create a child-resistant feature. Also as described below, stopping tabs  42  cooperatively engage with another element to create a pull-out stop that also functions as a spill-resistant feature. With the explanation below, one skilled in the art will understand that the child-resistance feature and stopping feature can both be created, alternatively, with either tabs  40 ,  42  individually or together. Accordingly, both tabs  40 ,  42  are a means for locking and a means for stopping. 
         [0027]    With respect to assembly, blank  10  is folded and connected, using conventional techniques, to create the combined internal slide card and inner tray  12 , best shown in  FIG. 2 . One sequence of folding and connecting the blank  10  to form the tray  12 , described merely for the purpose of teaching and not limitation, with reference to the visible side of the illustrated blank  10  as the face and the opposite side as the back, is as follows: The face of top panel  20  is folded and affixed to the face of top panel  18  so that the face of spine support panel  22  overlaps the face of spine panel  16 . The face of each of the outside wall panels  26 , top panel  28 , and inside wall panel  30  are folded toward each other to form an open-end channel. With the faces of panels  26 ,  28 , and  30  orientated toward each other, the face of securing panel  32  is attached to the face of base panel  14 . In addition, as described below, locking tab  40  will be folded so that the back of locking tab  40  is orientated toward the back of base panel  14 . Similarly, stopping tabs  42  will be folded so that the backs of stopping tabs  42  are orientated toward the backs of the respectively adjacent outside sidewall panels  26 . 
         [0028]    After assembly, the inner tray  12  is configured to receive and store an injectable device (not shown). In the illustrated embodiment of  FIG. 2 , a plunger handle may be received and secured by the plunger-receiving slot  34  while a needle may be received and secured by the needle-receiving apertures  36 ,  38 . By way of illustration and not limitation, the receiving slot  34  and cutouts  36 ,  38  include features for securing the injectables. Here, the receiving slot  34  is shaped as an hourglass because this shape holds a plunger handle in a particular position while allowing easy access. Those skilled in the art will understand that receiving slot  34 , as a means for securing an injectable, may be configured in various shapes, depending on the injectable and ease or complexity of access desired. For example, a receiving slot  34  in the shape of a “J,” “L,” “G,” and “H” all provide varying levels of security and access for the injectable. In addition, the means for securing may comprise inserts of different materials, such as plastic or rubber yokes, to further secure or removably lock the injectables in position. 
         [0029]    Similarly, here apertures  36 ,  38  are shaped as an “X” and as an oval because these shapes can hold a bare needle, capped needle, or the neck of a vial in a particular position while allowing easy access. Those skilled in the art will understand that apertures  36 ,  38 , as a means for securing an injectable, may be configured in various shapes depending on the injectable and ease or complexity of access desired. For example, an injectable comprising a plunger handle, barrel, and needle may be stored by placing the plunger handle in receiving slot  34  and the needle in the aperture  36 ,  38  located in the opposite inside sidewall panel  30 , with the barrel spanning the space in between. In this manner the plunger of a pre-filled injectable is protected from inadvertent pressure, and the user is protected from inadvertent contact with the needle. 
         [0030]      FIG. 3  shows an alternative embodiment of an inner card  100  for receiving and holding injectables, according to the present invention. The illustrated inner card  100  includes an internal slide  102  that comprises a base panel  104 , spine panel  106 , and top panel  108 . Here, rather than using paperboard to monolithically form the inner tray and slide card as described above, the inner tray  110  is thermoformed separately and then affixed to the slide card  102 . The inner tray  110  comprises a means for securing and holding injectables, such as the plunger  112  in the plunger-receiving recess  114  and the barrel  116  in the barrel-receiving recess  118 . The recesses  114 ,  118  may be configured to lock in or otherwise secure the injectable by including a means for resisting removal of the injectable, such as fold-over locking flaps, indentions, or inserts. Accordingly, a means for holding and storing a drug delivery device includes a tray constructed in a variety of ways. 
         [0031]    Here the inner tray  110  is also configured to allow for easy access to the injectables. By way of illustration and not limitation the injectables are arranged alternately so that the end user, who may have limited physical mobility such as that resulting from arthritis, can retrieve one injectable without affecting another. As illustrated, purposefully orientating the widest portion of the injectable, in this example the finger guard  120 , to take the most space to provide the greatest accessibility is a desirable feature of this embodiment. Such horizontal orientating also provides easy viewing of the products so the user may easily distinguish between them. Further, such orientating provides ample area to receive graphics. Patient and healthcare provider information, such as dose compliance, can be made easily visible to the user. 
         [0032]    The embodiment of  FIG. 3  further includes tab  122  which may function as a means for locking and/or as a means for stopping, like the locking tab  40  and stopping tab  42  described herein. 
         [0033]    Turning now to  FIGS. 4 and 5 , there is shown an outer sleeve  200 , for receiving an inner card  12 ,  100  and the related outer sleeve blank  202 . As best shown in  FIG. 4 , the illustrated blank  202  includes side panels  204 ,  206 ,  208 , spine panels  210 , end panels  216 ,  218 , and extension panels  220 . 
         [0034]    With regard to assembly, the blank  202  is folded and connected, using conventional techniques, to create the outer sleeve  200 , best shown in  FIG. 5  as a slip case. One sequence of folding and connecting the blank  202  is as follows, with reference to the visible side of the illustrated blank  202  as the face and the opposite side as the back: Side panel  204  is folded along fold lines  24  under the side panels  206 ,  208  and positioned over panel  208  so that the back of panel  204  may be affixed to the face of panel  208 . In this embodiment, panel  204  is overlaid and affixed to panel  208  so that the cutout  222  of panel  208  surrounds the release button  224 . In other words, the release button  224  is unobstructed by panel  208 . 
         [0035]    Tabs  226  are folded inwardly to create a closed end wall, such that the backs of tabs  226  are orientated toward the interior case created by the side panels  204 ,  206  and spine panels  210 . End panels  216 ,  218  are then folded inwardly so that the face of tabs  226  may be affixed to the back of panel  216  and the face of panel  216  may be affixed to the back of panel  218 , to complete the closed end wall. 
         [0036]    In addition, extension panels  220  are folded inwardly so that the back of panels  220  may be affixed to the backs of respectively adjacent side panels  206 ,  208 . Similarly, extension tabs  228  are folded inwardly so that the backs of tab  228  may be affixed to the respectively adjacent spine panels  210 . The folding of panels  220  converts the cutouts  230  into finger-access areas. 
         [0037]    Generally speaking, injectables are placed within inner tray  12 ,  100  and then the inner tray  12 ,  100  is inserted into outer sleeve  200 . The apparatus holds and protects the injectables until they are retrieved for use. In practice, and with reference to  FIGS. 1 and 2 , injectables are placed within the inner tray  12  and then several panels or tabs are folded before the internal card and inner tray  12  is inserted into the outer sleeve  200 . For purposes of teaching and not limitation, the following folding sequence is described. Top panel  20  is folded so as to cover the injectables and orientate the spine support panel  22  so as to provide support for the spine  16 . In the illustrated embodiment, the back of top panel  20  is now adjacent to the injectables and panel  22  is now substantially parallel to panel  16 . Further, locking tab  40  is folded outwardly, so that the back of tab  40  is close to or touching the back of base panel  14  and stopping tabs  42  are folded outwardly so that the backs of tabs  42  are close to or touching the back of the respectively adjacent sidewall panel  26 . 
         [0038]    With the internal card and inner tray  12  loaded with injectables and folded as described immediately above, the tray  12  is inserted, starting with the edge comprising the tabs  40 ,  42  and with tab  40  receivingly aligned with the catch formed by cutout  222  and release button  224 , into the void of outer sleeve  200 . The internal card and inner tray  12  is fully inserted into the outer sleeve  200 , to a fully closed position. As understood by those skilled in the art, the spring tension created by the outwardly folded tabs  40 ,  42  causes the leading edge of the tabs  40 ,  42  to press against the interior side of the panels  204 ,  208 ,  210 . The position of the tab  40  provides a locking feature and the tab(s)  42  provide a stopping feature. For purposes of teaching and not limitation, the locking feature is described with regard to tab  40 , and the stopping feature is described with regard to tab  42 . It will be understood that either tabs  40  or  42  could interchangeably perform either the locking or stopping features. 
         [0039]    In this illustration the locking feature includes the catch formed by the cutout  222 , the release button  224  and cooperatively interlocking tab  40 . The spring tension created by the compressed tab  40  causes the leading edge of tab  40  to engage the internal edge  240  of the panel  208 . With the tab  40  and leading edge  240  engaged, the inner tray  12  is locked and cannot be opened. This means for locking creates a child-resistant feature. To unlock the child-resistant feature of this embodiment and thereby open the tray  12 , the user depresses the release button  224 , created by the cut  23 , which in turn depresses the tab  40  to disengage the leading edge of the tab  40  from the internal edge  240 . It will be understood that another means for locking may be created by placing one or more release buttons in panel(s)  210  to releaseably engage tab(s)  42 . 
         [0040]    After releasing the optional locking feature, the inner card  12  may be pulled out, until the stopping tabs  42  engage the extension tabs  228 , to a fully open position. As will be understood by those skilled in the art, the spring tension created by the compressed tabs  42  causes the leading edge of the tabs  42  to engage the tabs  228 . Once engaged, the tray  12  cannot be further removed from the outer sleeve  200  but may be reinserted to a fully closed position if desired. In this manner, tabs  42 ,  228  act as a stopping device to prevent inner card  12  from being pulled completely out of outer sleeve  100 . It will be understood that another means for stopping can be created by allowing tab  40  to engage extension tabs  220 . 
         [0041]    The user may open and close the apparatus by withdrawing and replacing the inner tray  12  within the outer sleeve  200  as often as desired. In the fully open position, the user may fold back the top panel  20  to access an injectable. After accessing the desired injectable, the user replaces the top panel  20  and reinserts the inner tray  12  within the outer sleeve  200  for future use. 
         [0042]    Alternatively, an embodiment designed to be disposed of, together with used injectables, may be placed within a red plastic bag (not shown but provided with the embodiment) thereby giving notice of the contents. By way of illustration and not limitation, additional means for protecting and sealing an embodiment to be disposed of, together with used injectables, include sealable bags, a self-sealing outer sleeve, a sealable outer sleeve large enough to receive the inner tray  12  and outer sleeve  200 . Similarly, taping the inner tray  12  within the outer sleeve  200  with red tape giving notice of the contents is a means for protecting and sealing. 
         [0043]    With regard to the materials of construction, the illustrated embodiments comprise paperboard as a substrate for blanks  10 ,  202 , which is typically constructed from a sheet of bleached sulphate, solid unbleached sulphate, or clay-coated paperboard. Compositionally, the paperboard coating is a fluidized blend of materials, such as coating clay, calcium carbonate, and/or titanium dioxide, with starch or adhesive that is smoothly applied to the traveling surface. Successive densification and polishing finish the mineral-coated surface to a superior, graphic-print surface. Other embodiments may comprise vacuum-formed plastic or paper, press-formed paperboard, cardboard, or combinations thereof. 
         [0044]    It must be emphasized that the law does not require and it is economically prohibitive to illustrate and teach every possible embodiment of the present claims. Hence, the above-described embodiments are merely exemplary illustrations of implementations set forth for a clear understanding of the principles of the invention. Variations, modifications, and combinations may be made to the above-described embodiments without departing from the scope of the claims. All such variations, modifications, and combinations are included herein by the scope of this disclosure and the following claims.