Blood purification apparatus and method of use thereof

Abstract

This invention discloses a blood purification device and its usage method, relating to the field of medical device technology. A first housing and a second housing directly or indirectly form a hollow inner cavity and are capable of sliding relative to each other along the axial direction. During blood purification, blood flows through the fibrous membrane bundle, while dialysate flows through the inner cavity formed by the first and second housings, resulting in substance exchange between the blood and dialysate. When the fibrous membrane bundle becomes blocked, the first and second housings separate and move relative to each other along the axial direction. The fibrous membrane bundle is elastic, causing it to stretch. The shape of the micropores on the sidewalls of each membrane tube changes, allowing some of the blocking proteins to be squeezed out. When the length of the membrane bundle is restored, the size of the micropores on the sidewalls of each membrane tube is larger than in the initial state, further eliminating the blockage.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and more particularly to a blood purification device and a method for using the same. BACKGROUND

[0002] The blood purification device includes a hemodialyzer, a hemodialysis filter, a hemofilter, a plasma separator, etc., and achieves blood purification through principles such as diffusion, convection, adsorption, etc. Diffusion: solute transfers from one side with high concentration to the other side with low concentration through a semi-permeable membrane; Convection: there is a certain pressure difference on both sides of the semi-permeable membrane, and the solute to be removed diffuses to the side with low pressure along with water molecules; Adsorption: according to the interaction of positive and negative electrons or Van der Waals force, the substance to be removed is adsorbed.

[0003] The membrane material in the blood purification device has specific functional groups. When the membrane material is in contact with blood, the fibrinogen and other proteins contained in the blood interact with the functional groups of the membrane material and are adsorbed. The adsorbed proteins gradually change in structure, and the proteins are adsorbed and deposited on the membrane surface or in the membrane pores, causing the membrane pore size to be blocked, reducing the membrane flux and the ability to screen toxins.

[0004] The size of the membrane pore size is crucial to the performance of the dialysis membrane. Although the use of a dialyzer with a smaller pore size during dialysis can reduce the blockage of the dialysis membrane due to shear force, it is difficult to remove medium and large molecular toxins. Therefore, to ensure the removal of medium and large molecular toxins, a dialysis membrane with a larger membrane pore size is often used first. However, blood components such as large molecular proteins can easily enter the large pores, which can easily cause the membrane pore size to be blocked, thereby reducing the removal of medium and large molecular toxins. Therefore, it is particularly important to maintain the membrane pore size within a certain range for the removal of medium and large molecular toxins.

[0005] In recent years, research on membrane pore size has shown that temperature-responsive hollow fiber membranes can change their properties in response to changes in the external environment. For example, the temperature-sensitive material poly-N-isopropyl acrylamide (PNIPAAm) has a low critical solution temperature (LCST) of 30-34℃, and has a fast response speed. By utilizing the changeable properties of PNIPAAm in response to changes in the external environment, a separation membrane made of PNIPAAm can be reversibly deformed and is widely used in the field of temperature-responsive polyvinylidene fluoride (PVDF) separation membranes. If the size of the membrane is kept constant, the expansion and contraction of the membrane will cause the membrane pores to expand or shrink, thereby changing the size of the membrane pores and the permeability of the membrane. Although this method can change the size of the membrane pores in response to changes in the external environment, the functional groups in this method are introduced onto the surface of the membrane through chemical methods, which have poor stability and high cost. The temperature needs to be strictly controlled, which requires high energy consumption. After the material is modified, the surface functional groups change, which may activate blood components, and special temperature control equipment is needed to assist the operation.

[0006] For those skilled in the art, how to quickly and easily eliminate the problem of blocking the membrane surface pore size is a technical problem to be solved at present. SUMMARY

[0007] The present application provides a blood purification device, which quickly and easily eliminates the problem of blocking the membrane surface pore size by physical stretching deformation, and the specific scheme is as follows:

[0008] A blood purification device, comprising a first shell, a second shell and a fiber membrane bundle, the first shell and the second shell directly form a hollow inner cavity or indirectly form a hollow inner cavity through one or more adapter pipes, and can move relatively along the axial direction;

[0009] The fiber membrane bundle can flow through blood, and the inner cavity formed by the first shell and the second shell can flow through dialysate; the fiber membrane bundle has elasticity;

[0010] One end of the fiber membrane bundle is fixed to the first shell, and the other end is fixed to the second shell; when the first shell and the second shell move relatively apart along the axial direction, the fiber membrane bundle can be stretched.

[0011] Optionally, a rotating handle is further included, which is threadedly connected to one of the first shell and the second shell, and rotationally connected to the other one, and rotation of the rotating handle can drive the first shell and the second shell to adjust the axial length;

[0012] Alternatively, the rotating handle is threadedly connected to one of the first shell and the adapter pipe, the adapter pipe and the adapter pipe, and the adapter pipe and the second shell, and rotationally connected to the other one, and rotation of the rotating handle can drive the first shell, the adapter pipe and the second shell to adjust the axial length.

[0013] Optionally, a limiting device is arranged between the first shell and the second shell for limiting the limit position of movement.

[0014] Optionally, the rotating handle is threadedly connected to the outer surface of the second shell, the rotating handle is provided with a rotating groove, the edge of the first shell is provided with a rotating protrusion, the rotating protrusion is embedded in the rotating groove, and when the rotating handle is rotated by thread, the rotating groove and the rotating protrusion slide relatively, and the rotating handle drives the rotating protrusion to move axially through the rotating groove; the outer surface of the second shell is provided with a clamping protrusion, and the inner surface of the first shell is provided with a limiting groove, the clamping protrusion and the limiting groove cooperate to realize limiting.

[0015] Optionally, the edge of the second shell is provided with an inner sealing ring, and the distance between the inner sealing ring and the clamping protrusion is greater than the axial length of the limiting groove.

[0016] The limiting groove is provided with a scale line for identifying the position of the clamping protrusion.

[0017] Optionally, the stretching change of the fiber membrane bundle is 1%-5% of the initial length of the fiber membrane bundle or 1%-5% of the initial tension of the fiber membrane bundle.

[0018] Optionally, the first shell and the second shell are respectively provided with a port sealing glue and an end cover, the two ends of the fiber membrane bundle are respectively sealed by the port sealing glue, and the end cover is provided with a channel for blood inlet and outlet.

[0019] Optionally, a guide assembly is arranged between the first shell and the second shell, and the first shell and the second shell are allowed to move only in the axial direction.

[0020] The application further provides a use method of the blood purification device, which is applied to the blood purification device provided above and comprises the following steps:

[0021] The first shell and the second shell are separated from each other in the axial direction, and the fiber membrane bundle is stretched in the length direction;

[0022] The preset time t1 is maintained;

[0023] The fiber membrane bundle is restored to the original state in the length direction.

[0024] Optionally, the outer surface of the second shell is provided with a clamping protrusion, the inner surface of the first shell is provided with a limiting groove, and the clamping protrusion and the limiting groove are matched to realize limiting; and the fiber membrane bundle is stretched to the maximum length limited by the matching of the limiting groove and the clamping protrusion.

[0025] Compared with the prior art, the application provides a blood purification device, a first shell and a second shell directly or indirectly form a hollow inner cavity, and can slide relative to each other in the axial direction; when purifying blood, blood flows through the fiber membrane bundle, and the inner cavity formed by the first shell and the second shell can flow through dialysate, and material exchange occurs between the blood and the dialysate; when the fiber membrane bundle is blocked, the first shell and the second shell are relatively separated and moved in the axial direction, the fiber membrane bundle has elasticity, so that the fiber membrane bundle is stretched, the shape of each membrane tube micropore of the membrane bundle changes, a part of the blocked proteins can be squeezed out, and when the length of the membrane bundle is restored, the size of each membrane tube micropore of the membrane bundle is larger than that in the initial state, so that the blocking phenomenon is further eliminated. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to make the technical solutions of the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only constitute some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0027] Figure 1 The schematic diagram of the appearance structure of one specific embodiment of the blood purification device provided by the present application is shown in the figure.

[0028] Figure 2 The schematic diagram of the longitudinal section of one specific embodiment of the blood purification device provided by the present application is shown in the figure.

[0029] Figure 3 The schematic diagram of the local enlargement of the contact position of the first shell and the second shell is shown in the figure.

[0030] Figure 4 The schematic diagram of the local enlargement of the cooperation of the rotating handle and the first shell is shown in the figure.

[0031] Figure 5 The variation curve of the screening coefficient obtained in experiment 1 is shown in the figure.

[0032] Figure 6 The variation curve of the hemoglobin content of the filtrate obtained in experiment 1 is shown in the figure.

[0033] Figure 7 The variation curve of the screening coefficient obtained in experiment 2 is shown in the figure.

[0034] Figure 8 The variation curve of the hemoglobin content of the filtrate obtained in experiment 2 is shown in the figure.

[0035] Figure 9 The flow chart of one specific experimental process is shown in the figure.

[0036] The figure includes:

[0037] The first shell 1, the rotating bump 11, the limiting recess 12, the second shell 2, the clamping bump 21, the inner sealing ring 22, the fiber membrane bundle 3, the rotating handle 4, the rotating recess 41, the port sealing glue 5, and the end cover 6. DETAILED DESCRIPTION

[0038] The core of the present application is to provide a blood purification device, which quickly and simply eliminates the blockage problem of the membrane surface pore diameter by using the physical stretching deformation method.

[0039] In order to make those skilled in the art better understand the technical solutions of the present application, the blood purification device of the present application will be described in detail in combination with the accompanying drawings and specific embodiments.

[0040] Combining Figure 1 、 Figure 2 As shown in the accompanying drawings, the present application provides a blood purification device, which comprises a first shell 1, a second shell 2 and a fiber membrane bundle 3, etc. The first shell 1 and the second shell 2 directly form a hollow inner cavity or indirectly form a hollow inner cavity, and the first shell 1 and the second shell 2 can move relatively along the axial direction. The first shell 1 and the second shell 2 directly form a hollow inner cavity, which means that the first shell 1 and the second shell 2 are in sealed contact with each other, and a cavity is formed between the first shell 1 and the second shell 2. The first shell 1 and the second shell 2 indirectly form a hollow inner cavity, which means that there is one or more than one adapter pipe (not shown in the drawings) between the first shell 1 and the second shell 2. The first shell 1, the second shell 2 and the other adapter pipe structure are in sealed contact with each other, and a hollow cavity is formed. For more than two adapter pipes, the adapter pipes are connected by sliding and nesting each other. The two parts in relative sliding contact are sealed with each other. The adapter pipe is a cylindrical pipe with two through ends, which can be nested with its adjacent components and slide along the axial direction relatively, and the adapter pipe can keep relative sealing with its adjacent components.

[0041] The cavity formed by the first shell 1 and the second shell 2 can circulate dialysate, and the dialysate is located outside the fiber membrane bundle 3. The blood can circulate in the fiber membrane bundle 3. During the blood purification operation, the blood in the fiber membrane bundle 3 exchanges substances with the dialysate in the cavity formed by the first shell 1 and the second shell 2, so as to remove the toxins in the blood.

[0042] One end of the fiber membrane bundle 3 is fixed to the first shell 1, and the other end is fixed to the second shell 2. The fiber membrane bundle 3 has elasticity, and the fiber membrane bundle 3 can be formed by a plurality of membrane tubes. When the first shell 1 and the second shell 2 move relatively, the length of the fiber membrane bundle 3 can be changed. When the first shell 1 and the second shell 2 move relatively along the axial direction, the two ends of the fiber membrane bundle 3 move with the first shell 1 and the second shell 2 respectively, the distance between the two ends of the fiber membrane bundle 3 increases, which causes the fiber membrane bundle 3 to be stretched, and the length of the fiber membrane bundle 3 increases, but the elongation is still within the bearing range of the fiber membrane bundle 3, and the fiber membrane bundle 3 will not be broken.

[0043] The side wall of each membrane tube forming the fiber membrane bundle 3 has micropores, the fiber membrane bundle 3 is slightly stretched during purification filtration, the micropores on the side wall are kept in an open state, and material exchange occurs through the side wall micropores when blood and dialysate flow through the fiber membrane bundle respectively; as the purification process continues, a part of the micropores on the side wall are blocked, the filtration effect is reduced, and the micropores need to be unblocked; at this time, the first shell 1 and the second shell 2 move away in the opposite direction, the distance between the first shell 1 and the second shell 2 increases, the fiber membrane bundle 3 is stretched to increase the length, the side wall micropores of each membrane tube are deformed, the length of the micropores in the axial direction of the first shell 1 and the second shell 2 increases, and the width of the micropores in the width direction decreases, so that the protein and other substances blocking the micropores are extruded, the protein is extruded, and a part of the micropores are unblocked. When the first shell 1 and the second shell 2 move close in the opposite direction, the fiber membrane bundle 3 is retracted under the action of its own elasticity, and when the first shell 1 and the second shell 2 reach the initial position again, the side wall micropores gradually recover, the axial length gradually decreases, and the width gradually increases. Due to the stretching of the external force, after the fiber membrane bundle 3 returns to the original position, the size of the micropores cannot completely reach the size of the initial state, and the size of the recovered micropores is still larger than the size of the micropores in the initial state, which is equivalent to expanding the micropores, and can also eliminate a part of the blocking problem of the micropores.

[0044] The application eliminates the blocking problem through the process of stretching and recovering the fiber membrane bundle 3, uses the method of physical stretching to control the pore size of the micropores on the side wall of the membrane tube, makes the pore size of the micropores increase by a certain amplitude after being blocked, and then restores the performance of removing toxins of the membrane. The method is simple to operate, can be operated in clinical application without being taken off, does not introduce heat source, and can improve the removal capacity of middle and large molecular toxins.

[0045] On the basis of the above scheme, the application also comprises a rotating handle 4, the above provides two structural embodiments, the first one only comprises the first shell 1 and the second shell 2, and the second one is provided with a section of adapter pipeline between the first shell 1 and the second shell 2, so that the rotating handle 4 also has two different embodiments in the setting structure:

[0046] A, the rotating handle 4 is threadedly connected to one of the first shell 1 and the second shell 2, and rotationally connected to the other one, and the rotating handle 4 can drive the first shell 1 and the second shell 2 to adjust the axial length; in this embodiment, only the first shell 1 and the second shell 2 are included, and no adapter pipe is arranged, the rotating handle 4 is threadedly connected to the first shell 1, and rotates relative to the second shell 2, when the rotating handle 4 rotates, the second shell 2 moves relative to the first shell 1 along the axial direction; the axial positions of the rotating handle 4 and the second shell 2 remain unchanged, but the rotating handle 4 and the second shell 2 can rotate relative to each other, when the rotating handle 4 rotates relative to the first shell 1, the axial position of the rotating handle 4 on the first shell 1 changes, thereby driving the axial position of the second shell 2 to move, and the axial length of the entire blood purification device changes.

[0047] B, the rotating handle 4 is threadedly connected to one of the first shell 1 and the adapter pipe, the adapter pipe and the adapter pipe, and the adapter pipe and the second shell 2, and rotationally connected to the other one, and the rotating handle 4 can drive the first shell 1, the adapter pipe and the second shell 2 to adjust the axial length; this embodiment includes at least one section of the adapter pipe, and the rotating handle 4 can be arranged between any two adjacent ones of the first shell 1, the adapter pipe and the second shell 2.B1, for the structure in which one section of the adapter pipe is arranged, the rotating handle 4 can be arranged between the first shell 1 and the adapter pipe, and between the adapter pipe and the second shell 2.B2, for the structure in which two or more sections of the adapter pipe are arranged, the rotating handle 4 can be arranged between the two adjacent sections of the adapter pipe in addition to being arranged between the first shell 1 and the adapter pipe, and between the adapter pipe and the second shell 2. The rotating handle 4 can be arranged only one or more, when any one of the rotating handles 4 rotates, the axial length between the two adjacent structures changes, thereby changing the axial length of the entire blood purification device.

[0048] It should be noted that there is only axial relative movement between the second shell 2 and the first shell 1, and there is no relative circumferential rotation, so that the fiber membrane bundle 3 does not twist.

[0049] The limiting device for limiting the limit position is arranged between the first shell 1 and the second shell 2, and the axial maximum distance and the axial minimum distance between the first shell 1 and the second shell 2 are limited by the limiting device.

[0050] Combining Figure 2 and Figure 3 as shown, Figure 3 is Figure 2An enlarged view of the dashed box portion. The embodiment provided herein is to threadedly connect the rotating handle 4 to the outer surface of the second shell 2, the rotating handle 4 is a cylindrical structure, the inner wall is provided with internal threads, and the outer surface of the second shell 2 is provided with external threads.

[0051] In combination Figure 4 , the rotating handle 4 is provided with a rotating groove 41, and the edge of the first shell 1 is provided with a rotating protrusion 11, the rotating groove 41 and the rotating protrusion 11 are slidably nested with each other to achieve axial transmission, the rotating protrusion 11 is nested and installed in the rotating groove 41, and the axial transmission is achieved through the cooperation of the rotating groove 41 and the rotating protrusion 11, but the rotating groove 41 and the rotating protrusion 11 can rotate relative to each other.

[0052] In combination Figure 3 , the outer surface of the second shell 2 is protrusively provided with a clamping protrusion 21, the shape of the clamping protrusion 21 is not limited, the clamping protrusion 21 can be a continuous annular protrusion in the circumferential direction, or can be an independent split protrusion, and at least two clamping protrusions 21 are provided in the independent split protrusion. The inner surface of the first shell 1 is provided with a limiting groove 12, Figure 3 In the embodiment provided, the pipe wall at the position of the limiting groove 12 is thinner, so that the clamping protrusion 21 can extend into the limiting groove 12, and the clamping protrusion 21 cooperates with the limiting groove 12 to achieve limiting. When the clamping protrusion 21 contacts the axial end of the limiting groove 12, it cannot continue to move and reaches the limit position.

[0053] It should be noted that the present application is not limited to the specific Figure 3 In the embodiment provided, the limiting groove 12 limits the limit positions of the upper and lower ends of the clamping protrusion 21, and the shortest position of the second shell 2 and the first shell 1 can also limit the rotating handle 4 by using the protrusion provided on the second shell 2, and these specific implementation manners should be included in the protection scope of the present application.

[0054] In combination Figure 3 , the edge of the second shell 2 is provided with an inner sealing ring 22, and the inner sealing ring 22 contacts the inner wall of the first shell 1 to form a seal. The distance between the inner sealing ring 22 and the clamping protrusion 21 is greater than the axial length of the limiting groove 12. That is Figure 3 L7>L1 in the embodiment, so as to prevent the sealing ring 22 from falling into the limiting groove 12 due to sliding. The present application provides a specific structure size as an example in combination Figure 2 , L1=10mm; L2=190mm; L3=23mm; L4=15mm; L5=50mm; L6=44mm; L7=15mm.

[0055] The limiting groove 12 is provided with a scale line for identifying the position of the clamping protrusion 21, the limiting groove 12 is divided into a plurality of stops along the axial direction through the scale line, so as to facilitate indicating the position of the clamping protrusion 21.

[0056] On the basis of any of the above technical solutions, the stretching change amount of the fiber membrane bundle 3 is 1%-5% of the initial length of the fiber membrane bundle 3 or 1%-5% of the initial tension of the fiber membrane bundle 3, both of which contain end values. That is, when setting the stretching amount of the fiber membrane bundle 3, two standards can be used, one is the length change amount of the fiber membrane bundle 3, and the other is the tension change amount of the fiber membrane bundle 3. That is, the fiber membrane bundle 3 is stretched by 1%-5% based on the initial length of the fiber membrane bundle 3 or the fiber membrane bundle 3 is stretched by 1%-5% based on the initial tension of the fiber membrane bundle 3. The initial length is the length of the fiber membrane bundle 3 when it is normally used for dialysis, and the initial tension is the elasticity of the fiber membrane bundle 3 when it is normally used for dialysis.

[0057] The above-provided stretching range can prevent the fiber membrane bundle 3 from being broken, and also can achieve a relatively ideal effect of eliminating blockage. However, the present application is not limited to this stretching range.

[0058] In combination Figure 2 , the first shell 1 and the second shell 2 are respectively provided with the port sealing glue 5 and the end cover 6, the end of the first shell 1 and the end of the second shell 2 are respectively provided with the port sealing glue 5, the two ends of the fiber membrane bundle 3 are respectively filled with the port sealing glue 5, the cavity formed by the end cover 6 and the port sealing glue 5 is used for containing blood, and the end cover 6 is provided with a channel for blood to enter and exit. The side wall of the first shell 1 and the side wall of the second shell 2 are respectively provided with a channel for flowing dialysate.

[0059] In order to ensure that there is no relative rotation between the first shell 1 and the second shell 2, a guide assembly is arranged between the first shell 1 and the second shell 2, and the guide assembly only allows the first shell 1 and the second shell 2 to move in the axial direction. The guide assembly can be matched by the clamping protrusions 21 and the limiting grooves 12, or can be independently arranged in addition to the clamping protrusions 21 and the limiting grooves 12. The guide assembly is a protrusion arranged on one of the first shell 1 and the second shell 2 and a groove arranged on the other one, and preferably, the protrusion is two axially symmetrical protrusions, and the groove is two axially symmetrical grooves.

[0060] The present application also provides a use method of the blood purification device, which is applied to the above-provided blood purification device and includes the following steps:

[0061] The first housing 1 and the second housing 2 are separated from each other axially, stretching the fiber membrane bundle 3 along its length. In the above embodiment, the stretching of the fiber membrane bundle 3 can be achieved by the first housing 1 and the second housing 2 being separated axially by rotating the handle 4, thus stretching the length of the fiber membrane bundle 3; or it can be achieved through relative movement between the first housing 1 and the transfer pipe, between the two sections of the transfer pipe, and between the second housing 2 and the transfer pipe. Regardless of the stretching method used, the first housing 1 and the second housing 2 at both ends are separated from each other axially, increasing the distance between them.

[0062] Maintain for a preset time t1, that is, maintain the fiber membrane bundle 3 in a stretched state for a period of time. The preset time t1 can be several minutes or several seconds.

[0063] The fiber membrane bundle 3 is restored to its original shape along its length; the restored fiber membrane bundle 3 can continue to work normally.

[0064] In the above embodiments of the blood purification device, a locking protrusion 21 is provided on the outer surface of the second housing 2, and a limiting groove 12 is provided on the inner surface of the first housing 1. The locking protrusion 21 and the limiting groove 12 cooperate to achieve limiting. When the locking protrusion 21 and the limiting groove 12 are in contact with each other, the first housing 1 and the second housing 2 reach the position of maximum distance. The fiber membrane bundle 3 is stretched along its length, typically to the maximum stretched state, that is, stretched to the maximum length limited by the limiting groove 12 and the locking protrusion 21, so that the fiber membrane bundle 3 produces a large tensile deformation to achieve a better unblocking effect.

[0065] The following example illustrates the dialysis process:

[0066] During the initiation of dialysis treatment, the first shell 1 and the second shell 2 are in their initial state, with their total length at its shortest, and dialysis treatment proceeds according to the normal dialysis protocol. Figure 9 As shown in the process, after dialysis for 2 hours, rotate the handle 4 to increase the total length of the first shell 1 and the second shell 2 until the limiting groove 12 and the locking protrusion 21 form a limit, and the fiber membrane bundle 3 reaches the maximum stretching state. After the fiber membrane bundle 3 is held in the maximum stretching state for 1 minute, the locking protrusion is restored to the initial position until the dialysis is completed and the machine is removed.

[0067] The technical effectiveness of the blood purification device of the present invention is verified through specific experiments, using screening coefficient and blood leakage test as performance characterization.

[0068] Screening coefficient:

[0069] Take 2 new high-flux membrane pore size regulation function dialyzer respectively using 4L fresh pig blood for simulation of clinical dialysis, using 3.8% sodium citrate anticoagulation, anticoagulant and blood volume ratio is (1:9), the blood added 8mg beta2 microglobulin; according to YY0053-2016 "hemodialysis and related treatment-hemodialysis, hemodialysis filter, blood filter and blood concentrator" for screening coefficient determination, set the pump speed is 200mL / min, filter pump speed is 40mL / min. At the test 2h when the dialyzer rotating handle 4, from the initial position to stretch the fiber membrane bundle 3; 1min after the recovery to the initial position, until the end of the test. At different time sampling test beta2 microglobulin screening coefficient, repeat test 2 times, take the average value.

[0070] Blood leakage test:

[0071] Take 2 new membrane pore size regulation function dialyzer respectively using 4L fresh pig blood for simulation of clinical dialysis, using 3.8% sodium citrate anticoagulation, anticoagulant and blood volume ratio is (1:9). According to YY0053-2016 "hemodialysis and related treatment-hemodialysis, hemodialysis filter, blood filter and blood concentrator" for screening coefficient determination, set the pump speed is 200mL / min, filter pump speed is 40mL / min. At the test 2h when the dialyzer rotating handle 4, from the initial position to stretch the fiber membrane bundle 3; 1min after the recovery to the initial position, until the end of the test. Set the pump speed is 400mL / min, filter pump speed is 80mL / min. At different time sampling monitoring filter out the liquid 2h-4h time within the hemoglobin and red blood cell count, repeat test 2 times, take the average value.

[0072] Experiment 1: take 2 new membrane pore size regulation function polysulfone dialyzer respectively using 4L fresh pig blood for simulation of clinical dialysis, using 3.8% sodium citrate anticoagulation, anticoagulant and blood volume ratio is (1:9), the blood added 8mg beta2 microglobulin; according to YY0053-2016 "hemodialysis and related treatment-hemodialysis, hemodialysis filter, blood filter and blood concentrator" for screening coefficient determination, set the pump speed is 200mL / min, filter pump speed is 40mL / min. At the test 2h when the dialyzer rotating handle 4, from the initial position to stretch the fiber membrane bundle 3 to the maximum gear; 1min after the recovery to the initial position, until the end of the test. At different time sampling test beta2 microglobulin screening coefficient, repeat test 2 times, take the average value.

[0073] Table 1 test parameters

[0074] Simulated dialysis time / h 0 0.5 1 2 3 4 First screening factor 0.82 0.76 0.62 0.79 0.74 0.68 Second screening factor 0.80 0.72 0.62 0.77 0.72 0.70 Screening factor average 0.81 0.74 0.62 0.78 0.73 0.69

[0075] Combined with table 1, the screening coefficient change curve of Figure 5 is obtained.

[0076] Two new type of membrane pore size regulating function polysulfone dialyzers were taken respectively using 4L fresh pig blood for simulating clinical dialysis, using 3.8% sodium citrate anticoagulation, the ratio of anticoagulant to blood volume was (1:9). According to YY0053-2016 "Hemodialysis and related treatment-Hemodialysis, hemodialysis filter, hemofilter and blood concentrator", the pump speed was set to 200mL / min, and the filtrate pump speed was 40mL / min. At the test 2h, the dialyzer rotating handle 4 was stretched, the fiber membrane bundle 3 was stretched to the maximum stop position from the initial position; 1min later, it would return to the initial position until the test was completed. The pump speed was set to 400mL / min, and the filtrate pump speed was 80mL / min. At different time, the hemoglobin and red blood cell count in the filtrate within 2h-4h were monitored, the test was repeated twice, and the average value was taken.

[0077] Table 2 test parameters

[0078] Simulated dialysis time / h 2 2.5 3 3.5 4 First hemoglobin content / (mg / L) 0.013 0.021 0.022 0.012 0.011 Second hemoglobin content / (mg / L) 0.012 0.022 0.020 0.011 0.013 Average hemoglobin content of filtrate / (mg / L) 0.012 0.022 0.021 0.011 0.012

[0079] According to Table 2, the hemoglobin content change curve of the filtrate is obtained. Figure 6

[0080] Table 3 test parameters

[0081] Simulated dialysis time / h 2 2.5 3 3.5 4 First red blood cell number / (10^9 / L) 0 0 0 0 0 Second red blood cell number / (10^9 / L) 0 0 0 0 0 Average red blood cell number of filtrate / (10^9 / L) 0 0 0 0 0

[0082] Experiment 2:

[0083] Two new type of membrane pore size regulating function polysulfone dialyzers were taken respectively using 4L fresh pig blood for simulating clinical dialysis, using 3.8% sodium citrate anticoagulation, the ratio of anticoagulant to blood volume was (1:9). According to YY0053-2016 screening coefficient determination flow chart, the pump speed was set to 200mL / min, and the filtrate pump speed was 40mL / min. At the test 2h, the dialyzer rotating handle 4 was stretched, the fiber membrane bundle 3 was stretched to the maximum stop position from the initial position; 1min later, it would return to the initial position until the test was completed. The pump speed was set to 400mL / min, and the filtrate pump speed was 80mL / min. At different time, the hemoglobin and red blood cell count in the filtrate within 2h-4h were monitored, the test was repeated twice, and the average value was taken.

[0084] Table 4 test parameters

[0085] Simulated dialysis time / h 0 0.5 1 2 3 4 First screening factor 0.80 0.74 0.61 0.72 0.68 0.65 Second screening factor 0.78 0.71 0.61 0.71 0.67 0.66 Screening factor average 0.79 0.725 0.61 0.715 0.675 0.655

[0086] According to Table 4, the screening coefficient change curve shown in Figure 7

[0087] Table 5 test parameters

[0088] ​​ Simulated dialysis time / h 2 2.5 3 3.5 4 First hemoglobin content / (mg / L) 0.008 0.005 0.010 0.008 0.006 Second hemoglobin content / (mg / L) 0.008 0.007 0.011 0.009 0.006 Average hemoglobin content of filtrate / (mg / L) 0.008 0.006 0.0105 0.0085 0.006

[0089] The hemoglobin content change curve of the filtrate can be obtained according to Table 5. Figure 8 The hemoglobin content change curve of the filtrate can be obtained according to Table 5.

[0090] Table 6 test parameters

[0091]

[0092]

[0093] The main difference between Experiment 1 and Experiment 2 is the different stretching length of the fiber membrane bundle 3. According to the results of Experiment 1 and Experiment 2, it can be known that:

[0094] Table 1 and Figure 5 Table 4 and Figure 7 The screening coefficient change of the detection has a significant increase after 2h stretching, which proves that the blockage condition is relieved.

[0095] Table 2 and Figure 6 Table 5 and Figure 8 The hemoglobin content of the detection has no obvious change, and the red blood cell number of Table 3 and Table 6 detection is not detected, which proves that the fiber membrane bundle 3 is not damaged after stretching, and does not affect the normal blood purification process.

[0096] The above description of disclosed embodiments enables those skilled in the art to carry out or use the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to these embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A blood purification device, characterized by, It comprises a first shell (1), a second shell (2) and a fiber membrane bundle (3), the first shell (1) and the second shell (2) directly form a hollow cavity or indirectly form a hollow cavity through one or more than one adapter pipe, and can move relatively along the axial direction; The fiber membrane bundle (3) can flow through blood, and the first shell (1) and the second shell (2) form a cavity that can flow through dialysate; the fiber membrane bundle (3) has elasticity; One end of the fiber membrane bundle (3) is fixed to the first shell (1), and the other end is fixed to the second shell (2); when the first shell (1) and the second shell (2) move relatively along the axial direction, the fiber membrane bundle (3) can be stretched; It also comprises a rotating handle (4), which is threadedly connected to one of the first shell (1) and the second shell (2), and is rotationally connected to the other one, and the rotation of the rotating handle (4) can drive the first shell (1) and the second shell (2) to adjust the axial length; Alternatively, the rotating handle (4) is threadedly connected to one of the first shell (1) and the adapter pipe, the adapter pipe and the second shell (2), and is rotationally connected to the other one, and the rotation of the rotating handle (4) can drive the first shell (1), the adapter pipe and the second shell (2) to adjust the axial length.

2. The blood purification device of claim 1, wherein, The first shell (1) and the second shell (2) are provided with a limiting device for limiting the movement limit position.

3. The blood purification device of claim 2, wherein, The rotating handle (4) is threadedly connected to the outer surface of the second shell (2), the rotating handle (4) is provided with a rotating groove (41), the edge of the first shell (1) is provided with a rotating protrusion (11), the rotating protrusion (11) is embedded in the rotating groove (41), and when the rotating handle (4) is rotated by thread, the rotating groove (41) and the rotating protrusion (11) slide relative to each other, and the rotating handle (4) drives the rotating protrusion (11) to move axially through the rotating groove (41); The outer surface of the second shell (2) is provided with a clamping protrusion (21), and the inner surface of the first shell (1) is provided with a limiting groove (12), the clamping protrusion (21) and the limiting groove (12) cooperate to realize limiting.

4. The blood purification device of claim 3, wherein, The edge of the second shell (2) is provided with an inner sealing ring (22), and the distance between the inner sealing ring (22) and the clamping protrusion (21) is greater than the axial length of the limiting groove (12); The limiting groove (12) is provided with a scale line for identifying the position of the clamping protrusion (21).

5. The blood purification device according to any one of claims 1 to 4, characterized in that The stretching change of the fiber membrane bundle (3) is 1%-5% of the initial length of the fiber membrane bundle (3), or 1%-5% of the initial tension of the fiber membrane bundle (3).

6. The blood purification device of claim 5, wherein, The first shell (1) and the second shell (2) are respectively provided with port sealant (5) and end cover (6), two ends of the fiber membrane bundle (3) are respectively filled with the port sealant (5), and the end cover (6) is provided with a channel for blood to enter and exit.

7. The blood purification device of claim 5, wherein, The first shell (1) and the second shell (2) are provided with a guide assembly, and only the first shell (1) and the second shell (2) are allowed to move in the axial direction.

8. A method for using a blood purification device according to any one of claims 1 to 7, characterized in that Comprise: The first shell (1) and the second shell (2) are separated from each other in the axial direction, and the fiber membrane bundle (3) is stretched in the length direction; Maintain for a preset time t1; The fiber membrane bundle (3) is restored to its original length in the length direction.

9. The method of using a blood purification apparatus of claim 8, wherein, The outer surface of the second shell (2) is provided with a clamping convex point (21), the inner surface of the first shell (1) is provided with a limiting recess (12), and the clamping convex point (21) and the limiting recess (12) are matched to realize limiting; The fiber membrane bundle (3) is stretched in the length direction, specifically: the fiber membrane bundle (3) is stretched to the maximum length limited by the cooperation of the limiting recess (12) and the clamping convex point (21).

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