Intelligent infusion monitoring instrument with complication early warning function and use method thereof

Abstract

The application discloses a kind of intelligent infusion monitoring instrument with complication early warning function and its using method, it includes monitoring instrument body, the body is by front shell and back cover, infusion tube drip bottle cover and multiple function modules are composed, the front middle recess of front shell is used to place infusion tube, the upper recess of recess is equipped with pipe clamp, the rear of front shell and infusion tube drip bottle cover are used to place multiple function modules and control panel, back cover covers the rear of front shell, infusion tube drip bottle cover places drop speed detection module, multiple function modules include infusion tube flow control module, power module, liquid deficiency detection module, drop speed detection module, module is controlled by control panel, 4G / 5G internet of things chip, capacitive acquisition chip, integrated sensor chip (altitude, atmospheric pressure, temperature) are installed on control panel, switch button, indicator light.The whole structure of the application is simple and reasonable, efficient and stable, can greatly reduce the work intensity of medical staff, reduce the occurrence of infusion complication.

Description

Technical Field

[0001] This invention belongs to the technical field of infusion monitoring devices, and relates to an intelligent infusion monitoring device with complication early warning function and its usage method. Background Technology

[0002] An infusion monitor is a medical device used to monitor the drip rate and remaining fluid volume of an infusion. Existing infusion monitors have the following problems: I. Low data acquisition accuracy 1. The accuracy of infusion drip rate monitoring is insufficient. Single infrared drip rate detection is easily affected by factors such as ambient light, drug type, and infusion tubing material. 2. The fluid shortage detection method uses capacitor electrodes and infrared acquisition, which is easily affected by factors such as ambient temperature, drug type, and infusion tubing material. II. Infrared dripping rate alone can alter the properties of some infused medications. Infrared light used for detecting infusion drip rate is generally near-infrared light. However, near-infrared light can produce different degrees of chemical reactions with the following drugs: a) Doxorubicin (DOX) nanocarrier system, which triggers rapid and hypersensitive release of doxorubicin after 5 seconds of near-infrared (NIR) irradiation; b) Gefitinib prodrug system, which releases the drug through specific activation of glutathione (GSH) under near-infrared irradiation; c) Quinolone drugs; d) Hormonal drugs. III. Lack of personalized and dynamic adjustment in infusion rate The infusion rate for different groups of people and health conditions can only be indicated by an alarm. Patients need to control the infusion rate themselves according to the medical staff, or the medical staff need to make special rounds and interventions. This conventional approach not only prevents patients from resting in peace, but also increases the workload of medical staff. IV. Inconvenience in monitoring the infusion process When medical staff inspect intravenous infusions, they need to look at them up close, and some infusion monitoring devices even obstruct the infusion drip chambers, which increases the workload of medical staff. V. Infusion complications (such as drug extravasation, phlebitis, etc.) are difficult to predict in advance. In summary, current infusion monitoring devices only monitor the infusion process and cannot provide early warnings of potential complications. However, infusion monitoring has two crucial functional objectives: 1. To smoothly monitor the infusion process, confirming that the medication successfully enters the vein and completes the treatment; 2. To provide early warnings and interventions for adverse complications that may occur during infusion.

[0003] Therefore, an intelligent infusion monitoring device with complication early warning function was designed to overcome the above problems. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the existing technology and provide an intelligent infusion monitoring device with complication early warning function that is simple and reasonable in structure, highly efficient and stable, and greatly reduces the workload of medical staff, as well as its usage method.

[0005] This invention is achieved through the following technical solution: an intelligent infusion monitor with complication early warning function, comprising a monitor body, which consists of a front shell and a rear cover plate, and various functional modules disposed within the front shell. The front of the front shell has a recessed center for placing the infusion tube, and a tube clamp is installed above the recess to hold the infusion tube. An infusion tube drip sleeve is disposed below the front shell to cover the infusion tube drip chamber. Various functional modules and a control board are placed within the front shell and the infusion tube drip sleeve. The rear cover plate covers the rear of the front shell. The various functional modules include an infusion tube flow control module, a power supply module, a fluid shortage detection module, and a drip rate detection module. All modules are controlled by the control board, which also houses a 4G / 5G IoT chip, a capacitance acquisition chip, an integrated sensor chip, a switch button, and indicator lights. The integrated sensor chip is used to collect altitude data, atmospheric pressure data, and temperature data.

[0006] Preferably, a fluid shortage detection module is installed in the recessed part of the front shell. A power module and an infusion tube flow control module are installed on both sides of the fluid shortage detection module. Mounting posts are provided below the power module and above the infusion tube flow control module. Fixing holes are also provided on the control board at positions relative to the mounting posts. The power module, infusion tube flow control module, and fluid shortage detection module are fixed behind the power module, infusion tube flow control module, and fluid shortage detection module through the fixing holes. A button rod is also provided below the power module. The button rod extends forward to the button on the front shell and backward to the switch button on the control board. The drip rate detection module is installed on the outside of the infusion tube drip chamber sleeve and is used to detect the dripping status inside the infusion tube drip chamber.

[0007] Preferably, the control board is equipped with a main control chip, a capacitance acquisition chip, an integrated sensor chip, a switch button, indicator lights, a sound generator, a 4G / 5G IoT chip, and a battery management chip. The battery management chip connects to the battery and charging port; the 4G / 5G IoT chip connects to external devices; the indicator lights connect to the main chip's I / O port on the control board; the sound generator connects to the main chip's I / O port on the control board; the capacitance acquisition chip connects to the main chip's I / O port; and the integrated ADC sampling function of the capacitance acquisition chip connects to the low-capacity detection module and the drip rate detection module, converting capacitance changes into digital signals, which are then transmitted to the main control chip for data analysis. Simultaneously, the main control chip acquires data from the integrated sensor chip for analysis and calculation, ultimately obtaining compensated parameter values. The obtained data is then connected to external devices via the 4G / 5G IoT chip for further analysis. The main control chip is also connected to the infusion tube flow control module, allowing the infusion tube flow control module to activate promptly by detecting and analyzing the infusion status.

[0008] Preferably, the fluid shortage detection module consists of two arc-shaped electrodes, which are installed on the left and right sides respectively to form a semi-circular channel. The infusion tube is restricted between the two arc-shaped electrodes by the tube clamp above. The two arc-shaped electrodes are connected to the capacitance acquisition chip through cables below to collect data and transmit it to the main chip. The capacitance acquisition chip integrates an ADC sampling circuit.

[0009] Preferably, the infusion tube flow control module consists of a stepper motor, a motor bracket, a power gear, and a locking tongue rod. The stepper motor is mounted on the motor bracket, and the power gear is mounted above the motor bracket. The power gear is connected to the drive shaft of the stepper motor. The locking tongue rod has a gear side on its side and a locking tongue at its end. The gear side is connected to the power gear. The motor drives the locking tongue forward to lock the infusion tube.

[0010] Preferably, the drip rate detection module consists of a drip rate capacitance detection module and a drip rate infrared detection module. The drip rate capacitance detection module consists of capacitor plates arranged on opposite sides, and the drip rate infrared detection module consists of infrared photodiodes arranged on opposite sides. The capacitor plates arranged on opposite sides are installed above PCB substrates arranged on the left and right sides. The plates have through holes for installing the infrared photodiodes. One end of the infrared photodiode passes through the plates and is fixed behind the PCB substrate, while the other end is inserted into a through hole in the drip chamber sleeve of the infusion tube and fixed. The PCB substrate is suspended outside the drip chamber sleeve of the infusion tube and inserted into the bottom of the front shell for fixation. The infrared photodiode consists of an infrared emitter and an infrared receiver, arranged on opposite sides. There is one infrared receiver and at least two infrared emitters.

[0011] A method for using an intelligent infusion monitoring device with complication early warning function, the method including an installation method, a disassembly method, and an early warning method, wherein: Installation method: Hold the upper end of the drip chamber tubing of the infusion set with one hand, and hold the monitor with the other hand. Pull the monitor down to make the drip chamber cover inside the monitor fit against the upper end of the drip chamber of the infusion set. When you apply a little force, the tubing will be inserted into the clamp at the top of the product. Press and hold the switch button for 3 seconds. At this time, the control board will activate the fluid shortage detection module, the drip rate capacitance detection module, and the drip rate infrared detection module to monitor the infusion process. When the monitor detects that the infusion is completed, it will trigger the infusion tubing flow control module to automatically lock the tubing. All collected data and abnormalities can be fed back to the display terminal of medical staff or patients. Disassembly method: Briefly press the monitor switch or control it via mobile phone to unlock the monitor. Hold the upper end of the infusion set drip chamber with one hand and gently pull out the infusion tubing to remove it from the tubing clamp. Hold the monitor with the other hand and pull it up to expose the infusion tubing drip chamber completely. Then you can remove the monitor. The specific early warning method is as follows: 1) Data acquisition: The above-mentioned opening device is used to monitor the droplets in the drip chamber using infrared and capacitive detection tubes. The infrared sampling frequency is ≥100Hz, capturing the time interval and shape changes of the droplets. 2) Feature extraction algorithm: Time series analysis a. Calculate the time difference (Δt) between adjacent droplets after moving average filtering; b. Anomaly detection: Δt > 1.5 times the baseline value for more than 5 consecutive periods; 3) Frequency domain feature extraction: Perform a Fast Fourier Transform (FFT) on the Δt sequence to identify the characteristic frequency components in the 0.1-0.5 Hz range; 4) Decision-making algorithm: a. Support Vector Machine (SVM) classification; b. Input features: Δt variance, dominant frequency component, pressure gradient; c. Training data: Set up hundreds of normal / needle-removal samples collected clinically to improve the accuracy of early warning; 5) Dynamic threshold early warning: a. Baseline adaptive adjustment formula: b. Threshold ≥ 1.5σ Where σ is the average drip rate over the first 3 minutes, and exceeding the threshold will trigger an alarm. 6) Complication trend prediction model: An autoregressive integrated moving average model is used to predict the drip rate for the next 3 minutes, and an early warning is given when the predicted value is lower than the safety threshold. By using time series analysis and feature extraction, we can fit vital sign parameters associated with intravenous treatment complications and train data on the drip rate changes during the occurrence of hundreds of complications to provide early warning of abnormal situations. Feature extraction: Feature vector = [heart rate change rate, blood oxygen fluctuation amplitude, drip rate change rate, ...]; Early warning model: P = sigmoid(W·eigenvector + b); Where W is the weight matrix, b is the bias term, and sigmoid is the activation function.

[0012] As a preferred embodiment, the specific working method of the drip rate detection module is as follows: 1) Infrared detection: 940nm infrared emitting tubes and receiving tubes are installed on both sides of the drip chamber of the infusion tube. The detection is achieved by utilizing the property of droplets to block infrared light. It is suitable for most common drug solutions. 2) Capacitance detection: Counting is done by collecting regular changes in capacitance as the droplet falls; 3) Improve the accuracy of drop rate detection by combining data collected from integrated sensor chips with precise algorithms; The specific algorithm is as follows: Drop rate = α * infrared detection result + (1 − α) * capacitance detection result; Where α is the weighting coefficient. When α is 0, the result of capacitance detection is used. When α>0, the drip rate is calculated by combining infrared and capacitance detection to achieve the purpose of dual infrared and capacitance detection. In obtaining capacitance test results, a reference capacitance value is calibrated under standard conditions (e.g., 25℃, 1013hPa, altitude 0m). For other regions where temperature, air pressure, and altitude vary significantly, a compensation coefficient should be added when recording the capacitance change rate. The specific formula for this compensation coefficient is as follows: K T ,K P ,K A The compensation coefficients for temperature, air pressure, and altitude were determined through calibration experiments. Where C is the capacitance; K T Temperature; K P K represents air pressure. A Altitude; , represents the change in the dielectric constant of the drug solution.

[0013] Preferably, the fluid shortage detection module uses non-contact detection technology, which detects the fluid level by monitoring changes in the electric field around the infusion tube. The specific method is as follows: when there is fluid in the infusion tube, the fluid acts as a dielectric, changing the distribution of the surrounding electric field, which causes the capacitance value of the detection electrode to increase; when the fluid is drained, the capacitance value returns to its initial state. The data is collected by the capacitance acquisition chip, which converts the capacitance change into a digital signal output. The fluid shortage alarm is realized by using a linear change curve rule and threshold judgment.

[0014] Preferably, the liquid shortage detection module also includes a liquid shortage detection compensation algorithm. Since the capacitance is affected by temperature and the medication in the drip tube, a compensation algorithm is added to the liquid shortage detection module. The specific compensation algorithm is as follows: Among them, C 补偿 The capacitance value is the compensated value, and ΔT is the temperature change. This represents the change in the dielectric constant of the drug solution.

[0015] Compared with the prior art, the present invention has the following advantages: 1. This invention adopts an innovative dual droplet recognition scheme: it uses infrared light and capacitance detection fusion technology to improve the accuracy of drip rate detection; at the same time, when the drug solution being infused by the patient undergoes a change in drug properties under near-infrared light irradiation, the infrared drip rate detection is turned off and switched to capacitance drip rate monitoring mode only. Although the accuracy of drip rate recognition is reduced (capacitance detection recognition accuracy ≥90%), the infusion drip rate monitoring can still be kept under control. 2. The liquid shortage detection chip of the present invention adopts MC11S, a non-contact detection technology. It monitors the linear change law of capacitance value when liquid shortage occurs in the infusion pipeline, and combines the capacitance change compensation caused by temperature change to more accurately improve the accuracy of liquid shortage and drip rate judgment, and reduce detection errors caused by air bubbles or pipeline material. 3. The present invention is designed with a miniature DC stepper motor to drive the locking tongue rod to squeeze and change the flow diameter of the infusion tube, dynamically adjusting the infusion rate to ensure the safety and effectiveness of infusion. The innovative value of this function is that it can provide standard and safe infusion when the patient is unaware and at rest, and also reduces the difficulty for medical staff to accurately control the drip rate. 4. The indicator light of this invention allows medical staff to observe it from a distance and from multiple angles without disturbing the patient, and to quickly identify the infusion status and abnormality type, reducing the workload of medical staff and improving work efficiency. 5. By analyzing the patterns of complications associated with changes in infusion drip rates, an infusion database will be constructed to develop an early warning algorithm for infusion complications, thereby reducing medical accidents caused by infusion complications.

[0016] In summary, the infusion monitoring device designed in this invention can effectively realize the practical value of medical technology and enhance core market competitiveness. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of the present invention (front view).

[0018] Figure 2 This is a schematic diagram of the overall structure of the present invention (back side).

[0019] Figure 3 This is a schematic diagram of the internal structure of the present invention. Figure 1 (back).

[0020] Figure 4 This is a schematic diagram of the internal structure of the present invention. Figure 2 (back).

[0021] Figure 5 This is a schematic diagram of the control board in this invention.

[0022] Figure 6 This is a schematic diagram of the liquid shortage detection module in this invention.

[0023] Figure 7 This is a schematic diagram of the infusion tube flow control module in this invention.

[0024] Figure 8 This is a schematic diagram of the drip rate detection module in this invention. Detailed Implementation

[0025] To enable those skilled in the art to more clearly understand the purpose, technical solution, and advantages of the present invention, the present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0026] In the description of this invention, it should be understood that the orientation or positional relationship indicated by terms such as "upper", "lower", "left", "right", "inner", "outer", "lateral", and "vertical" is based on the orientation or positional relationship shown in the accompanying drawings and is only for the convenience of describing this invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, and therefore should not be construed as a limitation of this invention.

[0027] The invention will now be described in detail with reference to the accompanying drawings: Figure 1-3As shown, an intelligent infusion monitor with complication early warning function includes a monitor body, which consists of a front shell 1, a rear cover plate 2, and various functional modules disposed within the front shell 1. The front of the front shell 1 has a recess in the middle for placing the infusion tube 3, and a tube clamp 4 is installed above the recess to clamp the infusion tube 3. An infusion tube drip sleeve 6 is disposed below the front shell 1 to cover the infusion tube drip. Various functional modules and a control board 5 are placed inside the front shell 1 and the infusion tube drip sleeve 6. The rear cover plate 2 covers the rear of the front shell 1. The various functional modules include an infusion tube flow control module 7, a power supply module 8, a fluid shortage detection module 9, and a drip rate detection module 10. These modules are all controlled by the control board 5. The control board 5 is also equipped with a 4G / 5G IoT chip 15, a capacitance acquisition chip 11, an integrated sensor chip 12, a switch button 13, and an indicator light device 14. The integrated sensor chip 12 is used to collect altitude data, atmospheric pressure data, and temperature data.

[0028] A fluid shortage detection module 9 is installed in the recessed middle of the front shell 1. A power module 8 and an infusion tube flow control module 7 are installed on both sides of the fluid shortage detection module 9. Mounting posts are provided below the power module 8 and above the infusion tube flow control module 9. Fixing holes are also provided on the control plate 5 at positions relative to the mounting posts. The control plate 5 is fixed to the rear of the power module 8, the infusion tube flow control module 7, and the fluid shortage detection module 9 through the fixing holes. A button lever 16 is also provided below the power module 8. The button lever 16 extends forward to the button 17 on the front shell 1 and backward to the switch button 13 on the control plate 5. The drip rate detection module 10 is installed outside the infusion tube drip chamber sleeve 6 and is used to detect the dripping situation inside the infusion tube drip chamber 25.

[0029] like Figure 4-5As shown, the control board 5 is equipped with a main control chip 19, a capacitance acquisition chip 11, an altitude / atmospheric pressure sensor chip 12, a switch button 13, an indicator light device 14, a sound generator 24, a 4G / 5G IoT chip 15, and a battery management chip 27. The battery management chip 27 connects to the battery 22 and the charging port 23. The 4G / 5G IoT chip 15 connects to external devices. The indicator light device 14 connects to the main chip's I / O port on the control board 5. The sound generator 24 connects to the main chip's I / O port on the control board. The capacitance acquisition chip 11 connects to the main chip's I / O port. The ADC sampling function 26 integrated in the acquisition chip 11 is connected to the low fluid detection module 9 and the drip rate detection module 10, converting the capacitance change into a digital signal and then transmitting it to the main control chip 19 for data analysis. The main control chip 19 also acquires data from the integrated sensor chip 12 for analysis and calculation, and finally obtains the compensated parameter value. The obtained data is then connected to external devices for analysis via the 4G / 5G IoT chip 15. The main control chip 19 is also connected to the infusion tube flow control module 7, and by detecting and analyzing the infusion status, the infusion tube flow control module 7 can be activated in a timely manner.

[0030] like Figure 6 As shown, the fluid shortage detection module 9 consists of two arc-shaped electrodes 28, which are installed on the left and right sides respectively to form a semi-circular channel. The infusion tube 3 is restricted between the two arc-shaped electrodes 28 by the tube clamp 4 above. The two arc-shaped electrodes 28 are connected to the capacitance acquisition chip 11 below by cables to collect data and transmit it to the main chip. The capacitance acquisition chip 11 integrates an ADC sampling circuit.

[0031] like Figure 7 As shown, the infusion tube flow control module 7 consists of a stepper motor 29, a motor bracket 30, a power gear 31, and a locking tongue rod 32. The stepper motor 29 is mounted on the motor bracket 30, and the power gear 31 is mounted above the motor bracket 30. The power gear 31 is connected to the drive shaft 33 of the stepper motor 29. The locking tongue rod 32 has a gear side 34 on its side and a locking tongue 35 at its end. The gear side 34 is connected to the power gear 31. The motor drives the locking tongue 35 forward to lock the infusion tube 3.

[0032] like Figure 8As shown, the drip rate detection module 10 consists of a drip rate capacitance detection module and a drip rate infrared detection module. The drip rate capacitance detection module consists of capacitor plates 36 arranged on opposite sides, and the drip rate infrared detection module consists of infrared photodiodes arranged on opposite sides. The capacitor plates 36 arranged on opposite sides are installed above PCB substrates 37 arranged on the left and right sides. The plates have through holes for installing infrared photodiodes. One end of the infrared photodiode passes through the plate and is fixed behind the PCB substrate 37, and the other end is inserted into the through hole in the drip chamber sleeve 6 of the infusion tube and fixed. The PCB substrate 37 is suspended outside the drip chamber sleeve 6 of the infusion tube and inserted into the bottom of the front shell 1 for fixation. The infrared photodiode consists of an infrared emitter 39 and an infrared receiver 38 arranged on opposite sides. There is one infrared receiver 38 and at least two infrared emitters 39.

[0033] A method for using an intelligent infusion monitoring device with complication early warning function, the method including an installation method, a disassembly method, and an early warning method, wherein: Installation method: Hold the upper end of the drip chamber tubing of the infusion set with one hand, and hold the monitor with the other hand. Pull the monitor down to make the drip chamber cover inside the monitor fit against the upper end of the drip chamber of the infusion set. When you apply a little force, the tubing will be inserted into the tube clamp at the top of the product. Press and hold the switch for 3 seconds. At this time, the control board 5 will activate the fluid shortage detection module 9, the drip rate capacitance detection module, and the drip rate infrared detection module to monitor the infusion process. When the monitor detects that the infusion is completed, it will trigger the infusion tubing flow control module to automatically lock the tubing. All collected data and abnormalities can be fed back to the display terminal of medical staff or patients. Disassembly method: Briefly press the monitor switch or control it via mobile phone to unlock the monitor. Hold the upper end of the infusion set drip chamber with one hand and gently pull out the infusion tubing to remove it from the tubing clamp. Hold the monitor with the other hand and pull it up to expose the infusion tubing drip chamber completely. Then you can remove the monitor. The specific early warning method is as follows: 1) Data acquisition: The above-mentioned opening device is used to monitor the droplets in the drip chamber using infrared and capacitive detection tubes. The infrared sampling frequency is ≥100Hz, capturing the time interval and shape changes of the droplets. 2) Feature extraction algorithm: Time series analysis a. Calculate the time difference (Δt) between adjacent droplets after moving average filtering; b. Anomaly detection: Δt > 1.5 times the baseline value for more than 5 consecutive periods; 3) Frequency domain feature extraction: Perform a Fast Fourier Transform (FFT) on the Δt sequence to identify the characteristic frequency components in the 0.1–0.5 Hz range. 4) Decision-making algorithm: a. Support Vector Machine (SVM) classification; b. Input features: Δt variance, dominant frequency component, pressure gradient; c. Training data: Hundreds of normal / needle-dislodged samples collected clinically to improve the accuracy of early warning. 5) Dynamic threshold early warning: a. Baseline adaptive adjustment formula: b. Threshold ≥ 1.5σ Where σ is the average drip rate over the first 3 minutes, and exceeding the threshold will trigger an alarm. 6) Complication trend prediction model: An autoregressive integrated moving average model is used to predict the drip rate for the next 3 minutes. When the predicted value is lower than the safe level... Early warning at threshold; By using time series analysis and feature extraction, we can fit vital sign parameters associated with intravenous treatment complications and train data on the drip rate changes during the occurrence of hundreds of complications to provide early warning of abnormal situations. Feature extraction: Feature vector = [heart rate change rate, blood oxygen fluctuation amplitude, drip rate change rate, ...]; Early warning model: P = sigmoid(W·eigenvector + b); Where W is the weight matrix, b is the bias term, and sigmoid is the activation function.

[0034] The specific working method of the drip rate detection module is as follows: 1) Infrared detection: 940nm infrared emitting tubes and infrared receiving tubes are installed on both sides of the infusion drip chamber. The detection is achieved by utilizing the property of droplets to block infrared light. It is suitable for most common drug solutions. 2) Capacitance detection: Counting is achieved by collecting regular capacitance changes as the droplet falls; specifically, counting is achieved by collecting regular capacitance changes as the droplet falls, multi-band capacitance measurement (1kHz-1MHz), the infusion liquid information is sent through the HIS system, and the capacitance values ​​of different liquids are collected to construct a liquid dielectric property fingerprint database, and the accuracy of capacitance drop rate detection is gradually optimized through intelligent algorithms; 3) Improve the accuracy of drop rate detection by combining data collected from integrated sensor chips with precise algorithms; Temperature integrated sensor data acquisition includes: Auxiliary sensor, model: ICP-20100 A capacitance detection method based on dynamic dielectric constant compensation eliminates the influence of drug type (such as different conductivity) on the detection results.

[0035] Temperature sensor: (compensates for changes in the dielectric constant of the medium) Atmospheric pressure sensor: (to compensate for changes in drug solution density / viscosity) Altitude sensor: (indirectly compensates for the effect of air pressure on droplet formation) The specific algorithm is as follows: Drop rate = α * infrared detection result + (1 − α) * capacitance detection result; Where α is the weighting coefficient. When α is 0, the result of capacitance detection is used. When α>0, the drip rate is calculated by combining infrared and capacitance detection to achieve the purpose of dual infrared and capacitance detection. In obtaining capacitance test results, if the reference capacitance value is calibrated under standard conditions, but in areas where temperature, air pressure, and altitude vary, a compensation coefficient should be added when recording the rate of change in capacitance. The specific formula for this compensation coefficient is as follows: K T ,K P ,K A The compensation coefficients for temperature, air pressure, and altitude were determined through calibration experiments. Where C is the capacitance; K T Temperature; K P K represents air pressure. A Altitude; This represents the change in the dielectric constant of the drug solution.

[0036] Environmental capacitance calibration procedure: a. Calibrate the reference capacitance value under standard environmental conditions (e.g., 25℃, 1013hPa, altitude 0m); b. By changing temperature / air pressure / altitude, record the rate of change of capacitance and fit the compensation coefficient; The fluid shortage detection module uses non-contact detection technology to detect fluid level by monitoring changes in the electric field around the infusion tube. The specific method is as follows: when there is fluid in the infusion tube, the fluid acts as a dielectric, changing the distribution of the surrounding electric field, which increases the capacitance value of the detection electrode. When the fluid is drained, the capacitance value returns to its initial state. The data is collected by the ADC module, which converts the capacitance change into a digital signal output. The fluid shortage alarm is realized by using a linear change curve rule and threshold judgment.

[0037] The liquid shortage detection module also includes a liquid shortage detection compensation algorithm. Because the capacitance is affected by temperature and the drug in the drip tube, a compensation algorithm is added to the liquid shortage detection module. The specific compensation algorithm is as follows: Among them, C 补偿 The capacitance value is the compensated value, ΔT is the temperature change, and Δ ϵr , represents the change in the dielectric constant of the drug solution.

[0038] The low-liquidity detection module uses the MC11S, a non-contact detection technology. It detects the liquid level by monitoring changes in the electric field around the infusion tube. Its working principle is as follows: Capacitance change mechanism: When there is liquid in the infusion tube, the liquid acts as a dielectric and changes the distribution of the surrounding electric field, which leads to an increase in the capacitance value of the MC11S detection electrode; when the liquid is drained, the capacitance value returns to the initial state.

[0039] Signal conversion: The MC11S integrates an ADC module to convert capacitance changes into digital signal output, and realizes low liquid alarm through linear change curve rules and threshold judgment.

[0040] The innovative advantages of this design are as follows: Compared with traditional photoelectric or gravity sensors, capacitive detection has the following advantages: a) Non-contact: No need to directly contact the infusion tube, avoiding the risk of contamination; b) Strong anti-interference: Unaffected by liquid color or lighting conditions; c) Low power consumption: The MC11S chip has an operating current of only 0.5mA, which is suitable for battery-powered scenarios and reduces the impact of the monitor's weight on the infusion tube falling off.

[0041] The design features of this invention are as follows: drip rate control The product is equipped with a DC stepper motor, which drives the locking tongue lever to move by the stepper motor's electrical pulses. Its movement accuracy can reach 0.05 mm. By squeezing, it changes the flow diameter of the infusion tube, thereby changing the infusion drip rate. The locking tongue lever is automatically fine-tuned by comparing the drip rate data. This control method is based on the patient's age, health status, and vital signs data, and refers to medical standard requirements.

[0042] Indicator light device display The indicator light device consists of a drip rate indicator light for medical staff rounds and an infusion abnormality indicator light, wherein: a. Drip Rate Indicator for Medical Staff Monitoring: An RGB flashing indicator light is installed on the top of the product. During normal infusion, it displays green, and its flashing frequency is exactly the same as the drip rate. When the infusion is abnormal, it flashes yellow. When the infusion is completed or a complication is warned, it displays red. This allows medical staff to monitor the infusion status from a distance, improving their work efficiency and reducing their workload. It also makes it easier for caregivers to notice infusion abnormalities. Furthermore, its top placement will not cause light interference to the patient or those around them. Infusion Abnormality Indicator: One indicator light is set on the bottom of the product. When the drip rate is abnormal, another light will flash and use color (red light, yellow light) to remind the patient of the abnormal event. This indicator light is normally off when the drip rate is normal to ensure that it will not affect the patient. The indicator light is designed on the bottom so that both the patient and the caregiver can clearly know when it is flashing.

[0043] Complication early warning algorithm: Fluid dynamics principle of needle detachment causing abnormal drip rate When the needle is partially or completely removed from the blood vessel, the resistance of the infusion system changes abruptly from intravascular pressure (approximately 5-15 mmHg) to interstitial pressure (negative pressure or close to atmospheric pressure). At this time, the resistance to fluid flow increases by 3-5 times, which manifests as a sudden drop in drip rate (such as from 60 drops / min to below 10 drops / min) or intermittent stagnation.

[0044] Liquid column oscillation effect When the fluid seeps into the interstitial space after the needle is removed, the fluid column in the infusion tubing will oscillate periodically. a. Infiltration stage: The pressure of the liquid column decreases and the dripping rate slows down.

[0045] b. Retraction phase: The elastic blood vessel wall retracts, generating reverse pressure and briefly restoring the drip rate. This oscillation exhibits a periodic fluctuation of 0.1-0.5Hz.

[0046] This invention uses ARIMA time series to predict the drip rate for the next 3 minutes and provides an early warning when the predicted value is lower than a safety threshold (e.g., <15 drops / min).

[0047] 1) The intelligent infusion monitor with complication early warning function designed in this invention can effectively solve the problem of insufficient accuracy in existing infusion drip rate detection and fluid shortage detection; the infrared light used for drip rate detection in the intelligent infusion monitor with complication early warning function can alter the properties of some medications; the infusion rate can be automatically adjusted in a personalized and dynamic manner; during the infusion process, when the monitor detects that the infusion is completed, it triggers the infusion tubing flow control module to automatically lock the tubing; all collected data and abnormalities can be fed back to the display terminal of medical staff or patients. This design eliminates the need for medical staff to check frequently, greatly reducing their workload.

[0048] The specific embodiments described herein are merely illustrative of the principles and effects of the invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this invention should still be covered by the claims of this invention.

Claims

1. An intelligent infusion monitoring device with complication early warning function, comprising a monitoring body, the body consisting of a front shell, a rear cover, and various functional modules disposed within the front shell, characterized in that: The front of the front shell has a recessed center for holding the infusion tubing. A tubing clamp is installed above the recess to hold the tubing in place. An infusion tubing drip sleeve is located below the front shell to cover the drip chamber. Multiple functional modules and a control board are housed within the front shell and the drip chamber sleeve. A rear cover covers the rear of the front shell. These functional modules include an infusion tubing flow control module, a power supply module, a low-fluid-age detection module, and a drip rate detection module. All modules are controlled by the control board, which also houses a 4G / 5G IoT chip, a capacitance acquisition chip, an integrated sensor chip, power switches, and indicator lights. An integrated sensor chip is used to collect altitude, atmospheric pressure, and temperature data. A fluid shortage detection module is installed in the recessed area of ​​the front housing. A power module and an infusion tube flow control module are installed on either side of the fluid shortage detection module. Mounting posts are located below the power module and above the infusion tube flow control module. Fixing holes are also provided on the control board relative to the mounting posts, allowing the module to be fixed to the rear of the power module, infusion tube flow control module, and fluid shortage detection module. A button lever is located below the power module, extending forward to the button on the front housing and backward to the switch button on the control board. On the key, the drip rate detection module is installed on the outside of the infusion tubing drip chamber sleeve to detect the dripping situation inside the infusion tubing drip chamber; the control board is equipped with a main control chip, a capacitance acquisition chip, an integrated sensor chip, a switch button, indicator lights, a sound generator, a 4G / 5G IoT chip, and a battery management chip. The battery management chip connects to the battery and charging port, the 4G / 5G IoT chip connects to external devices, the indicator lights connect to the main chip's I / O port on the control board, the sound generator connects to the main chip's I / O port on the control board, the capacitance acquisition chip connects to the main chip's I / O port, and the capacitance acquisition chip integrates an ADC for sampling. The system connects to the fluid shortage detection module and the drip rate detection module, converting capacitance changes into digital signals, which are then transmitted to the main control chip for data analysis. The main control chip simultaneously acquires data from the integrated sensor chip for analysis and calculation, ultimately obtaining compensated parameter values. The obtained data is then connected to external devices via a 4G / 5G IoT chip for further analysis. The main control chip is also connected to the infusion tubing flow control module, enabling timely activation of the flow control module by detecting and analyzing the infusion status. The intelligent infusion monitor with complication early warning function includes installation, disassembly, and early warning methods, among which: Installation method: Hold the upper end of the drip chamber tubing of the infusion set with one hand, and hold the monitor with the other hand. Pull the monitor down to make the drip chamber cover inside the monitor fit against the upper end of the drip chamber of the infusion set. When you apply a little force, the tubing will be inserted into the clamp at the top of the product. Press and hold the switch button for 3 seconds. At this time, the control board will activate the fluid shortage detection module, the drip rate capacitance detection module, and the drip rate infrared detection module to monitor the infusion process. When the monitor detects that the infusion is completed, it will trigger the infusion tubing flow control module to automatically lock the tubing. All collected data and abnormalities can be fed back to the display terminal of medical staff or patients. Disassembly method: Briefly press the monitor switch or control it via mobile phone to unlock the monitor. Hold the upper end of the infusion set drip chamber with one hand and gently pull out the infusion tubing to remove it from the tubing clamp. Hold the monitor with the other hand and pull it up to expose the infusion tubing drip chamber completely. Then you can remove the monitor. The specific early warning method is as follows: 1) Data acquisition: By turning on the above-mentioned monitoring device, infrared and capacitive detection are used to monitor the droplets in the drip chamber. The infrared sampling frequency is ≥100Hz to capture the time interval and shape changes of the droplets. 2) Feature extraction algorithm: Time series analysis a. Calculate the time difference (Δt) between adjacent droplets after moving average filtering; b. Anomaly detection: Δt > 1.5 times the baseline value for more than 5 consecutive periods; 3) Frequency domain feature extraction: Perform a Fast Fourier Transform (FFT) on the Δt sequence to identify the characteristic frequency components in the 0.1-0.5 Hz range; 4) Decision-making algorithm: a. Support Vector Machine (SVM) classification; b. Input features: Δt variance, dominant frequency component, pressure gradient; c. Training data: Set up hundreds of normal / needle-removal samples collected clinically to improve the accuracy of early warning; 5) Dynamic threshold early warning: a. Baseline adaptive adjustment formula: b. Threshold ≥ 1.5σ Where σ is the average drip rate over the first 3 minutes, and exceeding the threshold will trigger an alarm. 6) Complication trend prediction model: An autoregressive integrated moving average model is used to predict the drip rate for the next 3 minutes, and an early warning is given when the predicted value is lower than the safety threshold. By using time series analysis and feature extraction, we can fit vital sign parameters associated with intravenous treatment complications and train data on the drip rate changes during the occurrence of hundreds of complications to provide early warning of abnormal situations. Feature extraction: Feature vector = [heart rate change rate, blood oxygen fluctuation amplitude, drip rate change rate, ...]; Early warning model: P = sigmoid(W·eigenvector + b); Where W is the weight matrix, b is the bias term, and sigmoid is the activation function.

2. The intelligent infusion monitoring device with complication early warning function according to claim 1, characterized in that: The fluid shortage detection module consists of two arc-shaped electrodes, which are installed on the left and right sides respectively to form a semi-circular channel. The infusion tube is restricted between the two arc-shaped electrodes by the tube clamp above. The two arc-shaped electrodes are connected to the capacitance acquisition chip through cables below to collect data and transmit it to the main chip. The capacitance acquisition chip integrates an ADC sampling circuit.

3. The intelligent infusion monitoring device with complication early warning function according to claim 1, characterized in that: The infusion tube flow control module consists of a stepper motor, a motor bracket, a power gear, and a locking tongue rod. The stepper motor is mounted on the motor bracket, and the power gear is mounted above the motor bracket. The power gear is connected to the drive shaft of the stepper motor. The locking tongue rod has a gear side on its side and a locking tongue at its end. The gear side is connected to the power gear. The motor drives the locking tongue forward to lock the infusion tube.

4. The intelligent infusion monitoring device with complication early warning function according to claim 1, characterized in that: The drip rate detection module consists of a drip rate capacitance detection module and a drip rate infrared detection module. The drip rate capacitance detection module consists of capacitor plates arranged on opposite sides, and the drip rate infrared detection module consists of infrared photodiodes arranged on opposite sides. The capacitor plates arranged on opposite sides are mounted above PCB substrates arranged on the left and right sides. The plates have through holes for mounting the infrared photodiodes. One end of the infrared photodiode passes through the plates and is fixed behind the PCB substrate, while the other end is inserted into a through hole in the drip chamber sleeve of the infusion tube and fixed. The PCB substrate is suspended outside the drip chamber sleeve of the infusion tube and inserted into the bottom of the front shell for fixation. The infrared photodiode consists of an infrared emitter and an infrared receiver, arranged on opposite sides. There is one infrared receiver and at least two infrared emitters.

5. The intelligent infusion monitoring device with complication early warning function according to claim 1, characterized in that: The specific working method of the drip rate detection module is as follows: 1) Infrared detection: Infrared emitting tubes and receiving tubes are installed on both sides of the drip chamber of the infusion tube. The detection is achieved by utilizing the property of droplets to block infrared light. It is suitable for most common drug solutions. 2) Capacitance detection: Counting is done by collecting regular changes in capacitance as the droplet falls; 3) Improve the accuracy of drop rate detection by combining data collected from integrated sensor chips with precise algorithms; The specific algorithm is as follows: Drop rate = α * infrared detection result + (1-α) * capacitance detection result; Where α is the weighting coefficient. When α is 0, the result of capacitance detection is used. When α>0, the drip rate is calculated by combining infrared and capacitance detection to achieve the purpose of dual infrared and capacitance detection. In obtaining the capacitance test results, a reference capacitance value is calibrated under a standard environment. The standard environment is 25℃, 1013hPa, and 0m altitude. For other regions where temperature, air pressure, and altitude vary significantly, a compensation coefficient should be added when recording the capacitance change rate, and a compensation method for the change in the dielectric constant of the chemical solution should also be incorporated. The specific formula for this compensation coefficient is as follows: K T ,K P ,K A The compensation coefficients for temperature, air pressure, and altitude were determined through calibration experiments. Where C is the capacitance; K T Temperature; K P K represents air pressure. A Altitude; This represents the change in the dielectric constant of the drug solution.

6. The intelligent infusion monitoring device with complication early warning function according to claim 1, characterized in that: The fluid shortage detection module uses non-contact detection technology to detect fluid level by monitoring changes in the electric field around the infusion tube. The specific method is as follows: when there is fluid in the infusion tube, the fluid acts as a dielectric, changing the distribution of the surrounding electric field, which increases the capacitance value of the detection electrode. When the fluid is drained, the capacitance value returns to its initial state. The data is collected by a capacitance acquisition chip, which converts the capacitance change into a digital signal output. The fluid shortage alarm is then triggered by a linear change curve rule combined with a threshold judgment.

7. The intelligent infusion monitoring device with complication early warning function according to claim 6, characterized in that: The liquid shortage detection module also includes a liquid shortage detection compensation algorithm. Because the capacitance is affected by temperature and the drug in the drip tube, a compensation algorithm is added to the liquid shortage detection module. The specific compensation algorithm is as follows: Among them, C 补偿 The capacitance value is the compensated value, and ΔT represents the temperature change. This represents the change in the dielectric constant of the drug solution.

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