Opening management system and opening detector

Abstract

To realize an opening management system that can report on the basis of an opening state.SOLUTION: An opening management system 10 comprises: a communication unit 61 capable of communicating with an opening detector 40 to be attached to a packaging material 20, and for detecting an opening state of the packaging material 20; and an information generation unit 62 for generating setting information for making the opening detector 40 perform predetermined processing related to opening detection.SELECTED DRAWING: Figure 1

Description

Technical Field

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[0001] This technology relates to an opening management system and an opening detector.

Background Art

[0002] Conventionally, in order to prevent patients from forgetting to take medicine, a management system that notifies patients of the medication time is known, and an example thereof is disclosed in Patent Document 1. The medication management system described in Patent Document 1 transmits schedule information such as the designated medication date and time by e-mail from an information distribution device installed in a dispensing pharmacy. The transmitted schedule information is received by a video device (specifically, a television receiver), and the television receiver performs a notification process to prompt medication. More specifically, the television receiver performs a telop display based on the schedule information, a linked display with an electronic program guide table, etc. According to the medication management system described in Patent Document 1, by notifying patients using a nearby television receiver, it is said that notification can be made reliably and effectively, and forgetting to take medicine can be prevented.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, the medication management system described in Patent Document 1 is a mechanism that notifies based on schedule information regardless of whether the medicine has been taken or not, and it is impossible to grasp which medicine the patient actually took. Therefore, even when the medication has been completed, a telop or the like continues to be displayed on the television receiver for a certain period of time. As a result, there is a concern that, despite having taken the medicine, the patient may accidentally take it again, or may take a medicine other than the designated medicine.

[0005] This technology was developed based on the circumstances described above, and aims to realize an opening management system and an opening detector that can provide notifications based on the opening status. [Means for solving the problem]

[0006] The means to solve the above problems are as follows:

[0007] <1> An opening management system comprising: a communication unit capable of communicating with an opening detector attached to the packaging material for detecting the opening state of the packaging material; and an information generation unit that generates setting information for causing the opening detector to perform predetermined processing related to opening detection.

[0008] <2> The setting information includes the detection time at which the tamper detection device detects tampering, and the predetermined process includes detecting the tampered state of the packaging material after the detection time, and issuing a notification if the tampered state is the same as the unopened state. <1> The opening management system described above.

[0009] <3> The setting information includes the detection frequency at which the tamper detection device detects tampering, and the predetermined process includes detecting the tampered state of the packaging material at the detection frequency, and issuing a notification if the tampered state is the same as the unopened state. <1> or <2> The opening management system described above.

[0010] <4> The above detection frequency is set to either periodic detection, which performs detection at regular intervals, or continuous detection. <3> The opening management system described above.

[0011] <5> The above setting information includes the frequency at which the tamper detector requests the transmission of the setting information. <1> from <4> An opening management system as described in any of the following.

[0012] <6> When the communication unit receives a request from the tamper detection device to transmit the setting information, it transmits the setting information to the tamper detection device. <5> The opening management system described above.

[0013] <7> The setting information includes the transmission frequency at which the opening detector transmits the opening status to the communication unit. <1> from <6> An opening management system as described in any of the following.

[0014] <8> The aforementioned tamper detection device comprises multiple devices, each having unique ID information, the configuration information includes the ID information, and the communication unit is capable of communicating with each of the aforementioned tamper detection devices. <1> from <7> An opening management system as described in any of the following.

[0015] <9> The opening management system according to any one of claims 1 to 8, wherein the packaging material contains a pharmaceutical product.

[0016] <10> the above <1> from <9> An opening detector comprising a communication unit capable of communicating with an opening management system described in any of the above, and a detection unit for detecting the opening state of the packaging material.

[0017] <11> The above includes a notification unit that issues a notification when the detection result of the detection unit indicates that the product is unopened. <10> The tamper-evident device described above.

[0018] <12> The detection unit detects the opened state of the packaging material after the detection time included in the setting information. <10> or <11> The tamper-evident device described above. [Effects of the Invention]

[0019] This technology enables the realization of an opening management system and an opening detector that can provide notifications based on the opening status. [Brief explanation of the drawing]

[0020] [Figure 1] Schematic diagram of the opening management system according to Embodiment 1 [Figure 2] Perspective view of a tamper-evident device attached to packaging material. [Figure 3] Perspective view of the tamper detection device [Figure 4] Perspective view of the internal components of the tamper detection device. [Figure 5] Perspective view of the unsealing detector with the second housing displaced upward [Figure 6] Perspective view of the enlarged right part of the first housing [Figure 7] Cross-sectional view taken along line I-I of FIG. 3 [Figure 8] Cross-sectional view taken along line II-II of FIG. 5 [Figure 9] Bottom view of the unsealing detector [Figure 10] Perspective view of the unsealing detector [Figure 11] Perspective view of the unsealing detector with the second housing displaced upward [Figure 12] Perspective view of the vicinity of the first protrusion and the second protrusion in FIG. 11, enlarged [Figure 13] Exploded perspective view of the packaging material [Figure 14A] Flowchart showing the processing of the unsealing management system [Figure 14B] Flowchart showing the processing of the unsealing management system [Figure 15A] Flowchart showing the processing of the unsealing management system [Figure 15B] Flowchart showing the processing of the unsealing management system [Figure 16] Schematic diagram of the unsealing management system according to Embodiment 2

Mode for Carrying Out the Invention

[0021] <Embodiment 1> The unsealing management system 10 according to Embodiment 1 will be described with reference to FIGS. 1 to <15B>. In some of the figures, the X-axis, Y-axis, and Z-axis are shown, and they are drawn so that the directions along each axis are common directions in each figure. Also, the directions along the X-axis, Y-axis, and Z-axis are defined as the left-right direction, front-back direction, and up-down direction, respectively. However, the above directions are only defined for convenience and should not be interpreted restrictively.

[0022] The tamper-evident management system 10 is a system for managing the administration of a drug T (an example of a contained item) based on the opened state of the packaging material 20 containing the drug T in tablet form. In this embodiment, the tamper-evident management system 10 is exemplified as a system for managing drug tamper-evident management, but the contained item may be something other than a drug T, and the tamper-evident management system 10 is broadly applicable to managing the opening of packaging materials. As shown in Figure 1, the tamper-evident management system 10 comprises a tamper-evident detector 40 attached to the packaging material 20, a management server (application server) 60, and an information processing terminal 70. The management server 60 and the information processing terminal 70 are connected to a communication network 80.

[0023] As shown in Figure 1, one tamper detection device 40 is attached to each package material 20. The tamper detection devices 40 are connected to the communication network 80 via Low Power Wide Area (LPWA) wireless communication. LPWA is a wireless communication technology that achieves long-distance transmission with reduced power consumption (for example, transmission power of 1W or less with a transmission distance of 10km or more), and is also known as a foundational technology for IoT (Internet of Things). LPWA communication services are provided by multiple telecommunications carriers, such as sigfox®, LoRa®, and NB-IoT. The tamper detection devices 40 are wirelessly connected to an LPWA base station 85, which is connected to an LPWA communication server (LPWA cloud server) 86. The communication server 86 is connected to the communication network 80. Therefore, the tamper detection devices 40 can communicate with a management server 60 connected to the communication network 80 via the communication server 86. Each tamper detection device 40 has unique ID information, and the management server 60 can communicate with each tamper detection device 40.

[0024] The tamper detection device 40 only needs to be connected to at least one of the management server 60 or the information processing terminal 70, and the tamper detection device 40 may use communication technologies other than LPWA as its communication means. For example, low-power wireless communication technologies such as BLE (Bluetooth Low Energy®) are preferred, but more common technologies such as Wi-Fi or LTE are also acceptable.

[0025] As shown in Figure 1, the information processing terminal 70 is a general-purpose information processing device such as a smartphone or computer. The information processing terminal 70 is intended for use by patients, as well as medical personnel at hospitals and pharmacies that prescribe the drug T, but the users are not particularly limited (hereinafter, the users of the information processing terminal 70 will simply be referred to as users). Multiple information processing terminals 70 may be provided, and each terminal may be used by a different user. The information processing terminal 70 executes a program for users to input registration information such as the time of administration of drug T and to display the opened status of drug T. In this embodiment, this program is assumed to be installed on the information processing terminal 70 as application software (hereinafter referred to as an app), but it may not be installed and may be executed, for example, through browser software. This allows for miniaturization of the opening detector 40 and reduces the power consumption of the opening detector 40.

[0026] The management server 60 provides information and processing results in response to requests from the information processing terminal 70 or the open detection device 40. The management server 60 refers to a means of implementing server functions that execute programs to realize these functions. In this embodiment, the management server 60 is exemplified as a server computer as shown in Figure 1, but it may also exist virtually in network space using distributed computing or the like. Furthermore, the management server 60 may perform processing using artificial intelligence.

[0027] As shown in Figure 1, the management server 60 includes at least a communication unit 61 for connecting to the communication network 80 and an information generation unit 62. The management server 60 can communicate with the information processing terminal 70 via the communication unit 61 and can also communicate with the tamper detection device 40 via the communication server 86. The information generation unit 62 generates setting information to cause the tamper detection device 40 to perform predetermined processing related to tamper detection based on registration information from the information processing terminal 70. The processing of the management server 60 will be described in detail later.

[0028] As shown in Figures 2 to 4, the tamper detection device 40 comprises a plurality (12 in this embodiment) of connection parts 41, an LPWA communication module 42, an LED 45 (an example of a notification part), a reset button 46 (an example of an operation part), a rechargeable battery 47 (an example of a power supply part), a circuit board 49, and a housing 50. The circuit board 49 mounts the connection parts 41, the communication module 42, the LED 45, the reset button 46, and a connector insertion part 37A for connecting an external power supply to the rechargeable battery 47. The housing 50 houses the circuit board 49 with the parts mounted on it and the rechargeable battery 47, and also serves as a mounting part for detachably holding the packaging material 20.

[0029] As shown in Figure 4, the connection portion 41 comprises a support 41A and a contact 41B. The support 41A is mounted on the substrate 49 and, in this embodiment, is substantially cylindrical, but its shape is not limited. The contact 41B protrudes upward from the upper surface of the support 41A (the surface opposite to the substrate 49), and at least its protruding end is conductive. When the packaging material 20 is attached to the tamper detector 40 (Figure 2), the contact 41B comes into contact with the circuit pattern 32 of the packaging material 20, which will be described later, and becomes electrically conductive.

[0030] As shown in Figure 4, the communication module 42 includes a communication unit 43 (specifically an antenna), a control unit 44 (specifically a microcomputer), and a storage unit 48 (specifically ROM and RAM). The communication unit 43 is wirelessly connected to the base station 85 and can communicate with the management server 60 via the communication server 86. The storage unit 48 stores the control program for the tamper detection device 40, ID information, and the like.

[0031] The control unit 44 controls each part of the tamper detector 40 based on the control program of the storage unit 48 and the setting information transmitted from the management server 60. The control unit 44 also includes a timer with a timing function and also serves as a detection unit for detecting the tampering of the packaging material 20. The control unit (detection unit) 44 sends current to the connection unit 41 and detects the voltage generated in the circuit pattern 32 of the packaging material 20. The control unit 44 then compares the detected voltage value with a predetermined threshold. If it is below the threshold, it determines that the circuit pattern 32 is not broken and the package is unopened. If it is above the threshold, it determines that the circuit pattern 32 is broken and the package is open. The control unit 44 may determine the open state based on the resistance value of the circuit pattern 32 that changes due to the breakage, or it may determine the open state based on the current value when a predetermined voltage is applied.

[0032] LED 45 lights up (flashes) in a predetermined pattern when the detection result (judgment result) of the control unit 44 indicates that the package is unopened, thereby notifying the user of missed medication. LED 45 also lights up when the opening detector 40 is connected to an external power supply, etc. LED 45 is built into the housing 50, and the light emitted from LED 45 is transmitted through the housing 50. More specifically, the housing 50 is made of a material and thickness that allows the light emitted from LED 45 to pass through. Note that LED 45 is merely one example of a notification unit, and the notification unit may be a light-emitting means other than an LED, a sound-emitting means such as a buzzer, a display means that displays a message, or a combination of these.

[0033] The housing 50 is made of resin material and, as shown in Figures 3 and 5, has a rounded, horizontally elongated rectangular parallelepiped shape. The housing 50 comprises a first housing 51 and a second housing 52. The first housing 51 occupies most of the housing 50 and has a recessed front upper part. The second housing 52 is a lid that covers the recess on the front upper part of the first housing 51. The second housing 52 is attached to the first housing 51 so as to be displaceable in the vertical direction (Z-axis direction). The packaging material 20 is held between the first housing 51 and the second housing 52 as the second housing 52 is displaced, as shown in Figure 2. In other words, the housing 50 has a clamping structure composed of the first housing 51 and the second housing 52 as the attachment part for the packaging material 20. The parts of the housing 50 will be described in detail below, but except for Figure 2, the illustration of the packaging material 20 will be omitted in order to clarify the structure of the housing 50.

[0034] As shown in Figures 5 to 8, the first housing 51 has a tray-shaped bottom 51A that opens upward and an upper part 51B that covers the opening of the bottom 51A from above. The bottom 51A houses a rechargeable battery 47, and a circuit board 49 is placed on top of the rechargeable battery 47. The upper part 51B covers the top of the circuit board 49. The upper part 51B is provided with a through hole 51B1 through which a connecting part 41 installed on the circuit board 49 passes, and the contact element 41B of the connecting part 41 protrudes from the through hole 51B1 and is exposed to the outside (Figures 6 and 11).

[0035] As shown in Figures 7 to 9, the bottom 51A of the first housing 51 is provided with two first communication holes 51C that communicate with two engaging portions 52B of the second housing 52, which will be described later. The first communication holes 51C are provided so as to overlap the engaging portions 52B in a plan view. In addition, a part of the opening edge of the first communication holes 51C of the bottom 51A of the first housing 51 protrudes upward, and a projection 51A1 is formed at the protruding end. The projection 51A1 engages (fits) with the convex portion 52B1 of the engaging portion 52B of the second housing 52 (Figures 7 and 8).

[0036] Furthermore, as shown in Figure 5, an alignment mark 51A2 (an example of an alignment part) is provided on the front surface of the bottom portion 51A. In this embodiment, the alignment mark 51A2 is formed as a protrusion at the center position in the left-right direction (X-axis direction) on the front surface of the bottom portion 51A. The alignment mark 51A2 serves as an indicator for aligning with a predetermined position on the packaging material 20 (for example, the end portion 32A of the circuit pattern 32 of the packaging material 20). This makes it easier to align the packaging material 20 when attaching it to the tamper detector 40, and ensures that the circuit pattern 32 of the packaging material 20 and the contactor 41B of the tamper detector 40 make reliable contact and conduction.

[0037] Furthermore, as shown in Figure 5, an insertion hole 51D for inserting a connector into the connector insertion section 37A is provided on the right side of the first housing 51, and as shown in Figure 10, a second communication hole 51E is provided on the back of the first housing 51 that communicates with the space where the reset button 46 is located. By inserting an operating pin or the like into the second communication hole 51E from the outside and pressing the reset button 46, the control unit 44 can be made to perform a reset process to return to the initial state.

[0038] As shown in Figures 7 to 8 and 11 to 12, the second housing 52 comprises a lid portion 52A, two engaging portions 52B, two first protrusions 52C, and a second protrusion 52D. The lid portion 52A extends above the portion in which the contactor 41B is exposed. The lid portion 52A comprises a ceiling wall portion 52A1 that covers the contactor 41B from above, and a right-side wall portion 52A2 (another example of an alignment portion) that covers the contactor 41B from the right. The lid portion 52A does not cover the contactor 41B from the front and left, and has a substantially L-shaped opening 52A3 that opens to the front and left. By providing the right-side wall portion 52A2 and the opening 52A3 on the lid portion 52A, when attaching the packaging material 20, the packaging material 20 can be inserted through the opening 52A3 and aligned in a contact state where it abuts against the right-side wall portion 52A2. Furthermore, since the left side of the lid 52A is open by the opening 52A3, it can be applied to packaging materials 20 of different sizes (length in the short side direction).

[0039] As shown in Figures 7 and 8, the engaging portion 52B extends downward from the lid portion 52A and engages (fits) with the bottom portion 51A of the first housing 51. A protrusion 52B1 is formed at the extended end of the engaging portion 52B, and the protrusion 52B1 engages with the projection 51A1 of the bottom portion 51A. When the protrusion 52B1 is positioned below the projection 51A1 (Figure 7, hereafter referred to as the first position), the second housing 52 is displaced downward, and the packaging material 20 is held between the first housing 51 and the second housing 52 in a clamped state. On the other hand, when the protrusion 52B1 is positioned above the projection 51A1 (Figure 8, hereafter referred to as the second position), the second housing 52 is displaced upward, and the packaging material 20 is not held between the first housing 51 and the second housing 52 in a non-clamped state. The engaging portion 52B engages with and connects to the bottom portion 51A of the first housing 51 in both the first and second positions.

[0040] When the lid portion 52A is pressed from above to below, the protrusion 52B1 of the engaging portion 52B slides down from the upper side of the projection 51A1 to the lower side, displacing it from the second position to the first position. Furthermore, when an operating pin or the like is passed through the first communication hole 51C from the outside and the protrusion 52B1 is operated by the operating pin or the like, the engaging portion 52B is displacing it from the first position to the second position. More specifically, as shown in Figure 9, if the tamper detection device 40 is positioned with the bottom portion 51A facing upwards, and an operating pin or the like is passed through the first communication hole 51C from the outside, and the protrusion 52B1 is moved left to right (for example, in the direction of the white arrow in Figure 7) while the protrusion 52B1 is pushed downwards (towards the upper part 51B), the protrusion 52B1 slides along the slope 51A1S of the projection 51A1. As a result, the engaging portion 52B is easily displaced from the first position to the second position. In this way, changing the packaging material 20 from a clamped state (first position) to a non-clamped state (second position) requires moving the protrusion 52B1 using an operating pin or the like, and cannot be directly operated by hand, thus making it easier to suppress erroneous operation. In addition, the packaging material 20 can be held more stably in the clamped state. Furthermore, in the non-clamped state (second position), the inclined surface 51A1S of the projection 51A1 is covered by the protrusion 52B1, so it becomes difficult to displace the protrusion 52B1 from the outside using an operating pin or the like and completely remove the second housing 52 from the first housing 51. As a result, the second housing 52 is connected to the first housing 51 so that it can be displaced vertically (in the Z-axis direction) relative to the first housing 51, but cannot be completely removed. Note that the first communication hole 51C communicating with the engaging portion 52B means that the first communication hole 51C communicates with the space where the engaging portion 52B exists (first position) in the clamped state.

[0041] The first protrusion 52C is made of a flexible soft material and is provided to protrude downward from the lid 52A, as shown in Figures 11 and 12. The first protrusion 52C is a horizontally elongated rectangular parallelepiped and there are two of them spaced apart in the left-right direction (X-axis direction). The second protrusion 52D is made of a hard material, is a tapered rod shape, and is provided between the two second protrusions 52D. When the packaging material 20 is attached to the tamper detection device 40 (Figure 2), the protruding surface (bottom surface) of the first protrusion 52C and the tip of the second protrusion 52D are pressed against the surface of the main body 21 of the packaging material 20.

[0042] By providing the first protrusion 52C and the second protrusion 52D, the holding force can be improved when the packaging material 20 is held between them. The first protrusion 52C and the second protrusion 52D do not come into contact with the circuit pattern 32 of the packaging material 20 and are non-conductive, so the holding force can be improved without affecting the opening detection. The material and shape of the first protrusion 52C and the second protrusion 52D can be changed as appropriate, as long as the holding force can be improved by an anti-slip effect, for example, they may be made of an elastic material, an adhesive material, a high-friction material, etc. Also, it is acceptable to provide only one of the first protrusion 52C and the second protrusion 52D, rather than both.

[0043] With the housing 50 configured as described above, the tamper detection device 40 and the packaging material 20 can be easily and securely attached without the use of separate fasteners. Furthermore, the displacement of the second housing 52 makes it easy to attach and detach.

[0044] As shown in Figure 13, the packaging material 20 comprises a main body 21 for containing the tablet drug T and an tamper-evident sheet 30 attached to the main body 21. In this embodiment, a well-known PTP (press-through package) is exemplified as the main body 21, but other materials are acceptable as long as they can contain the contents. The main body 21 is rectangular in shape overall and comprises a sheet-like container with a storage section 22 for containing the drug T and a lid material 24. The lid material 24 is attached to the sheet-like container and covers the opening 22A of the storage section 22, sealing the storage section 22.

[0045] As shown in Figure 13, the tamper detection sheet 30 has a planar shape and planar size that conforms to the main body 21 and is attached to the lid material 24 of the main body 21. The tamper detection sheet 30 is a sheet-like composite material in which a base material 31, a circuit pattern 32, and a protective layer 33 are laminated in order from the main body 21 side. The circuit pattern 32 is a plurality of wires formed by printing conductive ink or the like on the base material 31. The circuit pattern 32 is formed to include the same number of current paths as the number of housing sections 22, and a portion of each current path is assumed to overlap with the opening 22A of the housing section 22 in a plan view. The protective layer 33 is formed of a resin material and covers and protects the circuit pattern 32. The protective layer 33 is formed on the surface of each wire constituting the circuit pattern 32, excluding the ends 32A. In other words, the protective layer 33 does not cover the ends 32A of the circuit pattern 32, and the ends 32A are exposed to the outside.

[0046] The packaging material 20 is attached to the tamper detector 40 such that the surface (first main surface) of the tamper detection sheet 30 faces the first housing 51, and the surface (second main surface) of the main body 21 faces the second housing 52 (Figure 2). Once the packaging material 20 is attached, the end 32A of the circuit pattern 32 contacts the contact 41B of the connection part 41 of the tamper detector 40, creating electrical conductivity.

[0047] With the packaging material 20 configured as described above, when the pharmaceutical product T is pushed out of the storage section 22, the tamper detection sheet 30 is punctured along with the lid material 24. As a result, the circuit pattern 32 that overlaps with the storage section 22 in a plan view is broken. Consequently, the voltage value generated in the circuit pattern 32 is different before and after the break (before and after the pharmaceutical product T is pushed out), and as previously described, the control unit 44 of the tamper detection device 40 can determine whether the packaging material 20 is open or unopened.

[0048] Next, the specific processing of the opening management system 10 with the above configuration will be explained with reference to Figures 14A, 14B, 15A, and 15B. Hereinafter, the flow of information from the information processing terminal 70 to the management server 60, the communication server 86, and the opening detector 40 will be referred to as downlink communication, and conversely, the flow of information from the opening detector 40 to the communication server 86, the management server 60, and the information processing terminal 70 will be referred to as uplink communication.

[0049] The user launches the application on the information processing terminal 70 and enters the registration information for the tamper detection device 40. When entering the registration information, the user reads the ID information attached to the housing 50 of the tamper detection device 40 and enters it into the information processing terminal 70, or the information processing terminal 70 reads it directly, and the management server 60 records the correspondence between the ID information of the tamper detection device 40 and the identification information of the information processing terminal 70. The housing 50 of the tamper detection device 40 may be attached with an encrypted code instead of plain text ID information, and the management server 60 may decrypt the encrypted code into ID information. The ID information of the tamper detection device 40 may be device-specific information for the tamper detection device 40 and the information processing terminal 70. The identification information of the information processing terminal 70 may be device-specific information for the information processing terminal 70, or it may be information specific to the user using the information processing terminal 70.

[0050] As shown in Figure 14A, the entered registration information is transmitted downlink to the management server 60 by the information processing terminal 70 (S100). Specifically, the registration information includes the time of administration of drug T (an example of detection time), the frequency of opening detection by the opening detector 40, the notification settings of the opening detector 40, the frequency of transmission of opening detection results from the opening detector 40, and the frequency of requests for transmission of setting information from the management server 60. In addition, the ID information of the opening detector 40 and the identification information of the information processing terminal 70 are associated with the registration information transmitted downlink to the management server 60.

[0051] The medication time includes the time of each dose if medication is taken multiple times a day. For example, if medication is taken three times a day after meals, the time of each dose after breakfast, lunch, and dinner is included. The opening detection frequency is set to either perform detection periodically at regular intervals (hereinafter referred to as periodic detection) or continuous detection (hereinafter referred to as real-time detection), and further, the time interval for periodic detection (for example, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 60 minutes, 120 minutes). Setting it to periodic detection saves power compared to real-time detection, and power saving is further reduced by setting a longer time interval for periodic detection. In this embodiment, the case where periodic detection is set will be described in detail.

[0052] The notification setting for the tamper detection device 40 is the setting for the lighting pattern of the LED 45 when medication is missed (unopened), and multiple patterns with different lighting (flashing) times can be selected. The transmission frequency of the tamper detection result from the tamper detection device 40 is a setting for whether or not to transmit information (uplink) from the tamper detection device 40 only when there is a change in the tamper detection result. Setting it to transmit only when there is a change in the tamper detection result reduces the data transmission frequency of the tamper detection device 40, thus saving power. In this embodiment, the case in which data is transmitted only when there is a change in the tamper detection result will be specifically described.

[0053] The frequency of requests for the transmission of configuration information from the management server 60 (hereinafter referred to as the periodic downlink frequency) can be set to either once a day (for example, after the medication time following dinner) or multiple times a day (for example, after each medication time following breakfast, lunch, and dinner). By adjusting the periodic downlink frequency, the configuration information of the opening detector 40 can be updated while minimizing the power consumption of the opening detector 40 associated with the update. In this embodiment, the case where the periodic downlink frequency is set to be after each medication time will be described in detail.

[0054] As shown in Figure 14A, when activated, the tamper detection device 40 transmits initial data via uplink (S200). The data transmitted via uplink from the tamper detection device 40 (uplink data) includes ID information, tamper detection time, tamper detection result (determination result by the control unit 44 regarding the tamper status of each storage unit 22), remaining charge of the rechargeable battery 47, whether or not the circuit pattern 32 of the packaging material 20 is connected to the connection unit 41, and whether or not the independent mode is activated. The initial data is the uplink data when the tamper detection device 40 is activated or when the reset button 46 is turned ON. Because the uplink data includes the ID information of the tamper detection device 40, even if there are multiple tamper detection devices 40 (even if there are multiple packaging materials 20 (and thus pharmaceuticals T)), tamper detection can be performed for each tamper detection device 40, and notification based on the tamper status can be performed for each tamper detection device 40.

[0055] Independent mode is an operating mode that is activated when radio wave conditions are poor and the downlink data described later cannot be sent to the tamper detection sensor 40. In independent mode, uplink data is sent at periodic intervals determined by a timer in the control unit 44 of the tamper detection sensor 40, rather than at the data transmission frequency (transmission frequency of tamper detection results) set in the registration information entered in the app. According to independent mode, even if radio wave conditions are poor and downlink data cannot be sent to the tamper detection sensor 40 properly, uplink data will be sent from the tamper detection sensor 40. However, since the current time included in the downlink data is not sent to the tamper detection sensor 40, the process of flashing the LED 45 to issue an alert to notify of a missed dose is not executed when independent mode is activated.

[0056] As shown in Figure 14A, when the communication server 86 receives uplink data from the open detector 40, it forwards the uplink data to the management server 60 and also requests a callback (transmission request) for configuration information from the management server 60 (S300). The management server 60 receives the uplink data forwarded from the communication server 86 (S400). The information generation unit 62 of the management server 60 generates configuration information to cause the open detector 40 to perform predetermined processing related to open detection based on the registration information transmitted from the information processing terminal 70 in step S100, and outputs (transmits) this configuration information (hereinafter referred to as downlink data) in response to the callback request from the communication server 86 (S402). In this embodiment, the downlink data is configuration information generated as 64-bit data and includes the registration information described above and the current time.

[0057] As shown in Figure 14A, the communication server 86 receives downlink data from the management server 60 and forwards it to the tamper detection device 40 (S302). The downlink data overwrites the storage unit 48 of the tamper detection device 40, and the configuration information of the tamper detection device 40 is updated (S202). Therefore, after the update, the control unit 44 of the tamper detection device 40 will execute predetermined processing related to tamper detection based on the updated configuration information.

[0058] Next, the control unit 44 of the tamper detection device 40 determines whether it is the last dose of medication for the day (for example, the third dose if the medication is taken three times a day) as shown in Figure 14B (S204). If it is the last dose of medication (YES in S204), the control unit 44 sets a timer to switch the operating mode of the tamper detection device 40 to a power-saving mode (night mode) after a certain period of time (for example, after 4 hours) (S208). Night mode is a type of power-saving mode that, in addition to the operation of the standby mode described later, stops periodic detection. In power-saving mode, the tamper detection device 40 is kept in standby mode during times when there is no medication to be taken and tamper detection is not required, such as at night, thereby reducing power consumption.

[0059] After the timer is set, when the tamper detection device 40 requests downlink data for the next day (S210), the communication server 86 issues a callback request (S304), and the management server 60 outputs (transmits) downlink data (S404). The downlink data is transmitted to the tamper detection device 40 via the communication server 86 (S306). The downlink data overwrites the memory unit 48 of the tamper detection device 40, updating the configuration information of the tamper detection device 40 (S212). Then, after the timer setting time in step S206 has elapsed, the tamper detection device 40 switches to power-saving mode and enters a standby state (S214). On the other hand, if it is not the last medication dose in step S204 (NO in S204), the control unit 44 switches the operating mode of the tamper detection device 40 to power-saving mode (standby mode) (S214). Standby mode is a type of power-saving mode in which opening detection (current is passed through the connection part 41 of the opening detector 40 to detect the voltage generated in the circuit pattern 32 of the packaging material 20 and determine the opening state) is not performed.

[0060] After being switched to power-saving mode (S214 in Figure 14B), the tamper detection device 40 starts up from power-saving mode at a predetermined timing (for example, in the case of periodic detection, at a timing activated by the timer of the control unit 44 based on the detection interval included in the downlink data) as shown in Figure 15A (S220). The control unit 44 then detects the tampering of each storage unit 22 and determines the tampering status (S222), and if it is tampered with, it outputs (transmits) uplink data (S238). The uplink data is transmitted to the management server 60 via the communication server 86 (S320) (S420), and the tampering status is displayed on the information processing terminal 70 (S120). On the other hand, if the tampering status is not tampered with in step S222, the control unit 44 puts the tamper detection device 40 into power-saving mode (standby mode) (S226).

[0061] Next, the control unit 44, when the current time is after the medication time (YES in S228), deactivates the power-saving mode (standby mode) (S229) and performs opening detection again (S230). If the package remains unopened (NO in S230), the LED 45 flashes to issue an alert (S232) because the packaging material 20 has not been opened (and therefore the medicine T has not been taken out) even after the medication time has passed. On the other hand, if the package is opened (YES in S230), the process returns to step S222.

[0062] Next, the control unit 44 performs an open detection again after a set time interval for periodic detection (S234). If the package remains unopened (NO in S234), there is no change from the previous open detection result, which was the unopened state (NO in S230), so no uplink data is output (sent), the alert stops after a certain period of time (S236), and the process returns to step S222. On the other hand, if the package is opened (YES in S234), there is a change from the previous open detection result, which was the unopened state (NO in S230), so uplink data is output (sent) to the communication server 86 (S238). The uplink data includes data indicating the open time, which is the current time when the control unit 44 of the open detection device 40 detected the open state. As described above, the uplink data is sent to the management server 60 via the communication server 86 (S320) (S420), and the open status is displayed on the information processing terminal 70 (S120). The management server 60 transfers the uplink data to the information processing terminal 70, and the information processing terminal 70 displays the opening status, including at least the opening time, based on the uplink data. The management server 60 also obtains the ID information of the opening detector 40 included in the uplink data and transfers the uplink data to the information processing terminal 70 that has entered the registration information associated with this ID information.

[0063] Furthermore, after outputting uplink data (S238), the control unit 44 of the tamper detection device 40 determines whether the current time is after the last medication time (S240). The last medication time is the latest time among the multiple medication times included in the downlink data. The last medication time is a predetermined time after the medication time, and is the final time when the drug T should be taken. Since the drug T is required to be taken after the medication time, and at the latest by the last medication time, the packaging material 20 is required to be opened after the medication time, and by the last medication time. If the current time is not after the last medication time (NO in S240), the process returns to step S222 and the tamper detection process described above is repeated.

[0064] If the current time is after the last medication time (YES in S240), as shown in Figure 15B, the tamper detection device 40 requests downlink data (S242), a callback request is sent from the communication server 86 (S322), and downlink data is output (sent) from the management server 60 (S422). The downlink data is transmitted to the tamper detection device 40 via the communication server 86 (S324). The downlink data overwrites the storage unit 48 of the tamper detection device 40, and the setting information of the tamper detection device 40 is updated (S244). After the update, the tamper detection device 40 switches to power saving mode (S246).

[0065] <Embodiment 2> The opening management system 110 according to Embodiment 2 will be described with reference to Figure 16. In Embodiment 2, redundant explanations of the same configuration, operation, and effects as in Embodiment 1 will be omitted.

[0066] In the unsealing management system 110, the unsealing detector 140 is communicatively connected to the information processing terminal 170 via BLE (Bluetooth Low Energy (registered trademark)). The unsealing detector 140 includes a communication module for BLE, and the information processing terminal 170 has a BLE function. Thereby, the unsealing detector 140 is paired and connected to the information processing terminal 170, and can communicate with the management server 60 connected to the communication network 80 via the information processing terminal 170. In this way, even in a situation where LPWA communication is not available (for example, in an area where the base station 85 is not installed), unsealing detection and notification based on the unsealing state can be realized.

[0067] <Other embodiments> The present invention is not limited to the embodiments described above and in the drawings. For example, the following embodiments are also included in the technical scope of the present invention.

[0068] (1) The shape of the housing 50 shown in the figure is an example and can be changed as appropriate.

[0069] (2) The shape of the packaging material 20, the number and intervals of the accommodating portions 22, etc. shown in the figure are examples and can be changed as appropriate.

[0070] <Examples of utilization of uplink data> As described above, the management server 60 may transfer the uplink data to the information processing terminal 70 as it is, or may transmit various processed data generated by information processing based on the uplink data to the information processing terminal 70. Further, the management server 60 may transmit the uplink data or the processed data to terminals other than the information processing terminal 70 that has input the registration information.

[0071] The uplink data and processing data may be transmitted to a terminal used by a person taking the drug T packaged in the packaging material 20, to a terminal of a medical institution that prescribed the drug T, to a terminal of a pharmaceutical manufacturer that produces the drug T, to a terminal of a packaging material manufacturer that produces the packaging material 20, or to a terminal of a distributor along the distribution route of the drug T. It is desirable that the management server 60 be configured to prevent external access to the uplink data and processing data and to transmit the uplink data and processing data only to legitimate recipients. The management server 60 may also encrypt and record the uplink data and processing data so that only legitimate recipients can decrypt it.

[0072] As previously described, the management server 60 may perform the following information processing based on the uplink data. The management server 60 may create an opening time database that stores the registration information entered at the information processing terminal 70 and the opening time indicated by the uplink data. Furthermore, the management server 60 may determine whether the medication has been taken appropriately by comparing the medication time indicated by the registration information with the opening time, and send processed data indicating the determination result to various terminals. Such processed data is useful to prescribers of drug T, such as doctors and pharmacists, and is also useful to those who take drug T.

[0073] The management server 60 may generate processed data by statistically processing the opening times stored in the opening time database. Specifically, the management server 60 may statistically process the opening times for each attribute of the person taking drug T (e.g., age, gender, etc.), or for each type of drug T. Furthermore, the management server 60 may generate a predictive model to predict drug T adherence by performing machine learning using the opening times stored in the opening time database as training data. The management server 60 may send data indicating the adherence status predicted by the predictive model to each terminal as processed data.

[0074] The packaging material 20 is not necessarily limited to packaging pharmaceuticals T, and can be used to package any packaged item that is used or consumed after being opened. Furthermore, the packaging material only needs to be capable of to which the tamper detection device 40 can be attached, and does not necessarily need to seal the package. The packaging material may also be a seal that is attached across the container containing the packaged item and the packaged item itself, and may be broken when the packaged item is removed from the container. For example, the packaging material may be a seal that is attached across a file as the container and a book or pamphlet as the packaged item. For example, if the present invention is applied to packaged items with a fixed expiration date, such as food, it becomes possible to verify whether the item is being consumed at an appropriate time based on the opening time indicated by the uplink data. Even if the present invention is applied to packaged items with an unlimited expiration date, the consumption status of the packaged item can be grasped based on the opening time indicated by the uplink data, thus providing useful information to the supplier and producer of the packaged item. [Explanation of symbols]

[0075] 10: Opening management system, 20: Packaging material, 40, 140: Opening detector, 43: Communication unit, 44: Control unit (detection unit), 45: LED (notification unit), 61: Communication unit, 62: Information generation unit, T: Pharmaceuticals

Claims

1. A communication unit that can communicate with an tamper detection device attached to the packaging material to detect the opened state of the packaging material, The device comprises an information generation unit that generates setting information for causing the tamper detection device to perform predetermined processing related to tamper detection, The setting information includes the frequency at which the tamper detection device requests the transmission of the setting information, and the frequency at which the tamper detection device transmits the tamper status to the communication unit. When the communication unit receives a request from the tamper detection device to transmit the setting information, it transmits the setting information to the tamper detection device. The aforementioned predetermined process is, If the setting information is successfully transmitted from the communication unit to the opening detector, the opened status is transmitted to the communication unit at the transmission frequency, An opening management system that, if the setting information is not properly transmitted from the communication unit to the opening detector, transmits the opening status to the communication unit at periodic intervals determined by a timer provided in the opening detector, rather than at the transmission frequency.

2. The aforementioned setting information includes the detection time at which the tamper detection device detects tampering. The opening management system according to claim 1, wherein the predetermined processing includes detecting the opening state of the packaging material after the detection time, and issuing a notification if the opening state is the unopened state.

3. The aforementioned setting information includes the detection frequency at which the tamper detection device performs tamper detection. The opening management system according to claim 1 or claim 2, wherein the predetermined processing includes detecting the opening state of the packaging material at the detection frequency, and issuing a notification if the opening state is the unopened state.

4. The opening management system according to claim 3, wherein the detection frequency is set to either periodic detection, which is performed periodically at regular intervals, or continuous detection.

5. There are multiple tamper detection devices, each possessing unique ID information. The aforementioned configuration information includes the aforementioned ID information, The tampering management system according to any one of claims 1 to 4, wherein the communication unit is capable of communicating with each of the tampering detectors.

6. The opening management system according to any one of claims 1 to 5, wherein the packaging material contains a pharmaceutical product.

7. A communication unit capable of communicating with the opening management system described in any one of claims 1 to 6, An opening detector comprising a detection unit for detecting the opened state of the packaging material.

8. The opening detector according to claim 7, further comprising an alerting unit that issues an alert when the detection result of the detection unit indicates that the package is unopened.

9. The opening detector according to claim 7 or 8, wherein the detection unit detects the opening state of the packaging material after the detection time included in the setting information.

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