JPH03280964A - Manufacture of body fluid processing device - Google Patents
Manufacture of body fluid processing deviceInfo
- Publication number
- JPH03280964A JPH03280964A JP2082045A JP8204590A JPH03280964A JP H03280964 A JPH03280964 A JP H03280964A JP 2082045 A JP2082045 A JP 2082045A JP 8204590 A JP8204590 A JP 8204590A JP H03280964 A JPH03280964 A JP H03280964A
- Authority
- JP
- Japan
- Prior art keywords
- ufr
- body fluid
- treatment device
- fluid treatment
- pressure
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 210000001124 body fluid Anatomy 0.000 title claims description 24
- 239000010839 body fluid Substances 0.000 title claims description 24
- 238000004519 manufacturing process Methods 0.000 title claims description 7
- 238000000034 method Methods 0.000 claims abstract description 9
- 230000001954 sterilising effect Effects 0.000 claims abstract description 6
- 239000012528 membrane Substances 0.000 claims description 21
- 239000012510 hollow fiber Substances 0.000 claims description 14
- 239000007788 liquid Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 8
- 238000000108 ultra-filtration Methods 0.000 abstract description 5
- 239000012153 distilled water Substances 0.000 abstract description 4
- 239000004627 regenerated cellulose Substances 0.000 abstract description 2
- 239000012530 fluid Substances 0.000 abstract 4
- 239000007789 gas Substances 0.000 description 3
- 239000008223 sterile water Substances 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 229920000219 Ethylene vinyl alcohol Polymers 0.000 description 2
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 2
- 238000000502 dialysis Methods 0.000 description 2
- RCJVRSBWZCNNQT-UHFFFAOYSA-N dichloridooxygen Chemical compound ClOCl RCJVRSBWZCNNQT-UHFFFAOYSA-N 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000004952 Polyamide Substances 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
- 239000003570 air Substances 0.000 description 1
- 229910052786 argon Inorganic materials 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 229940109239 creatinine Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000004715 ethylene vinyl alcohol Substances 0.000 description 1
- -1 for example Chemical compound 0.000 description 1
- RZXDTJIXPSCHCI-UHFFFAOYSA-N hexa-1,5-diene-2,5-diol Chemical compound OC(=C)CCC(O)=C RZXDTJIXPSCHCI-UHFFFAOYSA-N 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 208000017169 kidney disease Diseases 0.000 description 1
- 125000005397 methacrylic acid ester group Chemical group 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920002239 polyacrylonitrile Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Landscapes
- External Artificial Organs (AREA)
Abstract
Description
【発明の詳細な説明】
[産業上の利用分野]
本発明は体液処理装置の製造方法に関するもので、体液
処理装置をモジュール化したのちに所定の処理を施すこ
とにより体液処理装置の限外濾過量(以下rUFRJと
略記する)を向上させることができる体液処理装置の製
造方法を提供するものである。[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a method for manufacturing a body fluid treatment device, in which ultrafiltration of the body fluid treatment device is performed by modularizing the body fluid treatment device and then performing a predetermined process. The purpose of the present invention is to provide a method for manufacturing a body fluid treatment device that can improve the amount of body fluid treatment (hereinafter abbreviated as rUFRJ).
[従来の技術及び発明が解決しようとする課題〕
腎疾患の透析患者から、尿素、クレアチニン等の老廃物
を除去すると同時に、多量の水分が除去されている。こ
れらの水分は、限外濾過圧をかけて除去するが、体液処
理装置の限外濾過能力を示す値としてUFRが設定され
る。[Prior Art and Problems to be Solved by the Invention] A large amount of water is removed from dialysis patients suffering from renal disease at the same time as waste products such as urea and creatinine are removed. These moistures are removed by applying ultrafiltration pressure, and UFR is set as a value indicating the ultrafiltration ability of the body fluid treatment device.
UFRは体液処理装置内に装填されている中空糸膜の膜
厚を数ミクロンのレベルでかえることにより調整されて
いるが、膜厚が極端に薄いため膜厚が均一化せず、UF
Hの調整は技術的に困難であった。UFRを向上させる
ため膜厚を薄くすることが試みられているが、膜厚を極
端に薄くすると、膜が限外濾過圧に絶えられず、透析治
療中に血液リークが発生し、致命的な事故に発展するお
それがあり、必ずしもよい方法ではない。UFR is adjusted by changing the thickness of the hollow fiber membrane loaded in the body fluid treatment device by several microns, but because the membrane thickness is extremely thin, the membrane thickness is not uniform, and UF
Adjustment of H was technically difficult. Attempts have been made to reduce the membrane thickness in order to improve UFR, but if the membrane thickness is made extremely thin, the membrane cannot sustain the ultrafiltration pressure, resulting in blood leakage during dialysis treatment, which can be fatal. This is not necessarily a good method as it may lead to an accident.
[課題を解決するための手段]
そこで本発明者は、鋭意検討を重ねた結果、膜厚を変化
させることなく、極端に薄くすることもなく体液処理装
置をモジュール化したのちに、中空糸膜に所定の処理を
施すことにより体液処理装置のUFRを向上させること
ができる体液処理装置の製造方法を発明するに至った。[Means for Solving the Problems] Therefore, as a result of extensive studies, the inventor of the present invention modularized the body fluid treatment device without changing the membrane thickness or making it extremely thin, and then developed a hollow fiber membrane. The present invention has led to the invention of a method for manufacturing a body fluid treatment device that can improve the UFR of the body fluid treatment device by performing a predetermined treatment on the body fluid treatment device.
すなわち、本発明は基本的に
■体液処理装置をモジュール化する工程、■体液処理装
置内のハウジング内に液体を充填した後、中空糸膜の内
部に無菌ガスを加圧充填する工程、
■滅菌処理工程、
からなる体液処理装置の製造方法を提供するものである
。That is, the present invention basically consists of: 1) modularizing the body fluid treatment device; 2) filling the housing of the body fluid treatment device with liquid, and then pressurizing the inside of the hollow fiber membrane with sterile gas; and 2) sterilization. The present invention provides a method for manufacturing a body fluid treatment device comprising the following steps.
本発明においては、
中空糸膜としては、セルロース系、酢酸セルロース系、
エチレン−ビニルアルコール系、ポリアクリロニトリル
系、メタクリル酸エステル系、ポリアミド系、ポリビニ
ルアルコール系。In the present invention, the hollow fiber membranes include cellulose-based, cellulose acetate-based,
Ethylene-vinyl alcohol type, polyacrylonitrile type, methacrylic acid ester type, polyamide type, polyvinyl alcohol type.
ポリオレフィン系、ポリエステル系等のポリマーより製
造したものを使用することができる。Those manufactured from polymers such as polyolefins and polyesters can be used.
充填液としては、体液に為害性のない無菌水が使用され
る。無菌水としては、例えば蒸留水、パイロジエンフリ
ー無菌水、生理食塩液等を使用することができる。Sterile water, which is not harmful to body fluids, is used as the filling liquid. As the sterile water, for example, distilled water, pyrogen-free sterile water, physiological saline, etc. can be used.
無菌ガスとしては、例えば無菌空気、窒素、アルゴン等
の不活性ガス等を使用することができる。As the sterile gas, for example, sterile air, nitrogen, inert gas such as argon, etc. can be used.
第1図及び第2図は、中空糸膜の材質、加圧条件、加圧
時間等の種々の条件を設定して、UFRを測定した結果
を示すもので、本発明の処理を施すことに、UFRが確
実に向上することが確認できる。また、第1図及び第2
図より前記無菌ガスの加圧力を大きくすること、加圧時
間を長くすることにより、UFRを向上させることがで
きることが確認できる。Figures 1 and 2 show the results of measuring UFR under various conditions such as the material of the hollow fiber membrane, pressurization conditions, and pressurization time. , it can be confirmed that the UFR is definitely improved. Also, Figures 1 and 2
From the figure, it can be confirmed that the UFR can be improved by increasing the pressurizing force of the sterile gas and lengthening the pressurizing time.
また、本発明では、前記充填液の温度を低温(0から1
5’C)に維持することによりUFRを向上させること
ができる。Further, in the present invention, the temperature of the filling liquid is set to a low temperature (0 to 1
5'C), UFR can be improved.
!工里]
体液処理装置内に、再生セルロースよりなる中空糸l1
l(内径200μ、膜厚1.1μ)をモジュール化した
のち、体液処理装置のハウジング内に、蒸留水を充填し
た後、中空糸膜の内部空間に無菌空気を、圧力2.0K
g/cm”、5分間加圧した。その後、高圧蒸気滅菌処
理(121′″Cl2O分間)を施した。UFRを測定
したところUFR値は7 、8 ml/mmHghrが
得られた。これより、従来のもの(UFR値6 、2
ml/mm)Ighr )と比較してUFR値が26%
向上した。! Hollow fibers made of regenerated cellulose are installed in the body fluid treatment device.
1 (inner diameter 200μ, membrane thickness 1.1μ) into a module, and after filling the housing of the body fluid treatment device with distilled water, sterile air was introduced into the inner space of the hollow fiber membrane at a pressure of 2.0K.
g/cm" for 5 minutes. Thereafter, high-pressure steam sterilization treatment (121'' Cl2O minutes) was performed. When the UFR was measured, a UFR value of 7.8 ml/mmHghr was obtained. From this, the conventional one (UFR value 6, 2
ml/mm)Ighr) UFR value is 26% compared to
Improved.
見立■ユ
体液処理装置内に、エチレン−ビニルアルコール共重合
体よりなる中空糸膜(内径175μ、膜厚25μ)をモ
ジュール化したのち、体液処理装置のハウジング内に蒸
留水を充填した後、中空糸膜の内部空間に無菌空気を、
圧力’、5Kg/cm’ 、5分間加圧した。その後、
γ線滅菌処理(25Mrad)を施した。After modularizing a hollow fiber membrane (inner diameter 175μ, membrane thickness 25μ) made of ethylene-vinyl alcohol copolymer into the Mitate ■ Yu body fluid treatment device, and filling the housing of the body fluid treatment device with distilled water, Sterile air is supplied to the inner space of the hollow fiber membrane.
Pressure was applied at 5 kg/cm' for 5 minutes. after that,
Gamma sterilization treatment (25 Mrad) was performed.
UFRを測定したところUFR値は10.6ml/nm
Hghrが得られた。これより、従来のもの(UFR値
8.5ml/mm)Ighr )と比較してUFR値が
25%向上した。When UFR was measured, the UFR value was 10.6ml/nm
Hghr was obtained. As a result, the UFR value was improved by 25% compared to the conventional one (UFR value 8.5 ml/mm).
[発明の効果]
以上説明したように本発明では、中空糸膜の厚さに依存
することなく、UFR値を飛躍的に向上させることがで
き、所望のUFR値を設定することができる。[Effects of the Invention] As explained above, in the present invention, the UFR value can be dramatically improved without depending on the thickness of the hollow fiber membrane, and a desired UFR value can be set.
第1図及び第2図は、中空糸膜の材質、加圧条件、加圧
時間等の種々の条件を設定して、UFRを測定した結果
を示す。FIG. 1 and FIG. 2 show the results of measuring UFR under various conditions such as the material of the hollow fiber membrane, pressurization conditions, and pressurization time.
Claims (1)
方法であって、 (1)体液処理装置をモジュール化する工程、(2)体
液処理装置内のハウジング内に液体を充填した後、中空
糸膜の内部に無菌ガスを加圧充填する工程、 (3)滅菌処理工程、 からなることを特徴とする体液処理装置の製造方法。[Claims] A method for manufacturing a body fluid treatment device in which a hollow fiber membrane is loaded in a housing, comprising: (1) modularizing the body fluid treatment device; (2) placing a liquid in the housing of the body fluid treatment device; A method for producing a body fluid treatment device, comprising the steps of: (3) sterilizing the hollow fiber membrane after filling the hollow fiber membrane with a sterile gas under pressure;
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2082045A JP2681705B2 (en) | 1990-03-29 | 1990-03-29 | Method for manufacturing body fluid treatment device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2082045A JP2681705B2 (en) | 1990-03-29 | 1990-03-29 | Method for manufacturing body fluid treatment device |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH03280964A true JPH03280964A (en) | 1991-12-11 |
JP2681705B2 JP2681705B2 (en) | 1997-11-26 |
Family
ID=13763545
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2082045A Expired - Fee Related JP2681705B2 (en) | 1990-03-29 | 1990-03-29 | Method for manufacturing body fluid treatment device |
Country Status (1)
Country | Link |
---|---|
JP (1) | JP2681705B2 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0800113A2 (en) | 1996-04-05 | 1997-10-08 | Fuji Photo Film Co., Ltd. | Silver halide color photographic light-sensitive material |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61109573A (en) * | 1984-11-01 | 1986-05-28 | 旭メデイカル株式会社 | Asceptic water filled serum separator and its production |
JPS63190605A (en) * | 1987-02-02 | 1988-08-08 | Daicel Chem Ind Ltd | Steam sterilization of hollow yarn-type ultrafiltration membrane module |
-
1990
- 1990-03-29 JP JP2082045A patent/JP2681705B2/en not_active Expired - Fee Related
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61109573A (en) * | 1984-11-01 | 1986-05-28 | 旭メデイカル株式会社 | Asceptic water filled serum separator and its production |
JPS63190605A (en) * | 1987-02-02 | 1988-08-08 | Daicel Chem Ind Ltd | Steam sterilization of hollow yarn-type ultrafiltration membrane module |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0800113A2 (en) | 1996-04-05 | 1997-10-08 | Fuji Photo Film Co., Ltd. | Silver halide color photographic light-sensitive material |
Also Published As
Publication number | Publication date |
---|---|
JP2681705B2 (en) | 1997-11-26 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
LAPS | Cancellation because of no payment of annual fees |