JPH03280965A - Manufacture for body fluid processing device - Google Patents

Abstract

PURPOSE:To make the initialized clearance maintainable and improvable by disentangling a hollow thread film bundle, while it is given vibration for a predetermined time, charging a housing with the vibration-processed hollow thread film and fixing it by a fixing agent into a module. CONSTITUTION:A hollow thread film bundle, consisting of regenerated cellulose, is arranged in a vibrator, given vibration and disentangled, and these hollow thread film bundles, with which the interior of a housing is charged, is fixed by polyurethane into a module. Thereafter, a high pressure steamy sterilizing process is applied by filling the inside of a body fluid processor with distilled water. When a blood urea nitrogen clearance is measured, a clearance value of 187+ or -5ml/min is obtained, and the clearance value is improved by about 13% as compared with the conventional blood urea nitrogen clearance value 165+ or -5ml/min. The clearance can be more improved as shown in the drawing thus by applying a vibratory process.

Description

Detailed Description of the Invention [Industrial Application Field] The present invention relates to a method for manufacturing a body fluid treatment device, in which a hollow fiber membrane bundle is mechanically loosened before modularizing the body fluid treatment device. The present invention provides a method for manufacturing a body fluid treatment device that can improve the clearance of the body fluid treatment device by modularizing the body fluid treatment device.

[Problems to be solved by the prior art and the invention] Waste products such as urea and creatinine are removed from dialysis patients with renal disease, and the value indicates the performance of a body fluid processing device that can remove these waste products. Urea clearance, talleatinine clearance, intermediate molecular weight clearance, etc. are set as such. These clearances are adjusted by setting the film thickness, bore size, etc. within predetermined ranges.

The current assembly process for body fluid treatment devices involves removing the film sheet binding the outer periphery of the hollow fiber reel, manually squeezing the hollow fiber membrane to loosen it, and then storing it in the housing to create a module6. In this method, the core of the hollow fiber membrane was difficult to unravel, so some lots were unable to achieve the preset clearance performance.

As a result of extensive research, the inventors of the present invention have come up with a method for manufacturing a body fluid treatment device that can reliably and uniformly unravel the hollow fiber membrane and reliably maintain and improve the initially set clearance.

[Means for Solving the Problems] That is, the present invention, as a first invention, includes: (1) disposing a hollow fiber membrane bundle in a vibrator and loosening the hollow fiber membrane bundle while applying vibration for a predetermined time; (2) housing. The present invention provides a method for manufacturing a body fluid treatment device comprising the steps of: loading the hollow fiber membrane subjected to the vibration treatment of [1] into the housing and fixing it to the housing with a fixing agent to form a module.

In addition, as a second invention, (1) a step of loading the hollow fiber membrane bundle into the housing and loosening the hollow fiber membrane bundle while applying vibration for a predetermined period of time with a vibrator; [2] carrying out the vibration treatment of [1]; The present invention provides a method for manufacturing a body fluid treatment device, which comprises a step of fixing the hollow fiber membrane to a housing with a fixing agent to form a module.

In the present invention, the hollow fiber membranes include cellulose-based, cellulose acetate-based,
Those manufactured from polymers such as ethylene-vinyl alcohol, polyacrylonitrile, methacrylic ester, polyamide, polyvinyl alcohol, polyolefin, and polyester can be used.

When filling the body fluid treatment device with a filling liquid as necessary, sterile water that is not harmful to body fluids is used. As the sterile water, for example, distilled water, pyrogen-free sterile water, physiological saline, etc. can be used.

As the vibrator, any device of any shape or structure can be used as long as it can unravel the hollow fiber membrane bundle, and means such as mechanical vibration, vibration using ultrasonic waves, etc. can be applied.

FIGS. 1 and 2 show changes in clearance before and after vibration treatment.

From FIG. 1 and FIG. 2, it can be confirmed that the present invention, which is subjected to vibration treatment, can improve the clearance.

A bundle of hollow fiber membranes made of regenerated cellulose (inner diameter 200μ, membrane thickness 11μ) was placed in a vibrator, and vibration was applied to loosen the hollow fiber membrane bundle. Load these hollow fiber membrane bundles into the housing and fix them with polyurethane.
It has been converted into a file.

Thereafter, the body fluid treatment device was filled with distilled water and subjected to high-pressure steam sterilization (121'C, 520 minutes). Blood urea nitrogen clearance was measured (187±5)
A clearance value of +nl/min was obtained. From this, the conventional value (blood urea nitrogen clearance value / (16
The clearance value was improved by 13% compared to 6±5) ml/ml h).

[l Hollow fiber membrane made of regenerated cellulose (inner diameter 20C) u, I
I! After loading a bundle of 11,000 fibers with a thickness of 8 μm into the housing, the bundle was placed in a vibrator to apply vibrations to loosen the hollow fiber membranes. After that, the hollow fiber membrane and housing were fixed with polyurethane to form a 1.8 m module.These were sterilized with ethylene oxide gas,
Blood urea nitrogen clearance was measured (192±
3) A clearance value of ml/it was obtained. From this, the conventional one (blood urea nitrogen clearance value +
(172±l O) ml/m1n), the clearance value was improved by 12%.

The incidence of defective products (those that could not provide the initially set clearance performance) of body fluid treatment devices manufactured according to the present invention has almost disappeared.

In the above embodiment, after modularizing one body fluid treatment device,
Although the case of high-pressure steam sterilization and ethylene oxide gas sterilization treatment was explained, it was confirmed that the clearance value was improved by 10% or more even in the case of γ-ray sterilization treatment.

[Effects of the Invention] As described above, the present invention can provide a body fluid treatment device that can reliably maintain and improve the initially set clearance.

[Brief explanation of drawings]

FIGS. 1 and 2 are data showing changes in clearance before and after vibration treatment.

Claims (2)

[Claims] (1) A method for manufacturing a body fluid treatment device in which a hollow fiber membrane is loaded into a housing, the method comprising: [1] placing a hollow fiber membrane bundle in a vibrator and loosening the hollow fiber membrane bundle while applying vibration for a predetermined period of time; A method for producing a body fluid treatment device, comprising the steps of: [2] loading the hollow fiber membrane subjected to the vibration treatment of [1] into a housing and fixing it to the housing with a fixing agent to form a module. (2) A method for manufacturing a body fluid treatment device in which a hollow fiber membrane is loaded into a housing, the method comprising: [1] Loading a hollow fiber membrane bundle into a housing and applying vibration for a predetermined period of time using a vibrator; A method for manufacturing a body fluid treatment device, comprising the steps of: loosening the bundle; and [2] fixing the hollow fiber membrane subjected to the vibration treatment of [1] to a housing with a fixing agent to form a module.