Hemodynamics-based in-aorta balloon counterpulsation system control method

Abstract

The invention provides an in-aorta balloon counterpulsation system control method based on hemodynamics, and relates to the technical field of medical system control. According to the method provided by the invention, hemodynamic monitoring signals of a target user are obtained in real time, wherein the hemodynamic monitoring signals comprise the total heart end diastole volume, the rate of variation per stroke, extravascular lung water and the heart index; the basic counterpulsation blood volume of the target user is determined according to the volume of the full heart diastole; optimizing the basic counterpulsation blood volume according to the variation rate per stroke, the extravascular lung water and the heart index to obtain a target counterpulsation blood volume of the target user; according to the target counterpulsation blood volume of the target user, the balloon inflation volume of the balloon counterpulsation system in the aorta is determined. According to the method, accurate determination of the balloon inflation volume of the balloon counterpulsation system in the aorta can be achieved, the processing efficiency and accuracy are improved, and the use requirements of different users are met.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical system control, and in particular to an aortic balloon pump system control method based on hemodynamics. BACKGROUND

[0002] An intra-aortic balloon pump (IABP) system is a key component used in the intervention treatment of cardiovascular diseases. The IABP system controls the blood flow through the aorta of a user by controlling the inflation and deflation of a balloon, so as to assist the heart by counterpulsation.

[0003] At present, the IABP system assists the heart by electrocardio-triggering, which can be understood as synchronizing the inflation and deflation of the balloon based on the electrical physiological activity of the heart of the user. In each cardiac cycle of the heart, a series of electrocardio signals are generated. The IABP system can accurately identify the systole and diastole stages of the heart by monitoring the electrocardio signals, and accordingly control the inflation and deflation of the balloon of the IABP system. Before the IABP system is used, the balloon inflation amount needs to be set, so that the IABP system adjusts the inflation trigger point and the deflation trigger point according to the balloon inflation amount, so that the balloon is inflated when the aortic valve is closed and is deflated before the aortic valve is opened. However, since the aortic diameters of different users are different, too large balloon inflation amount will cause excessive expansion of the aorta, and too small balloon inflation amount will cause the balloon to be unable to fill, resulting in risks to the user.

[0004] In the related art, the operator often needs to determine the balloon inflation amount according to personal experience, which has the disadvantages of low efficiency and poor accuracy, and cannot meet the use requirements of different users. Therefore, there is an urgent need for an aortic balloon pump system control method based on hemodynamics, which can accurately determine the balloon inflation amount of the aortic balloon pump system, improve the processing efficiency and accuracy, and meet the use requirements of different users. SUMMARY

[0005] The embodiments of the present application provide an aortic balloon pump system control method based on hemodynamics, which can accurately determine the balloon inflation amount of the aortic balloon pump system, improve the processing efficiency and accuracy, and meet the use requirements of different users.

[0006] To achieve the above object, the embodiments of the present application adopt the following technical solutions: In a first aspect, a control method of an intra-aortic balloon pump system based on hemodynamics is provided, which is applied to an intra-aortic balloon pump system, and the intra-aortic balloon pump system comprises a gas cylinder, a gas containing device, a balloon, a hemodynamics monitoring module, a processor, and a motor. The gas cylinder, the gas containing device, and the balloon are connected through a gas path. The processor is electrically connected with the motor and the hemodynamics monitoring module, and the motor is connected with the gas containing device. The method comprises the following steps: the hemodynamics monitoring module acquires a hemodynamics monitoring signal of a target user in real time, and the hemodynamics monitoring signal comprises a global end-diastolic volume, a beat-to-beat variability, extravascular lung water, and a cardiac index; the processor determines a basic counterpulsation blood volume of the target user according to the global end-diastolic volume; the processor optimizes the basic counterpulsation blood volume according to the beat-to-beat variability, the extravascular lung water, and the cardiac index to obtain a target counterpulsation blood volume of the target user; and the processor determines a balloon inflation amount of the intra-aortic balloon pump system according to the target counterpulsation blood volume of the target user.

[0007] The method provided by the application can determine the target counterpulsation blood volume corresponding to different users through coupling calculation of multiple parameters included in the hemodynamics monitoring signal, and then determine the balloon inflation amount of the corresponding intra-aortic balloon pump system through the target counterpulsation blood volume. Compared with the manual determination of the balloon inflation amount, the method provided by the application can accurately determine the balloon inflation amount of the intra-aortic balloon pump system, improve the processing efficiency and accuracy, and meet the use requirements of users in different cardiac function states and vascular conditions.

[0008] In a possible implementation manner of the first aspect, the processor determines the basic counterpulsation blood volume of the target user according to the global end-diastolic volume, which comprises the following steps: the processor determines an average value of the global end-diastolic volume in a historical time period; the processor determines a counterpulsation blood volume corresponding to the average value from a mapping relationship table according to the average value, wherein the mapping relationship table stores multiple values of the global end-diastolic volume and a counterpulsation blood volume corresponding to each value of the global end-diastolic volume; and the processor determines the counterpulsation blood volume corresponding to the average value as the basic counterpulsation blood volume.

[0009] The method provided by the application can quickly and accurately determine the basic counterpulsation blood volume through the average value of the global end-diastolic volume in the historical time period and the mapping relationship table. On the one hand, the average value of the global end-diastolic volume in the historical time period can filter out instantaneous fluctuation interference (such as respiratory influence) and prevent the balloon inflation amount from jumping sharply. On the other hand, the mapping relationship table can effectively reduce the calculation requirement for determining the basic counterpulsation blood volume, and can be flexibly configured in multiple different embedded systems.

[0010] In a possible implementation manner of the first aspect, the processor determines the basic counterpulsation blood volume of the target user according to the global end-diastolic volume, including: the processor determines an average value of the global end-diastolic volume in a historical time period; and the processor determines the basic counterpulsation blood volume according to the average value of the global end-diastolic volume in the historical time period by using a first formula. The first formula is: Q base =k1·GEDV avg +c1; wherein Q base is the basic counterpulsation blood volume, k1 is a slope coefficient, GEDV avg is the average value of the global end-diastolic volume in the historical time period, and c1 is an intercept constant.

[0011] In an example, k1=0.08 mL / (mL / m 2 ), and c1=10 mL.

[0012] The method provided by the application has the advantages of strong quantifiable controllability and good dynamic expandability, and k1 and c1 can be flexibly adjusted according to the actual situation of the target user, thereby meeting the use requirements in different use scenarios.

[0013] In a possible implementation manner of the first aspect, a second formula for determining the target counterpulsation blood volume of the target user is: wherein Q final is the target counterpulsation blood volume of the target user; α, β, and γ are weight coefficients, and β>α>γ; △SVV is a difference value between a current stroke volume variation and an average value of the stroke volume variation in a historical time period; △CI is a difference value between a current cardiac index and an average value of the cardiac index in the historical time period; and △EVLW is a difference value between a current extravascular lung water and an average value of the extravascular lung water in the historical time period; SVV ref is a preset reference value of the stroke volume variation, CI ref is a preset reference value of the cardiac index, and EVLW ref is a preset reference value of the extravascular lung water.

[0014] In an example, α=0.2, β=0.3, and γ=0.1; SVV ref =13%, CI ref =2.5 L / min / m 2 , and EVLW ref =7 mL / kg.

[0015] The method provided by the application can determine the target counterpulsation blood volume corresponding to different users by coupling calculation of multiple parameters included in the hemodynamic monitoring signal, and can strengthen the influence degree of different parameters by weight coefficients alpha, beta and gamma, so as to accurately determine the target counterpulsation blood volume, and further improve the processing efficiency and accuracy.

[0016] In a possible implementation form of the first aspect, the method further includes: generating, by the processor, first alarm information when the stroke volume variation of the target user is greater than 15% and the global end-diastolic volume of the target user is greater than 800 mL / m 2 , the first alarm information being used to prompt that the hemodynamic monitoring signal is logically abnormal. 2 In a possible implementation form of the first aspect, the method further includes: generating, by the processor, the first alarm information when the cardiac index of the target user is less than 1.8 L / min / m 2 and the stroke volume variation of the target user is less than 10%, the first alarm information being used to prompt that the hemodynamic monitoring signal is logically abnormal.

[0017] The method provided by the application can effectively warn when logical abnormalities occur between any two parameters by monitoring multiple parameters, for example, SVV>15% indicates that the target user currently has low volume, and GEDV>800 mL / m 2 indicates that the target user currently has high volume, and at this time, volume logical abnormalities occur.

[0018] In a possible implementation form of the first aspect, the method further includes: generating, by the processor, second alarm information when the change value of the stroke volume variation and / or the global end-diastolic volume within a preset time period is greater than a preset change threshold, the second alarm information being used to prompt that the hemodynamic monitoring signal is abnormal in monitoring accuracy, the preset change threshold of the stroke volume variation being ±5%, and the preset change threshold of the global end-diastolic volume being ±100 mL / m 2 .

[0019] The method provided by the application can improve the safety of the intra-aortic balloon counterpulsation system and avoid unnecessary risks by effectively monitoring the change value of the stroke volume variation and / or the global end-diastolic volume and warning when the change value is greater than the preset change threshold.

[0020] In a possible implementation form of the first aspect, the method further includes: generating, by the processor, third alarm information when the target counterpulsation blood volume of the target user is less than 15 mL or greater than 50 mL, the third alarm information being used to prompt that the target counterpulsation blood volume is abnormal.

[0021] The method provided by the present application can avoid the misadjustment of the intra-aortic balloon counterpulsation system, improve the safety of the intra-aortic balloon counterpulsation system, and avoid unnecessary risks.

[0022] In a possible implementation manner of the first aspect, before the processor determines the balloon inflation amount of the intra-aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user, the method further includes: determining, by the processor, a predicted value of extravascular lung water of the target user in a future time period according to historical data of the extravascular lung water of the target user by using a neural network model; determining, by the processor, an extravascular lung water increasing rate of the target user in the future time period according to the predicted value of the extravascular lung water of the target user in the future time period; and reducing, by the processor, the target counterpulsation blood volume of the target user by 5% when the extravascular lung water increasing rate in the future time period is greater than 1 mL / kg / min.

[0023] The method provided by the present application can accurately predict the extravascular lung water by using a neural network model according to historical data, determine the predicted increasing rate of the extravascular lung water according to the predicted value, reduce the target counterpulsation blood volume of the target user when the increasing rate is greater than a preset value, accurately control the balloon inflation amount, and improve the processing efficiency and accuracy.

[0024] In a possible implementation manner of the first aspect, the method further includes: setting, by the processor, the counterpulsation ratio of the intra-aortic balloon counterpulsation system to 1:1 when at least two of the following signals of the target user are lost: global end-diastolic volume, beat-to-beat variability, extravascular lung water, and cardiac index.

[0025] The method provided by the present application can avoid the error inflation and deflation of the balloon of the intra-aortic balloon counterpulsation system due to the loss of signals, improve the safety of the intra-aortic balloon counterpulsation system, avoid unnecessary risks, and provide sufficient time for technicians to quickly maintain the intra-aortic balloon counterpulsation system and acquire the lost global end-diastolic volume, beat-to-beat variability, extravascular lung water, and cardiac index signals again.

[0026] In a second aspect, an embodiment of the present application provides an intra-aortic balloon counterpulsation system, the intra-aortic balloon counterpulsation system comprising a gas cylinder, a gas containing device, a balloon, a hemodynamic monitoring module, a processor, and a motor; the gas cylinder, the gas containing device, and the balloon are connected through a gas path; the processor is electrically connected with the motor and the hemodynamic monitoring module respectively, and the motor is connected with the gas containing device; the hemodynamic monitoring module is configured to: acquire a hemodynamic monitoring signal of a target user in real time, the hemodynamic monitoring signal comprising a total cardiac end-diastolic volume, a beat-to-beat variability, extravascular lung water, and a cardiac index; the processor is configured to: determine a basic counterpulsation blood volume of the target user according to the total cardiac end-diastolic volume; optimize the basic counterpulsation blood volume according to the beat-to-beat variability, the extravascular lung water, and the cardiac index to obtain a target counterpulsation blood volume of the target user; and determine a balloon inflation amount of the intra-aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user.

[0027] It can be understood that the beneficial effects of the system of the second aspect provided above can refer to the beneficial effects of the first aspect and any possible design thereof, which will not be described here. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 FIG. 1 is a structural schematic diagram of an intra-aortic balloon counterpulsation system according to an embodiment of the present application; Figure 2 FIG. 2 is a flowchart of a control method of the intra-aortic balloon counterpulsation system according to an embodiment of the present application; Figure 3 FIG. 3 is a flowchart of another control method of the intra-aortic balloon counterpulsation system according to an embodiment of the present application; Figure 4 FIG. 4 is a flowchart of still another control method of the intra-aortic balloon counterpulsation system according to an embodiment of the present application. DETAILED DESCRIPTION

[0029] The technical solutions in the embodiments of the present application will be described below with reference to the drawings in the embodiments of the present application. In the description of the present application, unless otherwise specified, “ / ” represents a “or” relationship between the objects before and after the “ / ”, for example, A / B can represent A or B; “or” in the present application is only a description of the relationship between the objects, which means that there can be three relationships, for example, A or B, which means that A exists alone, A and B exist together, and B exists alone, where A and B can be singular or plural. In the description of the present application, unless otherwise specified, “multiple” means two or more than two. “At least one of the following” or the like means any combination of the items, including any combination of single item or multiple items.

[0030] In addition, in order to clearly describe the technical solutions of the embodiments of the present application, in the embodiments of the present application, the terms "first", "second", etc. are used to distinguish the same or similar items with basically the same function and role. Those skilled in the art can understand that the terms "first", "second", etc. do not limit the quantity and execution order, and the terms "first", "second", etc. also do not necessarily mean different.

[0031] Meanwhile, in the embodiments of the present application, the words "exemplary" or "for example" are used to represent as an example, illustration or description. Any embodiment or design scheme described as "exemplary" or "for example" in the embodiments of the present application should not be interpreted as more preferred or more advantageous than other embodiments or design schemes. On the contrary, the words "exemplary" or "for example" are used to present the relevant concept in a specific manner, for the convenience of understanding.

[0032] An intra-aortic balloon pump (IABP) system is a key component used in the intervention treatment of cardiovascular diseases. The IABP system controls the inflation and deflation of the balloon, and then controls the blood flow through the user's aorta, to assist the heart work through counterpulsation.

[0033] At present, the IABP system assists the heart work through electrocardio triggering, which can be understood as synchronizing the inflation and deflation process of the balloon based on the electrical physiological activity of the user's heart. In each cardiac cycle of the heart, a series of electrocardio signals will be generated. The IABP system can accurately identify the systole and diastole stages of the heart by monitoring the electrocardio signals, and control the inflation and deflation of the balloon of the IABP system accordingly. Before the use of the IABP system, the balloon inflation amount needs to be set, so that the IABP system adjusts the inflation trigger point and the deflation trigger point according to the balloon inflation amount, so that the balloon inflates when the aortic valve is closed, and deflates before the aortic valve is opened. However, due to the different diameters of the aortas of different users, excessive inflation of the balloon will cause excessive expansion of the aorta, and insufficient inflation of the balloon will cause the balloon to be unable to fill, resulting in risks to the user.

[0034] In the related art, the operator often needs to judge the balloon inflation amount according to personal experience, which has the disadvantages of low efficiency and poor accuracy, and cannot meet the use requirements of different users. Therefore, there is an urgent need for an intra-aortic balloon pump system control method based on hemodynamics, which can accurately determine the balloon inflation amount of the intra-aortic balloon pump system, improve the processing efficiency and accuracy, and meet the use requirements of different users.

[0035] In view of this, the embodiment of the present application provides an aortic balloon counterpulsation system control method based on hemodynamics, which is applied to an aortic balloon counterpulsation system, and the aortic balloon counterpulsation system comprises a gas cylinder, a gas containing device, a balloon, a hemodynamic monitoring module, a processor and a motor. The gas cylinder, the gas containing device and the balloon are connected through a gas circuit. The processor is electrically connected with the motor and the hemodynamic monitoring module, and the motor is connected with the gas containing device. The method comprises the following steps: the hemodynamic monitoring module acquires a hemodynamic monitoring signal of a target user in real time, the hemodynamic monitoring signal comprises total cardiac end-diastolic volume, beat-to-beat variability, extravascular lung water and cardiac index; the processor determines a basic counterpulsation blood volume of the target user according to the total cardiac end-diastolic volume; the processor optimizes the basic counterpulsation blood volume according to the beat-to-beat variability, the extravascular lung water and the cardiac index to obtain a target counterpulsation blood volume of the target user; and the processor determines a balloon inflation amount of the aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user.

[0036] The method provided by the present application can determine the target counterpulsation blood volume corresponding to different users through coupling calculation of multiple parameters included in the hemodynamic monitoring signal, and then determine the balloon inflation amount of the corresponding aortic balloon counterpulsation system through the target counterpulsation blood volume. Compared with the manual determination of the balloon inflation amount, the method provided by the present application can accurately determine the balloon inflation amount of the aortic balloon counterpulsation system, improve the processing efficiency and accuracy, and meet the use requirements of users with different cardiac function states and vascular conditions.

[0037] In some embodiments, the control method of the aortic balloon counterpulsation system provided by the embodiment of the present application can be executed by the aortic balloon counterpulsation system 100 (hereinafter referred to as counterpulsation system 100). Referring to Figure 1 , Figure 1 A structural schematic diagram of an aortic balloon counterpulsation system is shown for the embodiment of the present application. The counterpulsation system 100 comprises a gas cylinder 110, a gas containing device 120, a balloon 130, a hemodynamic monitoring module 140, a processor 150 and a motor 160. The gas cylinder 110, the gas containing device 120 and the balloon 130 are connected through a gas circuit. The processor 150 is electrically connected with the motor 160 and the hemodynamic monitoring module 140, and the motor 160 is connected with the gas containing device 120. The method comprises the following steps: the hemodynamic monitoring module 140 acquires a hemodynamic monitoring signal of a target user in real time, the hemodynamic monitoring signal comprises total cardiac end-diastolic volume, beat-to-beat variability, extravascular lung water and cardiac index; the processor 150 determines a basic counterpulsation blood volume of the target user according to the total cardiac end-diastolic volume; the processor 150 optimizes the basic counterpulsation blood volume according to the beat-to-beat variability, the extravascular lung water and the cardiac index to obtain a target counterpulsation blood volume of the target user; and the processor 150 determines a balloon inflation amount of the aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user.

[0038] It should be noted that, in combination Figure 1 The counterpulsation system 100 further comprises a pressure stabilizer 170, a solenoid valve 180 and an electrocardiogram monitoring module 190; the pressure stabilizer 170 is arranged between the gas cylinder 110 and the solenoid valve 180, and is configured to control the gas pressure output by the gas cylinder 110 within a preset gas pressure threshold range; the processor 150 and the electrocardiogram monitoring module 190 are electrically connected, and the motor 160 is connected with the gas containing device 120, wherein Figure 1 The dashed line in the figure represents the gas path for conveying gas, and the solid line represents electrical connection.

[0039] In one example, the gas containing device 120 is a gas cylinder.

[0040] The processor 160 is further configured to send the electrocardiogram signal of the target user to the processor 150 according to the electrocardiogram signal of the target user obtained by the electrocardiogram monitoring module 190, and determine a target heart cycle of the target user; the processor 160 is further configured to generate a control instruction according to the target heart cycle of the target user; and control the motor 160 to operate according to the control instruction, so as to adjust the internal pressure of the gas containing device 120 and complete the contraction and expansion operation of the balloon 130; wherein the heart cycle of the target user is a time sequence composed of the time interval between adjacent two heartbeats of the target user.

[0041] Illustratively, the processor 150 can include one or more processing cores. The processor 150 connects various parts in the counterpulsation system 100 through various interfaces and lines, and performs various functions and processes data of the counterpulsation system 100 by running or executing instructions, programs, code sets or instruction sets, and calling data. Alternatively, the processor 150 can be implemented in at least one of the following hardware forms: central processing unit (CPU), graphics processing unit (GPU), digital signal processing (DSP), field programmable gate array (FPGA), programmable logic array (PLA).

[0042] The following describes a counterpulsation system control method based on hemodynamics for an aortic balloon provided by an embodiment of the present application, with reference to the accompanying drawings.

[0043] Figure 2 A flowchart of a counterpulsation system control method based on hemodynamics for an aortic balloon provided by an embodiment of the present application. Optionally, the method can be performed byFigure 1 The counterpulsation system 100 shown is executed. This method may include the following steps: S1, the hemodynamic monitoring module acquires the target user's hemodynamic monitoring signals in real time.

[0044] The hemodynamic monitoring signals include global end-diastolic volume, stroke variability, extravascular lung water, and cardiac index. It should be noted that global end-diastolic volume is the total blood volume in all chambers of the target user's heart (left and right atria + ventricles) at end-diastole, reflecting overall cardiac preload. Stroke variability is the maximum rate of change in arterial pulse pressure during a respiratory cycle, reflecting the heart's sensitivity to preload. Extravascular lung water is the amount of fluid (including interstitium and alveoli) accumulating outside the pulmonary vessels, quantifying the degree of pulmonary edema. The cardiac index is the cardiac output per unit body surface area, characterizing cardiac pumping efficiency.

[0045] Specifically, the hemodynamic monitoring module includes an arterial catheter based on pulse-induced contour cardiac output (PiCCO) technology (hereinafter referred to as PiCCO catheter). The PiCCO catheter is placed inside the target user's artery and can acquire the target user's hemodynamic monitoring signals.

[0046] It should be understood that the above implementation of the hemodynamic monitoring module is only an example. The hemodynamic monitoring module can also use other technologies or devices to acquire hemodynamic monitoring signals. The embodiments of the present invention do not impose any particular restrictions on the specific implementation of the hemodynamic monitoring module to acquire hemodynamic monitoring signals.

[0047] In some embodiments, where the hemodynamic monitoring module and the balloon are positioned in the same artery as the target user, after S1, the method further includes: the processor filtering signals in the hemodynamic monitoring signal with frequencies less than or equal to a preset threshold.

[0048] It should be understood that during the measurement process of the hemodynamic monitoring module, the noise generated by the intra-aortic balloon counterpulsation system can affect the accuracy of the hemodynamic monitoring signal. However, the frequency of the hemodynamic monitoring signal is relatively high, while the frequency of the mechanical noise generated by the intra-aortic balloon counterpulsation system is relatively low. Therefore, filtering out the lower-frequency signals in the hemodynamic monitoring signal through a filter can effectively prevent the mechanical noise generated by the intra-aortic balloon counterpulsation system from interfering with the hemodynamic monitoring signal.

[0049] It should be noted that the preset threshold of the signal frequency can be flexibly set according to the actual working scenario, and the embodiments of the present invention do not impose any special restrictions on this.

[0050] The method provided in this embodiment of the invention, when the hemodynamic monitoring module and the balloon are placed in the same artery of the target user, allows the processor to filter signals with frequencies less than or equal to a preset threshold. This effectively avoids interference from noise generated by mechanical vibration during the operation of the intra-aortic balloon counterpulsation system on the hemodynamic monitoring signal, improves the accuracy of the hemodynamic monitoring signal, and thus enhances the accuracy and safety of the control of the intra-aortic balloon counterpulsation system.

[0051] S2. The processor determines the target user's baseline counterpulsation blood volume based on the total end-diastolic volume.

[0052] In one possible implementation, see Figure 3 The aforementioned S2 specifically includes: S211, The processor determines the average value of the global end-diastolic volume over a historical time period; S212. The processor determines the counterpulsation blood volume corresponding to the average value from the mapping table. The mapping table stores the values ​​of multiple global end-diastolic volumes and the counterpulsation blood volume corresponding to each global end-diastolic volume value. S213, The processor determines the counterpulsation blood volume corresponding to the average value as the base counterpulsation blood volume.

[0053] As described above, the method provided by this invention can quickly and accurately determine the baseline counterpulsation volume by using the average value of the total end-diastolic volume over a historical period and a mapping table. On the one hand, the average value of the total end-diastolic volume over a historical period can filter out transient fluctuations (such as respiratory effects), preventing drastic changes in balloon inflation. On the other hand, the mapping table can effectively reduce the computational power required to determine the baseline counterpulsation volume, allowing for flexible configuration in multiple different embedded systems.

[0054] In another implementation, see Figure 4 The aforementioned S2 specifically includes: S221, The processor determines the average value of the global end-diastolic volume over a historical time period; S222: The processor determines the baseline counterpulsation blood volume based on the average value of the whole heart end-diastolic volume over a historical period using the first formula. The first formula is: Q base =k1·GEDV avg +c1; Among them, Q base Baseline counterpulsation blood volume, k1 is the slope coefficient, GEDV avg c1 is the average value of the end-diastolic volume of the whole heart over a historical period, and c1 is the intercept constant.

[0055] The method provided in this embodiment of the invention determines the basic counterpulsation blood volume through a first formula, which has the advantages of strong quantitative controllability and good dynamic scalability. k1 and c1 can be flexibly adjusted according to the actual situation of the target user to meet the usage needs in different usage scenarios.

[0056] In one possible implementation, the above S2 specifically includes: The processor determines the target user's baseline counterpulsation blood volume based on the total end-diastolic volume at a preset frequency.

[0057] Specifically, the preset frequency is once per minute.

[0058] The method provided in this invention determines the target user's baseline counterpulsation blood volume based on the global end-diastolic volume once per minute, enabling minute-level control of the intra-aortic balloon counterpulsation system. In other words, it can accurately determine the balloon inflation volume of the intra-aortic balloon counterpulsation system at the minute level, improving processing efficiency and accuracy, and meeting the usage needs of users with different cardiac function states and vascular conditions.

[0059] S3. The processor optimizes the baseline counterpulsation blood volume based on stroke variability, extravascular lung water, and cardiac index to obtain the target counterpulsation blood volume for the target user.

[0060] In some embodiments, the second formula for determining the target counterpulsation blood volume of the target user is: Among them, Q final Target counterpulsation blood volume for the target user; α, β, and γ are weighting coefficients, with β > α > γ; △SVV is the difference between the current stroke variability and the average stroke variability over a historical period; △CI is the difference between the current cardiac index and the average cardiac index over a historical period; △EVLW is the difference between the current extravascular lung water and the average extravascular lung water over a historical period; SVV ref CI is the preset reference value for stroke variance. ref EVLW is the preset reference value for the heart index. ref This is a preset reference value for extravascular pulmonary edema.

[0061] S4. The processor determines the balloon inflation volume of the intra-aortic balloon counterpulsation system based on the target counterpulsation blood volume of the target user.

[0062] As can be seen from S1-S4 above, the method provided by the embodiments of the present invention can determine the target counterpulsation blood volume for different users by coupling and calculating multiple parameters included in the hemodynamic monitoring signal. Then, the balloon inflation volume of the corresponding intra-aortic balloon counterpulsation system can be determined by the target counterpulsation blood volume. Compared with the method of manually determining the balloon inflation volume, the method provided by the present invention can accurately determine the balloon inflation volume of the intra-aortic balloon counterpulsation system, improve processing efficiency and accuracy, and meet the usage needs of users with different cardiac function states and vascular conditions.

[0063] In some embodiments, the method further includes: the processor having a stroke variability greater than 15% and the target user's total end-diastolic volume greater than 800 mL / m². 2 In the case of a target user's cardiac index being less than 1.8 L / min / m2 and the target user's stroke variability being less than 10%, the processor generates a first alarm message, which is used to indicate an abnormality in the hemodynamic monitoring signal logic.

[0064] The method provided by this invention can provide effective early warning when logical anomalies occur between any two parameters by monitoring multiple parameters. For example, SVV > 15% indicates that the target user currently has low capacity, and GEDV > 800 mL / m 2 This indicates that the target user is currently experiencing high capacity, resulting in a capacity logic anomaly. Therefore, it can prevent mis-adjustment of the intra-aortic balloon pump (IABP) system, improve the safety of its use, and avoid unnecessary risks.

[0065] In some embodiments, the method further includes: if the processor generates a second alarm message when the change in stroke variability and / or total end-diastolic volume within a preset time period exceeds a preset threshold, the second alarm message is used to indicate abnormal hemodynamic monitoring signal accuracy, the preset threshold for stroke variability is ±5%, and the preset threshold for total end-diastolic volume is ±100 mL / m³. 2 .

[0066] The method provided by this invention can improve the safety of intra-aortic balloon counterpulsation system by effectively monitoring the changes in stroke variability and / or global end-diastolic volume, and by issuing an early warning when the changes exceed a preset threshold, thus avoiding unnecessary risks.

[0067] In some embodiments, the above method further includes: when the target counterpulsation blood volume of the target user is less than 15 mL or greater than 50 mL, the processor generates a third alarm message, which is used to indicate that the target counterpulsation blood volume is abnormal.

[0068] The method provided by this invention provides an early warning when the target counterpulsation blood volume is not within a preset range, thereby avoiding mis-adjustment of the intra-aortic balloon counterpulsation system, improving the safety of the intra-aortic balloon counterpulsation system, and avoiding unnecessary risks.

[0069] In some embodiments, before the processor determines the balloon inflation volume of the intra-aortic balloon counterpulsation system based on the target counterpulsation volume of the target user, the method further includes: the processor determining the predicted value of the target user's extravascular lung water in a future time period using a neural network model based on the target user's historical extravascular lung water data; the processor determining the rate of increase of the target user's extravascular lung water in a future time period based on the predicted value of the target user's extravascular lung water in a future time period; and if the rate of increase of the extravascular lung water in a future time period is greater than 1 mL / kg / min, the processor reduces the target counterpulsation volume of the target user by 5%.

[0070] The method provided by this invention accurately predicts extravascular lung edema using a neural network model based on historical data, and determines the predicted growth rate of extravascular lung edema based on the predicted value. If the growth rate is greater than a preset value, the target counterpulsation blood volume of the target user is reduced, thereby achieving accurate control of the balloon inflation volume and improving processing efficiency and accuracy.

[0071] In some embodiments, the method further includes setting the counterpulsation ratio of the intra-aortic balloon counterpulsation system to 1:1 when at least two of the following signals are lost in the target user: total end-diastolic volume, stroke variability, extravascular lung water, and cardiac index.

[0072] The method provided by this invention sets the counterpulsation ratio to 1:1 in the event of multiple signal loss, which can prevent incorrect inflation and deflation of the balloon in the intra-aortic balloon counterpulsation system due to signal loss, improve the safety of the intra-aortic balloon counterpulsation system, and avoid unnecessary risks. Furthermore, it provides sufficient time for technicians to quickly maintain the intra-aortic balloon counterpulsation system and reacquire lost signals such as global end-diastolic volume, stroke variability, extravascular lung water, and cardiac indexes.

[0073] In one possible implementation, the method provided by the embodiments of the present invention further includes the following steps: If the target user's cardiac index is less than a first threshold, the processor sets the counterpulsation ratio of the intra-aortic balloon counterpulsation system to 1:1 and changes the balloon inflation volume of the intra-aortic balloon counterpulsation system from a first value to a second value.

[0074] The intra-aortic balloon counterpulsation (IACP) system works by inflating the balloon during diastole and deflating it during systole. The counterpulsation ratio is the ratio of the number of balloon inflations / deflations to the user's heart rate, or the ratio of the number of assisted heartbeats by the IACP system to the user's heart rate. A 1:1 counterpulsation ratio means that for every heartbeat of the target user, the IACP system will perform one assisted heartbeat (balloon inflation / deflation).

[0075] Specifically, the ratio of the second value to the first value is the preset inflation volume growth ratio.

[0076] In one example, the preset inflation volume increase ratio is 115%. That is, the ratio of the second value to the first value is 115%. In other words, if the target user's cardiac index is less than the first threshold, the processor will change the balloon inflation volume of the intra-aortic balloon counterpulsation system from the current first value to the second value, which is increased by 15%.

[0077] It should be understood that the above preset inflation volume growth ratio is only an illustrative example, and the specific value of the preset inflation volume growth ratio is not particularly limited in the embodiments of the present invention.

[0078] The first threshold is determined based on the target user's age, blood pressure, and ventilation status.

[0079] In some embodiments, the first threshold CI threshold The formula for determining it is: CI threshold = (xA1 + yA2 + zA3) × CI base A1 = Age / 70; Where x is the first weighting coefficient, y is the second weighting coefficient, and z is the third weighting coefficient; A1 is the age influence factor; Age is the target user's age; A2 is the blood pressure influence factor; BP is the target user's maximum blood pressure; A3 is the ventilation status influence factor; and when the target user's ventilation status is mechanical ventilation, A3 = 1.5, and when the target user's ventilation status is non-mechanical ventilation, A3 = 1, CI base Preset heart rate index.

[0080] For example, x is 0.4, y is 0.4, z is 0.2, and the preset cardiac index is 2.2 L / min / m. 2 When the target user is 65 years old, has a systolic blood pressure of 85 mmHg, and is on mechanical ventilation, the first threshold is 1.94 L / min / m. 2 .

[0081] In another possible implementation, the first threshold can also be determined based on the target user's blood lactate level and body temperature, that is, different weighting coefficients are assigned to the blood lactate level and body temperature. This embodiment of the invention does not impose any particular restrictions on this.

[0082] The method provided in this invention sets different weighting coefficients for the target user's age, blood pressure, and ventilation status, and then determines a first threshold based on the target user's age, blood pressure, and ventilation status. This first threshold is lowered for target users who are older, have lower blood pressure, or have poorer ventilation status, making the first threshold adaptable to users with different statuses and characteristics. This meets the usage needs of different users in different usage scenarios and effectively improves the accuracy and safety of the intra-aortic balloon counterpulsation system.

[0083] In some embodiments, when the target user's cardiac index is less than a first threshold, the processor sets the counterpulsation ratio of the intra-aortic balloon counterpulsation system to 1:1 and changes the balloon inflation volume of the intra-aortic balloon counterpulsation system from a first value to a second value, specifically including: If the target user's cardiac index is less than a first threshold, the processor displays a first request on a preset interface. The first request requests a change in the counterpulsation ratio and balloon inflation volume of the intra-aortic balloon counterpulsation system. In response to the confirmation of the first request, the processor sets the counterpulsation ratio of the intra-aortic balloon counterpulsation system to 1:1 and changes the balloon inflation volume of the intra-aortic balloon counterpulsation system from a first value to a second value.

[0084] In this way, the method provided by this invention, by displaying a first request on a preset interface, enables the operator to quickly and accurately understand the current target user's cardiac index, and then adjust the intra-aortic balloon counterpulsation system in a timely manner based on the target user's cardiac index. Furthermore, the method provided by this invention allows the processor to rapidly control the counterpulsation ratio and balloon inflation volume of the intra-aortic balloon counterpulsation system upon receiving confirmation information input by the operator, effectively improving the accuracy and safety of the intra-aortic balloon counterpulsation system control.

[0085] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A method of controlling an intra-aortic balloon pump system based on hemodynamics, the method comprising: The application is applied to an intra-aortic balloon counterpulsation system, the intra-aortic balloon counterpulsation system comprises a gas cylinder, a gas containing device, a balloon, a hemodynamic monitoring module, a processor and a motor; the gas cylinder, the gas containing device and the balloon are connected through a gas path; The processor is electrically connected with the motor and the hemodynamic monitoring module respectively, and the motor is connected with the gas containing device; The method comprises: The hemodynamic monitoring module acquires a hemodynamic monitoring signal of a target user in real time, and the hemodynamic monitoring signal comprises a global end-diastolic volume, a beat-to-beat variability, extravascular lung water and a cardiac index; The processor determines a basic counterpulsation blood volume of the target user according to the global end-diastolic volume; The processor optimizes the basic counterpulsation blood volume according to the beat-to-beat variability, the extravascular lung water and the cardiac index to obtain a target counterpulsation blood volume of the target user; The processor determines a balloon inflation amount of the intra-aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user.

2. The method of claim 1, wherein, The processor determines a basic counterpulsation blood volume of the target user according to the global end-diastolic volume, comprising: The processor determines an average value of the global end-diastolic volume in a historical time period; The processor determines a counterpulsation blood volume corresponding to the average value from a mapping relationship table according to the average value, and the mapping relationship table stores a plurality of values of the global end-diastolic volume and a counterpulsation blood volume corresponding to each value of the global end-diastolic volume; the processor determines the counterpulsation blood volume corresponding to the average value as the basic counterpulsation blood volume.

3. The method of claim 1, wherein, The processor determines a basic counterpulsation blood volume of the target user according to the global end-diastolic volume, comprising: The processor determines an average value of the global end-diastolic volume in a historical time period; The processor determines a basic counterpulsation blood volume according to the average value of the global end-diastolic volume in the historical time period through a first formula; The first formula is: Q base = k1 · GEDV avg + c1; where Q base is the baseline counterpulsation volume, k1 is a slope coefficient, GEDV avg is the average of the total cardiac end-diastolic volume over a historical time period, and c1 is an intercept constant.

4. The method according to claim 2 or 3, characterized in that, A second formula for determining the target counterpulsation blood volume of the target user is: Wherein, Q final is the target counter-pulsation volume of the target user; α, β, γ are weight coefficients, and β > α > γ; △SVV is the difference between the current stroke volume variation and the average value of the stroke volume variation in the historical time period; △CI is the difference between the current cardiac index and the average value of the cardiac index in the historical time period; △EVLW is the difference between the current extravascular lung water and the average value of the extravascular lung water in the historical time period; SVV ref is the preset reference value of the stroke volume variation; CI ref is the preset reference value of the cardiac index; EVLW ref is the preset reference value of the extravascular lung water.

5. The method of claim 1, wherein, The method further comprises: The processor generates first alarm information in a case where a beat-to-beat variability of the target user is greater than 15% and a global end-diastolic volume of the target user is greater than 800 mL / m 2 The first alarm information is used to prompt a logic abnormality of the hemodynamic monitoring signal. The processor generates first alarm information when the cardiac index of the target user is less than 1.8 L / min / m2 and the beat-to-beat variability of the target user is less than 10%, and the first alarm information is used to prompt that the hemodynamic monitoring signal is logically abnormal.

6. The method of claim 5, wherein, The method further comprises: The processor generates second alarm information when the change value of the beat-to-beat variability and / or the change value of the global end-diastolic volume in the preset time period is greater than a preset change threshold value, the preset change threshold value of the beat-to-beat variability is ±5%, and the preset change threshold value of the global end-diastolic volume is ±100 mL / m 2 .

7. The method of claim 6, wherein, The method further comprises: The processor generates third alarm information when the target counterpulsation blood volume of the target user is less than 15 mL or greater than 50 mL, and the third alarm information is used to prompt that the target counterpulsation blood volume is abnormal.

8. The method of claim 7, wherein, Before the processor determines the balloon inflation amount of the intra-aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user, the method further comprises: The processor determines a predicted value of the extravascular lung water of the target user in a future time period through a neural network model according to historical data of the extravascular lung water of the target user; The processor determines that the extravascular lung water of the target user in the future time period is increasing at a rate greater than 1 mL / kg / min according to the predicted value of the extravascular lung water of the target user in the future time period; The processor reduces the target counterpulsation blood volume of the target user by 5% when the extravascular lung water in the future time period is greater than 1 mL / kg / min.

9. The method of claim 8, wherein, The method further comprises: The processor sets the counterpulsation ratio of the intra-aortic balloon counterpulsation system to 1:1 when at least two of the total cardiac end-diastolic volume, beat-to-beat variability, extravascular lung water, and cardiac index of the target user are lost.

10. An intra-aortic balloon counterpulsation system, characterized in that, The intra-aortic balloon counterpulsation system comprises a gas cylinder, a gas containing device, a balloon, a hemodynamic monitoring module, a processor, and a motor; the gas cylinder, the gas containing device, and the balloon are connected through a gas path; the processor is electrically connected to the motor and the hemodynamic monitoring module, respectively; the motor is connected to the gas containing device; The hemodynamic monitoring module is used to: Real-time acquisition of hemodynamic monitoring signals of a target user, the hemodynamic monitoring signals including total cardiac end-diastolic volume, beat-to-beat variability, extravascular lung water, and cardiac index; The processor is used to: Determine the basic counterpulsation blood volume of the target user according to the total cardiac end-diastolic volume; Optimize the basic counterpulsation blood volume according to the beat-to-beat variability, the extravascular lung water, and the cardiac index to obtain the target counterpulsation blood volume of the target user; Determine the balloon inflation amount of the intra-aortic balloon counterpulsation system according to the target counterpulsation blood volume of the target user.

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