Perfusion control device, method, ventricular assist system, storage medium and apparatus for a ventricular assist device

Abstract

The application relates to a perfusion control device, a method, a ventricular assist system, a storage medium and equipment for a ventricular assist device, the perfusion control device comprising: a reference perfusion module for determining a reference perfusion flow of a perfusion pump according to preset device parameters; a parameter acquisition module for acquiring physiological pressure parameters of a user and motor operation parameters of the ventricular assist device in real time, the motor operation parameters at least including a motor-side perfusion cavity pressure; a pressure barrier estimation module for determining an environment pressure outside the motor according to the physiological pressure parameters, and determining a pressure barrier value based on a difference between the motor-side perfusion cavity pressure and the environment pressure outside the motor; and a perfusion adjustment module for adaptively adjusting the reference perfusion flow according to at least one of the physiological pressure parameters, the motor operation parameters and the pressure barrier value, so as to maintain the pressure barrier value in a preset target interval.

Description

Technical Field

[0001] This invention relates to the field of ventricular assist device technology, and in particular to a perfusion control device, method, ventricular assist system, storage medium and device for ventricular assist devices. Background Technology

[0002] An interventional left ventricular assist device (such as an axial flow pump) is an implantable medical device used to assist cardiac function in patients with heart failure. When the device is working, the motor rotor rotates at high speed. To prevent blood from entering the motor and causing hemolysis and thrombosis, while also taking into account bearing lubrication and motor heat dissipation, a perfusion fluid (usually heparinized glucose solution) needs to be continuously injected between the motor rotor and stator to form a positive pressure barrier. The effective maintenance of this pressure barrier requires that the perfusion chamber pressure is always higher than the external blood pressure on the motor side and maintain a safe margin. That is, the difference between the perfusion pressure and the external blood pressure on the motor side is not lower than the safe threshold. This is the key mechanism to ensure the safe operation of the device.

[0003] Existing perfusion systems typically employ constant-rate perfusion or simple step-by-step perfusion strategies, continuously supplying perfusion fluid to the motor at a fixed or preset flow rate. However, under physiological conditions, the aortic pressure and left ventricular pressure in the human body exhibit periodic pulsation changes. In pulsation control mode, the device speed needs to be rapidly adjusted according to the heart's physiological cycle, with a high speed during systole and a low speed during diastole, causing a sharp fluctuation in external blood pressure on the motor side.

[0004] The aforementioned fixed injection strategy has significant limitations under this dynamic operating condition: When systolic blood pressure rises rapidly, the constant perfusion cannot respond to the increase in external pressure in time, causing the pressure barrier to be compressed, which poses a risk of blood backflow into the motor. When diastolic blood pressure drops suddenly, if the perfusion volume remains unchanged, excessive perfusion fluid will enter the bloodstream, increasing the patient's volume overload and the risk of hemolysis.

[0005] Furthermore, existing technologies lack a closed-loop adaptive adjustment mechanism based on real-time physiological parameters and motor operating parameters, making it impossible to quantitatively determine the increase or decrease in perfusion volume according to the real-time status of the pressure barrier, and also failing to provide targeted responses to perfusion strategies under abnormal operating conditions such as suction.

[0006] In summary, existing perfusion systems cannot achieve dynamic and precise maintenance of the pressure barrier under complex physiological conditions, and cannot meet the dual requirements of safety and physiological adaptability, thus posing significant risks in clinical use. Summary of the Invention

[0007] This invention discloses a perfusion control device, method, ventricular assist system, storage medium, and equipment for ventricular assist devices, aiming to solve the technical problems existing in the prior art. The invention adopts the following technical solution: In a first aspect, embodiments of the present invention provide a perfusion control device for a ventricular assist device, comprising: The reference injection module is used to determine the reference injection flow rate of the injection pump based on preset device parameters; The parameter acquisition module is used to acquire the user's physiological pressure parameters and the motor operating parameters of the ventricular assist device in real time. The motor operating parameters include at least the perfusion chamber pressure on the motor side. The pressure barrier estimation module is used to determine the external environmental pressure of the motor based on physiological pressure parameters, and to determine the pressure barrier value based on the difference between the pressure in the perfusion chamber on the motor side and the external environmental pressure of the motor. The perfusion regulation module is used to adaptively adjust the baseline perfusion flow rate based on at least one of physiological pressure parameters, motor operating parameters, and pressure barrier values, so as to maintain the pressure barrier value within a preset target range.

[0008] In a second aspect, embodiments of the present invention provide an infusion control method, which is applied to the infusion control device described in any of the preceding claims, the method comprising: The reference injection flow rate of the injection pump is determined based on the preset device parameters; Real-time acquisition of the user's physiological pressure parameters and the motor operating parameters of the ventricular assist device, including at least the motor-side perfusion chamber pressure; The external environmental pressure of the motor is determined based on physiological pressure parameters, and the pressure barrier value is determined based on the difference between the pressure in the motor-side infusion chamber and the external environmental pressure of the motor. The baseline perfusion flow rate is adaptively adjusted based on at least one of physiological pressure parameters, motor operating parameters, and pressure barrier values ​​to maintain the pressure barrier value within a preset target range.

[0009] Thirdly, embodiments of the present invention provide a ventricular assist system, including the perfusion control device as described in any of the preceding claims.

[0010] Fourthly, embodiments of the present invention provide a computer-readable storage medium storing at least one instruction, which is loaded and executed by a processor to implement the infusion control method described above.

[0011] Fifthly, embodiments of the present invention provide an electronic device, the electronic device including a processor and a memory, the memory storing at least one instruction, the instruction being loaded and executed by the processor to implement the infusion control method as described above.

[0012] One embodiment of the above invention has the following advantages or beneficial effects: This invention provides a perfusion control device that achieves closed-loop adaptive adjustment of the perfusion pump flow rate through the coordinated work of various functional modules. This overcomes the shortcomings of the existing technology, which makes it difficult to quantify the adjustment range of constant-rate perfusion or simple step-type perfusion, and helps to reduce the dual risks of blood backflow and over-perfusion.

[0013] In pulsation control scenarios, this invention identifies the systolic and diastolic phases of the cardiac cycle and drives the perfusion regulation module to perform feedforward enhancement regulation and linear decrement regulation respectively. This achieves active pre-compensation of perfusion flow with the cardiac physiological cycle, rather than passive response. It effectively alleviates the problem that the pressure barrier cannot keep up with blood pressure fluctuations in time in the pulsation mode of existing technologies. While reducing the risk of blood backflow and hemolysis, it avoids excessive perfusion fluid entering the blood and increasing the patient's volume load.

[0014] The present invention can also obtain the judgment result of the ventricular aspiration state and trigger an automatic reduction adjustment and timed recovery mechanism when an abnormality is detected, so as to avoid further damage to the collapsed ventricle by the perfusion fluid and improve the safety of the device under complex physiological conditions.

[0015] Furthermore, the perfusion regulation module's step-size fine-tuning mechanism allows for precise control of the perfusion volume under normal support mode. Moreover, when the pressure barrier value remains at an extremely low level, the perfusion regulation module can increase the perfusion flow rate to a preset maximum safe perfusion flow rate as an emergency acceleration strategy. These mechanisms together form a multi-layered safety protection system, ensuring precise control under normal operating conditions while providing emergency protection under extreme conditions, thus helping to extend the pump's service life and reduce the risk of hemolysis. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings: Figure 1 This is a structural block diagram of an infusion control device disclosed in one embodiment of the present invention; Figure 2 This is a flowchart of an infusion control method disclosed in one embodiment of the present invention. Detailed Implementation

[0017] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0018] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0019] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0020] like Figure 1 To address the problems existing in the prior art, this invention provides a perfusion control device 100 for a ventricular assist device, which includes at least a reference perfusion module 110, a parameter acquisition module 120, a pressure barrier estimation module 130, and a perfusion adjustment module 140.

[0021] Preferably, the reference perfusion module 110 is used to determine the reference perfusion flow rate of the perfusion pump according to preset device parameters; the parameter acquisition module 120 is used to acquire the user's physiological pressure parameters and the motor operating parameters of the ventricular assist device in real time, the motor operating parameters including at least the motor-side perfusion chamber pressure; the pressure barrier estimation module 130 is used to determine the motor external environment pressure according to the physiological pressure parameters, and to determine the pressure barrier value based on the difference between the motor-side perfusion chamber pressure and the motor external environment pressure; the perfusion adjustment module 140 is used to adaptively adjust the reference perfusion flow rate according to at least one of the physiological pressure parameters, motor operating parameters and pressure barrier value, so as to maintain the pressure barrier value within a preset target range.

[0022] In a preferred embodiment, the reference perfusion flow rate determined by the reference perfusion module 110 is related to the motor structure design parameters of the ventricular assist device and the anticoagulant blood risk of the perfusion fluid. Specifically, it can be determined by designing and simulating the motor structure (such as the rotor-stator clearance, bearing fit dimensions, etc.) and combining the experimental verification results of the anticoagulant performance of the perfusion fluid, to calibrate a reference perfusion flow rate range that meets the requirements of perfusion safety and stability. For example, the reference perfusion flow rate range can be set to 2 mL / h to 30 mL / h. After the perfusion control device 100 is started, the reference perfusion module 110 can determine a matching reference perfusion flow rate from the above-calibrated range based on the preset device parameters corresponding to the current ventricular assist device, as the initial reference for subsequent adaptive adjustment.

[0023] In a preferred embodiment, there is a pre-calibrated correspondence between the rotational speed of the injection pump and its corresponding output injection flow rate; that is, the reference injection flow rate is achieved by controlling the rotational speed of the injection pump.

[0024] After determining the reference injection flow rate, the reference injection module 110 can determine the corresponding target speed of the injection pump based on the correspondence, and control the injection pump to operate at the target speed, thereby achieving accurate output of the reference injection flow rate. Correspondingly, the adaptive adjustment of the injection flow rate by the injection adjustment module 140 is also achieved by adjusting the speed of the injection pump. That is, based on the target speed corresponding to the reference injection flow rate, by increasing or decreasing the speed of the injection pump, the actual output flow rate of the injection pump is increased or decreased accordingly, thereby achieving dynamic adjustment of the injection flow rate.

[0025] It should be noted that the perfusion pump and the axial flow pump described in this embodiment are two independent components with different functions in the ventricular assist device, and the two should not be confused.

[0026] The axial flow pump, located inside the patient's body, is the main actuator of the ventricular assist device (VAD). It contains a miniature motor that drives a high-speed impeller to pump blood from the left ventricle into the aorta, providing hemodynamic support for the patient's circulation. In this embodiment, the "motor" refers to this miniature motor inside the axial flow pump. Its real-time speed, motor current, and other operating parameters directly reflect the VAD's support status for the heart and are closely coupled with the patient's physiological pressure parameters such as ventricular pressure and aortic pressure.

[0027] The perfusion pump is located outside the patient's body. Its function is to continuously inject perfusion fluid into the gap between the rotor and stator of the axial flow pump motor through the perfusion tubing. This creates a pressure barrier between the rotor and stator, preventing blood from entering the motor, lubricating the bearings, and carrying away heat. The speed of the perfusion pump is only used to control the perfusion flow rate output to the motor's perfusion chamber. There is a pre-calibrated correspondence between the two. The speed of the perfusion pump itself does not directly participate in the ventricular assist device's assist in the heart's pumping function. It is fundamentally different from the speed, current, and other parameters of the axial flow pump motor in terms of physical meaning and target.

[0028] In a preferred embodiment, the physiological pressure parameters acquired by the parameter acquisition module 120 include aortic pressure. and left ventricular pressure The motor operating parameters collected by the parameter acquisition module 120 include motor current. Real-time rotation speed and the aforementioned motor-side injection chamber pressure .

[0029] In a preferred embodiment, aortic pressure The data is collected in real time by pressure sensors installed in the corresponding blood vessels or ventricular assist devices within the patient's body.

[0030] In a preferred embodiment, left ventricular pressure The pressure can be directly measured by a pressure sensor located at a corresponding position in the left ventricle; or, in embodiments without a left ventricular pressure sensor, the left ventricular pressure... Alternatively, it can be based on the operating parameters of the axial flow pump motor and in conjunction with aortic pressure. The left ventricular pressure is indirectly calculated through a pre-established estimation formula, thereby reducing the number of sensors deployed in the body while achieving indirect monitoring. Specifically, in this embodiment, the aforementioned estimation formula is not specifically limited, and those skilled in the art can choose any of the existing disclosed implementation methods.

[0031] In a preferred embodiment, the pressure in the motor-side injection chamber... The pressure is measured by a pressure sensor installed on the injection pipeline. Specifically, since the injection pipeline is connected to the injection chamber of the axial flow pump motor, the internal pressures of the two can be considered equal. Therefore, the pressure in the injection pipeline measured by the pressure sensor can be equivalently represented as the injection chamber pressure on the motor side. This avoids the structural complexity and reliability risks associated with directly deploying pressure sensors inside the axial flow pump motor filling chamber.

[0032] In a preferred embodiment, the motor current and real-time speed The current can be obtained in real time through the drive controller of the axial flow pump motor, for example, by acquiring the motor current through a current acquisition unit set in the motor drive circuit. The real-time speed of the motor is obtained through the speed feedback unit or position sensor inside the motor drive controller. This enables real-time monitoring of the operating status of the axial flow pump motor.

[0033] In a preferred embodiment, the pressure barrier estimation module 130 is based on aortic pressure. and left ventricular pressure The external environmental pressure of the motor was determined based on the hemodynamic model. Preferably, the hemodynamic model incorporates the external environmental pressure of the motor. Characterized by aortic pressure With left ventricular pressure The weighted combination is determined based on the position of the axial flow pump body of the ventricular assist device within the human body.

[0034] Specifically, the external environmental pressure of the motor The calculation formula is: (1) in, As a weighting coefficient, due to aortic pressure With left ventricular pressure The sum of the two weighting coefficients is always 1, so only one weighting coefficient needs to be defined. Preferably, the weighting coefficient is determined based on the different positions of the pump body within the human body. The value ranges from 0.6 to 0.8, and the specific value needs to be further refined and determined based on the data accumulated from clinical trials.

[0035] Specifically, after an axial flow pump is implanted in the body, its location generally spans the area between the left ventricle and the aorta. The actual blood pressure exerted on the outside of the motor is not simply equivalent to the aortic pressure. or left ventricular pressure It is not a single factor, but rather a combined result of the combined effects of pressure at both locations; therefore, the aortic pressure is used. With left ventricular pressure The weighted combination of these factors to characterize the external environmental pressure of the motor can more accurately reflect the actual mechanical environment in which the motor operates. Furthermore, the aforementioned weighting coefficients... The value range can be understood as follows: when the pump body is implanted closer to the aorta in the human body, the external environmental pressure of the motor is affected by the aortic pressure. The impact is relatively greater at this time. The larger value in the acceptable range; correspondingly, when the pump is implanted closer to the left ventricle, The smaller value in the range of possible values ​​allows the weighted combination result to more closely reflect the actual pressure level at the actual location of the motor.

[0036] Furthermore, the pressure barrier value for: (2) Pressure barrier value This value represents the net margin of the pressure barrier formed by the perfusion fluid between the motor rotor and stator relative to the external environmental pressure. A larger value indicates a stronger pressure barrier and a lower risk of blood backflow into the motor; conversely, a smaller value indicates a risk of the pressure barrier being compressed or even failing. Based on this, a safety threshold can be preset. (e.g., 50 mmHg) serves as an important basis for the subsequent infusion adjustment module 140 to determine whether the reference infusion flow rate needs to be adjusted.

[0037] In a preferred embodiment, the perfusion regulation module 140 is further configured to obtain a judgment result of ventricular aspiration state, the judgment result being determined based on physiological pressure parameters; when aspiration state is determined to occur, the baseline perfusion flow rate is reduced, the reduction adjustment including: reducing the baseline perfusion flow rate by a preset percentage, and restoring it to the flow rate before the reduction after a preset period of time.

[0038] It should be noted that the specific method and logic for determining the ventricular aspiration state are not limited to this embodiment. They can be determined by other functional modules or algorithms in the ventricular assist device based on physiological pressure parameters and output to the perfusion regulation module 140. Those skilled in the art can implement this using any of the embodiments disclosed in the prior art, and this embodiment does not limit it.

[0039] Specifically, aspiration refers to an abnormal physiological phenomenon during ventricular assist device (VAD) support, where the left ventricle is excessively emptied due to factors such as excessively high pump speed or insufficient ventricular volume, preventing it from returning to a normal filling state. During aspiration, the left ventricular pressure drops abnormally, and the collapsed ventricular wall tissue may come into contact with or collide with the axial flow pump inlet, causing damage to the ventricular wall tissue. This can also lead to adverse consequences such as arrhythmias, seriously affecting the patient's clinical safety.

[0040] When the judgment result indicates that an aspiration state has occurred, if the perfusion fluid is continuously injected into the gap between the motor rotor and stator at the original reference perfusion flow rate, it is easy for the perfusion fluid to enter the ventricular region that is already in a collapsed state. Therefore, when the judgment result indicates that an aspiration state has occurred, the reference perfusion flow rate is reduced to reduce the impact of the perfusion fluid on the collapsed ventricle and reduce the risk of tissue damage.

[0041] In a preferred embodiment, the preset reduction ratio can be 20%, that is, the baseline perfusion flow rate is reduced by 20%; the preset time period can be 2s, that is, the flow rate is reduced for 2s after reduction, and then restored to the baseline perfusion flow rate before reduction.

[0042] It should be noted that the specific values ​​of the above-mentioned preset ratio and preset time period are only a preferred embodiment. Those skilled in the art can make adaptive adjustments to the above parameters according to the specific specifications of the ventricular assist device, the actual application scenario, the individual physiological differences of patients, and other actual conditions. This embodiment does not limit this.

[0043] In a preferred embodiment, the perfusion regulation module 140 is also used to identify the start time of systole and the start time of diastole in the cardiac cycle based on the real-time speed change trend and the rate of change of motor current.

[0044] Preferably, the injection adjustment module 140 can detect the motor current. The derivative and target rotational speed The rising edge of the signal identifies the onset of systole in the cardiac cycle. As the heart enters systole, the ventricular assist device's speed command rapidly increases to provide more blood flow support. Consequently, the load on the axial flow pump motor increases with the speed, leading to increased motor current. Rapid changes occur, i.e., motor current. The derivative will show a significant increase. Therefore, the injection regulation module 140 can simultaneously monitor the motor current. Changes in derivative and target rotational speed Whether a rising edge occurs, if both satisfy the preset recognition conditions, the current time is determined to be the start time of the contraction period.

[0045] Preferably, the perfusion regulation module 140 identifies the onset of diastole in the cardiac cycle by determining the target rotational speed of the ventricular assist device after the heart enters diastole. Consequently, the real-time speed of the axial flow pump motor decreases. The corresponding trend is downward. Therefore, the injection adjustment module 140 can detect the real-time speed of the motor. The change from an upward to a downward trend indicates that the current moment is the beginning of the diastolic phase.

[0046] It should be noted that the perfusion control device 100 enters the pulsation mode by informing the perfusion control device 100 that the axial flow pump motor has entered the pulsation gear (i.e., pulsation mode), rather than the perfusion adjustment module 140 determining whether to enter the pulsation mode based on changes in parameters such as motor current and real-time speed. After receiving the pulsation mode information from the ventricular assist device, the perfusion adjustment module 140 monitors the real-time speed of the axial flow pump motor in real time, and continuously detects and identifies the onset of systole and diastole in the cardiac cycle based on the above method. Following the speed change cycle of the axial flow pump motor, it adjusts the speed adjustment cycle of the perfusion pump accordingly.

[0047] In this embodiment, the pulsating mode specifically refers to the periodic adjustment of the ventricular assist device's rotation speed command according to the patient's heart's physiological pulsation cycle. Specifically, a relatively higher rotation speed is used during cardiac systole to provide stronger support for the patient, while a relatively lower rotation speed is used during cardiac diastole. This ensures that the device's support effect matches the patient's own heart's systolic and diastolic rhythm, thus more closely resembling the patient's natural hemodynamic state. Compared to the steady-state support mode with a constant rotation speed, the pulsating mode places higher demands on the perfusion system's ability to dynamically maintain the stability of the pressure barrier.

[0048] In a preferred embodiment, in pulsating mode, the perfusion regulation module 140 is used to perform feedforward enhancement regulation on the baseline perfusion flow rate when the initial moment of systole is detected, so as to increase the perfusion pressure in advance and counteract the blood pressure shock.

[0049] Specifically, since blood pressure usually rises rapidly during cardiac systole, if the perfusion flow rate remains unchanged, the pressure barrier will be compressed, posing a risk of blood backflow into the motor. Therefore, after detecting the onset of systole, the perfusion regulation module 140 does not need to wait for the pressure barrier value to actually decrease before making feedback adjustments. Instead, it proactively increases the perfusion flow rate in advance, so that the perfusion pressure rises synchronously and in a timely manner. This allows sufficient pressure redundancy to be established in advance before blood pressure causes a substantial impact on the pressure barrier, achieving feedforward pre-compensation for blood pressure shocks.

[0050] Preferably, the feedforward enhancement modulation specifically includes: based on aortic pressure rate of change and target rotational speed With real-time speed The difference is used to determine the feedforward compensation flow. And based on feedforward compensation flow Increase the baseline injection flow rate.

[0051] Specifically, feedforward compensation flow The calculation formula is as follows: (3) in, For feedforward gain, This is the integral gain. In equation (3) above, the first term... Characterized based on aortic pressure The feedforward compensation component determined by the rate of change, aortic pressure The faster the rise, the more intense the blood pressure surge, and the greater the required feedforward compensation flow; the latter... Characterized based on target rotational speed With real-time speed The compensation component is determined by the difference between the two values. The larger the difference, the more it indicates that the axial flow pump motor speed has not yet reached the target speed, the ventricular assist device's support strength is still increasing, and the pressure barrier is more likely to be further compressed. Therefore, a corresponding increase in perfusion compensation flow rate is required. The combined effect of these two factors increases the feedforward compensation flow rate. It can comprehensively reflect both the trend of blood pressure change and the trend of motor speed change, thus more comprehensively and accurately predicting the degree of impact faced by the pressure barrier.

[0052] In a preferred embodiment, The value is divided into two levels: if the aortic pressure The fluctuations are significant, with a steep upward slope during systole, indicating that the patient's cardiac function is well preserved. A value between 0.25 and 0.35 is required, necessitating a strong feedforward gain. To respond quickly to drastic changes in blood pressure; conversely, aortic pressure The pulse pressure is flat and the pulse difference is small, indicating poor cardiac function in the patient. The value should be between 0.10 and 0.20. Preferably, the assessment is repeated every 10 cardiac cycles, and the mean aortic pressure within the sliding window is taken. Rate of change, table lookup and update This allows the feedforward enhancement modulation to continuously adapt to the patient's current cardiac function and blood pressure fluctuation characteristics, avoiding poor modulation effects due to the inability of a fixed feedforward gain to adapt to changes in the patient's physiological state.

[0053] In a preferred embodiment, The base value is 0.5, if the current real-time speed... Deviation from target speed More than 20%, The linear increase continues until the condition exceeding 20% ​​is no longer met. Linear regression of 0.5. This is understandable when the real-time rotational speed... With target speed When the degree of deviation increases, the corresponding increase will be made. This allows the feedforward compensation flow to be more sensitive to the speed deviation, accelerating the compensation speed of the injection flow and helping the pressure barrier keep up with the pace of speed changes more quickly; and when the speed deviation falls back to within 20%, The flow rate is gradually linearly regressed to the baseline value of 0.5 to avoid over-adjustment or oscillation of the perfusion flow rate due to a persistently high integral gain.

[0054] It should be noted that the above , The specific value range and evaluation cycle are only one preferred implementation method. Those skilled in the art can make adaptive adjustments to the above parameters according to the actual application scenario of the ventricular assist device, the actual physiological differences of individual patients, etc. This embodiment does not limit this.

[0055] In a preferred embodiment, in pulsating mode, the perfusion regulation module 140 is further configured to determine the pressure barrier value when the initial moment of diastole is detected. Is it greater than the preset safety threshold? and at the pressure barrier value Greater than the preset safety threshold At that time, the baseline injection flow rate is linearly reduced to avoid over-injection.

[0056] Specifically, as the heart enters diastole, blood pressure drops. If perfusion flow remains at the systolic level at this time, it will cause the pressure barrier value to decrease. A relative increase exceeding the reasonable range required to maintain an effective pressure barrier results in excessive perfusion fluid entering the bloodstream, increasing patient volume overload and the risk of hemolysis. Therefore, the perfusion regulation module 140 needs to promptly determine the current pressure barrier value after detecting the onset of diastole. Has the preset safety threshold been exceeded? If the flow rate exceeds the limit, the baseline perfusion rate will be reduced accordingly to ensure that the perfusion rate drops as blood pressure decreases, thus avoiding over-perfusion.

[0057] Preferably, the linear reduction adjustment specifically includes: based on the pressure barrier value Exceeding the preset safety threshold To determine the degree of reduction, the corresponding reduction adjustment coefficient is determined. And based on the reduction adjustment coefficient With pressure barrier value Exceeding the preset safety threshold The difference determines the reduction flow rate. This linearly reduces the baseline infusion flow rate.

[0058] Specifically, reduce flow rate The calculation formula is as follows: (4) From the above equation (4), it can be seen that the pressure barrier value Exceeding the preset safety threshold The larger the difference, the greater the excess of the current perfusion flow relative to the actual demand after the blood pressure drops. In this case, the determined reduction flow rate... The pressure barrier value is also correspondingly larger, thus enabling the reference injection flow rate to be adjusted according to the pressure barrier value. The actual excess should be reduced linearly and quantitatively to avoid under-adjustment or over-adjustment due to a mismatch between the reduction magnitude and the actual excess.

[0059] Preferably, based on the pressure barrier value Exceeding the preset safety threshold To what extent, adjust the reduction adjustment coefficient When the pressure barrier value Exceeding the preset safety threshold When the degree is small, a relatively small reduction adjustment coefficient is used. This allows for a gradual and precise reduction in infusion flow, avoiding excessive adjustment that could cause fluctuations in the pressure barrier; and when the pressure barrier value... Exceeding the preset safety threshold When the degree is large, a relatively large reduction adjustment coefficient is used. This allows the infusion flow rate to decrease more rapidly, thus alleviating the over-infusion condition in a timely manner. In a preferred embodiment, when , The value ranges from 0.02 to 0.12; when , The value ranges from 0.15 to 0.2.

[0060] It should be noted that the above... The specific value range and grading threshold are only one preferred implementation method. Those skilled in the art can make adaptive adjustments to the above parameters according to the actual application scenario of the ventricular assist device, individual physiological differences of patients, etc. This embodiment does not limit this.

[0061] In a preferred embodiment, when the perfusion regulation module 140 does not identify the cardiac cycle, the perfusion control device 100 is in normal support mode. After receiving the normal support mode information from the ventricular assist device, the perfusion regulation module 140 no longer identifies the start time of the systolic and diastolic phases of the cardiac cycle. In this mode, the perfusion regulation module 140 is used to fine-tune the reference perfusion flow rate step by step according to the deviation between the pressure barrier value and the preset target range, so as to maintain the pressure barrier value within the preset target range.

[0062] It should be noted that the perfusion control device 100 is triggered to enter the normal support mode by the ventricular assist device informing the perfusion control device 100 that the axial flow pump motor has switched to the normal support position (i.e., normal support mode), rather than the perfusion adjustment module 140 determining the current mode based on whether the cardiac cycle is detected.

[0063] Specifically, the normal support mode refers to the ventricular assist device operating at a relatively stable speed that does not change rapidly with the cardiac cycle, providing auxiliary support to the patient. Compared to the pulsatile mode, where the speed rapidly switches between systole and diastole, the patient's blood pressure and pressure barrier value are relatively stable in the normal support mode. In a preferred embodiment, when the device is in the normal support mode, the perfusion regulation module 140 continuously monitors the pressure barrier value. The baseline perfusion flow rate is continuously and precisely adjusted based on the monitoring results through methods such as step size fine-tuning to maintain the pressure barrier value within a reasonable preset target range. Preferably, the preset target range can be 50 mmHg to 60 mmHg.

[0064] In a preferred embodiment, the infusion adjustment module 140 is used to finely adjust the reference infusion flow rate downward by a preset minimum adjustment step size when the pressure barrier value is greater than the upper limit of the preset target range and continues to exceed the preset first time period, until the pressure barrier value falls back to the preset target range.

[0065] Preferably, the preset first time period can be 60 seconds, and the preset minimum adjustment step can be 0.5 mL / h, that is, when the pressure barrier value... When the pressure exceeds 60 mmHg and persists for more than 60 seconds, the perfusion adjustment module 140 finely adjusts the baseline perfusion flow rate downward in steps of 0.5 mL / h until the pressure barrier value falls back to the preset target range of 50 mmHg to 60 mmHg, thereby avoiding excessive perfusion fluid entering the blood due to excessive perfusion flow rate.

[0066] In a preferred embodiment, the infusion adjustment module 140 is further configured to, when the pressure barrier value is lower than the lower limit of the preset target range and continues to exceed the preset first time period, finely adjust the reference infusion flow rate upward with a preset minimum adjustment step size until the pressure barrier value rises to the preset target range.

[0067] Preferably, when the pressure barrier value When the pressure remains below 50 mmHg, the perfusion adjustment module 140 finely adjusts the baseline perfusion flow rate upward in increments of 0.5 mL / h until the pressure barrier value rises to the preset target range, thereby replenishing the perfusion flow rate in a timely manner and avoiding the risk of blood backflow due to insufficient pressure barrier strength.

[0068] In a preferred embodiment, the perfusion adjustment module 140 is further configured to increase the baseline perfusion flow rate to a preset maximum safe perfusion flow rate when the pressure barrier value remains below a preset extremely low threshold and reaches a preset second time period.

[0069] Preferably, the preset extremely low threshold can be 20 mmHg, and the preset second time period can be 3 seconds, that is, when the pressure barrier value... If the blood pressure remains below 20 mmHg for 3 seconds, it is determined that the pressure barrier is severely insufficient and there is an emergency risk of blood backflow into the motor. At this time, the perfusion adjustment module 140 no longer uses the conventional step-by-step fine adjustment method for gradual adjustment, but directly increases the reference perfusion flow rate to the preset maximum safe perfusion flow rate to rebuild the pressure barrier as quickly as possible, thereby providing necessary emergency protection for the device in emergency situations.

[0070] In a preferred embodiment, a preset maximum safe perfusion increment is established, meaning that the cumulative increase in the reference perfusion flow rate by the perfusion adjustment module 140 does not exceed a preset percentage of the reference perfusion flow rate. Preferably, the preset percentage can be 80%, for example, when the reference perfusion flow rate is 5 mL / h, the upper limit of the perfusion flow rate after adjustment by the perfusion adjustment module 140 is 9 mL / h. It is understood that by setting a preset maximum safe perfusion increment, a corresponding safety upper limit can be set for the process of the perfusion adjustment module 140 fine-tuning the reference perfusion flow rate upwards. This avoids the continuous accumulation and increase of the perfusion flow rate due to a prolonged period of persistently low pressure barrier values, thereby preventing other potential risks caused by excessive increases in the perfusion flow rate. This ensures both the maintenance effect of the pressure barrier and the overall safety of the perfusion system.

[0071] It should be noted that the specific values ​​of the preset target range, preset minimum adjustment step size, preset first time period, preset extremely low threshold and preset second time period are only one preferred embodiment. Those skilled in the art can make adaptive adjustments to the above parameters according to the actual application scenario of the ventricular assist device, the actual physiological differences of individual patients and other actual situations. This embodiment does not limit this.

[0072] It should also be noted that the acquisition and reduction adjustment of ventricular aspiration status by the perfusion regulation module 140 is independent of the pulsating mode or normal support mode of the ventricular assist device, and there is no sequential triggering relationship. Specifically, both pulsating mode and normal support mode are the operating settings of the axial flow pump, which are selected and switched by the physician according to the patient's clinical condition. When the ventricular assist device detects ventricular aspiration, it can prompt the physician to lower the operating setting of the axial flow pump through alarms or other means, but it does not automatically perform the setting switch on behalf of the physician. The perfusion control device 100 only adjusts the control method of the perfusion regulation module 140 on the perfusion pump speed according to the actual operating setting (i.e., pulsating mode or normal support mode) of the axial flow pump as informed by the ventricular assist device, without participating in or determining the selection and switching process of the axial flow pump's operating setting itself.

[0073] In another embodiment of the present invention, a ventricular assist system is further disclosed, including an axial flow pump, a perfusion pump, and an external control device. The axial flow pump serves as the main in vivo actuator of the ventricular assist system, providing hemodynamic support to the patient. The perfusion pump is located outside the body and is used to continuously inject perfusion fluid between the rotor and stator of the axial flow pump motor to form and maintain a pressure barrier. The external control device is used to monitor and control the operating status of the perfusion pump and the axial flow pump, thereby achieving coordinated operation of the overall function of the ventricular assist system.

[0074] In a preferred embodiment, the execution body of the perfusion control device 100 described in the foregoing embodiments is an external control device. That is, each functional module included in the perfusion control device 100 can realize its respective function through the corresponding software program in the external control device. The external control device collects the operating parameters of the axial flow pump motor and the patient's physiological pressure parameters, runs the corresponding software program to perform the aforementioned pressure barrier estimation and perfusion flow adaptive adjustment processes, and generates corresponding control commands to be sent to the perfusion pump to realize real-time adjustment of the output flow of the perfusion pump.

[0075] like Figure 2 In another embodiment of the present invention, an infusion control method is further disclosed, the method being applied to the infusion control device 100 described in the above embodiment, the method comprising: Step S210: Determine the reference injection flow rate of the injection pump based on the preset device parameters.

[0076] In a preferred embodiment, the reference perfusion flow rate is related to the motor structure design parameters of the ventricular assist device and the anticoagulant blood risk of the perfusion fluid. Specifically, this can be achieved by designing and simulating the motor structure (such as the rotor-stator clearance, bearing fit dimensions, etc.) and combining the experimental verification results of the anticoagulant performance of the perfusion fluid to calibrate a reference perfusion flow rate range that meets the requirements of perfusion safety and stability. For example, the reference perfusion flow rate range can be set to 2 mL / h to 30 mL / h. After the perfusion control device 100 is started, a matching reference perfusion flow rate can be determined from the above-calibrated range based on the preset device parameters corresponding to the current ventricular assist device, serving as the initial reference for subsequent adaptive adjustment.

[0077] Step S220: Real-time acquisition of the user's physiological pressure parameters and the motor operating parameters of the ventricular assist device, including at least the perfusion chamber pressure on the motor side.

[0078] In a preferred embodiment, physiological pressure parameters include aortic pressure. and left ventricular pressure Motor operating parameters include motor current. Real-time rotation speed and the aforementioned motor-side injection chamber pressure .

[0079] Step S230: Determine the external environmental pressure of the motor based on physiological pressure parameters, and determine the pressure barrier value based on the difference between the pressure of the infusion chamber on the motor side and the external environmental pressure of the motor.

[0080] In a preferred embodiment, based on aortic pressure and left ventricular pressure The external environmental pressure of the motor was determined based on the hemodynamic model. Preferably, the hemodynamic model incorporates the external environmental pressure of the motor. Characterized by aortic pressure With left ventricular pressure The weighted combination is determined based on the position of the axial flow pump body of the ventricular assist device within the human body.

[0081] Specifically, the external environmental pressure of the motor The calculation formula is: (1) in, These are the weighting coefficients. The value ranges from 0.6 to 0.8, and the specific value needs to be further refined and determined based on the data accumulated from clinical trials.

[0082] Furthermore, the pressure barrier value for: (2) Step S240: Based on at least one of physiological pressure parameters, motor operating parameters, and pressure barrier value, the baseline perfusion flow rate is adaptively adjusted to maintain the pressure barrier value within a preset target range.

[0083] In a preferred embodiment, it further includes: Step S241: Obtain the judgment result of ventricular aspiration state, the judgment result is determined based on physiological pressure parameters; when aspiration state is determined to occur, the baseline perfusion flow rate is reduced.

[0084] Preferably, the reduction adjustment specifically includes: reducing the baseline perfusion flow rate by a preset percentage, and then restoring it to the pre-reduction flow rate after a preset time period. Optionally, the preset percentage for the reduction adjustment can be 20%, that is, reducing the baseline perfusion flow rate by 20%; the preset time period can be 2 seconds, that is, continuing for 2 seconds after the reduction, and then restoring it to the pre-reduction baseline perfusion flow rate.

[0085] In a preferred embodiment, it further includes: Step S242: Based on the real-time rotational speed trend and the rate of change of motor current, the onset of systole and diastole in the cardiac cycle are identified, and the perfusion control device 100 enters the pulsation mode. In the pulsation mode, when in systole, the baseline perfusion flow rate is enhanced by feedforward adjustment to increase the perfusion pressure in advance and counteract the blood pressure shock; when in diastole, the pressure barrier value is determined. Is it greater than the preset safety threshold? and at the pressure barrier value Greater than the preset safety threshold At that time, the baseline injection flow rate is linearly reduced to avoid over-injection.

[0086] In a preferred embodiment, the motor current can be detected. The derivative and target rotational speed The rising edge of the sensor can be used to identify the onset of systole in the cardiac cycle; the real-time rotational speed of the motor can also be detected. The change from an upward to a downward trend indicates that the current moment is the beginning of the diastolic phase.

[0087] In a preferred embodiment, feedforward enhancement modulation specifically includes: based on aortic pressure rate of change and target rotational speed With real-time speed The difference is used to determine the feedforward compensation flow. And based on feedforward compensation flow Increase the baseline injection flow rate.

[0088] Specifically, feedforward compensation flow The calculation formula is as follows: (3) in, For feedforward gain, This is the integral gain.

[0089] In a preferred embodiment, The value is divided into two levels: if the aortic pressure The fluctuations are significant, with a steep upward slope during systole, indicating that the patient's cardiac function is well preserved. A value between 0.25 and 0.35 is required, necessitating a strong feedforward gain. To respond quickly to drastic changes in blood pressure; conversely, aortic pressure The pulse pressure is flat and the pulse difference is small, indicating poor cardiac function in the patient. The value should be between 0.10 and 0.20. Preferably, the assessment is repeated every 10 cardiac cycles, and the mean aortic pressure within the sliding window is taken. Rate of change, table lookup and update This allows the feedforward enhancement modulation to continuously adapt to the patient's current cardiac function and blood pressure fluctuation characteristics, avoiding poor modulation effects due to the inability of a fixed feedforward gain to adapt to changes in the patient's physiological state.

[0090] In a preferred embodiment, The base value is 0.5, if the current real-time speed... Deviation from target speed More than 20%, The linear increase continues until the condition exceeding 20% ​​is no longer met. Linear regression 0.5.

[0091] In a preferred embodiment, linear deceleration specifically includes: adjusting according to the pressure barrier value. Exceeding the preset safety threshold To determine the degree of reduction, the corresponding reduction adjustment coefficient is determined. And based on the reduction adjustment coefficient With pressure barrier value Exceeding the preset safety threshold The difference determines the reduction flow rate. This linearly reduces the baseline infusion flow rate.

[0092] Specifically, reduce flow rate The calculation formula is as follows: (4) In a preferred embodiment, when , The value ranges from 0.02 to 0.12; when , The value ranges from 0.15 to 0.2.

[0093] In a preferred embodiment, it further includes: In step S243, when cardiac cycle is not identified, the perfusion control device 100 is in normal support mode. In normal support mode, the reference perfusion flow rate is finely adjusted in steps according to the deviation between the pressure barrier value and the preset target range, so as to maintain the pressure barrier value within the preset target range.

[0094] In a preferred embodiment, the preset target range can be 50 mmHg to 60 mmHg.

[0095] In a preferred embodiment, when the pressure barrier value is greater than the upper limit of the preset target range and continues to exceed the preset first time period, the reference perfusion flow rate is finely adjusted downward by a preset minimum adjustment step size until the pressure barrier value falls back to the preset target range.

[0096] Preferably, the preset first time period can be 60s, and the preset minimum adjustment step can be 0.5mL / h.

[0097] In a preferred embodiment, when the pressure barrier value is lower than the lower limit of the preset target range and continues to exceed the preset first time period, the reference perfusion flow rate is finely adjusted upward by a preset minimum adjustment step size until the pressure barrier value rises to the preset target range.

[0098] Preferably, when the pressure barrier value When the pressure remains below 50 mmHg, finely adjust the baseline perfusion flow rate upward in increments of 0.5 mL / h until the pressure barrier value rises to within the preset target range.

[0099] In a preferred embodiment, when the pressure barrier value remains below a preset extremely low threshold and reaches a preset second time period, the baseline perfusion flow rate is increased to a preset maximum safe perfusion flow rate.

[0100] Preferably, the preset minimum threshold can be 20 mmHg, the preset second time period can be 3 seconds, and the preset maximum safe perfusion increment means that the cumulative increase in the baseline perfusion flow rate does not exceed a preset proportion of the baseline perfusion flow rate. Preferably, the aforementioned preset proportion can be 80%, for example, when the baseline perfusion flow rate is 5 mL / h, the upper limit of the adjusted perfusion flow rate is 9 mL / h.

[0101] It should be noted that the infusion control method disclosed in this embodiment and the infusion control device 100 disclosed in the foregoing embodiment originate from the same inventive concept, and the technical problems to be solved and the technical effects that can be achieved are the same. In this embodiment, steps S210 to S240 and their corresponding sub-steps correspond one-to-one with the functions implemented by each coplanar module in the foregoing device embodiment. Their specific implementation methods, preferred parameter values ​​and the technical effects that can be achieved can all be referred to the corresponding descriptions in the foregoing device embodiment, and will not be repeated in this embodiment.

[0102] It should also be noted that the acquisition and reduction adjustment of the ventricular aspiration status judgment result in step S241 are independent of the pulsating mode or normal support mode of the ventricular assist device, and there is no sequential triggering relationship. The pulsating mode and the normal support mode are both the working positions of the axial flow pump, which are selected and switched by the doctor according to the patient's clinical condition. The perfusion control device 100 only adjusts the control mode of the perfusion adjustment module 140 according to the actual working position of the axial flow pump as informed by the ventricular assist device, without participating in or determining the selection and switching process of the working position itself.

[0103] One embodiment of this application further provides a computer-readable storage medium storing at least one instruction, which is loaded and executed by a processor to implement the infusion control method described above.

[0104] One embodiment of this application further provides an electronic device, the electronic device including a processor and a memory, the memory storing at least one instruction, the instruction being loaded and executed by the processor to implement the infusion control method as described above.

[0105] Those skilled in the art will understand that all or part of the steps of the above embodiments can be implemented by hardware or by a program instructing related hardware. The program can be stored in a computer-readable storage medium, such as a read-only memory, a disk, or an optical disk.

[0106] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

Claims

1. A perfusion control device for a ventricular assist device, characterized in that, include: The reference injection module is used to determine the reference injection flow rate of the injection pump based on preset device parameters; The parameter acquisition module is used to acquire the user's physiological pressure parameters and the motor operating parameters of the ventricular assist device in real time. The motor operating parameters include at least the perfusion chamber pressure on the motor side. The pressure barrier estimation module is used to determine the external environmental pressure of the motor based on the physiological pressure parameters, and to determine the pressure barrier value based on the difference between the pressure of the perfusion chamber on the motor side and the external environmental pressure of the motor. The perfusion regulation module is used to adaptively adjust the reference perfusion flow rate according to at least one of the physiological pressure parameters, the motor operating parameters, and the pressure barrier value, so as to maintain the pressure barrier value within a preset target range.

2. The infusion control device according to claim 1, characterized in that, The physiological pressure parameters acquired by the parameter acquisition module include aortic pressure and left ventricular pressure; The pressure barrier estimation module determines the external environmental pressure of the motor based on the aortic pressure and the left ventricular pressure, according to a hemodynamic model.

3. The infusion control device according to claim 2, characterized in that, The hemodynamic model characterizes the external environmental pressure of the motor as a weighted combination of the aortic pressure and the left ventricular pressure, with each weight coefficient determined based on the position of the pump body of the ventricular assist device within the human body.

4. The infusion control device according to any one of claims 1-3, characterized in that, The perfusion regulation module is also used to obtain the judgment result of the ventricular aspiration state, the judgment result being determined based on the physiological pressure parameter; when the judgment result indicates that the aspiration state has occurred, the reference perfusion flow rate is reduced, the reduction regulation including: reducing the reference perfusion flow rate by a preset percentage, and restoring it to the flow rate before the reduction after a preset period of time.

5. The infusion control device according to claim 2, characterized in that, The motor operating parameters collected by the parameter acquisition module also include motor current and real-time speed; The perfusion regulation module is also used to identify the onset of systole and diastole in the cardiac cycle based on the change trend of the real-time rotation speed and the change rate of the motor current.

6. The infusion control device according to claim 5, characterized in that, The perfusion regulation module is also used to perform feedforward enhancement regulation on the baseline perfusion flow rate when the onset of systole is detected, so as to increase the perfusion pressure in advance and counteract the blood pressure shock.

7. The infusion control device according to claim 6, characterized in that, The feedforward enhancement adjustment includes: The feedforward compensation flow rate is determined based on the rate of change of aortic pressure and the difference between the target rotational speed and the real-time rotational speed, and the baseline perfusion flow rate is increased based on the feedforward compensation flow rate.

8. The infusion control device according to claim 5, characterized in that, The perfusion regulation module is also used to determine whether the pressure barrier value is greater than a preset safety threshold when the diastolic initiation time is detected, and to linearly reduce the reference perfusion flow rate when the pressure barrier value is greater than the preset safety threshold in order to avoid over-perfusion.

9. The infusion control device according to claim 8, characterized in that, The linear deceleration adjustment includes: Based on the degree to which the pressure barrier value exceeds the preset safety threshold, a corresponding reduction adjustment coefficient is determined, and the reduction flow rate is determined based on the difference between the reduction adjustment coefficient and the pressure barrier value exceeding the preset safety threshold, so as to linearly reduce the reference perfusion flow rate.

10. The infusion control device according to claim 1, characterized in that, The infusion adjustment module is also used to fine-tune the reference infusion flow rate in steps according to the deviation between the pressure barrier value and the preset target range, so as to maintain the pressure barrier value within the preset target range.

11. The infusion control device according to claim 10, characterized in that, The perfusion adjustment module is further configured to, when the pressure barrier value is greater than the upper limit of the preset target range and continues to exceed the preset first time period, finely adjust the reference perfusion flow rate downward with a preset minimum adjustment step size until the pressure barrier value falls back to the preset target range.

12. The infusion control device according to claim 10, characterized in that, The perfusion adjustment module is further configured to, when the pressure barrier value is lower than the lower limit of the preset target range and continues to exceed the preset first time period, finely adjust the reference perfusion flow rate upward with a preset minimum adjustment step size until the pressure barrier value rises to the preset target range.

13. The infusion control device according to claim 12, characterized in that, The perfusion adjustment module is also used to increase the baseline perfusion flow rate to a preset maximum safe perfusion flow rate when the pressure barrier value is continuously lower than a preset extremely low threshold and reaches a preset second time period.

14. A method for controlling infusion, characterized in that, The method is applied to the infusion control device as described in any one of claims 1-13, the method comprising: The reference injection flow rate of the injection pump is determined based on the preset device parameters; Real-time acquisition of the user's physiological pressure parameters and the motor operating parameters of the ventricular assist device, wherein the motor operating parameters include at least the perfusion chamber pressure on the motor side; The external environmental pressure of the motor is determined based on the physiological pressure parameters, and the pressure barrier value is determined based on the difference between the pressure of the infusion chamber on the motor side and the external environmental pressure of the motor. The baseline perfusion flow rate is adaptively adjusted based on at least one of the physiological pressure parameters, the motor operating parameters, and the pressure barrier value, so as to maintain the pressure barrier value within a preset target range.

15. A ventricular assist system, characterized in that, Includes the infusion control device as described in any one of claims 1-13.

16. A computer-readable storage medium, characterized in that, The storage medium stores at least one instruction, which is loaded and executed by a processor to implement the infusion control method as described in claim 14.

17. An electronic device, characterized in that, The electronic device includes a processor and a memory, the memory storing at least one instruction which is loaded and executed by the processor to implement the infusion control method as described in claim 14.

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