Precise control device for continuous infusion of boron-loaded medicine

Abstract

The invention discloses a precise control device for continuous infusion of a boron-loaded drug, which overcomes the defects of insufficient precise control, poor continuity and no dynamic closed loop in the existing boron neutron capture therapy. The device comprises a first shell and a second shell which are connected through a hinge, the device is further provided with an electromagnetic drive extrusion assembly, a fixing assembly and a rope ring, and the electromagnetic drive extrusion assembly comprises an electromagnet, a magnetic conductive block and a first elastic piece. The device further comprises a module which is specifically a data collecting and processing module and can collect liquid medicine parameters, pipeline parameters, physiological parameters and flow velocity data and remove abnormal data through filtering processing. And the influence factor calculation module can calculate a physiological state influence factor and an infusion resistance influence factor. Through electromagnetic pressure control, multi-factor calibration and multi-patient overall planning, the flow velocity precision meets the precision infusion requirement, the effective concentration of boron-loaded medicine in the body is stabilized in a treatment window, and the infusion interruption risk is greatly reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, more particularly, to a precision control device for boron drug delivery. BACKGROUND

[0002] As a precise radiotherapy technique with high relative biological effectiveness, boron neutron capture therapy (BNCT) is based on the specific accumulation of boron drug in tumor cells, and the neutron beam irradiation triggers the boron isotope fission reaction to produce short-range particles to kill tumor cells accurately. Clinical studies have shown that the concentration of boron isotope in the patient's body during neutron irradiation needs to be maintained within a certain treatment window. If the concentration fluctuates beyond a certain range, the treatment effect will be reduced or the risk of normal tissue damage will be increased. Therefore, international clinical guidelines recommend using a pre-treatment combined with continuous infusion during irradiation scheme. For example, a specific two-stage infusion method uses a certain duration of loading infusion combined with a certain duration of maintenance infusion to control the blood drug concentration fluctuation rate within a very small range, which puts high requirements on the precision and stability of the infusion device.

[0003] Currently, ordinary precision infusion pumps are commonly used in clinical practice to deliver boron drugs, but there are certain technical defects:

[0004] 1. Boron drug has a biphasic clearance kinetic characteristic, and there is a significant individual difference between the peak blood boron isotope concentration and the clearance rate. The flow rate needs to be adjusted dynamically according to the patient's physiological state. However, the existing infusion pump does not match the characteristics of boron drugs. First, the compatibility of consumables is poor. The elastic attenuation of ordinary infusion devices after a certain period of time of peristaltic extrusion leads to a large flow rate error. Second, there is no factor compensation mechanism to correct the flow rate deviation caused by changes in patient blood pressure, pipe bending, etc., which directly leads to deviation of the boron isotope concentration from the treatment window.

[0005] 2. The boron drug infusion in BNCT treatment needs to be continuous for a long time, and interruption for more than a certain time will cause a significant decrease in blood drug concentration. However, the existing equipment has multiple interruption risks: first, the equipment itself has defects, such as some infusion pumps that may have insufficient infusion or even complete interruption in standby mode or flow rate switching, with large extreme deviations. Second, the management of multiple patients is disordered. Clinically, multiple patients are often infused simultaneously, and the existing equipment lacks overall planning of the end time, making it difficult for medical staff to predict the priority processing order, which may lead to interruption due to untimely liquid replacement. Third, the response time is too long for abnormal handling, such as pipeline vibration and signal interference, which requires manual data screening and removal, and cannot meet the real-time correction requirements. SUMMARY

[0006] To solve the problems in the prior art, the present application aims to provide a precision control device for boron drug continuous infusion, which can achieve flow rate precision meeting the requirements of precision infusion through electromagnetic pressure control, multi-factor calibration, and multi-patient overall planning.

[0007] To solve the above problems, the application adopts the technical scheme as follows.

[0008] A precision control device for boron drug continuous infusion, comprising a first shell and a second shell, characterized in that: the first shell and the second shell are provided with an electromagnetic drive extrusion assembly, the electromagnetic drive extrusion assembly comprises an electromagnet, a first elastic member and a magnetic conducting block, the extrusion force of the magnetic conducting block on the infusion tube can be changed by adjusting the current of the electromagnet; a flow rate sensor is installed on the first shell or the second shell for detecting the flow rate of the liquid in the infusion tube.

[0009] Further comprising:

[0010] A data acquisition and processing module is used to acquire real-time flow rate data of boron drug liquid parameters, infusion tube pipeline parameters, patient physiological parameters and the flow rate sensor, and to pre-process the collected data to eliminate abnormal values and noise.

[0011] An influence factor calculation module calculates a physiological state influence factor based on the pre-processed patient physiological parameters, combined with the pre-set physiological index normal reference value, fluctuation range and weight factor, and calculates an infusion resistance influence factor based on the pre-processed liquid parameters, pipeline parameters and pre-set central venous pressure maximum safety value, resistance influence weight.

[0012] A target flow rate determination module is used to analyze the stability of real-time flow rate data, combined with the two influence factors and the pre-set boron drug basic infusion speed, to determine the target infusion flow rate; when the flow rate is unstable and is a non-continuous anomaly, the target flow rate is calibrated after eliminating abnormal data.

[0013] A dynamic flow rate regulation module is used to obtain the current flow rate in real time through the flow rate sensor, and compare it with the target flow rate; if the current flow rate is low, increase the electromagnet current to push the magnetic conducting block to extrude the infusion tube to increase the speed; if the current flow rate is high, reduce the current, the first elastic member rebounds to pull back the magnetic conducting block, the infusion tube resets to reduce the speed, and the flow rate is fine-tuned.

[0014] A priority cluster generation module calculates the end time of a single patient infusion according to the target infusion flow rate and the remaining boron drug amount, integrates all patient end times and clusters them, determines the priority processing cluster in chronological order, and ensures continuous infusion.

[0015] Further, the data acquisition and processing module further comprises:

[0016] A liquid parameter acquisition module is used to scan the electronic tag of the boron drug infusion bottle, obtain the type of boron drug to be infused and the liquid viscosity, and ensure that the liquid parameters are consistent with the actual infusion drug.

[0017] Pipeline parameter acquisition module, for obtaining the length and inner diameter of the infusion tube by reading the product specification of the infusion tube or scanning the identification on the outer wall of the infusion tube, and determining the physical characteristics of the pipeline;

[0018] Physiological parameter acquisition module, for synchronously recording the acquisition time of each parameter by acquiring the heart rate with an electrocardiogram monitor, measuring the body temperature with a temperature measuring device, and acquiring the real-time central venous pressure with a pressure sensor in communication with the infusion tube;

[0019] Flow rate data acquisition module, for starting the flow rate sensor, detecting the flow rate of the drug solution in the infusion tube in real time, recording the flow rate value at a preset time interval, and forming an initial flow rate data sequence;

[0020] Data preprocessing module, for integrating the data output by the drug solution parameter acquisition module, the pipeline parameter acquisition module, the physiological parameter acquisition module, and the flow rate data acquisition module, removing noise by using a filtering algorithm, eliminating abnormal data beyond the normal range, and outputting an effective data set after preprocessing.

[0021] Further, the influence factor calculation module further comprises:

[0022] Physiological preparation module, for calling the preset normal reference value of the physiological index, the normal fluctuation range, and the corresponding weight factor of the central venous pressure, heart rate, and body temperature;

[0023] Physiological factor calculation module, for comparing the preprocessed physiological parameters output by the data preprocessing module with the preset normal reference value, calculating the deviation degree of each index in combination with the normal fluctuation range, and weighting and summing to obtain the physiological state influence factor according to the weight factor.

[0024] Further, the influence factor calculation module further comprises:

[0025] Resistance preparation module, for calling the preset maximum safe value of the central venous pressure and the resistance influence weight, and calling the preprocessed drug solution viscosity and the length and inner diameter of the infusion tube output by the data preprocessing module;

[0026] Resistance factor calculation module, for calculating the physical resistance basic value based on the drug solution viscosity, the tube length, and the inner diameter, combining the proportional relationship between the current central venous pressure and the maximum safe value, and superimposing the resistance influence weight to obtain the infusion resistance influence factor.

[0027] Further, the target flow rate determination module further comprises:

[0028] Flow rate preparation module, for dividing the preprocessed flow rate data output by the data preprocessing module into equally spaced monitoring time points according to a preset monitoring period, extracting the flow rate values to form a complete flow rate data sequence;

[0029] Flow rate determination module, for analyzing the fluctuation of the flow rate data sequence, comparing with the preset stability determination standard, and determining whether the flow rate is stable.

[0030] The basic flow rate calculation module is configured to call a preset basic infusion speed of the boron drug, combine physiological state influence factors and infusion resistance influence factors, and preliminarily calculate a basic target flow rate.

[0031] Further, the target flow rate verification module further comprises:

[0032] The abnormal flow rate processing module is configured to, if the flow rate determination module determines that the flow rate is unstable and is a non-continuous abnormality, eliminate the abnormal flow rate value and regenerate a valid flow rate data sequence.

[0033] The target flow rate calibration module is configured to, based on the valid flow rate data sequence of the abnormal flow rate processing module, combine influence factors in the physiological factor calculation module and the resistance factor calculation module and the preset basic infusion speed, calibrate and determine a final target infusion flow rate.

[0034] Further, the dynamic flow rate regulation module further comprises:

[0035] The real-time flow rate acquisition module is configured to start a flow rate sensor, collect a current flow rate of the boron drug in the infusion tube at a preset frequency, and record the flow rate value and the collection time.

[0036] The flow rate comparison and analysis module is configured to calculate a difference between the current flow rate and the target infusion flow rate, and determine whether the current flow rate is within a target flow rate allowable deviation range.

[0037] Further, the dynamic flow rate regulation module further comprises:

[0038] The flow rate adjustment module is configured to, if the current flow rate is lower than the lower deviation limit, send a current increase signal to the electromagnet to enhance the suction force to make the magnetic block overcome the elastic force of the first elastic member to extrude the infusion tube and increase the flow rate; and if the current flow rate is higher than the upper deviation limit, send a current decrease signal to the electromagnet to weaken the suction force to make the first elastic member rebound to pull back the magnetic block, and the infusion tube is reset to reduce the flow rate.

[0039] The flow rate feedback module is configured to repeatedly perform the real-time flow rate acquisition module, the flow rate comparison and analysis module, and the flow rate adjustment module, to real-time feedback the flow rate adjustment result, to fine-tune the current of the electromagnet, and to keep the flow rate stable within the allowable deviation.

[0040] Further, the priority cluster generation module further comprises:

[0041] The end time calculation module is configured to calculate a remaining infusion time length based on the target infusion flow rate in the target flow rate calibration module and the remaining amount of the boron drug, and to obtain an infusion end time of a single patient by superimposing the current time.

[0042] The time data integration module is configured to collect end time results of all boron drug infusion patients, associate patient identity labels with the end time, and form an infusion end time data set.

[0043] A clustering analysis module is configured to divide the data set in the time data integration module into different infusion end period clustering clusters according to end time proximity.

[0044] Further, the cluster generation module further comprises:

[0045] A priority cluster determination module is configured to sort the clustering clusters according to average end time, and extract the clustering cluster at the top of the sorting as a priority processing cluster.

[0046] A continuity guarantee module is configured to preferentially check the infusion device state of the patient in the priority processing cluster, calibrate the flow rate control parameter, and avoid infusion interruption.

[0047] Compared with the prior art, the present application has the beneficial effects that:

[0048] The present application effectively solves the problem of insufficient precision control of existing infusion equipment through the flow rate regulation logic of the electromagnetic drive extrusion assembly and the multi-module cooperation, wherein the electromagnetic drive extrusion assembly can accurately control the extrusion force of the magnetic block on the infusion tube by adjusting the current, cooperate with the data acquisition and processing module to comprehensively collect the liquid medicine, pipeline and physiological parameters, and the influence factor calculation module to quantitatively analyze the key influencing factors, so that the target flow rate can be determined more in line with the actual needs of the patient. The closed-loop feedback mechanism of the dynamic flow rate regulation module can also correct the flow rate deviation in real time, ensure that the infusion precision of the boron drug meets the treatment requirements, and further ensure that the effective concentration of the drug in the patient's body is stably within the therapeutic window, thereby improving the treatment effect. BRIEF DESCRIPTION OF DRAWINGS

[0049] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor on the basis of these drawings.

[0050] Figure 1 It is an overall structural appearance view of the present application;

[0051] Figure 2 It is a structural schematic view of the first shell of the present application;

[0052] Figure 3 It is an internal cross-sectional view of the first shell and the second shell of the present application;

[0053] Figure 4 It is an enlarged view of A in the present application; Figure 3

[0054] Figure 5 It is a structural schematic view of the telescopic rod of the present application;​

[0055] Figure 6 The structure diagram of the fixed assembly of the application.

[0056] Explanation of figure numbers:

[0057] 1, infusion tube; 2, first shell; 3, second shell; 4, fixed assembly; 41, pressing block; 42, first inclined surface block; 43, third elastic member; 44, second inclined surface block; 5, first electromagnet; 6, magnetic guide block; 7, first elastic member; 8, limiting groove; 9, telescopic rod; 10, limiting plate; 11, movable groove; 12, second elastic member; 13, magnetic guide disc; 14, second electromagnet; 15, limiting block; 16, rope ring; 17, flow rate sensor. DETAILED DESCRIPTION

[0058] The technical solutions in the embodiments of the application will be clearly and completely described below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the application.

[0059] Please refer to Figures 1 to 6 A device for precise control of continuous infusion of boron-loaded drugs, comprising a first shell 2 and a second shell 3, characterized in that: the first shell 2 and the second shell 3 are provided with an electromagnetic drive extrusion assembly, the electromagnetic drive extrusion assembly comprises an electromagnet 5, a first elastic member 7 and a magnetic guide block 6, and the extrusion force of the magnetic guide block 6 on the infusion tube 1 can be changed by adjusting the current of the electromagnet 5; a flow rate sensor 17 is arranged on the first shell 2 or the second shell 3, for detecting the flow rate of the liquid in the infusion tube 1.

[0060] The device further comprises:

[0061] A data acquisition and processing module is configured to acquire real-time flow rate data of boron-loaded drug liquid parameters, infusion tube 1 pipeline parameters, patient physiological parameters and the flow rate sensor 17, and to pre-process the acquired data to eliminate abnormal values and noise.

[0062] An influence factor calculation module is configured to calculate a physiological state influence factor based on the pre-processed patient physiological parameters, in combination with preset physiological index normal reference values, fluctuation ranges and weight factors, and to calculate an infusion resistance influence factor based on the pre-processed liquid parameters and pipeline parameters, in combination with a preset central venous pressure maximum safety value and resistance influence weight.

[0063] The target flow rate determination module is configured to perform stability analysis on the real-time flow rate data, determine the target infusion flow rate in combination with the two influence factors and the preset boron drug infusion base speed, and calibrate the target flow rate after removing abnormal data when the flow rate is unstable and the abnormality is discontinuous.

[0064] The dynamic flow rate regulation module is configured to acquire the current flow rate in real time through the flow rate sensor 17, compare the current flow rate with the target flow rate, increase the current of the electromagnet 5 when the current flow rate is low, push the magnetic block 6 to extrude the infusion tube 1 to increase the flow rate, decrease the current when the current flow rate is high, and the first elastic member 7 pulls back the magnetic block 6 to reset the infusion tube 1 to decrease the flow rate, thereby realizing fine adjustment of the flow rate.

[0065] The priority cluster generation module is configured to calculate the infusion end time of a single patient according to the target infusion flow rate and the remaining amount of boron drug, integrate all the end times of the patients and cluster them, determine the priority processing cluster in time sequence, and ensure continuous infusion.

[0066] The data acquisition and processing module further comprises:

[0067] The drug solution parameter acquisition module is configured to scan the electronic tag of the boron drug infusion bottle, acquire the type of the boron drug to be infused and the viscosity of the drug solution, and ensure that the drug solution parameters are consistent with the actual infusion drug.

[0068] The pipeline parameter acquisition module is configured to acquire the length and inner diameter of the infusion tube 1 by reading the product manual of the infusion tube 1 or scanning the outer wall identification of the infusion tube 1, and determine the physical characteristics of the pipeline.

[0069] The physiological parameter acquisition module is configured to acquire the heart rate by using an electrocardiograph, acquire the body temperature by using a temperature measuring device, and acquire the real-time central venous pressure by using a pressure sensor in communication with the infusion tube 1, and synchronously record the parameter acquisition time.

[0070] The flow rate data acquisition module is configured to start the flow rate sensor 17, detect the flow rate of the boron drug in the infusion tube 1 in real time, record the flow rate value at a preset time interval, and form an initial flow rate data sequence.

[0071] The data preprocessing module is configured to integrate the data output by the drug solution parameter acquisition module, the pipeline parameter acquisition module, the physiological parameter acquisition module and the flow rate data acquisition module, remove noise by using a filtering algorithm, remove abnormal data beyond the normal range, and output an effective data set after preprocessing.

[0072] In use, in the embodiment, first, open the first shell 2 and the second shell 3, one end of the first shell 2 and the second shell 3 is connected by a hinge, clamp the first shell 2 and the second shell 3 on the infusion tube 1, then use the fixing assembly 4 to fix the first shell 2 and the second shell 3, the fixing assembly 4 includes a pressing block 41, a first inclined block 42, a third elastic piece 43 and a second inclined block 44; the specific fixing method is to combine the first shell 2 and the second shell 3, at this time, the second inclined block 44 fixedly connected to the first shell 2 will extrude the inclined surface of the first inclined block 42, the first inclined block 42 will move to the left after being extruded, and at the same time, the third elastic piece 43 is extruded, when the inclined surface of the first inclined block 42 is misaligned with the inclined surface of the second inclined block 44, the first inclined block 42 and the second inclined block 44 will be clamped and connected under the action of the third elastic piece 43, at this time, the first shell 2 and the second shell 3 are clamped on the infusion tube 1, when it is needed to open them, only need to press the pressing block 41, make the pressing block 41 drive the first inclined block 42 to extrude the third elastic piece 43, make the first inclined block 42 misalign with the second inclined block 44, so that the fixing of the first shell 2 and the second shell 3 can be released. After the first shell 2 and the second shell 3 are clamped on the infusion tube 1, a thin rope can be used, one end of the thin rope is tied to the rope ring 16, and the other end of the thin rope is tied to a hook for hanging an infusion bottle, so that the first shell 2 and the second shell 3 can be prevented from sliding on the infusion tube 1.

[0073] After the installation and fixing of the above device are completed, the functional modules of the device can be started to work, first, in the infusion preparation stage, the drug liquid parameter acquisition module is started first, the specific type of the drug to be infused is automatically read by scanning the electronic tag on the outer wall of the drug infusion bottle, such as boron-loaded preparation with different concentration ratios and drug liquid viscosity parameters, the process can directly verify whether the drug liquid information recorded by the electronic tag is consistent with the actual drug to be infused, so as to avoid the deviation of subsequent flow rate calculation caused by confusion of drug types or misreading of viscosity parameters; at the same time, the pipeline parameter acquisition module operates synchronously, the staff can obtain the physical parameters of the infusion tube 1 in two ways, one is to directly read the pipeline length and inner diameter data marked on the product specification of the infusion tube 1, the other is to scan the identification printed or pasted on the outer wall of the infusion tube 1, such as two-dimensional code and bar code containing pipeline parameters, and the module automatically analyzes and extracts the pipeline length and inner diameter information to clearly determine the physical characteristics of the infusion tube 1, which is convenient for subsequent calculation of infusion resistance.

[0074] When entering the infusion implementation phase, the physiological parameter acquisition module and the flow rate data acquisition module continue to work in parallel, wherein the physiological parameter acquisition module acquires the heart rate data of the patient in real time by means of the electrocardiograph through linkage with the external medical device, acquires the body temperature of the patient through a special temperature measuring device such as a body surface temperature sensor or an infrared thermometer, and monitors the central venous pressure of the patient in real time with the help of the pressure sensor in communication with the end of the infusion tube 1. When each physiological parameter is acquired, the module will synchronously record the specific acquisition time, so as to ensure that the physiological parameters and the time nodes are accurately corresponding, and facilitate subsequent analysis of the influence of the change of the physiological state with time on the infusion. The flow rate data acquisition module will start the flow rate sensor 17 to continuously detect the real-time flow rate of the boron drug in the infusion tube 1 according to the preset time interval of the device, and automatically record the corresponding flow rate value each time the detection is performed. With the advancement of the infusion process, these flow rate values arranged in time sequence will form an initial flow rate data sequence, which fully reflects the flow rate change in the initial stage of infusion.

[0075] Finally, the data preprocessing module integrates and optimizes all the data output by the above four modules. First, the module collects all the liquid parameters such as drug type and viscosity, pipeline parameters such as pipe length and inner diameter, physiological parameters such as heart rate, body temperature, central venous pressure and corresponding acquisition time, and initial flow rate data sequence to form an original data set. Then, the module removes noise signals in the original data by using a preset filtering algorithm such as sliding average filtering and Kalman filtering. For example, the instantaneous fluctuations in the flow rate data caused by slight shaking of the sensor and the slight deviations in the physiological parameters caused by signal interference of the equipment can be smoothed by filtering algorithm. Next, the module automatically identifies and eliminates abnormal data that are out of the normal range of each type of data, such as sudden rise and fall of flow rate caused by sensor failure and abnormal peak value of central venous pressure caused by temporary operation interference. After filtering and denoising and removing abnormal values, the data preprocessing module finally outputs an effective data set with complete structure and accurate data, which will be directly transmitted to the influence factor calculation module.

[0076] In some embodiments of the present application, the influence factor calculation module further comprises:

[0077] a physiological preparation module for calling preset normal reference values of physiological indicators, normal fluctuation ranges and weight factors corresponding to central venous pressure, heart rate and body temperature;

[0078] a physiological factor calculation module for comparing the preprocessed physiological parameters output by the data preprocessing module with the preset normal reference values respectively, calculating the deviation degree of each indicator in combination with the normal fluctuation range, and obtaining the physiological state influence factor by weighted summation according to the weight factors;

[0079] The resistance preparation module is configured to call preset central venous pressure maximum safety value, resistance influence weight, and call preprocessed liquid viscosity output by the data preprocessing module and the length and inner diameter of the infusion tube 1.

[0080] The resistance factor calculation module is configured to calculate a physical resistance basic value based on the liquid viscosity, the tube length and the inner diameter, combine the proportional relationship between the current central venous pressure and the maximum safety value, superimpose the resistance influence weight, and obtain the infusion resistance influence factor.

[0081] In the embodiment, the physiological preparation module calls three types of key parameters from the preset database of the device. The first type is the physiological index normal reference value, including the central venous pressure normal reference value, the heart rate normal reference value and the body temperature normal reference value corresponding to different groups such as adults and children. These reference values are set based on clinical diagnosis and treatment guidelines and large sample patient data. The second type is the physiological index normal fluctuation range, which is the reasonable fluctuation interval of each index based on the normal reference value, and is used to define the reasonable boundary of parameter deviation. The third type is the weight factor corresponding to each physiological index, such as the central venous pressure weight factor 0.4, the heart rate 0.3 and the body temperature 0.3. The weight distribution is determined according to the influence degree of each index on the infusion safety. For example, the central venous pressure directly reflects the venous load, and has a more significant influence on the infusion resistance and flow rate, so the weight is higher. These called parameters are transmitted to the physiological factor calculation module in real time.

[0082] The physiological factor calculation module calculates the physiological state influence factor based on the logic of deviation degree quantification and weighted summation. In the first step, the module first receives the preprocessed physiological parameters output by the data preprocessing module, that is, the real-time central venous pressure , the real-time heart rate , and the real-time body temperature , which have excluded abnormal values, and compares them with the corresponding normal reference values provided by the physiological preparation module, that is, the central venous pressure normal reference value , the heart rate normal reference value , and the body temperature normal reference value . In the second step, the normal fluctuation range of each index is combined with the normal fluctuation range provided by the physiological preparation module, that is, the central venous pressure normal fluctuation range , the heart rate normal fluctuation range , and the body temperature normal fluctuation range , to calculate the standardized deviation degree of each physiological index. The deviation degree needs to eliminate the unit difference of different indexes, so the actual value minus the reference value / half width of the fluctuation range formula is used for quantification, that is:

[0083] The central venous pressure deviation degree is ;

[0084] The heart rate deviation degree is ;

[0085] Body temperature deviation degree: ;

[0086] Wherein the normal fluctuation range is the difference between the upper limit value minus the lower limit value, which represents the maximum allowable deviation of the index from the reference value to the reasonable boundary; the deviation degree can be standardized to a value in the interval [-1, 1] by dividing the difference between the actual value and the reference value by the half-width, and the difference is positive, indicating higher than the reference value, and negative, indicating lower than the reference value, and the greater the absolute value, the more significant the deviation, facilitating cross-index comparison.

[0087] Thirdly, the physiological factor calculation module multiplies the standardized deviation degree of each index with the corresponding weight factor provided by the physiological preparation module, and the weight factor is the central venous pressure weight , heart rate weight , and body temperature weight , and the product is summed up to finally obtain the physiological state influence factor , the formula is: ;

[0088] Wherein the deviation degree of each index reflects its single influence degree on infusion, the weight factor reflects the influence priority of different indexes, and the weighted sum can integrate the multi-dimensional physiological index deviation into a single comprehensive influence factor, facilitating the subsequent unified calibration of the target flow rate; in the formula, the physiological state influence factor has no unit, and the numerical range is: to , a positive value indicates that the physiological state is higher than the normal level, and the flow rate may need to be reduced to ensure safety, and a negative value is the opposite, wherein , to ensure that the influence factor range is controllable.

[0089] Subsequently, the resistance-related modules work together, on the one hand, two types of parameters are called from the device preset database, one is the maximum safe value of central venous pressure , such as the maximum safe value of central venous pressure of adult 15cmH2O, which is set based on the clinical standard of avoiding venous overload, and the other is the resistance influence weight k, such as 0.8, which is determined based on the laws of fluid mechanics and clinical infusion experience, reflecting the influence strength of the resistance factor on the flow rate; on the other hand, the module calls the integrated preprocessed parameters from the data preprocessing module, including the drug liquid viscosity η, which is obtained by the drug liquid parameter acquisition module and verified by preprocessing, the length of the infusion tube 1 L, which is obtained by the pipeline parameter acquisition module, and the inner diameter of the infusion tube 1 r, which is obtained by the pipeline parameter acquisition module, which together constitute the input of the infusion resistance calculation and are directly transmitted to the resistance factor calculation module.

[0090] The resistance factor calculation module calculates the infusion resistance influence factor based on the logic integration of physical resistance and additional influence: first, the module calculates the physical resistance base value of the infusion pipe 1 and the drug solution itself according to the Poiseuille law in fluid mechanics, which is applicable to the calculation of the fluid resistance of a circular pipe under laminar flow conditions. The drug infusion of boron is mostly low-flow laminar flow. The Poiseuille law original formula is:

[0091] where Q is the flow rate, and the fluid resistance is defined as the ratio of the pressure difference to the flow rate, i.e. Therefore, the physical resistance base value formula can be obtained by modifying the Poiseuille law:

[0092] The physical resistance is determined by the viscosity of the drug solution, the length of the pipe, and the inner diameter of the pipe. The higher the viscosity, the greater the resistance. The longer the pipe, the greater the resistance. The thinner the inner diameter of the pipe, the greater the resistance. The Poiseuille law has quantified the mathematical relationship between these three factors and resistance. The resistance base value related only to the characteristics of the pipe and the drug solution can be directly obtained by modifying the pressure difference / flow rate. In the formula, is the physical resistance base value, i.e., the ratio of the pressure loss caused by resistance to the flow rate, is the pre-processed drug solution viscosity, L is the pre-processed infusion pipe 1 length, r is the pre-processed infusion pipe 1 inner diameter, and π is the circular constant, taking 3.1416.

[0093] Second, the module calculates the central venous pressure additional influence coefficient, i.e., the ratio of the current central venous pressure to the maximum safe value This coefficient reflects the additional influence of intravenous pressure on infusion resistance. The closer the central venous pressure to the maximum safe value, the greater the reverse pressure in the vein, and the higher the infusion resistance, which needs to be balanced by adjusting the flow rate.

[0094] Third, the module multiplies the physical resistance base value , the central venous pressure ratio , and the resistance influence weight k provided by the resistance preparation module to obtain the infusion resistance influence factor The formula is:

[0095] Where the physical resistance base value is the inherent resistance, and the central venous pressure ratio is the dynamic additional resistance coefficient. Multiplying the two can obtain the comprehensive actual resistance. Multiplying the resistance influence weight k can convert the resistance value into an influence factor that is calibrated and adapted to the target flow rate, avoiding excessive regulation range caused by excessive resistance absolute value. In the formula, is the infusion resistance influence factor. The larger the value, the higher the infusion resistance, and the electromagnetic iron 6 current needs to be appropriately increased to enhance the extrusion force to offset the resistance to the flow rate, ​​For the pre-processed real-time central venous pressure, the calculation time needs to be combined with Unit uniform, The preset maximum safe value of central venous pressure, k is the preset resistance influence weight, no unit, the value range is 0-1, used to adjust the influence degree of resistance on flow rate.

[0096] The physiological factor calculation module and the resistance factor calculation module convert the multi-dimensional parameters into quantifiable comprehensive influence factors through the standardization formula. The final output of physiology and resistance will be directly transmitted to the target flow rate determination module, which becomes the core basis for determining the final target flow rate combined with the basic infusion speed, and guarantees the accuracy and safety of boron drug infusion.

[0097] In some embodiments of the present application, the target flow rate determination module further comprises:

[0098] The flow rate preparation module is used to divide the pre-processed flow rate data output by the data preprocessing module into equal interval monitoring time points according to the preset monitoring period, and extract the flow rate value to form a complete flow rate data sequence;

[0099] The flow rate determination module is used to analyze the fluctuation of the flow rate data sequence, compare the preset stability determination standard, and determine whether the flow rate is stable;

[0100] The basic flow rate calculation module is used to call the preset boron drug basic infusion speed, combine the physiological state influence factor and the infusion resistance influence factor, and preliminarily calculate the basic target flow rate;

[0101] The abnormal flow rate processing module, if the flow rate determination module determines that the flow rate is unstable and is a non-continuous anomaly, eliminates the abnormal flow rate value and regenerates the effective flow rate data sequence;

[0102] The target flow rate calibration module, based on the effective flow rate data sequence of the abnormal flow rate processing module, combines the influence factors in the physiological factor calculation module and the resistance factor calculation module and the preset basic infusion speed, calibrates and determines the final target infusion flow rate.

[0103] In this embodiment, the first step is the basic data processing work of the flow rate preparation module. This module transforms the preprocessed flow rate data output by the data preprocessing module into structured analysis samples. The module first calls the device's preset monitoring time period parameters. This time period is typically set according to the clinical requirements of boron-loaded drug infusion, such as a single monitoring period of 5 minutes or 10 minutes, ensuring sufficient coverage of flow rate fluctuation cycles. Then, according to preset equal interval time points, such as every 10 seconds or 20 seconds, the interval length needs to balance data density and computational efficiency, avoiding data redundancy due to too short intervals and missed fluctuations due to too long intervals. The flow rate values ​​at the corresponding time points are extracted from the preprocessed flow rate data. For example, if the preset monitoring time period is 5 minutes with 10-second intervals, a total of 30 flow rate values ​​are extracted. These flow rate values ​​are arranged in chronological order to form a complete flow rate data sequence, denoted as . , where n is the number of time points. This sequence not only preserves the temporal correlation of flow velocities, but also provides a standardized dataset for subsequent stability analysis, with its output pointing simultaneously to both the flow velocity determination module and the target flow velocity calibration module.

[0104] Next is the stability analysis of the flow rate determination module. After receiving the complete flow rate data sequence output by the flow rate preparation module, the module needs to determine whether the current infusion flow rate is stable by quantifying the degree of fluctuation and comparing it with the judgment criteria.

[0105] The first step is for the module to calculate the statistical indicators of the sequence, starting with the average value of the sequence. This reflects the average flow velocity level within that period. Then, the relative deviation rate between the flow velocity value at each time point and the average value is calculated using the following formula: ;

[0106] The relative deviation rate eliminates the influence of the absolute value of the flow velocity. For example, the absolute deviation thresholds for high and low flow velocities differ, making the relative deviation more consistent in its judgment. The fluctuation level is converted into a percentage by dividing the absolute deviation by the average value and multiplying by 100%, facilitating comparison with preset standards. In the formula... The relative deviation rate of the flow velocity at the i-th time point is neither positive nor negative, and only reflects the fluctuation range. The flow velocity value at the i-th time point; This is the average value of the complete flow rate data sequence.

[0107] The second step involves the module invoking the device's preset stability criteria. These criteria include two indicators: first, the maximum permissible relative deviation rate, such as ±5%, set according to the requirements for precise boron-loaded drug infusion; exceeding this rate is considered excessive fluctuation; second, the percentage of consecutive stable times, such as ≥90%, meaning the proportion of time points in the sequence with deviation rates within the permissible range must reach this threshold. The module then processes all... Compare the number of time points m that meet the requirements with the maximum permissible relative deviation rate;

[0108] and calculate the proportion ; if the proportion is greater than or equal to the continuous stable time proportion, and there is no deviation rate exceeding the allowed range at three or more consecutive time points, it is determined that the flow rate is stable; if the proportion does not meet the standard, or there is a continuous abnormal time point, further determine the type of abnormality, if the abnormal time points are scattered, such as interval is greater than or equal to 2 normal time points, and the proportion of the number of abnormal values is less than or equal to 5%, it is determined to be a non-continuous abnormality, which is caused by temporary signal interference, slight shaking of infusion tube 1 and other accidental factors; if the abnormal time points are continuous or the proportion is too high, it is determined to be a continuous abnormality, which needs to trigger the device alarm to check the sensor failure or pipe blockage and other problems. The determination result will directly determine the subsequent process, if the flow rate is stable, it will enter the target flow rate calibration link, if it is a non-continuous abnormality, it will start the abnormal flow rate processing module, and if it is a continuous abnormality, it will terminate the current flow rate determination and alarm.

[0109] Then is the preliminary calculation of the theoretical value of the basic flow rate calculation module, which is combined with the preset basic infusion speed and the influence factor calculated in the previous stage to obtain the preliminary basic target flow rate, providing a theoretical benchmark for subsequent calibration. The module first calls the basic infusion speed of boron drug from the device preset database , which is the standard flow rate without considering individual physiological differences and infusion resistance, according to the drug concentration, patient weight, and treatment plan setting, such as adult conventional basic speed of 2 mL / h, and children adjusted by weight. Then, the module calls the physiological state influence factor physiological and the infusion resistance influence factor resistance output by the influence factor calculation module, and calls the preset influence factor adjustment coefficient, a is the physiological factor adjustment coefficient, b is the resistance factor adjustment coefficient, such as a = -0.1, b = 0.05, the coefficient value is determined based on clinical infusion test data to ensure that the adjustment range is within a safe range, and finally the basic target flow rate is preliminarily calculated through the weighted adjustment formula , the formula is: ;

[0110] , the basic infusion speed is the benchmark value, the physiological factor reflects the patient's state requirement for flow rate, such as is positive, indicating that the patient's physiological indicators are higher than the normal reference value, and the speed needs to be appropriately reduced, so a is negative; is negative, the speed needs to be increased, the resistance factor reflects the weakening of the infusion resistance to the flow rate, is greater, the resistance is stronger, and the speed needs to be appropriately increased to offset the resistance effect, so b is positive; through the form of 1+ adjustment term, the influence factor is converted to percentage adjustment of the basic speed, avoiding sudden changes in flow rate caused by excessive adjustment range. In the formula, is the preliminary calculated basic target flow rate, The preset boron drug infusion rate is The physiological state impact factor has no unit and a value range of -1-1; a is the preset physiological factor adjustment coefficient, which has no unit and is -0.1 here, representing that the flow rate is adjusted by ±10% for each change of 1 in physiology; The infusion resistance impact factor has a positive value; b is the preset resistance factor adjustment coefficient, which is 0.05 here, representing that the flow rate is adjusted by +5% for each increase of 1 Pa·s / m³ in resistance.

[0111] If the flow rate determination module determines that it is a non-continuous abnormality, the abnormal flow rate processing module is started for data correction. The module first needs to determine the basis for determining the non-continuous abnormality. The abnormal flow rate value is usually greatly deviated from the overall trend of the sequence, such as suddenly rising to twice the basic flow rate or suddenly dropping to close to 0, and the abnormal time point is isolated, such as only one time point is abnormal, and the front and back are normal flow rates. The module will further verify the abnormal value using the 3σ principle. First, calculate the standard deviation of the complete flow rate data sequence:

[0112] If a flow rate value satisfies or , it is confirmed as a statistical abnormal value. This principle is based on the normal distribution characteristics. 99.73% of normal data will fall within the range, and exceeding it is considered abnormal. Subsequently, the module eliminates all confirmed abnormal flow rate values, rearranges the remaining normal flow rate values in the original time order, and generates an effective flow rate data sequence, denoted as , where m is the number of normal time points. If the sequence length m after removing the abnormal values is still ≥ the preset minimum effective length, such as 80% of the original length, it is ensured that the data quantity is sufficient to support subsequent calibration, and the effective sequence is transmitted to the target flow rate calibration module. If m is lower than the minimum effective length, it is determined that the data quantity is insufficient, and the flow rate preparation module needs to be restarted to collect data.

[0113] Finally, the target flow rate calibration module performs precise setting work. The module needs to combine the theoretically calculated basic target flow rate with the actual monitored effective flow rate sequence to achieve precise calibration of the target flow rate through weighted fusion, avoiding the deviation caused by single reliance on theory or actual data. The module first receives two types of data, one is the output by the basic flow rate calculation module, and the other is the complete flow rate data sequence V output by the flow rate preparation module or the effective flow rate data sequence output by the abnormal flow rate processing module when there is a non-continuous abnormality. Then, the module calculates the actual average flow rate of the effective sequence. If it is a complete sequence, then , and if it is an effective sequence, then ​And call the preset weight coefficient c, 0 < c < 1, such as c = 0.4, the value is set according to the reliability of theory and practice, the theoretical value is based on the physiological and resistance parameters of the patient, the reliability is higher, so the weight is slightly lower; The actual value reflects the real-time infusion state, and the reliability is also important, so the weight is moderate, and finally the final target infusion flow rate is calculated by the weighted average formula , the formula is: ;

[0114] t The advantages of actual monitoring value and theoretical calculation value can be balanced by weighted average, and the actual average flow rate reflects the real state of the current infusion, avoiding occasional factors ignored by theoretical calculation, such as flow rate deviation caused by slight deformation of the pipeline; The basic target flow rate ensures that the flow rate meets the physiological needs of the patient and the characteristics of the drug, avoiding calibration deviation caused by temporary interference of the actual value; The influence of the final result is realized by the weight c and 1-c, realizing the accurate calibration of theoretical guidance and actual correction. The formula is the final target infusion flow rate, which is directly used as the regulation benchmark of the dynamic flow rate regulation module; is the actual average flow rate of the effective flow rate data sequence; c is the preset actual flow rate weight coefficient, which has no unit, and is 0.4 here, representing that the contribution of the actual average flow rate to the final target is 40%; is the basic target flow rate calculated initially; 1-c is the theoretical flow rate weight coefficient, which has no unit, and is 0.6 here, representing that the contribution of the theoretical calculation value is 60%.

[0115] After calibration, the target flow rate calibration module transmits to the dynamic flow rate regulation module as the benchmark for subsequent real-time flow rate comparison and current adjustment, and at the same time, the target flow rate is associated with the corresponding patient information and transmitted to the priority cluster generation module to provide data support for infusion end time calculation and priority cluster determination, finally realizing the dual goals of precise control and continuity guarantee of boron drug infusion.

[0116] In some embodiments of the application, the dynamic flow rate regulation module further comprises:

[0117] A real-time flow rate acquisition module is used to start the flow rate sensor 17, collect the current flow rate of the boron drug in the infusion tube 1 at a preset frequency, and record the flow rate value and the collection time;

[0118] A flow rate comparison and analysis module is used to calculate the difference between the current flow rate and the target infusion flow rate, and judge whether the current flow rate is within the allowable deviation range of the target flow rate;

[0119] The flow rate adjusting module sends a current increasing signal to the electromagnet if the current flow rate is lower than the lower deviation limit, to enhance the suction force to make the magnetic block overcome the elastic force of the first elastic member 17 to press the infusion tube 1, to increase the flow rate; and sends a current decreasing signal to the electromagnet if the current flow rate is higher than the upper deviation limit, to weaken the suction force to make the first elastic member 17 rebound to pull back the magnetic block, and the infusion tube 1 resets to reduce the flow rate.

[0120] The flow rate feedback module repeatedly operates the real-time flow rate acquisition module, the flow rate comparison and analysis module and the flow rate adjusting module to feedback the flow rate adjustment result in real time, to fine-tune the current of the electromagnet 5 until the flow rate is stabilized within the allowable deviation.

[0121] In the embodiment, first is the dynamic data acquisition of the real-time flow rate acquisition module, which is the sensing unit of the regulation link and starts immediately after the target flow rate calibration module outputs the final target infusion flow rate . The module first sends a start instruction to the flow rate sensor 17 to trigger the sensor to enter the real-time monitoring state; at the same time, the flow rate acquisition frequency preset by the device is called, which is set based on the response requirement of the boron drug precision infusion, such as 1 time per second. A too high frequency is easy to cause data redundancy, and a too low frequency cannot capture the flow rate fluctuation in time. 1 time per second can balance the response speed and calculation efficiency. In the monitoring process, the flow rate sensor 17 captures the flow state of the liquid in the infusion tube 1 in real time through the preset detection principle, and converts it into the corresponding flow rate value . At the same time, the module synchronously records the acquisition time of each flow rate value to form a data pair corresponding to the real-time flow rate and time. These data pairs are transmitted to the flow rate comparison and analysis module in real time to provide the latest dynamic data support for subsequent difference judgment, and are stored in the local database of the device to facilitate subsequent flow rate fluctuation tracing and abnormal analysis.

[0122] Then is the difference calculation and range judgment of the flow rate comparison and analysis module. After receiving the and transmitted by the real-time flow rate acquisition module, the module first calculates the flow rate difference between them, the formula is: ;

[0123] The direct difference between the current flow rate and the target flow rate can directly reflect the deviation direction and deviation degree of the two, ΔV>0 indicates that the flow rate is too high, and ΔV<0 indicates that the flow rate is too low, which provides a basis for the subsequent adjustment direction. In the formula, ΔV is the difference between the current flow rate and the target flow rate, a positive value represents that the flow rate is too high, and a negative value represents that the flow rate is too low; is the current flow rate collected by the real-time flow rate acquisition module; is the final target infusion flow rate output by the target flow rate calibration module.

[0124] Subsequently, the module needs to judge whether it is within the target flow rate allowable deviation range, which is set based on the accuracy requirements of boron drug infusion, such as ±3%, a large deviation will affect the accurate delivery of drug concentration, and in turn affect the treatment effect, the upper and lower limits need to be calculated by the target flow rate and the allowable deviation rate, the formula is: ; ;

[0125] Using percentage deviation rate instead of absolute deviation value to set the range can adapt to different numerical target flow rates, such as when the target flow rate is 2mL / h, ±3% deviation corresponds to ±0.06mL / h; when the target flow rate is 5mL / h, ±3% deviation corresponds to ±0.15mL / h, avoiding rigid deviation range due to different target flow rates. In the formula is the upper limit of the allowable deviation, the current flow rate needs to be reduced when it is higher than this value; is the lower limit of the allowable deviation, the current flow rate needs to be increased when it is lower than this value, is the preset allowable deviation rate, unitless, such as 0.03, which is 3%, determined by the clinical drug infusion accuracy standard; is the final target infusion flow rate.

[0126] The module compares and , , outputs three kinds of judgment results: if , the flow rate is qualified and no adjustment is needed; if , the flow rate is too low and needs to start the speed-up adjustment; if , the flow rate is too high and needs to start the speed-down adjustment, the judgment result will be transmitted to the flow rate adjustment module in real time, triggering the corresponding mechanical adjustment action.

[0127] Then the electromagnetic and mechanical linkage adjustment of the flow rate adjustment module works, based on the judgment result of the flow rate comparison and analysis module, by controlling the current change of electromagnet 5, linkage magnetic block 6 and first elastic member 7 change the extrusion force of infusion tube 1, and then adjust the flow rate, which is divided into two adjustment scenarios:

[0128] The first scenario is the low flow rate adjustment, when the judgment result is , the module sends a current increase signal to electromagnet 5, the electromagnetic attraction of electromagnet 5 is proportional to the square of the input current, after the current increases, the electromagnetic attraction of electromagnet 5 to magnetic block 6 is enhanced; at this time, magnetic block 6 moves to the direction of infusion tube 1 under the action of electromagnetic attraction, overcoming the elastic force of first elastic member 7, generating greater extrusion force to infusion tube 1; because infusion tube 1 has elasticity, its lumen shape will adaptively change when the extrusion force increases; with the increase of extrusion force, the flow rate of boron drug in infusion tube 1 gradually increases, until approaches .

[0129] The second scenario is flow rate adjustment when the determination result is , the module sends a current reduction signal to the electromagnet 5, and after the current is reduced, the electromagnetic attraction of the electromagnet 5 is weakened; when the electromagnetic attraction is less than the elastic force of the first elastic member 7, the first elastic member 7 rebounds under the action of the elastic restoring force, pulls the magnetic conductive block 6 to move away from the infusion tube 1, and the extrusion force of the magnetic conductive block 6 on the infusion tube 1 is reduced; the infusion tube 1 gradually recovers to the initial lumen shape under the action of its own elasticity, and the flow resistance and flow rate of the liquid in the tube gradually decrease until approaches , the current adjustment signal sent by the module contains a step adjustment amplitude, such as an increase or decrease of 5% of the rated current of the electromagnet each time, instead of a one-time large adjustment, which can avoid the sudden increase and decrease of the extrusion force caused by the sudden change of the current, thereby preventing the flow rate from overshooting, such as the flow rate directly rising from below the lower limit to above the upper limit, and ensuring the stability of the flow rate adjustment.

[0130] Finally, the closed-loop correction and stable maintenance of the flow rate feedback module, through repeated triggering of the operation of the first three modules, a continuous closed-loop regulation is formed to ensure that the flow rate is stable within the allowable deviation. The specific process is that after the flow rate adjustment module completes one current adjustment, the flow rate feedback module immediately sends a secondary acquisition instruction to the real-time flow rate acquisition module to trigger it to collect the current flow rate after adjustment at the original preset frequency ; then the flow rate comparison and analysis module calculates the difference ΔV' of and again, and determines whether is within the range of ; if it is still out of range, the flow rate adjustment module will make a small adjustment according to the new determination result, such as reducing the current adjustment amplitude to 2% of the rated current, to further avoid overshooting; the above acquisition, analysis and adjustment process will be repeated until the collected for three times in a row are within the allowable deviation range, and through three stable determination times, it can be ensured that the flow rate is not accidental, at this time the flow rate feedback module determines that the flow rate is stable, and the closed-loop regulation is suspended, and only the low-frequency monitoring of the real-time flow rate acquisition module is retained, such as adjusting to 1 / 5 seconds, to reduce energy consumption; if the flow rate exceeds the range again in subsequent monitoring, the module will immediately restore the high-frequency closed-loop regulation and restart the acquisition, analysis and adjustment process, to always maintain the continuity and precision of boron drug infusion. Through the close-loop logic, the electronic signal acquisition, data logic analysis and electromagnetic mechanical adjustment are deeply integrated, which not only realizes the real-time response of the flow rate, but also guarantees the precision and stability of the adjustment, finally meeting the precision control requirements of continuous boron drug infusion.

[0131] In some embodiments of the application, the priority cluster generation module further comprises:

[0132] an end time calculation module, based on the target infusion flow rate in the target flow rate calibration module and the remaining boron drug load, calculating the remaining infusion time, and superimposing the current time to obtain the end time of the single patient infusion;

[0133] a time data integration module for collecting the end time results of all boron drug infusion patients, associating the patient identity with the end time, and forming an infusion end time data set;

[0134] a clustering analysis module for dividing the data set in the time data integration module into different infusion end time period clustering clusters according to the end time proximity;

[0135] a priority cluster determination module for sorting the average end time of each clustering cluster, and extracting the clustering cluster at the top of the sorting as the priority processing cluster;

[0136] a continuity guarantee module for priority checking the infusion device state of the priority processing cluster patients, calibrating the flow rate control parameters, and avoiding infusion interruption.

[0137] In this embodiment, first is the single patient end time measurement work of the end time calculation module, which starts after the target flow rate calibration module outputs the final target infusion flow rate The task of this module is to calculate the end time of the single patient infusion. The module needs to obtain two parameters, one is the remaining boron drug load , which is obtained in two ways. If the infusion bottle is equipped with a weighing sensor, the difference between the initial liquid weight and the real-time remaining weight can be converted into the remaining volume by combining the liquid density; if a graduated infusion bottle is used, the image recognition module of the device reads the bottle scale to directly convert the remaining volume, ensuring that it is consistent with the actual remaining liquid amount; the second is the current time , which is provided by the real-time clock module built into the device.

[0138] Based on the above parameters, the module first calculates the remaining infusion time , according to the basic flow relationship of infusion time = liquid volume / infusion flow rate, the remaining time is the ratio of the remaining liquid amount and the target flow rate, the formula is: ;

[0139] After calculating , the module superimposes it with the current time to obtain the end time of the single patient infusion , and the time unit needs to be converted when superimposed, for example =09:30、 =1.5h, that is, 1 hour and 30 minutes, then =09:30+1:30=11:00, finally, the module will corresponding to the patient's identity, output single-patient end time data, transmitted to the time data integration module.

[0140] Then the time data integration module of the multi-patient data summary work, the module as the data hub, responsible for collecting all the patient data using the device for boron drug infusion, module through the device LAN or wireless communication module, such as Wi-Fi, Bluetooth. Real-time receiving each patient corresponding to the patient identity and infusion end time data pair, the module to these data pairs for structured integration, according to the patient identity as the index, for the corresponding value, the infusion end time data set, the data set needs to contain all the complete information of the patient, such as patient A, bed number 301, 11:00; patient B, bed number 302, 11:12; patient C, bed number 303, 10:58……, while automatically eliminating repeated or invalid data, such as not entering the identity data, to ensure the integrity and accuracy of the data set. After integration, the data set will be transmitted to the clustering analysis module.

[0141] Then the end of the period of the clustering analysis module of the grouping work, the module is according to the proximity of the end time to divide the patients in the data set into different clusters, to facilitate the medical staff to process in batches, reduce the risk of infusion interruption. Module first call device preset time proximity threshold , usually set to 15 minutes, the setting is based on clinical practice, medical staff to handle a group of patients to change the liquid, device inspection and other operations need 10-15 minutes, the threshold can ensure that the end time of the patients in the cluster is close, and the medical staff has enough time to process continuously, to avoid interruption; then, the module to all in the data set is sorted in ascending order of time, from early to late, such as 10:58, 11:00, 11:12, 11:15, 11:28……

[0142] The clustering process follows the principle of clustering, from the first , such as 10:58, as the initial cluster core, then in turn to judge the next and the initial cluster core time difference 15 minutes, if the next =11:00, the time difference is 2 minutes 15 minutes, then into the current cluster; if the next =11:12, the time difference between 10:58 is 14 minutes ≤ 15 minutes, still into the current cluster; if the next If the time difference between 11:28 and 10:58 is 30 minutes > 15 minutes, then 11:28 will be used as the new initial cluster core to create a new cluster. This process will continue until all clusters are clustered. All patients are assigned to their corresponding clusters, ultimately forming multiple clusters representing the end of the infusion process. Within each cluster, patients... All are within a 15-minute range, for example, cluster 1, 10:58, 11:00, 11:12; cluster 2, 11:15, 11:28... After clustering is completed, the module transmits the information of each cluster and the patients within the cluster to the priority cluster determination module.

[0143] The next step is the priority ranking task of the priority cluster determination module. This module needs to quantify the time priority of each cluster by the average cluster end time to determine the earliest cluster to be processed. The module first calculates the average end time of each cluster. For all patients within each cluster To perform time conversion, convert HH:MM to minutes, sum the values, divide by the number of patients within the cluster to obtain the average minutes, and then convert back to HH:MM format. The formula is: ;

[0144] patients in cluster The arithmetic mean of the cluster's end time is close, thus avoiding bias towards individual patients. Bias affects cluster priority determination; using minute conversion can eliminate calculation errors caused by time format, ensuring accurate results. In the formula... The average end time for clustering; Let i be the end time of the i-th patient within the cluster; This represents the number of patients within a cluster.

[0145] Calculate the clusters Then, the module presses Sort in ascending order, with earlier times having higher priority. Extract the cluster that ranks first in the sorting as the priority cluster for processing, for example, cluster 1. =11:03, Cluster 2 If the ratio is 11:21, then cluster 1 is the priority cluster for processing. After the priority cluster is determined, the module will assign the identity identifiers of all patients within the cluster... The device number is transmitted to the continuity assurance module, triggering the priority assurance process.

[0146] Finally, the infusion interruption prevention work of the continuity guarantee module is the core of the priority processing cluster, which ensures the uninterrupted infusion of patients in the cluster through state checking and parameter calibration double measures. The first step is the state checking of the infusion device. The module first monitors the state of the key components of the device used by the priority processing cluster patient in real time through the self-checking function of the device, including the signal stability of the flow rate sensor 17, whether there is signal interruption, data drift, the current output stability of the electromagnet 5, whether there is current fluctuation leading to abnormal extrusion force; at the same time, the module sends a priority cluster checking reminder to the medical staff terminal, prompting manual review of whether the infusion tube 1 is bent and whether the drug is about to run out, to ensure that the device hardware is fault-free.

[0147] The second step is the flow rate control parameter calibration. The module compares the target flow rate calibration module output priority processing cluster patient with the current actual set flow rate of the device. If the difference between the two is more than ±1%, according to the preset calibration threshold, the flow rate accuracy is ensured, then the calibration process is automatically started. The current parameters of the electromagnet 5 are fine-tuned through the dynamic flow rate control module. If the actual set flow rate is lower , the current is slightly increased to enhance the extrusion force of the magnetic conductive block 6 to increase the flow rate; if the actual set flow rate is higher , the current is slightly reduced to reduce the extrusion force through the first elastic member 7 to reduce the flow rate, until the difference between the actual set flow rate and is ≤±1%.

[0148] In addition, the module will trigger state checking and parameter calibration again 10 minutes before the priority processing cluster according to the preset warning time, and send an end reminder to the medical staff terminal to prompt the preparation of subsequent processing, to ensure smooth transition of the infusion process before and after without interruption. After all patients in the priority processing cluster complete the infusion, the module automatically acquires the next priority processing cluster, and repeats the above guarantee process to realize the continuity and safety of boron drug infusion for all patients.

[0149] In some embodiments of the present application, a plurality of limiting grooves 8 are formed in the lower end surface of the magnetic conductive block 6, and one of the limiting grooves 8 is provided with a limiting block 15. The lower end of the limiting block 15 is fixedly connected with an extension rod 9, the side wall of the extension rod 9 is sleeved with a second elastic member 12, the side wall of the extension rod 9 is fixedly connected with a limiting plate 10, and the limiting plate 10 is arranged above the second elastic member 12. An active groove 11 for compressing the second elastic member 12 is formed in the second housing 3 at the position of the second elastic member 12. The lower end of the extension rod 9 is fixedly connected with a magnetic conductive disc 13, and the lower side of the magnetic conductive disc 13 is provided with a second electromagnet 14. The second housing 3 is provided with a moving space for the magnetic conductive disc 13 between the magnetic conductive disc 13 and the second electromagnet 14.

[0150] The electromagnetic iron is continuously powered for a long time, which causes the internal temperature of the electromagnetic iron to rise, the resistance to increase, and the flow rate to be inaccurately adjusted. When the first electromagnetic iron 5 is powered, the second electromagnetic iron 14 is also powered at the same time, the second electromagnetic iron 14 magnetically attracts the magnetic guide disc 13, the magnetic guide disc 13 moves downward and drives the telescopic rod 9 to move downward to compress the second elastic member 12 and the limiting plate 10, and the limiting block 15 is separated from the limiting slot 8 at the same time. At this time, the magnetic guide block 6 can move left and right. When the actual flow rate is adjusted to be the same as the preset flow rate, the current in the second electromagnetic iron 14 is cut off first, and when the second electromagnetic iron 14 loses magnetism after being powered off, the second elastic member 12 pushes the limiting plate 10 to move upward, at this time, the telescopic rod 9 moves upward, and the limiting block 15 is clamped into the limiting slot 8, so that the fixing of the magnetic guide block 6 is realized, and the magnetic guide block 6 is prevented from being affected by the first elastic member 7. Then, the current in the first electromagnetic iron 5 is cut off. After each current adjustment is completed, the magnetic guide block 6 is fixed, and then the first electromagnetic iron 5 and the second electromagnetic iron 14 are powered off, so that the problem that the first electromagnetic iron 5 and the second electromagnetic iron 14 are continuously powered, the internal temperature rises, and the flow rate is inaccurately adjusted is avoided.

[0151] In some embodiments of the application, the telescopic rod 9 is made of a non-magnetic material, such as plastic, ceramic material, etc., so as to avoid the magnetic interference between the magnetic guide block 6 and the magnetic guide disc 13 through the telescopic rod 9 when the first electromagnetic iron 5 and the second electromagnetic iron 14 are powered. In addition, the magnetic guide block 6 and the magnetic guide disc 13 are made of iron, cobalt, nickel material or iron, cobalt, nickel mixed with other metals. The first elastic member 7, the second elastic member 12 and the third elastic member 43 of the application are made of springs or elastic rubber and other materials.

[0152] The above merely describes the preferred embodiments of the application; however, the protection scope of the application is not limited to this. Any person skilled in the art can make equivalent replacements or changes to the technical scheme of the application and the improved concept thereof within the technical range disclosed by the application, which should be covered by the protection scope of the application.

Claims

1. A precision control device for boron medicament continuous infusion, comprising a first housing (2) and a second housing (3), characterized in that: The first shell (2) and the second shell (3) are provided with an electromagnetic drive extrusion assembly, the electromagnetic drive extrusion assembly comprises an electromagnet (5), a first elastic member (7) and a magnetic conducting block (6), the extrusion force of the magnetic conducting block (6) on the infusion tube (1) can be changed by adjusting the current of the electromagnet (5); a flow rate sensor (17) is arranged on the first shell (2) or the second shell (3) and is used for detecting the flow rate of the liquid in the infusion tube; It also includes: A data acquisition and processing module is used for acquiring real-time flow rate data of boron drug-carrying liquid parameters, infusion tube pipeline parameters, patient physiological parameters and the flow rate sensor (17), and pre-processing the collected data to eliminate abnormal values and noise; An influence factor calculation module is used for calculating a physiological state influence factor based on the pre-processed patient physiological parameters, in combination with preset normal reference values, fluctuation ranges and weight factors of physiological indexes; and calculating an infusion resistance influence factor based on the pre-processed liquid parameters and pipeline parameters and preset maximum safe values and resistance influence weights of central venous pressure; A target flow rate determination module is used for performing stability analysis on the real-time flow rate data, in combination with the two influence factors and a preset basic infusion speed of boron drug-carrying liquid, to determine a target infusion flow rate; when the flow rate is unstable and is a non-continuous abnormality, the target flow rate is calibrated after eliminating abnormal data; A dynamic flow rate regulation module is used for acquiring a current flow rate in real time through the flow rate sensor (17) and comparing the current flow rate with the target flow rate; if the current flow rate is low, the current of the electromagnet (5) is increased to drive the magnetic conducting block (6) to extrude the infusion tube to increase the flow rate; if the current flow rate is high, the current is reduced, the first elastic member (7) rebounds to pull back the magnetic conducting block (6), the infusion tube is reset to reduce the flow rate, and the flow rate is finely adjusted. A priority cluster generation module is used for calculating the infusion end time of a single patient according to the target infusion flow rate and the remaining amount of boron drug-carrying liquid, integrating all patient end times and clustering, determining a priority processing cluster in time sequence, and guaranteeing continuous infusion.

2. The precision control device for boron drug infusion continuity according to claim 1, characterized in that, The data acquisition and processing module further includes: A liquid parameter acquisition module is used for scanning an electronic tag of a boron drug-carrying infusion bottle, acquiring the type of boron drug-carrying liquid to be infused and the viscosity of the liquid, and ensuring that the liquid parameters are consistent with the actual infusion drug; A pipeline parameter acquisition module is used for acquiring the length and inner diameter of the infusion tube by reading the product specification of the infusion tube or scanning the identification on the outer wall of the infusion tube, and determining the physical characteristics of the pipeline; A physiological parameter acquisition module is used for acquiring heart rate by an electrocardiograph, acquiring body temperature by a temperature measuring device, and acquiring real-time central venous pressure by a pressure sensor in communication with the infusion tube, and synchronously recording the acquisition time of each parameter; A flow rate data acquisition module is used for starting the flow rate sensor (17), detecting the flow rate of boron drug-carrying liquid in the infusion tube in real time, recording the flow rate value at a preset time interval, and forming an initial flow rate data sequence; A data preprocessing module is used for integrating the data output by the liquid parameter acquisition module, the pipeline parameter acquisition module, the physiological parameter acquisition module and the flow rate data acquisition module, removing noise by using a filtering algorithm, eliminating abnormal data beyond the normal range, and outputting an effective data set after preprocessing.

3. The precision control device for boron drug infusion continuity according to claim 2, characterized in that, The influence factor calculation module further includes: A physiological preparation module is used for calling preset normal reference values, normal fluctuation ranges and weight factors corresponding to central venous pressure, heart rate and body temperature of physiological indexes; The physiological factor calculation module compares the preprocessed physiological parameters output by the data preprocessing module with preset normal reference values respectively, calculates the deviation degree of each index according to the normal fluctuation range, performs weighted summation according to a weight factor, and obtains a physiological state influence factor.

4. The precision control device for boron drug infusion continuity according to claim 3, characterized in that, The influence factor calculation module further includes: The resistance preparation module is configured to call a preset maximum safe value of central venous pressure and a resistance influence weight, and to call the preprocessed liquid viscosity and the length and inner diameter of the infusion tube output by the data preprocessing module; The resistance factor calculation module calculates a physical resistance base value based on the liquid viscosity, the tube length and the inner diameter, combines the proportional relationship between the current central venous pressure and the maximum safe value, and superimposes the resistance influence weight to obtain an infusion resistance influence factor.

5. The precision control device for boron drug infusion continuity according to claim 4, characterized in that, The target flow rate determination module further includes: The flow rate preparation module is configured to divide the preprocessed flow rate data output by the data preprocessing module into equal-interval monitoring time points according to a preset monitoring period, and to extract flow rate values to form a complete flow rate data sequence; The flow rate determination module is configured to analyze the fluctuation of the flow rate data sequence, compare the preset stable determination standard, and determine whether the flow rate is stable; The base flow rate calculation module is configured to call a preset base infusion speed of boron drug, combine the physiological state influence factor and the infusion resistance influence factor, and preliminarily calculate a base target flow rate.

6. The precision control device for boron drug infusion continuity according to claim 5, wherein, The target flow rate determination module further includes: The abnormal flow rate processing module is configured to, if the flow rate determination module determines that the flow rate is unstable and is a non-continuous abnormality, eliminate the abnormal flow rate value and regenerate an effective flow rate data sequence; The target flow rate calibration module is configured to, based on the effective flow rate data sequence of the abnormal flow rate processing module, combine the influence factors in the physiological factor calculation module and the resistance factor calculation module and a preset base infusion speed, calibrate and determine a final target infusion flow rate.

7. A precision control device for boron medicament continuity infusion according to claim 6, characterized in that, The dynamic flow rate regulation module further includes: The real-time flow rate acquisition module is configured to start a flow rate sensor (17), collect the current flow rate of the boron drug in the infusion tube at a preset frequency, and record the flow rate value and the collection time; The flow rate comparison and analysis module is configured to calculate the difference between the current flow rate and the target infusion flow rate, and determine whether the current flow rate is within the target flow rate allowable deviation range.

8. The precision control device for boron drug continuous infusion of claim 7, wherein, The dynamic flow rate regulation module further includes: The flow rate adjustment module is configured to, if the current flow rate is lower than the lower limit of the deviation, send a current increase signal to the electromagnet to enhance the suction force to make the magnetic block overcome the elastic force of the first elastic member (17) to extrude the infusion tube and increase the flow rate; if the current flow rate is higher than the upper limit of the deviation, send a current decrease signal to the electromagnet to weaken the suction force to make the first elastic member (17) rebound to pull back the magnetic block, reset the infusion tube and reduce the flow rate; The flow rate feedback module is configured to repeatedly perform the real-time flow rate acquisition module, the flow rate comparison and analysis module and the flow rate adjustment module, to real-time feedback the flow rate adjustment result, to fine-tune the current of the electromagnet (5), and to keep the flow rate stable within the allowable deviation.

9. The precision control device for boron drug continuous infusion of claim 8, wherein, The priority cluster generation module further includes: The end time calculation module is configured to calculate the remaining infusion time length based on the target infusion flow rate in the target flow rate calibration module and the remaining amount of boron drug, and to superimpose the current time to obtain the infusion end time of a single patient; The time data integration module is configured to collect the end time results of all boron drug infusion patients, associate the patient identity with the end time, and form an infusion end time data set; The clustering analysis module is used for dividing the data set in the time data integration module into different infusion end time period clustering clusters according to the end time proximity.

10. The precision control device for boron drug continuous infusion of claim 9, wherein, The priority cluster generation module further comprises: The priority cluster determination module is used for sorting the average end time of each clustering cluster, and extracting the clustering cluster at the top of the sorting as a priority processing cluster; The continuity guarantee module is used for priority checking the infusion device state of the patient in the priority processing cluster, calibrating the flow rate control parameter, and avoiding infusion interruption.

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