CN1443082A - 具有正向流动特性的医用阀 - Google Patents

具有正向流动特性的医用阀 Download PDF

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CN1443082A
CN1443082A CN01812561A CN01812561A CN1443082A CN 1443082 A CN1443082 A CN 1443082A CN 01812561 A CN01812561 A CN 01812561A CN 01812561 A CN01812561 A CN 01812561A CN 1443082 A CN1443082 A CN 1443082A
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T·F·小范格罗
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Abstract

本发明公开了一种阀门，其用来有选择地使流体在第一和第二医用设备之间流动。该阀门具有一个带接口的外壳，该接口适用于连接第一医用设备如导液管的连接部分，该阀门还具有一个用柔性材料制成的密封件。该密封件的第一端与接口连通，第二端适用于连接第二医用设备，该密封件至少具有一个与第一端和第二端相通的切口。在处于静置状态时，该切口形成了限制性的流体通路以及一个相对较小的内部容积；在将第二医用设备引入切口时，该切口形成了一种扩大流体通路和相对较大的内部容积；在第二医用设备从密封件抽回时，该切口缩小并形成限制性的流体通路以及一个相对较小的内部容积。

Description

具有正向流动特性的医用阀
技术领域
本发明总的来说涉及一种医用阀门，特别是涉及一种阀门，当该阀门连接在第一医疗设备如流体源和第二医疗设备如导液管之间时，其能使流体在两个医疗设备之间流动，当第一医疗设备从阀门上取下时，其能引导流体朝着第二医疗设备的方向正向流过阀门。
背景技术
在医院和医护点肠胃外投药的流体处理中通常要使用连接器和阀门以便使流体有选择地在两点之间流动。这些阀门通常沿着导向病人或其它目标的流路布置。例如该管道可导向一导液管，该导液管的末端插在病人体内。
该阀门在布置上应使流体源或其它管线与之相连从而使流体从流体源流到病人处。当流体源或管线去掉时，该阀门关闭并封住通向病人的管线。
与阀门相连的部件包括：一个管或其它的医疗设备如管道、静脉注射(IV)装置(包括外周管和中心管)、背管、或类似的适于与医用阀相连的元件。遗憾的是，现有技术的阀门在将医用设备从阀门上取下时都存在问题。
这些阀门在内部形成了一个空间，流体或其它材料从设备经该空间流到与阀门相连的管线上。当医疗设备与阀门相连时，其通常会在阀门内占据一部分空间，从而将阀门内的流体(液体或空气)挤出。
当医疗设备从阀门取下时会出现一个问题。将设备取下时，该设备不再在阀门内占据一部分空间。阀门内空间的增加会使阀门和与阀门相连的管线内的液体流过来填补该空间。因此，取走设备会形成一个吸力将流体吸入阀门。
在医疗装置中，这种流体运动非常不好。当阀门与通向病人的流体管线相连时，流体从管线流向阀内空间会将血液从病人身体里抽向阀门。更严重的是该血液会在导液管的末端处凝结并堵塞该导液管，从而使其无法正常使用，甚至会使病人体内的血液凝结，出现生命危险。
克服堵塞问题的一种方法是在导液管靠近末端部分的内表面涂上一层膜从而防止血液粘到其内表面。该方法通常来说不能很好地防止导液管堵塞。
当导液管的内径很小时(例如，规格为27时)，血液堵塞导液管的危险大大提高。小直径的导液管能够减少其插入病人时的外伤和痛苦。但是，由于小直径导液管的通道很小，因此即使是很小的吸力也能将大量的液体通过导液管抽向阀门从而将血液吸入导液管的末端，从而堵塞导液管。
在考虑阀门必须满足的其它标准时，上述困难的克服就变得不那么容易了。例如，阀门在布置上不能有任何的流体滞留点。如果流体滞留在阀门的一个或多个区域，就会出现细菌的滋生及其它问题。
此外，阀门必须具有光滑的内部流路。尖锐边缘或尖锐角落都会使血细胞受损产生溶血。
由此就需要一种阀门来克服上述的问题。
发明内容
根据本发明的一个优选实施例，一种医用阀门，其用来有选择地使流体在第一和第二医用设备之间流动，该阀门包括：一个带接口的外壳，该接口适用于连接第一医用设备的连接部分；以及一个密封件。该密封件用柔性材料制成，其包括：一个下游端，该下游端与接口连通；一上游端，该上游端适用于连接第二医用设备；一个正常情况下基本为闭合的通道，该通道与下游端和上游端相通。在处于静置状态时，该通道具有一个相对较小的内部容积，当将第二医用设备引入该通道的上游时，该通道则具有一个相对较大的内部容积。在将第二医用设备从密封件抽回时(当第二医用设备回抽，上游端被初始封上)，该通道收缩并形成一个限制性的流体通路以及一个相对较小的内部容积，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向下游端。
本发明的另一个优选实施例提供了一种用于医用阀的阀门密封件，该阀门具有一个与第一医用设备流体相通的接口。该密封件包括：一个第一端，其与接口流体连通；一个第二端，其适用于连接第二医用设备；以及至少一个与第一端和第二端相通的切口。在处于静置状态时，该切口形成了限制性的流体通路以及一个相对较小的内部容积；在将第二医用设备引入切口时，该切口形成了一种扩大的流体通路和相对较大的内部容积；在第二医用设备从密封件回抽时，该切口缩小并形成限制性的流体通路以及一个相对较小的内部容积。
本发明的另一优选实施例提供了一种用来使流体沿着第一医用设备的方向从阀门正向流过的方法，其中的阀门将第一医用设备与第二医用设备相连并具有一个相关联的密封件。该密封件用来连接至少一部分第二医用设备并在第一和第二医用设备之间形成流体连通。该方法包括以下步骤：将第二医用设备从密封件回抽并且使密封件从较大的内部容积缩到一个相对较小的内部容积，从而使密封件内的任何流体沿着第一医用设备的方向排放。
本发明的另一个优选实施例提供了一种当注射器从注射器和导液管之间的一个阀门抽回时能够防止血液从病人流到导液管的方法。该方法包括以下步骤：将阀门的下游端与导液管相连并将注射器的端头插入一切口，该切口形成一个正常情况下基本为闭合的密封通道的上游端，该密封通道位于弹性密封件中并与阀门的下游端流体相通。这可使密封通道在打开时在注射器和密封通道的上游端之间形成密封接触。该方法进一步包括下面的步骤：将流体从注射器经密封通道注射到导液管并注射进病人体内，以及抽回注射器，使密封通道的侧壁回到其基本闭合的位置同时在上游端和注射器之间保持初始的密封接触。这样就形成一个力，将通道内的流体推向导液管。
本发明的另一个优选实施例提供了一种医用阀门，其通过一个关联密封件有选择地使流体在第一医用设备和第二医用设备之间流动。该阀门包括：一个接口，该接口用来连接第一医用设备的一个连接部分；以及一个密封件保持器，其与该接口流体相通。
本发明的另一个优选实施例提供了一种给病人血管输液的系统，该系统包括：一具有上游端和下游端的导液管，其与血管流体相通；以及一个注射器，该注射器用来将液体推入导液管。该系统进一步包括一个阀门，该阀门具有一个装置，该装置用来与导液管的上游端相连并能用来在注射器和导液管之间选择是否流体相通。该阀门进一步包括一个由柔性材料制成的密封件。该密封件具有：一个与所述装置流体相通的下游端；一个适合与注射器相接的上游端；以及一个正常情况下基本为闭合的通道，该通道与下游端和上游端相通。在处于静置状态时，该通道具有一个相对较小的内部容积，当将注射器引入该通道的上游端时，该通道则具有一个相对较大的内部容积。在将第二医用设备从密封件回抽时(当注射器回抽时，上游端被初始封上)，该通道缩回并形成一个限制性的流体通路以及一个相对较小的内部容积，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向下游端。
本发明的另一个优选实施例提供了一种制造医用阀门密封件的方法，其中的阀门具有：一个由柔性材料制成的阀体；以及至少一个切口，该切口布置在阀体内并在相邻的第一和第二切口壁之间形成。该方法包括：制出第一和第二功能件，每一功能件都包括第一或第二切口壁以及一个周边部分；以及将第一和第二功能件压制在一起从而使第一和第二切口壁彼此相对。该方法进一步包括：在第一和第二功能件的至少一部分周边上形成多余的柔性材料，这样第一和第二功能件和多余材料就形成一个整块，整块内形成切口。
本发明的另一个优选实施例提供了一种导液管，该导液管在医用设备和病人血液之间形成流通，该导液管包括一个长导液管或套管，该管具有：一个近端、一个远端以及至少一个贯穿套管的轴向腔。该导液管进一步包括一个阀门，该阀门能够有选择地开闭套管的近端。该阀门包括一个带有接口的外壳和一个密封件，其中的接口适合与套管的近端连接。该密封件由柔性材料制成，并具有：一个与所述接口流体相通的远端；一个适合与医用设备相接的近端；以及一个正常情况下基本为闭合的通道，该通道与远端和近端流体相通。在处于静置状态时，该通道具有一个相对较小的内部容积，当将医用设备引入该通道的近端时，该通道则具有一个相对较大的内部容积。在将医用设备从密封件回抽时，该通道缩小并形成一个限制性的流体通路以及一个相对较小的内部容积，近端随着医用设备的回抽被初始封上，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向远端。
本发明的另一个优选实施例提供了一种导液管，其包括一个长套管，该套管具有一个近端、一个远端以及至少一个内腔。其中远端适于插到病人的血管。该导液管进一步包括一个与套管近端相连的阀门。该阀门具有一个密封件，该密封件处于静置状态时会形成一个限制性的流体通路，该密封件还能膨胀形成一个扩大的流体通路从而使流体通过套管的近端。该密封件还能缩回形成限制性的流体通路，同时扩大后流体通道内的任何流体推入套管。
本发明的另一优选实施例中提供了一种将流体引入病人血管的方法，其包括将套管的远端插入病人的血管。该套管具有一个与其近端相连的阀门，该阀门包括一个外壳和一个密封件。该方法进一步包括：将一医用设备插入密封件，对医用设备进行操作从而使流体流过套管并进入病人的血管，将医用设备从密封件抽回。该密封件由柔性材料制成，并具有：一个与所述套管流体相通的远端；一个适合与医用设备相接的近端；以及一个正常情况下基本为闭合的通道，该通道与远端和近端流体相通。在处于静置状态时，该通道具有一个相对较小的内部容积，当将医用设备引入该通道的近端时，该通道则具有一个相对较大的内部容积。在将医用设备从密封件回抽时，该通道缩小并形成一个限制性的流体通路以及一个相对较小的内部容积，密封件的近端随着医用设备的回抽被原始封上，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向远端。
本发明的另一优选实施例中提供了一种有助于更换第一密封件可穿破的连接器的方法，其中的第一连接器与套管和第二密封件可穿破的连接器流体相通，其中套管与病人血管流体相通。该方法包括将一个阀门布置在第一密封件可穿破的连接器和套管的近端之间。该阀门包括一个外壳以及一个布置在外壳内的密封件。该密封件处于静置状态时会形成一个限制性的流体通路，该密封件还能膨胀形成一个扩大的流体通路从而使流体通过套管的近端。该密封件还能缩回形成限制性的流体通路，同时将扩大后流体通道内的任何流体都推入套管。该方法进一步包括：将第一密封件可穿破的连接器从阀门的近端取下从而使密封件缩回形成限制性的流体通路；以及将第二密封件可穿破的连接器与阀门相连从而使阀门扩大形成扩大的流路。
为了概述本发明以及其相对于现有技术的优点，上面已对本发明的目的和优点进行了描述。当然，本发明任一特定的实施例并非包括上面的所有目的和优点。因此，本领域的普通技术人员都清楚可以以一种方式实施或实现从而实现或优化这里公开的一个优点或一组优点，而不必考虑这里公开的其它目的或优点。
所有这些实施例都在本发明的范围之内。结合附图和优选实施例的详细说明，本领域的普通技术人员能够清楚地理解本发明的这些或其它实施例，本发明并不限于所公开的特定优选实施例。
附图说明
上面已经概述了本发明原理及其本质特征和优点，下面结合附图和优选实施例的详细说明，本领域的普通技术人员能够清楚地理解本发明的优选实施例及其改进方案，其中：
图1为本发明阀门与导液管和流体源如注射器相连时的示意图；
图2为阀门的立体图；
图3为阀门的正视图；
图4为阀门的侧视图；
图5为阀门内密封件的立体图；
图6A为密封件的正视图；
图6B为密封件的剖视图；
图7A为密封件的侧视图；
图7B为密封件的侧面剖视图；
图8为密封件的正视图，其中为一组医用设备插入该密封件时的截面示意图；
图9为阀门外壳的截面正视图；
图10为注射器插入阀门之前阀门和注射器的截面侧视图；
图11为注射器完全插入阀门时阀门的断面侧视图；
图12为注射器完全插入阀门时阀门的断面正视图；
图13为注射器部分抽回时阀门的断面侧视图；
图14为相比于图13，注射器进一步抽回时阀门的断面正视图；
图15为注射器部分插入时另一实施例阀门的断面侧视图；
图16为注射器完全插入时另一实施例阀门的断面侧视图；
图17为与注射器一起使用时阀门的正视图，该注射器具有一个Luer锁；
图18另一实施例阀门外壳的侧视图；
图19A-19E是密封件件制作流程的示意图；
图20用来制作密封件的上模箱的平面视图；
图21为导液管与本发明阀门和导线相连的部分剖视图；
图22为图21的导液管插入病人手臂时的立体图；以及
图23与导液管的阀门相连的密封件可穿破的连接器的部分剖视图。
具体实施方式
图1-9展示了本发明一优选实施例的阀门20。图1所展示的是阀门20的一个非常适合的特定用途。当然，阀门20可用于其它多种方式中。
如图1所示，阀门20最好用来控制流体从第二医用设备(其通常包括一个流体源如ISO标准的注射器24)流向第一医用设备(如这里所示的导液管22)。在这种布置中，导液管22与阀门20的一端相连，其尖部26插到病人的手臂内。注射器24具有一个环尖或注射头28，其插到阀门20的另一端，阀门20设成计能够与注射器24的注射头28相连，而不需在注射头上安装针尖。
如此连接时，阀门20可使流体从注射器24流到导液管22并进入病人体内。该阀门20在布置上还能在取下注射器24时防止流体流过阀门20。此外，当注射器24取下时，阀门20使流体正向流动即流体朝着病人的方向流动，从而防止血液进入导液管22产生逆流。
图2-4展示了本发明阀门20的一个优选实施例。阀门20包括一个相对刚性的外壳30和一个相对柔性的密封件32，密封件32布置在外壳30上或之内。外壳30的下端具有一个注射头锁件34从而有助于将阀门20与各种医用设备相连。本领域的普通技术人员都清楚可用其它的多个接口或连接来代替该注射头锁件34，如注射头滑动连接或带钩软管装置。
密封件32具有一个切口36(参见图2)，该切口36能使注射器24的注射头28在用户适当用力时进入密封件32。由此，注射头28就进到密封件32内的切口38(参见图3)中。随着注射头28的插入，密封件就能使流体从注射器24流过注射头28、切口38和注射头锁件34并进入导液管22或其它与注射头锁件34相连的医用设备。
图5-7B中为了清楚起见展示的是从外壳取下来的密封件32。密封件32具有一个本体40，该本体40在形式上可以是矩形的厚板。与3的整体一样，本体40优选由硅橡胶模制而成，肖氏硬度为区域50，作为选择也可由合成聚异戊二烯制成。本体40的一端是一个平的通常为矩形的颈部42和一个通常为圆形的横向法兰44。颈部42布置在第一和第二侧伸部分43a和43b之间，并且侧伸部分靠近法兰44的部分形成肩部43c和43d。本体40、颈部42和法兰44形成一个单元，该单元内形成(优选基本为平的)切口38。切口38从法兰44内的切口36(参见图2)延伸到本体40内在法兰44另一端形成的导向腔46。导向腔46优选基本为圆柱形，其中轴基本与密封件的纵轴平行或共线。切口38优选基本为一平面，其实际上没有厚度，除非将注射头连上。因此切口38(在其为静置状态，注射头28没有插入到密封件32中时)从切口36到导向腔46形成了一个非常限制性的流体流路。这里涉及流路所使用的“限制性的”是指一条不能使流体或者能使临床上忽略不计的流体通过的流路。
图6A-7B所示为切口38和尖部26的优选结构。切口38在密封件32的本体40内具有一个主体部分48。主体部分48最好是切口38宽度最大的区域，优选为约0.228″。切口38渐缩到一个点或宽度最小的区域50，该区域50最好位于颈部42内。切口38中宽度最小的区域50处优选为0.120″宽。换句话说，切口38在主体部分48内的宽度几乎是宽度最小的区域50的两倍。从切口38宽度最小的区域50向外渐扩到切口36，切口36的宽度优选为约0.200″。该扩张结构用来将注射头28导引到切口38中。切口38在颈部42相对的底端可具有斜角52，切口38在其底端与导向腔46相连从而使切口38和导向腔46之间流体相通。导向腔46优选具有一个定位导角54和一个到切口38的斜向部分56。导向腔46的内径优选为约0.040″。
在图7A和图7B的侧视图中可以看到：密封件32在安装到外壳30内之前为T型断面，其法兰44形成“T”的交叉部分。从侧面可以看到，切口38很薄，从密封件32的侧部到导向腔46实际上没有什么厚度。然而，当其装在外壳30中时，切口38的厚度(从侧面看去)将有所变化，这将在下面进行详细解释。
图8A-8D所展示的是注射头28引入切口38之后密封效果随切口38宽度变化之间关系。(为了清楚起见，图8A中没有展示注射头28)。图8B展示的是当注射头28完全插入切口38中时，切口38和注射头28在宽度最小的区域50处的布置。由于切口38在区域50处的宽度相对较窄，因此切口38在这里基本包在注射头28的整个外周上，在注射头28和切口38之间形成了一个相对较紧的周圈密封。换句话说，切口38在区域50处的周长小于注射头28的外周。
图8C和8D展示的是切口38较宽处的状态(即切口的主体部分48以及区域50的变化部分)，这里切口不再与注射头28的整个外周接触，在注射头28的端头和一个侧壁或两个侧壁之间留有空隙57。换句话说，主体部分48内开口的周长大于注射头28的外周。如下所述，切口38顶头的切口-注射头密封以及切口-注射头密封下面的流体空间(空隙57)有助于阀门20在抽回注射头28时实现正向流动功能。
图3、4和9展示了外壳30的优选结构以及其中密封件32的安装。外壳30优选由聚碳酸酯经模制形成，或者由适合的热塑性塑料形成。外壳30具有一个与注射头锁件34相连的密封件保持器58，该密封件保持器优选为圆柱结构，其也可是其它形状或结构只要能将密封件32固定在外壳30之内不影响阀门20的操作就行。该密封件保持器在注射头锁件34的对面具有一个轴孔60，此外还有第一和第二侧口62a、62b，侧口62a、62b具有第一和第二顶边63a、63b，该顶边包括最靠近轴孔60的侧口边缘。引管64(参见图9)从注射头锁件34伸向轴孔60，其包括一个内部容积66，该内部容积66与注射头锁件34内的腔体68流体相通。引管64优选为圆柱形或锥台形，其中轴与外壳30的纵轴平行或共轴。密封件保持器58靠近轴孔60的端头有一对凸耳70，从而注射头锁件或其它的螺纹连接(图中未示出)在轴孔60处与外壳30相连。
如图3和4所示，大部分密封件32都位于密封件保持器58内，其中密封件32的第一和第二侧伸部分43a、43b从第一和第二侧口62a、62b伸出。密封件32的导向腔46在位置上应至少使引管64部分伸入导向腔内，从而在密封件32和注射头锁件34之间形成流体相通。法兰44盖在轴孔60上并与开口的相邻边接触。作为优选，轴孔60和侧口62a、62b的顶边63a、63b之间的距离要比法兰44同侧伸部分43a、43b的肩部43c、43d之间距离稍微大一些。这种结构就将一个张力或预载荷加到法兰44与侧伸部分43a、43b之间的密封件32上。该预载荷在肩部43c、43d靠在顶边63a、63b上以及法兰44靠在轴孔60的边上时出现。在轴孔60的边靠在法兰44的下侧时，该预载荷使法兰44呈碗形或凹面。这样，碗形法兰44就能用来将注射头28引导插入到切口36中(参见图2)，并使切口36收缩增强密封件32防止流体流过的性能。该预载荷还可防止密封件沿其纵轴弯曲并将切口38的侧面沿其长度保持保持密闭。因此，该预载荷使法兰44下面的切口更薄，提高了切口38的密封性能。
图10-14展示了注射头28插入、取出切口38时阀门20的作用。图10所展示的是注射头28插入之前的阀门20，此时，切口38基本闭合或者是通过密封件32的流动通路非常有限，其厚度很簿(基本不存在)，由切口壁72a、72b之间的厚度Tmin表示。法兰44下面的整个切口38的长度上几乎都为这个很簿或者不存在的厚度Tmin。这种状态限制了流体在密封件32中的流动从而封断导液管22(参见图1)或者其它与注射头锁件34相连的医用设备。此时，切口38还在切口壁72a、72b之间的密封件32内形成了一个相对较小的内部容积Vmin。(这里在提到密封的内部容积时用到的“相对较小”是指该腔体要么不存在要么其大小在临床上可忽略不计)，在此初始状态下，密封32布置在引管64上，并且引管64基本不伸到切口38中。
图11和12展示的是注射头28完全插入切口38时的阀门20。这里，密封件32已被拉长或向下推到引管64上，至少有一部分引管64穿入切口38中。此时，切口38在密封件32内形成了一个扩展开了的流体通路，切口壁72a、72b展开到间Tmax。由此，密封件32就能使流体在注射器24和导液管22之间流动。此外，现在的切口38形成了一个较小的或最大的内部容积Vmax。除了注射头28的套管和引管64穿入切口38的部分所占的空间之外，Vmax包括了切口壁72a、72b之间的整个空间。因此，在注射器24的压力下，基本与V max相等量的流体就充满了切口壁72a、72b之间的切口38。这里还可参见图8C和8D中的空隙57。
图13和14展示的是切口38从阀门20回抽时切口38的作用情况。当注射头28和引管64退出切口时，切口壁72a、72b基本回缩到其原始状态从而在切口壁72a、72b再次形成窄路(接近Tmin)。切口壁72a、72b的回缩减少了侧壁之间的体积，即切口38的内部容积体积不断从Vmax减少。这样，切口内的流体量也必须从Vmax减少。由此，切口壁72a、72b回缩就使流体随着注射头28的回抽从切口38排出。
这样，排出的流体就不会从密封件32的顶部流出切口38。如上面参见图8A-8B的介绍，当注射头28回抽时，切口38在宽度最小的区域50与注射头28之间保持紧配合密封。此外，在阀门20的使用期间内，排出的流体不会流入注射器24内。因此，基本上所有的排出流体都必须通过引管64和注射头锁件34流出切口38，从而使阀门20在注射头28的回抽时形成正向流动特性。
图15-18展示的是上面的阀门20在一定操作状态下的变化情况。例如，如图15和16所示，外壳30可在轴孔60和一个或两个侧口62a、62b之间垂直形成一断口74。该断口74使密封件保持器58能随着注射头28(其与图17中的注射头锁件76相对)插入密封件32而展开。现已证明这种展示对于阀门20和注射头28的配合使用非常有利，此时阀门20不大可能将注射头28挤出或压出密封件32。
图18展示了另一例外壳30，相对于前面的外壳其具有曲线或流线形外观。该外壳或前述的外壳均可具有一个外涂层或者是一层相对较软的材料如热塑性塑料从而提高操作的舒适度和阀门20的主体性，在不用锐利的穿孔元件如针或刀片的情况下提供连接。
图19A-21展示了一种制造密封件32的优选方法。第一，分别在第一和第二模幅204a、204b和206a、206b之间模制形成一对功能件202a、202b。每一个功能件202都具有一个平面部分208，其在完整的密封件32中形成切口38的一个侧壁(参见图6A-7B)。法兰部分210与两个功能件202经模制一体形成。法兰部分210的侧面优选从平面部分208的上表面回缩从而提供一个空间，使顶模材料(这一点将在下面详细论述)在法兰部分210之间流动并与法兰部分210相连。可采用常规的技术和设备来实现功能件202的模制，优选是将热固型材料注入模幅204a、204b和206a、206b之间的空腔内，然后将模具和/或材料加热到所用材料的热固温度来进行。通过加压以防止材料从模幅之间漏出。
在初始模制步骤之后，如图19B-19C所示，用模幅之间的盖模模板212将模幅204a、206a和204b、206b压在一起。参见图20(其中功能件202的轮廓用虚线表示)，盖模模板212包括一个平板板体214，其上有一个盖模开口216切入板体214中。盖模开口216具有一个与整体密封件32外边相合的平面外周，其可包括一个心轴218，该心轴218从盖模开口216的底部伸出在盖模过程中形成导向腔46(参见图6A-7B)，这一点将在下面详细论述。模幅204a、206a以及盖模模板212的接触面最好基本为平面。这样，模幅204a、206a以及盖模模板212和功能件202a、202b就在盖模开口216的侧壁和功能件202a、202b的外缘之间以及模幅204a、206a之间形成空间或模腔220。
当模具(模幅204a、206a以及盖模模板212)如图19C布置时，将额外的热固型材料注入到模具中，从而充满模腔220形成剩余的密封件32。优选方案是，在模制出功能件202后，在其相对于初始模制仍有点热时，将额外的材料迅速注入(约几秒钟)。注入到模腔220的额外材料与功能件202的边缘相粘接并形成完整密封件32内切口38的边缘。换句话说就是将剩余的密封件盖模到功能件202的“夹层结构”上。作为优选，可在盖模的过程中用力将功能件202压在一起从而防止额外材料在功能件202的接触表面之间移动。这样可防止功能件202的接触表面在盖模的过程中彼此粘在一起，从而保持切口38的分开性质。
盖模模板212的厚度可做成与功能件202a、202b夹层结构的厚度几乎一样，从而形成一个如上所述的模腔220，该模腔220在盖模开口216的侧壁和功能件202a、202b的外缘之间以及在模幅204a、206a的表面之间有一个敞开的空间。这样，该盖模开口的厚度也与功能件夹层结构的厚度几乎相等，注入这里的所有或者几乎所有盖模材料仅与功能件202a、202b的边缘相粘接。在另一实施例中，盖模模板212的厚度大于功能件的厚度。这样，这种较厚的盖模模板就形成这样一个空腔，该空腔也在模幅204a、206a之间以及功能件202a、202b的外表面(即背离完全密封内的切口)之间形成一个敞开的空间。该模幅204a、206a优选配有突起、突脊、通道、间隙等从而在此盖模步骤中形成该空间，同时根据需要在盖模过程中将功能件压在一起。由此，在本实施例中，盖模材料与两个边缘和功能件202a、202b的外表面相粘接。换句话说，该盖模操作是将盖模材料注入到一个环绕大多数或整个功能件夹层结构的模腔内，而不是仅在功能件的边缘盖模制造。
在盖模操作中加入的材料优选为与模制功能件202所用的材料相同，然而，在其它实施例中，功能件的材料以及盖模材料可以不同，但如上所述应当是适于制造密封件的材料。因此，这里所用的“柔性材料”是指任何一种选自适用于密封件的材料。
在完成盖模之后，模幅204a、206a从盖模模板212取下，此时如图19D-19E所示，该盖模模板212包括有一个基本完整的密封件32。做好的密封件32很容易就能从盖模模板212取下，此时如上所述，形成的密封件就是一个其中有切口的整体模制材料。
参见图21和22，导液管和阀门的组件300可用来将流体输送到病人的血管中。导液管和阀门的组件300包括一长套管302和一阀门304，阀门304的近端与套管相连。在一实施例，套管302包括PICC套管。显然，阀门304类似于上面的阀门20，然而如图21所示，阀门304可通过一个与阀门304一体形成的带齿结构306与套管302相连。当然，也可采用其它类型的连接，这包括但不限于：粘接、化学粘接、螺纹连接和/或超声波热熔焊连接。为了便于套管302插入到病人的血管中，可将一个导线308布置在套管302的腔体中，并穿过阀门304的密封件32。在套管302的远端有一开口的情况下，导线可拧入病人的血流中，然后使套管302和阀门304组件在导线308上滑动直到套管302的远端也在病人的血流中。接着，将导线308取出将套管302留在血流中，这对本领域的普通技术人员来说是清楚的。作为选择，导线308和套管302可同时与病人的血流相通，然后再将导线取出。
在套管302不包括有导线腔或者在其远端没有开口时，可以不要导线308。如果使用这种套管302，可用本领域公知的引导针来引导导液管和阀门的组件300。该引导针可使用拆分型的，这样一旦将套管302布置好，套管302的远端置于病人的血流中，就可将引导针从病人身上取下。已知有许多将导液管引入病人的方法都能用在这里将导液管和阀门的组件300引入病人的血管中。用任何方法来插入导液管和阀门的组件300都在本发明的范围之内。此外，阀门304可与本领域已知的任一套管302一起使用。
图22中套管302经病人手臂上的一个插入点与病人的血管相通。然而，套管302也可选用其它任何合适的插入点插入。如上所述，可采用各种插入技术。例如，首先可将常规的引导管或针(图中未示出)布置在插入点处，带或不带导线308的套管302穿过引导管直到套管302的远端进入病人的血管。作为选择，可先仅将导线308穿过管并插入目标血管中，接着将套管302在导线上穿过引导管并进入血管中。在使用这些插入技术时，引导管最好是能够被撕掉从而在导线和/或套管穿过引导管进入血管时方便引导管的取下。作为另一种选择，也可不用引导针或管来插入套管302。这里要用到导线308，导线308最好在插入导液管和阀门的组件300后取下，仅将导液管和阀门的组件300留下来用来流体的输送或抽取设备。
一旦将套管302的远端部分插入到病人的血管中，阀门304就可用作管纽从而有助于各种医用设备与导液管之间的连接和更换，同时也助于将流体经导液管输送到病人。所有这些功能都能正常实现，同时还能保持阀门20的上述优点，即正向流动特性、导液管的流体密封等。举例来说，可将注射头型(Luer-type)注射器(参见图1，10-17)插入阀门304中，然后操作注射器使流体流过阀门304和套管302并流入病人的血管。注射器的头部一旦取出，阀门304会将套管302的近端重新密封并如上所述形成正向流动。作为选择，也可通过套管302和阀门304抽取血液。
显然，可将任何合适的医用设备如IV袋、其它的套管等连接到阀门304以便流体输送或用于所需的其它目的。如图23所示，可将连接器400与阀门304相连并与套管302和病人流体相通。这种布置在需要使用专用连接器时具有许多优点。例如在更换连接器400时，可在套管(或病人的血管)不暴露于大气的条件下将其从套管302的流通中取下，换上一个类似的连接器或其它任何合适的医用装置。如前所述，更换连接器400时，阀门304会重新密封套管302，同时在没有连接器400时防止血液从病人和套管302的近端流出。因此，当导液管和阀门的组件300用于普通的临床应用时可防止感染和失血。如图23所示，这种连接器400可以采用ICU Medical公司销售的CLAVE连接器。然而，也可用其它任一连接器或医用装置或设备与阀门304流体相通，从而将流体引到病人或从病人那里抽取血液，这包括但不限于可穿破型连接器、无针连接器、医用管、注射器或其它任何合适的医疗装置或设备。由此，套管302和阀门304的组件300就形成了一个闭合的、可清洗的衬套(hub)，该衬套可防止病人感染、失血等。
阀门304还可与标准的导液管衬套一起使用。这样，阀门304和套管302既可做成整体单元，也可由图23所示注射头或本领域公知的其它连接机构固定为可拆连接。在图23中，套管302的近端包括一个一体式衬套303。阀门304的远端与衬套303螺纹连接从而使阀门304与套管302流体相通没有渗漏。在更换本实施例的连接器400时，取下连接器400会使阀门304形成一个正向位移并防止套管302的远端被堵塞。可对阀门304的套管302进行清洗，可换上一个类型相同或不同的新连接器，其与阀门304流体相通使密封件32张开，经阀门304和套管302在连接器400和病人之间形成流通。
尽管本发明是采用优选实施例和实施方式的形式进行的说明，但本领域的普通技术人员都清楚本发明可从所公开的特定实施例延伸到其它的变化方案和/或本发明的使用、显而易见的改进以及等同方案。因此，本发明保护范围并非由特定实施例所限定，而是由下面的权利要求书限定。

Claims (45)

1.一种医用阀门，其用来有选择地使流体在第一和第二医用设备之间流动，该阀门包括：
一个具有接口的外壳，该接口适于连接第一医用设备的连接部分；以及
一个密封件，该密封件用柔性材料制成，其包括，一个下游端，该下游端与接口连通，一个上游端，该上游端适于连接第二医用设备，以及一个正常情况下基本为闭合的通道，该通道与下游端和上游端相通，在处于静置状态时，该通道具有一个相对较小的内部容积，当将第二医用设备引入该通道的上游端时，该通道则具有一个相对较大的内部容积，在将第二医用设备从密封件回抽时，该通道缩回并形成一个限制性的流体通路以及一个相对较小的内部容积，当第二医用设备回抽，上游端按原始封上，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向下游端。
2.如权利要求1所述的医用阀门，其中的切口具有一个宽度最小的区域，该区域在靠近密封件上游端的一个区域与第二医用设备的整个外周基本保持流体密封接触。
3.如权利要求1所述的医用阀门，其中的密封件包括：
一个由柔性材料制成的本体，并具有一个下游端和一个与下游端相反的上游端，本体的下游端和上游端在取向上对应于密封件的下游端和上游端；
一个导向腔，该导向腔布置在本体的下游端，与通道连通；
一个颈部，该颈部布置在本体的第二端以及
一个横向法兰，该法兰布置在颈部与本体相反的一端，该横向法兰至少有一个开口与通道相通。
4.如权利要求29所述的医用阀门，其中导向腔的中轴基本平行于密封件的纵轴或与该纵轴同轴。
5.如权利要求29所述的医用阀门，其中的密封件本体包括一个基本为矩形的柔性材料板，并且颈部与本体共面。
6.如权利要求29所述的医用阀门，其中的通道包括一个切口并且通道的开口包括一个切开的开口。
7.如权利要求32所述的医用阀门，其中的切口包括：
一个相对较薄、基本为平面并且宽度变化的通道；
一个宽度最小的区域；以及
一个宽度较大的区域，其位于宽度最小区域中远离切开的开口的一侧；
其中切口的宽度从切开的开口到宽度最小的区域逐渐变小。
8.如权利要求29所述的医用阀门，其中的密封件本体具有第一和第二侧部，并且外壳进一步包括：
一个密封件保持器，其与接口相连，该密封件保持器包括一个中空的柱件，该柱件从接口延伸并具有第一和第二侧口以及一个与接口相反的轴口；
一个引管，该引管与接口相连并相通，其接口伸向轴口，该引管的中轴与外壳的纵轴基本平行或者是共轴；
其中的密封件布置在密封件保持器中，这样引管至少是部分伸入导向腔中，法兰横跨轴口，密封件本体的第一和第二侧部伸入第一和第二侧口。
9.如权利要求8所述的医用阀门，其中的第一和第二侧口具有顶边，该顶边包括侧口中靠近轴口的边部，并且密封件本体的第一和第二侧部具有肩部，该肩部包括侧部中靠近横向法兰的伸出部分，侧口的顶边应距离轴口足够的远从而将张力分配到横向法兰和肩部之间的密封件，使横向法兰的外周靠在轴口边缘，并使横向法兰呈凹形，切开的开口靠近该凹形的最低部。
10.如权利要求8所述的医用阀门，其中当密封件为静置状态时，至少有一部分引管布置在导向腔内，并且在第二医用设备插入密封件时至少有一部分引管在密封件的轴向压缩下进到切口靠近导向腔的区域。
11.一种用于医用阀的阀门密封件，该阀门具有一个与第一医用设备流体相通的接口，该密封件包括：
一个第一端，其与接口连通；一个第二端，其适于连接第二医用设备；以及至少一个与第一端和第二端相通的切口，在处于静置状态时，该切口形成了限制性的流体通路以及一个相对较小的内部容积，在将第二医用设备引入切口时，该切口形成了一个扩大的流体通路和一相对较大的内部容积，在第二医用设备从密封件回抽时，该切口缩小并形成限制性的流体通路以及一个相对较小的内部容积。
12.如权利要求11所述的阀门密封件，其中的切口具有一个区域，该区域在靠近密封件第二端的一个区域与第二医用设备的整个外周基本保持流体密封接触。
13.如权利要求11所述的阀门密封件，其进一步包括：
一个本体，该本体由柔性材料制成，并具有一个第一端和一个与第一端相反的第二端，本体的第一端和第二端在方向上对应于密封件的第一端和第二端；
一个导向腔，该导向腔布置在本体的第一端中，其中轴与密封件的纵轴基本平行或共轴；
一个颈部，该颈部布置在本体的第二端以及
一个横向法兰，该法兰布置在颈部与本体相反的一端，该横向法兰至少有一个切开的开口；以及
在密封件内形成的至少一个切口，该切口与导向腔和切开的开口相通。
14.一种用来使流体沿着第一医用设备的方向从阀门正向流过的方法，其中的阀门将第一医用设备与第二医用设备相连并具有一个相连的密封件，该密封件用来连接至少一部分第二医用设备并在第一和第二医用设备之间形成流通，该方法包括以下步骤：
将第二医用设备从密封件回抽；并且
使密封件从较大的内部容积缩到一个相对较小的内部容积，从而使密封件内的任何流体沿着第一医用设备的方向排放。
15.一种当注射器从注射器和导液管之间的一个阀门抽回时能够防止血液从病人流到导液管的方法，该方法包括以下步骤：
将阀门的下游端与导液管相连；并且
将注射器的端头插入一切口，该切口形成一个正常情况下基本为闭合的密封件通道的上游端，该密封通道位于弹性密封件中并与阀门的下游端流体相通，这可使密封通道打开，同时在注射器和密封通道的上游端之间形成密封接触；
将流体从注射器经密封通道注射到导液管并注入病人体内；以及
回抽注射器，使密封通道的侧壁回到其基本闭合的位置，同时在上游端和注射器之间保持原始的密封接触，这样就形成一个力，将通道内的流体推向导液管。
16.如权利要求15所述的方法，其中将注射器的端头插入切口的步骤包括轴向压缩该密封件。
17.一种医用阀门，其通过一个关联密封件有选择地使流体在第一医用设备和第二医用设备之间流动，该阀门包括：
一个接口，该接口用来连接第一医用设备的一个连接部分；以及
一个密封件保持器，其与该接口流体相通。
18.一种控制病人血管输液的系统，该系统包括：
一个具有上游端和下游端的导液管，其与血管连通；以及
一个注射器，该注射器用来将液体推入导液管；以及
一个阀门，该阀门具有一装置，该装置用来与导液管的上游端相连并能用来在注射器和导液管之间选择是否流体相通，该阀门进一步包括：
一个由柔性材料制成的密封件，该密封件具有一个与所述装置连通的下游端，一个适合与注射器相接的上游端，以及一个正常情况下基本为闭合的通道，该通道与下游端和上游端相通，在处于静置状态时，该通道具有一个相对较小的内部容积，当将注射器引入该通道的上游端时，该通道则具有一个相对较大的内部容积，在将第二医用设备从密封件回抽时，该通道缩小并形成一个限制性的流体通路以及一个相对较小的内部容积，该上游端随着注射器的回抽被原始封上，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向下游端。
19.一种制造医用阀门密封件的方法，其中的阀门具有一个由柔性材料制成的阀体，以及至少一个切口，该切口布置在阀体内并在相邻的第一和第二切口壁之间形成，该方法包括：
模制第一和第二功能件，每一功能件都包括第一或第二切口壁以及一个周边部分；
将第一和第二功能件压制在一起从而使所述第一和第二切口壁彼此相对；以及
在第一和第二功能件的至少一部分所述周边部分上形成多余的柔性材料，这样所述第一和第二功能件和多余材料就形成一个整块，整块内形成切口。
20.如权利要求19所述的方法，其中：
所述第一第二功能件进一步包括外表面部分；以及
模制多余量柔性材料的步骤进一步包括将所述多余量的柔性材料模制到所述的外表面部分。
21.如权利要求19所述的方法，其中：
将第一和第二功能件压在一起的步骤包括一起移动第一和第二包含所述第一和第二功能件的模幅，从而使所述第一和第二切口壁彼此接触；以及
模制多余量柔性材料的步骤包括将一盖模模板布置在所述第一和第二模幅之间从而在各部分之间形成模腔，(i)所述模幅；(ii)所述功能件的所述周边部分；以及(iii)在所述盖模模板内一盖模开口的内边，然后将所述多余的柔性材料注入到所述的模腔内。
22.如权利要求19所述的方法，其中所述每个功能件进一步包括一个与所述相应的一个切口壁相连的法兰部分。
23.如权利要求21所述的方法，其中所述第一和第二模幅和所述盖模模板具有接触表面，该接触表面基本为平面。
24.如权利要求21所述的方法，其中所述盖模模板至少具有一个心轴从所述盖模模板的所述内边突出，当所述多余量柔性材料注入所述模腔时，所述心轴在所述密封件内形成导向腔。
25.如权利要求21所述的方法，其中所述多余量的柔性材料形成所述密封件的剩余部分。
26.如权利要求19所述的方法，其中：其中将所述第一和第二功能件压在一起的步骤包括加上足够的压力，从而防止所述多余量的柔性材料在所述第一和第二功能件之间移动。
27.一种导液管，该导液管在医用设备和病人血管之间形成流通，该导液管包括：
一个长套管，该管具有一个近端、一个远端以及至少一个贯穿所述套管的轴腔；以及
一个阀门，该阀门能够有选择地开闭套管的所述近端，所述阀门包括：
一个带有接口的外壳，其中的接口适合与套管的近端连接；以及
一个密封件，该密封件由柔性材料制成，并具有，一个与所述接口连通的远端，一个适合与医用设备相接的近端，以及一个正常情况下基本为闭合的通道，该通道与远端和近端流体相通，在处于静置状态时，该通道具有一个相对较小的内部容积，当将医用设备引入该通道的近端时，该通道则具有一个相对较大的内部容积，在将医用设备从密封件回抽时，该通道缩小并形成一个限制性的流体通路以及一个相对较小的内部容积，近端随着医用设备的回抽被原始封上，这样占据了一定内部容积的流体就被迫随着通道壁的塌缩流向远端。
28.如权利要求27所述的导液管，其中所述通道具有一个宽度最小的区域，该区域在靠近密封件近端的一个区域与医用设备的整个外周基本保持流体密封接触。
29.如权利要求27所述的导液管，其中的密封件包括：
一个本体，该本体由柔性材料制成，并具有一个远端和一个与远端相反的近端，本体的远端和近端在方向上对应于密封件的远端和近端；
一个导向腔，该导向腔布置在本体的远端，与通道连通；
一个颈部，该颈部布置在本体的第二端以及
一个横向法兰，该法兰布置在颈部与本体相反的一端，该横向法兰至少有一个通道口与通道相通。
30.如权利要求29所述的导液管，其中导向腔的中轴基本平行于密封件的纵轴或与该纵轴同轴。
31.如权利要求29所述的导液管，其中的密封件本体包括一个基本为矩形的柔性材料板，并且颈部与本体共面。
32.如权利要求29所述的导液管，其中的通道包括一个切口并且通道口包括一个切开的开口。
33.如权利要求32所述的导液管，其中的切口包括：
一相对较薄、基本为平面并且宽度变化的通道；
一个宽度最小的区域；以及
一个宽度较大的区域，其位于宽度最小区域中远离切开的开口的一侧；
其中切口的宽度从切开的开口到宽度最小的区域逐渐变小。
34.如权利要求27所述的导液管，其进一步包括一根导线，该导线布置在所述腔体和所述密封件内。
35.如权利要求27所述的导液管，其进一步包括一个与所述阀门相连的连接器。
36.一种导液管，其包括：
一个长套管，该套管具有一个近端、一个远端以及至少一个在所述近端和远端之间延伸的内部容积，所述远端适于插到病人的血管中；
一个与所述套管的近端相连的阀门，所述阀门具有一个密封件，该密封件处于静置状态时会形成一个限制性的流体通路，该密封件还能膨胀形成一个扩大的流体通路从而使流体通过所述套管的所述近端，所述密封件还能缩回形成所述限制性的流体通路，同时所述密封件将扩大后流体通道内的任何流体推入所述套管。
37.一种将流体引入病人血管的方法，该方法包括：
将套管的远端插入病人的血管，所述套管具有一个与其近端相连的阀门，所述阀门包括一个外壳和一密封件；
将一医用设备插入密封件并与之连通；
对所述医用设备进行操作从而使所述流体流过所述套管并进入病人的血管；以及
将所述医用设备从所述密封件抽回；
其中所述密封件由柔性材料制成，并具有一个与所述套管流体相通的远端，一个适合与所述医用设备相接的近端，以及一个正常情况下基本为闭合的通道，该通道与远端和近端连通，在处于静置状态时，该通道具有一个相对较小的内部容积，当将医用设备引入该通道的近端时，该通道则具有一个相对较大的内部容积，在将医用设备从密封件回抽时，该通道缩小并形成一个限制性的流体通路以及一个相对较小的内部容积，密封件的近端随着医用设备的回抽被原始封上，这样占据了一定内部容积的所述流体就被迫随着通道壁的塌缩流向远端。
38.如权利要求37所述的方法，其中所述通道具有一个宽度最小的区域，该区域在靠近密封件近端的一个区域与医用设备的整个外周基本保持流体密封件接触。
39.如权利要求37所述的方法，其中的密封件包括：
一个本体，该本体由柔性材料制成，并具有一个远端和一个与远端相反的近端，本体的远端和近端在方向上对应于密封件的远端和近端；
一个导向腔，该导向腔布置在本体的远端中，并与通道连通；
一个颈部，该颈部布置在本体的第二端以及
一个横向法兰，该法兰布置在颈部与本体相反的一端，该横向法兰至少有一个通道口与通道相通。
40.如权利要求37所述的方法，其中将所述套管的所述远端插入病人血管的步骤包括：
将一导引管插入血管；
将一导线的远端部分穿过所述的导引管并进入血管；
将所述套管布置在所述导线上；
使所述套管沿着所述导线前进直到所述远端进入血管；
将导线从所述套管抽回；以及
去掉所述的导引管。
41.如权利要求40所述的方法，其中将所述导引管去掉的步骤是在使所述套管沿着所述导线前进直到所述远端进入血管的步骤之后进行。
42.如权利要求40所述的方法，其中将所述导引管去掉的步骤是在使所述套管沿着所述导线前进直到所述远端进入血管的步骤之前进行。
43.如权利要求37所述的方法，其中的导线布置在所述套管和所述密封件之内。
44.如权利要求43所述的方法，其中将所述套管的远端插入病人血管内的步骤包括：
将所述套管的远端经所述导引管插入到血管中。
45.一种有助于用第二连接器来更换第一连接器的方法，其中的第一连接器与一根置入病人血管内的套管连通，所述方法包括：
将一阀门布置在所述第一连接器和所述套管的近端之间，所述阀门包括：
一个外壳；以及
一个布置所述外壳内的密封件，其中所述密封件在其处于静置状态时会形成一个限制性的流体通路，该密封件还能膨胀形成一个扩大的流体通路从而使流体通过所述套管的所述近端，所述密封件还能缩回形成所述限制性的流体通路，同时所述密封件将所述扩大后的流体通道内的任何流体都推入所述套管；
将所述第一连接器从所述阀门的近端取下，从而使所述密封件缩回形成所述限制性的流体通路；以及
将所述第二连接器与所述阀门相连，从而使所述阀门扩大形成所述扩大后的流路。
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CN113855905A (zh) * 2016-01-28 2021-12-31 德卡产品有限公司 滴注室和用于将流体输注到患者体内的设备
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