JPH0613737Y2 - Hemodialyzer - Google Patents

Description

[Detailed Description of the Invention] [Industrial application] The present invention relates to a hemodialyzer, and more specifically, a dialysate filter membrane for removing bacteria, endotoxin, etc. contained in a dialysate is a semipermeable membrane through a partition member. And a hemodialyzer integrally housed in a cylinder.

[Conventional technology]

Dialysis therapy for dialysis of blood to treat patients with renal insufficiency and to maintain life is already established and widely used. In addition to dialysis and removal of urea, uric acid, etc. accumulated in body fluids of patients due to improvement of membrane function, in addition to removal of medium molecular weight substances such as β ₂ -microglobulin to prevent hair root canal syndrome etc. The range of use is expanding. However, on the other hand, as the dialysis membrane becomes highly functional, the occurrence of unforeseen complications and diseases with different concepts has been observed.

[Problems to be solved by the invention] For example, osteomalacia, which is said to be caused by a fluorine compound in tap water, hypercalcemia that occurs when dialysis is performed using highly hard water, and sterilization of water supply. It is known that an anemia, which is said to be caused by chloramine produced by the reaction of chlor with ammonia, a fever due to endotoxin, or a complication syndrome caused by other bacteria causing an agglutination reaction with antibodies in the blood. ing. In particular, endotoxin may be dissociated into subunits and pass through the micropores of the semipermeable membrane in the presence of a certain kind of surface-active substance, and its solution has been demanded.

[Means for Solving the Problems]

As a result of diligent studies conducted by the present inventors in order to meet these demands, it has been found that bacteria and endotoxin contained in the dialysate enter the blood through the micropores of the semipermeable membrane during dialysis. We found that it was the cause and arrived at the present invention.
That is, the present invention is a hemodialyzer that purifies blood by bringing blood into contact with a dialysate through a hollow fiber semipermeable membrane housed in a cylinder, and a blood inlet and a blood outlet. Dialysate inlet and dialysate outlet,
A blood purification chamber containing a hollow fiber semipermeable membrane with a semipermeable membrane having a pore size of 0.001 to 0.05 μ and a dialysate purification chamber having a dialysate filtration membrane with a filtration membrane having a pore size of 0.5 μ or less. Blood composed of a partitioning member extending in the longitudinal direction that is divided into and a clean dialysate inlet provided in the partitioning member that allows the dialysate purified in the dialysate purification chamber to flow into the blood purification chamber. It is a dialyzer.

[Action]

Since the hemodialyzer of the present invention has such a structure, the bacteria and endotoxins present in the dialysate can be removed by the dialysate filter membrane and contact the patient's blood through the semipermeable membrane. Even if the pressure on the dialysate side becomes higher than the pressure on the blood side near the blood outlet of the semipermeable membrane and the dialysate enters the blood through the micropores of the semipermeable membrane, bacteria and endotoxins are removed. Since it is a dialyzed solution, various symptoms caused by bacteria and the like can be avoided.

〔Example〕

Next, an embodiment of the hemodialyzer of the present invention will be described with reference to the drawings.

FIG. 1 is a sectional view of a hemodialyzer using porous hollow fibers as a semipermeable membrane and a dialysate filtration membrane.

In the figure, 1 is a blood inlet, 2 is a blood outlet, 3 is a dialysate inlet, 4 is a dialysate outlet, 5 is a partition member, 6 is a hollow fiber (semipermeable membrane), 7 is a hollow fiber (dialysate). Filtration membranes 8 to 10 are sealing members, 11 is a purified dialysate storage chamber, 12 is a purified dialysate inlet, 13 is an outer cylinder, 14 is a blood purification chamber, and 15 is a dialysate purification chamber.

FIG. 1 shows a hemodialyzer having a cylindrical outer cylinder 13 extending in the longitudinal direction.
It is composed of a blood purification chamber 14 and a dialysate purification chamber 15 which are divided by a partition member 5. The outer cylinder 13 has a blood inlet 1 at the upper end, a blood outlet 2 at the lower end, a dialysate inlet 3 at the upper end of the outer cylinder 13, and a dialysate outlet 4 at other positions of the upper end. It is equipped with and is opened. The opening is connected to a plastic tube or the like to introduce or withdraw blood or dialysate.

In the dialysate purification chamber 15, a large number of porous hollow fibers are arranged substantially parallel to the longitudinal direction of the outer cylinder 13, the upper end of the fibers is closed by the sealing member 8 at the hollow part, and the lower end of the fibers is A hollow portion passing through the sealing member 10 is opened to the purified dialysate storage chamber 11.

The purified dialysate storage chamber 11 includes the partition member 9 and the blood purification chamber 14.
The sealing member 9 for sealing the lower end of the porous hollow fiber 6, the sealing member 10, the inner wall of the outer cylinder, and the partition member 5, and the opening provided in the partition member 5, that is, the purified dialysate inlet port. The purified dialysate stored in the storage chamber 11 from 12 flows into the blood purification chamber 14.

In the blood purification chamber 14, a large number of porous hollow fibers 6 are arranged substantially parallel to the longitudinal direction of the outer cylinder 13, and the upper and lower ends thereof are sealed by sealing members 8 and 9, and the hollow fibers are hollow. The part passes through the sealing members 8 and 9 and opens outside the sealing member.

The blood of the patient supplied from the blood inlet 1 passes through the hollow portion of the porous hollow fiber 6 and passes through the semipermeable membrane that constitutes the hollow fiber, and flows from the cleaning dialysate inlet 12 through the cleaning dialysate 12. Dialysis is carried out by contacting the activated dialysate, and purified blood is returned to the patient from the blood outlet 2 by a tube, a pump or the like.

In FIG. 1, the semipermeable membrane of the blood purification chamber 14 is made of porous hollow fiber, but it is also possible to use a sheet-shaped or tubular semipermeable membrane as a plate type or a coil type.

As the material of the semipermeable membrane, regenerated cellulose, cellulose acetate, polyvinyl alcohol, polyolefin, polysulfone, polyacrylonitrile, polymethylmethacrylate, etc. are used.

The pore size of the semipermeable membrane used in the blood purification chamber 14 is 0.001 to 0.05.
μ, preferably 0.005 to 0.1 μ. If the pore size is less than 0.001μ, the dialysis efficiency tends to decrease, and the pore size is 0.
If it exceeds 05μ, effective proteins such as albumin tend to be removed.

In the blood purification chamber 14 of FIG. 1, a large number of hollow fibers 6 are fixed at both ends by sealing members 8 and 9, and examples of the material of the sealing member include epoxy resin, polyurethane resin, silicone resin and the like. .

On the other hand, in FIG. 1, the dialysate filtration membrane 7 in the dialysate purification chamber 15 is made of porous hollow fiber, but it should be used as a plate type or a coil type by using a sheet-shaped or tubular microporous membrane. Is also possible. As a dialysate filtration membrane material,
Polyamide, polyester, polyvinyl alcohol,
Polycarbonate, polyolefin, polysulfone, polyacrylate, etc. are used, and an endotoxin-adsorptive membrane made of polyethylene or polypropylene is particularly preferable.

The pore diameter of the dialysate filtration membrane 7 is preferably 0.5 μ or less,
0.05 to 1.0 μ is preferable. If the pore size exceeds 0.5 μ, there is a risk that bacteria contained in the dialysate will pass through the dialysate filter membrane 7 and enter the purified dialysate.

In the dialysate purification chamber 15 of FIG. 1, the dialysate should pass through the dialysate inlet 3 from the outside of the porous hollow fiber 7 through the fine pores of the microporous membrane to enter the hollow portion of the fiber. However, conversely, the dialysate may be configured to leach from the hollow portion of the porous hollow fiber 7 to the outside of the fiber.

Both ends of the porous hollow fiber 7 are fixed by sealing members 8 and 9, and the fiber bundles are arranged substantially parallel to the longitudinal direction of the outer cylinder 14. The material of the sealing member 10 is epoxy resin, polyurethane resin, silicone. Resin etc. are mentioned.

The dialysate introduced through the dialysate inlet 3 is the dialysate filtration membrane 7.
The endotoxin and bacteria are removed by the method, and the purified dialysate that has passed through the filtration membrane 7 is stored in the purified dialysate storage chamber 11 from the hollow portion of the hollow fiber.

Next, the cleaning dialysate stored in the storage chamber 11 is a gap provided in the partition member 5, that is, the cleaning dialysate inlet.
From 12 to the blood purification chamber 14, through the fine pore membrane of the porous hollow fiber 6 housed in the purification chamber, it comes into contact with the blood flowing through the hollow portion of the hollow fiber for dialysis, and the dialysate is introduced. Exit 4
Spilled from.

The partition member 5 is arranged substantially parallel to the longitudinal direction of the outer cylinder 13,
The inside of the cylinder of the hemodialyzer is divided into a blood purification chamber 14 and a dialysate purification chamber 15, both ends of which are fixed by sealing members 8 and 10. Examples of the material of the partition member 5 include polyolefin, polycarbonate, polyacrylate, polyacrylonitrile / styrene, polyacrylonitrile / butadiene / styrene, polyvinyl chloride and the like, and the same material as the outer cylinder 14 is preferable.

An example of the present invention will be described below with reference to Examples and Comparative Examples.

Example 1 In the hemodialyzer shown in FIG. 1, the blood purification chamber 14 has an inner diameter of 200
μ, outer diameter 230 μ, average pore size 0.003 μ cellulose hollow fiber, effective membrane area 1.1 m ² , dialysate purification chamber 15 polyethylene hollow fiber (Mitsubishi Rayon Stellapore EHF-27
0T, mean lateral pore size 0.20μ), effective membrane area 300c
The dialysate was filtered through m ₂ .

The dialysis conditions are: dialysate volume 500 ml / min., Ultrafiltration rate 4.0 mi / hr.m.
It was mHg. Dialysis was performed on 36 patients, and the presence or absence of endotoxin antibody in the blood of the patients was determined by Elisa method (ELISA method).

The measuring method is to collect bacteria from dialysate (water), and after fixed culture,
The endotoxin was extracted by the phenol method and reacted with the blood of the patient using it as an antigen, and the presence or absence of endotoxin antibody was measured. The results are shown in Table 1.

Comparative Example 1 In the hemodialyzer shown in FIG.
Dialysis was carried out under the same conditions as in Example 1, using the semipermeable membrane used in 1. and a hemodialyzer in which the dialysate purification chamber 15 was removed from the dialysate purification chamber 15.

The blood of about 50 patients thus dialyzed was collected, and the presence or absence of endotoxin antibody was measured by the same method as in Example 1. The results are shown in Table 1.

Example 2 In the blood purification chamber 14 of the hemodialyzer of Example 1, cellulose hollow fibers having an inner diameter of 200 μ, an outer diameter of 230 μ, and an average pore diameter of 0.02 μ were used as the hollow fibers 6, and the effective filtration area was 1.1 m ² .
In the dialysate purification chamber 15, the polyethylene hollow fibers used in Example 1 were used for dialysis. The dialysis condition is a dialysate volume of 500 ml /
The ultrafiltration rate was 20 ml / hr.mmHg. The presence or absence of endotoxin antibody was measured in the same manner as in Example 1 in 41 patients. The results are shown in Table 1.

Comparative Example 2 In the hemodialyzer shown in FIG.
Dialysis was carried out under the same conditions as in Example 2, using the semipermeable membrane used in 1. and the hemodialyzer in which the dialysate filtration membrane 7 was removed in the dialysate purification chamber 15. The blood of about 50 patients thus dialyzed was collected, and the presence or absence of endotoxin antibody was measured by the same method as in Example 1. The results are shown in Table 1.

Comparative Example 3 Blood of a healthy person was collected, and the presence or absence of endotoxin antibody was measured by the same method as in Example 1.

As is clear from Table 1, the incidence of endotoxin antibody in the blood collected from the patients dialyzed by the hemodialyzer of the example equipped with the dialysate filtration membrane was the same as that of Comparative Example 3 collected from the blood of healthy persons. It is almost the same. In addition, the incidence of endotoxin antibody in Examples 1 and 2 was low as compared with blood collected from a patient dialyzed with a hemodialyzer of Comparative Example not equipped with a dialysate filtration membrane.

〔effect〕

Since the present invention is a hemodialyzer in which a dialysate membrane is integrally housed in a cylinder with a semipermeable membrane via a partition member, bacteria, endotoxin, etc. contained in the dialysate are removed in advance for dialysis. It is possible to prevent the complication syndrome caused by the bacteria causing an agglutination reaction with the antibody in the blood.

[Brief description of drawings]

FIG. 1 is a sectional view of a hemodialyzer using porous hollow fibers as a semipermeable membrane and a dialysate filtration membrane. In the figure, 1 is a blood inlet, 2 is a blood outlet, 3 is a dialysate inlet, 4 is a dialysate outlet, 5 is a partition member, 6 is a hollow fiber (semipermeable membrane), 7 is a hollow fiber (dialysate). Filtration membrane), 8 to 10 are sealing members, 11 is a purified dialysate storage chamber, 12 is a purified dialysate inlet, 13 is an outer cylinder, 14 is a blood purification chamber, and 15 is a dialysate purification chamber.

Claims (1)

[Scope of utility model registration request] 1. A hemodialyzer for purifying blood by bringing the blood into contact with a dialysate through a hollow fiber semipermeable membrane housed in a cylinder, a blood inlet and a blood outlet, and dialysis. A blood purification chamber that contains a liquid inlet and a dialysate outlet, and a hollow fiber semipermeable membrane with a semipermeable membrane with a pore size of 0.001 to 0.05μ in the cylinder, and a dialysate filter with a pore size of 0.5μ or less. A partition member extending in the longitudinal direction that is divided into a dialysate purification chamber containing a membrane, and a partition member that allows the dialysate purified in the dialysate purification chamber to flow into the blood purification chamber. A hemodialyzer comprising a clean dialysate inlet.