CN101522252B - 医用连接器 - Google Patents

医用连接器 Download PDF

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CN101522252B
CN101522252B CN2007800383134A CN200780038313A CN101522252B CN 101522252 B CN101522252 B CN 101522252B CN 2007800383134 A CN2007800383134 A CN 2007800383134A CN 200780038313 A CN200780038313 A CN 200780038313A CN 101522252 B CN101522252 B CN 101522252B
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CN101522252A (zh
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T·F·范格罗
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ICU Medical Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1038—Union screw connectors, e.g. hollow screw or sleeve having external threads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/261—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is increasing upon disconnection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/263—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/267—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector

Abstract

本发明提供一种与一个或多个医用器具一起使用的医用连接器。在一些实施例中，当医用器具从一端部或端口脱开连接时，该连接器使从另一端部或端口流入该连接器的逆向流动最小化或消除了该逆向流动。在一些实施例中，当医用器具从一端部或端口脱开连接时，该连接器产生了从另一端部或端口流出该连接器的正向流动。

Description

医用连接器
相关申请的交叉引用
本申请要求于2006年10月25日提交的美国临时专利申请NO.60/854,524(名为“医用连接器”)的优先权，其全部公开内容通过参考与本文结合。
技术领域
本发明总体涉及医用连接器。特别地，本发明某些实施例涉及与标准鲁尔连接器一起使用的医用连接器。在某些实施例中，当医疗器具从医用连接器的端部或端口移除时，该医用连接器在离开该医疗器具的方向产生正向流体流动。
背景技术
医用连接器通常用于在治疗患者过程选择性地打开和关闭流体通道。在一些连接器中，当连接器被关闭时产生了少量的逆向流体流动，从而抽吸流体离开患者并流向连接器。这种逆向流动可能导致流体线路的凝结或堵塞，显著地缩短了特定的注射位置可用的时间。在许多应用中，当阀关闭时最小化或消除这样的逆向流动或者产生流向患者的正向流体流动是有利的。
美国专利NO.6,599,273(其整体结合在本文中)包括对医用连接器的一些例子的总体描述，在该连接器中可能产生逆向流体流动。专利号为NO.6,245,048，6,428,520，6,695,817和公开号为NO.2006-0161115A1的美国专利申请(其整体结合在本文中)包括了对医用阀的一些例子的总体描述，在这些医用阀中当连接器关闭时在离开医用连接器方向产生正向的流体流动并且流向患者。目前有多种不同类型的医用连接器，引用前述专利仅是为了说明流体通过连接器传输的一些方式。本文所公开的方法、结构和原理可以用在或适用于前述专利中所公开的连接器(及其部件)以及本领域所已知的或已使用的多种不同类型的医用连接器中。
发明内容
在一些实施例中，描述了一种与第一和第二医用器具一起使用的医用连接器，其包括具有第一近端和第二远端的壳体，各端配置成用于附连到标准鲁尔连接器。在一些实施例中，该连接器还包括在该壳体中延伸的内部刚性件，该刚性件在其一侧具有至少一个开口。所述内部刚性件在其内部大体上是中空的，其中所述开口从该内部刚性件的外表面延伸到该中空的内部。大体上中空的柔性件放置在该壳体中并大体上包围所述内部刚性件。该柔性件包括在其内壁上的至少一个向内突起，其中所述向内突起的至少一部分可以被构形成与所述内部刚性件中的开口相配合，使得当连接器处于大体上关闭的位置时，流体不允许流过该连接器时，所述向内突起的所述一部分在该开口中，且当该连接器处于大体上打开的位置时，所述向内突起的所述一部分在该开口外，从而使得当该连接器处于大体上关闭的位置时该柔性件和/或该内部刚性件内部的内容积被减小了。
附图说明
因此通过总结本发明的总体特性及其一些特征和优点，本领域技术人员从参考以下附图的详细描述将会明白本发明的某些优选实施例和改进，其中：
图1是根据本发明的实施例处于第一位置的医用连接器和医用器具的侧视图；
图2是图1的医用连接器的顶部透视图；
图3是图1的医用连接器的底部透视图；
图4是图1的医用连接器的分解透视图；
图5是根据本发明实施例的医用连接器中一部件的底部透视图；
图6A是图5的医用连接器部件的剖视图；
图6B是图6A的医用连接器部件旋转90度的剖视图；
图7A是根据本发明实施例的医用连接器中一部件的剖视图；
图7B是图7A的医用连接器部件旋转90度的剖视图；
图8A是根据本发明实施例处于第一位置的医用连接器和医用器具的剖视图；
图8B是图8A的医用连接器和医用器具旋转90度的剖视图；
图9A是根据本发明的实施例的与医用器具相接合的医用连接器的剖视图；
图9B是图9A的医用连接器和医用器具旋转90度的剖视图。
具体实施方式
尽管说明书描述了实施例的各具体细节，但是应该了解说明书仅是说明性的并且不能以任何方式解释为对本发明的限制。另外，本发明的多种应用以及对本发明的改进对于本领域技术人员显而易见的，且也将被包含在本文所描述的总体思想中。例如，在通过引用结合到本文的专利文件中所示出和描述的装置中的任何结构可以被结合到本文所公开的结构中或者用于取代这些结构。
图1示出了靠近凹型连接器16的凸型鲁尔连接器10，该鲁尔连接器带有鲁尔端12和鲁尔锁紧接口14。该凹型连接器16具有近端18、远端20、且在其远端上具有凸型鲁尔22。所述远端20可以进一步包括鲁尔锁紧接口。该凹型连接器16包括壳体24。图2示出了凹型连接器16的透视图。示出了柔性件26的近端48。所述柔性件26包括孔27，所述孔是常闭的直到施加向远侧的力到柔性件26上。图3示出了该联接头的透视图，其中可见该连接器的远端20上的凸形鲁尔22。
图4是图2的连接器16的分解透视图。连接器16的一些内部件被示出，例如柔性件26和刚性件28。在已装配的结构实施例中，设有内部刚性件30并且该内部刚性件可以装配在柔性件26内部的腔室32中。在该分解透视图中示出孔27是关闭的。在一些实施例中，当柔性件26与壳体24隔开时，孔27是打开的。在一些实施例中，当柔性件26插入壳体24中时，壳体24的内腔与柔性件26的远端48的一部分的接触配合可以大体上关闭孔27，从而阻止了通过连接器16的流体流动路径。
图5示出了具有近端31和远端33的刚性件28的透视图。远端33包括径向突起件35。径向件35与壳体24的内壁中的相应部件相互作用从而在组装连接器16时将刚性件28固定在壳体24中。沿着连接器16的纵向轴线延伸的径向件35可以与壳体24相互作用从而在使用连接器16时(例如当凹型连接器被附接到连接器16的远端20时)阻止刚性件28在壳体24内部的旋转。
在一些实施例中，内部刚性件30具有多个开口。例如，开口34可以用于允许流体流动进入内部刚性件30里的内部通道或流体流动路径36中。在一些实施例中，两个开口34被设置在内部刚性件30的相对侧。还可以设置另外的类似于开口34的开口。在一些实施例中，可以在内部刚性件30的近端31设置开口。在一些实施例中，一个或多个开口34和38相结合(即配置相同开口用于接纳流体以及接纳一个或多个突起52(见图7A))。内部刚性件30可以是钝的、尖的、端部开口的、端部闭合的、或者比本文图中所示的更短或更长、更宽或更窄。内部刚性件30可以具有多种不同的形状。例如，它可以配置成如图所示的管形结构；可配置成带有一个或多个纵向开口或裂口的套筒，该开口或裂口沿着所述套筒的部分或整个长度延伸；或者该内部刚性件30可以整个除去。内部刚性件30可以固定就位在壳体24内或者它在壳体24内可以运动或浮动。在没有内部刚性件30时，一个或多个流体开口可以设置在壳体内部的腔室的远侧区域处或附近，以将壳体腔内的流体传送到连接器的凸形端。
在一些实施例中，一个或多个开口38被设置在刚性件30中，且可以位于开口34远侧的方向上。如下所述，在一些实施例中，当连接器16处于关闭的结构时(见图8A)，开口38将会容纳在柔性件26的内表面上的突起。在一些实施例中，开口38适合于接纳流体流动。在开口38用于方便流体流动通过内部刚性件30的情况下，可以包括或不包括有开口34。
图6A和6B示出了沿垂直面横断的、互成直角的刚性件28剖视图。在一些实施例中，如图所示，开口34，38的近侧边缘40，42可以是平状的并且大体上水平的，且开口34，38的远侧边缘44，46可以是倾斜的或带斜面的。
如图所示，流体流动路径36可以从内部刚性件30的近端沿着大体上轴向的直线路径延伸到凸形端22。在一些实施例中，如图所示，在内部刚性件30的远侧区域中的所述流体流动路径36大体上是非曲折的；例如流体流动路径36不会向垂直于或实质上不平行于内部刚性件30的轴线的方向偏转，和/或它可能不会包括在内部刚性件30的远侧区域中的流体流出的侧开口。这样的流体流动路径可以提供更高的流体流动速率并且在流体流动中产生更少的湍流(当流体包括血细胞时这是特别有利的)。
图7A和7B示出了沿垂直平面剖的、互成直角的柔性件26剖视图。柔性件26可以被向着远端方向施加到近端48的力而纵向地压缩和/或移动。多个向内突起的构件52设在柔性件26的内腔32中。在一些实施例中有一个这样的突起52。在所示的实施例中有两个突起52。在一些实施例中，可以有多个开口38，一些所述开口38可以沿着内部刚性件30的不同区域放置，并且还可以有附加的相对应的突起52设计用于选择性地装配在一个或多个开口38中或从该一个或多个开口38收回。在一些实施例中，如图所示，当连接器16处于大体上关闭的位置时，相对的突起52的内边缘或表面53可以被定位成相互接触和/或相互靠近。该突起52可以在内部刚性件30的流体流动路径36的中间位置延伸进入内部刚性件30中。在一些实施例中，在大体上打开的位置，所述内部刚性件30的壁部不位于的突起52的相对的边缘或表面53之间。开口38可以具有多种不同形状和尺寸。例如，一个或多个开口38可以是圆形、正方形、矩形、梯形、椭圆的等等。开口38可以大于开口34。在一些实施例中，开口38可以大约为内部刚性件30的长度的1/5、1/4、1/3、1/2或更大。突起52也可以具有多种形状和尺寸，且其形状和尺寸对应于或不同于开口38的形状和/或尺寸。如图所示，突起52可以大体上是平状的。在一些实施例中，一个或多个突起52的体积可以约等于或大于连接器适用于接纳鲁尔12的近侧区域的体积。
在一些实施例中，突起52的上部或近侧边缘54可以是倾斜的和/或带斜面的。类似地，突起52的下部或远侧边缘56也可以是倾斜的和/或带斜面的。这些表面是倾斜的或带斜面的可以有利于流体流动通过连接器16并且使流体流动中的湍流最小化。通常，刚性件28和柔性件26的形状、材料和结构是可以选择的，从而当连接器关闭时允许突起52位于开口38中，并且当该连接器打开时突起52可以完全地或部分地从开口38收回。当连接器16处于大体上关闭的位置时，该向内的突起52起作用从而使得连接器16中的流体空间以及流体流动路径相比于该连接器16处于大体上打开的位置时减小了。
在一些实施例中，柔性件26可以由硅有机化合物制成，并且连接器16的其余部件可以由聚合材料例如聚碳酸酯制成。柔性件26的近侧区域58可以包括带有增加壁部厚度的部分或结构(或合成材料)，这有助于该近侧区域58比在压缩过程中柔性件26收缩的部分更坚硬或更硬。通过为近侧区域58提供了增加的坚硬度或硬度，使得当阀关闭而柔性件26扩张到它的原始高度时，阀中的流体被迫回流进入柔性件26内部的流体路径32中的可能性较低。此外，在一些实施例中，柔性件26内部的流体通道32的近侧部分60具有的水平横断面积显著小于部件28的流体路径中的区域的水平横断面积，从而促进了流出连接器远端的流体流动并且阻碍了向着该连接器近端流动的逆向流体流动。
在一些实施例中，孔27沿着大体上垂直于向内的突起52的轴线延伸，如图7A所示。在一些实施例中，孔27沿着与突起52相同的平面延伸。
如图7A和B所示，近侧部分60具有非旋转地对称的横断面直径。在一些实施例中，近侧部分60在垂直于孔27的平面中具有较小的横截面直径并且在孔27所在的平面中具有较大的横截面直径。在一些实施例中，近侧部分60的一部分具有大体上呈矩形的横截面区域。
图8A示出了凸形鲁尔10和图1所示的凹型连接器的垂直剖面。在图8A和8B中，刚性件28的一部分位于柔性件26的内腔32中。向内的突起52位于开口38中，并且更具体的是，位于通过连接器16的流体流动路径中。连接器16中的流体流动大体上被闭塞了。柔性件26的近端48可以用消毒剂以横扫过连接器16的近端18的方式拭抹，并且该近端48可以延伸到壳体的上方、可以大体上与该壳体齐平、或可以凹进到该壳体内。
图9A和9B示出了凹型连接器16的实施例在连接到凸型鲁尔连接器10之后的、互相垂直的断面图。在一些实施例中，柔性件26可以被凸型鲁尔12向远向施加的力压缩和/或移动。如图所示，在压缩过程中内部刚性件的一部分可以在近侧方向上延伸超出孔27之外。在一些实施例中，当柔性件被压缩时内部刚性件30在近侧方向不延伸过柔性件26的近端48。在一些实施例中，当凸型鲁尔连接器10插入到连接器16中时，孔27可以自动地打开从而允许流体流动通过该连接器16。
在图9A和9B中，该医用连接器16是大体上打开的以允许在凸型鲁尔10和凹型连接器16的远端20之间的流体流动。如图9A所示，突起52可以部分地或完全地从开口38中收回，从而在连接器16的打开过程中流体路径36的内部容积显著大于当连接器16被关闭时(例如见图8A)流体路径36的内部容积。这减小了或消除了从患者流向该连接器16的近端18的逆向流体流动，或者当关闭时甚至产生了向该连接器16的远端20方向并流向患者的正向流体流动。在一些实施例中，在凸型鲁尔连接器10插入到凹型连接器16的过程中，近侧区域58抵抗压缩的程度大于位于该区域58远侧的柔性件26上的区域。在被压缩和/或移动之前和之后，近侧区域58可以大体上保持其高度，当流体流动可以通过连接器16，这可以减小在柔性件26的该部分中的任何真空效应。
以上所提供的描述仅是为了说明某些例子。这里所公开的本发明的思想、原理、结构、步骤以及方法可以运用到本文所附的专利所公开的装置和方法中以及多种其它类型的医用连接器中。

Claims (7)

1.一种与第一和第二医用器具一起使用的医用连接器，其包括：
具有第一近端和第二远端的壳体；
位于所述壳体中的内部刚性件，其包括在它侧壁上的至少一个开口和具有流体流动路径的大体上中空的内部，所述开口从所述内部刚性件的外表面延伸到所述内部刚性件的所述中空的内部；
位于所述壳体中的大体上中空的柔性件，所述柔性件包括在其内壁上的至少一个向内突起，所述向内突起的至少一部分被构型成当所述连接器处于大体上关闭的位置时该至少一部分装配在所述内部刚性件中的所述开口中，其中在所述大体上关闭的位置中时，所述向内突起的所述一部分位于所述开口中并且占据了所述内部刚性件的所述大体上中空的内部的流体流动路径的至少一部分，且在大体上打开的位置中时，所述向内突起的所述一部分位于所述开口外，从而使得当该连接器在所述关闭位置时所述柔性件的内容积相对于该连接器在所述打开位置时的所述柔性件的内容积被减小了。
2.根据权利要求1所述的连接器，其中，所述柔性件还包括在其近端上的孔。
3.根据权利要求2所述的连接器，其中，当所述连接器处于所述大体上打开的位置时，所述孔自然地被偏压到打开位置。
4.根据权利要求2所述的连接器，其中，当所述连接器处于所述大体上打开的位置时，所述内部刚性件穿过所述孔。
5.根据权利要求2所述的连接器，其中，当医用器具从所述连接器移除时，在所述柔性件的所述内容积的所述减小确立了从所述壳体的该远端流出的流体流动。
6.根据权利要求2所述的连接器，其中，所述向内突起的所述一部分包括在其远侧上的倾斜表面，以有利于所述一部分从所述内部刚性件中的所述开口进出的运动。
7.根据权利要求6所述的连接器，其中，在所述内部刚性件中的所述开口的远侧包括与所述向内突起的所述远侧相配合的倾斜部分，从而进一步有利于所述一部分从所述内部刚性件中的所述开口进出的运动。
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JP2011500103A (ja) 2011-01-06
DE602007014252D1 (de) 2011-06-09
ATE506985T1 (de) 2011-05-15
CN101522252A (zh) 2009-09-02
US20120245551A1 (en) 2012-09-27
JP5015258B2 (ja) 2012-08-29
US8398607B2 (en) 2013-03-19
BRPI0717401A2 (pt) 2013-11-12
US8105314B2 (en) 2012-01-31
DK2086623T3 (da) 2011-08-15
CA2665151C (en) 2015-03-31
EP2086623A2 (en) 2009-08-12
WO2008052140A3 (en) 2008-06-19
HK1133607A1 (en) 2010-04-01
US20080103482A1 (en) 2008-05-01

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