A pressure monitoring device for ECMO combined with plasma exchange

Abstract

This invention relates to the field of medical device technology, and more particularly to a pressure monitoring device for ECMO combined with plasma exchange. The device includes a first pressure detection module for detecting the pre-membrane and post-membrane pressures at both ends of the extracorporeal membrane oxygenation (ECMO) unit; a second pressure detection module for detecting the ducting and returning blood pressures at the connection points between the ECMO and plasma exchange devices; and a plasma ducting three-way valve, located at the connection between the ECMO output tubing and the plasma exchange device, for adjusting the ducting flow rate and ducting pressure of the plasma exchange device, thereby adjusting the valve opening based on the relationship between the post-membrane pressure and the ducting pressure. This invention determines the ducting valve opening by comparing the post-membrane pressure change curve with the ducting pressure change curve, and determines the returning blood valve opening based on the comparison between the pre-membrane pressure change curve and the returning blood pressure change curve, thus solving the problem of pressure differences at the connection points of the circulation tubing.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a pressure monitoring device for ECMO combined with plasma exchange. Background Technology

[0002] Plasma exchange is one of the important methods for purifying blood in the field of modern biomedical engineering. Its basic principle is to use a blood separator to separate the patient's blood into plasma and blood cell components (red blood cells, white blood cells, and platelets) in vitro. Then, the plasma containing harmful and pathogenic substances is discarded, and an equal amount of replacement fluid is used to replace the plasma. Finally, the blood cell components and plasma replacement fluid are returned to the patient's body.

[0003] Chinese Patent Publication No. CN120939342A discloses a plasma exchange device based on intelligent monitoring of pipeline pressure. The device includes a side support plate with clamping blocks installed on its inner side. An extraction pipeline and an input pipeline are respectively installed on the clamping blocks. A squeezing assembly is located between the extraction and input pipelines. The extraction pipeline is connected to a centrifugation assembly, and the input pipeline is connected to a replacement assembly. This invention solves the problem that existing technologies cannot detect pipeline pressure, leading to the failure to promptly detect pipeline leaks or abnormal blood flow. This invention can automatically identify the risk of pipeline leaks or abnormal blood flow and make timely adjustments, avoiding the failure to detect pipeline leaks and abnormal blood flow during plasma exchange, thus preventing harm to the patient's health. It ensures that the monitoring data is consistent with the actual physiological state, thereby improving the medical efficacy of plasma exchange.

[0004] Therefore, the existing technology has the following problems: In the process of ECMO combined with plasma exchange, since ECMO and plasma exchange are two independent extracorporeal circulation tubing, there is a pressure difference at the connection of the circulation tubing during the plasma exchange process, which leads to instability in the blood exchange process. Summary of the Invention

[0005] Therefore, the present invention provides a pressure monitoring device for ECMO combined with plasma exchange, which overcomes the problem in the prior art that, during the ECMO combined with plasma exchange process, since ECMO and plasma exchange are two independent extracorporeal circulation pipelines, there is a pressure difference at the connection of the circulation pipelines, which leads to instability in the blood exchange process.

[0006] To achieve the above objectives, the present invention provides a pressure monitoring device for ECMO combined with plasma exchange, comprising: The pressure detection module is used to detect the pre-membrane pressure, post-membrane pressure, blood evacuation pressure, and blood return pressure in the connecting tubing of the extracorporeal membrane oxygenation and plasma exchange device. A plasma regulating three-way valve is installed at the connection between the extracorporeal membrane oxygenation (ECMO) and plasma exchange devices. It includes a plasma entrapment three-way valve and a plasma return three-way valve, and adjusts the valve opening according to various pressure relationships. The data analysis module determines whether plasma exchange is stable based on changes in blood flow and arterial blood pressure; determines whether extracorporeal membrane oxygenation (ECMO) is operating smoothly based on changes in the difference between pre-membrane and post-membrane pressures; and determines whether blood flow needs adjustment based on the synchronicity of changes in the opening of the blood wick valve and the blood return valve. The control module adjusts the opening of the blood drainage valve based on the comparison between the post-membrane pressure change curve and the blood drainage pressure change curve; and adjusts the opening of the blood return valve based on the comparison between the pre-membrane pressure change curve and the blood return pressure change curve.

[0007] Furthermore, the pressure detection module includes: The pre-membrane pressure detection unit is located in the tubing between the blood pump and the extracorporeal membrane oxygenation (ECMO) system and is used to detect the pre-membrane pressure of blood before it enters the ECMO system. The post-membrane pressure detection unit is located on the pipeline between the extracorporeal membrane oxygenation (ECMO) and plasma exchange devices and is used to detect the post-membrane pressure of blood after passing through the ECMO. The blood duct pressure detection unit is installed at the inlet pipeline of the plasma exchange device to detect the blood duct pressure at the blood duct end of the plasma exchange device. The blood return pressure detection unit is located at the outlet pipeline of the plasma exchange device and is used to detect the blood return pressure at the outlet end of the plasma exchange device.

[0008] Furthermore, the data analysis module determines the slope of the dynamic blood pressure change curve based on the degree of change in arterial blood pressure within a preset unit time, and determines whether plasma exchange is stable based on the comparison between the dynamic blood pressure slope and the dynamic blood pressure slope threshold range. The blood flow rate is determined based on the blood flow rate drawn by the blood pump.

[0009] Furthermore, the data analysis module determines the membrane lung pressure difference based on the difference between the pre-membrane pressure and the post-membrane pressure, and determines whether the extracorporeal membrane oxygenation (ECMO) is operating stably based on the comparison between the membrane lung pressure difference and the membrane lung pressure difference threshold; if the membrane lung pressure difference is less than or equal to the membrane lung pressure difference threshold, it is determined that the ECMO is operating stably; if the membrane lung pressure difference is greater than the membrane lung pressure difference threshold, it is determined that the ECMO is not operating stably, and the valve opening is reduced according to the difference between the membrane lung pressure difference and the membrane lung pressure difference threshold. The valve opening includes the blood duct valve opening and the blood return valve opening.

[0010] Furthermore, the control module determines the slope of the post-membrane pressure curve based on the post-membrane pressure change curve; determines the slope of the blood drainage pressure curve based on the blood drainage pressure change curve; and adjusts the opening of the blood drainage valve based on the comparison between the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve.

[0011] Furthermore, the control module determines the difference in the post-membrane blood drainage slope based on the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve, and determines the opening degree of the blood drainage valve based on the comparison result of the difference in the post-membrane blood drainage slope and the threshold range of the difference in the post-membrane blood drainage slope. Based on the fact that the difference in the slope of the post-membrane blood drainage is greater than the maximum value of the threshold range of the difference in the slope of the post-membrane blood drainage, the opening of the blood drainage valve is increased according to the difference between the difference in the slope of the post-membrane blood drainage and the maximum value of the threshold range of the difference in the slope of the post-membrane blood drainage. Based on the difference in the slope of the post-membrane blood drainage being within the threshold range of the difference in the slope of the post-membrane blood drainage, the current opening of the blood drainage valve is maintained; Based on the fact that the difference in the slope of the post-membrane blood drainage is less than the minimum value of the threshold range of the difference in the slope of the post-membrane blood drainage, the opening of the blood drainage valve is reduced according to the difference between the minimum value of the threshold range of the difference in the slope of the post-membrane blood drainage and the difference in the slope of the post-membrane blood drainage.

[0012] Furthermore, the control module determines the slope of the pre-membrane pressure curve based on the pre-membrane pressure change curve; determines the slope of the return blood pressure curve based on the return blood pressure change curve; and adjusts the opening of the return blood valve based on the comparison between the slope of the pre-membrane pressure curve and the slope of the return blood pressure curve.

[0013] Furthermore, the control module determines the difference in the pre-membrane blood return slope based on the slope of the pre-membrane pressure curve and the slope of the blood return pressure curve, and determines the opening degree of the blood return valve based on the comparison result of the difference in the pre-membrane blood return slope and the threshold range of the difference in the pre-membrane blood return slope. Based on the fact that the difference in the slope of the pre-membrane blood return is greater than the maximum value of the threshold range of the difference in the slope of the pre-membrane blood return, the opening of the blood return valve is increased according to the difference between the difference in the slope of the pre-membrane blood return and the maximum value of the threshold range of the difference in the slope of the pre-membrane blood return. Based on the difference in the pre-membrane blood return slope within the threshold range of the difference in the pre-membrane blood return slope, the current opening of the blood return valve is maintained; Based on the fact that the difference in the slope of the pre-membrane blood return is less than the minimum value of the threshold range of the difference in the slope of the pre-membrane blood return, the opening of the blood return valve is reduced according to the difference between the minimum value of the threshold range of the difference in the slope of the pre-membrane blood return and the difference in the slope of the pre-membrane blood return.

[0014] Furthermore, the control module determines the valve change amplitude difference based on the synchronicity of the changes in the blood entrapment valve opening and the blood return valve opening, and adjusts the blood flow based on the comparison result of the valve change amplitude difference and the valve change amplitude difference threshold. The difference in valve variation amplitude is the absolute value of the difference in the opening amplitude of the blood inlet valve and the blood return valve within the same adjustment cycle.

[0015] Furthermore, the control module maintains the current blood flow rate based on the valve change amplitude difference being less than or equal to the valve change amplitude difference threshold; adjusts the blood flow rate according to the changing trend of the difference between the pre-membrane pressure and the post-membrane pressure based on the valve change amplitude difference being greater than the valve change amplitude difference threshold; decreases the blood flow rate based on an increasing trend in the pre-membrane pressure difference; and increases the blood flow rate based on a decreasing trend in the pre-membrane pressure difference.

[0016] Compared with existing technologies, the beneficial effects of this invention are as follows: During plasma exchange, the stability of extracorporeal membrane oxygenation (ECMO) is determined based on the degree of change in the difference between pre-membrane pressure and post-membrane pressure. This allows for early prediction of potential risks such as coagulation and increased resistance in the ECMO, providing preventative protection and avoiding irreversible damage. The opening of the duct valve is determined by comparing the post-membrane pressure change curve with the ducting pressure change curve, and the opening of the return valve is determined by comparing the pre-membrane pressure change curve with the return pressure change curve. This automatically adjusts the duct and return valves, maintaining stable pressure in the tubing during plasma exchange and improving safety. Furthermore, the synchronization of the duct and return valve openings determines whether blood flow adjustment is necessary. When the duct and return valve openings are not synchronized, it indicates whether overall blood flow adjustment is required, ensuring consistent flow matching and pressure balance between the main circulation of ECMO and the branch circulation of plasma exchange, thus enhancing the safety of plasma exchange.

[0017] Furthermore, in implementation, the pre-membrane pressure detection unit is precisely positioned between the blood pump and the extracorporeal membrane oxygenation (ECMO) unit, directly acquiring the pressure data at the ECMO inlet. This avoids pressure loss or interference during pipeline transmission, providing the most direct basis for judging the ECMO main circulation resistance and the stability of the blood pump output. The post-membrane pressure detection unit is correspondingly positioned between the ECMO unit and the plasma exchange device, enabling real-time acquisition of the blood pressure status after ECMO treatment. This data precisely corresponds to the pre-membrane pressure data, providing reliable data support for quickly calculating the ECMO pressure differential and predicting abnormalities such as ECMO coagulation and blockage, ensuring the accuracy of ECMO operation status assessment from the source.

[0018] Furthermore, during implementation, a pressure difference exists between the pre-membrane and post-membrane tubing of extracorporeal membrane oxygenation (ECMO). Therefore, it is necessary to determine whether ECMO is operating smoothly by comparing the membrane pressure difference with the membrane pressure difference threshold. This ensures stable arterial blood pressure and assesses the operational stability of the ECMO device. If the membrane pressure difference is less than or equal to the membrane pressure difference threshold, ECMO is considered to be operating smoothly, ensuring normal and stable operation within the normal membrane pressure difference range and avoiding alarms caused by small-scale membrane pressure differences that could affect the plasma exchange progress. If the membrane pressure difference is greater than the membrane pressure difference threshold, it indicates blockage in the ECMO system, indicating unstable operation. Reducing the valve opening based on the difference between the membrane pressure difference and the membrane pressure difference threshold reduces the plasma flow through the ECMO system, effectively alleviating the increasing trend of membrane resistance, delaying coagulation and blockage processes, and preventing serious impact on the plasma exchange effect.

[0019] Furthermore, during implementation, when adjusting the blood extraction valve opening, based on the fact that the post-membrane blood extraction slope difference is greater than the maximum value of the post-membrane blood extraction slope difference threshold range, the blood extraction valve opening is increased according to the difference between the post-membrane blood extraction slope difference and the maximum value of the post-membrane blood extraction slope difference threshold range. This can prevent pressure fluctuations in the main circulation tubing of extracorporeal membrane oxygenation (ECMO) when the post-membrane pressure rise rate is faster than the blood extraction pressure rise rate, resulting in insufficient blood extraction. Based on the fact that the post-membrane blood extraction slope difference is within the post-membrane blood extraction slope difference threshold range, the current blood extraction valve opening is maintained. Based on the fact that the post-membrane blood extraction slope difference is less than the minimum value of the post-membrane blood extraction slope difference threshold range, the blood extraction valve opening is decreased when the post-membrane pressure decrease rate is faster than the blood extraction pressure decrease rate, or when the blood extraction pressure rise rate is too fast, resulting in excessive blood extraction. This can prevent pressure fluctuations in the main circulation tubing of ECMO, thereby affecting the entire plasma exchange process.

[0020] Furthermore, during implementation, when adjusting the opening of the blood return valve, based on the fact that the difference in the pre-membrane blood return slope is greater than the maximum value of the threshold range for the difference in the pre-membrane blood return slope, the opening of the blood return valve is increased according to the difference between the pre-membrane blood return slope difference and the maximum value of the threshold range for the difference in the pre-membrane blood return slope. This can increase the opening of the blood return valve when the rate of change of the pre-membrane pressure is significantly faster than the rate of change of the blood return pressure, resulting in insufficient blood return, thus avoiding pressure fluctuations in the main circulation tubing of extracorporeal membrane oxygenation (ECMO). Based on the fact that the difference in the pre-membrane blood return slope is less than the minimum value of the threshold range for the difference in the pre-membrane blood return slope, the opening of the blood return valve is decreased according to the difference between the minimum value of the threshold range for the difference in the pre-membrane blood return slope and the difference in the pre-membrane blood return slope. This can decrease the opening of the blood return valve when the rate of decrease of the pre-membrane pressure is faster than the rate of decrease of the blood return pressure, or when the rate of increase of the blood return pressure is too fast, resulting in excessive blood return, thus avoiding impact on the main circulation tubing of ECMO and affecting the entire plasma exchange process.

[0021] Furthermore, in practice, maintaining the current blood flow rate based on the valve change amplitude difference being less than or equal to the valve change amplitude difference threshold indicates good synchronization in the opening adjustment of the blood intake valve and the blood return valve. This ensures a balance between the blood intake and blood return flow in the plasma exchange branch, preventing any impact on the main circulation blood flow of extracorporeal membrane oxygenation (ECMO). Adjusting the blood flow rate based on the changing trend of the pre- and post-membrane pressure difference (pre- and post-membrane pressure difference) when the valve change amplitude difference is greater than the valve change amplitude difference threshold, and decreasing the blood flow rate when the pre- and post-membrane pressure difference is increasing, reflects the synchronicity of the opening adjustment of the blood intake and blood return valves. A smaller valve change amplitude difference indicates better synchronization and a more balanced impact on pipeline pressure and blood flow. A larger valve change amplitude difference indicates asynchronous adjustment, which will lead to flow imbalance in the plasma exchange branch and consequently affect the stability of the main circulation blood flow in ECMO. Targeted adjustments to the blood flow rate are made based on the changing trends of the pre- and post-membrane pressure differences to prevent further imbalance. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the pressure monitoring device used in this embodiment for ECMO combined with plasma exchange; Figure 2 This is a schematic diagram of the pressure detection module in this embodiment; Figure 3 This is a flowchart illustrating the process of determining the opening degree of the blood extraction valve in this embodiment; Figure 4 This is a flowchart illustrating the process of determining the opening degree of the blood return valve in this embodiment.

[0023] In the diagram, 1-blood pump; 2-blood pump; 3-plasma exchange device; 4-plasma siphon valve; 5-plasma return valve. Detailed Implementation

[0024] To make the objectives and advantages of the present invention clearer, the present invention will be further described below with reference to embodiments; it should be understood that the specific embodiments described herein are merely for explaining the present invention and are not intended to limit the present invention.

[0025] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. Those skilled in the art should understand that these embodiments are merely illustrative of the technical principles of the present invention and are not intended to limit the scope of protection of the present invention.

[0026] It should be noted that in the description of this invention, the terms "upper", "lower", "left", "right", "inner", "outer", etc., which indicate directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. This is only for the convenience of description and is not intended to indicate or imply that the device or element must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation of this invention.

[0027] Furthermore, it should be noted that, in the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0028] Please see Figure 1 As shown, it is a structural schematic diagram of the pressure monitoring device used in this embodiment for ECMO combined with plasma exchange; This invention provides a pressure monitoring device for ECMO combined with plasma exchange, comprising: An arterial blood pressure detection module, used to detect the arterial blood pressure of the target plasma exchange recipient; The main circulation flow detection module is located at the outlet of blood pump 1 and is used to detect the blood flow rate drawn by the blood pump connected to extracorporeal membrane oxygenation 2. The pre-membrane pressure detection unit is located in the tubing between blood pump 1 and blood pump 2 and is used to detect the pre-membrane pressure of blood before it enters the extracorporeal membrane oxygenation system. The post-membrane pressure detection unit is located on the pipeline between the extracorporeal membrane oxygenation (ECMO) and plasma exchange devices and is used to detect the post-membrane pressure of blood after passing through the ECMO. The blood pressure detection unit is located at the inlet pipeline of the plasma exchange device and is used to detect the blood pressure at the blood outlet of the plasma exchange device 3. The blood return pressure detection unit is installed at the outlet pipeline of the plasma exchange device to detect the blood return pressure at the outlet end of the plasma exchange device. Plasma evacuation three-way valve 4; it is installed at the connection between the extracorporeal membrane oxygenation output pipeline and the plasma exchange device, and is used to regulate the evacuation flow rate and evacuation pressure of the plasma exchange device, so as to adjust the opening of the evacuation valve according to the relationship between the post-membrane pressure and the evacuation pressure. Plasma return three-way valve 5; it is installed at the connection between the pre-extracorporeal membrane oxygenation (ECMO) tubing and the plasma exchange device, and is used to regulate the return flow and return pressure of the plasma exchange device, so as to adjust the opening of the return valve according to the relationship between the pre-membrane pressure and the return pressure. The data analysis module, connected to the main circulation flow detection module, the arterial blood pressure detection module, the pre-membrane pressure detection unit, the post-membrane pressure detection unit, the blood spurting pressure detection unit, and the blood return pressure detection unit, determines whether plasma exchange is stable based on the degree of change in blood flow and arterial blood pressure; determines whether extracorporeal membrane oxygenation (ECMO) is operating smoothly based on the degree of change in the difference between pre-membrane and post-membrane pressures; and determines whether blood flow needs adjustment based on the degree of synchronization between the changes in the blood spurting valve opening and the blood return valve opening. The control module adjusts the opening of the blood drainage valve based on the comparison between the post-membrane pressure change curve and the blood drainage pressure change curve; and adjusts the opening of the blood return valve based on the comparison between the pre-membrane pressure change curve and the blood return pressure change curve.

[0029] The alarm module is used to issue alarms for dangerous commands issued by the data analysis unit.

[0030] During implementation, the stability of extracorporeal membrane oxygenation (ECMO) is determined by the degree of change in the difference between pre-membrane and post-membrane pressures. This allows for early prediction of potential risks such as coagulation and increased resistance in the ECMO, providing preventative protection and avoiding irreversible damage. The opening of the duct valve is determined by comparing the post-membrane pressure change curve with the ducting pressure change curve, and the opening of the return valve is determined by comparing the pre-membrane pressure change curve with the return pressure change curve. This automatic adjustment of the ducting and return valves ensures stable tubing pressure during plasma exchange, improving safety. Furthermore, the synchronization of the ducting and return valve openings determines whether blood flow adjustment is necessary. When the openings of the ducting and return valves are out of sync, it indicates the need to adjust the overall blood flow, ensuring consistent flow matching and pressure balance between the main circulation of ECMO and the branch circulation of plasma exchange, thus enhancing the safety of plasma exchange.

[0031] Please see Figure 2 As shown, it is a structural schematic diagram of the pressure detection module in this embodiment; Specifically, the pressure detection module includes: The pre-membrane pressure detection unit is located in the tubing between the blood pump and the extracorporeal membrane oxygenation (ECMO) system and is used to detect the pre-membrane pressure of blood before it enters the ECMO system. The post-membrane pressure detection unit is located on the pipeline between the extracorporeal membrane oxygenation (ECMO) and plasma exchange devices and is used to detect the post-membrane pressure of blood after passing through the ECMO. The blood duct pressure detection unit is installed at the inlet pipeline of the plasma exchange device to detect the blood duct pressure at the blood duct end of the plasma exchange device. The blood return pressure detection unit is located at the outlet pipeline of the plasma exchange device and is used to detect the blood return pressure at the outlet end of the plasma exchange device.

[0032] In this embodiment of the invention, each pressure detection unit of the pressure detection module adopts a high-precision pressure sensor. For example, the pre-membrane pressure detection unit is sealed and installed on the side wall of the pipeline between the blood pump and the extracorporeal membrane oxygenation (ECMO) system. It indirectly contacts the blood in the pipeline through a sterile isolation membrane to avoid blood contamination. The installation position avoids areas prone to pressure fluctuations, such as pipeline bends and interfaces, to ensure the stability of the detection data. The core function of the pre-membrane pressure detection unit is to detect the pre-membrane pressure of the blood before it enters the ECMO system in real time and provide real-time feedback on the pressure status at the ECMO inlet. It can be understood that each of the above pressure detection modules indirectly contacts the blood in the pipeline through a sterile isolation membrane to avoid blood contamination. The installation position avoids areas prone to pressure fluctuations, such as pipeline bends and interfaces, to ensure the stability of the detection data.

[0033] In implementation, the pre-membrane pressure detection unit is precisely positioned between the blood pump and the extracorporeal membrane oxygenation (ECMO) unit, directly acquiring the pressure data at the ECMO inlet. This avoids pressure loss or interference during pipeline transmission, providing the most direct basis for judging the ECMO main circulation resistance and the stability of the blood pump output. The post-membrane pressure detection unit is correspondingly positioned between the ECMO unit and the plasma exchange device, enabling real-time acquisition of the blood pressure status after ECMO treatment. This data precisely corresponds to the pre-membrane pressure data, providing reliable data support for quickly calculating the ECMO pressure differential and predicting abnormalities such as ECMO coagulation and blockage, ensuring the accuracy of ECMO operation status assessment from the source.

[0034] Specifically, the data analysis module determines the slope of the dynamic blood pressure change curve based on the degree of change in arterial blood pressure within a preset unit time, and determines whether plasma exchange is stable based on the comparison between the dynamic blood pressure slope and the dynamic blood pressure slope threshold range. The blood flow rate is determined based on the blood flow rate drawn by the blood pump.

[0035] The data analysis module receives blood pressure data transmitted from the arterial blood pressure detection module in real time, statistically analyzes the fluctuation range of arterial blood pressure within a preset unit time, such as 10 minutes, calculates the dynamic change rate of arterial blood pressure, and then determines the dynamic blood pressure slope. The dynamic blood pressure slope can directly reflect the stability of arterial blood pressure. If the arterial blood pressure slope is within the arterial blood pressure slope threshold range and the blood flow fluctuation range does not exceed the set range, the plasma exchange process is determined to be stable and no adjustment is required. If the arterial blood pressure slope exceeds the arterial blood pressure slope threshold range, such as a sudden rise or fall in blood pressure, or excessive fluctuation in blood flow, the plasma exchange process is determined to be unstable and an alarm should be issued. During plasma exchange, it is essential to ensure the stability of arterial blood pressure, as the stability of arterial blood pressure reflects the stability of the plasma exchange process.

[0036] Specifically, the data analysis module determines the membrane lung pressure difference based on the difference between the pre-membrane pressure and the post-membrane pressure, and determines whether the extracorporeal membrane oxygenation (ECMO) is operating stably based on the comparison between the membrane lung pressure difference and the membrane lung pressure difference threshold; if the membrane lung pressure difference is less than or equal to the membrane lung pressure difference threshold, it is determined that the ECMO is operating stably; if the membrane lung pressure difference is greater than the membrane lung pressure difference threshold, it is determined that the ECMO is not operating stably, and the valve opening is reduced according to the difference between the membrane lung pressure difference and the membrane lung pressure difference threshold. The valve opening includes the blood duct valve opening and the blood return valve opening.

[0037] In this embodiment of the invention, the membrane lung pressure difference = pre-membrane pressure - post-membrane pressure. The membrane lung pressure difference can reflect the flow resistance and operating status of extracorporeal membrane oxygenation (ECMO). According to the clinical ECMO operating standards, the normal range of membrane lung pressure difference is usually 10-15 mmHg. When it is within the range of 10-15 mmHg, it indicates that the membrane lung permeability is good, there is no obvious coagulation or blockage, and the ECMO operation is more stable. When the membrane lung pressure difference exceeds 15 mmHg, it indicates that the membrane lung resistance begins to increase, and there may be coagulation, blood cell or protein adhesion blocking the membrane lung. The risk of ECMO operation increases. Especially when the membrane lung pressure difference rises to 30 mmHg or above, the probability of irreversible damage to the membrane lung increases significantly, and red blood cell destruction is aggravated, which can easily lead to complications such as plasma leakage. In this embodiment of the invention, the membrane lung pressure difference threshold is set to 15 mmHg. Based on the membrane lung pressure difference being less than or equal to the membrane lung pressure difference threshold, it is determined that the extracorporeal membrane oxygenation is operating stably. Based on the membrane lung pressure difference exceeding the membrane lung pressure difference threshold, it is determined that the extracorporeal membrane oxygenation (ECMO) operation is unstable. The valve opening is reduced based on the difference between the membrane lung pressure difference and the threshold. In this embodiment of the invention, when the membrane lung pressure difference exceeds the threshold by 1 mmHg, the valve opening is reduced by 2%; when it exceeds the threshold by 2 mmHg, the valve opening is reduced by 4%; when it exceeds the threshold by 3 mmHg, the valve opening is reduced by 6%; when it exceeds the threshold by 4 mmHg, the valve opening is reduced by 8%; when it exceeds the threshold by 5 mmHg, the valve opening is reduced by 10%; when it exceeds the threshold by 6 mmHg, the valve opening is reduced by 12%; and when it exceeds the threshold by 7 mmHg, the valve opening is reduced by [missing information]. The valve opening is reduced by 14% when the pressure difference exceeds the membrane lung pressure threshold by 8 mmHg; by 18% when it exceeds the threshold by 9 mmHg; by 20% when it exceeds the threshold by 10 mmHg; and by 1% for every additional 1 mmHg exceeding the threshold by more than 10 mmHg. The maximum reduction is no more than 30%. This precisely reduces the blood flow in and out of the plasma exchange circuit, thereby alleviating the main circulation load of the extracorporeal membrane oxygenation system, reducing the blood flow through the membrane lung, thus lowering the membrane lung pressure difference, mitigating the increasing resistance trend, preventing further increases in membrane lung pressure difference, and buying time for medical staff to troubleshoot and treat membrane lung abnormalities.

[0038] During implementation, a pressure difference exists between the pre-membrane and post-membrane tubing of extracorporeal membrane oxygenation (ECMO). Therefore, comparing the ECMO pressure difference with a threshold value is necessary to determine the stability of the ECMO operation. Ensuring stable arterial blood pressure is crucial for assessing the ECMO device's operational stability. A ECMO pressure difference less than or equal to the threshold value indicates stable operation, ensuring the device operates within the normal ECMO pressure difference range and preventing alarms caused by small pressure differences that could affect plasma exchange progress. Conversely, a ECMO pressure difference greater than the threshold value indicates blockage, indicating unstable operation. Reducing the valve opening based on the difference between the ECMO pressure difference and the threshold value decreases the plasma flow through the ECMO, effectively mitigating the increasing resistance, slowing coagulation and blockage processes, and preventing severe impacts on plasma exchange efficacy.

[0039] Please see Figure 3 As shown, it is a flowchart of the process of determining the opening degree of the blood extraction valve in this embodiment; Specifically, the control module determines the slope of the post-membrane pressure curve based on the post-membrane pressure change curve; determines the slope of the blood drainage pressure curve based on the blood drainage pressure change curve; and adjusts the opening of the blood drainage valve based on the comparison between the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve.

[0040] Specifically, the control module determines the difference in the post-membrane blood drainage slope based on the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve, and determines the opening degree of the blood drainage valve based on the comparison result of the difference in the post-membrane blood drainage slope and the threshold range of the difference in the post-membrane blood drainage slope. Based on the fact that the difference in the slope of the post-membrane blood drainage is greater than the maximum value of the threshold range of the difference in the slope of the post-membrane blood drainage, the opening of the blood drainage valve is increased according to the difference between the difference in the slope of the post-membrane blood drainage and the maximum value of the threshold range of the difference in the slope of the post-membrane blood drainage. Based on the difference in the slope of the post-membrane blood drainage being within the threshold range of the difference in the slope of the post-membrane blood drainage, the current opening of the blood drainage valve is maintained; Based on the fact that the difference in the slope of the post-membrane blood drainage is less than the minimum value of the threshold range of the difference in the slope of the post-membrane blood drainage, the opening of the blood drainage valve is reduced according to the difference between the minimum value of the threshold range of the difference in the slope of the post-membrane blood drainage and the difference in the slope of the post-membrane blood drainage.

[0041] The control module receives real-time post-membrane pressure data transmitted by the pressure detection module and real-time blood flow pressure data transmitted by the blood flow pressure detection unit. In this embodiment of the invention, pressure data is collected at a preset time interval, which is set to 1 minute / set. Based on 30 sets of continuously collected pressure data, post-membrane pressure change curves and blood flow pressure change curves are fitted respectively. It can be understood that the data analysis module collects 30 or more sets of discrete post-membrane pressure and blood flow pressure data at an interval of 1 minute / set, such as 12 mmHg post-membrane pressure in the 1st minute, 12.1 mmHg in the 2nd minute, 11.9 mmHg in the 3rd minute, etc., for a total of 30 sets. Through mathematical algorithms such as linear regression, these scattered data that may have slight fluctuations are integrated and optimized to generate a smooth post-membrane pressure change curve and a smooth blood flow pressure change curve. The fitted curves can filter out the small errors of single data collection, such as instantaneous pressure fluctuations caused by slight vibration of the tubing. When the difference between the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve is within the preset reasonable range of ±0.1 mmHg / min, it indicates that the trends of post-membrane pressure and blood drainage pressure are matched, the blood drainage process is stable, and there is no need to adjust the opening of the blood drainage valve. When the slope of the post-membrane pressure curve is greater than the slope of the blood drainage pressure curve and the difference exceeds the reasonable range, it indicates that the rate of increase of post-membrane pressure is faster than the rate of increase of blood drainage pressure, resulting in insufficient blood drainage, and the opening of the blood drainage valve needs to be increased. When the slope of the post-membrane pressure curve is less than the slope of the blood drainage pressure curve and the difference exceeds the reasonable range, it indicates that the rate of decrease of post-membrane pressure is faster than the rate of decrease of blood drainage pressure, or the rate of increase of blood drainage pressure is too fast, resulting in excessive blood drainage, and the opening of the blood drainage valve needs to be decreased. The control module calculates the difference in post-membrane blood flow slope based on the slopes of the post-membrane pressure curve and the blood flow pressure curve. This difference is calculated as: Post-membrane blood flow slope difference = Post-membrane pressure curve slope - Blood flow pressure curve slope. This difference reflects the difference in the rate of change between post-membrane pressure and blood flow pressure. A positive difference indicates that the rate of change of post-membrane pressure is faster than that of blood flow pressure; a negative difference indicates that the rate of change of blood flow pressure is faster than that of post-membrane pressure. A larger absolute value of the difference indicates a greater difference in the rate of change between post-membrane pressure and blood flow pressure, and a higher risk of blood flow imbalance. In this embodiment of the invention, the threshold range for the difference in the slope of the retromembrane blood flow is set to [-0.3 mmHg / min, 0.3 mmHg / min], which is determined based on historical data; The fact that the difference in the post-membrane drainage slope is greater than the maximum value of the threshold range indicates that the rate of change in post-membrane pressure is significantly faster than the rate of change in drainage pressure, resulting in insufficient drainage. Therefore, the drainage valve opening needs to be increased based on the difference between the post-membrane drainage slope difference and the maximum value of the threshold range. In this embodiment of the invention, for every 0.1 mmHg / min increase in the difference between the post-membrane drainage slope difference and the maximum value of the threshold range, the drainage valve opening is increased by 2%. For example, the post-membrane drainage slope difference... If the blood flow rate exceeds the maximum threshold range of 0.1 mmHg / min (0.4 mmHg / min), the blood flow valve opening is increased by 2%; if the difference is 0.2 mmHg / min (0.5 mmHg / min), the blood flow valve opening is increased by 4%, and so on. The maximum increase in the blood flow valve opening should not exceed 15% to avoid excessive blood flow caused by excessive opening of the blood flow valve, and to ensure that the blood flow rate increases slowly and gradually matches the trend of changes in post-membrane pressure. Based on the fact that the difference in the post-membrane blood drainage slope is within the threshold range of the difference in the post-membrane blood drainage slope, it indicates that the rate of change of the post-membrane pressure and the blood drainage pressure are basically the same, the blood drainage process is stable, and there is no need to adjust the opening of the blood drainage valve. The current opening of the blood drainage valve is maintained. In this embodiment of the invention, the data analysis module maintains the current opening of the blood drainage valve at 30%. Since the difference in the post-membrane blood drainage slope is less than the minimum threshold value of the post-membrane blood drainage slope difference, it indicates that the rate of change in blood drainage pressure is significantly faster than the rate of change in post-membrane pressure, resulting in excessive blood drainage. Based on the difference between the minimum threshold value and the actual post-membrane blood drainage slope difference, the opening of the blood drainage valve is reduced. In this embodiment of the invention, the opening of the blood drainage valve is adjusted for every 0.1 mmHg / min increase in the difference between the minimum threshold value and the actual post-membrane blood drainage slope difference (i.e., the difference in post-membrane blood drainage slope is 0.1 mmHg / min less than the minimum threshold value). The valve opening is reduced by 2%. For example, if the difference in the post-membrane blood drainage slope is -0.4 mmHg / min, which is 0.1 mmHg / min less than the minimum threshold range for the difference in the post-membrane blood drainage slope, the valve opening is reduced by 2%. If the difference is -0.5 mmHg / min, which is 0.2 mmHg / min less than the minimum threshold range for the difference in the post-membrane blood drainage slope, the valve opening is reduced by 4%, and so on. The maximum reduction is no more than 15%, to avoid the valve opening being too small and causing poor blood drainage, and to ensure that the blood flow rate decreases slowly and gradually matches the trend of post-membrane pressure changes.

[0042] During implementation, when adjusting the blood evacuation valve opening, if the post-membrane blood evacuation slope difference is greater than the maximum value of the post-membrane blood evacuation slope difference threshold range, the blood evacuation valve opening is increased based on the difference between the post-membrane blood evacuation slope difference and the maximum value of the post-membrane blood evacuation slope difference threshold range. This increases the blood evacuation valve opening to prevent pressure fluctuations in the main circulation tubing of extracorporeal membrane oxygenation (ECMO) when the post-membrane blood evacuation slope difference is rising faster than the blood evacuation pressure. If the post-membrane blood evacuation slope difference is within the threshold range, the current blood evacuation valve opening is maintained. If the post-membrane blood evacuation slope difference is less than the minimum value of the post-membrane blood evacuation slope difference threshold range, the blood evacuation valve opening is decreased to prevent pressure fluctuations in the main circulation tubing of ECMO, thus affecting the entire plasma exchange process, when the post-membrane pressure decreases faster than the blood evacuation pressure decreases, or the blood evacuation pressure rises too quickly, leading to excessive blood evacuation.

[0043] Please see Figure 4 The diagram shown is a flowchart illustrating the process of determining the opening degree of the blood return valve in an embodiment. Specifically, the control module determines the slope of the pre-membrane pressure curve based on the pre-membrane pressure change curve; determines the slope of the return blood pressure curve based on the return blood pressure change curve; and adjusts the opening of the return blood valve based on the comparison between the slope of the pre-membrane pressure curve and the slope of the return blood pressure curve.

[0044] Specifically, the control module determines the difference in the pre-membrane blood return slope based on the slope of the pre-membrane pressure curve and the slope of the blood return pressure curve, and determines the opening degree of the blood return valve based on the comparison result between the difference in the pre-membrane blood return slope and the threshold range of the difference in the pre-membrane blood return slope. Based on the fact that the difference in the slope of the pre-membrane blood return is greater than the maximum value of the threshold range of the difference in the slope of the pre-membrane blood return, the opening of the blood return valve is increased according to the difference between the difference in the slope of the pre-membrane blood return and the maximum value of the threshold range of the difference in the slope of the pre-membrane blood return. Based on the difference in the pre-membrane blood return slope within the threshold range of the difference in the pre-membrane blood return slope, the current opening of the blood return valve is maintained; Based on the fact that the difference in the slope of the pre-membrane blood return is less than the minimum value of the threshold range of the difference in the slope of the pre-membrane blood return, the opening of the blood return valve is reduced according to the difference between the minimum value of the threshold range of the difference in the slope of the pre-membrane blood return and the difference in the slope of the pre-membrane blood return.

[0045] The control module receives real-time data on pre-membrane pressure from the pre-membrane pressure detection unit and real-time data on return blood pressure from the return blood pressure detection unit. Using the same method as fitting the blood duct pressure curve, it collects a set of pressure data every 1 minute, consistent with the blood duct detection. Based on 30 or more sets of continuously collected pressure data, it fits and forms pre-membrane pressure change curves and return blood pressure change curves respectively. Similarly, through a linear regression algorithm, it integrates and optimizes the scattered discrete pressure data to generate smooth and continuous curves, filtering out minor data errors caused by factors such as tubing vibration, and accurately reflecting the true change trend of pre-membrane pressure and return blood pressure over time. The pre-membrane pressure change curve is plotted with time on the horizontal axis and pre-membrane pressure value on the vertical axis, and the return blood pressure change curve is plotted with the same time on the horizontal axis and return blood pressure value on the vertical axis. When the slope is positive, the pressure tends to increase; when the slope is negative, the pressure tends to decrease; the larger the absolute value of the slope, the faster the pressure changes; when the slope approaches 0, the pressure is in a stable state. The control module compares the slope of the pre-membrane pressure curve with the slope of the blood return pressure curve in real time. The purpose is to ensure that the rate of change of blood return pressure matches the rate of change of pre-membrane pressure, so as to avoid the imbalance of plasma exchange blood return caused by the blood return pressure changing too fast or too slow, which would then impact the main circulation of extracorporeal membrane oxygenation. If the blood return pressure is too high, it will overshoot the pre-membrane pressure, and if the blood return pressure is too low, it will lead to poor blood return. When the difference between the slope of the pre-membrane pressure curve and the slope of the return blood pressure curve is within the preset reasonable range of ±0.1 mmHg / min, it indicates that the trends of pre-membrane pressure and return blood pressure are matched, the return blood process is stable, and there is no need to adjust the opening of the return blood valve. When the slope of the pre-membrane pressure curve is greater than the slope of the return blood pressure curve and the difference exceeds the reasonable range, it indicates that the rate of increase of pre-membrane pressure is faster than the rate of increase of return blood pressure, resulting in insufficient return blood, and the opening of the return blood valve needs to be increased. When the slope of the pre-membrane pressure curve is less than the slope of the return blood pressure curve and the difference exceeds the reasonable range, it indicates that the rate of decrease of pre-membrane pressure is faster than the rate of decrease of return blood pressure, or the rate of increase of return blood pressure is too fast, resulting in excessive return blood, and the opening of the return blood valve needs to be decreased. In this embodiment of the invention, the threshold range for the difference in the slope of the pre-membrane blood return is set to [-0.3 mmHg / min, 0.3 mmHg / min], which is determined based on historical data; The fact that the difference in the pre-membrane blood return slope is greater than the maximum value of the threshold range indicates that the rate of change in pre-membrane pressure is significantly faster than the rate of change in blood return pressure, resulting in insufficient blood return. Therefore, the opening of the blood return valve is increased based on the difference between the pre-membrane blood return slope difference and the maximum value of the threshold range. For every 0.1 mmHg / min that the difference exceeds the threshold range, the opening of the blood return valve is increased by 2%. For example, if the difference in the pre-membrane blood return slope is 0.4 mmHg / min, exceeding the threshold range, the valve opening is increased by 2%. The maximum threshold value is 0.1 mmHg / min, and the opening of the blood return valve increases by 2%. If the difference in the pre-membrane blood return slope is 0.5 mmHg / min, exceeding the maximum threshold value of 0.2 mmHg / min, the opening of the blood return valve increases by 4%, and so on. The maximum increase in the opening of the blood return valve shall not exceed 15% to avoid excessive blood return caused by excessive opening of the blood return valve, to prevent excessive blood return pressure from impacting the pre-membrane tubing of extracorporeal membrane oxygenation, and to ensure that the blood return flow increases slowly and gradually matches the trend of changes in pre-membrane pressure.

[0046] During implementation, when adjusting the opening of the blood return valve, the valve opening is increased based on the difference between the pre-membrane blood return slope difference and the maximum value of the threshold range. This increases the valve opening when the rate of change in pre-membrane pressure is significantly faster than the rate of change in blood return pressure, leading to insufficient blood return, thus preventing pressure fluctuations in the main circulation tubing of extracorporeal membrane oxygenation (ECMO). Conversely, the valve opening is decreased based on the difference between the pre-membrane blood return slope difference and the minimum value of the threshold range. This decreases the valve opening when the rate of decrease in pre-membrane pressure is faster than the rate of decrease in blood return pressure, or when the rate of increase in blood return pressure is too rapid, leading to excessive blood return, thus preventing impact on the main circulation tubing of ECMO and affecting the entire plasma exchange process.

[0047] Specifically, the control module determines the valve change amplitude difference based on the synchronicity of the changes in the opening of the blood entrapment valve and the blood return valve, and adjusts the blood flow based on the comparison result of the valve change amplitude difference and the valve change amplitude difference threshold. The difference in valve variation amplitude is the absolute value of the difference in the opening amplitude of the blood inlet valve and the blood return valve within the same adjustment cycle.

[0048] Specifically, the control module maintains the current blood flow rate based on the valve change amplitude difference being less than or equal to a valve change amplitude difference threshold; adjusts the blood flow rate based on the changing trend of the difference between the pre-membrane pressure and the post-membrane pressure based on the valve change amplitude difference being greater than the valve change amplitude difference threshold; decreases the blood flow rate based on an increasing trend in the pre-membrane pressure difference; and increases the blood flow rate based on a decreasing trend in the pre-membrane pressure difference.

[0049] In this embodiment of the invention, the adjustment cycle is set to be consistent with the pressure detection cycle, which is set to 1 minute / cycle, that is, the opening change of the blood duct valve and the blood return valve is counted every minute within the same adjustment cycle. The valve variation amplitude difference is defined as the absolute value of the difference between the opening amplitude changes of the blood duct valve and the blood return valve within the same adjustment cycle. The valve variation amplitude difference = |blood duct valve opening amplitude change - blood return valve opening amplitude change|. The valve variation amplitude difference can reflect the synchronicity of the adjustment of the blood duct valve and the blood return valve. The smaller the valve variation amplitude difference, the better the synchronicity of the two adjustments, and the more balanced the impact on pipeline pressure and blood flow. The larger the valve variation amplitude difference, the more asynchronous the two adjustments, which will lead to the imbalance of the plasma exchange branch flow and thus affect the stability of the main circulation blood flow of extracorporeal membrane oxygenation. In this embodiment of the invention, the threshold value for the difference in valve variation is set to 3%, which is determined based on historical data. When the difference in valve variation is ≤3%, it indicates that the blood intake valve and the blood return valve are well synchronized and there is no need to adjust the blood flow. When the difference in valve variation is >3%, it indicates that the blood intake valve and the blood return valve are not synchronized, which affects the pipeline flow. It is necessary to adjust the blood flow in a targeted manner based on the changing trend of the pressure difference before and after the membrane to avoid aggravating the flow imbalance. Based on the valve change amplitude difference being less than or equal to the valve change amplitude difference threshold, it indicates that the opening adjustment of the blood intake valve and the blood return valve is well synchronized, the blood intake flow and blood return flow of the plasma exchange branch are balanced, and there is no impact on the main circulation blood flow of the extracorporeal membrane oxygenation (ECMO) system. At this time, the control module maintains the current blood flow unchanged. The current blood flow is the flow output of the main circulation blood pump of the ECMO system, which is usually maintained at 2.5-3.5 L / min. It can be understood that the range of 2.5-3.5 L / min is selected according to the actual situation to ensure the coordinated and stable flow of the main circulation of ECMO and the branch of plasma exchange, and to avoid pressure fluctuations caused by unnecessary flow adjustment. The fact that the difference in valve variation amplitude is greater than the threshold of valve variation amplitude difference indicates that the blood entrapment valve and the blood return valve are not adjusted in sync, which will lead to an imbalance in plasma flow in the plasma exchange branch, and may affect the stability of the main circulation of extracorporeal membrane oxygenation. At this time, the control module needs to adjust the blood flow in a targeted manner based on the changing trend of the membrane pressure difference between the pre-membrane pressure and the post-membrane pressure. When the membrane lung pressure differential shows an increasing trend, it indicates that the extracorporeal membrane oxygenation resistance is rising. If the blood flow is too high at this time, it will further exacerbate the burden on the membrane lung, leading to a continuous increase in the membrane lung pressure differential and increasing the risk of coagulation and membrane lung injury. Therefore, the control module needs to reduce the blood flow, corresponding to a decrease in blood flow of 0.1 L / min for every 0.017 mmHg increase in membrane lung pressure differential per minute, with a maximum reduction not exceeding 0.5 L / min. This ensures that the blood flow decreases slowly, gradually alleviating the increasing trend of membrane lung resistance. Simultaneously, considering the asynchronous state of valve adjustment, it avoids drastic fluctuations in tubing pressure caused by excessively rapid adjustments to plasma flow. For example, if the membrane lung pressure differential increases from 15 mmHg to 15.017 mmHg within 1 minute (an increase of 0.017 mmHg per minute), the blood flow should decrease from 3.0 L / min to 2.9 L / min. If the cumulative increase is 0.17 mmHg within 10 minutes, the blood flow should decrease by 0.1 L / min simultaneously, ensuring precise matching between flow regulation and membrane lung pressure differential changes. When the membrane oxygenation pressure differential shows a decreasing trend, it indicates that the resistance to extracorporeal membrane oxygenation (ECMO) is decreasing and the ECMO operation is gradually improving. At this point, the blood flow rate can be appropriately increased to improve plasma exchange efficiency. Simultaneously, considering the asynchronous state of valve adjustment, it is crucial to ensure that the flow rate and valve opening changes are coordinated. This corresponds to a decrease in the ECMO pressure differential of 0.017 mmHg per minute, with a corresponding increase in blood flow of 0.1 L / min, and a maximum increase not exceeding 0.5 L / min. This avoids a sudden increase in pre-membrane pressure caused by excessively rapid blood flow increase, ensuring stable main circulation in ECMO oxygenation. For example, if the ECMO pressure differential decreases from 18 mmHg to 17.983 mmHg within 1 minute, the blood flow rate increases from 2.8 L / min to 2.9 L / min; if the cumulative decrease is 0.17 mmHg within 10 minutes, the blood flow rate increases by 0.1 L / min simultaneously, improving plasma exchange efficiency while ensuring the safety of ECMO operation.

[0050] In practice, maintaining the current blood flow rate based on a valve change amplitude difference less than or equal to a valve change amplitude difference threshold indicates good synchronization between the opening adjustments of the duct and return valves. This ensures a balance between the duct and return blood flow in the plasma exchange branch, preventing any impact on the main circulation blood flow in extracorporeal membrane oxygenation (ECMO). Adjusting the blood flow rate based on the changing trend of the pre- and post-membrane pressure difference (pre- and post-membrane pressure difference) when the valve change amplitude difference exceeds the threshold indicates a synchronicity between the duct and return valve opening adjustments. A smaller valve change amplitude difference indicates better synchronization and a more balanced impact on tubing pressure and blood flow. A larger valve change amplitude difference indicates a lack of synchronization, leading to flow imbalance in the plasma exchange branch and affecting the stability of the main circulation blood flow in ECMO. Targeted adjustments to the blood flow rate based on the changing trends of the pre- and post-membrane pressure differences are then made to prevent further imbalance.

[0051] The technical solution of the present invention has been described above with reference to the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is obviously not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will all fall within the scope of protection of the present invention.

[0052] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A pressure monitoring device for ECMO combined with plasma exchange, characterized in that, include: The pressure detection module is used to detect the pre-membrane pressure, post-membrane pressure, blood evacuation pressure, and blood return pressure in the connecting tubing of the extracorporeal membrane oxygenation and plasma exchange device. A plasma regulating three-way valve is installed at the connection between the extracorporeal membrane oxygenation (ECMO) and plasma exchange devices. It includes a plasma entrapment three-way valve and a plasma return three-way valve, and adjusts the valve opening according to the pressure relationship. The data analysis module determines whether plasma exchange is stable based on changes in blood flow and arterial blood pressure; determines whether extracorporeal membrane oxygenation (ECMO) is operating smoothly based on changes in the difference between pre-membrane and post-membrane pressures; and determines whether blood flow needs adjustment based on the synchronicity of changes in the opening of the blood wick valve and the blood return valve. The control module adjusts the opening of the blood drainage valve based on the comparison between the post-membrane pressure change curve and the blood drainage pressure change curve; and adjusts the opening of the blood return valve based on the comparison between the pre-membrane pressure change curve and the blood return pressure change curve.

2. The pressure monitoring device for ECMO combined with plasma exchange according to claim 1, characterized in that, The pressure detection module includes: The pre-membrane pressure detection unit is located in the tubing between the blood pump and the extracorporeal membrane oxygenation (ECMO) system and is used to detect the pre-membrane pressure of blood before it enters the ECMO system. The post-membrane pressure detection unit is located on the pipeline between the extracorporeal membrane oxygenation (ECMO) and plasma exchange devices and is used to detect the post-membrane pressure of blood after passing through the ECMO. The blood duct pressure detection unit is installed at the inlet pipeline of the plasma exchange device to detect the blood duct pressure at the blood duct end of the plasma exchange device. The blood return pressure detection unit is located at the outlet pipeline of the plasma exchange device and is used to detect the blood return pressure at the outlet end of the plasma exchange device.

3. The pressure monitoring device for ECMO combined with plasma exchange according to claim 2, characterized in that, The data analysis module determines the slope of the dynamic blood pressure change curve based on the degree of change in arterial blood pressure within a preset unit time, and determines whether plasma exchange is stable based on the comparison between the dynamic blood pressure slope and the dynamic blood pressure slope threshold range. The blood flow rate is determined based on the blood flow rate drawn by the blood pump.

4. The pressure monitoring device for ECMO combined with plasma exchange according to claim 3, characterized in that, The data analysis module determines the membrane lung pressure difference based on the difference between the pre-membrane pressure and the post-membrane pressure, and determines whether the extracorporeal membrane oxygenation is operating stably based on the comparison result between the membrane lung pressure difference and the membrane lung pressure difference threshold. Based on the membrane lung pressure difference being less than or equal to the membrane lung pressure difference threshold, the extracorporeal membrane oxygenation is determined to be in stable operation. Based on the membrane pressure difference being greater than the membrane pressure difference threshold, it is determined that the extracorporeal membrane oxygenation is not stable, and the valve opening is reduced according to the difference between the membrane pressure difference and the membrane pressure difference threshold. The valve opening includes the blood duct valve opening and the blood return valve opening.

5. The pressure monitoring device for ECMO combined with plasma exchange according to claim 4, characterized in that, The control module determines the slope of the post-membrane pressure curve based on the post-membrane pressure change curve; determines the slope of the blood drainage pressure curve based on the blood drainage pressure change curve; and adjusts the opening of the blood drainage valve based on the comparison between the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve.

6. The pressure monitoring device for ECMO combined with plasma exchange according to claim 5, characterized in that, The control module determines the difference in the post-membrane blood drainage slope based on the slope of the post-membrane pressure curve and the slope of the blood drainage pressure curve, and determines the opening degree of the blood drainage valve based on the comparison result of the difference in the post-membrane blood drainage slope and the threshold range of the difference in the post-membrane blood drainage slope. Based on the fact that the difference in the slope of the post-membrane blood drainage is greater than the maximum value of the threshold range of the difference in the slope of the post-membrane blood drainage, the opening of the blood drainage valve is increased according to the difference between the difference in the slope of the post-membrane blood drainage and the maximum value of the threshold range of the difference in the slope of the post-membrane blood drainage. Based on the difference in the slope of the post-membrane blood drainage being within the threshold range of the difference in the slope of the post-membrane blood drainage, the current opening of the blood drainage valve is maintained; Based on the fact that the difference in the slope of the post-membrane blood drainage is less than the minimum value of the threshold range of the difference in the slope of the post-membrane blood drainage, the opening of the blood drainage valve is reduced according to the difference between the minimum value of the threshold range of the difference in the slope of the post-membrane blood drainage and the difference in the slope of the post-membrane blood drainage.

7. The pressure monitoring device for ECMO combined with plasma exchange according to claim 6, characterized in that, The control module determines the slope of the pre-membrane pressure curve based on the pre-membrane pressure change curve; determines the slope of the return blood pressure curve based on the return blood pressure change curve; and adjusts the opening of the return blood valve based on the comparison between the slope of the pre-membrane pressure curve and the slope of the return blood pressure curve.

8. The pressure monitoring device for ECMO combined with plasma exchange according to claim 7, characterized in that, The control module determines the difference in the pre-membrane blood return slope based on the slope of the pre-membrane pressure curve and the slope of the blood return pressure curve, and determines the opening degree of the blood return valve based on the comparison result of the difference in the pre-membrane blood return slope and the threshold range of the difference in the pre-membrane blood return slope. Based on the fact that the difference in the slope of the pre-membrane blood return is greater than the maximum value of the threshold range of the difference in the slope of the pre-membrane blood return, the opening of the blood return valve is increased according to the difference between the difference in the slope of the pre-membrane blood return and the maximum value of the threshold range of the difference in the slope of the pre-membrane blood return. Based on the difference in the pre-membrane blood return slope within the threshold range of the difference in the pre-membrane blood return slope, the current opening of the blood return valve is maintained; Based on the fact that the difference in the slope of the pre-membrane blood return is less than the minimum value of the threshold range of the difference in the slope of the pre-membrane blood return, the opening of the blood return valve is reduced according to the difference between the minimum value of the threshold range of the difference in the slope of the pre-membrane blood return and the difference in the slope of the pre-membrane blood return.

9. The pressure monitoring device for ECMO combined with plasma exchange according to claim 8, characterized in that, The control module determines the valve change amplitude difference based on the synchronicity of the changes in the opening of the blood entrapment valve and the blood return valve, and adjusts the blood flow based on the comparison result of the valve change amplitude difference and the valve change amplitude difference threshold. The difference in valve variation amplitude is the absolute value of the difference in the opening amplitude of the blood inlet valve and the blood return valve within the same adjustment cycle.

10. The pressure monitoring device for ECMO combined with plasma exchange according to claim 9, characterized in that, The control module maintains the current blood flow rate based on the valve change amplitude difference being less than or equal to the valve change amplitude difference threshold; and adjusts the blood flow rate based on the changing trend of the difference between the pre-membrane pressure and the post-membrane pressure based on the valve change amplitude difference being greater than the valve change amplitude difference threshold. Based on the increasing trend of the difference before and after the membrane, blood flow is reduced; The pre- and post-membrane difference shows a decreasing trend, which increases blood flow.

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