Circuitry for drug infusion control and infusion control method

Abstract

This application relates to the field of medical device technology, and in particular to a circuit system and infusion control method for drug infusion control. The system includes: a main control module for receiving external commands and generating corresponding drive control signals; a drive execution module for receiving the drive control signals and driving the execution element; a position sensing module for real-time monitoring of the displacement state of the execution element and feeding back corresponding displacement detection signals to the main control module; a monitoring interlock module for independently shutting down the drive execution module in case of a fault or failure of the main control module; and an alarm module controlled by the main control module to issue warning information. The main control module is configured to verify the actual infusion volume based on the displacement detection signals, and, upon detecting a fault, shut down the drive execution module and trigger the alarm module via the monitoring interlock module. This system can accurately and stably control drug infusion.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a circuit system and infusion control method for drug infusion control. Background Technology

[0002] A transdermal drug delivery device is a wearable, minimally invasive drug delivery system designed to replace traditional intravenous infusions and achieve continuous and stable drug delivery. While traditional intravenous infusion is a landmark invention in the history of medication, its operation relies on venipuncture by professional medical personnel, and the process is primarily gravity-driven. This requires patients to remain in the hospital for extended periods, resulting in limited mobility and a poor patient experience. Especially in treatment scenarios requiring large doses of short-half-life drugs, such as chemotherapy drugs and antibiotics, such as those for tumors, bacterial infections, and postoperative pain, patients often need to remain bedridden for several hours or even 72 hours for infusion, leading to high treatment costs and significant patient discomfort due to prolonged immobilization. Therefore, there is an urgent need for a lightweight, portable, gravity-independent drug delivery device that can significantly improve patient convenience and comfort. Existing transdermal drug delivery devices are products of medical technology development, typically consisting of a wearable patch assembly and a drug delivery component.

[0003] In related technologies, taking insulin injection as an example, early insulin pumps were mostly tubular pumps, with the pump body connected to an indwelling needle attached to the skin via a thin infusion tubing. Although this allowed for more precise insulin infusion, the exposed tubing was prone to tangling, bending, or detachment, and the bulky pump body needed to be carried around, severely impacting the patient's daily convenience and privacy. Against this backdrop, the patch pump was developed as an innovative drug delivery device. Its core design concept highly integrates the pump body, reservoir, drive mechanism, and subcutaneous indwelling needle into a tiny wearable patch unit, which is directly adhered to the skin surface, completely eliminating exposed infusion tubing and achieving "catheterless" infusion, greatly improving patient comfort and freedom of movement.

[0004] However, current drug infusion control systems for patch-type insulin pumps have the following technical problems:

[0005] Existing drug infusion systems suffer from inaccurate infusion progress control and difficulty in convenient and stable drug infusion control, and therefore need to be optimized. Summary of the Invention

[0006] Therefore, it is necessary to provide a circuit system and infusion control method for drug infusion control that can accurately and stably control drug infusion.

[0007] This application provides a circuit system for drug infusion control, comprising:

[0008] The main control module is used to receive external commands and generate corresponding drive control signals;

[0009] The drive execution module, connected to the main control module, is used to receive the drive control signal and drive the execution element to operate;

[0010] A position sensing module, connected to the main control module, is used to monitor the displacement state of the actuator in real time and feed back the corresponding displacement detection signal to the main control module.

[0011] The monitoring interlock module is connected to the power module, the main control module, and the drive execution module, and is used to independently shut down the drive execution module in case of a fault or failure of the main control module.

[0012] An alarm module, connected to the main control module, is used to issue warning information under the control of the main control module;

[0013] The main control module is configured to verify the actual injection volume based on the displacement detection signal, and to shut down the drive execution module and trigger the alarm module through the monitoring interlock module when the fault condition is detected.

[0014] In one embodiment, the drive execution module includes:

[0015] An electrothermal actuator is used to convert electrical energy into heat energy to generate mechanical deformation, and to drive the actuator based on the mechanical deformation;

[0016] A constant power drive unit has an input terminal, an output terminal, and a current feedback terminal. The input terminal of the constant power drive unit is coupled to the output terminal of the main control module, the output terminal of the constant power drive unit is coupled to the electrothermal execution unit, and the current feedback terminal of the constant power drive unit is coupled to the current detection terminal of the main control module.

[0017] A power control unit is used to supply power to the electrothermal actuator. The input terminal of the power control unit is coupled to the electrothermal actuator, the output terminal of the power control unit is coupled to the power module, and the enable terminal of the power control unit is coupled to the monitoring interlock module.

[0018] In one embodiment, the main control module is further configured to adjust the duty cycle of the drive control signal according to the current feedback signal to keep the drive power constant, and to determine the infusion blockage state according to the comparison result of the current feedback signal and the preset current threshold.

[0019] In one embodiment, the position sensing module includes:

[0020] A displacement detection unit is used to detect the stroke position of the actuator and generate a displacement signal;

[0021] An attitude detection unit is used to detect the spatial tilt angle and generate an attitude signal, which is used to help correct the dose detection deviation caused by tilt.

[0022] In one embodiment, the monitoring interlock module includes:

[0023] A voltage monitoring unit, connected to the power supply module, is used to output an abnormal signal to the main control module when the power supply voltage is abnormal.

[0024] An active trigger unit is used to receive external key presses;

[0025] The reset execution unit is connected to the reset terminal of the main control module and is used to output a hardware reset signal;

[0026] The monitoring interlock module is also provided with a control output terminal connected to the enable terminal of the drive execution module, which is used to directly output a forced shutdown signal when the main control module fails.

[0027] In one embodiment, the monitoring interlock module is further configured to: when the power supply voltage is abnormal, the monitoring interlock module outputs the abnormal signal to the main control module; the main control module saves the current data and actively stops outputting the drive control signal; when the main control module crashes or the external button is triggered, the monitoring interlock module performs a hardware reset on the main control module, forcibly stopping the output of the drive control signal.

[0028] Secondly, this application also provides an infusion control method for drug infusion control, the method being applied to a circuit system for drug infusion control as described in any one of the first aspects, the method comprising:

[0029] The system receives infusion parameter instructions containing the target infusion dose from an external receiver via wireless communication.

[0030] The drive control signal is generated according to the instruction and output to the drive execution module to start drug infusion;

[0031] The displacement detection signal fed back by the position sensing module is acquired, and the actual infusion volume is calculated based on the displacement detection signal and compared and verified with the target dose in real time.

[0032] In response to the detection of a fault condition, the monitoring interlock module is activated to forcibly shut down the output of the drive execution module, triggers the alarm module to issue a warning and reports the fault information to the receiver. The fault conditions include infusion blockage, excessive dose deviation, abnormal power supply voltage or sensor signal loss.

[0033] In one embodiment, generating a drive control signal according to the instruction and outputting it to the drive execution module to initiate drug infusion includes:

[0034] Obtain the current feedback signal from the drive execution module, and adjust the duty cycle of the drive control signal according to the current feedback signal to keep the drive power constant.

[0035] In one embodiment, acquiring the displacement detection signal fed back by the position sensing module, calculating the actual infusion volume based on the displacement detection signal, and comparing and verifying it with the target dose in real time includes:

[0036] The spatial tilt angle detected by the attitude detection unit in the position sensing module is acquired and an attitude signal is generated.

[0037] The correction amount for the drug level measurement deviation caused by tilting is determined based on the attitude signal.

[0038] In one embodiment, the step of activating the monitoring interlock module to forcibly shut down the output of the drive execution module in response to detecting a fault condition, triggering the alarm module to issue a warning, and reporting the fault information to the receiver includes:

[0039] In response to detecting an abnormal power supply voltage, the system receives the abnormal signal output by the monitoring interlock module, saves the current data, and actively stops outputting the drive control signal.

[0040] In response to a main control module crash, the monitoring interlock module performs a hardware reset on the main control module and forcibly stops the output.

[0041] The aforementioned circuit system and infusion control method for drug infusion control, derived from the technical features described in the specification, can achieve the following beneficial effects in addressing the technical problems raised in the background art:

[0042] This application provides a circuit system for drug infusion control, including a main control module, a drive execution module, a position sensing module, a monitoring interlock module, and an alarm module. The main control module receives external commands and generates corresponding drive control signals. The drive execution module, connected to the main control module, receives the drive control signals and drives the actuator. The position sensing module, also connected to the main control module, monitors the displacement state of the actuator in real time and feeds back corresponding displacement detection signals to the main control module. The monitoring interlock module, connected to the power supply module, the main control module, and the drive execution module, independently shuts down the drive execution module in case of a fault or failure of the main control module. The alarm module, connected to the main control module, issues warning information under the control of the main control module. The main control module is configured to verify the actual infusion volume based on the displacement detection signals and, upon detecting a fault, shuts down the drive execution module and triggers the alarm module via the monitoring interlock module. In implementation, the coordinated operation of the main control module, drive execution module, position sensing module, and monitoring interlock module achieves closed-loop control and hardware-level safety protection for the infusion process. Specifically, the position sensing module monitors the displacement status of the execution element in real time and feeds it back to the main control module, enabling the main control module to dynamically verify the consistency between the actual infusion volume and the target dose, effectively improving infusion accuracy and overcoming the shortcomings of inaccurate initial dose setting and lack of real-time detection during the infusion process in traditional schemes. The monitoring interlock module is independently connected between the power supply module, main control module, and drive execution module. When infusion blockage, dose deviation exceeding limits, abnormal power supply voltage, or sensor signal loss occurs, or even when the main control module itself fails, the monitoring interlock module can independently and forcibly shut down the drive execution module without relying on the main control module's instructions, while simultaneously triggering the alarm module to issue a warning. This hardware-level safety interlock mechanism solves the problem of existing technologies heavily relying on handheld controllers and lacking autonomous safety shutdown capabilities, fundamentally reducing the risk of over-infusion due to main control system crashes or communication anomalies, and significantly improving the safety and reliability of the drug infusion system. Attached Figure Description

[0043] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0044] Figure 1 This is a schematic diagram of the system architecture of a circuit system for drug infusion control according to an embodiment of this application;

[0045] Figure 2This is a schematic diagram of the circuit connection of the drive execution module in an embodiment of this application;

[0046] Figure 3 This is a circuit connection diagram of the monitoring interlock module in an embodiment of this application;

[0047] Figure 4 This is a schematic flowchart of an infusion control method for drug infusion control according to an embodiment of this application;

[0048] Figure 5 This is a schematic flowchart of an infusion control method for drug infusion control according to another embodiment of this application;

[0049] Figure 6 This is a schematic flowchart of an infusion control method for drug infusion control according to another embodiment of this application;

[0050] Figure 7 This is a schematic flowchart of an infusion control method for drug infusion control according to another embodiment of this application.

[0051] Explanation of reference numerals in the attached diagram: 100, main control module; 200, drive execution module; 300, position sensing module; 400, monitoring interlock module; 500, alarm module; 600, receiver; 700, power supply module. Detailed Implementation

[0052] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0054] It is understood that the terms "first," "second," etc., used herein may be used to describe various elements, but these elements are not limited by these terms. These terms are only used to distinguish one element from another. For example, without departing from the scope of this application, a first resistor may be referred to as a second resistor, and similarly, a second resistor may be referred to as a first resistor. Both the first resistor and the second resistor are resistors, but they are not the same resistor.

[0055] It is understood that the term "connection" in the following embodiments should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have electrical signal or data transmission with each other.

[0056] It is understandable that "at least one" refers to one or more, and "multiple" refers to two or more. "At least a part of an element" refers to part or all of an element.

[0057] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising / including” or “having,” etc., specify the presence of the stated features, wholes, steps, operations, components, parts, or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof. Meanwhile, the term “and / or” as used in this specification includes any and all combinations of the associated listed items.

[0058] This application was made by the inventor based on his understanding and research into the following issues:

[0059] In related technologies, taking insulin injection as an example, early insulin pumps were mostly tubular pumps, with the pump body connected to an indwelling needle attached to the skin via a thin infusion tubing. Although this allowed for more precise insulin infusion, the exposed tubing was prone to tangling, bending, or detachment, and the bulky pump body needed to be carried around, severely impacting the patient's daily convenience and privacy. Against this backdrop, the patch pump was developed as an innovative drug delivery device. Its core design concept highly integrates the pump body, reservoir, drive mechanism, and subcutaneous indwelling needle into a tiny wearable patch unit, which is directly adhered to the skin surface, completely eliminating exposed infusion tubing and achieving "catheterless" infusion, greatly improving patient comfort and freedom of movement.

[0060] However, current drug infusion control systems for patch-type insulin pumps have the following technical problems:

[0061] Existing drug infusion systems suffer from inaccurate infusion progress control and difficulty in convenient and stable drug infusion control, and therefore need to be optimized.

[0062] To address the aforementioned issues, this application provides a circuit system and infusion control method for drug infusion control.

[0063] In one embodiment, it can be as follows Figure 1 As shown, this embodiment provides a circuit system for drug infusion control, including a main control module, a drive execution module, a position sensing module, a monitoring interlock module, and an alarm module.

[0064] The main control module is used to receive external commands and generate corresponding drive control signals.

[0065] The drive execution module is connected to the main control module and is used to receive the drive control signal and drive the execution element to operate.

[0066] The position sensing module is connected to the main control module and is used to monitor the displacement state of the actuator in real time and feed back the corresponding displacement detection signal to the main control module.

[0067] The monitoring interlock module is connected to the power module, the main control module, and the drive execution module, and is used to independently shut down the drive execution module in case of a fault or failure of the main control module.

[0068] The alarm module is connected to the main control module and is used to issue warning information under the control of the main control module.

[0069] Specifically, the main control module is configured to verify the actual injection volume based on the displacement detection signal, and to shut down the drive execution module and trigger the alarm module through the monitoring interlock module when the fault condition is detected.

[0070] By implementing the above-described circuit system for drug infusion control, the following beneficial effects can be achieved:

[0071] This application provides a circuit system for drug infusion control, including a main control module, a drive execution module, a position sensing module, a monitoring interlock module, and an alarm module. The main control module receives external commands and generates corresponding drive control signals. The drive execution module, connected to the main control module, receives the drive control signals and drives the actuator. The position sensing module, also connected to the main control module, monitors the displacement state of the actuator in real time and feeds back corresponding displacement detection signals to the main control module. The monitoring interlock module, connected to the power supply module, the main control module, and the drive execution module, independently shuts down the drive execution module in case of a fault or failure of the main control module. The alarm module, connected to the main control module, issues warning information under the control of the main control module. The main control module is configured to verify the actual infusion volume based on the displacement detection signals and, upon detecting a fault, shuts down the drive execution module and triggers the alarm module via the monitoring interlock module. In implementation, the coordinated operation of the main control module, drive execution module, position sensing module, and monitoring interlock module achieves closed-loop control and hardware-level safety protection for the infusion process. Specifically, the position sensing module monitors the displacement status of the execution element in real time and feeds it back to the main control module, enabling the main control module to dynamically verify the consistency between the actual infusion volume and the target dose, effectively improving infusion accuracy and overcoming the shortcomings of inaccurate initial dose setting and lack of real-time detection during the infusion process in traditional schemes. The monitoring interlock module is independently connected between the power supply module, main control module, and drive execution module. When infusion blockage, dose deviation exceeding limits, abnormal power supply voltage, or sensor signal loss occurs, or even when the main control module itself fails, the monitoring interlock module can independently and forcibly shut down the drive execution module without relying on the main control module's instructions, while simultaneously triggering the alarm module to issue a warning. This hardware-level safety interlock mechanism solves the problem of existing technologies heavily relying on handheld controllers and lacking autonomous safety shutdown capabilities, fundamentally reducing the risk of over-infusion due to main control system crashes or communication anomalies, and significantly improving the safety and reliability of the drug infusion system.

[0072] In one embodiment, such as Figure 1 and Figure 2 As shown, the drive execution module includes an electrothermal execution unit, a constant power drive unit, and a power control unit.

[0073] The electrothermal actuator is used to convert electrical energy into thermal energy to generate mechanical deformation, and to drive the actuator based on the mechanical deformation.

[0074] For example, the electrothermal actuator can refer to an actuator that operates using the electrothermal effect, and can be a shape memory alloy wire. The shape memory alloy wire can undergo a crystal phase transformation and shrink when heated by electricity, and return to its original shape after cooling when the power is turned off, thereby converting electrical energy into mechanical energy, thereby driving the piston of the insulin pump to perform the drug infusion action.

[0075] The constant power drive unit has an input terminal, an output terminal, and a current feedback terminal. The input terminal of the constant power drive unit is coupled to the output terminal of the main control module, the output terminal of the constant power drive unit is coupled to the electrothermal execution unit, and the current feedback terminal of the constant power drive unit is coupled to the current detection terminal of the main control module.

[0076] For example, a constant power drive unit can refer to a drive circuit that can keep the electrical power consumed by the load, i.e., the electrothermal actuator, basically constant during operation. The core function of the constant power drive unit is to compensate for power changes caused by factors such as power supply voltage fluctuations, ambient temperature changes, or load impedance drift, ensuring that the shape memory wire obtains stable heating energy each time it moves, thereby ensuring the consistency of piston stroke and the repeatability of infusion dosage.

[0077] Specifically, the constant power drive unit may include a MOSFET, a resistor, and a capacitor. The main control module is electrically connected to the gate of the MOSFET, the drain is electrically connected to one end of the shape memory wire, and the source is electrically connected to ground via a resistor. Simultaneously, the source is electrically connected to a low-pass filter circuit to the main control module. The main control module outputs a controllable PWM wave to control the MOSFET's operation, causing the shape memory wire to heat up and drive the process. The current flowing through the shape memory wire is converted into voltage via a resistor, fed back to the main control unit via an RC low-pass filter capacitor for calculation. By detecting the current magnitude, the duty cycle of the PWM wave in the main control unit is adjusted to meet the set constant power drive control, preventing overheating or insufficient drive of the shape memory wire. Furthermore, based on the set maximum current threshold that the shape memory wire can withstand, the blockage status of the insulin pump piston is determined.

[0078] The power control unit is used to provide power to the electrothermal actuator. It has an input terminal, an output terminal, and an enable terminal. The input terminal of the power control unit is coupled to the electrothermal actuator, the output terminal of the power control unit is coupled to the power module, and the enable terminal of the power control unit is coupled to the monitoring interlock module.

[0079] In this embodiment, in the drive execution module, the constant power drive unit drives the electrothermal execution unit to generate mechanical deformation to drive the execution element. Simultaneously, a real-time current signal is transmitted to the main control module through the current feedback terminal, achieving closed-loop monitoring of the drive power. This ensures reliable operation of the electrothermal execution unit under stable power and provides a data foundation for subsequent blockage detection, thereby contributing to improved stability and controllability of the infusion process.

[0080] In one embodiment, the main control module is further configured to adjust the duty cycle of the drive control signal according to the current feedback signal to keep the drive power constant, and to determine the infusion blockage state according to the comparison result of the current feedback signal and the preset current threshold.

[0081] In this embodiment, the main control module dynamically adjusts the duty cycle of the drive control signal based on the current feedback signal, keeping the drive power of the electrothermal actuator constant. This helps avoid insufficient drive or overheating damage caused by power fluctuations or environmental changes, improving the consistency and reliability of the actuator's operation. Simultaneously, the main control module compares the current feedback signal with a preset current threshold. When the current abnormally increases, it promptly determines infusion blockage, achieving integrated drive control and fault detection. Blockage diagnosis can be completed without adding additional sensors, simplifying the system structure and improving infusion safety.

[0082] In one embodiment, the position sensing module includes a displacement detection unit and an attitude detection unit.

[0083] The displacement detection unit is used to detect the stroke position of the actuator and generate a displacement signal.

[0084] For example, the displacement detection unit can refer to a sensing element used to sense the linear motion position of an actuator (such as an insulin pump piston). By monitoring the piston's position changes in real time, the volume of infused drug and the remaining drug amount can be calculated, providing core feedback data for closed-loop dose control.

[0085] The attitude detection unit is used to detect the spatial tilt angle and generate an attitude signal, which is used to help correct the dose detection deviation caused by the tilt.

[0086] For example, the attitude detection unit can refer to a sensing element used to sense the tilt angle of the device in space. Since patch-type insulin pumps are worn on different parts of the body (such as the abdomen, waist, upper arm, etc.), the device may be in different tilt positions, causing the liquid level in the reservoir to tilt, thus affecting the accuracy of liquid level detection. The attitude detection unit provides a data basis for software algorithms to correct liquid level deviations by acquiring the device's three-dimensional spatial angle in real time.

[0087] Specifically, the displacement detection unit is used to detect the stroke position of the actuator and generate a displacement signal. In specific implementations, the displacement detection unit can be implemented using a magnetoresistive displacement sensor, a Hall sensor combined with a magnetic grating, or a resistive linear displacement sensor. Taking a magnetoresistive displacement sensor as an example, a permanent magnet is installed on the actuator (piston). When the piston moves axially within the drug reservoir, the magnetoresistive sensor detects the change in magnetic field strength with distance, thereby outputting a voltage signal corresponding to the piston's stroke position. The main control module can calculate the distance the piston has advanced based on this displacement signal, combine it with the cross-sectional area parameters of the drug reservoir, calculate the actual infusion volume, and compare and verify this value with the target dose in real time to achieve closed-loop dose control.

[0088] The attitude detection unit detects the spatial tilt angle and generates an attitude signal, which is used to help correct dose detection deviations caused by tilt. In specific implementations, the attitude detection unit can be implemented using a three-axis accelerometer or a six-axis inertial measurement unit (IMU) to sense the tilt angle of the device in the pitch, roll, and yaw directions in real time. When the patch-type insulin pump is worn in different postures, such as the patient's abdomen (when switching between sitting and lying positions) or waist (when lying on their side), the drug level in the reservoir changes with the tilt angle, causing deviations when the displacement sensor calculates the remaining amount solely based on the piston position. The attitude detection unit reports this attitude signal to the main control module. The main control module calculates the liquid level correction amount corresponding to the current tilt angle based on a preset tilt compensation model or calibration curve, compensating and correcting the dose detection results, thereby improving the accuracy of dosage determination in the low-dose stage and avoiding false alarms or infusion deviations caused by changes in wearing posture.

[0089] In this embodiment, in the position sensing module, the displacement detection unit collects the stroke position of the actuator in real time, providing an accurate data basis for the closed-loop verification of the infusion dose; the posture detection unit synchronously senses the spatial tilt state of the device, and corrects the liquid level measurement deviation caused by the tilt through the posture signal, effectively eliminating the dose detection error caused by posture changes when the insulin pump is worn on different parts of the human body, which helps to further improve the detection accuracy in the low-dose stage and the overall accuracy of infusion control.

[0090] In one embodiment, it can be as follows Figure 1 and Figure 3 As shown, the monitoring interlock module includes a voltage monitoring unit, an active triggering unit, and a reset execution unit.

[0091] The voltage monitoring unit is connected to the power supply module and is used to output an abnormal signal to the main control module when the power supply voltage is abnormal.

[0092] For example, the voltage monitoring unit can refer to a monitoring circuit used to detect in real time whether the output voltage of the power module is within the normal range. When the power supply voltage is lower or higher than a preset threshold, the unit outputs an abnormal signal to the main control module, notifying it to perform corresponding protection actions.

[0093] The active triggering unit is used to receive external key presses.

[0094] For example, the active triggering unit can refer to an input interface circuit that receives external key presses from the user and converts them into electrical signals. When the user discovers that the device is malfunctioning or needs to stop the infusion urgently, they can actively trigger this unit by pressing the emergency button to initiate the forced shutdown process.

[0095] The reset execution unit is connected to the reset terminal of the main control module and is used to output a hardware reset signal.

[0096] For example, a reset execution unit can refer to an independent circuit capable of outputting a reset signal to the hardware reset pin of the main control module. Unlike software reset, hardware reset acts directly on the underlying layer of the main control chip, and can forcibly restore the main control module to its initial state in the event of a complete system crash or program malfunction.

[0097] Specifically, the monitoring interlock module is also provided with a power supply terminal for the drive execution module. The power supply terminal is controlled by the enable terminal and is used to directly output a forced shutdown signal when the main control module fails.

[0098] Specifically, in this example, the voltage monitoring unit is connected to the power supply module and is used to output an abnormal signal to the main control module when the power supply voltage is abnormal. In a specific implementation, the voltage monitoring unit can be implemented using a voltage monitoring chip in conjunction with a resistor divider network. The output voltage of the power supply module is connected to the monitoring input terminal of the voltage monitoring chip after being divided by resistors. The voltage monitoring chip has a reference voltage source and a comparator inside. When the voltage value after voltage division deviates from the preset window range (i.e., the power supply voltage is too low or too high), the output pin of the voltage monitoring chip changes from high level to low level, and this signal is transmitted to the abnormal signal input pin of the main control module. After detecting this low-level abnormal signal, the main control module immediately saves the current operating status and infusion data (including infused dosage, piston position, and other key parameters), and then actively shuts down the PWM control signal output, causing the drive execution module to stop working. This method prioritizes data integrity and is suitable for scenarios where the power supply is slowly decreasing but still allows the main control to complete data saving.

[0099] The active triggering unit receives external button presses. In its implementation, the active triggering unit consists of an emergency stop button, a pull-up resistor, and a debounce capacitor. One end of the button is grounded, and the other end is connected to the power supply voltage via the pull-up resistor. A debounce capacitor is connected in parallel to eliminate false trigger signals caused by button mechanical contact bounce. When the user presses the emergency stop button, the voltage level at the button terminal changes from high to low. This falling edge signal triggers the reset execution unit to initiate the hardware reset process. This mechanism gives the user the right to directly intervene in the device's operation under any circumstances; for example, when the patient feels unwell or observes a device malfunction, they can stop the infusion with a single button press.

[0100] The reset execution unit is connected to the reset pin of the main control module and is used to output a hardware reset signal. In practice, the reset execution unit can be implemented by a reset monitoring chip or a hardware watchdog circuit. When the active trigger unit is activated (the user presses the emergency button), the reset execution unit immediately outputs a low-level reset pulse to the hardware reset pin of the main control module for a certain duration. Upon receiving this pulse, the main control module forcibly performs a hardware reset, restoring all its I / O ports to their initial state and forcibly shutting down the PWM control signal output.

[0101] In this embodiment, the monitoring interlock module includes a voltage monitoring unit that monitors the power supply status in real time and actively reports any abnormalities to the main control module; an active triggering unit that supports emergency user intervention; and a reset execution unit that outputs a hardware reset signal when the main control module crashes. Simultaneously, the monitoring interlock module directly connects to the enable terminal of the drive execution module via an independent control output, allowing for direct forced shutdown of the power supply without relying on the main control module's instructions in the event of a main control module failure. This triple hardware protection mechanism helps reduce the risk of loss of control due to main control module crashes or communication anomalies, and enhances system security.

[0102] In one embodiment, the monitoring interlock module is further configured to: when the power supply voltage is abnormal, the monitoring interlock module outputs the abnormal signal to the main control module; the main control module saves the current data and actively stops outputting the drive control signal; when the main control module crashes or the external button is triggered, the monitoring interlock module performs a hardware reset on the main control module, forcibly stopping the output of the drive control signal.

[0103] In this embodiment, the monitoring interlock module ensures injection safety through two complementary mechanisms: When a power supply is abnormal, it outputs an abnormal signal to the main control module, which then saves the current operating data and actively stops the drive output, achieving a unified approach to data protection and smooth shutdown; when the main control module crashes or an emergency button is triggered, the monitoring interlock module directly performs a hardware reset on the main control module, forcibly stopping the drive control signal output without relying on the main control module's response. These two methods work together to cover both system anomalies and main control failure scenarios, achieving multi-level security protection from data preservation to forced hardware shutdown.

[0104] Based on the same inventive concept, embodiments of this application also provide an infusion control method for drug infusion control, which can, as follows: Figure 4 As shown, the method is applied to a circuit system for drug infusion control as described in any of the above embodiments, the method comprising:

[0105] Step 402: Receive infusion parameter instructions containing the target infusion dose from an external receiver via wireless communication.

[0106] Step 404: Generate a drive control signal according to the instruction and output it to the drive execution module to start drug infusion.

[0107] Step 406: Obtain the displacement detection signal fed back by the position sensing module, calculate the actual infusion volume based on the displacement detection signal, and compare and verify it with the target dose in real time.

[0108] Step 408: In response to the detection of a fault condition, the monitoring interlock module is activated to forcibly shut down the output of the drive execution module, triggering the alarm module to issue a warning and report the fault information to the receiver. The fault conditions include infusion blockage, excessive dose deviation, abnormal power supply voltage, or sensor signal loss.

[0109] By implementing the above-described infusion control method for drug infusion control, the following beneficial effects can be achieved:

[0110] This embodiment provides an infusion control method for drug infusion control. In implementation, infusion is initiated after receiving the target dose command via wireless communication. During the infusion process, displacement detection signals are acquired in real time to calculate the actual infusion volume and continuously compare it with the target dose for verification, forming a closed-loop dose control that effectively improves infusion accuracy. When any fault condition is detected, such as infusion blockage, excessive dose deviation, abnormal power supply voltage, or sensor signal loss, the monitoring interlock module is immediately activated to forcibly shut down the drive output, simultaneously triggering an alarm and reporting the fault information to the receiver. This method combines real-time dose verification with a multi-type fault rapid response mechanism, significantly enhancing the system's ability to handle abnormal conditions while ensuring infusion accuracy, thus improving the overall safety and reliability of drug infusion.

[0111] In one embodiment, such as Figure 5 As shown, step 404 includes:

[0112] Step 502: Obtain the current feedback signal from the drive execution module, and adjust the duty cycle of the drive control signal according to the current feedback signal to keep the drive power constant.

[0113] In this embodiment, by acquiring the current signal fed back by the drive execution module, the duty cycle of the drive control signal is adjusted in real time to keep the drive power constant. This avoids the instability of the drive force of the electrothermal execution unit caused by power fluctuations or changes in ambient temperature, ensuring the consistency and reliability of each infusion action, and improving the repeatability accuracy and system stability of drug infusion from the drive source.

[0114] In one embodiment, such as Figure 6 As shown, step 406 includes:

[0115] Step 602: Obtain the spatial tilt angle detected by the attitude detection unit in the position sensing module and generate an attitude signal.

[0116] Step 604: Determine the correction amount for the drug level measurement deviation caused by tilting based on the attitude signal.

[0117] In this embodiment, the spatial tilt angle is obtained by the posture detection unit and a posture signal is generated. Based on this, the correction amount of the drug liquid level measurement deviation caused by tilt is determined, which effectively eliminates the dose detection error caused by posture changes when the insulin pump is worn on different parts of the human body. This makes the liquid level judgment in the low-dose stage more accurate and improves the reliability of infusion dose verification from the sensing source.

[0118] In one embodiment, such as Figure 7 As shown, step 408 includes:

[0119] Step 702: In response to detecting an abnormal power supply voltage, receive the abnormal signal output by the monitoring interlock module, save the current data, and actively stop outputting the drive control signal.

[0120] Step 704: In response to the main control module crashing, the main control module is hardware reset and forced to stop output through the monitoring interlock module.

[0121] In this embodiment, differentiated handling strategies are configured for two fault scenarios: when the power supply voltage is abnormal, the main control module actively saves the current infusion data and stops driving the output, realizing data preservation and controllable shutdown under fault conditions; when the main control module crashes, the monitoring interlock module directly executes a hardware reset to forcibly stop the output, without relying on the main control module's response. The two mechanisms work together to cover two extreme cases: system-handle anomalies and complete main control failure, ensuring zero blind spots in infusion safety.

[0122] It is understood that the circuit system and infusion control method for drug infusion control described above can also take other forms, and are not limited to the forms mentioned in the above embodiments, as long as they can achieve the function of accurately and stably controlling drug infusion.

[0123] In the description of this specification, references to terms such as "some embodiments," "other embodiments," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative descriptions of the above terms do not necessarily refer to the same embodiments or examples.

[0124] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0125] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. A circuit system for drug infusion control, characterized in that, include: The main control module is used to receive external commands and generate corresponding drive control signals; The drive execution module is connected to the main control module and is used to receive the drive control signal and drive the execution element to operate. A position sensing module, connected to the main control module, is used to monitor the displacement state of the actuator in real time and feed back the corresponding displacement detection signal to the main control module. The monitoring interlock module is connected to the power module, the main control module, and the drive execution module, and is used to independently shut down the drive execution module in case of a fault or failure of the main control module. An alarm module, connected to the main control module, is used to issue warning information under the control of the main control module; The main control module is configured to verify the actual injection volume based on the displacement detection signal, and to shut down the drive execution module and trigger the alarm module through the monitoring interlock module when the fault condition is detected.

2. The circuit system for drug infusion control according to claim 1, characterized in that, The drive execution module includes: An electrothermal actuator is used to convert electrical energy into heat energy to generate mechanical deformation, and to drive the actuator based on the mechanical deformation; A constant power drive unit has an input terminal, an output terminal, and a current feedback terminal. The input terminal of the constant power drive unit is coupled to the output terminal of the main control module, the output terminal of the constant power drive unit is coupled to the electrothermal execution unit, and the current feedback terminal of the constant power drive unit is coupled to the current detection terminal of the main control module. A power control unit is used to supply power to the electrothermal actuator. The input terminal of the power control unit is coupled to the electrothermal actuator, the output terminal of the power control unit is coupled to the power module, and the enable terminal of the power control unit is coupled to the monitoring interlock module.

3. The circuit system for drug infusion control according to claim 2, characterized in that, The main control module is also configured to adjust the duty cycle of the drive control signal according to the current feedback signal to keep the drive power constant, and to determine the infusion blockage state according to the comparison result of the current feedback signal and the preset current threshold.

4. The circuit system for drug infusion control according to claim 1, characterized in that, The position sensing module includes: A displacement detection unit is used to detect the stroke position of the actuator and generate a displacement signal; An attitude detection unit is used to detect the spatial tilt angle and generate an attitude signal, which is used to help correct the dose detection deviation caused by tilt.

5. A circuit system for drug infusion control according to claim 1, characterized in that, The monitoring interlock module includes: A voltage monitoring unit, connected to the power supply module, is used to output an abnormal signal to the main control module when the power supply voltage is abnormal. An active trigger unit is used to receive external key presses; The reset execution unit is connected to the reset terminal of the main control module and is used to output a hardware reset signal; The monitoring interlock module is also provided with a control power supply terminal connected to the enable terminal of the drive execution module, which is used to directly output a forced shutdown power supply when the main control module fails.

6. A circuit system for drug infusion control according to claim 5, characterized in that, The monitoring interlock module is also configured to output the abnormal signal to the main control module when the power supply voltage is abnormal, and the main control module saves the current data and actively stops outputting the drive control signal. When the main control module crashes or the external button is triggered, the monitoring interlock module performs a hardware reset on the main control module and forcibly shuts off the power supply to the drive module.

7. An infusion control method for drug infusion control, characterized in that, The method is applied to a circuit system for drug infusion control as described in any one of claims 1 to 6, the method comprising: The system receives infusion parameter instructions containing the target infusion dose from an external receiver via wireless communication. The drive control signal is generated according to the instruction and output to the drive execution module to start drug infusion; The displacement detection signal fed back by the position sensing module is acquired, and the actual infusion volume is calculated based on the displacement detection signal and compared and verified with the target dose in real time. In response to the detection of a fault condition, the monitoring interlock module is activated to forcibly shut down the power supply to the drive execution module, triggering the alarm module to issue a warning and report the fault information to the receiver. The fault conditions include infusion blockage, excessive dose deviation, abnormal power supply voltage, or sensor signal loss.

8. The infusion control method according to claim 7, characterized in that, The step of generating a drive control signal according to the instruction and outputting it to the drive execution module to start drug infusion includes: Obtain the current feedback signal from the drive execution module, and adjust the duty cycle of the drive control signal according to the current feedback signal to keep the drive power constant.

9. The infusion control method according to claim 7, characterized in that, The process of acquiring the displacement detection signal fed back by the position sensing module, calculating the actual infusion volume based on the displacement detection signal, and comparing and verifying it with the target dose in real time includes: The spatial tilt angle detected by the attitude detection unit in the position sensing module is acquired and an attitude signal is generated. The correction amount for the drug level measurement deviation caused by tilting is determined based on the attitude signal.

10. The infusion control method according to claim 7, characterized in that, The mechanism for responding to a detected fault condition by activating the monitoring interlock module to forcibly shut down the power supply to the drive execution module, triggering the alarm module to issue a warning, and reporting the fault information to the receiver includes: In response to detecting an abnormal power supply voltage, the system receives the abnormal signal output by the monitoring interlock module, saves the current data, and actively stops outputting the drive control signal. In response to a main control module crash, the monitoring interlock module performs a hardware reset of the main control module and forcibly shuts off the power supply to the drive execution module.

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