Improved infusion system and medicine applied to CBP citric acid anticoagulation

Abstract

The invention provides an improved infusion system and medicine for citric acid anticoagulation applied to continuous blood purification (CBP). According to the system, an on-line conductivity sensor is additionally arranged in a citric acid infusion pipeline, real-time monitoring and intelligent feedback control over the concentration of citric acid are achieved, the infusion pump speed can be automatically adjusted, and it is ensured that the concentration is maintained within the set range (3.0-4.0 mmol / L). In addition, the system is further provided with a sound-light alarm function, an alarm is given out when the concentration fluctuation exceeds 0.5 mmol / L, and the treatment safety is guaranteed. Meanwhile, according to the optimized citric acid formula, the risk of hypocalcemia is effectively reduced by accurately adjusting the pH value of the solution and adding EDTA disodium. According to the system, through accurate monitoring, automatic adjustment and efficient pipeline management, the safety and effect of CBP treatment are greatly improved, and the system is suitable for treatment requirements of various complex patients. Through verification of the embodiment, the traditional Chinese medicine composition shows a good treatment effect and safety in practical application, and has a wide clinical popularization prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of citric acid anticoagulation, and particularly relates to an improved infusion system and medicine applied to CBP citric acid anticoagulation. BACKGROUND

[0002] Continuous hemodialysis, as a common treatment method, is widely used in the treatment of acute renal failure, chronic renal failure, severe infection, multiple organ failure and other diseases. In the CBP treatment process, the blood dialysis machine filters the patient's blood through the dialysis membrane to remove waste and excess water in the body, and prevents blood coagulation through anticoagulants to ensure the smooth progress of the dialysis process. Citric acid anticoagulation has been widely used in CBP treatment due to its low complication rate and good anticoagulation effect.

[0003] However, citric acid anticoagulation still faces many challenges in clinical application, especially in terms of concentration control, stability of anticoagulation effect and safety of treatment. There are certain technical bottlenecks. The traditional citric acid anticoagulation infusion method often relies on manual setting of infusion flow rate and concentration, which is easily affected by the experience of the operator and external environmental changes, resulting in large fluctuations in citric acid concentration, thereby causing blood coagulation abnormalities, hypocalcemia and other complications. In addition, the existing system lacks real-time monitoring of citric acid concentration and patient coagulation function, and fails to achieve precise automatic adjustment and feedback control, resulting in unstable treatment effect and certain safety hazards.

[0004] At present, although the common citric acid infusion system can achieve basic infusion control of the medicine, for example, the application number 201911221060.5 discloses an improved infusion system and medicine applied to CBP citric acid anticoagulation. The blood pump is connected with a blood filter, the blood filter is further connected with a venous pot, the upper end of the venous pot is connected with a group pump for pumping 4% sodium citrate solution for anticoagulation, the minimum dose of the 4% sodium citrate solution for anticoagulation pumped by the group pump is 10-20 ml / h, the blood filter is connected with an ultrafiltrate output pipe, and the upper end of the venous pot is further connected with a replacement liquid input pipe. However, the system in the above technical solution has the following problems:

[0005] Large concentration fluctuation: the concentration of citric acid is difficult to control accurately, and the fluctuation range is large, especially during long-term treatment, which may lead to insufficient or excessive anticoagulation, increasing the risk of bleeding and thrombosis.

[0006] Lack of real-time monitoring and adjustment mechanism: the traditional system lacks concentration monitoring and feedback adjustment mechanism, and cannot dynamically adjust the drug infusion rate according to real-time data, so that the treatment process relies on the static set concentration and flow rate, and cannot adapt to the real-time changes of the patient's physical condition.

[0007] Inadequate management of complications: During the citrate anticoagulation process, complications such as hypocalcemia are common risks, but the existing system for monitoring and adjusting blood calcium concentration is relatively lagging, and timely adjustment is not made, which may cause discomfort to the patient.

[0008] Risk of pipeline blockage and contamination: During treatment, the pipeline may form clumps or deposits due to the reaction of citrate with other substances in the blood, causing pipeline blockage problems. The existing system lacks effective pipeline cleaning and maintenance mechanisms, resulting in decreased system efficiency and increased risk of treatment interruption.

[0009] To solve the above problems, there is an urgent need for a more precise, intelligent, and automated citrate anticoagulation infusion system that can achieve real-time monitoring and adjustment of citrate concentration, ensuring stable anticoagulation effect and effectively avoiding treatment risks caused by hypocalcemia, pipeline blockage, and other problems.

[0010] The purpose of the present application is to solve the problems of concentration fluctuation, inadequate management of complications, and pipeline blockage in the prior art by introducing an intelligent feedback control mechanism, optimizing the drug formula, and using innovative coated pipelines and pipeline cleaning devices, thereby significantly improving the safety and effectiveness of citrate anticoagulation and providing a more stable and efficient technical solution for CBP treatment. SUMMARY

[0011] The present application relates to an improved infusion system and drug for continuous blood purification (CBP) citrate anticoagulation, aiming to improve the safety and effectiveness of citrate anticoagulation during CBP treatment through precise citrate concentration regulation, real-time monitoring, and intelligent feedback control mechanism, reduce the occurrence of complications, and improve treatment effectiveness. The system integrates concentration monitoring, automatic adjustment of pump speed, optimized drug formula, pipeline coating, cleaning device, and other technologies, and innovatively realizes full-process monitoring and automatic adjustment during citrate infusion, providing safer and more accurate treatment for patients.

[0012] 1. Intelligent feedback control system

[0013] The core part of the improved infusion system of the present application is the intelligent feedback control system. The system monitors the citrate concentration in the infusion circuit in real time through the online conductivity sensor installed at the end of the citrate infusion pipeline. The sensor transmits the collected concentration data to the feedback control system through electrical connection. According to the real-time monitoring data, the control system can automatically adjust the pump speed of the infusion pump to ensure that the concentration of citrate is always maintained within the preset target range.

[0014] Concentration monitoring: The online conductivity sensor takes a sample every 30 seconds, providing real-time feedback on the citrate concentration. Through linkage with the infusion pump, the system can adjust the pump speed based on the concentration data, keeping the concentration within the target range of 3.0 to 4.0 mmol / L.

[0015] Automatic pump speed adjustment: When the citrate concentration is detected to be lower than 3.0 mmol / L, the infusion pump will automatically increase the pump speed by 20% to supplement the insufficient citrate; when the concentration is higher than 4.0 mmol / L, the pump speed will automatically decrease by 20%. This adjustment range is optimized to ensure the precise stability of the citrate concentration during treatment.

[0016] Alarm mechanism: The system also has an audible and visual alarm function. When the concentration fluctuation amplitude exceeds 0.5 mmol / L, the system will promptly issue a warning message to prompt the operator to make adjustments, preventing unnecessary risks.

[0017] 2. Optimized citrate formulation

[0018] To improve treatment effectiveness and reduce complications, the formulation of citrate has been optimized in this invention. The concentration of sodium citrate solution is carefully adjusted to 40 mmol / L, and 3g of disodium EDTA is added before use to enhance the anticoagulation effect. The pH value of the solution is adjusted to between 7.2 and 7.4, and sterile filtration is performed to ensure the safety and stability of the drug.

[0019] Citrate solution preparation: The 1000ml sodium citrate solution is added with disodium EDTA before treatment and stirred uniformly to form an optimized drug formulation. Sterile filtration is performed to ensure the sterility of the drug and prevent bacterial contamination.

[0020] Method of use: According to the patient's blood flow (80-100ml / min), the citrate infusion rate is adjusted to 2.4-3.0ml / min to ensure the effectiveness and safety of citrate during treatment. At the same time, the invention also closely monitors the blood calcium concentration, and when the blood calcium concentration is lower than 0.9mmol / L, calcium supplement is given in time to maintain the balance of blood calcium in the body and prevent the occurrence of hypocalcemia.

[0021] 3. Coated silicone tubing

[0022] The infusion system of the invention uses medical-grade silicone tubing, which has been specially coated to enhance its durability and sterility. The coating process uses polyethylene glycol solution, which is soaked at room temperature for a certain period of time and then subjected to high-pressure sterilization. This can effectively reduce the formation of biofilm on the inner wall of the tubing, reduce infusion problems caused by contamination, and prevent tubing blockage.

[0023] Coating treatment: The medical-grade silicone tube is immersed in a 5% polyethylene glycol 2000 solution for 2 hours. The coating enhances the anticoagulant properties of the tube and has strong antibacterial effects.

[0024] Tube specifications and storage: The tube has an inner diameter of 2.5 mm and a wall thickness of 0.6 mm, suitable for different treatment needs. The coated tube is subjected to high-pressure sterilization and vacuum packaging to ensure its long-term stability and sterility, ensuring safety during use.

[0025] 4. Cleaning device

[0026] To effectively prevent tube blockage and reduce unnecessary treatment interruptions, the improved infusion system of the present application is equipped with a cleaning device. The cleaning device controls the cleaning branch through a solenoid valve, which is activated at regular intervals during the treatment interval. It uses sterile water for injection and an appropriate amount of heparin sodium for flushing, ensuring the cleanliness and patency of the tube.

[0027] Automatic switching to cleaning mode: The system automatically switches to cleaning mode every 30 minutes, with a flow rate of 20 ml / min for 5 minutes. After cleaning is complete, it automatically returns to treatment mode. This can avoid adverse events caused by tube blockage during treatment, ensuring treatment continuity and stability.

[0028] 5. Operation process and safety

[0029] Before treatment, the operator should carefully check the tube connection and the operation status of the electric control system to ensure that the system has no hidden faults. During treatment, the intelligent feedback control system will dynamically adjust the citric acid concentration and the pump speed of the infusion pump based on real-time monitoring data to ensure a safe and orderly treatment process.

[0030] Pre-treatment preparation: This includes blood vessel puncture, tube connection, blood flow adjustment, and citric acid infusion start operation to ensure smooth treatment.

[0031] Real-time monitoring and adjustment: The system continuously monitors citric acid concentration, coagulation function, and blood calcium concentration, and adjusts as necessary to ensure optimal treatment effectiveness.

[0032] Regular replacement of tubes and drugs: Tubes and drugs are replaced every 24 hours, and anticoagulant effect evaluation is performed regularly to ensure long-term treatment effectiveness and safety.

[0033] Advantages

[0034] Through the application of the improved infusion system and the medicine in the application, more accurate citric acid concentration regulation can be realized in the CBP treatment process, the pump speed of the infusion pump is automatically adjusted, and through the comprehensive design of the coating pipeline, the cleaning device and the like, the occurrence of complications such as pipeline blockage and hypocalcemia is effectively reduced, so that the safety and effectiveness of the CBP treatment are significantly improved.

[0035] Through clinical application, the coagulation function of the patient is stable, the fluctuation range of the citric acid concentration in the treatment process is small, and no adverse reactions such as bleeding or hypocalcemia occur. After treatment, the blood calcium concentration is kept within the normal range, the dialysis effect is good, and the quality of life of the patient is significantly improved.

[0036] In summary, the improved infusion system and the medicine for CBP citric acid anticoagulation in the application can significantly improve the accuracy, safety and effect in the treatment process through the synergistic effect of multiple technical means, and have a wide clinical application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description only illustrate the application, and other drawings can be obtained by those skilled in the art without creative labor on the basis of these drawings.

[0038] Figure 1 It is an anticoagulation infusion system schematic diagram of the application;

[0039] Figure 2 It is a CBP circulation process schematic diagram of the application;

[0040] Figure 3 It is a feedback control system framework schematic diagram of the application;

[0041] Figure 4 It is a pipeline structure cross-sectional view schematic diagram of the application;

[0042] Figure 5 It is a medicine formula preparation process schematic diagram of the application;

[0043] Figure 6 It is a running state dynamic schematic diagram of the application;

[0044] Figure 7 It is a control experiment result schematic diagram of the application;

[0045] Figure 8 It is a safety monitoring and alarm system schematic diagram of the application. DETAILED DESCRIPTION

[0046] The application will be described in detail below with reference to the drawings and specific embodiments. It should be noted that in order to make the embodiments more detailed, the following embodiments are the best, preferred embodiments, and other alternative ways can also be implemented by those skilled in the art for some known technologies; and the drawings are only used to describe the embodiments in more detail, and are not intended to specifically limit the application.

[0047] It should be noted that in the specification, "one embodiment", "embodiment", "exemplary embodiment", "some embodiments" and the like indicate that the described embodiment can include a specific feature, structure or property, but not necessarily every embodiment includes the specific feature, structure or property. In addition, when a specific feature, structure or property is described in combination with an embodiment, it should be within the knowledge of those skilled in the related art to implement such a feature, structure or property in combination with other embodiments, whether or not it is explicitly described.

[0048] Generally, the terms can be understood at least in part from the context of their usage. For example, depending at least in part upon the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in the singular or can be used to describe combinations of features, structures, or characteristics, in the plural, both singularly and in combination. Additionally, the term "based on" can be understood as not necessarily requiring exclusively derived from that which is stated, but instead can allow for being based on a combination of explicitly and inexplicitly described factors.

[0049] As Figure 1 As shown in Figs. 2 and 3, the system is installed with a high-precision online conductivity sensor at the end of the citric acid infusion line, which monitors the citric acid concentration in the circuit in real time. This sensor transmits data to the infusion pump through electrical connection, and can accurately adjust the pump speed according to the real-time detected concentration value, so as to maintain a stable drug concentration.

[0050] Concentration monitoring and adjustment: The system sets the target concentration range to 3.0-4.0 mmol / L, and samples and detects the citric acid concentration every 30 seconds. If the concentration is lower than 3.0 mmol / L, the infusion pump automatically increases the pump speed by 20%; if the concentration exceeds 4.0 mmol / L, the pump speed is automatically reduced by 20%. This adjustment mechanism can dynamically respond to concentration changes, ensuring that the citric acid concentration during treatment is always in the ideal range.

[0051] Alarm mechanism: When the concentration fluctuation amplitude exceeds 0.5 mmol / L, the system will issue a timely warning through audible and visual alarms, reminding the operator to pay attention to the change of drug concentration, so as to make a quick response. This mechanism plays an important role in preventing the concentration from being too low or too high, greatly enhancing the safety of treatment.

[0052] Automatic operation: The system can automatically adjust the infusion pump speed in the case of large concentration fluctuations without human intervention, reducing the complexity of manual operation and reducing the risk of human error.

[0053] II. Optimization of citric acid formulation, such as Figure 5 as shown

[0054] To ensure the maximum effect of citric acid anticoagulation, the preparation and use of sodium citrate solution are optimized in this invention:

[0055] Solution preparation: First, carefully prepare 1000ml of sodium citrate solution with a concentration of 40mmol / L. Add 3g of disodium EDTA and stir well to dissolve, to enhance the stability and anticoagulant effect of citric acid.

[0056] pH adjustment: The pH of the solution is accurately adjusted to maintain the ideal range of 7.2-7.4. This pH range can ensure that sodium citrate has the best anticoagulant effect in the body, while reducing the risk of crystallization of the solution.

[0057] Sterile processing: After the solution is clear, it is sterile filtered to ensure that the drug solution is not contaminated by microorganisms during infusion, ensuring the safety of treatment. Finally, the solution is divided into sterile infusion bags to provide high-quality treatment fluid for patients.

[0058] Infusion rate and blood calcium monitoring: According to the patient's blood flow standard (80-100ml / min), set the citric acid infusion speed to 2.4-3.0ml / min. During treatment, closely monitor the patient's blood calcium concentration, and if the concentration is less than 0.9mmol / L, supplement calcium in a timely manner to ensure that the blood calcium level is maintained within the normal range and prevent the occurrence of hypocalcemia.

[0059] III. Coated silicone tubing, such as Figure 4 as shown

[0060] To improve the safety and durability of the infusion system, advanced coated silicone tubing technology is used:

[0061] Coating treatment: Medical-grade silicone tubing is completely immersed in a 5% polyethylene glycol 2000 methyl ether solution and left to stand for 2 hours to ensure uniform coating. This coating not only improves the anticoagulant properties of the tubing, but also effectively reduces the risk of thrombosis.

[0062] Sterilization and preservation: After the tubing coating process is complete, it is subjected to high-pressure sterilization to kill any microorganisms that may be present, ensuring the sterility of the tubing. Then it is stored using vacuum packaging to ensure that the performance of the tubing is not compromised during long-term storage.

[0063] Customized production: The inner diameter of the pipeline is designed as 2.5mm, and the wall thickness is 0.6mm. It can be customized according to the needs of specific treatment equipment to ensure perfect connection with infusion bags and blood lines, providing stable drug infusion path.

[0064] Connection before use: Before use, the pipeline is accurately connected with citric acid infusion bag and blood line to ensure that each connection site is in airtight and sterile state, effectively preventing external pollution.

[0065] Four, connecting cleaning device, such as Figure 1 as shown

[0066] In order to avoid pipeline blockage and ensure long-term stable operation of the system, a cleaning device is designed:

[0067] Cleaning branch design: A cleaning branch controlled by a parallel electromagnetic valve is set at the end of the loop to regularly clean the pipeline. The cleaning fluid is sterile water for injection with added heparin sodium to enhance the anticoagulation effect.

[0068] Cleaning process: During the treatment interval, the system automatically switches to cleaning mode every 30 minutes, and the cleaning fluid is flushed at a rate of 20ml / min for 5 minutes. This process can effectively remove the drug residues that may accumulate in the pipeline, prevent thrombus formation, and ensure the smooth progress of subsequent treatment.

[0069] Automatic recovery: After cleaning, the system automatically switches back to normal treatment mode, without affecting the continuity and smoothness of treatment, reducing the need for manual intervention.

[0070] Five, operation process

[0071] The operation process of this system aims to ensure the efficiency and safety of the treatment process:

[0072] Equipment inspection: Before treatment, the operator should strictly check the integrity of the pipeline connection and the working state of the electric control system to ensure that the equipment has no hidden troubles.

[0073] Blood flow channel preparation: The arteriovenous puncture needle is accurately placed in the patient's blood vessel to ensure stable and reliable connection of the extracorporeal circulation pipeline and provide sufficient blood flow support for treatment.

[0074] Treatment start: Start the treatment program at a blood flow rate of 80ml / min, and start citric acid infusion to ensure accurate drug delivery.

[0075] As Figure 8 shown, real-time monitoring and adjustment: During the treatment process, the citric acid concentration and coagulation function are monitored in real time, and the infusion rate is adjusted in time according to the test data to ensure the realization of the treatment goal.

[0076] Treatment End and Circuit Maintenance: Each session is set for 3-4 hours, after treatment, the system automatically enters the cleaning mode to maintain the circuit. The circuit and drug solution are replaced every 24 hours, and the anticoagulation effect is regularly evaluated to ensure the safety and effectiveness of the treatment.

[0077] Example 1:

[0078] Standard Citrate Anticoagulation Therapy

[0079] Experimental Design:

[0080] Patient: Male, 50 years old, chronic renal failure patient

[0081] Citrate Concentration: 3.5 mmol / L

[0082] Blood Flow: 100 ml / min

[0083] Treatment Duration: 4 hours

[0084] Intelligent Feedback Control System: Enabled, target concentration range set to 3.0-4.0 mmol / L, concentration detection performed every 30 seconds, pump speed adjustment range of ±20%.

[0085] Monitoring Indicators: Citrate Concentration, Coagulation Function (APTT), Blood Calcium Concentration

[0086] Example 2:

[0087] Optimized Citrate Anticoagulation Therapy (Higher Concentration)

[0088] Experimental Design:

[0089] Patient: Female, 60 years old, severe liver disease patient, in hypercoagulable state

[0090] Citrate Concentration: 4.0 mmol / L

[0091] Blood Flow: 80 ml / min

[0092] Treatment Duration: 4 hours

[0093] Intelligent Feedback Control System: Enabled, target concentration range set to 3.0-4.0 mmol / L, concentration detection performed every 30 seconds, pump speed adjustment range of ±20%.

[0094] Monitoring Indicators: Citrate Concentration, Coagulation Function (APTT, PT, TT), Blood Calcium Concentration

[0095] Example 3:

[0096] Low Concentration Citrate Anticoagulation Therapy

[0097] Experimental Design:

[0098] Patient: Male, 45 years old, patient with acute renal failure

[0099] Citric acid concentration: 2.5 mmol / L

[0100] Blood flow: 90 ml / min

[0101] Treatment duration: 4 hours

[0102] Intelligent feedback control system: enabled, target concentration range set to 2.0-3.0 mmol / L, concentration detection performed every 30 seconds, pump speed adjustment range of ±20%.

[0103] Monitoring indicators: citric acid concentration, coagulation function (APTT), blood calcium concentration

[0104] Control experiment design:

[0105] Control group (without intelligent feedback control system):

[0106] Patient: same as the implementation group

[0107] Citric acid concentration: same as the implementation group

[0108] Blood flow: same as the implementation group

[0109] Treatment duration: 4 hours

[0110] Intelligent feedback control system: disabled (no pump speed adjustment)

[0111] Monitoring indicators: citric acid concentration, coagulation function (APTT), blood calcium concentration

[0112] Experimental data display:

[0113] Experimental group Citric acid concentration (mmol / L) Pump speed adjustment range APTT (prolonged times) Blood calcium concentration (mmol / L) Adverse events Example 1 (standard treatment) 3.5±0.2 ±20% 2-3 times 1.02±0.05 None Example 2 (optimized treatment) 4.0±0.3 ±20% 1.8-2.5 times 1.08±0.06 None Example 3 (low concentration treatment) 2.5±0.3 ±20% 1.5-2 times 1.10±0.04 None Control group (no feedback control) 3.5±0.5 None 2.5-4 times 0.95±0.08 Mild hypocalcemia

[0114] Data analysis:

[0115] Citric acid concentration: The citric acid concentration in Example 1 and Example 2 fluctuated less, both controlled within the set range, and did not exceed the predetermined fluctuation range (0.5 mmol / L). The concentration in the control group fluctuated greatly, with the risk of exceeding the range, especially the citric acid concentration was often low, which could not be accurately adjusted.

[0116] APTT (activated partial thromboplastin time): In Example 1 and Example 2, the patient's APTT was extended to maintain within the reasonable range of treatment (2-3 times), and there was no abnormal extension. In the control group, some patients' APTT was extended to more than 4 times, indicating unstable anticoagulation effect.

[0117] Blood calcium concentration: In the example, the blood calcium concentration was well controlled and maintained within the normal range (around 1.0 mmol / L). The control group showed mild hypocalcemia, indicating that the system failed to effectively control blood calcium levels, which could lead to complications.

[0118] Adverse events: No adverse events occurred in the example group, and the treatment effect was good. Mild hypocalcemia occurred in the control group, indicating that the intelligent feedback control system can effectively avoid the risk of low blood calcium.

[0119] The intelligent feedback control system performed excellently in ensuring accurate adjustment of citrate concentration, significantly reducing the incidence of adverse events.

[0120] Both high-concentration treatment (Example 2) and low-concentration treatment (Example 3) effectively controlled blood coagulation function and blood calcium levels, and no serious complications occurred, proving the feasibility of individualized treatment for different patients.

[0121] The control experiment results show that without the intelligent feedback control system, the treatment has large fluctuations in citrate concentration, unstable blood coagulation function, difficult to control blood calcium levels, poor treatment effect, and increased risk of complications.

[0122] Therefore, the intelligent feedback control system significantly improves the safety and effectiveness of citrate anticoagulation therapy, providing patients with a more precise and individualized treatment plan.

[0123] Example 4: Individualized citrate anticoagulation therapy for elderly patients

[0124] Experimental design:

[0125] Patient information: Female, 78 years old, acute heart failure patient with acute kidney injury, with mild liver dysfunction

[0126] Citrate concentration: 3.2 mmol / L (considering the decreased metabolic capacity of elderly patients, a moderately low concentration is used)

[0127] Blood flow: 75 ml / min (adjusted to a lower blood flow based on patient age and heart function status)

[0128] Treatment duration: 3 hours (shorten the single treatment time to reduce the burden on patients)

[0129] Intelligent feedback control system settings: enabled, target concentration range set to 3.0-3.5 mmol / L, concentration detection interval shortened to 20 seconds, and pump speed adjustment range reduced to ±15% to ensure smooth adjustment

[0130] Special monitoring indicators: citrate concentration, blood coagulation function (APTT, PT), blood calcium concentration, heart rate variability, blood pressure stability

[0131] Results:

[0132] Therapeutic Effect: The patient remained hemodynamically stable throughout the treatment, with citrate concentration controlled within the range of 3.2 ± 0.15 mmol / L, with fluctuations significantly smaller than the set safety threshold of 0.5 mmol / L. APTT was prolonged to 2.1 times the normal value, and coagulation function was well controlled.

[0133] Safety Assessment: Blood calcium concentration was maintained at 1.05 ± 0.03 mmol / L, and no symptoms of hypocalcemia occurred. The patient's heart rate and blood pressure remained stable during treatment, and no arrhythmia or blood pressure fluctuations occurred.

[0134] Complications: No bleeding, thrombosis or other serious complications occurred. The patient tolerated the treatment well, and the treatment process was smooth.

[0135] System Adjustment Frequency: The intelligent feedback control system made 6 fine adjustments during the treatment, all of which were small adjustments (±8-12%), reflecting the system's ability to fine-tune control for elderly patients.

[0136] Example 5: Precise citrate anticoagulation therapy for patients at high risk of bleeding

[0137] Experimental Design:

[0138] Patient Information: Male, 55 years old, patient with acute pancreatitis complicated by acute renal failure, with a history of gastrointestinal bleeding, and low platelet count (95 × 10 9 / L)

[0139] Citrate Concentration: 2.8 mmol / L (lower concentration strategy for patients at high risk of bleeding)

[0140] Blood Flow: 85 ml / min (moderate blood flow to balance treatment effectiveness and safety)

[0141] Treatment Duration: 4 hours

[0142] Intelligent Feedback Control System Settings: Enabled, target concentration range set to 2.5-3.0 mmol / L, concentration detection performed every 25 seconds, pump speed adjustment range set to ±15%, and bleeding risk warning mode activated

[0143] Special Monitoring Indicators: Citrate concentration, coagulation function (APTT, PT, TT, fibrinogen), platelet count, blood calcium concentration, hemoglobin level

[0144] Results:

[0145] Anticoagulation Effect: The citrate concentration was accurately controlled at 2.8 ± 0.12 mmol / L, and APTT was prolonged to 1.8 times the normal value, ensuring effective anticoagulation and avoiding the risk of excessive anticoagulation.

[0146] Bleeding Risk Control: No bleeding events occurred during treatment, hemoglobin levels remained stable (from 105 g / L before treatment to 103 g / L after treatment), and platelet counts did not significantly decrease.

[0147] Calcium Management: Blood calcium concentration was maintained at 1.08 ± 0.04 mmol / L, higher than the safety threshold, effectively avoiding the occurrence of hypocalcemia.

[0148] System Performance: The intelligent feedback control system performed well, with only 4 minor adjustments during treatment, and the adjustment range was within ± 10%, demonstrating precise control capabilities for high-risk bleeding patients.

[0149] Filter Life: The blood filter maintained good permeability throughout the 4-hour treatment process, without clotting or clogging, significantly improving filter usage efficiency.

[0150] Comparative Analysis Results

[0151] Through the verification of Examples 4 and 5, the applicability and safety of the improved infusion system in the special patient population are further confirmed:

[0152] Personalized Treatment Advantages: The system can adjust concentration settings and monitoring frequency according to different patients' age, underlying diseases, and risk factors, providing safe and effective treatment options for elderly patients and high-risk bleeding patients.

[0153] Precise Control Capability: The intelligent feedback control system exhibits excellent concentration control accuracy in various clinical situations, with a significantly smaller concentration fluctuation range than traditional methods, greatly improving treatment stability and predictability.

[0154] Safety Guarantee: In the special risk patient population, the system effectively prevents the occurrence of bleeding, thrombosis, hypocalcemia, and other complications through precise concentration control and real-time monitoring, significantly improving the safety of CBP treatment.

[0155] Clinical Practicality: The system has high automation, reducing the workload of medical staff, and avoiding human operational errors through intelligent adjustment, improving the convenience and reliability of clinical application.

[0156] These examples further verify the wide applicability of the invention in different clinical scenarios, providing a more perfect and reliable technical solution for CBP citrate anticoagulation therapy.

[0157] The present application encompasses any alternatives, modifications, equivalent methods and solutions made to the essence and scope of the present application. In order to make the public have a thorough understanding of the present application, specific details are described in the following preferred embodiments of the present application, and the present application can also be fully understood without the description of these details to those skilled in the art. In addition, in order to avoid unnecessary confusion to the essence of the present application, well-known methods, processes, procedures, elements and circuits, etc. are not described in detail.

[0158] The above is only the preferred embodiment of the present application, and it should be pointed out that for ordinary skilled in the art, without departing from the principles of the present application, a number of improvements and refinements can also be made, which should be considered as the protection scope of the present application.

Claims

1. A modified infusion system for CBP citrate anticoagulation, characterized in that The system comprises: An integrated infusion pump for continuous infusion of citrate according to the set citrate concentration and blood flow rate; An online conductivity sensor arranged at the end of the citrate infusion pipeline for real-time detection of the concentration of citrate in the circuit; A feedback control system electrically connected with the conductivity sensor, capable of automatically adjusting the pump speed of the infusion pump according to the real-time detected citrate concentration; An acousto-optic alarm system that issues an alarm when the citrate concentration deviates from the target range by more than a predetermined amplitude; The target concentration range is 3.0 to 4.0 mmol / L, and the concentration sampling and detection task is performed every 30 seconds, and the pump speed adjustment amplitude is ±20%.

2. The modified infusion system of claim 1, wherein, The feedback control system automatically adjusts the pump speed of the infusion pump according to the concentration data measured by the conductivity sensor, so as to maintain the citrate concentration within the target range.

3. The modified infusion system of claim 1, wherein, The system further comprises a cleaning device, which includes an electromagnetic valve and a cleaning liquid. The cleaning device is automatically switched to a cleaning mode during the treatment interval by the electromagnetic valve to flush the pipeline. The cleaning liquid is sterile water for injection, and heparin sodium is added to enhance the anticoagulation effect.

4. The modified infusion system of claim 1, wherein, The flushing rate of the cleaning device is 20 ml / min, and the flushing time is 5 minutes. After flushing, the system automatically returns to the treatment mode.

5. The modified infusion system of claim 1, wherein, The infusion pipeline is made of medical-grade silicone material and is treated by coating. The coating includes polyethylene glycol solution. The inner diameter of the pipeline is 2.5 mm, and the wall thickness is 0.6 mm, so as to ensure the sterility and durability of the pipeline.

6. The modified infusion system of claim 5, wherein, The silicone pipeline is stored in vacuum packaging to ensure stability and sterility after long-term storage.

7. A modified drug for CBP citrate anticoagulation, characterized in that, The drug contains a sodium citrate solution with a concentration of 40 mmol / L. Before use, 3 g of disodium EDTA is added, the pH value of the solution is adjusted to 7.2 to 7.4, and the solution is sterile filtered and divided into infusion bags before use.

8. The improved medicament as claimed in claim 7, wherein, The infusion rate of the drug is 2.4 to 3.0 ml / min, and the infusion speed is adjusted according to the patient's blood flow rate (80-100 ml / min).

9. The modified infusion system and pharmaceutical composition of claim 1, wherein, The infusion system is used together with the drug, and the citrate concentration, pump speed and anticoagulation effect are monitored and adjusted in real time by the intelligent feedback control system.

10. The modified infusion system of claim 1, wherein, The intelligent feedback control system includes at least one microprocessor, memory, input / output interface and control module, which is used for real-time reception of sensor feedback data and adjustment of infusion pump operation, to ensure that the citrate concentration during treatment is maintained within the preset range.

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