CN103477201B - 无菌采样系统 - Google Patents

无菌采样系统 Download PDF

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CN103477201B
CN103477201B CN201280009898.8A CN201280009898A CN103477201B CN 103477201 B CN103477201 B CN 103477201B CN 201280009898 A CN201280009898 A CN 201280009898A CN 103477201 B CN103477201 B CN 103477201B
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S·S·罗杰斯
D·M·卡茨
N·波洛克
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Abstract

无菌采样系统包括采样器组件和接口组件。各组件包括外壳，各外壳为各组件限定单独无菌腔。气闸设为使用中提供采样器组件和接口组件内无菌腔的无菌联接；及可再密封的液体连接机构定位成在气闸内操作。采样器组件和接口组件设成连起来时形成包括采样器组件和接口组件各自外壳的外部保护面，其提供无菌内腔和气闸及在外部非无菌气氛与内部无菌气氛之间的气密屏障。可再密封的液体连接机构容纳在无菌腔内并包括来自采样器组件和接口组件二者的至少一个液体连接器，且配置成在使用中至少一个液体连接器能穿过无菌腔和气闸移动以与液体连接机构中另一连接器连接而不接触气闸内任何内表面，且配置成使用中液体连接器能随后被再密封、断开连接和分开。

Description

无菌采样系统
技术领域
本发明涉及一种无菌采样系统。在例如生物处理设备和医用设备的领域中，确定需要从储器中无菌且超净地移除多个样品以及将多个样品注入到储器中。样品和储器必须不能被存在于大气中或者容器外的表面上的传染原污染。本发明寻求这样的需要：在不污染任何样品、不污染与样品或储器接触的采样器中的机构、或者不污染储器自身中液体的情况下，反复地建立并断开无菌的、超净的流体连接。该方法称为“无菌采样”。
背景技术
在医疗领域中，例如在静脉注射疗法中，目前利用单个或者两个橡胶隔膜来满意地实现洁净采样，确保转移到任何样品中的灰尘最少。一种常见方法是使用这样一种系统，其中，针包封在一个隔膜中，并且当被按压到第二隔膜上时，针刺穿这两个隔膜，从而形成了污染风险极低的流体通路。然而，当两个隔膜的两个表面接触时传染性微粒会被捕获在这两个表面之间，并且当针刺穿两个隔膜并滑动穿过两隔膜之间结合部时传染性微粒被转移到针上。在培养营养培养基的许多工艺中，单个传染性微粒会破坏产品。
发明内容
根据本发明，提供了一种无菌采样系统，包括：采样器组件和接口组件，每个组件包括一外壳，每个外壳为每个组件限定了一单独的无菌腔；气闸，其设置用于在使用中提供在采样器组件内的无菌腔和接口组件内的无菌腔的无菌联接；以及可再密封的液体连接机构，其定位成在气闸内操作，其中：采样器组件和接口组件被设置成使得当它们连接到一起时形成了外部保护面，该外部保护面包括采样器组件和接口组件各自的外壳，外部保护面提供了无菌的内腔和气闸以及在外部非无菌气氛与内部无菌气氛之间的气密屏障，并且其中，可再密封的液体连接机构容纳在无菌腔内并包括来自采样器组件和接口组件二者的至少一个液体连接器，并且可再密封的液体连接机构配置成使得在使用中至少一个液体连接器能穿过无菌腔和气闸移动，以与液体连接机构中的另一连接器连接，而不接触气闸内的任何内表面。
所述系统可以设置成使得在使用中液体连接器可以随后再密封、断开连接和分开。
本发明提供了一种采样方式，其中，储器和样品两者都能保持不受存在于大气中或者采样装置和储器的表面上的污染物的污染，并且其中，可以利用同一设备来获得多个样品。此外，本发明不需要例如用来注入高压蒸汽或者环氧乙烷的外部灭菌器件。相反，本发明可以由完全一次性部件制成。
附图说明
现在将参照附图来描述本发明的实例，其中：
图1a和1b是显示本发明原理的示意图；
图2显示了本发明第一优选实施例的外部形状；
图3a到3e显示了本发明第一优选实施例的机构和操作；
图4a到4e显示了本发明第二优选实施例的机构和操作；
图5显示了本发明第一优选实施例的局部剖视图；以及
图6显示了本发明第一优选实施例的进一步说明。
具体实施方式
本发明是一种无菌采样系统，其包括图1a中示意性地所示的两个配合组件。采样器组件2的功能是抽取或者注入单个样品，接口组件1的功能是在采样器组件与被采样的储器38之间提供接口。接口组件1通常在无菌培养期间与储器38保持在一起，并且允许通过使用采样器组件2的一个或多个单元来反复取样。
采样器组件和接口组件2、1一起包括以下部件。第一，设有外部保护面，其由采样器组件和接口组件11、6各自的外壳8、5构成。该外部保护面通过在外部非无菌气氛和内部无菌气氛之间形成屏障来构成无菌腔。第二，设有气闸，其允许采样器组件和接口组件中的无菌腔联接到一起。第三，设有可再密封的液体连接机构，其包括位于采样器组件和接口组件2、1的每个中的连接器。所述连接器中的至少一个移动穿过无菌腔和气闸，以与液体连接机构中另一对置的连接器配合，而不在可能是非无菌的任何表面上滑动。
液体连接机构、无菌腔18、外部保护面5、8和气闸11、6各自如图1中所示被示意性地示出，并且如下所描述地操作。首先，借助于气闸11、6使采样器组件2与接口组件1配合（图1bi）。打开气闸，保持无菌腔18不受外部空气的污染。第二，将液体连接机构7、9、10的各部件在无菌腔内联接起来，并且不滑过可能是非无菌的气闸表面11、6（图1bii）。从而，液体连接机构7、9、10形成了密封的无菌液体流动路径。然后，将样品注入到储器38中或者从其中抽取。然后，通过颠倒以上步骤来分开采样器组件和接口组件2、1：首先，再密封液体连接机构7、9、10并将其分开，并且然后脱开气闸。
本发明不依赖于组成机构的具体形式。该无菌采样系统的新颖性在于在气闸11、6和外部保护面5、8的保护下在无菌腔18内组合可再密封的液体连接机构，以便可以在连接机构的各部件不暴露于外部空气或者不接触可能是非无菌的任何表面的情况下形成液体连接，并且可以在不污染采样器组件或者接口组件的情况下断开液体连接。本发明的这些特性是系统实用性所必需的：在不污染样品或储器38或者不使用外部杀菌设备的情况下反复取样。
以下的说明从第一实施例开始，但是本发明不限于如下所述的几何结构、机构和运动。
如图2所示，第一实施例包括两个机械组件，即接口组件1和采样器组件2。接口组件具有连接至储器的连接器3，并且采样器组件具有连接至样品容器的连接器4。图2显示了用于特征3和4的阴式luer连接器。然而，备选实施例可包括倒钩式管接头、法兰式卫生级接头和法兰焊接式密封件，以连接到一次性袋式生物反应器或者一次性采样袋。
每个机械组件包括如图3的剖视图中详细示出的各自部件。接口组件1包括外壳5、闸板6和液体阀7。在这里，连接至储器的连接器是模制于外壳5外侧上的管接头3。采样器组件2包括壳套8、滑块9、内盖10和外盖11。通过装配在互锁孔16中的互锁钩15，闸板6被锁定在外壳5中的合适位置。
参见图3a-3e来描述第一实施例的操作机构和顺序。图3a显示了采样之前的第一实施例。
图3b中示出了采样的第一步，其中，将采样器组件2推入到接口组件1的配合孔12中。然后，使外盖11完全容纳在闸板的狭槽13中。同时，互锁凸起14将互锁钩15推出到互锁孔16外。这就允许闸板6竖直地滑动。壳套8和外壳5的配合面形成了气密表面17。
图3c中示出了采样的第二步，其中，闸板6滑下来。这使外盖11从壳套8上移离，其效果是将采样器组件和接口组件2、1中的无菌气氛联接到单个无菌腔18中。此时，无菌腔18包括内盖10和液体阀7之间的直接通路，而外盖11完全地离开无菌腔18而被收起。
图3d示出了采样的第三步。滑块9现在被推向接口组件，以使内盖10与液体阀7配合。内盖10包括对准件19，其与液体阀7上的凹部配合。液体阀7和内盖10在外壳5内形成了连续的、密封的、圆柱形滑动面20。
图3e示出了采样的第四步。液体阀7转动到打开位置，以便通道22现在形成了在连接储器的连接器3与连接至样品容器的连接器4之间的敞开通路。然后，利用储器的正压力或者向样品容器施加抽吸，样品流动通过。
取样后移除采样器组件2。移除运动与以上四个步骤刚好相反，导致采样器组件2的拆开，如图3a所示。
第一实施例的其它细节如下。
如图5中的断面图所示，可以在壳套8上设置凸部23来与闸板6中的狭槽24互锁，以使壳套8保持抵靠外壳5，以便在这两个部件之间形成气密封。图6显示了该气密封17的位置，其还包括位于两个配合面中至少一个上的顺应材料。可以在图3a所示的如下部件之间设置类似的凸部：在外盖11与壳套8之间，以及在内盖10与滑块9之间。
图6中示出了优选实施例所需的密封面，它们是：壳套8和外壳5之间的表面17；壳套8和滑块9之间的表面25；外壳5和闸板6之间的表面26；外壳5和液体阀7之间的表面27；外壳5和内盖10之间的表面28；滑块9和内盖10之间的表面29；滑块9和液体阀7之间的表面30；内盖10和液体阀7之间的表面31；以及壳套8和外盖11之间的表面32。
所有的密封面可以通过以下方式来形成：在以上列举的每对部件中的至少一个表面上包括有顺应材料，或者通过在各对部件的配合面之间包括有另外的顺应密封件（例如O形圈）。
图6中示出了另一可选特征，其限制滑块9和壳套8之间的移动范围。此处，柱33附连到滑块9上并且在壳套8中的凹槽34内移动。柱33确保滑块9不能被完全地从壳套8中拔出。
图6中还示出了组装到外壳5中的可透气的排气孔35。该排气孔35确保由内部零件的运动所引起的排气不会在图3c所示无菌腔18内产生气压变化。该排气孔35还确保外界气压变化不会在前述任何密封面之间产生漏气。所述排气孔可由过滤材料制成，以排除直径大于0.22微米的微粒。
该实施例的一种变例是使用一不同的液体连接机构，以便用替代的直线式或者回转式阀机构来替代液体阀7和内盖10。这些阀在现有技术中是众所周知的。
该实施例的另一变例是闸板6和外壳5的改变，以使闸板进行圆形滑动运动，而不是直线滑动运动。
图4a-4e中示出了本发明的第二实施例。该实施例与本发明原理是一致的，并且步骤的顺序类似于第一实施例。以下描述与第一实施例的差异。
如图4a所示，该例中液体连接机构包括一针35和一对隔膜：样品隔膜36和接口隔膜37。接口隔膜37把储器38与接口组件1密封隔离开。图4b至4e显示了将采样器组件2连接至储器38的内容物的操作顺序。参见图4b-4e，与第一实施例（图3b-3e）的操作顺序的差别是：液体连通现在是通过如箭头41所示推动滑块9直接经过图4d中所示的位置到图4e中的位置来形成的。因此，针35刺穿隔膜36和37两者并且进入储器38中，以便形成无菌的液体连接39。通过颠倒图4b到4e的步骤顺序来移除采样器。隔膜36和37两者都是由弹性体材料制成的，该弹性体材料能够在移除掉针之后再密封刺穿的孔。接口隔膜37设计成确保当移除了针35时接口隔膜37仍能维持液密密封和气密密封，即使在多次刺穿之后也一样。采样容器的一个可选实施例是如图4a所示的注射器40。

Claims (9)

1.一种无菌采样系统，包括：采样器组件和接口组件，每个组件包括一外壳，每个外壳为每个组件限定了一单独的无菌腔；气闸，其设置用于在使用中提供在采样器组件内的无菌腔和接口组件内的无菌腔的无菌联接；以及可再密封的液体连接机构，其定位成在气闸内操作，其中：采样器组件和接口组件被设置成使得当它们连接到一起时形成了外部保护面，该外部保护面包括采样器组件和接口组件各自的外壳，外部保护面提供了无菌的内腔和气闸以及在外部非无菌气氛与内部无菌气氛之间的气密屏障，并且其中，可再密封的液体连接机构容纳在无菌腔内并包括来自采样器组件和接口组件二者的至少一个液体连接器，并且可再密封的液体连接机构配置成使得在使用中至少一个液体连接器能穿过无菌腔和气闸移动，以与液体连接机构中的另一连接器连接，而不接触气闸内的任何内表面，其中，通过采样器组件中的外盖与在接口组件中的外壳内滑动的闸板配合来提供所述气闸。
2.根据权利要求1所述的无菌采样系统，其中，所述闸板沿直线路径滑动。
3.根据权利要求1所述的无菌采样系统，其中，所述闸板沿圆形或者弧形路径滑动。
4.根据前述权利要求中任一项所述的无菌采样系统，其中，通过包括两个部件的回转阀来提供所述液体连接机构，所述两个部件当连接到一起时提供了具有至少一个内部通道的密封圆柱面。
5.根据权利要求1到3中任一项所述的无菌采样系统，其中，通过可再密封的直线阀或者回转阀来提供所述液体连接机构。
6.根据权利要求1到3中任一项所述的无菌采样系统，其中，通过可变形隔膜、穿刺针和接口隔膜来提供所述液体连接机构。
7.根据权利要求1到3中任一项所述的无菌采样系统，其中，通过穿刺针、隔膜和直线阀来提供所述液体连接机构。
8.根据权利要求1到3中任一项所述的无菌采样系统，该无菌采样系统设置成使得在已经从接口组件中移除采样器组件之后就不再提供在采样器组件内的单独无菌腔。
9.根据权利要求1到3中任一项所述的无菌采样系统，该无菌采样系统配置成使得在使用中液体连接器能够随后被再密封、断开连接和分开。
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