EP1926465A1

EP1926465A1 - Electronic compliance packaging systems and methods

Info

Publication number: EP1926465A1
Application number: EP06735164A
Authority: EP
Inventors: Timothy Freeze; Thomas R. Grinnan
Original assignee: Meadwestvaco Corp
Current assignee: WestRock MWV LLC
Priority date: 2005-02-17
Filing date: 2006-02-16
Publication date: 2008-06-04
Also published as: CA2598474A1; WO2006088979A1

Abstract

Taught herein is a package (150) for electronically monitoring the removal of items. An item is placed in the receiving chamber (160) of a tray (126). A circuit (156) is positioned across a gate (157) that spans the chamber (160). To access the item the user breaks the gate (157) which in turn breaks the circuit (156). The breaking of the circuit (156) is an event registered and stored by an electronic monitoring device (158) in communication with the circuit. The information stored on the monitoring device (158) may be directly viewed by the user through a display interface or communicated to a remote party for viewing.

Description

ELECTRONIC COMPLIANCE PACKAGING SYSTEMS AND METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to co-pending U.S. Provisional Application No. 60/653,903, filed on February 17, 2005, which is entirely incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to packaging systems and methods. More specifically, the present invention is directed to packages and package inserts that include electronic circuitry for monitoring, measuring, or recording an event, such as the time and date of dispensing, removing, delivering, or otherwise accessing a packaged item.

BACKGROUND OF THE INVENTION

[0003] Many patients have difficulty remembering to take their prescribed medications at the correct time or in the correct dosage. The primary problem created by this type of human error is two-fold. First, because the patient does not maintain the required regimen the purpose of the treatment is compromised. Second, because the patient does not maintain the required regimen he or she is very likely to misreport compliance; thus the treating physician receives inaccurate feedback. The frequent and unfortunate, if not deadly, result is that an otherwise accurate course of treatment fails because of a lack of compliance, or because subsequent professional decisions are based on misinformation.

[0004] Some solutions to this problem have been attempted through systems and methods for tracking the usage and delivery of medications in the form of tablets. For example, mechanical tablet dispensing systems are known and, more recently, pharmaceutical packages with electronic monitoring features have been developed. The known pharmaceutical packages with electronic compliance generally include a conventional blister pack used for dispensing unit doses such as tablets, pills, capsules, chewables, and the like.

[0005] Conventional pharmaceutical packages have shortcomings with regard to monitoring healthcare items other than unit doses, such as syringes, injectables, vials, parenteral medicants, ampoules, contact lenses, birth control devices and the like, or any part or combination thereof. For example, typical healthcare items are simply shipped to the user wrapped in a thin plastic covering, packed tightly, and positioned vertically in boxes. Further, the current packaging systems and methods do not provide a means for recording or measuring individual events, such as the time and date an item such as a healthcare device was accessed or removed from its package. Nor do the conventional packaging systems and methods provide the ability to gather real-time information from users so as to provide an easy method to poll users on certain issues, such as performance side effects, pain, nausea or other related matters. As such, the existing packaging systems do not integrate compliance measurement and patient interaction with a package holding a healthcare item.

[0006] Accordingly, and more broadly, there remains a need in the art for a packaging system and method for electronically tracking, monitoring, or recording the dispensing, accessing, delivering, removing, or using of a packaged item, which is easily adapted for use with standard manufacturing processes and package configurations. The need extends beyond healthcare to any industry and use that requires a regimen or supply or replacement of a product.

SUMMARY OF THE INVENTION

[0007] The present invention overcomes the deficiencies of the known art and the problems that remain unsolved by providing packaging systems and methods that include electronic circuitry for integrating compliance monitoring and user interaction, and can be easily integrated into standard manufacturing processes and packaging configurations.

[0008] In accordance with one embodiment of the present invention, there is provided an electronic compliance packaging system comprising a tray with at least one chamber for housing an item, a slide card with at least one access window corresponding to the chamber, a trace circuit, and an electronic module for receiving information regarding the circuit. The slide card is configured to receive the tray, and an outer sleeve is configured to receive the combined tray and slide card.

[0009] Regarding the embodiments described herein, as well as those covered by the claims, the electronic module may be attached to or include a transmitter that relays to another device the information received and collected. The other device may be in close proximity with the package, such as may be the case with a reader, cell phone, PDA, any variation of computer, or wireless transceiver that queries the electronic device for the stored information. Alternatively, the other device may be remotely located, such as may be the case with a computer in communication with a network such as the internet that receives and relays the information stored in the electronic module.

[0010] Further, regarding the embodiments described herein as well as those covered by the claims, the optional outer sleeve may or may not be lockable such that it provides a child-resistant feature. In addition, the embodiments described herein as well as those covered by the claims may or may not include a spill resistant feature.

[0011] In accordance with another embodiment of the present invention, there is provided an electronic compliance packaging system comprising a foldable blank with a tray receiving area and attached tray to form a slide card. The slide card includes a trace circuit and electronic module for receiving information regarding the trace circuit.

[0012] In another embodiment of the present invention, there is provided an electronic compliance packaging system comprising a foldable blank constructed to form an integral tray and slide card. The slide card includes a trace circuit and electronic module for receiving information regarding the trace circuit.

[0013] In another embodiment of the present invention, there is provided a method for packaging items comprising the steps of printing a trace circuit and placing an electronic monitoring device in communication with the trace circuit. Steps include loading a tray with an item and mounting or inserting the tray on or within the slide card. Additional steps include inserting the slide card within an outer sleeve.

[0014] In a further embodiment of the present invention, there is provided a method for packaging items comprising the steps of constructing a blank so as to form an integral tray and slide card, loading the tray with an item, printing a trace circuit, and placing an electronic monitoring device in communication with the trace circuit. In addition, this method may include the steps of folding the slide card to cover the stored item and inserting the slide card into an outer sleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is a perspective view of a tray and slide card, in accordance with an embodiment of the present invention.

[0016] FIG. 2 is a plan view of a trace configuration printed on a slide card or tray, in accordance with an embodiment of the present invention. [0017] FIG. 3A is a plan view of an outer sleeve blank, in accordance with an embodiment of the present invention.

[0018] FIG. 3B is a perspective view of the outer sleeve blank, of FIG. 3A_M shown assembled.

[0019] FIG. 4 is a perspective view of an electronic compliance package system, in accordance with an embodiment of the present invention.

[0020] FIG. 5 is a top view of a foldable blank including a tray receiving area, in accordance with an embodiment of the present invention.

[0021] FIG. 6 is a top view of an embodiment of a tray including a plurality of chambers for holding uniform items, in accordance with an embodiment of the present invention.

[0022] FIG. 7 is a top view of an embodiment of a tray including a plurality of chambers for holding non-uniform items, in accordance with an embodiment of the present invention.

[0023] FIG. 8 is a top view of an integral tray and slide card, in accordance with an embodiment of the present invention.

[0024] FIG. 9 is an exploded perspective view of an electronic compliance package system, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

[0025] As required, detailed embodiments of the present invention are disclosed herein. It must be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms, and combinations thereof. As used herein, the word "exemplary" is used expansively to refer to embodiments that serve as an illustration, specimen, model or pattern. 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 components, systems, 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 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.

[0026] For purposes of teaching and not limitation, the illustrated embodiments are directed to packages that hold healthcare items.

[0027] Referring now to the drawings, wherein like elements are represented by like numerals throughout, FIG. 1 shows an electronic compliance packaging system 10 according to an embodiment of the present invention. The packaging system 10 includes a tray 12. The illustrated tray 12 is configured to receive and store one or more healthcare items, such as injectables, syringes, ampoules, vials, tubes, or any other drug delivery device. Herein, the phrase "injectables" may comprise a plunger, barrel, and needle, or parts thereof, used by a medical professional to treat a patient with a pharmaceutical drug, or the patient to treat him or herself. Further "drug delivery devices" is used broadly to refer to all healthcare apparatuses and parts thereof used in conjunction with administering to or transferring substances into or out of a body, such as but not limited to a human being.

[0028] By way of example and not limitation, a "drug delivery device" comprises a substance in the form of, or contained within, pills, tablets, chewables, aerosols, inhalers, trans-dermal patches, suppositories, injectable devices, contact lenses, birth control devices, parts thereof, and the like.

[0029] For purposes of teaching and not limitation, the illustrated tray 12 is constructed and erected from a single paperboard blank configured to hold drug delivery devices in the form of an injectable, but those skilled in the art will immediately understand that the tray 12 may be configured to hold any portable item. Both the exterior and interior configurations of the tray 12 are merely design choices, for example, the tray 12 can be manufactured and fabricated in a variety of different lengths, widths or heights and can be constructed of plastic, paperboard, cardboard, foam, or any other suitable material. Further, the tray 12 may be vacuum formed, thermoformed, injection molded, or constructed and erected using any of a variety of manufacturing processes that are well known by those skilled in the art.

[0030] The tray 12 includes a plurality of chambers 14 for releasably receiving and housing one or more drug delivery devices. The chambers 14 may be configured in whatever shape, size, or dimension is required to store the device, and may include cushioning materials or locking features.

[0031] The packaging system 10 further includes a slide card 16. The illustrated slide card 16 includes a top panel 18 and a bottom panel 20, which are both attached to side panels 22, 24. The slide card 16 can be fabricated from any suitable material, including plastic, foam, paper, cardboard, paperboard, or combinations thereof and can be fabricated in any dimension of choice. The slide card 16 further includes one or more access windows 26. Each access window 26 is intended to align with a corresponding chamber 14. Accordingly, when the tray 12 is fully inserted within the slide card 16, each access window 26 is disposed over a corresponding chamber 14.

[0032] The slide card 16 also includes sealing tabs or gates 28, which may be integrally formed with the top member 18 or the gates 28 may be separately attached to the top panel 18 so as to cover a portion of each access window 26. The sealing tab 28 assists in preventing an article from falling out of the corresponding chamber 14, and provides the breaching means for monitoring access to the drug delivery device disposed within the corresponding chamber 14. The slide card 16 further includes a locking tab 30 and a catch flap 32. As will be described in detail below, the locking tab 30 is designed to engage with additional elements to provide a child-resistant locking feature. Further, the locking tab 30 is designed to engage the catch flap 32 to provide a slip-resistant feature. In alternative embodiments the sealing tabs 28 are mounted to or are integrated to the tray 12, and are configured to span the respective chambers 14.

[0033] Referring now to FIG. 2, there is shown the slide card 16 including a trace circuit 34 that comprises a plurality of individual conductive traces 38, and an electronic module receiving area 36 for mounting an electronic module (not shown). The trace circuit 34 is an active circuit that conducts an electrical signal for transmitting information to an electronic module. The illustrated trace circuit 34 is applied directly to the slide card 16, in a manner well known by those skilled in the art. In alternative embodiments, the trace circuit 34 is applied to the tray 12.

[0034] In the illustrated embodiment, the trace circuit 34 is printed using conventional printing or lithography methods, such as but not limited to screen or off-set methods and laser or ink jet methods. The inks used in the printing method to form the conductive traces 38 are conductive inks, selected based on performance needs. Conductive inks typically include conductive metals such as but not limited to copper or silver. One non- limiting example used in the present invention is a carbon-based conductive ink readily understood by those skilled in the art. It should be understood that the trace circuit 34 may also be printed onto a plastic film, paper, card or any other suitable non-conductive material. The film, paper or card is then separately attached to the slide card 16 or tray 12 by appropriate attaching means.

[0035] As best illustrated in FIG. 2, the configuration of the trace circuit 34 is based in part on the position of the access windows 26 and sealing tabs 28. Typically, each individual closed conductive trace 38 extends from and returns to the electronic module located at the electronic module receiving area 36. Each conductive trace 38 bridges both the individual chamber 14 and access window 26 via the sealing tabs 28. Thus, in practice, when a sealing tab 28 is removed or torn open the respective conductive trace 38 is broken, thereby opening the closed circuit associated with that corresponding chamber 14. Here, opening the closed circuit signals the removal of an item, and the event is captured and recorded by the electronic module. Individual conductive traces 38 may be as wide or as narrow as required by the voltage and resistance requirements of the embodiment in use; in the illustrated embodiments it is shown to widen the conductive traces 38 that lay over the individual access windows 26 in order to reduce or eliminate false readings. It is contemplated that individual conductive traces 38 can be configured to accommodate switches, controls, audible elements, light emitting devices, and similar components that enhance monitoring functions.

[0036] As will be understood by those skilled in the art, the electronic module captures, stores, and communicates information regarding the packaged items. By way of example and not limitation, the electronic module may be any device comprising hardware, software, firm ware, or any combination thereof, for capturing, storing, possibly manipulating, and then communicating information regarding the packaged items. Here, the captured information includes signals received from the trace circuit 34. The information may be stored by the electronic module until the electronic module communicates the stored information to a person or another device.

[0037] By way of illustration and not limitation, there are many methods by which the electronic module may communicate the stored information. Some methods include the following examples: Transmitting the information in response to a query from a device, such as a reader in close proximity to the package, is one known method of communicating. Further, beginning a transmission to a remote receiver via a linked transmitter located in the package, such as is found in a cellular phone, is another known method of communicating. Beginning a transmission to a remote receiver via a linked transmitter placed in communication with the electronic module, such as found in a Bluetooth device, is another known method of communicating. Removing the electronic module from the package and connecting it to another device for extracting stored information, is another method of communicating. Further, simply providing a display device readable by a user on the package is a known method of communicating the stored information. These methods, and others, may be used to communicate the stored information to a person or another device.

[0038] Referring now to FIGs. 3A and 3B, there is shown a blank 40 which is folded and assembled using conventional techniques so as to create an outer sleeve 42 for housing the slide card 16 and tray 12. The blank 40 may be fabricated from any suitable materials, including but not limited to plastic, foam, paper, cardboard, paperboard, or any combination thereof. The outer sleeve 42 should be designed to meet the physical dimensions and characteristics of both the tray 12 and the slide card 16. In the illustrated embodiments the outer sleeve 42 is configured to completely enclose the tray 12 and slide card 16 when inserted within the outer sleeve 42, but such a configuration is not a requirement.

[0039] An embodiment of the present invention may include a child-resistant locking feature, such as will now be described. The blank 40 includes a top panel 44 comprising a release button 46 and an internal edge 47, a bottom panel 48, and an inward panel 50 including a stop slot 52 for preventing the slide card 16 from slipping out of the outer sleeve 42. The outer sleeve 42 further includes finger access cutouts 54 for releasably removing the slide card 16 and tray 12 from within a receiving void 56. In the locked position, wherein the slide card 16 with tray 12 is fully inserted into the receiving void 56, the spring tension created by the compressed locking tab 30 causes the leading edge of the tab to cooperatively engage with the internal edge 47 created by the cut that defines the release button 46. With the locking tab 30 and internal edge 47 engaged, the slide card 16 is releasably locked within the void 56. This means for locking creates a child- resistant feature. To unlock the child resistant feature of this embodiment, and thereby access the slide card 16, the user depresses the release button 46 which disengages the locking tab 30 and internal edge 47. Other means for locking may be substituted that meet the child resistant features of the present invention.

[0040] In assembling the electronic compliance packaging system 10 illustrated in FIG. 4, a plurality of drug delivery devices are securely disposed within the chambers 14 and the tray 12 (not shown here) is inserted within the slide card 16. As noted earlier, the slide card 16 includes a catch flap 32 that engages the tray 12 to securely hold the tray 12 within the slide card 16. Other means for closing, including the gluing of end-flaps, may be used to secure the tray 12 within the card 16. Also as described earlier, the slide card 16 includes a plurality of access windows 26 and corresponding gates 28 formed in the top panel 18. When the tray 12 is inserted and secured within the slide card 16, each access window 26 and gate 28 is aligned and positioned over a corresponding individual chamber 14. Cutouts 54 permit a user to easily insert or remove the slide card 16 from the outer sleeve 42.

[0041] In operation of the illustrated embodiment, a user accesses a drug delivery device by pressing the release button 46 to unlock and slide the card 16 from the outer sleeve 42. Once the slide card 16 has been at least partially removed from the outer sleeve 42, the user tears open a gate 28. Upon tearing the gate 28 bridging an access window 26, the user breaks a corresponding conductive trace 38 (not shown) and breaches the chamber 14 bridge associated with the selected item. Breaking the respective conductive trace 38 in turn opens a circuit. Upon breaking the conductive trace 38 a signal is received, recorded, and stored by the electronic module as the event of accessing the drug delivery device. Indicia regarding that event, including time and day, date, sequence, purpose of access, medical condition prompting access, what medication is taken, the dosage of medication, or any number of event labeling indicia, may be programmed in the electronic module or in any device or devices in communication with the electronic module. Event-related indicia stored by the electronic module, or a device in communication with the electronic module, may be downloaded, uploaded, read, retrieved, printed, displayed, transmitted, or otherwise communicated to a microprocessor, PDA, computer, cellphone, display, printer, transmitter, receiver, or other suitable means for receiving indicia.

[0042] In an embodiment directed to a method for packaging items, that method comprises the steps of printing a trace circuit 34 on the slide used 16 or tray 12 and placing an electronic monitoring device in communication with the circuit 34. That method further includes the step of loading a tray with at least one of the items to be monitored. Additional steps of packaging include inserting the tray within the outer sleeve, and inserting the tray within a slide card and then releasably inserting the slide card into the outer sleeve. [0043] Turning now to FIG. 5, there is shown a partial packaging system in accordance with an embodiment of the present invention. The packaging system includes a slide card 100 comprising a blank 110 including a base panel 116, spine panel 118, top panel 120, and tab 122 having a leading edge 123. The respective panels 116, 118, 120 are defined by fold-lines 124a and 124b. Depending upon the material used to construct the blank 110, fold-lines 124a, 124b are formed by scores, cuts, bends, perforations, live hinges, formed hinges, and the like. As described in detail below, tab 122 may function as part of a means for locking and/or as part of a means for stopping, by cooperatively engaging with a first element to create a child- resistant feature and/or cooperatively engaging with a second element to create a spill- resistant feature.

[0044] Patient and healthcare provider information, such as dose compliance, warnings, and instructions in written form or digital form can be made easily visible or accessible to the user through the ample billboard space found on either side of the panels 116, 120, or tab 122 or any other suitable area on the slide card 100.

[0045] As shown, the blank 110 is configured to connectedly receive a tray 126, 128 (best shown in FIGs. 6 and 7) at a tray receiving area 129. It should be understood that although a tray 126, 128 may be separately attached to the tray receiving area 129, the blank 110 can be fabricated to form an integral tray 126, 128 and slide card 100 structure.

[0046] The blank 110 may comprise paper, paperboard, cardboard, plastic, or any combinations thereof. Further, the blank 110 may comprise paperboard, bleached sulphate, solid unbleached sulphate, or clay-coated newsback, all of which are well- known design choices. Typically, the paperboard coating is a fluid blend of materials, such as coating clay, calcium carbonate, and/or titanium dioxide with starch or adhesive smoothly applied to the traveling surface. Successive densification and polishing finish the mineral-coated surface to a superior, graphic-printable surface.

[0047] When the blank 110 and/or tray 126, 128 is paper, fabrication techniques well known to those skilled in the art, including vacuum forming, are contemplated. When the blank 110 and/or tray 126, 128 is plastic, fabrication techniques well known to those skilled in the art, including thermo-forming, injection molding, and the like, are contemplated. Where the blank 110 is plastic, the fold-lines 124a, 124b may be live hinges, or, as explained below regarding the engaging feature of the tab 122, fold-line 124b may be a formed hinge with an upwardly or downwardly extending profile to create an internal spring tension that urges the tab 122 back toward a relatively relaxed or horizontal orientation when the tab 122 is first folded over toward base panel 116.

[0048] Turning now to FIG. 6 and FIG. 7, there are shown two embodiments of preformed trays 126, 128, which together with the slide card 100 of FIG. 5 comprise partial embodiments of the present invention. Here, both trays 126, 128 are constructed of plastic, in the manner well known by those skilled in the art, and are configured to receive and hold various items of various shapes. Also, as understood by those skilled in the art, both the exterior and interior tray configurations are merely design choices. Here, for purposes of teaching and not limitation, the exterior of the illustrated trays 126, 128 are configured to be affixed to and within the tray receiving area 129 (best shown in FIG. 5), while the interior of the illustrated trays 126, 128 are configured to receive and store drug delivery devices. One drug delivery device illustrated is a vial 130 for holding a medicament in liquid form and another is a syringe 132 to be used in conjunction with the vial 130.

[0049] For purposes of illustration and not limitation, tray 126 is configured to receive and store items of substantially uniform shape and size, such as the illustrated syringe 132 comprising a plunger 134, barrel 136, finger guard 138, and needle 140. The tray 126 comprises a means for securing and holding the syringe 132, such as the plunger-receiving recess 142, barrel-receiving recess 144, and needle-receiving recess 146. The recesses 142, 144, 146 may be configured to lock in or otherwise secure the item by including a means for resisting removal such as fold-over locking flaps, indentations, straps, inserts, and the like (not shown). Accordingly, a means for holding and storing a drug delivery device includes a pre-formed tray 126, 128 that can be configured in a variety of ways.

[0050] Regarding the illustrated embodiments, in practice the trays 126, 128 are pre-formed separately and then affixed to the blank 110 at the tray receiving area 129, the location being merely a design choice. As noted earlier, an embodiment of the present invention may comprise a monolithically formed card/tray combination, where the blank 110 is an integral part of the tray 126, 128, the two components being formed as a blank during fabrication.

[0051] For purposes of illustration and not limitation, tray 128 is configured to receive and store items of substantially unique shapes and sizes, such as the vial 130 and syringe 132. Thus, tray 128 comprises a means for securing and holding the vial 130, such as the vial-receiving recess 148, and a means for securing and holding the syringe 132 as described immediately above. The recess 148 may be configured to lock in or otherwise secure the item by including a means for resisting removal such as fold-over locking flaps, indentations, straps, inserts, and the like (not shown). As understood by one skilled in the art, the various recesses illustrated herein may be configured to receive and store any portable items of any shape or size.

[0052] Referring now to FIG. 8, there is shown an embodiment of an electronic compliance package 150 according to the present invention. In this embodiment, the electronic compliance package includes a tray 126 attached to a tray receiving area 129 of the blank 110 so as to form a slide card 100. The slide card 100 includes a plurality of conductive traces 156 printed thereon, and an electronic module 158. Individual conductive traces 156 bridge each access window 160 of a slide card 100 and each individual chamber of the tray 126. As described above, when a user wishes to access a drug delivery device located within a chamber of the tray 126, the user breaks a corresponding conductive trace 156 by tearing open a sealing tab 157. The tearing of the tab 157 opens the trace circuit and transmits a signal to the electronic module 158, which receives and stores the information regarding the signal.

[0053] In alternative embodiments, the tray 126 may be covered with a trace circuit film. The term "trace circuit film" may comprise a trace circuit and chip that is applied to plastic, paper, dielectric foil, paperboard, cardboard, film, Tyvek® or any other suitable material. In one non-limiting example, the trace circuit may be directly printed on a plastic film material that is used to cover the items disposed within the tray 126. The plastic film material may include perforations that extend along the length of the edges of each chamber wall. The perforations allow an individual to tear or peel away the part of the plastic film area that covers a corresponding individual chamber of the tray 126. As noted above, the conductive traces 156 of the trace circuit are designed to bridge across each individual access window 160 of the slide card 100 and each individual corresponding chamber of the tray 126. When the plastic film is removed or torn open along the perforations, a respective conductive trace 156 is broken, thus, opening the trace circuit and transmitting a signal to the electronic module 158.

[0054] In another embodiment, the tray 126, 128 can be integrally formed with the blank 110 so as to form the package 150. The trace circuit including the conductive traces 156 may be added to or printed directly on the slide card 100 or tray 126, 128, and the conductive traces 156 and electronic module 158 may be added to or printed on a trace circuit film that is subsequently used to cover the items disposed within individual chambers of the tray 126, 128. It is contemplated that the trace circuit will be designed and engineered such that individual conductive traces bridge each so that when an item is removed from a chamber, a conductive trace is broken and an event item is recorded. Because the breaking of individual conductive traces 156 signals the removal of an item so as to capture and record an event, individual conductive traces 156 are positioned over each individual chamber within the tray 126, 128 so access to a chamber breaks open a circuit and an event is monitored and recorded.

[0055] Referring now to FIG. 9, there is shown an electronic compliance package 200 including a child-resistant feature in accordance with an embodiment of the present invention. The electronic compliance package 200 includes an outer sleeve 202 for receiving a slide card 204. The outer sleeve 202 includes a void 206 for receiving the slide card 204, an extension panel 208 and a release button 210. The outer sleeve 202 further includes a first engaging tab cutout 212 having an internal edge 214, a second engaging tab cutout (not shown) and finger access cutouts 216. As explained below, first engaging tab cutout 212 and engaging tab 218 together form an embodiment of a means for locking, while the folded extension panel 208 and engaging tab 218 together form an embodiment of a means for stopping.

[0056] Generally speaking, drug delivery devices such as syringes, injectables, ampoules, vials, or any combination thereof, are placed within corresponding chambers in a tray 220. The tray 220 is attached to or can be formed integrally with the slide card 204. Conductive traces 222 and an electronic monitoring device 224 are configured and positioned so that each individual conductive trace 222 bridges a corresponding chamber of the tray and is in communication with the monitoring device.

[0057] For purposes of teaching and not limitation, the following folding sequence is described. Top panel 226 is folded so as to cover the tray 220 and orient the spine panel 228 adjacent to a side of the tray. Tab 218 is folded inwardly so that the face of tab 218 is proximate to the face of base panel 230. With the slide card 204 folded as described, the slide card 204 is inserted into the void 206 of the outer sleeve 202, starting with the edge formed by fold-line 232 and with the tab 218 receivingly aligned with the release button 210. Once fully inserted, the slide card 204 is in a fully closed and locked position.

[0058] With continued reference to FIG. 9, and as understood by those skilled in the art, the locking feature includes release button 210, cutout 212, and cooperatively engaging tab 218. The spring tension created by the folded tab 218 causes the tab edge 234 to engage the internal edge 214 of cutout 212 at locking position A. With the tab 218 and the internal edge 214 engaged, the inner tray 220 is locked within the outer sleeve 202 and cannot be accessed. This means for locking creates a child-resistant feature. As illustrated, internal edge 214 has a semi-circular convex profile that engages well with the semi-circular convex profile of tab edge 234. To unlock the child- resistant feature of this embodiment and thereby access the tray 220, a user depresses the release button 210, which in turn depresses the tab 218 to disengage the tab edge 234 from the internal edge 214.

[0059] After releasing the optional child-resistant feature, the slide card 204 can be extracted from the outer sleeve 202 to a fully open position. In the illustrated embodiments, a fully open position occurs when the tab 218 engages the interior of folded extension panel 208 at stopping position B. As will be understood by those skilled in the art, the spring tension created by the folded tab 218 causes the tab 218 to engage the folded interior of the extension panel 208. Once engaged, the slide card 204 cannot be further removed from the outer sleeve 202 but may be re-inserted to a fully closed position if desired. In this manner, the tab 218 also acts as a spill-resistant feature to prevent the slide card 204 from being pulled completely out of the outer sleeve 202.

[0060] In operation, the user may open and close the electronic compliance package by withdrawing and replacing the slide card 204 within the outer sleeve 202 as often as desired. Regarding the illustrated embodiments, from the fully closed position, the user grasps the slide card 204 at the top panel 226 and bottom panel 230, adjacent to the spine panel 228, from the finger access cutouts 216. The user then depresses the release button 210 in order to disengage the means for locking. Continuing to depress the button 210 while grasping and pulling laterally will withdraw the tray 220 from the outer sleeve 202. From the fully open position the user may fold back the optional top panel 226 to access an item held in the tray 220. Removing a drug delivery device from a chamber within the tray 220 breaks open a conductive trace (not shown), thereby transmitting a signal to the electronic monitoring device (not shown). As described above, the signal creates an event item, such as, the time, date, month, and year the drug delivery device was accessed. Each time a drug delivery device is removed from a chamber within the tray 220, a corresponding conductive trace is broken and a signal is transmitted to an electronic monitoring device. After accessing the desired device, the user folds the top panel 226 back over the tray 220 and reinserts the slide card 204 within the outer sleeve 202 for future use. [0061] In an embodiment directed to a method for packaging items, that method comprises the steps of constructing a blank to form an integral tray and slide card. The method of packaging further includes the step of loading a tray with an item. The step of packaging further includes locating a trace circuit proximate to the tray and in communication with an electronic module or monitoring device. The step of packaging further includes folding the slide card in a manner to cover the tray, and releasably inserting the slide card into an outer sleeve.

[0062] It is contemplated that the present invention is not limited to healthcare related goods, but may also be applicable to delicate, sensitive or unique items as well. Some non-limiting examples include small electronic or mechanical components, jewelry, tobacco products, food, expensive, precious or rare articles, or any other article that requires storage and monitoring. Further, the embodiments of the present invention may be constructed without child-resistant or spill-resistant features

[0063] 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, modification, and combinations may be made to the above-described embodiments without departing form the scope of the claims. All such variations, modifications, and combinations are included herein by the scope of this disclosure and the following claims.

Claims

CLAIMSWhat is claimed is:

1. An electronic compliance packaging system, comprising: a tray including at least one chamber, wherein said at least one chamber is configured to receive at least one item; a circuit spanning said at least one chamber; and an electronic monitoring device in communication with said circuit.

2. The electronic compliance packaging system of claim 1 , further comprising a slide card adapted to receive said tray.

3. The electronic compliance packaging system of claim 2, wherein said slide card includes at least one access window corresponding to said at least one chamber.

4. The electronic compliance packaging system of claim 3, wherein at least one gate spans said at least one access window.

5. The electronic compliance packaging system of claim 1 , further comprising an outer sleeve for receiving said tray.

6. The electronic compliance packaging system of claim 5, wherein said outer sleeve includes a means for locking said tray to said outer sleeve.

7. The electronic compliance packaging system of claim 5, wherein said outer sleeve includes a means for stopping said tray from releasing from said outer sleeve.

8. An electronic compliance packaging system, comprising: a blank including a tray receiving area; a tray including at least one chamber, said tray attached to said tray receiving area so as to form a slide card, wherein said at least one chamber is configured to receive at least one item; a circuit spanning said at least one chamber; and an electronic monitoring device in communication with said trace circuit.

9. The electronic compliance packaging system of claim 8, wherein said slide card includes at least one access window corresponding to said at least one chamber.

10. The electronic compliance packaging system of claim 9, wherein at least one gate spans said at least one access window.

11. The electronic compliance packaging system of claim 8, further comprising an outer sleeve for receiving said slide card.

12. The electronic compliance packaging system of claim 11, wherein said outer sleeve includes a means for locking said tray to said outer sleeve.

13. The electronic compliance packaging system of claim 11, wherein said outer sleeve includes a means for stopping said tray from releasing from said outer sleeve.

14. An electronic compliance packaging system, comprising: a blank configured to form an integral tray and slide card, wherein said tray includes at least one chamber configured to receive at least one item; a circuit spanning said at least one chamber; and an electronic monitoring device in communication with said circuit.

15. The electronic compliance packaging system of claim 14, wherein said slide card includes at least one access window corresponding to said at least one chamber of said tray.

16. The electronic compliance packaging system of claim 15, wherein at least one gate spans said at least one access window.

17. The electronic compliance packaging system of claim 14, further comprising an outer sleeve for receiving said integral tray and slide card.

18. The electronic compliance packaging system of claim 17, wherein said outer sleeve includes a means for locking said integral tray and slide card to said outer sleeve.

19. The electronic compliance packaging system of claim 17, wherein said outer sleeve includes a means for stopping said integral tray and slide card from releasing from said outer sleeve.

20. A method for packaging items, said method comprising the steps of: inserting a tray including at least one chamber within a slide card including at least one access window; loading said at least one chamber with at least one item; positioning a circuit to span said at least one chamber; locating an electronic monitoring device in communication with said circuit; and inserting said slide card within an outer sleeve.

21. The method for packaging items of claim 20, wherein said circuit is printed onto a non-conductive material and attached to one of said tray and said slide card.

22. A method for packaging items, said method comprising the steps of: constructing a blank so as to form a slide card comprising a tray receiving area and at least one access window; attaching a tray including at least one chamber to said tray receiving area; loading said at least one chamber of said tray with at least one item; positioning a circuit to span said at least one access window; locating an electronic monitoring device in communication with said circuit; and inserting said slide card within an outer sleeve.

23. The method for packaging items of claim 22, wherein said circuit is printed onto a non-conductive material and attached to one of said tray and said slide card.

24. A method for packaging items, said method comprising the steps of: constructing a first blank to form a tray, said tray including at least one chamber; constructing a second blank to form a slide card, said slide card including at least one access window; loading said at least one chamber of said tray with at least one item; positioning a circuit to span said at least one access window of said slide card; locating an electronic monitoring device in communication with said circuit; and inserting said slide card within an outer sleeve.

25. The method for packaging items of claim 24, wherein said trace circuit is printed onto a non-conductive material and attached to said slide card.