Medical device

Abstract

A medical device includes a tubing system including a fluid removal tubing connected to a human body to remove a body fluid therefrom, and a fluid return tubing for returning a treated body fluid to the human body; and a circulating treatment system including a circulating module connected to the tubing system for adding a body fluid to be treated into the circulating module to form a circulation; the treated body fluid in the circulation exits the circulating module, and a fluid residual remains in the circulating module; a total amount or a total rate of the fluid introduced into the circulating module is equal to a total amount or a total rate of the fluid exiting the circulating module; the circulating module has free enzymes, free enzyme preparations, or free enzyme carriers participating in the circulation with the fluid residual and being trapped in the circulation for selectively removing or generating specific molecules or molecule combinations and avoiding the free enzymes, the free enzyme preparations, or the free enzyme carriers from entering the human body.

Description

[0001] This application is a divisional application filed pursuant to Article 42 of the Implementing Regulations of the Patent Law. Its parent application is Chinese Invention Application No. 202080100237.0, filed on August 27, 2020, with Shanghai Xinguang Biomedical Co., Ltd. as the applicant, and entitled "Fluid Processing Method and Circulation Processing Equipment and System". The entire contents of the parent application are incorporated herein by reference. Technical Field

[0002] This application relates to the field of fluid processing technology, and in particular to a fluid processing method, a circulation processing device, a system, and a medical device. Background Technology

[0003] Traditional techniques for selectively processing liquid components include membrane separation, heating, sedimentation, catalysis, adsorption, chemical reactions, ion exchange, optical processing, and electrochemical treatment. However, these methods often suffer from poor selectivity or lack sustainability. For example, membrane separation cannot achieve effective and highly selective separation of small molecules; catalysts easily become mixed into the system during catalytic reactions; optical and electrochemical treatments lack selectivity; ion exchange cannot distinguish molecules with the same charge; adsorption is prone to saturation and is costly; and chemical reactions are often too vigorous and can negatively impact other components in the liquid. How to selectively alter the concentration of specific molecules or molecular combinations in a mixed fluid system without affecting other components remains a significant technological challenge.

[0004] Especially in medical applications, insufficient metabolic function or excessive intake can lead to the accumulation of certain molecules in the body, often inducing metabolic diseases. These include hereditary metabolic disorders caused by gene defects, such as phenylketonuria and mucopolysaccharidosis; acute alcohol poisoning caused by excessive alcohol intake; and age-related metabolic diseases such as diabetes, hyperlipidemia, and gout. Membrane separation technology has already been used clinically to remove pathogenic factors or toxins from the human body, such as in hemodialysis and plasma exchange. However, in existing membrane separation technologies, especially in medical applications, it is inevitable that other similar components, such as glucose, amino acids, albumin, vitamins, hormones, and electrolytes, will be separated or removed during dialysis or filtration of specific components in the solution. This generates waste liquid that contains both the aforementioned harmful components and other beneficial components. In other words, existing membrane separation technologies struggle to achieve selective separation or removal of specific components. Because membrane separation involves the loss of beneficial components, there are many limitations to its clinical application in order to avoid a large loss of beneficial components. The separation process is time-limited, and the removal effect or removal rate of membrane separation, such as the concentration control of specific components, is difficult to guarantee. At the same time, the continuous generation of waste liquid not only causes harm to patients, but also brings the risk of infection and the spread of pathogenic microorganisms. Summary of the Invention

[0005] In view of the shortcomings of the above-mentioned related technologies, the purpose of this application is to provide a medical device that solves the problems of low efficiency, poor selectivity, doping with beneficial components and resulting in continuous loss of beneficial components, and insufficient sustainability in existing fluid processing technologies and methods.

[0006] To achieve the above and other related objectives, the first aspect of this application discloses a medical device, comprising: a tubing system including a fluid outflow tubing connected to the human body to draw out bodily fluids, and a fluid return tubing for returning the treated bodily fluids to the human body; a circulation processing system including a circulation module connected to the tubing system for adding bodily fluids to be treated into the circulation module to form a circulation; the treated bodily fluids leaving the circulation module in the circulation, and a fluid reserve remaining in the circulation module; the total amount or total rate of fluid introduced into the tubing in the circulation module being equal to the total amount or total rate of fluid leaving the circulation module; the circulation module having free enzymes, free enzyme preparations, or free enzyme carriers that participate in the circulation along with the fluid reserve and are retained in the circulation, for selectively clearing or generating specific molecules or combinations of molecules and preventing the free enzymes, free enzyme preparations, or free enzyme carriers from entering the human body.

[0007] In some embodiments disclosed in the first aspect of this application, the circulation module includes a collection device disposed in the circulation module and having a collection cavity for mixing the fluid balance, free enzyme or free enzyme preparation or free enzyme carrier, and body fluid to be treated in the circulation module, so as to bring the free enzyme or free enzyme preparation or free enzyme carrier into contact with the target substance in the body fluid.

[0008] In some embodiments disclosed in the first aspect of this application, the circulation module includes a tangential flow filtration module for retaining free enzymes, free enzyme preparations, or free enzyme carriers that participate in the circulation along with the fluid balance, so as to prevent the free enzymes, free enzyme preparations, or free enzyme carriers from leaving the circulation.

[0009] In some embodiments disclosed in the first aspect of this application, the free enzyme or free enzyme preparation or free enzyme carrier is an enzyme-carrying microsphere, an enzyme-carrying microcapsule, or a water-soluble macromolecule that binds to the enzyme.

[0010] In some embodiments disclosed in the first aspect of this application, the circulation module is a metabolic circulation module or an enrichment circulation module.

[0011] In some embodiments disclosed in the first aspect of this application, the circulation module is further configured with an adsorption device for connection to the pipeline.

[0012] In some embodiments disclosed in the first aspect of this application, the circulation module is further configured with a processing unit for regulating the activity of the free enzyme, free enzyme preparation, or free enzyme carrier in the circulation.

[0013] In some embodiments disclosed in the first aspect of this application, the circulation module is further configured with a processing unit for controlling the type and total amount of free enzymes, free enzyme preparations or free enzyme carriers in the circulation by adding, supplementing or replacing free enzymes or free enzyme carriers or free enzyme carriers.

[0014] In some embodiments disclosed in the first aspect of this application, the circulation module is further configured with a sample addition device for adding, supplementing or replacing reaction substrates, drugs, or free enzymes or free enzyme preparations or free enzyme carriers into the pipeline.

[0015] In some embodiments disclosed in the first aspect of this application, the medical device in a first mode traps harmful macromolecules in the body fluid through the tangential flow filtration module.

[0016] In some embodiments disclosed in the first aspect of this application, the body fluid to be treated includes peritoneal fluid or peritoneal dialysis fluid.

[0017] In some embodiments disclosed in the first aspect of this application, the body fluid to be processed includes blood and / or blood-derived fluids.

[0018] In some embodiments disclosed in the first aspect of this application, the blood-derived fluid includes plasma, serum, hemodialysis fluid, or dialysis waste fluid.

[0019] In some embodiments disclosed in the first aspect of this application, the circulation processing system includes: a second type of circulation module, including a first separation module, a first side of the first separation module being connected between the fluid outlet pipeline and the fluid return pipeline to form an extracorporeal blood circulation; the first type of circulation module, connected to a second side of the first separation module via a pipeline to form a circulation of blood-derived fluid, including the second separation module and a catalytic unit that participates in the circulation along with the fluid surplus and is retained in the circulation by the second separation module, the catalytic unit being used to remove specific molecular components in the blood-derived fluid or generate preset reaction products, and then leading them out through the second separation module to the second side of the first separation module; the total amount or total rate of fluid introduced into the pipeline in the first type of circulation module is equal to the total amount or total rate of fluid leaving the first type of circulation module.

[0020] In some embodiments disclosed in the first aspect of this application, the circulation processing system includes: a second type of circulation module, including a first separation module, wherein a first side of the first separation module is connected between the fluid outlet pipeline and the fluid return pipeline to form an extracorporeal blood circulation; the first type of circulation module, connected via a pipeline between the second side of the first separation module and the fluid return pipeline to form a circulation of blood-derived fluid, includes a second separation module and a catalytic unit that participates in the circulation along with the remaining fluid and is retained in the circulation by the second separation module, wherein the catalytic unit is used to remove specific molecular components in the blood-derived fluid or generate preset reaction products, and then draws them out through the second separation module and collects them into the fluid return pipeline; the total amount or total rate of fluid introduced into the pipeline in the first type of circulation module is equal to the total amount or total rate of fluid leaving the first type of circulation module.

[0021] In some embodiments disclosed in the first aspect of this application, the circulation processing system includes: a second type of circulation module, including a first separation module, a first side of the first separation module being connected between the fluid outlet pipeline and the fluid return pipeline to form extracorporeal blood circulation; the first type of circulation module, connected via a pipeline between the second side of the first separation module and the fluid outlet pipeline to form circulation of blood-derived fluid, including the second separation module and a catalytic unit that participates in the circulation along with the fluid surplus and is retained in the circulation by the second separation module, the catalytic unit being used to remove specific molecular components in the blood-derived fluid or generate preset reaction products, and then leading them out through the second separation module and collecting them in the fluid outlet pipeline so as to re-enter the first separation module; the total amount or total rate of fluid introduced into the pipeline in the first type of circulation module is equal to the total amount or total rate of fluid leaving the first type of circulation module.

[0022] In some embodiments disclosed in the first aspect of this application, the first separation module includes a first separation component that is a porous membrane or a reverse osmosis membrane; the second separation module includes a second separation component that is a porous membrane or a reverse osmosis membrane; wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, and a nanofiltration membrane.

[0023] In some embodiments disclosed in the first aspect of this application, the first separation component or the second separation component includes one or more of a planar membrane, a tubular membrane, a spiral wound membrane, and a hollow fiber membrane.

[0024] In some embodiments disclosed in the first aspect of this application, the first separation module is a dialyzer or a plasma separator.

[0025] In some embodiments disclosed in the first aspect of this application, the medical device further includes at least one of a control device, a fluid storage device, a flow limiting device, a flow rate detection device, a pressure detection device, a temperature detection device, a temperature control device, an oxygen detection device, a bubble detection and removal device, an alarm device, and a concentration detection device.

[0026] In some embodiments disclosed in the first aspect of this application, the medical device is a blood purification device, an extracorporeal circulation clearance system, an extracorporeal enrichment clearance device, a hemodialysis device, a plasma exchange device, an extracorporeal peritoneal dialysis device, or an extracorporeal membrane oxygenation device.

[0027] In some embodiments disclosed in the first aspect of this application, the medical device is an extracorporeal circulation life support system grafted onto an artificial liver, artificial kidney, hemodialysis device, peritoneal dialysis device, plasma exchange device, plasma purification device, blood lipid purification device, molecular adsorption recirculation system, extracorporeal membrane oxygenation device, or leukocyte removal device.

[0028] In summary, the medical device of this application has the following beneficial effects: by allowing fluid to flow in a pipeline to form a circulation, the circulation includes a processing unit to process the fluid to selectively change the structure or concentration of molecules or combinations of molecules in the fluid; the fluid is processed through at least one of the circulations, and in any one of the circulations, the flow rates of the fluid to be processed introduced into the circulation and the fluid leaving the circulation are controlled to maintain a dynamic balance of the total amount of fluid in the circulation, thus maintaining the sustainability of the circulation. Therefore, the duration of the fluid processing method can be determined based on a preset processing target.

[0029] In general, this application provides a processing unit in the at least one cycle to perform cyclic processing on the fluid. The cyclic processing makes the processing more efficient and thorough. At the same time, based on the processing function of the processing unit, the fluid processing method can achieve highly selective removal or generation of target molecules or molecular combinations and avoid continuous loss of beneficial components. Attached Figure Description

[0030] Figure 1 The diagram shown is a simplified illustration of a first-type loop module of this application in one embodiment.

[0031] Figure 2 The diagram shown is a simplified illustration of a second type of loop module in one embodiment of this application.

[0032] Figure 3 The diagram shown is a simplified schematic of the metabolic cycle module of this application in one embodiment.

[0033] Figure 4 The results are shown in Experiment 1 of this application.

[0034] Figure 5 The diagram shown is a simplified illustration of the loop module of this application in one embodiment.

[0035] Figures 6a-6c The diagram shown is a simplified illustration of different operating states of the loop module in one embodiment of this application.

[0036] Figures 7a-7b The diagram shown is a simplified illustration of different operating states of the loop module in one embodiment of this application.

[0037] Figure 8 The diagram shown is a simplified illustration of a first-type loop module of this application in one embodiment.

[0038] Figure 9 The diagram shown is a simplified schematic of the metabolic cycle module of this application in one embodiment.

[0039] Figure 10 The results are shown in Experiment 2 of this application.

[0040] Figure 11 A simplified schematic diagram of two first-type loop modules connected in series in one embodiment.

[0041] Figure 12 A simplified schematic diagram of two metabolic cycle modules shown in series in another embodiment.

[0042] Figure 13 A simplified schematic diagram of multiple second-type loop modules shown in series in one embodiment.

[0043] Figure 14 A simplified schematic diagram of the second type of circulatory module and the metabolic circulatory module, shown in series, in another embodiment.

[0044] Figure 15 The results are shown in Experiment 4 of this application.

[0045] Figure 16 A simplified schematic diagram of a second-type loop module and a first-type loop module connected in series in one embodiment.

[0046] Figure 17 The diagram shown is a simplified illustration of the loop module of this application in one embodiment.

[0047] Figure 18a The diagram shown is a simplified schematic of one embodiment of the cyclic processing system of this application.

[0048] Figure 18b The diagram shown is a simplified schematic of one embodiment of the cyclic processing system of this application.

[0049] Figure 19 The diagram shown is a simplified illustration of the cyclic processing system of this application in another embodiment.

[0050] Figure 20 The diagram shown is a simplified schematic of the cyclic processing system of this application in another embodiment. Detailed Implementation

[0051] The following specific embodiments illustrate the implementation of this application. Those skilled in the art can easily understand other advantages and effects of this application from the content disclosed in this specification.

[0052] As described in the background section, all methods for separating or treating specific components in a mixed fluid system have certain limitations. Taking membrane separation technology as an example, membrane separation utilizes the selective separation of membranes to separate, purify, and concentrate different components of a mixture. It is a highly efficient, energy-saving, and environmentally friendly separation method. Filtration operations include normal flow filtration (NFF, also known as dead-end filtration) and tangential / cross-flow filtration (TFF). In NFF, the liquid passes vertically through the membrane, directly filtering out molecules. However, the retained molecules easily form a high-concentration gel and particle layer on the membrane surface, causing a sharp decrease in flow rate and flux. In TFF, the liquid flows parallel (tangentially) to the membrane surface. The transmembrane pressure generated by the liquid drives some solution and small molecules across the membrane, while retaining some solution and larger molecules. Throughout the process, the liquid continuously flows across the membrane surface at a certain velocity, scouring the membrane surface and carrying away particles deposited on the membrane surface from the TFF module.

[0053] In membrane separation technology, when filtering and separating specific components or molecules for removal, it is difficult to avoid the generation of waste liquid. This waste liquid usually contains beneficial components. For example, waste liquid in medical applications may contain glucose, amino acids, albumin, vitamins, hormones, electrolytes, etc. Therefore, the consumption of beneficial components during filtration is a problem in many membrane separation technology application scenarios.

[0054] Taking membrane separation based on steric hindrance as an example, it is essentially a process of retaining components with larger molecular weights or particle sizes in a mixture while filtering out components with smaller molecular weights or particle sizes; this is the directionality in the separation process. To facilitate the explanation of the methods, apparatus, and systems provided in this application, the application categorizes membrane separation scenarios by purpose, which can be broadly summarized into the following two modes:

[0055] Mode A: Large molecules are beneficial, small molecules are harmful, meaning small molecules are components that need to be removed;

[0056] Mode B: Macromolecules are harmful, small molecules are beneficial, meaning macromolecules are components that need to be removed.

[0057] In practical applications, mode B is more common and represents the final application developed for, such as in filtration and sterilization processes, water treatment, and purification. Mode B typically employs dead-end filtration; however, when the content of high-molecular-weight molecules is high, dead-end filtration is prone to clogging, limiting the membrane's continuous use or the upper limit of liquids it can handle. In such cases, pretreatment via precipitation, distillation, or other physical methods is generally required. If pretreatment is not possible, dead-end filtration cannot be used, for example, when the mixture contains blood or plasma.

[0058] Mode A is more common in biological applications, such as the concentration and purification of recombinant proteins, and hemodialysis and plasma exchange, all of which are processes for removing harmful or worthless small molecules from the system. Traditional plasma exchange technology is a typical example of the problems inherent in mode A. Because large molecules are beneficial, tangential flow is generally used to facilitate the return of trapped molecules to the original system and to prevent these components from depositing on the membrane surface, thus ensuring the continuity of the treatment process. However, in practical applications, due to a lack of strong selectivity, the small molecules removed in mode A often contain beneficial components, such as sugars, amino acids, and vitamins. This results in a significant loss of beneficial components when using physical membrane separation methods to treat blood, making the treatment process unsustainable.

[0059] Hereinafter, this application provides solutions in the following examples for how to selectively and efficiently remove target small molecules from a fluid in Mode A without affecting other molecules or components.

[0060] Meanwhile, this application provides an embodiment in which a catalytic unit with catalytic function selectively treats specific target molecules in a fluid. In this example, mode B can be used to prevent the catalytic unit from leaving the cycle and entering the system. For example, the catalytic unit is retained, which avoids the influence of the catalyst entering the system and allows the treatment process to continue.

[0061] Taking medical applications as an example, plasma exchange devices, based on membrane separation, are used in clinical scenarios such as kidney diseases, cryoglobulinemia, and hyperacute or acute antibody-mediated rejection after kidney transplantation. This process filters out large molecular pathogenic substances and immune complexes from the blood. However, the discarded waste fluid often contains beneficial components in addition to pathogenic factors. Therefore, the treatment process involves the loss of beneficial components in the blood, resulting in low sustainability of the plasma exchange process and limited efficiency in clearing pathogenic factors. In other scenarios, especially in traditional plasma exchange techniques, by employing… Plasma replacement therapy involves separating plasma and delivering plasma substitutes to patients to achieve blood renewal. However, the replacement fluid used in plasma substitutes can cause allergic reactions in humans, limiting its viable applications. It is typically used only for acute indications such as familial hypercholesterolemia, hyperlipoproteinemia, systemic lupus erythematosus (SLE), myasthenia gravis, rapidly progressive glomerulonephritis, and autoimmune diseases. Furthermore, the extraction of beneficial components, such as platelets, from plasma during replacement also results in the loss of these beneficial components, making this method less sustainable.

[0062] Taking the existing DFPP (double filtration plasmapheresis) as an example, the plasma is usually filtered twice in the corresponding filtration system. It uses a two-stage filtration process of plasma separation technology (i.e., separating plasma, red blood cells, platelets and white blood cells in the blood) and plasma component separation technology (i.e. separating specific components in the plasma). In the plasma component separation, large molecular pathogenic factors such as autoantibodies, immunoglobulins, immune complexes, inflammatory molecules or low-density lipoproteins are removed. Therefore, DFPP is usually used for severe diseases with large molecular pathogenic factors such as myasthenia gravis, Guillain-Barré syndrome, systemic lupus erythematosus (SLE), rheumatoid arthritis, hyperlipidemia, severe acute pancreatitis, and sepsis. However, it is not suitable for removing small and medium molecular pathogenic substances bound to albumin, and it is even less suitable for removing free small and medium molecular solutes.

[0063] DFPP achieves an A+B mode process. Typically, the molecules trapped between the membrane pore sizes or molecular weight cutoffs corresponding to the two filtration stages are the target molecules to be removed. DFPP can utilize tangential flow filtration technology to address the problems encountered in mode B, effectively avoiding clogging issues caused by dead-end filtration. However, in practical applications, while removing harmful large molecules, beneficial small molecules are inevitably still present. The separation process typically has a 10%–30% plasma rejection rate, which is the ratio of the plasma rejection pump's transfer rate to the plasma separation pump's transfer rate. More specifically, in a double plasma exchange process, the plasma rejection flow rate is typically 2.5–6 ml / min, meaning that even with double exchange, a patient will lose more than 300–720 mL of plasma after 2 hours of treatment. In other words, using DFPP for plasma exchange inevitably produces a certain volume of discarded plasma, i.e., waste fluid, after a period of time. This waste fluid contains beneficial components from the human body; if replacement fluid such as exogenous plasma is used, it may trigger allergic reactions. The continuous loss of beneficial components in existing DFPP technologies poses significant drawbacks and risks to this treatment method, limiting its application to certain acute and ICU settings. Therefore, DFPP has inherent time limitations (generally within 2-5 hours) and application scenario restrictions in clinical treatment. Furthermore, the time limitation also restricts the clearance effect of DFPP.

[0064] For example, the adsorption filtration purification system disclosed in patent CN103263704A separates human blood plasma to obtain a certain amount of plasma. The plasma is then introduced into a purification unit to perform multiple adsorption processes to regenerate some of the waste plasma, reducing the amount of fresh plasma required for plasma replacement. However, during the adsorption process of plasma regeneration, waste liquid, i.e., filtrate, is generated at the high-throughput filter used in the purification unit. Therefore, while a certain proportion of regenerated plasma is obtained during the waste plasma regeneration process, waste liquid is still being generated. Thus, the waste liquid problem and the potential for continuous loss of beneficial components due to the waste liquid still exist in this application. The use of replacement fluid to replenish the filtrate means that the risk of allergies caused by exogenous substances in the aforementioned DFPP still exists. At the same time, the high-throughput filter in this adsorption filtration purification system is only suitable for treating small molecule plasma toxins. Multiple filtrations are used to improve the filtration effect of small molecule toxins, and the effect achieved is the regeneration of a certain proportion of plasma in the waste plasma. This adsorption filtration purification system cannot remove large molecular weight pathogenic factors in the blood, limiting its application scenarios and making it difficult to use for collecting or removing different components in the blood. This application provides a fluid processing method, circulation processing apparatus, system, and medical device, which can be used to process various fluids, including those in medical settings, to selectively remove or alter the concentration of specific molecules or components in the fluid based on preset processing targets. Simultaneously, this application uses membrane separation in mode A to separate harmful components, and then uses a catalytic unit to process target molecules. In mode B, membrane separation also retains the catalytic unit in the circulation, forming a cyclical processing system. The fluid processing method and apparatus of this application can be used to implement effective and sustainable control of fluid composition.

[0065] This application provides a fluid processing method in a first aspect, comprising the following steps: adding a fluid to be processed into a pipeline to form a circulation; allowing the processed fluid in the circulation to leave the circulation; and allowing a fluid balance to remain in the circulation; the fluid processing method is implemented by at least one circulation, and the at least one circulation further includes a processing unit for processing the fluid in the circulation to selectively change the structure or concentration of molecules or combinations of molecules in the fluid, wherein the processing includes at least one of catalytic processing, filtration processing, adsorption processing, heating processing, enrichment processing, chemical processing, optical processing, and electrical processing.

[0066] The fluid contains the target substance. In some embodiments provided in this application, the fluid includes, but is not limited to, one or more mixtures of blood, plasma, serum, body fluid, tissue fluid, cleaning solution, dialysis fluid, recombinant protein solution, cell culture medium, microbial culture medium, pharmaceutical and medical water, pharmaceutical solutions, liquid foods, plant and animal extracts, natural water, industrial wastewater, and reclaimed water. In some examples, the fluid may also be a substance component obtained by processing fluids such as blood or plasma, for example, through filtration; in other examples, the fluid may also be a gas mixture, such as a gas mixture containing methane.

[0067] The fluid processing method of this application is applicable to different types of fluid processing, provided that a processing unit with corresponding selective processing capabilities can be configured based on the fluid composition. It should be understood that the fluid comprises at least two components, enabling the selective alteration of the structure or concentration of molecules or molecular combinations in the fluid performed by the processing unit. In the embodiments provided in this application, the selective alteration of the structure or concentration of molecules or molecular combinations in the fluid means that when the processing unit processes the fluid, it only alters the structure or concentration of some components in a mixture system, without affecting other components.

[0068] In particular, in some embodiments, the components in the fluid change dynamically over time. Here, in the examples provided in this application, the changes in the composition of the fluid include: changes in the types of substances in the fluid, such as increases or decreases, and / or changes in the concentration or total amount of at least one substance in the fluid.

[0069] Based on the specific composition of the fluid, in some examples, the material of the pipeline can be set to a special material corresponding to the fluid. For example, some pipelines in the circulation can be set as blood-specific pipelines, peristaltic pump-specific pipelines, corrosive liquid-specific pipelines, highly biocompatible pipelines, etc. Taking the application of the fluid treatment method in a medical scenario as an example, the pipeline is, for example, a blood delivery pipeline or a drug delivery pipeline, and the pipeline material includes, but is not limited to, soft polyvinyl chloride plastic, high-performance polyolefin thermoplastic elastomer (TPE), nano-biomedical materials, and resin materials.

[0070] The processing method is implemented by one loop or by two or more loops in combination; that is, the fluid processing method of this application can introduce the fluid to be processed into one of the loops, and after the processed fluid leaves the loop, it is introduced into another loop. At this time, the different loops can be regarded as a series relationship; or, the fluid can be diverted and introduced into different loops for processing and then the processed fluid is collected. At this time, the different loops can be regarded as a parallel relationship.

[0071] It should be noted that, in the embodiments provided in this application, the fluid to be processed refers only to the fluid introduced from the inlet of a specific cycle; that is, the fluid to be processed is a relative concept and is not intended to limit the fluid to be processed to the raw fluid that has not undergone any treatment. For example, when the fluid processing method is implemented through multiple cycles, the fluid drawn from one cycle is introduced into a subsequent cycle for processing and can be used as the fluid to be processed in the subsequent cycle.

[0072] In the embodiments provided in this application, all fluid located within the circulating pipeline can be considered as fluid margin, that is, the fluid margin is defined based on the spatial location of the fluid; when the fluid in the pipeline leaves the circulation, it is no longer referred to as fluid margin. Correspondingly, the fluid margin may include the fluid to be processed and the processed fluid.

[0073] The processing unit performs at least one of catalysis, filtration, adsorption, heating, enrichment, chemical treatment, optical treatment, and electrical treatment. The processing functions performed by the unit include changing the concentration of any component or molecular combination in the fluid to be treated, or altering the structure, charge state, or physical structure of any molecule. For example, in a mixture system, catalysis can alter the reaction rate of specific molecules to change the structure and concentration of molecules or molecular combinations in the mixture system; adsorption can directionally adsorb specific components in the mixture system, thereby changing the concentration of that specific component in the system; under specific conditions, such as within a certain temperature range, heating can decompose specific components in the mixture system; or membrane separation technology can retain specific components in the circulation to achieve an enrichment effect, thereby achieving selective treatment by changing the concentration of specific molecules or molecular combinations in the mixture system.

[0074] Here, the processing unit is a hardware module, device, apparatus, or control unit electrically connected to the pipeline, separation module, or other devices in the pipeline, located within the pipeline. The processing unit can be used to form or control components or devices in the circulation process to achieve fluid processing. In some embodiments, the processing unit can be controlled by a computer device (such as a personal computer, server, or network device), or it can be manually controlled.

[0075] For example, the processing unit may be a filter, adsorption device, or heating device connected to the pipeline, or it may be a sample addition device for adding catalyst to the pipeline, a control device for controlling the contact between the catalyst and the fluid, a temperature control device for controlling the activity of the catalyst, or a reaction substrate addition device corresponding to the catalyst.

[0076] In the specific implementation process, the fluid to be treated is added to the pipeline to form a circulation, wherein the treated fluid in the circulation leaves the circulation, and a fluid reserve is maintained in the circulation. Typically, the fluid to be treated is introduced into the circulation through the inlet, and the treated fluid leaves the circulation through the outlet. The circulation can be continuously replenished with fluid to be treated. It should be understood that in this case, the composition of the fluid reserve in the circulation is constantly updated, and the corresponding processing unit can continuously selectively process the fluid reserve in the circulation.

[0077] In the various embodiments provided in this application, the cycle can be used to represent a state in which fluid flows in the pipeline to form a cycle; at the same time, the cycle is used to represent a unit formed by hardware or structure including pipeline, devices connected or associated in the pipeline such as processing units, drive devices, etc., and including fluid in the aforementioned hardware or structure such as pipeline, and reactants added to the pipeline, etc.

[0078] It should be noted that the fluid to be treated is a mixture system. The fluid to be treated in this application is the mixture system after being treated by the processing unit, and is not limited to specific molecules or molecular components that are targeted by the processing unit. In different scenarios, the specific composition of the mixture system and the processing process performed by the processing unit may be different. Correspondingly, the fluid to be treated may be a mixture of at least one or more of the following: specific molecules or molecular components in the fluid to be treated, products generated by the reaction of specific molecules or molecular components, and other untreated components in the fluid to be treated.

[0079] The fluid processing method of this application selectively changes the structure or concentration of molecules or molecular combinations in a fluid through a processing unit. At the same time, by forming the circulation, a controllable contact environment is constructed between the processing unit and the fluid to be processed. Thus, while achieving highly selective processing of the mixture system, the processing efficiency or processing effect and the duration of the processing method can also be adjusted.

[0080] When processing fluids flowing in a pipeline, traditional processing methods are often inefficient and cannot fully achieve the desired results, or the processing is affected or limited by the interaction between flow rate and processing time.

[0081] In traditional unidirectional flow pipelines, to keep the pipeline full of fluid, the velocity of the fluid introduced into the pipeline must be equal to the velocity of the fluid discharged from the pipeline. Thus, the flow velocity inside the pipeline is necessarily affected by the inflow velocity or the outflow velocity. That is, the fluid velocity inside the pipeline is determined by the inflow velocity and the internal cavity structure of the pipeline. In practical scenarios, the flow velocity inside the pipeline is the dependent variable of the inflow velocity. At the same time, the fluid in the pipeline and other equipment or components associated with the pipeline have a one-time contact or one-time action, and the corresponding contact time or action time is also affected by the inflow velocity.

[0082] In the fluid processing method of this application, the processing process is made sustainable by circulating the fluid to be processed in the pipeline and maintaining the introduction of the fluid to be processed and the extraction of the processed fluid. In this example, the duration can be determined based on a preset processing target.

[0083] Meanwhile, based on the dynamic environment formed by the circulation, the fluid components in the circulation change dynamically. During the processing, the processing unit can continuously process the replenished fluid to be processed, thereby improving the processing efficiency of the processing unit. The circulating flow environment also enables the fluid to be processed to achieve better mixing and dispersion.

[0084] When a circulating pipeline serves as a container for the fluid to be treated or forms a space to hold the fluid, a sustainable equilibrium can be maintained simply by ensuring that the fluid to be treated is continuously introduced into the circulation and that the treated fluid is continuously being drawn out. The flow rate inside the pipeline can be relatively independent of the flow rate of the fluid to be treated introduced into the circulation. Therefore, the flow rate within the space of the pipeline can be controlled based on the required treatment effect. For example, by setting the flow rate inside the pipeline, the fluid to be treated can circulate multiple times within the pipeline to fully contact the treatment unit before being discharged from the circulation. Alternatively, if the treatment efficiency of the treatment unit is related to the flow rate, the corresponding flow rate inside the pipeline can be determined based on the treatment efficiency. By controlling the flow rate of the fluid to be treated introduced into the circulation (or the flow rate of the treated fluid leaving the circulation), the average contact time or interaction time between the fluid to be treated and the treatment unit can be controlled. Thus, the contact time or interaction time between the fluid to be treated and the treatment unit, and the fluid flow rate, can be controlled independently.

[0085] In some embodiments, the fluid in the circulation is driven by at least one drive device connected to the pipeline.

[0086] Here, the driving device includes, but is not limited to, a peristaltic pump, a pressure pump, an electric field, a heater, a hydraulic pump, or a vacuum pump, used to provide power to the fluid in the pipeline, causing the fluid to circulate in a preset flow direction. In this medical application scenario, the driving device should not directly contact the liquid, but only apply pressure to the pipeline and drive the liquid flow; a peristaltic pump is a preferred embodiment of the driving device.

[0087] In practical scenarios, the driving device can control the fluid flow rate in the pipeline based on application requirements, such as safety, operational economy, interception and separation effect, sustainability and other factors. In one example, when the fluid treatment method is used for disease treatment and the fluid to be treated is blood drawn from the human body, the flow rate of the fluid to be treated introduced into the circulation needs to be controlled within a preset range to ensure patient safety.

[0088] It should be understood that in the embodiments provided in this application, the separation effect is that the fluid balance in the circulation that has been processed by the processing unit and retained in the circulation forms a concentration difference with at least one component (e.g., a filterable component) in the fluid leaving the circulation through the drain port, rather than an absolute separation or removal effect. For example, the components in the fluid leaving the circulation through the drain port may also exist in the fluid balance, but at least one component has a different concentration in the circulation than in the fluid leaving the circulation.

[0089] It should be understood that, in the embodiments provided in this application, the retention means that when the treated fluid in the cycle leaves the cycle, a specific component or molecule is blocked in the cycle to maintain its flow. The retention effect is, for example, the proportion of a specific component or molecule that is blocked in the cycle.

[0090] In some implementations, the total amount or rate of fluid introduced into the pipeline is made equal to the total amount or rate of fluid leaving the circulation, so that the total amount of fluid in the pipeline is dynamically balanced.

[0091] In the cycle of introducing the fluid to be processed and withdrawing the processed fluid, it should be understood that the volume space in the pipeline is relatively fixed, and the total amount of fluid in the pipeline is dynamically balanced, which makes it easier to ensure the stability of the internal pressure of the pipeline.

[0092] The fluid flow rate is controlled by the drive device to ensure dynamic balance of the total fluid volume in the pipeline. During the circulation, the pressure in the pipeline can be maintained at a constant value or a fluctuation range determined by the constant value. This avoids problems such as pipeline rupture, negative pressure suction, and damage to fluid components, such as the rupture of red blood cells in blood, caused by pressure changes in the pipeline. Therefore, the circulation is sustainable.

[0093] The pressure within the pipeline is related to the total amount of fluid inside. For example, when the fluid volume continuously decreases, negative pressure can easily form in the relatively closed structure of the pipeline. Conversely, when the fluid volume continuously increases, the pressure inside the pipeline increases. Negative pressure or excessive pressure negatively impacts the interception and separation effects of fluid processing and the safety of the pipeline. Taking medical applications as an example, if the fluid is blood, excessive pressure in the pipeline could lead to pipe rupture or damage to the separation module, potentially causing treatment failure or even endangering the patient's health. Therefore, the drive device, while providing power for fluid circulation, can also be used to ensure that the pressure in the pipeline is at a preset level, or to adjust the pressure in the pipeline to a preset level.

[0094] In some embodiments, the circulation is a relatively closed space. For example, the circulation becomes a closed space after the inlet for introducing the fluid to be treated and the outlet for exiting the fluid are closed. Here, the circulation can also regulate its internal pressure through its own equilibrium stability. For example, when the circulation begins to exhibit a negative pressure state, this negative pressure state causes the rate at which the fluid to be treated is introduced into the circulation to be greater than the rate at which the fluid is exited, and the circulation can then reach a pressure equilibrium state again. Furthermore, after the fluid is introduced into the circulation, it can avoid contact with the external environment. In certain specific situations, such as blood transfusion or protein extraction in medical settings, the relatively closed space can create a sterile environment or reduce infection by bacteria, microorganisms, viruses, etc. In this example, the fluid processing method of this application, by forming a relatively closed circulation environment, reduces interference from the external environment when the fluid flows through the pipeline and is processed, thereby increasing the reliability of the processing process.

[0095] In some embodiments of this application, the loop adjusts the processing efficiency in at least one of the following ways:

[0096] The ratio of the total amount of fluid introduced into the pipeline per unit time to the total amount of fluid in the circulation is controlled to adjust the processing efficiency;

[0097] The processing efficiency is adjusted by controlling the ratio of the total amount of fluid leaving the circulation per unit time to the fluid flow rate in the circulation.

[0098] To better illustrate the advantages of the circulation method in this application compared to traditional single-pass processing, let Qin represent the fluid flow rate entering the circulation per unit time. Here, the fluid flow rate introduced into the circulation per unit time is the flow velocity of the fluid to be treated at the inlet of the circulation. Let Qfilter represent the fluid flow rate leaving the circulation per unit time, which is the flow velocity of the treated fluid leaving the circulation. Qcirculation represents the fluid flow rate circulating per unit time. Here, Qcirculation can also represent the fluid mass or fluid volume flowing through a specific area, such as the inner surface of a pipe, per unit time. Given a fixed hardware device or module connection method in the circulation, Qcirculation can be adjusted by controlling the flow velocity in the circulation. Vtotal represents the total fluid volume in the circulation. Typically, Vtotal is determined by the specifications of the equipment performing the fluid processing method of this application, such as the volume determined by the total length of the pipe flow path, the inner diameter of the pipe, etc. Let:

[0099]

[0100]

[0101] K1 can represent the ratio of the total amount of fluid introduced into the pipeline per unit time to the total amount of fluid in the circulation, and K2 can represent the ratio of the total amount of fluid leaving the circulation per unit time to the fluid flow rate in the circulation.

[0102] Smaller values ​​of K1 and K2 indicate a longer residence time of the fluid or target substance in the circulation, making it easier to process or resulting in higher processing efficiency. We assume a certain volume of fluid to be processed is introduced at a constant flow rate Q or a constant inflow velocity, either through a single flow in a straight pipeline or through a circulating system as described in this application. In both processing modes, assuming the pipeline contains processing units with identical processing efficiencies, the fluid processing method provided in this application can improve processing efficiency by increasing at least one of Vtotal and Qcirculation. Particularly when single-pass processing is insufficient, using the same processing unit or module in the circulating processing method described in this application can more effectively achieve the aforementioned processing effect. Furthermore, under otherwise identical conditions, increasing Qin improves the processing results for the target substance, and the circulating processing method described in this application shows a more significant improvement compared to traditional single-pass processing.

[0103] In one example, under equilibrium conditions, i.e., Qin and Qfilter are equal, the internal pipeline of the circulation remains full, and the total volume of the fluid remaining in the circulation remains relatively constant. By controlling the flow rate of the fluid to be treated introduced into the circulation, i.e., by controlling Qin, the average residence time of the fluid to be treated in the circulation can be determined, and correspondingly, the average contact time or interaction time between the fluid to be treated and the processing unit can be determined. For example, for a circulation used to perform the fluid treatment method of this application, the accommodating space of the pipeline in the circulation is a relatively fixed value. The lower the flow rate of the fluid to be treated introduced into the circulation, the longer the contact time or interaction time between the fluid to be treated and the processing unit in the circulation, thereby achieving adjustment of the treatment effect or efficiency.

[0104] In another example, the Q filter corresponding to the cycle is a fixed value. The Q cycle is controlled by adjusting the flow rate in the cycle. Based on the characteristic that the internal flow rate of the cycle and the inflow or outflow flow rate of the cycle-type processing can be relatively independent, the flow rate of the fluid in the cycle can be adjusted to a preset value without changing the flow rate of the treated fluid leaving the cycle. The preset value can be determined based on the relationship between processing efficiency and flow rate, thereby adjusting the processing efficiency in the cycle based on a preset target.

[0105] Here, the processing effect described in this application is, for example, the removal rate or generation rate corresponding to the molecules or molecular combinations that need to be removed or generated in the fluid to be processed. The removal rate or generation rate can be determined by comparing the fluid to be processed with the fluid that leaves the circulation after processing. The processing efficiency is, for example, the speed at which the processing unit selectively removes or generates molecules or molecular combinations.

[0106] In some embodiments of this application, the processing unit achieves catalytic treatment by controlling a catalytic unit in the cycle, wherein the processing unit controls the catalytic unit in at least one of the following ways:

[0107] The processing unit is used to add, supplement, replace, or update catalytic units to control the type and total amount of catalytic units in the cycle;

[0108] The processing unit is used to regulate the activity of the catalytic unit in the cycle.

[0109] In various embodiments where catalytic treatment is achieved through the processing unit, the cycle described in this application is also referred to as a metabolic cycle.

[0110] The processing unit is, for example, a component or device for adding or removing the catalytic unit from the cycle to achieve the addition, replenishment, replacement, or renewal of the catalytic unit; the processing unit may also be a structure or component for fixing the catalytic unit in a pipeline to achieve contact between the catalytic unit and the fluid to be treated in the pipeline; or, the processing unit may also be used to adjust the activity of the catalytic unit to achieve catalytic treatment. For example, the processing unit may be used to adjust the environment in which the catalytic unit is located in the cycle, such as temperature, pH, reaction substrate, and other factors affecting the activity of the catalytic unit.

[0111] In some embodiments, the catalytic unit is used to alter the chemical structure of a target substance in the fluid to generate a target product, or to alter the concentration of the target substance in the fluid. Here, the target substance is a component in the fluid to be treated, and the target product is a component generated from the target substance under the action of the catalytic unit. In some scenarios, the target substance is a molecule that needs to be removed or decomposed, and the treatment objective of the fluid to be treated is to decompose or degrade the target substance to reduce its concentration. In other scenarios, the treatment objective of the fluid to be treated is to generate a target product, thereby altering the chemical structure of the target substance based on the catalytic unit to obtain the target product.

[0112] It should be noted that in the embodiments provided in this application, the target substance is determined based on a preset target for fluid treatment. Furthermore, the target substance within the pipeline in different cycles can be the same type or the same component or molecule, or it can be different substances. Taking medical applications as an example, the target substance includes, but is not limited to, proteins, lipoproteins, enzymes, antibodies, DNA, amino acids, purines, sugars and polysaccharides, fats, cholesterol, vitamins, hormones, nutritional or energy molecules, biological factors, coagulation factors, metabolic waste, etc. Simultaneously, the target substance can be substances that need to be separated and filtered out or need to be catalytically decomposed, including but not limited to immunoglobulins, immune complexes, antibodies, rheumatoid factor, endotoxins and inflammatory mediators, bilirubin, LDL, viruses, etc. (which are discarded as filtrate or waste in some traditional applications). It can also be a synthetic or generated component in the treated fluid. The specific composition of the target substance can be changed based on the fluid composition and the preset treatment purpose.

[0113] In some embodiments, the catalytic unit includes a biocatalytic unit and a non-biocatalytic unit; wherein, the biocatalytic unit includes at least one of cells, proteins, enzymes, peptides and nucleic acids, and derivatives, conjugates, complexes, and assemblies in the form of microspheres, microcapsules, etc. formed based on at least one of them; the non-biocatalytic unit includes solid catalysts, metal catalysts, and derivatives, conjugates, complexes, and assemblies in the form of microspheres, microcapsules, etc. formed based on metal catalysts.

[0114] In some embodiments, the catalytic unit is formed by combining a catalytically functional substance, such as an enzyme, with a support, the support including, for example, an inorganic support, a synthetic polymer support, a natural polymer support, and a composite support.

[0115] Here, the catalytic unit is disposed within the pipeline or added during use, allowing it to contact the fluid and alter the structure or concentration of the target substance within it. The catalytic unit can be, for example, a catalyst or cell based on the degradation, decomposition, generation, catalysis, or alteration of the target substance's structure. It should be understood that the specific types, derivatives, assemblies, etc., of the catalytic unit are not limited to the foregoing examples. Generally, based on the determined type of target substance, any catalyst or other substance capable of achieving the preset treatment effect can be designed as a catalytic unit. Furthermore, the specific type and form of the catalytic unit adopted can be determined by comprehensively considering factors such as safety, catalytic effect, and catalyst stability in the specific application scenario.

[0116] It should be understood that, in the various embodiments of this application, the interaction between the catalytic unit and the target substance, in addition to catalytic reactions such as accelerating the decomposition, degradation, or generation of the target substance, may also include adsorption, local enrichment, and the influence of catalytic reactions or the target substance or product on the stability and catalytic activity of the catalyst. Such influence can be either beneficial or detrimental to the processing.

[0117] The target product and the target substance can be the same substance or different substances. That is, the effect of the catalytic unit on the target substance can be to cause changes in the chemical structure or biomolecular structure of the target substance, or it can be only a change in the physical structure, such as causing the dispersed target substance to be condensed or causing the condensed target substance to be dispersed.

[0118] The catalytic unit is located in or connected to the pipeline, meaning that the catalytic unit can maintain contact with the circulating fluid in the pipeline, thereby reacting with the target substance in the pipeline, and the composition of the fluid in the pipeline also changes dynamically.

[0119] In some embodiments, the catalytic unit is a circulating catalytic unit that circulates along with the fluid balance; or, the catalytic unit is a stationary catalytic unit defined or fixed in a predetermined area of ​​the pipeline.

[0120] The catalytic unit can be in a free state, circulating along with the remaining fluid; or, the catalytic unit can be confined to a predetermined local area within the pipeline. This predetermined area can be a local region within the pipeline or a device or equipment connected to the pipeline, such as a collection device for expanding the pipeline capacity, provided that the device or equipment can contact the remaining fluid in the circulation; or, the catalytic unit can be fixed in the predetermined area. For example, the catalytic unit can be fixed on the inner wall of the pipeline, the inner wall of a cavity connected to the pipeline, or a fiber or membrane within the pipeline or a cavity connected to the pipeline. That is, the catalytic unit can exist in a free or fixed state within the pipeline or in any device or structure connected to the pipeline, provided that the catalytic unit can contact the circulating fluid to react with the target substance.

[0121] In some embodiments, the cycle also includes a retention module disposed in the pipeline, the retention module having retention components to retain the circulating catalytic unit and / or retain any detached stationary catalytic units, so as to prevent the catalytic unit from leaving the cycle.

[0122] The interception module has interfaces at its two ends corresponding to the pipeline, so that the interception module is connected to the pipeline and forms a loop.

[0123] The interception module can be divided into two opposite sides by the interception component, wherein the opposite ends of one side are connected to the pipeline, and the other side can be connected to the drain port of the circulation, so that when the fluid passes through the interception module, the components intercepted in the direction of flow, such as the catalytic unit, flow through the interception module to the pipeline, and the treated fluid flows through the interception component to the drain port to leave the circulation.

[0124] In some embodiments, the interception component divides the interception module into a first side and a second side, and the cycle includes at least one of the following: a first type of metabolic cycle in which the pipeline inlet and outlet are connected to the first side, having at least one inlet in the pipeline and at least one outlet in the second side; and a second type of metabolic cycle in which the pipeline inlet and outlet are connected to the second side, having at least one inlet in the first side and at least one outlet in the first side.

[0125] In one example, the inlet and outlet of the cycle are connected to the same side of the interception module, and the inlet and outlet of the pipeline in the cycle are connected to the other side of the interception module, thus forming the second type of metabolic cycle; in another example, the inlet and pipeline in the cycle are connected to the same side of the interception module, and the outlet is connected to the other side of the interception module. In this example, the inlet is connected to a pipeline, thus forming the first type of metabolic cycle.

[0126] In the embodiments provided in this application, the catalytic unit is located in the pipeline, that is, the catalytic unit is always on the side forming the cycle and will not leave the cycle through the retention component. Based on the structure, physicochemical specificity, and carrier or derivative form of the catalytic unit, the movement state of the catalytic unit in the pipeline (i.e., the aforementioned free state or immobilized state) can be used to select different forms of retention components to form a retention effect on the catalytic unit.

[0127] In both the first and second types of metabolic cycles, the retention components are used to retain the catalytic unit. In the second type of metabolic cycle, when fluid is introduced into the cycle from the inlet, it must pass through the retention components to enter the cycle's pipeline. In some scenarios, the retention components can achieve the effect of pre-separating the fluid, for example, retaining large molecular components in the fluid on the first side of the retention module. The fluid passing through the retention components enters the cycle's pipeline to react under the action of the catalytic unit.

[0128] In the embodiments provided in this application, the catalytic unit is located in the pipeline, that is, the catalytic unit is always on the side forming the cycle and will not leave the cycle through the retention component. Based on the structure, physicochemical specificity, and carrier or derivative form of the catalytic unit, the movement state of the catalytic unit in the pipeline (i.e., the aforementioned free state or immobilized state) can be used to select different forms of retention components to form a retention effect on the catalytic unit.

[0129] When a circulating catalytic unit is used in the cycle, the retention module generally needs to achieve a retention rate of over 99% for the catalytic unit to ensure that the catalytic unit does not leave the cycle and affect the system, while also ensuring that the number of catalytic units in the cycle does not decrease to affect the treatment effect. The retention effect refers to the situation where, when the fluid in the cycle passes through the retention module, there is no significant concentration difference between the retained fluid and the instantaneous fluid leaving the cycle through the retention module, excluding components other than the circulating catalytic unit. The target substance or product and other components in the liquid to be treated may either leave the cycle due to the retention module or remain in the cycle.

[0130] Therefore, the retention component can be configured as a component with selective permeability characteristics, so that the catalytic unit in the fluid can be retained in the cycle, while the fluid to be treated and the treated products can leave the cycle through the retention module; thus, the fluid to be treated can be continuously replenished in the cycle, and the retention module can continuously guide the treated fluid out of the cycle.

[0131] The specific form of the retention module can be set according to the catalytic unit. Taking the catalytic unit as a free enzyme as an example, the corresponding retention component can be set as a structure that is not permeable to the free enzyme. For example, the average pore size of the retention component is smaller than the particle size of the free enzyme, so that the free enzyme is retained in the cycle.

[0132] Taking an enzyme as an example of a catalytic unit, the enzyme that can participate in the circulation along with the remaining fluid can also be an enzyme-carrying microsphere, an enzyme-carrying microcapsule, or a water-soluble macromolecule bound to the enzyme. In this example, problems such as enzyme deformation and inactivation caused by chemical reactions when the enzyme is bound to the carrier can be avoided. Based on the different forms of the enzyme carrier, the corresponding retention module in the circulation can be set in different forms to achieve enzyme retention. For example, the average pore size of the retention component is used to achieve the retention of the enzyme-carrying microsphere, while filtering out the treated fluid. Here, the size of the microsphere is much larger than that of the enzyme, which greatly increases the average pore size and molecular retention capacity of the retention component, breaking through the limitation of the retention pore size on the filtration flow rate and the influent flow rate. This can better control the flow rate of the fluid introduced into the circulation, which can also be represented by the aforementioned Q-in, increasing the amount of fluid entering and leaving the circulation, which is beneficial to increasing the absolute value of the throughput of the circulation treatment.

[0133] In one implementation, a corresponding retention module can be designed or selected by determining the catalytic unit and the target product category. This allows the retention module to retain the catalytic unit in the pipeline, while the target product can pass through the retention module to leave the circulation. Taking a medical application as an example, when the catalytic unit is an enzyme-carrying microsphere and the fluid to be treated is blood plasma, the enzyme-carrying microsphere causes biomolecules in the blood, such as toxic metabolites, to be decomposed into metabolites. Correspondingly, the retention module can be determined, for example, based on the particle size of the enzyme-carrying microsphere and the metabolites, so that the metabolites are driven to leave the circulation when passing through the retention module, and the enzyme-carrying microsphere, as the catalytic unit, is retained in the pipeline.

[0134] In this fluid treatment method, the utilization rate of the catalytic unit can be improved by retaining the catalytic unit on the circulation side; at the same time, by keeping the catalytic unit in the pipeline at all times, the catalytic unit can maintain contact with the fluid balance, thereby forming a continuous reaction effect such as continuous catalysis and continuous decomposition.

[0135] In some scenarios, by forming the catalytic units in a free state, the continuous impact and scouring of the catalytic units by the fluid can be avoided and mitigated, reducing the resulting breakage and minimizing protein deposition and gel layer formation. Here, the fluid processing method of this application can be used to create a dynamic reaction environment between the catalytic units and the target substance within the pipeline. The catalytic units, distributed in a free state within the pipeline, facilitate sufficient contact with the target substance. Simultaneously, the catalytic units can flow in the circulation direction within the pipeline in accordance with the dynamic environment, with tangential flow between the catalytic units and the inner wall of the pipeline, thus reducing collision problems of the catalytic units in the reaction environment. The fluid processing method of this application, while ensuring sufficient contact with the target substance to improve the catalytic effect, also reduces the probability of catalytic unit damage.

[0136] In some embodiments, the catalytic unit is retained in the pipeline by the retention component for circulation, and the reaction products, target substances, and other components in the fluid to be treated exit the circulation based on the retention module.

[0137] That is, when the catalytic unit is in a free state, it can participate in the circulation along with the fluid balance and participate in the catalytic reaction during the circulation process. The corresponding reaction products and other untreated components leave the circulation through the retention component. In this example, the components of the fluid balance are kept renewed by introducing fluid into the circulation, that is, the pipeline can be continuously replenished with target substances that can react with the catalytic unit, while the target products can leave the pipeline in a timely manner. This can be used to control the concentration of target substances inside the pipeline, thereby improving the catalytic efficiency of the catalytic unit. It should be understood that the catalytic efficiency of a catalyst is generally related to the substrate concentration. The target substance can be the substrate that reacts with the catalyst. The pipeline has a relatively fixed volume. By allowing the target product to leave the circulation, i.e., to leave the pipeline, the concentration of the target substance in the pipeline can be ensured.

[0138] In some embodiments, the retention component is a porous membrane or a reverse osmosis membrane, wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, and a nanofiltration membrane.

[0139] Here, the specific type of the retention component can be determined based on the difference in physicochemical properties between the fluid components and the circulating catalytic unit or the detached stationary catalytic unit. The retention component is used to retain the catalytic unit and filter other components in the fluid. The types of retention components include, for example, reverse osmosis membranes (average pore size 0.0001–0.001 μm), nanofiltration membranes (average pore size 0.001–0.01 μm), ultrafiltration membranes (average pore size 0.01–0.1 μm), microfiltration membranes (average pore size 0.1–10 μm), electrodialysis membranes, pervaporation membranes, liquid membranes, electrode membranes, etc.

[0140] In some embodiments, the retention component includes one or more of planar membranes, tubular membranes, spiral membranes, and hollow fiber membranes. In terms of microstructure, the retention component may include, for example, symmetrical membranes, asymmetrical membranes, composite membranes, multilayer composite membranes, etc.

[0141] In some embodiments, the average pore size or molecular weight cutoff (MWCO) of the retention component is related to at least one of the catalytic unit, the target substance, and the target product.

[0142] In one embodiment, to retain the catalytic unit in the pipeline, the average pore size or molecular weight cut-off of the retention component can be set to be smaller than the particle size or molecular weight of the catalytic unit; in some examples, to achieve the retention effect of the catalytic unit, the pore size or molecular weight cut-off of the retention component can be set to be much smaller than the catalytic unit.

[0143] For example, when the catalytic unit is in a free state circulating with the remaining fluid, the average pore size or molecular weight cutoff of the retention component is related to the catalytic unit. Here, the corresponding separation membrane capable of achieving the retention effect can be determined based on the specific structure of the catalytic unit. In some scenarios, the pore size and type of the separation membrane can be determined based on the retention component being configured to achieve a retention rate of over 95% of the catalytic unit. Alternatively, based on higher retention requirements, the retention rate of the retention component to the catalytic unit can be set to over 99% or even over 99.9% to determine the corresponding pore size and type of the separation membrane. Here, when the catalytic unit is an enzyme, the enzyme shedding problem present in existing enzyme therapies can be greatly reduced or even avoided.

[0144] In another embodiment, when the target substance is also a substance that needs to be retained by the retention module, the average pore size or molecular weight cut-off of the retention component is related to the target substance. In practical scenarios, based on the fluid composition and the determined target substance, a membrane suitable for retaining the target substance is selected. For example, when the target substance to be retained in the fluid has a particle size of 10 nm (i.e., 0.01 μm), the corresponding separation membrane as the retention component can be a nanofiltration membrane or a reverse osmosis membrane to achieve the retention of the target substance.

[0145] In some examples, the reaction product can exit the circulation module through the retention component, and correspondingly, the average pore size or molecular weight cutoff of the retention component can be set to be greater than the particle size or molecular weight of the target product.

[0146] Based on the target of intercepting or filtering the catalytic unit in the fluid, the corresponding interception component type is comprehensively determined. For example, when the catalytic unit is immobilized in the pipeline, it may be washed away by the fluid and become free in the circulation. In this case, the interception module can serve as a safeguard. Therefore, setting the catalytic unit as fixed or free, and the average particle size or molecular retention capacity of the interception component, can be determined based on the composition of the fluid and the type of catalytic unit. This ensures that the fluid and reaction products can leave the circulation through the interception module while the catalytic unit is retained in the circulation. Generally, when the interception component separates based on pore size, its pore size needs to be larger than the largest component in the fluid but smaller than the catalytic unit.

[0147] In some examples, the average pore size or molecular weight cutoff of the retention component suitable for retaining or filtering the target can be determined first based on the fluid composition, target substance, and catalytic unit. In some implementations, when the retention component separates from the membrane, the specific type of the separation membrane can be determined by considering factors such as the Donnan effect, adsorption, and dissolution of the separation membrane to set a membrane in the retention module that can achieve the preset retention and separation effects. In some examples, the type and size of the catalytic unit can be determined first based on the fluid composition and target substance, and then the pore size and molecular weight cutoff of the separation membrane can be further determined. In other examples, the fluid can be pretreated or circulated for separation to separate the fluid containing the target substance with a smaller average molecular weight, and then the type and size of the catalytic unit can be determined, and then the pore size and molecular weight cutoff of the separation membrane can be further determined. In terms of microstructure, the separation membrane may include, for example, symmetrical membranes, asymmetrical membranes, composite membranes, multilayer composite membranes, etc.

[0148] In some implementations, the interception module is a tangential / cross flow filtering module (TFFM).

[0149] It should be understood that, based on the separation method achieved by the transmembrane pressure difference at the boundary surface in tangential flow filtration, the pressure difference used to drive the transmembrane can be adjusted by controlling the fluid flow rate at the retention module, thereby adjusting the separation efficiency or retention efficiency.

[0150] In some examples, the tangential flow filtration module may employ existing tangential flow filtration membrane packs, such as MERCK's Pellicon cartridge ultrafiltration membrane packs, Asahi Kasei's leukocyte removal filters, virus removal filters, LEOCEED dialyzers, membrane-type plasma component separators, and BRAUN's plasma separators. It should be noted that, on one hand, the tangential flow filtration module can be used in different fields to achieve different separation effects, such as for material collection (e.g., retaining materials in the pipeline), industrial wastewater treatment, etc., and is not limited to the application scenarios of the aforementioned products. On the other hand, in practical scenarios, the tangential flow filtration module determines the corresponding membrane pore size or molecular weight cutoff, as well as the membrane geometry, based on the purpose of filtration or retention of each component in the fluid, and is not limited to the examples mentioned above.

[0151] In this example, separation is achieved by driving the pressure difference in the TFFM. The circulation not only retains the circulating catalytic unit in the fluid, but also allows the retained processing unit to continue participating in the circulation in the direction of flow, thus achieving cyclic processing. In this implementation, for example, the pressure difference can be adjusted by controlling the fluid flow rate through the TFFM in the circulation to change the fluid transmembrane exchange efficiency. Alternatively, the exchange efficiency can be changed by changing the type of the TFFM, such as changing the flow channel, the pore size of the porous membrane, or changing the fluid viscosity, such as diluting the fluid.

[0152] It should be understood that in TFFM, the fluid flow direction is tangential to the membrane surface, which can be regarded as the angle between the fluid flow direction and the membrane surface being 0°. In practical scenarios, when the angle between the fluid and the membrane surface is also other angles such as 5°, 10°, etc., the trapped substances can leave the membrane surface and continue to participate in the cycle.

[0153] In some embodiments, the fluid to be treated is added to the circulation through the inlet and then driven by the drive device to flow to the interception module.

[0154] The driving device is located between the inlet and the interception module, and drives the fluid in the pipeline to flow from the inlet through the driving device and into the interception module. With this configuration, the control device can control the flow rate of the fluid through the interception module.

[0155] In some embodiments, a driving device may also be provided on the pipeline that connects to the outlet of the interception module in the direction of fluid flow in the circulation, that is, the fluid is driven by the driving device to form a circulation after passing through the interception module.

[0156] It should be understood that the driving device can drive the fluid in the pipeline at different positions. The flow velocity, following the fluid flow direction, may change due to factors such as pipeline resistance, temperature, and pressure. In the embodiments provided in this application, the driving device is located between the inlet and the interception module and drives the fluid to be treated introduced from the inlet to flow to the interception module, thus controlling the fluid flow velocity at the interception module. Taking an embodiment where a separation membrane is provided in the interception module as an example, the flow angle of the fluid relative to the separation membrane can be set to different angles, such as 0° to 90°. The flow velocity of the fluid relative to the separation membrane is related to the interception and separation effect. The fluid treatment method of this application can control the interception and separation effect by setting the position of the driving device. The evaluation factors for the interception and separation effect include, but are not limited to, membrane flux, separation rate, the rejection rate of the circulating catalytic unit, and the permeation rate of other fluid components.

[0157] In real-world scenarios, the drive device can be installed at any location in the pipeline. The number and location of the drive device can be determined based on the pipeline shape, total fluid volume, drive device power, and preset flow rate for circulation.

[0158] In this fluid treatment method, the fluid circulation in the pipeline is controlled by the driving device to maintain a dynamic balance of the total fluid volume. The specific form of the corresponding retention module is determined based on the fluid composition and the circulating catalytic unit. This allows for the selective treatment of target molecules in the fluid. Furthermore, the pipeline can be used both for fluid flow and as a container during the treatment process; it can be considered a circulating processor or a circulating reactor. In practical scenarios, such as medical applications, this can effectively simplify the equipment structure or reduce equipment space for implementing the fluid treatment method, resulting in a user-friendly, portable, or wearable device. Simultaneously, when using a specific catalytic unit, the treatment result of the liquid to be treated can be controlled or determined by the following methods or conditions, including but not limited to: the retention and separation effect of the retention module, the proportion of filtration volume to the circulating liquid, and the treatment effect on specific components. The circulation time, i.e., the number of cycles or duration in the pipeline, can be controlled based on a preset treatment target.

[0159] In some embodiments, the drive device controls the fluid in the pipeline to flow at a preset flow rate so that the catalytic unit flows through the interception module into the pipeline.

[0160] For example, when the retention module is a TFFM (Fluidized Tolerancing Membrane), the fluid flow direction is parallel to the separation membrane in the TFFM. Here, as the fluid passes through the separation membrane in the TFFM, a transmembrane pressure difference perpendicular to the membrane surface is generated on both sides of the membrane. This pressure difference drives the low molecular weight components in the fluid to pass through the separation membrane and reach the other side. The low molecular weight components that pass through the separation membrane can thus leave the circulation. Simultaneously, the retained catalytic units or other pre-defined high molecular weight components are flushed off the membrane surface by the fluid momentum and continue to circulate in the pipeline. The pressure difference across the membrane in the TFFM is related to the preset flow rate. Furthermore, the continued circulation of the retained substances requires a certain momentum to overcome the polymerization barriers between catalytic units or high molecular weight components, as well as between the catalytic units or high molecular weight components and the membrane. The driving device controls the flow rate in the pipeline, which can be used to control the pressure difference across the separation membrane to achieve retention and separation effects, and can also be used to prevent polymerization barriers, ensuring the sustainability of the circulation in the pipeline.

[0161] In some embodiments, the preset flow rate is related to at least one of the following: catalytic unit, fluid composition, fluid temperature, filtration component structure, filtration component material, filtration module cavity structure, pipeline diameter, exchange efficiency between the target substance or reaction substrate and the catalytic unit, and fluid exchange efficiency. The fluid composition includes fluid component categories and corresponding concentrations of each component.

[0162] The fluid velocity at the interception module is related to various parameters, such as fluid density and viscosity, the boundary layer shape of the fluid at the interception module (e.g., the surface shape of the separation membrane, i.e., the membrane structure) and the cavity structure of the interception module, the interaction force between the fluid and the separation membrane (e.g., the membrane surface roughness determined by the membrane material and the attraction between the membrane and the fluid), and the velocity relationship between the interception module and the pipeline inlet determined by the cavity structure of the interception module and the pipeline diameter. The fluid velocity at the interception module may change. Here, the preset velocity is used to determine the fluid velocity at the pipeline inlet leading to the interception module. The preset threshold can be used as the initial velocity at the interception module. Based on the initial velocity and the influence parameters of the fluid velocity at the interception module, the pressure difference for separation can be generated by controlling the preset velocity. This prevents the intercepted macromolecules, such as catalytic units, from agglomerating on the membrane surface. Thus, macromolecules can flow from the pipeline inlet through the interception module to the pipeline outlet.

[0163] In some implementations, the preset flow rate is related to the fluid exchange efficiency. For example, in TFFM, the target product needs to reach a certain flow rate before being driven by the pressure difference across the separation membrane to flow to the other side of the retention module, thereby leaving the circulation. The pressure difference is related to the flow rate. When the flow rate is too low, the exchange efficiency of the target product, the target product, and other components in the fluid to be treated across the membrane may decrease. Therefore, the preset flow rate can also be determined by the exchange efficiency. Here, for example, the fluid flow rate Qcirculation or K2 in the circulation can be determined by controlling the preset flow rate to achieve the exchange efficiency and exchange time between the target substance or reaction substrate and the catalytic unit, thereby adjusting the treatment efficiency.

[0164] The preset flow rate can also be used to control the processing efficiency in the cycle. For example, the preset flow rate is related to the exchange efficiency between the target substance or reaction substrate and the catalytic unit. It should be understood that when the processing unit performs processing by contacting the target substance or reaction substrate, controlling the flow rate in the cycle can correspondingly control or adjust the contact state or mixing state between the target substance or reaction substrate and the catalytic unit.

[0165] In some embodiments, the cycle is further provided with a sample addition device for adding, supplementing, or replacing reaction substrates, catalytic units, drugs, and other auxiliary factors or activators into the pipeline.

[0166] In this example, the sampling device can serve as a processing unit. Through this device, catalytic units, reaction substrates, activators, etc., can be added, replenished, or replaced in the cycle under manual or computational control, thereby achieving fluid catalysis. In practical scenarios, the sampling device can also be used to control the concentration of catalytic units in the cycle. For example, when the concentration of the target substance in the fluid to be treated varies, the amount of catalytic units added to the pipeline can be controlled to achieve a preset reaction effect.

[0167] The sample dispensing device can be an integral component with the pipeline, or it can have two opposing inlets to connect the pipeline and ensure fluid circulation. Through the sample dispensing device, the catalytic unit or reaction substrate can be added to the pipeline immediately; wherein, the reaction substrate can be any component in the fluid to be treated or a substance that can react with any component in the fluid to be treated, and the reaction includes, but is not limited to, biological, chemical, and physical reactions. The cofactor or activator can be used to assist the catalytic unit in reacting with the target substance; for example, when the catalytic unit is a metalloenzyme that requires metal ions as a cofactor.

[0168] Taking the existing enzyme therapy approach as an example, enzymes that can serve as catalytic units are usually immobilized in containers, such as the inner wall of the container, fibers, membranes, or the inner wall of the cavity. That is, the enzyme is an inherent component of the processing device. After the enzyme is immobilized and the catalytic reaction begins, the activity of the enzyme in the device is difficult to adjust. At the same time, the inner wall of the container or membrane usually serves as the storage environment for the enzyme. For enzymes with short half-lives, there are many limitations on the overall storage requirements of the device and the requirements of the reaction time. For example, the entire device needs to be placed in a low-temperature environment to preserve the enzyme immobilized therein.

[0169] The sample dispensing device in the apparatus or device for performing the fluid processing method of this application can be used to enable the immediate updating, replacement, and replenishment of catalytic units. In practical applications, this is beneficial for controlling the catalytic efficiency in fluid processing. Simultaneously, it effectively expands the storage environment for the catalytic units; the catalytic units and pipelines can be stored under different conditions, reducing the overall storage requirements of the equipment used to perform the fluid processing method. For certain catalytic units, such as enzymes, they can be stored separately in a low-temperature environment, distinct from the equipment. Specific enzymes with short half-lives can be stored in lyophilized powder form, dispersed in the aqueous phase and injected into the sample dispensing device when needed, thus ensuring the activity of the enzyme reacting with the target substance.

[0170] In some embodiments, the sampling device includes at least one sampling port connected to the tubing, or the sampling device is a component adapted for injection.

[0171] The sample dispensing port is connected to the pipeline, meaning that substances such as catalytic units and reaction substrates injected through the sample dispensing port can enter the circulation through the sample dispensing device.

[0172] In one example, the sampling port of the sampling device may also be equipped with a corresponding stopcock or sealing cap, which is used to open during sampling and close after sampling to ensure that the inside of the pipeline remains relatively sealed.

[0173] In another example, the sample application device may be equipped with a permeable component, such as a rubber stopper, which can be used to form a sample application port by injection or puncture during sample application. For example, the catalytic unit or reaction substrate to be added to the pipeline is stored in a syringe, and the catalytic unit or reaction substrate is added to the sample application device by puncturing the rubber stopper with the syringe.

[0174] In some embodiments, the circulation configuration includes a collection device having a collection chamber for mixing the circulating catalytic unit, the fluid balance, and the liquid to be treated, so that the catalytic unit comes into contact with the target substance.

[0175] The collection device can be used to expand the circulation volume. In the examples where the fluid is liquid, the collection device can help the circulating liquid mix better with the circulating catalytic unit, thereby enabling the target substance to come into full contact with the circulating catalytic unit.

[0176] In some embodiments, the collecting device is also used to provide a sample inlet, an air outlet, or a liquid outlet. In this example, the collecting device can also serve as an integrated platform for various liquid inlets / outlets or air outlets and a mixing and confluence site for various liquids.

[0177] In one embodiment, by determining the location of the collecting device in the pipeline, the fluid in the collecting device tends to flow in the direction of circulation due to gravity when naturally placed. This design can avoid or reduce the generation of air bubbles in the pipeline. In this example, the collecting device can also be provided with an air inlet / outlet to regulate the internal air pressure of the circulation.

[0178] In some embodiments, the circulation loop is further provided with a flow channel regulating device for regulating the fluid flow direction in the pipeline; in some examples, the flow channel regulating device can regulate the fluid flow direction in the pipeline in at least one of the following ways:

[0179] The fluid flow direction is adjusted by regulating the opening state of the inlet and / or outlet of the circulation.

[0180] The direction of fluid flow is regulated by adjusting the opening state of at least one regulating pipe connected to the pipeline.

[0181] In some embodiments, the flow channel regulating device can be used to clean and replace the circulating catalytic unit. For example, by closing the inlet to stop supplying the fluid to be treated to the circulation, the circulation is switched to a concentrated circulation mode, where the treated liquid leaves the circulation while the catalytic unit remains in the circulation; the circulating catalytic unit can be cleaned by adding cleaning fluid to the circulation and discharging the cleaning fluid through at least one regulating pipe connected to the pipeline; after cleaning, a new catalytic unit can be added to the circulation to meet the treatment requirements of different target substances.

[0182] By controlling the pipe switches in the flow channel regulating device, the direction of fluid circulation and the flow channel in the pipeline can be changed. For example, under normal circulation conditions, the circulation continues to introduce the fluid to be treated and extract the treated fluid, and the circulating catalytic unit completes the circulating treatment normally. When the efficiency of the circulating catalytic unit decreases significantly or it loses its efficiency, the pipe switches on the regulating pipes are opened and the pipe switches on the pipeline are closed, as well as the pipe switch at the inlet is closed. One end of the two regulating pipes is connected to the pipeline, and the other end can serve as the inlet and outlet of the pipeline, respectively. The two regulating pipes cooperate with the pipeline to form a new flow channel. The circulating catalytic unit in the pipeline can be led out of the pipeline through the inlet and outlet. Cleaning fluid can also be introduced into the pipeline to adjust the pipeline to a cleaning mode. The cleaning fluid can enter the pipeline through the inlet and pass through the interception module to clean the pipeline wall and the interception module. After cleaning, a new circulating catalytic unit can be added to continue to selectively treat the target substances in the fluid. This can be the same treatment for the same target substance or different target substances, depending on the specific needs.

[0183] To illustrate the beneficial effects achieved by the first type of metabolic cycle provided in this application, the following experimental data are also provided:

[0184] Experiment 1:

[0185] Please see Figure 3 and Figure 4 ,in, Figure 3 The diagram shown is a simplified schematic of the metabolic cycle module used in Experiment 1 in one embodiment. Figure 4 Displayed as based on Figure 3 The data graph for Experiment 1 obtained from the metabolic cycle module.

[0186] like Figure 3 The illustrated metabolic circulation module includes tubing 11 and a retention module 30. Here, the retention module 30 is a unidirectional flow filtration module; the retention module 30 in Experiment 1 is a commercially available M-TFFM with a molecular rejection ratio of 10 kDa. Tubing 11 includes a drive device 13 and a sample dispensing device 301. Fluid from the retention module 30 is connected to the inlet of the metabolic circulation module, which, in the illustrated embodiment, is located at the sample dispensing device 301. Here, the sample dispensing device 301 can also function as a collection device.

[0187] Experimental procedure: Add 100 mL of glucose solution (10 mM, phosphate-buffered saline, PBS buffer) to the collection device connected to the inlet; drive the glucose solution to prefill the tubing using the drive device, wherein the total amount of liquid in the tubing is about 50 mL, and adjust the liquid flow rate at the inlet and the liquid flow rate at the outlet to make them equal, thus forming a balanced circulation.

[0188] After equilibrium is reached, add 1 mL of GOX (glucose oxidase) solution (containing 0.1 mg GOX, approximately 14.5 U in total) through the sample addition port, start timing, and take a sample in the collection device to determine the hydrogen peroxide concentration. The total amount of glucose degraded is then calculated from the hydrogen peroxide concentration.

[0189] Repeat the above experimental procedure, conducting three independent experiments, and take the average value of the glucose concentrations measured and calculated in the three experiments. Figure 4 The graph shows the change in glucose concentration over time, obtained from the average of three experiments.

[0190] As shown in the figure, the glucose concentration continued to decrease with increasing treatment time, but there was no significant decrease in the degradation rate. That is, continuous metabolism can take place in the metabolic cycle module, and the catalytic function is stable within 4 hours of the experiment, with very little activity decay.

[0191] To illustrate the beneficial effects achievable by the second type of metabolic cycle provided in this application, the following experimental data are also provided:

[0192] Experiment 2:

[0193] Please see Figure 9 and Figure 10 ,in, Figure 9 The diagram shown is a simplified schematic of the metabolic cycle module used in Experiment 2 in one embodiment. Figure 10 Displayed as based on Figure 9 The data graph for Experiment 2 obtained from the metabolic cycle module.

[0194] like Figure 9 The diagram shows the metabolic cycle module corresponding to the second type of metabolic cycle, including a tubing 21 and a retention module 30. Here, the retention module 30 is a unidirectional flow filtration module. In Experiment 2, the retention module 30 is a commercially available D-TFFM with a molecular retention capacity of 10 kD. The tubing 21 includes a drive device 23 and a sample feeding device 301.

[0195] Experimental procedure: 100 mL of phenylalanine solution (2 mM, PBS) was added to a container connected to the inlet. The liquid in the container could be connected to the first side of the separation module through the inlet, and the fluid that could pass through the separation component could flow into the pipeline. The pipeline was pre-filled with phenylalanine solution by a peristaltic pump. The total amount of liquid in the metabolic circulation module was about 10 mL. The flow rate of the liquid at the inlet and the flow rate of the liquid discharged from the outlet were adjusted to be equal to form a balanced circulation.

[0196] After equilibrium is reached, 3 mL of phenylalanine ammonia-lyase (approximately 2.84 U) is added through the sample dispensing port. Timing is started, and a sample is taken from the collection device to determine the concentration of the product trans-cinnamic acid. The concentration of trans-cinnamic acid is determined by its ultraviolet absorption peak at 280 nm. The concentration of phenylalanine is calculated from the concentration of trans-cinnamic acid.

[0197] Repeat the above experimental procedure, and conduct four independent experiments. Take the average value of the phenylalanine concentrations obtained from the four experiments. Figure 10 The graph shows the change in phenylalanine concentration over time, obtained from the average of four experiments.

[0198] As shown in the figure, the concentration of phenylalanine continued to decrease with increasing reaction time, indicating that continuous metabolism could take place in the metabolic cycle module. The catalytic function remained stable within 4 hours of the experiment, with minimal activity decay.

[0199] To illustrate the effect of the metabolic cycle of this application on the retention of the catalytic unit, this application also provides Experiment 3.

[0200] Experiment 3:

[0201] The experiment was conducted on the metabolic cycle module corresponding to the first type of metabolic cycle (molecular cutoff of 10 kD). Water was continuously added to the inlet to pre-fill the tubing. After equilibrium was reached, 1 mg of GOX (molecular weight of 160 kD) was added to the tubing of the metabolic cycle module through the sample addition port. The liquid discharged from the outlet of the metabolic cycle module, i.e., the filtrate, was collected separately. The concentration of GOX in the filtrate was measured by sampling. The results showed that 3.46 μg (i.e., 0.346%, obtained by sampling 1 mL three times and measuring activity) of GOX was discharged from the outlet for every 100 mL of filtered liquid.

[0202] Experiments were conducted on the metabolic cycle module corresponding to the second type of metabolic cycle (molecular cutoff of 10 kDa). Water was continuously added to the inlet to pre-fill the tubing. After equilibrium was reached, 1 mg of GOX was added to the tubing of the metabolic cycle module through the sample inlet, and the liquid discharged from the outlet was collected separately. The concentration of GOX in the liquid discharged from the outlet was measured. The results showed that 0.18-0.54% of 1 mg of GOX was discharged from the outlet during the 13-hour cycle.

[0203] That is, the metabolic cycle modules corresponding to the first type of metabolic cycle and the second type of metabolic cycle have good retention effects, thereby preventing the catalytic unit from entering the downstream cycle, such as the blood circulation in medical applications. This can prevent the loss of the catalytic unit and the decline of the catalytic function of the cycle. In specific scenarios, especially in medical applications, it can prevent the immune response caused by the catalytic unit or carrier entering the blood circulation or other body fluid circulation.

[0204] Based on the test results of Experiments 1, 2 and 3, in this embodiment where the catalytic unit is the enzyme, the metabolic cycle module of this application, in addition to solving the problems of enzyme shedding and entering downstream and even blood circulation, low efficiency of enzyme contact and exchange with the liquid to be treated, and sustainability of the treatment process, further provides a method in which the catalytic unit is replaceable, the treatment process is verifiable and traceable, to monitor and evaluate the entire selective treatment process.

[0205] To illustrate the beneficial effects achievable by the fluid processing method of this application, the following description is provided:

[0206] Taking enzymes as an example of the catalytic unit, an enzyme is a protein or RNA produced by living cells that has high specificity and high catalytic efficiency towards its substrate. In other words, enzymes perform catalytic functions in the synthesis and metabolism of biomolecules. Based on the specificity of enzymes, they can be used to selectively degrade or alter the concentration of a particular molecule in the body, and have significant medical value for the treatment of metabolic diseases, cancer, and some infectious diseases.

[0207] When enzymes are injected directly into the bloodstream as drugs, they are not only cleared by the immune system and lose their therapeutic function, but they also trigger immune responses. Polyethylene glycol (PEG)-modified enzymes can effectively reduce their immunogenicity, making them the only enzyme therapy technology used clinically. For example, pegloticase from Savent Pharmaceuticals was approved by the FDA in 2011 for the treatment of refractory gout that has failed conventional drug therapy, and pegvaliase-pqpz from BioMarin Pharmaceuticals was approved by the FDA in 2018 for the treatment of phenylketonuria in adults. However, because PEG modification cannot completely mask the antigenic nature of the enzyme, some patients experience severe infusion reactions and allergic reactions. More importantly, after repeated injections, PEG itself still produces an antigenic reaction, significantly reducing the drug's blood half-life and leading to severe drug resistance. These toxic side effects and drug resistance severely limit the clinical value of PEGylated enzymes, providing only short-term effects for patients with these chronic diseases before resistance develops.

[0208] Existing technologies include solutions that extract blood and use enzyme / catalytic units outside the body to continuously alter the concentration of specific molecules while preventing the enzyme / catalytic units from entering the bloodstream. For example, US Patent 4955857 uses a standard medical hemodialysis machine, encapsulating the therapeutic enzyme solution within a cavity or connecting both ends of the dialyzer and driving the flow of the enzyme solution. Blood passes through a hollow fiber membrane, and its substrate enters the cavity through osmosis and reacts with the enzyme solution. However, medical hemodialysis machines have excessively large pore sizes, leading to the diffusion of the therapeutic enzyme into the bloodstream, and the dialyzer also exhibits poor mass transfer efficiency.

[0209] Clara Ambrus et al. covalently immobilized enzymes on the outer side of a 10kD (KiloDalton) hollow fiber membrane, creating a multi-channel enzyme reactor. The substrate also diffused into the outer cavity to contact the enzyme. However, the mass transfer efficiency of reactors based on dialysis and diffusion was too low. In human trials, Ambrus et al.'s reactor only achieved a 30% reduction in blood phenylalanine concentration after three treatments. Furthermore, this design involves chemical immobilization of the enzyme, which easily leads to loss of activity. More importantly, enzyme-loaded reactors are very inconvenient to store and use, lack sterilization methods, and therefore lack clinical application value.

[0210] Similar to Clara Ambrus, Allan Hoffman et al. immobilized the enzyme on the outer side of a 10kD hollow fiber membrane, through which plasma filtered and flowed. However, the rapid, one-time flow of the substrate through the immobilized enzyme resulted in a short reaction time, low contact probability, insufficient enzyme utilization, and the detached enzyme directly entering the bloodstream, triggering an immune response. Both of the authors' animal experiments were forced to terminate due to negative reactions (pupil constriction and convulsions) in the animals.

[0211] US patent 3865726 and Y. Miura et al. stacked microspheres loaded with therapeutic enzymes in a packed column, allowing treatment to be achieved as blood passed through the column. However, direct perfusion of blood to the packed microspheres caused clogging problems. Robert Langer et al. used a water pump (US5232696) and mechanical rotation to suspend the enzyme-loaded microspheres, reducing clogging. However, this method of direct contact and collision between blood and microspheres easily activated the complement effect, resulting in a severe decrease in the number of white blood cells and platelets.

[0212] Patent US4013564 employs a diversion scheme, increasing blood flow resistance to force plasma through a porous membrane into a tributary, where it is filtered through enzyme-carrying microspheres to achieve metabolic effects. Robert Langer et al. used a combination of Taylor vortex and membrane separation, first filtering the plasma, then mixing it with enzyme-carrying microspheres, and finally mixing the treated plasma with the blood phase. However, unidirectional filtration of either blood or plasma still leads to unidirectional aggregation of enzyme-carrying microspheres, gradually reducing external mass transfer and metabolic efficiency. Furthermore, the detached enzymes can directly enter the bloodstream, triggering an immune response.

[0213] In other words, enzymes can be used to treat a variety of metabolic diseases. However, in existing enzyme therapy regimens, whether in vitro or in vivo, the immune response caused by antigen reaction or enzyme shedding is a major limitation to clinical use. At the same time, the stability of blood-enzyme contact is difficult to guarantee, making it difficult to control the catalytic effect of enzymes.

[0214] Furthermore, the fluid processing method of this application also addresses the problems of enzyme shedding or in vivo antigen reactions that exist in the prior art when enzymes are used to treat metabolic diseases. It should be understood that the fluid processing method of this application is intended to be performed in an in vitro device, thereby avoiding antigen reactions and drug resistance problems in in vivo enzyme therapy. Moreover, compared to in vitro therapy, the fluid processing method of this application provides a sustainable method for contacting the enzyme with the fluid to be treated, which can be used to achieve contact stability and control reaction time. Simultaneously, the enzyme, as a catalytic unit, can act on the target substance in a cycle in equilibrium, and the conditions of the reaction environment can be controlled to adapt to the catalytic activity of the enzyme, thereby obtaining a predictable clearance or catalytic effect. During the processing, the enzyme is retained in the cycle, which not only realizes the reuse of the enzyme but also avoids safety issues caused by it entering downstream or blood circulation.

[0215] Compared to in vitro therapies reported in the literature that are not clinically adopted, where the contact between enzymes and the liquid to be processed, such as blood, is typically a one-time contact, resulting in short reaction times and difficulty in controlling the catalytic effect, the fluid processing method of this application ensures that the enzyme, as a catalytic unit, is always in the circulation pipeline and maintains contact with the target substance in the fluid. This increases the probability of contact and exchange efficiency between the enzyme and the target substance, resulting in a continuous catalytic effect. In some embodiments, the catalytic unit circulates with the remaining fluid, thus being evenly distributed in the pipeline. In this example, the probability and time of contact between the catalytic unit and the substrate can also be increased by extending the pipeline or increasing the pipeline volume.

[0216] Meanwhile, the enzyme is retained in the tubing, avoiding enzyme loss and reduced catalytic effect during in vitro treatment, and also avoiding enzyme shedding that could trigger a subsequent immune response in the human body. At the same time, the total fluid volume in the tubing of the circulation module is dynamically balanced, so the circulation is sustainable, and the corresponding treatment time can be determined based on the preset treatment target, thereby achieving a controllable and selective removal effect of target substances in the blood.

[0217] In some embodiments provided in the first aspect of this application, the fluid processing method is implemented by at least one circulation module.

[0218] In some implementations, the at least one loop module further includes a first type of loop module.

[0219] The first type of circulation module includes a pipeline, comprising a first section and a second section; wherein the inlet of the first section is connected to at least one first inlet, and the outlet of the second section is connected to the first section; at least one separation module, including a separation component to divide the separation module into a first side and a second side, wherein the opposite ends of the first side are respectively connected to the first section and the second section; the second side is connected to at least one outlet; and at least one driving device, disposed in the first section, for driving the fluid circulation flow of the pipeline to control the dynamic balance of the total fluid volume in the pipeline.

[0220] In some embodiments, the at least one circulation module includes: a pipeline having an inlet and an outlet; a separation module including a separation component to divide the separation module into a first side and a second side, wherein opposite ends of the first side of the separation module are respectively connected to at least one inlet and at least one outlet, and opposite ends of the second side of the separation module are respectively connected to the inlet and outlet of the pipeline; and at least one driving device disposed in the pipeline for driving fluid in the pipeline to flow from the inlet to the outlet at a preset flow rate, so as to dynamically balance the total amount of fluid in the separation pipeline in the separation circulation mode. In the embodiments of this application, the circulation module that connects the pipeline inlet and outlet to the second side of the separation module is also referred to as a second type of circulation module.

[0221] The inlet and outlet of the circulation module are connected to the two ports corresponding to the separation module, so that the pipeline and the separation module can jointly form a circulation path. The driving device is used to control the fluid flow rate in the pipeline. For example, by controlling the fluid rate introduced into the circulation module to be equal to the fluid rate leaving the circulation based on the separation module, the total amount of fluid in the pipeline can be dynamically balanced.

[0222] The separation module contacts the fluid in the pipeline, thereby enabling selective permeation of components in the fluid based on the separation component. Components permeable to the separation component are allowed to pass through from one side to the other, achieving a separation effect. That is, the separation module can be considered a processing unit with selective processing capabilities for the fluid to be treated. In some examples, the fluid may also include a catalytic unit; correspondingly, the separation module can be configured with a structure or material that is impermeable to the catalytic unit, thus achieving a retention effect.

[0223] Here, the first side and the second side are used to distinguish the positions of the fluid components that can pass through the separation component and the trapped fluid. The positional relationship between the first side and the second side is determined by the cavity structure of the separation module and the structure of the separation component. For example, when the separation component is a planar structure and is arranged laterally in the separation module, the first side and the second side are the upper side and the lower side, respectively; or when the separation component is a planar structure and is arranged vertically in the separation module, the first side and the second side are the left side and the right side, respectively.

[0224] It should be understood that, in the embodiments provided in this application, the cavity in the separation module that is connected to the pipeline is the first side, and the other cavities in the separation module are the second side; in one example, when the separation module includes multiple cavities, for example, the separation module is divided into multiple cavities by multiple separation components in the form of a plate or membrane, the cavity connected to the pipeline is the first side, and the remaining cavities are the second side.

[0225] The separation component is a structure or material that has selective permeability to certain components in the fluid, such as a filter, a filter membrane, or a porous metal material.

[0226] In some embodiments, the separation component is a separation membrane, which can selectively remove molecules or combinations of molecules from the fluid to be treated by means of the selective permeability of the separation membrane, for example, causing molecules or combinations of molecules to be trapped in the circulation.

[0227] In some embodiments, the separation component is a porous membrane, including microfiltration, ultrafiltration, or nanofiltration membranes. Here, the average pore size or molecular weight cutoff (MWCO) of the porous membrane or reverse osmosis membrane is related to the target substance. In practical scenarios, based on the fluid composition and the identified target substance, a suitable porous membrane for retaining the target substance is selected. For example, when the target substance to be retained in the fluid has a particle size of 10 nm (i.e., 0.01 μm), a nanofiltration or reverse osmosis membrane can be used to achieve the retention of the target substance. Here, the specific type of separation membrane can be determined based on the differences in physicochemical properties between the fluid components and the target substance, and includes, for example: reverse osmosis membrane (average pore size 0.0001-0.001 μm), nanofiltration membrane (average pore size 0.001-0.01 μm), ultrafiltration membrane (average pore size 0.01-0.1 μm), microfiltration membrane (average pore size 0.1-10 μm), electrodialysis membrane, pervaporation membrane, liquid membrane, gas separation membrane, electrode membrane, etc.

[0228] Here, the specific type of separation membrane can be determined based on the differences in physicochemical properties between the fluid components and the target substance, and includes, for example: reverse osmosis membrane (average pore size 0.0001-0.001 μm), nanofiltration membrane (average pore size 0.001-0.01 μm), ultrafiltration membrane (average pore size 0.01-0.1 μm), microfiltration membrane (average pore size 0.1-10 μm), electrodialysis membrane, pervaporation membrane, liquid membrane, gas separation membrane, electrode membrane, etc.

[0229] In some embodiments, the separation membrane achieves the retention, filtration or exchange of components in the catalytic unit and fluid through steric hindrance, Donnan effect or electrostatic effect, adsorption, diffusion, charge repulsion effect, micropore effect or dissolution.

[0230] In some embodiments, particularly in medical applications, the separation membrane is a high-purity polymer with inert chemical properties and good blood and tissue compatibility.

[0231] In one embodiment, the separation component may be configured as a porous membrane or a reverse osmosis membrane, wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, and a nanofiltration membrane.

[0232] In some embodiments, the average pore size or molecular weight cutoff (MWCO) of the separation component is related to the target substance.

[0233] When the target substance is a substance that needs to be retained by the separation module, the average pore size or molecular weight cut-off of the porous membrane or reverse osmosis membrane is related to the target substance. In practical scenarios, based on the fluid composition and the determined target substance, a membrane suitable for retaining the target substance or filtering the target substance is selected. For example, when the target substance to be retained in the fluid has a particle size of 10 nm (i.e., 0.01 μm), the corresponding separation membrane can be a nanofiltration membrane or a reverse osmosis membrane to achieve the retention of the target substance.

[0234] In some practical applications, the pore size and type of the separation membrane can be determined based on the separation component's ability to retain more than 90% of the target substance. Alternatively, based on the requirement for higher separation effect, the retention rate of the separation component for the target substance can be set to more than 95% or even more than 99% to determine the corresponding pore size and type of the separation membrane.

[0235] In some embodiments, the average pore size or molecular weight cutoff of the separation component is related to at least one of the catalytic unit, the target substance, and the target product.

[0236] In one embodiment, the circulation module may further include a catalytic unit. To retain the catalytic unit in the pipeline, the average pore size or molecular weight cutoff of the separation component may be set to be smaller than the particle size or molecular weight of the catalytic unit. In this example, the arrangement of the separation component can refer to the aforementioned embodiment of the processing unit in the circulation for catalytic action, and will not be repeated here. It should be noted that in the circulation module, the separation component can also achieve selective permeation of some components in the fluid to be treated, while the retention component can be set to retain only the catalytic unit. At the same time, it should be understood that the target substance retained by the separation component and the target substance that can react under the action of the catalytic unit may refer to the same substance or different substances.

[0237] The separation component can also be configured as a separation membrane with different geometries to adapt to different fluids or achieve different filtration effects.

[0238] In some embodiments, the separation component includes one or more of planar membranes, tubular membranes, spiral membranes, and hollow fiber membranes. In terms of microstructure, the separation membrane may include, for example, symmetrical membranes, asymmetrical membranes, composite membranes, multilayer composite membranes, etc.

[0239] It should be noted that, based on the different geometric shapes of the separation membranes provided by the separation components, the positional relationship between the first side and the second side of the corresponding separation module may be different; for example, when the separation component is a planar membrane, the first side and the second side are opposite sides of a planar structure barrier; or, when the separation component is a hollow fiber membrane, the first side is the inner side of each fiber membrane tube wall, and the second side is the outer side of each fiber membrane tube wall.

[0240] The flow angle of the fluid relative to the separation membrane can be set to different angles, such as 0° to 90°. Here, when the flow angle of the fluid relative to the separation membrane is 0°, the fluid flows parallel to the surface of the separation membrane, such as in common tangential flow filtration; when the flow angle of the fluid relative to the separation membrane is 90°, the fluid flows perpendicular to the membrane surface, such as in conventional dead-end filtration (also known as vertical filtration).

[0241] In some embodiments, the flow channel in the separation module can be configured as a folded reciprocating form, a spiral form, or a flow channel size gradient form. For example, by folding the planar membrane to increase the contact area between the fluid and the planar membrane, the flow channel is configured as a folded reciprocating form to match the structural shape of the separation membrane, so as to ensure that the separation membrane separates the separation module into a first side and a second side.

[0242] In some embodiments, the drive device controls fluid to flow in the pipeline at a preset flow rate, so that the catalytic unit flows from one end of the pipeline through the separation module to the other end of the pipeline.

[0243] For example, when the separation module is a TFFM (Fluorescent Transmembrane Membrane), the fluid flow direction is parallel to the separation membrane in the TFFM. Here, as the fluid passes through the separation membrane in the TFFM, a transmembrane pressure difference perpendicular to the membrane surface is generated on both sides of the membrane. This pressure difference drives the low molecular weight components in the fluid to pass through the separation membrane and reach the other side. The low molecular weight components that pass through the separation membrane can thus leave the circulation. Simultaneously, the retained catalytic units or other pre-defined high molecular weight components are flushed away from the membrane surface by the fluid momentum and continue to circulate in the pipeline. The pressure difference across the membrane in the TFFM is related to the preset flow rate. Furthermore, the continued circulation of the retained substances requires a certain momentum to overcome the intermolecular or molecular-membrane polymerization barriers. The driving device controls the flow rate in the pipeline, which can be used to control the pressure difference across the separation membrane to achieve retention and separation effects, and can also be used to prevent polymerization barriers, ensuring the sustainability of the circulation in the pipeline.

[0244] In some embodiments, the preset flow rate is related to at least one of the following: catalytic unit, fluid composition, fluid temperature, separation component structure, separation component material, separation module cavity structure, pipeline diameter, and fluid exchange efficiency. The fluid composition includes fluid component categories and corresponding concentrations of each component.

[0245] The fluid flow rate at the separation module is related to various parameters, such as fluid density and viscosity, the boundary layer shape of the fluid at the separation module (e.g., the surface shape of the separation membrane, i.e., the membrane structure) and the cavity structure of the separation module, the interaction force between the fluid and the separation membrane (e.g., the membrane surface roughness determined by the membrane material and the attraction between the membrane and the fluid), and the flow rate relationship between the separation module and the pipeline inlet determined by the cavity structure of the separation module and the pipeline diameter. The fluid flow rate at the separation module may change. Here, the preset flow rate is used to determine the fluid flow rate at the pipeline inlet leading to the separation module. The preset threshold can be used as the initial flow rate at the separation module. Based on the initial flow rate and the influence parameters of the fluid flow rate at the separation module, the pressure difference generated by controlling the preset flow rate in the separation module can be used to prevent trapped macromolecules, such as catalytic units, from agglomerating on the membrane surface. Thus, macromolecules can flow from the pipeline inlet through the separation module to the pipeline outlet.

[0246] In some implementations, the preset flow rate is related to the exchange efficiency of the target product. For example, in TFFM, the target product needs to reach a certain flow rate and then be driven by the pressure difference across the separation membrane to flow to the other side of the separation module, thereby leaving the circulation. The pressure difference is related to the flow rate. When the flow rate is too low, the exchange efficiency of the target product flowing across the membrane may decrease. Therefore, the preset flow rate can also be determined by the exchange efficiency.

[0247] The drive device is used to control the fluid flow rate in the pipeline to dynamically balance the total fluid volume in the pipeline. Here, both the first type of circulation module and the second type of circulation module can perform sustainable fluid processing.

[0248] Please see Figure 1 and Figure 2 ,in, Figure 1 The diagram shown is a simplified illustration of a first-type loop module of this application in one embodiment. Figure 2 The diagram shown is a simplified schematic of a second type of circulating module of this application in one embodiment.

[0249] In the first type of loop module, the inlet is connected to the first side of the separation module 12, such as... Figure 1 In the example, the pipeline 11 is connected to the first side of the separation module 12. The processing unit that is intercepted in the fluid to be treated is located in the pipeline 11. The remaining components can leave the circulation through the separation component. By continuing the circulation, specific components can be processed in a cyclic manner. In some embodiments, the pipeline 11 may also be provided with a collection device to accommodate the total amount of liquid in the expanded circulation, to help the circulating liquid and the free processing unit mix better, and to serve as an integration platform for various inlet and outlet ports or inlet and outlet ports and a place for the convergence and mixing of various liquids.

[0250] In this example, the fluid balance in the control line 11 is based on the drive device 13 to form a sustainable circulation. At the same time, by controlling the fluid flow rate in the line 11, the problem of trapped processing units inhibiting polymerization on the surface of separation components such as separation membranes can be avoided.

[0251] In some embodiments, the first type of circulation module includes a catalytic unit, thus forming a metabolic circulation module. In the metabolic circulation module, the catalytic unit may be immobilized or confined within a predetermined region of the pipeline; or, the catalytic unit may circulate with the fluid, in which case the separation module retains free catalytic units in the circulation, ensuring that the catalytic unit remains in contact with the fluid to be treated within the pipeline and preventing catalytic unit loss.

[0252] In some embodiments, the circulation also includes a flow channel regulating device for regulating the fluid flow direction in the pipeline.

[0253] The flow channel regulating device can regulate the fluid flow direction in the pipeline in at least one of the following ways:

[0254] The fluid flow direction can be adjusted by regulating the opening state of the inlet and / or outlet;

[0255] The direction of fluid flow is regulated by adjusting the opening state of at least one regulating pipe connected to the pipeline.

[0256] In one implementation, the inlet is equipped with a pipeline switch for switching the circulation to a concentrated circulation mode when closed. Here, the pipeline switch can be, for example, a pipeline clamp, a switching valve, or a flow switch equipped with a sensor, etc., and this application does not impose any limitations.

[0257] The pipeline switch controls the opening and closing of the inlet. When the inlet is open, fluid is continuously replenished into the pipeline while fluid separated by the separation module is discharged, thus enriching the target substance in the pipeline. When the pipeline switch closes the inlet, the drive device controls the fluid in the pipeline to continue circulating, and the processed fluid is drawn out from the separation module side. In this state, the total amount of fluid in the pipeline decreases, and the corresponding concentration of the target substance increases, which means switching the fluid in the pipeline to a concentration circulation mode. In practical scenarios, when the target substance is a component to be collected, processing the fluid based on the concentration circulation mode can obtain a high concentration of the target substance. For example, when the target substance is platelets, platelets can be enriched through enrichment circulation and then concentrated through concentration circulation without the need for an in vitro separation process. This avoids repeated in vitro processing and waste of blood. Platelets obtained through concentration circulation can be used for applications such as cardiac surgery and wound treatment.

[0258] In some embodiments, the first type of circulation module alternately switches between concentration circulation and dilution modes based on the flow channel adjustment device to adjust the separation efficiency of the separation module.

[0259] Please continue reading. Figure 1 In practical scenarios, when the first type of circulation module continuously operates in circulation enrichment mode to trap the target substance, an increase in the concentration of the target substance inside the pipeline 11 may lead to a decrease in the separation efficiency of the separation module 12. For example, when the first separation module is TFFM, in some optional embodiments, the pipeline 11 can be configured as a replaceable consumable component. When the filtration efficiency drops to a certain level, the pipeline 11 can be replaced to perform the fluid processing method of this application. In other embodiments, please refer to... Figure 5 The diagram shown is a simplified illustration of the loop module of this application in one embodiment. Figure 5In the illustrated embodiment, the flow direction of the fluid in the pipeline is adjusted by the flow channel adjustment device 14 to achieve the sustainability of the pipeline. The fluid flow direction includes the direction of fluid flow within the pipeline and the flow channel.

[0260] Please combine Figure 5 , Figures 6a-6c ,in, Figures 6a-6c The diagram shows a simplified illustration of the pipe 11 and the flow channel regulating device 14 in different circulation modes in one embodiment. As shown, the flow channel regulating device 14 can be configured as a regulating pipe and a pipe switch that cooperate with the pipe 11, wherein the regulating pipes are respectively provided on the pipe 11, and the pipe switches are provided on each regulating pipe and on the pipe 11 between the regulating pipes.

[0261] By controlling the pipe switch in the flow channel regulating device 14, the direction of fluid circulation and the flow channel in the pipeline 11 can be changed. For example... Figure 6a In the indicated state, closing the pipe switch on the regulating pipe and opening the pipe switch on pipe 11 allows the fluid in pipe 11 to flow along the flow path of pipe 11, enabling circulation enrichment to collect the target substance; Figure 6b In the indicated state, once the target mass retained in the pipeline 11 has reached the preset target, the pipeline switch at the first inlet can be closed to switch the fluid in the pipeline 11 to a concentration and circulation mode. It should be noted that in actual scenarios, the step of concentrating and circulating the enriched target substance is an optional step. This step can be omitted if the molecular concentration in the fluid has reached a preset value or the separation effect of small molecules in the pipeline 11 has reached the preset target. Figure 6c In the indicated state, when the molecular concentration in the pipeline 11 reaches a preset value or affects the filtration effect, the pipeline switch on the regulating pipeline is opened and the pipeline switch on the pipeline 11 is closed, as well as the pipeline switch at the first inlet is closed. One end of each of the two regulating pipelines is connected to the pipeline 11, and the other end can serve as the inlet and outlet of the pipeline 11, respectively. The two regulating pipelines, together with the pipeline 11, form a new flow channel. Through the inlet and outlet, the fluid obtained from the cyclic enrichment or concentrated cyclic treatment in the pipeline 11 can be led out of the pipeline 11. Cleaning fluid can also be introduced into the pipeline 11 to adjust the pipeline 11 to a cleaning mode. The cleaning fluid can enter the pipeline 11 and the separation module 12 through the inlet and flow to the outlet to clean the pipe wall of the pipeline 11 and the separation module 12. After cleaning, the target substances trapped in the pipeline 11 and the separation module 12 are removed, and it can be used to continue to cyclically enrich the target substances in the fluid. Correspondingly, the flow channel regulating device 14 can be set as follows: Figure 6a The state shown is used to repeat fluid processing.

[0262] The cleaning solution is a solution free of the target substance, designed to remove the target substance from pipeline 11 and separation module 12. In some applications, such as industrial wastewater treatment, the cleaning solution may contain surfactants or disinfectants; in medical applications, the cleaning solution may be a physiological buffer solution that can participate in human blood circulation, such as physiological saline, phosphate buffered saline (PBS), etc.

[0263] In some embodiments, the flow channel regulating device 14 is a four-way valve. In a specific implementation, the four-way valve may also be configured as a four-way rotary valve.

[0264] Please see Figures 7a-7b The figure shows a simplified schematic diagram of the pipeline 11 and the flow channel regulating device 14 in different circulation modes in another embodiment. As shown, a four-way valve is provided in the pipeline 11, and the flow direction of the fluid in the pipeline 11 can be controlled by determining the connection state of different pipes in the four-way valve. The regulating process performed by the four-way valve is similar to... Figures 6a-6c The embodiments described are similar and will not be repeated here. In some examples, the four-way valve can also be rotated to adjust or switch different operating modes in pipeline 11.

[0265] In medical applications, to minimize the presence of small molecules in the concentrated target substance, after concentration, the inlet of the cleaning solution in the flow channel regulating device 14 is opened, and physiological saline or PBS is drawn in and circulated to dilute the concentrate. Then, the cleaning solution inlet is closed, and the concentration cycle is repeated. Repeating these steps multiple times removes most of the small molecules remaining in the concentrated target substance. For example, by enriching and circulating red blood cells from a blood donor, most proteins and small molecules are removed through the multiple concentration and dilution processes described above, reducing the impact of this loss on the blood donor. This also effectively reduces the impact of allergens and pathogens in the blood donor's blood on the patient. The cleaned red blood cells can then be directly infused into the patient through the flow channel regulating device 14, avoiding contact with the external environment.

[0266] Please see Figure 8 The image shows a simplified schematic diagram of a first-type circulation module performing the fluid processing method of this application in one embodiment.

[0267] It should be understood that in the fluid processing method of this application, the pipeline 11 provides space for processing or reaction during the circulating processing process while simultaneously allowing fluid to flow through it; in some examples, the collection device 15 may be optionally provided in the pipeline 11 to expand the internal volume of the pipeline 11, and the collection device 15 may be a container or storage space to expand the volume of the pipeline 11, for example... Figure 8The collection cylinder shown is an example of a collection device 15. Of course, the number, location, and container structure of the collection device 15 can be determined based on the collection needs, and this application does not impose any restrictions.

[0268] In one embodiment, the location of the collecting device 15 on the pipeline 11 is related to the location of the separation module 12; for example... Figure 8 In the illustrated embodiment, the collecting device 15 is positioned upstream of the separation module 12, and the fluid in the collecting device 15 tends to flow in the direction of circulation due to gravity. This design avoids or reduces the generation of air bubbles during circulation. In another embodiment, the position of the collecting device 15 can be determined based on the position of the outlet of the regulating pipe in the pipe regulating device. For example, the collecting device 15 can be positioned above the outlet of the regulating pipe so that when the pipe 11 is naturally placed, the fluid in the collecting device 15 tends to flow towards the outlet and naturally drain. The air inlet / outlet is located in the pipe or a device connecting to the pipe and is used to adjust the internal air pressure during circulation.

[0269] In some examples, the collecting device 15 can also be used to house the exhaust inlet and the sample inlet. For example, the exhaust inlet can be located on the upper part of the collecting device 15 to connect the space in the collecting device 15 that is not filled with fluid to the space of the external atmosphere or a gas storage device. In some examples, the collecting device 15 can also be used to house the inlet and outlet of the regulating pipe in the pipe regulating device; here, the flow regulating device can be integrated into the collecting device 15 to form a module.

[0270] In some embodiments, particularly when the fluid handling method is used in medical applications, a sterile filter membrane may be provided at the air inlet / outlet to ensure a sterile environment inside the circulation; similarly, when the circulation includes a sample dispensing device, a sterile filter membrane may also be provided at the corresponding sample dispensing port.

[0271] Please continue reading. Figure 2 In the second type of circulation module, the inlet is connected to the first side of the separation module 22, and the inlet and outlet of the pipe 21 are connected to the opposite ends of the second side of the separation module, so that the pipe 21 and the separation module 22 can form a circulation path.

[0272] In the second type of circulation module, the fluid can be processed in a circulation separation mode based on the dynamic balance of the total fluid volume in the control pipeline 21 controlled by the drive device 23, thus achieving sustainable circulation separation and processing. In a specific implementation, the total fluid volume balance in the pipeline 21 is achieved by controlling the fluid flow rate at the inlet and outlet to be equal.

[0273] The described circulation separation mode is as follows: the inlet continuously introduces fluid into the separation module 22, and specific components in the fluid flow through the separation components to the pipe 21 connected to the second side of the separation module 22. The specific components flow from the inlet of the pipe 21 to the outlet of the pipe 21 connected to the second side of the separation module 22 to form a circulation. At the same time, the outlet on the first side of the separation module 22 leads the fluid out of the circulation.

[0274] Based on the selective permeability of the separation component in the separation module 22 to fluid components, the fluid in the pipeline 21 is a fluid among the fluids to be treated that can permeate the separation component. In the various examples of this application, the fluid in the pipeline 21 of the second type of circulation module can also be called the separated fluid.

[0275] The drain outlet is connected to the first side of the separation module 22, thereby forming a reversible cyclic separation.

[0276] The reversible circulation separation means that the separated fluid in pipe 21 can return to the first side of separation module 22 in the direction of circulation. It is easy to understand that the separation module 22 achieves separation by driving molecules across the separation assembly through a directional pressure difference or flow rate. When the pressure difference across the separation module 22 changes sign, or when the flow rate direction changes, molecules that have passed through the separation assembly from the first side to the second side can also pass through the separation assembly again to flow back to the first side. That is, at the inlet end of the separation module, the pressure on the first side is greater than that on the second side, forming transmembrane pressure, allowing components in the fluid to enter the circulation through the separation module; at the outlet end of the separation module, the pressure on the second side is greater than that on the first side, forming reverse transmembrane pressure, allowing components that have entered the circulation through the separation module to leave the circulation and enter the outlet.

[0277] Here, the separation component of the second type of circulation module can pre-select and retain some components in the fluid to be treated, so that only a portion of the components in the fluid to be treated enter the pipeline. Correspondingly, the pore size or molecular retention capacity of the separation component in the second type of circulation module can be designed based on the composition of the fluid to be treated, the target substance, and the target product. In some examples, when a catalytic unit is provided in the second type of circulation module, the pore size or molecular retention capacity of the separation component also needs to retain the catalytic unit. For example, in blood purification for medical applications, the separation module can be designed to retain cellular components, such as red blood cells and white blood cells, and filter plasma on the first side, while retaining the circulating catalytic unit and filtering plasma on the second side, to avoid direct contact between cells and the circulating catalytic unit.

[0278] In some embodiments, the second type of circulation module includes a catalytic unit, thus forming a metabolic circulation module. In this module, the catalytic unit is immobilized or confined within a predetermined region of the pipeline; alternatively, the catalytic unit can circulate with the separation fluid within the pipeline. In this manner, the separation module retains free catalytic units on the second side of the separation module, i.e., in the circulation, ensuring that the catalytic unit remains in contact with the separation fluid within the pipeline and preventing catalytic unit loss. In this example, the target product generated by the separation fluid under the action of the catalytic unit can be reversibly recycled back to the first side of the separation module. The continuous replenishment of the separation fluid and the continuous discharge of the target product in the circulation ensures the continuous catalytic efficiency and good activity stability of the catalytic unit.

[0279] In some embodiments, the fluid processing method is implemented by N cycles, and the N sets of processing units corresponding to the N cycles process different molecules or combinations of molecules in the fluid respectively, so that different components in the fluid are distributed and processed in the N cycles; wherein, N is a positive integer greater than 2.

[0280] Here, the N groups of processing units may perform different types of processing. For example, following the cyclic connection sequence, the fluid to be processed may be filtered in the first cycle, heated in the second cycle, and catalytically processed in the third cycle.

[0281] Alternatively, the N sets of processing units may perform the same type of processing, but each may correspond to a different target substance; for example, the N sets of processing units corresponding to the N cycles may all be used to catalyze the fluid to be processed, so that different target substances are distributed in the N cycles and come into contact with different catalytic units respectively.

[0282] In some embodiments, fluid is introduced into N circulation modules for processing, the N circulation modules being connected in series and / or in parallel, wherein N is a positive integer greater than or equal to 2 (N≥2).

[0283] Herein, this application provides Embodiment A, in which the fluid processing method includes N serially connected cycles, wherein at least one of the N cycles is implemented by the first type of cycle module.

[0284] Please see Figure 11 The diagram shows a simplified schematic of any two adjacent first-type circulation modules in Embodiment A. Here, the fluid drawn from the drain port corresponding to the preceding circulation module is connected to the inlet port corresponding to the following circulation module.

[0285] The terms "front circulation module" and "rear circulation module" refer to any two adjacent circulation modules in a series of N circulation modules. The order of "front" and "rear" refers to the connection order, which is based on the flow direction of the fluid in the circulation module. That is, the fluid always flows from the front circulation module after being processed and then flows into the rear circulation module for further processing. Therefore, the fluid always enters the inlet of the rear circulation module from the outlet of the front circulation module.

[0286] Based on embodiment A, this application provides embodiment A1, in which each of the N cascaded cyclic modules is a cyclic enrichment module.

[0287] The circulating enrichment module is a module that can retain the target substance in the fluid within the pipeline to enrich the target substance. In the circulating enrichment module, the pipeline can also be referred to as an enrichment pipeline. The circulating enrichment module does not contain a catalytic unit.

[0288] By cascading (i.e., connecting in series) N cyclic enrichment modules, the fluid undergoes N cyclic processes following the connection sequence of the modules. In the cyclic enrichment mode corresponding to each module, the fluid velocity or flow rate at the inlet and outlet is equal. Therefore, continuous enrichment of the target substance can be achieved in each module. All N cascaded cyclic enrichment modules are in dynamic equilibrium under cyclic enrichment mode, thus the enrichment process is sustainable. It should be noted that, following the connection sequence, the fluid is sequentially intercepted for the target substance in the cascaded enrichment pipelines. Therefore, the fluid composition introduced at the first inlet of each enrichment pipeline is different, and correspondingly, the target substance enriched in different enrichment pipelines may be different.

[0289] Based on Example A, this application also provides Example A2, in which at least one of the N series-connected cycles includes a catalytic unit in the pipeline.

[0290] In one embodiment A2, the N (N≥2) cascaded circulation modules include a circulation enrichment module and a metabolic circulation module. The circulation enrichment module enriches specific components in the fluid to be treated, and then the fluid from which the specific components have been filtered out is introduced into the metabolic circulation module.

[0291] In the N series-connected circulation modules, the separation component in the circulation enrichment module can be used to retain the target substance to be enriched. By setting the specific form of the separation component corresponding to different circulation enrichment modules, different target substances can be obtained in different circulation enrichment modules. In some implementations, the circulation enrichment module enriches specific components in the fluid into the corresponding enrichment pipeline, thereby reducing the component categories in the fluid to be treated corresponding to the metabolic circulation module, for example, to components with a molecular weight of less than 1500 Dalton in the original fluid. Alternatively, in other embodiments, the first circulation module in the N series-connected circulation modules is a metabolic circulation module. After the target substance is catalyzed to generate the target product based on the metabolic circulation module, the target product is led to the next circulation module through the separation module, so that the target product can be enriched into different categories of components in different circulation enrichment modules. Different target substances enriched in the circulating enrichment module can also be adsorbed, concentrated, chemically treated, etc., based on the processing unit. Thus, different components in the fluid can be collected, removed, or reacted according to the preset treatment target. Based on the dynamic balance of the total fluid volume in each circulating module, the fluid treatment method is sustainable, which can realize the control of the treatment effect of different components, and at the same time, no waste liquid is generated during the treatment process.

[0292] In practical applications, taking medical applications as an example, when the N serially connected circulation modules are used for disease treatment, the fluid to be treated corresponding to the first circulation module is, for example, blood drawn from the human body, or plasma, blood components, or other bodily fluid components obtained by pre-processing blood through a processing unit. When the fluid to be treated includes components that need to be enriched and target products that need to be generated under the action of a catalytic unit, different components in the fluid can be enriched, catalyzed, or otherwise treated in different circulation modules to achieve the preset therapeutic effect. Simultaneously, by controlling the component categories of the fluids in different circulation modules, the concentration of the target substance acted upon by the catalytic unit in the circulation module can be controlled, which can be used to improve or control the catalytic efficiency.

[0293] In the aforementioned medical applications, the fluid processing method of this application can treat human body fluids in vitro, such as through enrichment circulation or metabolic circulation, to remove specific pathogenic factors or other components, or to generate specific target components. During this process, by retaining the catalytic unit in the circulation module, problems such as antigen reactions and drug resistance caused by the catalytic unit in the human body are avoided. Furthermore, based on the sustainability of the circulation module, the processing time can be extended according to the patient's treatment needs. Simultaneously, based on the combined use of the circulation enrichment module and the metabolic circulation module, the fluid processing method can be used to treat patients with multiple pathogenic factors in their bodies.

[0294] Furthermore, the catalytic units can be uniformly distributed in the pipeline, which solves the problem of catalytic units, such as enzymes, agglomerating in existing filtration methods, leading to a gradual decline in metabolic efficiency. The contact mode between the fluid to be treated and the catalytic units can be changed from the existing one-time contact to continuous contact, thereby improving the catalytic efficiency or utilization rate of the catalytic units. At the same time, the catalytic units can be immobilized in the pipeline or circulate with the remaining fluid in the pipeline. In addition to avoiding the aggregation of catalytic units, the collisions between the catalytic units and other fluid molecules, as well as with the inner wall of the pipeline, are reduced in the circulating motion mode, so that the catalytic units can be in a stable catalytic state.

[0295] This application provides Embodiment B, in which the fluid processing method includes N (N≥2) cascaded cycles, wherein at least one of the N cycles is implemented by the second type of cycle module. See also... Figure 13 The diagram shows a simplified schematic of N series-connected second-type circulation modules as described in Embodiment B. Each second-type circulation module includes a pipeline 21, a separation module 22, and a drive device 23.

[0296] In the following embodiments provided in this application, the pipeline 21 in the second type of circulation module may also be referred to as a separation pipeline, and the fluid in the separation pipeline may also be referred to as a separation fluid.

[0297] In embodiment B, the fluid in the separation pipe of the pre-circulation module is connected to the inlet of the post-circulation module, so that the fluid flows in N series-connected circulation modules, where N is a positive integer greater than or equal to 2. Here, the "pre-circulation module" and "post-circulation module" refer to any two adjacent circulation modules in the N series-connected second-type circulation modules. The order of "pre-" and "post-" refers to the connection order, which is based on the flow direction of the fluid in the circulation modules. That is, the fluid always flows from the pre-circulation module into the post-circulation module for further processing. Therefore, the fluid always enters the corresponding inlet of the post-circulation module from the inlet of the separation pipe in the pre-circulation module. Correspondingly, the outlet of the post-circulation module is connected to the outlet of the separation pipe in the pre-circulation module.

[0298] Based on Embodiment B, this application provides Embodiment B1, wherein the second type of circulation module can also be called a circulation separation module, that is, the fluid processing method described in Embodiment B1 is implemented by N circulation separation modules connected in series.

[0299] By connecting N of the aforementioned circulating separation modules in series, the fluid undergoes N separation cycles according to the connection sequence. In the circulation process corresponding to each separation pipeline, the fluid velocity or flow rate at the inlet and outlet is equal in the circulating separation mode, meaning that all N connected circulating separation modules are in dynamic equilibrium. Therefore, continuous circulating separation can be performed in each separation pipeline. It should be noted that, following the connection sequence, the fluid is sequentially intercepted by the target substance on the first side of each separation module. Therefore, the fluid composition introduced at the inlet of each circulating enrichment module is different, and correspondingly, the fluid composition in different separation pipelines is different.

[0300] In the examples provided in this application, the different fluid components include: different types of substances in the fluid and / or different concentrations or total amounts of at least one substance in the fluid.

[0301] Here, this application provides an embodiment of processing fluids by employing N cascaded cyclic separation modules, which can be used to retain components of different particle sizes or molecular weights, different chemical properties, or molecules with different charge properties in the fluid. By setting corresponding separation modules for different cyclic separation modules, based on the selective permeability of the different separation modules to the components in the fluid, the cyclic separation of different components under fine particle size classification can be achieved.

[0302] In the reversible cyclic separation formed in the second type of circulation module, the reversible circulation of the components is unidirectionally reversible, that is, the components in the pipeline can return to the upstream pipeline, while the fluid components retained on the first side of the separation module cannot enter the downstream pipeline. Here, in the embodiments provided in the first aspect of this application, for any second type of separation module, the pipeline connected to the first side of the separation module is the upstream pipeline, and the separation pipeline is the downstream pipeline.

[0303] In embodiment B1, based on the unidirectional reversible nature of the circulation, the types of fluid components in each circulation separation module decrease sequentially according to the connection order. In the N series-connected circulation modules, the fluid components exhibit a stepped separation. That is, based on the interception effect of the separation modules, the fluid in the separation pipeline connected to the second side of the separation module contains only specific components, while the fluid on the first side of the separation module can simultaneously include both the specific components and the intercepted components. Thus, in the series-connected separation pipelines, the types of fluid components in the separation pipelines gradually decrease according to the connection order.

[0304] In this example, based on the series-connected circulating separation module, fluid processing can target only a portion of the fluid components, such as the separated fluid, while untreated components can be reversibly separated and returned upstream via the separation pipeline. For example, ... Figure 13In the illustrated embodiment, when the fluid includes components a, b, c, and d, during the separation process, following the connection sequence, the fluid components in the first separation pipeline are b, c, and d, wherein component a is retained on the first side of the separation module corresponding to the first separation pipeline; the fluid components in the second separation pipeline are c and d, and component b is retained on the first side of the separation module corresponding to the second separation pipeline and can flow from there to the first separation pipeline. Simultaneously, component b can return to the first side of the first separation module based on the reversible cycle separation; the fluid component in the third separation pipeline is d, and component c is retained on the first side of the third separation module and can flow from there to the second separation pipeline. Simultaneously, component c can return to the first separation pipeline based on the reversible cycle separation. In practical scenarios, when component d is a component requiring further processing, the separated fluid in the third separation pipeline can be further processed, and other components in the fluid, such as a, b, and c, can flow back to the upstream pipeline, thus enabling the processing of specific components in the fluid.

[0305] In some examples, within the N series-connected circulating separation modules, the separated fluid in the separation pipeline can be further processed by the processing unit. This allows for the targeted extraction, removal, or other treatment of specific components in the fluid classified by fine particle size, thereby altering the concentration of these specific components. For instance, when the molecular weight range of each component in the fluid is 200–2000 Dalton, taking N = 2 as an example, following the connection sequence, the separation module in the pre-circulating separation module retains components with a molecular weight greater than 1100 Dalton, resulting in a separated fluid component in the pipeline of the pre-circulating separation module of 200–1100 Dalton. Similarly, the separation module in the post-circulating separation module retains components with a molecular weight greater than 800 Dalton, resulting in a separated fluid component in the separation pipeline of the post-circulating separation module of 200–800 Dalton.

[0306] Of course, in practical scenarios, the number of the N series-connected cyclic separation modules is any positive integer greater than 2. Correspondingly, multiple components in the fluid or components within multiple classification segments can be collected, extracted, or processed separately. Here, the classification segment can be a segment obtained by dividing based on at least one of the component's chemical properties, molecular weight or molecular particle size, and charge properties. It should be understood that the classification segment has multiple division criteria, and the corresponding separation component can be used to retain the substances within the classification segment on the first side of the separation module. Taking the separation component as a separation membrane as an example, different types of separation membranes have different selective permeability. By setting N sets of separation membranes, the fluid components can be classified or retained N times.

[0307] For example, when processing a fluid based on N cascaded cyclic separation modules, according to the connection order, large molecular components can be retained on the first side of the separation module of the first cyclic separation module based on molecular weight, components with specific chemical properties can be retained in the separation module of the second cyclic separation module based on the chemical properties of the fluid, and charged ions can be retained in the separation module of the third cyclic separation module based on the charge properties of the fluid components.

[0308] In practical scenarios, taking medical applications as an example, the N cascaded cyclic separation modules can be used to separate antibiotics, amino acids, enzyme preparations, and other proteins from fluids.

[0309] In some implementations, the average pore size or molecular rejection of the separation components of the N cascaded cyclic separation modules decreases progressively.

[0310] In this example, the components in the fluid are classified according to their molecular particle size or molecular weight. The separation modules of the N series-connected circulating separation modules can be designed based on the particle size or molecular weight of the components in the fluid. For example, the average pore size of the separation membrane in the N sets of separation modules corresponding to the N series-connected circulating separation modules can be gradually reduced or the molecular weight cut-off can be gradually reduced. Then, following the connection order, the molecular particle size or molecular weight of the target substance cut-off by the first side of the corresponding separation module in each separation pipeline gradually decreases.

[0311] Based on Example B, this application also provides Example B2, in which at least one of the N cascaded cycles is the metabolic cycle. The cycle including the catalytic unit can also be referred to as a metabolic cycle module. In this example, when the catalytic unit is in a free state, the catalytic unit should be simultaneously retained by the separation components in both the preceding and following cycle modules.

[0312] In one scenario, each of the N series-connected circulation loops is equipped with a catalytic unit. Here, the fluid treatment method can be used to treat different material components in various ways.

[0313] For example, in each circulation module, the catalytic unit is retained in the pipeline. In one implementation, each separation component is used to retain the catalytic unit, allowing the filtration of any component in the fluid and the target product generated by the fluid component under the action of the catalytic unit. Here, the target substance in the fluid can be multiple molecules or combinations of molecules. Different target substances can be catalyzed in N different circulation modules connected in series, or the same target substance can undergo multiple catalytic treatments based on different circulation modules. Simultaneously, based on the reversible circulation of the second type of circulation module, the target substance can be returned to the upstream pipeline. In some practical scenarios, the inlet and outlet of the first circulation module can be connected to the same container or human circulation system, thereby enabling the treatment of fluids in the container or the treatment of body fluids or body fluid components in the human circulation system.

[0314] For example, each circulation module retains the catalytic unit in the pipeline. In adjacent circulation modules, the separation components of the upstream and downstream circulation modules retain the catalytic unit in the pipeline. The target substance, target product, and other unreacted components in the fluid to be treated can reach the pipeline of the downstream circulation module through the separation component, thus coming into contact with the catalytic unit in the downstream circulation module. In this example, the N series-connected circulation modules can be used to catalyze different components in the fluid in different circulation modules. Based on the reversible nature of the circulation in the second type of circulation module, the obtained target product can also be returned to the upstream pipeline.

[0315] In another scenario, the N cascaded circulation modules include a separation circulation module and a metabolic circulation module. Here, based on the reversible circulation formed in the separation circulation module, the fluid treatment method can be used to separate mixtures of complex component systems into different circulation modules and to catalytically treat the simplified fluid components; alternatively, the fluid treatment method can catalytically treat the fluid and then progressively separate the fluid components into different circulation modules. Here, each circulation module can selectively include the treatment unit, enabling the adsorption, removal, enrichment, and electrochemical treatment of different components.

[0316] Therefore, this application provides a solution for how to selectively remove small molecules with similar molecular weights in the aforementioned Mode A. By using multiple cycles, the components in the fluid are distributed in a stepped manner in different circulation modules. By reprocessing the fluid in the pipelines of different circulation modules, highly selective removal of specific components, catalytic reactions, or other treatments can be achieved when the fluid components are classified into fine particles.

[0317] Please see Figure 14 The diagram shown is a simplified schematic of an implementation of embodiment B2, in which N cascaded cyclic modules include a metabolic cyclic module and a cyclic separation module.

[0318] In the embodiment shown in the figure, following the connection sequence, the two connected circulation modules are a circulation separation module and a metabolic circulation module, respectively. The inlet and outlet of the circulation separation module are connected to container 26.

[0319] In practical scenarios, the metabolic cycle module can also be connected to multiple cycle separation modules in series. Based on the separation effect of the separation components in each cycle module on the fluid, the component categories in each cycle module decrease in the connection order. That is, the components mixed in the fluid to be treated can be separated stepwise or in a stepwise manner. In the metabolic cycle module, the catalytic unit can process the mixed system after the component categories are simplified.

[0320] In a practical scenario, when the fluid to be processed corresponding to the first circulation module is a complex mixture such as blood plasma, the mixture can be gradually separated by a series of circulation modules, thereby improving the catalytic efficiency of the catalytic unit in the metabolic circulation module.

[0321] To illustrate the technical effects achievable by the N cascaded loop modules described in this implementation, this application also provides the following data:

[0322] Experiment 4:

[0323] Group 1: Figure 9 Based on the metabolic cycle module shown, the molecular cutoff of the separation module is 10 kDa. 100 mL of phenylalanine solution (2 mM, PBS) is added to the container connected to the inlet. The liquid in the container can be connected to the first side of the separation module through the inlet. The fluid that can pass through the separation component can flow into the pipeline. The pipeline is pre-filled with phenylalanine solution by driving a peristaltic pump. The total amount of liquid in the metabolic cycle module is about 10 mL. The liquid flow rate at the inlet and the liquid discharge rate at the outlet are adjusted to be equal to form a balanced cycle.

[0324] After equilibrium is reached, 3 mL of phenylalanine ammonia-lyase (approximately 2.84 U) is added through the sample dispensing port. Timing is started, and a sample is taken from the collection device to determine the concentration of the product trans-cinnamic acid. The concentration of trans-cinnamic acid is determined by its ultraviolet absorption peak at 280 nm. The concentration of phenylalanine is calculated from the concentration of trans-cinnamic acid.

[0325] Group 2: Compared to Group 1, the PBS solution was replaced with 40% serum, while other conditions remained the same as Group 1.

[0326] The third group: Experiments were conducted using multiple cascaded loop modules, where please refer to [link / reference needed]. Figure 14The molecular cutoffs of the two separation modules were 50 kDa and 10 kDa, respectively. A simplified schematic diagram of the circulation module used in the third group of experiments is shown in the figure, which depicts a circulation separation module connected in series with a metabolic circulation module. The series circulation module was pre-filled with 60 mL of PBS. The flow rate was adjusted by the drive device to bring the circulation modules to equilibrium. The volume of liquid in the circulation separation module was approximately 50 mL, and the volume in the metabolic circulation module was approximately 10 mL. The inlet and outlet of the first circulation separation module were connected to the same container. 100 mL of serum was added to the container, and 52 mg of phenylalanine (approximately 2 mM) was dissolved in it. The mixture was allowed to equilibrate for 30 min. Then, 3 mL of PAL (approximately 2.84 U) was added to the metabolic circulation module through the sample loading port, and a sample was taken from the container. The sampled liquid was diluted 10-fold, and then 40% trichloroacetic acid was added at a 1:1 ratio. After centrifugation, the concentration of the metabolite trans-cinnamic acid in the supernatant was directly measured.

[0327] Group 4: Compared to Group 3, the liquid volume in the circulatory separation module was approximately 10 mL, and the liquid volume in the metabolic circulation module was approximately 50 mL. All other conditions remained the same as in Group 3.

[0328] like Figure 15 As shown, the results of the trans-cinnamic acid concentration test are displayed for the four groups in Experiment 4. Curves 1, 2, 3, and 4 correspond to the experimental results of the first, second, third, and fourth groups, respectively.

[0329] As shown in the experimental results, the metabolic cycle module alone can maintain relatively stable catalytic function and sustainability when catalyzing target substances in liquids (see curve 1). However, in complex systems, such as serum with complex components, the protein components have a significant impact on the filtration and exchange of small molecules by a 10kD membrane, resulting in a decrease in catalytic efficiency achieved by the metabolic cycle module alone (see the comparison between curve 1 and curve 2). By combining the cyclic separation module and the metabolic cycle in this application, i.e., by reversibly separating the components of the fluid through the cyclic separation module before processing, the influence of components on the processing can be effectively reduced. For example... Figure 14 The circulating separation module shown is connected in series with the metabolic circulation module. When processing complex systems, it can achieve the gradual separation of mixtures, which can reduce the impact of fluid components on the separation and exchange efficiency of small-pore membranes, thereby improving the exchange efficiency and processing results in the metabolic circulation module (see curves 3 and 4).

[0330] In some embodiments, two adjacent cycles in the plurality of cycles used to perform the fluid processing method of this application may also be a first type of cycle module and a second type of cycle module.

[0331] Please see Figure 16 The diagram shows a simplified illustration of an adjacent second-type circulation module and a first-type circulation module in one embodiment. Here, the pipe 21 of the second-type circulation module is connected to the inlet and outlet of the first-type circulation module. For example, in this example, fluid flows from the inlet of the pipe 21 of the second-type circulation module to the inlet corresponding to the pipe 11 of the first-type circulation module, flows through the separation module 12 in the first-type circulation module to the outlet, and the fluid drawn from the outlet flows to the outlet of the pipe 21 of the second-type circulation module to form a circulation. That is, in this example, the first-type circulation module can be regarded as a sub-circulation in the second-type circulation module.

[0332] In one scenario, such as the removal of small molecule components, the components in the fluid can be separated in a stepwise manner based on one or more of the second type of circulation modules. Following the connection sequence, the subsequent second type of circulation modules contain only small molecule components. Correspondingly, the subsequent second type of circulation modules can be connected to the first type of circulation modules to enrich the small molecule components for removal or to catalytically treat the small molecule components to decompose or degrade them.

[0333] In one implementation, the second type of circulation module further includes a catalytic unit, which is retained in the corresponding circulation. In the second type of circulation module, the product generated after the target substance in the fluid is catalyzed can be connected to the inlet of the first type of circulation module. Correspondingly, the target product or other specific components generated can be enriched in the pipeline in the second type of circulation module. The fluid drawn from the outlet of the second type of circulation module can return to the first type of circulation module and can return to the upstream pipeline based on the reversible circulation of the first type of circulation module. This allows for different treatments of multiple components in the fluid, such as different substances being catalyzed and enriched respectively.

[0334] Alternatively, in another implementation, when the first type of circulation module also includes a catalytic unit, the first type of circulation module can further catalyze the target product, or catalyze other components in the fluid, thereby enabling multiple treatments of the same substance. For example, after catalytic treatment in the first circulation module, the generated product can be catalyzed again in the second circulation module, or different components can be catalyzed in different cycles. Since the first type of circulation module is a reversible cycle, the treated fluid can also be returned to the upstream pipeline.

[0335] In another scenario, following the connection order, when two adjacent circulation modules are a first-type circulation module and a second-type circulation module, similarly, some components in the fluid can be enriched or the target substance can be catalytically treated in the first-type circulation module. The fluid treated by the first-type circulation module is then introduced into the second-type circulation module for further separation or catalytic treatment. This will not be elaborated further here.

[0336] This application also provides an embodiment C, in which the fluid processing method includes N tandem metabolic cycles.

[0337] Please see Figure 12 The diagram shows a schematic of N metabolic cycles connected in series in one embodiment. Here, catalytic units can be provided in different cycles, allowing the structure or concentration of different target substances to be altered in different cycles, or different target products to be generated in different cycles. It should be understood that in the multiple metabolic cycles connected in series, the connection method between the tubing and the retention module in the metabolic cycles is not... Figure 12 The embodiments shown are limited to specific examples.

[0338] In the various embodiments provided in this application, the cycle including the catalytic unit can also be referred to as a metabolic cycle. The catalytic unit can be added to the tubing 11 of the cycle module, for example, via the sample addition device 301.

[0339] Here, in each of the cycles, the catalytic unit is immobilized or confined within a predetermined region of the pipeline 11, or the catalytic unit is retained in the pipeline 11 by the retention component to participate in the cycle. In each cycle, the concentration of the target substance in the corresponding fluid to be treated changes or a target product is generated.

[0340] In one implementation, the average pore size or molecular retention capacity of the retention module 30 in the circulation module is used to retain the catalytic unit in the circulation and to draw other components in the fluid out of the circulation. That is, the retention component is used to retain the catalytic unit in the circulation and allows the fluid treated by the catalytic unit to leave the circulation. Specifically, the method by which the retention component retains the catalytic unit can also be based on the chemical properties, charge characteristics, or particle size of the components, etc., and this application does not impose any limitations. By retaining the catalytic unit in the circulation, the catalytic unit can achieve continuous catalytic function. Simultaneously, by allowing the fluid treated by the catalytic unit to leave the circulation, the circulation can be continuously replenished with the fluid containing the target substance, thus ensuring the continuous catalytic effect and activity stability of the catalytic unit.

[0341] In some implementations, different target products can be generated in different cycle modules. For example, following the connection sequence, the target product obtained by catalysis by the catalytic unit in the previous cycle module can be used as the fluid to be processed in the next cycle module, thereby being catalyzed to generate a new target product in the next cycle module.

[0342] Here, by connecting multiple metabolic cycle modules in series, various target molecules in the fluid can be catalyzed or otherwise treated separately; alternatively, the same target molecule can be subjected to multiple catalytic or other treatments; or multiple target molecules can be subjected to multiple catalytic or other treatments separately. The target molecules can be molecules whose structure or concentration needs to be removed, degraded, decomposed, generated, or altered, including small molecules and biomacromolecules. In practical scenarios such as medical applications, the target molecules are, for example, any molecules in the blood circulation, lymphatic circulation, body fluids, brain or abdominal cavity fluids; and molecules absorbed or ingested in vitro, such as alcohol.

[0343] In some embodiments, the fluid processing method is implemented by N cycles, wherein the N cycles are connected in series, and specific molecules or combinations of molecules in the fluid undergo continuous reactions under the action of N sets of processing units corresponding to the N cycles. Following the connection order of the N cycles, the intermediate product generated by the processing unit in the previous cycle becomes the substrate to be processed in the subsequent cycle, wherein N is a positive integer greater than 2.

[0344] In one example, all N cycles are used to catalytically treat the fluid to be treated. Following the order of connection, the specific type of catalytic unit corresponding to each cycle can be preset by the treatment target of the fluid. For example, the N cycles are used to achieve a cascade of catalytic reactions, that is, the products of the previous cycle are treated twice or multiple times in the subsequent cycle. For instance, in an application for acute alcohol poisoning, the catalytic unit in the first cycle is ethanol oxidase, used to oxidize ethanol to produce acetaldehyde and hydrogen peroxide; the second cycle contains acetaldehyde oxidase to oxidize acetaldehyde from the first cycle to acetic acid and hydrogen peroxide; the third cycle contains catalase to decompose hydrogen peroxide from the previous cycle into oxygen.

[0345] In this embodiment C provided by the present application, the N metabolic cycles in series include a first type of metabolic cycle and / or a second type of metabolic cycle.

[0346] In embodiment C, any two adjacent cycles include the following cases:

[0347] In one scenario, two adjacent cycles are both type I metabolic cycles;

[0348] In another scenario, both adjacent cycles are type II metabolic cycles;

[0349] In another scenario, two adjacent cycles are type I metabolic cycles and type II metabolic cycles.

[0350] In one example, following the connection order, the two adjacent cycles are connected from a second type of metabolic cycle to a first type of metabolic cycle.

[0351] That is, in Examples A, B, and C, the fluid treatment method can be used to perform catalytic treatment or other treatment on one or more components in a fluid, to perform multiple catalytic treatments or other treatments on the same component in a fluid, and to perform catalytic treatments and other treatments on different components in a fluid.

[0352] Here, in the multiple metabolic cycles connected in series, any cycle can be either a first-type or a second-type metabolic cycle. Both can achieve selective treatment of the fluid in the circulating pipeline as described in the preceding embodiments, allowing for catalytic or other treatments on multiple target molecules in the fluid; or, multiple catalytic or other treatments on the same target molecule; or, multiple catalytic or other treatments on multiple target molecules, which will not be elaborated further here. In some scenarios, the retention component of the second-type metabolic cycle can also be used to achieve a fluid separation effect. This can be considered as the fluid to be treated in the second-type metabolic cycle being separated by the retention component, allowing the separated fluid to enter the circulating pipeline for reaction under the action of the catalytic unit.

[0353] It should be noted that in the embodiments provided in this application, each circulation module may selectively include a catalytic unit, or each circulation module may selectively include other processing units besides the separation module to process the fluid in the pipeline of the circulation module, or the fluid introduced at the inlet of each circulation module or the fluid drawn from the outlet of the circulation module may be pre-treated or re-treated under the action of the processing unit; the above embodiments A, B and C are only several classifications of different circulation connection methods and the setting of catalytic units therein, to illustrate the implementation mode and beneficial effects of the fluid treatment method of this application, but are not intended to limit the circulation module that performs the fluid treatment method of this application to the foregoing embodiments.

[0354] It should be understood that the circulation module can serve as a unit for executing the fluid treatment method of this application. In some embodiments, the fluid treatment method can be implemented by a single unit. In embodiments including multiple units, the connection method between the units and the optional components in each unit, such as the processing unit and the optional catalytic unit, can be changed. For example, the multiple circulation modules implementing the fluid treatment method of this application can be connected in parallel, or in parallel and series. In practical use, based on the preset treatment target of the fluid to be treated, other combined treatment effects can be formed through other connection methods and other settings of the catalytic unit and the processing unit. In some scenarios, the circulation module executing the fluid treatment method of this application can also be used in conjunction with or integrated with other devices, apparatuses, or modules to form a new device.

[0355] In some embodiments of the first aspect of this application, a step of pretreatment or retreatment of the fluid is further included, wherein the pretreatment or retreatment includes at least one of filtration, adsorption, heating, catalytic, enrichment, concentration, chemical, optical, and electrical treatment. Corresponding to practical applications, the pretreatment or retreatment can be implemented by processing modules such as adsorption devices, reactors, extraction devices, ion exchange devices, filtration devices, heating devices, etc.

[0356] The processing module pre-treats the fluid, i.e., processes the initially obtained fluid, and introduces the treated fluid into the circulation through the inlet. Connecting the fluid processed by the processing module to the inlet of the circulation constitutes the pre-treatment performed by the processing module. In practical scenarios, the pre-treatment may involve removing impurities from the fluid through methods such as precipitation, centrifugation, or ion exchange; or, in medical applications, corresponding to plasma exchange scenarios, the pre-treatment performed by the processing module may involve separating the initially obtained whole blood to obtain plasma and cellular components, and then introducing the plasma into the circulation for further processing.

[0357] In this application, the term "connection" refers to a mechanical structure that allows fluid to flow through it. In some contexts, the term "connection" is also commonly referred to as "linkage" or "connection".

[0358] The processing module reprocesses the fluid, that is, it processes the fluid surplus in the cycle; or, the processing module processes the processed fluid drawn from the drain port of the cycle, which is reprocessing; in the embodiment where the fluid processing method is implemented by multiple cycles, processing the fluid surplus in any cycle, or processing the processed fluid drawn from the drain port of any cycle, is also reprocessing.

[0359] Here, the type of preprocessing or reprocessing performed by the processing module can be determined based on processing needs. For example, when fluid components that need to be filtered out are trapped in the pipeline, the processing module can concentrate the fluid leaving the circulation based on the need to purify the beneficial components in the fluid.

[0360] For example, in one embodiment, the processing module is a separation device. The fluid is pretreated by the separation device, and the separated fluid is then introduced into the circulation for further processing. The separation device can, for example, use methods such as precipitation, centrifugation, ion exchange, or membrane separation to remove impurities from the fluid. The circulation can then process the pretreated fluid. In practical scenarios, such as plasma exchange, the filtration device separates the initially obtained whole blood into plasma and cellular components. Based on the circulation, target substances in the plasma are enriched. If the target substance is a pathogenic factor, the filtered plasma from the second side of the separation module and the cellular components separated by the processing module are collected and returned to the human body. This cyclic enrichment process can alter the concentration of pathogenic factors in the plasma within the human circulatory system.

[0361] In some embodiments of the first aspect of this application, the fluid is introduced from a storage unit into the circulation for processing, and the fluid processed by the circulation is connected to the storage unit, wherein the storage unit includes a container, a storage device, a human body, and an animal body.

[0362] Please see Figure 17 The diagram shows a simplified schematic of the circulation module in one embodiment. Here, the storage unit 16 is only used to store or connect the fluid introduced through the inlet and the fluid exited through the outlet. Therefore, the storage unit 16 can be a container or storage space, and in specific application scenarios, it can also be the blood circulation of a human or animal body. This application does not impose any limitations.

[0363] For example, in one scenario, the inlet and outlet are connected to the same storage device or container. Here, the drive device 13 controls the dynamic balance of the total fluid volume in the pipeline 11, and correspondingly, the total fluid volume in the storage device or container is dynamically balanced. When there is a target substance in the fluid that needs to be separated or extracted, the fluid is introduced from the storage device or container into the pipeline 11 and circulates through the separation module 12 to achieve continuous separation. The separated fluid is led out of the circulation module via the separation module 12 and returns to the storage device or container. As the circulation continues, the target substance in the fluid in the storage device or container gradually decreases while the total fluid volume remains unchanged. The circulation module collects the target substance in the pipeline 11 without generating waste liquid. Since the total fluid volume in the storage device or container remains unchanged, the circulation process can continue.

[0364] In another scenario, when the storage unit 16 is a human body, the fluid can be human blood, plasma, serum, tissue fluid, or other bodily fluids. In this example, the connection between the inlet and outlet and the human body can be direct or indirect. A direct connection means the fluid at the inlet and outlet can be connected to the human circulatory system. An indirect connection means the first inlet and / or the first outlet is connected to a processing module connected to the human circulatory system. This processing module, for example, is used to separate plasma from whole blood, and the inlet is connected to the separated plasma. Therefore, based on the fluid processing method of this application, by introducing plasma into the pipeline 11 to circulate and enrich the pathogenic factors to be filtered out, while simultaneously allowing beneficial components in the plasma to be continuously separated to the other side of the separation module 12 and leave the circulation, waste plasma can be avoided during the enrichment of the target substance. By continuously separating and processing the plasma in the human body, the concentration of the target substance in the plasma can be changed, effectively solving the problem of continuous loss of beneficial components.

[0365] In another scenario, when the pipeline 11 includes a catalytic unit, the fluid in the storage section can be continuously introduced into the circulation module. The target substance in the fluid generates a target product under the action of the catalytic unit. The target product is then drawn out through the separation module 12 and returned to the storage section. In this scenario, the permeability of the separation module 12 to the target substance can be set to either retention or permeability. It should be understood that the target substance retained in the pipeline 11 can contact the catalytic unit and react. The target substance leaving the circulation from the separation module 12 can be reintroduced into the circulation through the inlet to contact the catalytic unit. Therefore, by immobilizing or retaining the catalytic unit in the pipeline 11, a continuous catalytic effect can be achieved. Correspondingly, the concentration of the target product in the storage section gradually increases, while the concentration of the target substance gradually decreases.

[0366] In the above scenario, when the storage unit is the human body, the fluid processing method can be used to treat various metabolic diseases and other diseases caused by the accumulation or deficiency of specific molecules. For example, the separation module pre-processes bodily fluids such as blood drawn from the human body, such as separating whole blood into plasma components and cell components. The plasma components are then introduced into the circulation module. Based on the type of metabolic disease, the corresponding metabolites that need to be decomposed are determined. A catalytic unit, such as an enzyme, that can react with the metabolites is set in the pipeline. Through the circulation, the metabolites in the plasma of the human body can be cleared. Alternatively, the circulation can catalyze the generation of specific molecules lacking in the human body, such as the target product. Based on the sustainability of the circulation, a controllable clearing effect of metabolites or a generation effect of specific molecules can be achieved, while avoiding problems such as antigen reactions and enzyme shedding caused by enzymes in the human body.

[0367] In some embodiments of this application, the cycle further includes at least one of a control device, a storage device, a collection device, a flow limiting device, a pressure detection device, a temperature detection device, a temperature control device, a bubble detection and removal device, an alarm device, and a concentration detection device.

[0368] Here, the control device can be used to control the drive device to determine the fluid flow rate in the circulating pipeline, or to control the pipeline switch of the inlet to determine the circulation mode of fluid treatment in the pipeline, or to control the flow channel regulating device to determine the fluid flow direction; furthermore, the control device can also be used to receive detection parameter information of the fluid in the pipeline under different circulation modes for adjusting control parameters, thereby the circulation module can form a negative feedback system. For example, the control device controls the temperature control device to perform heating or cooling based on the temperature information detected by the temperature monitoring device; in some examples, the temperature control device can also be a constant temperature device.

[0369] The storage device can be used to store fluid from the drain outlet of the circulation or fluid in the pipeline of the circulation. In some examples, the storage device can also be connected to a processing module.

[0370] The bubble detection device can serve as a control signal. For example, during concentration circulation, bubble detection can indicate that the collection device is nearing emptying, allowing for dilution or discharge of the concentrated target substance. The bubble detection device can also serve as an early warning signal, indicating that the equipment is not operating normally, including but not limited to excessive emptying of the circulating liquid, improper placement of the collection device, or the presence of bubbles or leakage in the liquid to be treated.

[0371] In one example, the control device determines the control signal for the alarm device based on the detection parameters to control the internal state of the pipeline. In some implementations, there are multiple control signals corresponding to different alarm types. For example, when the control device determines that the internal pressure of the pipeline is abnormal based on the detection value of the pressure detection device, it triggers control signal a to cause the alarm device to issue an alarm corresponding to the pressure abnormality; when the control device determines that the internal concentration of the pipeline has reached a preset value, causing the cycle to stop or the concentration to be abnormal, based on the detection value of the concentration detection device, it triggers control signal b to cause the alarm device to issue an alarm corresponding to the concentration abnormality.

[0372] It should be noted that in the embodiments provided in this application, the control device is located in the pipeline, which does not limit the position of the control device. It is sufficient that the control device is electrically connected to each drive device, detection device or sensor in the pipeline. Therefore, the control device can of course be located outside the pipeline. The control device is used to obtain the working status information in the pipeline and to control the working status in the pipeline.

[0373] In some embodiments, the loop also includes a flow rate detection device for detecting the dynamic state inside the pipeline to generate adjustment information for the internal working state of the pipeline.

[0374] The flow velocity detection device is used, for example, to detect at least one of the inlet flow velocity, the outlet flow velocity, and the fluid flow velocity at the separation module, thereby determining the dynamic state inside the pipeline. In one case, the flow velocity detection device determines whether the fluid inside the pipeline is in a weak dynamic state, such as when the fluid velocity is below a preset range or the fluid velocity filtered out at the outlet decreases significantly. This allows for the determination of the operating state of the separation module or retention module, such as whether there is molecular aggregation or blockage in the separation or retention components. The flow velocity detection device can thus generate adjustment information for the operating state inside the pipeline.

[0375] The adjustment information may be, for example, information on switching the pipeline to a concentration circulation mode or a cleaning mode, or information on adjusting the flow rate in different areas of the pipeline.

[0376] In practical scenarios, the adjustment information can be generated by the control device after receiving the flow rate signal. The control device controls the flow channel adjustment device, drive device, etc. in the pipeline based on the adjustment information to adjust the internal working state of the pipeline.

[0377] In some scenarios, the adjustment information generated by the control device is based on at least one of the flow rate detection device, pressure detection device, and concentration detection device. For example, the control device receives at least one of the flow rate information, pressure information, and fluid concentration information within the management system and then integrates them to generate adjustment information to control the flow channel adjustment device, drive device, etc. in the pipeline.

[0378] In some embodiments, the fluid treatment method selectively removes or generates specific molecules or combinations of molecules for disease treatment. These specific molecules or combinations of molecules (also referred to as target molecules) are often pathogenic factors or consequences in the course of disease development, or are essential for disease development or the maintenance of health. Controlling the concentration of target molecules is beneficial for the treatment of the disease or the control of complications. The diseases include, but are not limited to, at least one of the following: familial hypercholesterolemia, hyperlipoproteinemia, systemic lupus erythematosus, autoimmune diseases, myasthenia gravis, rapidly progressive glomerulonephritis, fatty liver, cirrhosis, acute liver failure, hyperlipidemia, severe acute pancreatitis, sepsis, Guillain-Barré syndrome, obesity, phenylketonuria, mucopolysaccharidosis, hypoalkaline phosphataseemia, hereditary hyperammonemia, hyperuricemia, gout, hyperglycemia, ketoacidosis, diabetes, and cancer.

[0379] It should be understood that the fluid treatment method achieves therapeutic effects by selectively removing pathogenic factors or other molecules or combinations of molecules related to the survival of pathogenic factors from the patient's bodily fluids, or by catalyzing specific molecules or combinations of molecules to generate other target products. This alters the concentration of different molecules in the patient's body, thereby achieving a therapeutic effect. It should be understood that the concentration alteration includes a concentration from 0 to a specific value, i.e., the generation of new substances, and also includes a concentration reduction to 0, i.e., the removal of existing substances from the body. Therefore, the fluid treatment method of this application can be used to treat a variety of diseases, and is not limited to the foregoing examples. It should be understood that any scheme that achieves a therapeutic effect by altering the concentration of any molecule in the body using the method provided in this application is within the scope of the fluid treatment method.

[0380] In any embodiment provided in this application, the treatment includes preventive (i.e., preventative), blocking, curative, or palliative measures that can lead to the desired physiological effect. Furthermore, the term "treatment" herein refers to an action aimed at partially or completely alleviating, delaying the onset, inhibiting the progression, reducing the severity, and / or decreasing the probability of the occurrence of one or more symptoms of a particular disease, abnormality, and / or medical condition.

[0381] In the embodiments provided in this application, the removal is not limited to completely removing a component from the originally obtained fluid; removal is considered to be achieved simply by reducing the concentration or total amount of the component in the fluid.

[0382] In some embodiments, the fluid processing method is an in vitro metabolic fluid processing method, comprising:

[0383] In step S10, the fluid to be treated is drawn out of the body to selectively remove or generate specific molecules or combinations of molecules;

[0384] In step S11, the treated fluid is returned to the body.

[0385] Here, the fluid to be processed is any bodily fluid or bodily fluid component in the human or animal body, such as blood, serum, plasma, etc. By processing the fluid to be processed through any of the aforementioned embodiments provided in the first aspect of this application, while retaining the processing unit in the recirculation, and returning the processed fluid without the processing unit to the body, a fluid processing method for in vitro metabolism can be formed.

[0386] Based on the characteristics of in vitro metabolic processing, compared with in vivo processing, the fluid processing method of this application reduces the limitations caused by biosafety when processing body fluids or body fluid components. For example, physical methods such as high temperature or ionization can be used in the selective removal or generation of specific molecules or molecular combinations. It also includes some processing methods that are toxic to the human body but can be avoided from entering the human body, such as some non-biological catalysts, adsorbents, etc., as long as the method is selective in processing the components in the liquid.

[0387] In some embodiments, the fluid treatment method uses enzymes or enzyme preparations to act on the fluid to be treated drawn from outside the body to selectively remove or generate specific molecules or combinations of molecules and prevent the enzymes or enzyme preparations from entering the human or animal body, thereby controlling the molecular composition and concentration in the body fluids of the human or animal body. That is, in this example, this application also provides a method for enzymes or enzyme preparations to act on the human body or change the concentration of specific molecules or combinations of molecules in the human body.

[0388] Please see Figure 18a and Figure 18b The diagram shows a simplified schematic of an extracorporeal circulatory metabolic system that can be used to perform the extracorporeal metabolism fluid processing method in different embodiments. It should be understood that in the embodiments provided in this application, the extracorporeal circulatory metabolic system is a circulatory processing system, and when the circulatory processing system acts on a human or animal body, it can be considered an extracorporeal circulatory metabolic system.

[0389] Please refer to the following: Figure 18a and Figure 18b As shown in the figure, the extracorporeal circulation metabolic system includes a pipeline system and circulation processing equipment, wherein the pipeline system includes a fluid outflow pipeline and a fluid return pipeline.

[0390] like Figure 18a As shown, the fluid outlet pipeline and the fluid return pipeline are connected to the same storage unit 26. When the fluid processing method is used to form an extracorporeal circulation metabolic system, the storage unit 26 can be a human or animal body, for example... Figure 18aThe illustrated embodiment. In this example, blood or other bodily fluids drawn from a human or animal body enter the circulation processing device through the retention module 30. The circulation processing device is the second metabolic circulation module used to form the second type of metabolic cycle. The following description uses blood as an example of the liquid to be processed. The blood circulates in the pipeline of the second metabolic circulation module and contacts the catalytic unit to catalyze the target substance. Simultaneously, the processed blood can return to the storage unit 26 (i.e., the human body) through the retention module. In this example, the fluid volume within the second metabolic circulation module is dynamically balanced, and the corresponding amount of bodily fluid in the human body will not be lost over time. Therefore, the in vitro metabolic process is sustainable, and the metabolic time can be determined based on the target molecules being processed in the human body. Furthermore, the in vitro circulation metabolic system can control its processing efficiency for the target substance by adjusting the internal flow rate of the metabolic cycle and the flow rate of the liquid drawn from the human body. Specific methods for controlling processing efficiency can be found in the embodiments provided earlier in this application, and will not be repeated here.

[0391] In some embodiments of this application, the pipeline system further includes at least one of an anticoagulation system, a control device, a separated fluid storage device, a pressure detection device, a temperature detection device, a temperature control device, an oxygen detection device, a bubble detection and removal device, an alarm device, and a concentration detection device.

[0392] The pipeline system may optionally include the aforementioned devices. It should be understood that the pipeline system is primarily used for fluid traction, and the aforementioned devices can be installed in the pipeline system according to actual needs in different application scenarios. For example, ... Figure 18b As shown, when the circulation processing system is a human extracorporeal circulation device and the pipeline system is used for blood transport, the pipeline system can typically be equipped with a bubble detection and removal device 31, an air capture device 32, a pressure detection device 33, and an anticoagulation system 34.

[0393] In some implementations, the anticoagulation system 34 is coupled to the piping system. For example, when the piping system is used for blood transport, the piping system is made into an anticoagulation system by adding heparin, tissue plasminogen activator, antithrombin, and other anticoagulation components to the piping system. The anticoagulation components flow with the fluid in the piping system.

[0394] The bubble detection and removal device 31 can be used to ensure that bubbles are removed from the fluid before it enters the circulation processing device, or to remove bubbles when the processed fluid is drawn out of the circulation processing device. For example, in a medical setting, the fluid, such as blood, needs to have bubbles removed before it is returned to the human blood circulation after processing.

[0395] The circulating processing device, based on the fluid processing method of this application, can be used to selectively remove or generate specific molecules or combinations of molecules from the fluid to be processed. For example, it can be a first-type circulating module, a second-type circulating module, a metabolic circulating module, or a circulating module with multiple cycles connected in series or in parallel. In the embodiment shown in 18b, the circulating processing device is a first metabolic circulating module formed by a first-type metabolic cycle, wherein the addition, replacement, or renewal of the catalytic unit can be controlled by the sample addition device 301.

[0396] Taking the extracorporeal circulation metabolic system used for blood processing as an example, to meet processing needs, the raw blood or other bodily fluids drawn from the human body can also undergo pretreatment, for example... Figure 18b In the illustrated embodiment, the inlet of the fluid outlet pipeline is connected to whole blood drawn from the human body. Under the pretreatment of a processing module 40, the whole blood is separated into cellular components and plasma components. The plasma components can be connected to the inlet of the metabolic circulation module. Thus, the target substances in the plasma components can come into contact with the catalytic unit in the metabolic circulation module and their structure or concentration is changed under the action of the catalytic unit. The catalytic unit is, for example, an enzyme. Based on the specificity of enzyme catalysis, specific molecular components in the plasma are removed or preset reaction products are generated. The processed plasma components can be drawn out from the separation module and connected to the fluid return pipeline and converge with the cellular components. In the illustrated embodiment, the plasma components and cellular components processed by the metabolic circulation module leave the metabolic circulation through the interception module 30 and flow to the collection device in the fluid return pipeline.

[0397] Here, the total fluid volume in the extracorporeal circulation metabolic system is kept in dynamic balance, thus ensuring sustainability. During the continuous processing, the circulating treatment equipment continuously processes body fluids or body fluid components from the human or animal body, such as continuously decomposing target substances or continuously generating target products, or continuously enriching target molecules. After being reinfused into the human or animal body, the concentration of target substances or target molecules in the body can continuously decrease, or the concentration of target products in the body can gradually increase. This allows for the controllable removal or generation of specific molecules or combinations of molecules in the body.

[0398] Please see Figure 19 The diagram shows a simplified schematic of an extracorporeal circulatory metabolic system in another embodiment, which can be used to perform the fluid handling method for the extracorporeal metabolism.

[0399] In the illustrated embodiment, the extracorporeal circulation metabolic system includes a tubing system and a circulation processing device, wherein the tubing system includes a fluid outlet tubing and a fluid return tubing.

[0400] The circulating treatment device includes multiple circulating modules connected in series, which, in order of connection, are a circulating separation module, a circulating separation module, and a metabolic circulation module. In this example, the fluid to be treated in the fluid outlet pipeline is connected to the inlet corresponding to the first circulating separation module. The series-connected circulating separation modules allow for the stepwise separation of components in the fluid. Connecting the subsequent circulating separation module to a metabolic circulation module allows for catalytic treatment of fluids containing only a portion of the components (including the target substance). The catalytic unit is retained in the metabolic circulation module, which then performs continuous catalytic treatment. The treated fluid from the metabolic circulation module is led out from the outlet and connected to a fluid return pipeline. Components that do not enter the metabolic circulation module can flow to the outlet of the first circulating separation module based on the reversible nature of the circulation in the circulating separation module. The fluid led out from the outlet of the first circulating separation module, along with the fluid treated by the metabolic circulation module (which includes, for example, the target product), is connected to the fluid return pipeline and can then be returned to the human body. The catalytic unit can also optionally be added to the metabolic cycle module via a sample addition device 301.

[0401] like Figure 19 In the embodiment shown, when the circulation processing system is a human extracorporeal circulation device and the pipeline system is used for blood transport, the pipeline system can typically be equipped with a bubble detection and removal device 31, an air capture device 32, a pressure detection device 33, and an anticoagulation system 34.

[0402] In a specific application scenario, the extracorporeal circulation metabolic system is used, for example, for the processing of blood in a human or animal body. At the separation module corresponding to the first circulation separation module, components such as cells and platelets in the blood are intercepted and connected to a collection device located on the fluid return pipeline through the drain port of the first circulation separation module. The components entering the pipeline of the first circulation separation module are mainly non-cellular substances. These non-cellular substances circulate under the drive of the driving device and undergo medium molecular weight molecule exchange at the second circulation separation module. The medium molecular weight molecules can flow through the separation module of the second circulation separation module into its pipeline. Then, the medium molecular weight molecules in the pipeline can be filtered out at the separation module to form a solution containing the target substance. The solution containing the target substance is connected to the inlet of the metabolic circulation module. The target substance can then flow into the pipeline of the metabolic circulation module and contact the catalytic unit in the pipeline. Under the action of the catalytic unit, the target substance is decomposed or degraded, resulting in a decrease in concentration, or the target substance can generate a target product under the action of the catalytic unit. The product after the target substance is decomposed or the target product can be connected to the collection device through the interception module 30 to combine with the blood retention fluid, such as the aforementioned cells and platelets.

[0403] Please see Figure 20The diagram shows a simplified schematic of an extracorporeal circulatory metabolic system, which can be used to perform the fluid handling method for the extracorporeal metabolism, in another embodiment.

[0404] As shown in the figure, the extracorporeal circulation metabolic system includes a tubing system and a circulation processing device. The tubing system includes a fluid outlet tubing and a fluid return tubing. In this example, the circulation processing device is a metabolic circulation module that can be used to form the metabolic cycle. The fluid outlet tubing is connected to a processing module 40, which is, for example, a filtration device or a separation device, used to separate the fluid processed by the processing module 40 into a retained fluid and a filtered fluid. The filtered fluid filtered or separated from the processing module 40 is connected to the inlet of the metabolic circulation module. The fluid processed by the metabolic circulation module is led out from the outlet and connected to the upstream of the processing module 40 (in the illustrated example, a collection device connected to the upstream of the processing module 40). That is, the fluid processed by the metabolic circulation module can be processed again by the processing module 40. At the same time, the retained fluid at the processing module 40 is connected to the tubing return tubing.

[0405] Taking the illustrated extracorporeal circulation metabolic system in a medical scenario as an example, the fluid outflow pipeline and fluid return pipeline are used to draw blood from the human body and return the blood processed by the extracorporeal circulation metabolic system to the human body, respectively. Here, the processing module 40 is, for example, a filtration module, used to separate some components, such as plasma components, from the whole blood drawn from the human body. The plasma components are drawn to the inlet of the metabolic circulation module through pipelines. The filtered plasma, processed by the metabolic circulation module, is drawn out from the outlet and connected to the upstream of the filtration module. Thus, following the flow direction, the filtered plasma is processed again by the filtration module. The retained fluid obtained from the filtration module is the renewed whole blood. The renewed whole blood is connected to the fluid return pipeline for delivery to the human body. That is, in this embodiment, the plasma components can be circulated and processed by the metabolic circulation module. At the same time, by setting the connection method between the metabolic circulation module and the processing module 40, the processing module 40 can also be used to realize the circulation filtration of plasma.

[0406] certainly, Figure 18a , Figure 18b , Figure 19 and Figure 20 These are just a few examples of the extracorporeal circulation metabolic system. In actual applications, the type, number, and connection order of the circulation modules in the circulation processing device can be changed to suit treatment needs.

[0407] It should be understood that in clinical applications, the fluid processing method of this application can be used to change the concentration of specific molecules or combinations of molecules in a patient's body. However, for different types of diseases, the medical intervention required by the patient may include other means. For example, for patients with renal insufficiency, the fluid processing method of this application can help achieve in vitro metabolism to remove pathogenic factors accumulated in the patient's body. However, at the same time, complications or comorbidities that may accompany renal insufficiency may include anemia, pyelonephritis, urinary tract diseases, etc. In this case, the fluid processing method of this application can be used in combination with drugs and other treatment methods such as surgery, dietary care, etc., for the treatment of the disease.

[0408] In some embodiments, the fluid processing method is used in conjunction with drugs for disease treatment. For example, the fluid processing method of this application alters the concentration of specific molecules or combinations of molecules in a patient's body, such as by reducing the concentration of specific molecules or generating specific molecules. Simultaneously, drug treatment is used in conjunction with the patient's disease treatment based on the fluid processing method. The combined drugs may be, for example, drugs targeting disease complications, anticoagulants targeting extracorporeal circulation metabolism, vasoactive drugs targeting the disease itself, anti-infective drugs, etc.

[0409] The fluid processing method provided in the first aspect of this application involves circulating fluid through a pipeline to form a cycle, maintaining a dynamic balance of fluid volume within the cycle to ensure its sustainability, and processing the fluid through at least one of the cycles. A processing unit is provided within the at least one cycle to process the fluid. This processing unit selectively alters the structure or concentration of molecules or molecular combinations within the fluid. The fluid processing method of this application has the following beneficial effects:

[0410] In any of the aforementioned cycles, the dynamic balance of the total fluid volume in the cycle can be satisfied to maintain the sustainability of the cycle; therefore, the duration of the fluid treatment method can be determined based on a preset treatment target.

[0411] The fluid treatment method of this application selectively changes the structure or concentration of molecules or molecular combinations in a fluid through a treatment unit. At the same time, by forming the circulation, a controllable contact environment is constructed between the treatment unit and the fluid to be treated. Thus, while achieving highly selective treatment of the mixture system, the treatment efficiency or treatment effect and the duration of the treatment method can also be adjusted.

[0412] Based on the dynamic environment formed by the circulation, the fluid components in the circulation change dynamically. During the processing, the processing unit can continuously process the replenished fluid to be processed, thereby improving the processing efficiency of the processing unit. The circulation flow environment also enables the fluid to be processed to achieve better mixing and dispersion.

[0413] The flow velocity inside the pipeline in the circulation can be relatively independent from the flow velocity of the fluid to be treated introduced into the circulation. Therefore, the average contact time or action time between the fluid to be treated and the processing unit can be controlled by controlling the flow velocity of the fluid to be treated introduced into the circulation. At the same time, the flow velocity of the fluid inside the pipeline in the circulation can be controlled based on the processing efficiency.

[0414] In the cycle, the inlet and outlet can be connected to the same storage device or human body circulation, as well as animal body circulation. During the treatment process, the fluid in the storage device or human body circulation can be maintained based on the sustainability of the cycle, while the continuous generation of waste liquid can be avoided during this treatment process.

[0415] The cycle can be equipped with a catalytic unit to achieve the removal or generation of specific target molecules. Based on the specificity of the catalytic unit, it can achieve the removal or generation of specific molecules or combinations of molecules in the fluid. The cycle can be continuously replenished with the fluid to be treated containing the target substance, which can ensure the continuous catalytic effect (efficiency) and activity stability of the catalytic unit.

[0416] Meanwhile, the catalytic unit can be configured to participate in the circulation in a free form and be retained in the circulation by the separation component, which can avoid and mitigate the continuous impact and scouring of the catalytic unit by the fluid, reducing the resulting breakage. In embodiments where the catalytic unit is an enzyme, protein deposition and gel layer formation can be reduced. That is, the fluid treatment method can be used to create a dynamic reaction environment between the catalytic unit and the target substance within the pipeline. The catalytic unit being distributed in a free form in the pipeline is beneficial for full contact with the target substance. At the same time, the catalytic unit can flow in the circulation direction in accordance with the dynamic environment within the pipeline, and the flow between the catalytic unit and the inner wall of the pipeline is tangential, which can reduce the collision problem of the catalytic unit in the reaction environment. While fully contacting the target substance to improve the catalytic effect, it also reduces the probability of the catalytic unit being damaged.

[0417] The catalytic unit is retained in the cycle, which can effectively avoid or reduce the loss of the catalytic unit. In specific scenarios such as medical applications, when the catalytic unit is an enzyme, the problem of in vivo immune response caused by enzyme shedding in the prior art can be effectively avoided or mitigated. That is, this application also provides a method for enzymes or enzyme preparations to act on the human body or change the concentration of specific molecules or combinations of molecules in the human body.

[0418] The fluid processing method allows for the immediate updating, replacement, and replenishment of the catalytic unit, which is beneficial for controlling the catalytic efficiency in fluid processing in practical applications. At the same time, it can effectively expand the storage environment of the catalytic unit, allowing the catalytic unit and pipeline to adopt different storage conditions, reducing the overall storage requirements of the equipment used to perform the fluid processing method, and helping to ensure the activity of the catalytic unit.

[0419] By replacing and updating the catalytic unit, the activity stability of the catalytic unit can be ensured in the cycle, or the processing of different fluids or different target substances can be realized in the cycle module. For example, in medical applications, replacing the catalytic unit can be adapted to the treatment of different types of diseases.

[0420] The fluid flow rate can be controlled during the cycle to regulate the material exchange efficiency or filtration effect at the separation module.

[0421] When the fluid treatment method is implemented through multiple cycles, the type of cycle module, connection method, specific form of treatment unit in the cycle, and setting of catalytic unit are determined by the preset treatment target. This allows for the separate catalytic treatment or other treatment of one or more components in the fluid, multiple catalytic treatments or other treatments of the same component in the fluid, and separate catalytic treatments and other treatments of different components in the fluid. Each cycle can satisfy an equilibrium state, and the multiple cycles used to implement the fluid treatment method are sustainable.

[0422] The multiple cycles allow for the segmented enrichment of different components in the fluid within different cycles, or the gradual separation of fluid components within different cycles. This enables highly selective removal or generation of specific components, effectively avoiding the problem of continuous loss of beneficial components in fluid processing in existing technologies. Simultaneously, the gradual separation of fluid components within different cycles allows the catalytic unit to process a mixed system with simplified component categories, thereby improving the catalytic efficiency of the catalytic unit.

[0423] Based on the sustainability of the cycle, in medical applications, the hardware device implementing the fluid handling method can be configured as wearable to enable continuous treatment of patients.

[0424] In a second aspect, this application also provides a circulation processing apparatus, comprising at least one circulation module, wherein a fluid to be treated is added to the pipeline of the circulation module to form a circulation, wherein the treated fluid in the circulation leaves the circulation module, and a fluid reserve is retained in the circulation module; the at least one circulation module further comprises a processing unit, the processing unit processing the fluid in the circulation to selectively change the structure or concentration of molecules or molecular combinations in the fluid, wherein the processing includes at least one of catalytic processing, filtration processing, adsorption processing, heating processing, enrichment processing, chemical processing, optical processing, and electrical processing.

[0425] The circulating processing device includes one circulating module, or two or more combined circulating modules; that is, the circulating processing device of this application can introduce the fluid to be processed into one of the circulating modules, and the processed fluid, after leaving the circulating module, is introduced into another circulating module. In this case, the different circulating modules can be regarded as being in series; or, the fluid can be diverted and introduced into different circulating modules for processing, and then the processed fluid can be collected. In this case, the different circulating modules can be regarded as being in parallel.

[0426] The fluid contains the target substance. In some embodiments provided in the second aspect of this application, the fluid includes, but is not limited to, one or more mixtures of blood, plasma, serum, body fluid, tissue fluid, washing fluid, dialysis fluid, recombinant protein solution, cell culture medium, microbial culture medium, pharmaceutical and medical water, pharmaceutical solutions, liquid foods, plant and animal extracts, natural water, industrial wastewater, and reclaimed water. In some examples, the fluid may also be a component of a fluid such as blood or plasma obtained after treatment, such as filtration; in other examples, the fluid may also be a gas mixture, such as a gas mixture containing methane.

[0427] In some embodiments of the second aspect of this application, the circulation module further includes at least one driving device connected to the pipeline for driving the fluid flow to form a circulation.

[0428] In some embodiments of the second aspect of this application, the total amount or total rate of fluid introduced into the pipeline in the circulation module is equal to the total amount or total rate of fluid leaving the circulation module.

[0429] In some embodiments of the second aspect of this application, the circulation module adjusts the processing efficiency in the circulation by at least one of the following methods: controlling the ratio of the total amount of fluid introduced into the circulation module per unit time to the total amount of fluid in the circulation module to adjust the processing efficiency; controlling the ratio of the total amount of fluid leaving the circulation module per unit time to the fluid flow rate in the circulation module to adjust the processing efficiency.

[0430] In some embodiments of the second aspect of this application, the processing unit achieves catalytic treatment by controlling the catalytic units in the cycle, wherein the processing unit controls the catalytic units in at least one of the following ways: the processing unit is used to add, supplement, replace, or update the catalytic units in the cycle module to control the type and total amount of catalytic units in the cycle; the processing unit is used to adjust the activity of the catalytic units in the cycle module.

[0431] In some embodiments of the second aspect of this application, the catalytic unit is used to catalytically treat the fluid in the cycle to change the structure of the target substance in the fluid and generate the target product; or, the catalytic unit is used to change the concentration of the target substance.

[0432] In some embodiments of the second aspect of this application, the catalytic unit includes a biocatalytic unit and a non-biocatalytic unit; wherein, the biocatalytic unit includes at least one of cells, proteins, enzymes, polypeptides and nucleic acids, and derivatives, conjugates, complexes, and assemblies in the form of microspheres or microcapsules formed based on at least one of them; the non-biocatalytic unit includes a metal catalyst and derivatives, conjugates, complexes, and assemblies in the form of microspheres or microcapsules formed based on the metal catalyst.

[0433] In some embodiments of the second aspect of this application, the catalytic unit is a circulating catalytic unit that circulates along with the fluid balance; or, the catalytic unit is a stationary catalytic unit defined or fixed in a predetermined region of the pipeline.

[0434] In some embodiments of the second aspect of this application, the circulation module further includes a retention module disposed in the pipeline, the retention module having retention components to retain the circulating catalytic unit and / or retain any detached stationary catalytic unit, so as to prevent the catalytic unit from leaving the circulation module.

[0435] In some embodiments of the second aspect of this application, the circulation module further includes a flow channel regulating device for regulating the fluid flow direction in the circulation to clean or replace the circulating catalytic unit.

[0436] In some embodiments of the second aspect of this application, the retention component is a porous membrane or a reverse osmosis membrane, wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, and a nanofiltration membrane.

[0437] In some embodiments of the second aspect of this application, the retention component includes one or more of a planar membrane, a tubular membrane, a spiral membrane, a spiral membrane, and a hollow fiber membrane.

[0438] In some embodiments of the second aspect of this application, the interception module is a tangential flow filtering module.

[0439] In some embodiments of the second aspect of this application, the interception component divides the interception module into a first side and a second side, and the circulation includes at least one of the following: a first metabolic circulation module whose pipeline inlet and outlet are connected to the first side, having at least one inlet connected to the pipeline and at least one outlet connected to the second side; and a second metabolic circulation module whose pipeline inlet and outlet are connected to the second side, having at least one inlet connected to the first side and at least one outlet connected to the first side.

[0440] In some embodiments of the second aspect of this application, in the first metabolic cycle module, the fluid to be treated is added to the cycle from the inlet and then driven to the retention module by a drive device.

[0441] In some embodiments of the second aspect of this application, the driving device controls the fluid in the pipeline to flow at a preset flow rate so that the catalytic unit flows through the interception module into the pipeline.

[0442] In some embodiments of the second aspect of this application, the preset flow rate is related to at least one of the following: catalytic unit structure, fluid composition, fluid temperature, trapping component structure, trapping component material, trapping module cavity structure, pipeline diameter, and fluid exchange efficiency.

[0443] In some embodiments of the second aspect of this application, the average pore size or molecular retention amount corresponding to the retention component is related to at least one of the catalytic unit, the target substance, and the target product.

[0444] In some embodiments of the second aspect of this application, the circulation module includes a sample addition device for adding, replenishing, or replacing reaction substrates, drugs, or catalytic units into the pipeline.

[0445] In some embodiments of the second aspect of this application, the sample dispensing device includes at least one sample dispensing port connected to the tubing, or the sample dispensing device is a component adapted for injection.

[0446] In some embodiments of the second aspect of this application, the circulation module further includes a collection device having a collection cavity for mixing the circulating catalytic unit, the fluid balance, and the liquid to be treated, so as to bring the catalytic unit into contact with the target substance.

[0447] In some embodiments of the second aspect of this application, the collecting device is further configured to provide at least one of a sample inlet, an air outlet, and a liquid outlet.

[0448] In some embodiments of the second aspect of this application, the circulation module includes: a pipeline having an inlet and an outlet; a separation module including a separation component to divide the separation module into a first side and a second side, wherein the opposite ends of the first side of the separation module are respectively connected to at least one inlet and at least one outlet, and the opposite ends of the second side of the separation module are respectively connected to the inlet and outlet of the pipeline; and at least one driving device disposed in the pipeline for driving the fluid in the pipeline to flow from the inlet to the outlet at a preset flow rate, so as to dynamically balance the total amount of fluid in the separation pipeline in the separation circulation mode.

[0449] In some embodiments of the second aspect of this application, fluid is introduced into N circulation modules for processing, the N circulation modules being connected in series and / or in parallel, wherein N is a positive integer greater than 2.

[0450] In some embodiments of the second aspect of this application, the N circulation modules are connected in series, and in accordance with the connection order, the average pore size or molecular rejection of the separation components of the N circulation modules decreases step by step.

[0451] In some embodiments of the second aspect of this application, the separation component is a porous membrane or a reverse osmosis membrane, wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, and a nanofiltration membrane.

[0452] In some embodiments of the second aspect of this application, the separation component includes one or more of a planar membrane, a tubular membrane, a spiral membrane, a spiral membrane, and a hollow fiber membrane.

[0453] In some embodiments of the second aspect of this application, the preset flow rate is related to at least one of the target substance, fluid composition, fluid temperature, separation component structure, separation component material, separation module cavity structure, pipeline diameter, and fluid exchange efficiency.

[0454] In some embodiments of the second aspect of this application, the circulating processing device includes N circulating modules, and N sets of processing units corresponding to the N circulating modules respectively process different molecules or combinations of molecules in the fluid, so that different components in the fluid are distributed and processed in the N circulating modules; wherein, N is a positive integer greater than 2.

[0455] In some embodiments of the second aspect of this application, the circulating processing device includes N circulating modules, wherein the N circulating modules are connected in series, and specific molecules or combinations of molecules in the fluid undergo continuous reactions under the action of N sets of processing units corresponding to the N circulating modules. In accordance with the connection order of the N circulating modules, the intermediate product generated by the processing unit in the previous circulating module is the substrate to be processed in the subsequent circulating module; wherein N is a positive integer greater than 2.

[0456] In the examples of the circulating processing device comprising N circulating modules, the type (or specific structure) of each circulating module, such as a metabolic circulating module or a circulating module including a separation module, the connection method between each circulating module, and the processing effect of the N circulating modules on the fluid can all refer to the embodiments of the fluid processing method provided in the first aspect of this application, which cascade multiple equivalent circulating modules of the first type of metabolic cycle, the second type of metabolic cycle, the first type of circulating module, and the second type of circulating module, such as the aforementioned embodiments A, B, and C, which will not be repeated here.

[0457] In some embodiments of the second aspect of this application, the inlet and outlet of the circulating processing device are connected to the same storage unit, wherein the storage unit includes a container, a storage device, a human body, and an animal body.

[0458] In some embodiments of the second aspect of this application, the circulating processing device further includes at least one processing module for pre-treating or re-treating the fluid in the fluid processing device, wherein the pre-treating or re-treating includes at least one of filtration, adsorption, heating, catalytic, enrichment, concentration, chemical, optical, and electrical treatment.

[0459] In some embodiments of the second aspect of this application, the circulating processing equipment further includes at least one of a control device, a fluid storage device, a flow limiting device, a flow rate detection device, a pressure detection device, a temperature detection device, a temperature control device, an oxygen detection device, a bubble detection and removal device, an alarm device, and a concentration detection device.

[0460] In some embodiments of the second aspect of this application, the control device generates adjustment information on the internal operating state of the pipeline based on at least one of a flow rate detection device, a pressure detection device, and a concentration detection device.

[0461] In some embodiments of the second aspect of this application, the cyclic processing device selectively removes or generates specific molecules or combinations of molecules for disease treatment. These specific molecules or combinations of molecules (also referred to as target molecules) are often pathogenic factors or consequences in the course of disease development, or are crucial to the development of disease or the maintenance of health. Controlling the concentration of target molecules is beneficial to the treatment of disease or the control of complications. The diseases include, but are not limited to, at least one of familial hypercholesterolemia, hyperlipoproteinemia, systemic lupus erythematosus, autoimmune diseases, myasthenia gravis, rapidly progressive glomerulonephritis, fatty liver, cirrhosis, acute liver failure, hyperlipidemia, severe acute pancreatitis, sepsis, Guillain-Barré syndrome, obesity, phenylketonuria, mucopolysaccharidosis, hypoalkaline phosphataseemia, hereditary hyperammonemia, hyperuricemia, gout, hyperglycemia, ketoacidosis, diabetes, and cancer.

[0462] It should be understood that the circulating processing device provided in the second aspect of this application can be used to perform the fluid processing method described in any embodiment of the embodiments provided in the first aspect of this application. Correspondingly, the specific structure of the circulating module in the circulating processing device, such as pipelines, interception modules, separation modules, driving devices, sampling devices, processing units, etc., as well as their connection methods, their combination methods with the processing modules, and the fluid processing effects achieved, can all refer to the embodiments provided in the first aspect of this application, and will not be repeated here.

[0463] In some scenarios, the circulation module in the circulation processing device can be used as an independent sales unit. Here, the circulation processing device can be a connected device or an independent component with a connection relationship, i.e., an independent circulation module. The connection relationship can be one or more. For example, the circulation processing device includes multiple circulation modules, which can be connected with different connection relationships to suit different processing needs. Alternatively, to adapt to the needs of the scenario, only some of the components can be selectively connected.

[0464] In a third aspect, this application also provides a circulation processing system, including at least one circulation processing device as described in any embodiment of the second aspect of this application, and a pipeline system, wherein the pipeline system includes a fluid outlet pipeline and a fluid return pipeline.

[0465] In some embodiments, the piping system further includes at least one of an anticoagulation system, a control device, a fluid storage device, a pressure detection device, a temperature detection device, a temperature control device, an oxygen detection device, a bubble detection and removal device, an alarm device, a flow limiting device, and a concentration detection device.

[0466] In some embodiments, the circulatory processing system is an extracorporeal circulation metabolic system, wherein the fluid outflow line is used to draw out the fluid to be processed from the body, and the fluid return line is used to return the processed fluid to the body.

[0467] Here, the fluid to be treated is any bodily fluid or bodily fluid component in the human or animal body, such as blood, serum, plasma, etc. The fluid to be treated is processed by the circulating treatment device, and the treated fluid is returned to the body.

[0468] Based on the characteristics of in vitro metabolic processing, compared with in vivo processing, the limitations imposed by biosafety on the in vitro circulating metabolic system of this application are reduced when processing body fluids or body fluid components. For example, physical methods such as high temperature or ionization can be used in the selective removal or generation of specific molecules or combinations of molecules.

[0469] In some embodiments, the extracorporeal circulation metabolic system involves enzymes or enzyme preparations acting on the fluid to be treated drawn from the body to selectively remove or generate specific molecules or combinations of molecules and to prevent the enzymes or enzyme preparations from entering the human or animal body, thereby controlling the molecular composition and concentration of body fluids in the human or animal body. That is, in this example, the extracorporeal circulation metabolic system provides a pathway for enzymes or enzyme preparations to act on the human body or alter the concentration of specific molecules or combinations of molecules in the human body.

[0470] For example, the enzyme or enzyme preparation can serve as a catalytic unit in a metabolic cycle. The fluid to be treated, drawn out of the body, comes into contact with the enzyme or enzyme preparation in an in vitro metabolic system, thereby undergoing catalytic treatment to change its molecular composition and concentration. At the same time, based on the retention module configured in the metabolic cycle, the enzyme or enzyme preparation serving as the catalytic unit is retained in the cycle by the retention module, thereby preventing it from entering the human or animal body.

[0471] Specifically, the in vitro metabolic system includes a tubing system and at least one circulation processing device as described in any embodiment of the second aspect of this application, for example... Figures 18a to 20 The embodiments shown can also be used to perform the fluid processing method for in vitro metabolism described in any of the embodiments provided in the first aspect of this application; the specific structure and connection method of the circulation processing device in the in vitro metabolism system can be referred to the embodiments provided in the first aspect of this application, and will not be repeated here.

[0472] In a fourth aspect, this application also provides a medical device comprising a cyclic processing system as described in the embodiments provided in the third aspect of this application.

[0473] The medical device can be used for medical purposes, and can be an instrument, device, appliance, material or other article used alone or in combination on the human body, and may also include the necessary software; it can be used to achieve the prevention, diagnosis, treatment, monitoring, relief or compensation of diseases.

[0474] In the embodiments provided in this application, the medical device may be, for example, a blood purification device, an extracorporeal circulation clearance system, an extracorporeal enrichment clearance device, a hemodialysis device, a plasma exchange device, an extracorporeal peritoneal dialysis device, or an extracorporeal membrane oxygenation device. In other embodiments, the medical device may also be a module integrated into other extracorporeal circulation devices, such as an artificial liver, an artificial kidney, a hemodialysis device, a peritoneal dialysis device, a plasma exchange device, a plasma purification device, a lipid purification device, a molecular adsorption recirculation system, an extracorporeal membrane oxygenation device, a leukocyte removal device, an extracorporeal circulation life support system, etc. In some embodiments, the medical device may be used alone as a medical device or treatment device, or it may be integrated into other medical devices or instruments involving the extracorporeal treatment of blood or other bodily fluids to form a new device.

[0475] When the cyclic processing system provided in the third aspect of this application is used for medical purposes, it can be used as a medical device.

[0476] The medical applications include the treatment of fluids obtained from the human body, as well as the acquisition of pharmaceuticals, pharmaceutical water, and medical water for treatment processes. For example, the circulating treatment system can be used to treat tap water to obtain dilution water that can be used as concentrated dialysis fluid.

[0477] In some embodiments provided in the fourth aspect of this application, the medical device selectively removes or generates specific molecules or combinations of molecules for disease treatment. These target molecules are often pathogenic factors or consequences in the course of disease development, or are essential for the development of disease or the maintenance of health. Controlling the concentration of target molecules is beneficial for the treatment of disease or the control of complications. The diseases include, but are not limited to, at least one of familial hypercholesterolemia, hyperlipoproteinemia, systemic lupus erythematosus, autoimmune diseases, myasthenia gravis, rapidly progressive glomerulonephritis, fatty liver, cirrhosis, acute liver failure, hyperlipidemia, severe acute pancreatitis, sepsis, Guillain-Barré syndrome, obesity, phenylketonuria, mucopolysaccharidosis, hypoalkaline phosphataseemia, hereditary hyperammonemia, hyperuricemia, gout, hyperglycemia, ketoacidosis, and diabetes.

[0478] It should be understood that in clinical applications, the extracorporeal circulation metabolic system of this application can be used to change the concentration of specific molecules or combinations of molecules in a patient's body. However, for different types of diseases, the medical intervention required by the patient may include other means. For example, for patients with renal insufficiency, the medical device of this application can help achieve extracorporeal metabolism to remove pathogenic factors accumulated in the patient's body. However, at the same time, complications or comorbidities that may accompany renal insufficiency may include anemia, pyelonephritis, urinary tract diseases, etc. In this case, the medical device of this application can be used in combination with drugs and other treatment methods such as surgery, dietary care, etc. to jointly treat the disease.

[0479] In some embodiments, the medical device is used in combination with drugs for disease treatment. For example, the medical device of this application alters the concentration of specific molecules or combinations of molecules in a patient's body, such as reducing the concentration of specific molecules or generating specific molecules. Simultaneously, drug treatment is used in conjunction with the patient's disease treatment based on the medical device. The combined drugs may be, for example, drugs targeting disease complications, anticoagulants targeting extracorporeal circulation metabolism, vasoactive drugs targeting the disease itself, anti-infective drugs, or other disease treatment-related drugs. As long as the treatment device and drugs described in this application can independently treat the disease or benefit health, or the combined effect of both can achieve or achieve a better therapeutic effect.

[0480] This application also provides a computer-readable storage medium in a fifth aspect, storing at least one program. This at least one program, when invoked by a processor, executes and implements the fluid processing method as described in any embodiment of the embodiments provided in the first aspect of this application.

[0481] If the aforementioned functions are implemented as software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application.

[0482] In the embodiments provided in this application, the computer-readable and writable storage medium may include read-only memory, random access memory, EEPROM, CD-ROM or other optical disc storage devices, disk storage devices or other magnetic storage devices, flash memory, USB flash drive, portable hard drive, or any other medium capable of storing desired program code in the form of instructions or data structures and accessible by a computer. Additionally, any connection may be appropriately referred to as a computer-readable medium. For example, if instructions are transmitted from a website, server, or other remote source using coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of the medium. However, it should be understood that computer-readable and writable storage media and data storage media do not include connections, carrier waves, signals, or other transient media, but are intended for non-transient, tangible storage media. The disks and optical discs used in the application include compact discs (CDs), laser discs, optical discs, digital multifunction discs (DVDs), floppy disks, and Blu-ray discs, where disks typically copy data magnetically, while optical discs use lasers to copy data optically.

[0483] In one or more exemplary aspects, the functions described in the computer program of the fluid processing method of the first aspect of this application can be implemented in hardware, software, firmware, or any combination thereof. When implemented in software, these functions can be stored or transmitted as one or more instructions or code onto a computer-readable medium. The steps of the methods or algorithms disclosed in this application can be embodied in processor-executable software modules, wherein the processor-executable software modules can reside on a tangible, non-transitory computer-readable and writable storage medium. The tangible, non-transitory computer-readable and writable storage medium can be any available medium accessible to a computer.

[0484] The flowcharts and block diagrams in the foregoing figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of this application. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those indicated in the figures. For example, two consecutively indicated blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, can be implemented by a dedicated hardware-based system that performs the specified function or operation, or by a combination of dedicated hardware and computer instructions.

[0485] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this application should still be covered by the claims of this application.

Claims

1. A medical device, characterized in that, include: Piping systems include fluid outflow pipes connected to the human body to drain bodily fluids, and fluid return pipes for returning treated bodily fluids to the human body. A circulation processing system includes a circulation module connected to the piping system for adding body fluid to be treated into the circulation module to form a circulation; the treated body fluid leaving the circulation module during circulation, and a fluid reserve remaining in the circulation module; the total amount or rate of fluid introduced into the circulation module through the piping is equal to the total amount or rate of fluid leaving the circulation module; the circulation module contains free enzymes, free enzyme preparations, or free enzyme carriers that participate in the circulation along with the fluid reserve and are retained in the circulation, for selectively removing or generating specific molecules or combinations of molecules and preventing the free enzymes, free enzyme preparations, or free enzyme carriers from entering the human body; the body fluid to be treated includes blood and / or blood-derived fluids; The cyclic processing system includes: The second type of circulation module includes a first separation module, the first side of which is connected between the fluid outlet pipeline and the fluid return pipeline to form extracorporeal blood circulation; The first type of circulation module, connected to the second side of the first separation module via pipeline to form a circulation of blood-derived fluid, includes a second separation module and a catalytic unit that participates in the circulation along with the fluid balance and is retained in the circulation of the first type of circulation module by the second separation module. The catalytic unit is used to remove specific molecular components in the blood-derived fluid or generate preset reaction products, and then leads them out through the second separation module. The total amount or total rate of fluid introduced into the pipeline in the first type of circulation module is equal to the total amount or total rate of fluid leaving the first type of circulation module. The catalytic unit is a free enzyme, a free enzyme preparation, or a free enzyme carrier. The circulation module includes a tangential flow filtration module for retaining free enzymes, free enzyme preparations, or free enzyme carriers that participate in the circulation along with the remaining fluid, so as to prevent the free enzymes, free enzyme preparations, or free enzyme carriers from leaving the circulation; the tangential flow filtration module is the second separation module.

2. The medical device according to claim 1, characterized in that, The circulation module includes a collection device disposed in the circulation module and having a collection cavity, for mixing the fluid balance, free enzyme or free enzyme preparation or free enzyme carrier, and the body fluid to be treated in the circulation module, so that the free enzyme or free enzyme preparation or free enzyme carrier comes into contact with the target substance in the body fluid.

3. The medical device according to claim 1, characterized in that, The free enzyme, free enzyme preparation, or free enzyme carrier is an enzyme-carrying microsphere, an enzyme-carrying microcapsule, or a water-soluble macromolecule that binds to the enzyme.

4. The medical device according to claim 1, characterized in that, The circulation module is a metabolic circulation module.

5. The medical device according to claim 1, characterized in that, The circulation module is also equipped with an adsorption device for connecting to the pipeline.

6. The medical device according to claim 1, characterized in that, The circulation module is also equipped with a processing unit for regulating the activity of free enzymes, free enzyme preparations, or free enzyme carriers in the circulation.

7. The medical device according to claim 1, characterized in that, The circulation module is also equipped with a processing unit for controlling the type and total amount of free enzymes, free enzyme preparations, or free enzyme carriers in the circulation by adding, supplementing, or replacing them.

8. The medical device according to claim 1, characterized in that, The circulation module is also equipped with a sample addition device for adding, replenishing or replacing reaction substrates, drugs, or free enzymes, free enzyme preparations or free enzyme carriers into the pipeline.

9. The medical device according to claim 1, characterized in that, The medical device uses the tangential flow filtration module to trap harmful macromolecules in the body fluid under both macromolecular harmful and small molecule beneficial modes.

10. The medical device according to claim 1, characterized in that, The blood-derived fluid includes plasma, serum, hemodialysis fluid, or dialysis waste fluid.

11. The medical device according to claim 1, characterized in that, The blood-derived fluid drawn out through the second separation module is transported to the second side of the first separation module.

12. The medical device according to claim 1, characterized in that, The blood-derived fluid drawn out through the second separation module is collected in the fluid return pipeline.

13. The medical device according to claim 1, characterized in that, The blood-derived fluid drawn out through the second separation module is collected in the fluid outlet pipeline so that it can re-enter the first separation module.

14. The medical device according to claim 1, characterized in that, The first separation module includes a first separation component that is a porous membrane or a reverse osmosis membrane; the second separation module includes a second separation component that is a porous membrane or a reverse osmosis membrane; wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, and a nanofiltration membrane.

15. The medical device according to claim 14, characterized in that, The first separation component or the second separation component includes one or more of planar membranes, tubular membranes, spiral wound membranes, and hollow fiber membranes.

16. The medical device according to claim 1, characterized in that, The first separation module is a dialyzer or a plasma separator.

17. The medical device according to claim 1, characterized in that, It also includes at least one of the following: control device, fluid storage device, flow limiting device, flow rate detection device, pressure detection device, temperature detection device, temperature control device, oxygen detection device, bubble detection and removal device, alarm device, and concentration detection device.

18. The medical device according to claim 1, characterized in that, The medical equipment mentioned is a blood purification device, an extracorporeal circulation clearance system, an extracorporeal enrichment clearance device, a hemodialysis device, a plasma exchange device, an extracorporeal peritoneal dialysis device, or an extracorporeal membrane oxygenation device.

19. The medical device according to claim 1, characterized in that, The medical device is an extracorporeal circulation life support system grafted onto an artificial liver, artificial kidney, hemodialysis equipment, peritoneal dialysis equipment, plasma exchange equipment, plasma purification equipment, blood lipid purification equipment, molecular adsorption recirculation system, extracorporeal membrane oxygenation equipment, or leukocyte removal equipment.

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