Reconfigurable smart packaging

Abstract

A smart box capable of monitoring blister cards having a range of formats is presented. The smart box includes a sensor system capable of detecting changes in the cover film and / or contents of a blister card at substantially any position within the lateral extent of the blister card. In some embodiments, an adapter is included that enables any of a group of blister cards having different configurations (e.g., number of reservoirs, size, shape, and / or spacing between reservoirs) to be installed in the same smart box. In some embodiments, the adapter includes a wall that mitigates crosstalk between adjacent reservoirs and sensors. A sensor system according to the present disclosure provides at least one signal for each reservoir on each blister card in the group of blister cards. In some embodiments, the sensor system has a detector element density that is at least equal to the highest reservoir density in any blister card in the group of blister cards.

Description

[0001] CROSS REFERENCE TO RELATED APPLICATIONS

[0002] The following cases are also incorporated herein by reference:

[0003] i. U.S. Patent Application No. 16 / 156,603 filed on October 10, 2018 (Attorney Docket No. 3005-008US1) (hereinafter referred to as the "'603 Application");

[0004] ii. U.S. Patent Application No. 14 / 879,874 filed on October 9, 2015 (Attorney Docket No. 3005-002US1) (hereinafter referred to as the "'874 Application");

[0005] iii. U.S. Patent Application No. 15 / 170,121 filed on June 1, 2016 (Attorney Docket No. 3005-002US2) (hereinafter referred to as the "'121 Application");

[0006] iv. U.S. Patent Application No. 15 / 223,779, filed on July 29, 2016 (Attorney Docket No. 3005-004US1) (hereinafter referred to as the "'779 Application"); and

[0007] v. U.S. patent application Ser. No. 16 / 333,021, filed on Mar. 13, 2019 (Attorney Docket No. 3005-006US1) (hereinafter “the '021 Application”).

[0008] If there is any contradiction or inconsistency in the language between this application and any of the cases incorporated by reference that might affect the interpretation of the claims in this case, the claims in this application should be interpreted consistent with the language in this application. Technical Field

[0009] The present disclosure relates generally to packaging, and more particularly, to smart packaging. Background Art

[0010] Worldwide, healthcare expectations and expenditures are growing. There is a strong desire to find ways to improve healthcare outcomes and reduce healthcare costs. Improving medication adherence (i.e., dosing regimen compliance) is a strategy that promises to improve outcomes and reduce healthcare costs. The reason is that, in order to be effective, prescription and over-the-counter drugs (aka medicines) require good adherence to a specific dosing regimen—taking the correct dose at the correct time (dosing window) at the correct frequency (dosing interval) for the prescribed duration.

[0011] Unfortunately, nonadherence to dosing regimens is common and results in costly problems in many ways, from increased healthcare costs to economic losses to the pharmaceutical industry to severe negative human impacts. When patient compliance is poor, efficient recovery is less likely, which prolongs recovery duration and may require additional interventions. As a result, treatment outcomes are compromised and healthcare costs increase.

[0012] A major part of healthcare costs is attributed to the treatment of chronic diseases. Chronic diseases are diseases that last longer than three months. They cannot be prevented by vaccination, nor do they go away on their own or be cured by medication. Therefore, treatment usually addresses the symptoms to relieve the patient's discomfort. Examples of chronic diseases include cardiovascular disease, cancer, diabetes, epilepsy and seizures, obesity, depression, schizophrenia, asthma, and chronic obstructive pulmonary disease (COPD), among others. Chronic diseases often lead to complications, for example, obese people may develop high blood pressure, diabetes, etc.

[0013] Chronic diseases are prevalent, especially among older populations. Nearly half of Americans have at least one chronic disease, and at least half of them have two or more. As a result, chronic diseases account for approximately 75% of total U.S. health care spending, which was $3.5 trillion in 2017. Trends are broadly similar around the world.

[0014] It is common for patients, especially those with chronic conditions, to take more than one medication—some patients even take more than a dozen. Many of these medications require multiple doses per day. For example, a patient taking medications A, B, C, D, E, and F must: (i) take A and C four times per day, i.e., morning, noon, evening, and night; (ii) take B every other day; (iii) take D and E in the morning and evening; and (iv) take F at noon. It is clear, therefore, that managing compliance with such a dosing regimen is challenging. This challenge increases with the number of medications and their corresponding dosing regimen variations.

[0015] One way to improve compliance is to package patient medications by dose, with instructions for when and how many doses to take. One conventional packaging solution uses blister cards, where each blister on the card contains medication for each dosing window. These blister cards tend to be larger than blister cards for a single medication because the blisters must be large enough to accommodate multiple medications per dose. In addition, such blister cards tend to be configured in a weekly format, e.g., a 7×4 blister array.

[0016] Another conventional method for improving drug compliance adopts "reminders" that can be automated and delivered in the form of alarms, text messages, calls and / or emails. Typically, a mobile device (typically a smart phone or tablet computer) running mobile application software is used as a user interface for receiving such notifications. Alternatively, the drug can be placed in a box / container / package incorporated into an electronic device for tracking compliance and sending audio / video notifications. In some cases, the box / container / package is wirelessly linked to the mobile device and notifications are provided to the user via the mobile device, on the container / package, or both. Methods such as the above method are generally referred to as "smart packaging". Summary of the invention

[0017] The present disclosure teaches systems and methods that facilitate tracking compliance with medication dosing regimens through connected smart packaging.Smart boxes according to the present disclosure are particularly suitable for use with medications provided in blister cards, multi-dose blister cards, and the like.

[0018] As with smart boxes known in the prior art, the smart box according to the present invention includes a sensor system that can monitor the status of the covering film and / or the contents in the reservoirs of the blister card; however, the prior art sensor system is configured to monitor specific blister cards having a specific configuration (e.g., reservoir size, shape and / or spacing between reservoirs).

[0019] In sharp contrast to the prior art, a smart box according to the present disclosure includes a sensor system that can be used to monitor multiple blister cards with different configurations. An embodiment according to the present disclosure includes multiple adapters, each of which can be installed in the same smart box to enable it to accept any one of a group of blister cards with different configurations. In some embodiments, the adapter is an annular frame with a uniform outer shape and size and an inner ring based on the lateral range of different blister cards in the group of blister cards. In some embodiments, some of the adapters include a grid of walls arranged to surround each blister on a corresponding blister card in the group of blister cards to securely position and hold the blister card in the smart box. In addition, in some embodiments, the wall is also used to reduce optical crosstalk between adjacent storage tanks and sensor elements.

[0020] The illustrative embodiment is a smart box including a housing, which includes an electronic module and a detection module. The electronic module includes electronic circuitry for interfacing with a sensor system to monitor a blister card and communication circuitry for communicating with an external device, such as a mobile phone, and for other electronic functions. The detection module includes a receiver and a sensor system.

[0021] The receiver includes a base, an adapter, and a frame, wherein the base supports the adapter and blister card, the adapter positions the blister card, and the frame secures the blister card and adapter against the base. The adapter includes a grid of walls defining cells that substantially match the three-dimensional shape of the reservoirs of the blister card so that the blisters of the blister card removably "nest" in the cells. The walls also serve as light barriers that mitigate optical crosstalk between adjacent reservoirs and the sensor element.

[0022] In an illustrative embodiment, the sensor system includes a plurality of photodiodes arranged in an array on a substrate residing between the base and the adapter. The photodiode array is configured such that at least one photodiode is positioned below each reservoir. Thus, when the capping film of a reservoir is removed and its contents are dispensed, its corresponding photodiode will detect light transmitted through the reservoir and generate an output signal indicating that the contents have been dispensed.

[0023] In some embodiments, the smart box includes a plurality of adapters, each adapter having an inner ring adapted for a different blister card in a set of blister cards. In some embodiments, each adapter includes a grid of walls and cells, wherein each arrangement matches the configuration of a different blister card in a set of blister cards. In some embodiments, the sensor system includes a photodiode array having a density equal to or greater than the highest reservoir density of the reservoirs of a set of blister cards operable by the smart box.

[0024] In some embodiments, the adapter includes a wall containing electrodes defining a sensor system, wherein the electrodes are operable to monitor the contents of each reservoir via electrical capacitance tomography.

[0025] In some embodiments, the sensor system includes a focal plane array that can provide the position of any light incident thereon.Thus, the focal plane array is capable of monitoring the status of a blister card having any configuration.

[0026] In some embodiments, the sensor system includes a plurality of connectors electrically coupleable to a conductive lidding film of a blister card, wherein the connectors enable monitoring of the state of the lidding film via tomography techniques such as electrical resistance tomography (ERT) and electrical impedance tomography (EIT).

[0027] According to an embodiment of the present disclosure, a smart box (500) is provided for monitoring the status of a first blister card (122), wherein the first blister card comprises a first plurality of blisters (210) and a first cover film (204) having a first plurality of dispensing areas (212), wherein the first plurality of blisters (210) and the first plurality of dispensing areas jointly define a first plurality of reservoirs (208) containing a first content (208), wherein the first plurality of blisters jointly define a first blister area (218), and wherein the smart box comprises a detection module (106), wherein the detection module comprises ... blisters (210) and a first plurality of dispensing areas (212). The invention comprises: a receiver (112) configured to position and secure the first blister card, wherein the receiver is positioned in a first body portion (P2), and wherein the receiver includes a first adapter (508) having a flange (520), the flange having an outer perimeter (OP1) and a first inner perimeter (IP1), the outer perimeter being based on a size of the first body portion and the inner perimeter being based on the first blister area; and a sensor system (114) configured to monitor a state of at least one of the first cover film and the first content.

[0028] According to another embodiment of the present disclosure, a smart box (500) is provided for monitoring the status of any blister card in a group of blister cards (122), each blister card in the group of blister cards comprising a plurality of blisters (210) and a cover film (204) having a plurality of dispensing areas (212), the plurality of blisters (210) and the plurality of dispensing areas jointly defining a plurality of reservoirs (208) containing a first content (208), wherein the plurality of blisters jointly define a blister area (218), and each blister card in the group of blister cards has a different configuration, wherein the smart box comprises: a first main body portion (P2) for holding a receiver (112), the receiver being reconfigurable to position and secure each blister card in the group of blister cards; the receiver; and a sensor system (114) operable to monitor the status of each blister card in the group of blister cards. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 Depicted is a functional block diagram of a pharmaceutical kit according to the present disclosure.

[0030] Figure 2A A schematic diagram depicting a perspective view of a blister card 122 .

[0031] Figure 2B A schematic diagram depicting a cross-sectional view of an example reservoir of a blister card 122 .

[0032] Figure 2C -D depicts a schematic plan view of the front (forming film side) and back (lidding film side) of the blister card 122.

[0033] 3A-B respectively depict schematic diagrams of a perspective top view and a plan bottom view of the box 100.

[0034] Figure 3C A schematic diagram depicting an exploded cross-sectional view of the receiver 112 , the sensor system 114 , and the blister card 122 .

[0035] Figure 3D Schematic diagram depicting a top view of sensor system 114 .

[0036] Figure 3E -F depicts a schematic diagram of an example of an electrically actuatable latch suitable for use in accordance with the present disclosure.

[0037] Figure 4A Schematic diagram depicting a perspective top view of an alternative embodiment of a smart box according to the present disclosure.

[0038] Figure 4B A schematic diagram depicting a cross-sectional view of a portion of detection module 402 .

[0039] Figure 5A Schematic diagram depicting a cross-sectional view of another alternative detection module according to the present disclosure.

[0040] Figure 5B -C depict a top view and a perspective view of the adapter 508, respectively.

[0041] Figure 5D -E depicts a schematic diagram of an alternative adapter according to the present disclosure.

[0042] Fig. 6A Schematic diagram depicting a cross-sectional view of yet another alternative detection module according to the present disclosure.

[0043] Figure 6B Detection module 600 is depicted with an optional cover 606 added.

[0044] Fig. 7A Schematic diagram depicting an exploded perspective view of salient features of yet another alternative smart box according to the present disclosure.

[0045] Figure 7B -C is a schematic diagram depicting an exploded perspective view of a smart box 700 configured for use with blister cards that are larger and smaller than the blister card 122, respectively.

[0046] Fig. 8A -B depicts an exploded schematic perspective view of two alternative receivers according to the present disclosure. DETAILED DESCRIPTION

[0047] It should be noted that although embodiments according to the present disclosure are described herein with respect to medication as an exemplary application, the concepts of the present disclosure are applicable to a wide range of other applications; therefore, the use of medication should not be viewed as limiting the scope of utility of the concepts described herein. Other examples of applications in which the smart packaging concepts of the present disclosure may be used include, but are not limited to, other forms of medication, non-drug products (e.g., vitamins, supplements, etc.), food, chewing gum, beverages, cosmetics and beauty care products, razor blades, consumer electronics, toner cartridges, toys, tools, etc. In other words, the teachings of the present disclosure are applicable to a wide range of product tracking applications.

[0048] Therefore, for the purposes of this specification, including the appended claims, the term "contents" is used as a generic term covering all products packaged in a blister card format.

[0049] Furthermore, although the examples described herein relate to monitoring the status of blister cards containing medications in the form of tablets, many types of medications and non-medicines (e.g., vitamins, supplements, breath fresheners, etc.) are provided in forms other than tablets but suitable for packaging in blister cards, such as capsules, lozenges, powders, gels, liquids, etc. For purposes of this specification, including the appended claims, the term "tablet" is used as a generic term to encompass all such pharmaceutical and non-medicinal forms.

[0050] Figure 1 Depicted is a functional block diagram of a drug cartridge according to the present disclosure. Cartridge 100 includes housing 102 , electronics module 104 , and detection module 106 .

[0051] The housing 102 is a non-modular molded plastic box having a first portion containing the electronic module 104 and a second portion containing the detection module 106. The second portion includes a body and a cover that can be opened and closed to enable insertion of a blister card 122 and then control access thereto. In the depicted example, the body and cover are connected along one edge via a flexible hinge portion. As discussed below, the body also includes an electrically actuatable buckle that engages a latch on the cover to control access to the blister card.

[0052] It should be noted that although the box 100 is a non-modular box including inseparable electronic and detection modules, the teachings of the present disclosure are applicable to smart boxes having detachable electronic and detection modules, and the description of non-modular boxes should not be considered to limit the scope of the appended claims. An example of a modular smart box according to the present disclosure is described in the '021 application.

[0053] Electronics module 104 is a module that contains electronic circuitry 108 for interfacing to sensor system 114 and communications circuitry 110. Electronics module 104 is similar to the electronic modules described in detail in the '874, '121, '779, and '021 applications.

[0054] The electronic circuit system 108 enables the electronic module to receive and condition (e.g., provide pre-amplification, digitization, etc.) one or more signals from the sensor system 114 of the detection module 106, provide power regulation and management, display information to a user, etc. In some embodiments, the electronic circuit system 108 includes one or more of the following:

[0055] i. controller / processor; or

[0056] ii. storage; or

[0057] iii. sensor circuitry; or

[0058] iv. power circuit system; or

[0059] v. Display circuitry and / or one or more displays; or

[0060] vi. Sleep mode circuitry; or

[0061] vii. Energy storage systems; or

[0062] viii. clock circuit system; or

[0063] ix. Energy harvesting systems; or

[0064] x. sensor interface circuitry; or

[0065] xi. Situation alert (e.g., LCD display, speaker, buzzer, etc.); or

[0066] xii. Sensors, such as environmental (e.g., touch, temperature, acceleration, humidity, shock, geographic location, etc.), biosensors (e.g., bioimpedance, biopotential, breathalyzer, alcohol detector, etc.), etc.; or

[0067] xiii. Any combination of i, ii, iii, iv, v, vi, vii, viii, ix, x, xi and xii.

[0068] Communications circuitry 110 enables communications with external device 116. In the depicted example, communications circuitry 110 includes a wireless Bluetooth Low Energy (BLE) transceiver for transmitting / receiving status signals 118 to / from external device 116 for operable communications 120. In some embodiments, communications circuitry includes various wired and / or wireless communications electronics such as FireWire, USB, Lightning connector, dock connector, cellular, WiFi, near field communications (NFC) radio, optical links, etc.

[0069] The detection module 106 includes a receiver 112 and a sensor system 114. The receiver 112 includes a fixture configured to position and hold the blister card 122 in a position that enables its state to be monitored by the sensor system 114. The detection module 106 is described in detail below.

[0070] In the depicted example, the external device 116 is a smart phone that communicates with the electronic module 104 via the communication circuit system 110 and runs a software application (i.e., a mobile application) that provides assistance to the patient and / or caregiver to achieve and maintain good compliance with the prescribed drug regimen. In some embodiments, the external device 116 is a different device, such as a different mobile device (e.g., a smart watch, a tablet computer, etc.), a calculator, a gateway, and / or a base station. Preferably, the software application running on the external device 116 is supported by data analysis, which includes artificial intelligence and machine learning. In some embodiments, the external device 116 is connected to a cloud backend via wireless and / or wired communication.

[0071] The smart box and smartphone app determine the status of the blister card and provide visual and / or audible indication of compliance. If non-compliance with the regimen is detected, the smartphone contacts one or more people in the user-defined support group (e.g., caregiver, spouse, children, doctor, etc.) to alert them that the user may need help.

[0072] In the depicted example, box 100 is a smart box for tracking the status of blister card 122, which contains medicinal contents for a one-week medication regimen, and the medication regimen has four medication periods (A to D) for each of 7 days (Monday to Sunday). In physical form, smart box 100 is similar to those described in detail in '874, '121, '779 and '021 applications. It should be noted that although the depicted example is configured to monitor the status of blister cards with 7×4 medication arrangements, the principles of the present disclosure can be applied to smart boxes suitable for use with any actual blister card arrangement and medication schedule. For example, a 7×4 blister card may correspond to a single daily dose within 4 weeks, while a 4×1 blister card may correspond to a single daily dose within 4 days or a weekly dose within 4 weeks. In addition, the geometric placement of the blister reservoir may vary due to human factors associated with different use cases.

[0073] Figure 2A A schematic diagram depicting a perspective view of a blister card 122 .

[0074] Figure 2B A schematic diagram depicting a cross-sectional view of an example reservoir of a blister card 122 . Figure 2B The view depicted in the diagram shows the Figure 2A206 - 1A to 206 - 7D.

[0075] Figure 2C -D depicts a schematic plan view of the front (forming film side) and back (lidding film side) of the blister card 122.

[0076] The blister card 122 includes a molded film 202 and a lidding film 204 configured to define reservoirs 206-1A to 206-7D. The reservoirs 206-1A to 206-7D contain contents 208-1A to 208-7D, respectively, each of which is an appropriate dose for a specific dosing window of a weekly medication regimen. In the depicted example, the reservoirs 206-1A to 206-7D (collectively referred to as "reservoirs 206") are arranged in a seven-row and four-column format.

[0077] The formed film 202 is a thermoformed plastic layer in which cavities are formed for holding medicinal contents, thereby defining blisters 210 - 1A to 210 - 7D (collectively referred to as blisters 210 ).

[0078] In the depicted example, the lidding film 204 is a thin sheet of aluminum foil. In some embodiments, the lidding film 204 is a sheet of different conductive materials. In some embodiments, the lidding film 204 includes a sheet of conductive material and a sheet of electrically insulating material, such as a sheet of paper (with a printed calendar or instructions), on the bottom side of the lidding film and / or sandwiched between the lidding and the forming film. In some embodiments, the lidding film 204 is a sheet of non-conductive material (e.g., paper, etc.) or a laminate of non-conductive materials (e.g., paper and polymers, etc.).

[0079] After the contents 208-1A to 208-7D (collectively referred to as the contents 208) are dispensed into the blister 210, the lidding film 204 is joined with the forming film 202 to seal the cavity, thereby completing the reservoir 206 and enclosing the contents 208. The portions of the lidding film 204 below the blisters 210-1A to 210-7D define dispensing zones 212-1A to 212-7D, respectively, through which the contents 208-1A to 208-7D are dispensed. The dispensing zones 212-1A to 212-7D (collectively referred to as the dispensing zones 212) are all positioned within the two-dimensional region 214. Each dispensing zone 212 is characterized by a perimeter 216, which is defined by a ring at which its corresponding blister 210 is joined with the lidding film 204.

[0080] Each of the blisters 210 is characterized by a width w1 in the x-direction, a depth d1 in the y-direction, and a height h1 in the z-direction. The blisters 210 are spaced apart by inter-reservoir spacings sx1 and sy1 in the x- and y-directions, respectively. For a multi-dose blister card, at least one of the width, depth, height, and spacing of the blisters 210 may be non-uniform across the blister card.

[0081] The perimeters 216 collectively define a blister region 218 , which is a two-dimensional region whose lateral extent is defined by the outer edges of the perimeters 216 of the outer rows and columns of blisters 212 .

[0082] Blister card 122 also includes a label 220 for providing dosing regimen information directly on the back of the blister card. In some cases, label 220 includes other information, such as a calendar indicating a drug regimen, manufacturing information (date, batch number, etc.), etc.

[0083] In some embodiments, box 100 is configured to monitor the status of a blister card in which at least one reservoir contains contents other than a plurality of tablets. In some embodiments, some reservoirs may be left empty, for example, to simply maintain a customary regimen routine or to accommodate a dosing regimen that does not use all reservoirs of a given blister card format. In some embodiments, one or more of such empty reservoirs may not have an intact lidding film or no lidding at all.

[0084] As will be apparent to one skilled in the art, at least some of the reservoirs 206 are larger than those of a single-drug blister card so that they can hold a dose of pharmaceutical content comprising multiple tablets. An exemplary multi-tablet reservoir has a volume of 2 cubic inches, with the dispensing area 212 being approximately 1×2 inches and the blister height being approximately 1 inch. The spacing between reservoirs 206 (i.e., the inter-reservoir spacing of the blister card 122) is 1 / 4 inch in each of the x and y dimensions. Thus, a 7×4 format blister card size filled with such reservoirs requires that the area 214 be approximately 10×10 inches.

[0085]

[0013] An aspect of the present disclosure is to implement the teachings herein of monitoring of any blister card.

[0086] Those skilled in the art will recognize after reading this specification that the design features of the smart box 100 described herein are based on the specific arrangement of the blister card 122, and the sensing technology for monitoring its status, and are therefore only exemplary. In the scope of the present disclosure, countless alternative design features are possible.

[0087] Figure 3A -B are schematic diagrams depicting a perspective top view and a plan bottom view of the box 100, respectively.

[0088] The housing 102 includes a body 302, a lid 304, and a lid cover 306. The body 302 extends along the entire bottom side of the cartridge 100. The lid cover 306 is rigidly fixed to the body 302 to enclose and protect the components of the electronic module 102, while the lid 304 is a removable "clamshell" lid attached to the body 304 via a hinge (not shown) along the length of the detection module 106. Thus, the lid 304 can be opened to enable access to the contents 208 and closed to protect the blister card 122.

[0089] The body 302 includes body portions P1 and P2, which respectively hold the electronic module 104 and the detection module 106. The body portion P2 includes a dispensing hole 318 and a viewing port 320.

[0090] In the depicted example, since the case 100 is non-modular, the body portions P1 and P2 are continuous sections of the unitary body 302. As will be apparent to one skilled in the art after reading this disclosure, for embodiments in which the smart case is modular, the body portions P1 and P2 are typically separate elements that can be reversibly connected as described in the '021 application.

[0091] Dispensing apertures 318 are configured to enable their respective contents 208 to pass through body portion P2 when dispensed.

[0092] The viewing port 320 is an opening in the body portion P2 that is configured to expose a portion of the blister card 122 for viewing. The viewing port 320 is optionally included to enable information printed on the blister card (eg, a bar code, etc.) to be read through the body 302.

[0093] In the depicted example, the housing 102 includes a latch 308 configured to reversibly secure the lid 304 and the body 302 in a closed configuration. The latch 308 includes a buckle 310A disposed on the body 302 and a lock 310B disposed on the lid 304. To unlock the latch 308 and enable the lid 304 to move relative to the body 302, the user mechanically decouples the buckle 310A from the lock 310B. A wide range of conventional mechanical latch designs can be used for the latch 308, including passive designs based on magnets, zippers, Velcro, adhesive membranes, etc.

[0094] In the depicted example, receiver 112 includes a base 312 and a frame 314 .

[0095] The base 312 is the bottom portion of the body 302 and is configured to receive the sensor system 114 and the blister card 122. The base 312 includes a dispensing hole 318 that has a one-to-one correspondence with the reservoir 206.

[0096] The frame 314 is a rigid annular element including a large central opening, the opening being configured to expose all of the reservoirs 206 when the blister card 122 is installed in the box 100. The frame 314 can be rotated about a hinge (not shown) so that it can be closed over the blister card 122 and latched in place. Once the frame 314 is closed and latched, the blister card is securely held in an arrangement operably coupled to the sensor system 114, which is disposed on the base 312. In some embodiments, the frame 314 includes a plurality of openings, each of which is configured to expose one or more reservoirs. In some embodiments, after the blister card is inserted, the frame 314 is placed separately over the blister card. In such embodiments, the frame 314 is typically reversibly fixed in place by machinery, magnets, electromagnets, latches, etc.

[0097] Figure 3C A schematic diagram depicting an exploded cross-sectional view of the receiver 112 , the sensor system 114 , and the blister card 122 . Figure 3C The view depicted is through Figure 3A The line bb shown in FIG.

[0098] Figure 3D A schematic diagram depicting a top view of sensor system 114. Sensor system 114 includes substrate 322, vias 324, and connectors 316-1 through 316-16.

[0099] The sensor system 114 includes connectors 316-1 to 316-16 configured to electrically couple with the capping film 204 and provide a signal 124 to the electronic circuit system 108. The sensor system 114 enables monitoring of the state of the capping film 204 via electrical resistance tomography (ERT) imaging, which is typically performed by the electronic circuit system 108. As will be appreciated by those skilled in the art and as discussed in the '603 application, ERT imaging of the capping film 204 can be used to detect that a hole has been formed in the dispensing area 212 and the location of the hole. Thus, the sensor system 114 can determine when one of the contents 208-1A to 208-7D has been dispensed and identify which dose has been dispensed. In some embodiments, different tomography techniques (e.g., electrical impedance tomography (EIT), electrical capacitance tomography (ECT), etc.) are used to accommodate non-conductive capping films.

[0100] Each of the connectors 316-1 to 316-16 (collectively, connectors 316) is a contact bump disposed on the top surface of the substrate 322 and configured to enable the blister card 122 to be operably coupled to the sensor system 114 without significant deformation of the blister card. The connectors 316 are electrically coupled to the electronic module 104 via conventional electrical traces (not shown) disposed on the substrate 322.

[0101] In some embodiments, connector 316 is not a contact bump, such as a leaf spring "slide" contact, a "zero insertion force" (ZIF) connector that closes over the blister card after it has been inserted, etc. In some embodiments, connector 316 is configured to capacitively contact a conductive lidding film (e.g., from the lidding film side, through an insulating layer disposed on the bottom side of lidding film 204, through the molding film when connector 316 is placed on the molding film side of blister card 122, etc.). Those skilled in the art will recognize, after reading this specification, that the geometry and distribution of such resistive or capacitive contacts can vary greatly to meet a wide range of performance specifications.

[0102] The substrate 322 is a printed circuit board (PCB) that incorporates through-holes 324 that are configured to enable the contents 208 to pass through the substrate 322 as they are dispensed. It should be noted that while the depicted example includes the substrate 322 being a PCB, a myriad of alternative materials may be used for the substrate 322 without departing from the scope of the present invention.

[0103] Although in the illustrative embodiment, the sensor system 114 is an optical sensor-based system, in some embodiments, the sensor system 114 is based on different sensing technologies, wherein a plurality of sensors (e.g., capacitive sensors, strain sensors, optical sensors, acoustic sensors, tactile sensors, resistive sensors, impedance sensors, thermal sensors, magnetic sensors, etc.) having a one-to-one correspondence with the dispensing zones 212-1A to 212-7D are employed. Examples of sensors suitable for such sensing schemes are described in detail in the '874, '121, '779, and '021 applications.

[0104] It is well known that some drugs, such as opioids, are highly addictive. One aspect of the present disclosure is that access to such drugs can be controlled via a smart box that includes an electrically actuated latch that enables programming of a dosing regimen so that the smart box can only be opened during a dosing window. Such embodiments have the prospect of mitigating drug abuse by users. In addition, if a user removes more than the required dose during an approved dosing window, it can be detected by the box 100 (including whether the blister card is completely removed) and an alert can be immediately issued to the appropriate party.

[0105] Figure 3E -F depicts a schematic diagram of an example of an electrically actuatable latch suitable for use in accordance with the present disclosure.

[0106] Each of the latches 326 and 328 includes a striker 310A, a hasp 310B, and a solenoid 330 .

[0107] The solenoid 330 is a conventional solenoid mechanically coupled to the debris 310B. The solenoid 330 is configured to disengage the buckle 310B from the lock 310A only in response to a command from the electronic module 104, thereby unlocking the body 302 and the lid 304 to enable access to the contents 208. In some embodiments, the latch 308 can only be actuated for authorized users (such as determined by a user-entered access code, fingerprint, audio or image recognition, etc.) and / or only during an appropriate dosing window. In such embodiments, the box 100 provides protection measures to prevent accidental ingestion of the contents 208 (e.g., by children, etc.), over-medication or abuse by users, etc.

[0108] In some applications, it may be problematic to push the contents contained in a reservoir through its respective dispensing area and dispensing aperture. For example, in the depicted example, when dispensing contents 208 from a multi-tablet reservoir 206, one or more tablets may break when pressed against each other. The likelihood of tablet breakage increases with the number of tablets in the reservoir—particularly as the height and / or volume of the reservoir increases to accommodate more tablets and / or the tablets themselves are fragile. Tablet breakage is also a problem with large disc-shaped tablets—even when housed in individual conformal reservoirs.

[0109] Thus, in some cases, it is preferred that the contents of a reservoir be accessible by removing at least a portion of its corresponding dispensing area rather than by pushing the contents through its corresponding dispensing area. In such cases, the blister card 122 is typically held in the box 100 so that its cover film faces the user. Once a sufficient portion of the dispensing area 212 is removed, the user can manually remove its corresponding contents or flip the blister card to allow the tablets to fall out of the reservoir 206.

[0110] Figure 4A Schematic diagram depicting a perspective top view of an alternative embodiment of a smart box according to the present disclosure.

[0111] The cartridge 400 includes the housing 102, the electronic module 104, and the detection module 402. The cartridge 400 is similar to the cartridge 100; however, the cartridge 400 is configured to monitor a blister card held together with its cover film facing the cover 304, including a sensor system having a one-to-one correspondence with the reservoir 206, and having the sensor system disposed on the inner surface of the cover 304.

[0112] Figure 4B A schematic diagram depicting a cross-sectional view of a portion of detection module 402 . Figure 4B The cross-sectional views shown are through Figure 4A The detection module 402 includes a receiver 404 and a sensor system 406.

[0113] Receiver 404 includes base 312 and frame 314. Receiver 404 is similar to receiver 112; however, receiver 404 is configured to position blister card 122 in an inverted orientation (i.e., lidding film 204 is distal to base 312) and such forming film 202 is disposed directly on base 312. Thus, reservoir 206 is aligned with dispensing aperture 318, which serves as a viewing aperture that enables a user to see contents 208. In some embodiments, dispensing aperture 318 facilitates registration of the lateral position of blister card 122 by capturing a portion of its blister.

[0114] For operation using blister cards whose lidding films contain printed instructions, it is preferred that the frame 314 be optically clear or incorporate openings to expose the information.

[0115] The sensing system 406 includes photodiodes 408-1A through 408-7D (collectively referred to as photodiodes 408). The photodiodes 408 have a one-to-one correspondence with the reservoirs 206-1A through 206-7D and are disposed on the inner surface of the cover 304. The sensor system 406 also includes conventional electrical connections from the photodiodes 408 to enable them to provide signals 124 to the electronic module 104 (not shown), such as a flexible ribbon cable passing through the hinge cavity.

[0116] In operation, the box 400 is opened to provide access to the dispensing area 212, thereby enabling a user to remove the appropriate contents from the blister card 122 by removing at least some of the dispensing area from the reservoir of the blister card 122.

[0117] Once the proper dose has been dispensed, the lid 304 is closed. Due to the lack of lidding film material in the dispensing area of ​​the dispensed contents, light can pass through these reservoirs to be detected by those photodiodes 408 aligned with them. These photodiodes provide output signals to the electronic module 104, which determines whether the output signal configuration has changed, thus indicating which content has been dispensed. Since the reservoirs whose dispensing areas are still intact will substantially block light, their corresponding photodiodes will substantially not produce output signals.

[0118] When the light incident on the photodiode 408 is at a maximum value, it is determined that its corresponding storage tank is empty. When no light is incident on the photodiode 408, it is determined that its corresponding storage tank is intact (i.e., full). However, in some cases, after the dispensing area of ​​the storage tank has been opened, a partial dose will remain in the storage tank. This will affect the amount of light incident on its corresponding photodiode 408, thereby providing an indication of an incomplete administration event. In addition, a sensor system that can detect the magnitude of the light received by the photodiode realizes monitoring of a blister card whose capping film is optically transparent (e.g., nylon film, transparent plastic, etc.). In some embodiments, machine learning and artificial intelligence enable the light signal at a certain point between zero and the maximum value to be related to the amount of the contents remaining in the storage tank (e.g., tablet type, remaining quantity, etc.).

[0119] In the depicted example, the light passing through the dispensing hole 318 is ambient light. In some embodiments, one or more light sources are included in the box 400 (e.g., disposed on the base 312) to provide light detected by the photodiode 408. In some embodiments, a different light source is provided for each reservoir. In such embodiments, the inclusion of the dispensing hole 318 in the body 302 is optional.

[0120] It should be noted that while the sensing system 406 includes sensors that employ optical sensing technology, a sensing system based on any of a wide range of sensing technologies may be employed in accordance with the present disclosure. Sensing technologies that may be employed in embodiments in accordance with the present disclosure include, but are not limited to, capacitive sensing, strain sensing, optical sensing, acoustic sensing, tactile sensing, resistive sensing, impedance sensing, thermal sensing, magnetic sensing, and tomography. Examples of alternative sensing methods suitable for use in accordance with the present disclosure are described in detail in the '874, '121, '779, and '021 applications.

[0121] Figure 5A Schematic diagram depicting a cross-sectional view of another alternative detection module according to the present disclosure. Figure 5A The cross-sectional view shown in Figure 4B . Detection module 500 includes a sensor system 502 and a receiver 504. Cartridge 500 is similar to cartridge 400; however, in cartridge 500, sensor system 502 is a photodiode-based sensor system disposed below blister card 122. Additionally, receiver 504 includes an optional adapter 508 that includes a mesh that serves as a wall of light blocking features between adjacent reservoirs 206.

[0122] Sensor system 502 is similar to sensor system 406 ; however, in sensor system 502 , photodiode 408 is positioned on substrate 506 .

[0123] Substrate 506 is a PCB on which photodiode 408 is mounted. In some embodiments, substrate 506 is another suitable substrate on which photodiode 408 is disposed. In some embodiments, photodiode 408 is monolithically integrated on or in substrate 506. In some embodiments, substrate 506 is an organic or inorganic semiconductor that facilitates the fabrication of photodiode 408.

[0124] The sensor system 502 is configured to interrogate the lidding film of the blister card 122 when the lid 304 is open by virtue of the photodiode 408 which detects ambient light passing through the reservoir 206 whose dispensing area 212 has been removed. However, in some embodiments, one or more light sources are disposed on the interior surface of the lid 304 to provide light detectable by the photodiode 408 when the lid is closed.

[0125] Receiver 504 includes a base 510 , a frame 314 (not shown), and an optional adapter 508 .

[0126] The base 510 mechanically supports the sensor system 502, the adapter 508, and the blister card 122. In the depicted example, the base 510 is the bottom of the body 302. Note that since the contents 208 are dispensed from the top side of the detection module 500, the base 510 does not require a dispensing hole 318.

[0127] In some cases, light can leak from an opened reservoir to the photodiode of an adjacent reservoir (known as "optical crosstalk"), which can cause problems. For example, optical crosstalk can cause confusion as to which of the contents 208-1A to 208-7D has been dispensed, or corrupt an analysis used to determine the amount and type of contents remaining in a partially empty reservoir.

[0128] Thus, in the depicted example, the inclusion of an optional adapter 508 in the receiver 504 provides significant advantages over prior art smart boxes. First, the wall of the adapter substantially blocks light from passing between adjacent reservoirs of a blister card, thereby mitigating optical crosstalk between adjacent reservoirs and the photodiode. Second, as discussed below, the adapter can enable the same smart box to accommodate a wide range of blister cards having different configurations. In some embodiments, the adapter 508 is not included.

[0129] Figure 5B -C depicts a top view and a perspective view, respectively, of the adapter 508. The adapter 508 includes a wall 512 and a flange 514. In the depicted example, the adapter 508 is made of injection molded plastic and is substantially optically opaque. In some embodiments, the adapter 508 is made of a different suitable opaque material (e.g., metal, ceramic, etc.).

[0130] The adapter 508 includes a grid of orthogonal walls 512 having a height h1 equal to the height h1 of the blister 210 so that the adapter 508 provides mechanical support for the blister card 122. The walls 512 collectively define a cell 516 characterized by a width w2 in the x-direction, a depth d2 in the y-direction, and a height h2 in the z-direction. Typically, at least one of the dimensions of the cell 516 is based on the dimensions of the blister 210. In the depicted example, the cell 516 has substantially the same three-dimensional shape as the blister 210; therefore, all three dimensions of the cell match those of the blister (i.e., w2=w1, d2=d1, and h2=h1). Thus, the cell 516 captures the blister 510, thereby limiting lateral movement of the blister card 122.

[0131] The flange 514 is an annular plate extending outward from the wall 512 at the top of the adapter 508. The flange 514 has an outer perimeter OP1 and an inner perimeter IP1. The value of OP1 is selected based on the size of the main body portion P2, and is generally selected so that the adapter 508 can fit snugly within the main body portion P2. The value of IP1 is selected so that all of the blisters 210 of the blister card 122 can fit within the flange. In the depicted example, IP1 is configured to match the perimeter of the blister area 218. In some embodiments, IP1 is configured to be larger than the perimeter of the blister area 218, as described above and with respect to Figure 2C Discussed.

[0132] In the depicted example, the adapter 508 is integral with the detection module 500 (i.e., non-removable); however, in some embodiments, the adapter is removable so that different adapters can be used with the same smart box, thereby enabling the box to be used with a set of blister cards having different configurations. The adapter 508 can be removably secured in the detection module using a variety of latching schemes (snap, slide, lock, magnetic, electromagnetic, etc.).

[0133] Note that the wall 512 of the adapter 508 is substantially straight and vertical and has thicknesses tx and ty in the x and y directions, respectively, based on the inter-reservoir spacings sx1 and sy1 between blisters 210. However, in some embodiments, the wall 512 has a shape that provides additional functionality.

[0134] Figure 5D -E depicts a schematic diagram of an alternative adapter according to the present disclosure. Adapter 518 is an annular element having a flange 520 and an opening 522 .

[0135] Flange 520 is similar to flange 514 and has an outer perimeter OP1 that enables it to fit snugly within body portion P2.

[0136] The opening 520 has an inner perimeter IP1 that substantially matches the perimeter of the blister region 218. Thus, the blisters 210 of the blister card 122 fit snugly into the opening 520, thereby mitigating lateral movement of the blister card relative to the flange 520. In some embodiments, the opening 520 is larger than the blister region 218 in at least one dimension.

[0137] The flange 520 also includes an optional groove 522 having a perimeter that substantially matches the perimeter of the blister card 122 and a height h2 that is equal to the combined thickness of the forming film 202 and the lidding film 204. Thus, the blister card fits snugly within the groove 522 even when the opening 520 is larger than the blister area 218.

[0138] In the depicted example, the height of the groove 522 above the bottom of the flange 520 is equal to the height h1 of the blister 210. However, in some embodiments, the groove 522 resides at a different height above the bottom of the flange 520.

[0139] Fig. 6A Schematic diagram depicting a cross-sectional view of yet another alternative detection module according to the present disclosure. Detection module 600 is similar to detection module 500; however, detection module 600 includes an adapter whose walls conform to the blister shape of the blister card it is intended for. Adapter 602 includes flange 514 and wall 604.

[0140] The wall 604 of the adapter 602 is tapered to conform to the shape of the blister 606, which has side walls that taper inward from the lidding film 204 (i.e., the top of the blister is narrower than the base where it meets the lidding film). In other words, the wall 602 defines a cell that tightly surrounds the blister 606. Thus, the large contact area between the blister 606 and the wall 604 enables the conformal wall 604 to better "grip" the blister card and hold it in its desired position. The grip between the wall and the blister can be further enhanced by the wall having a sticky surface.

[0141] It should be noted that walls 512 and 604 represent only two example shapes of adapter walls within the scope of the present disclosure. In some embodiments, the shape of the wall is determined by the additional functionality desired for the adapter.

[0142] In some embodiments, the adapter incorporates electrical functionality, such as indicator lights, electrodes / elements for other types of sensing (e.g., capacitive, acoustic, optical, magnetic, tactile, etc.), etc. For example, in some embodiments, the adapter wall contains capacitive electrodes that enable imaging of the contents of the reservoir via electrical impedance tomography, as described in the '121 application, or via a capacitive sensing scheme as described in the '779 application. Electrical connection to an electrical device disposed on the wall of the adapter can be established via, for example, an electrical connector, proximity contacts, etc.

[0143] It should be noted that in some embodiments, the height of the walls of the adapter is selected based on their desired functionality beyond their light blocking capabilities. For example, although walls 512 and 604 have a height h1 (i.e., the same height as blister 210), the walls may be shorter or longer than the height of the blister to control the vertical position of blister card 122, secure the blister card in place, and / or optimize sensing capabilities. For example, in embodiments where walls 512 and / or 604 include electrodes for implementing capacitive sensing, it may be beneficial to position the bottom of the blister near their respective capacitive sensors.

[0144] In some embodiments, not all of the electronic circuitry of the smart box is located in the electronic module 104. Instead, in some embodiments, the substrate 506 (or base 312 or cover 304 or receiver 112 or any combination thereof) contains some electronic functionality beyond that associated with their respective sensor systems. This is particularly advantageous for modular smart boxes according to the present disclosure.

[0145] Furthermore, in some embodiments, the photodiode-based sensor system includes a photodiode array having more elements than the number of reservoirs on the blister card for which it is intended. As discussed below, a sensor system having a higher sensor density than reservoirs can, for example, provide more detection data per reservoir, enable use of the same smart box with blister cards having different sizes and / or formats, etc. For a smart box that is intended to be operable for a set of blister cards having different configurations, it is preferred that the density of photodiodes of the photodiode-based sensor system is equal to or greater than the highest reservoir density of any of the set of blister cards.

[0146] Figure 6B Detection module 600 is depicted with an optional cover 606 added.

[0147] Cover 606 is a thin decorative layer configured to hide sensor system 502. Cover 606 includes apertures 608 formed in the layer to enable light to pass through the layer and be received by photodiode 408. In the depicted example, aperture 608 is a through hole; however, a wide range of apertures are within the scope of the present disclosure, such as transparent areas used as windows, etc. In some embodiments, aperture 608 includes one or more optical elements (e.g., lenses, diffraction gratings, blazed gratings, etc.) for facilitating detection of light at photodiode 408.

[0148] It should be noted that the material and structure of cover 606 are based on the sensing technology used in sensor system 502. For example, for aesthetic reasons, it is often desirable to hide sensor system 502; therefore, in such examples, optically opaque materials are desirable. However, when sensor system 502 employs capacitive sensing, the material of cover 606 must be electrically insulating and thin, and the cover will typically not include aperture 608.

[0149] As will be appreciated by one of ordinary skill in the art, the smart pill boxes (or other smart packaging) known in the prior art are configured to operate in conjunction with only one specific blister card configuration and will not work with blister cards having a different configuration. For the purposes of this specification, including the appended claims, the "configuration" of a blister card is defined as the size and shape of the entire blister card, and its blister card parameters, including the number, size, shape, and inter-reservoir spacing between its reservoirs. However, one aspect of the present disclosure is that the smart box can be configured to accept any one of a set of blister cards having different configurations by employing a suitable adapter for each blister card in the set, if necessary.

[0150] Fig. 7A Schematic diagram depicting an exploded perspective view of the salient features of a reconfigurable smart case according to the present disclosure. Case 700 is similar to case 500; however, case 700 includes an optional stylus 702, stylus housing 704, access tab 708, etc., all of which are positioned in body portion P1. Fig. 7A In the example shown in , the cartridge 700 is configured to monitor the status of the blister card 122, as discussed above.

[0151] The stylus 702 is designed to pierce the dispensing area 212 and scoop out the contents 208 from the reservoir 206. Although this function can typically be accomplished by a user using a finger or another object (e.g., a fork, spoon, etc.), the stylus 702 can provide significant advantages. For example, the stylus 702 includes optional serrations 706 to facilitate piercing and removing the capping film 204 in the dispensing area 212.

[0152] In the depicted example, the body portion P1 also includes an access tab 708 to facilitate removal of the adapter 508. In some embodiments, the adapter 508 includes opposing grooves in the flange 514 to further facilitate removal of the blister card 122.

[0153] Fig. 7AAdditional example user interfaces are also depicted, such as a sound port 710, a wired interface 712, and a visual indicator 714. Non-limiting examples of user interfaces suitable for use with smart cases according to the present disclosure are described in detail in the '874, '121, '779, and '021 applications. It should be noted that the depicted interfaces and their locations are merely exemplary and that many different interfaces at any suitable location may be included in the smart box without departing from the scope of the present disclosure.

[0154] The sound ports 710 include perforations and / or holes that allow sound to pass into and out of the box 700. They are used in conjunction with microphones, speakers, sirens, buzzers, etc. for verbal interaction with the user, audible alarms, and any other acoustic interfaces.

[0155] The wired interface port 712 is a conventional connection (eg, USB, micro USB, etc.) for enabling wired two-way communication and / or charging of an energy storage unit.

[0156] Indicator 714 is a display element (e.g., a light emitting diode, an incandescent lamp, a liquid crystal element, etc.) used to provide a visual alert and / or status indication to the user (e.g., a visual dosing time reminder, the box is functioning correctly, the energy storage unit is charging / being charged, the current compliance status, a problem must be resolved, etc.).

[0157] Indicator 716 is a visual display element configured to flash to attract the user's attention. Indicator 716 is optionally included to assist hearing-impaired users in recognizing that interaction with box 700 is required (e.g., a dosing window is occurring or about to occur, a dose has been missed, a dose has been improperly dispensed, etc.).

[0158] In some embodiments, one or more user interfaces are disposed on the inner surface 718 of the cover 304. Such user interfaces may include, for example, one or more displays, touch switches, mirrors, tabs / holders (e.g., for holding paper, labels, tablet computers, smartphones, etc.), etc. to implement desired functions and features.

[0159] Figure 7B -C is a schematic diagram depicting an exploded perspective view of the smart box 700 as configured for use with blister cards that are larger and smaller than the blister card 122, respectively.

[0160] The box 700L represents the smart box 700 as configured to accept and monitor the blister card 122L. The box 700L includes the box 700 and the adapter 508L.

[0161] Blister card 122L has the same outer dimensions (i.e., overall size and shape) as blister card 122; however, at least one of the blister card parameters (wL, dL, hL) of blister card 122L is different from those of blister card 122. Specifically, in the depicted example, blister card 122L includes the same reservoirs (i.e., reservoirs 206) as blister card 122; thus, wL=w1, dL=d1, and hL=h1). However, the reservoirs' inter-reservoir spacings sxL and syL are greater than the inter-reservoir spacings of blister card 122 along each of the x and y dimensions. Thus, blister card 122L is characterized by a blister region 218L (not shown) having a larger perimeter than blister region 218.

[0162] Adapter 508L includes a flange 514L having the same outer perimeter (OP1) as adapter 508, thereby enabling adapter 508L to be securely seated in body portion P2. Because the inner dimensions of flange 514L are configured to accept blister card 122L, flange 514L has an inner perimeter IPL (not shown) that is greater than the inner perimeter of flange 514. Thus, flange 514L is narrower than flange 514—in fact, it does not exist along both of the outer edges of adapter 508L.

[0163] The size and spacing of the walls 512 of the adapter 508L are selected based on the parameters of the blister card 122L. Since the reservoirs 206 are characterized by the larger inter-reservoir spacing in the blister card 122L, the walls 512L are thicker.

[0164] In a similar manner, box 700S includes box 700 and adapter 508S, wherein adapter 508S is configured to receive blister card 122S. Blister card 122S also has the same outer dimensions (i.e., overall size and shape) as blister card 122; however, at least one of the blister card parameters (wS, dS, hS) of blister card 122S is different from the blister card parameters of each of blister cards 122 and 122L. Specifically, in the depicted example, blister card 122S includes the same reservoirs (i.e., reservoirs 206) as blister card 122; therefore, wS=w1, dS=d1, and hS=h1). However, the reservoir inter-reservoir spacing sxS and syS is less than the reservoir inter-reservoir spacing of blister card 122 along each of the x and y dimensions. Thus, the blister card 122S is characterized by a blister region 218S (not shown) having a smaller perimeter than the blister region 218 .

[0165] Thus, the adapter 508S includes a flange 514S having the same outer dimensions as the adapter 508, thus enabling it to be securely seated in the body portion P2. The inner perimeter IPS (not shown) of the flange 514S is configured to receive the blister card 122S, thus it is smaller than the inner perimeter of the flange 514 and the flange 514S is wider than the flange 514.

[0166] It should be noted that an adapter such as adapter 508S may be used to accommodate any blister card having outer dimensions that are no greater than the outer dimensions of blister card 122 .

[0167] Since reservoirs 206 are characterized by smaller inter-reservoir spacing in blister card 122S, wall 512S is thinner than wall 512 .

[0168] Since adapters can be manufactured fairly cheaply (eg, by plastic injection molding), they provide an inexpensive way to accommodate numerous blister cards in the same smart box.

[0169] It should be noted that the examples provided above represent only some of a wide range of methods within the scope of the present disclosure to enable a smart box to accommodate a wide range of blister card sizes and / or reservoir geometries.

[0170] In order to accommodate blister cards having different reservoir configurations, the box must contain a sensor system capable of monitoring the contents of each individual reservoir, regardless of its location within the blister card. For example, a sensor system that has a one-to-one correspondence with the distribution of reservoirs in a given blister card is generally not suitable for use with any blister card other than the type for which it was designed.

[0171] As briefly described above, in some embodiments, the photodiode-based sensor system preferably includes a plurality of photodiodes having a density greater than the highest storage slot density of any blister card with which the sensor system can operate. Specifically, the number and density of the photodiodes are preferably selected so that for each blister card in a set of blister cards with which the smart box is intended to operate, there is at least one photodiode in an optically isolated storage slot position. However, there are special conditions that allow the use of the same number of photodiodes as storage slots for different blister cards. For this special case, the different blister cards must have: (1) the same number of storage slots; (2) a common overlap area between their corresponding blister cards. For a set of such blister cards, a single arrangement of photodiodes having a one-to-one correspondence with the storage slots can be provided so that each photodiode resides in the overlapping area of ​​the corresponding storage slot of each of the different blister cards.

[0172] In some embodiments, the smart box employs a sensor system comprising a focal plane array that can receive light and image substantially all of the reservoirs on the blister card, regardless of their position. This sensor system will be able to monitor virtually any reservoir arrangement.

[0173] It should be noted that similar strategies can be used with sensor systems based on sensing technologies other than optical sensing, such as resistive sensing, impedance sensing, capacitive sensing, acoustic sensing, tactile sensing, etc. as described in detail in the '874, '121, '779 and '02 applications. In fact, a highly dense sensing system can enable identification of the geometry of an unknown blister card inserted into a smart box.

[0174] Additionally, artificial intelligence and machine learning can be used to determine the geometry and contents of the blisters / blister cards, thereby allowing identification of unknown blister cards and their characteristics, as well as the characteristics of adapters loaded into the smart box.

[0175] It should be noted that when the dispensing area is pierced to achieve removal of the contents of the reservoir, a downward force is generally applied to the blister card. Therefore, in some embodiments, the adapter 508 includes features that act as detents to hold the blister card 122 in place. As described above, one or more surfaces of the wall 512 may also be provided with a "sticky" surface that mitigates slippage of the blister card relative to the adapter.

[0176] Fig. 8A -B depicts exploded schematic perspective views of two alternative receivers according to the present disclosure. Receiver 800A includes base 510 (not shown), adapter 508A, and frame 802A.

[0177] The frame 802A includes ribs 804 that are configured to be located between the receptacles 206 of the blister card 122 when the frame is latched in place.

[0178] The frame 802A is attached to the adapter 508A by a hinge 806 located along the edge of the adapter where it meets the frame 802A. The frame 802A also includes a conventional latch (not shown) configured to attach to the flange 514 and secure the frame 802A over the blister card 122 to hold the blister card in place.

[0179] Receiver 800B is similar to receiver 800A; however, in receiver 800B, frame 802B is magnetically attached to adapter 508B rather than via a hinge.

[0180] Each of the frame 802B and the adapter 508B includes a fastener 808 configured to hold the frame in place once the frame is placed over the blister card, which also locks the blister card in place. In the depicted example, the fastener 808 is a permanent magnet; however, other conventional fasteners (e.g., Velcro, mechanical latches, electromagnetic fasteners, etc.) may be used as fasteners 808 without departing from the scope of the present invention.

[0181] It should be noted that some blister cards are designed to make them safer for children by using a multi-layer cover film that is difficult to break or tear. Typically, the layers include a metal foil (e.g., aluminum) on the inside, paper on the outside, and a thin polymer layer sandwiched between the metal and paper. In such blister cards, peeling off the cover film is a core step in gaining access to the contents of the reservoir. Unfortunately, this peeling action applies an upward force to the blister card; however, when the frames 802A and 802B are latched, the frames hold the blister card in place.

[0182] Thus, embodiments according to the present disclosure are suitable for use with such "peel-off" blister cards, even if the user chooses to remove the blister card from the base, tear off a dose (i.e., one or more reservoirs) along the perforated line of the card, and then place the card back into the base. It should be noted that if the user is expected to always remove the peel-off card as just described, then the base does not need to include a frame, thereby simplifying card removal and reinsertion of the card.

[0183] As long as the blister card is properly positioned in the receiver of a smart box according to the present disclosure, the blister card can be interrogated for reservoirs removed from the card, empty reservoirs, partially empty reservoirs, and intact reservoirs. It should be noted that for a smart box including a photodiode-based sensing system, the reservoir area removed from the blister card causes more light to be incident on its corresponding photodiode or diodes rather than on the empty blisters remaining on the card.

[0184] It will be apparent to those skilled in the art that a reservoir may be considered a specially shaped bottle, container, vial, tub, tube, bag, can, cassette, etc. Thus, the application of the smart box according to the present disclosure is not limited to the blister card format.

[0185] In addition, the type of material contained in the content compartment may determine the preferred type of sensing technology used in the smart box. For example, the content compartment may contain loose pills, liquids, gels, syrups, suspensions, powders, pastes, creams, strips, steam, sprays, etc. that are at least partially optically transparent. Therefore, it may be determined that sensing technology other than optical detection. In some examples, if, for example, the contents are electrically insulating, then capacitive sensing schemes (including electrical impedance tomography) will be preferred. If the contents are conductive, then resistance or impedance sensing (including resistance or impedance tomography) may be preferred. In some examples, acoustic sensing may be preferred.

[0186] It should be understood that the present disclosure teaches only some exemplary embodiments and that those skilled in the art may readily devise many variations of the invention after reading the present disclosure and that the scope of the invention is determined by the appended claims.

Claims

1. A smart box (500) for monitoring the status of any blister card in a set of blister cards (122) having different configurations, each blister card in the set of blister cards comprising a plurality of blisters (210) and a cover film (204) having a plurality of dispensing areas (212), the plurality of blisters (210) and the plurality of dispensing areas together defining a plurality of reservoirs (208) containing a first content (208), wherein the plurality of blisters together define a blister area (218), and each blister card in the set of blister cards has a different configuration, wherein the smart box comprises: a first body portion (P2) for holding a receiver (112) reconfigurable to position and secure each blister card in the set of blister cards; the receiver, wherein the receiver is configured to include any of a plurality of adapters removably positioned in the first body portion, each adapter configured to position a different blister card in the set of blister cards and having an outer perimeter (OP1) and an inner perimeter (IP1), the outer perimeter being based on a size of the first body portion and the inner perimeter being based on the blister area, wherein each adapter is configured to mechanically support each blister card; and A sensor system (114) is operable to monitor a status of each blister card in the set of blister cards.

2. The smart box of claim 1, wherein the receiver comprises the plurality of adapters.

3. The smart box of claim 1 , wherein a first adapter of the plurality of adapters comprises a first plurality of walls ( 512 ) defining a first plurality of cells ( 516 ), and wherein at least one dimension ( tx1 , ty1 ) of at least one of the first plurality of walls is based on a first inter-reservoir spacing ( sx1 , sy1 ) of a first blister card in the set of blister cards, and further wherein at least one dimension ( w2 , d2 , h2 ) of a first cell of the first plurality of cells is based on at least one dimension ( w1 , d1 , h1 ) of a first blister of the plurality of blisters of the first blister card.

4. A smart box according to claim 3, wherein the sensor system includes a plurality of photodiodes (408), the photodiodes being configured so that, for each blister card in the set of blister cards, light transmitted through each of its plurality of reservoirs is incident on a different photodiode in the plurality of photodiodes, and wherein a first wall in the plurality of walls is configured to inhibit light transmitted through a first reservoir (506-5C) in the plurality of reservoirs from being incident on at least one photodiode (408-4C) in the plurality of photodiodes.

5. The smart box of claim 1, wherein the sensor system comprises a first sensor (408-5C) configured to monitor a state of at least one of a first dispensing area (212-5C) of the plurality of dispensing areas and a first content (210-5C) of the plurality of contents.

6. The smart box of claim 5, wherein the first sensor is selected from the group consisting of a capacitive sensor, a strain sensor, an optical sensor, an acoustic sensor, a tactile sensor, a resistive sensor, an impedance sensor, a thermal sensor, and a magnetic sensor.

7. The smart box of claim 5, wherein the first sensor is a photodiode (408-5C) configured to receive light transmitted through the first reservoir (206-5C) when a corresponding dispensing area (212-5C) of the first reservoir (206-5C) is at least partially removed.

8. The smart box of claim 1, wherein the sensor system comprises a plurality of sensors (408) having a sensor density greater than or equal to a highest slot density of the set of blister cards.

9. The smart box of claim 1, wherein the sensor system includes a focal plane array configured to image at least a portion of each blister card in the set of blister cards when the blister card is positioned in the receiver.

10. A smart box according to claim 1, wherein the receiver further includes a frame (802A) configured to be removably attached to a first adapter among the plurality of adapters, wherein the frame and the first adapter are sized and arranged to secure a first blister card among the set of blister cards when the frame is attached to the first adapter.

11. The smart box of claim 10, wherein the frame and first adapter are attached via a hinge (806).

12. The smart box of claim 10, wherein at least one of the frame and the first adapter includes a fastener (808) configured to hold the frame and the adapter in a first arrangement.

13. The smart box according to claim 1, further comprising: a plurality of connectors (316) arranged around a perimeter of a first blister card in the set of blister cards when the first blister card is positioned in the receiver, the plurality of connectors (316) being configured to electrically couple with the first cover film when the first blister card is positioned in the receiver, the sensor system comprising a plurality of contacts; and An electronic module (104) is configured to receive at least one signal (124) from the plurality of connectors and generate a tomographic image of the first capping film based on the plurality of electrical signals.

14. The smart box of claim 7, wherein the first reservoir is adjacent to a second reservoir (206-4C) of the plurality of reservoirs, and wherein the first adapter includes a wall (512) disposed between the first and second reservoirs, the wall being configured to block propagation of light from the second reservoir to the first photodiode.

15. The smart box of claim 1, wherein the smart box comprises a housing including a body, a cover, and a latch for reversibly securing the cover and body in a closed configuration, wherein the latch is electrically actuatable.

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