JPS6241665A - Production of artificial dialyser - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

Detailed Description of the Invention (9) Background of the Invention (Technical Field) The present invention relates to a method for manufacturing an artificial dialysis device. Specifically, the present invention relates to a method for manufacturing an artificial dialysis device using regenerated cellulose hollow fibers, which has high dialysis ability and low water removal ability.

(Prior art) Artificial dialysis machines used for hemodialysis of patients suffering from renal failure, poisonous poisoning, etc. are designed to remove toxic metabolites such as urea, uric acid, and creatinine contained in body fluids, Part of the water in the body fluid is removed by passing through the dialysis membrane of the dialysis device and transferring it into the dialysate due to the concentration difference.Person 1: Dialysis One of the important functions of the device is the dialysis membrane installed in artificial dialysis devices such as 7 and 9.
There are t-Rose-based substances such as cellulose acetate, polysulfone, polyacrylic acid, -1, methylmethacryl, and polymethylmethacrylate, but these are currently in practical use. The thing is goni and 1・-rJfJ′ cow 1′ and le[-1
-・S film, special #J, copper reed! , ) 71 “Nor 1”
- regenerated cellulose membrane from Also, Hitojutoru Aki 1.
8 necks (31, ZonotM made 1-strand hollow fiber type, -1 tile type, flat membrane k) (can be classified into 8 types), but the hollow fiber type is 1-strand type (31, 1-strand hollow fiber type, 1-layer type, flat membrane k). There are some things that show performance and can be obtained from 2.
Now, it is necessary to select an artificial dialysis device such as Kui with appropriate water removal and dialysis capabilities depending on the patient's symptoms.For example, for patients who are initially introduced to artificial dialysis, Therefore, an artificial dialysis device with relatively low water removal capacity is appropriate. .

This artificial dialysis device with a low water removal capacity is required to thicken the membrane thickness of the regenerated cellulose hollow fibers used conventionally, or to produce regenerated cellulose hollow fibers (5°).

In C3, adjustment of the amount of glycerin included during plasticization and adjustment of the concentration m' of Nornization can also be obtained by changing the drying conditions. But Mugarako (7) J
) Method 1. - Control of the amount of water removed by
It would require a 5A production line, which was extremely unreasonable.

II. According to one aspect of the invention, an object of the present invention is to provide a method for manufacturing a novel artificial dialysis device. The purpose of the present invention is to provide a method for manufacturing a dialysis device to a person who uses regenerated cellulose hollow fibers with a water capacity at temperatures as low as C3°C, maintains high dialysis ability, and reduces water removal ability. The present invention (3J5, d) is aimed at providing a method for manufacturing a one-dish dialysis device suitable for patients who are initially introduced to artificial dialysis. The purpose of this invention is to provide a method for manufacturing a dialysis device in 11 ways to steam sterilize the ability to perform sterilization.

For these purposes, the regenerated cellulose hollow fiber bundle is loaded into the cylindrical body of an artificial dialysis device, and both ends of the bundle are fixed to the cylindrical body). [1-S hollow fiber navy blue4. :100=120 degrees C The present invention further provides an artificial dialysis device with an internal dialysis device.
;'': Harmless to living organisms 4 [Fill with aqueous solution 1-21ζ: Perform high perspiration steam sterilization after 4 [t]
This is the third example of the fA construction method. The present invention is based on a method in which the hollow fibers are made of copper) 7 m (near cell "1-spun spinning dope") dialysis membrane packaging 3 m
I] Method 4: Demonstrate. Method of manufacturing an artificial dialysis apparatus according to the present invention (Masara (:, Contact C, t, water vapor is passed into the hollow fiber) 7) ,) Noguar, 1 This invention is good.
, ``]'' refers to an artificial dialysis apparatus in which the above-mentioned contact with water is carried out by passing water vapor through one or two passages outside the hollow fiber.

Detailed description of the invention for 8 Hereinafter, the present invention will be explained in detail based on the drawings.

FIG. 1 is a drawing that does not show the steam treatment process in Example 14-5 of the method for manufacturing an artificial dialysis apparatus of the present invention.

The manufacturing method of the artificial dialysis apparatus of the present invention is shown in FIG. Assembling the artificial dialysis machine'J, the circuit arm connected to the blood stream 4 or 10 on one side of the dialysis machine 3, a temperature controller on the way, and the dialysis generator 6 via the groove 5. j
- Connect the tube 7 and heat the air generated by the steam generator to 100=120'C, preferably 100-・1
The water vapor is adjusted to 10'C and sent to the artificial dialysis machine 3 from the turbo 1 or the dialysate boat 16, and the water vapor is transferred to the regeneration cell 11-su of the artificial dialysis machine 3. There are some that are characterized by C4, which makes contact with

The regenerated cellulose hollow fibers of the artificial dialysis device 3 used in the production method of the present invention may be of any material as long as it has a high dialysis ability, but preferably regenerated cellulose hollow fibers obtained from copper ammonia cellulose, such as A spinning stock solution made by mixing a permeation performance control agent with a copper ammonia cellulose solution and coordinating it as necessary is discharged from an annular spinning hole, and at the same time a non-coagulable liquid is introduced and filled into the center of the interior, and then solidified. The wheat is coagulated and regenerated by passing through a liquid, and the hollow fibers thus obtained are washed, treated with glycerin if necessary, and dried by an appropriate method. Further, the regenerated cellulose hollow fiber has a film thickness of 5 to 30 μm, preferably 1
It is about 0 to 25 μm.

Such regenerated cellulose hollow fibers are cut to a predetermined length and then bundled to achieve the required membrane area.
It is loaded into the cylindrical body 2 of an artificial dialysis machine. The regenerated cellulose hollow fiber bundle 1 is fixed to the cylindrical body 2 in accordance with a conventional method. For example, both ends of the regenerated cellulose hollow fiber bundle 1 are fixed to the cylindrical body 2 with potting agents 8 and 9 such as polyurethane. This is done by sealing both ends together. Headers 11.12 each having an inlet port 4 or an outlet port 10 for blood are abutted on both ends of the cylindrical body 2, and caps 13.14 connect the headers 11.12 and the cylindrical body 2, respectively. It is fixed. Note that an inlet port 15 and an outlet port 16 for dialysate are provided at both ends of the cylindrical body 2, respectively.

After assembling the artificial dialysis machine 3 in this way, the blood inflow port 4 (or the discharge port 10) of the artificial dialysis machine 3 is assembled.
) is connected to a circuit tube 7 which is connected to a steam generator 6 via a temperature control mechanism 5 on the way. In this state, the steam generator 6 and temperature adjustment mechanism 5 are operated to send water vapor at a predetermined temperature from the circuit tube 7 to the blood port 4 of the artificial dialysis device 3. The water vapor has a temperature of 100 to 120°C, preferably 100 to 110°C.
temperature. The higher the temperature of this water vapor, the lower the water removal ability of the artificial dialysis machine.
C is optimal. This steam processing time is 30 to 12
0 seconds, preferably 60 to 120 seconds, and the pressure of the steam to the hollow fibers is 0.5 to 3 kg/
Cm2, preferably 1-2 kM CI'2.

The water vapor entering through the blood port 4 passes through the inside of each regenerated cellulose hollow fiber, and then flows out of the artificial dialysis apparatus 3 through the other blood port 10 and dialysate ports 15 and 16.

Surprisingly, it has been revealed that by performing such a simple steam treatment, the water removal ability of the regenerated cellulose hollow fibers can be reduced without affecting the dialysis ability of the hollow fibers in any way. . The exact reason for this is not known, but after the shape of the hollow fibers is almost determined by the steam treatment (in the case of regenerated cellulose, after solidification), it is heated to around or above the highest temperature in the manufacturing history. It seems that a change occurred in the membrane structure of the hollow fibers.

The artificial dialysis machine, which has been assembled and subjected to steam treatment as described above, is then placed inside the machine (blood chamber,
Dialysate) is an aqueous solution that is harmless to living organisms, such as physiological saline,
It is filled with distilled water and sterilized by high-pressure steam sterilization, radiation sterilization, etc., and then provided as a wet-type artificial dialysis device. The filling of the aqueous solution is preferably performed after the steam treatment and before the hollow fibers are dried. If the hollow fibers are allowed to dry, their performance may deteriorate. Furthermore, when radiation sterilization is used as the sterilization method, it is not necessary to completely fill the artificial dialysis device with an aqueous solution, and only a temperature-controlled state is sufficient.

In addition, water vapor can be introduced into the artificial dialysis machine using the header '11.
．． This may be done before installing 12. In this case, a connector (not shown) may be provided at the end of the circuit tube 7 to be attached to the end of the cylindrical body 2 in a substantially airtight manner. In the above explanation, water vapor is brought into contact with the inside of the hollow fiber. P- may be in contact with the outside of the P-.

In addition, contact of water vapor to the hollow fiber 1, j:, from the viewpoint of the form of the dialysis machine, water vapor 4. It is more certain to introduce (-d::5).

Next [5] Give an example of two actual doors, C4, R light, and G4.

Example 'I Inner IY approx. 2 C) OII cuff, membrane Fe 12 tiη
1, Effective 1 (235mn+ copper-)' Shinia cell '-
''-Using 800 hollow fibers to assemble an artificial dialysis device with an effective membrane area of approximately 1.0 Blood bow 1 J, Su 10
Introducing water vapor at 0'C for 30 seconds 21. After that, before the hollow fiber assembly was dried (3 people), the inside of the dialysis device was filled with distilled water (-) the pressure was 1 to 2 kmcm2, the temperature was 116"C.
in,? ) Steam sterilization was performed for 0 minutes. In order to examine the performance of the obtained artificial dialysis device, the water removal capacity and the removal capacity of urea, creatinine, and vitamin B12 were measured. The results are shown in Table 1.

In addition, water removal 1 finger 1. Top, 1-M1″ (?11) 10
0mm 1-1g strip ('i -C37°C downstream speed 200
ml,/min - from the city water to the blood side of the dialysis machine N.
Circulate and measure the ultrafiltration rate (U FR'):
(Note'l: (pi- + interest'O) /2 = 200 mm
Hg) Also, regarding the removal ability of urea, Klepnodzi 1, Ninyo 3J, and vitamin 1312, an aqueous solution containing 2mMdl of each component was run on the blood side of an artificial dialysis machine at 37°C and at a rate of 200mρ/min. , -p), 37°C city water is poured into the dialysate side at a flow rate of 500 ml/min, and the difference in the bottom angle on the blood side at this time is 0. Maintain (state M = u in 7) and the artificial side solution on the blood side.

Example 2 A semi-finished artificial dialysis device assembled in the same manner as in Example 1 was subjected to a steam treatment by passing steam at 110°C for 60 seconds from the blood bowl 1 on the C side. , the artificial dialysis machine was filled with distilled water, the pressure was 1.2kMCm2, and the temperature was 1.
31: Steam sterilization was performed at 116°C for 90 minutes. The water removal ability and urea, creatinine, and vitamin B12 removal ability of the obtained artificial dialysis device were measured.
゛. The results are shown in Table 1.

Example 3 Intercropping was carried out as in Example 1, except that water vapor was introduced from the dialysate port on one side.

Comparative Example 1-2 Example 1 Mr. I'il (5: Fill the artificial dialysis machine with distilled water without applying hot air treatment to the half-finished product of the assembled artificial dialysis machine, and the pressure was 1, 2. kg/cni2, fa
A product was obtained by steam sterilization at 116°C (ε) for 90 minutes. The terminals are shown in Table 1.

(The following is a blank space) IV. Specific Effects of the Invention As described above, the present invention provides a method for inserting a regenerated cellulose hollow fiber bundle into the cylindrical body of an artificial dialysis device, fixing both ends of the bundle to the cylindrical body, and then , 1 to the regenerated cellulose hollow fibers.
Since the method for manufacturing an artificial dialysis device is characterized by contacting with water vapor at a temperature of 00 to 120°C, in the manufacturing process of regenerated cellulose hollow fibers, the amount of glycerinone to be included during plasticization and the Normanization concentration can be controlled. When controlling the water removal ability through adjustment or changes in drying conditions, it is possible to control the water removal ability more stably and with simple operations, and since water vapor is used, there is no damage to the hollow fibers. Because it has little effect on dialysis performance, it is suitable for providing a wet-type artificial dialysis device with a relatively low water removal capacity, which is required for dialysis patients such as those who are initially introduced to artificial dialysis. I'll do what I can. Furthermore, according to the manufacturing method of the present invention, artificial dialysis devices having different water removal capacities can be manufactured using regenerated cellulose hollow fibers prepared under the same conditions, and the regenerated cellulose hollow fibers have different water removal capacities. There is no need to set up a production line.

In addition, an artificial dialysis machine that requires 1q requires steam processing time of 3
0 to 120 seconds, and is more excellent when the regenerated cellulose hollow fibers are obtained from a copper ammonia cellulose spinning dope.

[Brief explanation of the drawing]

FIG. 1 is a diagram showing a steam treatment process in an embodiment of the manufacturing method of the present invention. DESCRIPTION OF SYMBOLS 1... Regenerated cellulose hollow fiber bundle, 2... Cylindrical body, 3... Artificial dialysis device, 4, 10... Blood port, 5... Temperature control mechanism, 6... Steam generator.

Claims (6)

[Claims] (1) Inserting a bundle of regenerated cellulose hollow fibers into the cylindrical body of an artificial dialysis device and fixing both ends to the cylindrical body, and then contacting the regenerated cellulose hollow fibers with water vapor at 100 to 120°C. A method for manufacturing an artificial dialysis device characterized by: (2) The method for manufacturing an artificial dialysis device according to claim 1, wherein the water vapor is passed for 30 to 120 seconds. (3) Manufacture of an artificial dialysis apparatus according to claim 1 or 2, wherein the artificial dialysis apparatus is subjected to high-pressure steam sterilization after filling the artificial dialysis apparatus with an aqueous solution that is harmless to living organisms. Method. (4) Claim 1, wherein the regenerated cellulose hollow fibers are obtained from a copper ammonia cellulose spinning dope.
3. A method for manufacturing an artificial dialysis device according to any one of items 1 to 3. (5) The contact with the water vapor is performed by passing the water vapor into the hollow fiber.
A method for manufacturing an artificial dialysis device according to any one of Item 4. (6) The contact with the water vapor is performed by passing the water vapor to the outside of the hollow fiber.
3. A method for manufacturing an artificial dialysis device according to any one of items 1 to 3.