CN103338740A - 用于收集和分配药剂和/或营养的液体溶液器械的、不用针可刺破的、并且可自动和密封地重新闭合的气密连接器 - Google Patents

用于收集和分配药剂和/或营养的液体溶液器械的、不用针可刺破的、并且可自动和密封地重新闭合的气密连接器 Download PDF

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CN103338740A
CN103338740A CN2012800067814A CN201280006781A CN103338740A CN 103338740 A CN103338740 A CN 103338740A CN 2012800067814 A CN2012800067814 A CN 2012800067814A CN 201280006781 A CN201280006781 A CN 201280006781A CN 103338740 A CN103338740 A CN 103338740A
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保罗·朱塞佩·戈比·弗拉蒂尼
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Abstract

描述了一种连接器(1)，该连接器(1)用于打算收集和分配液体溶液的器械，这些液体溶液用于药剂和/或营养用途。连接器包括封闭塞子(7)，该封闭塞子(7)通过按压无针引入/收集柄脚(18)是可刺破的。封闭塞子(7)包括具有封闭唇边(9)的单向阀，这些封闭唇边(9)通过引入所述柄脚(18)是可打开的，并且在抽出引入柄脚之后是弹性地可重新闭合的，并且封闭塞子(7)还包括可刺破的和弹性密封可重新闭合的薄膜(11)，该薄膜(11)放置成，气密地封闭所述单向阀的进口端部。所述封闭唇边(9)布置在弹性可变形塑料材料本体(30)的一个端部处，该弹性可变形塑料材料本体(30)由薄矩形截面凹槽(10)纵向横穿，凹槽在另一个端部上由所述可刺破和弹性可重新闭合的薄膜(11)封闭。

Description

用于收集和分配药剂和/或营养的液体溶液器械的、不用针可刺破的、并且可自动和密封地重新闭合的气密连接器
本发明涉及一种气密连接器，该气密连接器不用针是可刺破的，并且是自动和密封地可重新闭合的，用于打算收集和分配液体溶液的器械，这些液体溶液用于药剂和/或营养用途。
在打算用来分配用于药剂和/或营养用途的液体溶液的所有医疗器械中，为了不同目的，如液体的引入和收集、循环回路的创建、等等，在待被连接的各种部分之间的连接是至关重要的。
具体地说，用于药剂和/或营养用途的液体溶液的储装袋是已知的，可用来引入另外物质和/或用来收集在袋中包含的溶液的柔性管从这些储装袋延伸。
这样的柔性管由气密密封连接器封闭，这些气密密封连接器为了引入和收集目的应该另外是可刺破的，并且然后在操作的结束处是气密可重新闭合的。
具体地说，用于上述用途的连接器是已知的，这些连接器包括热塑性本体，这些连接器可用注射器的针刺破。
不需要针的连接器也是已知的，因为它们由塑性本体封闭，该塑性本体可在封闭本体中滑动，以建立在注射器连结(Luer鲁尔锁)等与柔性管的内部之间的连通。
最后，不用针可打开的连接器是已知的，例如由US2008/093571、WO95/15194及US5,268,771是已知的，这些连接器设有封闭塞子，该封闭塞子由可变形塑性本体形成，由凹槽纵向横穿，在该凹槽中，注射器Luer是可插入的，以确定弹性可变形单向阀的临时打开，在引入或收集操作之后当Luer缩回时，该弹性可变形单向阀然后自动地关闭。
全部这些已知解决方案都具有问题，这些问题分别包括：对于具有针的注射器的需要，这可能导致意外伤害；在使用之前气密封闭的缺少；在第一次打开操作之后不完美的密封封闭；比较高成本；及其它。
鉴于现有技术，本发明具有制造一种连接器的目的，该连接器从气密封闭状态开始，不用针可以刺破，以执行用来引入和收集液体的操作，并且该连接器在操作的结束之后然后可以密封地重新闭合。
本发明允许借助于封闭塞子达到这样一种目的，该封闭塞子通过按压无针引入/收集柄脚(如注射器的luer)是可刺破的，其中，封闭塞子包括具有封闭唇边的单向阀，这些封闭唇边通过引入所述柄脚是可打开的，并且在抽出引入柄脚之后是弹性地可重新闭合的，其特征在于，所述封闭塞子还包括可刺破的和弹性密封可闭合的薄膜，该薄膜放置成，气密地封闭所述单向阀的进口端部。
依靠本发明，得到重要的便利效果，如在使用之前的气密封闭、在引入/收集柄脚的每次引入和抽出操作之后重新闭合的密封安全性、当抽出柄脚时任何回流效应的消除、低成本、针的缺少。
本发明的实施例通过在附图中的非限制性例子表示，其中：
图1在轴向截面中表示根据本发明的连接器；
图2表示相对于图1从顶部看到的所述连接器的封闭塞子；
图3表示相对于图1从底部看到的所述封闭塞子；
图4在沿在图1中的线IV-IV取得的截面图中表示所述封闭塞子；
图5在轴向截面中表示连接器的进口端部，该进口端部用保护可除去帽盖完成；
图6表示像图1中的连接器那样的连接器、和在注射器的连接器用来穿孔连接器的封闭塞子之前的注射器；
图7按放大比例表示在连接之后的连接器和注射器；
图8表示在注射器的脱开之后同一连接器的轴向截面；
图9以俯视平面图表示在图8中的连接器；
图10-13表示根据本发明的连接器的一些使用方法。
在图1-4中表示的连接器包括主体2，该连接器作为整体用附图标记1指示，该主体2优选地由聚丙烯碳酸酯制成，由轴向孔3横穿。主体2包括轴环4和轴向延伸部5。
用于封闭塞子7的聚丙烯聚碳酸酯支架6固定到轴环4上，该封闭塞子7由弹性可变形塑料材料制成，具体地说由TPE SEBS聚异戊二烯硅酮制成，并且环形带8绕支架6布置和固定。
封闭塞子7包括本体30和一对逐渐变薄侧部唇边9，在这对逐渐变薄侧部唇边9之间，优选地在模压步骤期间，制成薄矩形截面凹槽10，该凹槽在下部端部上是敞开的，并且紧在薄气密封闭薄膜11之前的顶部上终止，该薄气密封闭薄膜11与塞子7的其余部分制成一件。
值得注意的是，凹槽(10)的长度和薄膜(11)的厚度之和比注射器鲁尔luer的长度短。
两个侧部唇边9包括凹形外部凹口12，这些凹形外部凹口12从侧部唇边9的下部端部横向延伸，从凹槽10开始。上部轴环13安置在支架6的顶部上。
如果要求，保护塞子14向支架6和封闭塞子7伸出，如图5所示。在连接器1的第一次使用之前，容易可断开连结点15将帽盖14在环形带8内保持到位。
考虑到连接器的期望用途，其元件的材料适当地经受抗微生物处理。具体地说，可以提供银离子的使用，这些银离子约束到细胞壁上，并且透过其，阻碍细胞DNA的复制、及禁止微生物呼吸。可选择地，可以提供离子等离子体的使用。
图6表示容器1(连接器1)，该连接器1作为在图1-4中的连接器，没有帽盖14，并且具有轴向延伸部5，该轴向延伸部5啮合在柔性管16中，用来将液体引入到它的储装器械中或者从该储装器械收集液体。在这样一种条件下，薄膜11将塞子7气密封地封闭，防止液体穿过轴向孔3的任何进入或离开。具有鲁尔luer或连接柄脚18的注射器17准备借助于连接器1连接到管16上。
将鲁尔(luer)18压靠封闭塞子7的顶部，进行连接。按这种方式，luer18将薄膜11穿孔，并且插入在凹槽10中，使两个侧部唇边9远离地运动，以到达轴向孔3的进口，如图7所示。
由于如提到的那样，凹槽10的和薄膜11的整体轴向高度比注射器的luer(鲁尔)的长度短，所以如此引入的luer18允许注射器16按双向方式操作，因而允许液体通过柔性管16的引入和收集。
注射器也可以是称作“Luer(鲁尔)锁”的类型的，即具有阳luer(鲁尔)，该阳luer由内螺纹同轴外部窝(在图6中用虚线和用附图标记31指示)部分地包围。在这种情况下，luer(鲁尔)18的插入通过将注射器的外部套管31拧到塞子7的支架6上而发生，为了这个目的利用支架6的外部沟槽32(图7)。
在操作的结束处，注射器的luer18可以从封闭塞子7的凹槽10中抽出，由弹性应力闭合的封闭塞子7的侧部唇边9到达在图8中的位置，该位置与在图1中的原始位置相同。薄膜11也弹性地闭合，因而再次得到连接器的气密闭合，如图9所示，在图9中，虚线19象征薄膜的重新接触和闭合点。
侧部唇边9的外部凹口12的凹形形状促进和强迫凹槽10的和薄膜11的闭合，因而得到单向阀的功能，该单向阀防止在luer的抽出期间和之后液体从柔性管16离开。
图10-13表示根据本发明的连接器的使用方法。具体地说，图10表示其对于柔性袋20的柔性引入/收集管的应用，该柔性袋20用来包含药剂和/或营养溶液，并且图11表示其与附件21的组合，该附件21用来连结用于液体溶液或粉末的小瓶22的封闭头部。图12表示根据本发明的连接器对于输液管件23的联接，该输液管件23具有侧部连结，并且图13表示其对于附件24的联接，该附件24用于各种类型的输液器械25。
值得注意的是，附件24是在EP1004329中描述的类型的，即按两个部分26和27制成，这两个部分26和27相对于彼此可转动，以允许附件对于输液器械25的螺旋固定，而不需要旋转打算用于注射器的(鲁尔)luer的插入的部分。

Claims (18)

1.一种连接器(1)，用于打算收集和分配液体溶液的器械，这些液体溶液用于药剂和/或营养用途，该连接器(1)包括封闭塞子(7)，该封闭塞子(7)通过按压无针引入/收集柄脚(18)是可刺破的，其中，封闭塞子(7)包括具有封闭唇边(9)的单向阀，这些封闭唇边(9)通过引入所述柄脚(18)是可打开的，并且在抽出所述引入柄脚之后是可弹性地可重新闭合的，其特征在于，所述封闭塞子(7)还包括可刺破的和可弹性密封可重新闭合的薄膜(11)，该薄膜(11)放置成，气密地封闭所述单向阀的进口端部。
2.根据权利要求1所述的连接器，其特征在于，所述封闭唇边(9)布置在可弹性可变形的塑料材料本体(30)的一个端部处，该弹性可变形塑料材料本体(30)由薄矩形截面凹槽(10)纵向横穿封闭，该薄矩形截面凹槽(10)在一个端部上是敞开的，并且在另一个端部上由所述可弹性密封可重新闭合的薄膜(11)封闭。
3.根据权利要求2所述的连接器，其特征在于，所述凹槽(10)的长度和所述薄膜(11)的厚度之和比注射器的鲁尔的长度短。
4.根据权利要求2或3所述的连接器，其特征在于，所述封闭唇边(9)设有凹形外部凹口(12)，这些凹形外部凹口(12)从所述封闭唇边(9)的下端横向延伸，从所述凹槽(10)的敞开端部开始延伸。
5.根据权利要求2或3或4所述的连接器，其特征在于，所述薄膜(11)与所述可弹性变形的塑料材料本体(30)制成一个零件，并且所述凹槽(10)在所述一个零件的模压步骤期间形成。
6.根据权利要求5所述的连接器，其特征在于，所述可弹性变形的塑料材料本体(30)由TPE SEBS聚异戊二烯硅酮(polyisoprenesilicone)制成。
7.根据权利要求2所述的连接器，其特征在于，由可弹性变形的塑料材料制成的所述本体(30)布置在支架(6)内部，该支架(6)固定到主体(2)上，该主体(2)被轴向孔(3)横穿。
8.根据权利要求7所述的连接器，其特征在于，所述支架(6)设有外部沟槽(32)，该外部沟槽(32)适于旋拧鲁尔型注射器的外部端座。
9.根据权利要求7所述的连接器，其特征在于，所述主体(2)具有轴向延伸部(5)，该轴向延伸部(5)适于插入柔性管(16)，该柔性管(16)用来将液体引入到其储装器械中或从该储装器械收集液体。
10.根据权利要求7所述的连接器，其特征在于，它包括帽盖(14)，该帽盖(14)重叠到和由容易断开连结点(15)连接到所述主体(2)上，用来在连接器(1)的第一次使用之前保护所述封闭塞子(7)。
11.根据权利要求7所述的连接器，其特征在于，所述支架(6)和所述主体(2)由聚丙烯聚碳酸酯(polypropylene polycarbonate)制成。
12.根据以上权利要求任一项所述的连接器，其特征在于，全部其元件都经受抗微生物处理。
13.根据权利要求12所述的连接器，其特征在于，所述抗微生物处理是基于银离子。
14.根据权利要求12所述的连接器，其特征在于，所述抗微生物处理用离子等离子体进行。
15.根据以上权利要求任一项所述的连接器，其特征在于，它应用于柔性管，该柔性管用来引入到柔性袋(20)和从该柔性袋(20)收集，该柔性袋(20)用来包含用于药剂和/或营养用途的液体溶液。
16.根据以上权利要求任一项所述的连接器，其特征在于，它应用于附件(21)，该附件(21)适于连结用于液体溶液或粉末的小瓶(20)的封闭头部。
17.根据以上权利要求任一项所述的连接器，其特征在于，它应用于具有侧部连结的管线。
18.根据以上权利要求任一项所述的连接器，其特征在于，它应用于附件(24)，该附件(24)用于各种类型的管线，其中，所述附件(24)按两个部分(26，27)制成，这两个部分(26，27)相对于彼此是可转动的。
CN201280006781.4A 2011-01-28 2012-01-24 用于收集和分配药剂和/或营养的液体溶液器械的、不用针可刺破的、并且可自动和密封地重新闭合的气密连接器 Active CN103338740B (zh)

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