JPH0212112B2 - - Google Patents
Info
- Publication number
- JPH0212112B2 JPH0212112B2 JP61029393A JP2939386A JPH0212112B2 JP H0212112 B2 JPH0212112 B2 JP H0212112B2 JP 61029393 A JP61029393 A JP 61029393A JP 2939386 A JP2939386 A JP 2939386A JP H0212112 B2 JPH0212112 B2 JP H0212112B2
- Authority
- JP
- Japan
- Prior art keywords
- blood purification
- purification device
- blood
- air bubbles
- vacuum
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/06—Packaging for specific medical equipment
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Urology & Nephrology (AREA)
- External Artificial Organs (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Description
【発明の詳細な説明】
〔発明の属する技術分野〕
この発明は、内部に水または液体を充填後放射
線滅菌を行なう血液浄化装置の製造方法に関する
ものである。DETAILED DESCRIPTION OF THE INVENTION [Technical Field to which the Invention Pertains] The present invention relates to a method for manufacturing a blood purification device that performs radiation sterilization after filling the inside with water or liquid.
近時、内部に水または液体を充填後放射線滅菌
を行なう血液浄化装置は、医療用具の発達ととも
に増加してきている。たとえば、中空糸型血液浄
化装置などでは、使用前に生理食塩水で装置内を
プライミングするが、中空糸内に液が完全に充填
され、気泡が残らないようにていねいな脱泡操作
が必要である。そこで最近では、この脱泡操作を
簡便にするために、内部にあらかじめ水または液
体を充填し、生理食塩水の置換を容易に行なえる
ようにした血液浄化装置（ウエツトタイプ）が増
加してきている。そして、このようなウエツトタ
イプの血液浄化装置を滅菌するに際しては、γ線
滅菌等の放射線滅菌を行なうのが一般化してい
る。しかし、従来の血液浄化装置においては、滅
菌前の水充填工程では細心の注意で水または液体
を充填し、気泡を完全に除去して滅菌を行なう
が、通常の滅菌包装では、放射線滅菌工程で血液
導出入部付近に少なからず気泡が混入しているの
が現状である。この気泡混入の原因は、血液導出
入部材に使用しているＯリング等の弾性シール材
および血液導出ポート部のポートキヤツプが通常
シリコンゴム等の材料で作られていて若干の通気
性があるために、放射線滅菌工程で内部の水分が
蒸発し、代わりに気泡が混入するためと思われ
る。この現象は、滅菌工程後の放置によつても発
生する。
In recent years, the number of blood purification devices that perform radiation sterilization after being filled with water or liquid has increased with the development of medical equipment. For example, in hollow fiber blood purification devices, the inside of the device is primed with physiological saline before use, but careful defoaming is required to ensure that the hollow fibers are completely filled with liquid and that no air bubbles remain. be. Recently, in order to simplify this defoaming operation, there has been an increase in the number of blood purification devices (wet type) that are filled with water or liquid in advance so that physiological saline can be easily replaced. When sterilizing such a wet type blood purification device, radiation sterilization such as gamma ray sterilization is generally used. However, in conventional blood purification devices, water or liquid is filled with great care in the water filling process before sterilization and sterilization is performed by completely removing air bubbles, but with normal sterilization packaging, the radiation sterilization process The current situation is that there are quite a few air bubbles mixed in near the blood outlet/inlet part. The cause of this air bubbles is that the elastic sealing materials such as O-rings used in the blood inlet/outlet member and the port caps of the blood outlet ports are usually made of materials such as silicone rubber and have some air permeability. This is thought to be because the moisture inside evaporates during the radiation sterilization process and air bubbles are mixed in instead. This phenomenon also occurs when the product is left unused after the sterilization process.
このように、従来の血液浄化装置では気泡が混
入しているために、実際の使用時には血液導入側
の気泡が中空糸内に入り、そのままでは容易に抜
けず中空糸の一部がエアーロツク状態となり、血
液滞流を起こし、性能の低下や血液凝固等の問題
が発生しやすいという欠点を有していた。 In this way, in conventional blood purification devices, air bubbles are mixed in, so during actual use, the air bubbles on the blood introduction side enter the hollow fibers and cannot be easily removed, leaving a part of the hollow fibers in an air-locked state. However, it has the disadvantage that it causes blood stagnation, which tends to reduce performance and cause problems such as blood coagulation.
〔発明の目的〕
そこでこの発明の目的は、先に述べた問題点を
改良するために、製造が容易で内部に気泡混入の
ない血液浄化装置を提供することにある。[Object of the Invention] Therefore, an object of the present invention is to provide a blood purification device that is easy to manufacture and does not contain air bubbles inside, in order to improve the above-mentioned problems.
先の目的を達成するため、創意工夫の結果、内
部に水または液体を充填してなるケース本体を真
空包装した後に放射線滅菌を行なえば、滅菌時滅
菌バツク内部が真空に保たれているために、本体
内への気泡混入が皆無であることが判明した。
In order to achieve the above objective, as a result of ingenuity, if the case body, which is filled with water or liquid inside, is vacuum packed and then subjected to radiation sterilization, the inside of the sterilization bag is kept in a vacuum during sterilization. It was found that there were no air bubbles mixed into the main body.
また、包装材は酸素透過度10c.c.／m2・24hrs・
atm（20℃、65％RH）以下の高バリヤー材で真空
包装を行なうことによつて、滅菌後経時的に真空
包装部の真空度が低下することによる気泡混入を
防止することができ、更に好適である。 In addition, the packaging material has an oxygen permeability of 10c.c./m2・24hrs・
By performing vacuum packaging with a high barrier material below ATM (20℃, 65% RH), it is possible to prevent air bubbles from being mixed in due to the decrease in the degree of vacuum in the vacuum packaging section over time after sterilization. suitable.
また、通常の包装材で真空包装した後、放射線
滅菌を実施し、その上に酸素透過度10c.c.／m2・
24hrs・atm（20℃ 65％RH）以下の高バリヤー
材で二重包装することによつても、同様に経時的
真空度の低下を防ぐことができる。 In addition, after vacuum packaging with normal packaging material, radiation sterilization is performed, and an oxygen permeability of 10c.c./m2 .
Deterioration of the degree of vacuum over time can be similarly prevented by double packaging with a high barrier material of 24hrs・atm (20℃ 65%RH) or less.
更に、血液浄化装置が疎水性中空糸膜である場
合、少しでも気泡が混入したときには、中空糸内
から気泡が容易に抜けないため、本発明の有効性
が増大する。 Further, when the blood purification device is a hydrophobic hollow fiber membrane, even if even a small amount of air bubbles are mixed in, the air bubbles cannot be easily removed from the hollow fibers, thereby increasing the effectiveness of the present invention.
次に、この発明にかかわる血液浄化装置の好適
な実施例について、添付図面を参照しながら以下
詳細に説明する。 Next, preferred embodiments of the blood purification device according to the present invention will be described in detail below with reference to the accompanying drawings.
第２図は、血液浄化装置本体の断面図で、通常
円筒形のケース本体１０、血液導出入部材１２、
ケース本体と血液導出入部材を液体密に密封する
ためのＯリング等の弾性シール材１４、および本
体に液体充填後血液導出入ポート１６に取り付け
るポートキヤツプ１８で構成されている。このよ
うに構成された血液浄化装置本体は、通常内部に
水等の液体を気泡が存在しないようにていねいに
充填された後、第３図に示すように滅菌バツク２
０で包装後、放射線滅菌されるのが一般的であ
る。ところで、このように包装された血液浄化装
置本体は、弾性シール材１４およびポートキヤツ
プ１８が通常シリコンゴムで作られているため、
若干の通気性があり放射線滅菌時に内部の水分が
蒸発し、代わりに気泡が混入する欠点を有してい
た。これに対して、本発明の実施例を示す第１図
では、血液浄化装置本体を滅菌バツク２２に入れ
た後、バツク内を真空ポンプで真空にして端部シ
ールすること（真空包装）により、血液浄化装置
本体の外周部に空気が存在しないために、弾性シ
ール材１４やポートキヤツプ１８からの気泡混入
が皆無であり、使用時の気泡混入トラブルを完全
に排除することができる。
FIG. 2 is a sectional view of the main body of the blood purification device, showing the normally cylindrical case main body 10, the blood introduction/input member 12,
It is comprised of an elastic sealing material 14 such as an O-ring for liquid-tightly sealing the case body and the blood lead-in/out member, and a port cap 18 that is attached to the blood lead-in/out port 16 after the main body is filled with liquid. The body of the blood purification device constructed in this way is normally filled with a liquid such as water carefully to avoid the presence of air bubbles, and then placed in a sterilization bag 2 as shown in Fig. 3.
After being packaged at zero, it is generally sterilized by radiation. By the way, in the body of the blood purification device packaged in this way, since the elastic sealing material 14 and the port cap 18 are usually made of silicone rubber,
It has some air permeability and has the disadvantage that the moisture inside evaporates during radiation sterilization and air bubbles are mixed in instead. On the other hand, in FIG. 1 showing an embodiment of the present invention, after the blood purification device body is placed in a sterilization bag 22, the inside of the bag is evacuated with a vacuum pump and the ends are sealed (vacuum packaging). Since there is no air around the outer periphery of the blood purification device body, there is no air bubbles mixed in from the elastic sealing material 14 or port cap 18, and troubles caused by air bubbles mixed in during use can be completely eliminated.
しかし、このように真空包装後、放射線滅菌し
た血液浄化装置は、包装材の酸素透過度の多いも
のを使用した場合、真空包装後経時的にバツク内
真空度が低下し、血液浄化装置本体に気泡が除々
に混入することもある。これは、製作後使用まで
の期間（保管期間）が長いと問題となる。そのよ
うな場合、酸素透過度10c.c.／m2・24hrs・atm（20
℃ 65％RH）以下の高バリヤー包装材で真空包
装することによつて、真空度の経時的低下を防ぐ
ことができる。ここで酸素透過度は、JIS Ｚ
1707食品包装用プラスチツクフイルムの気体透過
度試験による方法の値である。 また、通常の包
装材で真空包装し、放射線滅菌した後に酸素透過
度10c.c.／m2・24hrs・atm（20℃ 65％RH）以下
の高バリヤー包装材で二重包装することによつて
も、同様に経時的気泡混入を防止することができ
る。 However, if a blood purification device that has been vacuum packed and sterilized by radiation is used as a packaging material with high oxygen permeability, the degree of vacuum inside the bag will decrease over time after vacuum packaging, and the blood purification device itself will be damaged. Air bubbles may be gradually mixed in. This becomes a problem if the period (storage period) from manufacture to use is long. In such cases, oxygen permeability 10c.c./m2・24hrs・atm (20
By vacuum packaging with high-barrier packaging material (℃ 65% RH) or less, it is possible to prevent the degree of vacuum from decreasing over time. Here, the oxygen permeability is JIS Z
1707 This is the value of the gas permeability test of plastic film for food packaging. In addition, the product is vacuum-packaged using normal packaging material, sterilized by radiation, and then double-packed with high-barrier packaging material with an oxygen permeability of 10c.c./m2・24hrs・atm (20℃ 65%RH) or less. However, it is possible to similarly prevent air bubbles from being mixed in over time.
以上、この発明にかかる血液浄化装置の製造方
法によれば、前記説明からも明らかなように、血
液浄化装置本体の外周部には真空包装により気体
接触がないので、放射線滅菌工程での気泡混入を
完全に防ぐことができるため、使用時に脱泡操作
が不要であるばかりでなく、脱泡不十分による血
液滞流を原因とする性能の低下や血液凝固等の問
題が発生することを完全に防ぐことができる。更
に、血液浄化装置が疎水性中空糸膜を使用してい
る場合には、少しでも気泡が中空糸内に入つたと
きには、血液浄化装置に振動を与える等の脱泡操
作を行なつても容易に抜けないため、気泡混入を
完全に防ぐ必要があり、本発明の有効性が増大す
るものである。
As mentioned above, according to the method for manufacturing a blood purification device according to the present invention, as is clear from the above description, there is no gas contact with the outer circumference of the blood purification device body due to vacuum packaging, so air bubbles may be mixed in during the radiation sterilization process. Because it can completely prevent the degassing operation during use, it also completely prevents problems such as performance deterioration and blood coagulation caused by blood stagnation due to insufficient defoaming. It can be prevented. Furthermore, if the blood purification device uses a hydrophobic hollow fiber membrane, if even a small amount of air bubbles gets into the hollow fiber, it is easy to remove the bubbles by applying vibration to the blood purification device. Therefore, it is necessary to completely prevent air bubbles from being mixed in, which increases the effectiveness of the present invention.
以上、この発明にかかわる血液浄化装置の好適
な実施例について説明したが、この実施例に限定
されることなく、種々の変更を加えることができ
ることはもちろんである。 Although the preferred embodiments of the blood purification device according to the present invention have been described above, the present invention is not limited to these embodiments, and it goes without saying that various changes can be made.
第１図は、本発明の製造方法により製造した血
液浄化装置の包装状態を示す断面図。第２図は、
一般的血液浄化装置本体を示す半断面図。第３図
は、従来の製造方法により製造した血液浄化装置
の包装状態を示す断面図。
１０……ケース本体、１２……血液導出入部
材、１４……弾性シール材、１６……血液導出入
ポート、１８……ポートキヤツプ、２０……滅菌
バツク、２２……滅菌バツク。
FIG. 1 is a sectional view showing a packaged state of a blood purification device manufactured by the manufacturing method of the present invention. Figure 2 shows
FIG. 1 is a half-sectional view showing a general blood purification device main body. FIG. 3 is a sectional view showing a packaged state of a blood purification device manufactured by a conventional manufacturing method. DESCRIPTION OF SYMBOLS 10... Case body, 12... Blood lead-in/outlet member, 14... Elastic sealing material, 16... Blood lead-in/out port, 18... Port cap, 20... Sterilization bag, 22... Sterilization bag.
Claims (1)
を液密に充填し、ついでこれを真空包装した後、
放射線滅菌することを特徴とする血液浄化装置の
製造方法。 ２ 前記真空包装を、酸素透過度10c.c.／m2・
24hrs・atm（20℃、65％RH）以下の包装材を用
いて行なう特許請求の範囲第１項に記載の血液浄
化装置の製造方法。 ３ 前記放射線滅菌後に、さらに酸素透過度10
c.c.／m2・24hrs・atm（20℃、65％RH）以下の包
装材で二重包装する前記特許請求の範囲第１項ま
たは第２項に記載の血液浄化装置の製造方法。[Claims] 1. Water or liquid is liquid-tightly filled into the case body of the blood purification device, and then vacuum-packed, and then
A method for manufacturing a blood purification device characterized by radiation sterilization. 2. The vacuum packaging is carried out at an oxygen permeability of 10c.c./m2 .
A method for manufacturing a blood purification device according to claim 1, which is carried out using a packaging material of 24 hours/atm (20° C., 65% RH) or less. 3 After the radiation sterilization, the oxygen permeability is further increased to 10
The method for manufacturing a blood purification device according to claim 1 or 2, wherein the blood purification device is double-wrapped with packaging material having a temperature of cc/m 2 24 hrs atm (20° C., 65% RH) or less.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61029393A JPS62186866A (en) | 1986-02-13 | 1986-02-13 | Production of blood purifier |
| KR1019860006176A KR890001002B1 (en) | 1986-02-13 | 1986-07-28 | Production of blood purification |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61029393A JPS62186866A (en) | 1986-02-13 | 1986-02-13 | Production of blood purifier |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS62186866A JPS62186866A (en) | 1987-08-15 |
| JPH0212112B2 true JPH0212112B2 (en) | 1990-03-19 |
Family
ID=12274894
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP61029393A Granted JPS62186866A (en) | 1986-02-13 | 1986-02-13 | Production of blood purifier |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JPS62186866A (en) |
| KR (1) | KR890001002B1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002028233A (en) * | 2000-07-13 | 2002-01-29 | Nikkiso Co Ltd | Blood purifier cap and blood purifier equipped therewith |
| KR101935123B1 (en) * | 2014-09-29 | 2019-01-03 | 아사히 가세이 메디컬 가부시키가이샤 | Hollow fiber membrane-type blood purification device |
-
1986
- 1986-02-13 JP JP61029393A patent/JPS62186866A/en active Granted
- 1986-07-28 KR KR1019860006176A patent/KR890001002B1/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| KR890001002B1 (en) | 1989-04-18 |
| JPS62186866A (en) | 1987-08-15 |
| KR870007702A (en) | 1987-09-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| EXPY | Cancellation because of completion of term |