CN104507440A - 用于在货架贮存时维持尖端无菌的容器封闭的双帽系统 - Google Patents
用于在货架贮存时维持尖端无菌的容器封闭的双帽系统 Download PDFInfo
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- CN104507440A CN104507440A CN201380039679.9A CN201380039679A CN104507440A CN 104507440 A CN104507440 A CN 104507440A CN 201380039679 A CN201380039679 A CN 201380039679A CN 104507440 A CN104507440 A CN 104507440A
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Abstract
一种容器封闭系统包括容器，其被配置成容纳治疗性液体并且具有被配置成分配治疗性液体剂量的分配尖端。通气帽被配置成装配到包括分配尖端的容器的至少一部分上并且具有允许空气进入限定在通气帽和分配尖端之间的腔体和从该腔体出来的一个或多个通气孔。第二帽被配置成装配到通气帽的至少一部分上。显窃启密封件耦合到第二帽和容器及通气帽中的一个或两个。
Description
相关申请
本申请要求2012年7月26日提交的美国临时申请序列号61/675,909的优先权，其公开内容据此通过引用整体并入本文。
概述
本公开的实施方案涉及包括通气帽和上帽的容器封闭系统和药物递送系统。根据一些实施方案，容器封闭系统包括容器，其被配置成容纳治疗性液体并且具有被配置成分配治疗性液体剂量的分配尖端。通气帽被配置成装配到包括分配尖端的容器的至少一部分上并且具有允许空气进入限定在通气帽和分配尖端之间的腔体中和从该腔体中出来的一个或多个通气孔。第二帽被配置成装配到通气帽的至少一部分上。显窃启密封件耦合到第二帽和容器及通气帽中的一个或两个。
根据不同的方面，容器被配置成分配多个单剂量的呈眼科溶液、乳液或悬浮液形式的治疗性液体。在一些实施方案中，治疗性液体选自由比马前列素、溴莫尼定、噻吗咯尔、环孢霉素、加替沙星、氧氟沙星、泼尼松龙、肉毒碱和酮咯酸组成的组。在一些情况中，通风帽中的一个或多个通风孔被配置成允许空气进入腔体和从该腔体出来，足以在分配治疗性液体剂量之后加速干燥在容器的分配尖端处的剩余治疗性液体。
在一些情况中，第二帽被配置成转动并且从装置去除，以及显窃启密封件被配置成响应于第二帽的转动而破坏。根据不同的实现方式，通气帽和第二帽限定整体结构，并且显窃启密封件被配置成脱离第二帽。根据一些实施方案，通气帽、第二帽、以及显窃启密封件限定整体结构，以及显窃启密封件被配置成脱离通气帽和第二帽。根据一些方面，第二帽限定第二通气帽，并且相对于容器转动第二通气帽使得通气帽和第二通气帽的通气孔重叠。
根据一些实现方式，通气帽包括突出物，其被布置在通气帽上，以在通气帽装配到容器上时建立与容器的分配尖端的接触。在一些情况中，突出物被配置成当通气帽装配到容器上时密封容器的分配尖端。
根据不同的实现方式，第二帽包括去湿系统。在一些情况中，容器的分配尖端和通气帽中的一个或两个包括抗微生物剂。根据不同的实施方案，治疗性液体是无防腐剂的治疗性液体。在一些情况中，容器包括位于分配尖端处并且被配置成防止液体返回到容器中的单向阀。根据一些实施方案，单向阀被配置成防止来自容器外部源的治疗性液体的污染物。在一些情况中，容器和分配尖端由一种或多种聚合物形成，所述聚合物选自由低密度聚乙烯、高密度聚乙烯、和/或高抗冲聚苯乙烯组成的组。
根据另一个实施方案，方法包括将治疗性液体贮存在被配置成容纳治疗性液体的容器的储库中。容器包括被配置成分配治疗性液体剂量的分配尖端。通气帽被配置成装配到包括分配尖端的容器的至少一部分上并且具有允许空气进入限定在通气帽和分配尖端之间腔体和从该腔体出来的一个或多个通气孔。第二帽被配置成装配到通气帽的至少一部分上。显窃启密封件耦合到第二帽和容器及通气帽中的一个或两个。在一些实施方案中，容器被配置成分配以眼科溶液、乳液或悬浮液为形式的多个单剂量治疗性液体。
根据另一个实施方案，方法包括从被配置成容纳治疗性液体的容器去除帽，容器包括被配置成分配治疗性液体剂量的分配尖端。帽包括通气帽，其被配置成装配到包括分配尖端的容器的至少一部分上，并且具有允许空气进入限定在通气帽和分配尖端之间的腔体和从该腔体出来的一个或多个通气孔。第二帽被配置成装配到通气帽的至少一部分上。该方法还包括从容器分配治疗性液体。
根据以下详细的讨论和附图，可以理解这些和其它特征。
附图说明
图1和2示出了容器封闭系统，其包括通气帽、上帽、以及被配置成被破坏使得显窃启密封件和上帽从容器去除的显窃启；
图3和4图示了容器封闭系统，其包括通气帽、上帽、以及被配置成被破坏使得显窃启密封件从容器去除而不需要去除上帽的显窃启；以及
图5-7示出了容器封闭系统，其中，上帽包括一个或多个通气孔并且被配置成相对于通气帽和容器旋转，以使得设置在上帽上的至少一个通气孔和设置在通气帽上的至少一个通气孔可以重叠。
发明详述
本公开的实施方案通常涉及容器封闭和药物递送系统。根据一些实施方案，容器封闭或药物递送系统被配置用于通过分配尖端分配多个单剂量的呈溶液、乳液或悬浮液形式的治疗剂。在管理治疗剂的剂量之后，剩余量的剂和/或其它污染物(例如，体液)可以残留在分配尖端的外侧表面上。留在分配尖端上的剩余材料具有促进微生物生长的可能性。通气孔可以被增加到容器的帽，以加速剩余剂的干燥时间并且由此减少微生物生长的可能性。在容器贮存过程中，在帽中的通气孔可以通过允许环境空气和分配尖端接触来降低容器的无菌。上帽被布置在通气帽的至少一部分上，覆盖通气帽上的通气孔并且减少危及分配尖端无菌的可能性。
现在转到图1和2，图示了包括通气帽和无通气帽的容器封闭系统。出于简化的目的，附图中所图示的实施方案将被描述为容器封闭系统，虽然要理解的是，这些实施方案还适用于不同类型的药物递送系统。图1和2以及其它附图中所示出的容器封闭系统100，200可以被配置成分配无防腐剂的治疗剂。容器封闭系统100，200包括具有被配置成在其中贮存治疗性液体的隔室120、220的容器110、210。隔室120、220在各个实施方案中是无菌的，其中隔室120、220被实施为贮存治疗性液体。要指出的是，在图1和2和其它附图中所叙述的容器封闭实施方案还可以被配置用于分配包括防腐剂的治疗剂。
容器110、210具有分配尖端130、230，治疗性液体是通过分配尖端来分配的。分配尖端130、230具有通常变细的锥形形状，其适当地被确定尺寸用于将治疗剂分配到用户身体的局部部分，例如眼睛、鼻孔和/或耳朵。例如，隔室110、210可以被实施为含有无防腐剂的眼科治疗剂并且分配尖端130、230可以被配置成使得用户在延长的时间(例如，一个月)多次给眼睛分配眼科治疗剂。容器和分配尖端可以由低密度聚乙烯、高密度聚乙烯、和/或高抗冲聚苯乙烯形成。
多种治疗剂可以使用根据本公开的实施方案所实现的容器封闭系统来分配。这些治疗剂的非限制性的、非详尽的列表包括比马前列素、溴莫尼定、噻吗咯尔、环孢霉素、加替沙星、氧氟沙星、泼尼松龙、肉毒碱和酮咯酸。根据本公开的实施方案所实现的系统不限于递送无防腐剂的治疗剂，而且还可以适于递送防腐的治疗剂。
根据一些实施方案，容器110、210包括单向阀，其可以任选地包括过滤器。单向阀被配置成允许容器内部所含有的治疗剂通过分配尖端130、230，但是防止治疗剂和/或其它液体或污染物再次进入容器。各种类型的阀可以被实现以提供流体从容器到分配尖端130、230的单向流动，包括例如从Rexam得到的Novelia阀以及从AptarPharma得到的眼科挤压分配器的阀系统。
在一些实施方案中，容器110、210被配置成以重复的基础在预定的持续时间分配单剂量治疗剂。例如，容器110、210可以被配置成每天分配单剂量的治疗剂，持续一个月。根据一些实施方案，容器110、210被配置成分配作为单剂量的预定容积的治疗剂。在这个实施方案中，单向阀可以被配置成调节治疗剂的容积，以使得在每次应用时分配计量剂量的治疗剂。合适的精密计量阀可以例如从Rexam得到。而且，可以使用各种可得到的弹簧承载的单向阀，其在驱动递送单剂量的药物产品时打开。在驱动之后，阀返回到其初始位置并且密封开口。根据各个实施方案，本文描述的容器封闭系统可以被实现具有可挤压的导管。可选地，或附加地，泵机构可以被实现以便于计量或不计量地分配在容器110、210内部所含有的治疗剂。
包括一个或多个通气孔145的通气帽140、240被装配到容器110、210的至少一部分上，从而允许环境空气在通气帽140、240与分配尖端130、230之间通过。一个或多个通气孔145可以被配置成允许空气进入在分配尖端130、230和通气帽140、240之间的腔体和从该腔体出来，足以在分配治疗性液体剂量之后加速在干燥容器110、210的分配尖端130、230处的剩余治疗性液体和/或其它污染物。
图1和2和其它附图中所示出的容器封闭系统100、200包括突出物140、240，其被配置成可释放地接合分配尖端130、230的远端部分。当被适当地放置在分配尖端130、230处时，密封件在通气帽140、240和分配尖端130、230之间形成。根据治疗剂性质和使用申请，密封件可以被实现为提供理想程度的密封(例如，液密的、气密的、或机械紧密的)。
上帽160装配到通气帽140的至少一部分上。上帽160覆盖一个或多个通气孔145，以帮助在贮存容器110时维持无菌。在一些情况中，上帽160和通气帽140限定整体结构。根据本文所描述的不同实现方式，上帽160被配置成从通气帽140去除。
根据一些实施方案，抗微生物添加剂被设置在容器封闭系统的选定表面处，例如在分配尖端的表面上，和/或易受微生物污染的上帽。大量的眼科多剂量容器封闭系统和药物递送系统可以从根据本公开的实施方案的抗微生物表面保护的结论而受益，包括含有未防腐的、部分防腐的、和防腐的眼科产品。
例如，以下抗微生物添加物可以被并入涂层中，其可以被应用到可适于制造根据本公开的其它实施方案的容器封闭系统的聚合材料：银纳米颗粒、生物安全、F3000、三氯生、奥麦丁锌、锌离子、铜离子、铈离子、AEGISTM抗微生物剂、PEI-TCS聚合物、硫酸鱼精蛋白和洗必泰、单独的或其任何组合。
一个或多个通气帽、上帽以及分配尖端可以包括去湿系统以促进加速干燥残留的治疗性液体和/或其它污染物。这种治疗剂的非限制性的、非详尽的列表包括硅胶、氧化钙、和分子筛。
显窃启密封件170、270装配到上帽160、260的一部分上。在图1、2和其它附图中的一些情况中，显窃启密封件170、270是卷绕在容器110、210的一部分和/或上帽160、260周围的条带。在一些情况中，显窃启密封件170、270覆盖容器110、210或上帽160、260的全部或基本上全部。显窃启密封件170、270被配置成当用户施加力时被破坏。在图1和2中所示出的代表性实施例中，显窃启密封件170、270附接到上帽160、260，并且破坏显窃启密封件170、270使得上帽160、260从容器110、210去除。在一些情况中，上帽160、260被配置成当去除显窃启密封件170、270时被丢弃，从而将通气帽140、240留在容器110、210上。
在一些情况中，破坏显窃启密封件不从容器封闭系统去除上帽。在图3和4中所图示的典型的实施例中，显窃启密封件370、470被配置成被破坏和去除而不需要去除上帽360、460。在一些实施方案中，上帽360、460和通气帽340、440限定整体结构，以使得当将容器用于应用治疗性液体时，通气帽340、440和上帽360、460一起被去除以提供分配尖端330、430的入口，并且在施加治疗性液体的剂量之后被替换。在一些实现方式中，撕开显窃启密封件370、470暴露了通气帽和/或上帽中的通气孔345。根据各个实施方案，上帽360、460被配置成被去除以便暴露通气帽340、440上的一个或多个通气孔345，以及通气帽340、440被配置成被去除以暴露分配尖端330、430。
根据本文描述的各个方面，上帽包括一个或多个通气孔。图5-7图示了典型的实施例，其中上帽560、660包括一个或多个通气孔并且被配置成相对于通气帽540、640和容器510、610旋转，使得设置在上帽上的至少一个通气孔和设置在通气帽540、640上的至少一个通气孔重叠，从而使得分配尖端530、630通过重叠的通气孔暴露到环境空气。在该典型的实施例中，通气帽540、640和上帽560、660可以限定整体结构或可以是如之前所描述的分离的可拆卸结构。显窃启密封件570、670附接到上帽560、660，以及通气帽540、640中的至少一个。显窃启密封件570、670被配置成脱离上帽560、660和/或通气帽540、640。
图5示出了容器密封系统500，其包括：包括一个或多个通气孔545的通气帽540以及设置在通气帽540的至少一部分上的上帽560。在该典型的实施例中，上帽560防止通气帽540上的一个或多个通气孔545允许环境空气进入在通气帽540和分配尖端530之间的腔体。图6图示了与图5相同的容器封闭系统500、600，但是具有相对于通气帽640旋转的上帽660。上帽660上的通气孔至少部分地与通气帽640上的通气孔重叠，从而使得分配尖端630通过重叠的通气孔暴露到环境空气。
图7图示了包括上帽和通气帽的帽组件701。正如以前所描述的，结合图5和6，该典型的实施例包括通气的上帽。图7示出了在上帽上的通气孔与通气帽上的通气孔部分地重叠，从而允许空气通过通气孔。通气孔746的一部分被上帽的一部分761覆盖。
为了图示和描述的目的已呈现先前对典型的实施方案的描述。不意在是详尽的或限制本发明到所公开的精确形式。根据上述教导，许多修改和改变是可能的。所公开实施方案的任何一个或全部特征可以独立地或以任何组合来应用，并不意味着是限制性的，而仅仅是说明性的。本发明的范围旨在未被该详细描述限制，而是由随附于此的权利要求来确定。
Claims (20)
1.一种用于分配治疗性液体的装置，包括：
容器，其被配置成容纳所述治疗性液体并且具有被配置成分配所述治疗性液体剂量的分配尖端；
通气帽，其被配置成装配到包括所述分配尖端的所述容器的至少一部分上，并且具有允许空气进入限定在所述通气帽和所述分配尖端之间的腔体和从所述腔体出来的一个或多个通气孔；
第二帽，其被配置成装配到所述通气帽的至少一部分上；以及
显窃启密封件，其耦合到所述第二帽和所述容器及所述通气帽中的一个或两个。
2.如权利要求1所述的装置，其中所述容器被配置成分配多个单剂量的呈眼科溶液、乳液或悬浮液形式的所述治疗性液体。
3.如权利要求1所述的装置，其中所述通气帽中的一个或多个通气孔被配置成允许空气进入所述腔体或从所述腔体出来，足以在分配所述治疗性液体剂量之后加速干燥在所述容器的所述分配尖端处的剩余治疗性液体。
4.如权利要求1所述的装置，其中所述第二帽被配置成转动并且从所述装置去除，以及所述显窃启密封件被配置成响应于所述第二帽的所述转动而破坏。
5.如权利要求1所述的装置，其中所述通气帽和所述第二帽限定整体结构，并且所述显窃启密封件被配置成脱离所述第二帽。
6.如权利要求1所述的装置，其中所述通气帽、所述第二帽、以及所述显窃启密封件限定整体结构，以及所述显窃启密封件被配置成脱离所述通气帽和所述第二帽。
7.如权利要求6所述的装置，其中所述第二帽限定第二通气帽，并且相对于所述容器转动所述第二通气帽使得所述通气帽和所述第二通气帽的通气孔重叠。
8.如权利要求7所述的装置，其中所述容器含有超过一个剂量的治疗性液体。
9.如权利要求1所述的装置，其中所述通气帽包括突出物，其被布置在所述通气帽上，以在所述通气帽装配到所述容器上时建立与所述容器的所述分配尖端的接触。
10.如权利要求9所述的装置，其中所述突出物被配置成当所述通气帽装配到所述容器上时密封所述容器的所述分配尖端。
11.如权利要求1所述的装置，其中所述第二帽包括去湿系统。
12.如权利要求1所述的装置，其中所述容器的所述分配尖端和所述通气帽中的一个或两个包括抗微生物剂。
13.如权利要求1所述的装置，其中所述治疗性液体是无防腐剂的治疗性液体。
14.如权利要求1所述的装置，其中所述治疗剂是呈溶液、乳液或悬浮液的形式，以及所述治疗剂选自由比马前列素、溴莫尼定、噻吗咯尔、环孢霉素、加替沙星、氧氟沙星、泼尼松龙、肉毒碱和酮咯酸组成的组。
15.如权利要求1所述的装置，其中所述容器包括位于所述分配尖端处并且被配置成防止液体返回到所述容器中的单向阀。
16.如权利要求15所述的装置，其中所述单向阀被配置成防止来自所述容器外部源的所述治疗性液体的污染物。
17.如权利要求1所述的装置，其中所述容器和所述分配尖端由一种或多种聚合物形成，所述聚合物选自由选自低密度聚乙烯、高密度聚乙烯、和/或高抗冲聚苯乙烯组成的组。
18.一种方法，包括：
将治疗性液体贮存在被配置成容纳所述治疗性液体的容器的储库中，所述容器包括：
分配尖端，其被配置成分配所述治疗性液体剂量；
通气帽，其被配置成装配到包括所述分配尖端的所述容器的至少一部分上，并且具有允许空气进入限定在所述通气帽和所述分配尖端之间的腔体和从所述腔体出来的一个或多个通气孔；
第二帽，其被配置成装配到所述通气帽的至少一部分上；以及
显窃启密封件，其耦合到所述第二帽和所述容器及所述通气帽中的一个或两个。
19.如权利要求18所述的装置，其中所述容器被配置成分配多个单剂量的呈眼科溶液、乳液或悬浮液形式的所述治疗性液体。
20.一种方法，包括：
从被配置成容纳所述治疗性液体的容器去除帽，所述容器包括被配置成分配所述治疗性液体剂量的分配尖端，所述帽包括：
通气帽，其被配置成装配到包括所述分配尖端的所述容器的至少一部分上，并且具有允许空气进入限定在所述通气帽和所述分配尖端之间的腔体和从所述腔体出来的一个或多个通气孔；以及
第二帽，其被配置成装配到所述通气帽的至少一部分上；以及
从所述容器分配所述治疗性液体。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN202111433061.3A CN114099332A (zh) | 2012-07-26 | 2013-07-26 | 用于在货架贮存时维持尖端无菌的容器封闭的双帽系统 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| US201261675909P | 2012-07-26 | 2012-07-26 | |
| US61/675,909 | 2012-07-26 | ||
| PCT/US2013/052237 WO2014018847A1 (en) | 2012-07-26 | 2013-07-26 | Dual cap system for container-closures to maintain tip sterility during shelf storage |
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| CN202111433061.3A Division CN114099332A (zh) | 2012-07-26 | 2013-07-26 | 用于在货架贮存时维持尖端无菌的容器封闭的双帽系统 |
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| CN104507440A true CN104507440A (zh) | 2015-04-08 |
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| CN201380039679.9A Pending CN104507440A (zh) | 2012-07-26 | 2013-07-26 | 用于在货架贮存时维持尖端无菌的容器封闭的双帽系统 |
| CN202111433061.3A Pending CN114099332A (zh) | 2012-07-26 | 2013-07-26 | 用于在货架贮存时维持尖端无菌的容器封闭的双帽系统 |
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Country Status (18)
| Country | Link |
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| US (3) | US10806628B2 (zh) |
| EP (2) | EP2877138B1 (zh) |
| JP (1) | JP6409192B2 (zh) |
| KR (1) | KR102124667B1 (zh) |
| CN (2) | CN104507440A (zh) |
| AU (1) | AU2013295636B2 (zh) |
| BR (1) | BR112015001755B1 (zh) |
| CA (1) | CA2879703C (zh) |
| CO (1) | CO7180200A2 (zh) |
| ES (1) | ES2952616T3 (zh) |
| HK (1) | HK1210408A1 (zh) |
| MX (1) | MX2015001220A (zh) |
| MY (1) | MY175070A (zh) |
| NZ (1) | NZ703922A (zh) |
| RU (1) | RU2644257C2 (zh) |
| SG (2) | SG10201801222YA (zh) |
| WO (1) | WO2014018847A1 (zh) |
| ZA (1) | ZA201500355B (zh) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US10482167B2 (en) * | 2015-09-24 | 2019-11-19 | Mcafee, Llc | Crowd-source as a backup to asynchronous identification of a type of form and relevant fields in a credential-seeking web page |
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Also Published As
| Publication number | Publication date |
|---|---|
| SG11201500529TA (en) | 2015-02-27 |
| KR20150034774A (ko) | 2015-04-03 |
| US10806628B2 (en) | 2020-10-20 |
| JP2015529490A (ja) | 2015-10-08 |
| US20210015661A1 (en) | 2021-01-21 |
| CA2879703C (en) | 2021-11-16 |
| SG10201801222YA (en) | 2018-04-27 |
| EP4265236A2 (en) | 2023-10-25 |
| EP2877138B1 (en) | 2023-06-28 |
| KR102124667B1 (ko) | 2020-06-18 |
| US20140031767A1 (en) | 2014-01-30 |
| JP6409192B2 (ja) | 2018-10-24 |
| BR112015001755B1 (pt) | 2021-08-24 |
| CA2879703A1 (en) | 2014-01-30 |
| WO2014018847A1 (en) | 2014-01-30 |
| CO7180200A2 (es) | 2015-02-09 |
| HK1210408A1 (zh) | 2016-04-22 |
| AU2013295636B2 (en) | 2017-12-14 |
| EP2877138A1 (en) | 2015-06-03 |
| RU2644257C2 (ru) | 2018-02-08 |
| RU2015105803A (ru) | 2016-09-20 |
| ZA201500355B (en) | 2015-12-23 |
| CN114099332A (zh) | 2022-03-01 |
| BR112015001755A2 (pt) | 2017-07-04 |
| NZ703922A (en) | 2017-04-28 |
| AU2013295636A1 (en) | 2015-02-05 |
| MY175070A (en) | 2020-06-04 |
| MX2015001220A (es) | 2015-04-14 |
| US20240074894A1 (en) | 2024-03-07 |
| ES2952616T3 (es) | 2023-11-02 |
| EP4265236A3 (en) | 2023-11-29 |
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