JP2003159325A - Hemodialyzer and manufacturing method thereof - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a means for reducing blood residue on a contact surface of an embedded portion of a hollow string bundle of the hemodialyzer and a variation in the capability of the dialyzer to remove substances after treatment with the hemodialyzer whose hollow string bundle is inserted in a tube shaped plastic vessel and both ends of the bundle are embedded with a potting material. <P>SOLUTION: A share percentage of the hollow string bundle in a contact portion of blood in the embedded portion of the hollow string bundle in the hemodialyzer of a tube shaped plastic type is set to not less than 87 percent in relation to an inner diameter of the vessel. Further, an offset of the roundness of the hollow string bundle on the surface to contact blood in the embedded portion of the hollow string bundle is set to not more than 3 percent. This kind of hemodialyzer whose hollow string bundle wound like a film in advance is placed between a plurality of rollers with different peripheral velocities and allowed to rotate for a fixed length of time before it is inserted in the tube shaped plastic vessel and finally manufactured when fixed with the potting material. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a hemodialyzer and a method for manufacturing the same.

[0002]

2. Description of the Related Art Conventionally, a hemodialyzer used for hemodialysis therapy or filtration therapy is designed to remove waste or harmful substances accumulated in blood from the blood based on the principle of diffusion or filtration. Since it was first put into practical use as a drum type hemodialyzer in the middle of the 20th century, it is still being used effectively for the treatment of patients with partial or complete loss of renal function. Removal of wastes or harmful substances is generally carried out mainly through a membrane, and as a material of the membrane, a membrane made of regenerated cellulose or a membrane made of a synthetic polymer such as polyacrylonitrile, polysulfone or polyethylene is used. Although it is publicly known and has a flat membrane or a hollow fiber membrane, in recent years, a hollow fiber membrane having a large contact area with blood and high processing ability has been widely used.

Further, the shape of the hemodialyzer is that if hollow fiber membranes are bundled, hundreds to tens of thousands are bundled and loaded into a cylindrical plastic container, and then a polyurethane resin is mainly filled to fix the hollow fibers to the container. Then, a semi-finished product is created, and a part for introducing blood is attached, and sterilization is performed to obtain a hemodialyzer. Further, in blood treatment, in the case of a hemodialyzer using a hollow fiber, blood is allowed to flow inside the hollow fiber, and a dialysate containing an inorganic electrolyte or the like is allowed to flow outside the hollow fiber to remove the target substance of blood. Is removed by diffusion or filtration on the dialysate side.

In dialysis treatment, blood is introduced into a dialyzer and circulated for a predetermined time, and then blood remaining in the dialyzer is pushed out by physiological saline and returned to the body. At that time, the blood may remain not only in the hollow fiber but also in the part where the blood is introduced. Therefore, a method of devising the shape of the contact surface of the hollow fiber-embedded part with blood (Japanese Patent Laid-Open No. Hei 10 (1999) -242242).
No. 4-309360) was devised, but its complicated shape had a factor of reducing productivity and cost.

Further, the main factor that determines the substance removal performance of a hemodialyzer is the performance of the hollow fiber that is in direct contact with blood or dialysate, that is, the mass transfer coefficient, which has conventionally permeated the material and substance of the hollow fiber. The size and distribution of the pore size and the thickness of the membrane that determines the permeation resistance have been studied and put to practical use. on the other hand,
In order to maximize the performance of these hollow fibers, the shape of the dialyzer container plays an important role.The pressure loss inside and outside the hollow fiber, that is, the relationship between the container length and the container inner diameter, and the length of the dialyzer container The filling rate, which indicates how densely the hollow fibers are packed near the center in the direction, has been studied and put to practical use.

[0006] Further, as a device to make the flow of dialysate uniform to improve the removal efficiency and reduce the variation in the removal performance, a method of inserting a spacer filament between the hollow fibers (Japanese Patent No. 3080430, Japanese Patent Publication No. 59-18084, Japanese Patent Laid-Open No. 8-
No. 246283) or a method of making a hollow fiber into a small corrugated shape called crimp (Japanese Patent Publication No. Sho 57-194007). These methods are, for example, for a hollow fiber bundle containing a spacer filament, a spacer filament. Requires a complicated technique such as inserting between the hollow fibers or knitting the hollow fibers with a spacer filament.For crimped yarns, the hollow fibers may be broken or clogged at the corrugated part. There was a side inferior in sex.

[0007]

DISCLOSURE OF THE INVENTION The present invention reduces the residual blood on the blood contact surface of the hollow fiber embedding part of the hemodialyzer after the hemodialysis treatment and reduces the variation in the substance removal performance of the dialyzer. That is the purpose. Further, it is an object of the present invention to provide a very simple manufacturing method which solves the above problems.

[0008]

Means for Solving the Problems In order to solve the above-mentioned problems, the inventors have made earnest studies as to the shape of the hollow fiber bundles and the state of existence of the hollow fiber bundles in the hollow fiber embedded portion. The presence of hollow fibers in the embedding part of the hollow fiber potting material makes the existence state of the hollow fiber in a specific state, so that blood remains less on the blood contact surface in the hollow fiber embedding part of the hemodialyzer after the hemodialysis treatment. It was further found that it is possible to further reduce the variation in the substance removal performance of the dialyzer. In addition, as a result of studying a manufacturing method for achieving these objects, a method for adjusting the shape of the hollow fiber bundle before inserting into a cylindrical plastic container was found, and the present invention was completed.

That is, the present invention has the following structure in order to achieve the above object. (1) In a hemodialyzer in which a hollow fiber bundle is inserted into a tubular plastic container and both ends of the bundle are embedded with potting material, a hollow fiber bundle with respect to the inner diameter of the container at the blood contact surface of the hollow fiber embedding part A hemodialyzer with an occupation rate of 87% or more. (2) The hemodialyzer according to (1), wherein the roundness deviation of the hollow fiber bundle on the blood contact surface of the hollow fiber embedded portion is 3% or less. (3) The shape of the hollow fiber is linear along the fiber axis
The hemodialyzer according to (1) or (2). (4) Hollow fiber material is based on polysulfone (1) to
The hemodialyzer according to any one of (3). (5) In the method for producing a hemodialyzer in which a hollow fiber bundle is inserted into a tubular plastic container and both ends of the bundle are embedded with potting material, a plurality of film-wound hollow fiber bundles having different peripheral speeds are used. The method for producing a hemodialyzer according to any one of (1) to (4), which is placed between rollers, rotated for a certain period of time, and then inserted into a cylindrical plastic container and fixed with a potting material.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION The occupation ratio of the hollow fiber bundle to the inner diameter of the container on the blood contact surface of the hollow fiber embedding part indicates the ratio of the diameter of the hollow fiber bundle to the inner diameter of the container on the blood contact surface of the hemodialyzer. calculate. The inner diameter of the container should be at least 5 places on the blood contact surface of the hemodialyzer.
Measure with a caliper or the like, and use the arithmetic mean value of the maximum and minimum values as the container inner diameter. On the other hand, the diameter of the hollow fiber bundle should be at least 5 when the blood contact surface of the hollow fiber embedding part is directly viewed and the portion where the bundle is cracked as if an extreme crack had occurred.
After measuring at more than one point and obtaining the maximum and minimum diameters,
Using the arithmetic mean value as the hollow fiber bundle diameter, the occupancy rate is calculated by the following formula (1).

[0011]

[Equation 1] Occupancy rate (%) = 100 x hollow fiber bundle diameter ÷ container inner diameter (1)

That is, the occupancy rate of the hollow fiber bundle in this test is based on the inner diameter of the dialyzer container near the center in the longitudinal direction as a reference for calculation, and shows how much hollow fiber is packed in the container. Different from the filling rate, it is a parameter indicating how the hollow fibers spread on the blood contact surface fixed by the potting material. Focusing on this occupancy rate, the inventors conducted a detailed examination of the conditions under which the dialyzer was made, and made a thorough study of the relationship between the size of the occupancy rate and the amount of blood remaining in the dialyzer after blood circulation. It was also found that by setting the occupancy rate of the hollow fiber bundle to the dialyzer container on the blood contact surface to be 87% or more, preferably 90% or more, less blood remains in the blood introducing part. The upper limit of this occupancy rate is, by definition, 100%.
However, if the occupancy rate is increased until the hollow fibers come into contact with the inside of the container, the potting material such as urethane resin is difficult to penetrate and pinholes are easily generated, which reduces productivity,
It is desirable to be 95% or less. The reason why this effect is obtained by setting the occupancy rate to 87% or more is that when the occupancy rate of the hollow fiber bundle to the dialyzer container in the blood contact surface is increased, the blood contact surface in which the hollow fiber does not exist becomes smaller. The stagnation part in the circulation becomes small, blood coagulation does not occur easily, and when performing the operation of returning blood to the body,
It is presumed that the operation of returning blood with physiological saline becomes easy and no blood remains.

On the other hand, the uneven circularity of the hollow fiber bundle on the blood contact surface of the hollow fiber-embedded portion in the present invention means that the hollow fiber bundle has a perfect circularity when the blood contact surface of the hollow fiber-embedded portion is directly viewed. It is a scale for quantifying whether or not it is potted while keeping, or is biased by being affected by being deformed by being swept away when pouring a potting material such as urethane, and calculated by the following. That is, by directly looking at the blood contact surface of the hollow fiber embedding part, the diameter of the hollow fiber bundle is measured at a minimum of 5 points or more, excluding the portion where the bundle is broken as if it had extremely cracked, and the maximum diameter and the maximum diameter are measured. Obtain the small diameter and calculate the roundness using the following formula (2).

[0014]

[Equation 2]       Roundness deviation (%) = 100 x (maximum diameter-minimum diameter) ÷ minimum diameter (2)

The circularity deviation in this test is a parameter showing the deviation of the hollow fiber bundle diameter on the blood contact surface.
The small deviation indicates that the difference between the maximum diameter and the minimum diameter of the bundle is small, and that the hollow fibers are evenly present in a perfect circle on the blood contact surface. Therefore, the inventors focused on the roundness deviation, and made a detailed study on the manufacturing conditions of the dialyzer, and conducted a thorough study of the relationship between the roundness deviation and the substance removal performance of the dialyzer, and found that the same number of hollow fibers were used. Despite being built-in, the deviation in roundness deviation is surprisingly reduced by setting the deviation in circularity to 3% or less, and more preferably, setting the deviation in circularity to 1% or less. Found. The lower limit of the circularity deviation referred to here is 0% by definition.

Although the reason why the dialyzer satisfying these conditions achieves the object stated in the subject is not always clear, it is possible to suppress the roundness deviation of the hollow fiber bundle to prevent the hollow fiber bundle from being rounded, especially between the hollow fiber bundle and the container. It is presumed that the space between the hollow fiber bundle and the container became constant in the vicinity of the inflow or outflow area of the dialysate, and the flow of the dialysate was reduced among the individual dialysers, resulting in a dialyzer that achieved its purpose.

Further, the dialysis treatment is completed by setting the occupation ratio of the hollow fiber bundle to the dialyzer container on the blood contact surface of the hemodialyzer to be 87% or more and the circularity deviation of the hollow fiber bundle to be 3% or less. After that, it was possible to obtain a dialyzer in which blood did not remain in the blood introducing part of the dialyzer and variation in removal performance of low molecular weight substances was small.

Conventionally, in a hemodialyzer, generally, hundreds to tens of thousands of hollow fibers are wound on a film, inserted into a dialyzer container through a funnel-shaped guide, and a jig for receiving a potting material is attached. The potting material is centrifugally poured into the potting material, or it is dipped in a resin that has been left still to fix the hollow fiber to the container. In the latter method of immersing the hollow fiber bundle in the standing resin, it is difficult for the resin to penetrate between the hollow fibers,
Since it is difficult to fix all tens of thousands of hollow fibers to a container, a method of pouring a potting material while centrifuging is generally used at present. However, in this method, the potting material flows in vigorously due to the centrifugal force, so that the hollow fibers tend to fall down, and it is possible to make each hollow fiber stand upright and to keep the bundle of hollow fibers in a perfect circle on the blood contact surface. was difficult. These phenomena are known techniques in which the tip of the hollow fiber bundle is fixed in advance with resin or the like and then the potting material is centrifugally injected to avoid disorder of the bundle (JP 2000-210538, JP 2000-210539). Since the hollow fibers are temporarily fixed, the hollow fibers can be aligned, but when the potting material is injected, the hollow fiber bundle spreads, that is, the hollow fibers on the blood contact surface in the present specification. The occupancy of the bundle tended to be suppressed.

Therefore, the inventors have paid attention to the state of the hollow fiber bundle immediately before inserting it into the dialyzer container, and as a result of earnest study,
The following inventions have been reached. That is, the inventors have found a method in which a hollow fiber bundle wrapped in a film is placed between a plurality of rollers and rotated for a certain period of time to make the hollow fibers into a perfect circle in the film, and then inserting the hollow fiber into a dialyzer container. Specifically, the plurality of rollers are two rollers having a sponge such as porous urethane attached on the surface thereof, or more preferably three rollers, and the hollow fiber bundle film is always in contact with each roller. Then, rotate the bundle for a certain period of time. The perfect circle state of the hollow fibers in the film can be controlled relatively easily by the contact pressure of the roller, the number of rotations, and the rotation time.However, if the treatment is carried out for too long, the hollow fibers will spread too much in the film and Since it becomes difficult to insert it into the hemodialyzer container, it is necessary to determine the roller contact pressure, rotation speed, and rotation time according to the container and hollow fiber bundle used. In particular, the roller peripheral speed, which is the product of the number of rotations of the roller and the roller peripheral length, is different when the peripheral speeds of a plurality of rollers are the same, and the hollow fibers are not uniformly dispersed in the film. By doing so, it was found that the bundle was dispersed from the outer periphery to the central portion.

The reason why the hollow fibers are dispersed in the film by this treatment is that the hollow fibers are rubbed with each other to generate static electricity and repel each other to swell and disperse in the film to form a perfect circle.
Or, if this treatment is carried out for a long time, the hollow fibers in an aligned state gradually become disordered in appearance, so that by performing the treatment, the hollow fibers move in the film one by one, and the hollow fibers move to each other. Since they overlap with each other, it is considered that they swell and disperse in the film to form a perfect circle.

The material of the hemodialysis membrane used here is not particularly limited, but if it is a known material used for hemodialysis, for example, a regenerated cellulose-based membrane or polysulfone is used as a base material to obtain hydrophilicity. In addition, a polysulfone-based film having a hydrophilic polymer such as PVP, polyvinyl alcohol, or polyethylene glycol, a cellulose triacetate film, or a polymethylmethacrylate film can be used. Among them, a hollow fiber membrane obtained by adding PVP to polysulfone is mentioned as a preferred specific example of the present invention. However, since polysulfone has a hydrophobic property, a lot of static electricity is generated when this treatment is performed. However, it is considered that the hollow fibers repel each other electrostatically and become bulky. In addition, since the polysulfone membrane has a moderate elasticity (moderate pliability), when this treatment is performed, the hollow fibers easily move without being entangled, and the hollow fibers may overlap with each other. It is thought that it is easy to get rid of it.

Further, as the shape of the hollow fiber, a bundle in which spacer filaments are inserted between the hollow fibers described in the prior art,
Although it is applicable to a crimped hollow fiber, as a particularly preferred embodiment, the hollow fiber is a straight hollow fiber,
So-called straight yarn can be mentioned. It is considered that this is because when the bundle is rotated between the rollers, the hollow fibers are more easily moved, and the hollow fibers are overlapped with each other, so that the phenomenon of swelling in the film easily occurs. A hollow fiber type blood treatment membrane obtained by adding PVP to a polysulfone-based polymer that can be used in the present invention is disclosed in, for example, JP-A-12-13542.
The hollow fiber produced by the known method described in 2 is inserted into a tubular film to form a hollow fiber bundle.

The obtained hollow fiber bundle was placed between a plurality of rollers having different peripheral speeds, rotated for a certain period of time, loaded into a cylindrical container, and the film covering the hollow fibers was removed,
Set in a centrifuge, inject potting material such as polyurethane resin, and adhere and fix to a container. The semi-finished product obtained by cutting and removing the excess adhesive is provided with a stopper and a packaging material, and then sterilized to obtain the hemodialyzer of the present invention.
The above semi-finished product may be filled with pure water or a liquid in which a water-soluble substance such as sodium pyrosulfite and acetone sodium bisulfite is dissolved, and after plugging, sterilization may be performed. As the sterilization operation, any method of ethylene oxide gas sterilization, high-pressure steam sterilization, or radiation sterilization of irradiating radiation such as γ-rays can be arbitrarily selected and used. It has been found that the hemodialyzer thus obtained is a hemodialyzer with less residual blood in the hollow fiber embedded portion of the hemodialyzer and / or has less variation in dialyzer substance removal performance.

[0024]

EXAMPLES The present invention will be described below in more detail with reference to Examples and Comparative Examples, but the present invention is not limited to these Examples. In the Examples and Comparative Examples, the occupancy rate measurement of the hollow fiber bundle with respect to the inner diameter of the container on the blood contact surface, the circularity deviation measurement, and the blood introduction part residual blood test were performed according to the following methods.

(Measurement of Hollow Fiber Bundle Occupancy Rate) The occupancy rate of the hollow fiber bundle to the inner diameter of the container on the blood contact surface of the hollow fiber embedded portion is defined as the ratio of the hollow fiber bundle diameter to the inner diameter of the container on the blood contact surface of the hemodialyzer. Show. For the inner diameter of the container, the inner diameter of the container on the blood contact surface of the hemodialyzer is measured at least at five points using calipers, and the arithmetic mean value of the maximum and minimum values is taken as the inner diameter of the container. On the other hand, the diameter of the hollow fiber bundle is measured by directly looking at the blood contact surface of the hollow fiber embedding portion and measuring the diameter of the hollow fiber bundle at a minimum of 5 points or more, excluding the portion where the bundle is cracked as if an extreme crack had occurred. The maximum and minimum diameters are calculated by using the

The occupancy rate was calculated by the following equation.

[0026]

[Equation 1]       Occupancy (%) = 100 x hollow fiber bundle diameter ÷ container inner diameter (1)

(Measurement of roundness deviation) By emphasizing the hollow fiber embedding portion, the diameter of the hollow fiber bundle should be at least 5 points or more by a caliper or the like, except for the portion where the bundle is broken like an extremely cracked portion. The roundness was calculated by the following equation (2) by actually measuring and setting the maximum diameter and the minimum diameter of the hollow fiber bundle.

[0028]

[Equation 2]       Roundness deviation (%) = 100 x (maximum diameter-minimum diameter) ÷ minimum diameter (2)

(Blood introduction part residual blood test) In the blood introduction part residual blood test, bovine whole blood (37 ° C, total protein content 6.5 g / dl) was used at a flow rate of 20.
The blood was flown at 0 ml / min for 15 minutes, and then physiological saline was flown at a flow rate of 50 ml / min for 4 minutes. Then, the blood introducing part was observed, and it was visually determined whether blood remained on the outer periphery.

(Low molecular weight substance removal performance measurement) Regarding the low molecular weight substance (urea) removal performance measurement, according to the dialyzer performance evaluation standard (Japan Society for Artificial Organs, September 1982), blood side solution flow rate 200 ml / min, dialysis Liquid side liquid flow rate 5
It was carried out at 00 ml / min, and the urea concentration (Ci
n) and the urea concentration (Cout) on the outlet side,

The solute clearance was calculated by the following equation.

[Equation 3] Clearance = Cin / Cout × 200 The unit of the numerical value obtained here is ml / min, which indicates how much solution in the blood side solution (200 ml / min in this measurement) the solute was removed. .

[0031]

Example 1 As shown in FIG. 1, an inner diameter of 200 μm and a film thickness of 45
Prepare a hollow fiber bundle (4) containing 9200 μm polysulfone hollow fibers in a tubular film, and use three rollers (1, 2, 3) with an outer diameter of 45 mm and a sponge layer on the outer surface for all rollers. Are in contact with the hollow fiber bundle, and the centers of the circles of the rollers are at the vertices of an equilateral triangle, and the rotation speed of the three rollers is 200 rpm, 250 rpm, 280 rpm, and the hollow fiber bundle is rotated for 2 seconds. It was The hollow fiber bundle is in a state of swelling in the tubular film, after inserting this hollow fiber bundle into the polycarbonate cylindrical container, set it in the centrifuge and inject the urethane resin, gel up the urethane resin, centrifuge I took it out. In order to cure urethane resin sufficiently
After being put for 24 hours, excess urethane resin was cut, a blood introducing part component was attached, pure water was filled, a stopper was applied, and gamma rays of 25 kGy were irradiated to obtain a test product (product of the present invention).

Five pieces of the obtained test product were taken out at random, urea clearance was measured, and the average value and standard deviation were calculated. Furthermore, after performing a residual blood test using bovine blood on the same test product, disassemble the blood introducing part,
Measures the occupancy of the hollow fiber bundle with respect to the inner diameter of the container on the blood contact surface of the hollow fiber embedding part and the circularity deviation of the hollow fiber bundle.
It was calculated. The obtained numerical values are shown in Table 1.

[0033]

[Table 1]

[0034]

[Example 2] A hollow fiber bundle was prepared in which 9200 polysulfone hollow fibers having an inner diameter of 200 µm and a film thickness of 45 µm were put in a tubular film, and a roller 3 having an outer diameter of 45 mm and having a sponge layer on the outer surface.
Arrange the book so that all the rollers are in contact with the hollow fiber bundle and the center of the circle of the rollers is the apex of an equilateral triangle.
The rotation speed of the rollers of the book was set to 200 rpm, 250 rpm, and 280 rpm, and the hollow fiber bundle was rotated for 4 seconds. The obtained hollow fiber bundle was subjected to the same treatment as in Example 1, and the obtained test product (product of the present invention) was subjected to the same test as in Example 1 and the numerical values obtained are shown in Table 1.

[0035]

Example 3 A hollow fiber bundle having 9200 polysulfone hollow fibers having an inner diameter of 200 μm and a film thickness of 45 μm put in a tubular film was prepared, and a roller 3 having an outer diameter of 45 mm and having a sponge layer on the outer surface was prepared.
Arrange the book so that all the rollers are in contact with the hollow fiber bundle and the center of the circle of the rollers is the apex of an equilateral triangle.
The rotation speed of the rollers of the book was set to 300 rpm, 350 rpm, and 380 rpm, and the hollow fiber bundle was rotated for 2 seconds. The obtained hollow fiber bundle was subjected to the same treatment as in Example 1, and the obtained test product (product of the present invention) was subjected to the same test as in Example 1 and the numerical values obtained are shown in Table 1.

[0036]

[Example 4] A hollow fiber bundle was prepared in which 9200 polysulfone hollow fibers having an inner diameter of 200 µm and a film thickness of 45 µm were put in a tubular film, and a roller 3 having an outer diameter of 45 mm and having a sponge layer on the outer surface was prepared.
Arrange the book so that all the rollers are in contact with the hollow fiber bundle and the center of the circle of the rollers is the apex of an equilateral triangle.
The rotation speed of the rollers of the book was set to 300 rpm, 350 rpm, and 380 rpm, and the hollow fiber bundle was rotated for 4 seconds. The obtained hollow fiber bundle was subjected to the same treatment as in Example 1, and the obtained test product (product of the present invention) was subjected to the same test as in Example 1 and the numerical values obtained are shown in Table 1.

[0037]

[Comparative Example 1] A hollow fiber bundle was prepared in which 9200 polysulfone hollow fibers having an inner diameter of 200 μm and a film thickness of 45 μm were put in a tubular film, and the hollow fiber bundle was inserted into a polycarbonate cylindrical container without being rotated between rollers and was made of urethane resin. After fixing,
Table 1 shows the numerical values obtained by performing the same test as in Example 1 on the test product (control) obtained by the same treatment as in Example 1.

[0038]

EFFECTS OF THE INVENTION According to the present invention, by a very simple method, it is possible to reduce the blood residue on the blood contact surface of the hollow fiber embedding part of the hemodialyzer after the hemodialysis treatment, and to remove the substance of the dialyzer. It was possible to reduce the variation of the.

[Brief description of drawings]

FIG. 1 is a plan view showing a positional relationship between a roller and a hollow fiber bundle when the hollow fiber bundle of Example 1 is placed between a plurality of rollers and the rollers are rotated.

[Explanation of symbols]

1, 2, 3 ... Roller 4 ··· Hollow fiber bundle

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) B01D 63/02 B01D 63/02 71/68 71/68 F term (reference) 4C077 AA12 BB01 CC01 EE01 EE03 LL05 PP15 4D006 GA13 HA02 HA18 JA02A JA13A JB04 MA01 MA34 MB01 MC62 MC62X PA01 PB09 PC47

Claims (5)

[Claims] 1. A hemodialyzer in which a bundle of hollow fibers is inserted into a cylindrical plastic container, and both ends of the bundle are embedded with potting material. A hemodialyzer with an occupancy rate of 87% or more. 2. The hemodialyzer according to claim 1, wherein the roundness deviation of the roundness of the hollow fiber bundle at the blood contact surface of the hollow fiber embedded portion is 3% or less. 3. The hemodialyzer according to claim 1, wherein the hollow fiber has a linear shape along the fiber axis direction. 4. The hemodialyzer according to claim 1, wherein the material of the hollow fiber is polysulfone as a base material. 5. A method for manufacturing a hemodialyzer in which a hollow fiber bundle is inserted into a cylindrical plastic container and both ends of the bundle are embedded with potting material, wherein hollow film bundles preliminarily film-wound have different peripheral speeds. The method for producing a hemodialyzer according to any one of claims 1 to 4, wherein the hemodialyzer is placed between a plurality of rollers, rotated for a certain period of time, and then inserted into a cylindrical plastic container and fixed with a potting material.