Internal filtration enhanced dialyzer

Abstract

The utility model discloses an internal filtration enhancement type dialyzer, which relates to the technical field of blood purification, and is characterized in that a support body shell and a deformation shell are relatively connected in a sealing manner to form a cylindrical shell in a surrounding manner; the inner cavity of the shell is used for allowing the hollow fiber membrane bundle to pass through; the deformation shell can deform relative to the supporting body shell, the deformation shell protrudes inwards so that the local radial size of an inner cavity of the shell can be reduced, the pressure drop of the dialysate inflow end and the dialysate outflow end can be increased, then the transmembrane pressure generated inside and outside the hollow fiber membrane bundle is increased, and the internal filtration flow is increased. By changing the shell structure of the internal filtration enhanced dialyzer, the shell structure is locally deformed, so that the pressure drop of the dialysate inflow end and the dialysate outflow end is increased, the capability of removing middle and macromolecular toxins is enhanced, and the internal filtration enhanced dialyzer is simple to operate, low in cost and high in safety.

Description

Technical Field

[0001] The utility model relates to the technical field of blood purification, and further to an inner filtration enhanced dialyzer. Background Art

[0002] Hemodialysis is one of the renal replacement therapies for patients with acute and chronic renal failure, with good therapeutic effects and high safety. So far, although the therapeutic effect of removing small molecule toxins in patients through hemodialysis has been very significant, how to better improve the removal of medium and large molecule toxins has attracted much attention.

[0003] Hemodiafiltration (HDF) is a special blood purification method based on hemodialysis. It uses a high-permeability diafiltration membrane to increase the ultrafiltration rate, filter out a large amount of body fluid containing toxins from the blood, and simultaneously input an equal amount of replacement fluid. It is a combination of hemodialysis and hemofiltration. It is significantly better than simple hemodialysis in removing medium and large molecular toxins from the patient's body.

[0004] The hemodiafiltration (HDF) treatment mode has a good clearance rate of low molecular weight proteins (medium and large molecular weight toxins), but the operation is complicated and the equipment and labor costs are high, which limits its wide application. High-flux dialyzers provide a new way to remove medium and large molecular weight toxins because of the positive correlation between the internal filtration flow and the convection effect (convection is the main way to remove medium and large molecular weight toxins). Therefore, the internal filtration flow has become a key research object.

[0005] The existing technology adopts changing the hollow fiber membrane pore design, increasing the hollow fiber length, reducing the hollow fiber inner diameter, increasing the membrane filament filling density, etc., which can improve the internal filtration flow of the beta dialyzer, but there are problems such as complex operation, high cost, and poor safety. In addition, from the perspective of clinical treatment, different patients have different degrees of kidney damage and different needs for toxin removal. The existing technology cannot meet the needs of different patients.

[0006] Therefore, developing an efficient, safe, and adjustable internal filtration enhanced hemodialyzer has important practical application value. Utility Model Content

[0007] The utility model provides an inner filtration enhanced dialyzer, a deformable shell is arranged on the support shell, and the outer shell structure of the inner filtration enhanced dialyzer is changed to make the outer shell structure partially deformed, thereby increasing the pressure drop between the inflow end and the outflow end of the dialysate, and enhancing the removal ability of medium and large molecular toxins. The utility model has simple operation, low cost and high safety. The specific scheme is as follows:

[0008] An inner filtration enhanced dialyzer comprises a shell, wherein the shell comprises a supporting shell and a deformable shell which are relatively sealed and connected, wherein the supporting shell and the deformable shell together form a cylindrical shell; the inner cavity of the shell is used for a hollow fiber membrane bundle to pass through;

[0009] The deformable shell can deform relative to the supporting shell to reduce the local radial size of the shell cavity, increase the pressure drop between the dialysate inlet and outlet ends, and further increase the transmembrane pressure generated inside and outside the hollow fiber membrane bundle, thereby increasing the internal filtration flow rate.

[0010] Optionally, the support shell and the deformation shell are integrally formed;

[0011] The thickness of the support shell is greater than the thickness of the deformable shell; a plurality of closed areas are arranged on the support shell, and each of the closed areas forms a deformable shell;

[0012] The support shell is provided with a first buckle, and the deformable shell is provided with a second buckle; when the deformable shell is squeezed inwardly, the first buckle and the second buckle are locked and matched to keep the deformable shell protruding toward the inner cavity of the shell, thereby reducing the cross-sectional area of ​​the inner cavity.

[0013] Optionally, the first buckle and the second buckle are arranged on one side of the inner cavity of the shell;

[0014] The first buckle is a female buckle, the second buckle is a male buckle, and the central area of ​​the deformable shell is arched inwardly so that the first buckle and the second buckle are buckled together.

[0015] Optionally, the width of the second buckle is not greater than 1 / 2 of the transverse width of the deformable shell, and a guide bevel is provided to guide the buckling direction, and the guide bevel has an introduction angle of 15° to 60°.

[0016] Optionally, inner surfaces of the support shell and the deformation shell are flush.

[0017] Optionally, the deformable shell is circular, elliptical or rounded rectangular.

[0018] Optionally, a group of at least two deformable shells are arranged at the same circumferential position, and two adjacent groups of deformable shells are staggered.

[0019] Optionally, the support shell is provided with at least two sections, and a cylindrical deformable shell is provided between the two sections of the support shell. The deformable shell can be squeezed inwardly so that the deformable shell protrudes toward the inner cavity of the shell, thereby reducing the cross-sectional area of ​​the inner cavity.

[0020] Optionally, it further comprises end caps arranged at both ends of the shell, the two ends of the hollow fiber membrane bundle are respectively fixed to the two ends of the shell, and the end caps are arranged to provide channels for blood circulation;

[0021] The shell is provided with a channel for the dialysate to flow.

[0022] Optionally, the housing is made of any one or two of SBS, SEBS-based TPR, ABS plastic, and polypropylene;

[0023] The filling rate of the hollow fiber membrane bundle relative to the housing is 20 to 80%.

[0024] The utility model provides an inner filtration enhanced dialyzer, wherein a support body shell and a deformable shell are relatively sealed and connected to form a cylindrical shell; the inner cavity of the shell is used for the hollow fiber membrane bundle to pass through; the deformable shell can be deformed relative to the support body shell, and the deformable shell bulges inwardly to reduce the local radial size of the inner cavity of the shell, increase the pressure drop between the dialysate inflow end and the outflow end, thereby increasing the transmembrane pressure generated inside and outside the hollow fiber membrane bundle, and increasing the inner filtration flow rate. The utility model changes the outer shell structure of the inner filtration enhanced dialyzer, causing the outer shell structure to be partially deformed, thereby increasing the pressure drop between the dialysate inflow end and the outflow end, enhancing the ability to remove medium and large molecular toxins, and is simple to operate, low cost, and high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 This is a schematic structural diagram of the first embodiment of the inner filtration enhanced dialyzer provided by the utility model, in which the deformable shell is in an undeformed state;

[0027] Figure 2 This is a schematic structural diagram of a first embodiment of the inner filtration enhanced dialyzer provided by the utility model, in which the deformable shell is deformed;

[0028] Figure 3 A side cross-sectional view of a first embodiment of the inner filtration enhanced dialyzer provided by the utility model, in which the deformable shell is deformed;

[0029] Figure 4 A schematic diagram of the inner filtration enhanced dialyzer provided by the utility model being applied to a dialysis process;

[0030] Figure 5A front view schematic diagram of a second embodiment of the inner filtration enhanced dialyzer provided by the utility model, in which the deformable shell is not deformed;

[0031] Figure 6 A front view schematic diagram of a second embodiment of the inner filtration enhanced dialyzer provided by the utility model showing a deformed state of the deformable shell;

[0032] Figure 7 This is a curve of the transmembrane pressure change on both sides of the pressure method model membrane.

[0033] The figure includes:

[0034] Shell 1 , support shell 11 , deformation shell 12 , first buckle 13 , second buckle 14 , hollow fiber membrane bundle 2 , end cover 3 , dialyzer 4 , dialysate outlet 41 , dialysate recovery port 42 , blood pump 5 . DETAILED DESCRIPTION

[0035] In order to enable those skilled in the art to better understand the technical solution of the present invention, the inner filtration enhanced dialyzer of the present invention will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0036] Combination Figure 1 , Figure 2 As shown, the utility model provides an inner filtration enhanced dialyzer. Figure 1 The middle part shows the cross-sectional structure of the middle area of ​​the shell, and the circular area on the right shows an enlarged view of the local structure of the cross-sectional area; Figure 2 The middle part shows the cross-sectional structure of the middle area of ​​the shell, and the circular area on the right shows an enlarged view of the local structure of the cross-sectional area.

[0037] The inner filtration enhanced dialyzer comprises a shell 1, which is set to be through-connected at both ends, one end of the shell 1 is the inflow end, and the other end is the outflow end. Generally, the shell 1 is a cylindrical structure, and the inner cavity of the shell 1 is used for the hollow fiber membrane bundle 2 to pass through. The shell 1 comprises a support body shell 11 and a deformable shell 12 which are relatively sealed and connected. The support body shell 11 and the deformable shell 12 are kept in a sealed connection, and the connection position is kept sealed to avoid internal liquid leakage. The support body shell 11 and the deformable shell 12 can be made of the same material, or they can be made of different materials spliced ​​together; when the same material is used, the deformation of the support body shell 11 and the deformable shell 12 can be achieved by controlling the thickness; when different materials are used, the strength of the support body shell 11 is greater than the strength of the deformable shell 12, the support body shell 11 can be regarded as a rigid body, and the deformable shell 12 can be regarded as an elastic body or a plastic body, the deformation of the support body shell 11 can be ignored, and the deformable shell 12 can undergo elastic or plastic deformation. The supporting body shell 11 and the deformable shell 12 can be processed in an integrally formed manner, or can be manufactured separately and sealed and spliced.

[0038] The support shell 11 and the deformable shell 12 together form a cylindrical shell 1, and the support shell 11 and the deformable shell 12 respectively form a part of the side wall of the shell 1. The inner cavity of the shell 1 is used for the hollow fiber membrane bundle 2 to pass through. The length direction of the hollow fiber membrane bundle 2 is parallel to the length direction of the shell 1 and extends in the same direction. The space between the hollow fiber membrane bundle 2 and the shell 1 is for the dialysate to circulate, and the inside of the hollow fiber membrane bundle 2 is for the blood to circulate. When in use, combined with Figure 4 As shown, the blood and dialysate flow in opposite directions. Figure 4 It includes a dialyzer 4 and a blood pump 5, which pump the patient's blood into the dialyzer; 41 is the dialysate outlet of the dialyzer, and 42 is the dialysate recovery port of the dialyzer.

[0039] When using, follow Figure 4 The dialyzer is connected to the dialysis machine and forms a dialysis cycle with the patient, wherein the blood and the dialysate flow in the directions indicated by the arrows in the figure. After the treatment has been running stably for 1 hour, samples are taken at the blood inlet and blood outlet of the dialyzer to test the toxin clearance rate. If the clearance test result does not reach the expected clearance effect, the deformable shell 12 is pushed in to improve the treatment effect; and during the treatment process, if the patient has no adverse feelings, the deformable shell 12 can be further pushed in according to the above steps to achieve a higher level of treatment effect. The utility model does not need to be connected to other exogenous devices, and can achieve the same treatment effect in the hemodialysis filtration treatment mode in a simple hemodialysis treatment mode.

[0040] The deformable shell 12 can be deformed relative to the supporting body shell 11, and the deformation direction of the deformable shell 12 is toward the inner cavity of the shell 1, so that the deformable shell 12 bulges toward the inner cavity of the shell 1, and in the area where the deformable shell 12 deforms inward, the local radial size of the inner cavity of the shell 1 is reduced, and the radial size reduction of the shell 1 occurs at the position of the deformable shell 12, not the entire area of ​​the shell 1. Each deformable shell 12 can be deformed independently, and the number of deformable shells 12 that are deformed can be controlled according to usage requirements, so that a part of the deformable shells 12 are deformed, or all of the deformable shells 12 are deformed.

[0041] When the deformable shell 12 is deformed to bulge inward, the local inner diameter of the shell 1 is reduced. Under the same dialysate flow rate, the flow rate of the reduced inner diameter area of ​​the shell 1 increases, the flow rate of the dialysate changes, and then the pressure difference between the blood and the dialysate changes. That is, the utility model increases the pressure drop between the dialysate inflow end and the outflow end of the shell 1 by changing the local inner diameter of the shell 1, thereby increasing the transmembrane pressure generated inside and outside the hollow fiber membrane bundle 2 and increasing the internal filtration flow rate.

[0042] The internal filtration flow rate is calculated by geometric model simulation, assuming that the pressure difference between blood and dialysate is linear, and the slope changes when the pressure difference is zero. The calculation can be performed by simply detecting the inlet and outlet pressures on the dialysate side and the blood side:

[0043] Assuming that the pressure difference between blood and dialysate is linear, the slope changes when the pressure difference is zero, such as Figure 7 As shown:

[0044] The pressure method is used to calculate the internal filtration flow rate equation as follows:

[0045] 1) Transmembrane pressure TMP (mmHg):

[0046]

[0047] in:

[0048] P BI : blood inlet pressure, mmHg;

[0049] P BO : Blood outlet pressure, mmHg;

[0050] P DI : dialysate inlet pressure, mmHg;

[0051] P DO : Dialysate outlet pressure, mmHg.

[0052] 2) Ultrafiltration rate UFR (mL / mmHg·h):

[0053]

[0054] in:

[0055] Q UF : Net ultrafiltration flow, mL / min (set);

[0056] 3) Internal filtration flow rate Q IF (mL / min):

[0057] TMP I =P BI -P DO

[0058] TMP O =P BO -P DI

[0059]

[0060]

[0061] Q IF =Q BF +Q UF

[0062] in:

[0063] TMP I : Transmembrane pressure at blood inlet, mmHg;

[0064] TMP O : Transmembrane pressure at blood outlet, mmHg;

[0065] Q BF : Overtaking flow rate, mL / min;

[0066] x0: point where transmembrane pressure is zero (TMP=0), cm.

[0067] From the description of the calculation of the inner filtration flow rate by the pressure method, it can be seen that the net ultrafiltration flow rate is calculated on both sides of the zero point with the transmembrane pressure as the zero point as the dividing line. According to the law of conservation of mass, the inner filtration flow rate Q IF It is the overtaking flow Q BF and net ultrafiltration flow Q UF The sum of the two is obtained by solving the equation to obtain the point x0 where the transmembrane pressure is zero. Substituting x0 into the internal filtration flow calculation equation again can obtain the corresponding value.

[0068] Therefore, the greater the pressure drop from the inlet to the outlet on the blood side or the dialysate side, the greater the transmembrane pressure on both sides of the hollow fiber membrane, and the more conducive to the occurrence of the inner filtration phenomenon. The equivalent diameter of the dialysate side at the position where the deformable shell 12 is pushed in is reduced, and the pressure drop at both ends of the dialysate side is increased, which in turn leads to a greater transmembrane pressure inside and outside the membrane, increasing the inner filtration flow rate, enhancing the transmembrane transport capacity of the fluid, and improving the removal capacity of medium and large molecular toxins. The utility model can improve the removal capacity of medium and large molecular toxins by only changing the local inner diameter size of the shell 1, and is simple to operate, low cost, and high safety.

[0069] On the basis of the above scheme, the utility model provides a specific setting form, the support body shell 11 and the deformable shell 12 are integrally formed, which can be easily processed and manufactured. The thickness of the support body shell 11 is greater than the thickness of the deformable shell 12. The thickness of the support body shell 11 is set to 1.5 to 4 mm, and the deformable shell 12 is thinned and designed to be 1 / 4 to 2 / 3 of the thickness of the support body shell 11.

[0070] The thickness of the support shell 11 is greater than that of the deformation shell 12, so as to ensure that the support shell 11 has sufficient strength and the deformation shell 12 can be deformed. Figure 1 , Figure 2 In the illustrated embodiment, a plurality of closed areas are provided on the support shell 11, the thickness of each closed area is less than the thickness of the support shell 11, and each closed area forms a deformable shell 12, which can be deformed by bulging inwards by pressing inwards.

[0071] Combination Figure 1 , Figure 2As shown in the enlarged structure of FIG, the support body shell 11 is provided with a first buckle 13, and the deformable shell 12 is provided with a second buckle 14. The first buckle 13 and the second buckle 14 can be fastened with each other. The first buckle 13 is located at the edge of the support body shell 11, and the second buckle 14 is located at the edge of the deformable shell 12. Figure 1 When the deformable shell 12 is not deformed, the first buckle 13 and the second buckle 14 are in a non-fastening state; Figure 2 When the deformable shell 12 is squeezed inward by an external force, the deformation degree of the middle area of ​​the deformable shell 12 is the largest, and the deformation degree of the edge area is smaller. When the deformable shell 12 is deformed, the second buckle 14 rotates around the connection position between the deformable shell 12 and the supporting shell 11, and the second buckle 14 approaches the first buckle 13, and finally the first buckle 13 and the second buckle 14 are locked and matched to keep the deformable shell 12 protruding toward the inner cavity of the shell 1, thereby reducing the cross-sectional area of ​​the inner cavity. In this embodiment, the middle area of ​​the deformable shell 12 is arched and protruding, the deformation amplitude in the middle is large, and the deformation amplitude at the edge is small. The deformation amplitudes of various positions of the entire deformable shell 12 are not completely equal. Figure 2 As shown, the maximum position of the deformable shell 12 protruding toward the inner cavity exceeds the inner surface of the supporting shell 11, so that the position where the deformable shell 12 is located reduces the inner diameter of the shell 1. The second buckle 14 is buckled close to the first buckle 13 to prevent the deformable shell 12 from rebounding.

[0072] Combination Figure 1 , Figure 2 As shown, in this embodiment, a plurality of deformable shells 12 are distributed in an array on the support shell 11. By individually changing the state of each deformable shell 12 and setting a corresponding number of deformable shells 12 at appropriate positions, different numbers and positions of deformation can achieve different degrees of adjustment of the internal filtration flow rate.

[0073] Going further, combined Figure 1 As shown, the first buckle 13 and the second buckle 14 are arranged on one side of the inner cavity of the shell 1, and the first buckle 13 and the second buckle 14 can contact the dialysate inside. The first buckle 13 is a female buckle, and the second buckle 14 is a male buckle. The central area of ​​the deformable shell 12 is arched inward, so that the first buckle 13 and the second buckle 14 are buckled. Figure 1 As shown, the first buckle 13 is a wedge-shaped pointed protrusion, and the second buckle 14 includes a cantilever and a wedge-shaped pointed protrusion arranged at the end of the cantilever, and the two wedge-shaped pointed protrusions can be hooked with each other. The second buckle 14 is arranged at the edge of the deformable shell 12, at least at two opposite side positions, and four or more second buckles 14 can also be arranged. The first buckle 13 and the second buckle 14 are arranged correspondingly, and are set according to the needs of use.

[0074] Specifically, the width of the second buckle 14 is not greater than 1 / 2 of the lateral width of the deformable shell 12. The width referred to here is Figure 1 A guide angle is provided to guide the buckling direction, and the guide angle is 15° to 60°, preferably 30° to 45°. Figure 1 The included angle α is shown in the figure. The introduction angles of the second buckle 14 and the first buckle 13 are equal. After the deformable shell 12 is pushed in, the second buckle 14 moves in the introduction direction and is buckled with the first buckle 13, as shown in FIG. Figure 2 As shown, after the external force of pushing in is lost, the position of the deformable shell 12 can be fixed based on the locking effect of the buckle to prevent it from popping out.

[0075] In one embodiment, in combination Figure 1 As shown, when the deformable shell 12 is not deformed, the inner surfaces of the support shell 11 and the deformable shell 12 are flush, and a recessed step is formed between the outer surface of the deformable shell 12 and the support shell 11. The deformable shell 12 and the support shell 11 may also be designed with uneven inner surfaces.

[0076] Specifically, the deformable shell 12 is circular, elliptical or rounded rectangular, and can adopt different shapes. Usually, the long side of the deformable shell 12 is parallel to the length direction of the shell 1. The deformable shell 12 is circular or elliptical, which can be easily pushed in, wherein the long semi-axis direction of the ellipse corresponds to the axial direction of the shell, and the short semi-axis direction corresponds to the lateral direction of the dialyzer.

[0077] The size and number of the deformable shells 12 are related to the size of the shell itself: 1 to 12 deformable shells 12 should be evenly set in the cross-sectional direction of the shell 1, preferably 3 to 8, and the size should meet the requirement that there is at least 5 mm spacing between the deformable shells 12; this setting can facilitate the insertion of different numbers of deformable shells 12 according to actual needs to meet the needs of different patients. The equivalent diameter of the dialysate side at the position where the deformable shell 12 is pushed in is reduced, and the pressure drop at both ends of the dialysate side is increased, which leads to a greater transmembrane pressure inside and outside the membrane filaments, increases the internal filtration flow rate, enhances the transmembrane transport capacity of the fluid, and improves the removal capacity of medium and large molecular toxins.

[0078] Combination Figure 1 , Figure 2 As shown, the multiple deformable shells 12 can be regarded as multiple groups, at least two deformable shells are divided into one group, at least two deformable shells 12 in one group are arranged at the same circumferential position, that is, the deformable shells 12 with the same axial position are regarded as one group, and the two adjacent groups of deformable shells 12 are staggered. The deformable shells 12 are not closely connected, and there is a certain spacing between them in the transverse and longitudinal directions to avoid excessive resistance when the dialysate flows through the deformable shells 12.

[0079] Combination Figure 5 , Figure 6 As shown, the utility model provides another embodiment, the support body shell 11 is provided with at least two sections. Figure 5 , Figure 6 The three-section support body shell 11 is taken as an example. A cylindrical deformable shell 12 is arranged between two adjacent sections of the support body shell 11. The deformable shell 12 is a ring-shaped thin shell structure. The deformable shell 12 can be squeezed inwardly so that the deformable shell 12 protrudes toward the inner cavity of the shell body 1, thereby reducing the cross-sectional area of ​​the inner cavity. In this embodiment, the deformable shell 12 can be squeezed inwardly by an external constraint structure, such as an elastic ring, a rope, etc.; the deformable shell 12 can also be made of special materials, such as heat shrinkable materials, and the deformable shell 12 can be shrunk and deformed by heating. The deformable shell 12 can be Figure 5 The state shown is contracted to Figure 6 In this embodiment, the entire deformable shell 12 can undergo shrinkage deformation in the circumferential direction, and the area where the deformable shell 12 is located can undergo shrinkage deformation in the entire circumferential direction.

[0080] Based on any of the above-mentioned technical solutions and their mutual combinations, the utility model also includes end caps 3 arranged at both ends of the shell 1, and the two ends of the hollow fiber membrane bundle 2 are respectively fixed at the two ends of the shell 1. The end caps 3 are provided with a channel for blood circulation, which is used to connect the extracorporeal blood circulation circuit; a channel for dialysate circulation is provided on the shell 1, which is used to connect the pipeline for transporting the dialysate.

[0081] The shell 1 is made of any one or two of SBS, SEBS-based TPR, ABS plastic, and polypropylene; the filling rate of the hollow fiber membrane bundle 2 relative to the shell 1 is 20-80%, and more preferably 40-70%. The entire shell 1 can be injection molded or sealed spliced. TPR is a modified material based on thermoplastic styrene-butadiene rubber (such as SBS, SEBS) as the basic raw material, with added resin (such as PP, PS), filler, plasticizer oil and other functional additives.

[0082] Specific experiment 1:

[0083] according to Figure 4 The dialyzer is connected to the dialysis machine, wherein the dialyzer shell is 271 mm long and 42 mm in inner diameter. The dialyzer is provided with 30 longitudinal elliptical deformable shells 12 (5 in cross section and 6 rows in axial direction), the major semi-axis length of the deformable shell 12 is 10 mm, the minor semi-axis length is 5 mm, and the blood flow Q is set on the dialysis machine. B =200mL / min, dialysate flow rate Q D =500mL / min, dehydration volume Q F=10mL / min, pig blood is used as the simulated fluid to replace the patient to form a dialysis cycle. After running stably for 60 minutes, take samples from the blood side inlet and outlet, test the β2-microglobulin clearance rate, read the pressure gauge data, and calculate the internal filtration flow rate at this time; after pushing in two rows of deformable shells 12 by pressing, continue to run for 60 minutes, take samples from the blood side inlet and outlet, test the β2-microglobulin clearance rate, read the pressure gauge data, and calculate the internal filtration flow rate at this time; then press and push all the deformable shells 12, run for 60 minutes, take samples from the blood side inlet and outlet, test the β2-microglobulin clearance rate, read the pressure gauge data, and calculate the internal filtration flow rate at this time. The experimental data are shown in Table 1.

[0084] Table 1. β2-microglobulin clearance and internal filtration flow

[0085] Variable shell push amount (row) 0 2 6 <![CDATA[β2 - microglobulin clearance rate (mL / min)]]> 60.3 63.7 66.8 Internal filtration flow rate (mL / min) 20.33 24.38 28.02

[0086] Specific experiment 2:

[0087] according to Figure 4 The dialyzer is connected to the dialysis machine, wherein the dialyzer (shell length 230 mm, inner diameter 35 mm) is provided with 16 circular deformable shells 12 (2 in cross section, 8 rows in axial direction), the radius of the deformable shell 12 is 12 mm, and the blood flow Q is set on the dialysis machine. B =200mL / min, dialysate flow rate Q D =500mL / min, dehydration volume Q F =10mL / min, pig blood is used as a simulated fluid to replace the patient to form a dialysis cycle. After running for 60 minutes, samples of the blood side inlet and outlet are taken to test the β2-microglobulin clearance rate, and the pressure gauge data is read to calculate the internal filtration flow rate at this time; after pushing in four rows of deformable shells 12 by pressing, continue to run for 60 minutes, take samples of the blood side inlet and outlet, test the β2-microglobulin clearance rate, read the pressure gauge data, and calculate the internal filtration flow rate at this time; after all the deformable shells 12 are pressed and pushed in, run for 60 minutes, take samples of the blood side inlet and outlet, test the β2-microglobulin clearance rate, read the pressure gauge data, and calculate the internal filtration flow rate at this time. The experimental data are shown in Table 2.

[0088] Table 2. β2-microglobulin clearance and internal filtration flow

[0089] Variable shell push amount (row) 0 4 8 <![CDATA[β2 - microglobulin clearance rate (mL / min)]]> 42.1 47.7 50.0 Internal filtration flow rate (mL / min) 12.61 16.24 19.09

[0090] It can be seen from the above data that pushing in the deformable shell 12 can increase the internal filtration flow rate of the dialyzer, and the internal filtration flow rate of the dialyzer can be controlled by different pushing numbers to meet the dialysis needs of different patients.

[0091] The utility model designs the dialyzer shell into two parts: a support shell 11 and a deformable shell 12. Pushing the deformable shell 12 can control the equivalent diameter of the dialyzer on the dialysate side, increase the pressure drop at both ends of the dialysate, generate a greater transmembrane pressure inside and outside the membrane filaments, increase the inner filtration flow rate, and realize a design of an adjustable inner filtration enhanced dialyzer.

[0092] Comprehensively considering the economic cost of dialyzer preparation, the treatment effect of the dialyzer, and the convenience of dialyzer use to improve the internal filtration flow rate has the least impact on the clinical treatment process, the lowest technical difficulty, the highest possibility of implementation, and the best safety compared to other solutions. The dialyzer shell is designed to be two parts, and is thinned at regular positions on the uniform support shell, so that the resistance of the shell at this position is reduced when it is pushed inward, and it can be pushed in manually, that is, the deformed shell 12, which can reduce the equivalent diameter of the dialysate side at this position after being pushed in, increase the pressure drop at both ends of the dialysate side, enhance the internal filtration flow rate, and enhance the toxin operation efficiency; different numbers of deformed shells 12 are pushed in to control the internal filtration flow rate of the dialyzer, so as to meet the treatment needs of different patients; and the entire shell can be formed by injection molding of a single material, without introducing other new materials, and without causing other potential safety problems.

[0093] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be 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 present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An inner filtration enhanced dialyzer, characterized in that: The invention comprises a shell (1), wherein the shell (1) comprises a supporting shell (11) and a deformable shell (12) which are relatively sealed and connected, wherein the supporting shell (11) and the deformable shell (12) together form the cylindrical shell (1); the inner cavity of the shell (1) is used for allowing the hollow fiber membrane bundle (2) to pass through; The deformable shell (12) can be deformed relative to the support shell (11) so as to reduce the local radial dimension of the inner cavity of the shell (1), thereby increasing the pressure drop between the dialysate inlet and outlet ends, thereby increasing the transmembrane pressure generated inside and outside the hollow fiber membrane bundle (2) and increasing the internal filtration flow rate.

2. The inner filtration enhanced dialyzer according to claim 1, characterized in that: The support body shell (11) and the deformation shell (12) are integrally formed; The thickness of the support shell (11) is greater than the thickness of the deformable shell (12); a plurality of closed areas are provided on the support shell (11), and each of the closed areas forms a deformable shell (12); The support shell (11) is provided with a first snap buckle (13), and the deformable shell (12) is provided with a second snap buckle (14); when the deformable shell (12) is pressed inwardly, the first snap buckle (13) and the second snap buckle (14) are locked and matched to keep the deformable shell (12) protruding toward the inner cavity of the shell (1), thereby reducing the cross-sectional area of ​​the inner cavity.

3. The inner filtration enhanced dialyzer according to claim 2, characterized in that: The first buckle (13) and the second buckle (14) are arranged on one side of the inner cavity of the shell (1); The first buckle (13) is a female buckle, the second buckle (14) is a male buckle, and the central area of ​​the deformable shell (12) is arched inwards, so that the first buckle (13) and the second buckle (14) are buckled.

4. The inner filtration enhanced dialyzer according to claim 3, characterized in that: The width of the second buckle (14) is no greater than 1 / 2 of the transverse width of the deformable shell (12), and a guide bevel is provided to guide the buckling direction, and the guide bevel has an introduction angle of 15° to 60°.

5. The inner filtration enhanced dialyzer according to claim 2, characterized in that: The inner surfaces of the support shell (11) and the deformation shell (12) are flush.

6. The inner filtration enhanced dialyzer according to claim 2, characterized in that: The deformable shell (12) is circular, elliptical or rounded rectangular.

7. The inner filtration enhanced dialyzer according to claim 2, characterized in that: A group of at least two deformable shells (12) are arranged at the same circumferential position, and two adjacent groups of deformable shells (12) are staggeredly distributed.

8. The inner filtration enhanced dialyzer according to claim 1, characterized in that: The support body shell (11) is provided with at least two sections, and a cylindrical deformable shell (12) is provided between the two sections of the support body shell (11). The deformable shell (12) can be pressed inwardly so that the deformable shell (12) protrudes toward the inner cavity of the shell body (1), thereby reducing the cross-sectional area of ​​the inner cavity.

9. The inner filtration enhanced dialyzer according to any one of claims 1 to 8, characterized in that: It also includes end covers (3) arranged at both ends of the shell (1), the two ends of the hollow fiber membrane bundle (2) are respectively fixed to the two ends of the shell (1), and the end covers (3) are provided with channels for blood circulation; The housing (1) is provided with a channel for the circulation of dialysate.

10. The inner filtration enhanced dialyzer according to claim 9, characterized in that: The housing (1) is made of any one or two of SBS, SEBS-based TPR, ABS plastic, and polypropylene; The filling rate of the hollow fiber membrane bundle (2) relative to the shell (1) is 20 to 80%.

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