CN1802182A - 用于容纳血液制品的抗破裂吹塑冷藏袋 - Google Patents

用于容纳血液制品的抗破裂吹塑冷藏袋 Download PDF

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CN1802182A
CN1802182A CNA2004800160522A CN200480016052A CN1802182A CN 1802182 A CN1802182 A CN 1802182A CN A2004800160522 A CNA2004800160522 A CN A2004800160522A CN 200480016052 A CN200480016052 A CN 200480016052A CN 1802182 A CN1802182 A CN 1802182A
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mould
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P·H·克尔霍
P·金斯利
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Thermogenesis Corp
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    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832—Reciprocating joining or pressing tools
    • B29C66/8322—Joining or pressing tools reciprocating along one axis
    • B29C66/83221—Joining or pressing tools reciprocating along one axis cooperating reciprocating tools, each tool reciprocating along one axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/42—Component parts, details or accessories; Auxiliary operations
    • B29C49/48—Moulds
    • B29C49/4802—Moulds with means for locally compressing part(s) of the parison in the main blowing cavity
    • B29C2049/4805—Moulds with means for locally compressing part(s) of the parison in the main blowing cavity by closing the mould halves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C2791/00—Shaping characteristics in general
    • B29C2791/001—Shaping in several steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2793/00—Shaping techniques involving a cutting or machining operation
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
    • B29C49/04—Extrusion blow-moulding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C57/00—Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor, e.g. collapsible mandrels
    • B29C57/10—Closing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Abstract

一种抗破裂医疗制品冷藏袋(10)以及吹塑成形方法。

Description

用于容纳血液制品的抗破裂吹塑冷藏袋
                       技术领域
以下发明一般涉及防止容纳血液制品的袋由于与把该血液制品储存在液态氮中有关的温度剧变而导致其破裂的工具和方法。更具体的，本发明旨在一种用于提供血液袋的制造方法及制品。
                       背景技术
液态氮是许多细胞血液制品的优选存储介质，这是因为其相当低的温度能显著延长该细胞血液制品的保存期。在其极端温度下操作液态氮需要相当高程度的工程技巧，即使最大且最有经验的医药产品制造商，也要规避用于构造其内将存放血液制品的袋所需要的工程技术。
总的来说，令工业中已不知所措的一个问题具体涉及塑料袋的边缘连到一起的区域。这些接缝通常利用射频焊接制得。在与浸入液态氮中有关的温度剧变过程种，这些接缝易于破裂。请参见所附Baxter的新近公告，该公告是关于被世界上最大的保健及医疗设备公司之一回避解决的该长期存在的问题。
本申请人通过提供由塑料制成的袋，已经解决了此长期存在的问题，该塑料响应于热和压力并在真空成形处理中保持其形状。该塑料在真空成形处理中形成为壳体。优选是半壳的壳体部分沿着限定每个半壳外周的周壁接合到一起。袋的主壁与周边支架之间的过渡被圆角弯曲部打断，该圆角弯曲部有助于分配与使用液态氮时普遍的温度极限有关的力。此袋相当有效。采用这种袋的人们报告由液态氮中的温度剧变导致的接缝破裂极少。然而，这些袋需要略大的劳动强度且因而昂贵，外部密封仍然是与袋破裂有关的原因。结果，它们的应用主要限于“外来(exotic)”应用，例如干细胞保存，在这些应用中袋的成本不是主要考虑的因素。然而，对于受益于液态氮存储的普通血液存储情况，广泛使用的袋需要更经济的制造方法并使袋破裂的可能性降低至零。
以下现有技术反映本申请人知晓的技术状态，且将其包括在此以履行本申请人公开相关现有技术的公认义务。然而还保证，对于在下文中更详细地公开并具体要求保护的本发明，这些参考文献中没有任何一个文献单独地教导了本发明核心，也没有在考虑到任何可想到的结合时导致本发明的核心显而易见。
专利号           授权日           发明人
6,146,124      2000年11月14日       Coelho等
            其它现有技术-非专利文献
BAXTER，文章名“Correct Utilization of Cryocyte FreezingContainers”(8页)
                       发明内容
本发明提供一种能够抵抗例如液态氮中的低温剧变并且使制造成本降低十倍的袋。
造成这种经济效率和成本减少的技术源自采用吹塑技术按照特定方式制造该冷藏袋。令人惊讶的是，本申请人已经发现：当依据本发明制造时，在吹塑过程中，(在制模过程中当模具部分形成物理配准时)从模具部分转移且形成在袋内的模缝线(parting line)能够抵抗液态氮常见的温度剧变。一个原因看来似乎是模具部分接合处的塑料的结构完整性与在模具空腔内形成的其它位置的构成壁之间的差异相当小。换句话说，模具的模缝线不会区分出薄弱区域，这是因为不能区分位于模具部分处的塑料与其它位置的塑料。
在实践中，处于半熔融状态的一定量塑料被引入敞开的模具内。随后，限定模具的模具部分闭合以形成模具空腔。接着，把气体引入熔融塑料的中央，以使该塑料膨胀至由限定空腔的模具部分所限定的边界。优选地，在仍然处于气体压力下的同时，改变模具部分的温度以允许塑料不仅迅速凝固而且消除构造中的应力。一旦塑料已凝固，将模具部分分离而且袋就形成了。
                      工业应用性
通过论述以下本发明目的来说明本发明的工业应用性。
本发明的主要目的是提供一种用于形成易受温度剧变影响的袋的新颖方法及由此所形成的袋。
本发明的另一目的是提供一种具有如上特征的设备，其制造远不像现有技术那样昂贵。
本发明的另一目的是提供一种具有如上特征的设备，其能够抵抗液态氮中的温度剧变。
本发明的另一目的是提供一种具有如上特征的设备，其在结构上极耐用且适用于批量生产技术。
本发明的另一目的是提供一种将暴露于温度极限而在过去的薄弱位置处不会破裂的袋。
从第一优点考虑，本发明目的是提供一种抗破裂医用冷藏袋，用于在低温下储存血液制品，以便该血液制品从液相改变为固相、然后恢复到液相，该袋组合包括：用于血液制品的外壳，该外壳具有一对经由周边端壁互连的第一和第二平行且间隔开的侧壁，该周边端壁限定了每个所述侧壁的边界，所述端壁包括由在一种可敞开的模具内形成的袋所导致的可辨认模缝线。
从第二优点考虑，本发明目的是提供一种抗破裂医用冷藏袋，用于在低温下储存血液制品以便所述血液制品从液相改变为固相，所述袋这样形成：把塑料引入由模具部分包围的区域内；闭合所述模具部分，使得当所述模具部分靠在一起时，所述塑料被所述模具部分包围，所述模具部分的内部与所要形成的袋的形状一致；把气体注入所述塑料内，以便所述塑料膨胀至所述模具的内部边界，使所述塑料与所述模具内部一致；使所述塑料凝固以保持为所述模具的形状；以及从所述模具中移出由此形成的所述袋。
当结合附图考虑以下详细说明时，这些及其它目的将变得明显。
                附图的简要说明
图1是依据本发明的吹塑袋的透视图。
图1A是图1所示一个方向的剖视细部。
图2A示出了一个孔口的连接部件的侧视图。
图2B是图2A所示部件的端视图。
图3A是用于形成图1所示袋的模具的透视图。
图3B示意性示出了模制过程中第一阶段的模具剖视图。
图3C示出了相对于图3B的第二阶段。
图3D示出了吹塑过程中的第三阶段。
图3E在透视图中示出了修剪之前最后所形成的袋。
图4A在剖视图中示出了套圈。
图4B示出了利用工具插入袋内的套圈。
图4C示出了位于袋内的套圈。
图4D示出了被定向以在袋内密封接合的套圈。
图4E示出了被密封在位的套圈。
图4F是图4E所示的侧视图。
图4G示出了形成在套圈上的第二密封。
图4H示出了成形之后的第二密封。
图4I是图4H所示的侧视图。
图5是依据本发明方法的流程图。
            实施本发明的最佳方式
参考附图，类似数字指示类似部件，数字10指依据本发明的袋，数字100指模具。
就袋10而言，其由吹塑过程形成，生成第一平面侧壁2、第二平面侧壁4以及限定该第一和第二侧壁2、4周界的周缘侧壁6。该周缘侧壁6成圆角以提供恒定的曲率半径R(图1A)，这样该壁沿着袋且尤其是侧壁的每个方向都具有恒定的厚度T，使得没有任何结构弱化区域。吹塑过程有助于确保该侧壁(过去是薄弱区域)同其它袋壁一样坚固。图1A还清楚示出了模缝线8的存在，将结合采用吹塑的成形过程来更详细地说明该模缝线8。
一种示例性袋具有提供第一存储区14与第二存储区16之间分界的隔离件12。两存储区14、16经由第一通道18和第二通道20相互连接。这两条通道分别横跨隔离件12的上部和下部以在第一存储区与第二存储区之间提供流体连通。每个存储区都提供有其自己的孔口。具体的，第一存储区14包括第一孔口24。类似的，第二存储区16包括第二孔口26。这些孔口用于从袋10的内部移走制品。第三孔口22用于把制品引入袋内。在实践中，第三孔口接收制品，且该制品经由第一和第二通道在第一存储区与第二存储区之间分配。随后，如果这些存储区不需要同时使用，则将第一和第二存储通道18、20热封以在该存储区之间提供阻隔，使得经由任一存储区自己的孔口使用该存储区。第一和第二孔口24、26都利用套圈32(图4A)加固，该套圈32具有一种容纳在其内且必须被刺穿以存取袋10的容纳物的隔件34。套圈基本为圆筒形，且其底壁上具有倒V形槽口36以及其顶壁上具有倒角38。当插入袋10内时，V形槽口与周缘侧壁的内部配准，使倒V的顶点基本与成圆角侧壁的内部在同一平面上，以允许彻底抽出袋内的所有容纳物。第三孔口22提供有进口管30以便于把液体引入袋的内部。
图3A至D示出了形成图1所示袋的模具。模具100由多个部分形成，在所示例子中由两个部分80A和80B形成。如图3A所示，第一部分80A具有示出了其背面的第二部分80B的镜像，这样模具的所有面都清楚示出了。因此，每个部分都包括第一平面壁102和圆角侧壁106。侧壁106的尺寸是最终形成袋的圆角周缘侧壁6的一半。还示出了一种形成隔离件12的凸出区112。凸出区112允许借助位于其纵向末端处的间隙118和120形成第一和第二通道18和20。注意，通向袋的圆角周缘侧壁6的间隙118和120包括台阶部119，该台阶部119提供位于第一和第二通道18和20处且位于袋的周缘侧壁内的互补颈缩部19。通过具有向下颈缩部，通道更易于被密封。如前所提到的，这允许将第一存储区14和第二存储区16相隔离。
模具100内还形成有歧管70。如所示，歧管由两个半部即第一半部70A和第二半部70B组成，该第二半部70B是详示在图3A中的第一半部70A的镜像。该歧管限定了一种允许形成以下将要描述的孔口的树状物。歧管70包括其轴向延伸通向袋的第一孔口24的主管72。另外，歧管包括从主管72横向发散出的第一横向分支74和第二横向分支76。横向分支74和76包括使其重定向为与管72平行的弯管78，以便将分支76引向第三孔口22以及将分支74引向第二孔口26。
图3B示出了处于敞开状态以接收用以形成袋的塑料材料棒85的模具。一旦棒85已位于模具100的范围内，该模具就闭合(图3C)并形成袋的外部轮廓。参照图3D，歧管70接收一种经由歧管把气体注入模具内部的型坯(parison)90。这迫使塑料棒85变成中空且塑料与内部模具的边界一致，从而制造一种其外壳与模具内表面互补的袋。
如图3D所示，模具优选是导热的且允许发生热传递ΔT，以控制该模具以及所形成袋的温度。出于多个原因，此温度控制是关键的。例如，对模具的精确温度控制可优化产品成形的周期。即，通过谨慎控制模具的温度曲线，能够优化产量。然而此外，对模具温度控制的结果还涉及能通过控制所模制的袋在移出之前经历的温度剧变来对所形成的制品进行应力消除。
无论如何，在图3E所示制品已通过如该图所示修剪线修剪掉歧管之后，获得如图1所示的最终制品。最后步骤表示在图4中，图4描绘了套圈32插入任一经过图3E所示修剪后残存的歧管直立部内的方式。
如所提到的，每个套圈的一端处都包括倒角38。这允许插入工具40通过经由倒角的自对中来定位。插入工具40包括一种与卡持盘44连接的杆42。卡持盘44摩擦卡持着套圈32，并将该套圈32放入将要形成孔口的管和分支内。一旦套圈被插入至使得槽口36配准以便该槽口36的顶点与内周壁共面，第一加热砧50(由第一U形角状物46和第二U形角状物48组成)就作好准备以把套圈接合到由所要形成孔口的歧管残留的未修剪材料内。通过“加热”意思是热激励、声激励或者RF激励。注意到，模具在邻近于歧管与袋的接合处提供有凸耳形成凹室128。这些凸耳形成凹室128结果形成凸耳28，该凸耳28形成在外周面上且与模缝线共面地向上伸出。当角状物50如图4E所示准备闭合时，凸耳28介于角状物元件之间，防止该角状物形成电弧。图4F是其侧视图。一旦套圈已与袋连成一体，可取出插入工具40。然后，利用具有第一平面元件54和第二平面元件56的第二加热砧52来密封在取出插入工具40之后存在的开口。这些砧元件联合形成与第一接头58协作的第二接头60，该第二接头60提供确保袋无菌的密封接触区。
此外，已经对本发明进行了说明，但应明白的是可采取大量结构变形和适应性变化而不脱离如这里及以上所阐述以及如这里及以下权利要求所限定的本发明范围和公允意义。

Claims (2)

1.一种抗破裂医用冷藏袋，用于在低温下储存血液制品，以便所述血液制品从液相改变为固相、然后恢复到液相，所述袋组合包括：
用于所述血液制品的外壳，所述外壳具有一对经由周边端壁互连的第一和第二平行且间隔开的侧壁，所述周边端壁限定了每个所述侧壁的边界，所述端壁包括由在一种可敞开的模具内形成的袋所导致的可辨认模缝线。
2.一种抗破裂医用冷藏袋，用于在低温下储存血液制品以便所述血液制品从液相改变为固相，所述袋这样形成：
把塑料引入由模具部分包围的区域内，
闭合所述模具部分，使得当所述模具部分靠在一起时，所述塑料被所述模具部分包围，所述模具部分的内部与所要形成的袋的形状一致，
把气体注入所述塑料内，以便所述塑料膨胀至所述模具的内部边界，使所述塑料与所述模具内部一致，
使所述塑料凝固以保持为所述模具的形状，以及
从所述模具中移出由此形成的所述袋。
CNA2004800160522A 2003-06-11 2004-06-14 用于容纳血液制品的抗破裂吹塑冷藏袋 Pending CN1802182A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114945786A (zh) * 2019-11-18 2022-08-26 赛多利斯斯泰迪姆北美 用于冷冻、储存和解冻容纳在柔性袋中的生物制药材料的储存单元以及为此种储存单元组装保护系统的方法

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7442178B2 (en) * 2005-03-09 2008-10-28 Jacques Chammas Automated system and method for blood components separation and processing
US9301520B2 (en) 2007-12-21 2016-04-05 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US8177123B2 (en) * 2008-09-24 2012-05-15 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US9199016B2 (en) 2009-10-12 2015-12-01 New Health Sciences, Inc. System for extended storage of red blood cells and methods of use
US11284616B2 (en) 2010-05-05 2022-03-29 Hemanext Inc. Irradiation of red blood cells and anaerobic storage
US9034280B2 (en) 2009-12-16 2015-05-19 General Electric Corporation High-throughput methods and systems for processing biological materials
US8333704B2 (en) * 2009-12-18 2012-12-18 Massachusetts Institute Of Technology Handheld force-controlled ultrasound probe
ES2959120T3 (es) 2010-08-25 2024-02-20 Hemanext Inc Método para potenciar la calidad y la supervivencia de glóbulos rojos durante el almacenamiento
PT3539381T (pt) 2010-11-05 2023-09-26 Hemanext Inc Irradiação de glóbulos vermelhos e armazenamento anaeróbico
US9067004B2 (en) 2011-03-28 2015-06-30 New Health Sciences, Inc. Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly
JP6157050B2 (ja) * 2011-06-22 2017-07-05 株式会社ジェイ・エム・エス 細胞凍結保存容器
FR2977451B1 (fr) * 2011-07-08 2013-08-16 Maco Pharma Sa Kit pour la conservation d'un produit biologique comprenant une poche tridimensionnelle et une enveloppe tridimensionnelle adaptee
JP6097293B2 (ja) 2011-08-10 2017-03-15 ニュー・ヘルス・サイエンシーズ・インコーポレイテッドＮｅｗ Ｈｅａｌｔｈ Ｓｃｉｅｎｃｅｓ， Ｉｎｃ． 一体型の白血球、酸素及び／又は二酸化炭素減損・血漿分離フィルタ装置
US9427512B2 (en) 2012-06-08 2016-08-30 Pall Corporation Filter device
US9421317B2 (en) 2012-06-08 2016-08-23 Pall Corporation Cell harvesting device and system
CN104582669B (zh) * 2012-08-27 2018-07-31 泰尔茂株式会社 血液袋以及具备该血液袋的血液袋系统
US9877476B2 (en) 2013-02-28 2018-01-30 New Health Sciences, Inc. Gas depletion and gas addition devices for blood treatment
US9346571B2 (en) 2013-10-31 2016-05-24 Pall Corporation Multi-chamber freezing bag
AU2015301509B2 (en) 2014-08-14 2018-04-12 Boehringer Ingelheim Animal Health USA Inc. Novel cryopreservation bags and method of use thereof for closed system, high capacity cell-banking
CN113694272A (zh) 2015-03-10 2021-11-26 希玛奈克斯特股份有限公司 氧减少一次性套件、装置及其使用方法
KR102661405B1 (ko) 2015-04-23 2024-04-25 헤마넥스트 인코포레이티드 혐기성 혈액 저장 용기
WO2016183018A1 (en) * 2015-05-12 2016-11-17 Syngen, Inc. Cryogenic storage bag
US11013771B2 (en) 2015-05-18 2021-05-25 Hemanext Inc. Methods for the storage of whole blood, and compositions thereof
BR112018073923A2 (pt) 2016-05-27 2019-02-26 New Health Sciences, Inc. armazenamento anaeróbico de sangue e método de inativação de patógenos
WO2019004304A1 (ja) * 2017-06-27 2019-01-03 国立大学法人 東京大学 細胞保存容器
CN112292032B (zh) * 2018-04-24 2022-05-24 W.L.戈尔及同仁股份有限公司 用于储存和运输生物制药的柔性容器
JP7297094B2 (ja) * 2019-04-23 2023-06-23 スマート ボトル，インコーポレーテッド 可撓性容器およびその中に付属品を設置するためのプロセス
CN115891288B (zh) * 2022-12-06 2024-05-17 嘉兴市天和制药有限公司 一种血小板存储袋连续生产设备及方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2850422A (en) * 1955-01-20 1958-09-02 Fenwal Lab Inc Fluid container port structure attaching method
USRE31135E (en) * 1977-07-22 1983-02-01 Baxter Travenol Laboratories, Inc. Flexible collapsible containers, and method of molding
US5257692A (en) * 1987-10-07 1993-11-02 Cryolife, Inc. Three envelope package for sterile specimens
GB8727228D0 (en) * 1987-11-20 1987-12-23 Guardline Disposables Ltd Waste bag
US6358239B1 (en) * 1992-01-24 2002-03-19 I-Flow Corporation Platen pump
JPH07323488A (ja) * 1994-05-31 1995-12-12 Tokan Kogyo Co Ltd バッグ状容器の製造方法
US5789147A (en) * 1994-12-05 1998-08-04 New York Blood Center, Inc. Method for concentrating white cells from whole blood by adding a red cell sedimentation reagent to whole anticoagulated blood
US7169547B2 (en) * 1994-12-05 2007-01-30 New York Blood Center, Inc. High concentration white blood cells as a therapeutic product
US5655797A (en) * 1995-12-21 1997-08-12 Edstrom Industries, Inc. Sanitary fitting
JPH09173419A (ja) * 1995-12-26 1997-07-08 Nissho Corp 冷凍バッグ
US6146124A (en) * 1996-06-25 2000-11-14 Thermogenesis Corp. Freezing and thawing bag, mold, apparatus and method
US6656550B1 (en) * 1996-10-08 2003-12-02 Alan M. Zamore Dilatation device of uniform outer diameter

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114945786A (zh) * 2019-11-18 2022-08-26 赛多利斯斯泰迪姆北美 用于冷冻、储存和解冻容纳在柔性袋中的生物制药材料的储存单元以及为此种储存单元组装保护系统的方法
CN114945786B (zh) * 2019-11-18 2024-05-17 赛多利斯斯泰迪姆北美公司 用于冷冻、储存和解冻容纳在柔性袋中的生物制药材料的储存单元以及为此种储存单元组装保护系统的方法

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