Manufacturing method of hemodialyzer

Abstract

A manufacturing method of a hemodialyzer comprises the steps that after a tightening ring and a fixing ring are assembled, the tightening ring and the fixing ring are screwed with the threaded end of a dialyzer shell to form a shell assembly; extracting the PE outer wrapping membrane of the hollow fiber bundle arranged in the shell assembly, and blowing away the hollow fiber bundle at the end part of the shell assembly to form uniformly distributed hollow fiber membrane filaments; welding the aluminum sheet with the end parts of the hollow fiber membrane filaments and the tightening ring so as to melt the end parts of the hollow fiber membrane filaments and bond the tightening ring and the aluminum sheet together; injecting glue; and cutting rubber. According to the dialyzer, the tightening ring and the fixing ring are adopted, so that the sealing performance between the dialyzer shell and the tightening ring is enhanced, the phenomenon of glue leakage on the inner wall is avoided, meanwhile, the thickness of the tightening ring is small, the use amount of glue can be reduced, and therefore the cost is saved. The sealing performance of the end part is enhanced through a film sealing mode of sintering an aluminum sheet, the glue leakage phenomenon of the end part is avoided, meanwhile, the hollow fiber membrane filaments at the two ends are uniformly distributed, and the dialysis effect can be effectively improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a method for manufacturing a hemodialyzer. Background Art

[0002] The production process of hemodialyzers is roughly divided into: film sealing process, glue injection process, glue cutting process, wet water leak detection process, drying process and integrity testing process. Among them, the film sealing process is a key process in the production of hemodialyzers, which is to seal the ends of tens of thousands of tiny hollow fiber filaments inside the dialyzer and then install the glue filling cap, so as to prevent glue from entering the hollow fiber membrane during the later glue injection, causing the hollow fiber membrane to block the holes and affect the membrane utilization rate.

[0003] At present, the commonly used film sealing processes on the market are: 1. Direct heating and sintering process, generally using a tool to clamp the membrane filaments at both ends of the dialyzer shell equipped with hollow fiber membranes, and then directly heat and sinter them. After completion, install the glue filling cover for glue injection. With this clamping method, the sealing performance between the tool and the end of the dialyzer shell is poor, and glue leakage is prone to occur. 2. The sintering film sealing method that uses plastic film materials to directly wrap the membrane filaments. There are many situations in this film sealing process where the two ends of the hollow fiber membrane filaments cannot be completely sealed. At the same time, the membrane filaments or membrane materials will remain on the two end surfaces of the dialyzer shell and the heating tooling, and they need to be cleaned before the glue filling cover can be installed for glue injection. If the glue filling cover is installed without clearing the residue, there will be a gap between the shell and the glue filling cover. When injecting glue, glue will leak out of the gap and the product will be scrapped.

[0004] In addition, the existing assembly method of the glue-filled cover is to connect the two ends of the dialyzer shell by snap-fit ​​to achieve the effect of glue injection sealing. However, the snap-fit ​​is easy to deform and the buckle position is not tight, which makes it easy for glue to leak between the connection between the glue-filled cover and the dialyzer shell during the glue injection production process, resulting in a high scrap rate of the product. At the same time, the internal volume of the glue-filled cover is large, and more glue is required to fill it, thereby increasing the production cost, and therefore cannot meet the needs of continuous large-scale production. Summary of the invention

[0005] Based on this, the purpose of the present invention is to provide a method for manufacturing a hemodialyzer, which can avoid glue leakage, improve the product qualification rate and reduce production costs.

[0006] A method for manufacturing a hemodialyzer comprises the following steps: Step S10, assembling the tightening ring and the fixing ring, and then tightening them with the threaded end of the dialyzer housing to form a housing assembly; Step S11, extracting the PE outer membrane of the hollow fiber bundle loaded into the shell component, and blowing the hollow fiber bundle at the end of the shell component to form evenly distributed hollow fiber membranes; Step S12, welding the aluminum sheet, the end of the hollow fiber membrane and the tightening ring, so that the end of the hollow fiber membrane is melted and the tightening ring and the aluminum sheet are bonded together; Step S13, centrifugally injecting glue from the injection hole of the dialyzer housing and curing it, so that the end of the hollow fiber membrane is integrated with the end of the dialyzer housing and the tightening ring; Step S14, after removing the fixing ring, cutting off the tightening ring, and installing the sealing ring and the dialyzer end cover to form a finished hemodialyzer.

[0007] Furthermore, one end of the tightening ring protrudes from the outer end surface of the fixing ring, and the other end is pressed by the fixing ring and fits with the end of the dialyzer housing.

[0008] Further, the tightening ring comprises a step end and a protruding pointed end connected to each other, and the protruding pointed end protrudes from the outer end surface of the fixing ring; The outer wall of the step end is in contact with the inner wall of the fixing ring, and the end surface of the step end is in contact with the end surface of the dialyzer housing.

[0009] Furthermore, the interior of the protruding pointed end includes a straight channel connected to the step end, and an inclined channel connected to the straight channel; From inside to outside, the inner diameter of the inclined channel gradually increases.

[0010] Furthermore, the inner diameter of the straight channel is smaller than the inner diameters of the two ends of the dialyzer housing, and the inner wall inclination angle of the inclined channel is 5° to 80°.

[0011] Furthermore, the end of the fixing ring extends toward the center line to form a pressing ring, and the pressing ring presses the step end.

[0012] Furthermore, the hardness of the fixing ring is greater than the hardness of the tightening ring.

[0013] Furthermore, before welding, the end of the hollow fiber membrane protrudes from the end of the tightening ring by a distance of 3 mm to 20 mm.

[0014] Furthermore, the thickness of the aluminum sheet is 0.01 mm to 0.2 mm, and the diameter of the aluminum sheet is not less than the diameter of the tightening ring.

[0015] Furthermore, one end surface of the sealing ring contacts the dialyzer end cover, and the other end surface contacts the cured rubber surface in the dialyzer housing.

[0016] Compared with the prior art, in the present invention, by adopting a tightening ring and a fixing ring, the sealing performance between the dialyzer housing and the fixing ring is enhanced to avoid glue leakage on the inner wall. At the same time, the thickness of the tightening ring is small, which can reduce the amount of glue used, thereby saving costs. The sealing method of sintering the aluminum sheet is used to enhance the sealing performance of the end, avoid glue leakage at the end, and the hollow fiber membrane filaments at both ends are evenly distributed, which can effectively improve the dialysis effect. In addition, due to the good sealing effect, the fixing ring will not stick to glue, so it can be reused, thereby saving costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a structural schematic diagram of the hemodialyzer in the present invention; Figure 2 for Figure 1 A cross-sectional schematic diagram of a hemodialyzer; Figure 3 for Figure 2 The right end of the enlarged picture; Figure 4 It is a cross-sectional schematic diagram of the hemodialyzer of the present invention before sealing; Figure 5 for Figure 4 Enlarged view on the right.

[0018] Description of main component symbols: 10. Tightening ring; 11. Fixing ring; 12. Dialyzer housing; 13. Hollow fiber membrane; 14. Aluminum sheet; 15. Sealing ring; 16. Dialyzer end cap; 17. Rubber surface.

[0019] The following specific implementation manner will further illustrate the present invention in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0020] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. Several embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.

[0021] See also Figures 1 to 5 A method for manufacturing a hemodialyzer provided in one embodiment of the present invention comprises the following steps: Step S10, assembling the tightening ring 10 and the fixing ring 11, and then tightening them with the threaded end of the dialyzer housing 12 to form a housing assembly; Step S11, extracting the PE outer membrane of the hollow fiber bundle loaded into the shell component, and blowing the hollow fiber bundle at the end of the shell component to form evenly distributed hollow fiber membranes 13; Specifically, in this step, the PE membrane outpacking is to fix tens of thousands of hollow fiber membrane filaments into a cylindrical bundle structure. After the hollow fiber membrane bundle is assembled with the dialyzer shell assembly, the PE membrane outpacking is pulled out through the equipment tooling, and then blown away by an automatic air gun by rotating 360°, thereby completing the assembly of the hollow fiber membrane filaments and the dialyzer shell assembly.

[0022] Step S12, welding the aluminum sheet 14, the end of the hollow fiber membrane 13 and the tightening ring 10, so that the end of the hollow fiber membrane is melted and the tightening ring 10 and the aluminum sheet 14 are bonded together; Specifically, in this step, the equipment automatically places the aluminum sheet 14 inside the tooling of the sintering equipment and fixes it, and the heated welding head slowly pushes the aluminum sheet 14 a certain distance so that the aluminum sheet 14 fits with the end of the hollow fiber membrane 13 for sintering.

[0023] Step S13, centrifugally injecting glue from the injection hole of the dialyzer housing 12 and curing it, so that the end of the hollow fiber membrane 13, the end of the dialyzer housing 12 and the tightening ring 10 are integrated; Step S14, after removing the fixing ring 11, cutting off the tightening ring 10, and installing the sealing ring 15 and the dialyzer end cover 16 to form a finished hemodialyzer.

[0024] It should be noted that in the present invention, by adopting a tightening ring 10 and a fixing ring 11, the sealing performance between the dialyzer housing 12 and the fixing ring 11 is enhanced to avoid glue leakage on the inner wall. At the same time, the thickness of the tightening ring 10 is small, which can reduce the amount of glue (the amount of glue can be reduced by about 1 / 4 to 1 / 3), thereby saving costs. The sealing method of sintering the aluminum sheet 14 can enhance the sealing performance of the end and avoid glue leakage at the end. At the same time, the hollow fiber membrane filaments 13 at both ends are evenly distributed, which can effectively improve the dialysis effect. In addition, due to the good sealing effect, there will be no glue on the fixing ring, so it can be reused, thereby saving costs.

[0025] See also Figure 4 and Figure 5 In a preferred embodiment of the present application, one end of the tightening ring 10 protrudes from the outer end surface of the fixing ring 11 , and the other end is pressed by the fixing ring 11 and fits with the end of the dialyzer housing 12 .

[0026] It should be noted that the hardness of the fixing ring 11 is greater than that of the tightening ring 10 , so that the fixing ring 11 can compress the tightening ring 10 and improve the sealing performance.

[0027] See also Figure 4 and Figure 5In a preferred embodiment of the present invention, the tightening ring 10 includes a step end and a protruding pointed end connected to each other, and the protruding pointed end protrudes from the outer end surface of the fixing ring 11 to facilitate welding with the aluminum sheet 14; The outer wall of the step end is fitted with the inner wall of the fixing ring 11, and the end face of the step end is fitted with the end face of the dialyzer housing 12, which is a mirror structure to improve the sealing performance.

[0028] See also Figure 4 and Figure 5 In a preferred embodiment of the present invention, the interior of the protruding pointed end includes a straight channel connected to the step end, and an inclined channel connected to the straight channel; From inside to outside, the inner diameter of the inclined channel gradually increases to facilitate welding.

[0029] Furthermore, the inner diameter of the linear channel is smaller than the inner diameter of the dialyzer housing 12, so that after the glue is cured, the hollow fiber membrane 13 at the edge and the inner wall of the dialyzer housing 12 are filled with cured glue, so as to improve the sealing performance after it contacts the sealing ring 15.

[0030] Preferably, the inner wall inclination angle of the inclined channel is 5°~80°.

[0031] See also Figure 4 and Figure 5 In a preferred embodiment of the present invention, the end of the fixing ring 11 extends toward the center line to form a pressure ring, and the pressure ring presses the step end. The fixing ring 11 is formed by injection molding, and a threaded structure is distributed on its inner side, and a tightening portion is provided on the outer side. The threaded structure can cooperate with the thread of the dialyzer housing 12, and the tightening portion is for facilitating the rotation of the fixing ring 11. When the fixing ring 11 is locked with the dialyzer housing 12, the bottom surface (mirror structure) of the tightening ring 10 and the end surface (mirror structure) of the dialyzer housing 12 cooperate tightly without gaps. The shape of the tightening portion is not limited to structural forms such as grooves, convex grooves, and convex ribs.

[0032] See also Figure 4 and Figure 5 In a preferred embodiment of the present invention, before welding, the end of the hollow fiber membrane 13 protrudes from the end of the tightening ring 10 by 3 mm to 20 mm to facilitate welding, so as to firmly bond the tightening ring 10 to the aluminum sheet 14 to achieve a sealing effect.

[0033] Furthermore, the material of the hollow fiber membrane 13 is not limited to polysulfone, polyethersulfone, copper morphology membrane, hemomorphology membrane, triacetate cellulose membrane and other materials.

[0034] In a preferred embodiment of the present invention, the thickness of the aluminum sheet 14 is 0.01 mm to 0.2 mm, and the diameter of the aluminum sheet 14 is not less than the diameter of the tightening ring 10. The material of the aluminum sheet 14 is not limited to pure aluminum, aluminum alloy, or aluminum composite film. The shape is not limited to square, round, or oval. The surface of the aluminum sheet is not limited to a smooth surface, a matte surface, a leather grain surface, or a rough surface.

[0035] See also Figure 2 and Figure 3 In a preferred embodiment of the present invention, one end face of the sealing ring 15 contacts the dialyzer end cover 16, and the other end face contacts the cured rubber surface 17 in the dialyzer housing 12. Since the cured rubber surface 17 has a certain flexibility, the sealing effect between the two can be increased.

[0036] In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same or similar parts between the embodiments can be referred to each other. The above-mentioned embodiments only express several implementation methods of the present invention, and their descriptions are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be based on the attached claims.

Claims

1. A method for manufacturing a hemodialyzer, characterized in that: The following steps are involved: Step S10, assembling the tightening ring and the fixing ring, and then tightening them with the threaded end of the dialyzer housing to form a housing assembly; Step S11, extracting the PE outer membrane of the hollow fiber bundle loaded into the shell component, and blowing the hollow fiber bundle at the end of the shell component to form evenly distributed hollow fiber membranes; Step S12, welding the aluminum sheet, the end of the hollow fiber membrane and the tightening ring, so that the end of the hollow fiber membrane is melted and the tightening ring and the aluminum sheet are bonded together; Step S13, centrifugally injecting glue from the injection hole of the dialyzer housing and curing it, so that the end of the hollow fiber membrane is integrated with the end of the dialyzer housing and the tightening ring; Step S14, after removing the fixing ring, cutting off the tightening ring, and installing the sealing ring and the dialyzer end cover to form a finished hemodialyzer.

2. The method for manufacturing a hemodialyzer according to claim 1, characterized in that: One end of the tightening ring protrudes from the outer end surface of the fixing ring, and the other end is pressed by the fixing ring and fits with the end of the dialyzer housing.

3. The method for manufacturing a hemodialyzer according to claim 2, characterized in that: The tightening ring comprises a step end and a protruding pointed end connected to each other, wherein the protruding pointed end protrudes from the outer end surface of the fixing ring; The outer wall of the step end is in contact with the inner wall of the fixing ring, and the end surface of the step end is in contact with the end surface of the dialyzer housing.

4. The method for manufacturing a hemodialyzer according to claim 3, characterized in that: The interior of the protruding pointed end includes a straight channel connected to the step end, and an inclined channel connected to the straight channel; From inside to outside, the inner diameter of the inclined channel gradually increases.

5. The method for manufacturing a hemodialyzer according to claim 4, characterized in that: The inner diameter of the straight channel is smaller than the inner diameters of the two ends of the dialyzer housing, and the inner wall inclination angle of the inclined channel is 5° to 80°.

6. The method for manufacturing a hemodialyzer according to claim 3, characterized in that: The end of the fixing ring extends toward the center line to form a pressing ring, and the pressing ring presses the step end.

7. The method for manufacturing a hemodialyzer according to any one of claims 1 to 6, characterized in that: The hardness of the fixing ring is greater than the hardness of the tightening ring.

8. The method for manufacturing a hemodialyzer according to any one of claims 1 to 6, characterized in that: Before welding, the end of the hollow fiber membrane protrudes from the end of the tightening ring by a distance of 3 mm to 20 mm.

9. The method for manufacturing a hemodialyzer according to any one of claims 1 to 6, characterized in that: The thickness of the aluminum sheet is 0.01 mm ~ 0.2 mm, and the diameter of the aluminum sheet is not less than the diameter of the tightening ring.

10. The method for manufacturing a hemodialyzer according to any one of claims 1 to 6, characterized in that: One end surface of the sealing ring contacts the dialyzer end cover, and the other end surface contacts the cured rubber surface in the dialyzer housing.

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