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CN1681710A - 无菌可置换单元 - Google Patents

无菌可置换单元 Download PDF

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CN1681710A
CN1681710A CNA038223961A CN03822396A CN1681710A CN 1681710 A CN1681710 A CN 1681710A CN A038223961 A CNA038223961 A CN A038223961A CN 03822396 A CN03822396 A CN 03822396A CN 1681710 A CN1681710 A CN 1681710A
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container
room
fluid
distributing box
chamber
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CN100379652C (zh
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詹姆士·R·埃尔斯沃斯
保罗·麦戈文
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Fengshou Biological Co ltd
Globus Medical Inc
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Abstract

设计成用作离心机中的可置换加工单元的容器包括由桥接部分连接的第一和第二室，桥接部分允许流体在所述室之间传输。所述室中的一个具有倾斜的地板，该地板将流体引向较小的底部，以在收集的流体中提供更大的深度。容器还包括凸轮面，其便于容器在希望的方位上插入离心机中。此外，可以提供键以确保容器用于正确的离心机中。

Description

无菌可置换单元
技术领域
本发明涉及在处理离心机里的流体中使用的容器的技术，更具体地，本发明涉及一种可置换容器，其具有多个用来在离心机中加工血液和其它生理产品的室。
背景技术
从US5707331中已知一种使用多室容器的滗析离心机。根据该专利，无菌加工可置换件提供了彼此相邻布置的两个室，以便两个室之一中的上清液可以通过重力排流或离心转移技术，滗析到另一个室中。
发明内容
根据本发明，无菌加工可置换单元提供了便于流体分离和容易制造的部件，容器包括基部和盖子，它们两者能便宜地模制，如通过注模法。基部包括两个室，其间具有分隔件。分隔件优选地包括在两个室的顶部连接的间隔壁，但它也可以是单个的壁，分隔件的顶部构形成允许上层流体在其上流过，流入相邻的室中。
每个室的尺寸设计成容纳将被接收在特定室中的流体，和便于室中物质组分的离心分离。一个室大致为管状，其尺寸能接收预定体积的血液，血液将被加工以生产所希望浓度的自体富含血小板的血浆。在优选实施方式中，该室设计成在一种情况下接收25ml血液，在另一种情况下接收60ml血液。接收滗析血浆的第二室可以小于第一室，并进一步提供更小的底部用来接收从滗析血浆分离的血小板，以便于这些血小板的抽出。优选地，使底部的横截面减小以使血小板的高度增加，进一步便于血小板的抽出。
第二室的地板优选地逐渐变细以将分离的血小板引向第二室的底部，以便可以在随后的步骤中将它们容易地取出。在优选实施方式中，容器的一般构形是圆形，第二室的锥形地板优选地是螺旋形的。
地板的螺旋形构形也可以用来将容器定向在接收容器的离心机架中。机架通过耳轴枢轴地安装到离心机转子，当使用者将容器插入到机架中时，在没有定向时，容器的螺旋形地板接合机架的一部分，例如机架侧部上的定向凸出部。在优选实施方式中，一裙部从底面向下延伸以形成凸轮面，凸轮面接合机架以在插入过程中将容器定向在机架中。裙部可以构形成提供该凸轮面，室的内侧地板可以具有与裙部相同的形状或不同的形状。这允许第二室的地板构形成便于血小板朝着第二室的底部移动，和允许裙部构形成便于容器的定向。
容器还具有确保容器正确地接合在机架中的外部部件，例如，机架可以设有键，该键与容器上的键合作以确保将容器正确地容纳在机架中。此外，特定离心机的机架可以不同于另一种离心机的机架，以确保不会将为一个离心机专门设计的容器意外地用于另一个离心机。
优选地，第二室的底部构形成当在滗析定向中和在第二离心过滤期间呈现的定向中时，适应容器的定向，由此血小板从滗析血浆中分离。
容器的盖子盖住基部以提供无菌性，同时允许无菌地进入所述室中。因而，盖子包括每个室的无菌入口，和一气孔，用来允许在将血液引入第一室期间排出的空气流出和血浆和/或血小板从第二室退回期间的空气进入。
容器还包括被容纳在第一室中的浮动分配器。浮动分配器设计成出现在一个位置，该位置在血浆和红血球之间的交界面处或附近，其中血浆和红血球在初始离心加工过程中已经分离。浮动分配器是杯形的，设计成在其外围和第一室的内部之间提供一空间，以允许血浆、红血球和其它细胞组分在离心分离过程中通过。优选的分配器还包括中心孔，以允许组分在离心分离过程中通过。在滗析过程中，分配器绕着与室的纵向轴线成横向的轴线倾斜，从而充当一阀，该阀阻止位于分配器下面的红血球的滗析。
附图说明
图1是根据本发明的容器的透视图；
图2是沿图1的线2-2获得的横截面；
图3是图1的容器的装配图；
图4是图1的容器的基部的透视图；
图5是图4的基部的侧视图；
图6是图4的基部的顶视图；
图7是图2中指出的容器部分的放大细节；
图8是优选浮动分配器的横向截面；
图9是图8中指出的分配器部分的放大细节。
具体实施方式
参考附图，根据本发明的优选容器2一般包括基部4和盖子6，基部提供了第一室8和第二室10。第一室8优选地是圆柱形，由圆柱形外壁14形成，但也可以具有其它形状。第一室容纳浮动分配器12，浮动分配器12漂浮在被引入第一室里的流体中，在优选实施方式中，分配器12也是圆柱形的。应该懂得，第一室的构形必须与分配器配合以允许分配器漂浮在流体中。
几个壁相交以提供第二室10的希望形状。第一外壁16大致为圆柱形，至少部分地在第一室8周围延伸。内壁18也大致为圆柱形，并通过桥接部分20在它们的上端结合到第一室的外壁14。
第二室10包括第一地板部22(看图3，4，6)，第一地板部22布置成朝着第二室的底部24倾斜，地板22优选地是螺旋形的。底部包括表面26和28，表面26和28进一步减小底部的横截面。应该懂得，螺旋形表面22将通过离心作用分离的血小板引向底部，减小的底部横截面导致减小的容积，这使所收集的血小板的垂直长度更大，便于通过套管将它们从第二室中取出。
在优选实施方式中，表面28如此定向，即在血小板的收集过程中当容器受到离心作用时，表面28是垂直的。例如，底部可以定向成相对于基部的上表面成大约7°。
盖子6包括提供无菌进入第一室的第一入口30和提供无菌进入第二室的第二入口32，这些入口优选地由柔性合成材料制造，并插入形成盖子剩余部分的材料中的孔内。当然，其它构造也是可能的，并且它们可以与盖子的剩余部分成一整体。还提供了气孔33以在保持所述室的无菌性的同时，允许空气进入和排出。
盖子提供了中央部34，其相对于外侧部36升高，它们两者通过中间壁38部分地连接。在滗析过程中，血浆越过桥接部分20并穿过桥接部分20与壁38之间的通道40，这样，该通道将血浆引入第二室中。
第一室下表面的外部可以设有脚部42，以便于将容器搁在桌子或其它平坦表面上。
优选地，容器适合于在特定方向上保持在离心机的机架中。在一个实施方式中，第二室的地板22的螺旋形状还充当引导件，以帮助操作者将容器定向在机架中。然而，优选地，裙部44从地板延伸以提供该引导作用，并允许两个部件具有专门适合于特定目的的不同形状。另外，例如以46所示的凹口在地板22的上端之间形成于容器中，该凹口设计成在容器正确地对齐在机架中时，接合机架中的相似成形件。凹口可以具有不同形状，可以包括其它部件，例如与机架中一部件接合的隆起(未示出)，由此具有大部分共同部件的容器可以通过凹口的形状或构形(例如宽度)或其它部件的存在彼此区别开来。
图7表示基部的上缘48和盖子的周边50之间的首选接合。上缘48向上延伸并稍向外张开以接合周边50，形成封住流体的密封。该接合是这样的，即盖子可以在没有胶粘剂或粘结剂的情况下连接到基部上。
图8和9表示优选的浮动分配器。该分配器是杯形的，这样安装在第一室中，在分配器的外表面52和形成第一室的壁14的内表面之间设有小的空间。优选地，分配器底部设有孔口56以允许被分离的组分通过，该孔口可以形成于壁底部54的升高部58中。在优选实施方式中，孔口的直径大约是0.058英寸，升高部58升高大约0.02英寸，孔口的入口倒角为与水平面成大约135度。
在所附权利要求的范围内的修改对本领域技术人员来说是明显的。

Claims (11)

1.一种容器，包括：
形成通过桥接部分连接的第一室和第二室的基部，当所述容器处于预定方位中时，桥接部分允许所述第一室中的流体流到所述第二室中；
其中所述室中的一个包括狭窄的底部和倾斜的地板部，所述地板部布置成将所述流体引向所述底部。
2.如权利要求1所述的容器，其中所述倾斜的地板是螺旋形的。
3.如权利要求2所述的容器，还包括定向装置，其形成凸轮面以定向所述容器。
4.如权利要求3所述的容器，其中所述定向装置包括裙部，其从所述室中所述的那一个的底部延伸。
5.如权利要求2所述的容器，还包括螺旋形的裙部，其从所述室中所述的那一个向下延伸。
6.如权利要求1所述的容器，其中所述第一和第二室由桥接部分连接，所述容器还包括盖住所述第一和第二室的盖子，所述盖子具有盖住所述第一室的升高部、盖住所述第二室的凹入部和一中间壁，该中间壁与所述桥接部分一起形成通道以接收所述流体。
7.如权利要求6所述的容器，其中所述盖子包括进入装置，用来提供无菌进入所述第一和第二室。
8.如权利要求7所述的容器，其中所述进入装置包括所述升高部中的第一入口和所述凹入部中的第二入口。
9.如权利要求7所述的容器，还包括所述第一室中的浮动分配器。
10.如权利要求9所述的容器，其中所述浮动分配器是圆柱形的，包括允许流体在离心分离过程中通过的孔口。
11.如权利要求10所述的容器，其中所述浮动分配器包括隆起，隆起中具有所述孔口。
CNB038223961A 2002-09-19 2003-09-17 用于无菌可置换单元的容器 Expired - Lifetime CN100379652C (zh)

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AU2003272492B2 (en) 2007-12-20
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CN100379652C (zh) 2008-04-09
EP1549552B1 (en) 2013-06-26
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