Blood purification pipeline flushing device and flushing method

Abstract

The application discloses a blood purification pipeline flushing device and a flushing method. The flushing device comprises a first liquid storage tank for storing flushing liquid 1, a second liquid storage tank for storing flushing liquid 2, a third liquid storage tank for storing flushing liquid 3, and a waste liquid tank. The blood purification pipeline is sequentially flushed with the flushing liquid 1, the flushing liquid 2 and the flushing liquid 3. The absorbance value of the circulating flushing liquid 1 is detected. If the absorbance value is greater than a preset absorbance threshold value, the flushing of the flushing liquid 1 is stopped, and the blood purification pipeline is circularly flushed with the flushing liquid 2. After a set time of circular flushing, the blood purification pipeline is flushed with the flushing liquid 3. The PH value of the flushing liquid 3 flowing out of the blood purification pipeline is detected. If the PH value is 6.5-7.0, the flushing is completed. The blood purification pipeline is flushed with specific flushing liquid in a specific order, which can block the dissolution of organic harmful substances such as DEHP and epoxy soybean oil, reduce the opportunity of harmful dissolved substances in the pipeline product entering the human body, and has good flushing effect.

Description

Technical Field

[0001] This invention belongs to the field of medical equipment technology, specifically relating to a blood purification pipeline flushing device and flushing method. Background Technology

[0002] Blood purification tubing is the pathway for blood or other fluids during blood purification treatment, coming into direct or indirect contact with the body's blood. Common blood purification tubing is primarily made of polyvinyl chloride (PVC), and plasticizers (such as DEHP) and stabilizers (such as epoxidized soybean oil) are often added to the raw materials to improve its processing performance and product flexibility. Due to the presence of plasticizers, stabilizers, and other substances in the raw materials, plasticizers, stabilizers, and other harmful substances may leach out of the blood purification tubing before and during use.

[0003] To reduce the potential presence of foreign objects, particles, and other harmful substances in the blood purification tubing, it is pre-flushed with saline solution before clinical use. However, saline solution is a highly polar solvent, capable of removing only inorganic substances, highly polar substances, and substances with poor adhesion to the inner surface of the tubing. It has limited ability to remove organic substances such as DEHP and epoxidized soybean oil that precipitate from the tubing surface. Human blood, on the other hand, possesses both polar and non-polar solvent properties; therefore, the likelihood of harmful organic substances such as DEHP and epoxidized soybean oil entering the body during treatment is relatively high.

[0004] The "Guiding Principles for Technical Review of Registration of Single-Use Hemodialysis Tubing" (No. 146 of 2016) stipulates that for blood purification tubing made of DEHP-plasticized polyvinyl chloride as raw material, a suitable extraction solution (such as 46% ethanol-water) can be used to simulate the most stringent clinical use conditions (such as a flow rate of 200 mL / min and a circulation of 37°C for 5.5 hours) to detect the total amount of DEHP dissolved. However, the above method has a long extraction time for DEHP and the equipment and operation process are relatively complex. Summary of the Invention

[0005] The purpose of this invention is to provide a blood purification tubing flushing device that can effectively remove organic harmful substances from blood purification tubing and has a good flushing effect.

[0006] Another objective of this invention is to provide a blood purification tubing flushing method that provides good flushing effect and can effectively remove organic harmful substances from blood purification tubing, thereby minimizing the chance of harmful leaching substances from blood purification tubing products entering the human body.

[0007] To achieve the aforementioned primary objective, the present invention adopts the following technical solution:

[0008] A blood purification tubing flushing device includes: a liquid storage unit, comprising a first liquid storage tank for storing flushing solution ①, a second liquid storage tank for storing flushing solution ②, a third liquid storage tank for storing flushing solution ③, and a waste liquid tank, wherein the liquid storage unit sequentially provides flushing solution ①, flushing solution ②, and flushing solution ③ to flush the blood purification tubing; a flushing solution inlet pipe and a flushing solution outlet pipe connected to the blood purification tubing; and a detection unit, comprising a flow meter, a pH meter, and an ultraviolet spectrophotometer, wherein the pH meter is equipped with... The system includes: a circulating pump that provides driving force for the liquid in the pipeline; a heater that heats the liquid in the pipeline; a first storage tank that inputs flushing liquid ① into the flushing liquid inlet pipe, and flushing liquid ① can flow back to the first storage tank through the flushing liquid outlet pipe; a second storage tank that inputs flushing liquid ② into the flushing liquid inlet pipe, and flushing liquid ② can flow back to the second storage tank through the flushing liquid outlet pipe; and a third storage tank that inputs flushing liquid ③ into the flushing liquid inlet pipe, and flushing liquid ③ can flow to the waste liquid tank through the flushing liquid outlet pipe.

[0009] As described above, in the blood purification tubing flushing device, optionally, the first liquid storage tank includes a storage chamber and a return chamber. The first liquid storage tank is connected to the flushing fluid inlet pipe via a first outlet branch pipe and a second outlet branch pipe, and to the flushing fluid outlet pipe via a first return branch pipe. The storage chamber of the first liquid storage tank is connected to the first outlet branch pipe, and the return chamber of the first liquid storage tank is connected to the second outlet branch pipe and the first return branch pipe. The first outlet branch pipe and the second outlet branch pipe are selectively connected to the flushing fluid inlet pipe. The ultraviolet spectrophotometer is mounted on the first return branch pipe. The second... The storage tank includes a storage chamber and a return chamber. The second storage tank is connected to the flushing fluid inlet pipe via a third and a fourth outlet branch pipe, and to the flushing fluid outlet pipe via a second return branch pipe. The storage chamber of the second storage tank is connected to the third outlet branch pipe, and the return chamber of the second storage tank is connected to the fourth outlet branch pipe and the second return branch pipe. The third and fourth outlet branch pipes are selectively connected to the flushing fluid inlet pipe. The third storage tank is connected to the flushing fluid inlet pipe via a fifth outlet branch pipe. The waste liquid tank is connected to the flushing fluid outlet pipe via a waste liquid collection branch pipe.

[0010] Optionally, in the blood purification tubing flushing device described above, the first and second outlet branches are connected to the flushing fluid inlet pipe via a first three-way valve, and the third and fourth outlet branches are connected to the flushing fluid inlet pipe via a second three-way valve; and / or, a first pipeline control valve is provided on the first return branch, a second pipeline control valve is provided on the second return branch, a third pipeline control valve is provided on the fifth outlet branch, and a fourth pipeline control valve is provided on the waste fluid collection branch.

[0011] Optionally, in the blood purification tubing flushing device described above, the first storage tank is divided into an independent storage chamber and a return chamber by a partition, and the second storage tank is divided into an independent storage chamber and a return chamber by a partition.

[0012] Optionally, in the blood purification tubing flushing device described above, a spiral water-drawing coil is provided inside the liquid storage chamber, with the inlet of the spiral water-drawing coil located at the bottom of the liquid storage chamber and the outlet located at the upper part of the liquid storage chamber, connected to the outlet branch pipe; and / or, a heater and a temperature sensor are provided on the flushing fluid inlet pipe.

[0013] To achieve the second objective mentioned above, the present invention adopts the following technical solution:

[0014] A method for flushing blood purification tubing, using the aforementioned blood purification tubing flushing device, includes the following steps:

[0015] Add flushing solution ① to the first storage tank, flushing solution ② to the second storage tank, and flushing solution ③ to the third storage tank. Flushing solution ① is an alkaline solution containing an organic solvent, flushing solution ② is a weakly acidic solution, and flushing solution ③ is sterile water. After connecting the blood purification tubing to be flushed...

[0016] S1. Use flushing solution ① to circulate and flush the blood purification tubing. After the set flushing time, use an ultraviolet spectrophotometer to detect the absorbance value of the flushing solution ①. If the measured absorbance value is greater than the preset absorbance threshold, stop flushing with flushing solution ① and proceed to step S2. Otherwise, continue to circulate and flush until the measured absorbance value is greater than the preset absorbance threshold.

[0017] S2. Use flushing solution ② to circulate and flush the blood purification tubing; after the set flushing time, proceed to step S3.

[0018] S3. Use flushing solution ③ to flush the blood purification tubing;

[0019] S4. Detect the pH value of the flushing solution ③ flowing out of the blood purification tubing. If the detected pH value is 6.5 to 7.0, the tubing flushing is completed. Otherwise, continue flushing with flushing solution ③ until the pH value reaches 6.5 to 7.0, then stop flushing.

[0020] A method for flushing blood purification tubing, using the aforementioned blood purification tubing flushing device, includes the following steps:

[0021] Add flushing solution ① to the first storage tank, flushing solution ② to the second storage tank, and flushing solution ③ to the third storage tank. After connecting the blood purification tubing to be flushed,

[0022] S1. Flush the blood purification tubing with flushing solution ①:

[0023] S101. Use flushing solution ① for initial flushing. Connect the flushing solution ① in the storage chamber of the first storage tank to the flushing solution inlet pipe to flush the blood purification pipeline. After flushing, the flushing solution ① flows back to the return chamber of the first storage tank. The flow meter continuously detects the flow rate of the flushing solution ①.

[0024] S102. Use flushing fluid ① for cyclic flushing. When the flow meter detects that the flow rate of flushing fluid ① has reached the preset volume of flushing fluid, connect the flushing fluid ① in the return chamber of the first storage tank to the flushing fluid inlet pipe to repeatedly cyclic flush the blood purification pipeline. After the set time of cyclic flushing, use the ultraviolet spectrophotometer to detect the absorbance value of flushing fluid ①. If the measured absorbance value is greater than the preset absorbance threshold, stop flushing with flushing fluid ① and proceed to step S2. Otherwise, continue cyclic flushing until the measured absorbance value is greater than the preset absorbance threshold.

[0025] During the rinsing process, the second storage tank, the third storage tank, and the waste tank are not connected to the rinsing fluid inlet pipe and the rinsing fluid outlet pipe.

[0026] S2. Flush the blood purification tubing with flushing solution ②:

[0027] S201. The first flush is performed using flushing fluid ②. The flushing fluid ② in the storage chamber of the second storage tank is connected to the flushing fluid inlet pipe to flush the blood purification pipeline. The flushed flushing fluid ② is returned to the return chamber of the second storage tank. The flow meter continuously detects the flow rate of the flushing fluid ②.

[0028] S202. Use flushing fluid ② for circulating flushing. When the flow meter detects that the flow rate of flushing fluid ② has reached the preset volume of flushing fluid, connect the flushing fluid ② returned from the return chamber of the second storage tank to the flushing fluid inlet pipe to repeatedly circulate and flush the blood purification pipeline. After the set time of circulating flushing, proceed to step S3.

[0029] During the rinsing process, the first storage tank, the third storage tank, and the waste tank are not connected to the rinsing fluid inlet pipe and the rinsing fluid outlet pipe.

[0030] S3. Use flushing solution ③ to flush the blood purification pipeline. Connect the flushing solution ③ in the third storage tank to the flushing solution inlet pipe to flush the blood purification pipeline. The flushing solution outlet pipe is connected to the waste liquid tank. The flushed flushing solution ③ flows into the waste liquid tank.

[0031] During the rinsing process, neither the first storage tank nor the second storage tank is connected to the rinsing fluid inlet pipe or the rinsing fluid outlet pipe;

[0032] S4. Detect the pH value of the flushing solution ③ flowing out of the blood purification tubing. If the detected pH value is 6.5 to 7.0, the tubing flushing is completed. Otherwise, continue flushing with flushing solution ③ until the pH value reaches 6.5 to 7.0, then stop flushing.

[0033] A method for flushing blood purification tubing, comprising the following steps:

[0034] S1. Use flushing solution ① to circulate and flush the blood purification tubing. The flushing solution ① is an alkaline solution containing organic solvent. After the set flushing time, use an ultraviolet spectrophotometer to detect the absorbance value of the flushing solution ①. If the measured absorbance value is greater than the preset absorbance threshold, stop flushing with flushing solution ① and proceed to step S2. Otherwise, continue the circulation and flushing until the measured absorbance value is greater than the preset absorbance threshold.

[0035] S2. Use flushing solution ② to circulate and flush the blood purification tubing. The flushing solution ② is a weakly acidic solution. After circulating and flushing for a set time, proceed to step S3.

[0036] S3. Rinse the blood purification tubing with flushing solution ③, wherein the flushing solution ③ is sterile water;

[0037] S4. Detect the pH value of the flushing solution ③ flowing out of the blood purification tubing. If the detected pH value is 6.5 to 7.0, the tubing flushing is completed. Otherwise, continue flushing with flushing solution ③ until the pH value reaches 6.5 to 7.0, then stop flushing.

[0038] Optionally, the rinsing solution ① is prepared by anhydrous ethanol, NaOH and water in a mass percentage ratio of 70%–94%: 1%–10%: 5%–20%; and / or, the rinsing solution ② is a 0.5%–1.0% anhydrous citric acid solution.

[0039] Optionally, when using rinsing solution ① for cyclic rinsing, the cyclic rinsing duration is recorded by a timer. When the cyclic rinsing duration reaches the cyclic rinsing duration threshold t, the absorbance value of rinsing solution ① is detected using the ultraviolet spectrophotometer. If the measured absorbance value α is less than the preset absorbance threshold α0, the cyclic rinsing duration threshold t is modified to t+Δt, Δt=(α0 / α-1) / t, and cyclic rinsing continues until the measured absorbance value is greater than the preset absorbance threshold; and / or, when using rinsing solution ② for cyclic rinsing, the cyclic rinsing duration is recorded by a timer. When the cyclic rinsing duration reaches the cyclic rinsing duration threshold t, rinsing with rinsing solution ② is stopped.

[0040] As can be seen from the above technical solution, the present invention uses a specific flushing solution to flush the blood purification tubing in a specific sequence. During the flushing process, flushing solution ① can form a glassy "crystal thin layer" on the inner wall of the blood purification tubing, blocking the leaching of harmful organic substances such as DEHP and epoxidized soybean oil, thereby reducing the chance of harmful leaching substances from the tubing entering the human body. Flushing solution ② can neutralize alkaline substances in the tubing, while also protecting the tubing and improving its anticoagulant effect. Flushing solution ③ can further remove foreign objects from the tubing. The flushing process does not require a long flushing time, is simple, and has a good flushing effect. Attached Figure Description

[0041] To more clearly illustrate the embodiments of the present invention, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0042] Figure 1 This is a schematic diagram of the blood purification pipeline flushing device according to an embodiment of the present invention;

[0043] Figure 2 This is a block diagram showing the connection between the control unit, the detection unit, and the valve assembly in an embodiment of the present invention.

[0044] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings. Detailed Implementation

[0045] The present invention will now be described in detail with reference to the accompanying drawings. In the detailed description of the embodiments of the present invention, for ease of explanation, the drawings illustrating the device structure will be partially enlarged without adhering to the general scale. Furthermore, the schematic diagrams are merely examples and should not be construed as limiting the scope of protection of the present invention. It should be noted that the drawings are in a simplified form and use non-precise scales, solely for the purpose of conveniently and clearly illustrating the embodiments of the present invention. Additionally, in the description of this application, terms such as "first" and "second" are used only to distinguish descriptions and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Terms such as "positive," "negative," "bottom," "upper," and "lower" indicate orientation or positional relationships based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0046] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" 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; they can also refer to the internal connection of two components; and they can refer to a wireless connection or a wired connection. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0047] Studies have shown that the migration and diffusion of plasticizers in PVC (polyvinyl chloride) occurs through the gaps between PVC chain segments. PVC containing plasticizers can be considered to be in a rubbery state, with flexible PVC molecular chains. When PVC does not contain plasticizers, it can be considered to be in a glassy state, with a dense molecular chain structure and no gaps. When PVC products are briefly immersed in an organic solvent, the plasticizers on the surface of the PVC products migrate into the organic solvent first, forming a plasticizer-free glassy "crystalline thin layer" on the surface of the PVC products. When the plasticizers inside the PVC migrate back into the solvent, they are blocked by this "crystalline thin layer," slowing down the migration and diffusion rate.

[0048] Based on the above principles, this invention employs the following steps to flush PVC blood purification tubing:

[0049] S1. Use flushing solution ① to circulate and flush the blood purification tubing. Flushing solution ① is an alkaline solution containing organic solvents. After the set flushing time, use an ultraviolet spectrophotometer to detect the absorbance value of the circulating flushing solution ①. If the measured absorbance value is greater than the preset absorbance threshold, stop flushing with flushing solution ① and proceed to step S2. Otherwise, continue the circulation and flushing until the measured absorbance value is greater than the preset absorbance threshold.

[0050] S2. Use flushing solution ② to circulate and flush the blood purification tubing. Flushing solution ② is a weakly acidic solution. After the set flushing time, proceed to step S3.

[0051] S3. Rinse the blood purification tubing with flushing solution ③, which is sterile water.

[0052] S4. Detect the pH value of the flushing solution ③ flowing out of the blood purification tubing. If the detected pH value is 6.5 to 7.0, the tubing flushing is completed. Otherwise, continue flushing with flushing solution ③ until the pH value reaches 6.5 to 7.0, then stop flushing.

[0053] By flushing the blood purification tubing with a specific flushing solution in a specific sequence, a glassy "crystal thin layer" forms on the inner wall of the tubing during the flushing process. This prevents the leaching of harmful organic substances such as DEHP and epoxidized soybean oil, reducing the chance of harmful leaching substances from the tubing entering the body. Moreover, the flushing operation is simple, the flushing effect is good, and the total flushing time can be shortened.

[0054] Based on the above principles, this invention also includes a flushing device specifically designed for PVC blood purification tubing. For example... Figure 1 As shown, the blood purification tubing flushing device of this embodiment includes a storage unit, a detection unit, a circulation pump M, and a control unit W. The storage unit stores the flushing fluid. In this embodiment, the storage unit includes a first storage tank A, a second storage tank B, a third storage tank C, and a waste tank D. The first storage tank A stores flushing fluid ①, which is an alkaline solution containing organic solvents. The second storage tank B stores flushing fluid ②, which is a weakly acidic cleaning solution. The third storage tank C stores flushing fluid ③, which is sterile water, such as sterile water for injection. The waste tank D is used to collect the waste fluid after flushing the blood purification tubing.

[0055] In this embodiment, the first storage tank A has a first outlet, a second outlet, and a return outlet. The first outlet is connected to a first outlet branch pipe a1, the second outlet is connected to a second outlet branch pipe a2, and the return outlet is connected to a first return branch pipe a3. The first storage tank A is connected to the flushing fluid inlet pipe 1 via the first outlet branch pipe a1 and the second outlet branch pipe a2, and to the flushing fluid outlet pipe 2 via the first return branch pipe a3. The flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2 are connected to both ends of the blood purification pipeline to be flushed, so that the flushing fluid can be input from the flushing fluid inlet pipe 1 into the blood purification pipeline and discharged from the blood purification pipeline via the flushing fluid outlet pipe 2. In this embodiment, a circulation pump M is installed on the flushing fluid inlet pipe 1, which provides driving force for circulating the liquid in the pipeline.

[0056] In this embodiment, the first storage tank A is divided into two independent spaces by a partition 3: a storage chamber I and a return chamber II. Storage chamber I stores clean flushing fluid, while return chamber II stores flushing fluid used during cyclic flushing. Storage chamber I is connected to the first outlet, and return chamber II is connected to the second outlet and return port. In this embodiment, the first outlet branch pipe a1 and the second outlet branch pipe a2 are connected to the flushing fluid inlet pipe 1 via a first three-way valve K1. A first pipeline control valve K2 is installed on the first return branch pipe a3, which controls the opening or closing of the first return branch pipe a3. The pipeline control valve can be a solenoid valve.

[0057] The flushing solution ① stored in the first storage tank A is used to dissolve and migrate organic substances such as plasticizers and stabilizers on the inner surface of the blood purification tubing into the flushing solution ① during the cleaning process. After the plasticizers and stabilizers migrate from the inner surface of the blood purification tubing, the inner surface gradually becomes a dense glassy thin layer (crystalline thin layer) with a compact molecular chain structure, which can prevent further migration of plasticizers from inside the blood purification tubing. In specific applications, the flushing solution ① includes anhydrous ethanol, NaOH, and water. More specifically, anhydrous ethanol, NaOH, and water are prepared in a mass percentage ratio of (70%–94%):(1%–10%):(5%–20%) to form the flushing solution ①.

[0058] The structure of the second storage tank B in this embodiment is the same as that of the first storage tank A, also having a first outlet, a second outlet, and a return outlet. The tank interior is divided into two independent storage chambers, I and II, by a partition. The first outlet is connected to storage chamber I, and the second outlet and return outlet are connected to return chamber II. The first outlet is connected to a third outlet branch pipe a4, the second outlet is connected to a fourth outlet branch pipe a5, and the return outlet is connected to a second return branch pipe a6. The third outlet branch pipe a4 and the fourth outlet branch pipe a5 are connected to the flushing fluid inlet pipe 1 via a second three-way valve K3, allowing for selective connection. A second pipeline control valve K4 is installed on the second return branch pipe a6, controlling its opening or closing.

[0059] The flushing solution ② stored in the second storage tank B is used to neutralize the residual flushing solution ① on the inner surface of the blood purification tubing, changing the pH within the tubing and simultaneously protecting the tubing components and improving its anticoagulant effect. In specific applications, the flushing solution ② in this scheme can be a 0.5%–1.0% anhydrous citric acid solution by mass. Citric acid (also known as citric acid) has in vitro anticoagulant properties.

[0060] The third storage tank C is connected to the flushing fluid inlet pipe 1 via the fifth outlet branch pipe a7, and a third pipeline control valve K5 is installed on the fifth outlet branch pipe a7. The waste liquid tank D is connected to the flushing fluid outlet pipe 2 via the waste liquid collection branch pipe a8, and a fourth pipeline control valve K6 is installed on the waste liquid collection branch pipe a8.

[0061] The flushing solution ③ stored in the third storage tank C is used to dilute and flush away the residual flushing solution ② in the blood purification tubing, and can also remove and flush away foreign objects in the blood purification tubing to achieve the purpose of cleaning.

[0062] The detection unit in this embodiment includes a flow meter L1, a velocity meter L2, a pH meter PH, and an ultraviolet spectrophotometer Z. The flow meter L1 is installed on the flushing fluid inlet pipe 1 to detect the flow rate of the flushing fluid in the pipeline. The velocity meter L2 is installed on the flushing fluid outlet pipe 2 to detect the flow velocity of the liquid in the pipeline. The pH meter PH is installed on the flushing fluid outlet pipe 2 to detect the acidity or alkalinity of the flushing fluid after flushing. The ultraviolet spectrophotometer Z is installed on the first return branch pipe a3 to detect the absorbance of the flushing fluid ① returning to the first storage tank A. In this embodiment, the ultraviolet spectrophotometer Z is located at the return port of the first storage tank A. As the flushing solution ① continuously circulates and flushes the blood purification tubing, the concentration of plasticizer in the flushing solution ① gradually increases. The concentration of plasticizer in the flushing solution ① is detected by measuring its absorbance. When the absorbance value reaches a preset threshold, it indicates that the concentration of plasticizer flushed out of the flushing solution ① has reached the standard, and the flushing effect meets the requirements. At this point, the use of flushing solution ① to flush the blood purification tubing can be stopped. The preset absorbance threshold of this invention is an empirical value, which can be derived by summarizing the absorbance value of the flushing solution ① through multiple experiments, following the testing principles specified in the "Guiding Principles for Technical Review of Registration of Single-Use Hemodialysis Tubing" (No. 146, 2016). In this embodiment, the ultraviolet spectrophotometer Z detects ultraviolet absorbance in the 250–320 nm wavelength range.

[0063] The temperature of the rinsing fluid ① affects its solubility for plasticizers; the higher the temperature, the stronger the solubility. Therefore, in this embodiment, a heater H is installed on the rinsing fluid inlet pipe 1 to heat the rinsing fluid in the inlet pipe 1. However, if the temperature of the rinsing fluid ① is too high, continuous rinsing of the blood purification tubing will accelerate the aging of the tubing components. Therefore, a temperature sensor T is also installed on the rinsing fluid inlet pipe 1 to detect the temperature of the rinsing fluid ①. The temperature sensor T is located after the heater H. In specific applications, the temperature of the rinsing fluid ① can be controlled between 35 and 40°C.

[0064] like Figure 2 As shown, the control unit in this embodiment is a centralized controller, which is electrically connected to the detection instruments in the detection unit used to detect various physical property values. The centralized controller is also connected to the circulating pump, heater, and various valves in the pipeline, such as three-way valves and solenoid valves. The centralized controller can receive, store, and process electrical signals from the detection unit, and output electrical signals to control the operation of components such as the detection unit, circulating pump, heater, and valve assemblies. For example, based on the temperature detected by the temperature sensor, when the temperature of the flushing fluid ① flowing in the pipeline is below 35°C, the temperature sensor feeds a signal to the control unit, which then controls the heater to turn on for heating; when the temperature of the flushing fluid ① is above 40°C, the temperature sensor feeds a signal to the control unit, which then controls the heater to turn off, stopping heating and preventing the flushing fluid ① from overheating.

[0065] like Figure 1 As shown, the end of the flushing fluid inlet pipe 1 is connected to connector E1, which is connected to the inlet of the blood purification pipeline to be flushed; the end of the flushing fluid outlet pipe 2 is connected to connector E2, which is connected to the outlet of the blood purification pipeline to be flushed. The flushing fluid in each storage tank of the storage unit flows into the blood purification pipeline through the flushing fluid inlet pipe 1 and connector E1, and after flushing the blood purification pipeline, it flows out from connector E2 and flushing fluid outlet pipe 2.

[0066] A flow meter L1, located near connector E1, is installed on the flushing fluid inlet pipe 1 to detect the amount of flushing fluid used. A heater H and a temperature sensor T are sequentially installed between the circulating pump M and the flow meter L1. A pH meter is installed on the flushing fluid outlet pipe 2, located between the flow meter L2 and connector E2.

[0067] In this embodiment, both the first storage tank A and the second storage tank B are equipped with independent and non-communicating storage and return chambers. This allows for the rinsing fluid to be circulated during the rinsing process, ensuring cleaning effectiveness while conserving fluid usage. Optionally, the storage chamber is positioned above the return chamber, and the second outlet is located at the bottom of the return chamber. This prevents fluid accumulation in the return chamber and facilitates the drainage of the rinsing fluid. The return outlet is located above the second outlet.

[0068] Optionally, a spiral pumping coil 4 is installed inside the liquid storage chamber I. The inlet end of the spiral pumping coil 4 is located at the bottom of the liquid storage chamber I, and the outlet is located at the top of the liquid storage chamber, communicating with the first liquid outlet. When the spiral pumping coil 4 draws in and transports the liquid at the bottom of the liquid storage chamber I upward, it can enhance the turbulence of the liquid being drawn in the coil, preventing the drawn liquid from precipitating and crystallizing.

[0069] The first outlet branch pipe a1 (the third outlet branch pipe a4) and the second outlet branch pipe a2 (the fourth outlet branch pipe a5) are connected to the flushing fluid inlet pipe 1 via a three-way valve in an optional manner. When the first outlet branch pipe a1 (the third outlet branch pipe a4) and the flushing fluid inlet pipe 1 are connected by the three-way valve, the flushing fluid in the storage chamber I flows into the flushing fluid inlet pipe 1, and the amount of flushing fluid used is monitored by the flow meter L1. When the preset amount is reached, the first outlet branch pipe a1 (the third outlet branch pipe a4) is closed by the three-way valve, so that the second outlet branch pipe a2 (the fourth outlet branch pipe a5) and the flushing fluid inlet pipe 1 are connected, and the flushing fluid flowing back to the return chamber II is used for circulating flushing.

[0070] When flushing blood purification tubing using the flushing device of this embodiment, the timing for entering or exiting the circulation flushing is determined by detecting the flow rate, the timing for ending the flushing solution circulation is determined by detecting the absorbance, the method for correcting the circulation flushing duration by comparing the detected absorbance value with the preset absorbance threshold, and the timing for ending the flushing is determined by detecting the pH value. The flushing method based on the blood purification tubing flushing device of this invention is described below. After adding various flushing solutions to their respective storage tanks, the blood purification tubing to be flushed is connected. The flushing device sets parameters such as the flushing solution flow rate v, the circulation flushing duration threshold t, the heating temperature, the preset flushing solution volume Q, the ultraviolet wavelength L for detecting absorbance, and the preset absorbance threshold a. The flushing method includes the following steps:

[0071] S1. Flush the blood purification tubing with flushing solution ①. The flushing process is as follows:

[0072] S101. Perform the initial flushing using flushing solution ①. Connect the flushing solution ① from the storage chamber I of the first storage tank A to the flushing solution inlet pipe 1. Start the circulation pump M to flush the blood purification pipeline. After flushing, the flushing solution ① flows back to the return chamber II of the first storage tank A. At this time, the first three-way valve K1 controls the connection between the first outlet branch pipe a1 and the flushing solution inlet pipe 1, the second outlet branch pipe a2 is closed, and the first pipeline control valve K2 on the first return branch pipe a3 is open. The second three-way valve K3 and the second return branch pipe... The second pipeline control valve K4 on a6, the third pipeline control valve K5 on the fifth outlet branch a7, and the fourth pipeline control valve K6 on the waste liquid collection branch a8 are all closed; during this process, the flow meter L1 continuously monitors the flow rate of the flushing fluid ①; during the first flush, the circulation path of the flushing fluid ① is as follows: the storage chamber I of the first storage tank A → the first outlet branch a1 → the flushing fluid inlet pipe 1 → the blood purification pipeline (not shown) → the flushing fluid outlet pipe 2 → the first return branch a3 → the return chamber II of the first storage tank A;

[0073] S102. The flushing fluid ① is circulated and flushed. When the flow meter L1 detects that the flow rate of the flushing fluid ① reaches the preset flushing fluid volume Q, the flushing fluid ① returned from the return chamber II of the first storage tank A is connected to the flushing fluid inlet pipe 1 to repeatedly circulate and flush the blood purification pipeline. When the flow meter L1 detects that the flow rate of the flushing fluid ① reaches the preset flushing fluid volume Q, it sends a feedback signal to the control unit W. The control unit W controls the first three-way valve K1 to connect the second outlet branch pipe a2 and the flushing fluid inlet pipe 1, and the first outlet branch pipe a1 is closed. One pipeline control valve K2 remains open; the second three-way valve K3, the second pipeline control valve K4 on the second return branch a6, the third pipeline control valve K5 on the fifth outlet branch a7, and the fourth pipeline control valve K6 on the waste collection branch a8 remain closed; during circulating flushing, the circulation path of the flushing fluid ① is: return chamber II of the first storage tank A → second outlet branch a2 → flushing fluid inlet pipe 1 → blood purification pipeline (not shown) → flushing fluid outlet pipe 2 → first return branch a3 → return chamber II of the first storage tank A;

[0074] Optionally, during cyclic rinsing, the duration of cyclic rinsing is recorded by a timer. When the duration of cyclic rinsing reaches the cyclic rinsing duration threshold t, the ultraviolet spectrophotometer Z is controlled to detect the absorbance value of the rinsing solution ①. If the measured absorbance value α is greater than the preset absorbance threshold α0, the connection of rinsing solution ① to the rinsing solution inlet pipe 1 is stopped, the rinsing of rinsing solution ① is stopped, and the process proceeds to step S2. If the measured absorbance value α is less than the preset absorbance threshold α0, the cyclic rinsing duration threshold t is modified to t+Δt, and step S102 is continued for cyclic rinsing until the measured absorbance value α is greater than the preset absorbance threshold α0; Δt=(α0 / α-1) / t;

[0075] S2. Flush the blood purification tubing with flushing solution ②. The flushing process is as follows:

[0076] S201. Use flushing fluid ② for the first flush. After the flushing fluid ① in the pipeline is emptied (when the flow meter L1 detects that the flow rate in the pipeline is 0, it is considered that the flushing fluid in the pipeline has basically flowed back into the return chamber), connect the flushing fluid ② in the storage chamber I of the second storage tank B to the flushing fluid inlet pipe 1 to flush the blood purification pipeline. After flushing, the flushing fluid ② flows back into the return chamber II of the second storage tank B. At this time, the second three-way valve K3 controls the connection between the third outlet branch pipe a4 and the flushing fluid inlet pipe 1, the fourth outlet branch pipe a5 is closed, and the second pipeline control on the second return branch pipe a6 is activated. Valve K4 is turned on; the first three-way valve K1, the first pipeline control valve K2 on the first return branch a3, the third pipeline control valve K5 on the fifth outlet branch a7, and the fourth pipeline control valve K6 on the waste collection branch a8 are all turned off; during this process, flow meter L1 continuously detects the flow rate of flushing fluid ②; during the first flush, the circulation path of flushing fluid ② is: storage chamber I of the second storage tank B → third outlet branch a4 → flushing fluid inlet pipe 1 → blood purification pipeline (not shown) → flushing fluid outlet pipe 2 → second return branch a6 → return chamber II of the second storage tank B;

[0077] S202, the flushing fluid ② is circulated and flushed. When the flow meter L1 detects that the flow rate of the flushing fluid ② reaches the preset volume Q of the flushing fluid, the flushing fluid ② returned from the return chamber II of the second storage tank A is connected to the flushing fluid inlet pipe 1 to repeatedly circulate and flush the blood purification pipeline. When the flow meter L1 detects that the flow rate of the flushing fluid ② reaches the preset volume Q, it sends a feedback signal to the control unit W. The control unit W controls the second three-way valve K3 to connect the fourth outlet branch pipe a5 with the flushing fluid inlet pipe 1, and closes the third outlet branch pipe a4. Pipeline control valve K4 remains open; the first three-way valve K1, the first pipeline control valve K2 on the first return branch a3, the third pipeline control valve K5 on the fifth outlet branch a7, and the fourth pipeline control valve K6 on the waste collection branch a8 remain closed; during circulating flushing, the circulation path of the flushing fluid ② is: return chamber II of the second storage tank B → fourth outlet branch a5 → flushing fluid inlet pipe 1 → blood purification pipeline (not shown) → flushing fluid outlet pipe 2 → second return branch a6 → return chamber II of the second storage tank B;

[0078] During the cyclic rinsing, the cyclic rinsing duration is recorded by a timer. When the cyclic rinsing duration reaches the cyclic rinsing duration threshold t, the rinsing of the rinsing fluid ② is stopped, and the process proceeds to step S3.

[0079] S3. Use flushing fluid ③ for flushing. After flushing fluid ② in the pipeline is drained (when the flow rate in the pipeline detected by flow meter L1 is 0), connect flushing fluid ③ in the third storage tank C to the flushing fluid inlet pipe to flush the blood purification pipeline. The flushing fluid outlet pipe 2 is connected to the waste liquid tank D, and the flushed flushing fluid ③ flows into the waste liquid tank D. At this time, the third pipeline control valve K5 on the fifth outlet branch pipe a7 and the fourth pipeline control valve K6 on the waste liquid collection branch pipe a8 are both open, allowing the fifth outlet branch pipe to... a7 is connected to the flushing fluid inlet pipe 1, and the waste fluid collection branch pipe a8 is connected to the flushing fluid outlet pipe 2. The first three-way valve K1, the second three-way valve K3, the first pipeline control valve K2 on the first return branch a3, and the second pipeline control valve K4 on the second return branch a6 are all closed. During flushing, the flushing path of the flushing fluid ③ is: the third storage tank C → the fifth outlet branch pipe a7 → the flushing fluid inlet pipe 1 → the blood purification pipeline (not shown) → the flushing fluid outlet pipe 2 → the waste fluid collection branch pipe a8 → the waste fluid tank D.

[0080] S4. Detect the pH value of the flushing solution ③ flowing out of the blood purification tubing. If the detected pH value is 6.5 to 7.0, the tubing flushing is completed. Otherwise, continue flushing with flushing solution ③ until the pH value reaches 6.5 to 7.0, then stop flushing.

[0081] The above method is illustrated using a structure where the first and second storage tanks have independent storage and return chambers. In other embodiments, the first and second storage tanks may also have only one internal cavity for storage, with the rinsing fluid flowing back into the storage tank's internal cavity during cyclic flushing. However, compared to storage tanks with independent storage and return chambers, this structure allows for separate storage of cyclic and clean rinsing fluids. Unused and cyclic rinsing fluids do not affect each other, and the cyclically returned rinsing fluid will not contaminate the unused rinsing fluid. It also eliminates the need for frequent replacement of the clean rinsing fluid in the storage tanks, making pipeline flushing operations more convenient. When using the rinsing fluids from the first and second storage tanks to cyclically flush the blood purification pipeline, after each type of rinsing fluid is used, the rinsing fluid can be collected in the waste tank via the rinsing fluid outlet pipe.

[0082] The centralized controller of the control unit of the present invention includes a data memory and a processor. The memory is used to store computer programs, and the processor is used to execute the computer programs to implement the aforementioned method.

[0083] The present invention will be further described below through specific embodiments.

[0084] Example 1

[0085] Anhydrous ethanol, NaOH, and water were mixed in a mass ratio of 70%:10%:20% to prepare rinsing solution ①, which was then added to storage chamber I of the first storage tank A. When preparing rinsing solution ①, NaOH was first dissolved in water, and then anhydrous ethanol was added. Rinsing solution ② consisted of 1.0% anhydrous citric acid, and rinsing solution ③ consisted of sterile water for injection. The blood purification tubing to be rinsed was connected. The rinsing solution flow rate v was set to 50 mL / min, the rinsing time threshold was set to 10 min, the heating temperature of rinsing solution ① was set to 37℃, the preset volume Q of the rinsing solution was set to 500 mL, the ultraviolet wavelength was set to 275 nm, and the preset absorbance threshold was set to 0.5.

[0086] S1. Flush the blood purification tubing with flushing solution ①;

[0087] S101. Turn on the flushing device, connect the first outlet branch pipe a1 connected to the first liquid storage chamber Ⅰ of the first liquid storage tank A and the first return branch pipe a3 connected to the return liquid chamber Ⅱ of the first liquid storage tank A to the flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2 respectively, and use clean flushing fluid ① to perform the first flushing of the blood purification pipeline. After flushing, the flushing fluid ① flows back to the return liquid chamber Ⅱ of the first liquid storage tank A.

[0088] S102. When the flow meter L1 detects that the total flow rate of the flushing fluid ① reaches 500mL, the second outlet branch pipe a2, which is connected to the return chamber II of the first storage tank A, is connected to the flushing fluid inlet pipe 1. The flushing fluid ① in the return chamber II of the first storage tank A is used to repeatedly circulate and flush the blood purification pipeline. The timer is started to record the duration of the circulation flushing. After 10 minutes of repeated flushing with the flushing fluid ①, the ultraviolet absorbance (DEHP) at a wavelength of 275nm is detected using the ultraviolet spectrophotometer Z. The absorbance is detected to be 0.221, which is lower than the preset threshold of 0.5. The signal is fed back to the control unit, and the threshold of the circulation flushing duration is changed to 22.6min (Δt=12.6min). When the absorbance is detected to be 0.507, the cycle is stopped. The threshold of the circulation flushing duration is recorded and modified to 22.6min. Then the timer is reset to zero. The first three-way valve K1 is closed, and the circulation pump M continues to work, draining the flushing fluid ① in the pipeline into the return chamber II of the first storage tank A.

[0089] S2. Flush the blood purification tubing with flushing solution ②;

[0090] S201. After the flushing fluid ① in the pipeline is drained, the third outlet branch pipe a4, which connects to the storage chamber Ⅰ of the second storage tank B, and the second return branch pipe a6, which connects to the return chamber Ⅱ of the second storage tank B, are connected to the flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2, respectively. The blood purification pipeline is flushed for the first time using clean flushing fluid ②. After flushing, the flushing fluid ② flows back to the return chamber Ⅱ of the second storage tank B.

[0091] S202. When the flow rate of the flushing fluid ① in the flow meter L1 reaches 500mL, connect the fourth outlet branch pipe a5, which is connected to the return chamber II of the second storage tank B, and the flushing fluid inlet pipe 1. Use the flushing fluid ② in the return chamber II of the second storage tank B to repeatedly circulate and flush the blood purification pipeline. At the same time, start the timer to record the duration of the flushing fluid ② circulation. When the circulation flushing duration reaches the circulation flushing duration threshold of 22.6min, close the second three-way valve K3, keep the circulation pump M working, and discharge the flushing fluid ② in the pipeline into the return chamber II of the second storage tank B.

[0092] S3. Use flushing solution ③ to flush the blood purification pipeline; after the flushing solution ② in the pipeline is drained, connect the fifth outlet branch pipe a7 connected to the third storage tank C to the flushing solution inlet pipe 1, connect the waste liquid collection branch pipe a8 connected to the waste liquid tank D to the flushing solution outlet pipe 2, use flushing solution ③ to flush the blood purification pipeline, and the flushing solution ③ after flushing flows to the waste liquid tank D.

[0093] S4. Use a pH meter to detect the acidity or alkalinity of the flushing fluid ③ flowing from the blood purification tubing. If the pH value reaches 6.7, send a feedback signal to the control unit to stop flushing.

[0094] Example 2

[0095] The difference between this embodiment and Embodiment 1 is that the rinsing solution ① is prepared by mixing anhydrous ethanol, NaOH, and water in a mass ratio of 80%:5%:15%, the rinsing solution ② is 1.0% anhydrous citric acid, and the rinsing solution ③ is sterile water for injection. Connect the blood purification tubing to be rinsed. Set the rinsing solution flow rate v to 50 mL / min, the rinsing time threshold to 10 min, the heating temperature of rinsing solution ① to 37°C, the preset volume Q of the rinsing solution to 500 mL, the ultraviolet wavelength to 275 nm, and the preset absorbance threshold to 0.5.

[0096] S1. Flush the blood purification tubing with flushing solution ①;

[0097] S101. Turn on the flushing device and connect the first outlet branch pipe a1 and the first return branch pipe a3 connected to the first storage tank A to the flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2 respectively. Use clean flushing fluid ① to flush the blood purification pipeline for the first time. After flushing, the flushing fluid ① flows back to the return chamber II of the first storage tank A.

[0098] S102. When the flow meter L1 detects that the flow rate of the flushing fluid ① reaches 500mL, the second outlet branch pipe a2 connected to the first storage tank A is connected to the flushing fluid inlet pipe 1. The flushing fluid ① in the return chamber II of the first storage tank A is used to repeatedly circulate and flush the blood purification pipeline. The timer records the duration of the circulation flushing. After 10 minutes of repeated flushing with the flushing fluid ①, the ultraviolet spectrophotometer Z is used to detect the ultraviolet absorbance at a wavelength of 275nm. The absorbance is detected to be 0.258, which is lower than the preset absorbance threshold of 0.5. The signal is fed back to the control unit, and the threshold for the circulation flushing duration is changed to 19.4min (Δt=9.4min). When the absorbance is detected to be 0.505, the cycle is stopped. The circulation flushing duration threshold is recorded and modified to 19.4min. Then the timer is reset to zero. The first three-way valve K1 is closed, and the circulation pump M continues to work, draining the flushing fluid ① in the pipeline into the return chamber II of the first storage tank A.

[0099] S2. Flush the blood purification tubing with flushing solution ②;

[0100] S201. After the flushing fluid ① in the pipeline is drained, the third outlet branch pipe a4 and the second return branch pipe a6 connected to the second storage tank B are connected to the flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2 respectively. The blood purification pipeline is flushed for the first time using clean flushing fluid ②. The flushing fluid ② after flushing is returned to the return chamber II of the second storage tank B.

[0101] S202. When the flow rate of the flushing fluid ① in the flow meter L1 reaches 500mL, connect the fourth outlet branch pipe a5 connected to the second storage tank B and the flushing fluid inlet pipe 1, and use the flushing fluid ② in the return chamber II of the second storage tank B to repeatedly circulate and flush the blood purification pipeline; at the same time, start the timer to record the duration of the flushing fluid ② circulation; when the circulation flushing duration reaches the circulation flushing duration threshold of 19.4min, close the second three-way valve K3, keep the circulation pump M working, and discharge the flushing fluid ② in the pipeline into the return chamber II of the second storage tank B;

[0102] S3. Use flushing solution ③ to flush the blood purification pipeline; after the flushing solution ② in the pipeline is drained, connect the fifth outlet branch pipe a7 connected to the third storage tank C to the flushing solution inlet pipe 1, connect the waste liquid collection branch pipe a8 connected to the waste liquid tank D to the flushing solution outlet pipe 2, use flushing solution ③ to flush the blood purification pipeline, and the flushing solution ③ after flushing flows to the waste liquid tank D.

[0103] S4. Use a pH meter to detect the acidity or alkalinity of the flushing fluid ③ flowing from the blood purification tubing. If the pH value reaches 6.8, send a feedback signal to the control unit to stop flushing.

[0104] Example 3

[0105] The difference between this embodiment and Embodiment 1 is that the rinsing solution ① is prepared by mixing anhydrous ethanol, NaOH, and water in a mass ratio of 94%:1%:5%. Rinsing solution ② is 0.5% anhydrous citric acid, and rinsing solution ③ is sterile water for injection. Connect the blood purification tubing to be rinsed. Set the rinsing solution flow rate v to 50 mL / min, the rinsing time threshold to 10 min, the heating temperature of rinsing solution ① to 37°C, the preset volume Q of rinsing solution to 500 mL, the ultraviolet wavelength to 275 nm, and the preset absorbance threshold to 0.5 using the control unit.

[0106] S1. Flush the blood purification tubing with flushing solution ①;

[0107] S101. Turn on the flushing device and connect the first outlet branch pipe a1 and the first return branch pipe a3 connected to the first storage tank A to the flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2 respectively. Use clean flushing fluid ① to flush the blood purification pipeline for the first time. After flushing, the flushing fluid ① flows back to the return chamber II of the first storage tank A.

[0108] S102. When the flow meter L1 detects that the flow rate of the flushing fluid ① reaches 500mL, the second outlet branch pipe a2 connected to the first storage tank A is connected to the flushing fluid inlet pipe 1. The flushing fluid ① in the return chamber II of the first storage tank A is used to repeatedly circulate and flush the blood purification pipeline. The timer records the duration of the circulation flushing. After 10 minutes of repeated flushing with the flushing fluid ①, the ultraviolet spectrophotometer Z is used to detect the ultraviolet absorbance at a wavelength of 275nm. The absorbance is detected to be 0.247, which is lower than the preset absorbance threshold of 0.5. The signal is fed back to the control unit, and the threshold for the circulation flushing duration is changed to 20.2min (Δt=10.2min). When the absorbance is detected to be 0.509, the cycle is stopped. The circulation flushing duration threshold is recorded and modified to 20.2min. Then the timer is reset. The first three-way valve K1 is closed, and the circulation pump M continues to work, draining the flushing fluid ① in the pipeline into the return chamber II of the first storage tank A.

[0109] S2. Flush the blood purification tubing with flushing solution ②;

[0110] S201. After the flushing fluid ① in the pipeline is drained, the third outlet branch pipe a4 and the second return branch pipe a6 connected to the second storage tank B are connected to the flushing fluid inlet pipe 1 and the flushing fluid outlet pipe 2 respectively. The blood purification pipeline is flushed for the first time using clean flushing fluid ②. The flushing fluid ② after flushing is returned to the return chamber II of the second storage tank B.

[0111] S202. When the flow rate of the flushing fluid ① in the flow meter L1 reaches 500mL, connect the fourth outlet branch pipe a5 connected to the second storage tank B and the flushing fluid inlet pipe 1, and use the flushing fluid ② in the return chamber II of the second storage tank B to repeatedly circulate and flush the blood purification pipeline; at the same time, start the timer to record the duration of the flushing fluid ② circulation; when the circulation flushing duration reaches the circulation flushing duration threshold of 20.2min, close the second three-way valve K3, keep the circulation pump M working, and discharge the flushing fluid ② in the pipeline into the return chamber II of the second storage tank B;

[0112] S3. Use flushing solution ③ to flush the blood purification pipeline; after the flushing solution ② in the pipeline is drained, connect the fifth outlet branch pipe a7 connected to the third storage tank C to the flushing solution inlet pipe 1, connect the waste liquid collection branch pipe a8 connected to the waste liquid tank D to the flushing solution outlet pipe 2, use flushing solution ③ to flush the blood purification pipeline, and the flushing solution ③ after flushing flows to the waste liquid tank D.

[0113] S4. Use a pH meter to detect the acidity or alkalinity of the flushing fluid ③ flowing from the blood purification tubing. If the pH value reaches 6.5, send a feedback signal to the control unit to stop flushing.

[0114] Unrinsed blood purification tubing was used as a control sample, and the absorbance of the extracted solution was measured. Following the testing principles outlined in the "Technical Review Guidelines for Registration of Single-Use Hemodialysis Tubing" (No. 146, 2016), the unrinsed tubing sample and a glass flask were connected to form a closed circulation system. The tubing sample was filled with a 46% ethanol-water solution (simulating extreme extraction of human blood), and another 46% ethanol-water solution was added to the glass flask, bringing the total volume to 500 ml. The tubing sample was placed in a water bath and heated to 37±1℃. Using a suitable constant flow pump, the solution was circulated at a flow rate of 200 mL / min for 5.5 h (simulating the maximum treatment time of hemodialysis in humans). The liquid was collected, and the absorbance of the collected liquid at a wavelength of 275 nm was measured.

[0115] The blood purification tubing rinsed in Examples 1-3 was also subjected to absorbance testing of the extracted solution using the same method. The results are shown in the table below. In the table, the total processing time for Examples 1-3 is the total time for rinsing the tubing sequentially with the three rinsing solutions. The total processing time for the unrinsed samples is the processing time for extracting DEHP according to the method outlined in the "Guidelines for Technical Review of Registration of Single-Use Hemodialysis Tubing".

[0116]

[0117] The results in the table above show that when the pipe samples rinsed in Examples 1-3 were subjected to simulated extraction again, the absorbance of the extract at 275 nm decreased by more than 0.25. Based on the direct correlation between substance concentration and absorbance, this indicates that the rinsing method of the present invention can reduce the DEHP migration rate in the pipes by more than 50%. This also demonstrates that when the pipe products are briefly immersed in rinsing solution ①, the DEHP on the inner surface of the pipe products can migrate into rinsing solution ①, forming a glassy "crystalline thin layer" without plasticizer on the inner surface. This layer can prevent the remaining DEHP in the pipes from migrating back into the solvent, thereby slowing down the rate of DEHP migration and diffusion.

[0118] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A blood purification tubing flushing device, characterized in that, include: The liquid storage unit includes a first liquid storage tank for storing a first flushing solution, a second liquid storage tank for storing a second flushing solution, a third liquid storage tank for storing a third flushing solution, and a waste liquid tank. The liquid storage unit sequentially provides the first flushing solution, the second flushing solution, and the third flushing solution to flush the blood purification pipeline. The flushing fluid inlet and flushing fluid outlet are connected to the blood purification tubing. The detection unit includes a flow meter, a pH meter, and an ultraviolet spectrophotometer, wherein the pH meter is installed on the flushing liquid outlet pipe; A circulating pump that provides driving force for liquids in pipelines; A heater for heating liquids in a pipeline; The first storage tank inputs a first flushing solution into the flushing solution inlet pipe, and the first flushing solution can flow back to the first storage tank through the flushing solution outlet pipe for cyclic flushing; the second storage tank inputs a second flushing solution into the flushing solution inlet pipe, and the second flushing solution can flow back to the second storage tank through the flushing solution outlet pipe for cyclic flushing; the third storage tank inputs a third flushing solution into the flushing solution inlet pipe, and the third flushing solution can flow to the waste liquid tank through the flushing solution outlet pipe; The first storage tank is divided into an independent storage chamber and a return chamber by a partition, and the second storage tank is divided into an independent storage chamber and a return chamber by a partition.

2. The blood purification tubing flushing device as described in claim 1, characterized in that: The first liquid storage tank includes a storage chamber and a return chamber. The first liquid storage tank is connected to the flushing fluid inlet pipe through a first outlet branch pipe and a second outlet branch pipe, and is connected to the flushing fluid outlet pipe through a first return branch pipe. The storage chamber of the first liquid storage tank is connected to the first outlet branch pipe, and the return chamber of the first liquid storage tank is connected to both the second outlet branch pipe and the first return branch pipe. The first outlet branch pipe and the second outlet branch pipe are selectively connected to the flushing fluid inlet pipe. The ultraviolet spectrophotometer is mounted on the first return branch pipe. The second liquid storage tank includes a storage chamber and a return chamber. The second liquid storage tank is connected to the flushing fluid inlet pipe through a third and a fourth outlet branch pipe, and to the flushing fluid outlet pipe through a second return branch pipe. The storage chamber of the second liquid storage tank is connected to the third outlet branch pipe, and the return chamber of the second liquid storage tank is connected to the fourth outlet branch pipe and the second return branch pipe. The third outlet branch pipe and the fourth outlet branch pipe are selectively connected to the flushing fluid inlet pipe. The third liquid storage tank is connected to the flushing liquid inlet pipe via the fifth liquid outlet branch pipe; The waste liquid tank is connected to the flushing liquid outlet pipe via a waste liquid collection branch pipe.

3. The blood purification tubing flushing device as described in claim 2, characterized in that: The first and second outlet branches are connected to the flushing fluid inlet pipe via a first three-way valve, and the third and fourth outlet branches are connected to the flushing fluid inlet pipe via a second three-way valve. And / or, a first pipeline control valve is provided on the first return liquid branch pipe, a second pipeline control valve is provided on the second return liquid branch pipe, a third pipeline control valve is provided on the fifth outlet liquid branch pipe, and a fourth pipeline control valve is provided on the waste liquid collection branch pipe.

4. The blood purification tubing flushing device as described in claim 2, characterized in that: The liquid storage chamber is equipped with a spiral water pumping coil. The inlet of the spiral water pumping coil is located at the bottom of the liquid storage chamber, and the outlet is located at the top of the liquid storage chamber and connected to the liquid outlet branch pipe. And / or, the flushing fluid inlet pipe is equipped with a heater and a temperature sensor.

5. A method for flushing blood purification tubing, characterized in that, Flushing blood purification tubing using the blood purification tubing flushing device as described in any one of claims 1 to 4 includes the following steps: A first flushing solution is added to the first storage tank, a second flushing solution is added to the second storage tank, and a third flushing solution is added to the third storage tank. The first flushing solution is an alkaline solution containing an organic solvent, the second flushing solution is a weakly acidic solution, and the third flushing solution is sterile water. After connecting the blood purification tubing to be flushed... S1. Use the first flushing solution to circulate and flush the blood purification tubing. After the set flushing time, use an ultraviolet spectrophotometer to detect the absorbance value of the first flushing solution used in circulation. If the measured absorbance value is greater than the preset absorbance threshold, stop flushing with the first flushing solution and proceed to step S2. Otherwise, continue circulating and flushing until the measured absorbance value is greater than the preset absorbance threshold. S2. Use the second flushing solution to circulate and flush the blood purification tubing; after the set flushing time, proceed to step S3. S3. Use the third flushing solution to flush the blood purification tubing; S4. Detect the pH value of the third flushing solution flowing out of the blood purification tubing. If the detected pH value is 6.5~7.0, the tubing flushing is completed. Otherwise, continue flushing with the third flushing solution until the pH value reaches 6.5~7.0, then stop flushing.

6. A method for flushing blood purification tubing, characterized in that, The blood purification tubing flushing device as described in any one of claims 2 to 4 is characterized by comprising the following steps: A first flushing solution is added to the first storage tank, a second flushing solution is added to the second storage tank, and a third flushing solution is added to the third storage tank. The first flushing solution is an alkaline solution containing an organic solvent, the second flushing solution is a weakly acidic solution, and the third flushing solution is sterile water. After connecting the blood purification tubing to be flushed... S1. Flush the blood purification tubing with the first flushing solution: S101. Use the first flushing solution for the first flushing. Connect the first flushing solution in the storage chamber of the first storage tank to the flushing solution inlet pipe to flush the blood purification pipeline. The first flushing solution after flushing is returned to the return chamber of the first storage tank. The flow meter continuously detects the flow rate of the first flushing solution. S102. Use the first flushing solution for cyclic flushing. When the flow meter detects that the flow rate of the first flushing solution reaches the preset volume of the flushing solution, connect the first flushing solution in the return chamber of the first storage tank to the flushing solution inlet pipe to repeatedly cyclic flush the blood purification pipeline. After the cyclic flushing is set for a set time, use the ultraviolet spectrophotometer to detect the absorbance value of the first flushing solution. If the measured absorbance value is greater than the preset absorbance threshold, stop the flushing of the first flushing solution and proceed to step S2. Otherwise, continue the cyclic flushing until the measured absorbance value is greater than the preset absorbance threshold. During the first flushing process, the second storage tank, the third storage tank, and the waste tank are not connected to the flushing liquid inlet pipe and the flushing liquid outlet pipe. S2. Flush the blood purification tubing with the second flushing solution: S201. The first flushing is performed using the second flushing solution. The second flushing solution in the storage chamber of the second storage tank is connected to the flushing solution inlet pipe to flush the blood purification pipeline. The flushed second flushing solution is returned to the return chamber of the second storage tank. The flow meter continuously detects the flow rate of the second flushing solution. S202. Use the second flushing fluid for circulating flushing. When the flow meter detects that the flow rate of the second flushing fluid reaches the preset volume of the flushing fluid, connect the second flushing fluid returning from the return chamber of the second storage tank to the flushing fluid inlet pipe to repeatedly circulate and flush the blood purification pipeline. After the set time of circulating flushing, proceed to step S3. During the second flushing process, the first storage tank, the third storage tank, and the waste tank are not connected to the flushing fluid inlet pipe and the flushing fluid outlet pipe. S3. Use the third flushing solution to flush the blood purification pipeline. Connect the third flushing solution in the third storage tank to the flushing solution inlet pipe to flush the blood purification pipeline. The flushing solution outlet pipe is connected to the waste liquid tank. The flushed third flushing solution flows into the waste liquid tank. During the rinsing process, neither the first storage tank nor the second storage tank is connected to the rinsing fluid inlet pipe or the rinsing fluid outlet pipe; S4. Detect the pH value of the third flushing solution flowing out of the blood purification tubing. If the detected pH value is 6.5~7.0, the tubing flushing is completed. Otherwise, continue flushing with the third flushing solution until the pH value reaches 6.5~7.0, then stop flushing.

7. A method for flushing blood purification tubing, characterized in that, Includes the following steps: S1. The blood purification tubing is flushed with a first flushing solution, which is an alkaline solution containing an organic solvent. After a set flushing time, the absorbance value of the first flushing solution is detected using an ultraviolet spectrophotometer. If the measured absorbance value is greater than the preset absorbance threshold, the flushing with the first flushing solution is stopped and the process proceeds to step S2. Otherwise, the flushing continues until the measured absorbance value is greater than the preset absorbance threshold. S2. Use a second flushing solution to circulate and flush the blood purification tubing. The second flushing solution is a weakly acidic solution. After circulating and flushing for a set time, proceed to step S3. S3. Rinse the blood purification tubing with a third flushing solution, wherein the third flushing solution is sterile water; S4. Detect the pH value of the third flushing solution flowing out of the blood purification tubing. If the detected pH value is 6.5~7.0, the tubing flushing is completed. Otherwise, continue flushing with the third flushing solution until the pH value reaches 6.5~7.0, then stop flushing.

8. The rinsing method as described in claim 5, 6, or 7, characterized in that: The first rinsing solution is prepared by anhydrous ethanol, NaOH and water in a mass percentage ratio of 70%–94%: 1%–10%: 5%–20%; And / or, the second rinsing solution is a 0.5% to 1.0% anhydrous citric acid solution.

9. The rinsing method as described in claim 5, 6, or 7, characterized in that: When rinsing with the first rinsing solution, the rinsing time is recorded by a timer. When the rinsing time reaches the rinsing time threshold t, the absorbance value of the first rinsing solution is detected by the ultraviolet spectrophotometer. If the measured absorbance value α is less than the absorbance preset threshold α0, the rinsing time threshold t is modified to t+Δt, Δt=(α0 / α-1) / t, and the rinsing continues until the measured absorbance value is greater than the absorbance preset threshold. And / or, when using the second flushing solution for cyclic flushing, the cyclic flushing duration is recorded by a timer. When the cyclic flushing duration reaches the cyclic flushing duration threshold t, the rinsing with the second flushing solution is stopped.

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