CN107771093A - 用于混合两种组分和用于在存储条件下保持真空的注射器 - Google Patents

用于混合两种组分和用于在存储条件下保持真空的注射器 Download PDF

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CN107771093A
CN107771093A CN201680036630.1A CN201680036630A CN107771093A CN 107771093 A CN107771093 A CN 107771093A CN 201680036630 A CN201680036630 A CN 201680036630A CN 107771093 A CN107771093 A CN 107771093A
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plunger
syringe
cylinder
barrier film
vacuum chamber
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CN107771093B (zh
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克里斯蒂安·拉森
L·S·艾利
T·I·詹森
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Ferrosan Medical Devices AS
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Abstract

本发明涉及一种用于混合两种物质的注射器，所述两种物质已经例如在储存条件下分开地保留在注射器内。具体地说，本发明涉及一种注射器，其用于1)将干组分保留在真空中，以及2)将干组分与水性介质混合以形成可流动物质。一个实施方式涉及用于保留和混合第一和第二物质的注射器，其包括：包括可密封和/或可封闭的远侧出口和用于容纳第一物质的真空腔室的圆筒，结合有用于容纳第二物质的储存腔室并且构形成轴向地移动通过圆筒的近端的柱塞，分隔真空腔室和储存腔室的隔膜，以及用于刺穿隔膜的尖锐构件，诸如一个或多个针。

Description

用于混合两种组分和用于在存储条件下保持真空的注射器
技术领域
本发明涉及一种用于混合两种物质的注射器，所述两种物质已经例如在储存条件下被分开地保持在注射器内。具体地说，本发明涉及一种注射器，其用于1)将干组分保留在真空中，以及2)将干组分与水性介质混合以形成可流动物质。
背景技术
不同物质的混合过程和操作可能是耗时的。一些类型的药物被提供并存储在两个分开的腔室中。这种药物可以包括固体组分和液体溶剂，并且被称为两部分配方。固体组分可以是例如粉状药物。所述物质还可以包括两种液体物质和/或两种药物。在用药之前，组分必须被混合。
一般来说，注射器可以被看作简单的泵装置，其由管中的柱塞组成，用于用药注射、引入静脉注射药物或应用复合剂。有许多注射器能够混合和输送两种物质，包括自动注射器。在这些注射器的一些中，有两个腔室和用于在通常通过针输送混合物之前在所述腔室之一中或在第三腔室中混合物质的机构。
US4048999示出了一种用于医疗目的的双腔室注射器，其具有一个用于液体的腔室和一个用于固体或另一种液体的容器。注射器具有塞子，该塞子具有将注射器连接到药水瓶的轴向孔，以及密封轴向孔的第二塞子，并且适于通过向内致动注射器的活塞而将注射器中的液体排出到容器中。
可以被认为在本领域中已知的是，在注射器中包括能够将一种组分从一个腔室转移到另一个腔室的内针，由此混合组分。WO2010/020800A1示出了具有混合装置的自动注射器，其具有用于两种不同组分的第一和第二腔室。自动注射器包括注射针和内部转移针，其中转移针能够刺穿自动注射器内的塞子以建立通过针的流体连接，并且在注射两种组分之前将两种组分混合。
具有几个腔室和用于混合几种组分的装置的已知注射器具有许多缺点。混合和注射通常依赖于缺乏精确控制的手动移动或利用电力来控制混合和注射。这些设计往往过于复杂，需要精确的整理才能工作。
发明内容
本发明涉及一种用于保留和混合第一和第二物质的注射器，其包括圆筒，圆筒包括可密封和/或可封闭的远端出口和用于容纳第一物质的真空腔室。注射器优选地包括柱塞，所述柱塞优选地结合有用于容纳第二物质的储存腔室。柱塞可以构形成轴向地移动通过圆筒的近端。注射器优选地包括分隔真空腔室和储存腔室的隔膜。可以提供诸如一个或多个针的尖锐构件作为适于刺穿隔膜的注射器部分。注射器优选地构形成使得隔膜和尖锐构件相对于彼此可轴向滑动，优选地与圆筒相对于柱塞的轴向移位相对应。即，注射器优选地构形成使得柱塞相对于圆筒的轴向移位对应于隔膜和尖锐构件相对于彼此的轴向移位。例如，如果隔膜附接到柱塞，则尖锐构件附接到圆筒，或反之亦然。
注射器可以构形成使得柱塞在圆筒中从第一位置到预定的第二位置的轴向移位通过尖锐构件刺穿隔膜并且在储存腔室和真空腔室之间建立流体通道。优选地，真空腔室中的真空由此将第二物质吸入真空腔室中；真空腔室中的真空由此使储存腔室的内容物转移到真空腔室中，优选地没有柱塞从所述预定的第二位置的移位。即，储存腔室由此被排空或几乎排空。
本发明公开的注射器的一个优点在于，储存腔室结合在柱塞中用于容纳第二物质。利用柱塞内的空间来存储组分之一使得注射器更紧凑和更轻。柱塞是注射器的可移动部分(相对于圆筒)的事实也可以使得设计简单，因为可以将尖锐构件安装在圆筒上，这通常比让针作为移动部件更稳定。
本发明公开的注射器的另一个优点是用于容纳第一物质的圆筒中的真空腔室。如果在真空腔室中产生真空，则可利用真空将柱塞移向真空腔室/真空腔室内部，并将第二物质从储存腔室吸至真空腔室。通过首先在真空腔室中施加真空和然后让真空1)拉动柱塞，和2)将储存腔室的内容物抽入真空腔室，由此物质被混合，可以以非常受控和自动的方式提供混合过程而不涉及柱塞的手动推力或手动移动。如果柱塞的部件是在部件总是具有相同的尺寸和形状的过程中制造的，并且以相同的方式施加产生真空，那么也可以期望每次都以相同的方式进行混合。
适于刺穿隔膜的尖锐构件是本发明公开的注射器的另一个优点，其中注射器构形成使得隔膜和尖锐构件可相对于彼此轴向滑动。如果被针扎的部件被附接到圆筒并且可相对于尖锐构件轴向滑动(其可以是柱塞的一部分，构成两个腔室之间的分隔屏障)，则真空腔室中的真空可以用于使柱塞移向真空腔室，由此尖锐构件刺穿所述构件并在两个腔室之间提供流体连接。
几个上述特征的组合也可以被认为进一步改进了设计，其可以与一系列附加机构一起使用以便利用本发明。例如，注射器还可以包括不同种类的锁定构件，以控制柱塞在圆筒内的轴向位置。如果在真空腔室内施加真空，则机械锁定机构可以确保柱塞不移向真空腔室直到用户移除锁定。
此外，柱塞内的可轴向滑动的塞子可以用于限制柱塞中的储存腔室。注射器可以构形成使得当储存腔室中的物质被转移到真空腔室时，塞子在柱塞内向远侧滑动。此外，当第一腔室的储存器的物质已经被转移到真空腔室时，塞子可以进一步用于堵塞两个腔室之间的流体连接。优选地，塞子由也可以被尖锐构件刺穿的材料制成。因为，在一个实施方式中，尖锐构件在刺穿隔膜之后穿过隔膜伸出，在优选的实施方式中，塞子由也可以被尖锐构件刺穿的材料制成，这允许塞子被真空腔室的真空抽吸到其与柱塞或构件的远端邻接的位置。
本发明的这些和其他方面在本发明下面的详细描述中阐述。
附图说明
图1A示出了本发明公开的具有第一和第二锁定元件的注射器的一个实施方式的横截面图，其在第一构形中在真空腔室中保持真空。
图1B示出了图1A的注射器，其中第一锁定元件已经被移除，并且真空腔室中的真空的抽吸力已经使柱塞移动到一个位置，在该位置中，储存腔室中的第二物质通过尖锐构件和隔膜之间的轴向分隔部分被转移到真空腔室。第二锁定元件防止柱塞进一步移向真空腔室。
图1C示出了图1A-B的注射器，其中真空腔室中的真空已经清空了储存腔室并且使塞子移动以邻接隔膜。第二锁定元件仍然防止柱塞进一步移向真空腔室。
图1D示出了图1A-C的注射器，其中第二锁定元件已被移除。塞子邻接隔膜。在该构形中，柱塞可以被向下推以通过注射器的出口输送真空腔室中的混合内容物。
图1E示出了图1A-D的注射器，其中柱塞和塞子已经被向下推向真空腔室以清空真空腔室的内容物。在这个位置中，塞子已经被尖锐构件刺穿。
图1F示出了图1A-E的注射器，其处于这样的位置中，其中通过将柱塞推到最终位置，真空腔室的所有内容物已被清空。
图2示出了本发明公开的注射器的一个实施方式的近端，其具有与柱塞接合的锁定元件，真空旁路通道以及适于匹配真空旁路通道的纵向突起。
图3A示出了本发明公开的注射器的示例性柱塞的图示。
图3B示出了图3A中的柱塞的横截面图。
附图仅是示例性的，不应被解释为限制本发明的范围。
定义
“环境压力”在本文中与术语“大气压力”可互换使用。它是周围地区的压力，即过程发生位置处的压力。
“减压”是低于环境压力的压力，即低于某一过程操作的周围区域压力的压力。
“真空”在本文中被定义为气压小于环境压力(即周围的大气压力)的区域。在地球上的海平面，大气压力在25℃时约为1巴，即1000毫巴。下表显示了地球上海平面处的“低”、“中”和“高”真空的近似压力，单位为毫巴(mbar)。
压力(毫巴)
大气压力 1000
低真空 1000至100
中真空 100至0.001
高真空 ＜0.001
具体实施方式
如所述的，本发明涉及一种用于保留和混合第一和第二物质的注射器，其包括：包括可密封和/或可封闭的远端出口和用于容纳第一物质的真空腔室的针管，结合有用于容纳第二物质的储存腔室并且构形成轴向地移动通过针管的近端的柱塞，分隔真空腔室和储存腔室的隔膜，以及用于刺穿隔膜的尖锐构件，诸如一个或多个针，其中注射器构形成使得隔膜和尖锐构件可相对于彼此轴向滑动。
通过将柱塞结合在储存腔室中，与圆筒包含用于分离物质的两个腔室的解决方案相比，可以使得注射器更紧凑和更轻。在一个实施方式中，储存腔室被完全包含在柱塞中，和/或其中储存腔室至少部分地由柱塞的外壁限定。优选地，储存腔室是在柱塞的壁内的封闭容积，可能具有盖或罩，替代地在中空柱塞内具有塞子。在一个实施方式中，储存腔室由柱塞的中空部分限定。
注射器优选地构形成使得隔膜和尖锐构件可相对于彼此轴向滑动。想法是，隔膜将两种物质保持在分开的容器(即储存腔室和真空腔室)中，最初在两者之间没有流体连接。隔膜和尖锐构件相对于彼此可轴向滑动的事实意味着，如果尖锐构件构形成使得尖锐构件的尖端指向隔膜，则在它们相遇时，尖锐构件可以刺穿和破坏隔膜。优选地，在这样的设计中，尖锐构件附接在圆筒内，优选地附接在圆筒的远端指向柱塞和隔膜。与具有在圆筒内移动的针相比，这可以被看作是稳定的解决方案。
构形和锁定机构
本发明公开的注射器可以在一种或多种构形中操作。在一个实施方式中，注射器可以构形成在第一构形中将真空保持在真空腔室中，所述第一构形优选为注射器的存储状态。在这种构形中，真空腔室是封闭的容器。这种构形不仅可以用于将物质储存在真空腔室中，而且也可以被认为是“充能”状态，因为在真空腔室中存在固有的能量。当真空腔室从密闭容器变成与另一容积相连时，会产生吸力。因此，如果注射器构形成在第一构形中将真空保持在真空腔室中，那么可以通过将真空腔室连接到储存腔室来释放该力。在第一构形中，可以说注射器处于具有固有能量的状态中，该状态稍后可以用于混合两个腔室的物质，优选地不添加任何外部的手动力来移动柱塞。
在第一构形中，隔膜和尖锐构件优选地在圆筒内轴向分开。这确保了真空腔室保持封闭的容积，保持真空，直到尖锐构件刺穿隔膜为止。
在一个实施方式中，在第二构形中，注射器构形成在真空腔室和储存腔室之间提供液体连通。优选地，在这种构形中，尖锐构件刺穿隔膜。可以说尖锐构件在两个腔室之间产生液体连通。如果在第一构形中真空被施加到真空腔室，则第二构形可以充当两种物质在真空腔室中混合的构形。这是通过来自真空腔室的抽吸力以及两个腔室现在处于液体连通的事实来实现的。因此根据该描述，储存腔室和真空腔室可以在第一构形中流体地断开，并且在第二构形中流体连接。
本发明还涉及用于实现上述构形的机械装置。在第一构形中，隔膜和尖端构件优选地在圆筒内轴向分开，而真空被保持在真空腔室中。如上所述，在真空状态中，存在将(通常可轴向移动的)柱塞拉向真空腔室的固有的力。柱塞的移位可以通过锁定机构来机械地防止；因此，在一个实施方式中，本发明公开的注射器还包括可移除的锁定构件，锁定构件构形成接合并限制柱塞在圆筒内的远侧轴向移位。实现这种锁定机构有几种方式。在一个实施方式中，锁定构件构形成接合从圆筒的近端伸出的柱塞的近侧部分。图1A示出了这种解决方案的例子。在该示例中，第一锁定元件9邻接柱塞凸缘11并防止柱塞朝向真空腔室移动。在一个实施方式中，第一位置由与柱塞接合的第一和第二锁定元件联合确定，并且其中第二位置仅由与柱塞接合的第二锁定元件确定。在所提及的实例中(图1A和1B)，第一锁定元件被圆筒凸缘12的上侧间接锁定(在第一锁定元件9和圆筒凸缘12之间具有第二锁定元件10)。该例子不应被看作是将第一锁定元件限制成这个解决方案——可以设想限制柱塞在圆筒内的远侧轴向移位的可移除锁定构件的其他机械锁定解决方案。因此，在另一个实施方式中，锁定构件构形成在柱塞相对于圆筒的两个不同的轴向位置中接合和限制柱塞在圆筒内的远侧轴向移位。
在本发明公开的注射器的一个实施方式中，锁定构件包括第一锁定元件和第二锁定元件，每个所述锁定元件构形成接合和限制柱塞在圆筒内的远侧轴向移位。两个锁定元件可以放置成使得第一锁定元件和第二锁定元件被构形成在彼此的轴向延伸部分上接合柱塞。第二锁定元件可以用于相对于圆筒将柱塞(和可能的尖锐构件)锁定在第二位置中。在这种状态下，两种物质可以在真空腔室中混合，但是机械地防止柱塞进一步朝向圆筒的远端移动以输送混合的内容物。因此，在本发明公开的注射器的一种构形中，柱塞从第一位置到预定的第二位置的轴向移位通过尖锐构件刺穿隔膜，并在储存腔室和真空腔室之间建立流体通路。两个构形的例子分别示出在图1A和b中。在一个实施方式中，第一构形对应于柱塞在圆筒中的第一轴向位置(图1A，第一和第二锁定元件存在)，第二构形对应于柱塞在圆筒中的第二轴向位置(图1B，第一锁定元件被移除，第二锁定元件存在)。如上所述，和如在图1A和1B的示例中可以看到的，在一个实施方式中，注射器构形成使得柱塞被锁定在第一构形中，和在一个实施方式中，注射器构形成使得柱塞被锁定在所述第二构形中。
在一个实施方式中，本发明公开的注射器构形成使得柱塞在所述第一构形中被限制了在远侧方向上的轴向移位，优选地借助于用于在所述第一构形中接合和锁定柱塞的可移除的第一和第二锁定元件。关于这一点，远侧方向具有柱塞朝向圆筒的远端移动的含义。如上所述，这意味着，在优选的实施方式中，柱塞在远侧方向上被锁定，从而使尖锐构件不刺穿隔膜并且物质不能混合。当柱塞被解锁(例如通过移除锁定构件)时，真空腔室中的真空导致柱塞从第一位置轴向移位到第二位置。类似地，在第二构形中，可以限制柱塞在远侧方向上的轴向移位，优选地借助于适于在所述第二构形中接合和锁定柱塞的可移除的第二锁定元件。
本发明公开的注射器的另一方面涉及包括一个或多个液体旁路通道的尖锐构件，所述液体旁路通道构形成在隔膜被刺穿时在储存腔室和真空腔室之间提供液体连通，这将在下面进一步解释。关于注射器的部件的构形和/或位置，本发明提出了在隔膜被尖锐构件刺穿时如何在两个腔室之间提供液体路径的解决方案。发明人已经认识到，通过相对于尖锐构件在轴向方向上锁定隔膜(优选位于柱塞的远端处)，旁路通道可以定位成使得它允许物质从储存腔室流到真空腔室。因此，在一个实施方式中，注射器构形成使得在第二构形和/或第二位置中，所述一个或多个旁路通道中的至少一个与隔膜轴向对齐。图1B中可以看到这种对齐的例子，其中旁路通道15(尖锐构件中的小凹口或凹槽)与隔膜7轴向对齐，从而使物质可以从储存腔室6流到真空腔室4。
隔膜和尖锐构件
如所述的，本发明公开的注射器具有分隔真空腔室和储存腔室的隔膜，和用于刺穿隔膜的尖锐构件，例如一个或多个针。在优选的实施方式中，隔膜将真空腔室的近端和储存腔室的远端分隔开。在一个实施方式中，隔膜附接到和/或形成柱塞的远端。如果柱塞具有空心本体或中空部分，则这意味着隔膜构成柱塞的一部分或整个底部/远侧。图1A-F中示出了这种实现方式的例子。注射器的柱塞可以是具有圆形端部(像试管)或基本上平坦的远端的圆柱形，其中在柱塞是圆柱形的情况下，远端基本上是圆形的。因此，在一个实施方式中，远端的一部分可以被能被尖锐构件刺穿的材料代替。优选地，柱塞由诸如塑料之类的硬质材料制成，隔膜由软的/较软的材料制成，例如橡胶状材料。这个实施方式的理念是，在圆筒内的柱塞向远侧移位时，尖锐构件应刺穿隔膜。在这方面，柱塞(包括隔膜)可以被认为是设计的移动部件，而圆筒可以被认为是固定部件。注射器优选地包括柱塞和圆筒之间的密封接合，例如呈柱塞的远端中的橡胶密封件的形式，其也有助于在本发明公开的注射器的第一构形中保持真空腔室中的真空。如图3中所示，隔膜7可以通过环形突起19附接到柱塞5的远端。隔膜7包括可刺穿的隔膜阻隔件7'和提供与圆筒2的密封接合的密封凸缘20。
在一个实施方式中，尖锐构件附接在圆筒内，优选地附接在圆筒的远端。在这种构形中，尖锐构件和隔膜可以相对于彼此移动。尖锐构件优选地在圆筒内轴向延伸，即沿圆筒的纵向方向延伸。在图1A的示例中，可以看到尖锐构件如何附接到圆筒的远端，在圆筒内从圆筒的远端轴向延伸并指向圆筒的近端。
如所述的，具有能够刺穿储存腔室和真空腔室之间的隔膜的尖锐构件的理念是为了提供旁路通道，旁路通道利用真空腔室的真空从储存腔室抽吸物质以与真空腔室的物质混合。因此，在本发明公开的注射器的一个实施方式中，尖锐构件包括一个或多个液体旁路通道，其构形成在隔膜被刺穿时在储存腔室和真空腔室之间提供液体连通。液体旁路通道可以呈空心针的形式。液体旁路通道也可以利用锁定机构和上述第二构形。发明人已经认识到，如果第二构形对应于柱塞在圆筒中的第二锁定轴向位置，则该已知位置可以用于设计液体旁路通道。如在例如图1B中可以看到的，锁定机构确保尖锐构件和所述构件相对于彼此具有预定的锁定位置。在该构形中，为柱塞的预定轴向位置，优选地仅为所述预定轴向位置，提供在储存腔室和真空腔室之间的液体连通。在图1B中，旁路通道15与隔膜轴向对齐，从而通过尖锐构件的小凹口在储存腔室与真空腔室之间提供液体路径。由于尖锐构件在与凹口齐平的位置在径向上较细，并且在径向上较厚的部分已经穿过隔膜到达该锁定位置，所以隔膜可以被认为在与凹口齐平的位置具有大于尖锐构件的横截面的开口，从而在两个腔室之间提供液体旁路通道。如附图所例示的形成为凹口的液体旁路通道的另一个优点在于液体(和流体)连通仅在柱塞相对于圆筒的一个预定轴向位置中建立。如果柱塞在柱塞内部进一步向远侧移动，如图1E和1F中所示，则如果隔膜和尖锐构件构形成当隔膜被尖锐构件刺穿但隔膜与液体旁路通道分开时提供流体和/或液体的紧密接合，储存腔室和真空腔室之间的液体(和流体)连通再次关闭。因此，本发明公开的注射器可构形成使得当尖锐构件刺穿隔膜并且隔膜与所述一个或多个液体旁路通道轴向地分开时，隔膜和尖锐构件形成密封接合。
关于本发明公开的注射器的“尖锐”应该被广义地理解为它可以是能够刺穿或破坏隔膜的任何尖锐结构，典型地是具有尖锐顶部的结构，例如针。在一个实施方式中，尖锐构件被形成为细长的尖锐元件，其中尖锐元件的一端(优选地近端)是尖锐的，例如针状尖锐。以与柱塞和圆筒的近侧相同的方式限定近侧，即与远侧相对，即与注射器的出口和外部的针相对。
在一个实施方式中，液体旁路通道位于尖端构件的近端附近。这具有如下优点：尖端构件的其余部分(即，在旁路通道下方朝向真空腔室的远侧部分)可以作为混合容器保持在锁定的第二位置中。在一个实施方式中，一个或多个液体旁路通道被形成为尖端构件的一个或多个凹口，例如一个或多个径向凹口，其位置远离尖锐元件的近侧部分。形成为一个或多个凹口的液体旁路通道可以被设置为离尖锐构件的近端小于1mm，或小于2mm，或小于3mm，或小于4mm，或小于5mm，或小于6mm，或小于7mm，或小于8mm，或小于10mm，或小于12mm，或小于14mm，或小于16mm，或小于18mm，或小于20mm。
塞子
在本发明的另一个实施方式中，注射器还包括在柱塞内可轴向滑动的塞子，其优选地与可以是中空的柱塞的内部可密封地接合，从而使储存腔室可以被塞子(近侧地)限定在中空柱塞内。这意味着塞子可以构成封闭的储存腔室的近侧的侧壁——储存腔室优选地位于柱塞的远端中并且在远侧由柱塞的远端限定，在近侧由可轴向滑动的塞子限定。优选地，塞子可在柱塞内部轴向滑动，并且可以用于当第一腔室的储存器的物质已经被转移到真空腔室时堵塞住两个腔室之间的流体连接。由于塞子限定了储存器的近侧的侧壁，所以当塞子已经被吸入到邻接柱塞或构件的远端的远侧位置时，储存腔室也可以被看作是空的或几乎空的容积。在这个位置中，储存腔室的内容物已经被转移到真空腔室。
在一个实施方式中，由于尖锐构件在刺穿隔膜之后穿过隔膜突出，所以在优选的实施方式中，塞子由也可以被尖锐构件刺穿的材料制成，这允许塞子被真空腔室的真空抽吸到它邻接柱塞或构件的远端的位置。
在优选的实施方式中，塞子被放置在柱塞内部，并且在甚至更优选的实施方式中，塞子被完全包含在柱塞的中空本体内。如果柱塞是圆柱形的，即具有基本上圆形的横截面，则塞子也应该具有基本上类似的横截面，以便密封储存腔室。在这种类型的实施方式中，塞子可以被认为是凹入到柱塞的中空本体内。优选地，可轴向滑动的塞子适于优选地仅借助于真空腔室中的真空所施加的抽吸力被尖锐构件刺穿。
当物质从储存腔室排出/转移到真空腔室时，塞子通常被吸向柱塞的远端。因此，在本发明公开的注射器的一种构形中，当隔膜被刺穿并且在真空腔室和储存腔室之间提供液体连通时，随着塞子在空心本体内的轴向远侧移位，真空腔室中的真空将包含在储存腔室中的液体抽吸到真空腔室中。此外，在这种构形中，塞子构形成在储存腔室中的第二物质排放/奔流到真空腔室期间，在柱塞的中空本体内向远侧轴向移位。
塞子的其他实施方式也是可能的。塞子可以由可膨胀材料或弹性材料制成，或者替代地，塞子可以形成为适于配合并隐藏在中空柱塞内的第二个小柱塞。除了柱塞已经被证明为了保持内部容积被密封和推动容积以通过针或其他液体连接来转移它的目的而工作的优点之外，其打开了在第二柱塞中具有第三腔室(即第二隔开的储液器)和混合多于两种物质的可能性。
真空旁路通道
如所述的，目前公开的发明涉及一种注射器，其包括用于容纳第一物质的真空腔室。存在在封闭容积(腔室)中实现真空的几种方法。本发明公开的注射器的一个实施方式还包括一个或多个真空旁路通道，其位于圆筒中和/或柱塞中并且构形成使得柱塞在真空腔室内的柱塞的至少第一轴向位置中密封地接合真空腔室，即保持真空的状态，和使得经由所述一个或多个真空旁路通道在柱塞在真空腔室内的至少第二轴向位置中穿过柱塞建立流体连通。因此，(多个)真空旁路通道可以构形成在柱塞在真空腔室内的预定轴向位置处破坏真空腔室和柱塞之间的密封。例如，如果所述一个或多个真空旁路通道16是形成在真空腔室的近端的内表面中的一个或多个纵向凹槽17，如图2中所示，则可以提供这一点。替代地，一个或多个真空旁路通道可以形成在柱塞中。一个或多个真空旁路通道构形成使得可以经由直接位于真空腔室处的压力阀在真空腔室和环境大气之间直接提供流体连通，而与柱塞的位置无关。
物质
本发明公开的注射器用于两个腔室中的许多不同的物质。一些类型的药物被提供并储存在两个分开的腔室中，并在使用前混合。这种药物可以包括固体组分和液体溶剂，并且被称为两部分配方。固体组分可以例如是粉状药物。在注射器的一个实施方式中，腔室预填充有第一和第二物质，其中第一物质是干燥组合物，并且其中第二物质是水性介质。优选地，将干组分放置在真空腔室中，并将水性介质置于储存腔室中。类似地，注射器可以预填充第一和第二物质，其中第一物质是药物的干燥组分，和其中第二物质是所述药物的湿组分中的水性介质。本发明公开的注射器也适合于作为第一物质与冻干物质一起使用，例如冻干药物。
其他圆筒和柱塞的相关方面
圆筒优选地包括用于处理混合的最终产物的出口。该出口优选地是可封闭的和/或可密封的以便在真空腔室中保持真空。出口可以例如是鲁尔型出口，并且它有利地位于圆筒的远端。出口可以进一步形成为适于与另一个匹配的连接器相连的连接器部分，例如适于将软管连接到注射器。连接器部分可以是标准类型的连接器部分，例如鲁尔锁或鲁尔滑动连接器，优选地为公鲁尔锁或鲁尔滑动连接器。连接器部分可以设置有用于与匹配的连接器固定连接的螺纹部分，该螺纹部分可以设置在连接器部分的内侧。
优选地，圆筒具有开放的近端，其中柱塞延伸穿过近端，其可以被认为是注射器的标准解决方案。通常，注射器构形成使得柱塞可以轴向地移位通过圆筒的开放的近端。
本发明公开的注射器的容量可以通过对圆筒和柱塞进行成形和缩放比例来调节，然后可以在圆筒和柱塞的界限内选择真空腔室和储存腔室的容积。圆筒的容积和/或真空腔室的容积可以在0.1和500mL之间，更优选在1和100mL之间，更优选在2和50mL之间，更优选在3和30mL之间，更优选小于25mL，更优选小于20mL，更优选小于15mL，更优选小于10mL，最优选在5和10mL之间。
相应地，柱塞的空心本体的容积和/或储存腔室的容积在0.1和500mL之间，更优选在1和100mL之间，更优选在2和50mL之间，更优选在3和30mL之间，更优选小于25mL，更优选小于20mL，更优选小于15mL，更优选小于10mL，最优选在5和10mL之间。
本发明公开的注射器优选为一次性使用的一次性注射器。注射器的不同组件(圆筒，柱塞，塞子，阀，阀部件等等)优选地适合于通过单循环注塑成型来制造。
例子
本发明公开的注射器1的一个实施方式在图1A-1F中例示。圆筒2设置有真空腔室4、出口3、外部针14和圆筒凸缘12。柱塞5具有储存腔室6和柱塞凸缘11，隔膜7形成柱塞5的远端。在圆筒2的内部，有附接在圆筒2远端的尖锐构件8，尖锐构件8具有旁路通道15。注射器还包括柱塞5内部的(可轴向滑动的)塞子13，其与柱塞5的内部可密封地接合。注射器还分别包括第一和第二锁定元件9和10，以将柱塞5和圆筒2)的位置相对于彼此锁定(即，也将隔膜和尖锐构件之间的位置相对于彼此锁定)。
图1A-F可以说示出了下列过程：注射器从在真空腔室4和储存腔室6中具有两种分离的物质的预装载状态，经过物质被混合的状态，并最终输送混合物质。
在图1A中，注射器1被锁定在第一构形中。在这种构形中，可以将真空发生器连接到真空腔室4并产生真空，由此建立注射器的固有能量和将柱塞5拉向真空腔室4的真空力。然而，第一和第二锁定元件9和10防止柱塞移动。
在图1B中，第一锁定元件9已经被移除，结果柱塞被真空力拉到第二位置，其中第二锁定元件10阻止柱塞进一步移动。尖锐构件8刺穿隔膜7，第一物质可以开始通过旁路通道15从储存腔室6流到真空腔室4，旁路通道15与(被刺穿的)隔膜7轴向对齐。
在图1C中，储存腔室6的内容物(物质)已经转移到真空腔室4，在真空腔室，两种物质已被混合。塞子13也被真空力拉动而与柱塞5的远端邻接。
在图1D中，第二锁定元件10已被移除，使得能够将柱塞5进一步推向真空腔室4以通过出口3和外部针14排出混合内容物。
在图1E中，柱塞5已被进一步推(或被真空力进一步拉)向真空腔室4。最后，在图1F中，已通过沿远侧方向将柱塞5推到最终位置而排出/输送混合内容物。
图2示出了注射器1的近侧部分，其中第一锁定元件9卡扣配合到柱塞5的近端，从而限制柱塞5能沿远侧方向移动到圆筒2中。圆筒2包括真空旁路通道16。第一锁定元件9设置有纵向突起17，其适于匹配圆筒2中的真空旁路通道16。第一锁定元件9是抓住柱塞5的近侧部分的刚性塑料元件，并且锁定元件9的刚性和延伸部分将柱塞5锁定在由锁定元件9的长度限定的相对于圆筒2的轴向位置中。锁定元件9不会阻止柱塞5沿近侧方向移出圆筒2。然而，当在真空腔室中保持真空时，真空的较低压力会将柱塞5拉向真空腔室。即，注射器构形成使得柱塞5可以被锁定在圆筒2中，即，被限制沿近侧方向和远侧方向的纵向/轴向运动。锁定元件9中的纵向突起17适于匹配圆筒2中的真空旁路通道16，以在该锁定构形中提供锁定元件9的旋转锁定，有助于确保注射器1不能被容易地篡改处于锁定构形中的状态。
图3A和3B示出了本发明公开的注射器的示例性柱塞5的图示。柱塞5包括柱塞凸缘11和由可滑动塞子13(图3中未示出)限定的储存腔室6。隔膜7附接到柱塞5的远端。隔膜7包括环形突起20，以使得柱塞与圆筒2的内部密封地接合。隔膜7还包括薄的隔膜阻隔件7'，其可以被尖锐构件8刺穿。隔膜通过与圆形突起19接合而附接到柱塞。柱塞还包括纵向突起18，其适于匹配圆筒2中的真空旁路通道16和/或第一锁定元件9的纵向突起17。
本发明的进一步细节
1.一种用于保留和混合第一和第二物质的注射器，包括
-包括可密封和/或可封闭的远侧出口和用于容纳第一物质的真空腔室的圆筒，
-结合有用于容纳第二物质的储存腔室并且构形成轴向地移动通过所述圆筒的近端的柱塞，
-分隔所述真空腔室和所述储存腔室的隔膜，和
-用于刺穿所述隔膜的尖锐构件，诸如一个或多个针，
其中所述注射器构形成使得所述隔膜和所述尖锐构件可相对于彼此轴向滑动。
2.根据前述项中任一项所述的注射器，其中所述储存腔室被(完全)包含在所述柱塞中，和/或其中所述储存腔室至少部分地由所述柱塞的外壁限定。
3.根据前述项中任一项所述的注射器，其中所述柱塞相对于所述圆筒的轴向移位对应于所述隔膜和所述尖锐构件相对于彼此的轴向移位。
4.根据前述项中任一项所述的注射器，其中所述注射器构形成使得所述隔膜和所述尖锐构件相对于彼此可轴向滑动，优选地与所述圆筒相对于所述柱塞的轴向移位相对应。
5.根据前述项中任一项所述的注射器，构形成使得所述柱塞在所述圆筒中从第一位置到预定的第二位置的轴向移位通过所述尖锐构件刺穿所述隔膜并且在所述储存腔室和所述真空腔室之间建立流体通道。
6.根据前述5项中任一项所述的注射器，于是所述真空腔室中的真空将所述第二物质吸入所述真空腔室中，从而将所述储存腔室的内容物转移到所述真空腔室中，优选地没有所述柱塞从所述预定的第二位置的移位。
7.根据前述项中任一项所述的注射器，构形成在第一构形中保持所述真空腔室中的真空，所述第一构形优选为所述注射器的储存状态。
8.根据第7项所述的注射器，构形成使得在所述第一构形中，所述隔膜和所述尖锐构件被分开，优选地在所述圆筒内沿轴向分开。
9.根据前述项中任一项所述的注射器，构形成在第二构形中在所述真空腔室和所述储存腔室之间提供液体连通。
10.根据第9项所述的注射器，构形成使得在所述第二构形中，所述尖锐构件刺穿所述隔膜。
11.根据前述第9-10项中任一项所述的注射器，还包括液体旁路装置，并且构形成使得通过所述液体旁路装置来提供所述真空腔室和所述储存腔室之间的所述液体连通。
12.根据前述项中任一项所述的注射器，其中所述隔膜将所述真空腔室的近端和所述储存腔室的远端分开。
13.根据前述项中任一项所述的注射器，构形成使得所述尖锐构件在所述柱塞在所述圆筒内向远侧移位时刺穿所述隔膜。
14.根据前述项中任一项所述的注射器，其中所述隔膜附接到所述柱塞的远端和/或形成所述柱塞的远端。
15.根据前述项中任一项所述的注射器，其中所述尖锐构件附接在所述圆筒内，优选地附接在所述圆筒的远端。
16.根据前述项中任一项所述的注射器，其中所述尖锐构件在所述圆筒内轴向延伸。
17.根据前述项中任一项所述的注射器，其中所述尖锐构件在所述圆筒内从所述圆筒的远端轴向地延伸并指向所述圆筒的近端。
18.根据前述项中任一项所述的注射器，其中所述尖锐构件包括一个或多个液体旁路通道，其构形成在所述隔膜被刺穿时提供所述储存腔室与所述真空腔室之间的液体连通。
19.根据第18项所述的注射器，其中对于所述柱塞的预定轴向位置，优选地仅对于所述预定轴向位置，提供所述储存腔室与所述真空腔室之间的所述液体连通。
20.根据前述第18-19项中任一项所述的注射器，构形成使得当所述尖锐构件刺穿所述隔膜并且所述隔膜与所述一个或多个液体旁路通道轴向分离时，所述隔膜和所述尖锐构件形成密封接合。
21.根据前述项中任一项所述的注射器，还包括可移除的锁定构件，其构形成接合并限制所述柱塞在所述圆筒内的远侧轴向移位。
22.根据第21项所述的注射器，其中所述锁定构件构形成与从所述圆筒的近端伸出的所述柱塞的近侧部分接合。
23.根据前述第21-22项中任一项所述的注射器，其中所述锁定构件构形成接合并限制所述柱塞在所述圆筒内在所述柱塞相对于所述圆筒的两个不同轴向位置中的远侧轴向移位。
24.根据前述第21至23项中任一项所述的注射器，其中所述锁定构件包括第一锁定元件和第二锁定元件，每个所述锁定元件都构形成接合并限制所述柱塞在所述圆筒内的远侧轴向移位。
25.根据第24项所述的注射器，其中所述第一锁定元件和所述第二锁定元件构形成在彼此的轴向延伸部分接合所述柱塞。
26.根据前述项中任一项所述的注射器，其中所述第一构形对应于所述柱塞在所述圆筒中的第一轴向位置，和其中所述第二构形对应于所述柱塞在所述圆筒中的第二轴向位置。
27.根据前述项中任一项所述的注射器，构形成使得所述柱塞被锁定在所述第一构形中。
28.根据前述项中任一项所述的注射器，构形成使得所述柱塞被锁定在所述第二构形中。
29.根据前述项中任一项所述的注射器，构形成使得优选地借助于用于在所述第一构形中接合并锁定所述柱塞的所述可移除的第一和第二锁定元件，在所述第一构形中限制所述柱塞沿远侧方向的轴向移位。
30.根据前述项中任一项所述的注射器，构形成使得优选地借助于适于在所述第二构形中接合并锁定所述柱塞的可移除的第二锁定元件，在所述第二构形中限制所述柱塞沿远侧方向的轴向移位。
31.根据前述项中任一项所述的注射器，构形成使得在解锁所述柱塞时，所述真空腔室中的真空导致所述柱塞从第一位置轴向移位到第二位置。
32.根据前述项中任一项所述的注射器，构形成使得所述柱塞从第一位置到预定第二位置的轴向移位通过所述尖锐构件刺穿所述隔膜，并且在所述储存腔室和所述真空腔室之间建立流体通路。
33.根据第32项所述的注射器，其中所述第一位置由接合所述柱塞的所述第一和第二锁定元件联合确定，和其中所述第二位置仅由接合所述柱塞的所述第二锁定元件确定。
34.根据前述项中任一项所述的注射器，其中所述柱塞是中空的。
35.根据前述项中任一项所述的注射器，还包括在所述柱塞内部的可轴向滑动的塞子，所述塞子与所述柱塞的中空的内部可密封地接合，以使得所述储存腔室由所述中空柱塞内的塞子限定。
36.根据第35项所述的注射器，其中所述储存腔室位于所述柱塞的远端中，并且在远侧由所述柱塞的远端限定，在近侧由所述可轴向滑动的塞子限定。
37.根据前述第35-36项中任一项所述的注射器，其中所述塞子被完全容纳在所述柱塞的中空本体内。
38.根据前述第35-37项中任一项所述的注射器，其中所述塞子凹入在所述柱塞的所述中空本体内。
39.根据前述第35-38项中任一项所述的注射器，其中所述塞子构形成在所述储存腔室中的所述第二物质排放/奔流到所述真空腔室期间在所述柱塞的中空本体内向远侧轴向移位。
40.根据前述第35-39项中任一项所述的注射器，构形成使得在所述隔膜被刺穿并且在所述真空腔室和所述储存腔室之间提供液体连通时，伴随着所述塞子在所述中空本体内的轴向远侧移位，所述真空腔室中的真空将包含在所述储存腔室中的液体吸入真空腔室。
41.根据前述第35至40项中任一项所述的注射器，其中所述可轴向滑动的塞子构形成由所述尖锐构件刺穿。
42.根据前述项中任一项所述的注射器，其中所述尖锐构件被形成为细长尖锐构件，其中所述尖锐构件的一端，优选地所述近端，是尖锐的，例如像针一样尖锐。
43.根据前述项中任一项所述的注射器，其中所述尖锐构件包括一个或多个液体旁路通道。
44.根据第43项所述的注射器，其中所述一个或多个液体旁路通道位于所述尖锐构件的近端附近。
45.根据前述第43-44项中任一项所述的注射器，其中所述一个或多个液体旁路通道形成为所述尖锐构件的一个或多个凹口，例如一个或多个径向凹口，其位置远离所述尖锐元件的近侧部分。
46.根据前述第43-45项中任一项所述的注射器，构形成使得在所述第二构形和/或第二位置中，所述一个或多个旁路通道中的至少一个与所述隔膜轴向对齐。
47.根据前述项中任一项所述的注射器，还包括一个或多个真空旁路通道，其位于所述圆筒中和/或所述柱塞中，并被构形成使得所述柱塞至少在所述柱塞在所述真空腔室内的第一轴向位置中密封地接合所述真空腔室，和使得至少在所述柱塞在所述真空腔室内的第二轴向位置中经由所述一个或多个真空旁路通道建立横穿所述柱塞的流体连通。
48.根据前述项中任一项所述的注射器，其中所述注射器预填充有第一和第二物质，和其中所述第一物质是干燥组合物，和其中所述第二物质是水性介质。
49.根据前述项中任一项所述的注射器，其中所述注射器预填充有第一和第二物质，和其中所述第一物质是药物的干燥组分，和其中所述第二物质是所述药物的湿组分中的水性介质。
50.根据前述项中任一项所述的注射器，其中所述第一物质是冻干物质，例如冻干药物。
51.根据前述项中任一项所述的注射器，其中所述圆筒包括开放的近端。
52.根据前述项中任一项所述的注射器，构形成使得所述柱塞的近端延伸穿过所述圆筒的开放的近端。
53.根据前述项中任一项所述的注射器，构形成使得所述柱塞可以轴向移位通过所述圆筒的开放的近端。
54.根据前述项中任一项所述的注射器，其中所述圆筒包括可密封/可封闭的出口，例如鲁尔型出口。
55.根据前述项中任一项所述的注射器，其中所述圆筒包括位于所述圆筒的所述远端处的可密封/可封闭的出口。
56.根据前述项中任一项所述的注射器，其中所述出口包括在远端的连接器部分，例如鲁尔型连接器部分。
57.根据前述项中任一项所述的注射器，还包括所述柱塞和所述圆筒之间的密封的接合。
58.根据前述项中任一项所述的注射器，其中所述储存腔室由所述柱塞的中空部分限定。
59.根据前述项中任一项所述的注射器，其中所述塞子形成为适于配合和凹入在所述中空柱塞内的小柱塞。
60.根据前述项中任一项所述的注射器，其中所述储存腔室和所述真空腔室在所述第一构形中流体地隔开。
61.根据前述项中任一项所述的注射器，其中所述储存腔室和所述真空腔室在所述第二构形中流体连接。
62.根据前述项中任一项所述的注射器，其中所述一个或多个真空旁路通道构形成在所述柱塞在所述真空腔室内的预定轴向位置处破坏所述真空腔室和所述柱塞之间的密封。
63.根据前述项中任一项所述的注射器，其中所述一个或多个真空旁路通道是在所述真空腔室的近端的内表面中形成的一个或多个纵向凹槽。
64.根据前述项中任一项所述的注射器，其中所述一个或多个真空旁路通道形成在所述柱塞中。
65.根据前述项中任一项所述的注射器，其中所述圆筒的容积和/或所述真空腔室的容积在0.1和500mL之间，更优选在1和100mL之间，更优选在2和50mL之间，更优选在3和30mL之间，更优选小于25mL，更优选小于20mL，更优选小于15mL，更优选小于10mL，最优选在5和10mL之间。
66.根据前述项中任一项所述的注射器，其中所述柱塞的中空本体的容积和/或所述储存腔室的容积在0.1和500mL之间，更优选在1和100mL之间，更优选在2和50mL之间，更优选在3和30mL之间，更优选小于25mL，更优选小于20mL，更优选小于15mL，更优选小于10mL，最优选在5和10mL之间。
67.根据前述项中任一项所述的注射器，其中所述圆筒、所述柱塞、所述塞子、所述阀和/或所述轴向可移位的阀元件适于通过单循环注塑成型来制造。

Claims (22)

1.一种用于保留和混合第一物质和第二物质的注射器，所述注射器包括
-圆筒，其包括可密封和/或可封闭的远侧出口和用于将第一物质保留在真空中的真空腔室，
-柱塞，所述柱塞结合有用于容纳第二物质的储存腔室并且构形成轴向地移动通过所述圆筒的近端，
-分隔所述真空腔室和所述储存腔室的隔膜，和
-用于刺穿所述隔膜的尖锐构件，诸如一个或多个针，
其中所述注射器构形成使得所述柱塞在所述圆筒中从第一位置到预定的第二位置的轴向移位通过所述尖锐构件刺穿所述隔膜并且在所述储存腔室和所述真空腔室之间建立流体通道，于是所述真空腔室中的真空将所述第二物质吸入所述真空腔室中，从而在所述柱塞没有从所述预定的第二位置移位的情况下，将所述储存腔室的内容物转移到所述真空腔室中。
2.根据前述权利要求中任一项所述的注射器，构形成在第一构形中保持所述真空腔室中的真空，所述第一构形优选为所述注射器的储存状态。
3.根据前述权利要求中任一项所述的注射器，其中，所述尖锐构件附接在所述圆筒内。
4.根据前述权利要求中任一项所述的注射器，其中，所述尖锐构件附接在所述圆筒的远端。
5.根据前述权利要求中任一项所述的注射器，还包括可移除的锁定构件，其构形成接合并限制所述柱塞在所述圆筒内的远侧轴向移位，所述锁定构件包括第一锁定元件和第二锁定元件，所述锁定元件的每一个构形成接合并限制所述柱塞在所述圆筒内的远侧轴向移位。
6.根据前述权利要求6中任一项所述的注射器，其中，所述可移除的锁定构件构形成接合并限制所述柱塞在所述圆筒内在所述柱塞相对于所述圆筒的两个不同轴向位置中的远侧轴向移位。
7.根据前述权利要求2至6中任一项所述的注射器，其中，所述第一构形对应于所述柱塞在所述圆筒中的第一轴向位置，和其中，所述第二构形对应于所述柱塞在所述圆筒中的第二轴向位置。
8.根据前述权利要求6至7中任一项所述的注射器，其中，所述柱塞相对于所述圆筒的两个不同的轴向位置分别对应于所述柱塞在所述圆筒中的所述第一轴向位置和所述第二轴向位置。
9.根据前述权利要求5-8中任一项所述的注射器，其中，所述第一锁定元件和所述第二锁定元件构形成在彼此的轴向延伸部分中接合所述柱塞。
10.根据前述权利要求2-8中任一项所述的注射器，构形成使得所述柱塞被锁定在所述第一构形中。
11.根据前述权利要求6-9中任一项所述的注射器，构形成使得所述柱塞被锁定在所述第二构形中。
12.根据前述权利要求2至11中任一项所述的注射器，构形成使得借助于用于在所述第一种构形中接合并锁定所述柱塞的可移除的第一锁定元件和第二锁定元件，在所述第一构形中限制所述柱塞沿远侧方向的轴向移位。
13.根据前述权利要求6-12中任一项所述的注射器，构形成使得借助于适于在所述第二构形中接合并锁定所述柱塞的可移除的第二锁定元件，在所述第二构形中限制所述柱塞沿远侧方向的轴向移位。
14.根据前述权利要求中任一项所述的注射器，还包括在所述柱塞内部的可轴向滑动的塞子，所述塞子与所述柱塞的中空的内部可密封地接合，以使得所述储存腔室由所述中空柱塞内的塞子限定。
15.根据权利要求14所述的注射器，其中，所述塞子构形成在所述储存腔室中的所述第二物质排放/奔流/转移到所述真空腔室期间在所述柱塞的中空本体内向远侧轴向移位。
16.根据前述权利要求14-15中任一项所述的注射器，构形成使得在所述隔膜被刺穿并且在所述真空腔室和所述储存腔室之间提供液体连通时，伴随着所述塞子在所述中空本体内的轴向远侧移位，所述真空腔室中的真空将包含在所述储存腔室中的液体吸入所述真空腔室。
17.根据前述权利要求中任一项所述的注射器，其中，所述尖锐构件包括一个或多个液体旁路通道，所述一个或多个液体旁路通道构形成在所述隔膜被刺穿时在所述储存腔室和所述真空腔室之间提供液体连通。
18.根据前述权利要求中任一项所述的注射器，其中，所述尖锐构件包括一个或多个液体旁路通道，所述一个或多个液体旁路通道形成为所述尖锐构件的一个或多个凹口，例如一个或多个径向凹口，所述一个或多个凹口的位置远离所述尖锐元件的近侧部分。
19.根据权利要求17-18所述的注射器，构形成使得在所述第二构形和/或第二位置中，所述一个或多个旁路通道中的至少一个与所述隔膜轴向对齐。
20.根据权利要求17-19中任一项所述的注射器，构形成使得当所述尖锐构件刺穿所述隔膜并且所述隔膜与所述一个或多个液体旁路通道轴向分离时，所述隔膜和所述尖锐构件形成密封接合。
21.根据前述权利要求中任一项所述的注射器，其中，所述储存腔室由所述柱塞的中空部分限定，和其中，所述隔膜附接到所述柱塞的远端和/或形成所述柱塞的远端，以使得所述隔膜将所述真空腔室的近端与所述储存腔室的远端分隔开。
22.根据前述权利要求中任一项所述的注射器，其中，所述注射器预填充有第一物质和第二物质，和其中所述第一物质是药物的干燥组分，和其中所述第二物质是所述药物的湿组分中的水性介质。
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