Method and apparatus for monitoring drug injectors

Abstract

One embodiment of the present invention relates to a drug injector monitoring method and apparatus, and provides a drug injector monitoring method and apparatus for monitoring the battery state, drug remaining amount, temperature, and pressure of a drug injector so that a fixed amount of drug can be stably injected.

Description

Technical Field

[0001] The present invention relates to a method and apparatus for monitoring a drug injector, and more particularly, to a method and apparatus for monitoring the safety state of a drug injector.

Background Art

[0002] Drugs can be injected into the body in various forms such as oral, subcutaneous, and intravenous administration depending on the type, treatment purpose, method, etc. A drug injector utilizing a drug pump can automatically inject a drug into the body at a desired speed and volume for a required time. Therefore, a drug injector utilizing a drug pump is not only used in hospital and patient's daily life environments but can also be utilized in various forms.

[0003] An insulin pump, generally called an insulin injector, is for diabetic patients in whom insulin is not secreted or only a small amount is secreted, and it serves as a medical device like the pancreas that supplies insulin into the body accurately at externally determined times to regulate blood sugar.

[0004] Such an insulin pump is a technology used for insulin-dependent diabetic patients. Therefore, an insulin pump is attached to a patient and can continuously inject a drug for 24 hours. If an accurate amount of the drug is not stably injected by continuously injecting the drug into the patient, it may have an adverse effect on the patient's health.

[0005] The reason why the drug is not stably injected through the pump is caused by various reasons such as malfunction of the pump and clogging of the drug injection port. Therefore, it is necessary to develop a technology that can integrally monitor this.

Disclosure of the Invention

Problems to be Solved by the Invention

[0006] An embodiment of the present invention has a technical problem of providing a method and apparatus for monitoring the safety state of a drug injector.

[0007] However, the technical problems that the embodiments of the present invention aim to solve are not limited to those described above, and other technical problems may exist. [Means for solving the problem]

[0008] As a technical means for achieving the above-mentioned technical challenges, a method for monitoring a drug injector according to one aspect of the present invention includes the steps of: a) obtaining at least one state information regarding the operation of the drug injector from the drug injector; and b) outputting a notification signal regarding the state of the drug injector or outputting a control signal to interrupt the drug injection operation of the drug injector based on the result of comparing the state information with a reference value for each state information, wherein the state information includes the remaining battery level of the drug injector, the remaining drug level, temperature data of a specific area within the drug injector, or pressure data of a specific area within the drug injector.

[0009] Furthermore, a drug injector monitoring device according to another aspect of the present invention includes a memory for storing a drug injector monitoring program, and a processor for executing the program stored in the memory, wherein the processor executes the drug injector monitoring program to obtain at least one state information regarding the operation of the drug injector from the drug injector, and based on the result of comparing the state information with a reference value for each state information, outputs a notification signal regarding the state of the drug injector or outputs a control signal to interrupt the drug injector's drug injector operation, wherein the state information includes the remaining battery level of the drug injector, the remaining drug level, temperature data of a specific area within the drug injector, or pressure data of a specific area within the drug injector. [Effects of the Invention]

[0010] The drug injector monitoring method and apparatus according to the embodiment of the present invention can sense the pressure, temperature, battery level, and drug level of the drug injector, and can detect whether the drug injector is in a state where it can stably inject drugs. Through this, it is possible to prevent the problem of the user being injected with an inaccurate amount of drugs and to determine whether or not the drug injector is malfunctioning. [Brief explanation of the drawing]

[0011] Figure 1 is a schematic diagram of a drug infusion monitoring system according to an embodiment of the present invention.

[0012] Figure 2 is a diagram showing the configuration of a user terminal and a drug injector according to an embodiment of the present invention.

[0013] Figure 3 is a diagram showing the configuration of a processor according to an embodiment of the present invention.

[0014] Figure 4 is a diagram showing the configuration of a processor according to an embodiment of the present invention.

[0015] Figure 5 is an illustrative diagram of a drug injector according to an embodiment of the present invention.

[0016] Figure 6 is an illustrative diagram of an electroosmotic pump according to an embodiment of the present invention.

[0017] Figure 7 is a flowchart illustrating a method for monitoring a drug injector according to an embodiment of the present invention.

[0018] Figure 8 is a flowchart illustrating a method for terminating a drug injection operation and generating a warning notification according to an embodiment of the present invention.

[0019] Figure 9 is a flowchart illustrating a method for terminating a drug injection operation and generating a warning notification according to an embodiment of the present invention.

[0020] Figure 10 is a flowchart illustrating a method for terminating a drug injection operation and generating a warning notification according to an embodiment of the present invention.

[0021] Figure 11 is a flowchart of a method for terminating a drug injection operation and generating a warning notification according to an embodiment of the present invention.

[0022] The present invention will be described in detail below with reference to the attached drawings. However, the present invention can be embodied in various different forms and is not limited to the embodiments of the present invention described herein. Furthermore, the attached drawings are merely for the purpose of facilitating the understanding of the embodiments of the present invention disclosed herein, and do not limit the technical ideas disclosed herein. All terms used herein, including technical and scientific terms, should be interpreted in the sense that a person of ordinary skill in the art to which the present invention pertains would generally understand. Predefined terms should be interpreted to have additional meanings that correspond to relevant technical documents and the content now disclosed, and should not be interpreted in an overly idealistic or restrictive sense unless otherwise defined.

[0023] In the drawings, parts unrelated to the description have been omitted in order to clearly illustrate the present invention, and the size, form, and shape of each component shown in the drawings can be varied in various ways. Parts that are the same or similar throughout the specification are denoted by the same or similar reference numerals.

[0024] The suffixes "module" and "part" used in the following description are added or mixed for the sake of ease of drafting the specification and do not have any distinguishing meaning or role in themselves. Furthermore, in describing the embodiments of the present invention disclosed herein, detailed descriptions of relevant prior art have been omitted where it is determined that such descriptions may obscure the gist of the embodiments disclosed herein.

[0025] Throughout the specification, when a part is "connected (joined, contacted or coupled)" to another part, it includes not only the case where it is "directly connected (joined, contacted or coupled)", but also the case where it is "indirectly connected (joined, contacted or coupled)" with another member interposed therebetween. Also, when a part "includes (comprises or has)" a certain component, it means that other components can be further "included (comprised or had)" without excluding other components, unless otherwise stated specifically to the contrary.

[0026] The terms representing ordinal numbers such as the first, the second, etc. used in this specification are used only for the purpose of distinguishing one component from another and do not limit the order or relationship of the components. For example, the first component of the present invention may be named the second component, and similarly the second component may be named the first component. The singular forms used in this specification should be construed to include plural forms as well, unless clearly indicating the opposite meaning.

[0027] Hereinafter, referring to FIGS. 1 and 2, a monitoring system for a drug injector according to an embodiment of the present invention (hereinafter referred to as "monitoring system for a drug injector") will be described.

[0028] The monitoring system for a drug injector includes a drug injector (100) and a user terminal (200). The drug injector (100) means a device for injecting a drug into a patient or a user. The drug injector (100) can include not only an insulin patch or an insulin pump that can adhere to a user and inject a drug, but also other devices for injecting a drug.

[0029] The user terminal (200) can mean a terminal device for generating control signals for the drug injector (100) and for monitoring the status of the drug injector (100). The user terminal (200) includes a display unit for displaying data to the user and can display notifications to the user using the display, sound, vibration, low-frequency stimulation signals, etc. The drug injector (100) can inject drugs according to the control signals generated from the user terminal (200).

[0030] The user terminal (200) can mean, for example, a laptop computer, desktop computer, laptop computer, wireless communication device that is portable and mobile, or any type of handheld wireless communication device such as a smartphone or tablet PC, all of which are handheld wireless communication devices.

[0031] The drug injector (100) can generate a pulse sequence using a drug injection control signal generated from a user terminal (200), and perform a drug injection operation using the generated pulse sequence. In another embodiment, the user terminal (200) generates a pulse sequence, and the drug injector (100) can perform a drug injection operation using the pulse sequence generated from the user terminal (200).

[0032] The drug injector (100) provides data related to monitoring the drug injector (100) to the user terminal (200) through a communication connection with the user terminal (200) and receives control signals from the user terminal (200). The communication network shown in Figure 1 can be realized by any type of wireless communication network, such as wired networks like Local Area Networks (LANs), Wide Area Networks (WANs), or Value Added Networks (VANs), or mobile radio communication networks or satellite communication networks. Examples of wireless communication networks include, but are not limited to, 3G, 4G, 5G, 3GPP® (3rd Generation Partnership Project), LTE (Long Term Evolution), WiMAX (World Interoperability for Microwave Access), Wi-Fi, Bluetooth®, infrared communication, ultrasonic communication, visible light communication (VLC), and LiFi.

[0033] In another embodiment, the drug injector monitoring system may further include a data storage unit (300) in addition to the drug injector (100) and user terminal (200). The data storage unit (300) can receive, store, and save data transmitted from the user terminal (200) for a certain period of time. Furthermore, the data storage unit (300) can perform data analysis and processing functions, such as generating machine learning or user-customized injection algorithms, using information related to drug injection, such as drug injection history, drug injection results, and user information.

[0034] The data storage unit (300) may include a data storage module (310), a data extraction module (320), a data processing module (330), and a data analysis module (340) to perform the functions described above. The data storage module (310) performs the function of storing information related to drug injection, such as user information, drug injection history, and drug injection results, from the drug injector (100) or user terminal (200).

[0035] The data extraction module (320) can extract data related to drug infusion from the data storage module (310) or from public data, big data, etc., and can perform functions to classify the stored data according to set criteria. The data extraction module (320) can generate and provide to the user the user's drug infusion patterns and data statistics related to drug infusion.

[0036] The data processing module (330) can perform preprocessing using data obtained from the data storage module (310) or the data extraction module (320), and can also perform data filtering and conversion to data related to drug injection. The data analysis module (340) can perform machine learning to generate user-customized injection algorithms using data obtained from the data storage module (310), the data extraction module (320), and the data processing module (330).

[0037] The data storage unit (300) can be formed in the form of a device such as a server or terminal, and can operate in a cloud computing service model such as SaaS (Software as a Service), PaaS (Platform as a Service), or IaaS (Infrastructure as a Service). Alternatively, the data storage unit (300) can be built in the form of a server in a private cloud, public cloud, or hybrid cloud system.

[0038] Figure 2 is a diagram showing the configuration of a drug injector and user terminal according to an embodiment of the present invention.

[0039] Referring to Figure 2, the drug injector (100) includes a control unit (110), a drive unit (121), a drug storage unit (122), a notification generation unit (123), a power supply unit (124), and a sensing unit (130).

[0040] The control unit (110) performs the function of controlling the operation of the drug injector (100). The control unit (110) may include a communication module (111), memory (112), and a processor (113).

[0041] The communication module (111) performs the sending and receiving of information with the user terminal (200). The communication module (111) can mean a device that includes hardware and software necessary to send and receive signals such as control signals or data signals via wired or wireless connection with other network devices. The communication module (111) can receive data used for the control program of the drug injector from the user terminal (200) and transmit control signals related to operation to the user terminal (200).

[0042] The memory (112) stores the drug injector control program and the drug injector monitoring program. The names of the drug injector control program and the drug injector monitoring program are set for explanatory purposes only and do not restrict the functions of the programs by name. The memory (112) can store at least one of the following: information and data input to the communication module (111), information and data necessary for functions performed by the processor (113), and data generated by the execution of the processor (113).

[0043] The processor (113) is configured to execute a control program for a drug injector stored in memory (112). The processor (113) may include various types of devices for controlling and processing data. The processor (113) can mean a hardware-integrated data processing device having physically structured circuitry to perform functions expressed in code or commands contained within a program. The processor (113) can be embodied in the form of a microprocessor, a central processing unit (CPU), a processor core, a multiprocessor, an ASIC (application-specific integrated circuit), an FPGA (field programmable gate array), etc., but the scope of the present invention is not limited thereto.

[0044] The processor (113) can control the operation of the drive unit (121), drug storage unit (122), notification generation unit (123), power supply unit (124), and sensing unit (130). The processor (113) can also generate a pulse sequence to ensure the drug injector (100) injects a precise amount of drug, and control the drug injector (100) to perform the drug injection operation according to the pulse sequence. The specific functions of the processor (113) will be described in detail with reference to Figure 3, which will be discussed later.

[0045] The drive unit (121) may include a drug infusion pump, which is a pressure generating unit that generates pressure to perform drug infusion in response to a drug infusion control signal, a needle, a cannula, etc., for injecting the drug into the user's body. The configuration of the drive unit (121) is not limited to this, and can mean all configurations for performing drug infusion depending on the type of drug injector (100).

[0046] The notification generation unit (123) can generate notifications to provide to the user when an abnormality occurs related to the drug injector (100), such as when the drug injector (100) is unable to perform the drug injection operation, when there is a possibility of an error exceeding a preset standard value occurring between the set drug injection amount and the actual drug injection amount, or when drug injection must be immediately interrupted.

[0047] The notification generation unit (123) can use a method to generate notifications using methods that can attract the user's attention, such as sound, vibration, or low-frequency stimulation. Furthermore, the notification generation unit (123) can display different types of notifications to the user, such as a warning notification generated when drug injection by the drug injector (100) must be immediately interrupted, a caution notification to inform the user in advance when the drug injector (100) is approaching a condition for interrupting drug injection, and a notification display stage that simply displays the current status of the drug injector (100).

[0048] The sensing unit (130) measures data to monitor the operating status of the drug injector (100) so that the drug injector (100) can inject the correct amount of drug in a stable state. The sensing unit (130) may include a pressure sensor (131), a temperature sensor (132), a battery sensor (133), a drug remaining amount measurement module (134), etc.

[0049] The pressure sensor (131) measures the pressure in the drug injector (100). For example, the pressure sensor (131) can directly or indirectly measure the pressure in the drive unit (121) that generates pressure in the drug injector (100) or in the flow path through which the drug moves. The temperature sensor (132) measures the temperature of the drug injector (100). For example, it measures the temperature of the pressure generating unit (drive unit, 122) that generates pressure in the drug injector (100).

[0050] The battery sensor (133) measures the remaining battery level of the drug injector (100). The function of the battery sensor (133) is not limited to this, and it can further perform functions such as determining the remaining power level or remaining operating time of the power supply unit (124).

[0051] The drug remaining amount measurement module (134) can directly or indirectly measure the amount of drug remaining in the drug storage unit (122). For example, it can perform a function to calculate the remaining amount of drug using the amount of drug initially stored in the drug storage unit (122) and the amount of drug discharged by the drug injection operation. In addition, the drug remaining amount measurement module (134) may include a configuration that senses the remaining amount not only by using the volume of the remaining drug, but also by using drug characteristics such as the weight of the remaining drug.

[0052] The user terminal (200) can display information related to the drug injector (100) to the user. The user terminal (200) can also receive infusion-related data from the user, generate control signals for the drug injector (100), and manage data related to drug infusion. The user terminal (200) comprises a communication module (210), memory (220), and a processor (240), and may further include a database (230).

[0053] The communication module (210) performs the transmission and reception of information with the drug injector (100). The communication module (210) can mean a device that includes hardware and software necessary to transmit and receive signals, such as control signals or data signals, with other network devices via wired or wireless connections. The communication module (210) can receive data from the drug injector (100) used for the drug injector's control program, or transmit control signals related to the drug injector (100) to the drug injector (100). In addition, the communication module (210) can receive data related to the operation of the drug injector, and the user terminal (200) can display the received data to the user via a display.

[0054] The memory (220) stores the drug injector control program and the drug injector monitoring program. The names of the drug injector control program and the drug injector monitoring program are set for explanatory purposes only and do not restrict the functions of the programs by their names. The memory (220) can store at least one of the following: information and data input to the communication module (210), information and data necessary for the functions performed by the processor (240), and data generated by the execution of the processor (240).

[0055] Memory (220) should be interpreted as a general term for non-volatile storage devices that continuously maintain stored information even without a power supply, and volatile storage devices that require power to maintain stored information. Furthermore, memory (220) can perform the function of temporarily or permanently storing data processed by the processor (240). In addition to volatile storage devices that require power to maintain stored information, memory (220) may include magnetic storage media or flash storage media, but the scope of the present invention is not limited to these.

[0056] The database (230) can refer to a configuration in which operational data of the drug injector (100), data necessary for monitoring the drug injector, data for machine learning, big data, etc., are stored. The database (230) may constitute part of the memory (220), but it does not necessarily have to be located inside the user terminal (200); it can also be located outside of it.

[0057] The processor (240) is configured to execute a control program for a drug injector stored in memory (220). The processor (240) may include various types of devices for controlling and processing data. The processor (240) can mean a hardware-integrated data processing device having physically structured circuitry to perform functions expressed in code or commands contained within a program. The processor (240) can be embodied in the form of a microprocessor, a central processing unit (CPU), a processor core, a multiprocessor, an ASIC (application-specific integrated circuit), an FPGA (field programmable gate array), etc., but the scope of the present invention is not limited to these.

[0058] The processor (240) executes the drug injector control program, generates control signals for the drug injector, calculates the drug injection amount in response to user input, and manages data related to drug injector status monitoring and drug injection. The specific functions of the processor will be described in detail with reference to Figure 4 below.

[0059] Figure 3 is a conceptual diagram showing the functions of the processor (113) according to an embodiment of the present invention. The operation of the processor (113) according to an embodiment of the present invention will be described below with reference to Figure 3.

[0060] The processor (113) may include an injection control module (115) and a safety control module (116). The processor (113) can receive a drug injection signal generated using a drug injector control program stored in memory (112) and perform the function of generating a control signal so that the drive unit (121) can be controlled. The processor (113) can also monitor whether the drug injector (100) is in a stable operating state and control the operation of the drug injector (100) or generate warnings and notifications.

[0061] The injection control module (115) can control the operation of the drug injector (100) by converting a drug injection signal generated from the user terminal (200) into a signal for controlling the drive unit (121). At this time, the injection control module (115) can execute a function or program for controlling the operation of the drug injector (100). The injection control module (115) can not only perform signal conversion, but can also receive drug injection amounts for each injection mode, or drug injection rate (injection amount) per unit of time, injection period, etc. from the user terminal (200), and use this to generate control signals for the drive unit (121).

[0062] Here, the infusion mode can include a basal infusion mode, an ad-hoc basal infusion mode, and an immediate infusion mode. The basal infusion mode can mean an infusion mode in which the drug is continuously infused at a slow rate. In other words, the basal infusion mode means an infusion mode in which the drug is infused at a basal infusion rate over a constant period of time to maintain a constant blood glucose level for the user.

[0063] An ad-hoc basal infusion mode refers to an infusion mode that temporarily changes the infusion rate of the basal infusion mode for a short period of time or a set period of time. Therefore, an ad-hoc basal infusion mode refers to an infusion mode that is performed in response to a temporary change in the user's blood glucose level, such as when the user is planning to exercise or when their blood glucose level temporarily decreases after exercising.

[0064] The immediate infusion mode refers to an infusion method that delivers a bolus dose of medication in the shortest possible time. Therefore, the immediate infusion mode is used to deliver corrective bolus injections to lower elevated blood glucose levels to normal levels when a user's blood glucose rises rapidly, and meal bolus injections delivered before meals or snacks to maintain elevated or expected elevated blood glucose levels within the target blood glucose range after a meal.

[0065] Furthermore, the infusion control module (115) can set priorities for the base infusion mode, temporary base infusion mode, and immediate infusion mode described above. By setting priorities between infusion modes, the infusion control module (115) can perform drug infusion operations according to the priority order even when the drug injector (100) receives multiple drug infusion signals having different infusion modes.

[0066] The infusion control module (115) can generate a pulse sequence for controlling the drive unit (121) using the drug infusion signal generated from the user terminal (200). To this end, the infusion control module (115) can perform the following functions.

[0067] The injection control module (115) generates drug injection conditions based on input information to the drug injector (100) or user input information entered using a user terminal (200), and sets a pulse sequence to be applied to the drive unit of the drug injector (100) or the drug injection pump based on the target drug injection amount included in the drug injection conditions. The pulse sequence consists of at least one pulse block having at least one preset voltage or current level arranged sequentially, and the pulse sequence can be set so that the sum of the drug injection amounts supplied by each pulse block included in the pulse sequence corresponds to the target drug injection amount.

[0068] At this time, the input information may include one or more of the following: the user's biometric information used for drug infusion, the target drug infusion amount, the target blood glucose level, the target drug infusion period, and the target drug infusion rate. The input information may also include one or more of the following: the target drug infusion amount, the drug infusion rate, or the user's biometric information, entered by the user through a user terminal connected to the drug infusion device. Furthermore, the infusion control module (115) can derive the target drug infusion amount based on the input information.

[0069] The injection control module (115) can retrieve and set pulse sequences from memory that are pre-stored for each target drug injection volume. For example, optimal pulse sequences for various target drug injection volumes can be designed in advance and stored in memory in the form of a lookup table. When the target drug injection volume is reached, the corresponding pulse sequence can be retrieved from the lookup table and used.

[0070] Furthermore, the injection control module (115) selects a pulse block from among a plurality of pulse blocks that supplies the maximum drug injection amount while being less than or equal to the target drug injection amount, as a priority pulse block, and sets the pulse sequence so that the priority pulse block is placed at least once, but does not exceed the target drug injection amount.

[0071] Furthermore, if the total amount of drug injection supplied by the priority pulse blocks does not reach the target drug injection amount, the injection control module (115) can select a pulse block that supplies the maximum drug injection amount, while being less than or equal to the remaining drug injection amount, as a suboptimal pulse block and place it once or more times.

[0072] The injection control module (115) can configure the pulse sequence such that there is a fixed time interval between pulse blocks.

[0073] In this case, if the drive unit (121) utilizes an electroosmotic pump, each pulse block may be defined by the voltage value and voltage application time applied to the electroosmotic pump. A pulse block may include a stabilization time to stabilize the electroosmotic pump. A pulse block is defined by the forward voltage, reverse voltage, and voltage application time applied to the electroosmotic pump, and the stabilization time may mean the time during which 0V is applied between the forward voltage application time and the reverse voltage application time to stabilize the electroosmotic pump.

[0074] Furthermore, a pulse block is defined by the forward current, reverse current, and current application time applied to the electroosmotic pump, and the stabilization time can mean the time during which 0A is applied between the forward current application time and the reverse current application time to stabilize the electroosmotic pump.

[0075] The safety control module (116) uses multiple signals measured by the sensing unit (130) to monitor the operating status of the drug injector (100) and determines whether the drug injector (100) is in a state where it can stably inject drugs. Therefore, if the safety control module (116) determines that the conditions are such that the drug injector (100) cannot stably perform its drug injection operation, it interrupts the drug injection or generates a notification to the user. Here, the notification can be generated using a method that allows the drug injector (100) to attract the user's attention, such as sound, vibration, or low-frequency stimulation.

[0076] Furthermore, the safety control module (116) can display different types of notifications to the user, such as a warning notification to inform the user that drug injection by the drug injector (100) will be immediately interrupted if the drug injection operation of the drug injector (100) is not performed normally, a warning notification to alert the user in advance when the drug injector (100) is approaching a condition for drug injection interruption, and a notification display stage that simply displays the current status of the drug injector (100).

[0077] Figure 4 is a conceptual diagram showing the functions of a processor (240) according to an embodiment of the present invention. The operation of the processor (240) according to an embodiment of the present invention will be described below with reference to Figure 4.

[0078] The processor (240) may include an injection condition setting module (241), a drug injector management module (243), and a data management module (244), and may further include a pulse sequence setting module (242). The injection condition setting module (241) performs the function of setting the drug injection amount, drug injection rate, drug injection period, etc. of the drug injector (100). Specifically, it can generate an injection information input interface so that the user can input information for setting the drug injection amount, or it can derive the drug injection amount using one or more of the user's input information or the user's biometric information. In addition, it can monitor the status of the drug injector (100) and generate a notification generation signal or a drug injection interruption signal.

[0079] The infusion condition setting module (241) performs the function of inputting or managing information related to drug infusion, such as user-specific infusion volume thresholds used in the infusion program and infusion calculator, infusion volume thresholds used in the drug injector (100), and user information. In addition, the infusion condition setting module (241) can perform the function of automatically calculating and displaying to the user the user's blood glucose level, infusion drug amount, drug infusion period, etc.

[0080] The infusion condition setting module (241) can generate and provide interfaces to the user for the base infusion calculator, temporary base infusion calculator, and bolus infusion calculator. The interface to the base infusion calculator may include input fields for time interval settings and rate settings, allowing the user to set time intervals and input drug infusion rates for each time interval. The base infusion calculator interface can provide the user with recommended drug infusion rates for each time period using user input information, biometric data, drug infusion history data, etc.

[0081] The temporary basal infusion calculator interface can include information to temporarily change the drug infusion rate of basal infusions, such as whether the user is exercising or has decreased activity levels. Therefore, the temporary basal infusion calculator interface can include input fields for information related to the user's exercise time, type of exercise, exercise intensity, and decreased activity levels. The temporary basal infusion calculator interface can use the user's input information, biometric data, exercise-related information, drug infusion history data, etc., to provide the period during which temporary basal infusions are necessary and the recommended infusion rate.

[0082] The bolus infusion calculator interface may include a corrective bolus calculation interface and a meal bolus calculation interface. The corrective bolus calculator interface may include a blood glucose input field for the user to input blood glucose information. If the blood glucose level entered by the user is above a threshold, the corrective bolus calculator interface can derive and provide to the user the corrective bolus infusion amount to correct the user's blood glucose to the target blood glucose level. The meal bolus calculator interface may include a meal information input field for the user to input meal times, information on the food consumed, the amount of carbohydrates consumed, blood glucose information, etc. Using the user's meal information, the meal bolus calculator interface can provide the user with recommended drug infusion amounts, recommended drug infusion rates, and recommended drug infusion periods to maintain the user's blood glucose within the target blood glucose range.

[0083] Furthermore, the injection condition setting module (241) can perform the function of transmitting a drug injection signal to the drug injector (100) using the derived drug injection amount, drug injection rate, drug injection period, etc.

[0084] The drug injector management module (243) receives data related to the operation of the drug injector (100) from the sensing unit (130) of the drug injector (100), and uses the received data to determine whether the drug injector (100) is operating normally. For example, it can determine whether the drug injector (100) is capable of normal operation by comparing one or more of the temperature data, pressure data, battery data, and drug level data of the drug injector (100) with a preset standard. If one or more of the temperature data, pressure data, battery data, and drug level data of the drug injector (100) do not meet the standard, the drug injector management module (243) can generate a warning notification to provide to the user or stop the drug injector (100) from injecting.

[0085] The drug injector management module (243) can determine whether the drug injector (100) is functioning correctly and generate operational caution and warning notifications for the drug injector (100), or interrupt the operation of the drug injector (100) and generate a drug injection interruption notification. In addition to displaying the operating status of the drug injector (100) (normal, stopped, abnormal), it can also perform a function to display the injection mode.

[0086] The drug injector management module (243) is configured to run a drug injector monitoring program and perform the following functions and procedures: The drug injector management module (243) monitors whether the drug injector satisfies safe operating conditions that allow it to operate stably, generates a warning notification if the drug injector deviates from safe operating conditions, or controls the drug injector (100) to stop the drug injection operation if it does not meet limit operating conditions.

[0087] The drug injector management module (243) can obtain at least one state information regarding the operation of the drug injector (100) from the drug injector (100). Furthermore, based on the result of comparing the state information with a reference value for each state information, the drug injector management module (243) can output a notification signal regarding the state of the drug injector, or output a control signal to interrupt the drug injector's drug injector operation.

[0088] At this time, the status information may include one or more of the following: battery level, drug level, temperature of a specific area within the drug injector, or pressure of a specific area within the drug injector, as measured by the sensing unit (130) of the drug injector (100).

[0089] The drug injector management module (243) can output a notification signal if the change per hour of at least one of the following data—battery level, drug level, temperature, or pressure—is greater than or equal to a reference rate of change.

[0090] The drug injector management module (243) can output a control signal to interrupt drug injection from the drug injector (100) if the temperature of the drug injector (100) is above a preset maximum temperature value or below a preset minimum temperature value.

[0091] The drug injector management module (243) can output a warning notification signal if the battery level of the drug injector (100) is below a first battery level value, and can output a control signal to interrupt drug injection by the drug injector (100) if the battery level of the drug injector (100) is below a second battery level value which is lower than the first battery level value.

[0092] The drug injector management module (243) can output a warning notification signal if the remaining drug amount in the drug injector (100) is less than or equal to a first drug amount value, and can output a control signal to interrupt drug injection by the drug injector (100) if the remaining drug amount in the drug injector (100) is less than or equal to a second drug amount value which is lower than the first drug amount value.

[0093] The drug injector management module (243) can output a control signal to perform a preset flow path blockage prevention operation when the pressure of the drug injector (100) is equal to or greater than a first pressure value, and can output a warning notification signal and a control signal to interrupt drug injection by the drug injector when the pressure of the drug injector (100) is equal to or greater than a second pressure value which is higher than the first pressure value.

[0094] Here, the flow path obstruction prevention operation can mean performing the drug injection operation by increasing the amount of drug injected by the drug injector (100) or the volume of the injected drug. The flow path obstruction prevention operation can also include temporarily increasing the drug injection rate of the drug injector (100). For example, if the drug injector (100) performs the drug injection operation using an electrical pulse block corresponding to a first drug injection amount, the flow path obstruction prevention operation can mean performing the drug injection operation using an electrical pulse block corresponding to a second drug injection amount having a drug injection amount or volume of injected drug equal to or greater than the first drug injection amount.

[0095] By increasing the amount of drug injected and the volume of the injected drug, the drug injection operation can be performed at a greater pressure, and the amount and volume of drug moving through the flow path of the drug injector (100) will increase, which will allow for the removal of foreign matter from the flow path and the prevention of blockage of the flow path.

[0096] The drug injector management module (243) can simultaneously receive data from the drug injector (100), including the battery level, drug level, and temperature and pressure data for a specific area within the drug injector (100).

[0097] The drug injector management module (243) can receive data from the drug injector (100) regarding the battery level, drug level, and temperature and pressure data for a specific area within the drug injector (100) only during the period in which the drug injector (100) is performing drug injection operations.

[0098] For example, the drug injector (100) includes an electroosmotic pump (150), and the temperature in a specific region may be the temperature of the electroosmotic pump (150). In the same example, the pressure in a specific region may be the pressure of the electroosmotic pump (150).

[0099] The data management module (244) performs the function of storing and managing data related to drug infusion. The data management module (244) can store data related to patch operation or drug infusion, as well as user information. For example, the data management module (244) can store all data generated by the operation of the drug injector (100), such as blood glucose input information, drug infusion information, carbohydrate input information, and notification occurrence information. The data management module (244) can work in conjunction with the data storage unit (300) to accumulate data for a certain period and transmit it to the data storage unit (300).

[0100] Furthermore, the data management module (244) can not only store data but also encrypt users' personal information. In addition, the data management module (244) can manage users' accounts (IDs) and passwords, users' personal information, etc., for the operation of the drug injector (100).

[0101] The pulse sequence setting module (242) can set a pulse sequence for controlling the drive unit (121) of the drug injector (100) using the drug injection conditions derived using the injection condition setting module (241). In other words, it can perform the same function as the injection control module (115) of the drug injector (100). Therefore, the pulse sequence can be set using either the drug injector (100) or the processor (113, 240) included in the user terminal (200).

[0102] The structure of the drug injector (100) will be described below with reference to Figure 5.

[0103] The drug injector (100) may include a pressure measuring section (140, 131), an electroosmotic pump (150), a transfer chamber (160), a first isolation material (141), a second isolation material (161), an inhalation passage (162), a discharge passage (163), an inhalation route (170), and a discharge route (180).

[0104] The electroosmotic pump (150) includes a membrane and a first electrode positioned on one side of the membrane and a second electrode positioned on the other side of the membrane. By alternately supplying voltage or current polarity to the first and second electrodes, forward and reverse electrochemical reactions repeatedly occur. This causes the fluid inside the electroosmotic pump to move back and forth, generating pressure for transferring the drug.

[0105] The electroosmotic pump (150) may be provided with a first isolation member (141) and a second isolation member (161) on both sides to airtightly seal the electroosmotic pump (150). The shape of the first isolation member (141) and the second isolation member (161) changes due to the positive or negative pressure generated by the electroosmotic pump (150). The change in shape of the first isolation member (141) causes a change in pressure in the pressure chamber (140). The change in shape of the second isolation member (161) causes a change in pressure in the transfer chamber (160). In other words, the pressure generated by the electroosmotic pump (150) is transmitted to the pressure chamber (140) and the transfer chamber (160) using the first isolation member (141) and the second isolation member (161).

[0106] A path for the drug to move may be formed on one side of the transfer chamber (160). Specifically, the inhalation path (170) may include a drug reservoir or be connected to a drug reservoir. When negative pressure is generated in the electroosmotic pump (150), the drug will move into the transfer chamber (160) through the inhalation path (170) and the inhalation passage (162). At this time, the second isolation material (161) can prevent the drug from flowing into the electroosmotic pump (150).

[0107] Furthermore, the discharge pathway (180) may include or be connected to an infusion device for injecting the drug into the body. When positive pressure is generated by the electroosmotic pump (150), the drug present in the transfer chamber (160) will move through the discharge pathway (163) and the discharge pathway (180).

[0108] A pressure measuring unit (140, 131) may be positioned on the other side of the electroosmotic pump (150). That is, the pressure measuring unit (140, 131) is positioned on the opposite side of the drug path or on a side that does not come into contact with the drug path, relative to the electroosmotic pump (150).

[0109] The pressure measuring section (140, 131) may include a pressure chamber (140) and a pressure sensor (131). The pressure chamber (140) represents the space through which the pressure generated by the electroosmotic pump (150) is transmitted. The pressure sensor (131) can measure the pressure in the pressure chamber (140) to detect blockages in the flow channels (162, 163, 170, 180).

[0110] Specifically, the electroosmotic pump (150) alternately generates pressure. This ensures that the pressure transmitted to the transfer chamber (160) and the pressure transmitted to the pressure chamber (140) have a certain correlation. If the drug passages (162, 163, 170, 180) become blocked or malfunction occurs, the pressure will change. This will result in a change in the pressure transmitted to the pressure chamber (140). The pressure measuring units (140, 131) measure these pressure changes to detect blockages and abnormalities in the passages.

[0111] Data measured by the drug level module (134), pressure sensor (131), temperature sensor (132), and battery sensor (133) can be transmitted to the terminal (200) using the communication module. The terminal (200) uses the received data to determine whether the drug injector (100) is operating under safe operating conditions that allow for stable operation. If the drug injector (100) deviates from safe operating conditions, it generates a warning notification to the user or interrupts the drug injector (100)'s drug injection operation to prevent the user from receiving too much or too little drug.

[0112] The configuration of the electroosmotic pump (150) according to an embodiment of the present invention will be described in more detail below with reference to Figure 6.

[0113] Referring to Figure 6, a drug injector (100) according to an embodiment of the present invention may include an electroosmotic pump (150) that generates pressure for transferring a drug. The electroosmotic pump (150) is a pump that utilizes the movement of fluid by the electroosmotic phenomenon that occurs when a voltage or current is applied to both ends of a porous membrane (membrane, 151) using electrodes. The electroosmotic pump (150) may include a membrane (151), two electrodes (152, 153) positioned on both sides of the membrane (151), a power source (154) for applying a voltage or current to the electrodes, and a flow path (155) for the fluid to move.

[0114] Generally, silica and glass are used as materials for porous membranes (151), and when these are placed in an aqueous solution, their surfaces become negatively charged. When a voltage or current is applied in this state, fluid movement occurs from the (+) electrode (152) to the (-) electrode (153). The porous membrane (151) has many pathways through which fluids can pass, and if one of these pathways is magnified, the surface of the negatively charged fluid pathway can be made charge-balanced by mobile cations with a positive charge that can move.

[0115] When a voltage or current is applied under these conditions, mobile cations move along the surface from the (+) electrode (152) to the (-) electrode (153), causing the entire fluid, connected by a hydrogen bond network, to flow smoothly. This phenomenon is called electroosmosis, and a pump that utilizes this principle is called an electroosmotic pump.

[0116] Electrodes used in electroosmotic pumps can be porous electrodes such as platinum mesh (Pt mesh), porous carbon paper or carbon cloth, or various electrode materials coated on porous structures, in order to facilitate fluid movement. In addition, various materials that can be fixed by drop coating or spin coating when applied to an impermeable substrate can also be used as electrodes.

[0117] The electroosmotic pump (150) generates reversible forward and reverse electrochemical reactions by alternately supplying voltage or current polarity to the (+) electrode section (152) and the (-) electrode section (153). As the forward and reverse electrochemical reactions occur repeatedly, the second fluid inside the electroosmotic pump performs repeated reciprocating motion. Furthermore, the (+) electrode section (152) and the (-) electrode section (153) undergo repeated wear and regeneration due to the repetitive forward and reverse reversible electrochemical reactions.

[0118] Therefore, if the drug injector (100) includes an electroosmotic pump, the drug injector monitoring system can control the magnitude and application of the voltage or current applied to the electrodes (152, 153) to control the pressure generated from the electroosmotic pump and the pulsed volume of drug discharged.

[0119] The drug injector monitoring method according to embodiments of the present invention will be described below with reference to Figures 7 to 11. The steps described below can be performed by the terminal (200) and the processor (240) of the terminal (200) or by the drug injector (100) and the processor (113) of the drug injector (100). Therefore, the embodiments of the present invention described earlier with reference to Figures 1 to 6 can also be applied to the embodiments described below.

[0120] Referring to Figure 7, the drug injector monitoring method according to the present invention includes a drug injector data reception stage (S1000), a safe operating range deviation determination stage (S2000), and a drug injector status notification generation stage (S3000).

[0121] The drug injector monitoring method according to the present invention compares the battery level, drug level, temperature and pressure data of a drug injector (100), and a specific area within the drug injector with their respective reference values, and provides a notification regarding the status of the drug injector (100) or interrupts the drug injector (100) operation according to the comparison result. Here, the reference values ​​include a safety operating condition, which is the reference value for providing notifications to the user, and a limit operating condition, which is the reference value for interrupting the drug injector (100) operation.

[0122] In the drug injector data reception stage (S1000), at least one piece of status information regarding the operation of the drug injector (100) is obtained from the drug injector (100). The status information may include one or more of the following: battery level data of the drug injector (100), drug level data, temperature data of a specific area within the drug injector (100), and information regarding the pressure of a specific area within the drug injector.

[0123] In the drug injector data reception stage (S1000), in order to reduce battery consumption of the drug injector (100), the timing of data measurement and reception may be synchronized, or data measurement and reception may be performed according to a preset order.

[0124] For example, by synchronizing the timing of transmission and reception of battery level data, drug level data, temperature data, and pressure data of the drug injector (100) and receiving them simultaneously, or by transmitting and receiving them according to a preset order, the power consumed for data transmission can be reduced.

[0125] Alternatively, power consumption can be reduced by measuring battery level data, drug level data, temperature data, and pressure data only during the period when the drug injector (100) is operating or performing a drug infusion operation.

[0126] In the safety operating condition deviation detection stage (S2000), status information is compared with a standard value for each status information. For example, battery level data, drug level data, temperature data, and pressure data are each compared with a preset safety operating condition. The safety operating condition refers to the operating conditions necessary for the drug injector (100) to stably inject the correct amount of drug. Therefore, in addition to battery level, drug level, temperature, and pressure, various other data necessary for the drug injector to stably inject the correct amount of drug may be included.

[0127] In the drug injector status notification generation stage (S3000), if at least one of the battery level data, drug level data, temperature data, and pressure data exceeds the safe operating conditions, a notification is provided to the user using the terminal (200) or drug injector (100). The notification may use not only sound and display notifications, but also vibration, low-frequency stimulation signals, and display notifications. In addition, the type of notification can be differentiated and provided to the user by changing the number and intensity of notification signals such as sound, vibration, low-frequency stimulation signals, and display brightness.

[0128] Furthermore, the safety operating condition deviation determination stage (S2000) and the drug injector status notification generation stage (S3000) may include a step to generate a notification if the change per hour of at least one of the operating conditions is greater than or equal to a reference rate of change. That is, the safety operating condition deviation determination stage (S2000) may further include a step to determine whether the change per hour of at least one of the battery level data, drug level data, temperature data, and pressure data is greater than or equal to a reference rate of change. The reference rates of change for battery level, drug level, temperature, and pressure can each be set individually.

[0129] The drug injector status notification generation stage (S3000) may further include a step in which a notification is generated if the change per unit time of at least one of the following data—battery level data, drug level data, temperature data, and pressure data—exceeds a reference rate of change. This allows the user to recognize whether there has been a sudden change in the safe operating conditions of the drug injector, and to confirm or prevent abnormal operation and failure of the drug injector.

[0130] If the rate of change per hour of any one or more of the following—battery level, drug level, temperature, and pressure—exceeds the standard rate of change, there is a possibility that the conditions for the drug injector (100) to stably perform drug injection operations are abnormal or that a malfunction has occurred in the device. Therefore, by notifying the user that an abnormality has occurred in the safe operating conditions of the drug injector (100), malfunctions of the drug injector (100) can be detected and prevented.

[0131] The drug injector monitoring method according to the present invention may further include a step for determining deviation from the limit operating range (S4000) and a step for interrupting drug injection operation (S5000).

[0132] In the threshold operating condition deviation determination stage (S4000), the battery level data, drug level data, temperature data, and pressure data are each compared with the preset threshold operating conditions. The threshold operating conditions refer to operating conditions under which, when the drug injector (100) performs a drug injection operation, there is a possibility that it will adversely affect the user or that more drug than the preset error range may be injected. Therefore, in addition to the battery level, drug level, temperature, and pressure, various other data may be included to ensure that the drug injector can stably inject the correct amount of drug.

[0133] In the drug injection operation interruption phase (S5000), if at least one of the following data points—battery level data, drug level data, temperature data, and pressure data—exceeds the limit operating conditions, the drug injector (100) is controlled to interrupt the drug injection operation. When the drug injection operation is to be interrupted, a notification of the drug injection operation interruption can be provided to the user using the terminal (200) or the drug injector (100).

[0134] The following describes the method for terminating drug injection operations and generating notifications based on temperature data, with reference to Figure 8.

[0135] The temperature data reception stage (S110) refers to the stage of receiving temperature data from the drug injector (100). Therefore, the temperature data reception stage (S110) may be included in the drug injector data reception stage (S1000).

[0136] In the operating condition comparison stage (S120), it is determined whether the temperature value corresponding to the received temperature data falls within a preset operating temperature range. The minimum temperature can be set to any value within the range of 10-20 degrees Celsius or the maximum temperature range of 40-50 degrees Celsius, but is not limited to these values ​​and may be appropriately changed depending on the type of drug, the specifications of the electroosmotic pump, the electrode reaction rate of the electroosmotic pump, etc.

[0137] For example, if the temperature of the drug injector (100) becomes high, a difference in gas solubility within the drug in the drug injector (100) may occur, increasing the likelihood of bubble formation. A higher likelihood of bubble formation increases the possibility of errors between the set drug injection volume and the actual drug injection volume. In addition, excessively high or low temperatures may affect battery performance. Therefore, the minimum and maximum temperature values ​​of the drug injector (100) may be set based on the gas solubility of the drug at different temperatures.

[0138] In the drug infusion interruption phase (S130), if the temperature value of the drug injector (100) deviates from the range of the minimum and maximum temperature values, the drug injector (100) is controlled to interrupt the drug infusion operation. In other words, the power supply applied to the electroosmotic pump of the drug injector (100) can be controlled to be shut off.

[0139] If drug injection is interrupted, a warning notification is generated so that the user can detect the danger. In addition to displaying the warning notification using a terminal (200), the method may also include controlling the drug injector (100) to generate the warning notification.

[0140] Furthermore, warning notifications are not limited to displaying the content of the warning to the user via a display; they may also include methods of attracting the user's attention by generating various stimulus signals such as sound, vibration, and low-frequency stimulation signals. Warning notifications based on battery level, drug level, and pressure, as described later, can also be applied in the same way.

[0141] The following describes how to stop drug injection operations and generate warning notifications based on battery level data, with reference to Figure 9.

[0142] The battery data reception stage (S210) refers to the stage in which battery data of the drug injector (100) is received. Therefore, the battery data reception stage (S210) may be included in the drug injector data reception stage (S1000).

[0143] In the first operating condition comparison stage (S220), it is determined whether the battery level value corresponding to the received battery data is less than a preset first allowable battery level value. The first allowable battery level value is a value arbitrarily set by the user. Therefore, the first allowable battery level value can represent the battery level value that the user wants to be notified about.

[0144] In the first warning notification generation stage (S230), a first warning notification is generated if the battery level of the drug injector (100) is less than the first acceptable battery level. User notification can mean a notification indicating that the battery level of the drug injector (100) has reached the first acceptable battery level set by the user.

[0145] In the second operating condition comparison stage (S240), it is determined whether the battery level value corresponding to the received battery data is less than a preset second allowable battery level value. The second allowable battery level value is a battery level value that is close to the value at which the drug injection operation of the drug injector (100) must be stopped, and is used to warn the user of the risk that drug injection may be interrupted.

[0146] The second permissible battery level value can represent the degree to which the stable operation of the drug injector (100) may be at risk if the battery is rapidly depleted due to changes such as temperature, increased number of operations, or increased number of communications.

[0147] The second allowable battery level can be set to approximately 30% of the total battery capacity, but is not limited to this value; it can be set to any value greater than or equal to the third allowable battery level.

[0148] In the second warning notification generation stage (S250), if the battery level of the drug injector (100) is below the second allowable battery level, a warning notification is generated so that the user can detect danger. The first and second warning notifications are expressed differently from each other, so that the user can distinguish between them. That is, one or more of the following may be set differently: the melody, frequency, volume, number of notifications, vibration frequency, vibration intensity, intensity of the low-frequency electrical stimulation signal, and frequency of the low-frequency electrical stimulation signal.

[0149] In the third operating condition comparison stage (S260), it is determined whether the battery level value corresponding to the received battery data is less than a preset third allowable battery level value. The third allowable battery level value can mean a value less than or equal to the second allowable battery level value. The third allowable battery level value can mean a battery level value at which there is a risk that the drug injector (100) will stop operating while performing a drug injection operation. Alternatively, the third allowable battery level value can mean a battery level value at which the drug injector (100) may stop during a drug injection operation, or a battery level value at which the drug injector (100) may adversely affect operation in its current state. The third allowable battery level value can be set to approximately 10% of the total battery capacity, but is not limited to this, and can be set to any value less than or equal to the second allowable battery level value.

[0150] In the drug injection interruption phase (S270), if the remaining battery level of the drug injector (100) falls below the third allowable battery level, the drug injector (100) is controlled to interrupt the drug injection operation. This prevents a situation where the drug injector (100) stops its drug injection operation due to power depletion during the drug injection operation, resulting in an error in the amount of drug injected.

[0151] The following describes the method for halting drug infusion operations and generating warning notifications based on drug remaining amount data, with reference to Figure 10.

[0152] The drug data reception stage (S310) refers to the stage of receiving drug data from the drug injector (100). Therefore, the drug data reception stage (S310) may be included in the drug injector data reception stage (S1000).

[0153] In the first operating condition comparison stage (S320), it is determined whether the remaining drug amount corresponding to the received drug data is less than a preset first drug amount. The first drug amount corresponds to a value arbitrarily set by the user. Therefore, the first drug amount can mean the drug amount that the user wants to be notified of. In the case of insulin, the first drug amount can be set to 20U (200μl), but is not limited to this and may be changed depending on the specifications of the electroosmotic pump, the type of drug or insulin, the infusion control method, etc.

[0154] In the first warning notification generation stage (S330), if the drug level in the drug injector (100) is less than the first drug level, a first warning notification is generated so that the user can detect the danger.

[0155] In the second operating condition comparison stage (S340), it is determined whether the remaining drug amount corresponding to the received drug data is less than a preset second drug amount value. The second drug amount value represents the degree to which there is a risk that the drug injector (100) may not be able to inject a sufficient amount of drug if the drug is rapidly consumed due to changes such as temperature or an increase in the number of injections. The second drug amount value can also represent the drug amount at which user attention is required as the remaining drug amount decreases.

[0156] The second drug remaining amount can be set to 13U (130μl) in the case of insulin, but it is not limited to this value; it can be set to any value greater than or equal to the third drug remaining amount.

[0157] In the second warning notification generation stage (S350), if the drug level in the drug injector (100) is less than the second drug level, a second warning notification is generated so that the user can detect the danger. As described above, the first and second warning notifications are expressed differently from each other, which means that the user can distinguish between the first and second warning notifications.

[0158] In the third operating condition comparison stage (S360), it is determined whether the remaining drug amount corresponding to the received drug data is less than a preset third drug amount value. The third drug amount value refers to the drug amount at which the drug injector (100) cannot inject a sufficient amount of drug.

[0159] Furthermore, the third drug remaining amount value can mean a value less than or equal to the second drug remaining amount value. While the third drug remaining amount value can be set to approximately 8 U (80 μl) when the drug is insulin, it is not limited to this value and can be set to any value less than or equal to the second drug remaining amount value.

[0160] In the drug infusion interruption phase (S370), if the remaining drug amount in the drug injector (100) falls below the third drug amount value, the drug injector (100) is controlled to interrupt the drug infusion operation. Therefore, it is possible to prevent a situation in which the drug injector (100) runs out of drug during the drug infusion operation and is unable to inject a sufficient amount of drug, resulting in an error in the amount of drug injected.

[0161] The following describes the method for halting drug injection operations and generating warning notifications based on pressure data, with reference to Figure 11.

[0162] The pressure data reception stage (S410) refers to the stage of receiving pressure data from the drug injector (100). Therefore, the pressure data reception stage (S410) may be included in the drug injector data reception stage (S1000).

[0163] In the first operating condition comparison stage (S420), it is determined whether the pressure value corresponding to the received pressure data is less than a preset first allowable pressure value. The first allowable pressure value can be set to a value of 10.0 kPa or higher, but is not limited to this, and may be changed depending on the specifications of the electroosmotic pump, the type of drug, the temperature, and the volume of the injected drug.

[0164] For example, if the volume of the drug to be input is 0.5 μl, the first allowable pressure value can be set to a value of 10.0 kPa or higher; if the volume of the drug to be input is 1.0 μl, the first allowable pressure value can be set to a value of 16.0 kPa or higher; and if the volume of the drug to be input is 3.0 μl, the first allowable pressure value can be set to a value of 70.0 kPa or higher.

[0165] In the flow path blockage prevention operation stage (S430), if the pressure value of the drug injector (100) is less than the first allowable pressure value, the pressure data reception stage (S410) is repeated. If the pressure value of the drug injector (100) is equal to or greater than the first allowable pressure value, it is determined that there is a risk of the flow path becoming blocked, and the flow path blockage prevention operation is performed. The flow path blockage prevention operation refers to an operation to remove or prevent blockage in the flow path through which the drug moves, such as increasing the injection rate of the drug to be injected or increasing the amount of drug injected.

[0166] During the flow path blockage prevention operation phase (S430), if the pressure value of the drug injector (100) is equal to or greater than the first allowable pressure value, a warning notification can be generated so that the user can detect the danger.

[0167] In the second operating condition comparison stage (S440), it is determined whether the pressure value corresponding to the received pressure data is less than a preset second allowable pressure value. The second allowable pressure value can mean a pressure value greater than or equal to the first allowable pressure value. The second allowable pressure value is a pressure value at which, if the drug injector (100) exceeds the second allowable pressure value and performs drug injection, an error in the amount of drug injected may occur due to blockage of the flow path, raising concerns about adverse effects on the user's health.

[0168] For example, if the volume of the drug to be input is 0.5 μl, the second allowable pressure value can be set to a value of 12.0 kPa or higher; if the volume of the drug to be input is 1.0 μl, the second allowable pressure value can be set to a value of 19.5 kPa or higher; and if the volume of the drug to be input is 3.0 μl, the second allowable pressure value can be set to a value of 83.0 kPa or higher.

[0169] In the drug injection interruption stage (S450), if the pressure value of the drug injector (100) is less than the second allowable pressure value, the pressure data reception stage (S410) is repeated. If the pressure value of the drug injector (100) is equal to or greater than the second allowable pressure value, the drug injector (100) is controlled to interrupt the drug injection operation. Therefore, it is possible to prevent a situation in which the drug is injected with an error between the set drug injection amount and the actual amount of drug injected due to blockage of the flow path.

[0170] One embodiment of the present invention may also be embodied in the form of a recording medium containing computer-executable commands, such as program modules executed by a computer. The computer-readable medium may be any available medium accessible by a computer, and includes all volatile and non-volatile media, removable and non-removable media. The computer-readable medium may also include computer storage media. Computer storage media include all volatile and non-volatile, removable and non-removable media embodied in any method or technique for storing information such as computer-readable commands, data structures, program modules, or other data.

[0171] Although the methods and apparatus of the present invention have been described in relation to specific embodiments, some or all of their components or operations can be embodied using a computer system having a general-purpose hardware architecture.

[0172] The foregoing description of the present invention is illustrative, and a person with ordinary skill in the art to which the invention pertains will understand that it can be readily modified into other specific forms without altering the technical idea or essential features of the invention. Therefore, the embodiments described above should be understood in all respects as illustrative and not limiting. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described in a distributed manner may be implemented in a combined manner.

[0173] The scope of the present invention is defined by the claims, which are set forth below rather than by the detailed description above, and all modifications or altered forms derived from the meaning and scope of the claims and the concept of equivalents thereof should be interpreted as being included within the scope of the present invention.

Claims

1. In a method for monitoring the status of a drug injector performed by a processor, a) A step of obtaining at least one state information regarding the operation of the drug injector from the drug injector, and b) The step of outputting a notification signal regarding the status of the drug injector or outputting a control signal to interrupt the drug injector operation based on the result of comparing the status information with a reference value for each status information, The status information includes, among the battery level of the drug injector, the drug level, temperature data of a specific area within the drug injector, and pressure data of a specific area within the drug injector, at least the pressure data. Step b) above is performed based on the pressure data included in the state information, If the pressure of the drug injector is greater than or equal to a first pressure value and less than a second pressure value that is higher than the first pressure value, a control signal is output to perform a preset flow path blockage prevention operation. The step includes outputting a warning notification signal and a control signal to interrupt drug injection by the drug injector if the pressure of the drug injector is equal to or greater than the second pressure value. Method for monitoring drug injectors.

2. A monitoring method according to claim 1, The above step b) is, A method for monitoring a drug injector, comprising the step of outputting a notification signal when the amount of change per hour of at least one of the following: battery level, drug level, temperature data, or pressure data is greater than or equal to a reference rate of change.

3. A monitoring method according to claim 1, Step b) above is performed based on the temperature data included in the state information, A method for monitoring a drug injector, comprising the step of outputting a control signal to interrupt drug injection by the drug injector when the temperature of the drug injector is above a preset maximum temperature value or below a preset minimum temperature value.

4. A monitoring method according to claim 1, Step b) above is performed based on the remaining battery amount included in the status information, If the battery level of the drug injector is below the first battery level value, a warning notification signal is output. A method for monitoring a drug injector, comprising the step of outputting a control signal to interrupt drug injection by the drug injector when the remaining battery level of the drug injector is below a second battery level, which is lower than the first battery level.

5. A monitoring method according to claim 1, Step b) above is performed based on the remaining amount of drug included in the status information, If the remaining drug amount in the drug injector is less than or equal to the first remaining drug amount value, a warning notification signal is output. A method for monitoring a drug injector, comprising the step of outputting a control signal to interrupt drug injection from the drug injector when the remaining drug amount in the drug injector is less than or equal to a second drug amount, which is lower than the first drug amount.

6. A monitoring method according to claim 1, The aforementioned flow path blockage prevention operation is, An operation to increase the amount of drug injected by the drug injector or the volume of the injected drug, or This is an operation to temporarily increase the drug injection rate of the drug injector. Method for monitoring drug injectors.

7. A monitoring method according to claim 1, A method for monitoring a drug injector, wherein, in step a) above, the remaining battery level of the drug injector, the remaining drug level, the temperature of a specific area within the drug injector, and the pressure data of a specific area within the drug injector are simultaneously received from the drug injector.

8. A monitoring method according to claim 1, A method for monitoring a drug injector, wherein, in step a) above, the remaining battery level of the drug injector, the remaining drug level, the temperature of a specific area within the drug injector, and the pressure data of a specific area within the drug injector are received from the drug injector only during the period in which the drug injector performs drug injection operations.

9. A monitoring method according to claim 1, The drug injector includes an electroosmotic pump, The temperature of the aforementioned specific region is the temperature of the electroosmotic pump, The pressure in the specified region is the pressure of the electroosmotic pump, and the method for monitoring a drug injector.

10. A monitoring method according to claim 1, A method for monitoring a drug injector, wherein the pressure in the specified region is the pressure at the drug dispensing section of the drug injector.

11. In a drug infusion device status monitoring system, Memory for storing the drug injector monitoring program, and Includes a processor that executes the program stored in the memory, The processor executes the drug injector monitoring program, obtains at least one state information regarding the operation of the drug injector from the drug injector, and based on the result of comparing the state information with a reference value for each state information, outputs a notification signal regarding the state of the drug injector or outputs a control signal to interrupt the drug injector's drug injector operation. The status information includes, among the battery level of the drug injector, the drug level, temperature data of a specific area within the drug injector, and pressure data of a specific area within the drug injector, at least the pressure data. The processor, based on the pressure data included in the state information, If the pressure of the drug injector is greater than or equal to a first pressure value and less than a second pressure value that is higher than the first pressure value, a control signal is output to perform a preset flow path blockage prevention operation. If the pressure in the drug injector is equal to or greater than the second pressure value, a warning notification signal and a control signal to interrupt drug injection from the drug injector are output. A monitoring device for drug injectors.

12. A monitoring device according to claim 11, The aforementioned processor, A drug injector monitoring device that outputs the notification signal when the change per hour of at least one of the following is greater than or equal to a reference rate of change: battery level, drug level, temperature data, or pressure data.

13. A monitoring device according to claim 11, The processor, based on the temperature data included in the state information, A drug injector monitoring device that outputs a control signal to interrupt drug injection from the drug injector when the temperature of the drug injector is above a preset maximum temperature value or below a preset minimum temperature value.

14. A monitoring device according to claim 11, The processor, based on the remaining battery amount included in the status information, A drug injector monitoring device that outputs a warning notification signal when the battery level of the drug injector is below a first battery level value, and outputs a control signal to interrupt drug injection by the drug injector when the battery level of the drug injector is below a second battery level value which is lower than the first battery level value.

15. A monitoring device according to claim 11, The processor, based on the remaining amount of drug included in the state information, If the remaining drug amount in the drug injector is less than or equal to the first remaining drug amount value, a warning notification signal is output. A drug injector monitoring device that outputs a control signal to interrupt drug injection from the drug injector when the remaining drug amount in the drug injector is less than or equal to a second drug remaining value which is lower than the first drug remaining value.

16. A monitoring device according to claim 11, The aforementioned processor, If the pressure of the drug injector is greater than or equal to the first pressure value and less than the second pressure value, a control signal is output to perform an operation to increase the amount of drug injected by the drug injector or the volume of injected drug, or an operation to temporarily increase the drug injection rate of the drug injector, as the flow path blockage prevention operation. A monitoring device for drug injectors.

17. A monitoring device according to claim 11, A drug injector monitoring device that simultaneously receives data from the drug injector, including the remaining battery level of the drug injector, the remaining drug level, the temperature of a specific region within the drug injector, or the pressure of a specific region within the drug injector.

18. A monitoring device according to claim 11, A drug injector monitoring device, wherein the remaining battery level of the drug injector, the remaining drug level, the temperature of a specific area within the drug injector, or the pressure data of a specific area within the drug injector are received from the drug injector only during the period in which the drug injector is performing its drug injection operation.

19. A monitoring device according to claim 11, The drug injector includes an electroosmotic pump, The temperature of the aforementioned specific region is the temperature of the electroosmotic pump, A monitoring device for a drug injector, wherein the pressure in the specified region is the pressure of the electroosmotic pump.

20. A monitoring device according to claim 11, A monitoring device for a drug injector, wherein the pressure in the specified region is the pressure at the drug dispensing section of the drug injector.

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