Patent Application
20090194434
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
a and 2b illustrate views of the slide card.
Referring to
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.
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.
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.
Referring to
When folded, the slide card 20 forms two opposed panels each capable of containing blister packs 23. In
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,
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.
Referring to
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.
Referring to
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.
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.
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.
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.
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.
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.
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
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.
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.
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
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.
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.
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.
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.
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.
