Method and device for calibrating flow velocity of infusion pump in clinical use process

Abstract

The invention discloses a method and device for calibrating the flow speed of an infusion pump in the clinical use process, and relates to the field of real-time monitoring. The method comprises the steps that an empty infusion bag is weighed, the total amount of liquid medicine is calculated, and the total infusion duration is estimated in combination with the density and the initial flow speed; setting a periodic calibration interval and a flow velocity tolerance range according to the characteristics of the liquid medicine; in the infusion process, a five-point sampling average method is adopted to continuously monitor the weight and the pipeline pressure, the actual flow velocity is reversely deduced regularly through the weight of residual liquid medicine and compared with a set value, and the speed is adjusted and verified if the actual flow velocity is out of tolerance; triple dynamic calibration is synchronously implemented, wherein the precision of the whole process is guaranteed through periodic calibration, real-time calibration is triggered through continuous weight kick, and final calibration is carried out at the last stage of infusion. The method has the advantages that through double weighing, differential calibration interval and adaptability deviation threshold setting, full-process dynamic calibration, accurate data collection and real-time pressure monitoring are combined, flow velocity accuracy, clinical safety and scene adaptability are considered, and it is effectively guaranteed that infusion is reliable and controllable in the whole process.

Description

Technical Field

[0001] This invention relates to the field of real-time monitoring, and in particular to a method and apparatus for calibrating the flow rate of an infusion pump during clinical use. Background Technology

[0002] In current medical practice, infusion pumps are crucial devices for precise drug delivery, and the accuracy of their flow rate directly affects patient medication safety and efficacy. Due to frequent daily use, prolonged operation, and the natural aging of components, the actual output flow rate may deviate from the factory-set theoretical value. This slight deviation is particularly critical when administering high-risk medications, potentially leading to serious risks of underdosing or overdosing. Therefore, regular flow rate calibration of infusion pumps in clinical use has become a mandatory and essential component of equipment management and quality control in medical institutions.

[0003] Currently available infusion pump flow rate calibration methods mostly rely on third-party annual calibration or fixed-interval verification, which cannot adapt to changes in drug characteristics and flow rate during infusion in real time. Accumulated errors due to equipment drift are also common. Most methods do not use a unified deviation threshold, ignoring the flow differences of low, medium, and high viscosity drugs, resulting in excessive measurement errors in the low-flow range and insufficient calibration accuracy for high-viscosity drugs. Sampling methods are mostly single-point or small-scale repeated measurements, lacking data noise reduction processing, making the accuracy of weight and flow rate data susceptible to interference. Furthermore, insufficient monitoring of tubing pressure only allows for passive responses to basic faults such as blockages and empty bottles, making it difficult to provide early warnings of risks. Some methods require disassembling tubing or collecting drained drugs, which is cumbersome and time-consuming, reducing clinical efficiency and posing risks of leakage, waste, and equipment damage. Moreover, the lack of a final calibration mechanism at the end of the infusion process means that flow rate deviations in the residual drug stage cannot be corrected. Overall, the adaptability and safety are far inferior to the target method's full-process dynamic calibration system. Summary of the Invention

[0004] To improve existing methods and systems, this paper provides a method and device for calibrating the flow rate of infusion pumps during clinical use. This method combines dual weighing, differentiated calibration intervals and adaptation deviation threshold settings with dynamic calibration throughout the entire process, accurate data acquisition and real-time pressure monitoring, taking into account flow rate accuracy, clinical safety and scenario adaptability, and effectively ensuring reliable and controllable infusion throughout the entire process.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A method for calibrating the flow rate of an infusion pump during clinical use includes: The infusion bag and infusion tubing without medication were weighed, and the bag was weighed again after medication was added. The total weight of the medication was calculated, and the actual density of the medication was obtained by a density measuring instrument. Based on the total weight of the liquid medicine, the actual density of the liquid medicine, and the preset initial flow rate, the total time expected to complete the flow of all the liquid medicine is calculated. Flow rate calibration intervals of 2, 5, and 10 minutes are set according to the flow rate. Flow rate deviation range thresholds are set based on the viscosity and type of the liquid medicine. The infusion pump executes the drug delivery process based on the initially set flow rate, and simultaneously begins to accumulate infusion time. Weight data is collected using a five-point sampling averaging method, and the liquid pressure in the infusion tube is monitored in real time to provide hazard warnings. Based on the set flow rate calibration interval, the total weight of the remaining drug solution at that moment is obtained. The cumulative weight of the drug solution delivered during the flow rate calibration interval is calculated based on the total weight of the drug solution. The volume of the delivered drug solution is calculated based on the cumulative weight of the delivered drug solution and the actual density of the drug solution. The actual flow rate during the flow rate calibration interval is obtained by combining the cumulative infusion time. The relative deviation between the actual flow rate and the initial set flow rate is calculated, the percentage of the relative deviation is obtained and compared with the flow rate deviation threshold. If it is within the allowable range, the original flow rate is maintained; if it exceeds the range, the actual flow rate is adjusted and the flow rate adjustment is verified. Threshold judgments are performed sequentially at each flow rate calibration interval node. If the change in the collected weight data exceeds the preset weight threshold within three consecutive sampling periods, it is determined to be a sudden change in flow rate, and the real-time calibration process is immediately triggered. When the total weight of the remaining liquid collected drops to the sum of the initial empty bag weight and the preset residual weight, the current actual flow rate is calculated and compared with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, the final calibration is performed.

[0006] Preferably, the step of weighing the infusion bag and infusion tubing before it is filled with medication, weighing it again after filling it with medication, calculating the total weight of the medication, and obtaining the actual density of the medication using a density measuring instrument specifically includes: Weigh the empty infusion bag along with the infusion tubing before it is filled with medication, and record the initial total weight of the empty bag. The medication is loaded into the infusion bag, the infusion tubing is reconnected and the air is purged. After the infusion needle is inserted into the patient's blood vessel, the infusion bag containing the medication and the infusion tubing are weighed a second time and recorded as the initial total weight of the medication. Subtract the total weight of the initial empty bag from the total initial weight of the initial liquid to obtain the total weight of the medicine in the infusion bag in the initial state. The actual density of the liquid medicine in its initial state is obtained by using a density measuring instrument.

[0007] Preferably, the step of calculating the expected total time for all the medicine to flow based on the obtained total weight of the medicine, the actual density of the medicine, and the preset initial flow rate, and setting flow rate calibration intervals of 2, 5, and 10 minutes according to the flow rate, and setting the flow rate deviation range threshold based on the viscosity and type of the medicine specifically includes: The total expected time for all the medicine to flow is calculated based on the total weight of the medicine, the actual density of the medicine, and the preset initial flow rate. When the initial flow rate is greater than or equal to 100 ml / h, the time interval is set to 2 minutes; when the initial flow rate is between 20 and 100 ml / h, the time interval is set to 5 minutes; when the initial flow rate is less than 20 ml / h, the time interval is set to 10 minutes. The flow rate deviation threshold is set based on the viscosity and type of the drug solution. The threshold is a relative deviation threshold. The threshold range is set to 3% for low viscosity drug solutions, 5% for medium viscosity drug solutions, and 8% for high viscosity drug solutions.

[0008] Preferably, the infusion pump executes the drug delivery process based on an initially set flow rate, simultaneously begins accumulating infusion time, collects weight data using a five-point sampling averaging method, and monitors the liquid pressure within the infusion tubing in real time for hazard warnings, specifically including: The infusion pump starts delivering the medication based on the initial set flow rate, while simultaneously recording the cumulative infusion time and continuously weighing to obtain the weight changes of the infusion bag and infusion tubing. Using the five-point sampling average method, weight data is collected every two seconds. After five consecutive collections, the maximum and minimum values ​​are removed, and the average of the remaining three data points is taken as the valid weight data. The system monitors the liquid pressure inside the infusion tubing in real time. If the pressure exceeds a preset threshold, the infusion pump will immediately trigger an audible and visual alarm and simultaneously suspend the drug delivery process.

[0009] Preferably, the step of obtaining the total weight of the remaining medication at a given time based on the set flow rate calibration interval, calculating the cumulative weight of medication delivered during the flow rate calibration interval based on the total weight of medication, calculating the volume of medication delivered based on the cumulative weight of medication and the actual density of the medication, and obtaining the actual flow rate during the flow rate calibration interval in conjunction with the cumulative infusion time specifically includes: When the cumulative infusion time reaches the flow rate calibration interval, the weight of the infusion bag containing the remaining medication along with the infusion tubing is collected to obtain the total weight of the remaining medication at that time point. The total weight of the drug solution remaining at the time point is subtracted from the initial total weight of the drug solution to calculate the cumulative weight of the drug solution delivered to the patient within the flow rate calibration interval. Based on the actual density of the liquid medicine and the cumulative weight of the liquid medicine delivered, the cumulative volume of liquid medicine delivered within the flow rate calibration interval is calculated. Based on the cumulative volume of drug delivered within the flow rate calibration interval, divide by the cumulative infusion time corresponding to the time point to obtain the actual flow rate of the time point; Based on the above calculation process, the actual flow rate of the timing node at each flow rate calibration interval is calculated and obtained.

[0010] Preferably, the step of calculating the relative deviation between the actual flow rate and the initially set flow rate, obtaining the percentage of the relative deviation, and comparing it with a flow rate deviation threshold, and maintaining the original flow rate if it is within the allowable range, and adjusting the actual flow rate if it exceeds the range, and performing flow rate adjustment verification specifically includes: The relative deviation between the actual flow rate and the initial set flow rate at each timing node is calculated, and the percentage of the relative deviation is obtained. If the relative deviation percentage is within the flow rate deviation threshold range, the infusion pump will continue to deliver the medicine at the current set flow rate and automatically enter the next timed calibration cycle. If the relative deviation percentage exceeds the threshold range, when the actual flow rate is greater than the initial set flow rate, the current set flow rate will be adjusted to the initial set flow rate minus the difference between the two; when the actual flow rate is less than the initial set flow rate, it will be adjusted to the initial set flow rate plus the difference between the two. After calibration, actual flow rate data is collected every five seconds. If the relative deviation of the actual flow rate collected in five times is within the threshold, the flow rate is operated according to the calibrated flow rate. If it still exceeds the threshold, the calibration operation is repeated.

[0011] Preferably, the step of sequentially performing threshold judgment at each flow rate calibration interval node, and determining that if the change in the collected weight data exceeds a preset weight threshold within three consecutive sampling periods, is a sudden change in flow rate, and immediately triggering the real-time calibration process, specifically includes: For each timed node in the infusion process, repeat the timed weighing, actual flow rate calculation, deviation judgment and calibration operations; The set flow rate after each calibration is used as the reference set flow rate for the current node. The actual flow rate and relative deviation percentage of each node are calculated in sequence. The current flow rate is maintained or a new calibration is performed depending on whether the deviation exceeds the threshold. If the change in weight data exceeds the threshold within three consecutive sampling cycles during the cyclic calibration process, a sudden change in flow rate is determined, and the current timed calibration cycle is immediately paused and the calibration operation is repeated.

[0012] Preferably, when the total weight of the collected remaining liquid drops to the sum of the initial empty bag weight and the preset residual weight, the current actual flow rate is calculated and compared with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, the final calibration is performed. Specifically, this includes: The total weight of the remaining liquid is continuously monitored. When the weight drops to the sum of the initial empty bag weight and the preset residual weight, the final calibration process is triggered. Collect the total weight of the remaining drug solution, calculate the cumulative weight of the drug solution delivered at the last calibration node, and obtain the actual flow rate at the last time by combining the actual density of the drug solution and the cumulative infusion time. Compare the final actual flow rate with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, immediately perform a calibration operation to adjust the set flow rate.

[0013] Furthermore, a flow rate calibration device for infusion pumps during clinical use is proposed, comprising: Initialization configuration module: weighs the empty bag before infusion and weighs it after filling with infusion, calculates the initial total weight of the infusion, and obtains the actual density of the infusion through a density measuring instrument; Parameter setting module: Automatically divides the calibration time interval based on the initial set flow rate, and sets the corresponding flow rate deviation alarm threshold according to the properties of the drug solution; Dynamic monitoring module: controls the infusion pump to run at the set flow rate, continuously collects weight data using the five-point sampling averaging method, and monitors pipeline pressure in real time. If an abnormality is detected, an alarm will be issued and the infusion will be interrupted immediately. Flow rate calculation module: At each calibration time point, the actual average flow rate for the previous time period is calculated based on the weight change, drug density, and time. Calibration decision module: Compares the calculated actual flow rate with the target value. If the deviation exceeds the tolerance, it automatically adjusts the pump speed and ensures that the new flow rate is stable within the allowable range through short-term verification. Special operating condition handling module: used to deal with emergencies and perform a final calibration before the end of infusion; Processor: The processor is used to handle the calculation process of each formula and the construction calculation process of each model.

[0014] Compared with the prior art, the advantages of the present invention are: By combining double weighing of empty bags and filled solutions with the actual density of the medication, reliable data support is provided for flow rate calculation. Differentiated calibration intervals are dynamically defined based on the initial flow rate, and corresponding deviation thresholds are set according to the medication viscosity, achieving personalized adaptation of calibration parameters. A five-point sampling averaging method is used to eliminate abnormal data, improving the accuracy of weight acquisition. Simultaneous real-time monitoring of tubing pressure triggers an immediate alarm and shutdown in case of abnormalities, strengthening clinical safety. Through full-process control including timed calibration, real-time calibration for sudden flow rate changes, and final calibration, flow rate deviations are dynamically corrected. Post-calibration, stability is ensured through multiple cycles of verification, effectively avoiding flow rate deviations caused by changes in medication characteristics and tubing conditions. The overall process balances dynamic adjustment and risk warning, ensuring precise and controllable flow rate throughout the infusion process while adapting to the medication and flow rate requirements of different clinical scenarios, significantly improving the reliability and safety of infusion pump clinical applications. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the method proposed in this invention; Figure 2 This is a schematic diagram of the basic data acquisition proposed in this invention; Figure 3 This is a schematic diagram of the parameter setting and threshold configuration proposed in this invention; Figure 4This is a schematic diagram of the multi-dimensional real-time monitoring proposed in this invention; Figure 5 This is a schematic diagram of the timed node weighing and actual flow velocity calculation proposed in this invention; Figure 6 This is a schematic diagram of the flow velocity deviation determination and calibration proposed in this invention; Figure 7 This is a schematic diagram of the cyclic calibration proposed in this invention; Figure 8 This is a schematic diagram of the final calibration proposed in this invention. Detailed Implementation

[0016] The following description is intended to disclose the invention and enable those skilled in the art to implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art.

[0017] An infusion pump flow rate calibration device for clinical use, comprising: Initialization configuration module: weighs the empty bag before infusion and weighs it after filling with infusion, calculates the initial total weight of the infusion, and obtains the actual density of the infusion through a density measuring instrument; Parameter setting module: Automatically divides the calibration time interval based on the initial set flow rate, and sets the corresponding flow rate deviation alarm threshold according to the properties of the drug solution; Dynamic monitoring module: controls the infusion pump to run at the set flow rate, continuously collects weight data using the five-point sampling averaging method, and monitors pipeline pressure in real time. If an abnormality is detected, an alarm will be issued and the infusion will be interrupted immediately. Flow rate calculation module: At each calibration time point, the actual average flow rate for the previous time period is calculated based on the weight change, drug density, and time. Calibration decision module: Compares the calculated actual flow rate with the target value. If the deviation exceeds the tolerance, it automatically adjusts the pump speed and ensures that the new flow rate is stable within the allowable range through short-term verification. Special operating condition handling module: used to deal with emergencies and perform a final calibration before the end of infusion; Processor: The processor is used to handle the calculation process of each formula and the construction calculation process of each model.

[0018] See Figure 1 As shown, a method for calibrating the flow rate of an infusion pump during clinical use includes: Step 1: Weigh the infusion bag along with the infusion tubing before it is filled with medication. Weigh it again after filling it with medication, calculate the total weight of the medication, and obtain the actual density of the medication using a density measuring instrument. Step 2: Based on the obtained total weight of the liquid medicine, the actual density of the liquid medicine, and the preset initial flow rate, calculate the total time expected to complete the flow of all the liquid medicine. Set flow rate calibration intervals of 2, 5, and 10 minutes according to the flow rate. Set the flow rate deviation range threshold based on the viscosity and type of the liquid medicine. Step 3: The infusion pump executes the drug delivery process based on the initial set flow rate, and at the same time starts to accumulate infusion time. Weight data is collected by the five-point sampling averaging method, and the liquid pressure in the infusion tube is monitored in real time to provide a danger warning. Step 4: Based on the set flow rate calibration interval, obtain the total weight of the remaining medicine at that moment, calculate the cumulative weight of the medicine delivered during the flow rate calibration interval based on the total weight of the medicine, calculate the volume of the delivered medicine based on the cumulative weight of the delivered medicine and the actual density of the medicine, and obtain the actual flow rate during the flow rate calibration interval by combining the cumulative infusion time. Step 5: Calculate the relative deviation between the actual flow rate and the initial set flow rate, obtain the percentage of relative deviation, and compare it with the flow rate deviation threshold. If it is within the allowable range, maintain the original flow rate; if it exceeds the range, adjust the actual flow rate and verify the flow rate adjustment. Step 6: Perform threshold judgment at each flow rate calibration interval node in sequence. If the change in the collected weight data exceeds the preset weight threshold within three consecutive sampling periods, it is determined to be a sudden change in flow rate, and the real-time calibration process is immediately triggered. Step 7: When the total weight of the collected remaining liquid drops to the sum of the initial empty bag weight and the preset residual weight, calculate the current actual flow rate and compare it with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, perform the final calibration.

[0019] See Figure 2 As shown, the infusion bag without medication was weighed along with the infusion tubing. After medication was added, it was weighed again to calculate the total weight of the medication. The actual density of the medication was obtained using a density measuring instrument, specifically including: Weigh the empty infusion bag along with the infusion tubing before it is filled with medication, and record the initial total weight of the empty bag. The medication is loaded into the infusion bag, the infusion tubing is reconnected and the air is purged. After the infusion needle is inserted into the patient's blood vessel, the infusion bag containing the medication and the infusion tubing are weighed a second time and recorded as the initial total weight of the medication. Subtract the total weight of the initial empty bag from the total initial weight of the initial liquid to obtain the total weight of the medicine in the infusion bag in the initial state. The actual density of the liquid medicine in its initial state is obtained by using a density measuring instrument.

[0020] See Figure 3As shown, based on the obtained total weight of the liquid medicine, the actual density of the liquid medicine, and the preset initial flow rate, the total time expected to complete the flow of all the liquid medicine is calculated. Flow rate calibration intervals of 2, 5, and 10 minutes are set according to the flow rate. The flow rate deviation range threshold is set based on the viscosity and type of the liquid medicine, specifically including: The total expected time for all the medicine to flow is calculated based on the total weight of the medicine, the actual density of the medicine, and the preset initial flow rate. When the initial flow rate is greater than or equal to 100 ml / h, the time interval is set to 2 minutes; when the initial flow rate is between 20 and 100 ml / h, the time interval is set to 5 minutes; when the initial flow rate is less than 20 ml / h, the time interval is set to 10 minutes. The flow rate deviation threshold is set based on the viscosity and type of the drug solution. The threshold is a relative deviation threshold. The threshold range is set to 3% for low viscosity drug solutions, 5% for medium viscosity drug solutions, and 8% for high viscosity drug solutions.

[0021] Specifically, the viscosity grade of the drug solution is obtained. The viscosity grade is divided into three levels according to the kinematic viscosity standard: low viscosity drug solution (kinematic viscosity less than 5 mm² / s), medium viscosity drug solution (kinematic viscosity between 5 mm² / s and 15 mm² / s), and high viscosity drug solution (kinematic viscosity greater than 15 mm² / s). The system automatically matches the flow rate deviation threshold based on the identified viscosity grade and drug type: For low-viscosity drugs (antibiotics, electrolyte solutions), the threshold is set to ±2%; for general rehydration solutions, the threshold is set to ±3%. Medium viscosity drug solutions: For types such as nutrient solutions and traditional Chinese medicine injections, the threshold is set at ±5%; for anticoagulant drugs, the threshold is set at ±4%. High-viscosity drug solutions: For blood products and protein-based drugs, the threshold is set at ±7%; for chemotherapy drugs, due to the high precision requirements of dosage, the threshold is set at ±3%. The threshold configuration allows medical staff to manually fine-tune it according to specific clinical needs. The fine-tuning range must not exceed ±1% of the basic threshold of the corresponding viscosity grade, and the fine-tuning operation must be recorded, noting the reason for the adjustment and the operator.

[0022] See Figure 4 As shown, the infusion pump executes the drug delivery process based on the initially set flow rate, simultaneously accumulating infusion time, collecting weight data using a five-point sampling averaging method, and monitoring the liquid pressure within the infusion tubing in real time to provide hazard warnings. Specifically, this includes: The infusion pump starts delivering the medication based on the initial set flow rate, while simultaneously recording the cumulative infusion time and continuously weighing to obtain the weight changes of the infusion bag and infusion tubing. Using the five-point sampling average method, weight data is collected every two seconds. After five consecutive collections, the maximum and minimum values ​​are removed, and the average of the remaining three data points is taken as the valid weight data. The system monitors the liquid pressure inside the infusion tubing in real time. If the pressure exceeds a preset threshold, the infusion pump will immediately trigger an audible and visual alarm and simultaneously suspend the drug delivery process.

[0023] See Figure 5 As shown, based on the set flow rate calibration interval, the total weight of the remaining drug solution at that moment is obtained. The cumulative weight of the drug solution delivered during the flow rate calibration interval is calculated based on the total weight of the drug solution. The volume of the delivered drug solution is calculated based on the cumulative delivered weight and the actual density of the drug solution. The actual flow rate during the flow rate calibration interval is obtained by combining the cumulative infusion time. Specifically, this includes: When the cumulative infusion time reaches the flow rate calibration interval, the weight of the infusion bag containing the remaining medication along with the infusion tubing is collected to obtain the total weight of the remaining medication at that time point. The total weight of the drug solution remaining at the time point is subtracted from the initial total weight of the drug solution to calculate the cumulative weight of the drug solution delivered to the patient within the flow rate calibration interval. Based on the actual density of the liquid medicine and the cumulative weight of the liquid medicine delivered, the cumulative volume of liquid medicine delivered within the flow rate calibration interval is calculated. Based on the cumulative volume of drug delivered within the flow rate calibration interval, divide by the cumulative infusion time corresponding to the time point to obtain the actual flow rate of the time point; Based on the above calculation process, the actual flow rate of the timing node at each flow rate calibration interval is calculated and obtained.

[0024] Specifically, the effective cumulative delivered drug weight is converted with the updated actual drug density to obtain the cumulative delivered drug volume, and the result is retained to two decimal places to ensure accuracy. The cumulative delivered drug volume is divided by the cumulative infusion time corresponding to the current node to obtain the actual flow rate of that timing node, and the result is rounded to one decimal place. If the actual flow rate is less than 0.1 ml / h or greater than the rated maximum flow rate of the infusion pump of 600 ml / h, a second recalculation is immediately initiated to re-check the original weight and density data. If the recalculation result is still abnormal, a flow rate calculation abnormality alarm will pop up, the calibration process will be paused, and medical staff will be prompted to check the equipment. After completing the actual flow rate calculation for the first timed node, the system binds and stores the actual flow rate, remaining total weight, cumulative volume, current density, and timestamp data for that node, generating a unique node index. When the cumulative infusion time reaches the next calibration interval, the entire process described above is repeated to calculate the actual flow rate for the second, third, and all subsequent timed nodes in sequence.

[0025] See Figure 6As shown, by calculating the relative deviation between the actual flow rate and the initially set flow rate, the percentage of the relative deviation is obtained and compared with the flow rate deviation threshold. If it is within the allowable range, the original flow rate is maintained; if it exceeds the range, the actual flow rate is adjusted, and the flow rate adjustment verification is performed. Specifically, this includes: The relative deviation between the actual flow rate and the initial set flow rate at each timing node is calculated, and the percentage of the relative deviation is obtained. If the relative deviation percentage is within the flow rate deviation threshold range, the infusion pump will continue to deliver the medicine at the current set flow rate and automatically enter the next timed calibration cycle. If the relative deviation percentage exceeds the threshold range, when the actual flow rate is greater than the initial set flow rate, the current set flow rate will be adjusted to the initial set flow rate minus the difference between the two; when the actual flow rate is less than the initial set flow rate, it will be adjusted to the initial set flow rate plus the difference between the two. After calibration, actual flow rate data is collected every five seconds. If the relative deviation of the actual flow rate collected in five times is within the threshold, the flow rate is operated according to the calibrated flow rate. If it still exceeds the threshold, the calibration operation is repeated.

[0026] Specifically, the calibration process itself may be a trigger for sudden changes in flow rate. For example, changes in flow rate may cause pressure fluctuations in the pipeline, high-viscosity liquids may generate instantaneous turbulence due to changes in shear force, pressure changes may release tiny bubbles in the pipeline, and temporarily change the flow resistance, etc. If the relative deviation percentage exceeds the preset threshold range, the calibration procedure is immediately initiated. First, the current actual flow rate and the set flow rate data are locked to prevent interference from subsequent calculations. The set flow rate after calibration is calculated using the difference compensation method: when the actual flow rate is greater than the initial set flow rate, the set flow rate after calibration = the initial set flow rate - (actual flow rate - initial set flow rate), ensuring that the downward adjustment is completely matched with the actual deviation. When the actual flow rate is less than the initial set flow rate, the set flow rate after calibration = the initial set flow rate + (initial set flow rate - actual flow rate), ensuring that the upward adjustment accurately compensates for the actual deviation. The set flow rate after calibration is retained to one decimal place and must be within the rated flow rate range of the infusion pump. If the calculation result exceeds this range, it is automatically clamped to the nearest rated boundary value.

[0027] See Figure 7 As shown, threshold judgments are performed sequentially at each flow rate calibration interval node. If the change in the collected weight data exceeds the preset weight threshold within three consecutive sampling periods, it is determined to be a sudden change in flow rate, and the real-time calibration process is immediately triggered. Specifically, this includes: For each timed node in the infusion process, repeat the timed weighing, actual flow rate calculation, deviation judgment and calibration operations; The set flow rate after each calibration is used as the reference set flow rate for the current node. The actual flow rate and relative deviation percentage of each node are calculated in sequence. The current flow rate is maintained or a new calibration is performed depending on whether the deviation exceeds the threshold. If the change in weight data exceeds the threshold within three consecutive sampling cycles during the cyclic calibration process, a sudden change in flow rate is determined, and the current timed calibration cycle is immediately paused and the calibration operation is repeated.

[0028] Specifically, during the cyclic calibration, the weighing module maintains continuous sampling and performs trend analysis on each set of effective weight data. The trigger threshold is set to one percent of the initial total weight of the liquid. The specific judgment logic is as follows: if the difference in effective weight change between two adjacent sampling cycles exceeds half of the fluctuation threshold within three consecutive sampling cycles, and the weight change in the three cycles shows a unidirectional increasing or decreasing trend, then it is judged as a sudden change in flow rate, and the real-time calibration process is immediately triggered. After the flow rate change is determined, the current timing calibration cycle is paused, and real-time calibration is set as the highest priority task. First, the sampling interval is shortened to 1 second / time, and eight sets of weight data are collected continuously. The seven-point sampling average method is used (one maximum value and one minimum value are removed, and the average of the remaining six data is taken) to reduce the measurement error caused by liquid sloshing and pipeline vibration at the moment of change. At the same time, the most recently stored actual density of the drug solution is called to calculate the actual flow rate at the moment of change. The deviation judgment and calibration execution process of real-time calibration includes relative deviation calculation, threshold comparison, calibration value calculation, AES encrypted transmission, and 30-second dynamic verification. If the dynamic verification is qualified, the calibrated flow rate is used as the new benchmark flow rate setting, and the timed calibration cycle is restarted to ensure the accuracy of the time interval of the next timed node. If the real-time calibration secondary verification is still unqualified, a flow rate change calibration failure alarm is triggered, the infusion is suspended, and the fault information is recorded.

[0029] See Figure 8 As shown, when the total weight of the collected remaining liquid drops to the sum of the initial empty bag weight and the preset residual weight, the current actual flow rate is calculated and compared with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, the final calibration is performed. Specifically, this includes: The total weight of the remaining liquid is continuously monitored. When the weight drops to the sum of the initial empty bag weight and the preset residual weight, the final calibration process is triggered. Collect the total weight of the remaining drug solution, calculate the cumulative weight of the drug solution delivered at the last calibration node, and obtain the actual flow rate at the last time by combining the actual density of the drug solution and the cumulative infusion time. Compare the final actual flow rate with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, immediately perform a calibration operation to adjust the set flow rate.

[0030] Specifically, the actual flow rate at the end of the calibration is compared with the set flow rate after the last calibration, and the relative deviation percentage is calculated. If the deviation exceeds the threshold, the final calibration is performed immediately. The calibration value calculation logic remains unchanged, but the dynamic verification process is extended to 60 seconds. The actual flow rate is collected every 5 seconds, requiring all data deviations to be within the threshold range and the average deviation to be ≤0.5%, to ensure the stability of the final flow rate. If the requirements are still not met after the final calibration, the infusion is not stopped, but the deviation data is marked as exceeding the final tolerance, and an alarm is triggered simultaneously. The formula for calculating the average deviation of the last calibration is:

[0031] in, This represents the average percentage deviation after the last calibration. The actual flow rate collected in the i-th sample during the final verification. The set flow rate after the last calibration. This represents the number of samples taken in the final verification.

[0032] It should be noted that the order of the above embodiments of the present invention is merely for descriptive purposes and does not represent the superiority or inferiority of the embodiments. Furthermore, the above description focuses on specific embodiments of this specification. Additionally, the processes depicted in the accompanying drawings do not necessarily require a specific or sequential order to achieve the desired results. In some embodiments, multitasking and parallel processing are possible or may be advantageous.

[0033] The various embodiments in this specification are described in a progressive manner. The same or similar parts between the various embodiments can be referred to each other. Each embodiment focuses on describing the differences from other embodiments.

[0034] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for calibrating the flow rate of an infusion pump during clinical use, characterized in that, include: The infusion bag and infusion tubing without medication were weighed, and the bag was weighed again after medication was added. The total weight of the medication was calculated, and the actual density of the medication was obtained by a density measuring instrument. Based on the total weight of the liquid medicine, the actual density of the liquid medicine, and the preset initial flow rate, the total time expected to complete the flow of all the liquid medicine is calculated. Flow rate calibration intervals of 2, 5, and 10 minutes are set according to the flow rate. Flow rate deviation range thresholds are set based on the viscosity and type of the liquid medicine. The infusion pump executes the drug delivery process based on the initially set flow rate, and simultaneously begins to accumulate infusion time. Weight data is collected using a five-point sampling averaging method, and the liquid pressure in the infusion tube is monitored in real time to provide hazard warnings. Based on the set flow rate calibration interval, the total weight of the remaining drug solution at that moment is obtained. The cumulative weight of the drug solution delivered during the flow rate calibration interval is calculated based on the total weight of the drug solution. The volume of the delivered drug solution is calculated based on the cumulative weight of the delivered drug solution and the actual density of the drug solution. The actual flow rate during the flow rate calibration interval is obtained by combining the cumulative infusion time. The relative deviation between the actual flow rate and the initial set flow rate is calculated, the percentage of the relative deviation is obtained and compared with the flow rate deviation threshold. If it is within the allowable range, the original flow rate is maintained; if it exceeds the range, the actual flow rate is adjusted and the flow rate adjustment is verified. Threshold judgments are performed sequentially at each flow rate calibration interval node. If the change in the collected weight data exceeds the preset weight threshold within three consecutive sampling periods, it is determined to be a sudden change in flow rate, and the real-time calibration process is immediately triggered. When the total weight of the remaining liquid collected drops to the sum of the initial empty bag weight and the preset residual weight, the current actual flow rate is calculated and compared with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, the final calibration is performed.

2. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, The process of weighing the infusion bag and tubing before it is filled with medication, weighing it again after filling it with medication, calculating the total weight of the medication, and obtaining the actual density of the medication using a density measuring instrument specifically includes: Weigh the empty infusion bag along with the infusion tubing before it is filled with medication, and record the initial total weight of the empty bag. The medication is loaded into the infusion bag, the infusion tubing is reconnected and the air is purged. After the infusion needle is inserted into the patient's blood vessel, the infusion bag containing the medication and the infusion tubing are weighed a second time and recorded as the initial total weight of the medication. Subtract the total weight of the initial empty bag from the total initial weight of the initial liquid to obtain the total weight of the medicine in the infusion bag in the initial state. The actual density of the liquid medicine in its initial state is obtained by using a density measuring instrument.

3. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, The process involves calculating the expected total time for all the medicine to flow based on the obtained total weight of the medicine, the actual density of the medicine, and the preset initial flow rate. Flow rate calibration intervals of 2, 5, and 10 minutes are set according to the flow rate. The flow rate deviation range threshold is set based on the viscosity and type of the medicine. Specifically, this includes: The total expected time for all the medicine to flow is calculated based on the total weight of the medicine, the actual density of the medicine, and the preset initial flow rate. When the initial flow rate is greater than or equal to 100 ml / h, the time interval is set to 2 minutes; when the initial flow rate is between 20 and 100 ml / h, the time interval is set to 5 minutes; when the initial flow rate is less than 20 ml / h, the time interval is set to 10 minutes. The flow rate deviation threshold is set based on the viscosity and type of the drug solution. The threshold is a relative deviation threshold. The threshold range is set to 3% for low viscosity drug solutions, 5% for medium viscosity drug solutions, and 8% for high viscosity drug solutions.

4. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, The infusion pump executes the drug delivery process based on an initially set flow rate, simultaneously accumulating infusion time, collecting weight data using a five-point sampling averaging method, and monitoring the liquid pressure within the infusion tubing in real time to provide hazard warnings. Specifically, this includes: The infusion pump starts delivering the medication based on the initial set flow rate, while simultaneously recording the cumulative infusion time and continuously weighing to obtain the weight changes of the infusion bag and infusion tubing. Using the five-point sampling average method, weight data is collected every two seconds. After five consecutive collections, the maximum and minimum values ​​are removed, and the average of the remaining three data points is taken as the valid weight data. The system monitors the liquid pressure inside the infusion tubing in real time. If the pressure exceeds a preset threshold, the infusion pump will immediately trigger an audible and visual alarm and simultaneously suspend the drug delivery process.

5. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, The process of obtaining the total weight of the remaining medication at a given flow rate calibration interval, calculating the cumulative weight of medication delivered during the flow rate calibration interval based on the total weight of medication, calculating the delivered medication volume based on the cumulative delivered medication weight and the actual density of the medication, and obtaining the actual flow rate during the flow rate calibration interval by combining the cumulative infusion time specifically includes: When the cumulative infusion time reaches the flow rate calibration interval, the weight of the infusion bag containing the remaining medication along with the infusion tubing is collected to obtain the total weight of the remaining medication at that time point. The total weight of the drug solution remaining at the time point is subtracted from the initial total weight of the drug solution to calculate the cumulative weight of the drug solution delivered to the patient within the flow rate calibration interval. Based on the actual density of the liquid medicine and the cumulative weight of the liquid medicine delivered, the cumulative volume of liquid medicine delivered within the flow rate calibration interval is calculated. Based on the cumulative volume of drug delivered within the flow rate calibration interval, divide by the cumulative infusion time corresponding to the time point to obtain the actual flow rate of the time point; Based on the above calculation process, the actual flow rate of the timing node at each flow rate calibration interval is calculated and obtained.

6. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, The process of calculating the relative deviation between the actual flow rate and the initially set flow rate, obtaining the percentage of the relative deviation, and comparing it with a flow rate deviation threshold, involves maintaining the original flow rate if it is within the allowable range, and adjusting the actual flow rate if it exceeds the range, followed by flow rate adjustment verification. Specifically, this includes: The relative deviation between the actual flow rate and the initial set flow rate at each timing node is calculated, and the percentage of the relative deviation is obtained. If the relative deviation percentage is within the flow rate deviation threshold range, the infusion pump will continue to deliver the medicine at the current set flow rate and automatically enter the next timed calibration cycle. If the relative deviation percentage exceeds the threshold range, when the actual flow rate is greater than the initial set flow rate, the current set flow rate will be adjusted to the initial set flow rate minus the difference between the two; when the actual flow rate is less than the initial set flow rate, it will be adjusted to the initial set flow rate plus the difference between the two. After calibration, actual flow rate data is collected every five seconds. If the relative deviation of the actual flow rate collected in five times is within the threshold, the flow rate is operated according to the calibrated flow rate. If it still exceeds the threshold, the calibration operation is repeated.

7. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, The step of sequentially performing threshold judgments at each flow rate calibration interval node, and determining that if the change in the collected weight data exceeds the preset weight threshold within three consecutive sampling periods is a sudden change in flow rate, immediately triggering the real-time calibration process, specifically includes: For each timed node in the infusion process, repeat the timed weighing, actual flow rate calculation, deviation judgment and calibration operations; The set flow rate after each calibration is used as the reference set flow rate for the current node. The actual flow rate and relative deviation percentage of each node are calculated in sequence. The current flow rate is maintained or a new calibration is performed depending on whether the deviation exceeds the threshold. If the change in weight data exceeds the threshold within three consecutive sampling cycles during the cyclic calibration process, a sudden change in flow rate is determined, and the current timed calibration cycle is immediately paused and the calibration operation is repeated.

8. The method for calibrating the flow rate of an infusion pump during clinical use according to claim 1, characterized in that, When the total weight of the collected remaining liquid drops to the sum of the initial empty bag weight and the preset residual weight, the current actual flow rate is calculated and compared with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, the final calibration is performed. Specifically, this includes: The total weight of the remaining liquid is continuously monitored. When the weight drops to the sum of the initial empty bag weight and the preset residual weight, the final calibration process is triggered. Collect the total weight of the remaining drug solution, calculate the cumulative weight of the drug solution delivered at the last calibration node, and obtain the actual flow rate at the last time by combining the actual density of the drug solution and the cumulative infusion time. Compare the final actual flow rate with the set flow rate after the last calibration. If the relative deviation exceeds the threshold, immediately perform a calibration operation to adjust the set flow rate.

9. An infusion pump flow rate calibration device for clinical use, used to implement the infusion pump flow rate calibration method for clinical use as described in any one of claims 1-8, characterized in that, include: Initialization configuration module: weighs the empty bag before infusion and weighs it after filling with infusion, calculates the initial total weight of the infusion, and obtains the actual density of the infusion through a density measuring instrument; Parameter setting module: Automatically divides the calibration time interval based on the initial set flow rate, and sets the corresponding flow rate deviation alarm threshold according to the properties of the drug solution; Dynamic monitoring module: controls the infusion pump to run at the set flow rate, continuously collects weight data using the five-point sampling averaging method, and monitors pipeline pressure in real time. If an abnormality is detected, an alarm will be issued and the infusion will be interrupted immediately. Flow rate calculation module: At each calibration time point, the actual average flow rate for the previous time period is calculated based on the weight change, drug density, and time. Calibration decision module: Compares the calculated actual flow rate with the target value. If the deviation exceeds the tolerance, it automatically adjusts the pump speed and ensures that the new flow rate is stable within the allowable range through short-term verification. Special operating condition handling module: used to deal with emergencies and perform a final calibration before the end of infusion; Processor: The processor is used to handle the calculation process of each formula and the construction calculation process of each model.

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