TWI653063B - Dialyzer and fabricating method thereof - Google Patents

Abstract

A hemodialyzer and a method of manufacturing the same. The hemodialyzer includes an outer casing, a hydrophilic layer, a fixed layer, a plurality of hollow fiber membranes, and two end caps. The outer casing has a first opening and a second opening, and the outer casing is provided with a dialysate input port and a dialysate outlet, wherein the entire circumference of the outer casing between the first opening and the dialysate input port is the first portion And the entire circumference of the outer casing between the second opening and the dialysate outlet is a second portion. The hydrophilic layer is disposed on the inner wall of the first portion and the inner wall of the second portion, wherein the hydrophilic layer is different from the outer casing. The fixing layer is disposed on the hydrophilic layer and fixes the hollow fiber membrane to the inner wall of the outer casing.

Description

Hemodialyzer and method of manufacturing same

The present invention relates to a blood processing apparatus and a method of manufacturing the same, and more particularly to a hemodialyzer and a method of manufacturing the same.

Because patients with renal failure cannot discharge body-derived products, urea, creatinine, phosphate, vitamin B12 and other body wastes, artificial dialysis is needed to compensate for the original excretory function of the kidneys. A common manual dialysis method is, for example, the use of a hemodialyzer to dialysis a patient's blood.

The outer casings used in hemodialyzers are mostly polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polysulfone (PS) and polyethylene terephthalate. Polyethylene terephthalate (PET) and other materials, in which polyvinyl chloride contains halogen, polyethylene terephthalate and polycarbonate will decompose toxic dioctyl phthalate and bisphenol A (bisphenol A, BPA).

However, many of the hemodialyzer housings currently use materials that are less compatible with the encapsulant. Therefore, the development of a hemodialyzer with good compatibility between the outer casing and the encapsulant is an urgent task.

The invention provides a hemodialyzer and a method for manufacturing the hemodialyzer, which have good adhesion between the outer casing of the hemodialyzer and the encapsulant.

The hemodialyzer of the present invention comprises an outer casing, a hydrophilic layer, a fixed layer, a plurality of hollow fiber membranes, and two end caps. The outer casing has an opposite first opening and a second opening, and the outer casing is provided with a dialysate input port and a dialysate outlet, wherein the entire circumference of the outer casing between the first opening and the dialysate input port is A portion, and the entire circumference of the outer casing between the second opening and the dialysate outlet is a second portion. The hydrophilic layer is disposed on the inner wall of the first portion and the inner wall of the second portion, wherein the hydrophilic layer and the outer casing are of different materials. A plurality of hollow fiber membranes are disposed in the outer casing. The fixing layer is disposed on the hydrophilic layer, and both ends of the hollow fiber membrane are fixed to the inner wall of the outer casing. The two end covers are respectively disposed at both ends of the outer casing.

In an embodiment of the invention, the first portion and the second portion may include a groove, and the hydrophilic layer is disposed in the groove.

In an embodiment of the invention, the surface roughness of the inner walls of the first and second portions is, for example, 0.1 micrometer to 1.5 millimeters.

In an embodiment of the invention, the outer casing and the hydrophilic layer are integrally formed, for example, in a two-material injection manner.

In an embodiment of the invention, the material of the hydrophilic layer may include a hydrophilic resin having a hydrophilic functional group.

In an embodiment of the invention, the hydrophilic functional group of the hydrophilic resin may include -COOH, -COOR, -COR, -R ₁ OR ₂ , -Ar-OR, -Ar ₁ -O-Ar ₂ , -ROH, -R ₁ SO ₂ R ₂ , -RCONH ₂ , -NH, -CONR, -TiO, -SiO, -COOM or Ca ₁₀ ⁺ (PO ₄ ) ₆ (OH) ₂ ^- , wherein R, R ₁ and R _{2 is} each independently a hydrocarbon group, and Ar, Ar ₁ and Ar ₂ are each independently an aryl group, and M is a metal.

In an embodiment of the invention, the hydrophilic resin may be, for example, polymethylmethacrylate (PMMA), polysulfone (PS) or polyamide (PA).

In an embodiment of the invention, the hydrophilic resin may have a hydrophobic end.

In an embodiment of the invention, the material of the outer casing is, for example, polypropylene, polybutene (PB), polyethylene (PE) or a combination thereof.

The method of manufacturing a hemodialyzer of the present invention comprises the following steps. First, a hydrophilic layer is formed on the inner wall of the outer casing, wherein the outer casing has opposite first openings and second openings, and the hydrophilic layer and the outer casing are made of different materials. Next, a plurality of hollow fiber membranes are loaded into the outer casing. Then, a fixed layer is formed on the hydrophilic layer, wherein the fixed layer fixes both ends of the hollow fiber membrane to the inner wall of the outer casing. Thereafter, the end caps are mounted on both ends of the outer casing.

In an embodiment of the invention, the inner wall of the outer casing may include a groove, and a hydrophilic layer is formed in the groove.

In an embodiment of the invention, the inner wall of the outer casing has a rough surface, and the hydrophilic layer is formed on the rough surface, wherein the surface roughness of the rough surface is, for example, 0.1 micrometer to 1.5 millimeter.

In an embodiment of the invention, the method of forming a hydrophilic layer on the inner wall of the outer casing is integrally formed, for example, in a two-material injection manner.

In an embodiment of the invention, the material of the hydrophilic layer is, for example, a hydrophilic resin having a hydrophilic functional group.

In an embodiment of the present invention, the hydrophilic functional group of the hydrophilic resin is, for example, -COOH, -COOR, -COR, -R ₁ OR ₂ , -Ar-OR, -Ar ₁ -O-Ar ₂ , -ROH, -R ₁ SO ₂ R ₂ , -RCONH ₂ , -NH, -CONR, -TiO, -SiO, -COOM, and Ca ₁₀ ⁺ (PO ₄ ) ₆ (OH) ₂ ^- , wherein R, R ₁ and R _{2 is} each independently a hydrocarbon group, and Ar, Ar ₁ and Ar ₂ are each independently an aryl group, and M is a metal.

In an embodiment of the invention, the hydrophilic resin is, for example, polymethyl methacrylate, polyfluorene or polyamine.

In an embodiment of the invention, the hydrophilic resin may have a hydrophobic end.

In an embodiment of the invention, the material of the outer casing is, for example, polypropylene, polybutylene, polyethylene or a combination thereof.

In an embodiment of the invention, the step of forming a fixing layer on the hydrophilic layer comprises: mounting a potting cover on both ends of the outer casing; injecting the fixing layer material into the outer casing; and performing a centrifugation process to fill the fixed layer material And into the first opening and the second opening; and curing the fixing layer material, wherein at least a portion of the fixing layer is in contact with the hydrophilic layer.

Based on the above, the inner wall of both ends of the hemodialyzer outer casing of the present invention has a hydrophilic layer formed thereon, and the hydrophilic layer can improve the surface energy of the inner wall of both ends of the outer casing, thereby facilitating bonding with the hydrophilic fixing layer. .

The above described features and advantages of the invention will be apparent from the following description.

1 is a schematic view of a hemodialyzer according to an embodiment of the present invention. 2 and FIG. 3 are partial enlarged views of a region A of the hemodialyzer 10 of FIG. 1, wherein FIG. 2 and FIG. 3 only enlarge one end of the hemodialyzer, but the regions of FIGS. 2 and 3 may be visually required. A is applied to the other end not shown. For the sake of clarity and convenience of explanation, FIG. 1 omits the hydrophilic layer, and FIG. 2 and FIG. 3 omits the hollow fiber membrane.

Referring to FIGS. 1 and 2 , the hemodialyzer 10 includes an outer casing 100 , a hydrophilic layer 110 , a fixed layer 120 , a plurality of hollow fiber membranes 130 , and an end cap 140 . The outer casing 100 is, for example, a hollow tubular structure to accommodate the hollow fiber membrane 130. The material of the outer casing 100 is, for example, a hydrophobic material. In the present embodiment, the material of the outer casing 100 is, for example, polypropylene, polybutene, polyethylene or a combination thereof, but the invention is not limited thereto. In another embodiment, other hydrophobic materials may also be used as the material for the outer casing 100. The outer casing 100 has an opposite first opening 100a and a second opening 100b, and the outer casing 100 is provided with a dialysate input port 102 and a dialysate outlet 104. In the present embodiment, the dialysate input port 102 is adjacent to the first opening 100a, and the dialysate output port 104 is adjacent to the second opening 100b.

In the present embodiment, the outer casing 100 includes a first portion 103 and a second portion 105. Specifically, the entire circumference of the outer casing 100 between the first opening 100a and the dialysate input port 102 is defined as a first portion 103, and the outer casing 100 is located between the second opening 100b and the dialysate outlet 104. The entire circumference is defined as the second portion 105.

In the present embodiment, the hydrophilic layer 110 is disposed on the inner wall of the first portion 103 of the outer casing 100 and on the inner wall of the second portion 105. The hydrophilic layer 110 is different from the outer casing 100. Specifically, the host material of the hydrophilic layer 110 is substantially different from the host material of the outer casing 100. In one embodiment, the polymer monomer constituting the hydrophilic layer 110 is different from the polymer monomer constituting the outer shell 100. The material of the hydrophilic layer 110 is, for example, a hydrophilic resin having a hydrophilic functional group. In the present embodiment, the hydrophilic functional group of the hydrophilic resin is, for example, -COOH, -COOR, -COR, -R ₁ OR ₂ , -Ar-OR, -Ar ₁ -O-Ar ₂ , -ROH, -R ₁ SO ₂ R ₂ , -RCONH ₂ , -NH, -CONR, -TiO, -SiO, -COOM or Ca ₁₀ ⁺ (PO ₄ ) ₆ (OH) ₂ ^- , wherein R, R ₁ and R ₂ are each independently The hydrocarbon group, Ar, Ar ₁ and Ar ₂ are each independently an aryl group, and M is a metal. However, the present invention is not limited thereto, and the hydrophilic functional group of the hydrophilic resin may be other suitable hydrophilic functional groups. In an embodiment, depending on the choice of materials, R ₁ and R ₂ may be the same or different, and Ar ₁ and Ar ₂ may be the same or different. In one embodiment, -R ₁ SO ₂ R ₂ is a functional group corresponding to polyfluorene. In the present embodiment, the hydrophilic resin includes a hydrophobic end and a hydrophilic end, wherein the hydrophilic end includes the above-described hydrophilic functional group, and the hydrophobic end is, for example, a hydrocarbon long chain. The carbon number of the hydrocarbon long chain at the hydrophobic end and the weight average molecular weight of the hydrophilic resin are not limited. In one embodiment, the hydrophilic resin is, for example, polymethyl methacrylate, polyfluorene or polyamine. When the hydrophilic resin is, for example, polymethyl methacrylate, wherein the hydrophilic terminal functional group of polymethyl methacrylate is -COOH, the hydrophobic end of polymethyl methacrylate is -CH.

Since the hydrophilic layer 110 is formed on the inner wall of the first portion 103 of the outer casing 100 and the inner wall of the second portion 105, wherein the hydrophobic end of the hydrophilic resin can have good adhesion to the hydrophobic outer casing 100, The hydrophilic end of the hydrophilic resin enhances the surface energy of the inner portions of the first portion 103 and the second portion 105, thereby facilitating bonding with the hydrophilic fixing layer 120.

Referring to FIG. 2, the first portion 103 of the outer casing 100 includes a groove 108, and the groove 108 is spaced from the dialysate input port 102 by a distance. The second portion 105 of the outer casing 100 also has a recess 108, and the recess 108 is spaced from the dialysate outlet 104 by a distance (not shown). In an embodiment, the groove 108 is, for example, a stepped groove or other structure as long as the thickness of the outer casing 100 at the groove 108 is less than the thickness at the non-groove. In the present embodiment, the groove 108 may be continuously extended over the entire circumference of the first portion 103 or the second portion 105, or a plurality of grooves 108 may be dispersedly disposed in the first portion 103 or the second portion 105. However, the invention is not limited thereto. The width of the groove 108 in the longitudinal direction of the outer casing 100 is, for example, 0.5 micrometers to 10 millimeters. In the present embodiment, the position, shape and number of the grooves 108 are for reference only, and the present invention is not limited thereto, and the position and number of the grooves 108 may be changed depending on process requirements.

Since the first portion 103 and the second portion 105 include the grooves 108, it helps to secure the hydrophilic layer 110 in the grooves 108. Further, the hydrophobic end of the hydrophilic resin in the hydrophilic layer 110 may be bonded to the hydrophobic surface of the groove 108, and the exposed surface of the hydrophilic layer 110 is hydrophilic, thereby facilitating bonding with the hydrophilic fixed layer 120. .

Fig. 3 is a view showing the arrangement relationship between the outer casing 100 and the hydrophilic layer 110 in the hemodialyzer according to another embodiment of the present invention. The difference between the embodiment of Figure 3 and the embodiment of Figure 2 is that the first portion 103 of the outer casing 100 of Figure 2 includes a recess 108, while the first portion 103 of the outer casing 100 of Figure 3 is not provided with a recess. . In this embodiment, the inner wall of the first portion 103 of FIG. 3 is a rough surface. Likewise, the inner wall of the second portion 105 is a rough surface. Specifically, the inner surfaces of the first portion 103 and the second portion 105 have a surface roughness of 0.1 μm to 1.5 mm. The surface roughness of the inner walls of the first portion 103 and the second portion 105 is within the above range, and the joint area of the hydrophilic layer 110 with the first portion 103 and the second portion 105 can be increased. Further, the hydrophobic end of the hydrophilic resin in the hydrophilic layer 110 may be bonded to the hydrophobic surfaces of the first portion 103 and the second portion 105, and the surface of the hydrophilic layer 110 is hydrophilic, thereby contributing to hydrophilicity. The fixed layer 120 is joined.

Similarly, in the embodiment shown in FIG. 2, when the first portion 103 and the second portion 105 include the recess 108, the recess 108 may also have a rough surface with a surface roughness of 0.1 micrometer to 1.5 millimeters. The bondability with the hydrophilic layer 110 can be further improved.

It should be noted that the outer casing 100 and the hydrophilic layer 110 of the above different materials may be integrally formed by two-shot injection. The two-shot injection molding method described above employs two injection molding steps to form the outer casing 100 and the hydrophilic layer 110. Specifically, the outer casing 100 may be formed by performing one injection molding step, and then another injection molding step may be performed to form the hydrophilic layer 110. Alternatively, the injection molding step may be performed first to form the hydrophilic layer 110, and then another injection molding step may be performed to form the outer casing 100. Therefore, the fusion bonding layer 111 is further included at the heterojunction between the outer casing 100 and the hydrophilic layer 110 (as shown in FIGS. 2 and 3). In an embodiment, the molten bonding layer 111 includes a material of the outer casing 100, a material of the hydrophilic layer 110, or a mixture thereof. The molten bonding layer 111 is bonded to the outer casing 100 and the hydrophilic layer 110 by, for example, a viscous or chemical bonding of at least one of the two materials in a molten state to have an integrally formed structure. It is explained here that when the inner wall of the outer casing 100 has a groove or a rough surface, the hydrophilic layer 110 formed in this manner is filled into the recess of the groove or the rough surface, so that the integrally formed outer casing 100 It is coplanar with the inner wall surface of the hydrophilic layer 110.

In addition, the material for two-shot injection molding must be properly selected. In one embodiment, the first injection molded material needs to have a higher softening point or melting temperature than the second injection molded material. If it is the opposite, it will cause a melt scouring effect, causing the shape of the first injection molding to be deformed. In one embodiment, the hardness of the first injection molded material is higher than the hardness of the second injection molded material. In one embodiment, the material shrinkage rates selected for the two shots are between 0.2% and 5%, respectively, and the difference between the shrinkage of the first shot-formed material and the shrinkage of the second shot-formed material is 0% to 4.8%. In the present embodiment, the definition of shrinkage means the difference between the size of the cavity and the size of the molded article at room temperature divided by the cavity size. The shrinkage rate depends on the thermal expansion and contraction of the material itself and the molding conditions. In the two-shot injection molding process, the first injection-molded material and the second injection-molded material are successively subjected to a molding process, so if the first injection-molded material shrinks and the second injection-molded material If the difference in shrinkage is too large, the interface strength will decrease, which will cause warpage. In one embodiment, the difference between the shrinkage of the first injection molded material and the shrinkage of the second injection molded material is 1%. In another embodiment, in one embodiment, the difference between the shrinkage of the first injection molded material and the shrinkage of the second injection molded material is 0.6%. In one embodiment, the difference between the shrinkage of the first injection molded material and the shrinkage of the second injection molded material is 0.4%.

1 to 3, the fixed layer 120 is disposed on the hydrophilic layer 110 and filled in the first opening 100a and the second opening 100b. The material of the pinned layer 120 is, for example, a hydrophilic material such as polyurethane (PU). In an embodiment, the fixing layer 120 is disposed on the inner wall of the two ports of the outer casing 100, and at least a portion of the fixing layer 120 is in contact with the hydrophilic layer 110 of the first portion 103 or the second portion 105, so that the outer casing 100 and The pinned layer 120 has good bonding characteristics.

The plurality of hollow fiber membranes 130 are fixed by the fixed layer 120 and disposed in the outer casing 100. The hollow fiber membrane 130 is selectively permeable and semi-permeable. The material of the hollow fiber membrane 130 is, for example, cellulose acetate, polyfluorene, polyethersulfone (PES) or polymethyl methacrylate. In the present embodiment, in order to increase the compatibility of the hollow fiber membrane 130 with the human body, the hollow fiber membrane 130 may further include a hydrophilic polymer in addition to the above-described main component material. The hydrophilic polymer is, for example, polyvinylpyrrolidone (Poly(vinyl pyrrolidone), PVP), polyethylene (poly (ethylene glycol), PEG), polyvinyl alcohol (PVA), polyethylene oxide (Poly(vinyl alcohol), PVA). Poly(ethylene oxide), PEO), Poly(ethylenimine), PEI or Poly(acrylate), PAA. In the present embodiment, a method of preparing the hollow fiber membrane 130 is, for example, a dry-wet spinning method. In Fig. 1, the number of hollow fiber membranes 130 is merely an example, and the present invention is not limited thereto, and the number of hollow fiber membranes 130 can be changed as needed. In one embodiment, the number of hollow fiber membranes 130 is from about 7,000 to 12,000.

The end caps 140 are respectively disposed at two ends of the outer casing 100, wherein the two end covers 140 are respectively provided with a blood outlet port 112 and a blood input port 114. In this embodiment, the dialysate input port 102 is disposed near the blood outlet port 112, and the dialysate outlet port 104 is disposed adjacent to the blood input port 114, so that the flow direction of the blood and the dialysate in the tube body is opposite. Good dialysis effect.

4 is a flow chart showing a method of manufacturing a hemodialyzer according to an embodiment of the present invention. Referring to Figures 1, 2 and 4, the method of manufacturing the hemodialyzer of the present embodiment will be described below with reference to the hemodialyzer of Figs.

First, step S100 is performed: providing the outer casing 100 and the hydrophilic layer 110. In the present embodiment, the outer casing 100 and the hydrophilic layer 110 can be integrally molded in a two-material injection manner. The structure of the outer casing 100 and the hydrophilic layer 110 has been described in detail in the above embodiments, and thus will not be described again.

Next, step S110 is performed: a plurality of hollow fiber membranes 130 are loaded into the outer casing 100. In the present embodiment, both ends of the hollow fiber membrane 130 in the outer casing 100 are partially exposed to the outer casing 100.

Then, step S120 is performed to form a fixed layer 120 on the hydrophilic layer 110, wherein the fixed layer 120 fixes both ends of the hollow fiber membrane 130 to the inner wall of the outer casing 100. Step S120 may further include sub-steps S122, S124, S126, and S128.

First, the sub-step S122 is performed: a glue cap (not shown) is attached to both ends of the outer casing 100. In this step, the glue cap is usually attached directly to the hollow fiber membrane 130 for fixation.

Then, sub-step S124 is performed: the fixed layer material is injected into the outer casing 100. Specifically, a fixed layer material (not shown) is poured into the outer casing 100 through the dialysate input port and the dialysate output port. In this embodiment, the material of the fixed layer to be poured is a hydrophilic material such as polyurethane.

Next, sub-step S126 is performed: performing a centrifugation process to fill the first opening 100a and the second opening 100b with the fixed layer material. Specifically, during the centrifugation process, the fixed layer material is uniformly distributed at both ends of the outer casing 100, and the first opening 100a and the second opening 100b are filled and sealed. In the present embodiment, during the centrifugation process, the fixed layer material is simultaneously solidified to form the fixed layer 120. The method of curing the fixing layer material is, for example, heat curing, UV/infrared curing, moisture curing, or a combination thereof.

In the present embodiment, since the hydrophilic layer 110 is provided on the inner walls of both ends (i.e., the first portion 103 and the second portion 105) of the outer casing 100, the hydrophilic resin of the hydrophilic layer 110 has a hydrophilic functional group. Therefore, it has good adhesion to the fixed layer 120 which is also hydrophilic. In addition, since the outer casing 100 has a special structural design (the first portion 103 and the second portion 105 include grooves or the inner surface surfaces of the first portion 103 and the second portion 105 have a specific surface roughness), the outer casing 100 The hydrophilic layer 110 can be effectively fixed and the contact area with the hydrophilic layer 110 can be increased.

Thereafter, sub-step S128 is performed: a slitting process is performed to cut both ends of the hollow fiber membrane 130. Specifically, after the fixing layer 120 in the outer casing 100 is cured, the glue caps at both ends of the outer casing 100 are removed, and the excess fixed layer 120 and the hollow fiber membrane 130 exposing both ends of the outer casing 100 are cut off. In one embodiment, the fixed layer 120 and the hollow fiber membrane 130 after the slitting process can protrude from both end faces of the outer casing 100.

Next, step S130 is performed: the end caps 140 are mounted on both ends of the outer casing 100. In one embodiment, the end caps 140 are mounted on both ends of the outer casing 100 by first mounting a seal on both ends of the outer casing 100, and then fixing the end caps 140 to the ends of the outer casing 100, wherein the seals are Can increase liquid tightness. In another embodiment, the end caps 140 are mounted on both ends of the outer casing 100 by welding the end caps 140 to the ends of the outer casing 100 by ultrasonic welding. So far, the hemodialyzer of the present invention has been completed.

In one embodiment, the hemodialyzer manufactured above can be sterilized in one step. The means of sterilization is, for example, ethylene oxide sterilization, gamma sterilization or steam sterilization.

Hereinafter, the invention will be more specifically described by exemplifying the examples of the invention. However, the materials, the methods of use, and the like shown in the following examples may be appropriately modified without departing from the spirit of the invention. Therefore, the scope of the invention should not be construed as limited by the examples shown below.

Instance

Hollow fiber membrane Manufacturing

First, a spinning solution was prepared in which the spinning solution included 20 wt% of polyfluorene (main material), 10 wt% of polyvinylpyrrolidone (hydrophilic polymer), and 70 wt% of N-methylpyrrolidone (solvent). Next, a hollow fiber membrane was prepared by a dry-wet spinning method. Specifically, the above-mentioned spinning solution is discharged by a liquid injection method (non-coagulability) using a double ring nozzle, and the discharged spinning solution is immersed in water as a non-solvent through an air gap, and is solidified and non-solved. After solvent washing and drying, about 9000 bundles of hollow fiber membranes were obtained.

Manufacture of outer casing and hydrophilic layer

In this embodiment, the outer casing and the hydrophilic layer on the inner wall of the outer casing are fabricated by a two-shot injection method. The outer casing is made of medical grade polypropylene (melting point of about 150 ° C ~ 160 ° C). The material of the hydrophilic layer is a medical grade polymethyl methacrylate (melting point of about 130 ° C ~ 140 ° C). Specifically, the first injection step is first performed to mold the polypropylene in the mold, and the mold is opened after being filled and held by the mold, and the semi-finished product is left on the mold. Next, a second ejection step is performed to fill the grooves in the mold with polymethyl methacrylate, and then demolded to obtain an integrally formed outer shell having a hydrophilic layer.

End cap manufacturing

In the present embodiment, the end cap is manufactured by injection molding. The end cap is made of medical grade polypropylene (melting point of about 150 ° C ~ 160 ° C).

Packing and sterilization of hemodialyzer

The hollow fiber membrane manufactured above is placed in the outer casing by an automatic device, and after the potting cap is attached to both ends of the outer casing, the fixing layer material (polyurethane) is injected into the outer casing and centrifuged and solidified. Remove the glue cap, cut the film and attach the end cap. Ultrasonic welding and sterilization.

In summary, the inner wall of both ends of the hemodialyzer outer casing of the present invention is formed with a hydrophilic layer, and the hydrophilic layer can improve the surface energy of the inner wall of both ends of the outer casing, thereby contributing to the fixation with hydrophilicity. Layer bonding.

Although the present invention has been disclosed in the above embodiments, it is not intended to limit the present invention, and any one of ordinary skill in the art can make some changes and refinements without departing from the spirit and scope of the present invention. The scope of the invention is defined by the scope of the appended claims.

10‧‧‧hemodialyzer

100‧‧‧ outer casing

100a‧‧‧first opening

100b‧‧‧second opening

102‧‧‧ dialysate input

103‧‧‧ first

104‧‧‧ dialysate outlet

105‧‧‧Part II

108‧‧‧ Groove

110‧‧‧Hydrophilic layer

111‧‧‧fused joint

112‧‧‧ blood outlet

114‧‧‧ blood input port

120‧‧‧Fixed layer

130‧‧‧Hollow fiber membrane

140‧‧‧End cover

S100, S110, S120, S130‧‧‧ steps

Sub-steps S122, S124, S126, S128‧‧

A‧‧‧ area

1 is a schematic view of a hemodialyzer according to an embodiment of the present invention. Fig. 2 is a partial enlarged view of the hemodialyzer of Fig. 1. Fig. 3 is a partially enlarged view of a hemodialyzer according to another embodiment of the present invention. 4 is a flow chart showing a method of manufacturing a hemodialyzer according to an embodiment of the present invention.

Claims (20)

A hemodialyzer comprising: an outer casing having opposite first openings and a second opening, wherein the outer casing is provided with a dialysate input port and a dialysate outlet, wherein the outer casing is located at the first The entire circumference between the opening and the dialysate input port is a first portion, and the entire circumference of the outer casing between the second opening and the dialysate outlet is a second portion; a layer disposed on an inner wall of the first portion and an inner wall of the second portion, the hydrophilic layer being different from the outer casing; a plurality of hollow fiber membranes disposed on the outer casing a fixed layer disposed on the hydrophilic layer, and fixing both ends of the hollow fiber membrane to an inner wall of the outer casing; and two end covers disposed at both ends of the outer casing. The hemodialyzer according to claim 1, wherein the first portion and the second portion comprise a groove, and the hydrophilic layer is disposed in the groove. The hemodialyzer according to claim 1, wherein the inner surface of the first portion and the second portion has a surface roughness of 0.1 μm to 1.5 mm. The hemodialyzer according to claim 1, wherein the outer casing and the hydrophilic layer are integrally molded in a two-material injection manner. The hemodialyzer according to claim 1, wherein the material of the hydrophilic layer comprises a hydrophilic resin having a hydrophilic functional group. The hemodialyzer according to claim 5, wherein the hydrophilic functional group of the hydrophilic resin comprises -COOH, -COOR, -COR, -R ₁ OR ₂ , -Ar ₁ -OR ₂ , -Ar-O-Ar, -ROH, -R ₁ SO ₂ R ₂ , -RCONH ₂ , -NH, -CONR, -TiO, -SiO, -COOM or Ca ₁₀ ⁺ (PO ₄ ) ₆ (OH) ₂ ^- Wherein R, R ₁ and R ₂ are each independently a hydrocarbon group, and Ar, Ar ₁ and Ar ₂ are each independently an aryl group, and M is a metal. The hemodialyzer according to claim 5, wherein the hydrophilic resin comprises polymethyl methacrylate, polyfluorene or polyamine. The hemodialyzer according to claim 5, wherein the hydrophilic resin has a hydrophobic end. The hemodialyzer according to claim 1, wherein the material of the outer casing comprises polypropylene, polybutene, polyethylene or a combination thereof. The hemodialyzer according to claim 4, further comprising a fusion bonding layer disposed between the hydrophilic layer and the outer casing. A method of manufacturing a hemodialyzer, comprising: forming a hydrophilic layer on an inner wall of an outer casing, wherein the outer casing has opposite first openings and second openings, the hydrophilic layer being different from the outer casing a plurality of hollow fiber membranes are loaded into the outer casing; a fixed layer is formed on the hydrophilic layer, wherein the fixed layer is disposed at both ends of the outer casing to sandwich the hollow fiber membrane Ends are fixed to inner walls of both ends of the outer casing; and end caps are mounted on both ends of the outer casing. The method of manufacturing a hemodialyzer according to claim 11, wherein the inner wall of the outer casing includes a groove, and the hydrophilic layer is formed in the groove. The method of manufacturing a hemodialyzer according to claim 11, wherein the inner wall of the outer casing has a rough surface, and the hydrophilic layer is formed on the rough surface, wherein the rough surface The surface roughness is from 0.1 micron to 1.5 mm. The method of manufacturing a hemodialyzer according to claim 11, wherein the method of forming the hydrophilic layer on the inner wall of the outer casing comprises integrally molding in a two-material injection manner. The method of producing a hemodialyzer according to claim 11, wherein the material of the hydrophilic layer comprises a hydrophilic resin having a hydrophilic functional group. The method for producing a hemodialyzer according to claim 15, wherein the hydrophilic functional group of the hydrophilic resin comprises -COOH, -COOR, -COR, -R ₁ OR ₂ , -Ar-OR , -Ar ₁ -O-Ar ₂ , -ROH, -R ₁ SO ₂ R ₂ , -RCONH ₂ , -NH, -CONR, -TiO, -SiO, -COOM, and Ca ₁₀ ⁺ (PO ₄ ) ₆ (OH ₂ ^- , wherein R, R ₁ and R ₂ are each independently a hydrocarbon group, and Ar, Ar ₁ and Ar ₂ are each independently an aryl group, and M is a metal. The method of producing a hemodialyzer according to claim 15, wherein the hydrophilic resin comprises polymethyl methacrylate, polyfluorene or polyamine. The method of producing a hemodialyzer according to claim 15, wherein the hydrophilic resin has a hydrophobic end. The method of manufacturing a hemodialyzer according to claim 11, wherein the material of the outer casing comprises polypropylene, polybutene, polyethylene or a combination thereof. The method for manufacturing a hemodialyzer according to claim 11, wherein the step of forming the fixing layer on the hydrophilic layer comprises: installing a potting cover on the two ends of the outer casing; Impressing a layer of material into the outer casing; and performing a centrifugation process to fill the first opening and the second opening; and curing the fixed layer material, wherein at least a portion of the fixed layer The hydrophilic layer is in contact.