JPH0582221B2 - - Google Patents
Info
- Publication number
- JPH0582221B2 JPH0582221B2 JP1137823A JP13782389A JPH0582221B2 JP H0582221 B2 JPH0582221 B2 JP H0582221B2 JP 1137823 A JP1137823 A JP 1137823A JP 13782389 A JP13782389 A JP 13782389A JP H0582221 B2 JPH0582221 B2 JP H0582221B2
- Authority
- JP
- Japan
- Prior art keywords
- bag
- gas
- inner bag
- outer bag
- bacteria
- 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
- 239000000463 material Substances 0.000 claims description 34
- 239000012567 medical material Substances 0.000 claims description 18
- 230000001954 sterilising effect Effects 0.000 claims description 17
- 238000007789 sealing Methods 0.000 claims description 15
- 239000011888 foil Substances 0.000 claims description 9
- 238000004806 packaging method and process Methods 0.000 claims description 8
- 229910052751 metal Inorganic materials 0.000 claims description 6
- 239000002184 metal Substances 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 229920005989 resin Polymers 0.000 claims description 5
- 239000011347 resin Substances 0.000 claims description 5
- 239000000470 constituent Substances 0.000 claims description 4
- 238000005520 cutting process Methods 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 230000007062 hydrolysis Effects 0.000 claims 1
- 238000006460 hydrolysis reaction Methods 0.000 claims 1
- 239000007789 gas Substances 0.000 description 22
- 238000004659 sterilization and disinfection Methods 0.000 description 10
- 241000894006 Bacteria Species 0.000 description 7
- 239000000047 product Substances 0.000 description 4
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 3
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 239000002985 plastic film Substances 0.000 description 3
- 229920006255 plastic film Polymers 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 238000007872 degassing Methods 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- 239000011261 inert gas Substances 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229920003002 synthetic resin Polymers 0.000 description 2
- 239000000057 synthetic resin Substances 0.000 description 2
- 239000012780 transparent material Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 241000222120 Candida <Saccharomycetales> Species 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 241000245772 Gasteria Species 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 239000004775 Tyvek Substances 0.000 description 1
- 229920000690 Tyvek Polymers 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 239000003570 air Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000010981 drying operation Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000002648 laminated material Substances 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000004745 nonwoven fabric Substances 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920006149 polyester-amide block copolymer Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 239000004633 polyglycolic acid Substances 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
- Y02E60/00—Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
- Y02E60/10—Energy storage using batteries
Description
【発明の詳細な説明】
［産業上の利用分野］
この発明は生体内に埋入して水分で分解する性
質を備えた、加水分解性医用材料を包装する方法
及び包装物に関する。DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a method and package for packaging a hydrolyzable medical material that has the property of being implanted in a living body and decomposed by moisture.
［従来の技術］
加水分解性医用材料を包装するには、包装の中
に水分が入ると保存中に劣化するため、水分を含
まない状態で包装し、且つ保存中にも外部から水
分が入らないようにする必要がある。また、手術
時等に無菌状態で包装された医用材料を袋から取
り出す必要があるので、袋の外側も無菌状態に保
つ必要がある。したがつて、収納物は二重袋の内
袋内に入れられ、且つ内袋の外側は完全無菌の状
態にすることが望まれる。[Prior Art] When packaging hydrolyzable medical materials, if moisture gets into the packaging, it will deteriorate during storage, so it is necessary to package it in a moisture-free state and to prevent moisture from entering from outside during storage. It is necessary to make sure that there is no such thing. Furthermore, since it is necessary to take out the medical materials packaged in a sterile state from the bag during a surgery or the like, it is necessary to maintain the outside of the bag in a sterile state as well. Therefore, it is desirable that the stored items be placed in the inner bag of the double bag, and that the outside of the inner bag be kept completely sterile.
ここで細菌としては、例えば大腸菌、緑膿菌、
ブドウ球菌、溶血性連鎖球菌、カンジタ、アルビ
カンス等がある。 Examples of bacteria here include Escherichia coli, Pseudomonas aeruginosa,
These include staphylococcus, hemolytic streptococcus, candida, and albicans.
従来は、その対策として例えば特公昭64−6793
号公報に示されているような無菌二重パツケージ
の製造方法が提案されている。即ち、医用材料
を、ラミネートした金属箔シートの内袋に入れ、
この内袋をガス透過性で細菌不透過性の素材から
なり、内袋より高温で溶融する材料をラミネート
した外袋に入れて外袋のみヒートシールする。そ
の後、外袋全体を滅菌することにより外袋を通し
て内袋の内外面を滅菌し、真空下に滅菌ガスを除
去し乾燥した後、最後に内袋を外袋の外側から低
温でヒートシールしていた。この方法によつて、
内袋の内外面は滅菌された状態のままでこの包装
物を自由に移送でき、使用に際しては、外袋を開
封し、ピンセツトで内袋を取り出して手術台へ運
び、その場で内袋を開封して包装された医用材料
を使用していた。 Conventionally, as a countermeasure, for example,
A method for producing a sterile double package as shown in the above publication has been proposed. That is, medical materials are placed in an inner bag made of a laminated metal foil sheet,
This inner bag is placed in an outer bag made of a material that is gas permeable but impermeable to bacteria and laminated with a material that melts at a higher temperature than the inner bag, and only the outer bag is heat-sealed. After that, the entire outer bag is sterilized, the inner and outer surfaces of the inner bag are sterilized through the outer bag, the sterilization gas is removed under vacuum, and the inner and outer bags are dried.Finally, the inner bag is heat-sealed from the outside of the outer bag at a low temperature. Ta. By this method,
The package can be freely transported while the inner and outer surfaces of the inner bag remain sterilized. When using the package, open the outer bag, remove the inner bag with tweezers, carry it to the operating table, and remove the inner bag on the spot. Medical materials that had been opened and packaged were used.
［発明が解決しようとする課題］
しかしながら、上記のような従来のものにおい
ては、内袋が開いている状態で外袋に入れる作業
を行わなければならず、その際に内袋か収納物が
落下する恐れがあつた。また、外袋をシールした
後に内袋をシールするので、ガス透過性で細菌不
透過性の材料は、通常は不透明性の材料が用いら
れており、内袋のシール状態が外袋を介しては見
えないので、内袋の開口部分を確実にシールする
ことは困難であり、シールミスが起こり易い欠点
があつた。その対策として高価な透明材料製の外
袋を用いる必要も生じる。[Problems to be Solved by the Invention] However, in the conventional products as described above, it is necessary to put the inner bag into the outer bag while the inner bag is open, and at that time, the inner bag or the stored items may be There was a risk of falling. In addition, since the inner bag is sealed after the outer bag is sealed, gas-permeable and bacteria-impermeable materials are usually made of opaque materials, and the sealing state of the inner bag is maintained through the outer bag. Since the opening of the inner bag cannot be seen, it is difficult to reliably seal the opening of the inner bag, and there is a drawback that sealing errors are likely to occur. As a countermeasure, it becomes necessary to use an outer bag made of an expensive transparent material.
また、内袋が開口しているので、外袋に入れた
後に行う外袋のシール、滅菌、真空乾燥等の各種
の作業中に収納物が内装からはみ出す恐れがあ
り、はみ出してしまうと、内袋のシールが完全に
行われないことは勿論、はみ出した収納物は外袋
を通して入つてくる水分によつて劣化し、使用不
能となる欠点があつた。それを防ぐためには、内
装から収納物がはみ出さないように細心の注意を
はらう必要があつた。 In addition, since the inner bag is open, there is a risk that the stored items may protrude from the inner bag during various operations such as sealing, sterilizing, and vacuum drying the outer bag after placing it in the outer bag. Of course, the bag was not completely sealed, and the protruding stored items deteriorated due to moisture entering through the outer bag, making them unusable. In order to prevent this, it was necessary to take great care to ensure that stored items did not protrude from the interior.
更に、滅菌ガスとして使用されるエチレンオキ
サイドガス或いはその混合ガスは、滅菌後、除去
されることが望まれるが、その際、内袋の口が外
袋に押されて閉じられるときには除去されにく
く、外袋の中の状態が見にくいこととあいまつ
て、安全を見込んで長時間ガス抜きあるいは不活
性ガスとのガス交換を行わなければならない欠点
もあつた。同様に内袋の口が外袋に押されて閉じ
ている時には滅菌ガスが内袋内に入りにくく、安
全を見込んで長時間滅菌を行わなければならなか
つた。 Furthermore, it is desirable that the ethylene oxide gas or its mixed gas used as a sterilization gas be removed after sterilization, but in this case, it is difficult to remove when the opening of the inner bag is closed by being pressed against the outer bag. Coupled with the fact that it was difficult to see the condition inside the outer bag, it also had the disadvantage of requiring long periods of degassing or gas exchange with inert gas to ensure safety. Similarly, when the opening of the inner bag is closed by the outer bag, it is difficult for sterilizing gas to enter the inner bag, and sterilization must be carried out for a long time to ensure safety.
一方、上記従来のものは、最後に外袋の外から
内袋の口のみシールする必要があるので、内袋の
ラミネート材の熱溶融温度を外袋のそれより低い
温度にしなければならないので、内袋と外袋のヒ
ートシール温度に差を設ける必要があり、特別の
素材の組み合わせが必要となる欠点もあつた。 On the other hand, with the above conventional method, it is necessary to seal only the opening of the inner bag from the outside of the outer bag at the end, so the thermal melting temperature of the laminate material of the inner bag must be lower than that of the outer bag. It was necessary to provide a difference in heat-sealing temperature between the inner bag and the outer bag, and it also had the disadvantage of requiring a special combination of materials.
［課題を解決するための手段］
本願の各発明は、上記従来のものの欠点を解消
するため、少なくともその構成素材の一部にガス
透過性で且つ細菌不透過性の素材を用いた袋に加
水分解性医用材料を収納し、袋口をシールして密
封された内袋を構成する工程と、少なくとも、そ
の構成素材の一部、望ましくは袋口部分にガス透
過性で且つ細菌不透過性の素材部分を有し、他の
部分は熱接着性樹脂をコーテイングもしくはラミ
ネートした金族箔素材、望ましくはアルミ箔材料
よりなる外袋に内袋を収納し、袋口をシールして
密封された二重袋を構成する工程と、前記二重袋
をガス滅菌し、必要により真空でガス除去し、ま
たは他のガスと交換し或いは乾熱による乾燥を行
う工程と、外袋のガス透過性で且つ細菌不透過性
の素材部分が、内袋を収納する外袋部分と連通し
ないように外袋をヒートシールする工程とにより
加水分解性医用材料の包装を行うものであり、更
に外袋のガス透過性で且つ細菌不透過性の素材部
分を、内袋を収納する外袋部分と連通しないよう
にヒートシールした後、カツトして除去する工程
をも加えて包装を行つて、少なくともその構成素
材の一部にガス透過性で且つ細菌不透過性の素材
を用いた内袋と、熱接着性樹脂をコーテイングも
しくはラミネートした金属箔素材、望ましくはア
ルミ箔よりなる外袋との二重袋構造よりなり、内
袋内に加水分解性医用材料を収納した包装物を構
成したものであつて、それにより確実に滅菌され
た二重袋を安価に得られるようにしたものであ
る。[Means for Solving the Problems] In order to eliminate the drawbacks of the above-mentioned conventional products, each invention of the present application involves adding water to a bag in which at least a part of its constituent material is made of gas-permeable and bacteria-impermeable material. A step of configuring a sealed inner bag by accommodating the degradable medical material and sealing the bag opening; The inner bag is housed in an outer bag made of metal foil material coated or laminated with thermoadhesive resin, preferably aluminum foil material, and the bag opening is sealed. a step of forming a double bag, a step of gas sterilizing the double bag, removing the gas with a vacuum if necessary, exchanging it with another gas, or drying it by dry heat; and a step of making the outer bag gas permeable and Hydrolyzable medical materials are packaged by heat-sealing the outer bag so that the bacteria-impermeable material part does not communicate with the outer bag part that houses the inner bag, and the outer bag is also gas-permeable. After heat-sealing the transparent and bacteria-impermeable material portion so that it does not communicate with the outer bag portion that houses the inner bag, packaging is performed by adding a step of cutting and removing the material, so that at least the constituent materials of the material are removed. It has a double bag structure consisting of an inner bag partially made of a material that is gas permeable and impermeable to bacteria, and an outer bag made of a metal foil material coated or laminated with thermoadhesive resin, preferably aluminum foil. This is a package in which a hydrolyzable medical material is housed in an inner bag, thereby making it possible to obtain a double bag that is reliably sterilized at a low cost.
［作用］
本願の各発明は上記のように包装することによ
り、最初、医用材料の収納物は内袋内に密封さ
れ、それを外袋に入れて外袋を密封し、滅菌及び
乾燥を行い、最後に外袋のガス透過性で且つ細菌
不透過性の部分が、収納した内袋と重ならない位
置になるように調整した後、ヒートシールし、更
に好ましくは当該部を除去するものである。[Function] By packaging as described above, each invention of the present application first seals the medical material stored in the inner bag, then puts it in the outer bag, seals the outer bag, and sterilizes and dries it. Finally, after adjusting the gas-permeable and bacteria-impermeable part of the outer bag to a position where it does not overlap with the stored inner bag, heat sealing is performed, and more preferably, this part is removed. .
［実施例］
本発明の実施例を第１図〜第４図に基づいて説
明する。[Example] An example of the present invention will be described based on FIGS. 1 to 4.
第１図に示すように、内袋１内には例えばコラ
ーゲン、ポリグリコール酸、ポリ乳酸、カプロラ
クトン、Ｐ−ジオキサノン等のホモあるいはコー
ポリマーからなる、体内に埋入して水分で分解す
る性質の加水分解性医用材料２を包装する。な
お、包装される医用材料２としては、例えば手術
用縫合糸、ステープル、スポンジ、ピン、人工皮
膚、止血材、人工腱、靭帯、除放性剤、血管等が
ある。本発明による内袋の材質としては、例えば
上質紙、和紙、タイベツク（登録商標）、不織布、
紙／合成樹脂ラミネート、紙／合成樹脂コーテイ
ング等のガス透過性で細菌不透過性の素材、ポリ
プロピレン、ポリエチレン、ポリエステル、ポリ
アミド等のヒートシール性のプラスチツクフイル
ムが好適に用いられる。その際、内袋全体をガス
透過性で細菌不透過性の素材を用いても、また前
記したヒートシール性のプラスチツクフイルムを
その一部に用いても良い。 As shown in Figure 1, the inner bag 1 contains homo- or copolymers such as collagen, polyglycolic acid, polylactic acid, caprolactone, and P-dioxanone, which have the property of being implanted in the body and decomposed by water. The hydrolyzable medical material 2 is packaged. The medical materials 2 to be packaged include, for example, surgical sutures, staples, sponges, pins, artificial skin, hemostatic materials, artificial tendons, ligaments, sustained release agents, blood vessels, and the like. Materials for the inner bag according to the present invention include, for example, high-quality paper, Japanese paper, Tyvek (registered trademark), nonwoven fabric,
Gas-permeable but bacteria-impermeable materials such as paper/synthetic resin laminates, paper/synthetic resin coatings, and heat-sealable plastic films such as polypropylene, polyethylene, polyester, and polyamide are preferably used. In this case, the entire inner bag may be made of a gas-permeable but bacteria-impermeable material, or the above-mentioned heat-sealable plastic film may be used for a portion thereof.
第１図の実施例においては、裏面にガス及び細
菌不透過性のヒートシール性のプラスチツクフイ
ルム３を用い、表面にはガス透過性で細菌不透過
性のフイルム４を用いている。このような素材か
らなる内袋に、第１図に示すように医用材料２を
収納した後、その開口をヒートシールし、ヒート
シール部５を形成して密封する。この内袋１はこ
の状態で予め滅菌を施すこともできる。 In the embodiment shown in FIG. 1, a heat-sealable plastic film 3 that is impermeable to gases and bacteria is used on the back side, and a film 4 that is gas-permeable and impermeable to bacteria is used on the front side. After the medical material 2 is stored in the inner bag made of such a material as shown in FIG. 1, the opening is heat-sealed to form a heat-sealed portion 5 and sealed. The inner bag 1 can also be sterilized in advance in this state.
次いで、この内袋１を、第２図に示すように外
袋６の中に入れる。この外袋６は、一部を除いて
アルミ箔等の金属箔に対し、内袋と同様のヒート
シール性樹脂をコーテイングあるいはラミネート
したものを用いる。この外袋６に収納される内袋
１が、外袋６の開口から外袋内に挿入されたと
き、少なくとも内袋１の挿入端より外側の外装６
の部分には、内袋１と同様の素材からなるガス透
過性で細菌不透過性の素材からなる部分７を貼
着、接着等により設ける。外袋６内に内袋１を収
納後、外袋６の開口をヒートシールし、ヒートシ
ール部８を形成する。このようにして得られた二
重袋の断面は、第３図に示すように、内袋１及び
外袋６共に各々全周がシールされた状態となる。 Next, this inner bag 1 is placed into an outer bag 6 as shown in FIG. The outer bag 6 is made of a metal foil such as aluminum foil coated or laminated with a heat-sealing resin similar to the inner bag, except for a part. When the inner bag 1 stored in the outer bag 6 is inserted into the outer bag from the opening of the outer bag 6, the outer bag 1 at least outside the insertion end of the inner bag 1
A portion 7 made of the same material as the inner bag 1 and made of a gas-permeable but bacteria-impermeable material is attached to the portion by pasting, gluing, or the like. After storing the inner bag 1 in the outer bag 6, the opening of the outer bag 6 is heat-sealed to form a heat-sealed portion 8. As shown in FIG. 3, the cross section of the double bag thus obtained is in a state where both the inner bag 1 and the outer bag 6 are sealed all around.
その後、この外袋全体に対して、エチレンオキ
サイドガスや、空気、炭酸ガス、エチレンオキサ
イドガス等の三成分を混合した滅菌ガスを供給す
る。この滅菌ガスは、その他プロピレンオキサイ
ド、ホルムアルデヒド等の殺菌ガスをしようする
ことも可能である。滅菌ガスは外袋６の上部の部
分７に形成されたガス透過性で細菌不透過性のシ
ートから外袋６内に入り、外袋６の内面及び内袋
１の外面を滅菌するとともに、更に内袋１のガス
透過性で細菌不透過性のフイルム４から内袋内に
入り、収納された医用材料２及び内袋１の内面の
滅菌を行う。次いでこの二重袋は真空装置により
ガス抜きを行い、滅菌ガスを排出した後、あるい
は同時に乾燥炉で乾燥することにより、外袋６の
内部ばかりでなく内袋１の内部もガス及び水分が
抜かれる。更に必要に応じ内外袋内に不活性ガス
等を封入しても良い。 Thereafter, ethylene oxide gas, a sterilization gas containing a mixture of three components such as air, carbon dioxide, and ethylene oxide gas is supplied to the entire outer bag. Other sterilizing gases such as propylene oxide and formaldehyde may also be used as the sterilizing gas. The sterilizing gas enters the outer bag 6 through the gas-permeable, bacteria-impermeable sheet formed in the upper part 7 of the outer bag 6, sterilizes the inner surface of the outer bag 6 and the outer surface of the inner bag 1, and further The material enters the inner bag through the gas-permeable but bacteria-impermeable film 4 of the inner bag 1, and the stored medical material 2 and the inner surface of the inner bag 1 are sterilized. Next, this double bag is degassed using a vacuum device, and after the sterilization gas is discharged, or at the same time, it is dried in a drying oven, so that not only the inside of the outer bag 6 but also the inside of the inner bag 1 is degassed. Ru. Furthermore, if necessary, an inert gas or the like may be sealed in the inner and outer bags.
その後、直ちに外袋上部に設けられたガス透過
性で細菌不透過性の部分７の少し下方である、第
２図中のＡ−Ａ部分をヒートシールし、ヒートシ
ール部９を形成し、外袋６が金属箔素材のみで構
成された密封された二重袋を構成する。 Thereafter, immediately heat-seal the portion A-A in FIG. 2, which is slightly below the gas-permeable but bacteria-impermeable portion 7 provided at the top of the outer bag, to form a heat-sealed portion 9, and then The bag 6 constitutes a sealed double bag made only of metal foil material.
この状態でも最終製品として、その機能上は充
分ではあるが、更にこのヒートシール部９の部分
あるいはその上方を切断し、第４図に示すように
ガス透過性で細菌不透過性の部分７を切除し、残
つた外袋６を最終製品としても良い。 Even in this state, the final product is functionally sufficient, but the heat-sealed portion 9 or its upper part is cut to form a gas-permeable and bacteria-impermeable portion 7, as shown in FIG. After cutting, the remaining outer bag 6 may be used as the final product.
［発明の効果］
本発明は、以上のように内袋を先に密封したの
で、内袋を外袋に挿入する際等の各種作業時にお
いて、従来のもののように内容物が落下すること
がなくなる。特に最終的なシールは外袋のシール
であるので、シールの状況がよくわかり、シール
ミスを生じることがない。そのため外袋に高価な
透明材料を用いる必要もなくなる。また、内袋は
密封されているので、各種作業中に内袋から収納
物がはみ出すことがなく、従来のようなはみ出し
によるシール不良や製品不良を生じることがな
い。[Effects of the Invention] In the present invention, since the inner bag is sealed first as described above, the contents do not fall out during various operations such as inserting the inner bag into the outer bag unlike in the conventional case. It disappears. In particular, since the final seal is the seal on the outer bag, the status of the seal can be clearly seen, and sealing errors will not occur. Therefore, there is no need to use an expensive transparent material for the outer bag. In addition, since the inner bag is sealed, the stored items will not protrude from the inner bag during various operations, and there will be no seal failure or product failure due to protrusion as in the past.
更に、滅菌、ガス抜き、乾燥作業時において、
従来のように、開口していた内袋の口がつぶされ
て閉じられ、これらの作業に安全を見込んで多く
の時間をかけなければならないという欠点も解消
され、作業効率が向上する。しかも内袋を外袋に
入れる前に予め滅菌しておくことも可能となり、
その際には最終的な滅菌は二次滅菌となり、滅菌
効率が向上する。 Furthermore, during sterilization, degassing, and drying operations,
This eliminates the drawback that the opening of the inner bag is crushed and closed as in the past, which requires taking a lot of time to ensure safety, thereby improving work efficiency. Moreover, it is now possible to sterilize the inner bag before putting it into the outer bag.
In this case, the final sterilization is secondary sterilization, which improves sterilization efficiency.
しかも、最終的な外袋のシールは、内袋の存在
しない部分をシールするので、従来のような内袋
を外袋より低温で融着するような材質の選択が不
必要となり、内袋及び外袋共に同じヒートシール
性樹脂を用いることができるので安価となる。 Moreover, since the final seal of the outer bag seals the part where the inner bag does not exist, there is no need to select a material that fuses the inner bag at a lower temperature than the outer bag, which is the case in the past. Since the same heat-sealable resin can be used for both the outer bag and the outer bag, the cost is reduced.
また、外袋のガス透過性で細菌不透過性の部分
を切除する際には、製品が小型化し、取扱いの便
が良くなる。 Furthermore, when the gas-permeable but bacteria-impermeable portion of the outer bag is removed, the product becomes smaller and easier to handle.
以上のように本発明は、加水分解性医用材料を
包装するのに好適である。 As described above, the present invention is suitable for packaging hydrolyzable medical materials.
第１図ないし第４図は本発明の実施例を示し、
第１図は内袋の一部を切除した正面図、第２図は
内袋を外袋に入れた状態の正面図、第３図は第２
図のＢ−Ｂ部分の断面図、第４図は第２図のＡ−
Ａ部分をヒートシールした後、切断した状態を示
す正面図である。
１……内袋、２……医用材料、３……ガスおよ
び細菌不透過性フイルム、４……ガス透過性で且
つ細菌不透過性フイルム、５，８，９……ヒート
シール部、６……外袋、７……ガス透過性で且つ
細菌不透過性フイルム部分。
1 to 4 show embodiments of the present invention,
Figure 1 is a front view with a part of the inner bag removed, Figure 2 is a front view of the inner bag inserted into the outer bag, and Figure 3 is a front view of the inner bag.
A sectional view of the B-B portion in the figure, Figure 4 is a cross-sectional view of the A-B in Figure 2.
It is a front view which shows the state which cut|disconnected after heat-sealing the A part. DESCRIPTION OF SYMBOLS 1...Inner bag, 2...Medical material, 3...Gas and bacteria impermeable film, 4...Gas permeable and bacteria impermeable film, 5, 8, 9...Heat seal portion, 6... ... Outer bag, 7... Gas-permeable and bacteria-impermeable film portion.
Claims (1)
で且つ細菌不透過性の素材を用いた袋に加水分解
性医用材料を収納し、袋口をシールして密封され
た内袋を構成する工程； 少なくともその構成素材の一部にガス透過性で
且つ細菌不透過性の素材部分を有し、他の部分は
熱接着性樹脂をコーテイングもしくはラミネート
した金属箔素材よりなる外袋に内袋を収納し、袋
口をシールして密封された二重袋を構成する工
程； 前記二重袋をガス滅菌し、かかるガスを真空で
除去し、又は他のガスと交換し、あるいは乾熱に
よる乾燥を行う工程； 外袋のガス透過性で且つ細菌不透過性の素材部
分が内袋を収納する外袋部分と連通しないように
外袋をヒートシールする工程； よりなる加水分解性医用材料の包装方法。 ２ 外袋のガス透過性で且つ細菌不透過性の素材
部分を内袋を収納する外袋部分と連通しないよう
にヒートシールした後、カツトして除去する工程
よりなる請求項１記載の加水分解性医用材料の包
装方法。[Claims] 1. A bag made of gas-permeable and bacteria-impermeable material for at least a part of its constituent materials, containing a hydrolyzable medical material, and sealing the bag opening to seal the inside. Step of constructing the bag: At least a part of the constituent material has a gas-permeable and bacteria-impermeable material part, and the other part is made of a metal foil material coated or laminated with thermoadhesive resin. accommodating the inner bag and sealing the bag opening to form a sealed double bag; sterilizing the double bag with gas and removing such gas with a vacuum or replacing it with another gas; or A step of drying by dry heat; a step of heat-sealing the outer bag so that the gas-permeable and bacteria-impermeable material portion of the outer bag does not communicate with the outer bag portion that houses the inner bag; Packaging method for medical materials. 2. The hydrolysis process according to claim 1, which comprises the step of heat-sealing the gas-permeable and bacteria-impermeable material portion of the outer bag so that it does not communicate with the outer bag portion housing the inner bag, and then cutting and removing the material. Packaging method for medical materials.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1137823A JPH031871A (en) | 1989-05-30 | 1989-05-30 | Method for packing hydrolyzable medical material and package |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1137823A JPH031871A (en) | 1989-05-30 | 1989-05-30 | Method for packing hydrolyzable medical material and package |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH031871A JPH031871A (en) | 1991-01-08 |
| JPH0582221B2 true JPH0582221B2 (en) | 1993-11-18 |
Family
ID=15207684
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP1137823A Granted JPH031871A (en) | 1989-05-30 | 1989-05-30 | Method for packing hydrolyzable medical material and package |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH031871A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011013640A1 (en) | 2009-07-31 | 2011-02-03 | マニー株式会社 | Packaging bag for medical supplies, packaging bag containing medical supplies, and method for packaging medical supplies |
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|---|---|---|---|---|
| JP3999369B2 (en) * | 1998-09-08 | 2007-10-31 | 岡田紙業株式会社 | Sterilization bag |
| JP2002085521A (en) * | 2000-09-13 | 2002-03-26 | Terumo Corp | Blood circuit set storage vessel |
| JP2002347781A (en) * | 2001-05-24 | 2002-12-04 | Gunze Ltd | Hydrolyzable packaging bag for medical material and packaging method using the same |
| JP4201520B2 (en) * | 2002-04-09 | 2008-12-24 | 株式会社カナエ | How to use sterile bags |
| CN1321699C (en) * | 2002-10-29 | 2007-06-20 | 米利波尔公司 | Integrity testable autoclavable, sterile transfer bag |
| JP2017047969A (en) * | 2015-09-03 | 2017-03-09 | 住友ベークライト株式会社 | Manufacturing method of package including sterile sealed space, sterile sealing bag body, and package including sterile sealed space |
| JP6819230B2 (en) * | 2016-11-08 | 2021-01-27 | 住友ベークライト株式会社 | Packaging bag for cell culture container |
| KR102254344B1 (en) * | 2019-11-19 | 2021-05-21 | 엔피씨(주) | Cooling box |
| JP7446926B2 (en) | 2020-06-05 | 2024-03-11 | 株式会社東海理化電機製作所 | Control device and control method |
| JP7414648B2 (en) | 2020-06-05 | 2024-01-16 | 株式会社東海理化電機製作所 | Control device and control method |
| KR102297335B1 (en) * | 2020-08-27 | 2021-09-03 | 주식회사 플라즈맵 | Sterilizer storage device and sterilization device |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61100255A (en) * | 1984-10-22 | 1986-05-19 | ネクスタ株式会社 | Sterilized bag comprising resin film |
| JPS61172560A (en) * | 1984-11-15 | 1986-08-04 | フアイザ−・ホスピタル・プロダクツ・グル−プ・インコ−ポレ−テツド | Aseptic double package |
-
1989
- 1989-05-30 JP JP1137823A patent/JPH031871A/en active Granted
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61100255A (en) * | 1984-10-22 | 1986-05-19 | ネクスタ株式会社 | Sterilized bag comprising resin film |
| JPS61172560A (en) * | 1984-11-15 | 1986-08-04 | フアイザ−・ホスピタル・プロダクツ・グル−プ・インコ−ポレ−テツド | Aseptic double package |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011013640A1 (en) | 2009-07-31 | 2011-02-03 | マニー株式会社 | Packaging bag for medical supplies, packaging bag containing medical supplies, and method for packaging medical supplies |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH031871A (en) | 1991-01-08 |
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