JPH02218374A - Sterilization processing for hollow fiber type blood processing device and the sterilized device - Google Patents

Abstract

PURPOSE:To carry out sterilization without deteriorating the quality of a hollow fiber by attaching salt onto the whole surface of a hollow fiber film by allowing the salt to flow in a cylindrical body and carrying out sterilization processing for a blood processing device with a autoclave or a radioactive ray type sterilization device. CONSTITUTION:The dialysis liquid is introduced into a cylindrical body 1 on the side parts of the cylindrical body head parts 2a and 2b, and flow pipes 3a and 3b for the discharge outside the cylindrical body 1 are installed, and a number of hollow fibers 4 are accommodated in bundled state into the cylindrical body 1, and the hollow fiber 4 is constituted of the dialyze film such as cellulose film, and blood can flow inside. When such a hollow fiber film type blood processing device is sterilization-treated, if the salt such as sodium chloride is used as the protecting material for the hollow fiber for sterilization, the hollow fiber protecting effect is developed sufficiently, and since the salt can be easily cleaned, priming is facilitated. Further, the adhesion quantity of the salt is preferably set to 2-40% of the weight of the hollow fiber. In other words, after the salt is attached onto the whole outer surface of the hollow fiber film in the cylindrical body 1 by allowing the salt solution to flow in the cylindrical body 1, sterilization for the blood processing device is carried out by using an autoclave or a radioactive ray type sterilization device.

Description

Detailed Description of the Invention "Field of Industrial Application" This invention is a method for sterilizing a hollow fiber membrane type blood processing device that performs blood purification (dialysis) using a hollow fiber membrane. The present invention relates to a sterilization method that can be performed without deterioration, and a sterilized hollow fiber membrane type blood processing device that can be easily brimmed before use.

``Prior Art'' As is well known, a hollow fiber membrane type blood processing device that uses a hollow fiber membrane as a dialysis membrane is known as a medical device that artificially performs blood purification processing (X).

That is, a large number of blood flow paths and dialysate flow paths are formed in the container using a large number of hollow fiber membranes, and the blood and dialysate are brought into contact through the hollow fiber membranes, and waste products in the blood are transferred to the dialysate. This is a device designed to discharge water inside.

As such a blood processing apparatus, one having the structure shown in FIG. 1 is conventionally known.

Reference numeral 1 in the figure indicates a cylindrical body, and both ends of this cylindrical body 1 are enlarged in diameter to form cylinder heads 2a and 2b. At the sides of the cylinder heads 2a, 2b are flow pipes 3a, 3 for introducing the dialysate into the cylinder 1 and discharging it outside the cylinder 1.
b is provided.

A large number of hollow fibers (dialysis membranes) 4 are housed in a bundled state in the cylinder 1 having the above structure. These hollow fibers 4 are cellulose membranes, CA (cellulose acetate) membranes, PAN (,
It is composed of biocompatible and dialyzable synthetic membranes such as polyacrylonitrile (polyacrylonitrile) membrane, PMMA (polymethyl methacrylate) membrane, and PVA (polyvinyl acetate) membrane.
It has an inner diameter of 30-1000μ and allows blood to flow inside.

After the hollow fibers 4 in the converged state are housed in the cylinder 1, both ends of the hollow fibers 4 are fixed in the upper 38 simplified body 1 with a sautéing material 5.5 such as polyurethane resin or silicone resin. This po-noting material is 5.5
The hollow fibers 4 are open on the outer end surface thereof.

A lid 7.8 is fitted and fixed to the cylinder 1 so as to cover both openings 6a and 6b. This lid 7.8 is formed into a can-knob shape, and the lid 7.8 and the cylinder head 2a, 2bl are glued together, and the lid 7.8 and the cylinder 1 are tightly connected. There are 5 airtight tanks.

The upper lid body 8 is provided with a blood circulation tube 9a, and the lower lid body 71 is provided with a blood circulation tube 9b. The blood is allowed to flow in, and further into each hollow fiber 4, and the blood is caused to flow out from the blood circulation tube 9b of the lower lid 7.

In the above configuration, the dialysate passes between the hollow fibers 4, and waste products in the blood are discharged into the dialysate outside the hollow fibers 4 through these hollow fiber membranes. will be held.

By the way, a hollow fiber membrane type blood processing device having such a configuration and function must be sterilized before being made into a finished product (a dry product with no water, solution, etc. filled inside). Sterilization is performed by autoclave sterilization or radiation (gamma ray) sterilization, but if the hollow fibers are simply sterilized as they are, the hollow fibers made of cellulose membranes will deteriorate due to temperature rise, etc. In addition, a glycerin aqueous solution (5~
40% concentration) to adhere to the hollow fiber membrane. In this way, in conventional hollow fiber membrane blood processing devices, sterilization can be completed without causing deterioration of the hollow fibers by circulating an aqueous glycerin solution inside the cylinder and attaching glycerin to the hollow fiber membranes. The sterilized product is coated with glycerin.

"Problems to be Solved by the Invention" By the way, the following problems have occurred in the conventional sterilization method for hollow fiber membrane type blood processing devices, and it is currently desired to solve them. be.

In other words, glycerin is attached to the inside of the cylinder and the surface of the hollow fibers, and this glycerin makes briming, which must be performed before using the device, very difficult.
The problem is that it takes time to prepare the device.

On the other hand, a method of attaching alcohol or water, which is easy to clean, to the hollow fiber surface may also be considered. However, in the case of water,
If the surface of the hollow fiber is simply wet, it will not have a protective effect on the hollow fiber, and the product will not be effective unless some water remains inside the cylinder even after sterilization, so the product is no longer a dry device. , and is not practical.

Furthermore, the method using alcohol has the problem that it is explosive and dangerous when heated during sterilization, and alcohol is harmful, making it difficult to manufacture.

This invention was made in view of the above circumstances, and it is possible to sterilize a hollow fiber membrane type blood processing device that performs blood purification (dialysis) using hollow fiber membranes without deteriorating the internal hollow fibers. It is an object of the present invention to provide a sterilization method that can be used and a sterilized hollow fiber membrane type blood processing device that can be easily brimmed before use.

"Means for Solving the Problems" The present inventors have conducted extensive research to solve the above-mentioned conventional problems, and have come to the following findings.

In other words, if salt is used as a protective material for hollow fibers against sterilization, the salt will have a sufficient effect of protecting the hollow fibers even if it is attached to the hollow fibers in the absence of water, and moreover, salt can be easily washed away. It has been found that briming is very easy. The amount of salt used is preferably 2 to 40% of the weight of the hollow fibers. I mean,
If it is less than 2%, a sufficient hollow fiber protection effect cannot be obtained, and if it exceeds 40%, a large amount of salt crystals will be generated within the hollow fibers, making it difficult to perform briming. Moreover, as the salt to be used, common salt is most preferable in view of biocompatibility.

The present invention has been made based on this knowledge.

That is, the method of the present invention includes a pretreatment step in which a salt solution is circulated and passed through the cylinder to adhere salt to the entire surface of the hollow fiber membrane in the cylinder, and the hollow fiber membrane type blood processing apparatus is sterilized in an autoclave. or a sterilization step of sterilizing with a radiation sterilizer, the method of the present invention is a method for sterilizing a hollow fiber membrane type blood processing device, and the device of the present invention is capable of sterilizing the entire outer surface of each hollow fiber. This is a sterilized hollow fiber membrane type blood processing device.

"Function" According to the hollow fiber blood processing device having the above configuration, the salt adhering to the entire surface of the hollow fibers relieves the load caused by heat and radiation, and the hollow fiber membranes do not deteriorate during the sterilization process.

Furthermore, since the form of salt deposition that causes such an effect does not particularly require moisture, a dry type device can be easily provided.

Furthermore, cleaning and filling with a solution before use can be carried out very efficiently since the salt is highly soluble. Since physiological saline is usually used as the briming solution, briming becomes easier and safer when saline is used as the adhesion salt.

Examples of this invention will be shown below.

"Example" In the device having the structure shown in Fig. 1, the amount of salt deposited is reduced by flowing saline solution ■ with a concentration of about 1% and saline solution ■ with a concentration of about 25% into the cylinder 1. The yarn weight was 2% (■) and 40% (■), respectively. Continuing,
These devices were placed in an autoclave and sterilized under the following conditions.

・Steam temperature: 121'C ・Time: 20 minutes On the other hand, for comparison, we prepared a device ■ to which a glycerin aqueous solution of about 20% concentration was attached as before, and this also It was also autoclaved under the same conditions.

In this way, the clearance and ultrafiltration rate were measured for each of the sterilized devices (effective membrane area: 1.0 m') (2), (2), and (2). For clearance measurement, use 100ml/ll of urea ion-exchanged aqueous solution and creatinine ion-exchanged aqueous solution instead of blood.
1in, 200m12/sin, 300tQ/w
In addition to changing the flow rate to flow inside the hollow fiber, 500 m&/a of non-component ion-exchanged water was poured into the cylinder instead of dialysate.
+in, and the degree of deterioration of the hollow fibers of the devices was examined in each of the devices ①, ②, and ②.

The clearance (m12/m1n) is determined by the following formula.

Ct, = ((Cat cBo)/Ca1t
QaQ a1 = Blood side solution inlet side flow rate (m(/wi
n).

On the other hand, the ultrafiltration rate (UFR; mN/mmHg-h
To measure r), an ion-exchanged aqueous solution is circulated between the blood side and the dialysate side, and the filtration amount (U F ; ++ff/br) is determined from the amount of decrease in the blood side solution over 10 minutes.
It is divided by P (mmHg). TMP is calculated using the following formula.

TMP= ((Pao+Pat) (PDO+PD
1)) /2 Here, PBi = inlet pressure on the blood side,
P Bo'' pressure on the outlet side of the blood side, P Dl'' pressure on the inlet side of the dialysate side, Poo = pressure on the outlet side of the dialysate side.

In the above equation, C□=inlet side concentration of blood side solution, CBo=outlet side concentration of blood side solution, Co. = outlet side concentration of dialysate side solution, In this case, the inlet side flow rate of blood side solution is 200/s
in, and the flow rate on the outlet side is 500 m12.

The measurement results are shown in Table 1. As is clear from these tables, the clearance (m12
/+n1n) and ultrafiltration rate (fflQ/ffi11g-
hr) were also the same as those of the conventional device (2), and it was confirmed that the hollow fiber membranes were not deteriorated by the sterilization treatment. Moreover, unlike conventional devices, priming before use can be performed extremely easily.

By the time the priming using the physiological saline in the apparatuses (■) and (■) of the present invention is completed, the physiological saline has a flow rate of 8 (L).
J/min required 5 minutes, whereas in the conventional device (2), a flow rate of approximately 80 mff/ml of physiological saline was required for 15 minutes.

(Hereinafter, blank space) "Effects of the Invention" As explained above, the present invention includes a pretreatment step in which a salt solution is distributed and passed through the cylinder to adhere salt to the entire surface of the hollow fiber membrane inside the cylinder. , a method for sterilizing a hollow fiber membrane type blood processing device, which comprises a sterilization step of sterilizing the hollow fiber membrane type blood processing device using an autoclave sterilizer or a radiation sterilizer; This is a sterilized hollow fiber membrane type blood processing device characterized by the fact that salt is attached.

Therefore, according to the present invention, the salt attached to the entire surface of the hollow fiber reduces the load caused by heat and radiation, and the hollow fiber does not deteriorate during the sterilization process. Furthermore, since the form of salt deposition that causes such an effect does not particularly require moisture, a dry type device can be easily provided.

Furthermore, cleaning and filling with a solution before use can be carried out very efficiently since the salt is highly soluble.

Physiological saline is usually used as the priming solution, so when salt is used as the adhesion salt, priming becomes easier and safer.

[Brief explanation of the drawing]

FIG. 1 is a side sectional view of a hollow fiber membrane type blood processing device. ■...Cylinder body, 2...Cylinder head, 3a...Blood inlet, 3b...Blood outlet, 4......・Hollow fiber (dialysis membrane), 5... Potting material, 6a, 6b... Opening of cylinder, 7.8...
...Lid body, 9a...Blood circulation tube, 9b...Blood circulation tube.

Claims (8)

[Claims] (1) A large number of hollow fibers converged into a columnar appearance are housed in a cylinder with dialysate flow tubes protruding from both ends, and both ends are fixed with potting material to prevent blood flow. A method for sterilizing a hollow fiber membrane type blood processing device in which a cap-like lid body having a flow tube is integrally connected to both ends of the cylinder body, the method comprising: circulating and passing a salt solution through the cylinder body; A hollow fiber membrane type blood processing device comprising a pretreatment step of attaching salt to the entire surface of the hollow fiber membrane in the cylinder, and a sterilization step of sterilizing the hollow fiber membrane type blood processing device using an autoclave sterilizer or a radiation sterilizer. Sterilization method for blood processing equipment. (2) The method for sterilizing a hollow fiber membrane type blood processing device according to claim 1, wherein the hollow fiber membrane is composed of a cellulose membrane. (3) The method for sterilizing a hollow fiber membrane type blood processing device according to claim 1 or 2, wherein the amount of salt attached is 2% to 40% of the weight of the hollow fibers. (4) The method for sterilizing a hollow fiber membrane type blood processing device according to any one of claims 1 to 3, wherein the salt is sodium chloride. (5) A large number of hollow fibers converged into a columnar appearance are housed in a cylinder with dialysate flow pipes protruding from both ends, and both ends are fixed with a potting material;
A cap-like lid body having a blood circulation protrusion is integrally connected to both ends of the cylindrical body, and the sterilized product is characterized in that salt is attached to the entire outer surface of each of the hollow fibers. Hollow fiber membrane type blood processing device. (6) The sterilized hollow fiber membrane type blood processing device according to claim 5, wherein the hollow fibers are made of a cellulose membrane. (7) The sterilized hollow fiber membrane type blood processing device according to claim 5 or 6, wherein the amount of salt attached is 2% to 40% of the weight of the hollow fibers. (8) The sterilized hollow fiber membrane type blood processing device according to any one of claims 5 to 7, wherein the salt is sodium chloride.