JP6230575B2 - Cryopreservation bag and method for enclosing living tissue in a cryopreservation bag - Google Patents

Cryopreservation bag and method for enclosing living tissue in a cryopreservation bag Download PDF

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JP6230575B2
JP6230575B2 JP2015159110A JP2015159110A JP6230575B2 JP 6230575 B2 JP6230575 B2 JP 6230575B2 JP 2015159110 A JP2015159110 A JP 2015159110A JP 2015159110 A JP2015159110 A JP 2015159110A JP 6230575 B2 JP6230575 B2 JP 6230575B2
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bead
bag
living tissue
cryopreservation
bleed
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JP2017036076A (en
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晏夫 黒▲崎▼
晏夫 黒▲崎▼
昇 本村
昇 本村
綾 齋藤
綾 齋藤
克彦 上田
克彦 上田
公俊 佐藤
公俊 佐藤
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UEDA SEITAI CO.,LTD.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms

Description

本発明は人、動物、植物などの生体組織を凍結保存する際に使用する凍結保存用バッグと、同バッグに対する生体組織の封入方法に関する。凍結保存用バッグは、例えば２枚重ねにしたフッ素系樹脂シートを赤外線レーザービームで溶着して袋状の容器として形成する。   The present invention relates to a cryopreservation bag used when cryopreserving a living tissue such as a human being, an animal, or a plant, and a method for enclosing the living tissue in the bag. The cryopreservation bag is formed as a bag-like container by, for example, welding two fluororesin sheets stacked with an infrared laser beam.

この種の凍結保存用バッグは、例えば特許文献１に開示されている。そこでは、２枚重ねにした熱可塑性樹脂フィルムを、支持体と放熱材とで挟み込んで加圧し、放熱材の側から赤外レーザービームを両フィルムに照射して溶着ビードを形成し、袋状の凍結保存用バッグを形成している。同文献には熱可塑性樹脂フィルムとして、溶着が困難なフッ素系樹脂を用いることや、赤外レーザービームを水平面内で操作して、収容部と出入口とが一筆書き状に連続する溶着ビードを熱可塑性樹脂フィルムの接触面に形成することが開示されている。収容部および出入口は、出入口の左右幅が小さな瓶状に形成してある。   This type of cryopreservation bag is disclosed in Patent Document 1, for example. There, a thermoplastic resin film made up of two sheets is sandwiched between a support and a heat dissipation material and pressed, and both films are irradiated with an infrared laser beam from the heat dissipation material side to form a weld bead. Forming a cryopreservation bag. In this document, a fluororesin that is difficult to weld is used as a thermoplastic resin film, and an infrared laser beam is operated in a horizontal plane to heat a welding bead in which a container and an entrance are continuous in a single stroke. It is disclosed to form on the contact surface of a plastic resin film. The accommodating portion and the entrance / exit are formed in a bottle shape in which the width of the entrance / exit is small.

国際公開第２００３−０３９８４３号（１１ページ実施例１、図２１）International Publication No. 2003-039843 (page 11, Example 1, FIG. 21)

特許文献１の凍結保存用バッグにおいては、２枚重ねにしたフッ素系樹脂などの熱可塑性樹脂フィルムに赤外レーザービームを照射して、生体組織が充填される収容部と出入口を瓶状に形成している。そのため、左右幅が小さな出入口から生体組織を収容部に注入する必要があり、生体組織の注入に手間がかかり注入作業を速やかに行えない。また、生体組織を収容部に注入した後には、収容部に入り込んだ空気を脱気して封口処理を行うが、出入口に連続する収容部の肩部分に空気が留まりやすいため、脱気作業に多くの手間がかかってしまう。   In the cryopreservation bag of Patent Document 1, an infrared laser beam is applied to a thermoplastic resin film such as a two-layered fluororesin to form a container and an inlet / outlet filled with living tissue in a bottle shape. doing. For this reason, it is necessary to inject the living tissue into the accommodating portion from the entrance with a small left-right width, and it takes time to inject the living tissue, and the injecting operation cannot be performed quickly. In addition, after injecting the living tissue into the housing part, the air that has entered the housing part is deaerated to perform a sealing process, but the air tends to stay on the shoulder part of the housing part that is continuous with the entrance and exit. It takes a lot of work.

袋状に形成されるこの種の凍結保存用バッグは、収容部に生体組織を充填した状態において、収容部に臨むフィルム壁が外膨らみ状に変形して、収容部の横断面形状が凸レンズ状になる。そのため、生体組織が充填された凍結保存用バッグを凍結させるとき、収容部の周縁付近の生体組織は凍結しやすいものの、収容部の中央付近の生体組織は凍結しにくく、収容部における凍結の進行状況にばらつきがあり、全ての生体組織を凍結させるのに多くの時間がかかってしまう。   This type of cryopreservation bag formed in a bag shape has a convex lens-like cross-sectional shape in which the film wall facing the housing portion is deformed into an outwardly bulging shape in a state where the housing portion is filled with living tissue. become. Therefore, when freezing a cryopreservation bag filled with living tissue, the living tissue near the periphery of the housing portion is likely to freeze, but the living tissue near the center of the housing portion is difficult to freeze, and the freezing progress in the housing portion The situation varies and it takes a lot of time to freeze all living tissues.

本発明の目的は、凍結保存用バッグの構造を改良して生体組織の注入作業と、収容部に入り込んだ空気の脱気作業を楽にしかも速やかに行える凍結保存用バッグと、凍結保存用バッグに対する生体組織の封入方法を提供することにある。
本発明の目的は、収容部における凍結の進行状況を概ね均等化でき、さらに生体組織をより短い時間で凍結させることができる凍結保存用バッグを提供することにある。 An object of the present invention is to provide a cryopreservation bag and a cryopreservation bag in which the structure of the cryopreservation bag is improved so that the operation of injecting a living tissue and the deaeration of the air that has entered the container can be performed easily and quickly. The object is to provide a method for enclosing biological tissue.
An object of the present invention is to provide a cryopreservation bag that can substantially equalize the progress of freezing in a storage section and that can freeze a living tissue in a shorter time.

本発明に係る凍結保存用バッグは、２枚重ねにしたフッ素系樹脂シートＳ１・Ｓ２に赤外線レーザービームを照射して、両シートＳ１・Ｓ２の界面に形成された外郭線ビード１で、生体組織を収容する収容部２が区画されており、収容部２の一端に、収容部２に連続する通気口３と、通気口３より広幅の抽気部４が形成され、収容部２の他端に、生体組織を収容部２に充填する充填口９が形成されている。そして、充填口９が開口され、抽気部４の端部寄りが第１シールビード５で封止され、充填口９を介して収容部２内に生体組織を充填することができる第１形態と、充填口９が第２シールビード１８で封止され、第１シールビード５に沿ってバッグ壁１９が分離除去されることで抽気部４の端部寄りに抽気開口２０が形成され、収納部２内に生体組織を充填したのちに抽気開口２０を介して収納部２内に残留する空気を放出することができる第２形態と、充填口９が第２シールビード１８で封止され、抽気部４が第３シールビード２２で封止され、収納部２内に生体組織が封入される第３形態の、計３個の形態を採ることができるように構成されていることを特徴とする。 The cryopreservation bag according to the present invention irradiates two layers of fluororesin sheets S1 and S2 with an infrared laser beam to form an outer bead 1 formed at the interface between both sheets S1 and S2, and It is compartment housing 2 for accommodating the at one end of the housing 2, and the vent 3 continuous to the accommodating portion 2, wide bleed portion 4 is formed from vents 3, the other end of the housing 2 In addition, a filling port 9 for filling the accommodating portion 2 with a living tissue is formed. Then, the filling port 9 is opened, the end portion of the bleed portion 4 is sealed with the first seal bead 5, and the living tissue can be filled into the accommodating portion 2 through the filling port 9. The filling port 9 is sealed with the second seal bead 18, and the bag wall 19 is separated and removed along the first seal bead 5, so that a bleed opening 20 is formed near the end of the bleed portion 4, and the storage portion 2 and the filling port 9 is sealed with a second seal bead 18 so that air remaining in the storage portion 2 can be released through the extraction opening 20 after the living tissue is filled in the extraction opening 20. The part 4 is sealed with a third seal bead 22 and is configured to be able to take a total of three forms, a third form in which a living tissue is enclosed in the storage part 2. .

収容部２を区画する外郭線ビード１は、左右一対の左ビード部６および右ビード部７を備えている。左右の両ビード部６・７を、四角形状に形成したフッ素系樹脂シートＳ１・Ｓ２のひとつの辺部と交差させて、左右の両ビード部６・７の間に充填口９を開口する。   The outer bead 1 that divides the housing portion 2 includes a pair of left and right left bead portions 6 and a right bead portion 7. The left and right bead portions 6 and 7 are made to intersect with one side portion of the fluororesin sheets S1 and S2 formed in a square shape, and a filling port 9 is opened between the left and right bead portions 6 and 7.

通気口３の左右幅をＢ１とし、抽気部４の左右幅をＢ２とし、収容部２の左右幅をＢ３とするとき、各部の左右幅が不等式（Ｂ１＜Ｂ２＜Ｂ３）を満足するように設定する。   When the left-right width of the vent 3 is B1, the left-right width of the extraction part 4 is B2, and the left-right width of the storage part 2 is B3, the left-right width of each part satisfies the inequality (B1 <B2 <B3). Set.

収容部２が、平行に形成される左右一対の左ビード部６および右ビード部７と、これら両ビード部６・７から通気口３へ向かって先すぼまり状に傾く肩ビード部８で区画する。   The accommodating portion 2 is composed of a pair of left and right left bead portions 6 and 7 formed in parallel, and a shoulder bead portion 8 inclined in a tapered shape from both the bead portions 6 and 7 toward the vent hole 3. Partition.

抽気部４と、通気口３と、収容部２の左右両側にラベルＬを収容するラベルポケット１５を形成する。   A label pocket 15 for accommodating the label L is formed on both the left and right sides of the bleed portion 4, the vent 3, and the accommodating portion 2.

収容部２において対向するフッ素系樹脂シートＳ１・Ｓ２どうしを、規制ビード２４で一体化する。収容部２に生体組織が充填された状態において、収容部２の周囲壁が外膨らみ状に変形するのを規制ビード２４で規制する。   The fluororesin sheets S <b> 1 and S <b> 2 that are opposed to each other in the housing portion 2 are integrated with a regulation bead 24. In the state where the housing portion 2 is filled with the living tissue, the restriction bead 24 restricts the peripheral wall of the housing portion 2 from being deformed outwardly.

規制ビード２４は、収容部２の周囲壁の中央に形成する。   The regulation bead 24 is formed at the center of the peripheral wall of the housing portion 2.

本発明に係る生体組織の封入方法では、収容部２の一端に、収容部２に連続する通気口３と、通気口３より広幅の抽気部４とが形成されて、抽気部４の端部寄りが第１シールビード５で封止されており、収容部２の他端に、生体組織を収容部２に充填するための充填口９が開口してある凍結保存用バッグに対して、以下の手順で生体組織を封入する。
生体組織を充填口９から収容部２に充填する第１手順と、
生体組織が充填された凍結保存用バッグの充填口９を第２シールビード１８で封止する第２手順と、
第１シールビード５に沿ってバッグ壁を切断して、第１シールビード５を含むバッグ壁１９を分離し、抽気部４の端部寄りに抽気開口２０を形成する第３手順と、
凍結保存用バッグを抽気開口２０が上になる状態で起立させて、収容部２内の生体組織を通気口３から抽気部４へ押し出しながら、バッグ内の空気を抽気開口２０から放出する第４手順と、
少なくとも抽気部４のバッグ壁を密着させて仮封止部２１を形成し、仮封止部２１を第３シールビード２２で封止する第５手順を経て生体組織を封入する。 In the method for enclosing biological tissue according to the present invention, a vent 3 continuous to the accommodating portion 2 and a bleed portion 4 wider than the vent 3 are formed at one end of the accommodating portion 2. For the cryopreservation bag in which the side is sealed with the first seal bead 5 and the filling port 9 for filling the living body tissue into the housing part 2 is opened at the other end of the housing part 2. The biological tissue is encapsulated by the procedure of
A first procedure for filling the accommodating portion 2 with the biological tissue from the filling port 9;
A second procedure of sealing the filling port 9 of the cryopreservation bag filled with the biological tissue with the second seal bead 18;
Cutting the bag wall along the first seal bead 5 to separate the bag wall 19 including the first seal bead 5 and forming a bleed opening 20 near the end of the bleed portion 4;
The cryopreservation bag is erected with the bleed opening 20 facing upward, and the living tissue in the storage part 2 is pushed out from the vent 3 to the bleed part 4 and the air in the bag is released from the bleed opening 20. Procedure and
At least the bag wall of the extraction unit 4 is brought into close contact with each other to form the temporary sealing unit 21, and the biological tissue is sealed through the fifth procedure of sealing the temporary sealing unit 21 with the third seal bead 22.

本発明に係る凍結保存用バッグにおいては、２枚重ねにしたフッ素系樹脂シートＳ１・Ｓ２の界面に外郭線ビード１を形成して、生体組織を収容する収容部２を形成した。また、収容部２の一端に通気口３と、通気口３より広幅の抽気部４を形成し、抽気部４の端部寄りを第１シールビード５で封止した。さらに、収容部２の他端に、生体組織を収容部２に充填する充填口９を開口した。こうした凍結保存用バッグによれば、広幅の充填口９を大きく開口した状態で生体組織を充填できる。従って、収容部と出入口が瓶状に形成してあって、左右幅が小さな出入口から生体組織を収容部に注入する必要があった従来の凍結保存用バッグに比べて、生体組織の収容部２への充填や注入を、簡便にしかも速やかに行うことができる。また、収容部２内の生体組織を通気口３から広幅の抽気部４へ押し出して液位を上げ、さらに抽気部４のバッグ壁を密着させながら空気を抽気開口２０から放出することができるので、収容部２に入り込んだ空気の脱気作業を楽にしかも速やかに行うことができる。さらに、通気口３より広幅の抽気部４において脱気作業を行うので、通気口３を通過した生体組織が、抽気部４において液位が急激に上昇するのを防止できるので、脱気作業時に生体組織が抽気開口２０から誤って放出されるのをよく防止できる。   In the cryopreservation bag according to the present invention, the outer shell bead 1 is formed on the interface between the two fluorine resin sheets S1 and S2 to form the accommodating portion 2 that accommodates the living tissue. In addition, a vent 3 and a bleed portion 4 wider than the vent 3 were formed at one end of the accommodating portion 2, and the end portion of the bleed portion 4 was sealed with a first seal bead 5. Furthermore, a filling port 9 for filling the housing portion 2 with biological tissue was opened at the other end of the housing portion 2. According to such a cryopreservation bag, it is possible to fill a living tissue with the wide filling port 9 opened widely. Therefore, compared with the conventional cryopreservation bag in which the storage portion and the entrance / exit are formed in a bottle shape, and it is necessary to inject the biological tissue into the storage portion from the entrance / exit having a small lateral width, the storage portion 2 for living tissue The filling and injection into the can be performed easily and quickly. In addition, the living tissue in the housing portion 2 can be pushed out from the vent 3 to the wide bleed portion 4 to raise the liquid level, and air can be discharged from the bleed opening 20 while the bag wall of the bleed portion 4 is closely attached. The deaeration work of the air that has entered the housing part 2 can be performed easily and quickly. Furthermore, since the deaeration operation is performed in the bleed portion 4 wider than the vent 3, the living tissue that has passed through the vent 3 can be prevented from rapidly rising in the bleed portion 4. It is possible to well prevent the biological tissue from being accidentally released from the extraction opening 20.

左右一対のビード部６・７を含んで外郭線ビード１を形成し、前記両ビード部６・７をフッ素系樹脂シートＳ１・Ｓ２のひとつの辺部と交差させるようにすると、左右の両ビード部６・７を形成するだけで両者の間に充填口９を形成することができる。従って、赤外線レーザービームを照射して凍結保存用バッグを形成する際の手間を軽減して、凍結保存用バッグの製造コストを削減できる。また、充填口９が開口する側の辺部は、生体組織を収容部２に収容したのち第２シールビーム１８で封止するが、このとき第２シールビーム１８を直線状の辺部に沿って形成すればよいので、第２シールビーム１８による封止構造を簡素化できるうえ、封止機能を安定した状態で発揮させることができる。   When the outer bead 1 is formed including a pair of left and right bead portions 6 and 7 and the bead portions 6 and 7 are made to intersect with one side portion of the fluororesin sheets S1 and S2, the left and right bead portions The filling port 9 can be formed between them only by forming the portions 6 and 7. Therefore, it is possible to reduce the labor for forming the cryopreservation bag by irradiating the infrared laser beam, and to reduce the manufacturing cost of the cryopreservation bag. Further, the side portion on the side where the filling port 9 is opened is sealed with the second seal beam 18 after the living tissue is accommodated in the accommodating portion 2. At this time, the second seal beam 18 is aligned along the linear side portion. Therefore, the sealing structure by the second seal beam 18 can be simplified and the sealing function can be exhibited in a stable state.

通気口３の左右幅Ｂ１と、抽気部４の左右幅Ｂ２と、収容部２の左右幅Ｂ３が不等式（Ｂ１＜Ｂ２＜Ｂ３）を満足するように設定してあると、生体組織の収容部２への充填や注入を簡便に行いながら、収容部２に入り込んだ空気の脱気作業を楽にしかも的確に行うことができる。従って、生体組織の凍結保存用バッグに対する充填および封入から、冷凍保存に至る一連の作業を、病院の臨床現場や試験研究現場などにおいて誰でもが確実に行える。   When the left and right width B1 of the ventilation port 3, the left and right width B2 of the bleed portion 4, and the left and right width B3 of the storage portion 2 are set so as to satisfy the inequality (B1 <B2 <B3), the living tissue storage portion It is possible to easily and accurately perform the deaeration work of the air that has entered the housing portion 2 while performing easy filling and injection into the housing 2. Therefore, anyone can reliably perform a series of operations from filling and enclosing a living tissue into a cryopreservation bag to cryopreservation at a clinical site or a test research site in a hospital.

左右一対のビード部６・７と、これら両ビード部６・７から通気口３へ向かって先すぼまり状に傾く肩ビード部８で収容部２を区画すると、脱気作業に際して抽気部４が上になる状態で凍結保存用バッグを起立保持した状態において、生体組織に含まれている空気の泡を、肩ビード部８で案内して通気口３から抽気部４へ浮上させることができる。従って、収容部２に入り込んだ空気の脱気作業をさらに円滑に行って、脱気作業に要する手間と時間を軽減することができる。また、空気の泡が収容部２内の生体組織に残存するのを防止できるので、液体窒素から取出した状態において、空気の泡の残存に伴う凍結保存用バッグの膨張変形や破裂をよく防止できる。   When the accommodating portion 2 is partitioned by a pair of left and right bead portions 6 and 7 and a shoulder bead portion 8 inclined in a tapered shape from both the bead portions 6 and 7 toward the vent 3, the bleed portion 4 is degassed. In the state where the cryopreservation bag is erected and held in a state where the airflow is up, air bubbles contained in the living tissue can be guided by the shoulder bead portion 8 and floated from the vent 3 to the extraction portion 4. . Therefore, the deaeration work of the air that has entered the storage unit 2 can be performed more smoothly, and the labor and time required for the deaeration work can be reduced. Further, since it is possible to prevent air bubbles from remaining in the living tissue in the storage unit 2, it is possible to well prevent expansion deformation and rupture of the cryopreservation bag due to the remaining air bubbles in the state of being taken out from liquid nitrogen. .

抽気部４、通気口３、収容部２の左右両側にラベルポケット１５が形成してあると、生体組織の管理番号や封入処理の日付などが記入されたラベルＬをラベルポケット１５に収容することにより、凍結保存用バッグの管理を正確に、しかもミスなく行うことができる。従って、凍結保存用バッグの勘違い等による取違いが生じるのを防止して、検査ミスや判断ミスなどの重大な医療過誤を引起こす事故を確実に防止できる。また、ラベルＬをラベルポケット１５に収容するので、凍結保存用バッグの取扱い時にラベルＬが汚損され、あるいは紛失するのを一掃して、長期にわたる凍結保存用バッグの管理を的確に行うことができる。   When label pockets 15 are formed on both the left and right sides of the bleeder 4, the vent 3, and the housing 2, the label L in which the management number of the living tissue, the date of the sealing process, and the like are entered is accommodated in the label pocket 15. Thus, the cryopreservation bag can be managed accurately and without mistakes. Therefore, it is possible to prevent occurrence of a mistake due to misunderstanding of the cryopreservation bag and to surely prevent an accident that causes a serious medical error such as an inspection error or a determination error. Further, since the label L is accommodated in the label pocket 15, it is possible to clean up the cryopreservation bag over a long period of time by eliminating the contamination or loss of the label L when handling the cryopreservation bag. .

フッ素系樹脂シートＳ１・Ｓ２どうしを規制ビード２４で一体化すると、収容部２に生体組織が充填された状態において、収容部２の周囲壁が外膨らみ状に変形するのを規制ビード２４で規制できる。こうした凍結保存用バッグによれば、生体組織が充填され封口処理が施された凍結保存用バッグを凍結させるとき、外郭線ビード１の付近の生体組織が凍結するのに並行して、規制ビード２４の近傍の生体組織をも同時に凍結させることができる。また、生体組織が充填された凍結保存用バッグの前後厚みが大きくなるのを規制ビード２４で規制して、収容部２に収容された生体組織を速やかに凍結させることができる。従って、従来の凍結保存用バッグに比べて、収容部２の内部における凍結の進行状況を概ね均等化して、収容部２に充填された生体組織をより短い時間で凍結することができる。   When the fluororesin sheets S1 and S2 are integrated with the regulation bead 24, the regulation bead 24 regulates deformation of the peripheral wall of the housing part 2 into an outwardly bulging shape when the living body tissue is filled in the housing part 2. it can. According to such a cryopreservation bag, when the cryopreservation bag filled with the biological tissue and subjected to the sealing process is frozen, the biological bead in the vicinity of the contour bead 1 is frozen in parallel with the regulation bead 24. Can also be frozen at the same time. In addition, it is possible to quickly freeze the living tissue housed in the housing portion 2 by restricting the thickness of the cryopreservation bag filled with the living tissue by the restriction bead 24. Therefore, as compared with the conventional cryopreservation bag, the progress of freezing in the interior of the storage unit 2 can be substantially equalized, and the living tissue filled in the storage unit 2 can be frozen in a shorter time.

収容部２の周囲壁の中央に規制ビード２４を形成すると、他の部位に規制ビード２４が形成してある場合に比べて、生体組織が充填された凍結保存用バッグの前後厚みをより小さくすることができる。従って、収容部２の内部における凍結の進行状況をさらに均等化して、収容部２に充填された生体組織をさらに短時間で凍結することができる。   When the regulation bead 24 is formed at the center of the peripheral wall of the housing portion 2, the thickness of the cryopreservation bag filled with the biological tissue is made smaller than that in the case where the regulation bead 24 is formed in another part. be able to. Therefore, it is possible to further equalize the progress of freezing in the interior of the storage unit 2 and freeze the living tissue filled in the storage unit 2 in a shorter time.

本発明に係る生体組織の封入方法によれば、生体組織の収容部２への充填や注入を簡便に行いながら、収容部２に入り込んだ空気の脱気作業を楽にしかも的確に行うことができる。従って、生体組織の凍結保存用バッグに対する充填および封入から、冷凍保存に至る一連の作業を、病院の臨床現場や試験研究現場などにおいて誰でもが確実に行える。   According to the method for enclosing biological tissue according to the present invention, it is possible to easily and accurately perform the deaeration operation of the air that has entered the storage unit 2 while easily filling and injecting the biological tissue into the storage unit 2. . Therefore, anyone can reliably perform a series of operations from filling and enclosing a living tissue into a cryopreservation bag to cryopreservation at a clinical site or a test research site in a hospital.

本発明に係る凍結保存用バッグの正面図である。It is a front view of the bag for cryopreservation concerning the present invention. 凍結保存用バッグに対する生体組織の充填状況を示す斜視図および縦断面図である。It is the perspective view and longitudinal cross-sectional view which show the filling condition of the biological tissue with respect to the bag for cryopreservation. 凍結保存用バッグの１次封口処理を示す正面図および縦断面図である。It is the front view and longitudinal cross-sectional view which show the primary sealing process of the bag for cryopreservation. 凍結保存用バッグの切断処理を示す正面図および縦断面図である。It is the front view and longitudinal cross-sectional view which show the cutting process of the bag for cryopreservation. 凍結保存用バッグの２次封口処理を示す正面図および縦断面図である。It is the front view and longitudinal cross-sectional view which show the secondary sealing process of the bag for cryopreservation. 凍結保存用バッグのラベル封入処理を示す正面図および横断面図である。It is the front view and cross-sectional view which show the label enclosure process of the bag for cryopreservation. 凍結保存用バッグの別の実施例を示す正面図である。It is a front view which shows another Example of the bag for cryopreservation. 図７におけるＡ−Ａ線断面図である。It is the sectional view on the AA line in FIG. 凍結保存用バッグにおける外郭線ビードの別の実施例を示す正面図である。It is a front view which shows another Example of the outline bead in the bag for cryopreservation. 凍結保存用バッグにおける外郭線ビードのさらに別の実施例を示す正面図である。It is a front view which shows another Example of the outline bead in the bag for cryopreservation. 簡易構造化した凍結保存用バッグの参考例を示す正面図である。It is a front view which shows the reference example of the bag for cryopreservation simplified.

図１ないし図６は、本発明に係る凍結保存用バッグの実施例を示す。凍結保存用バッグは、２枚重ねにした透明のフッ素系樹脂シートＳ１・Ｓ２に赤外線レーザービームを照射して、前記両シートＳ１・Ｓ２の界面に左右一対の外郭線ビード１を形成し、外郭線ビード１で挟まれた両シートＳ１・Ｓ２の間に生体組織を収容する収容部２と、収容部２に連続する通気口３と、通気口３に連続する抽気部４とを形成してなる。抽気部４の端部寄りは、第１シールビード５で封止されている。通気口３はバッグ壁の左右中央に形成してある。   1 to 6 show an embodiment of a cryopreservation bag according to the present invention. The cryopreservation bag is irradiated with an infrared laser beam on the two transparent fluororesin sheets S1 and S2 to form a pair of left and right outer bead lines 1 at the interface between the two sheets S1 and S2. A storage section 2 that stores the living tissue between the sheets S1 and S2 sandwiched between the wire beads 1, a vent 3 that continues to the storage 2, and a bleed section 4 that continues to the vent 3 are formed. Become. Near the end of the bleed portion 4 is sealed with a first seal bead 5. The vent 3 is formed in the left and right center of the bag wall.

フッ素系樹脂シートＳ１・Ｓ２は、完全フッ素化樹脂と、部分フッ素化樹脂と、フッ素化樹脂共重合体のいずれか一つを形成素材にして、赤外線レーザーの透過を許す透明シートとして形成してある。具体的な形成素材としては、ポリテトラフルオロエチレン（ＰＴＦＥ）、ポリクロロトリフルオロエチレン（ＰＣＴＦＥ）、ポリフッ化ビニリデン（ＰＶＤＦ）、ポリフッ化ビニル（ＰＶＦ）、ペルフルオロアルコキシフッ素系樹脂（ＰＦＡ）、四フッ化エチレン・六フッ化プロピレン共重合体（ＦＥＰ）、エチレン・四フッ化エチレン共重合体（ＥＴＦＥ）、クロロトリフルオロエチレン共重合体（ＥＣＴＦＥ）などがある。この実施例では、縦長長方形状のフッ素系樹脂シートＳ１・Ｓ２を、厚みが１００μｍの四フッ化エチレン・六フッ化プロピレン共重合体製のシートで形成して、両シートＳ１・Ｓ２に赤外線レーザービームを照射して凍結保存用バッグを形成するようにした。   The fluorine-based resin sheets S1 and S2 are formed as a transparent sheet that allows transmission of an infrared laser using any one of a fully fluorinated resin, a partially fluorinated resin, and a fluorinated resin copolymer as a forming material. is there. Specific forming materials include polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), perfluoroalkoxy fluorine-based resin (PFA), four fluorine. Ethylene / hexafluoropropylene copolymer (FEP), ethylene / tetrafluoroethylene copolymer (ETFE), chlorotrifluoroethylene copolymer (ECTFE), and the like. In this embodiment, the vertically long rectangular fluorine-based resin sheets S1 and S2 are formed of a sheet made of a tetrafluoroethylene / hexafluoropropylene copolymer having a thickness of 100 μm, and an infrared laser is applied to both sheets S1 and S2. The beam was irradiated to form a cryopreservation bag.

収容部２は、左右一対の左ビード部６および右ビード部７と、これら両ビード部６・７から通気口３へ向かって先すぼまり状に傾く肩ビード部８で区画されており、左右の両ビード部６・７の上端部はフッ素系樹脂シートＳ１・Ｓ２の短辺部と直交状に交差していて、両ビード部６・７の間に生体組織を収容部２に充填するための充填口９が開口してある。抽気部４は、左右一対の抽気左ビード部１２と抽気右ビード部１３と、これら両ビード部１２・１３から通気口３へ向かって先すぼまり状に傾く傾斜ビード部１４とで漏斗状に形成してある。抽気部４と、通気口３と、収容部２の左右両側、より詳しくは傾斜ビード部１４と通気口３を形成するビード部と肩ビード部８に臨んで、ラベルＬを収容するためのラベルポケット１５がフッ素系樹脂シートＳ１・Ｓ２の間に形成される。   The accommodating portion 2 is defined by a pair of left and right left bead portions 6 and 7 and a shoulder bead portion 8 inclined in a tapered shape from both the bead portions 6 and 7 toward the vent hole 3. The upper end portions of the left and right bead portions 6 and 7 intersect the short side portions of the fluororesin sheets S1 and S2 in an orthogonal manner, and the living tissue is filled between the bead portions 6 and 7 in the accommodating portion 2. A filling port 9 is opened. The bleeder 4 includes a pair of left and right bleed left bead 12, bleed right bead 13, and an inclined bead 14 inclined in a tapered shape from both the beads 12, 13 toward the vent 3. Is formed. A label for accommodating the label L facing the bleeder 4, the vent 3 and the left and right sides of the accommodating part 2, more specifically the bead part and the shoulder bead part 8 forming the inclined bead part 14 and the vent 3 The pocket 15 is formed between the fluorine resin sheets S1 and S2.

図１に示すように、通気口３の左右幅をＢ１とし、抽気部４の左右幅をＢ２とし、収容部２の左右幅をＢ３とするとき、各部の左右幅は不等式（Ｂ１＜Ｂ２＜Ｂ３）を満足するように設定してある。具体的には、フッ素系樹脂シートＳ１・Ｓ２の短辺部の長さを１１６ｍｍとするとき、Ｂ１は２０ｍｍ、Ｂ２は７０ｍｍ、Ｂ３は１００ｍｍとした。このように、抽気部４は通気口３より広幅に形成され、収容部２および充填口９は通気口３よりさらに広幅に形成してある。   As shown in FIG. 1, when the left-right width of the vent 3 is B1, the left-right width of the extraction part 4 is B2, and the left-right width of the housing part 2 is B3, the left-right width of each part is inequality (B1 <B2 < B3) is set to be satisfied. Specifically, when the length of the short side portion of the fluororesin sheets S1 and S2 is 116 mm, B1 is 20 mm, B2 is 70 mm, and B3 is 100 mm. In this way, the extraction part 4 is formed wider than the vent 3, and the accommodating part 2 and the filling port 9 are formed wider than the vent 3.

以上のように構成した凍結保存用バッグは、血液などの生体組織を収容部２に充填し封止したのち、液体窒素に浸漬して凍結保存するが、凍結保存用バッグに対する生体組織の封入は以下の手順に従って行う。
まず、図２（ａ）に示すように、充填口９を開口した状態で、生体組織を充填口９から収容部２に充填する（第１手順）。このとき、収容部２と同じ幅の充填口９を大きく開口した状態で生体組織を充填できるので、生体組織の収容部２への充填や注入を、簡便にしかも速やかに行うことができる。次に、収容部２内の空気を押し出しながら、充填口９側のバッグ壁を密着させて、図３に示すように生体組織が充填された凍結保存用バッグの充填口９を第２シールビード１８で封止する（第２手順）。この状態の収容部２には、僅かに空気が含まれていることが多く、この空気を放出するために、図４に示すように第１シールビード５に沿ってバッグ壁を切断して、第１シールビード５を含むバッグ壁１９を分離除去し、抽気部４の端部寄りに抽気開口２０を形成する（第３手順）。 The cryopreservation bag configured as described above is filled with and sealed with a biological tissue such as blood, and then immersed in liquid nitrogen for cryopreservation. Follow the steps below.
First, as shown in FIG. 2A, with the filling port 9 opened, the living tissue is filled into the accommodating portion 2 from the filling port 9 (first procedure). At this time, since the living tissue can be filled with the filling port 9 having the same width as that of the accommodating portion 2 being opened, filling and injection of the living tissue into the accommodating portion 2 can be performed easily and quickly. Next, the bag wall on the side of the filling port 9 is brought into close contact with the air inside the housing portion 2 while pushing out the air in the housing portion 2, and the filling port 9 of the cryopreservation bag filled with the living tissue as shown in FIG. 18 is sealed (second procedure). The container 2 in this state often contains a little air, and in order to release this air, the bag wall is cut along the first seal bead 5 as shown in FIG. The bag wall 19 including the first seal bead 5 is separated and removed, and the extraction opening 20 is formed near the end of the extraction unit 4 (third procedure).

抽気開口２０が形成された凍結保存用バッグを、図４（ａ）に示すように抽気部４が上、収容部２が下になる状態にして、図示していないスタンドで起立保持する。次に、収容部２内の生体組織を通気口３から抽気部４へ押し出して液位を上げ、さらに抽気部４のバッグ壁を密着させながら空気を抽気開口２０から放出する（第４手順）。このとき、凍結保存用バッグをスタンドで起立保持することにより、生体組織に含まれている空気の泡を、肩ビード部８で案内して通気口３から抽気部４へ浮上させることができる。また、広幅の抽気部４のバッグ壁を密着させながら空気を抽気開口２０から放出することにより抽気部４内の空気の全てを確実に排出できる。さらに、抽気部４から収容部２の上部に至る間のバッグ壁を密着させて仮封止部２１を形成することができる。この状態で、図５（ａ）に示すように仮封止部２１を第３シールビード２２で封止する（第５手順）ことにより、生体組織のみを収容部２内に封入することができる。この実施例では、仮封止部２１のうち、肩ビード部８の上部を左右に横断する状態で第３シールビード２２を形成した。   The cryopreservation bag in which the bleed opening 20 is formed is held upright by a stand (not shown) in a state where the bleed portion 4 is at the top and the storage portion 2 is at the bottom as shown in FIG. Next, the living tissue in the storage unit 2 is pushed out from the vent 3 to the extraction unit 4 to raise the liquid level, and further, air is released from the extraction opening 20 while closely contacting the bag wall of the extraction unit 4 (fourth procedure). . At this time, by holding the cryopreservation bag upright on the stand, air bubbles contained in the living tissue can be guided by the shoulder bead portion 8 and floated from the vent 3 to the extraction portion 4. Moreover, all the air in the extraction part 4 can be reliably discharged | emitted by discharge | releasing air from the extraction opening 20, making the bag wall of the wide extraction part 4 contact | adhere. Further, the temporary sealing portion 21 can be formed by closely contacting the bag wall between the extraction portion 4 and the upper portion of the housing portion 2. In this state, as shown in FIG. 5A, the temporary sealing portion 21 is sealed with the third seal bead 22 (fifth procedure), whereby only the living tissue can be sealed in the accommodating portion 2. . In this embodiment, the third seal bead 22 is formed so as to cross the upper portion of the shoulder bead portion 8 left and right in the temporary sealing portion 21.

上記のようにして生体組織が封入された凍結保存用バッグには、生体組織の管理番号や封入処理の日付などを記入して凍結保存する。しかし、撥水性および撥油性に優れたフッ素系樹脂シートＳ１・Ｓ２は、たとえ油性のマーカーであってもシート表面に文字や記号を記入することはできない。こうした不便を解消するために、生体組織の管理番号や封入処理の日付などをラベルＬに記入し、このラベルＬを左右いずれか一方のラベルポケット１５に封入している。この実施例では、図６に示すように、ラベルポケット１５を横断する第３シールビード２２に沿って、抽気左ビード部１３側のラベルポケット１５にラベルＬを配置し、一対のフッ素系樹脂シートＳ１・Ｓ２の間にラベルＬを配置した。さらに、抽気左ビード部１３と平行で、第３シールビード２２と交差する閉止ビード部２３を形成して、ラベルＬを分離不能に封入した。封入されたラベルＬの表示は、透明のフッ素系樹脂シートＳ１（またはＳ２）を介して明確に視認することができる。   In the cryopreservation bag in which the living tissue is sealed as described above, the management number of the living tissue, the date of the sealing process, etc. are entered and stored frozen. However, the fluororesin sheets S1 and S2 having excellent water repellency and oil repellency cannot be written with characters or symbols on the sheet surface even if they are oily markers. In order to eliminate such inconvenience, the management number of the living tissue, the date of the sealing process, and the like are entered in the label L, and the label L is sealed in either the left or right label pocket 15. In this embodiment, as shown in FIG. 6, a label L is disposed in the label pocket 15 on the extraction left bead portion 13 side along the third seal bead 22 crossing the label pocket 15, and a pair of fluorine resin sheets A label L is arranged between S1 and S2. Further, a closed bead portion 23 that is parallel to the bleed left bead portion 13 and intersects with the third seal bead 22 is formed, and the label L is enclosed in an inseparable manner. The display of the enclosed label L can be clearly visually recognized through the transparent fluororesin sheet S1 (or S2).

以上のように構成した凍結保存用バッグによれば、広幅の充填口９を大きく開口した状態で生体組織を充填できるので、生体組織の収容部２への充填や注入を、簡便にしかも速やかに行うことができる。また、収容部２内の生体組織を通気口３から広幅の抽気部４へ押し出して液位を上げ、さらに抽気部４のバッグ壁を密着させながら空気を抽気開口２０から放出することができるので、収容部２に入り込んだ空気の脱気作業を楽にしかも速やかに行うことができる。   According to the cryopreservation bag configured as described above, since the living tissue can be filled with the wide filling port 9 opened widely, the filling and injection of the living tissue into the container 2 can be performed easily and quickly. It can be carried out. In addition, the living tissue in the housing portion 2 can be pushed out from the vent 3 to the wide bleed portion 4 to raise the liquid level, and air can be discharged from the bleed opening 20 while the bag wall of the bleed portion 4 is closely attached. The deaeration work of the air that has entered the housing part 2 can be performed easily and quickly.

図７および図８は、凍結保存用バッグの別の実施例を示す。上記の凍結保存用バッグにおいては、収容部２に生体組織を充填すると、図８に想像線で示すように、収容部２の中央部の周囲壁が外膨らみ状に変形してしまう。こうした収容部２の周囲壁の変形を規制するために、収容部２において対向するフッ素系樹脂シートＳ１・Ｓ２どうしを、規制ビード２４で一体化した。詳しくは、収容部２の周囲壁の中央に規制ビード２４を縦長直線状に形成して、収容部２の周囲壁が充填された生体組織によって外膨らみ状に変形するのを規制している。外郭線ビード１と規制ビード２４は、どちらが先に形成してあってもよい。   7 and 8 show another embodiment of a cryopreservation bag. In the above-described cryopreservation bag, when the housing part 2 is filled with a living tissue, the peripheral wall of the central part of the housing part 2 is deformed into an outward bulge as shown by an imaginary line in FIG. In order to regulate such deformation of the surrounding wall of the housing portion 2, the fluororesin sheets S <b> 1 and S <b> 2 facing each other in the housing portion 2 are integrated with a regulation bead 24. More specifically, a regulating bead 24 is formed in a vertically long straight shape at the center of the peripheral wall of the housing portion 2 to restrict deformation to an outward bulging shape by a living tissue filled with the peripheral wall of the housing portion 2. Either the outer bead 1 or the regulation bead 24 may be formed first.

上記のように、規制ビード２４を備えた凍結保存用バッグによれば、生体組織が充填された状態の収容部２は、その周囲壁の中央部分が規制ビード２４で一体化されているので、外膨らみ状に変形することができず、図８に示すように、規制ビード２４の左右の周囲壁が薄い凸レンズ状に変形する。この状態の規制ビード２４の左右の収容部２における厚みは、想像線で示すように規制ビード２４が設けられていない場合の収容部２における厚みに比べて充分に小さくできる。また、生体組織が充填された凍結保存用バッグを凍結させるとき、収容部２の周縁の左右ビード部６・７、および肩ビード部８の付近の生体組織が凍結するのに並行して、規制ビード２４の近傍の生体組織をも同時に凍結させることができる。また、厚みが小さい分だけ、規制ビード２４の左右の周囲壁の間に保持された生体組織を速やかに凍結させることができる。従って、従来の凍結保存用バッグに比べて、収容部２の内部における凍結の進行状況を概ね均等化して、収容部２に充填された生体組織をより短い時間で凍結させることができる。   As described above, according to the cryopreservation bag provided with the regulation bead 24, the housing part 2 in the state filled with the biological tissue is integrated with the regulation bead 24 at the central portion of the peripheral wall thereof. As shown in FIG. 8, the right and left peripheral walls of the regulation bead 24 are deformed into a thin convex lens shape. In this state, the thickness of the right and left accommodating portions 2 of the regulating beads 24 can be made sufficiently smaller than the thickness of the accommodating portion 2 when the regulating beads 24 are not provided, as indicated by the imaginary lines. Further, when freezing the cryopreservation bag filled with the living tissue, the right and left bead portions 6 and 7 on the periphery of the storage portion 2 and the living tissue in the vicinity of the shoulder bead portion 8 are frozen in parallel. The living tissue near the bead 24 can also be frozen at the same time. Further, the living tissue held between the left and right peripheral walls of the regulation bead 24 can be quickly frozen by the small thickness. Therefore, as compared with the conventional cryopreservation bag, the progress of freezing in the interior of the storage unit 2 can be substantially equalized, and the living tissue filled in the storage unit 2 can be frozen in a shorter time.

図９および図１０はそれぞれ凍結保存用バッグのさらに別の実施例を示す。図９に示す凍結保存用バッグにおいては、左ビード部６および右ビード部７を下すぼまり状のなだらかな湾曲線状に形成して、収容部２と通気口３と抽気部４をビアグラスの外郭線状に形成した。また、図１０に示す凍結保存用バッグにおいては、左ビード部６および右ビード部７を外突湾曲線状に形成して、収容部２と通気口３と抽気部４をワイングラスの外郭線状に形成した。このように、収容部２と通気口３と抽気部４を滑らかに連続させると、凍結保存用バッグをスタンドで起立保持した状態において、収容部２に含まれていた空気の泡を通気口３から抽気部４へ円滑に案内浮上させて、抽気開口２０から確実に放出することができる。図１０における充填口９の左右幅は、収容部２の最大左右幅より僅かに小さいが、抽気部４の左右幅よりは充分に大きく、従って、充填口９を大きく開口した状態で生体組織を充填できる。従って、図１で説明した凍結保存用バッグと同様に、生体組織の収容部２への充填や注入を簡便にしかも速やかに行うことができる。   9 and 10 each show still another embodiment of a cryopreservation bag. In the cryopreservation bag shown in FIG. 9, the left bead portion 6 and the right bead portion 7 are formed in a slender, gently curved line, and the storage portion 2, the vent 3, and the extraction portion 4 are made of beer glass. It was formed in a contour line shape. Further, in the cryopreservation bag shown in FIG. 10, the left bead portion 6 and the right bead portion 7 are formed in an outwardly curved line shape, and the container portion 2, the vent hole 3, and the bleed portion 4 are surrounded by the outline of the wine glass. Formed. Thus, when the accommodating part 2, the vent hole 3, and the bleed part 4 are smoothly continued, the air bubbles contained in the accommodating part 2 are removed from the vent hole 3 in a state where the cryopreservation bag is held upright by the stand. The air can be smoothly guided and floated from the bleeder portion 4 to be discharged from the bleeder opening 20 with certainty. The left and right width of the filling port 9 in FIG. 10 is slightly smaller than the maximum left and right width of the housing portion 2, but is sufficiently larger than the left and right width of the extraction portion 4. Can be filled. Therefore, similarly to the cryopreservation bag described with reference to FIG. 1, filling and injection of the living tissue into the container 2 can be performed easily and quickly.

図１１は簡易構造化した凍結保存用バッグの参考例を示す。図１１（ａ）においては、外郭線ビード１を左ビード部６と右ビード部７と、これら両者６・７の下端同士を繋ぐ底ビード部３０を一筆書き状に連続させて逆門形に形成した。また、図１１（ｂ）においては、外郭線ビード１を左ビード部６と右ビード部７と、これら両者６・７の下端同士を繋ぐ下突湾曲状の底ビード部３０を一筆書き状に連続させてＵ字状に形成した。さらに、図１１（ｃ）においては、左ビード部６および右ビード部７を外突湾曲線状に形成し、これら両者６・７の下端同士を繋ぐ下突湾曲状の底ビード部３０を一筆書き状に連続させて、徳利状に形成した。また、収容部２に連続して通気口３と抽気部４を設けるようにした。これらの凍結保存用バッグにおいては、いずれもフッ素系樹脂シートＳ１・Ｓ２の上縁の充填口９から生体組織を収容部２に充填したのち、収容部２内の生体組織の液位を充填口９側へ上げ、バッグ壁を密着させながら空気を充填口９から放出したのち、第３シールビード２２で封止する。 FIG. 11 shows a reference example of a cryopreservation bag having a simplified structure. In FIG. 11 (a), the outer bead 1 has a left bead portion 6 and a right bead portion 7, and a bottom bead portion 30 that connects the lower ends of both the spheres 6 and 7 is formed in a reverse gate shape in a continuous manner. Formed. In FIG. 11 (b), the outer bead 1 has a left bead portion 6 and a right bead portion 7, and a bottom bead portion 30 having a curved lower end connecting the lower ends of the both 6 and 7 in a single stroke. Continuously formed into a U-shape. Further, in FIG. 11 (c), the left bead portion 6 and the right bead portion 7 are formed in an outwardly curved line shape, and the bottom bead-shaped bottom bead portion 30 that connects the lower ends of the both 6 and 7 is drawn with one stroke. It was formed into a virtue certificate in succession to the letter. In addition, the vent 3 and the bleed portion 4 are provided continuously to the housing portion 2. In these cryopreservation bags, the living tissue is filled into the housing portion 2 from the filling port 9 on the upper edge of the fluororesin sheets S1 and S2, and then the liquid level of the living tissue in the housing portion 2 is filled. The air is discharged from the filling port 9 while the bag wall is brought into close contact with the bag 9 and then sealed with the third seal bead 22.

収容部２の外郭形状は四角形状である必要はなく、円形、楕円形、四角形以外の多角形、ハート形など必要に応じて任意の形状から選定することができるが、単純な形状であることが好ましい。生体組織の封入方法に適用される凍結保存用バッグに関しては、２枚重ねにしたフッ素系樹脂シートＳ１・Ｓ２に赤外線レーザービームを照射して形成した凍結保存用バッグに限定するものではなく、フッ素系樹脂シート以外の樹脂シートで形成した凍結保存用バッグにも等しく適用できる。   The outer shape of the accommodating portion 2 does not need to be a square shape, but can be selected from any shape such as a circle, an ellipse, a polygon other than a rectangle, a heart shape, etc., as long as it is simple. Is preferred. The cryopreservation bag applied to the biological tissue sealing method is not limited to the cryopreservation bag formed by irradiating the two-layered fluororesin sheets S1 and S2 with an infrared laser beam. The present invention is equally applicable to a cryopreservation bag formed of a resin sheet other than a resin sheet.

１ 外郭線ビード
２ 収容部
３ 通気口
４ 抽気部
５ 第１シールビード
６ 左ビード部
７ 右ビード部
８ 肩ビード部
９ 充填口
Ｓ１・Ｓ２ フッ素系樹脂シート DESCRIPTION OF SYMBOLS 1 Outer wire bead 2 Housing | casing part 3 Ventilation hole 4 Extraction part 5 1st seal bead 6 Left bead part 7 Right bead part 8 Shoulder bead part 9 Filling port S1, S2 Fluorine-based resin sheet

Claims (8)

２枚重ねにしたフッ素系樹脂シート（Ｓ１・Ｓ２）に赤外線レーザービームを照射して、前記両シート（Ｓ１・Ｓ２）の界面に形成された外郭線ビード（１）で、生体組織を収容する収容部（２）が区画されており、
収容部（２）の一端に、収容部（２）に連続する通気口（３）と、通気口（３）より広幅の抽気部（４）とが形成され、収容部（２）の他端に、生体組織を収容部（２）に充填するための充填口（９）が形成されており、
充填口（９）が開口され、抽気部（４）の端部寄りが第１シールビード（５）で封止され、充填口（９）を介して収容部（２）内に生体組織を充填することができる第１形態と、
充填口（９）が第２シールビード（１８）で封止され、第１シールビード（５）に沿ってバッグ壁（１９）が分離除去されることで抽気部（４）の端部寄りに抽気開口（２０）が形成され、収納部（２）内に生体組織を充填したのちに抽気開口（２０）を介して収納部（２）内に残留する空気を放出することができる第２形態と、
充填口（９）が第２シールビード（１８）で封止され、抽気部（４）が第３シールビード（２２）で封止され、収納部（２）内に生体組織が封入される第３形態の、計３個の形態を採ることができるように構成されていることを特徴とする凍結保存用バッグ。 Irradiate the two-layered fluororesin sheet (S1, S2) with an infrared laser beam, and contain living tissue with the outer bead (1) formed at the interface between the two sheets (S1, S2). The housing part (2) is partitioned ,
At one end of the storage part (2), a vent (3) continuous to the storage part (2) and a bleed part (4) wider than the vent (3) are formed, and the other end of the storage part (2) In addition, a filling port (9) for filling the living body tissue into the housing part (2) is formed,
The filling port (9) is opened, the end portion of the bleed portion (4) is sealed with the first seal bead (5), and the living tissue is filled into the accommodating portion (2) through the filling port (9). A first form that can be
The filling port (9) is sealed with the second seal bead (18), and the bag wall (19) is separated and removed along the first seal bead (5) so that it is closer to the end of the bleed portion (4). A second configuration in which a bleed opening (20) is formed, and air remaining in the storage section (2) can be released through the bleed opening (20) after filling the storage section (2) with living tissue. When,
The filling port (9) is sealed with the second seal bead (18), the extraction part (4) is sealed with the third seal bead (22), and the living tissue is enclosed in the storage part (2). 3 embodiment, the cryopreservation bag, characterized that you have been configured to be able to take a total of three forms. 収容部（２）を区画する外郭線ビード（１）が、左右一対の左ビード部（６）および右ビード部（７）を備えており、
左右の両ビード部（６・７）を、四角形状に形成したフッ素系樹脂シート（Ｓ１・Ｓ２）のひとつの辺部と交差させて、左右の両ビード部（６・７）の間に充填口（９）が開口してある請求項１に記載の凍結保存用バッグ。 The outer bead (1) defining the housing part (2) includes a left and right pair of left and right bead parts (6) and (7),
Fill the space between the left and right bead parts (6, 7) by crossing the left and right bead parts (6, 7) with one side of the square fluororesin sheet (S1, S2). The cryopreservation bag according to claim 1, wherein the mouth (9) is open. 通気口（３）の左右幅を（Ｂ１）とし、抽気部（４）の左右幅を（Ｂ２）とし、収容部（２）の左右幅を（Ｂ３）とするとき、各部の左右幅が不等式（Ｂ１＜Ｂ２＜Ｂ３）を満足するように設定してある請求項１、または２に記載の凍結保存用バッグ。   When the left-right width of the vent (3) is (B1), the left-right width of the extraction part (4) is (B2), and the left-right width of the housing part (2) is (B3), the left-right width of each part is inequality. The cryopreservation bag according to claim 1 or 2, which is set so as to satisfy (B1 <B2 <B3). 収容部（２）が、平行に形成される左右一対の左ビード部（６）および右ビード部（７）と、これら両ビード部（６・７）から通気口（３）へ向かって先すぼまり状に傾く肩ビード部（８）で区画してある請求項３に記載の凍結保存用バッグ。   The accommodating portion (2) is a pair of left and right left bead portions (6) and right bead portion (7) formed in parallel, and leads from both the bead portions (6, 7) toward the vent (3). The cryopreservation bag according to claim 3, wherein the bag is partitioned by a shoulder bead portion (8) inclined like a cone. 抽気部（４）と、通気口（３）と、収容部（２）の左右両側にラベル（Ｌ）を収容するラベルポケット（１５）が形成してある請求項３、または４に記載の凍結保存用バッグ。   The freezing according to claim 3 or 4, wherein a label pocket (15) for accommodating a label (L) is formed on the left and right sides of the bleed portion (4), the vent (3), and the accommodating portion (2). Storage bag. 収容部（２）において対向するフッ素系樹脂シート（Ｓ１・Ｓ２）どうしが、規制ビード（２４）で一体化されており、
収容部（２）に生体組織が充填された状態において、収容部（２）の周囲壁が外膨らみ状に変形するのを規制ビード（２４）で規制している請求項３から５のいずれかひとつに記載の凍結保存用バッグ。 The fluororesin sheets (S1, S2) facing each other in the housing part (2) are integrated with the regulation bead (24),
The restriction bead (24) regulates deformation of the peripheral wall of the accommodation part (2) into an outwardly bulging shape in a state where the living part is filled in the accommodation part (2). The cryopreservation bag according to one. 規制ビード（２４）が、収容部（２）の周囲壁の中央に形成してある請求項６に記載の凍結保存用バッグ。   The bag for cryopreservation according to claim 6, wherein the regulation bead (24) is formed at the center of the peripheral wall of the housing part (2). 収容部（２）の一端に、収容部（２）に連続する通気口（３）と、通気口（３）より広幅の抽気部（４）とが形成されて、抽気部（４）の端部寄りが第１シールビード（５）で封止されており、収容部（２）の他端に、生体組織を収容部（２）に充填するための充填口（９）が開口してある凍結保存用バッグに対する生体組織の封入方法であって、
生体組織を充填口（９）から収容部（２）に充填する第１手順と、
生体組織が充填された凍結保存用バッグの充填口（９）を第２シールビード（１８）で封止する第２手順と、
第１シールビード（５）に沿ってバッグ壁を切断して、第１シールビード（５）を含むバッグ壁（１９）を分離し、抽気部（４）の端部寄りに抽気開口（２０）を形成する第３手順と、
凍結保存用バッグを抽気開口（２０）が上になる状態で起立させて、収容部（２）内の生体組織を通気口（３）から抽気部（４）へ押し出しながら、バッグ内の空気を抽気開口（２０）から放出する第４手順と、
少なくとも抽気部（４）のバッグ壁を密着させて仮封止部（２１）を形成し、仮封止部（２１）を第３シールビード（２２）で封止する第５手順を経ることを特徴とする凍結保存用バッグに対する生体組織の封入方法。 At one end of the accommodating part (2), a vent (3) continuous to the accommodating part (2) and an extraction part (4) wider than the vent (3) are formed, and the end of the extracting part (4) Close to the part is sealed with a first seal bead (5), and a filling port (9) for filling the accommodation part (2) with the living tissue is opened at the other end of the accommodation part (2). A method of enclosing living tissue in a cryopreservation bag,
A first procedure for filling the living tissue from the filling port (9) into the accommodating portion (2);
A second procedure of sealing the filling port (9) of the cryopreservation bag filled with the biological tissue with a second seal bead (18);
The bag wall is cut along the first seal bead (5) to separate the bag wall (19) including the first seal bead (5), and the bleed opening (20) is located near the end of the bleed portion (4). A third step of forming
The cryopreservation bag is erected with the bleed opening (20) facing upward, and the living tissue in the housing part (2) is pushed out from the vent (3) to the bleed part (4), while the air in the bag is A fourth procedure for discharging from the bleed opening (20);
At least the bag wall of the extraction part (4) is brought into close contact with each other to form the temporary sealing part (21), and the fifth procedure of sealing the temporary sealing part (21) with the third seal bead (22) is performed. A method of enclosing biological tissue in a cryopreservation bag, which is characterized.
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