A dialysis device and system

Abstract

The utility model discloses a kind of dialysis device and system, it is related to hemodialysis technical field, to solve the problem that dialysis membrane is easily contaminated in hemodialysis treatment process, the device includes dialyzer, blood port is respectively equipped on the end cover of dialyzer, four dialysate ports are equipped on shell;Blood side pipeline, including the first blood pipeline and the second blood pipeline of parallelly arranged, for respectively connecting two blood ports;Dialysate side pipeline, including the first dialysate pipeline and the second dialysate pipeline, for series connection four dialysate ports;Among them, the first blood pipeline, the second blood pipeline, the first dialysate pipeline and the second dialysate pipeline are equipped with three ways and switch device, and three ways are equipped between two switch devices, and switch device is used to switch the flow direction of blood and dialysate;So set, reverse flushing to dialyzer can be realized, effectively remove protein and other macromolecular substances attached on dialysis membrane, reduce membrane pollution.

Description

Technical Field

[0001] This utility model relates to the field of hemodialysis technology, and more specifically, to a dialysis device and system. Background Technology

[0002] Hemodialysis is an important renal replacement therapy for acute and chronic renal failure. Based on the transmembrane transport mechanism of a semipermeable membrane, it removes metabolic waste through diffusion and convection. Diffusion relies on the concentration gradient across the membrane and can efficiently remove small molecule toxins; convection relies on the transmembrane pressure difference and can effectively remove medium and large molecule toxins.

[0003] However, during routine hemodialysis, the blood is in continuous contact with the dialysis membrane. Substances such as fibrinogen, albumin, and platelets gradually adhere to the inner surface and pores of the membrane, causing membrane fouling. Membrane fouling primarily manifests as decreased dialysis flux and altered pore size. This not only significantly affects toxin removal but also increases transmembrane pressure. When transmembrane pressure abnormally increases beyond the membrane's tolerance limit, it can lead to membrane rupture, causing blood leakage or dialysate backflow, resulting in serious consequences such as infection and hemolysis. Simultaneously, membrane fouling also causes albumin loss, leading to hypoalbuminemia, which in turn can cause edema, malnutrition, decreased immunity, and may exacerbate inflammatory responses and cardiovascular risks.

[0004] Therefore, how to solve the problem of easy contamination of dialysis membranes during hemodialysis treatment is an urgent problem to be solved by those skilled in the art. Utility Model Content

[0005] In view of this, the purpose of this utility model is to provide a dialysis device that can realize the reverse flow of blood and dialysate, thereby backwashing the dialyzer to effectively remove proteins and other macromolecules attached to the dialysis membrane, reduce membrane fouling, and improve dialysis efficiency.

[0006] Another objective of this invention is to provide a dialysis system including the above-mentioned dialysis apparatus, which can reduce membrane fouling and improve dialysis efficiency and process safety.

[0007] To achieve the above objectives, this utility model provides the following technical solution:

[0008] A dialysis device, comprising:

[0009] A dialyzer includes a housing, a hollow fiber membrane bundle, and end caps. The end caps are provided with blood ports, and the housing is provided with four dialysate ports.

[0010] The blood-side tubing includes a first blood tubing and a second blood tubing arranged in parallel, for connecting two blood ports respectively;

[0011] The dialysate side tubing includes a first dialysate tubing and a second dialysate tubing, which are used to connect four dialysate ports in series;

[0012] The first blood line, the second blood line, the first dialysate line, and the second dialysate line are all equipped with a T-junction and a switch device, and a T-junction is provided between the two switch devices. The switch device is used to switch the flow direction of blood and dialysate.

[0013] Preferably, the four dialysate ports are symmetrically arranged on both sides of the housing, and the four dialysate ports are located at the two ends of the housing, respectively.

[0014] Preferably, the first blood line and the second blood line are connected to the blood port via a T-junction.

[0015] Preferably, the blood port is equipped with a regulating valve, which has three interfaces, which are respectively connected to the blood port, the first blood line, and the second blood line. The regulating valve is used to switch the blood flow path.

[0016] Preferably, the regulating valve is a plug valve.

[0017] Preferably, the switching device is one or more of a conduit stop clamp, a spring stop clamp, and a manual valve.

[0018] A dialysis system includes a dialysis apparatus and a dialysis machine as described in any of the preceding claims, the dialysis machine including a body and a blood pump, a dialysate inlet, and a dialysate outlet disposed on the body.

[0019] Preferably, it also includes a controller, and the switching device on the dialysis device is an automatic control valve. The controller is signal-connected to the automatic control valve and is used to control the opening and closing of the automatic control valve.

[0020] Preferably, the dialysis machine also includes a controller, and the switching device on the dialysis device is an automatic control valve. The controller is signal-connected to the automatic control valve and is used to control the opening and closing of the automatic control valve.

[0021] Preferably, the regulating valve on the dialysis device is a solenoid valve, and the controller is connected to the solenoid valve via a signal to control the opening and closing of the solenoid valve.

[0022] The dialysis device provided by this utility model includes a dialyzer, a blood-side tubing, a dialysate-side tubing, a three-way valve, and a switching device. Specifically, the dialyzer includes a shell, a hollow fiber membrane bundle, and end caps. The hollow fiber membrane bundle can efficiently diffuse and convection, removing small and medium-to-large molecular toxins from the blood. The end caps are respectively provided with blood ports, and the shell is provided with four dialysate ports. The blood-side tubing includes a first blood tubing and a second blood tubing arranged in parallel, used to connect the two blood ports respectively. The blood-side tubing is responsible for introducing blood into the dialyzer and drawing out the dialyzed blood. Through the parallel blood tubing, bidirectional blood flow can be achieved, which can reduce the adhesion of substances such as proteins in the blood to the dialysis membrane, thereby reducing membrane fouling and improving the dialysis effect.

[0023] The dialysate-side tubing includes a first dialysate tubing and a second dialysate tubing, which are used to connect four dialysate ports in series. The dialysate-side tubing is responsible for introducing dialysate into the dialyzer and drawing out the dialysate after dialysis. The series connection of the dialysate tubing ensures that the dialysate flows fully within the dialyzer, improving the utilization efficiency of the dialysate and reducing dialysate waste. The first blood tubing, the second blood tubing, the first dialysate tubing, and the second dialysate tubing are all equipped with a T-junction and a switching device, and a T-junction is provided between the two switching devices. The switching device is used to switch the flow direction of blood and dialysate to achieve reverse flow of blood and dialysate, thereby performing reverse flushing of the dialyzer. This reverse flushing can effectively remove proteins and other macromolecules attached to the dialysis membrane, reduce membrane fouling, and thus significantly reduce the increase in transmembrane pressure, avoiding the risk of membrane rupture due to high pressure, improving the dialysis effect and the safety of the process. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the dialysis device provided by the present invention;

[0026] Figure 2 for Figure 1 A schematic diagram of a flow path for a liquid in a medium.

[0027] Figure 3 for Figure 1 A schematic diagram of another flow path for the liquid in the middle;

[0028] Figure 4This is a schematic diagram of the structure of the dialysis device provided by this utility model connected to the dialysis machine;

[0029] Figure 5 for Figure 1 A schematic diagram of membrane fiber pressure;

[0030] Figure 6 This is a schematic diagram of the performance data of Embodiment 1 provided by this utility model;

[0031] Figure 7 This is a schematic diagram of the performance data of Embodiment 2 provided by this utility model.

[0032] Figure label:

[0033] 1-Dialyzer, 11-Shell, 12-Hollow fiber membrane bundle, 13-End cap;

[0034] 2-Blood port, 21-First port, 22-Second port;

[0035] 3-Dialysis fluid port, 31-First inlet, 32-Second inlet, 33-First outlet, 34-Second outlet;

[0036] 4-Blood side line, 41-First blood line, 42-Second blood line;

[0037] 5-Dialysis fluid side line, 51-First dialysis fluid line, 52-Second dialysis fluid line;

[0038] 6-Tee;

[0039] 7-Switch device, 71-First switch clamp, 72-Second switch clamp, 73-Third switch clamp, 74-Fourth switch clamp, 75-Fifth switch clamp, 76-Sixth switch clamp, 77-Seventh switch clamp, 78-Eighth switch clamp;

[0040] 8-Blood pump;

[0041] 9-dialysate inlet;

[0042] 10 - Dialysis fluid outlet. Detailed Implementation

[0043] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0044] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0045] The core of this invention is to provide a dialysis device that enables reverse flow of blood and dialysate, thereby backwashing the dialyzer 1 to effectively remove proteins and other macromolecules adhering to the dialysis membrane, reducing membrane fouling and improving dialysis efficiency. Another core aspect of this invention is to provide a dialysis system including the aforementioned dialysis device, which can reduce membrane fouling, improve dialysis efficiency, and enhance process safety.

[0046] Please refer to Figure 1 A dialysis device includes a dialyzer 1, a blood-side tubing 4, a dialysate-side tubing 5, a three-way valve 6, and a switching device 7.

[0047] Specifically, the dialyzer 1 includes a housing 11, a hollow fiber membrane bundle 12, and end caps 13. The hollow fiber membrane bundle 12 can efficiently diffuse and convection to remove small and medium-to-large molecular toxins from the blood. The end caps 13 are located at both ends of the housing 11, and each of the two end caps 13 has a blood port 2. The housing 11 has four dialysate ports 3. The blood-side pipeline 4 includes a first blood pipeline 41 and a second blood pipeline 42 connected in parallel, which are used to connect the two blood ports 2 respectively. The blood-side pipeline 4 is responsible for introducing blood into the dialyzer 1 and drawing out the dialyzed blood. Through the parallel blood pipelines, bidirectional blood flow can be achieved, which can reduce the adhesion of substances such as proteins in the blood to the dialysis membrane, thereby reducing membrane fouling and improving the dialysis effect.

[0048] The dialysate-side tubing 5 includes a first dialysate tubing 51 and a second dialysate tubing 52, which are used to connect four dialysate ports 3 in series. The dialysate-side tubing 5 is responsible for introducing dialysate into the dialyzer 1 and drawing out the dialysate after dialysis. The series-connected dialysate tubing ensures that the dialysate flows fully in the dialyzer 1, improving the utilization efficiency of the dialysate and reducing the waste of dialysate. The first blood tubing 41, the second blood tubing 42, the first dialysate tubing 51, and the second dialysate tubing 52 are all equipped with a tee 6 and a switching device 7, and a tee 6 is provided between the two switching devices 7. The switching device 7 is used to switch the flow direction of blood and dialysate to achieve reverse flow of blood and dialysate, thereby performing reverse flushing of the dialyzer 1. This reverse flushing can effectively remove proteins and other macromolecules attached to the dialysis membrane, reduce membrane fouling, and thus significantly reduce the increase of transmembrane pressure, avoid the risk of membrane rupture due to high pressure, and improve the dialysis effect and the safety of the process.

[0049] The dialysis device configured in the above manner enables reverse flushing of dialyzer 1 during treatment, reducing membrane fouling caused by blood contact with the dialysis membrane, improving solute clearance efficiency, and reducing transmembrane pressure rise.

[0050] Please refer to Figure 2 Four dialysate ports 3 are symmetrically arranged on both sides of the housing 11, and the four dialysate ports 3 are located at the two ends of the housing 11 respectively.

[0051] It should be noted that the housing 11 has four dialysate ports 3 symmetrically arranged. One side has a first dialysate inlet 31 and a second dialysate inlet 32, and the other side has a first dialysate outlet 33 and a second dialysate outlet 34. The first dialysate inlet 31 and the second dialysate inlet 32 ​​are connected by a first dialysate conduit 51, and the first dialysate outlet 33 and the second dialysate outlet 34 are connected by a second dialysate conduit 52. A fifth switch clamp 75 and a sixth switch clamp 76 are distributed on the first dialysate conduit 51, and a seventh switch clamp 77 and an eighth switch clamp 78 are distributed on the second dialysate conduit 52, which can control the dialysate flow path. In practical applications, the four dialysate ports 3 do not necessarily need to be symmetrical; as long as dialysate can flow in from one end and out from the other end, it is acceptable.

[0052] The four dialysate ports 3 are symmetrically arranged on both sides of the housing 11 and located at both ends of the housing 11. This design ensures that the dialysate can flow into and out of the dialyzer 1 evenly, which improves the utilization efficiency of the dialysate, reduces the waste of dialysate, reduces the turbulence of dialysate in the dialyzer 1, reduces the mechanical impact on the dialysis membrane, and extends the service life of the dialysis membrane.

[0053] Furthermore, the blood ports 2 on the end cap 13 are a first port 21 and a second port 22, which are connected through a first blood conduit 41 and a second blood conduit 42. The first blood conduit 41 is provided with a first switch clamp 71 and a second switch clamp 72, and the second blood conduit 42 is provided with a third switch clamp 73 and a fourth switch clamp 74 for controlling the blood flow path.

[0054] During treatment, open the second switch clamp 72 on the first blood line 41 and the third switch clamp 73 on the second blood line 42; close the first switch clamp 71 on the first blood line 41 and the fourth switch clamp 74 on the second blood line 42; open the fifth switch clamp 75 on the first dialysate line 51 and the eighth switch clamp 78 on the second dialysate line 52; and close the sixth switch clamp 76 on the first dialysate line 51 and the seventh switch clamp 77 on the second dialysate line 52. Blood and dialysate are respectively... Figure 3 The flow proceeds in the direction indicated by the middle arrow. During this process, proteins in the inner wall of the membrane filaments and pores near the second port 22 are adsorbed onto the dialysis membrane. After running for a period of time, the second switch clamp 72 and the third switch clamp 73 on the already opened blood-side pipeline 4, and the fifth switch clamp 75 and the eighth switch clamp 78 on the dialysate-side pipeline 5 are simultaneously closed. The first switch clamp 71 and the fourth switch clamp 74 on the currently closed blood-side pipeline 4, and the sixth switch clamp 76 and the seventh switch clamp 77 on the dialysate-side pipeline 5 are then opened. At this time, blood and dialysate flow in different directions. Figure 2 The flow direction indicated by the middle arrow is cross-flow. During this process, proteins in the inner wall of the membrane fibers and pores near the second port 22 are flushed out through transmembrane transport of the dialysate, achieving the purpose of flushing the membrane fibers. Simultaneously, proteins and other substances gradually adhere near the first port 21, reducing membrane permeability and effectiveness. Then, at regular intervals, the flow directions of blood and dialysate are changed to maintain a constant cross-flow, repeatedly flushing the filter, reducing membrane fouling, and improving the effectiveness of dialysis treatment.

[0055] In the above embodiment, the first blood line 41 and the second blood line 42 are connected to the blood port 2 via a tee 6. One end of the first blood line 41 and the second blood line 42 are connected to the blood port 2 on one of the end caps 13 via a tee 6, and the other end of the first blood line 41 and the second blood line 42 are connected to the blood port 2 on the other end cap 13 via a tee 6. This design allows blood to flow bidirectionally within the dialyzer 1, thereby reducing the adhesion of substances such as proteins in the blood to the dialysis membrane, thus reducing membrane fouling and improving dialysis efficiency.

[0056] In practical applications, a regulating valve can also be installed directly at blood port 2. This regulating valve can be a stopcock valve with three interfaces: one interface connects to the first blood line 41, one interface connects to the second blood line 42, and the other interface connects to blood port 2 of the dialyzer. The handle of the stopcock valve can be manually operated to switch between the first blood line 41 and the second blood line 42. Specifically, rotating the handle of the stopcock valve connects one end of the first blood line 41 to the first port 21 and one end of the second blood line 42 to the second port 22. When it is necessary to switch the blood flow direction, manually rotating the handle of the stopcock valve connects the other end of the first blood line 41 to the second port 22 and the other end of the second blood line 42 to the first port 21. During use, the switching operation can be performed periodically according to the needs of dialysis treatment to achieve bidirectional blood flow, reduce membrane fouling, and improve dialysis efficiency. At this time, a switching device 7 can be installed on the first blood line 41 and the second blood line 42, or it can be omitted; there is no restriction on this.

[0057] In one feasible implementation, the switching device 7 is configured as one or more of a conduit stop clamp, a spring stop clamp, and a manual valve.

[0058] It should be noted that the switching device 7 is used to control the flow direction of blood and dialysate, ensuring that the flow of fluid can be completely blocked when necessary. The catheter stop clamp, spring stop clamp, and manual valve provide reliable flow control, ensuring that no fluid leakage occurs during dialysis and improving the safety of the dialysis process. The catheter stop clamp and spring stop clamp are simple in design and easy to operate, allowing medical staff to easily control the flow of fluid, reducing operation time and effort and improving work efficiency. The manual valve can specifically be a shut-off valve; there are no restrictions on its application.

[0059] In the above cases, the filling rate of the hollow fiber membrane bundle 12 is 20%-80%.

[0060] Understandably, the hollow fiber membrane bundle 12 is sealed within the housing 11 with sealant, and the filling rate is 20%-80%, more preferably 40%-70%. A filling rate of 20%-80% for the hollow fiber membrane bundle 12 ensures sufficient membrane surface area within the dialyzer 1 for the exchange of substances between blood and dialysate. Within this filling rate range, the hollow fiber membrane bundle 12 provides sufficient surface area for efficient diffusion and convection, removing small and medium-to-large molecular weight toxins from the blood and improving dialysis efficiency. A reasonable filling rate reduces transmembrane pressure fluctuations during dialysis, improves the stability of the dialysis process, reduces the risk of dialysis membrane rupture, and enhances the safety of the dialysis process. Different filling rates can be selected based on the patient's specific condition to optimize dialysis effects and improve the personalization and adaptability of treatment.

[0061] Furthermore, the housing 11 is a plastic structure formed by one-time injection molding.

[0062] It should be noted that the housing 11 is made of a one-piece injection-molded plastic structure, such as polypropylene (PP) or polycarbonate (PC), ensuring the integrity and robustness of the housing 11. The one-piece injection-molded plastic structure has a uniform material distribution and high mechanical strength, capable of withstanding the pressure and mechanical stress generated during dialysis, ensuring the stable operation of the dialyzer 1. The one-piece molded housing 11 reduces seams and connection points, lowering the risk of fluid leakage due to manufacturing defects or wear during use, and improving the safety of the dialysis process. The housing 11 is manufactured using medical-grade plastic materials (such as PP and PC), which have good biocompatibility and will not cause adverse reactions in patients. Medical-grade plastic materials can reduce the adhesion of bacteria and microorganisms, lowering the risk of infection and ensuring the hygiene and safety of the dialysis process. The one-piece injection molding process reduces manufacturing costs and improves production efficiency.

[0063] In the above embodiments, the blood-side tubing 4 and the dialysate-side tubing 5 are polyvinyl chloride (PVC) tubing.

[0064] Understandably, polyvinyl chloride (PVC) tubing has good biocompatibility, will not contaminate blood or dialysate, and will not cause adverse reactions in patients. PVC material reduces the adhesion of bacteria and microorganisms, lowering the risk of infection and ensuring the hygiene and safety of the dialysis process. The good transparency of PVC tubing allows healthcare personnel to directly observe the flow of blood and dialysate during dialysis, enabling timely detection and handling of any abnormalities, thus improving the safety and reliability of the dialysis process. PVC tubing is also relatively inexpensive, readily available, and easy to process, reducing the overall cost of the dialysis device.

[0065] Please refer to Figure 4 A dialysis system includes a dialysis apparatus and a dialysis machine as described above. The dialysis machine includes a body and a blood pump 8, a dialysate inlet 9, and a dialysate outlet 10 disposed on the body.

[0066] As a feasible implementation, the dialysis system also includes a controller, and the switching device 7 on the dialysis device is an automatic control valve. The controller is signal-connected to the automatic control valve and is used to control the opening and closing of the automatic control valve.

[0067] Understandably, before treatment, medical staff still select a dialyzer 1 with an appropriate membrane area based on the patient's dry weight. After completing the pre-treatment preparations, the dialysis device is connected to the dialysis machine. The controller controls the switching device 7, which precisely controls the opening and closing of the automatic control valves, thereby automatically switching the flow direction of blood and dialysate. The dialysis machine precisely controls the blood flow and pressure to ensure a stable dialysis process. Precise control of blood flow and pressure optimizes dialysis results, improves solute removal efficiency, and shortens dialysis time. Precise control reduces risks caused by abnormal flow or pressure, such as dialysis membrane rupture and blood leakage, improving the safety of the dialysis process. Simultaneously, it can monitor various parameters during the dialysis process in real time, such as pressure and flow, and issue alarms in abnormal situations. This allows for timely detection and handling of abnormalities during dialysis, reducing the occurrence of complications and improving the safety of the dialysis process. In this embodiment, the number and location of the automatic control valves can be referenced... Figure 1 The setting method of the switch clip and the operating principle of the switch device 7 are described in the reference section. Figure 2 and Figure 3 This will not be elaborated upon here.

[0068] As a feasible implementation, the dialysis machine also includes a controller. The switching device 7 on the dialysis unit is an automatic control valve. The controller is signal-connected to the automatic control valve and is used to control the opening and closing of the automatic control valve. Through the controller's precise control of the opening and closing of the automatic control valve, as well as the degree of opening and closing, the automated control reduces human error and improves the stability and reliability of the dialysis process. Integrating the controller into the dialysis machine, this integrated design makes the dialysis process more automated and intelligent, reduces the number of steps for medical staff, and improves work efficiency. In this embodiment, the number and location of the automatic control valves can be referenced... Figure 1 The setting method of the switch clip and the operating principle of the switch device 7 are described in the reference section. Figure 2 and Figure 3 This will not be elaborated upon here.

[0069] Furthermore, with a controller installed, a solenoid valve can be directly installed at blood port 2. This solenoid valve has three interfaces: one interface connects to the first blood line 41, one interface connects to the second blood line 42, and the other interface connects to blood port 2 of the dialyzer. The solenoid valve is signal-connected to the dialyzer's controller, which can automatically control the switching of the solenoid valve according to a preset program, thereby switching between the first blood line 41 and the second blood line 42. Specifically, the controller controls the solenoid valve to connect one end of the first blood line 41 to the first port 21 and one end of the second blood line 42 to the second port 22. When it is necessary to switch the blood flow direction, the controller sends a signal, and the solenoid valve automatically switches, connecting the other end of the first blood line 41 to the second port 22 and the other end of the second blood line 42 to the first port 21. During use, the controller automatically performs the switching operation according to a preset time interval (such as every 30 minutes or 60 minutes), achieving bidirectional blood flow, reducing membrane fouling, and improving dialysis efficiency. At this time, a switch device 7 can be installed on the first blood line 41 and the second blood line 42. The number and location of the switch devices 7 can be referenced. Figure 1 The setting method of the switch clip and the operating principle of the switch device 7 are described in the reference section. Figure 2 and Figure 3 This will not be elaborated on here, and it is optional to leave it unset; there are no restrictions on this.

[0070] In a preferred embodiment, the blood-side tubing 4 of the dialysis device is connected to the blood pump 8 via the blood supply tubing, and the dialysate-side tubing 5 of the dialysis device is connected to the dialysate inlet 9 and the dialysate outlet 10 via the liquid supply tubing and the return tubing, respectively.

[0071] It should be noted that the blood-side tubing 4 of the dialysis unit is connected to the blood pump 8 via the supply line, and the dialysate-side tubing 5 is connected to the dialysate inlet 9 and the dialysate outlet 10 via the supply line and return line, respectively. This ensures smooth flow of blood and dialysate, efficient flow of blood and dialysate during dialysis, reduces flow resistance, and improves dialysis efficiency. Connecting the blood pump 8 via the supply line allows for precise control of blood flow and pressure, ensuring stable dialysis. The dialysate-side tubing 5, connected to the dialysate inlet 9 and the dialysate outlet 10 via the supply line and return line, ensures unidirectional flow of the dialysate, reducing the risk of contamination.

[0072] In the above situation, both the blood supply line and the fluid supply line are equipped with pressure detection devices and flow detection devices for real-time monitoring of the pressure and flow rate within the lines.

[0073] Understandably, both the blood supply line and the fluid supply line are equipped with pressure and flow detection devices. These devices can monitor the pressure and flow rate within the lines in real time and transmit the data to the dialysis machine. Based on the real-time pressure and flow data, the dialysis machine can precisely control the flow rate of blood and dialysate, ensuring the stability and consistency of the dialysis process, improving solute removal efficiency, shortening dialysis time, and enhancing patient treatment outcomes.

[0074] During treatment, the blood side and the dialysate side are subjected to, for example... Figure 5 The influence of pressure is illustrated by the line x representing the length of dialyzer 1 (x=0 being the blood inlet). The two lines represent the pressures on the blood and dialysate sides at different locations. When the pressure difference between the two sides is zero (x=x0), the fluid flow direction changes: at x<x0, the pressure on the blood side is greater than that on the dialysate side, and the fluid is mainly transported across the membrane from the blood side to the dialysate side; at x>x0, the pressure on the dialysate side is greater than that on the blood side, and the fluid is mainly transported across the membrane from the dialysate side to the blood side. Therefore, membrane fouling mainly occurs in the blood inlet direction, where proteins and other substances in the blood preferentially contact the dialysis membrane, resulting in more severe membrane fouling. However, in the blood outlet direction, the fluid mainly flows from the dialysate side across the membrane to the blood side, effectively flushing the hollow fiber membrane pores and inner surface, significantly reducing membrane fouling at this location.

[0075] The membrane fouling process exhibits distinct phases: in the initial stage of system operation (usually the first 30 minutes), the membrane fouling rate is rapid, and the degree of fouling is significantly aggravated; as the operating time increases, the fouling rate gradually slows down, eventually reaching a dynamic equilibrium. During treatment, the second switch clamp 72 and the third switch clamp 73 on the blood-side line 4 are opened, the first switch clamp 71 and the fourth switch clamp 74 are closed, and the eighth switch clamp 78 and the fifth switch clamp 75 on the dialysate-side line 5 are opened, while the seventh switch clamp 77 and the sixth switch clamp 76 are closed. Blood and dialysate are respectively... Figure 3 The flow proceeds in the direction indicated by the middle arrow. During this process, proteins in the inner wall of the membrane filaments and the membrane pores near the second port 22 are adsorbed onto the dialysis membrane. After running for a period of time, preferably 30 minutes, the second switch clamp 72 and the third switch clamp 73 on the already opened blood-side pipeline 4, and the eighth switch clamp 78 and the fifth switch clamp 75 on the dialysate-side pipeline 5 are simultaneously closed. Meanwhile, the first switch clamp 71 and the fourth switch clamp 74 on the currently closed blood-side pipeline 4, and the seventh switch clamp 77 and the sixth switch clamp 76 on the dialysate-side pipeline 5 are opened. At this time, blood and dialysate flow in different directions. Figure 2The flow direction indicated by the middle arrow is cross-flow. During this process, proteins in the inner wall of the membrane fibers and pores near the second port 22 are flushed out through transmembrane transport of the dialysate, achieving the purpose of flushing the membrane fibers. Simultaneously, proteins and other substances gradually adhere near the first port 21, reducing membrane permeability and effectiveness. Then, at regular intervals, the flow directions of blood and dialysate are changed to maintain a constant cross-flow, repeatedly flushing the filter, reducing membrane fouling, and improving the efficacy of dialysis treatment. This treatment addresses the problem of decreased membrane fiber permeability and effectiveness caused by membrane fouling, improves the removal of toxins and solutes, reduces transmembrane pressure alarms, avoids albumin loss, and enhances treatment safety and effectiveness.

[0076] In addition to the dialysis machines disclosed in the above embodiments, the structures of other parts of the dialysis machine are described in the prior art and will not be repeated here.

[0077] Example 1

[0078] Please refer to Figure 6 Under in vitro conditions, the dialysis device was connected to the dialysis machine and a pressure gauge was connected. Pig blood was used as the simulated fluid, and the blood flow rate QB = 200 mL / min, dialysate flow rate QD = 500 mL / min, and dehydration rate QF = 10 mL / min were set. After dialysis preparation, the patient was connected, and the direction of operation was changed every 30 minutes. Transmembrane pressure was monitored at 15 min, 45 min, 105 min, and 235 min of dialysis. The water flux of dialyzer 1 was tested before the test and after 240 min of operation (after the test). Under the same operating and testing conditions, and using existing technology as a comparison, dialyzer 1 with the same membrane material and membrane area as dialyzer 1 in the dialysis device was connected to the dialysis machine for data monitoring and comparison.

[0079] Example 2

[0080] Please refer to Figure 7 Under in vitro conditions, the dialysis device was connected to the dialysis machine, and a pressure gauge was connected. Pig blood was used as the simulated fluid, and the blood flow rate QB = 200 mL / min, dialysate flow rate QD = 500 mL / min, and dehydration rate QF = 10 mL / min were set. After dialysis preparation, the patient was connected, and the operating direction was changed every 60 minutes. Transmembrane pressure was monitored at 15 min, 45 min, 105 min, and 235 min of dialysis. The water flux of dialyzer 1 was tested before the test and after 240 min of operation (after the test). Under the same operating and testing conditions, and using existing technology as a comparison, dialyzer 1 with the same membrane material and membrane area as dialyzer 1 in the dialysis device was connected to the dialysis machine for data monitoring and comparison.

[0081] The performance of dialyzer 1 in the dialysis apparatus was compared with that of dialyzer 1 in the prior art. Before the test, the water flux values ​​of the two were basically the same. During the simulated operation, when the dialysis apparatus did not change its operating direction (comparison of 15 min TMP values ​​in specific embodiment one, and 15 and 30 min TMP values ​​in specific embodiment two), the transmembrane pressure (TMP) of the two apparatuses showed a similar upward trend, indicating that the degree of membrane floc fouling was similar. However, after the dialysis apparatus changed its operating direction, its TMP decreased significantly, indicating that the contaminants on the membrane were effectively removed and the membrane permeability was restored. By the end of the operation (235 minutes), the TMP value of the dialysis apparatus was much lower than that of dialyzer 1, proving that the device can significantly reduce the impact of membrane fouling.

[0082] Water flux test results further validated this conclusion: after the test, the water flux of dialyzer 1 in the prior art decreased significantly compared to before the test, while the water flux of dialyzer 1 in the dialysis device only decreased slightly. These data fully demonstrate that the dialysis device described in this technology can effectively control membrane fouling and significantly improve the operating efficiency of dialyzer 1.

[0083] In summary, the dialysis device provided by this invention cleverly achieves the reverse flushing function of dialyzer 1 during treatment, effectively reducing membrane fouling caused by blood contact with the dialysis membrane, significantly improving solute removal efficiency, and successfully suppressing the tendency of transmembrane pressure to rise. By simply operating the switching device 7, the reverse flow of blood and dialysate can be achieved, thereby repeatedly flushing the dialysis membrane. This process requires no introduction of additional solvents, no interruption of dialysis treatment, and no disruption of the entire closed system. It not only significantly improves mass transfer during dialysis but also avoids other potential safety issues, providing patients with a safer, more efficient, and economical dialysis treatment option.

[0084] It should be noted that in this specification, relational terms such as first and second are used only to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities.

[0085] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0086] The dialysis device and system provided by this utility model have been described in detail above. Specific examples have been used to illustrate the principle and implementation of this utility model. The descriptions of the embodiments above are only for the purpose of helping to understand the method and core idea of ​​this utility model. It should be noted that for those skilled in the art, several improvements and modifications can be made to this utility model without departing from the principle of this utility model, and these improvements and modifications also fall within the protection scope of this utility model.

Claims

1. A dialysis device, characterized in that, include: The dialyzer (1) includes a housing (11), a hollow fiber membrane bundle (12) and an end cap (13). The end cap (13) is provided with a blood port (2) and the housing (11) is provided with four dialysate ports (3). The blood side pipeline (4) includes a first blood pipeline (41) and a second blood pipeline (42) arranged in parallel, for connecting the two blood ports (2) respectively. The dialysate side line (5) includes a first dialysate line (51) and a second dialysate line (52), which are used to connect the four dialysate ports (3) in series. The first blood line (41), the second blood line (42), the first dialysate line (51) and the second dialysate line (52) are each provided with a tee (6) and a switch device (7), and the tee (6) is provided between the two switch devices (7). The switch device (7) is used to switch the flow direction of blood and dialysate.

2. The dialysis apparatus according to claim 1, characterized in that, The four dialysate ports (3) are symmetrically arranged on both sides of the housing (11), and the four dialysate ports (3) are respectively located at both ends of the housing (11).

3. The dialysis apparatus according to claim 1, characterized in that, The first blood line (41) and the second blood line (42) are connected to the blood port (2) through the tee (6).

4. The dialysis apparatus according to claim 1, characterized in that, The blood port (2) is equipped with a regulating valve, which has three interfaces. The three interfaces are respectively connected to the blood port (2), the first blood line (41), and the second blood line (42). The regulating valve is used to switch the blood flow path.

5. The dialysis apparatus according to claim 4, characterized in that, The regulating valve is a plug valve.

6. The dialysis apparatus according to claim 1, characterized in that, The switching device (7) is one or more of the following: a conduit stop clamp, a spring stop clamp, and a manual valve.

7. A dialysis system, characterized in that, The dialysis apparatus and dialysis machine as described in any one of claims 1-6, wherein the dialysis machine includes a body and a blood pump (8), a dialysate inlet (9), and a dialysate outlet (10) disposed on the body.

8. The dialysis system according to claim 7, characterized in that, It also includes a controller, and the switching device (7) on the dialysis device is an automatic control valve. The controller is signal-connected to the automatic control valve and is used to control the opening and closing of the automatic control valve.

9. The dialysis system according to claim 7, characterized in that, The dialysis machine also includes a controller, and the switching device (7) on the dialysis device is an automatic control valve. The controller is signal-connected to the automatic control valve and is used to control the opening and closing of the automatic control valve.

10. The dialysis system according to claim 8 or 9, characterized in that, The regulating valve on the dialysis device is a solenoid valve, and the controller is signal-connected to the solenoid valve to control the opening and closing of the solenoid valve.

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