WO2006023294A1

WO2006023294A1 - Package with failure-resistant conductive traces

Info

Publication number: WO2006023294A1
Application number: PCT/US2005/027870
Authority: WO
Inventors: Rune Haraldsson; Thanhhung Le
Original assignee: Meadwestvaco Corporation
Priority date: 2004-08-05
Filing date: 2005-08-04
Publication date: 2006-03-02

Abstract

Taught herein is a package with electronic circuitry for use in monitoring the removal of items. The package may be assembled with a plurality of cards, including a blister pack (20), a backing card (30), and a trace card (40). The blister pack includes at least one protruding receptacle (29) having an open side. The backing card includes at least one breachable gate (32), mated to the blister card such that the gate spans across the open side of the receptacle. The trace card includes at least one breachable gate (32), circuitry (42), and reinforcement of the circuit (70) at likely points of failure (24) mated to the backing card so that the gates are aligned. In another embodiment the package is formed from a single foldable panel rather than individual panels. In another embodiment the circuitry is applied directly to a package surface that includes at least one breachable gate or an operable flap.

Description

PACKAGE WITH FAILURE-RESISTANT CONDUCTIVE TRACES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to co-pending U.S. Provisional Application No. 60/598,965, filed on August 5, 2004, which claims priority to co-pending U.S. Provisional Application No. 60/537,297, filed on January 20, 2004, both of which are entirely incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to systems and methods used for electronically monitoring the dispensing, accessing, delivering, or using of packaged items. More specifically, the present invention is directed to improving the performance of circuits used in electronic compliance packaging. The embodiments illustrated are pharmaceutical packages that include electronic circuitry for use with an electronic monitoring device.

BACKGROUND OF THE INVENTION

[0003] With regard to packages that incorporate electronic monitoring features, it is known to construct an apparatus for dispensing items from a uniquely-shaped, single, foldable sheet that includes an internal electronic circuit. Further, it is known to construct a multi-layer protective seal which likewise includes an internal electronic circuit. Although the known devices create unique packages and provide certain features, they do not provide solutions that can be cost- effectively integrated into standard manufacturing processes or used together with existing package configurations.

[0004] In addition, the known devices do not provide for an economical structure or method of reinforcing the conductive traces against stresses that occur during shipping or use. [0005] Accordingly, there remains in the art a need for a system and method for electronically monitoring the dispensing of packaged items, particularly small items such as but not limited to medications in pharmaceutical packages, that are easily adapted for use with standard manufacturing processes, easily integrated into existing package configurations, and provide reinforcement against stresses that adversely affect the performance of the conductive traces.

SUMMARY OF THE INVENTION

[0006] The present invention overcomes the deficiencies of the known art and the problems that remain unsolved by providing internal surface areas such as fold-over cards, insertable cards, and package surfaces with conductive traces or circuitry, that may be easily integrated into existing manufacturing processes and package configurations to provide electronic monitoring functionality. The conductive traces, whether positioned on a separate surface to be used with a package or applied directly to the package surface, is enhanced to provide failure-resistant conductive traces.

[0007] One component of an illustrated embodiment is a fold-over card. This fold-over card includes an array of open cells. Another component of an illustrated embodiment is a blister card. This blister card includes an array of receptacles with open sides for receiving items. A third component of an illustrated embodiment is a backing card that includes an array of breachable closed cells or gates. After the items are deposited into the receptacles, the backing card is positioned to capture the items and seal the open side of the receptacles. A subsequent component of this embodiment is a trace card comprising an array of breachable closed cells or gates, and conductive trace circuitry that spans these closed cells and is in communication with an electronic monitoring device. This embodiment may be folded from a single sheet of substrate or layered with individual substrates, or a combination thereof. Here the circuitry is printed on the substrate using conductive inks and conventional printing methods.

[0008] In assembling the above-referenced cards, the gates of the trace card are aligned with the gates of the backing card, or the receptacles in the absence of a backing card, to facilitate access to the items. To access the items the user exerts sufficient force on the item from a pliable end of the receptacle, the item is pushed through the first gate, whether the first gate is located on a fold-over card or backing card. The user continues to push the item until it breaches the circuit spanning the related gate of the trace card. Upon breaching the cell bridge and related gate, the related closed circuit is broken. The information about breaking of the circuit is received and stored by an electronic monitoring device as the event of accessing the item.

[0009] The unintentional breaking of the circuit, such as may occur by the repeated folding and unfolding of a package flap that the circuit crosses, is prevented by providing means for a failure-resistant conductive trace at the location of the possible unintentional break. Means for a failure-resistant conductive trace include non-conductive and somewhat flexible materials that bridge a precarious characteristic of a package such as a gap, offset, ridge, crease, fold, score line, perforation line, lap, and foldable lines or creases of any kind, to provide reinforcement to the conductive trace spanning that characteristic. Such means for failure-resistant conductive trace include non-conductive and somewhat flexible or elastic materials including elastomers, adhesive tapes, polymers, and dielectric layers such as additional ink layer(s) disposed above and/or under the conductive trace at the precarious characteristic. It will be understood that the entire trace substrate may be considered precarious, such as when the entire substrate is very flexible, and therefore the entire substrate may receive reinforcement to provide for a failure- resistant conductive trace circuit. [0010] Additional embodiments are contemplated and taught herein. One embodiment comprises a combined fold-over and blister card, together with a backing card and a trace card. Another embodiment comprises a combined blister and backing card, together with a trace card. Yet another embodiment comprises a fold-over card, a blister card, a foil backing, and a trace card with a dielectric overlay. Additional embodiments include various combinations of single sheet, foldable, multi-panel cards - separately or in combination with single sheet single panel cards - that may be arranged to function as taught herein. Examples include a wallet-style fold- over card for use of and by itself, or for use with an outer sleeve.

[0011] Further embodiments include means for failure-resistant conduct trace on one or more surfaces of a package comprising a breachable gate configured to receive conductive trace, wherein the gate is near or adjacent to an item to be accessed. Further embodiments include reinforcement spanning a precarious location associated with any package, which supports and/or protects the conductive trace.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 is an exploded view of an embodiment according to the present invention.

[0013] FIG. 2 is an exploded view of an embodiment according to the present invention.

[0014] FIG. 3 is a plan view of the circuitry of FIG. 1 and FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

[0015] Generally speaking, the systems and methods described herein are directed to providing for electric monitoring of an item from a defined location, such as an enclosed package. By applying what is taught herein to existing package configurations or package assembly methods, it is easy to provide a package that includes a circuit comprising failure resistant conductive trace. [0016] As required, embodiments of the present invention are disclosed herein. However, it is to 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. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention. For purposes of teaching and not limitation, the illustrated embodiments are directed to blister packs held in pharmaceutical packages. It will be understood that the concepts taught and claimed by the present invention are applicable to an unlimited array of items in any package configuration.

[0017] Referring now to the drawings wherein like elements are represented by like numerals, FIG. 1 illustrates an exploded view of an exemplary package with Failure-Resistant Conductive Traces ("FRCT") 10, configured for use with the dispensing of medications from a blister pack.

[0018] One component of this FRCT package 10 is a punched fold-over card 20. Typically a fold-over card is a substrate constructed of inexpensive disposable sheet-like material such as paper, paperboard, cardboard, plastic, or any combination thereof. This fold-over card 20 includes an array of open cells 22, formed by a prior pre-assembly step, such as cutting, punching, scoring, or forming, depending on the material used. The illustrated fold-over card 20 further includes score lines 24 to facilitate folding and unfolding, and a locking tab 26.

[0019] Another component of this FRCT package 10 is a blister pack 28. This blister pack 28 includes an array of blister cells 29. Typically, a blister pack 28 is thermo-formed from a plastic-type material to create blister cells 29— pliable protruding (concave when viewed from side A of the blister pack) receptacles for receiving and storing items (not shown) to be accessed by a user. The actual configuration of the blister packs 28 and materials used are merely design choices.

[0020] Following an exemplary assembly process of a pharmaceutical manufacturer, side B of the blister pack 28 is receivingly mated to side C of the fold-over card 20 so that each blister cell 29 is aligned with and nested within a respective open cell 22. In this configuration the blister cells 29 are ready to receive the items. Of course, side A of the blister pack 28 may be mated with side D of the fold-over card 20 so that each blister cell 29 is aligned with a respective open cell 22 and ready to receive the items. The order of assembling the blister pack 28 does not determine when the items are deposited into the blister cells 29. Accordingly the manufacturer does not need to alter its assembly process with regard to the present invention.

[0021] Another component of this FRCT package 10 is a backing card 30. This backing card 30 includes an array of closed cells or gates 32, which are best described as locations designed to facilitate breaching a card by pushing through a perforated or scored cell gate. Here the backing card 30 is constructed of non-conductive material. After the items are deposited into the blister cells 29, the backing card 30 is attached to the fold-over card 20 in a manner that captures the items and seals the blister cells 29. The backing card 30 may perform additional functions including displaying graphics, providing structural support, and insulating against the electronic circuit described below, hi the illustrated embodiment the backing card 30 is attached to side A of the blister pack 28 and/or side C of the fold-over card 20. For the reasons explained below, each closed cell 32 should be aligned with a respective blister cell 29. In other embodiments the fold-over card 20 and backing card 30 may be formed from a single foldable panel. [0022] It may be, because of design criteria or the nature of the items being packaged and monitored, that the fold-over card 20 and backing card 30 may be combined to perform the same functions. For example, in the illustrated embodiment the open cells 22 may be replaced with closed cells 32 and side A of the blister pack 28 may be attached directly to side D of the fold- over card 20 after the items are deposited into the blister cells 29. Alternatively the blister pack 28 may be configured to resemble the fold-over card 20 and attached directly to the backing card 30, after the items are deposited into the blister cells 29, such that each blister cell 29 is aligned with a respective closed cell 32.

[0023] A subsequent component of this FRCT package 10 is a trace card 40 comprising an array of closed cells 32 and conductive trace or circuitry 42. Here the trace card 40 substrate is a non-conductive material such as but not limited to paper, paperboard, cardboard, plastic, or any combination thereof. Here also, by way of illustration and not limitation, the configuration of the trace card 40 mimics the configuration of the fold-over card 20 or backing card 30. It is contemplated that the configuration of the trace card 40 is merely a design choice selected to best fit with new or existing packages or package manufacturing processes.

[0024] In some embodiments a FRCT package is a wallet style fold-over card comprising a conventional blister pack and conductive trace, with or without an outer sleeve, hi other embodiments the fold-over card 20 and trace card 40 may be formed from a single foldable panel, hi other embodiments the trace card 40 is a surface of a package, such as the interior, bottom, top, or sidewalls of a cardboard box.

[0025] Here the conductive trace or circuitry 42 is printed on the trace card 40 using conventional printing or lithography methods such as but not limited to screen or offset methods. The inks used in the printing method to form the circuitry 42 are conductive inks, selected based on the performance needs of the individual circuits 44. Conductive inks typically include conductive metals such as but not limited to copper or silver. Here the ink used to form the illustrated circuitry 42 is a carbon-based conductive ink.

[0026] As best illustrated in FIG. 3, the configuration of the circuitry 42 is likewise a design choice which, in the illustrated embodiments, is based at least in part on the positions of the cells 29, 32. As is shown in FIG. 3, each individual, closed circuit 44 typically extends from and returns to an electronic monitoring device (EMD, not shown) located at an electronic monitoring receiving area 46 and bridges a closed cell 32. In practice, when a closed cell 32 of the trace card 40 is opened as described below, the respective circuit 44 is broken. Here the breaking of a circuit 44 signals the removal of an item, an event that is captured and recorded by the EMD. It is contemplated that individual circuits 44 may be configured to accommodate switches, controls, and similar components that enhance monitoring functions. In other embodiments the trace card 40 is a wall of a package and the opening of a gate 32, or an operable flap, permits access to an item located in within the package.

[0027] Individual circuits 44 may be as wide or as narrow as required by the voltage and resistance requirements of the embodiment in use, and in the illustrated embodiments it is shown to widen the circuitry 42 over cells 32 and score lines 24 to reduce or eliminate false readings. Accordingly, the circuitry 42 comprises cell bridges 48 and score line bridges 50. Additional structural enhancements for eliminating false readings are described below.

[0028] In assembling the FRCT package 10 illustrated herein, the gates 32 of the trace card 40 are aligned with the gates 32 of the backing card 30 (or the blister cells 29, in the absence of a closed cell backing card), to facilitate access to the items. To access the item, the user breaches the cell bridge 48 associated with the selected item. Here, upon exerting sufficient force on the item from the outside surface of the blister cell 29, the item is pushed through the first gate 32, whether the first gate 32 is located on the fold-over card 20 or backing card 30. The user continues to push the item until it breaches the cell bridge 48 spanning the related gate 32 of the trace card 40. Regarding embodiments wherein the conductive trace is positioned on a surface or wall of a package, the gate 32 may be broken first and then the item removed. This is a useful configuration when it is undesirable to push the item through the gate 32.

[0029] Upon breaching the cell bridge 48 and related gate 32, the related closed circuit 44 is broken. The event of breaking the circuit 44 is information that is received and stored by the EMD as the event of accessing the item. Indicia regarding that event, including time of day, date, sequence, or any number of event-labeling indicia, as programmed in the EMD or devices in communication with EMD, may also be recorded and stored by the EMD. The event-related indicia stored by the EMD may be read, retrieved, or transmitted by the EMD in a manner understood by those skilled in the art.

[0030] In an exemplary method of operation, the EMD continuously or periodically sends a signal to each cell bridge 48. If an item has been removed, the resistance of an individual circuit will be high as the gate 32 and the conductive material have been removed. Thus little or no electrical signal will be returned to the EMD via the ground region 52. If the EMD is programmed with specific resistance levels, then the EMD can determine if an item has been removed from the FRCT package 10 by measuring the resistance level of a particular circuit 44. By keeping track of which items have been removed, the EMD can monitor and detect each successive removal. The EMD could also record the time and store it to a memory unit or transmit it to an external device (not illustrated). It is to be understood that the above description is but one of many ways to program and monitor the contents of the FRCT 10. [0031] The embodiment illustrated in FIG. 1 is described as being constructed of materials and by methods common to the industry example provided. The advantages of constructing embodiments with inexpensive materials and by manufacturing methods commonly used by the respective industry are readily apparent and do not require further explanation. Likewise, producing a system with a look and feel readily familiar to most consumers provides known advantages. Accordingly, the use of insertable cards 20, 30, 40 to provide flexibility to an existing package configuration, or the use of an existing package, is another advantage of the present invention.

[0032] For example, after assembly the FRCT package 10 may be combined with the outer sleeve taught in U.S. Patents 6,412,636, 6,230,893, and 6,047,829, assigned to the present applicant, by folding and inserting the FRCT package 10 into the outer sleeve as taught by those patents. Alternatively, the circuitry 42 and an EMD may be attached to or combined with the inner slide card taught by those patents. Thereafter, the unit dose packaging system taught there, like any package configuration that includes an embodiment of the conductive trace, is enabled to electronically monitor the dispensing, accessing, delivering, or using of the packaged items.

[0033] Optional embodiments of the FRCT package that do not include an outer sleeve may not require a locking tab 26, or may require appendages that engage elements of related packaging for various purposes, such as providing child-resistant features.

[0034] With regard to FIG. 2, in the healthcare industry it is known to use foil guard technology to seal and protect pharmaceuticals delivered in blister packs 28. Applying the teachings of the present invention to the illustrated FRCT 60, there is shown a blister card 28 for receiving tablets (not shown) configured to receive a protective film of foil 62 that seals the blister cells 29 by being positioned immediately adjacent to side A of the blister pack 28 and/or side C of the fold-over card 20.

[0035] Integrating the trace card 40 into the known foil guard technology requires only minor enhancement to the circuitry 42. It is known that foil 62 is conductive and the circuitry 42 is conductive. As shown in FIG. 3, to eliminate electrical interference between the foil 62 and circuitry 42 with minimal impact on the present standard foil guard manufacturing process, a dielectric circuit overlay 64 is provided, m the illustrated embodiment, the dielectric circuit overlay 64 is a non-conductive ink printed directly over the conductive printed circuitry 42 using the printing processes referenced herein. It will be understood that the overlay 64 may exactly follow and cover each circuit 44 and components 48, 50, or more broadly cover the circuit side of the trace card 40 where non-conductivity between the circuitry 42 and foil 62 is desired. It will be further understood that the overlay 64 may be any non-conductive covering, whether inks, plastics, resins, or insulators of any material convenient to the manufacturer that provides a sufficient dielectric barrier between the foil 62 and circuitry 42.

[0036] By adding the trace card 40 with its circuitry 42 and dielectric circuit overlay 64 to the standard foil guard technology manufacturing process, possibly as a last step or an outsourced step, the pharmaceutical manufacturer can add monitoring and compliance functions with minimum impact to its existing processes.

[0037] The embodiments taught herein are directed to single-use disposable packing; however, such embodiments are not a limitation as reusable packing is contemplated. For example, the blister cells 29 illustrated may be constructed of a durable latex, and the backing card 30 illustrated may be constructed of a rigid metal or plastic with closed cells 32 that permit repeated access, such as are available with a hinged or replaceable friction-fit gate. [0038] In practice, the user will access the items a number of times during the usable life of the package. It is contemplated that each time the user attempts to access the items, he or she must first unfold the package, extract the desired item, and refold and re-secure the package in preparation for the next use. Score lines 24 are provided to facilitate the expected and repeated cycle of unfolding and folding.

[0039] As will be understood by one skilled in the art, the cycle of folding and unfolding the package will stress the circuitry 42 on the trace card 40. One result of this stress may be the cracking of the conductive trace, which may result in the breaking of a circuit 44. The breaking of a circuit by removing an item, as explained above, is an event that is captured and recorded by the EMD. Because it is the recording of an intentional breaking of a circuit by removing an item that is of interest, rather than a false recording that is the result of an unintentional breaking of a circuit, aspects of the present invention seek to prevent the unintentional breaking of a circuit by providing a means for a failure-resistant conductive trace.

[0040] Means for a failure-resistant conductive trace include strengthening the circuitry at those locations most susceptible to stresses, such as a weak line. A weak line includes gaps, offsets, creases, ridges, folds, score lines, laps between adjacent panels, the hinge edge of an operable flap, corners, and similar obstacles in the trace substrate that may interfere with the reliability of the conductive trace. Methods and structures for strengthening the circuitry 42, best illustrated by the non-conductive trace reinforcement 70 shown in FIGS. 1 and 2, include by way of illustration and not limitation: non-conductive and at least somewhat flexible or elastic materials including elastomers, adhesive tapes, polymers, and dielectric layers, such as a non- conductive ink layer 64, disposed above and/or under the circuitry 42 at the obstacle. [0041] It is contemplated that the non-conductive trace reinforcement 70 may be positioned in any number of orientations including transversely with respect to the individual circuits 44 and parallel to the weak lines 24, or parallel to the individual circuit 44 and transverse to the weak lines 24. It is also contemplated that means for non-conductive trace reinforcement 70 may be positioned over part or over all of the trace substrate 40.

[0042] 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. AU such variations, modifications, and combinations are included herein by the scope of this disclosure and the following claims.

Claims

We claim:

1. A system for providing failure-resistant conductive traces, comprising: a substrate having a surface suitable for receiving an electronic circuit;

a weak line integral to said surface;

an electronic circuit comprising conductive traces applied to said surface, wherein at least a portion of said circuit spans said weak line; and

a non-conductive trace reinforcement attached to said surface contiguous to said span and said portion.

2. The system of claim 1, wherein said substrate is foldable.

3. The system of claim 1, wherein said weak line is a fold line.

4. The system of claim 1, further including an electronic device receiving area in communication with said circuit.

5. The system of claim 4, further including an electronic device mounted to said receiving area.

6. The system of claim 1, wherein said reinforcement is at least partially flexible or elastic.

7. The method of claim 1, wherein said weak line is a characteristic selected from a group of obstacles consisting of: gaps, creases, ridges, folds, fold lines, score lines, laps, corners, hinges, and offsets.

8. The method of claim 1, wherein said non-conductive trace reinforcement is selected from a group of at least partially flexible materials consisting of: adhesive tapes, dielectric layers, elastomers, and polymers.

9. A method for providing an electronic compliance package, comprising:

providing a package comprising at least one inner surfaces and at least one weak line;

applying a conductive trace circuit to said inner surface;

crossing said weak line with a least a portion of said circuit; and

attaching a non-conductive trace reinforcement to said weak line contiguous to said circuit portion.

10. The method of claim 9, wherein said weak line is a characteristic selected from a group of obstacles consisting of: gaps, creases, ridges, folds, fold lines, score lines, laps, corners, hinges, and offsets.

11. The method of claim 9, wherein said non-conductive trace reinforcement is selected from a group of at least partially flexible materials consisting of: adhesive tapes, dielectric layers, elastomers, and polymers.

12. The method of claim 9, further comprising providing an electronic device configured to monitor access to articles held within said package.

13. The method of claim 12, furthering comprising connecting said device to said circuit.