Blood purification system, control method thereof, and storage medium

Abstract

The application relates to the technical field of medical devices, and provides a blood purification system, a control method thereof and a storage medium, the blood purification system comprising: a purification module comprising an adsorption device and a dialysis filter arranged in series, the adsorption device being used for adsorbing and removing endotoxins and cytokines in blood; a liquid circulation loop module comprising a pipeline assembly and a power device, the pipeline assembly being used for constructing an extracorporeal circulation loop connected with the purification module, providing a flow channel for liquid, and the power device being used for providing power for liquid flow; a data acquisition module used for acquiring key data of the operation of the blood purification system; and a control module used for controlling the operation of the liquid circulation loop module according to the key data fed back by the data acquisition module. The application improves the reliability and easy operability of the blood purification system.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a blood purification system, its control method, and a storage medium. Background Technology

[0002] Sepsis is a systemic inflammatory response syndrome caused by infection, which often progresses to multiple organ dysfunction syndrome, with an acute kidney injury rate as high as 40-60%. Currently, the clinical application of perfusion combined with CRRT (Continuous Renal Replacement Therapy) is carried out in parallel or sequential manner. The combined system involves multiple connectors and monitoring units, with complex tubing connections, which is inconvenient to operate; moreover, it lacks online monitoring, cannot dynamically adjust the system operation, and has poor reliability. Summary of the Invention

[0003] This application provides a blood purification system, its control method, and a storage medium, aiming to improve the reliability and ease of operation of the blood purification system.

[0004] To achieve the above objectives, this application provides a blood purification system, the blood purification system comprising: The purification module includes an adsorption device and a dialysis filter arranged in series, wherein the adsorption device is used to adsorb and remove endotoxins and cytokines from the blood; The liquid circulation loop module includes a piping assembly and a power unit. The piping assembly is used to construct an external circulation loop connecting the purification module to provide a flow channel for the liquid, and the power unit is used to provide power for the liquid flow. The data acquisition module is used to collect key data on the operation of the blood purification system; The control module is used to control the operation of the liquid circulation loop module based on the key data fed back by the data acquisition module.

[0005] In some embodiments of this application, the adsorption device includes an endotoxin cytokine adsorption column, the interior of which is filled with a styrene-divinylbenzene copolymer adsorption resin. The adsorption resin has a particle size distribution of 300-800 μm, a pore size range of 10-50 nm, and a specific surface area ≥1000 m² / g.

[0006] In some embodiments of this application, the key data include endotoxin concentration, cytokine concentration, pH value, and lactic acid concentration; the endotoxin concentration and the cytokine concentration are collected from the outlet of the adsorption device.

[0007] In some embodiments of this application, the liquid circulation loop module further includes at least two base liquid tanks and a mixer, wherein the at least two base liquid tanks contain replacement fluids of different electrolyte concentrations; the power unit includes at least two metering pumps, each of which draws replacement fluid from the base liquid tanks in proportion, mixes it in the mixer to generate a replacement fluid of a target concentration, and delivers the replacement fluid of the target concentration to the extracorporeal circulation loop.

[0008] In some embodiments of this application, the blood purification system further includes a safety protection module connected to the control module. The control module is also used to control the safety protection module to perform alarm / protection operations based on the key data.

[0009] In some embodiments of this application, the blood purification system further includes a human-computer interaction module, which is connected to the control module. The control module is also used to control the human-computer interaction module to output interactive prompt information based on the key data.

[0010] Furthermore, to achieve the above objectives, this application also provides a control method for a blood purification system, wherein the blood purification system is as described above, and the method includes: Obtain key data on the operation of the blood purification system; The operation of the liquid circulation loop module is controlled based on the aforementioned key data.

[0011] In some embodiments of this application, the key data includes pH value and lactic acid concentration, and controlling the operation of the liquid circulation loop module based on the key data includes: When a first preset condition is met, the liquid circulation loop module is controlled to increase the electrolyte concentration of the replacement fluid injected into the extracorporeal circulation loop; wherein, meeting the first preset condition includes at least one of the following: the pH value is less than or equal to a preset pH threshold, and the increase in lactic acid concentration is greater than or equal to a first preset amplitude threshold. When the second preset condition is met, the liquid circulation loop module is controlled to reduce the electrolyte concentration of the replacement fluid injected into the extracorporeal circulation loop; wherein, meeting the second preset condition includes the lactic acid concentration showing a decreasing trend and being less than or equal to a preset lactic acid concentration threshold.

[0012] In some embodiments of this application, the key data includes endotoxin concentration and cytokine concentration, and controlling the operation of the liquid circulation loop module based on the key data includes: When a third preset condition is met, the liquid circulation loop module is controlled to reduce the blood flow rate in the extracorporeal circulation loop. The third preset condition includes the rate of decrease of the endotoxin concentration being higher than the rate of decrease of the cytokine concentration.

[0013] In some embodiments of this application, the key data includes endotoxin concentration and lactic acid concentration, and the method further includes: When the endotoxin concentration rises above the first reference data and the increase in lactic acid concentration is less than the first preset threshold, the first interactive prompt message is output. When the endotoxin concentration drops below the second reference data, a second interactive prompt message is output.

[0014] In some embodiments of this application, the key data includes endotoxin concentration and cytokine concentration, and the method further includes: When there is no significant change in the concentration of endotoxin and the concentration of cytokines, an alarm message is output to remind relevant personnel to replace the adsorption device.

[0015] In addition, to achieve the above objectives, this application also provides a computer-readable storage medium storing a computer program that, when executed by a processor, implements the steps of the control method for the blood purification system described above.

[0016] This application discloses a blood purification system, its control method, and a storage medium. The blood purification system includes a purification module, a liquid circulation loop module, a data acquisition module, and a control module. The purification module includes an adsorption device and a dialysis filter connected in series. The adsorption device adsorbs and removes medium-to-large molecular inflammatory mediators (such as endotoxins and cytokines) from the blood, while the dialysis filter removes small molecular metabolic wastes (such as creatinine and urea nitrogen) from the blood. The liquid circulation loop module includes a piping assembly and a power unit. The piping assembly constructs an extracorporeal circulation loop connecting the purification module, providing a flow path for the liquid, and the power unit provides power for the liquid flow. The data acquisition module collects blood purification data. The system collects key data for the operation of the blood purification system. The control module, based on key data feedback from the data acquisition module, controls the operation of the liquid circulation loop module. The blood purification system, based on an integrated pipeline interface and support frame, physically forms a compact "treatment module" by connecting the series-connected adsorption device and dialysis filter. This reduces redundant connectors and monitoring units found in traditional combinations, lowers extracorporeal blood volume and coagulation risk, increases reliability, and facilitates operation. Furthermore, the intelligent feedback control of the liquid circulation loop module based on monitored key data improves the reliability of the blood purification system, achieving precise and dynamic purification of the blood of sepsis patients, thus enhancing the safety and individualization of treatment. Further, by constructing an integrated blood purification system based on the physical foundation of an "endotoxin-cytokine adsorption column and CRRT filter in series," and with multi-level monitoring and predictive feedback of "pH-lactic acid-endotoxin" as its core, the system monitors the endotoxin concentration at the adsorption column outlet in real time, predicts the patient's metabolic trend, and dynamically adjusts blood flow rate and electrolyte concentration in the replacement fluid based on real-time pH and lactate levels, achieving a precise transition from "correcting disturbances" to "maintaining homeostasis." Attached Figure Description

[0017] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of a blood purification system provided in an embodiment of this application; Figure 2 This is a schematic diagram illustrating the treatment process and principle of a blood purification system provided in an embodiment of this application; Figure 3 This is a schematic block diagram of a blood purification system provided in an embodiment of this application; Figure 4This is a schematic flowchart illustrating the steps of a control method for a blood purification system provided in an embodiment of this application; Figure 5 This is a schematic flowchart illustrating the steps of another blood purification system control method provided in the embodiments of this application; Figure 6 This is a schematic flowchart illustrating the steps of another blood purification system control method provided in the embodiments of this application; Figure 7 This is a schematic flowchart illustrating the steps of another blood purification system control method provided in the embodiments of this application. Detailed Implementation

[0019] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0020] The flowchart shown in the attached diagram is for illustrative purposes only and does not necessarily include all content and operations / steps, nor does it necessarily have to be performed in the order described. For example, some operations / steps can be broken down, combined, or partially merged, so the actual execution order may change depending on the actual situation.

[0021] It should be understood that the terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise.

[0022] It should also be understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0023] Sepsis is a systemic inflammatory response syndrome caused by infection, often progressing to multiple organ dysfunction syndrome, with an acute kidney injury rate as high as 40-60%. Blood purification involves drawing the patient's blood out of the body using blood purification equipment and removing certain pathogenic substances through consumables to purify the blood and achieve therapeutic goals. This includes hemoperfusion and CRRT (Continuous Venous-Venous Hemofiltration) therapy. Hemoperfusion utilizes adsorbents to selectively adsorb and remove pathogenic substances from the blood. CRRT is a blood purification technique that continuously and slowly removes water and solutes through extracorporeal circulation to replace kidney function. It mainly includes treatment modes such as continuous venous-vein filtration (CVVH), continuous venous-venous hemodiafiltration (CVVHDF), and continuous venous-venous hemodialysis (CVVHD).

[0024] Currently, the clinical application of perfusion combined with CRRT is carried out in parallel or sequential manner. There is a lack of an integrated treatment system that is tailored to the pathological characteristics of sepsis. The combined system has complex tubing connections, which is inconvenient to operate and has high medical costs. Furthermore, the existing adsorption materials have single pore size and poor adsorption selectivity, which have limitations. There is also a lack of online monitoring, which makes it impossible to dynamically adjust the system operation and has poor reliability.

[0025] To address the aforementioned issues, embodiments of this application provide a blood purification system, its control method, and a storage medium to improve the reliability and ease of operation of the blood purification system.

[0026] Please see Figure 1 , Figure 1 This is a schematic diagram of the structure of a blood purification system provided in an embodiment of this application, as shown below. Figure 1 As shown, the blood purification system 1000 may include a purification module 100, a liquid circulation loop module 200, a data acquisition module 300, and a control module 400. The purification module 100 includes an adsorption device 110 and a dialysis filter 120 arranged in series. Exemplarily, the adsorption device 110 includes an endotoxin / cytokine adsorption column, and the dialysis filter 120 includes a CRRT filter; however, this application does not limit the scope of the application. The adsorption device 110 is used to adsorb and remove medium to large molecular mediators in the blood, such as endotoxins and cytokines; the dialysis filter 120 is used to remove small molecular mediators in the blood, such as creatinine and urea nitrogen. The dialysis filter 120 can be configured with an appropriate effective membrane area based on the patient's condition.

[0027] For example, taking the adsorption device 110 as an endotoxin-cytokine adsorption column, the column is filled with styrene-divinylbenzene copolymer adsorption resin. This resin has a bimodal pore size distribution and a surface modified with hydrophobic-cationic bifunctional ligands, enabling it to adsorb endotoxins and cytokines. The bimodal pore size distribution provides rapid channels and adsorption sites for substances such as endotoxins and cytokines of different molecular weights, avoiding filtration blockage or incomplete adsorption caused by single-pore sizes. Furthermore, special ligands with both hydrophobic and cationic properties are chemically grafted onto the styrene-divinylbenzene copolymer backbone. The hydrophobic portion efficiently adsorbs nonpolar or hydrophobic molecules, such as lipids, through hydrophobic interactions; the cationic portion captures substances that are typically negatively charged in the inflammatory environment of sepsis through electrostatic adsorption. This dual "hydrophobic-electrostatic" mechanism achieves efficient and synergistic adsorption of heterogeneous mixtures of endotoxins and cytokines, rather than simple physical filtration, thus improving adsorption performance.

[0028] As an alternative implementation, the cationic ligand on the adsorption resin can be a monomer containing an amino group (primary amine) at one end and a hydrophobic fatty chain at the other end. For example, monomers such as butylamine, hexylamine, and hexadecylamine can be selected. The cationic ligand can also be a monomer containing amino groups (primary amine) at both ends and a hydrophobic fatty chain at the middle end. For example, monomers such as octyldiamine, decanediamine, and lysine can be selected. By selecting cationic ligands containing both amine groups and hydrophobic fatty chains, a strong adsorption effect can be achieved on the lipid A moiety of endotoxin. Since lipid A contains negatively charged phosphate groups, after the cationic ligand is grafted onto the adsorption resin backbone, a secondary amine structure is formed. This structure has a strong electrostatic adsorption effect in solution and can form a strong electrostatic force with the phosphate groups on the endotoxin lipid A moiety, thus adsorbing the endotoxin through electrostatic interaction. At the same time, lipid A also contains hydrophobic fatty chains. The hydrophobic fatty chains in the cationic ligand can be adsorbed together with the fatty chains of the endotoxin lipid A moiety through hydrophobic interaction, thus adsorbing the endotoxin through hydrophobic interaction. This achieves a dual adsorption site form of electrostatic adsorption and hydrophobic adsorption, which can improve the adsorption capacity of the adsorption resin for endotoxin.

[0029] As an alternative implementation, the hydrophobic fatty chain in the cationic ligand contains 4 to 30 carbon atoms. This avoids the situation where a small number of carbon atoms in the hydrophobic fatty chain weakens the hydrophobic adsorption force of the cationic ligand, affecting the adsorption performance of endotoxins. It also avoids the situation where an excessive number of carbon atoms in the hydrophobic fatty chain leads to a low grafting rate due to the large molecular weight of the cationic ligand hindering diffusion during grafting. Furthermore, an excessively large molecular weight of the grafted cationic ligand may alter the structure of the adsorption resin, adversely affecting the adsorption of cytokines. Therefore, limiting the number of carbon atoms in the hydrophobic fatty chain of the cationic ligand within the aforementioned range ensures that the adsorption resin has good adsorption effects on both cytokines and endotoxins. Preferably, the hydrophobic fatty chain in the cationic ligand contains 5 to 16 carbon atoms.

[0030] For example, the adsorption resin has a particle size distribution of 300-800 μm, a pore size range of 10-50 nm, and a specific surface area (measured by BET method) ≥1000 m² / g, thereby ensuring that the adsorption resin has a good adsorption capacity for endotoxins and cytokines in the blood.

[0031] The series design of the adsorption device 110 and the dialysis filter 120 brings about a synergistic effect. The blood first passes through the adsorption device 110 and then through the dialysis filter 120 for purification. The adsorption device 110 removes most of the medium and large molecules in the blood first, which significantly reduces the membrane fouling load of the subsequent dialysis filter 120. This allows the dialysis filter 120 to maintain a high clearance rate of small molecule toxins during long-term treatment and extends the service life of the dialysis filter 120 in a single treatment.

[0032] The liquid circulation loop module 200 includes a tubing assembly 210 and a power unit 220. The tubing assembly 210 includes an arterial tubing 211, a venous tubing 212, etc., and is used to construct an extracorporeal circulation loop connecting the purification module 100. It integrates the adsorption device 110 and the dialysis filter 120 in series within the same extracorporeal circulation tubing, forming an integrated blood purification system. The extracorporeal circulation loop provides a flow path for blood, replacement fluid, and other liquids. The power unit 220 includes a blood pump 221, a heparin pump 222, a dialysate pump 223, a replacement fluid pump 224, a waste fluid pump 225, and at least two metering pumps 226. For example, the blood pump 221, heparin pump 222, dialysate pump 223, and replacement fluid pump 224 can all be peristaltic pumps, and the heparin pump 222 can also be a linearly driven injection pump. The power unit 220 provides power for the flow of blood, replacement fluid, and other liquids.

[0033] For example, the tubing assembly 210 also includes a venous reservoir 213, a dialysate bag 214, a waste fluid bag 215, at least two base fluid tanks 216, a mixer 217, etc. The dialysate bag 214 contains dialysate; the waste fluid bag 215 is used to collect and store treatment waste fluid; the at least two base fluid tanks 216 contain replacement fluids of different electrolyte concentrations, for example, one base fluid tank 216 contains a normal concentration replacement fluid and the other a high concentration replacement fluid. Each metering pump 226 draws replacement fluid proportionally from the corresponding base fluid tank 216, and then mixes it in the mixer 217 to generate a replacement fluid of the target concentration, providing a concentration-adjustable replacement fluid that is delivered to the extracorporeal circulation loop, for example, providing a concentration-adjustable replacement fluid to the venous reservoir 213. The dialysate bag 214 can also be replaced by a configuration of at least two base fluid tanks 216, metering pumps 226, and a mixer 217 to provide a concentration-adjustable dialysate delivery to the dialysis filter 120.

[0034] Combination Figure 1 and Figure 2 As shown, the treatment process and principle of the Blood Purification System 1000 are as follows: The inlet of arterial tubing 211 is connected to the patient's artery, and the outlet of venous tubing 212 is connected to the patient's vein, forming an extracorporeal circulation loop. During treatment, blood drawn from the patient is purified through a series of adsorption devices 110 and dialysis filters 120, and the purified blood is then returned to the patient. Pumps provide the driving force to ensure the fluid within the tubing is transported at the desired flow rate and direction. The dialysis filter 120 has a hollow fiber membrane inside, with blood and dialysate distributed in chambers separated by the membrane. The dialysate and blood exchange substances on both sides of the membrane, and the waste fluid is collected by a waste bag 215, while the blood enters a venous reservoir 213. Metering pumps 226 proportionally pump replacement fluid to a mixer 217 for mixing, resulting in a suitable concentration of replacement fluid that enters the venous reservoir 213 to mix with the blood. The venous reservoir 213 buffers the blood flow rate and removes air bubbles. Continuous replenishment of fresh dialysate and replacement fluid during treatment ensures the patient's electrolyte balance.

[0035] The data acquisition module 300 includes a key indicator detection device (not shown in the figure), a bubble detector 310, a blood detector 320, and a pressure sensor (used for detection). Figure 1The system includes sensors for arterial pressure, pre-filter pressure, extra-membrane pressure, and venous pressure at corresponding locations in the tubing components; a temperature sensor in the heater 330 (not shown in the figure); and a flow rate sensor for detecting pump speed (not shown in the figure). The data acquisition module 300 collects key data on the operation of the blood purification system 1000. This key data includes endotoxin concentration, cytokine (such as IL-6 and TNF-α) concentration, pH value, lactate concentration, and electrolyte signals. For example, each key data point has a different priority. pH value directly reflects the acid-base balance and has the highest priority; lactate concentration is a direct metabolic factor causing pH changes and has the second highest priority; endotoxin concentration is a predictive upstream indicator of inflammation and metabolic disorders and has a lower priority than lactate concentration.

[0036] The key indicator detection device integrates various biosensors for online detection of these key data. For example, the key indicator detection device is connected to an extracorporeal circulation loop, such as... Figure 1 Sampling point 218 is used to detect the endotoxin and cytokine concentrations in the blood at the outlet of the adsorption device 110. These concentrations directly reflect the immediate toxin load and the residual removal capacity of the adsorption device 110. In addition, the pH, lactate, and electrolyte signals of the blood in the venous line 212 are also detected. The electrolyte signals include the concentrations of electrolyte ions, such as sodium, potassium, and chloride ions.

[0037] For example, the key indicator detection device integrates an online endotoxin detection device and an online cytokine detection device. A very small amount of blood is diverted from the outlet of the adsorption device 110 using microfluidic technology. Endotoxin-related detection methods (such as the Limulus Amebocyte Lysate (LAL) assay and EAA assay) and cytokine detection methods (such as chemiluminescence immunoassay) are then used to continuously and in real-time monitor the concentrations of endotoxins and cytokines based on the online endotoxin and cytokine detection devices. This online monitoring of endotoxin and cytokine concentrations facilitates monitoring of the clearance effect and saturation status of the adsorption device 110 during treatment.

[0038] It should be noted that in some other embodiments, the key indicator detection device can be replaced by a semi-automatic mode of "offline monitoring + manual input", that is, sampling is taken from the corresponding pipeline location at regular intervals, key data such as endotoxin concentration and cytokine concentration are obtained using a point-of-care testing (POCT) instrument, and then the data collection method is manually entered into the system by medical staff.

[0039] like Figure 3As shown, the control module 400 of the blood purification system 1000 is connected to the liquid circulation loop module 200 and the data acquisition module 300. The control module 400 is a programmable controller system such as a CPU (Central Processing Unit) or PLC (Programmable Controller). The data acquisition module 300 feeds back the collected key data to the control module 400. The control module 400 is used to regulate the operation of the liquid circulation loop module 200 based on the key data fed back by the data acquisition module 300.

[0040] For example, if the monitored endotoxin and cytokine concentrations indicate that the rate of endotoxin decline is higher than that of cytokines, the blood flow rate can be automatically reduced proportionally until the rates of endotoxin and cytokine decline are equal (i.e., the difference between their rates is within 5%) or the blood flow rate reaches a minimum allowable value (i.e., a system-preset safe flow rate threshold, such as 50 ml / min). This prolongs the blood's residence time in the adsorption column, enhancing adsorption. Clinical studies have found that reducing blood flow rate improves the adsorption efficiency of the adsorption column for target substances. Therefore, when the adsorption efficiency of cytokines lags behind that of endotoxins, reducing blood flow rate enhances the adsorption of cytokines, fully utilizing the effectiveness of the adsorption column.

[0041] For example, the concentrations of potassium ions and bicarbonate ions in the dialysate / replacement fluid can be automatically adjusted based on the electrolyte signal monitored by the ion-selective electrode (integrated in the key indicator detection device or used in conjunction with bedside detection).

[0042] For example, each metering pump 226 is connected to a base fluid tank 216 of different concentrations of replacement fluid / dialysis fluid (e.g., one base fluid tank 216 contains high-concentration bicarbonate, and another base fluid tank 216 contains normal-concentration bicarbonate). After receiving instructions from the control module, each metering pump 226 automatically adjusts the proportion of fluid drawn from its corresponding base fluid tank 216, generates a fluid of the target concentration in the mixer 217, and then delivers it to the extracorporeal circulation loop. The entire process is dynamic and continuous; the system constantly fine-tunes the fluid concentration based on monitoring results to stabilize the patient's acid-base status within the ideal range.

[0043] For example, such as Figure 1 As shown, the blood purification system 1000 also includes a safety protection module 500, which includes an arterial clamp 510, a venous clamp 520, and an alarm (not shown in the figure), wherein the alarm can be an audible and visual alarm. Figure 3As shown, the safety protection module 500 is connected to the control module 400. The control module 400 is also used to control the safety protection module 500 to perform alarm / protection operations based on key data, such as issuing alarms, opening and closing arterial clamps 510 and vein clamps 520, etc.

[0044] For example, such as Figure 3 As shown, the blood purification system 1000 also includes a human-machine interaction module 600, which includes a touch screen, etc. The human-machine interaction module 600 is connected to the control module 400. The control module 600 is also used to control the human-machine interaction module 600 to output interactive prompt information based on key data, such as outputting a prompt that the endotoxin cytokine adsorption column may be saturated.

[0045] Based on the monitored key data, the control module 400 adjusts the operation of the liquid circulation loop module 200 and / or controls the issuance of alarms, interactive prompts, etc. For example, when the concentrations of cytokines (such as IL-6) and endotoxins do not change significantly for multiple (such as 3) consecutive monitoring cycles (such as once every 30 minutes), such as when the relative standard deviation (RSD) of the cytokine concentrations for multiple monitoring cycles is less than a specific value (such as 5%), it is determined that the adsorption device 110 may be approaching saturation, and a replacement warning is issued.

[0046] For example, when the endotoxin concentration is detected to have increased by more than 30% of the initial endotoxin concentration before treatment for two consecutive times, while the lactate concentration and pH value do not change significantly (e.g., the relative standard deviation (RSD) of the detection values ​​for three consecutive monitoring cycles is less than 5%), an early warning is issued to relevant personnel, such as indicating that "the inflammatory burden may worsen, and the risk of subsequent metabolic acidosis should be monitored, and preparations should be made to adjust the bicarbonate concentration." By analyzing the trend of endotoxin concentration changes, the possible changes in subsequent lactate concentration and pH value can be predicted, thus achieving predictive regulation based on upstream indicators.

[0047] For example, when lactate concentration decreases consecutively (e.g., twice) and the absolute value drops below 4.0 mmol / L, the patient's metabolic status is considered to have improved, suggesting that the concentration of bicarbonate replacement solution be gradually reduced by 10-20% from a higher correction level (e.g., 35 mmol / L); conversely, if lactate concentration rises, it should be increased accordingly. This achieves a precise transition from "correcting disorder" to "maintaining homeostasis," avoiding the risk of overcorrection (e.g., metabolic alkalosis).

[0048] The Blood Purification System 1000 is based on online monitoring of endotoxin and cytokine concentrations, combined with pH and lactate concentrations monitored to maintain acid-base balance. It introduces multiple online real-time monitoring and intelligent feedback control to dynamically adjust treatment parameters according to the patient's inflammatory status. Dynamic adjustment is essentially a precise transition from "correcting disorders" to "maintaining homeostasis." The drawback of not adjusting is that if high concentrations of bicarbonate are continued to be used after the patient's own metabolic capacity recovers, it will lead to metabolic alkalosis, which will cause new clinical risks such as a leftward shift of the oxygen dissociation curve (tissue hypoxia), hypokalemia, and arrhythmia. The system predicts and adjusts the buffer salt concentration based on the level of inflammatory mediators to achieve individualized and precise regulation of water and electrolyte balance.

[0049] In the above embodiments, the blood purification system 1000 is based on an integrated pipeline interface and support frame, which makes the adsorption device 110 and the dialysis filter 120 physically form a compact "treatment module". This module uses a shared pressure monitoring point and safety alarm circuit, which reduces the redundant connectors and monitoring units in the traditional combination method, reduces the extracorporeal blood volume and coagulation risk, and improves the reliability and ease of operation of the blood purification system 1000.

[0050] Please see Figure 4 , Figure 4 This is a schematic flowchart of a control method for a blood purification system provided in one embodiment of this application. This method can be applied to the blood purification system 1000 of the above embodiment, for example, in the control module 400 of the blood purification system 1000.

[0051] like Figure 1 As shown, the control method of the blood purification system specifically includes steps S101 to S102.

[0052] S101. Obtain key data on the operation of the blood purification system; S102. Control the operation of the liquid circulation loop module based on the key data.

[0053] The following is combined with Figure 1-2 Detailed introduction to the workflow and operation of the 1000 blood purification system and its control method: First, the system pre-charge phase: First, pre-charge the adsorption device 110 according to the pre-charge requirements for the endotoxin cytokine adsorption column to ensure that the endotoxin cytokine adsorption column is fully wetted. Then, pre-charge the dialysis filter 120 to ensure that air is removed.

[0054] Second, in the treatment initiation phase: Establish an extracorporeal circulation loop, set the initial blood flow rate of blood pump 221 to 50 mL / min, and gradually increase it to the target flow rate of 150-200 mL / min; turn on the dialysis system, and generally set the dialysate flow rate of dialysate pump 223 to below 500 mL / min; administer heparin or citrate anticoagulation according to the anticoagulation protocol via heparin pump 222.

[0055] Third, the treatment operation phase: The system operates according to preset parameters, online monitoring is initiated, and sampling point 218 is located at the outlet of the endotoxin-cytokine adsorption column. It continuously analyzes the diverted blood, comparing real-time endotoxin and cytokine concentrations with their rate of decline and preset target values. The system continuously monitors three key data types based on the integrated data acquisition module 300 and processes them according to preset priorities: A) Direct signal of acid-base balance: pH value (highest priority), the monitoring cycle can be set, for example, once every 30 minutes.

[0056] B) Metabolic factor signals: lactate concentration (second priority), the monitoring cycle can be set to, for example, once every 30 minutes.

[0057] C) Predictive signals of infection source: the concentration of endotoxins and cytokines and their rate of decline (located at the outlet of the endotoxin-cytokine adsorption column), with the monitoring cycle set, for example, once every 30 minutes.

[0058] D) Electrolyte signals: sodium, potassium, and chloride ion concentrations.

[0059] Based on key monitoring data, feedback control is implemented, including: if the endotoxin clearance rate meets the target but the cytokine clearance rate lags behind, the system can automatically reduce the blood flow rate proportionally and issue an alarm to remind operators to pay attention to the saturation of the endotoxin and cytokine adsorption column. Simultaneously, the system can automatically adjust the concentrations of potassium ions and bicarbonate ions in the dialysate / replacement fluid based on electrolyte signals monitored by ion-selective electrodes (integrated into the key indicator detection device or used in conjunction with bedside monitoring).

[0060] For example, corresponding rules are preset, and the system performs feedback control based on the preset rules. For instance, the preset rules include: 1) Safety and Correction Levels (based on pH and lactate concentration): If the pH value is <7.25, a prompt will be made to start a high-concentration bicarbonate replacement solution (e.g., 35 mmol / L) and an alarm will be triggered immediately. If the lactate concentration decreases in two consecutive tests and the current value is ≤4.0 mmol / L, it is determined that metabolism has improved, and the instruction will suggest reducing the bicarbonate concentration by 15% (e.g., from 32 mmol / L to 27.2 mmol / L). If the lactic acid concentration increases by more than 10% in two consecutive tests, the instruction will prompt to increase the bicarbonate concentration by 10%.

[0061] 2) Prediction and early warning levels (based on endotoxin concentration): If the endotoxin concentration increases by more than 30% of the initial endotoxin concentration before treatment in two consecutive tests, and the lactate concentration does not increase significantly, the system will issue an alert: "An upward trend in endotoxins has been detected, indicating that inflammatory activity may be increasing. Please pay attention to subsequent changes in lactate and pH, and prepare to adjust the carbonated regimen." If the endotoxin concentration decreases by more than 50% of the patient's initial endotoxin concentration before treatment in two consecutive tests, it is considered that the inflammatory burden will be significantly reduced, and the system can suggest an assessment of whether the treatment intensity needs to be adjusted.

[0062] 3) Equipment status monitoring hierarchy (based on adsorption efficiency): If the relative standard deviation (RSD) of three consecutive measurements of endotoxin concentration and cytokine (such as IL-6) concentration is less than 5%, the endotoxin-cytokine adsorption column is considered to be saturated, and the system will prompt "consider replacing the endotoxin-cytokine adsorption column".

[0063] For example, controlling the operation of the liquid circulation loop module based on the key data includes: when a first preset condition is met, controlling the liquid circulation loop module to increase the electrolyte concentration of the replacement fluid injected into the extracorporeal circulation loop; wherein, meeting the first preset condition includes at least one of the pH value being less than or equal to a preset pH threshold and the increase in lactic acid concentration being greater than or equal to a first preset amplitude threshold; when a second preset condition is met, controlling the liquid circulation loop module to decrease the electrolyte concentration of the replacement fluid injected into the extracorporeal circulation loop; wherein, meeting the second preset condition includes the lactic acid concentration showing a decreasing trend and being less than or equal to a preset lactic acid concentration threshold.

[0064] The preset pH threshold can be flexibly set according to actual conditions, such as 7.25, and no specific limitation is made in this application. For example, if the monitored pH value is less than or equal to the preset pH threshold, such as less than 7.25, a prompt will be made to start a high-concentration (e.g., 35 mmol / L) bicarbonate replacement solution and an alarm will be triggered. The system will control and increase the concentration of bicarbonate replacement solution injected into the extracorporeal circulation loop.

[0065] In this article, "increase" or "decrease" means: | the value detected this time Previous test value | ÷ Previous test value × 100%.

[0066] The first preset threshold for lactate concentration can be flexibly set according to actual conditions, such as 10%, and is not specifically limited in this application. For example, if the lactate concentration increases by more than 10% in two consecutive tests, the system will prompt an increase of 10% in the concentration of bicarbonate replacement solution. The preset lactate concentration threshold can be flexibly set according to actual conditions, such as 4.0 mmol / L, and is not specifically limited in this application. For example, if the lactate concentration decreases in two consecutive tests, and the current lactate concentration is less than or equal to 4.0 mmol / L, metabolic improvement is determined, and the system will control the reduction of the concentration of bicarbonate replacement solution injected into the extracorporeal circulation loop (by 15%), for example, from 32 mmol / L to 27.2 mmol / L, to reduce the patient's metabolic burden.

[0067] For example, controlling the operation of the liquid circulation loop module based on the key data includes: when a third preset condition is met, controlling the liquid circulation loop module to reduce the blood flow rate in the extracorporeal circulation loop, wherein meeting the third preset condition includes the rate of decrease of the endotoxin concentration being higher than the rate of decrease of the cytokine concentration.

[0068] For example, when both endotoxin and cytokine concentrations are detected to be decreasing, and the rate of decrease in endotoxin concentration is higher than that of cytokine concentration, the control fluid circulation loop module reduces the blood flow rate in the extracorporeal circulation loop by 20%-30%, until the rate of decrease in endotoxin and cytokine concentrations is equal (i.e., the difference in their rates of decrease is within 5%) or the blood flow rate reaches the minimum allowable value (i.e., the system's preset safe flow rate threshold, such as 50 ml / min). The rate of decrease in both endotoxin and cytokine concentrations is represented as: | Current concentration detection value Previous concentration value | ÷ Monitoring period (e.g., 30 minutes).

[0069] It should be noted that, in addition to the feedback control methods listed above, predictive control models based on machine learning can also be used to predict the trend of toxin changes and make pre-adjustments based on the patient's previous data. This application does not limit the scope of these methods.

[0070] For example, such as Figure 5 As shown, step S103 is included after step S101.

[0071] S103. When the endotoxin concentration rises above the first reference data and the increase in lactic acid concentration is less than the first preset threshold, output the first interactive prompt message.

[0072] The first reference data corresponding to the endotoxin concentration can be flexibly set according to the actual situation, such as 30% of the initial detection value of the patient's endotoxin concentration before treatment. This application does not impose specific restrictions. For example, if the increase in the endotoxin concentration in two consecutive detections exceeds 30% of the initial detection value of the patient's endotoxin concentration before treatment, and the increase in the lactate concentration in two consecutive detections does not exceed 10%, and the lactate concentration does not increase significantly, then the first interactive prompt message such as "An increasing trend of endotoxin was detected, indicating that the inflammatory activity may be enhanced. Please pay attention to subsequent changes in lactate and pH, and prepare to adjust the carbonated regimen" will be output as an early warning. This is predictive logic, which reflects the intelligence of the system.

[0073] For example, such as Figure 6 As shown, step S104 is included after step S101.

[0074] S104. When the endotoxin concentration drops below the second reference data, output the second interactive prompt message.

[0075] The second reference data corresponding to the endotoxin concentration can be flexibly set according to the actual situation, such as being set to 50% of the initial detection value of the patient's endotoxin concentration before treatment. This application does not impose specific restrictions. For example, if the decrease in the endotoxin concentration in two consecutive detections exceeds 50% of the initial detection value of the patient's endotoxin concentration before treatment, it is considered that the inflammatory burden will be significantly reduced, and a second interactive prompt message such as "Does the treatment intensity need to be adjusted?" can be output.

[0076] For example, such as Figure 7 As shown, step S105 is included after step S101.

[0077] S105. When there is no significant change in endotoxin concentration and cytokine concentration, an alarm message is output to remind relevant personnel to replace the adsorption device.

[0078] For example, if the relative standard deviation (RSD) of three consecutive measurements of cytokine (such as IL-6) concentration is less than 5%, it is considered that there is no significant change. Similarly, if the relative standard deviation (RSD) of three consecutive measurements of endotoxin concentration is less than 5%, it is considered that there is no significant change. Based on this, it is determined that the adsorption device 110 is approaching saturation for the adsorption of the cytokine and outputs an early warning such as "Consider replacing the endotoxin cytokine adsorption column" to remind relevant personnel to replace the endotoxin cytokine adsorption column.

[0079] The entire process forms a closed-loop automatic control cycle of "monitoring-analysis-decision-execution".

[0080] The key technical parameters involved in the treatment process are as follows: Blood flow rate control: Initially 50-100 mL / min, then stabilize at 150-200 mL / min. The system can automatically fine-tune within ±30 mL / min based on online monitoring data.

[0081] Adsorption time: It not only depends on a fixed time, but also mainly refers to online monitoring data. When the relative standard deviation (RSD) of three consecutive detection values ​​of endotoxin concentration and cytokine (such as IL-6) concentration is less than 5%, the system indicates that the endotoxin and cytokine adsorption column may be saturated.

[0082] Dialysis protocol: CVVH (continuous venous-venous hemofiltration) or CVVHDF (continuous venous-venous hemodiafiltration) mode is used, and the composition of the replacement fluid can be dynamically adjusted according to the online monitoring results.

[0083] Anticoagulation regimen: local anticoagulation with citrate, targeting ACT (activated clotting time) of 180-220 seconds.

[0084] Monitoring frequency: Endotoxins and cytokines are monitored online in real time at a frequency of 30 minutes / time, which can be combined with routine biochemical monitoring.

[0085] Fourth, the final stage of treatment: Gradually reduce the blood flow rate to 50 mL / min; flush the blood back with approximately 200 mL of normal saline until the blood is completely removed from the endotoxin cytokine adsorption column and dialysis filter; record the treatment time, blood volume processed, complications, and other information.

[0086] This application also provides a computer-readable storage medium storing a computer program, which, when executed by a processor, implements the steps of the control method for the blood purification system described above.

[0087] The computer-readable storage medium can be an internal storage unit of the blood purification system or control module described in the foregoing embodiments, such as the hard disk or memory of the blood purification system or control module. Alternatively, the computer-readable storage medium can be an external storage device of the blood purification system or control module, such as a plug-in hard disk, smart media card (SMC), secure digital card (SD card), flash card, etc., equipped on the blood purification system or control module.

[0088] Since the computer program stored in the storage medium can execute any of the blood purification system control methods provided in the embodiments of this application, the beneficial effects that any of the blood purification system control methods provided in the embodiments of this application can achieve can be realized, as detailed in the preceding embodiments, and will not be repeated here.

[0089] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or system that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or system. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or system that includes that element.

[0090] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the scope of the technology disclosed in this application, and these modifications or substitutions should all be covered within the scope of protection of this application.

Claims

1. A blood purification system, characterized in that, The blood purification system includes: The purification module includes an adsorption device and a dialysis filter arranged in series, wherein the adsorption device is used to adsorb and remove endotoxins and cytokines from the blood; The liquid circulation loop module includes a piping assembly and a power unit. The piping assembly is used to construct an external circulation loop connecting the purification module to provide a flow channel for the liquid, and the power unit is used to provide power for the liquid flow. The data acquisition module is used to collect key data on the operation of the blood purification system; The control module is used to control the operation of the liquid circulation loop module based on the key data fed back by the data acquisition module.

2. The blood purification system as described in claim 1, characterized in that, The adsorption device includes an endotoxin cytokine adsorption column, which is filled with styrene-divinylbenzene copolymer adsorption resin. The adsorption resin has a particle size distribution of 300-800 μm, a pore size range of 10-50 nm, and a specific surface area ≥1000 m² / g.

3. The blood purification system as described in claim 1, characterized in that, The key data include endotoxin concentration, cytokine concentration, pH value, and lactic acid concentration; the endotoxin concentration and the cytokine concentration are collected from the outlet of the adsorption device.

4. The blood purification system as described in claim 1, characterized in that, The liquid circulation loop module further includes at least two base liquid tanks and a mixer. The at least two base liquid tanks contain replacement fluids with different electrolyte concentrations. The power unit includes at least two metering pumps. Each metering pump draws replacement fluid from the base liquid tanks in proportion and mixes them in the mixer to generate a replacement fluid of the target concentration. The replacement fluid of the target concentration is then delivered to the extracorporeal circulation loop.

5. The blood purification system as described in claim 1, characterized in that, The blood purification system also includes a safety protection module, which is connected to the control module. The control module is also used to control the safety protection module to perform alarm / protection operations based on the key data.

6. The blood purification system as described in claim 1, characterized in that, The blood purification system also includes a human-computer interaction module, which is connected to the control module. The control module is also used to control the human-computer interaction module to output interactive prompt information based on the key data.

7. A control method for a blood purification system, characterized in that, The blood purification system is the blood purification system as described in any one of claims 1 to 6, and the method includes: Obtain key data on the operation of the blood purification system; The operation of the liquid circulation loop module is controlled based on the aforementioned key data.

8. The control method as described in claim 7, characterized in that, The key data includes pH value and lactic acid concentration. Controlling the operation of the liquid circulation loop module based on the key data includes: When a first preset condition is met, the liquid circulation loop module is controlled to increase the electrolyte concentration of the replacement fluid injected into the extracorporeal circulation loop; wherein, meeting the first preset condition includes at least one of the following: the pH value is less than or equal to a preset pH threshold, and the increase in lactic acid concentration is greater than or equal to a first preset amplitude threshold. When the second preset condition is met, the liquid circulation loop module is controlled to reduce the electrolyte concentration of the replacement fluid injected into the extracorporeal circulation loop; wherein, meeting the second preset condition includes the lactic acid concentration showing a decreasing trend and being less than or equal to a preset lactic acid concentration threshold.

9. The control method as described in claim 7, characterized in that, The key data includes endotoxin concentration and cytokine concentration. Controlling the operation of the liquid circulation loop module based on the key data includes: When a third preset condition is met, the liquid circulation loop module is controlled to reduce the blood flow rate in the extracorporeal circulation loop. The third preset condition includes the rate of decrease of the endotoxin concentration being higher than the rate of decrease of the cytokine concentration.

10. The control method as described in claim 7, characterized in that, The key data include endotoxin concentration and lactic acid concentration, and the method further includes: When the endotoxin concentration rises above the first reference data and the increase in lactic acid concentration is less than the first preset threshold, the first interactive prompt message is output. When the endotoxin concentration drops below the second reference data, a second interactive prompt message is output.

11. The control method as described in claim 7, characterized in that, The key data include endotoxin concentration and cytokine concentration, and the method further includes: When there is no significant change in the concentration of endotoxin and the concentration of cytokines, an alarm message is output to remind relevant personnel to replace the adsorption device.

12. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program that, when executed by a processor, implements the steps of the control method for the blood purification system as described in any one of claims 7 to 11.

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