JP4034850B2 - Cryopreservation bag - Google Patents

Cryopreservation bag Download PDF

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JP4034850B2
JP4034850B2 JP15824697A JP15824697A JP4034850B2 JP 4034850 B2 JP4034850 B2 JP 4034850B2 JP 15824697 A JP15824697 A JP 15824697A JP 15824697 A JP15824697 A JP 15824697A JP 4034850 B2 JP4034850 B2 JP 4034850B2
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bag
cryopreservation bag
cryopreservation
port
air
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JPH111247A (en
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毅 宇野
輝久 広部
健一 斎藤
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Nipro Corp
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5861—Spouts
    • B65D75/5872—Non-integral spouts
    • B65D75/5883—Non-integral spouts connected to the package at the sealed junction of two package walls

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
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  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Description

【０００１】
【発明の属する技術分野】
本発明は、骨髄液、末梢血または臍帯血由来の造血幹細胞等を極低温下で保存する際に用いる凍結保存用バッグに関する。
【０００２】
【従来の技術】
近年骨髄移植に変わる幹細胞移植療法として末梢血幹細胞移植、臍帯血幹細移植が注目されている。末梢血幹細胞および臍帯血幹細胞は骨髄移植とは異なり、幹細胞採取後、凍結保護剤を添加して−８０℃から−１９６℃の極低温下で凍結保存され、必要に応じて解凍し、移植が行われる。この凍結保存の際に使用されるバッグとして、例えば、特開平8-173505号公報に開示されるような、内側の超高分子量ポリエチレンの層と、該超高分子量ポリエチレンの層よりも融点が低く、該超高分子量ポリエチレンと相溶性のある外側の熱可塑性樹脂の層が加熱溶着されてなる積層フィルムにより構成された凍結バッグが知られている。
【０００３】
【発明が解決しようとする課題】
従来の凍結保存用バッグの開発は主に破損を回避する為の素材の開発のみに重点が置かれ、バッグ形状は考慮されることがなかった。しかし、凍結時にバッグ内に存在するエアー部分に衝撃が加わると容易に破損する虞れがある。また、エアー部分は厚みむらの原因にもなり、この厚みむらが原因で細胞の凍結完了の時間や解凍時間に差が生じ、細胞が損傷しやすいという問題がある。さらにまた、凍結保存用バッグに収容されている造血幹細胞等の貴重な細胞成分は、例えば血液成分１mlの残液に、約１０7 〜１０8 個程の有核細胞が含まれているため、わずかなロスも移植に影響することが考えられる。このためバッグ内の残液量の少ないバッグ形状が望まれている。
【０００４】
例えば、従来の凍結保存用バッグは、図４に示すように、流入ポート１１と流出ポート１２をバッグの同一辺上に設けたものや、図５に示すように、バッグの一辺の両端に側部の辺と平行に設けたものが知られている。しかし図４および図５に示すような位置に流入ポートと流出ポートを有するバッグ形状では、血液排出時にポート内やその廻りに血液やエアーがトラップされ、貴重な幹細胞成分を無駄にしてしまう虞があるとともに、バッグ内のエアーを簡単な操作で、完全に抜き取ることができず、バッグ破損の原因になっていた。
本発明は、如上の事情に鑑みてなされたもので、凍結時に存在するバッグ内のエアーを簡単な操作で取り除くことができ、しかも貴重な内容液を余すことなく排出できるようにした凍結保存用バッグをを提供することを目的とする。
【０００５】
【課題を解決するための手段】
本発明は周縁部にシール部と、少なくとも２つの頂点とを有する凍結保存用バッグであって、該凍結保存用バッグは、任意の頂点に設けられた流出ポートと、該流出ポートの対面に位置するシール部に設けられた懸垂穴と、残りの頂点に設けられた流入ポートとを備えてなり、前記流入ポートおよび流出ポートを設けた頂点の内角の対頂角の角度範囲内に向けて流入ポートおよび流出ポートが夫々設けられてなる凍結保存用バッグである。
ここで凍結保存用バッグは多角形のものが好ましく採用され、この際、懸垂穴は流出ポートの対面に位置する頂点の外シール部に設けられることが好ましい。
さらに、流入ポートは連結管に接続されているのが好ましい。
【０００６】
【発明の実施の形態】
次に本発明の実施の形態を図面に基づいて説明する。
図１は本発明の凍結保存用バッグの一実施例の形態を示す平面図であり、図２は本発明の凍結保存用バッグの他の実施例の形態を示す平面図であり、図３は本発明の凍結保存用バッグのさらに他の実施例の形態を示す平面図である。
図１〜３に示す凍結保存用バッグは、周縁部にシール部１４を有する少なくとも２つの頂点を有する凍結保存用バッグ１であり、この凍結保存用バッグ１は、任意の頂点に設けられた流出ポート１２と、該流出ポート１２の対面に位置する外シール部１４に設けられた懸垂穴１３と、残りの頂点に設けられた流入ポート１１とを備えてなり、前記流入ポート１１および流出ポート１２を設けた頂点の内角の対頂角の角度範囲内に向けて流入ポート１１および流出ポート１２が夫々設けられている。
そして図１において、流入ポート１１には連通管２が接続されており、この連通管２は閉塞部材２１と導入用接続部２２、２３を有している。
【０００７】
凍結保存用バッグ１は、−１９６℃までの極低温下でも耐えうる耐寒性と、耐衝撃性を有すると共に、収容する内容液に対して無毒な内面を有するシートまたはフィルムを用いることが好ましい。このシートまたはフィルムをヒートシールおよび高周波ウェルダーにより、ポート部、底部、側面部をシールして、袋状にしたものである。その形状は、任意の頂点に流出ポートを備え、この流出ポートの対面に位置するシール部に懸垂穴を備え、残りの頂点に流入ポートを備えた構成であれば特に限定はない。例えば、図１に示すような四角形の形状や、図２に示す三角形の形状や、図３に示す半楕円の形状のものが挙げられる。
【０００８】
流出ポート１２は廃液性を考慮して、凍結保存用バッグ１の任意の頂点に設けられ、流出ポート１２が設けられた頂点の内角の対頂角の角度範囲内すなわち頂点に隣接する２つの辺がなす内角に対して向かい合う角度の範囲内に向くように設けられている。前記角度範囲を越えると廃液性が悪くなり、貴重な血液成分を無駄にする虞れがある。そして流出ポート１２の対角に位置する頂点の外シール部１４１には懸垂穴１３が設けられている。これは、吊りスタンド（図示しない）などに吊り下げた時に流出ポート１２がほぼ重力方向に向くように、懸垂穴１３と流出ポート１２の位置と方向が工夫されている。上記構成によれば、凍結保存用バッグ１内の血液成分を流出ポート１２から無駄なく排出することができる。また流出ポート１２は、排出時まで液が流出しない手段（例えば折れ棒や薄膜で閉鎖されたチューブである膜チューブ等）が具備され、さらに先端はキャップ１２１等で保護されていることが好ましい。
【０００９】
流入ポート１１は、血液を注入する際に混入したエアーを容易に排出できるよう、流出ポート１２と懸垂穴１３を有した頂点以外の頂点に設けられ、流入ポート１１が設けられた頂点の内角の対頂角の角度範囲内に向くように設けられている。前記角度範囲を越えると一回の操作で確実にエアーを抜き取るのが難しい。そして流入ポート１１には、使用時まで閉塞される手段（例えば折れ棒等）が具備されているのが好ましい。
【００１０】
連通管２は、ある程度の透明性と可撓性を有する合成樹脂で形成されるものが好ましく、塩化ビニル樹脂、シリコンゴム、ポリウレタン樹脂、ポリエチレン樹脂、エチレン−酢酸ビニル共重合体、エチレン−α−オレフィン共重合体等が採用される。この連通管２は、図１において、分岐管２６を介して２つの分岐路２４、２５に分岐されたものが採用されており、分岐路２４、２５には閉塞部材２１と導入用接続部２２、２３が設けられている。図１において、導入用接続部２２にはメスルアーコネクタをプロテクターで保護したものが、接続部２３にはプラスチック針からなるものがそれぞれ採用されており、使用用途に応じて適宜選択できる構成となっている。連通管２は必ずしも図１に示すような２方向に分岐された構成である必要はなく、１方向のみでもよい。そして連通管２にはその通路を適宜開閉することが可能な閉塞部材２１が設けられおり、閉塞部材２１としてはクランプや鉗子等の他に特公昭46-36526号、特公昭60-27870号、特公平4-36028 号等に記載のローラークランプが用いられる。
【００１１】
凍結保存用バッグ１の形成材料としては、−１９６℃までの極低温下でも耐えうる耐寒性と、耐衝撃性を有すると共に、収容する内容液に対して無毒な内面を有するものが使用される。例えば、特公昭49-8079 号公報に記載のポリイミドフィルムとフッ素化エチレンプロピレン重合体フィルムとの積層フィルムからなるものや、実公昭55-55069号記載のテトラフルオロエチレンとエチレンの共重合体フィルムからなるものや、特公昭55-44977号公報に記載の電子線照射し２軸延伸されたエチレン−酢酸ビニル共重合体のフィルムからなるものや、特公昭62-57351号公報に記載の２軸延伸された架橋ポリエチレンフィルムを用いたものや、特公昭60-49429号公報に記載の２軸延伸ポリエチレンテレフタレート等のフィルムと超高分子量ポリエチレンフィルムとの積層フィルムを用いたものや、特開平3-295557号公報に記載の超高分子量ポリエチレンを用いたものや、特開平8-173505号公報に記載の内側に超高分子量ポリエチレンの層と、該超高分子量ポリエチレンよりも融点が低く、該超高分子量ポリエチレンと相溶性のある外側の熱可塑性樹脂の層が加熱溶着されてなる積層フィルムを用いたもの等が挙げられる。
【００１２】
次に、図１に示す凍結保存用バッグを用いた凍結保存方法の一例について説明する。ドナーから採取された血液は血液バッグに収容され、遠心分離処理を施したのち幹細胞等を多く含む血液成分は別の血液バッグに収容される。この血液バッグにグリセリンや、ジメチルスルフォキサイドを主成分とした凍結防止剤を適宜注入した後、凍結保存を行う。凍結保存をする際には、導入用接続部２２、２３を介して凍結防止剤を含む血液を凍結保存用バッグ１に収容する。完全に血液成分が凍結保存用バッグ１内に収容された後、流入ポート１１を持ち上げて凍結保存用バッグ１内にあるエアーを流入ポート１１のある角に集める。この集められたエアーはシリンジ等の吸引手段を用いて吸引するか、手などで押し出して、連通管２を通じてどちらか一方の接続部から排出される。凍結保存用バッグ１のエアーが完全に抜き取られたら、流入ポート１１から１〜２cm先をチューブシーラでシールして連通管２を切り離し、液体窒素等の冷凍手段を用いて冷凍保存する。そして、冷凍保存した血液を必要に応じて解凍して使用する。冷凍保存後の血液成分の使用の際は、凍結保存用バッグ１の流出ポート１２のキャップ１２１を開封し、輸血セット等を接続した後、吊りスタンド等に懸垂穴１３を引っ掛け、凍結保存用バッグ１を垂直に保持して、人体に投与する。もしくは同様の方法を用いて血液成分を一度凍結保存用バッグ１から分離バッグに移し、生理食塩水等で薄めてから、輸血セット等を用いて人体に投与する等して使用される。
【００１３】
〔実施例１〕
本発明の凍結保存用バッグを用いて残存空気量と残液量の測定を行った。
超高分子量ポリエチレンと直鎖状低密度ポリエチレンの２層フィルムに流入ポート、流出ポートおよび懸垂穴を設けて周縁部をヒートシールし、図１に示すような長方形のバッグを作成し、これに流入ポートに連通管を接続して凍結保存用バッグとした。
この凍結保存用バッグに疑似血液であるポリビニルピロリドンとソルビットの混合液１００mlをシリンジを用いて凍結保存用バッグに注入した。注入の際には、プロテクターを開封し、メスルアーコネクターにシリンジを嵌合させて充填した。充填後、前記シリンジを用いて所定量のエアーを凍結保存用バッグ内に注入したのち、流入ポートを持ち上げエアーを集め、前記シリンジを用いて凍結保存用バッグ内のエアーを一回抜き取った。そして一回の抜取り操作で残存するエアーの量を１mlのシリンジを用いて測定した。ｎ＝１０で測定を行い、残存空気量の平均値を求めた。その結果を表１に示す。
また、エアーを抜き取った後、流入ポートの１〜２cm上をチューブシーラで溶着して切り離した。その後、懸垂穴をバッグ吊り下げ具に掛け、自然落差で凍結保存用バッグ内の液を排出した。排出後、凍結保存用バッグの重量を測定し、空バッグの重量との差を測定した。ｎ＝１０で測定を行い、残液量の平均値を求めた。その結果を表１に示す。
【００１４】
〔比較例１〕従来用いられていた、図４に示すようなバッグの一辺に流入ポートと流出ポート有する凍結保存用バッグを用いて残存空気量と残液量の測定を行った。疑似血液であるポリビニルピロリドンとソルビットの混合液１００mlをシリンジを用いて凍結保存用バッグに注入した。注入の際には、プロテクターを開封し、メスルアーコネクターにシリンジを嵌合させて充填した。充填後、前記シリンジを用いて所定量のエアーを凍結バッグ内に注入したのち、流入ポートを持ち上げエアーを集め、前記シリンジを用いて凍結保存用バッグ内のエアーを一回抜き取った。そして一回の抜取り操作で残存するエアーの量を１mlのシリンジを用いて測定した。ｎ＝１０で測定を行い、残存空気量の平均値を求めた。その結果を表１に示す。また、エアーを抜き取った後、流入ポートの１〜２cm上をチューブシーラで溶着して切り離した。その後、バッグ吊り下げ具に掛け、自然落差で凍結保存用バッグ内の液を排出した。排出後、凍結保存用バッグの重量を測定し、空バッグの重量との差を測定した。ｎ＝１０で測定を行い、残液量の平均値を求めた。その結果を表１に示す。
【００１５】
〔比較例２〕従来用いられていた、図５に示すようなバッグの一辺の両端に流入ポートと流出ポート有する凍結バッグを用いて残存空気量と残液量の測定を行った。疑似血液であるポリビニルピロリドンとソルビットの混合液１００mlをシリンジを用いて凍結保存用バッグに注入した。注入の際には、プロテクターを開封し、メスルアーコネクターにシリンジを嵌合させて充填した。充填後、前記シリンジを用いて所定量のエアーを凍結保存用バッグ内に注入したのち、流入ポートを持ち上げエアーを集め、前記シリンジを用いて凍結保存用バッグ内のエアーを一回抜き取った。そして一回の抜取り操作で残存するエアーの量を１mlのシリンジを用いて測定した。ｎ＝１０で測定を行い、残存空気量の平均値を求めた。その結果を表１に示す。また、エアーを抜き取った後、流入ポートの１〜２cm上をチューブシーラで溶着して切り離した。その後、バッグ吊り下げ具に掛け、自然落差で凍結保存用バッグ内の液を排出した。排出後、凍結保存用バッグの重量を測定し、空重量との差を測定した。ｎ＝１０で測定を行い残液量の平均値を求めた。その結果を表１に示す。
【００１６】
【表１】

Figure 0004034850
【００１７】
表１より、本発明の凍結保存用バッグは、従来使用されていた凍結保存用バッグに比べて残存空気量も少なく、残液量も少ないことがわかる。
【００１８】
【発明の効果】
本発明の凍結保存用バッグは、エアー抜きと排液性とが優れるように流入ポートおよび流出ポートの位置とポートの向きが工夫されているので、バッグ内のエアーを確実に抜くことができ、またバッグ内の液を余すことなく排出するとができる。このため、凍結保存の際に衝撃によるバッグ破損が少なくなり、またバッグ内の貴重な血液成分を有効に利用することができるようになった。
【図面の簡単な説明】
【図１】本発明の一実施の形態を示す平面図。
【図２】本発明の他の実施の形態を示す平面図。
【図３】本発明の他の実施の形態を示す平面図。
【図４】従来の凍結保存用バッグの一例を示す説明図。
【図５】従来の凍結保存用バッグの他の一例を示す説明図。
【符号の説明】
１ 凍結保存用バッグ
１１ 流入ポート
１２ 流出ポート
１３ 懸垂穴
１４ シール部
２ 連通管
２１ 閉塞部材
２２、２３ 導入用接続部[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a cryopreservation bag used for storing bone marrow fluid, peripheral blood or umbilical cord blood-derived hematopoietic stem cells and the like at extremely low temperatures.
[0002]
[Prior art]
In recent years, peripheral blood stem cell transplantation and umbilical cord blood stem cell transplantation have attracted attention as stem cell transplantation therapies replacing bone marrow transplantation. Unlike bone marrow transplantation, peripheral blood stem cells and umbilical cord blood stem cells are cryopreserved at a cryogenic temperature of −80 ° C. to −196 ° C. with the addition of a cryoprotectant after stem cell collection, and are thawed as necessary. Done. As a bag used in this cryopreservation, for example, as disclosed in JP-A-8-173505, an inner ultrahigh molecular weight polyethylene layer and a melting point lower than that of the ultrahigh molecular weight polyethylene layer are disclosed. There is known a freezing bag constituted by a laminated film in which an outer thermoplastic resin layer compatible with the ultrahigh molecular weight polyethylene is heat-welded.
[0003]
[Problems to be solved by the invention]
The development of conventional cryopreservation bags mainly focused on the development of materials to avoid breakage, and the bag shape was not considered. However, when an impact is applied to the air portion existing in the bag at the time of freezing, there is a risk of being easily damaged. In addition, the air portion also causes unevenness of the thickness. Due to the unevenness of the thickness, there is a problem that the time for completing freezing of cells and the thawing time are different, and the cells are easily damaged. Furthermore, precious cell components such as hematopoietic stem cells contained in a cryopreservation bag contain, for example, about 10 7 to 10 8 nucleated cells in the remaining liquid of 1 ml of blood components. A slight loss may affect the transplant. For this reason, the bag shape with little residual liquid amount in a bag is desired.
[0004]
For example, a conventional cryopreservation bag has an inflow port 11 and an outflow port 12 provided on the same side of the bag as shown in FIG. 4, or is provided on both sides of one side of the bag as shown in FIG. What was provided in parallel with the side of a part is known. However, in the bag shape having the inflow port and the outflow port at the positions shown in FIGS. 4 and 5, there is a possibility that blood and air are trapped in and around the port when blood is discharged, and valuable stem cell components are wasted. In addition, the air in the bag could not be completely removed by a simple operation, causing the bag to break.
The present invention has been made in view of the above circumstances, and can be used for freezing storage in which air in a bag existing at the time of freezing can be removed by a simple operation and valuable content liquid can be discharged without being left behind. The object is to provide a bag.
[0005]
[Means for Solving the Problems]
The present invention relates to a cryopreservation bag having a seal portion at the periphery and at least two vertices, and the cryopreservation bag is located at an outflow port provided at an arbitrary apex and facing the outflow port. A suspension hole provided in the sealing portion and an inflow port provided at the remaining apex, and an inflow port and an inflow port toward an angle range of an internal angle of the apex provided with the inflow port and the outflow port, and It is a cryopreservation bag provided with an outflow port.
Here, a polygonal bag is preferably used as the cryopreservation bag, and in this case, the suspension hole is preferably provided in the outer seal portion at the apex located on the opposite side of the outflow port.
Furthermore, the inflow port is preferably connected to the connecting pipe.
[0006]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a plan view showing an embodiment of a cryopreservation bag according to the present invention, FIG. 2 is a plan view showing another embodiment of a cryopreservation bag according to the present invention, and FIG. It is a top view which shows the form of the further another Example of the bag for cryopreservation of this invention.
The cryopreservation bag shown in FIGS. 1 to 3 is a cryopreservation bag 1 having at least two vertices having a seal portion 14 at a peripheral portion, and this cryopreservation bag 1 is an outflow provided at an arbitrary vertex. A port 12, a suspension hole 13 provided in the outer seal portion 14 located on the opposite side of the outflow port 12, and an inflow port 11 provided at the remaining apex, and the inflow port 11 and the outflow port 12. The inflow port 11 and the outflow port 12 are respectively provided in the angle range of the vertical angle of the inner angle of the apex provided with.
In FIG. 1, a communication pipe 2 is connected to the inflow port 11, and this communication pipe 2 has a closing member 21 and connecting portions 22 and 23 for introduction.
[0007]
The cryopreservation bag 1 is preferably a sheet or film that has cold resistance that can withstand even at extremely low temperatures up to −196 ° C. and impact resistance, and has an inner surface that is non-toxic to the contained liquid. This sheet or film is formed into a bag shape by sealing the port portion, the bottom portion, and the side portion with a heat seal and a high frequency welder. The shape is not particularly limited as long as an outflow port is provided at an arbitrary vertex, a suspension hole is provided in a seal portion located on the opposite side of the outflow port, and an inflow port is provided at the remaining vertex. For example, a quadrangular shape as shown in FIG. 1, a triangular shape as shown in FIG. 2, or a semi-elliptical shape as shown in FIG.
[0008]
The outflow port 12 is provided at an arbitrary apex of the cryopreservation bag 1 in consideration of waste liquid properties, and two sides adjacent to the apex angle range of the inner angle of the apex where the outflow port 12 is provided, that is, adjacent to the apex are formed. It is provided so as to face the range of angles facing the inner angle. If the angle range is exceeded, the waste liquid property is deteriorated, and there is a possibility that valuable blood components are wasted. A suspension hole 13 is provided in the outer seal portion 141 at the apex located at the diagonal of the outflow port 12. The position and direction of the suspension hole 13 and the outflow port 12 are devised so that the outflow port 12 faces substantially in the direction of gravity when suspended on a suspension stand (not shown). According to the above configuration, blood components in the cryopreservation bag 1 can be discharged from the outflow port 12 without waste. Further, the outflow port 12 is preferably provided with a means (for example, a membrane tube that is a tube closed by a folding rod or a thin film) that does not allow the liquid to flow out until it is discharged, and the tip is preferably protected by a cap 121 or the like.
[0009]
The inflow port 11 is provided at the apex other than the apex having the outflow port 12 and the suspension hole 13 so that air mixed when blood is injected can be easily discharged, and the inner angle of the apex where the inflow port 11 is provided. It is provided so as to face the angle range of the vertical angle. When the angle range is exceeded, it is difficult to extract air reliably by a single operation. The inflow port 11 is preferably provided with means (for example, a broken bar) that is closed until it is used.
[0010]
The communication pipe 2 is preferably formed of a synthetic resin having a certain degree of transparency and flexibility, such as vinyl chloride resin, silicon rubber, polyurethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, ethylene-α- An olefin copolymer or the like is employed. In FIG. 1, the communication pipe 2 is branched into two branch paths 24 and 25 via a branch pipe 26, and the branch paths 24 and 25 include a closing member 21 and an introduction connecting portion 22. , 23 are provided. In FIG. 1, the introduction connecting portion 22 is protected by a protector with a female connector, and the connecting portion 23 is made of a plastic needle, and can be appropriately selected according to the intended use. ing. The communication pipe 2 does not necessarily have a configuration branched in two directions as shown in FIG. 1, and may be only in one direction. The communication pipe 2 is provided with a closing member 21 capable of opening and closing the passage as appropriate. As the closing member 21, in addition to a clamp, a forceps and the like, Japanese Patent Publication No. 46-36526, Japanese Patent Publication No. 60-27870, The roller clamp described in Japanese Patent Publication No. 4-36028 is used.
[0011]
As a material for forming the cryopreservation bag 1, a material having a cold resistance and an impact resistance that can endure even at an extremely low temperature up to −196 ° C. and having an inner surface that is non-toxic to the contained liquid is used. . For example, a film made of a laminate of a polyimide film and a fluorinated ethylene propylene polymer film described in Japanese Patent Publication No. 49-8079, or a copolymer film of tetrafluoroethylene and ethylene described in Japanese Utility Model Publication No. 55-55069. Or a biaxially stretched film described in JP-B-62-57351, or a biaxially stretched ethylene-vinyl acetate copolymer film described in JP-B-55-44977. Using a cross-linked polyethylene film, a film using a biaxially stretched polyethylene terephthalate film described in Japanese Patent Publication No. 60-49429, etc. and an ultrahigh molecular weight polyethylene film; Using the ultra high molecular weight polyethylene described in Japanese Patent Publication No. JP-A 8-173505, and an ultra high molecular weight polyethylene layer on the inner side described in JP-A 8-173505, A lower melting point than polyethylene, such as those using a laminate film outer layer of the thermoplastic resin with a ultrahigh molecular weight polyethylene and compatibility formed by heat welding and the like.
[0012]
Next, an example of a cryopreservation method using the cryopreservation bag shown in FIG. 1 will be described. The blood collected from the donor is stored in a blood bag, and after centrifugation, blood components containing a large amount of stem cells and the like are stored in another blood bag. A cryopreservation agent containing glycerin or dimethyl sulfoxide as a main component is appropriately injected into the blood bag and then cryopreserved. When cryopreserving, blood containing the cryoprotectant is accommodated in the cryopreservation bag 1 through the connection portions 22 and 23 for introduction. After the blood components are completely contained in the cryopreservation bag 1, the inflow port 11 is lifted to collect air in the cryopreservation bag 1 at a corner where the inflow port 11 is located. The collected air is sucked using a suction means such as a syringe, or pushed out by hand or the like, and is discharged from one of the connection portions through the communication pipe 2. When the air in the cryopreservation bag 1 is completely extracted, the communication pipe 2 is cut off by sealing a portion 1 to 2 cm away from the inflow port 11 with a tube sealer, and is stored frozen using a freezing means such as liquid nitrogen. Then, the frozen blood is thawed and used as necessary. When using blood components after cryopreservation, the cap 121 of the outflow port 12 of the cryopreservation bag 1 is opened, a blood transfusion set or the like is connected, and the suspension hole 13 is hooked on a suspension stand or the like, so that the cryopreservation bag 1 is held vertically and is administered to the human body. Alternatively, blood components are once transferred from the cryopreservation bag 1 to a separation bag using the same method, diluted with physiological saline, etc., and then administered to the human body using a transfusion set or the like.
[0013]
[Example 1]
The amount of residual air and the amount of residual liquid were measured using the cryopreservation bag of the present invention.
A two-layer film of ultrahigh molecular weight polyethylene and linear low-density polyethylene is provided with an inflow port, an outflow port, and a suspension hole, and the periphery is heat sealed to create a rectangular bag as shown in FIG. A communicating tube was connected to the port to obtain a cryopreservation bag.
Into this cryopreservation bag, 100 ml of a mixture of polyvinylpyrrolidone and sorbit, which is simulated blood, was injected into the cryopreservation bag using a syringe. At the time of injection, the protector was opened, and a syringe was fitted to the female luer connector and filled. After filling, a predetermined amount of air was injected into the cryopreservation bag using the syringe, the inflow port was raised to collect air, and the air in the cryopreservation bag was extracted once using the syringe. The amount of air remaining in one extraction operation was measured using a 1 ml syringe. Measurement was performed at n = 10, and an average value of the remaining air amount was obtained. The results are shown in Table 1.
Moreover, after extracting air, 1-2 cm above the inflow port was welded with a tube sealer and separated. Thereafter, the suspension hole was hung on the bag hanging tool, and the liquid in the cryopreservation bag was discharged with a natural drop. After discharging, the weight of the cryopreservation bag was measured, and the difference from the weight of the empty bag was measured. Measurement was performed at n = 10, and an average value of the remaining liquid amount was obtained. The results are shown in Table 1.
[0014]
Comparative Example 1 has been used conventionally, was measured residual air amount and the residual solution amount using the cryopreservation bag having bag side to the inlet port and the outlet port as shown in FIG. 100 ml of a mixture of polyvinylpyrrolidone and sorbit, which is simulated blood, was injected into a cryopreservation bag using a syringe. At the time of injection, the protector was opened, and a syringe was fitted to the female luer connector and filled. After filling, a predetermined amount of air was injected into the freezing bag using the syringe, the inflow port was raised to collect air, and the air in the cryopreservation bag was extracted once using the syringe. The amount of air remaining in one extraction operation was measured using a 1 ml syringe. Measurement was performed at n = 10, and an average value of the remaining air amount was obtained. The results are shown in Table 1. Moreover, after extracting air, 1-2 cm above the inflow port was welded with a tube sealer and separated. After that, it was hung on a bag hanging tool, and the liquid in the cryopreservation bag was discharged with a natural drop. After discharging, the weight of the cryopreservation bag was measured, and the difference from the weight of the empty bag was measured. Measurement was performed at n = 10, and an average value of the remaining liquid amount was obtained. The results are shown in Table 1.
[0015]
Comparative Example 2 has been used conventionally, was measured residual air amount and the residual solution amount using the frozen bag having bag across the inlet port and the outlet port of one side, such as shown in FIG. 100 ml of a mixture of polyvinylpyrrolidone and sorbit, which is simulated blood, was injected into a cryopreservation bag using a syringe. At the time of injection, the protector was opened, and a syringe was fitted to the female luer connector and filled. After filling, a predetermined amount of air was injected into the cryopreservation bag using the syringe, the inflow port was raised to collect air, and the air in the cryopreservation bag was extracted once using the syringe. The amount of air remaining in one extraction operation was measured using a 1 ml syringe. Measurement was performed at n = 10, and an average value of the remaining air amount was obtained. The results are shown in Table 1. Moreover, after extracting air, 1-2 cm above the inflow port was welded with a tube sealer and separated. After that, it was hung on a bag hanging tool, and the liquid in the cryopreservation bag was discharged with a natural drop. After discharging, the weight of the cryopreservation bag was measured, and the difference from the empty weight was measured. Measurement was performed at n = 10, and the average value of the remaining liquid amount was obtained. The results are shown in Table 1.
[0016]
[Table 1]
Figure 0004034850
[0017]
From Table 1, it can be seen that the cryopreservation bag of the present invention has a small amount of residual air and a small amount of residual liquid as compared with a conventionally used cryopreservation bag.
[0018]
【The invention's effect】
The cryopreservation bag of the present invention is devised in terms of the position of the inflow port and the outflow port and the direction of the port so that the air venting and drainage are excellent, so the air in the bag can be surely extracted, Further, the liquid in the bag can be discharged without leaving any excess. For this reason, the bag breakage due to impact during cryopreservation is reduced, and valuable blood components in the bag can be used effectively.
[Brief description of the drawings]
FIG. 1 is a plan view showing an embodiment of the present invention.
FIG. 2 is a plan view showing another embodiment of the present invention.
FIG. 3 is a plan view showing another embodiment of the present invention.
FIG. 4 is an explanatory view showing an example of a conventional cryopreservation bag.
FIG. 5 is an explanatory view showing another example of a conventional cryopreservation bag.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Cryopreservation bag 11 Inflow port 12 Outflow port 13 Suspension hole 14 Seal part 2 Communication pipe 21 Closure member 22, 23 Introduction connection part

Claims (4)

周縁部にシール部と、少なくとも２つの頂点とを有する凍結保存用バッグであって、該凍結保存用バッグは、任意の頂点に設けられた流出ポートと、該流出ポートの対面に位置するシール部に設けられた懸垂穴と、残りの頂点に設けられた流入ポートとを備えてなり、前記流入ポートおよび流出ポートを設けた頂点の内角の対頂角の角度範囲内に向けて流入ポートおよび流出ポートが夫々設けられてなる凍結保存用バッグ。  A cryopreservation bag having a seal portion at the periphery and at least two vertices, wherein the cryopreservation bag includes an outflow port provided at an arbitrary apex, and a seal portion located opposite to the outflow port And an inflow port provided at the remaining apex, and the inflow port and the outflow port are directed toward the angle range of the vertical angle of the inner angle of the apex provided with the inflow port and the outflow port. Each cryopreservation bag is provided. 凍結保存用バッグが多角形である請求項１記載の凍結保存用バッグ。  The cryopreservation bag according to claim 1, wherein the cryopreservation bag is polygonal. 懸垂穴が流出ポートの対面に位置する頂点の外シール部に設けられてなる請求項１または２記載の凍結保存用バッグ。The cryopreservation bag according to claim 1 or 2, wherein the suspension hole is provided in an outer seal portion at the apex located on the opposite side of the outflow port. 請求項１〜３記載いずれか１項に記載の凍結保存用バッグの流入ポートに連結管が接続された凍結保存用バッグ。 Cryopreservation bag connection pipe is connected to the inlet port of the cryopreservation bag according to any one of claims 1 to 3, wherein.
JP15824697A 1997-06-16 1997-06-16 Cryopreservation bag Expired - Lifetime JP4034850B2 (en)

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JP5109631B2 (en) * 2007-12-10 2012-12-26 ニプロ株式会社 Cryopreservation bag and cryopreservation method
JP5298614B2 (en) * 2008-04-22 2013-09-25 大日本印刷株式会社 A self-supporting flat pouch
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