JP3244409B2 - Hollow fiber membrane dialysis filter - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hollow fiber diafiltration filter used in blood purification therapy.

[0002]

2. Description of the Related Art In blood purification therapy, a method for replacing a large amount of liquid includes a hemodiafiltration method and an online hemodiafiltration method.
(Henderson, LWet al: Trans.Am.Soc.Artif.Intern.Org
ans 24465-467 (1978)) and Push / Pull hemodiafiltration
(Usuda, M. et al: Trans.Am.Soc.Artif.Intern.Organs 28
24-27 (1982)). In the hemodiafiltration method, a large amount of liquid replacement requires a large amount of a pyrogen-free replacement solution, and the preparation of the replacement solution is complicated and the cost is high because the replacement solution is expensive. The on-line hemodiafiltration method and the Push / Pull hemodiafiltration method overcome these problems by using dialysate as a replacement solution, but require a dedicated device, which complicates the circuit configuration. There is a disadvantage that.

[0003] Therefore, the inventor of the present invention provided a stenosis portion at approximately the center 1/3 on the dialysate side of the diafiltration filter, and used the back-filtered dialysate as a replacement solution in a large amount without requiring a dedicated device. A diafiltration filter capable of liquid replacement was devised (Japanese Patent Application No. Hei 6-23437).
No. 3). In the diafiltration filter, the pressure of the dialysate flowing through the second flow path is higher than the pressure of the bodily fluid flowing through the first flow path at the upstream of the dialysate in the constriction, and On the downstream side, the pressure of the dialysate flowing through the second flow path is set to be lower than the pressure of the bodily fluid flowing through the first flow path. On the downstream side, the amount of filtration from the blood side to the dialysate side can be increased, so that a large amount of blood and dialysate can be replaced.

Here, in order to further improve the efficiency of large-volume liquid replacement and to remove toxic substances more excellently, it has been studied to further increase the dialysate-side pressure loss and improve the large-volume liquid replacement efficiency.

On the other hand, JP-A-51-133185 discloses that
In a state where the outer periphery of the bundle of the hollow fiber membranes is partially surrounded and supported in the longitudinal direction by the support material, the bundle is stored in the processing chamber of the separation device,
Although a method of increasing the filling rate of the hollow fiber membrane type permselective membrane has been proposed, the method of storing the hollow fiber membrane is complicated because a decompression device or the like is used, and the hollow fiber membrane is not damaged and is simple. There is no production means and it has not been put to practical use.

[0006]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a hollow fiber membrane type diafiltration filter which can be manufactured more easily in a dialysis filter capable of replacing a large amount of liquid by using a back-filtrated dialysate as a replacement liquid. Is the purpose.

It is another object of the present invention to provide a hollow fiber membrane type diafiltration filter which is capable of replacing a large amount of liquid by using a back-filtrated dialysate as a replacement liquid and which has improved solute removal performance. One purpose.

[0008]

Means for Solving the Problems The above objects have, in a cylindrical housing, a bundle of hollow fiber membranes, and a first flow path and a second flow path separated by the hollow fiber membrane. A dialysis filter that performs dialysis and ultrafiltration between a bodily fluid flowing through the first flow path and the dialysate flowing through the second flow path via the hollow fiber membrane; longitudinal flow of the secondary flow path
Dialysate swelling insert to reduce road cross-sectional area, and
Using the stenosis part forming member having swelling property and dialysis fluid.
This is achieved by a hollow fiber membrane type diafiltration filter characterized in that a constriction is provided in the middle of the two flow paths .

The present invention is also the hollow fiber membrane type dialysis filter, wherein the interposed body is inserted between the outer periphery of the bundle of hollow fiber membranes and the inner surface of the housing.

[0010] The present invention is also the hollow fiber membrane type diafiltration filter, wherein the interposer is inserted in a gap between the hollow fiber membranes.

[0011] In the present invention, the intercalator may have a dialysate content of 50%.
The hollow fiber membrane type diafiltration filter of not less than% by weight.

[0012]

According to the present invention, in the hollow fiber membrane diafiltration filter, the pressure loss of the second flow path is preferably 20 to 300 mmHg.
Is a hollow fiber diafiltration filter.

The present invention is the above-mentioned hollow fiber membrane type diafiltration filter, wherein the hollow fiber membrane filling ratio is 70 to 78%.

The present invention is the hollow fiber membrane type diafiltration filter, wherein the interposed body has a dialysate content of 50 to 2,600% by weight.

According to the present invention, there is provided the above-mentioned hollow fiber membrane type diafiltration filter, wherein the interposer is a hollow fiber membrane type dialysis filter having a dialysate content of 100 to 2,000% by weight. In the hollow fiber membrane diafiltration filter, the pressure loss of the second flow path is 50 to 200 mmHg.

[0017]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A dialysis filter according to the present invention will be described below with reference to the drawings.

FIG. 1 is a circuit diagram schematically showing a configuration example of a blood extracorporeal circuit including the dialysis filter of the present invention.
As shown in FIG. 1, the extracorporeal blood circulation circuit 10 includes a blood removal line 11A, a diafiltration filter 1, a blood return line 11B, and a water removal control unit 17.

The blood removal line 11A comprises a tube 12, a blood supply pump 13 and a defoaming chamber 14 installed in the middle of the tube 12, and one end of the blood removal line 11A is connected to a needle tube. And the other end is connected to the blood inlet 34 of the diafiltration filter 1.

The blood return line 11B is connected to a tube 15
And a defoaming chamber 16 installed in the middle of the tube 15, and one end of the blood return line 11B is connected to a patient's vein via a needle tube.

The water removal control means 17 comprises a tube 18 having one end connected to a dialysate inlet 36 of the diafiltration filter 1.
A tube 19 having one end connected to the dialysate outlet 37 of the diafiltration filter 1; a double pump 20 for feeding dialysate into the tubes 18 and 19 at the same flow rate and in opposite directions, respectively; The bypass tube 21 has two ends connected to the tube 19 so as to bypass the tube 19, and a water removal pump 22 provided in the middle of the bypass tube 21.

As the pump 13, a roller pump is preferably used.

The dual pump 20 converts the rotational motion of the motor into the reciprocating motion of the plunger, and alternately receives and discharges dialysate and dialysate drainage by a check valve mechanism.

The water removal pump 22 is configured to convert the rotational movement of the motor into the reciprocating movement of the plunger and to send out the dialysate drainage in the cylinder in a certain direction.

Next, the operation of the extracorporeal blood circulation circuit 10 will be described.

The blood removed from the patient by the operation of the pump 13 flows through the blood removal line 11A, is temporarily stored in the chamber 14 and defoamed, and then flows into the dialysis filter 1 through the blood inlet 34. I do. The blood flowing out from the blood outlet 35 flows through the blood return line 11B, and is
The blood is returned to the patient after being stored and defoamed.

On the other hand, by the operation of the double pump 20, dialysate supplied from a dialysate reservoir (not shown) flows through the tube 18 and is introduced into the housing 3 of the dialysate 1 through the dialysate inflow port 36. As described later, dialysis and filtration are performed with the blood through the hollow fiber membranes 41 in the inside of the filter 3, and the dialysis solution is discharged from the dialysate outlet 37.
The discharged dialysate is transferred via the tube 19 and collected. At this time, when the water removal pump 22 is operated at a predetermined rotation speed, the dialysate supply amount to the dialysis filter 1 and the dialysate recovery amount from the dialysate 1 correspond to the discharge amount of the water removal pump 22. A minute difference occurs, and this amount is the amount of water removed from the blood passing through the dialysate 1. Therefore, by adjusting the rotation speed (discharge amount) of the water removal pump 22, the water removal amount can be adjusted.

FIG. 2 is a longitudinal sectional view showing one embodiment of the diafiltration filter 1 of the present invention. As shown in the figure, the dialysis filter 1 has a cylindrical main body 31 and covers 38 and 3 on both ends thereof.
9, header 32 connected and fixed in a liquid-tight manner
, And 33. A blood inlet 34 protrudes from the top of the header 32,
A blood outlet 35 protrudes from the top of the header 33. A dialysis fluid inlet 36 protrudes from the side of the cylindrical body 31 on the header 33 side, and the cylindrical body 31
A dialysis fluid outlet 37 is formed on the side of the header 32 on the side of.

The cylindrical body 31, the headers 32 and 3
3, and the covers 38 and 39 are made of, for example, polyethylene, polypropylene, polycarbonate, polymethyl methacrylate, acrylic resin, hard polyvinyl chloride,
It is made of various hard resins such as styrene-butadiene copolymer resin and polystyrene, and is preferably transparent or translucent to secure the visibility inside. Further, the header 32 and the cover 33 may be colored in different colors in order to easily distinguish between the blood entry side and the blood entry side.

A bundle 4 of hollow fiber membranes 41 is housed in the housing 3 over substantially the entire length thereof. in this case,
The hollow fiber membranes 41 constituting the bundle 4 are, for example, 100 to 7
The number of hollow fiber membranes is about 0000, and the hollow fiber membranes 41 are arranged in parallel and separated from each other along the longitudinal direction of the housing 3.

Examples of the hollow fiber membrane 41 include regenerated cellulose, cellulose derivatives, polymethyl methacrylate, polyolefins such as polyethylene and polypropylene, polysulfone, polyacrylonitrile, polyamide, polyimide, polyether nylon, silicone, and polytetrafluoroethylene. And polyester-based polymer alloys.

The effective membrane area of the entire hollow fiber membrane 41 is not particularly limited, but is preferably 100 cm ^{2 to} 6.0 m ^2.
Degree, more preferably about 0.2 to 2.0 m ² . Both ends of each hollow fiber membrane 41 are respectively connected to the cylindrical main body 3.
At one end, the hollow fiber membrane 41 is liquid-tightly supported and fixed by the partition walls 51 and 52 in a state where the end opening of the hollow fiber membrane 41 is not closed.

The partition walls 51 and 52 are made of a potting material such as polyurethane, silicone or epoxy resin. In the presence of the bundle 4 of the hollow fiber membranes 41, the liquid potting material is centrifugally injected into the cylindrical main body 31. Is formed by injecting into both ends and curing.

A blood inflow chamber 61 is formed in a space surrounded by the header 32 and the partition wall 51, and a blood outflow chamber 62 is formed in a space surrounded by the header 33 and the partition wall 52. A first flow path (blood flow path) 6 through which blood flows is formed in the inner cavity (hollow portion) of each hollow fiber membrane 41, and both ends of the first flow path 6 are respectively connected to the blood. Inflow chamber 61
And the blood outflow chamber 62.

In a space surrounded by the cylindrical body 31 of the housing 3 and the partition walls 51 and 52, the gap between the bundle 4 of the hollow fiber membranes 41 and the inner peripheral surface of the cylindrical body 31 and the adjacent hollow fiber In the gap between the membranes 41, a second flow path (dialysate flow path) 7 through which the dialysate flows is formed. That is, the first flow path 6 and the second flow path 7 are separated by each hollow fiber membrane 41. The upstream side of the second flow path 7 communicates with the dialysate inlet 36, and the downstream side communicates with the dialysate outlet 37.

With such a configuration, the blood flowing from the blood inlet 34 into the blood inflow chamber 61 flows through the first flow path 6, is collected in the blood outflow chamber 62, and flows out from the blood outlet 35. On the other hand, the dialysate flowing from the dialysate inlet 36 flows through the second flow path 7 in a direction opposite to the blood flow, and flows out of the dialysate outlet 37.

In the second flow path 7, the inner surface between the dialysate inlet 36 and the dialysate outlet 37 of the cylindrical body 31 and the bundle 4 of the hollow fiber membranes 41 have dialysate swellability. Insert 8
Is provided so that the cross-sectional area of the second flow path 7 is reduced, and dialysis flowing through the second flow path 7 near the dialysate inlet 36 and the dialysate outlet 37 is provided. It is configured to produce a desired difference in liquid pressure.

[0038]

Accordingly, the blood flowing through the first flow path 6 is first dialyzed (diffusion of solute) and ultrafiltered (dewatered) through each hollow fiber membrane 41 on the dialysate outlet side, On the dialysate outlet side, ultrafiltration (replacement fluid) in the reverse direction from the dialysate side to the blood side is performed through each hollow fiber membrane 41.

As described above, replacement is performed when the pressure on the dialysate side is higher than the pressure on the blood side, and the amount of filtration from the blood side to the dialysate side is increased when the pressure on the dialysate side is lower than the pressure on the blood side. Therefore, a large amount of blood can be replaced with dialysate. In addition, such a large amount of liquid replacement can be performed with a single dialysis filter 1 without using a dedicated device or the like separately provided. At this time, the directions in which the blood and the dialysate flow may be the same or opposite.

In this case, the ultrafiltration rate (pure water filtration coefficient) in the dialysis filter 1 is preferably at least 20 ml / m ² · hr · mmHg at a water flow rate of 200 ml / min. More preferably, it is 30 ml / m ² · hr · mmHg or more at 300 ml / min.

The interposer 8 is connected to the bundle 4 of the hollow fiber membrane 41.
Is inserted between the outer periphery of the hollow fiber membrane 41 and the inner surface of the tubular main body 31 by, for example, using a nonwoven fabric, woven fabric, or a string made of a dialysate swellable material as the interposer 8. , And inserted into the cylindrical main body 31 together with the bundle 4 of the hollow fiber membranes 41, or a non-woven fabric, a woven fabric, a string, or the like made of a dialysate swellable material is previously adhered to the inner surface of the cylindrical main body 31. After that, the bundle 4 of the hollow fiber membranes 41 can be inserted and inserted. In any case, the space occupied by the interposer 8 during manufacture is considerably smaller than the space occupied by the interposer 8 when swollen by the inflow of dialysate. The bundle 4 can be easily loaded.

Further, such an insert 8 is connected to each hollow fiber membrane 4.
For example, when the bundle 4 of the hollow fiber membranes 41 is manufactured, the fiber made of the dialysate swellable material is used as the interposer 8 as one bundle with the hollow fiber membranes 41 when the bundle 4 of the hollow fiber membranes is produced. , And is loaded into the cylindrical main body 31. Alternatively, one to several tens of hollow fiber membranes 41 may be previously entangled with the fibrous interposer 8 made of a dialysate swellable material, and the bundles may be loaded in the tubular main body 31 as a bundle. Further, it may be used in combination with the above-described method in which the bundle is inserted between the outer periphery of the bundle 4 of the hollow fiber membranes 41 and the cylindrical main body 31. At this time, the space occupied by the interposer 8 at the time of manufacturing is considerably smaller than the space occupied by the interposer 8 when swollen by the inflow of the dialysate, so that the bundle 4 of the hollow fiber membranes 41 in the tubular main body 31 is formed. Can be easily loaded.

When the inserts 8 are inserted between the hollow fiber membranes 41, the distribution of the inserts 8 in the cross-sectional direction of the bundle 4 of the hollow fiber membranes 41 is uniform or non-uniform (for example, bundles). 4 may be dense at the center and rough at the outer periphery, or vice versa.

With such a configuration, the pressure loss can be increased more easily than providing a constriction in a part of the bundle of hollow fiber membranes, and the hollow fiber membrane is not damaged.

The interposed body is inserted into the gap between the inner surface of the cylindrical body 31 between the dialysate inlet 36 and the dialysate outlet 37 and the outer periphery of the bundle 4 of the hollow fiber membranes 41. By reducing the inner diameter of a portion exceeding at least one third in the longitudinal direction of 31 or by inserting the hollow fiber membrane 41 into all or a part of the gap between the hollow fiber membranes 41, the hollow fiber membrane filling rate is 65%. The configuration is as described above. The hollow fiber membrane filling rate is
It is calculated by equation (1). When the interposer is not used, the cross-sectional area of the interposer is zero. The hollow fiber filling ratio is preferably 65% or more, more preferably 70 to 78%. Below this, the pressure difference between the dialysate inlet and the dialysate outlet is small, making it difficult to obtain a liquid replacement effect. If it is too large, the hollow fiber membrane may be crushed.

[0047]

(Equation 1)

Further, according to the present invention, as shown in FIG. 2 , when the bundle 4 of the hollow fiber membranes 41 is formed, the bundle 4 is wound around the outer periphery of the bundle 4 of the hollow fiber membranes 41 substantially at the center. The amount of the interposer 8 made of the dialysate swellable material is made larger than the other parts, or the hollow fiber membrane 41 is formed into a warp or a weft of about 1 to several tens bundles, and is made of the dialysate swellable material. the fiber as weft or warp, to form a narrowed portion 9 by weaving hollow fiber membrane central portion with a constant width (more than 1/3 of the length of the hollow fiber membrane effective length).

Examples of the insert having a swelling property of the dialysate usable in these cases include, for example, (cross-linked) polyacrylate or (cross-linked) acrylic acid-acrylate copolymer (for example, Japan Co., Ltd.). AQUALIC made by catalyst,
ARASORB manufactured by Arakawa Chemical Industry Co., Ltd., WONDERGEL manufactured by Kao Corporation, AQUA manufactured by Iron and Steel Chemical Industry Co., Ltd.
AKEEP, D.C. W.
A. L. PAR made by National Starch
MASORB, FAVOR manufactured by Stockausen
Etc.), isobutylene-maleic acid copolymer (for example, KI Gel manufactured by Kuraray Isobutin Co., Ltd.), starch-acrylic acid graft copolymer or a saponified product thereof (for example, SUNWET, Grai manufactured by Sanyo Chemical Industries, Ltd.)
n GPC manufactured by Processing, SGP manufactured by Henkel, Mag manufactured by Super Absorbent
ic Water Gel, Unisex LYO
GEL, etc.), saponified vinyl acetate-acrylate copolymer (for example, SUMIK manufactured by Sumitomo Chemical Co., Ltd.)
AGEL), vinyl acetate-unsaturated dicarboxylic acid copolymer (for example, GP manufactured by Nippon Synthetic Chemical Industry), carboxymethylcellulose (for example, Buckeye Cellul)
ose CLD, Enka AKUCELL, etc.),
Composite fiber of acrylonitrile fiber inner core and acrylate copolymer outer layer (for example, LANSEA manufactured by Toyobo Co., Ltd.)
L).

Of these, a composite fiber comprising an inner core of acrylonitrile fiber, which is a super absorbent fiber, and an outer layer of an acrylate copolymer is most preferred. The superabsorbent fiber is disclosed in Toyobo Co., Ltd. catalog "Lanseal F superabsorbent fiber".

Further, the interposer may be formed by combining these fibers having a swelling property of the dialysate with a silicone resin, a fluorine resin, a urethane resin, an epoxy resin or the like by impregnation or fixing.

Further, the dialysate-containing swelling material used for these intercalators and stenotic portions has a dialysate content of 50% by weight or more, preferably 50 to 2,600% by weight, more preferably 100 to 2,000% by weight. %. If it is smaller than this, it is not easy to load the bundle 4 of the hollow fiber membranes 41 into the tubular main body 31, and if it is larger than this, it is difficult to maintain the swelling state of the dialysate swellable material. Here, the dialysis solution rate is
When M ′ is the weight of the dialysate swellable material at the time of the dialysate and m ′ is the weight of the dialysate swellable material at the time of drying, the dialysate content H
= [(M′−m ′) / m ′] × 100.

FIG. 2 shows a state in which a dialysate swelling material is wound around a substantially central portion of the second flow path 7 in the longitudinal direction, and is loaded on a cylindrical main body 31 having the above-mentioned interposed body sheet adhered to the inner surface thereof. This is a dialysis filter produced by forming a stenosis portion 9 by using a dialysis filter.

FIG. 3 shows a diagram of the extracorporeal circuit shown in FIG.
In the case where the dialysis filter and the insert 8 shown in FIG.
5 is a graph showing pressure distributions of blood flowing through a first flow path 9 and dialysate flowing through a second flow path 10. As shown in the figure, the pressure of the blood flowing through the first flow path 9 decreases almost linearly from the upstream to the downstream, while the pressure of the dialysate flowing through the second flow path 10 is: Interposer 8 and stenosis 9
By reducing the inner diameter of the dialysis filter, the pressure gradient becomes larger than the pressure distribution of the dialysis filter having only the constricted portion 9 without the interposed body, and the dialysis outlet side corresponds to the first flow path 6. The pressure becomes higher than the blood pressure at the site, and becomes lower than the blood pressure at the site corresponding to the first flow path 6 on the dialysate inflow side. Therefore, the blood flowing through the first flow path 6 is first supplied to each hollow fiber membrane 41 at the dialysate outlet.
Is performed and diffusion and ultrafiltration (water removal) are performed, and then, at the dialysate inflow side, more ultrafiltration in the reverse direction from the dialysate side to the blood side through each hollow fiber membrane 41 (replacement fluid) ) Is performed

The pressure loss on the dialysate side of the dialysis filter constructed as described above is preferably about 20 to 300 mmHg, and 50 to 2 mmHg.
About 00 mmHg is more preferable. As a result, the large-volume replacement of blood and dialysate as described above is efficiently performed. At pressures lower than this, the remarkable effect as described above cannot be obtained,
Above this, the diafiltration filter housing, the dialysate circuit, the pump, etc., are overburdened and need to be stronger than conventional ones. The constituent materials, arrangement density, installation area, and the like of the interposer 8 and the constriction 9 are appropriately adjusted so as to obtain such a pressure difference. As shown in FIG. 2, the interposition body 8 is provided in the dialysate-side flow path of each bundle 4 of the hollow fiber membranes 41 housed in the cylindrical main body 31 to reduce the cross-sectional area of the second flow path. Alternatively, by providing the interposer 8 and the stenosis part 9,
By increasing the pressure difference on the dialysate side and increasing the reverse filtration from the dialysate side to the blood side, the filtration from the blood side to the dialysate side is increased, and solute removal by large volume liquid replacement is possible. Become.

The diafiltration filter of the present invention can also be used as a purification device for plasma and blood components separated from blood.

Hereinafter, the diafiltration filter of the present invention will be described in more detail with reference to specific examples.

[0058]

[0059]

[0060]

[0061]

[0062]

[0063]

Example 1 A bundle of about 10,000 polyamide hollow fiber membranes (inside diameter 215 μm, outside diameter 335 μm) (effective membrane area 1.2
m ² ) was prepared, and an acrylated dialysate-swellable acrylic fiber (dialysis solution content:
1,963%) to form a stenosis portion, and this bundle of hollow fiber membranes was inserted into a housing in which a dialysis solution swellable fiber cloth was adhered to the inner surface to form an insert. A potting material was injected into both ends of each hollow fiber membrane inserted into the housing, cured to fix each hollow fiber membrane, and both ends were sliced to open each hollow fiber membrane. At both ends of the housing,
Wearing the port, it was fixed in a liquid-tight manner by fusion to obtain a dialysis filter of the structure shown in FIG. The effective length and inner diameter of the housing were 175 mm and 42 mm, respectively. The hollow fiber filling rate of the interposed body insertion portion was 71.8%.
The filling rate of the stenosis was 78%.

Comparative Example 1 Polyamide hollow fiber membrane (inner diameter 2
About 10,000 bundles (effective membrane area: 1.2 m ² ) of 15 μm, outer diameter of 335 μm) were prepared, and acrylated dialysate-swellable acrylic fibers (dialysis solution ratio: (1,963%) to form a constriction, and this bundle of hollow fiber membranes was inserted into the housing. A potting material was injected into both ends of each hollow fiber membrane inserted into the housing, cured to fix each hollow fiber membrane, and both ends were sliced to open each hollow fiber membrane. Ports were attached to both ends of the housing, and these were liquid-tightly fixed by fusion to obtain a diafiltration filter. The effective length and inner diameter of the housing were 175 mm and 42 mm, respectively. The filling rate of the stenosis was 78%.

[Experiment 1 ] Using Example 1 and Comparative Example 1 , the cytochrome C (molecular weight 1) was determined using the circulation circuit shown in FIG.
2,400). Table 1 shows the results.
The filtration flow rate was 12 ml / min.

[0066]

[Table 1]

As shown in Example 1 , the clearance of cytochrome C was increased by 11 ml / min according to the present invention, and a remarkable improvement in performance was observed.

[0068]

Example 2 Polysulfone hollow fiber membrane (200 μm inner diameter)
m, outer diameter 280 μm) About 11,000 bundles (effective membrane area 1.2 m ² ) were prepared, and acrylated dialysate-swellable acrylic fibers (dialysis solution content: (1,963%) to form a constriction, and a cloth of dialysate swellable fiber was wound around the bundle of hollow fiber membranes and inserted into the housing. A potting material was injected into both ends of each hollow fiber membrane inserted into the housing, cured to fix each hollow fiber membrane, and both ends were sliced to open each hollow fiber membrane. At both ends of the housing, by mounting the port, it was fixed in a liquid-tight manner by fusion to obtain a dialysis filter of the structure shown in FIG. The effective length and inner diameter of the housing were 175 mm and 42 mm, respectively. The hollow fiber filling rate of the interposed body was 70.4%. The filling rate of the stenosis was 78%.

Comparative Example 2 A bundle of about 11,000 polysulfone hollow fiber membranes (200 μm inner diameter, 280 μm outer diameter)
(Effective membrane area 1.2 m ² ) is prepared, and acrylated dialysate swellable acrylic fiber is
(Dialysis solution ratio: 1,963%) was wound around to form a constriction, and the bundle of hollow fiber membranes was inserted into the housing. A potting material was injected into both ends of each hollow fiber membrane inserted into the housing, cured to fix each hollow fiber membrane, and both ends were sliced to open each hollow fiber membrane. Ports were attached to both ends of the housing, and these were liquid-tightly fixed by fusion to obtain a diafiltration filter. The effective length and inner diameter of the housing were 175 mm and 42 mm, respectively. The filling rate of the stenosis was 78%.

[Experiment 2 ] Using Example 2 and Comparative Example 2 , cytochrome C (molecular weight 1) was determined by the circulation circuit shown in FIG.
2,400). Table 2 shows the results.
The filtration flow rate was 12 ml / min.

[0071]

[Table 2]

Example 2 of the present invention had a higher clearance value.

Example 3 A bundle of about 9,000 polyacrylonitrile hollow fiber membranes (245 μm inner diameter, 305 μm outer diameter) (effective membrane area: 1.2 m ² ) was prepared, and acrylic A stenosis portion is formed by winding acidified dialysate swellable acrylic fiber (dialysis solution content: 1,963%), and this bundle of hollow fiber membranes is attached to the inner surface of a dialysate swellable fiber cloth. It was inserted into the housing in which the insert was formed. A potting material was injected into both ends of each hollow fiber membrane inserted into the housing, cured to fix each hollow fiber membrane, and both ends were sliced to open each hollow fiber membrane. Ports were attached to both ends of the housing, and these were fixed in a liquid-tight manner by fusion to obtain a diafiltration filter having the structure shown in FIG.
The effective length and inner diameter of the housing were 175 mm and 42 mm, respectively. The hollow fiber filling rate of the interposed body was 75.2%. The filling rate of the stenosis was 78%.

Comparative Example 3 A bundle of about 9,000 polyacrylonitrile hollow fiber membranes (245 μm in inner diameter, 305 μm in outer diameter) (effective membrane area: 1.2 m ² ) was prepared. The acidified dialysate swellable acrylic fiber (dialysis solution content: 1,963%) was wound around to form a constriction, and this bundle of hollow fiber membranes was inserted into the housing. A potting material was injected into both ends of each hollow fiber membrane inserted into the housing, cured to fix each hollow fiber membrane, and both ends were sliced to open each hollow fiber membrane. Ports were attached to both ends of the housing, and these were fixed in a liquid-tight manner by fusion to obtain a diafiltration filter having the structure shown in FIG. The effective length and inner diameter of the housing were 175 mm and 42 mm, respectively. The filling rate of the stenosis was 78%.

[Experiment 3 ] Using Example 3 and Comparative Example 3 , the cytochrome C (molecular weight 1) was determined by the circulation circuit shown in FIG.
2,400). Table 3 shows the results.
The filtration flow rate was 12 ml / min.

[0076]

[Table 3]

In Example 3 of the present invention, the clearance value and the replacement liquid amount were significantly higher.

[0078]

As described above, according to the present invention, a bundle of hollow fiber membranes, a first flow path and a second flow path separated by the hollow fiber membrane are provided in a cylindrical housing. A diafiltration filter that performs dialysis and ultrafiltration between a bodily fluid flowing through the first flow path and the dialysate flowing through the second flow path via the hollow fiber membrane, Longitudinal direction of the second flow path
A dialysate swelling insert that reduces the flow channel cross-sectional area,
And using a stenosis portion forming member having swelling properties with dialysate
Since the constriction is provided in the middle of the second flow path , the second
The pressure loss of the flow path can be remarkably increased, and the filtration unit and the replacement fluid unit can be controlled, so that a large amount of liquid can be easily replaced. Dialysate on the intercalator and stenosis forming member
Since the swellable material is used, the filling rate of the hollow fiber membrane can be increased without damaging the hollow fiber membrane.

Further, since the insert is inserted between the outer periphery of the bundle of the hollow fiber membranes and the inner surface of the housing, manufacture is easy.

Further, since the interposed member is inserted in the gap between the hollow fiber membranes, a high pressure loss can be obtained.

Since the intercalator has a dialysate content of 50% by weight or more, the bundle of hollow fiber membranes can be easily loaded, and the hollow fiber membrane is not damaged.

[0082]

In the hollow fiber membrane type diafiltration filter, since the pressure loss of the second channel is 20 to 300 mmHg, the pressure difference between the first channel and the corresponding second channel is reduced. , Filtration and replacement fluid can be sufficiently performed.

[0084]

[Brief description of the drawings]

FIG. 1 is a schematic circuit configuration diagram of a configuration example of a blood extracorporeal circuit including a dialysis filter of the present invention.

FIG. 2 is a longitudinal sectional view showing one embodiment of the dialysis filter of the present invention.

FIG. 3 is a graph showing a pressure distribution of the dialysis filter shown in FIG. 2 of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Dialyzer 3 Housing 31 Cylindrical main body 32, 33 Header 34 Blood inlet 35 Blood outlet 36 Dialysate inlet 37 Dialysate outlet 38, 39 Cover 4 Bundle 41 Hollow fiber membrane 51, 52 Partition wall 6 1st flow Path 61 Blood inflow chamber 62 Blood outflow chamber 7 Second flow path 8 Insertion body 9 Stenosis 10 Blood extracorporeal circuit 11A Blood removal line 11B Blood return line 12 Tube 13 Pump 14 Chamber 15 Tube 16 Chamber 17 Water removal control means 18, 19 Tube 20 Double pump 21 Bypass tube 22 Water removal pump

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-6-63369 (JP, A) JP-A-4-212372 (JP, A) JP-A-3-65225 (JP, A) JP-A-1- 221162 (JP, A) JP-A-1-111403 (JP, A) JP-A-62-64373 (JP, A) JP-A-60-53156 (JP, A) JP-A-59-108564 (JP, A) (58) Field surveyed (Int. Cl. ⁷ , DB name) A61M 1/00-1/34 B01D 63/02

Claims (4)

(57) [Claims] 1. A bundle of hollow fiber membranes in a cylindrical housing,
It has a first flow path and a second flow path separated by the hollow fiber membrane, and flows through the second flow path and the bodily fluid flowing through the first flow path through the hollow fiber membrane A dialysis filter that performs dialysis and ultrafiltration with a dialysate, wherein the dialysate swelling property reduces the cross-sectional area of the second flow path in the longitudinal direction.
Insert having stenosis and swelling of dialysate
A hollow fiber membrane diafiltration filter characterized in that a constriction is provided in the middle of the second flow path using a member . 2. The hollow fiber membrane according to claim 1, wherein said interposed body is inserted between an outer periphery of said bundle of hollow fiber membranes and an inner surface of said housing. Type dialysis filter. 3. The hollow fiber membrane type diafiltration filter according to claim 1, wherein said interposed body is inserted in a gap between said hollow fiber membranes. 4. The hollow fiber membrane type diafiltration filter according to claim 1, wherein the intercalator has a dialysate content of 50% by weight or more.