Medical devices

Abstract

To provide a medical device that can prevent the misuse of used items. [Solution] A medical device 1 to which a consumable 2 is attached and used, wherein the consumable 2 has a defined usage time limit, and the consumable 2 has an information display unit 21 that displays individual identification information of the consumable 2, a reading unit 3 that reads the individual identification information from the information display unit 21, and a consumable management unit 41 that monitors the usage time of the consumable 2 based on the individual identification information displayed by the information display unit 21 and determines whether the usage time of the consumable 2 has reached the usage time limit.

Description

Technical Field

[0001] The present invention relates to medical devices such as blood purification devices.

Background Art

[0002] When replacing consumables in a medical device, there is a risk of accidentally reinstalling a used item or installing a used item in another device. In particular, for durable consumables such as filters that do not change shape before and after use, it is difficult to distinguish between before and after use, and there is a problem that it is easy to accidentally install a used item.

[0003] Therefore, for example, in Patent Document 1, it has been proposed to prevent reuse by providing "information storage means" in the consumable itself.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, when providing information storage means in a consumable as in Patent Document 1 above, there is a problem that the cost of the consumable increases. Therefore, it is required to suppress the misuse of used items without providing information storage means in the consumables.

[0006] Therefore, an object of the present invention is to provide a medical device capable of suppressing the misuse of used items.

Means for Solving the Problems

[0007] A medical device according to one embodiment of the present invention is a medical device to which a consumable is attached and used, wherein the consumable has a defined usage time limit, the consumable has an information display unit that displays individual identification information of the consumable, a reading unit that reads the individual identification information from the information display unit, and a consumable management unit that monitors the usage time of the consumable based on the individual identification information displayed by the information display unit and determines whether the usage time of the consumable has reached the usage time limit. [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a medical device that can suppress the misuse of used products. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic diagram showing a medical device according to one embodiment of the present invention. [Figure 2] This is a schematic diagram of a blood purification device used as a medical device. [Figure 3] This figure shows an example of a consumables information database. [Figure 4] This figure shows an example of a connection configuration for multiple medical devices. [Figure 5] This is a flowchart for managing consumables in medical devices. [Figure 6] This figure shows an example of a connection configuration for multiple medical devices. [Modes for carrying out the invention]

[0010] [Embodiment] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

[0011] (Outline configuration of medical device 1) Figure 1 is a schematic diagram showing a blood purification device 10 as a medical device 1 according to this embodiment. The medical device 1 according to this embodiment is a device to which consumables 2 are attached and which performs treatment (in this case, blood purification treatment) using said consumables 2. Here, we will explain the case where the medical device 1 is a blood purification device 10, but the medical device 1 is not limited to the blood purification device 10.

[0012] Furthermore, the consumables 2 managed in this embodiment are durable consumables such as filters. Durable consumables are consumables 2 that have a relatively long usage period and a specified usage limit. Here, the usage limit is the usage period during which the consumables 2 can be used normally, and is the upper limit of usage time set by the manufacturer, etc., in order to prevent malfunctions such as failures or reduced effectiveness due to overuse, i.e., the usage period during which replacement of the consumables is recommended. The expiration date, which will be described later, is the date that indicates the deadline by which the consumables 2 can be used, regardless of whether the consumables 2 have been used or not, and means that consumables 2 that have exceeded their expiration date may not be usable normally due to deterioration over time, etc. The expiration date is usually set to a date after a predetermined period has elapsed from the date of manufacture.

[0013] As shown in Figure 1, the blood purification device 10, which is a medical device 1 according to this embodiment, uses a dialysate filter 2a as a consumable 2. Here, as an example, the case in which the consumable 2 to be managed is a dialysate filter 2a is described, but it may also be a blood purifier 2b (also called a dialyzer), and various consumables can be targeted. In particular, it is desirable to designate the dialysate filter 2a and blood purifier 2b, which have a significant impact on treatment when misused, as consumables 2 to be managed.

[0014] As shown in Figure 2, the blood purification device 10 as a medical device 1 includes a blood circuit 101 through which blood from the patient flows, a blood pump 102 provided in the blood circuit 101 to pump the fluid within the blood circuit 101, and a blood purifier 2b provided in the blood circuit 101. The blood purification device 10 also includes a dialysate supply unit 103 for supplying dialysate, a dialysate supply path 104 connecting the dialysate supply unit 103 and the blood purifier 2b, a first fluid delivery pump 105 provided in the dialysate supply path 104, a drainage discharge path 106 for discharging drainage from the blood purifier 2b, a second fluid delivery pump 107 provided in the drainage discharge path 106, a water removal path 106a provided in the drainage discharge path 106 to bypass the second fluid delivery pump 107, and a water removal pump 109 provided in the water removal path 106a. The discharge volumes of the first fluid delivery pump 105 and the second fluid delivery pump 107 are controlled to be the same, and by controlling the discharge volume of the water removal pump 109, the removal of water from the blood is controlled.

[0015] In this embodiment, the dialysate filter 2a used as consumable 2 is installed in the dialysate supply passage 104. The dialysate filter 2a purifies the dialysate by capturing substances such as endotoxins contained in the dialysate. A bypass line 108 is connected to the dialysate filter 2a, and dialysate of inappropriate concentration and temperature, as well as air, are discharged to the drainage discharge passage 106 via this bypass line 108. The bypass line 108 is provided with a valve 108a that opens and closes the bypass line 108. A valve 110 is provided in the dialysate supply passage 104 between the dialysate filter 2a and the blood purifier 2b, and a valve 111 is provided in the drainage discharge passage 106 downstream of the blood purifier 2b. When supplying dialysate to the blood purifier 2b, valves 110 and 111 are opened and valve 108a is closed. When discharging dialysate of inappropriate concentration and temperature, valves 110 and 111 are closed and valve 108a is opened. Note that the configuration shown in Figure 2 is merely an example, and the specific configuration of the blood purification device 10 can be changed as appropriate.

[0016] (Configuration for managing consumables 2) Returning to FIG. 1, the consumable 2 has an information presenting unit 21 that presents the individual identification information (individual number, ID) of the consumable 2. The medical device 1 includes a reading unit 3 that reads the individual identification information from the information presenting unit 21. Here, the case where the information presenting unit 21 is a two-dimensional code is shown, but it may be other codes such as barcodes or characters. The two-dimensional code which is the information presenting unit 21 is printed on a label, for example, and the label is attached to the dialysate filter.

[0017] In the present embodiment, the reading unit 3 is composed of a so-called code reader. The code reader includes a camera 31 that images the two-dimensional code which is the information presenting unit 21, and an image processing unit (not shown) that extracts information from the information presenting unit 21 (here, the two-dimensional code) in the image imaged by the camera 31. When the information presenting unit 21 is characters, the reading unit 3 may be composed of an input device such as a keyboard.

[0018] In the present embodiment, the information presenting unit 21 includes not only the individual identification information of the consumable 2 but also the usage limit time and expiration date information of the consumable 2. The information read by the reading unit 3, that is, the individual identification information, usage limit time, and expiration date information of the consumable 2 are registered in the storage unit 5 as the read information 51. Note that the usage limit time and expiration date may not be included in the information presenting unit 21. In this case, for example, the usage limit time for each consumable 2 may be stored in the storage unit 5 as a database, and the usage limit time corresponding to the individual identification information may be specified by referring to the database. Also, the above database may be stored in an external device (for example, the network device 111 in FIG. 6 described later), and the information such as the usage limit time may be acquired from the external device.

[0019] The medical device 1 includes a control unit 4 that controls each part of the medical device 1, and a storage unit 5 that stores information related to such control. Here, the description of the specific control of the medical device 1 and the like is omitted. The control unit 4 has a consumable management unit 41, an operation restriction unit 42, and an information sharing unit 43. These consumable management unit 41, operation restriction unit 42, and information sharing unit 43 are realized by appropriately combining computing elements such as a CPU, memory, software, interfaces, and the like. The storage unit 5 is realized by an appropriate storage area in the memory.

[0020] (Consumable management unit 41, consumable information database 52) Based on the individual identification information presented by the information presentation unit 21, the consumable management unit 41 monitors the usage time of the consumable 2 and determines whether the usage time of the consumable 2 has reached the usage limit time. More specifically, first, the consumable management unit 41 searches the consumable information database (consumable information DB) 52 stored in the storage unit 5 using the individual identification information of the read information 51. If the information of the target consumable 2 is not registered in the consumable information database 52, the individual identification information, usage limit time, and expiration date information included in the read information 51 are newly registered in the consumable information database 52.

[0021] Figure 3 is a diagram showing an example of the consumable information database 52. As shown in Figure 3, the consumable information database 52 is a database in which the individual number (individual identification information), usage time, usage limit time, expiration date, etc. of the consumable 2 are associated and stored. Note that the consumable information database 52 may further include information other than the items shown in Figure 3, for example, information such as the manufacturer, classification, and type of the consumable 2.

[0022] The consumables management unit 41 registers the usage time of consumables 2 in the consumables information database 52. The consumables management unit 41 then compares the usage time of consumables 2 with the usage limit time to determine whether the usage time has reached the usage limit time (i.e., whether the usage time is equal to or greater than the usage limit time). The consumables management unit 41 also has a function to obtain the current date and determines whether the current date has exceeded the expiration date. The method for obtaining the current date can be set as appropriate and is not particularly limited.

[0023] Furthermore, in this embodiment, the medical device 1 is equipped with a display unit 6 such as a monitor, and the consumables management unit 41 is configured to display information such as the individual number and usage time of the consumables 2 on the display unit 6. (See Figure 1)

[0024] (Operation limiting unit 42) The operation restriction unit 42 performs a warning process to issue a warning when the consumable management unit 41 determines that the usage time of consumable 2 has reached the usage limit time, or that the expiration date has been exceeded, and also performs an operation restriction process to restrict the operation of using consumable 2. The warning process is a process that warns the user by, for example, emitting sound or light, or displaying a warning message on the display unit 6. The operation restriction process is a process that restricts treatment using consumable 2. In this embodiment, for example, blood purification treatment by the blood purification device 10 is interrupted. This prevents treatment from continuing using consumable 2 that has reached its usage limit time or has expired, thereby improving the safety of the treatment.

[0025] (Information Sharing Department 43) The information sharing unit 43 performs information sharing processing to share information about consumables 2, including their usage time, i.e., the consumables information database 52, with other devices when medical device 1 is connected to other devices (other medical device 1) in a communicative manner, as shown in Figure 4. This information sharing processing can be performed when the consumables information database 52 is updated, for example, when a new consumable 2 is registered or at the end of treatment. By performing information sharing processing, it becomes possible to determine whether the usage limit time has been reached by taking into account the usage time of consumables 2 used by other devices, thereby more reliably suppressing the misuse of consumables 2 and improving the safety of treatment. Note that information sharing processing is not performed when medical device 1 is used alone. Although Figure 4 describes a case where multiple medical devices 1 communicate with each other via wired communication, the system is not limited to this, and multiple medical devices 1 may be configured to communicate with each other via wireless communication.

[0026] (Control flow) Next, the control flow related to the management of consumables 2 in the medical device 1 will be explained using Figure 5. As shown in Figure 5, first, in step S1, the two-dimensional code, which is the information display unit 21 of the consumable 2, is read by the reading unit 3. The information read by the reading unit 3 is stored in the storage unit 5 as read information 51. For example, in the process of replacing the dialysis fluid filter, which is a consumable 2, the control unit 4 may be configured to display a message on the display unit 6 prompting the user to read the information display unit 21 (two-dimensional code) of the new dialysis fluid filter.

[0027] Subsequently, in step S2, the consumables management unit 41 searches the consumables information database 52 based on the individual identification information of the read information 51 and picks up the information for consumables 2. If the information for consumables 2 is not in the consumables information database 52, it registers the information for consumables 2. Then, in step S3, the information sharing unit 43 performs information sharing processing. In the information sharing processing, if there is an update to the consumables information database 52 (i.e., if new information for consumables 2 is registered), it performs processing to share the consumables information database 52 with other devices (i.e., processing to update the consumables information database 52 of other devices).

[0028] Subsequently, in step S4, the consumables management unit 41 determines whether the current date exceeds the expiration date of consumable 2. If the result in step S4 is Yes, in step S9, the operation restriction unit 42 performs a warning process and an operation restriction process (in this case, interruption of blood purification treatment), and then proceeds to step S10. If the result in step S4 is No, in step S5, it is determined whether the usage time of consumable 2 is longer than or equal to the usage limit time. If the result in step S5 is Yes, in step S9, the operation restriction unit 42 performs a warning process and an operation restriction process (in this case, interruption of blood purification treatment), and then proceeds to step S10.

[0029] If the result in step S5 is No, then in step S6, it is determined whether water has been started (or is continuing) to flow through consumable 2. Note that "water flow" includes not only dialysis fluid but also washing water and disinfectant. If the result in step S6 is Yes, then in step S7, the usage time in the consumable information database 52 is updated, and then the process returns to step S5. If the result in step S6 is No, then in step S8, it is determined whether water flow has ended. If the result in step S8 is No, the process returns to step S6. If the result in step S8 is Yes, the process proceeds to step S10.

[0030] In step S10, the information sharing unit 43 performs information sharing processing. In the information sharing processing, if there is an update to the consumables information database 52 (for example, if the usage time is updated), it performs processing to share the consumables information database 52 with other devices (i.e., processing to update the consumables information database 52 of other devices). After that, the processing ends.

[0031] (modified version) In this embodiment, the case in which a consumables information database 52 is shared among multiple medical devices 1 has been described. However, as shown in Figure 6, multiple medical devices 1 may be connected to a network device 111, such as a server device, via a network 110 such as the Internet, enabling them to communicate with each other, and the consumables information database 52 may be stored in the network device 111. In this case, each medical device 1 will refer to the consumables information database 52 stored in the network device 111 to determine whether the usage limit has been reached, etc. Also, in this case, when each medical device 1 uses a consumable 2, it will update the usage time in the consumables information database 52 in the network device 111 via the network 110.

[0032] Furthermore, information regarding usage time limits and expiration dates may be registered manually using an input device, or data may be entered via removable media such as a memory stick.

[0033] Furthermore, although this embodiment describes a case where the durable consumable 2, which is the consumable under management, is a dialysis fluid filter 2a or a blood purifier 2b, it is not limited to these, and the consumable 2 may be, for example, rubber parts for valves or sealing parts for pumps. If a label with the information display unit 21 printed on it cannot be attached to the consumable 2, the label may be attached to the package of the consumable 2.

[0034] Furthermore, the information display unit 21 may be an IC tag such as an RFID tag. In this case, an IC reader can be used as the reading unit 3. In addition, if the information display unit 21 is composed of a code such as a two-dimensional code, it is also possible to configure the system to read the code using a smartphone or the like and transfer the read information from the smartphone or the like to the medical device 1.

[0035] (Operation and Effects of the Embodiment) As described above, in the medical device 1 according to this embodiment, the consumable 2 has an information display unit 21 that displays individual identification information of the consumable 2, a reading unit 3 that reads the individual identification information from the information display unit 21, and a consumable management unit 41 that monitors the usage time of the consumable 2 based on the individual identification information displayed by the information display unit 21 and determines whether the usage time of the consumable 2 has reached the usage limit time.

[0036] This configuration allows the medical device 1 to monitor the usage time of consumable 2 without providing information storage means in the consumable 2, making it possible to suppress the misuse of used consumable 2 with a low-cost and simple configuration. Furthermore, according to this embodiment, it is possible to suppress problems such as a decrease in the quality of treatment (for example, a decrease in the quality of dialysis fluid) and malfunctions or interruptions during treatment caused by the user intentionally using consumable 2 beyond the usage limit or expiration date. In addition, since consumable 2 without an information display unit 21 cannot be used in the first place, it is also possible to suppress the use of counterfeit products or other items whose operation is not guaranteed as consumable 2.

[0037] (Summary of the embodiments) Next, the technical concept understood from the embodiments described above will be described using the reference numerals and other symbols from the embodiments. However, the reference numerals and other symbols in the following description are not limited to the components in the claims that are specifically shown in the embodiments.

[0038] [1] A medical device (1) to which a consumable (2) is attached and used, wherein the consumable (2) has a specified usage time limit, the consumable (2) has an information display unit (21) that displays individual identification information of the consumable (2), a reading unit (3) that reads the individual identification information from the information display unit (21), and a consumable management unit (41) that monitors the usage time of the consumable (2) based on the individual identification information displayed by the information display unit (21) and determines whether the usage time of the consumable (2) has reached the usage time limit.

[0039] [2] The medical device (1) according to [1], wherein the consumable (2) is a dialysis fluid filter (2a) or a blood purifier (2b).

[0040] [3] The medical device (1) according to [1], wherein the information display unit (21) is a barcode or a two-dimensional code, and the reading unit (3) is a code reader.

[0041] [4] The medical device (1) according to [1], wherein the information display unit (21) includes the information of the usage time limit.

[0042] [5] The individual identification information includes information on the expiration date, and the consumables management unit (41) determines whether the expiration date has been exceeded, the medical device (1) as described in [1].

[0043] [6] The medical device (1) according to [1], further comprising an operation limiting unit (42) that limits the operation of using the consumable (2) when the consumable management unit (41) determines that the usage time of the consumable (2) has reached the usage limit time.

[0044] [7] The medical device (1) according to [1], further comprising an information sharing unit (43) for sharing information about the consumables (2), including the usage time of the consumables (2), with other devices.

[0045] Although embodiments of the present invention have been described above, the embodiments described above do not limit the invention as defined in the claims. Furthermore, it should be noted that not all combinations of features described in the embodiments are necessarily essential for solving the problem of the invention. In addition, the present invention can be implemented with appropriate modifications without departing from its spirit. [Explanation of Symbols]

[0046] 1…Medical devices 2…Consumables 2a…Dialysis fluid filter 2b... Blood purifier 21…Information presentation section 3...Reading section 31... Camera 4…Control Unit 41…Consumables Management Department 42...Operation limiting unit 43…Information sharing department 5...Storage section 51... Read information 52…Consumables Information Database

Claims

1. A medical device to which consumables are attached and used, The aforementioned consumables have a specified usage time limit. The aforementioned consumable has an information display unit that displays individual identification information of the consumable, A reading unit that reads the individual identification information from the information display unit, The consumables management unit monitors the usage time of the consumables based on the individual identification information presented by the information presentation unit and determines whether the usage time of the consumables has reached the usage limit time. Medical device.

2. The aforementioned consumable is a dialysis fluid filter or a blood purifier. The medical device according to claim 1.

3. The information display unit is a barcode or a two-dimensional code. The reading unit is a code reader. The medical device according to claim 1.

4. The information display unit includes the information on the usage time limit, The medical device according to claim 1.

5. The individual identification information includes information on the expiration date, The consumables management unit determines whether the expiration date has been exceeded. The medical device according to claim 1.

6. The consumables management unit includes an operation limiting unit that restricts the operation to use the consumables when it determines that the usage time of the consumables has reached the usage limit time. The medical device according to claim 1.

7. The system includes an information sharing unit that shares information about the consumables, including their usage time, with other devices. The medical device according to claim 1.

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