Abstract:
Described herein is an apparatus and method for attaching a removable and reusable electronic component to a to a slide card that can be preprinted with electrical traces for the purpose of collecting data on pill expression. A removable and reusable electronic component can be coupled with a slide card incorporating preprinted electrical traces, using a hub like plastic seating component attached to and through the slide card.

Description:
BACKGROUND 
       [0001]    Unit dose packaging is an attractive packaging format for certain pharmaceutical applications because it is convenient, yet sturdy enough to be opened and closed numerous times until the course of medication is completed, and also enables the user to track the consumption of doses according to the prescribed schedule. Examples of such packaging are described in U.S. Pat. No. 6,047,829 (Johnstone), which is commonly assigned with this application. 
         [0002]    The Johnstone patent relates to a unit dose paperboard package that includes an outer paperboard sleeve, an inner paperboard slide card that is lockably retained within the sleeve. The sleeve includes a plurality of side panels operatively connected to each other such that one of said plurality of side panels includes a first inner slide card releasing means, and another of said side panels includes a second inner slide card releasing means, such that the inner slide card retaining and releasing means are located substantially adjacent to said unit dose dispensing means. 
         [0003]    An improvement over that described and claimed in U.S. Pat. No. 6,047,829 is contained in another commonly assigned patent (U.S. Pat. No. 6,412,636). In this patent the package is rendered less susceptible to unintentional opening and has improved structural stability. Child resistance is a feature particularly desired for pharmaceutical packaging, and is mandated by the Poison Prevention Packaging Act of 1970. 
         [0004]    In addition to child resistance it is also desirable that the unit dose packaging system be senior friendly to permit easy withdrawal of the package contents with minimum manipulation. Such a withdrawal means should be easy to use even if the patients manual dexterity or strength is reduced. 
         [0005]    The aforesaid patents permit the user to track consumption of medication doses (e.g., pills) by visually inspecting the packaging. However, significantly more data can be obtained pertaining to the consumption of unit doses if a reusable electronics component that automatically tracked and transmitted dosing events was able to be removably integrated with the packaging. 
       SUMMARY 
       [0006]    One embodiment of the disclosure describes a unit dose paperboard package insert. The unit dose package insert includes a paperboard blank comprised of a bottom panel and a top panel. The bottom panel includes one or more areas of weakness outlined by perforations. The bottom panel further includes an electrical trace element having at least first and second ends positioned away from the areas of weakness wherein the electrical trace element intersects the one or more areas of weakness such that when an area of weakness is compromised the electrical trace element is broken for that area of weakness. The top panel includes one or more unit dose cut out areas and an electronics seating hub component cut out area. The unit dose package insert also includes a blister pack comprised of one or more sealed unit doses positionable atop the bottom panel such that the unit doses are substantially above the unit dose cut out areas. There is also an electronics seating hub component adapted to mechanically receive a removable, reusable electronics component wherein the electronics seating hub component is positioned proximate to the termination of the electrical trace element ends. The top panel substantially covers and is adhered to the bottom panel to secure the blister packs and electronics seating hub component securely between the top and bottom panel such that the sealed unit doses protrude through the unit dose cut out areas and the electronics seating hub component protrudes through the electronics seating hub component cut out area. 
         [0007]    The blank can further include a crease that defines a boundary between the top panel and the bottom panel such that folding the blank along the crease positions the top panel substantially covering the bottom panel aligning the cut out areas of the top panel with the areas of weakness of the bottom panel. A pair of additional creases can also be included in which the space in between the creases defines an end panel when the unit dose package insert is folded back over itself along each crease. 
         [0008]    In one embodiment, the electronics seating hub component comprises a housing including first and second pairs of opposing walls. One wall of the first pair of opposing walls includes at least one opening at the base of the wall that is adapted to receive a tab that is attached to an electronics component. The opposite wall of the first pair of opposing walls includes a cut out area to facilitate insertion and removal of the electronics component within the electronics seating hub component. One wall of the second pair of opposing walls includes a detent adapted to receive a corresponding inverted detent that is attached to an electronics component such that the electronics component remains seated in place upon lining up the detent and inverted detent. 
         [0009]    In another embodiment, the electronics seating hub component comprises a pair of opposed rigid side members, each including a dovetail slot extending substantially the length of each side member. There is also rigid cross member including one or more electrical contacts that are electrically coupled with the electrical trace element ends. An electronics component having a corresponding dovetail slot can be slidably seated with the electronics seating hub component. 
         [0010]    In another embodiment, the disclosure describes a reusable electronics component that can be electrically coupled with a disposable unit dose package to collect and disseminate data pertaining to the expression of unit doses. The reusable electronics component includes a seating mechanism adapted to fit into an electronics seating hub component, a microcontroller, an RF module coupled with the microcontroller for sending and receiving data wirelessly, an electrical trace contact interface coupled with the microcontroller for electrically coupling the reusable electronics component with electrical traces present on the disposable unit dose package, and a software application coupled with the microcontroller for detecting when a unit dose has been expelled from the disposable unit dose package. The reusable electronics component can further include a display for displaying data, an indicator light for providing a visual status indication, a speaker for providing an audible status indication, a power jack for recharging an internal power source of the electronics component, and a data port for providing a wired data output mechanism. 
         [0011]    In yet another embodiment of the disclosure, a method of assembling a unit dose package insert is described. A blank comprised of a top panel and a bottom panel, wherein the top panel and a bottom panel include one or more creases, cut outs, and perforations required to accommodate a blister pack and an electronics seating hub component is formed. Electrical traces are applied to the blank in a desired pattern so as to ensure each unit dose has a portion of the electrical trace associated therewith. The blister pack is adhered to the bottom panel of the blank such that each unit dose is substantially over a perforated area. The electronics seating hub component is also adhered to the bottom panel such that electrical trace terminations are coupled with corresponding electrical trace contacts in the electronics seating hub component. The top panel is then sealed to the bottom panel thereby encasing the blister pack and the electronics seating hub component firmly and immovably between the top and bottom panels of the unit dose package insert. The electrical traces can be comprised of conductive ink that is printed onto the blank. 
         [0012]    In another embodiment of the disclosure, a unit dose package system is described. The unit dose package system includes a slide card insert comprised of a blank that includes a bottom panel and a top panel. The bottom panel includes one or more areas of weakness outlined by perforations. The bottom panel further includes an electrical trace element having at least first and second ends positioned away from the areas of weakness wherein the electrical trace element intersects the one or more areas of weakness such that when an area of weakness is compromised the electrical trace element is broken for that area of weakness. The top panel includes one or more unit dose cut out areas and an electronics seating hub component cut out area. The unit dose package insert also includes a blister pack comprised of one or more sealed unit doses positionable atop the bottom panel such that the unit doses are substantially above the unit dose cut out areas. There is also an electronics seating hub component adapted to mechanically receive a removable, reusable electronics component wherein the electronics seating hub component is positioned proximate to the termination of the electrical trace element ends. The top panel substantially covers and is adhered to the bottom panel to secure the blister packs and electronics seating hub component securely between the top and bottom panel such that the sealed unit doses protrude through the unit dose cut out areas and the electronics seating hub component protrudes through the electronics seating hub component cut out area. The unit dose package system further includes a reusable electronics component mechanically and electrically coupled with the electronics seating hub component to create a complete electrical circuit between each unit dose and the reusable electronics component. A cover adapted to receive the slide card insert such that the slide card insert is lockably and slidably engaged within the cover is also included. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  illustrates a unit dose packaging system according to one embodiment of the disclosure including an internal slide card and outer sleeve with child resistant button release means. 
           [0014]      FIGS. 2   a  and  2   b  illustrate views of the slide card. 
           [0015]      FIG. 3  is an illustration of an electronics component that can be removably coupled with a slide card according to one embodiment of the disclosure. 
           [0016]      FIG. 4  is a block diagram illustrating components of an electronic component like that illustrated in  FIG. 3 . 
           [0017]      FIG. 5  illustrates one embodiment of an electronics seating hub and an electronics component. 
           [0018]      FIG. 6  illustrates another embodiment of an electronics seating hub and an electronics component. 
           [0019]      FIG. 7  is an exploded view of the various layers and components that comprise a finished slide card according to an embodiment of the disclosure. 
           [0020]      FIG. 8  is a data flow diagram that describes a process for assembling a slide card according to an embodiment of the disclosure. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0021]    Referring to  FIG. 1 , an embodiment of the unit dose package comprises a slide card  20 , which can be releasably, lockably engaged with an outer sleeve  10 . The outer sleeve  10  is comprised of a top panel  11  and a bottom panel  12 , which are foldably connected by side panels  13  and  14 , and an end panel  15 , which secures one end opening of the package. 
         [0022]    The top panel  11  can include a release mechanism  16 , which is formed by a series of connected cuts in the sleeve substrate made by conventional techniques. The cut edges form a flexible tab that can be depressed to exert pressure on one or more layers of substrate underlying top panel  11  to release a locking mechanism  38  of slide card  20  that engages a reciprocal locking mechanism  39  of the outer sleeve  10  and allow the slide card  20  to be withdrawn sufficiently to expose one or more blisters  23  that have been associated with slide card  20 . 
         [0023]    Top panel  11  can further include a notch  17  that provides a finger hold to facilitate withdrawal of slide card  20 . A corresponding notch (not shown) having similar dimensions as notch  17  is positioned parallel to but offset from notch  17  in the edge of the bottom panel. Notch  17  is shown positioned close to the center of the edge of top panel  11  while its corresponding notch on the opposite side panel is positioned off center such that there is incomplete overlap with notch  17 . The position of these notches along the outer edges of the sleeve  10  and their placement in relation to each other may be varied depending on the overall dimensions of the package. 
         [0024]    Slide card  20  can be folded along creases to form an end panel  22  and also define a second area  21  that can be utilized for additional blister packaging. An electronics component  25  is shown seated within an electronics seating hub component  24 . The electronics component  25  when seated in electronics seating hub component  24  have a height dimension that is very close to the height of end panel  22 . This is so that when the slide card  20  is fully inserted in outer sleeve  10 , the end panel  22  cannot be collapsed. This provides an additional measure of child resistance to the packaging. In addition, a protruding element  45  is placed such that when the slide card  20  is folded over onto itself to create opposing top and bottom panels, the protruding element  45  on the top panel will be proximate to the electronics component  25 /electronics seating hub component  24  on the bottom panel in a manner that prevents the top panel from sliding out further enhancing the child resistant aspect of the packaging. 
         [0025]    Referring to  FIGS. 2A and 2B , a slide card  20  is shown in an isometric view. As just described, the slide card  20  includes an electronics seating hub component  24  that can be positioned proximate to one or more electrical trace ends (not shown) so as to enable the contacts  28  (see, e.g.,  FIG. 5 ) of the electronics component  25  to operatively connect or to the one or more electrical trace ends. Dashed lines define creases for an end panel  22  and a locking mechanism  38 . The slide card  20  can be folded along the creases to create the end panel  22  and a locking mechanisms  38  such that when the slide card  20  is folded and inserted into the outer sleeve  10 , a packaging solution is created that allows the slide card  20  to be coupled with the outer sleeve  10  in a slidable and lockable manner. It is noted that the protruding element is not shown in  FIGS. 2A and 2B , but can of course be present. 
         [0026]    When folded, the slide card  20  forms two opposed panels each capable of containing blister packs  23 . In  FIG. 2A , the electronics seating hub component  24  is shown on what could be considered the lower panel of the slide card  20  while in  FIG. 2B , the electronics seating hub component  24  is shown on what could be considered the upper panel of the slide card  20 . Thus, the electronics seating hub component  24  can be situated strategically on the slide card  20  and is not necessarily restricted to a single location. 
         [0027]    Also shown within the electronics seating hub component  24  is a set of electrical trace contacts  32 . These contacts terminate a corresponding set of electrical traces (not shown) that can be pre-printed on the slide card to correspond with each unit dose of the blister packs  23 . When an electronics component  25  is operatively seated within the electronics seating hub component  24 , a corresponding set of contacts  28  (see,  FIG. 5  for an example embodiment) operatively engages the trace contacts to complete an electronics circuit. It should be noted that the placement and number of electrical trace contacts  32  within an electronics seating hub component  24  can be a design choice that is best adapted to a given configuration. 
         [0028]    In practical use of a packaging system, a user can simply remove and re-use an electrical component  25  each time a new slide card  20  of unit doses is received. As an additional benefit, the height dimension of the electrical component  25  adds additional structural support to a folded slide card when seated. 
         [0029]    Referring to  FIG. 3 , an example electronics component  25  is illustrated from an exterior perspective. In addition to internal electrical components, the electronics component  25  can include one or more of a display  50 , a set of LED lights  51 ,  52 ,  53 , a speaker  54 , a power jack  55 , and a data port  56 . Depending on the hardware and software capabilities of the electronics component  25 , a display can be utilized to illustrate the current date/time, the date/time of the last recorded dose, and the date/time of the next scheduled dose. This information can be pre-programmed by the user via a device that can be coupled either wirelessly or via data port  56  to the software within the electronics component  25 . In addition, one or more LED lights  51 ,  52 ,  53  can be color coded to indicate the current status of the next unit dose. For instance, a green LED  51  could indicate that a user is current with his medication. A yellow LED  52  could indicate that the user is within an hour of the next scheduled unit dose, and a red LED  53  could indicate that the user is past due on his next schedule dose. A speaker  54  could beep to give the user an audible status indicator. For instance, one beep could indicate that the next scheduled dose is within minutes while 3 beeps could indicate that the next scheduled dose is past due. The beeps can be repeated for a predetermined cyclical period. 
         [0030]    The electronics component  25  can be powered by removable or re-chargeable batteries. If re-chargeable, a power jack  55  can allow an external source to re-charge the internal batteries when a power cable is inserted into the power jack  55 . A data port can accept a data cable that would allow a wired transfer of data between the electronics component  25  and another device. This could be in addition to or in lieu of a wireless transmission mechanism. The data port can be a USB cable for instance but may also be adapted for other data formats as well. 
         [0031]    Referring to  FIG. 4 , a block diagram of the internal components of an example electronics component  25  is illustrated. A microcontroller  60  coordinates the activities of the remaining components. A pin trace contact interface  63  provides the mechanism to complete circuit(s) individually between the rest of the electronics component  25  and a plurality of blister packs wherein each blister pack can be individually associated with an electrical trace such that rupturing a blister pack will also break the electrical trace associated with the blister pack. Such an event can create a detectable change in electrical potential throughout the entire circuit that indicates the dispensing of a unit dose. There is an assumption that the unit dose is then ingested by a user as prescribed. 
         [0032]    The electronics component  25  can further comprise one or more of an RF module  61  and associated antenna  62 , one or more batteries  64 , a display  50 , a speaker  54 , LED indicator lights  51 - 53 , a power jack  55 , a data port  56 , and software applications with associated memory  65 . 
         [0033]    The software applications and associated memory  65  can be programmed to respond variously to the detection of a rupture blister package. The event can be recorded and date/time stamped as data and packed into a message format suitable for wireless transmission over the RF module  61 . The RF module  61  can include cellular protocols such as GSM or CDMA, or can be limited to more short range communication protocols such as Bluetooth, WiFI, or WiMax. Data can be received and/or sent between the electronics component  25  and one or more external devices utilizing the RF module  61  and a corresponding appropriate network. Or, the data can be sent out via the data port  56  which can be a USB cable or other suitable cable/data format pairing. 
         [0034]    As described earlier, the microcontroller  60  can include a clock element that knows the current date/time and, in conjunction with the software application(s)  65  that has been programmed with a dosage schedule, provides visual and/or audible alerts and reminders to the user via the LED indicators  51 - 53  or the speaker  54 . 
         [0035]      FIG. 5  illustrates one embodiment of an electronics seating hub and an electronics component. In this example, the electronics component  25  includes one or more tabs  26  that are somewhat hook shaped. One or more detents  27  can also be included on either side of the electronics component  25  to help keep it in place when mechanically coupled with the electronics seating hub component  24 . Also shown are a series of electrical trace contacts  28 . The electronics seating hub component  24  is comprised of a housing  29  having a corresponding number of inverted detents  31  on the interior surface that are positioned to correspond with detents  27  when the electronics component  25  is mechanically coupled with the electronics seating hub component  24 . The housing  29  further comprises electrical trace contacts  32  and one or more openings  30  that are adapted to receive the one or more tabs  26  such that the tabs  26 , when properly manipulated will fit through the openings  30  and seat the electronics component  25  securely in the electronics seating hub component  24 . To help achieve this, the housing  29  can include a cut out area  40  on the housing wall opposite the wall containing the openings  30 . The cut out area  40  allows the user to more easily grip the electronics component when inserting and removing it into the electronics seating hub component  24 . 
         [0036]    In operation, the electronics component  25  is tilted so that the tabs  26  can fit through the openings  30  of the electronics seating hub component  24 . The electronics component  25  can then be pivoted or rocked downward until the detents  27  and inverted detents  31  engage one another. This will also bring contacts  28  and contacts  32  into an operatively electrically coupled relationship and complete the circuitry contained on the slide card  20  and within the electronics component  25 . 
         [0037]    It should be noted that the orientation and placement of the contacts  28 ,  32 , tabs  26 , openings  30 , cut out areas  40  and detents  27 ,  31  described above can be design choices and are not limited to only the configuration shown. 
         [0038]      FIG. 6  illustrates another embodiment of an electronics seating hub and an electronics component. In this embodiment, the electronics seating hub component  24  is comprised of a rigid member  33  having opposing side members  41 ,  42  connected by an end member  43 . The side members  41 ,  42  include a dovetail  34  slot extending substantially the length of the side members  41 ,  42 . A plurality of electrical trace contacts  35  can be disposed on the interior surface of the end member  43 . 
         [0039]    The electrical component  25  includes a portion having a matching dovetail  36  pattern and electrical contacts  37  such that the electrical component can be slidably inserted into the electronics seating hub component  24  by aligning the matching dovetail portions. Upon full insertion of the electronics component  25  into the electronics seating hub component  24 , contacts  35  and  37  will contact one another to create an electrically coupled relationship. 
         [0040]    The coupling between the electronics seating hub component  24  and the electronics component  25  can be configured in other ways in addition to those described above. The embodiments described herein are not limited to merely the configurations described with reference to  FIGS. 5 and 6 . 
         [0041]      FIG. 7  is an exploded view of the various layers and components that comprise a slide card according to an embodiment of the disclosure. The slide card  20  starts as a reinforced blank that has been designed to receive one or more blister packs  79  comprised of individual unit doses  23 . The slide card  20  generally comprises a bottom panel  71  and a top panel  72 . The top panel  72  is designed to be folded over and sealed on top of the bottom panel  71 . Alternatively, the top  72  and bottom  71  panels can be separate from one another wherein the top panel  72  is positioned over the bottom panel  71  rather than folded into place. 
         [0042]    The bottom panel includes areas of weakness defined by perforations  74  such that sufficient force downward will cause the perforated area to tear leaving an opening in the bottom panel  71  capable of passing a unit dose. An electrical ink trace element  73  is applied to the bottom panel  71  such that each perforated area includes part of the electrical trace element  73 . The electrical trace element  73  terminates in an area reserved for an electrical seating hub component  24 . In addition, creases  77  allow for the slide card to be folded into another spatial dimension once the top panel  72  has been folded over the bottom panel  71 . There is space  78  reserved on the panel for additional traces and blister packs as desired. 
         [0043]    The top panel includes first cut out areas  75  for each individual unit dose  23  of blister pack  79 . A second cut out area  76  is designed to allow the electrical seating hub component  24  to protrude from the slide card  20  once assembled. A third cut out area  46  is designed to allow protruding element  45  to protrude from the slide card  20  once assembled. 
         [0044]    A locking mechanism  38  can also be included to provide enhanced child resistant functionality. The locking mechanism  38  is adapted to engage a first reciprocal catch  39  that is within the outer sleeve  10  shown in  FIG. 1 . To release the slide card locking mechanism  38 , a user would depress the release mechanism  16  shown in  FIG. 1 . 
         [0045]    Protruding element  45  also provides enhanced child resistant functionality in that it encounters electronics seating hub component  24  and electronics component  25  when a user tries to remove the top panel of the slide card  20 . This action is prevented because the protruding element can not be pulled over the electronics seating hub component  24  and electronics component  25 . 
         [0046]    The illustrated electrical traces  73  can be applied directly on the slide card  20 , in a manner well known by those skilled in the art. The electrical traces  73  can be printed on the slide card  20  using conventional printing or lithography methods such as but not limited to screen or off-set methods. The inks used in the printing method to form the circuitry are conductive inks, selected based on the performance needs of the individual circuits. Conductive inks typically include conductive metals such as but not limited to copper or silver. The ink used to form the illustrated electrical traces  73  can be a carbon-based conductive ink readily understood by those skilled in the art. 
         [0047]    The electronics component  25  is designed to be reusable with respect to multiple unit dose slide card inserts. Thus, the actual electronics component is not shipped with the unit dose slide card insert originally. Rather, a user is responsible for inserting the electronics component  25  into the electronics seating hub component  24  when receiving the unit dose packaging system. However, since the electronics component  25  itself aids in enhancing the child resistant aspect of the packaging, the original packaging can have a dummy electronics component already seated in the electronics seating hub component  24 . When a user receives the unit dose packaging system containing the dummy electronics component, he simply removes the dummy component and inserts the real electronics component  25 . 
         [0048]      FIG. 8  is a data flow diagram that describes a process for assembling a slide card such as that illustrated in  FIG. 7  according to an embodiment of the disclosure. The steps do not necessarily occur in chronological order. At  81 , electrical traces are printed on the blank in the desired pattern so as to ensure each unit dose has a portion of the electrical trace associated therewith. At  82 , the blank is then manipulated to contain all the creases, cut outs, and perforations required to accommodate the blister pack(s) and electronics seating hub component. At  83 , the blister pack(s) are adhered to the bottom panel of the blank such that each unit dose is substantially over a perforated area. At  84 , the electronics seating hub component is then adhered to the bottom panel such that the electrical trace terminations of the printed conductive ink are mated to corresponding electrical trace contacts in the electronics seating hub component. At  85 , the blank is then folded over and sealed according to the creases thereby encasing the blister pack(s) and electronics seating hub component firmly and immovably between the top and bottom panels of the slide card. 
         [0049]    As an alternative process for assembling a slide card, a blister pack and electronics seating hub component may be placed on the top panel, with the blister cavities and electronics seating hub component protruding through apertures in the top panel. These components may be adhered to the top card. The bottom panel would be folded over and the entire structure sealed at one time. 
         [0050]    It is believed that the present disclosure includes many other embodiments that may not be herein described in detail, but would nonetheless be appreciated by those skilled in the art from the disclosures made. Accordingly, this disclosure should not be read as being limited only to the foregoing examples or only to the designated preferred embodiments.