WO2024096266A1

WO2024096266A1 - Control method for medicinal fluid injection device

Info

Publication number: WO2024096266A1
Application number: PCT/KR2023/011279
Authority: WO
Inventors: 김선환
Original assignee: 이오플로우㈜
Priority date: 2022-11-03
Filing date: 2023-08-02
Publication date: 2024-05-10
Also published as: KR20240064952A

Abstract

Disclosed is a method for controlling a medicinal fluid injection device that is attached to a target and injects medicinal fluid, wherein, when a first wireless communication connection is completed between the medicinal fluid injection device and a controller, both devices exchange encryption keys through second wireless communication instead of the first wireless communication connection, and when the controller receives an input of a signal through an input or output module or remotely from an integrated management server connected to a network, it is determined whether the input signal is a specific injection signal and then, if the input signal is the specific injection signal, the input signal is transmitted through the second wireless communication, and thus, there is an effect of reinforcing security.

Description

Control method of chemical injection device

The present disclosure provides a method for controlling a chemical injection device.

Development of insulin injectors used by diabetic patients is actively underway. Diabetic patients inject insulin into the body through an insulin pen or insulin pump, but the disadvantage of using these devices is that they are very less active in daily life.

Accordingly, a smart insulin patch was developed, but since there is a risk that can occur when the insulin patch independently controls blood sugar, the insulin patch is mainly used by connecting it to a dedicated controller. Smart insulin patches and dedicated controllers mainly perform short-distance communication such as Bluetooth, but this communication method poses a security problem as there is a high risk of being hacked by other devices within a short distance.

The above-mentioned background technology is technical information that the inventor possessed for deriving the present invention or acquired in the process of deriving the present invention, and cannot necessarily be said to be known art disclosed to the general public before filing the application for the present invention.

The present invention discloses various embodiments of a method for controlling a chemical injection device. The technical challenges that this embodiment aims to achieve are not limited to the technical challenges described above, and other technical challenges can be inferred from the following embodiments.

As a technical means for achieving the above-described technical problem, a first aspect of the present disclosure includes the steps of connecting a chemical solution injection device that is attached to an object and injects a chemical solution and a controller through first wireless communication; exchanging encryption keys between the controller and the chemical injection agent through second wireless communication; determining whether the signal received by the controller is a first type of injection signal; If it is determined that the injection signal is a first type, the controller encrypts the signal using the encryption key; transmitting, by the controller, an encrypted signal to the chemical injection device through the second wireless communication; Decrypting the encrypted signal by the chemical injection device using the encryption key; and controlling the injection of the drug solution according to the signal decoded by the drug injection device. Disclosed is a control room for a chemical solution injection device, including a.

Here, the first wireless communication is connected only when the chemical injection device and the controller are within a first distance and the chemical injection device and the controller go through a pairing process, and the second wireless communication is connected to the chemical injection device. and the controller is within a second distance that is shorter than the first distance, and can be used without a pairing process.

Here, the first type of injection signal is an injection signal input from an integrated management server connected to the controller through a network and transmitted to the controller.

Here, the first type of injection signal is an injection signal that is directly input through the input/output module of the controller and controls the injection of the drug solution into the object immediately.

Here, in the step of determining whether the signal received by the controller is a first type of injection signal, if the determination is not the first type of injection signal, the controller transmits the signal through the first wireless communication to inject the chemical solution. delivering to the device; and controlling the drug injection device according to the signal received by the drug injection device. Includes.

Here, cases where the injection signal is not the first type include cases where it is a general control signal or a second type injection signal.

Other aspects, features and advantages in addition to those described above will become apparent from the following drawings, claims and detailed description of the invention.

According to the problem-solving means of the present disclosure described above, a specific type of injection signal that emphasizes the importance of security among the signals that control the chemical solution injection device uses a communication method in which communication is performed only at a very close distance between the controller and the chemical solution injection device. By delivering it to the injection device, it has the effect of preventing hacking by conventional short-distance communication methods and enhancing user safety.

In addition, according to the problem solving means of the present disclosure, a specific type of injection signal in which the importance of security is emphasized is encrypted through encryption key exchange using a communication method in which communication is performed only at a very close distance, thereby adding a step of encrypting it at a very close distance. The communication method in which communication is carried out only has the effect of further strengthening security by solving the problem of intentionally or unintentionally transmitting signals by tapping between the two devices.

1 is a conceptual diagram illustrating a chemical injection management system according to an embodiment of the present invention.

Figure 2 is a block diagram showing the schematic configuration of a controller according to an embodiment of the present invention.

Figure 3 shows an input/output screen of the controller for explaining the chemical injection method by the basic injection program of the controller.

Figure 4 is a graph showing the amount of chemical injection by time according to the basic injection program of Figure 3.

Figure 5 shows a screen of the input/output module of the controller to explain the method of drug injection by bolus injection of the controller.

Figure 6 is a graph showing the drug injected through the bolus injection of Figure 5 over time.

Figure 7 shows a chemical injection device according to an embodiment of the present invention.

FIG. 8 is a block diagram briefly illustrating the control module of the chemical injection device of FIG. 7 and its associated components.

Figure 9 is a flowchart showing a control method of a chemical injection device according to an embodiment of the present invention.

The present disclosure provides a method for controlling a chemical injection device. A first aspect of the present disclosure includes the steps of connecting a chemical solution injection device that is attached to an object and injects a chemical solution and a controller through first wireless communication; exchanging encryption keys between the controller and the chemical injection agent through second wireless communication; determining whether the signal received by the controller is a first type of injection signal; If it is determined that the injection signal is a first type, the controller encrypts the signal using the encryption key; transmitting, by the controller, an encrypted signal to the chemical injection device through the second wireless communication; Decrypting the encrypted signal by the chemical injection device using the encryption key; and controlling the injection of the drug solution according to the signal decoded by the drug injection device. Discloses a control room for a chemical injection device, including a.

Below, with reference to the attached drawings, embodiments of the present invention will be described in detail so that those skilled in the art can easily implement the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. In order to clearly explain the present invention in the drawings, parts unrelated to the description are omitted, and similar parts are given similar reference numerals throughout the specification.

In the following embodiments, terms such as first and second are used not in a limiting sense but for the purpose of distinguishing one component from another component.

In the following examples, singular terms include plural terms unless the context clearly dictates otherwise.

In the following embodiments, terms such as include or have mean the presence of features or components described in the specification, and do not exclude in advance the possibility of adding one or more other features or components.

In the following embodiments, when a part of a film, region, component, etc. is said to be on or on another part, it is not only the case where it is directly on top of the other part, but also when another film, region, component, etc. is interposed between them. Also includes cases where there are.

In the drawings, the sizes of components may be exaggerated or reduced for convenience of explanation. For example, the shape, size, and thickness of each component shown in the drawings are arbitrarily shown for convenience of explanation, so the present invention is not necessarily limited to what is shown.

In the following embodiments, the x-axis, y-axis, and z-axis are not limited to the three axes in the Cartesian coordinate system, but can be interpreted in a broad sense including these. For example, the x-axis, y-axis, and z-axis may be orthogonal to each other, but may also refer to different directions that are not orthogonal to each other.

In cases where an embodiment can be implemented differently, a specific process sequence may be performed differently from the described sequence. For example, two processes described in succession may be performed substantially at the same time, or may be performed in an order opposite to that in which they are described.

Hereinafter, the present disclosure will be described in detail with reference to the attached drawings.

Figure 1 is a conceptual diagram showing a chemical injection management system 1 according to an embodiment of the present invention.

The chemical injection management system 1 may include a chemical injection device 10, a controller 20, and an integrated management server 30.

The chemical injection device 10 is attached to an object to be injected with a chemical liquid. The drug injection device 10 can measure the user's biometric values such as blood sugar level, blood pressure, and heart rate, and inject the drug stored inside into the subject in a set amount. In an optional embodiment, the chemical injection device 10 may be mounted on the user's body. In another optional embodiment, the drug injection device 10 may be mounted on an animal to inject a drug solution.

The chemical injection device 10 may include a storage unit (200 in FIG. 7) that stores a chemical solution to be periodically injected to the user, and the storage unit (200 in FIG. 7) according to an injection signal generated by the controller 20. 200), the chemical solution may be controlled to be injected into the user. For example, the drug solution may include an insulin-based drug solution for diabetic patients. Hereinafter, the case where the drug solution is insulin will be described as an example. However, the present invention is not limited to this, and the medicinal solution may be of various types, such as glucagon, anesthetic, analgesic, dopamine, growth hormone, smoking cessation aid, and cardiac medicinal solution.

The chemical injection device 10 may be connected one-to-one (point to point) with the controller 20 through first wireless communication. Here, the first wireless communication can be connected when the chemical injection device 10 and the controller 20 are within a first distance (within about 1 m). In addition, the first wireless communication requires a process of pairing the chemical injection device 10 and the controller 20, and the connection is maintained until both devices release the connection. For example, the first wireless communication may be Bluetooth or Bluetooth Low Energy.

Additionally, the chemical injection device 10 can receive signals from the controller 20 through second wireless communication. Here, the second wireless communication is different from the first wireless communication, and the second wireless communication can be used when the chemical injection device 10 and the controller 20 are at a second distance (within about several tens of centimeters) closer than the above-mentioned first distance. You can. Unlike the first wireless communication, the second wireless communication does not require the chemical injection device 10 and the controller 20 to pair or release, and the chemical injection device 10 and the controller 20 approach within a second distance. A second wireless communication connection is established just by commanding or tapping. For example, the second wireless communication may be NFC (Near Field Communication).

The controller 20 may transmit a signal to the chemical injection device 10 and receive data. In detail, the controller 20 transmits a general control signal for controlling the drug injection device 10 in addition to the injection signal for injecting the drug solution into the object to which the drug injection device 10 is attached and the injection of the drug solution ( 10) can be controlled. In addition, the controller 20 receives device data from the chemical injection device 10, such as the chemical injection history, the amount of chemical liquid stored in the storage unit (200 in FIG. 7), the remaining battery capacity, whether the injection port is clogged, and whether the device is malfunctioning, and injects the chemical liquid. The device 10 can be monitored, and the user can be monitored by receiving biometric values such as the user's blood sugar level, blood pressure, and heart rate measured from the drug injection device 10.

The controller 20 refers to a communication terminal that can use an application in a communication environment. Here, the controller 20 may be a user's portable terminal. To explain this in more detail, the controller 20 can be used in the form of a smart remote control, any type of smartphone, computer (e.g., desktop, laptop, tablet, etc.), handheld computing device (e.g., PDA, email client, etc.) etc.), a wearable device that can be attached or mounted on the user's body, or any other type of computing or communication platform, but the present invention is not limited thereto.

The controller 20 may be connected to the integrated management server 30 through a network. Here, the network may be a wireless communication network and may be of a different type from the first wireless communication or the second wireless communication. For example, the network may be a mobile radio communication network, a wireless local area network, or Wi-Fi.

The integrated management server 30 may synchronize data with the controller 20. A third party other than the user, such as a guardian or medical staff, can remotely transmit a signal to the drug injection device 10 through the integrated management server 30. Of course, in this case, in order to maintain security, the integrated management server 30 does not directly transmit the signal to the chemical injection device 10, but the integrated management server 30 transmits the signal to the controller 20 and the controller 20 ) can be used to transmit the signal back to the chemical injection device 10. The integrated management server 30 can receive and store device data, such as a history of chemical injection, from the controller 20, and receive and store measured biometric values. In addition, the integrated management server 30 may generate, manage, and analyze statistical pathology data through stored drug injection history and biometric values and provide it in the form of a report to users, guardians, and medical staff.

Figure 2 is a block diagram showing the schematic configuration of the controller 20 according to an embodiment of the present invention.

The controller 20 includes a first wireless communication module 21, a second wireless communication module 22, a network module 23, an input/output module 24, a signal type determination module 25, and an encryption module 26. can do. Although only the configuration related to one embodiment of the present invention is shown in FIG. 2, the controller 20 may further include various configurations necessary for the operation of the controller 20 in addition to the illustrated configuration. In addition, the illustrated components are shown separately according to their roles or operations for convenience of explanation. One component may be combined with other components to form a single component, and one component may be combined with several separate components. It can also be implemented separately.

The first wireless communication module 21 connects the controller 20 and the chemical solution injection device 10 to first wireless communication for transmitting and receiving a first signal. The first wireless communication module 21 performs scanning of the surrounding chemical injection device 10 in response to a new device registration request in which the user wishes to register a new chemical injection device 10, and injects the chemical solution. A connection request signal is transmitted to the device 10, and when the wireless connection begins, connection parameters are transmitted and received to complete the first wireless communication connection. The first wireless communication module 21 can be connected when it is within a first distance (within about 1 m) from the chemical injection device 10 and the controller 20, and the connection is maintained until both connected devices are disconnected. . For example, the first wireless communication module may be a Bluetooth or Bluetooth Low Energy module.

The second wireless communication module 22 connects the controller 20 and the chemical solution injection device 10 to second wireless communication for transmitting and receiving a second signal. The second wireless communication module 22 connects the two devices in response to the controller 20 approaching the chemical injection device 10 within a second distance. Here, the second distance (within about several tens of centimeters) is closer than the first distance. For example, the second wireless communication module may be an NFC (Near Field Communication) module capable of reading and writing.

According to one embodiment of the present invention, the first signal transmitted by the first wireless communication module 21 and the second signal transmitted by the second wireless communication module 22 are different. According to one embodiment, the second signal transmitted by the second wireless communication module 22 includes an injection signal. On the other hand, the first signal transmitted by the first wireless communication module 21 includes a control signal and data rather than an injection signal. According to another embodiment, the second signal transmitted by the second wireless communication module 22 includes only the specific injection signal. On the other hand, the first signal transmitted by the first wireless communication module 21 includes injection signals other than the specific injection signal described above, all general control signals, and data.

In detail, the injection signal according to one embodiment means that the drug injection device 10 controls the driving module (300 in FIG. 8) to inject the drug stored in the storage unit (200 in FIG. 8) into the object through the needle (N in FIG. 8). This is a command to inject. Additionally, the injection signal refers to all signals that change the injection amount, such as starting, changing, canceling, or stopping the injection of a chemical solution. The injection signal may include an injection signal by bolus injection, an injection signal by a basic injection program, a remote injection signal by the management server 30, etc. Meanwhile, the control signal refers to a signal that controls the alarm unit (800 in FIG. 8) of the chemical injection device 10, a signal that controls the sensor unit (900 in FIG. 8), or a signal that controls the battery (500 in FIG. 8). It may include, but is not limited to, commands for controlling the chemical injection device 10. In addition, the data here refers to device data such as the history of chemical injection from the chemical injection device 10, the amount of chemical liquid stored in the storage unit (200 in FIG. 8), remaining battery power, whether the injection port is clogged, and whether the device is malfunctioning, or the chemical injection device It may be biometric values such as the user's blood sugar level, blood pressure, and heart rate measured from (10).

In detail, in another embodiment, a specific injection signal transmitted by the second wireless communication module 22 refers to a first type of injection signal. First, the injection signal is a command for controlling the driving module (300 in FIG. 8) in the drug injection device 10 to inject the drug stored in the storage unit (200 in FIG. 8) into the object through the needle (N in FIG. 8). am. Here, the first type of injection signal may be an injection signal by bolus injection according to one embodiment, and may be a remote injection signal input to the controller 20 through the integrated management server 30 according to another embodiment. You can.

On the other hand, the specific signal transmitted by the first wireless communication module 21 refers to the injection signal, all control signals and data excluding the first type of injection signal. Here, the injection signals excluding the first type of injection signal may include the second type of injection signal. Here, the second type of injection signal may be an injection signal based on a basic injection program. The remaining general control signals may include all control signals necessary for controlling the chemical injection device 10 except chemical injection. For example, the remaining general control signals include a signal that controls the alarm unit (800 in FIG. 8) of the chemical injection device 10, a signal that controls the sensor unit (900 in FIG. 8), or a signal that controls the battery (500 in FIG. 8). It may include, but is not limited to, etc. In addition, the data here refers to device data such as the history of chemical injection from the chemical injection device 10, the amount of chemical liquid stored in the storage unit (200 in FIG. 8), remaining battery power, whether the injection port is clogged, and whether the device is malfunctioning, or the chemical injection device It may be biometric values such as the user's blood sugar level, blood pressure, and heart rate measured from (10).

Hereinafter, the first type of injection signal and the second type of injection signal will be described in more detail.

FIG. 3 shows an input/output screen of the controller 20 for explaining the chemical injection method using the basic injection program of the controller 20. Figure 4 is a graph showing the amount of chemical injection by time according to the basic injection program of Figure 3. FIG. 5 shows an input/output module screen of the controller 20 to explain the method of injecting a chemical solution by bolus injection of the controller 20. Figure 6 is a graph showing the drug injected through the bolus injection of Figure 5 over time.

The controller 20 may implement a basic injection program or a drug injection method by bolus injection.

Referring to Figures 3 and 4, the basic injection program is an injection that schedules in advance to inject a user-set amount of chemical solution at a user-set rate at a user-specified time for a set period of time (e.g., 24 hours). It's a method. Referring to FIG. 3(a), the user can set the target blood sugar range through the input/output module 24 of the controller 20. In other words, you can divide the time into day and night and set the target blood sugar range you want to achieve during that time. Because you consume food during the day, your blood sugar level is likely to remain high, so you can set a target blood sugar range that is different from that at night to lower your blood sugar level accordingly and maintain it within a certain range. Referring to FIG. 3(b), the user can set the maximum basic injection speed of the chemical solution, and referring to FIG. 3(c), the user can set different basic injection speeds for each time period. Since blood sugar can rise rapidly after consuming food, it is helpful to maintain a normal blood sugar range by setting a different basic infusion rate for each time zone in conjunction with meal or snack times.

Referring to FIG. 4, according to the basic injection program set in FIG. 3, the chemical solution is injected at an amount and rate (U/hr) set for each time period. For example, it can be seen that a somewhat small amount of chemical solution is injected at night or before morning, and a somewhat large amount of chemical solution is injected from morning to evening. Here, U on the vertical axis of FIG. 4 is a unit, 1 unit is 1/24 mg of purified insulin, and 1 mg of insulin means 24 units. The horizontal axis means time.

The infusion signal based on the target blood sugar range for each time slot, maximum basal infusion rate, and basic infusion rate for each time slot set by the basic infusion program is defined as a second type of infusion signal. As for the second type of injection signal, the user can directly set the basic injection program through the controller 20, as shown in FIG. 3. The second type of injection signal set in this way can be transmitted from the controller 20 to the chemical injection device 10 through the first wireless communication.

Next, referring to Figures 5 and 6, bolus injection, unlike basic injection, is an immediate injection whenever necessary to lower blood sugar level that rises after a meal due to ingestion of food or to correct high blood sugar level to target blood sugar level. This is a method of injecting a chemical solution. As shown in Figure 5(a), the user can set the injection amount of the medicine according to the intake of carbohydrates through the input/output module of the controller 20, and can also directly set the injection amount of the medicine to be injected, as shown in Figure 5(b). Blood sugar can rise rapidly, especially after consuming carbohydrates, so after consuming foods high in carbohydrates, bolus injection is used to quickly return to the normal blood sugar range.

Referring to FIG. 6, unlike FIG. 4 discussed above, according to the bolus injection set in FIG. 5, the drug solution is administered for a short time (several minutes (min) ( FIG. 6 (a)) or several hours ( FIG. 6 ( It is injected at the amount and rate set in b)).

The injection signal that commands immediate injection of a drug solution based on the injection amount of the drug solution set by bolus injection is defined as a first type of injection signal. As for the first type of injection signal, the user may directly set bolus injection through the controller 20, as shown in FIG. 5. The first type of injection signal set in this way can be transmitted from the controller 20 to the chemical injection device 10 through the second wireless communication.

According to an optional embodiment, a user, medical staff, or guardian may set the basic injection program of FIG. 3 or the bolus injection of FIG. 5 through a web or application provided by the integrated management server 30. In this case, of course, the injection signal based on the basic injection program set in the integrated management server 30 is transmitted to the chemical injection device 10 through the controller 20. The injection signal set using the integrated management server 30 is defined as a first type injection signal, and the first type injection signal set in this way is transmitted from the controller 20 to the chemical injection device 10 through the second wireless communication. It can be delivered.

Injection signals that are directly related to the user's life and health must be subject to thorough security management. If the injection signal is made only through the first wireless communication, the user is not free from the threat of malicious hacking. Because primary wireless communication allows communication between devices within a radius of several tens of meters, it is vulnerable to hacking. Accordingly, there is a risk that problems may occur, such as the user not being able to receive injection of the medication when needed, or receiving excessive medication injected in a situation where it is not needed.

According to one embodiment of the present invention, the security-critical injection signal is transmitted to the chemical injection device 10 through the second wireless communication rather than the first wireless communication, thereby strengthening security and promoting user safety. .

In addition, according to another embodiment of the present invention, a specific type of injection signal that emphasizes the importance of security among injection signals is transmitted to the drug injection device 10 through second wireless communication rather than first wireless communication, thereby protecting the user. It has the effect of enhancing safety.

Specifically, the first type of injection signal transmitted through the second wireless communication is an injection signal that commands immediate injection of a drug solution based on the injection amount of the drug solution set by bolus injection, or is set in the integrated management server 30 and is sent to the controller ( 20) It may be a remote injection signal input. This is because, first of all, in the case of an injection signal set by bolus injection, the drug solution can be immediately injected into the subject, so there is a risk that the subject's health may be threatened by a malicious attack. In addition, in the case of a remote injection signal set by the integrated management server 30, there is a physical distance from the controller 20 and the chemical injection device 10, and there is a risk of hacking by a third party, so the user cannot control the controller. This is because it may be considered vulnerable in terms of security compared to the injection signal input directly into (20).

The second wireless communication establishes a communication connection only when both devices approach very closely. In other words, the first type of injection signal can be transmitted to the chemical injection device 10 only when the controller 20 is tapped on the chemical injection device 10 attached to the user. Accordingly, there is an effect of solving the security problem of first wireless communication.

Meanwhile, among the injection signals, a second type of injection signal, for example, is set directly by the user in the controller 20, and includes the target blood sugar range for each time period set by the basic infusion program, the maximum basal infusion rate, and the basic infusion rate for each time period. Since the based injection signal has already been scheduled, access control is more difficult than the first type of injection signal, and is transmitted from the controller 20 to the chemical injection device 10 through the first wireless communication.

Meanwhile, among the signals, general control signals other than injection signals, for example, signals that control the alarm unit of the chemical injection device 10, signals that control the sensor unit, or signals that control the battery, are more susceptible to malicious attacks than injection signals. Even if it is subject to hacking, there is little direct risk to the object to which the chemical injection device 10 is attached, so the chemical injection device ( 10) is transmitted.

In addition, data, for example, device data such as history of chemical injection from the chemical liquid injection device 10, amount of chemical liquid stored in the storage unit, remaining battery power, whether the injection port is clogged, and whether the device is malfunctioning, or information from the chemical liquid injection device 10 Since the user's measured biometric values such as blood sugar level, blood pressure, heart rate, etc. have a relatively low security level compared to the injection signal, the medicine is injected from the controller 20 through the first wireless communication, as in the case of the second type of injection signal. transmitted to device 10.

Returning to Figure 2, the network module 23 connects the controller 20 and the integrated management server 30 to a network for transmitting and receiving signals. The network module 23 may receive signals from the integrated management server 30. Here, the signal may include an injection signal, and here the injection signal may be generated by medical staff or guardians in addition to the user through a web or application provided by the integrated management server 30.

The input/output module 24 includes an input unit and an output unit, and includes an input unit that receives information from the user through a keyboard, keypad, virtual keyboard, touch display, button, camera, etc., and provides information to the user through a display, speaker, light, vibrator, etc. It may include an output unit that outputs.

The signal type determination module 25 determines whether to use the first wireless communication module or the second wireless communication module when the signal received from the network module 23 and the signal input through the input/output module 24 are transmitted to the chemical injection device 10. Decide whether to use the wireless communication module. In detail, the signal type determination module 25 according to one embodiment receives a signal and first determines whether the input signal is an injection signal. Additionally, the signal type module 25 according to another embodiment receives a signal, first determines whether the input signal is an injection signal, and if it is determined to be an injection signal, determines what type of injection signal it is.

First, the signal type determination module 25 determines whether the signal received from the network module 23 and the signal input through the input/output module 24 are injection signals. If the signal is not an injection signal but a general control signal, the signal type determination module 25 transmits the control signal to the first wireless communication module 21. If the signal is not an injection signal but data, the signal type determination module 25 stores the data in a storage unit (not shown) or inputs it to a processor (not shown) and uses it to control the controller 20.

If the determination result signal is an injection signal, the signal type determination module 25 determines whether the type of the injection signal is the first type or the second type. If the injection signal is a first type of injection signal, the signal type determination module 25 transmits the first type of injection signal to the second wireless communication module 22. If the injection signal is a second type of injection signal, the signal type determination module 25 transmits the second type of injection signal to the first wireless communication module 21.

The signal type determination module 25 can store a table displaying the types of signals, and determine the signal type by comparing the table with the input signal. The corresponding configuration may be stored as a plurality of algorithms.

The encryption module 26 performs encryption for additional security of the signal transmitted using the second wireless communication. Here, the signal may be an injection signal according to one embodiment, and may be a first type injection signal according to another embodiment. In detail, the encryption module may include an encryption/decryption unit, a storage unit, a key management unit, etc., not shown. The key management unit generates or extracts an encryption key for exchange with the chemical injection device 10 through the second wireless communication. The encryption/decryption unit encrypts the injection signal or the first type of injection signal to be transmitted through the second wireless communication using the extracted encryption key. The storage unit stores the encrypted injection signal or the first type of injection signal. The stored injection signal or the first type of injection signal is transmitted to the drug injection device 10 through the second wireless communication.

The key management unit may randomly generate or extract a new encryption key according to the registration each time a new chemical injection device 10 is registered. However, it is not limited to this, and the user can arbitrarily set the encryption key in the form of a private key.

The encryption/decryption unit encrypts the injection signal or the first type of injection signal using the extracted encryption key and stores it in the storage. It can be encrypted using any one of various encryption methods such as symmetric and asymmetric encryption algorithms. .

According to one embodiment of the present invention, the safety of the user is ensured by transmitting the injection signal or the first type of injection signal, which emphasizes the importance of security, to the chemical injection device 10 through second wireless communication rather than first wireless communication. It can be strengthened. Here, the injection signal or the first type of injection signal has the feature of further strengthening security by adding an additional encryption process. For example, if the injection signal or the first type of injection signal does not go through the encryption process, a third party may intentionally or unintentionally inject the drug into the user by tapping the controller 20 on the drug injection device 10. There are concerns. However, according to one embodiment of the present invention, the injection signal or the first type of injection signal is encrypted using an encryption key, so that the controller 20 and the chemical injection device 10, for which the encryption key has already been exchanged by a key exchange method, ), the injection signal or the first type of injection signal can actually operate, and injection of the chemical solution by an unauthorized third party can be prevented.

Figure 7 shows a chemical injection device 10 according to an embodiment of the present invention. FIG. 8 is a block diagram briefly illustrating the control module of the chemical injection device 10 of FIG. 7 and its associated components.

Referring to FIGS. 7 and 8 together, one embodiment of the chemical injection device 10 may include a housing 11 covering the outside and an attachment portion 12 located adjacent to the user's skin. The chemical injection device 10 includes a plurality of parts disposed in the internal space between the housing 11 and the attachment portion 12.

The chemical injection device 10 includes a needle assembly 100, a storage unit 200, a driving module 300, a battery 500, a driving unit 400, an alarm unit 800, and a plurality of sensor units (see FIG. 8). 900) and a control module (1000 in FIG. 8).

The chemical injection device 10 may have a base body comprised of at least one body to form a frame supporting internal components. The base body may have a first body 13, a second body 14, and a third body 15 depending on the arrangement. In the drawing, the base body is shown to be composed of a first body 13, a second body 14, and a third body 15, but this is not limited to this and the base body may be provided as one body or may be provided as a plurality of components. there is.

A control module (1000 in FIG. 8) may be placed inside the chemical injection device 10. A control module (not shown), which is a circuit board, is disposed below the second body 14 and can control the overall operation of the chemical injection device 10. The control module (1000 in FIG. 8) is in electrical contact with the driving module 300, battery 500, alarm unit 800, and a plurality of sensor units (900 in FIG. 8) to control their operation. there is.

The needle assembly 100 may be mounted on the first body 13. One end of the needle (N) is connected to the reservoir 200 so that a medicinal solution can be delivered, and the other end is inserted into a cannula and can move along the cannula. Since the cannula has a conduit shape that can accommodate the needle (N), the medical solution discharged from the needle (N) can be injected into the user. In the drug injection device 10, the user can simply rotate the needle assembly 100, insert the cannula into the object, and start injection of the drug solution.

The storage unit 200 is mounted on the first body 13 and the third body 15 and is connected to the needle assembly 100. A chemical solution is stored in the internal space of the storage unit 200, and a fixed amount of the chemical solution can be moved to the needle (N) as the plunger (230 in FIG. 8) moves. The plunger (230 in FIG. 8) can move linearly along the longitudinal direction of the storage unit 200 by driving the driving module 300 and the driving unit 400. When the chemical solution is replenished in the storage unit 200, the plunger (230 in FIG. 8) may retract, and when the chemical liquid is discharged from the storage unit 200, the plunger (230 in FIG. 8) may advance.

The driving module 300 may generate driving force and transmit the driving force to the driving unit 400. The driving force transmitted by the driving unit 400 moves the plunger (230 in FIG. 8) along the longitudinal direction of the storage unit 200, and in this process, the chemical solution may be discharged.

The driving module 300 can be any type of device that has chemical suction power and chemical liquid discharge power by electricity. For example, all types of pumps, such as mechanical displacement micropumps and electromagnetic motion micropumps, can be used. A mechanical displacement micropump is a pump that uses the movement of solids or fluids, such as gears or diagrams, to create a pressure difference to induce the flow of fluid, and is called a diaphragm displacement pump or fluid displacement pump. ), rotary pump, etc. Electromagnetic micropumps are pumps that use energy in the form of electricity or magnetism directly to move fluid, and include electrohydrodynamic pumps (EHD), electroosmotic pumps, and magnetohydrodynamic pumps ( Magneto hydrodynamic pump, electro wetting pump, etc.

The battery 500 can supply electricity to the chemical injection device 10 to activate each component. In the drawing, a pair of batteries 500 is shown, but the battery 500 is not limited thereto, and may be set in various ways depending on the capacity, usage range, usage time, etc. of the chemical injection device 10. The battery 500 is disposed adjacent to the driving unit 400 and can supply electricity to the driving unit 400. In addition, the battery 500 is connected to the control module 1000, and based on the electrical signal measured by the sensor unit (900 in FIG. 8), the rotation speed or rotation speed of the driving unit 400 is stored in the storage unit 200. Data on the amount of medicine stored, the amount of medicine injected into the user, etc. can be measured.

Meanwhile, the sensor unit (900 in FIG. 8) detects device abnormalities such as the amount of medicine stored in the storage unit, whether the inlet is clogged, leakage of medicine, temperature outside the allowable limit, etc., and detects biometric values such as the user's blood sugar level, blood pressure, and heart rate. Measurements may be performed and the results may be transmitted to the control module 1000. The alarm unit (800 in FIG. 8) can generate an alarm with sound, light, vibration, etc. in response to a signal from the control module 1000.

Referring to FIG. 8, the control module 1000 may include a first wireless communication unit 1011, a second wireless communication unit 1021, an encryption unit 1022, a chemical injection control unit 1023, and an integrated control unit 1012. there is. Although FIG. 8 shows only the components related to one embodiment of the present invention, the controller 20 may further include various components necessary for the operation of the controller 20 in addition to the illustrated components.

The first wireless communication unit 1011 is a first wireless communication unit for the controller 20 and the chemical injection device 10 to transmit and receive injection signals other than the injection signal according to one embodiment or the first type of injection signal according to another embodiment. Connect communication. Additionally, the first wireless communication unit 1011 connects the first wireless communication for transmitting and receiving general control signals and data. The first wireless communication unit 1011 performs advertising by injecting a chemical solution into the storage unit 200, that is, by triggering the injection of the chemical solution, and transmitting an advertising message corresponding to the pairing request signal, and the controller ( 20), and when the wireless connection starts, the first wireless communication connection is completed by transmitting and receiving connection parameters. For example, the first wireless communication unit 1011 may be a Bluetooth or Bluetooth Low Energy module.

The second wireless communication unit 1021 connects the controller 20 and the chemical injection device 10 to second wireless communication for transmitting and receiving an injection signal according to one embodiment or a first type of injection signal according to another embodiment. . The second wireless communication unit 1021 performs a connection between the two devices in response to the controller 20 approaching within a second distance. Here, the second distance (within about several tens of centimeters) is closer than the first distance. For example, the second wireless communication unit 1021 may be a Near Field Communication (NFC) module.

The integrated control unit 1012 controls each component of the chemical injection device 10 through various signals. For example, the integrated control unit 1012 controls the on/off of the alarm unit with a signal that controls the alarm unit 800 of the chemical injection device 10, and controls the alarm unit 800 with a signal to control the sensor unit 900 to determine if the device is malfunctioning. It is possible to detect the user's blood sugar level, blood pressure, heart rate, etc., and measure the remaining amount of the battery using a signal that controls the battery 500. Based on this, the integrated control unit 1012 can generate device data and biometric values.

According to one embodiment, the chemical injection control unit 1023 controls the driving module 300 based on the injection signal received through the second wireless communication unit 1021 to store the liquid in the storage unit 200 as described above with reference to FIG. 7. Allow the stored chemical solution to be discharged through the needle (N). In addition, according to another embodiment, the chemical injection control unit 1023 is based on the first type of injection signal received through the second wireless communication unit 1021 and the second type of injection signal received through the first wireless communication unit 1011. The driving module 300 is controlled to allow the chemical solution stored in the storage unit 200 to be discharged through the needle N as described above with reference to FIG. 7 .

The encryption unit 1022 performs decryption of the encrypted injection signal or the first type of injection signal. In detail, the encryption unit 1022 may include an encryption/decryption unit, a storage unit, a key management unit, etc., which are not shown, similar to the encryption module of the controller 20. The key management unit extracts or generates an encryption key to be exchanged with the controller 20 through the second wireless communication. The encryption/decryption unit decrypts the injection signal or the first type of injection signal received through the second wireless communication using the exchanged encryption key. The storage unit stores the decoded injection signal or the first type of injection signal. The stored injection signal or the first type of injection signal is transmitted to the drug injection control unit 1023 to control drug injection.

Figure 9 is a flowchart showing a control method of the chemical injection device 10 according to an embodiment of the present invention.

Referring to FIG. 9, in step 101, a chemical solution is injected into the storage unit (200 in FIG. 8) of the chemical solution injection device 10. The user can fill the storage portion (200 in FIG. 8) of the drug injection device 10 with the drug solution by inserting the syringe into the drug injection port of the attachment portion of the drug injection device 10.

In step 102, the chemical injection device 10 and the controller 20 are connected through first wireless communication. In detail, the medicine injection device 10 performs advertising by transmitting an advertising message corresponding to a pairing request signal by injecting the medicine, that is, by triggering the medicine injection. The controller 20 performs scanning of the surrounding chemical injection device 10 in response to a new device registration request in which the user wishes to register a new chemical injection device 10, and Send a connection request signal. When the chemical injection device 10 receives a connection request signal from the controller 20, a wireless connection begins and both devices transmit and receive connection parameters, thereby completing the first wireless communication connection. As described above, the first wireless communication connection may be a Bluetooth or Bluetooth Low Energy connection.

In step 103, the controller 20 requests a second wireless communication connection for encryption key exchange. The controller 20 connects the first wireless communication between the two devices and extracts or generates an encryption key. When the encryption key is extracted or created, the controller 20 generates sound, light, and a pop-up information through the input/output module 24 to connect the chemical injection device 10 and the second wireless communication for the purpose of exchanging the encryption key to the user. request. Meanwhile, the chemical injection device 10 also extracts or generates an encryption key when the controller 20 and the first wireless communication are connected.

In step 104, the controller 20 exchanges an encryption key with the chemical injection device 10 through a second wireless communication. Here, the second wireless communication connection is performed by the controller 20 approaching or tapping the chemical injection device 10 within a second distance. Here, the second wireless communication may be a Near Field Communication (NFC) method. The encryption key exchanged in both devices is stored in both devices and used for later transmission and decryption of the encrypted signal, thereby maintaining a high level of security in relation to signal transmission.

In step 105, the controller 20 receives a signal from the user. The controller 20 may receive a signal directly from the user through the input/output module 24, but according to an optional embodiment, the user and medical staff, in addition to the user, through the web or application of the integrated management server 30 as in step 105a. A signal may be received from a third party, such as a guardian, and transmitted to the controller 20 through the network. Here, the signal may include an injection signal and a general control signal other than an injection signal. The injection signal may include a first type of injection signal and a second type of injection signal. The first type of infusion signal may include an infusion signal by bolus injection and, in an optional embodiment, a remote infusion signal input to the controller 20 via the integrated management server 30. The second type of injection signal may refer to all injection signals except the first type of injection signal. The general control signal may include a signal for controlling the chemical injection device 10 excluding the injection signal.

In step 106, the controller 20 determines whether the input signal is an injection command (one embodiment) or a first type injection command (another embodiment). In detail, the controller 20 must determine whether to use the first wireless communication or the second wireless communication after encryption when the signal is transmitted to the chemical injection device 10. According to one embodiment, the controller 20 determines whether the input signal is an injection signal. According to another embodiment, the controller 20 first determines whether the input signal is an injection signal, and if it is determined to be an injection signal, it determines what type of injection signal it is.

If the signal is not an injection signal, that is, a general control signal, the controller 20 transmits the control signal to the chemical injection device 10 through the first wireless communication. (S107) If the signal is not an injection signal or a control signal but data, the controller 20 can use it to control the controller 20 by storing the data in a storage unit (not shown) or inputting it to a processor (not shown). there is.

If the signal is an injection signal, according to one embodiment, the controller 20 transmits the corresponding injection signal to the chemical injection device 10 through the second wireless communication (S107). In another embodiment, if the signal is an injection signal If it is a signal, the controller 20 determines whether the type of injection signal is the first type or the second type. If the injection signal is a second type of injection signal, the controller 20 transmits the second type of injection signal to the chemical injection device 10 through the first wireless communication (S107).

The chemical injection device 10 controls the chemical injection device 10 according to the signal transmitted in step 107 (S108), and sends the chemical injection device 10 control result as data to the controller 20 through the first wireless communication. It can be delivered. (S109) For example, in another embodiment, if the second type of injection signal is transmitted through the first wireless communication and the signal transmitted in step 107 is the second type of injection signal, the drug injection device 10 may perform the first According to two types of injection signals, drug injection can be performed based on the target blood sugar range for each time slot, maximum basal infusion rate, and basic infusion rate for each time slot preset by the basic injection program, and the results can be transmitted to the controller 20. . As another example, if the signal transmitted in step 107 is a general control signal, the chemical injection device 10 may record the chemical injection history resulting from monitoring the storage unit, alarm unit, sensor unit, or battery, the amount of chemical liquid stored in the storage unit, and the battery. Device data such as remaining amount, whether the inlet is clogged, and whether the device is malfunctioning, or measured biometric values such as the user's blood sugar level, blood pressure, and heart rate, can be transmitted to the controller 20.

Returning to step 106, in one embodiment, if the signal is an injection signal, the controller 20 encrypts the first type of injection signal using the encryption key exchanged in step 104. Since injection signals require increased security compared to other control signals or data, user safety can be promoted through additional security procedures. In another embodiment, if the signal is an injection signal and the injection signal is a first type of injection signal, the controller 20 encrypts the first type of injection signal using the encryption key exchanged in step 104. (S110) Here, the first type of injection signal is a signal that can have an immediate effect on the user's human body or can be input by a third party other than the user, so additional security procedures are introduced to protect the user's safety. You can.

In step 111, the controller 20 requests a second wireless communication connection for signal transmission. In detail, when encryption is completed, the controller 20 requests a second wireless communication connection with the chemical injection device 10 for the purpose of transmitting an encrypted signal to the user through sound, light, and guidance pop-up through the input/output module.

In step 112, the user approaches or taps the chemical injection device 10 with the controller 20 within a second distance, so that the controller 20 sends an encrypted signal through the second wireless communication to the chemical injection device 10. Pass it to

In step 113, the chemical injection device 10 decodes the received signal. The chemical injection device 10 decrypts the signal using the encryption key exchanged in step 104.

In step 114, the chemical injection device controls the chemical injection according to the decoded signal (S114), and transmits the chemical injection control result as data to the controller 20 through the first wireless communication. (S115) For example, the drug injection device 10 immediately performs drug injection based on the injection amount of the drug set by bolus injection according to the decoded first type injection signal and sends the result to the controller 20. It can be passed on. In addition, the chemical injection device 10 may perform injection of the chemical solution in the manner input through the integrated management server 30 according to the decrypted first type injection signal and transmit the result to the controller 20.

According to one embodiment of the present invention, the injection signals, such as the first type of injection signal, the second type of injection signal, and the remote injection signal, are all transmitted to the drug injection device 10 through the second wireless communication, and the injection signal Control signals and data other than may be transmitted to the chemical injection device 10 through first wireless communication. As a result, signal transmission can be performed in a security-enhanced manner for all injection signals.

Meanwhile, according to another embodiment of the present invention, an injection signal among signals and a specific type of injection signal that emphasizes the importance of security among injection signals is transmitted to the chemical injection device 10 through second wireless communication rather than first wireless communication. This has the effect of strengthening user safety. That is, the second wireless communication is established only when both devices approach very closely. In other words, only when the controller 20 is tapped on the chemical injection device 10 attached to the user, a specific injection signal can be transmitted to the chemical injection device 10. Therefore, there is an effect of solving security weaknesses caused by short-distance hacking that may occur when using the first wireless communication.

According to one embodiment of the present invention, security is further strengthened by adding a step of encrypting a specific type of injection signal through encryption key exchange through a second wireless communication. That is, in order to protect the user from a third party maliciously and forcibly approaching both devices and transmitting a specific type of injection signal to the chemical injection device 10, only both devices that have exchanged encryption keys can transmit a specific injection signal. By enabling the use of , it has the feature of solving security weaknesses caused by malicious coercive actions that may occur when second wireless communication is available.

Meanwhile, according to an optional embodiment of the present invention, steps 103, 104, 110, and 113 may be omitted and performed. In this case, since additional security procedures are omitted, the security level for the second type of injection signal may be lowered, but user convenience is increased because the user does not need to perform tapping of both devices for encryption key exchange. There is an increasing effect.

Meanwhile, according to another embodiment of the present invention, the steps performed by the controller may be implemented as software (e.g., program) including one or more instructions stored in a storage medium that can be read by a machine. You can.

For example, the processor of the device may call at least one instruction among one or more instructions stored from a storage medium and execute it. This allows the device to be operated to perform at least one function according to the at least one instruction called. The one or more instructions may include code generated by a compiler or code that can be executed by an interpreter. A storage medium that can be read by a device may be provided in the form of a non-transitory storage medium. Here, 'non-transitory' only means that the storage medium is a tangible device and does not contain signals (e.g. electromagnetic waves). This term refers to cases where data is stored semi-permanently in the storage medium. There is no distinction between temporary storage cases.

Meanwhile, according to another embodiment of the present invention, each step may be included and provided in a computer program product.

Computer program products are commodities and can be traded between sellers and buyers. The computer program product may be distributed in the form of a machine-readable storage medium (e.g. compact disc read only memory (CD-ROM)) or through an application store (e.g. Play StoreTM) or between two user devices. It may be distributed in person or online (e.g., downloaded or uploaded). In the case of online distribution, at least a portion of the computer program product may be at least temporarily stored or temporarily created in a machine-readable storage medium, such as the memory of a manufacturer's server, an application store's server, or a relay server.

Additionally, in this specification, “unit” may be a hardware component such as a processor or circuit, and/or a software component executed by the hardware component such as a processor.

The scope of this embodiment is indicated by the patent claims described later rather than the detailed description above, and should be interpreted to include all changes or modified forms derived from the meaning and scope of the claims and their equivalent concepts.

Claims

A step of making a first wireless communication connection between a controller and a chemical solution injection device that is attached to the object and injects a chemical solution;

exchanging encryption keys between the controller and the chemical injection device through second wireless communication;

determining whether the signal received by the controller is an injection signal;

If the determination result is an injection signal, the controller encrypts the signal using the encryption key;

transmitting, by the controller, an encrypted signal to the chemical injection device through the second wireless communication;

Decrypting the encrypted signal by the chemical injection device using the encryption key; and

Controlling injection of a chemical solution according to a signal decoded by the chemical injection device;

A control method of a chemical liquid injection device comprising a.
According to paragraph 1,

The first wireless communication is connected only when the chemical injection device and the controller are within a first distance and the chemical injection device and the controller go through a pairing process,

The second wireless communication is a method of controlling a chemical injection device in which the chemical injection device and the controller are within a second distance shorter than the first distance and can be used without a pairing process.
According to paragraph 1,

The first wireless communication is Bluetooth or Bluetooth low energy,

The second wireless communication is NFC (Near Field Communication), a method of controlling a chemical injection device.
According to paragraph 1,

The injection signal is an injection signal input from an integrated management server connected to the controller through a network and transmitted to the controller.
According to paragraph 1,

The injection signal is directly input through the input/output module of the controller and is an injection signal that controls the drug solution to be immediately injected into the object.
According to paragraph 1,

In the step of determining whether the signal received by the controller is an injection signal,

If it is determined that the injection signal is not the injection signal, the controller transmits the signal to the chemical injection device through the first wireless communication; and

Controlling the drug injection device according to a signal received by the drug injection device;

A control method of a chemical liquid injection device comprising a.
According to clause 6,

A method of controlling a chemical injection device, including a case where the case other than the injection signal is a general control signal or data for controlling the drug injection device.