CN1182893C - 无针连接器 - Google Patents
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Abstract
本发明公开了一种利用可再密封预裂隔膜阀(402)的无针连接器(450)。阀(402)相对于阀的外壳(418)被弹性约束。外壳构形成用于接纳具有路厄氏尖端(18)的标准凸形路厄氏锁,该锁通过开口穿透阀以在外壳内延伸,路厄氏锁的路厄氏锁定凸缘绕外壳延伸。阀(402)包括覆盖开口的盘状上部(404)、与外壳(418)间隔开并从盘状上部向下延伸进入由外壳(418)限定的通道内的下部(406),以及使隔膜与外壳接合的环状裙边(408)。连接器(450)在路厄氏尖端(18)长时间以及路厄低锁配件多次连接和拆开之后呈现令人满意的泄漏压力。
Description
发明领域
本发明总的来说涉及无针液体连接装置,更具体地说涉及在医疗应用中用于与导管或容器重复建立密封连接的装置。
发明背景
一种十分流行的健康护理治疗形式是输液或静脉内(I.V.)治疗,从而在任意长时间内将用于医疗或其它目的的液体输注到病人体内。在进行这种输液治疗中,往往需要在各器件之间建立连接关系,从而沿液体通道在两器件之间进行液体运输,最终将液体输送到病人体内。例如有一种广泛用于将药物液体注射到病人体内的给药装置,而其它装置与该给药装置连接以进行适当的给药。
一种广泛用于在医疗装置之间进行连接、从而建立液体通道的连接器为路厄氏连接组件。在路厄氏连接组件中,具有截头圆锥形状的凸形路厄氏尖端元件或配件被插入到具有截头圆锥形状接纳腔的凹形路厄氏元件或配件内,从而相对的圆锥形表面彼此接触,构成密封摩擦配合。
在建立连接之前,穿过每个路厄氏配件并进入与路厄氏配件接合的元件腔内的通道与外界环境是相通的。所述腔和穿过路厄氏连接器的通道构成液体通道的一部分,并且在使用前应为无菌的,而在使用过程中其被密封,以防细菌进入。因此,这些连接组件和相应的元件被包裹在无菌包中,并且一般在与病人静脉系统建立以流体方式连通之前实现连接。
路厄氏连接组件一般有两种类型。一种类型一般称为路厄氏滑片,这种类型的连接由凸形路厄氏尖端和凹形路厄氏元件之间的摩擦配合来维持。另一种类型一般称为路厄氏锁定连接,其中凸形路厄氏尖端被具有螺纹内表面的环状凸缘包绕。凹形元件在其外表面上形成有相应的螺纹。将螺纹凸缘与具有螺纹的外表面啮合即在凸形路厄氏尖端和凹形元件之间建立了连接,同时防止两者意外分离。
为了确保在由多数制造商提供的各元件之间能够进行通用的路厄氏连接,路厄氏连接组件的制成满足通用标准。十分重要的标准组如ANSI和ISO标准。这些标准包括凸形滑片和路厄氏锁定组件的尺寸标准。在这些标准尺寸中,其标准由环形锁定凸缘和凸形路厄氏尖端之间的间隙或空隙确定。构形成与标准凸形路厄氏锁建立连接关系的任何凹形连接装置应能够在上述间隙或空隙范围内与路厄氏尖端和锁定凸缘啮合。
ISO标准中的其它标准包括路厄氏连接所需的一些性能。这种需求中的其中一种为在路厄氏锁型连接已建立之后,为了防止意外分离,路厄氏连接应可抵抗8磅的轴向移动力和小于2.8英寸/盎司的螺丝旋出扭矩而不会产生分离。路厄氏连接在已施加16英寸/盎司的连接扭矩之后还应保持45磅/平方英寸的密封度。在标准路厄氏连接中,这种抗力和密封由在相对的圆锥形表面之间的摩擦来提供。
一旦I.V.治疗元件被放置在与人体以流体方式连通的系统中,液体通道应与外界环境隔绝,以防止污染,并且该通道还应密封,从而不允许任何体液泄漏到周围环境中。但是大多数治疗需定期与液体通道相通。由于穿过凹形路厄氏连接元件的液体通道部分与外界环境相通,从而在液体通道被设置成与人体以流体方式连通之后,这些元件不再与液体通道形成密封连接。
在一个输液治疗的普通例子中,借助给药装置将包含有药剂溶液的液体从I.V.溶液容器中经由在静脉内延伸的导管注入到主液流中。含有药剂的液体可从注射器、辅助医疗装置或类似装置中被注射到一装置中,在该装置中,含有药剂的液体与液流混合。在另一常见例子中,液体被直接从在身体内延伸的导管中注入或抽取出。另外,向导管中注射少量的盐或肝磷脂,使导管被定期冲洗,以保证通畅。
如可以看出的那样,非常希望在尽可能长的时间内在不影响病人安全的情况下持续使用导管和给药装置。更换导管和给药装置费时且费用昂贵。因此,装置或导管在整个使用过程中可多次被连接或拆开。例如,在更换导管或装置之前,可超过100次地连接或拆开处于连接位置的导管或装置。另外,可建立连接关系,并且在拆开之前持续保持连接状态。例如,可建立连接状态,并使这种连接保持7天以上的时间,而且这种连接应随时能够使用,随后的连接或拆开在不相对外界环境产生泄漏的情况下进行。
对连接器的另一个较高期望是,希望这种连接器能够对在装置内存在的加压液体密封,或希望该连接器具有超过所期望压力的泄漏压力。例如,期望连接器在短时间内、例如当给定药剂弹丸被射入装置中时具有超过20磅/平方英寸的泄漏压力,并且在药物治疗输液过程中具有的泄漏压力超过大小为6磅/英寸的持续压力。
此外,连接器可暴露于负压中,特别是当这种连接器位于静脉内泵入口的上游时更是如此。当连接器暴露于负压中时不能阻止连接器被抽吸,这将可能导致空气被吸入和/或细菌进入液体通道。
可期望本申请具有其它许多特性。在许多连接器中不能被“冲洗”的死角应减为最少或被消除,因为它们会成为细菌生长的环境。另外,连接器的起动容积应为最小。
由于静脉内治疗在世界范围内被采用,并且每年使用百万个连接件,在这种治疗中所使用的元件费用决定着治疗成本,因此希望连接器的制造应快速、低成本。一般来说,构成一个元件的部分数量越少,所需模子的数量也越少,并且组装成装置的速度越快,而模子数量的减少和组装速度的提高一般使制造费用降低,从而使成本降低。
另一方面,无论连接器具有何种构形,均十分期望连接器具有较低的制造瑕疵。即使很少量的制造缺陷一般也是不允许的,因为仅一个制造缺陷也可能使病人或健康护理者处于危险状态。
另外,还十分期望通入连接器的入口周围的任何表面均可被清洗或消毒。一般来说,未破损或光滑的表面有利于清洗或采用其它消毒技术。
如上所述,尽管路厄氏连接器在医学环境下使用很广泛,但这种连接器不能满足上面描述的许多所需要求。这是出于这样一种事实,即:与路厄氏连接器相通的开口不密封,这样在未连接的情况下,开口和液体通道对外界环境来说是开放的,这将使病人的健康受到威胁。
妨碍在给药装置或注射装置中使用路厄氏连接器组件的另一个原因是,这种连接器不能对装置中的加压液体进行密封,除非连接器被密封或连接到匹配连接器上。显然路厄氏配件的开口使这种加压液体泄漏。
为了实现与延伸至装置或导管内的液体通道的密封连接以及断开该连接,许多装置在该装置或导管上有一个或多个注射部件,该部件在外壳上具有固体弹性隔膜。采用锋利的针来刺破隔膜,使该部件与液体通道相连。尽管这种连接器具有许多期望特性以实现密封连接,但锋利的针会存在针头阻塞的危险。
为了避免出现针头阻塞的危险,在已研究出的一种无针系统的一个实施例中采用可再密封的隔膜,该隔膜形成有一个裂缝并被压缩在外壳中。这种无针系统使用起来很好,但所述隔膜不能被凸形路厄氏尖端刺破,因此采用直径小于凸形路厄氏尖端的钝套管。如果需要进行连接的装置具有路厄氏连接器,这些钝的套管通常连接于路厄氏配件。由于需要钝套管,因此潜在地增加了使用这种类型的连接器的费用。
另一类型的无针系统采用的连接器被构造成直接与凸形路厄氏尖端建立连接关系,而无论这种路厄氏尖端为路厄氏滑片的一部分或为路厄氏锁的一部分。但是,以类似于上面描述的路厄氏锁连接的方式与凸形路厄氏尖端建立的连接必须使路厄氏尖端与锁定凸缘之间的间隙满足标准,并且还应满足针对这种连接设定的其它标准。
采用直接与凸形路厄氏尖端建立连接的这些系统连接器的例子见美国专利5,685,866,该专利公开的内容在此被引入本申请中作为参考。这些连接器均存在缺点,因而妨碍其被医疗人员广泛接受。总的来说,这些装置与上面讨论的连接器装置所需品质相比,并且与采用锋利针和弹性隔膜或采用钝套管和预裂弹性隔膜的注射配件的使用标准相比性能不够好。
例如,一些连接器采用设置在外壳内的弹性护套(boot)或其它密封件,该护套由于凸形路厄氏尖端的导入而塌缩。移去尖端时,这种塌缩的护套然后应回复,以再次密封该连接。许多这种护套保留在塌缩位置,从而导致泄漏。另外,这些移动部分在可移动的护套和外壳之间存在一个接触界面,液体可流入该外壳中并在此聚集,而这种聚集的液体为细菌的生长提供繁殖环境,同时这种凹形表面和缝隙难于消毒。另外,长钉作为流动限制器,并且当液体流过长钉开口时可能会出现一些紊乱。而且,在抽回凸形路厄氏尖端时,护套可能不会快速回复以密封连接器的进出通道,液体通道可能暂时暴露在外界环境中。
这种路厄氏尖端连接器的一种类型是在外壳内有一个刺入塌缩护套的长钉。该长钉在与护套相邻的近端有一个开口,当长钉刺入塌缩的护套时,所述开口为开放的,为液流提供一内部通道,并且使裂缝扩展。在护套回复时,护套中的任何裂缝或开口应被再密封。但是,这种长钉设计在多次连接和拆开之后存在不能令人满意的泄漏问题,因此不能扩展用到给药装置或导管中。
另外,这些连接器有多个部分,这增加了制造成本和出现故障的机会。这些设计还使连接器存在无法清洗的空间,这样,不流动的液体可能聚集。此外,一些这种装置具有从处在外壳内但位于主液体通道之外的空间至主液体通道的潜在通道,这可能使在外壳内生长的细菌进入液体通道。而且当护套处于未压缩位置时,外壳与护套之间的接触面难于擦洗。
美国专利5,616,130描述的一种装置(该专利公开的内容在此被引入本申请中作为参考)采用细长的凸轮来张开处于塌缩护套中的裂缝,这可能会造成使上面描述的长钉和护套出现一些弊端。
一般来说,具有与凸形尖端和处在标准路厄氏锁上的锁定凸缘相啮合之端部的护套式连接器没有什么问题。当路厄氏尖端与连接器啮合时,密封机构低于该尖端的端部,这样与凸形路厄氏锁啮合的连接器外壳的端部具有很大的挠性。
为了克服这些缺陷,人们研究了采用作为部件之一的预裂隔膜的无针连接器。这些连接器与由路厄氏尖端在隔膜上刺破的裂缝建立连接关系。美国专利5,578,059描述和示出了这样一种连接器,该专利公开的内容在此被引入本申请中作为参考。在公开的阀中,采用弹性预裂隔膜形成与外界环境的隔障。通过在固定器和外壳之间夹紧一个下部凸缘来使隔膜密封地紧固或保持在外壳上。可以看出,具有裂缝的径向延伸部分由从下部凸缘向上延伸的外轴向延伸柱形部分的柱状力保持在其位置上。但是隔膜不能对装置内的加压液体进行密封。这样,阀采用第二个下部单向阀来克服压力进行密封。
为了满足ISO尺寸标准和扭矩移动阻抗标准,固定器的外部分形成有锥螺纹,这样与路厄氏锁的直螺纹结构的连接类似于标准NPTF/NPSI连接。锥螺纹结构延伸至外壳的端部,与凸形路厄氏锁上的螺纹啮合。这种螺纹结构在连接过程中会使啮合力增加的过快,这可能会导致路厄氏锁与连接器锁住。
这些装置有一些其它弊端。阀包括一些部件来构成外壳、周围阀(environmental valve)和单向阀,而元件数量多增加了制造成本。另外,由隔膜的轴向延伸部分的柱形强度保持隔膜的位置使得该部分具有较大的厚度。这样对隔膜来说,当凸形路厄氏尖端刺过所期望深度时,为了使轴向延伸的壁和环状的外壳适合装配在路厄氏尖端和锁定凸缘之间的间隔中,外壳必须薄。这种薄外壳在反复连接或拆开时可能会破损。
美国专利5,533,708描述了第二种连接器,该专利公开的内容被引入本申请中作为参考。这种连接器也采用了预裂隔膜,该隔膜被支撑在轴向延伸的柱形上,该柱形具有足够的厚度以便在凸形路厄氏尖端导入时支撑隔膜。进一步提供足够柱形强度的轴向延伸部分也构造成特定的锥形形状,其包括加厚的下部。为了在路厄氏尖端导入和移去时密封裂缝,隔膜的预裂径向部分形成有偏心肋。
这种连接器还采用了使下部径向凸缘将隔膜密封固定到外壳上的固定器。这种连接器包括三个独立的部件。另外,隔膜的加厚轴向延伸部分迫使固定器变薄,这样可推算出由于固定器受力,因此固定器优选的材料为金属,从而增加了制造成本。此外可以相信,这种阀在长时间的保持连接状态之后将不能呈现令人满意的泄漏压力,这可能归因于由于尖端和固定器之间的隔膜材料可察觉到的高度压缩而致使隔膜材料处于压缩。
为了提供所需的旋出阻力,固定器向外接近端部时逐渐变细,与凸形路厄氏锁上的螺纹建立摩擦啮合。
一些使用者期望的另一特征是,当路厄氏尖端移去时,连接器不会将液体从接合的管或导管中虹吸到连接器中,因为这可能引起液体流入导管的另一端而可能导致管被堵塞。另外,希望连接器在路厄氏尖端移去时实际上从连接器中排出液体,并且最好是以可控方式排出该液体。
因此,本发明的主要目的是克服现有技术中妨碍无针阀被广泛接受的那些缺陷,其中该无针阀不需钝头套管。
本发明还有其它次要目的,这些目的如果令人满意可促进市场接受度,但并不必须使各个目的都令人满意。本发明的一个目的是提供无针连接器配件,它可由凸形路厄氏尖端驱动,而不需锋利的针或适配器如钝头套管等。相关的目的是可与标准路厄氏锁配件啮合的连接器。另一相关的目的是这种连接器可与标准凸形路厄氏锁相连接,并且尽可能多地满足路厄氏连接器的ISO和ANSI标准。
本发明的另一个目的是提供具有足够强度以避免破裂或破碎的连接器。
本发明的还一个目的是提供采用最少量部件的连接器装置,从而使出现不正常操作的机会减为最少。
本发明的另一个目的是提供一种能够多次连接和拆开的连接器,同时在给药装置中一般存在的压力下能够保持密封液体。相关的目的是提供一种能够进行至少100次连接和拆开操作而不影响性能的连接器。
本发明的还一个目的是提供一种在拆开时保持6磅/平方英寸的恒定泄漏压力、而在保持连接状态4天之后瞬时压力为20磅/平方英寸的连接器。
本发明的还一个目的是提供一种可快速制造的连接器。相关的目的是提供一种制造过程中很少出现潜在缺陷的连接器。
本发明的另一个目的是提供一种不可清洗空间为最小的连接器,其中不可清洗的空间可使不流动的液体聚集以形成细菌生长的媒介。相关的目的是提供一种形成密封液体通路的连接器,这样在采用无菌技术进行操作的过程中使进入液体通路的细菌为最少。还一个相关的目的是提供一种需要较少起动体积的连接器。
本发明的还一个目的是提供一种连接器,该连接器对流过其的液体的限制为最少或无限制。另外本发明的一个目的是提供一种在任何入口周围具有光滑未破损表面的连接器,以利于采用无菌技术。
本发明的另一个目的是提供一种形成连续封闭系统的连接器,该系统在插入凸形路厄氏尖端的过程中或之后以及在瞬间抽出路厄氏尖端之后使液体通道与外界环境密封。
本发明的还一个目的是提供一种连接器,该连接器在移去路厄氏尖端时不会将液体从连接的医疗装置虹吸至连接器中。相关的目的是提供一种连接器,在移去路厄氏尖端的过程中以及可能在移去之后,液体从该连接器中流出。
发明概述
采用可再密封阀的连接器可达到上述主要目的,其中所述阀具有一个至少延伸穿过阀的一部分的开口。阀相对于一个外壳被弹性约束,并且阀和外壳构形成用于接纳具有一个尖端的穿刺部件,该尖端通过开口刺破阀。
根据本发明,提供了一种与凸形路厄氏尖端建立密封连接的连接器装置,包括:一个形成有远端开口和中央通道的外壳,其尺寸适于接纳凸形路厄氏尖端,所述通道从所述远端开口沿近端方向延伸;一个相对于所述外壳被弹性约束的隔膜,所述隔膜包括环绕所述远端开口密封延伸的第一径向部分、和与所述第一径向部分成一整体并在所述通道内从所述径向部分的近端表面开始延伸的第二部分;在所述隔膜上形成的一个开口,使得当所述路厄氏尖端经所述隔膜插入时,所述第一径向部分和所述第二部分环绕该路厄氏尖端弹性延伸,由此所述隔膜将所述通道内的液体密封;所述隔膜还包括一个第三部分,该第三部分的一端与所述第二部分接合并且沿近端方向从所述第二部分向所述外壳延伸,所述第三部分与所述外壳密封连接,以在所述隔膜和所述外壳之间限定一个空间,从所述路厄氏尖端排出的流体流经所述隔膜和所述外壳而不会流入所述空间内。
根据本发明的一个优选实施例,所述隔膜具有与所述第一径向部分成一整体的一个环状裙边,所述环状裙边在所述外壳靠近其远端开口处的外表面上延伸并与之接合,从而将所述隔膜相对于所述外壳弹性地加以约束。
根据本发明的另一优选实施例,所述隔膜包括一个由所述裙边和所述第一径向部分形成的环形通道,所述外壳的一远端边缘部分被容纳在所述环形通道内。
根据本发明的还一优选实施例,所述远端边缘部分形成一个容纳在所述环形通道内的远端平台,所述远端平台的至少一部分与所述隔膜接合。
根据本发明的又一优选实施例,所述远端平台的整个长度与所述隔膜接合。
根据本发明的还一优选实施例,所述连接器包括将所述外壳靠近其远端开口处的外表面和所述远端平台连接到所述隔膜上的粘接剂。
根据本发明的另一优选实施例,所述连接器包括将所述第一径向部分连接到所述外壳上的一定量的所述粘接剂,该粘接剂的量等于或少于当所述外壳的取向为使所述远端边缘部分处于向下方向、所述粘接剂被涂敷到所述外表面上时在所述外壳的远端边缘部分内表面上的粘接剂量。
根据本发明的还一优选实施例,所述可再密封隔膜的所述第二部分构形成在近端方向上具有大致为矩形的截面。
根据本发明的还一优选实施例,所述外壳包括一个其外表面为基本恒定直径的远端边缘部分、以及从所述远端边缘部分向近端延伸的大体截头圆锥形的第二部分,所述第二部分具有螺纹,以便与环形凸缘螺纹啮合。
根据本发明的又一优选实施例,所述隔膜包括与所述第一径向部分接合的环状裙边,所述环状裙边在所述远端边缘部分的所述外表面上延伸并与之接合。
根据本发明的另一优选实施例,当将尖端从所述外壳中取出时,由被密封的第二通道所限定的容积减小。
特别构造成可以对一般在与人体流体相通的液体通道中存在的压力进行密封的阀可达到上述一个或多个次要目的。可再密封的阀最好是一隔膜,并且隔膜和外壳特别构造成用于接纳凸形路厄氏尖端。在一个实施例中,该隔膜包括大体为盘状且覆盖着由外壳限定的开口的上部和从上部向下延伸的一个部分,同时阀的开口延伸穿过上部和下部。
阀的上部相对于外壳通过环形裙边的整体接合而被弹性夹持,并且在第一实施例中,环形裙边可与外壳的内表面接合,在第二实施例中,环形裙边包绕外壳的外表面并与之连接。
附图说明
图1为本发明无针连接器的第一实施例的剖视图;
图2为图1所示连接器的剖视图,示出了与凸形路厄氏尖端的连接;
图3为构成图1所示连接器一部分的隔膜的剖视图;
图3a为构成图1所示连接器一部分的隔膜的底视图;
图4为本发明无针连接器的第二实施例的剖视图;
图5为构成图4所示连接器一部分的隔膜的剖视图;
图5a为构成图4所示连接器一部分的隔膜的底视图;
图6为图4所示连接器的透视图;
图7为与图4所示的连接器类似且包括Y座部分的连接器的剖视图;
图8为本发明无针连接器的第三实施例的剖视图;
图9为本发明无针连接器的备选实施例的剖视图;
图10为图9所示连接器的剖视图,示出了与凸形路厄氏尖端的连接;
图11为本发明无针连接器又一备选实施例的剖视图;以及
图12为图11所示连接器的剖视图,示出了与凸形路厄氏尖端的连接;
图13为本发明无针连接器另一备选实施例的剖视图;
图14为图13所示连接器的剖视图,示出了与凸形路厄氏尖端的连接;
图15为本发明无针连接器另一备选实施例的剖视图;以及
图16为图15所示连接器的剖视图,示出了与凸形路厄氏尖端的连接。
发明详述
下面的说明不对本发明的保护范围进行限定,所描述的实施例和在各实施例中公开的特征的组合对发明的技术方案来说不是绝对必需的。
参见图1,本发明连接器装置的第一实施例总的来说表示为10。连接器10一般可与穿刺部件12(图2)多次以流体方式连通。在一个例子中,连接器10可与一导管14接合,该导管与人体以流体方式连通。导管14可以是外周导管15、医用导管或类似导管,并形成与人体以流体方式连通的通道16,以便使液体流向或流出人体。连接器10还可与其它装置如小瓶或小瓶适配器(未示出)等接合,或连接器可用于代替开放型凹形路厄氏配件、如管塞上的配件。
参见图2,在一个例子中,穿刺部件12最好为符合ANSI或ISO标准的凸形路厄氏滑片或路厄氏锁13;但是适当修改外壳和隔膜后的其它穿刺部件的例子可包括钝头套管、针、特别设计的连接器等。路厄氏锁13包括路厄氏尖端18,该尖端在所示实施例中被锁定凸缘20环绕,并构成注射器24的端部。可采用穿刺部件12的其它装置包括I.V.组件、集血器和腹膜透析装置等。
仍参见图1,连接器10包括外壳26和最好是隔膜28的弹性可再密封部件27,该部件位于外壳的上端30,以便密封由上端30限定的开口32。隔膜28可操作地与外壳26相连,同时中央部分34相对于外壳被弹性约束,这样当穿刺部件12插入开口时,中央部分34可向下伸长进入外壳。当穿刺部件12移去时,中央部分34弹性缩回。外壳26形成轴向延伸的通道36,该通道从开口32向下延伸,并与由导管14限定的下部通道16以流体方式连通。可再密封部件27特别构造成当中央部分34处于图1所示的闭塞位置时密封开口32。
隔膜28的中央部分34具有大体盘状的上部38和在通道内轴向向下延伸的下部40。可再密封开口44如一裂缝46向下延伸,最好穿过上部38和下部40。可以预见,开口44可构造成其初始可仅延伸穿过上部38和下部40之中的一个或全部;但穿刺部件12完全延伸穿过隔膜28将迫使开口还完全延伸穿过隔膜28。优选将开口44以这种方式构形,即当穿刺部件12完全延伸穿过隔膜28时,上部38和下部40环绕穿刺部件弹性伸长来密封,防止从穿刺部件和隔膜之间的界面处产生泄漏。
裂缝在水平方向上的长度最好小于路厄氏尖端18的尖端部分周长的一半。
如图3和3a所示,在第一实施例中,下部40形成基本上为矩形的水平剖面。垂直延伸的侧壁48和端壁50略微变细,这样下部40形成梯形垂直剖面,这有利于在制造时,特别是当形成开口44时注模和定位该隔膜。开口44可直着向下延伸,或其取向相对于竖向来说有一角度。另外,开口44可以是一裂缝46,或可以是弯曲的或略微螺旋旋转的,从而有助于开口的密封。
再参见图1,隔膜28包括在通道36内向下延伸的环状裙边52,该裙边与外壳26的内表面54接合,以便相对于外壳弹性约束中央部件34。所述接合最好是采用粘接剂将裙边52的外表面56粘接到内表面54上。由于路厄氏尖端18(图2)在将中央部分34移入通道36时对裙边52和外壳26之间的接合处施加了剪切力,因此隔膜28包括延伸在外壳上边缘60上并与之接合的径向唇缘58。唇缘58与边缘60的接合至少部分支撑裙边52,并有助于对抗剪切力。在第一实施例中,唇缘58与边缘60的接合采用粘接剂粘接,与外壳与裙边52的接合方式相同。
参见图2,为了确保普遍的通用性,路厄氏连接装置的尺寸最好符合ISO标准。例如,包括锥形的路厄氏尖端18的尺寸按标准设定。类似地,在锁定凸缘20内侧上的螺纹64限定的净空半径按标准设定。如可以理解的那样,当凸形路厄氏尖端18在连接器10内延伸并且锁定凸缘20环绕连接器的外部延伸时,连接器和它的元件的大小被限制为在路厄氏尖端和锁定凸缘之间的空间范围内。同时,按照ISO标准,凸形路厄氏尖端18应能穿刺的预期插入深度“D”为.300英寸,这样又对连接器12和它的特别是环绕外壳26上端30的元件大小进行了限制,即必须符合路厄氏尖端18和锁定凸缘20之间的空间尺寸。
在图2中示出了路厄氏尖端18迫使隔膜28进入开口位置。具体地说,尖端18延伸穿过开口44至期望深度D,在尖端18内的通道66和通道36之间建立以流体方式连通。为了使得对液体的流动限制达到最小,邻近尖端12的通道36最好与通道16相通,不带有任何第二阀或其它障碍物,从而使液体能流动。隔膜28的上部38绕枢轴向下变形、伸长和沿环状裙边52和尖端外表面68延伸。此外,隔膜28的下部40环绕尖端外表面68向下延伸和伸长,绕尖端18建立密封。
主要再次参见图1,在移去尖端18时,隔膜28弹性回复至封闭位置。
当尖端18插入连接器10至期望深度D时,外壳26和尖端之间存在一限定量的环状空间,隔膜28的一部分可能移至该空间内;但是在穿刺部件12伸展进入开口44之前、过程中以及之后,隔膜28的构形和尺寸必须保证其密封,以形成封闭系统。
参见图1和2,在一些医疗环境下的应用中,特别希望连接器构造成为针对20磅/平方英寸的压力密封。如上所述,在如这里引入本申请作为参考的美国专利5,135,489中描述的采用预裂缝隔膜和钝头套管穿刺部件的各种连接器设计中,通过采用加厚隔膜和使外壳径向压缩隔膜,从而来密封延伸穿过隔膜的裂缝以实现密封。当小直径的钝头套管受力穿过裂缝时,隔膜进一步被径向压缩而环绕套管密封,并且隔膜部分在轴向上出现很小的移动。
但是,即使相应于外壳开口来说直径比钝头套管大得多的路厄氏尖端18可受力而穿过这种隔膜中的裂缝,此时在径向上也没有空间来为隔膜的移动部分提供接纳空间。这样,在大多数医疗操作中所需的插入力可能会特别大。然而已发现,使隔膜28变薄,从而使得隔膜在尖端和外壳之间移动和进行调节,同时维持相同的径向压缩不能使该隔膜具有密封能力来克服在静脉内治疗过程中存在于液体通道中的压力,即“泄漏压力”。出乎意料地的是,增加加薄隔膜的径向压缩并没有使连接器10的泄漏压力出现相应比率的增加。
由变薄的上部38和向下延伸的下部40构成的隔膜28以及使开口44向下延伸穿过除上部38之外的下部40在不需相应大大增加隔膜厚度和压缩的前提下大大地增加了泄漏压力。另外,试验已表明,下部40的长度“L1”(图3)与泄漏压力的增加相关。但是,增加外壳26内下部40的长度L1必将增加了隔膜28的质量,从而当路厄氏尖端18穿刺再密封部件28时插入力将增加,并且可能妨碍尖端18延伸穿过整个开口44。
第一实施例的构形为将下部40的预定长度L1、上部38的厚度和压缩进行独特组合,在呈现可接受插入力的同时使连接器10的泄漏压力大于20磅/平方英寸。第一实施例的其它特征是,在路厄氏尖端多次插入以及路厄氏尖端长期存在之后仍可克服6磅/平方英寸的压力进行再密封。
作为一个例子,在第一实施例中,隔膜构成为上部38的厚度为0.040英寸,具有大于或等于3.5%的径向压缩,下部40的长度L1约为0.080英寸(从而使开口长度为0.125英寸),这样产生的连接器10可接纳路厄氏尖端18至期望深度D,同时保持泄漏压力超过20磅/平方英寸。
特别参见图3和3a,优选的是下部38构形成宽度“W1”近似于0.060英寸,长度“L2”约为0.190英寸。环形裙边52构形成厚度约为0.010英寸。隔膜28的顶面70略凹,以减少尖端18插入穿过开口44时进入外壳26的材料量。可以想到,顶面70可以为平坦的,或为凸形表面,或者也可以两者兼有。另外,顶面70构造成完整的,没有裂缝或其它小穴,这有利于采用一般的无菌技术例如擦洗等来对隔膜进行消毒。隔膜28还构造成顶面延伸而完全覆盖外壳的上端30,以便呈现看起来更好的顶面。
再参见图1,为了能够容纳标准尺寸的路厄氏配件,外壳26构形成的通道的直径“D1”为0.235英寸。为了在组装时有利于穿插过隔膜28,通道36的上端向外逐渐变细,这样在开口32处形成略大的直径,其为0.250英寸。
参见图2,可以看出,插入尖端18并压缩上部38并且可能使下部贴向环形裙边52将分别使厚度层至少为0.50和0.40英寸。但是,当插入具有标准路厄氏尺寸的穿刺部件12的一个实施例至0.300英寸的期望深度D时,将仅使尖端和外壳26之间的环状空间为0.030英寸。出乎意料的是,隔膜的弹性材料在拉伸时伸长并变形进入该小空间内,同时在长时间存在之后不会出现较低的泄漏压力,这归因于隔膜28的压缩。
再参见图3a,下部40构造成具有圆角74,从而在下部和裙边52之间形成间隙77。圆角74使得在下部40和裙边52之间仍具有间隙的同时使侧壁48和裂缝46尽可能长。在尖端插入而导致泄漏的过程中使侧壁48无间隙地与裙边52接合可产生不相等的拉伸力,并使下部40环绕尖端18而变形。为了产生间隙77,阀部件27在间隙77处的垂直厚度小于下部的长度L1。最好是间隙77构形成使阀部件27在该间隙处的垂直厚度等于隔膜28的上部38的厚度。
在中央部分34与裙边52的并置处形成为一尖锐角,该角构成了铰接点78。绕外壳开口的整个圆周延伸的铰接点78还有利于在尖端18插入时增加隔膜28的挠性和变形。
在一个实施例中,隔膜28为由Lionville,Pa的West Company提供的弹性材料制成。可以想到,润滑隔膜将有助于路厄氏尖端18的插入。可在形成裂缝时实现润滑,或采用其它方式,如将润滑剂掺入隔膜材料内,或在顶面涂敷润滑剂来实施上述润滑。在第二实施例中,隔膜28可采用相似的材料制成,如由Lexington Medical of Rock Hill,SouthCarolinar生产的氯化聚异戊二烯。另外,可在组装外壳和隔膜之后采用Dow Corning of Midland,Michigan生产的硅油来润滑裂缝。外壳26为刚性的,并且优选由Eastar of Kingsport,Tennessee生产的DN003制成。
尽管所示的外壳26在下端构形成路厄氏连接件84,但外壳也可构造成为任何装置的一部分,如Y-座86(图7)的注射臂、管塞或分支管上的入口等(未示出),从而如期望那样建立密封连接关系。另外,外壳26的下端可通过向上延伸穿过开口44的导引线(未示出)与导管15形成一体。还可参见图6,特别是当采用外壳26作为导管15的注射座时,外壳26的外部形成有多个纵向延伸的凹痕86,这有助于抓握连接器10。
参见图1,为了与锁定凸缘20进行螺纹啮合,外壳26的上端30可形成有一对径向延伸的耳88,该耳构形成与螺纹64啮合。参见图4,在外壳26的一部分92上形成为另一些螺纹90,该螺纹将与凸缘20上的螺纹64啮合。
最好是采用大量注模型腔的注模方式来将外壳26注模成一个单件,这有利于高速制作。类似地,阀部件27最好以高速注模方式构成一个单件,并且下部40的形状特别适合于与阀部件27以期望的取向对齐,从而在那里形成开口44。
参见图4-6,本发明无针连接器的第二实施例总的来说用100表示,该实施例特别适于在不存在无法接受的泄漏的前提下多次与标准凸形路厄氏锁13(图2)连接和脱开。另外,第二实施例与第一实施例10中的部件对应的部件用相同的参考符号表示。
连接器100包括外壳102和位于外壳上端106上的弹性可再密封阀部件104。阀部件104包括中央部分34和下部44;但最好为隔膜105的阀部件104还包括邻近上端106并环绕外壳102的上部110延伸的环状裙边部分108。最好是裙边108以特定方式粘接到外表面112上,从而使阀104连接到外壳102,并且外壳在路厄氏尖端18(图2)插入时弹性约束中央部分34。
参见图4,5和5a,可以发现,阀104相对于外壳102构形以及连接到外壳上的这种方式对连接器100能够达到所需性能标准来说十分重要。最好是阀104在中央部分34和裙边108之间限定一圆环状接纳通道118。外壳102的上端106的一远端边缘部分被接纳在通道118中,形成一个容纳在通道118中的远端平台,并以期望方式与阀104接合。
中央部分34构形成使上边缘部分106对中央部分施加6%至7%的压缩。为了提供足够的再密封,期望阀102的上部40形成0.60至0.50英寸的厚度,并且下部限定的长度L3为0.080英寸。
最好是下部40形成的宽度“W2”近似为0.060英寸,长度“L4”约为0.165英寸。环形裙边108构形成厚度约为0.010英寸。隔膜28的顶面70微凹,从而减少尖端18(图2)插入穿过开口44时被压入外壳102中的材料量。可以想到,顶面70可以是平坦的,或具有凸形表面,或者两者兼有,并且适于采用如擦洗等消毒技术。
在中央部分34和外壳102的上端106之间的界面处,阀部件104形成峰利的角部,并因此形成铰接点78。与第一实施例10类似,下部40与外壳间隔开以形成间隙77。
业已发现,将上边缘116限定的上附着区117环绕整个上边缘粘接到阀104上对连接器100能够保持令人满意的泄漏压力来说很重要,并且对在100次或更多次连接和拆开之后仍能维持泄漏压力来说更重要。粘接也可以将隔膜28锚定到上边缘上,并且防止当尖端18插入且隔膜弹性伸长时,隔膜28与上边缘116之间摩擦。
将外表面112与裙边108的内表面粘接也十分重要,但应在中央部分34和外壳102之间的界面处移入最少量的粘接剂。如果在隔膜28和内表面119之间的界面内聚集的粘接剂使外壳102裂开或使隔膜28压缩,则在长时间存在之后将相应出现泄漏。
将粘接剂施加给外壳、从而使上附着区117和外表面112接受这种粘接剂、同时使移入外壳内的粘接剂为最少的一种优选方法是,将外壳垂直放置,使上边缘116面朝下。最好是采用注入方式将粘接剂施加到外表面112上,在重力作用下粘接剂向下流动,且浸润附着区117。重力还阻止了粘接剂移入外壳102的内表面。更优选的步骤包括将外壳102的上端部分110插入一个腔内(未示出),在外壳102下施加负压空气,这样空气沿外壳向下流动,这样也阻止了粘接剂向上进入外壳内部。
业已发现,UV固化粘接剂、如购自Rocky Hill,Connecticut的Loctite公司的Loctite 3011,3311和3301适于用作各种连接器10,100,200的粘接剂。粘接剂应在足够长的时间内固化。
参见图4和6,图中示出了与锁定凸缘20的螺纹啮合,其中螺纹90沿外表面112的一部分延伸。螺纹90的上端127与外壳102的上边缘116间隔开,以形成没有螺纹、脊或类似物的表面124,以便有助于裙边108与表面124的粘接。在优选实施例中,表面124还可以形成有很小的斜度或锥度,这样在粘接阀104和外壳102时裙边108不会向上滑出。最好是裙边108沿外壳124向下延伸的长度L5为约0.07至0.08英寸。
再参见图2,为了使在移去穿刺部件12时锁定凸缘20上的螺纹64对裙边108之下边缘126的破碎损坏程度为最小,使螺纹不会碰到边缘126是十分重要的。因此希望下边缘126与螺纹90的上边缘127是分开的,这样所限定的间隙128的宽度小于螺纹64的宽度。
为了有助于使穿刺部件12与连接器100可分离地啮合,并且尽可能减少或消除裙边108的破碎,裙边108的厚度可以设定为使裙边108和锁定凸缘20上螺纹64的内边表面64a之间干涉最小。但是,在给定裙边厚度和外壳厚度的情况下,裙边108所限定的直径越小,在部件12插入时用于容纳穿刺部件12和阀14的体积越小。
业已发现,其中上部110外径为0.25英寸、所限定开口144的直径为0.22英寸的外壳在裙边108和满足ISO标准的路厄氏连接器的锁定凸缘20之间具有适当的空间,并且该外壳具有足够的侧壁强度以防止破碎,当路厄氏尖端插入至外壳102内时具有足够的空间来使隔膜28和路厄氏尖端18移动。
参见与图2有关联的图4,截头圆锥形状的ISO标准路厄氏尖端限定的直径范围为0.155英寸至0.175英寸。这样,当ISO标准路厄氏尖端18插入期望的插入深度D时,可以料到尖端和外壳102限定的两者之间的空间为0.031至0.021英寸。令人吃惊的是,当插入凸形路厄氏尖端18时,具有一个上部38且该上部厚度约为0.055英寸的阀102绕路厄氏尖端延伸,并在不需要令人无法接受的插入力作用下在较小空间内被压缩。另外,尽管可以想到由于尖端和外壳之间的压缩而使隔膜28被压缩,这将导致在长时间之后存在泄漏问题,但已意外发现阀部件104在长时间存在之后能维持适当的泄漏压力。
如图7所示,在尖端插入时隔膜28移动压缩进入到尖端18和外壳102之间的空间中,其基本上填充了下部40和外壳102之间的空间至一定深度,该深度对应于下部绕尖端18延伸长度的大部分。被压缩的隔膜28移动或冲泻出在该空间内聚集的任何液体。从尖端18注射进入外壳102内部的液体在外壳内冲洗着任何剩余空间。这样避免了液体滞留的穴部。用尖端18填充通道36以及移动的隔膜104还将起动体积降低至低水平。
参见图7,本发明无针连接器的实施例总的来说表示为130。具体地说,所示的连接器130构形为Y-座连接组件86的一部分。如本领域通常了解的那样,Y-座连接组件86特别适用于沿着从接合管的上部或入口段134延伸出的主流动通道132将补充液体添加到液流中,其中液流流过Y-座组件86并沿着接合管的下部或出口段136流出。
所示的无针连接器130基本上对应于无针连接器100的第二实施例,但可再密封的阀部件140和靠近阀部件的外壳138的形状可对应于第一实施例10、第二实施例100或后面将描述的实施例200中的外壳和阀部件。
如可以理解的那样,一旦路厄氏尖端18刺过阀部件140,尖端中的通道66布置成直接与延伸进入出口段136的主液体通道132部分以流体方式连通而不需任何中间阀,这样减少了对液流的任何约束。
参见图8,本发明无针连接器的优选的第三实施例总的来说表示为200。第三实施例200具有一个外壳202,并包括在第二实施例100中相应描述的可再密封阀部件104。外壳202与第一实施例100类似,只是在间隙128下面的外壳部分204已改变,这样连接器200具有更高的抗脱开扭矩。在第三实施例中与第一或第二实施例10的元件相应的元件用相同的参考数字标识。
具体地说,外壳202包括具有基本上为恒定外径的表面124的上部110,该表面被裙边108延伸覆盖。中部206从上部116向下延伸,而下部208从中部向下延伸。下部208最好限定基本上为恒定的直径,该直径大于由上部116限定的直径。中部206构形成作为从上部116至相对较宽的下部208的过渡部分。中部206最好为截头圆锥形。
参见图2和8,外壳202限定一组双头螺纹210,该螺纹向下沿外壳环绕中部206和下部208延伸。在优选构形中,当螺纹210沿下部和中部延伸时限定了恒定的主直径,这样随着螺纹沿中部向下移动,螺纹的高度减少。但是由下部208限定的直径大于由在锁定凸缘20上的内螺纹64所限定的次直径,这样在螺纹64与中部206和下部208之间存在滑动摩擦啮合。摩擦啮合使得连接器200在尖端18已穿刺过所期望的插入深度D时为接合的路厄氏锁提供可接受的抗脱开扭矩。
采用具有环绕裙边108的上部所限定的直径近似于螺纹64的标准主直径,截头圆锥形中部206所限定的直径从小于由裙边108所限定的直径增加至下部208的直径,而下部限定的直径大于内螺纹64的次直径,使得使用者的感觉类似于与标准凹形路厄氏连接装置在进行连接。
当使用者首先将锁定凸缘20插至连接器200上时,在上部116和环绕裙边108上滑动凸缘,使路厄氏尖端18位于连接器200的中央,并使错扣的可能性减为最小。当尖端和凸缘20延伸盖住连接器200时,螺纹64随后与螺纹210啮合,并且连接器200必将相对于凸缘20旋转,使凸缘20与连接器200螺纹接合。
在旋转时,尖端18延伸穿过开口44并与阀104发生摩擦,尽管这种接触对拧动来说阻力十分小。螺纹64与中部206啮合并开始产生滑动摩擦啮合,而当尖端旋转前进时,所需的前进扭矩或拧开螺纹的扭矩慢慢增加。然后螺纹64与具有恒定直径的下部208啮合,这使速度减慢,或者在可引起锁定凸缘锁定在连接器上的不可接受的移动扭矩出现之前使移动扭矩增加。
另外,凸形路厄氏锁13可由许多不同类型的硬质材料制成。重要的是连接器200与路厄氏锁的连接在锁定凸缘20上施加应力,这种应力会使凸缘断裂破损。采用具有恒定直径的下部208还适应于容纳各种材料的路厄氏锁,同时防止锁定凸缘20的受力过大。
这样已对无针连接器的五个示范性实施例进行了描述。可以相信,这些实施例具有的特征解决了许多问题,这些问题影响了相对于必须由锋利针或钝头套管来穿刺的那种连接器而言这种无针连接器的广泛接受性。
参见图9,总的来说用300表示一种特别适于处于较高泄漏压力下的连接器的备选实施例。连接器300包括一个弹性可再密封部件301,如附着在外壳304上的隔膜302。隔膜302包括基本上为盘状的上部306和基本上呈管状的延伸部308,该延伸部向下悬置在由外壳304形成的通道310内。延伸部308附着在外壳304上,以形成用以传送经开口316注入的液体的密封导管314。该开口316最好是延伸穿过上部306的一裂缝318。
还是主要参见图1,与隔膜28的方式类似,开口316可延伸而部分穿过隔膜302,并可以预料该开口在路厄氏尖端18穿刺时将整个延伸穿过隔膜。此外,上部306可以与隔膜28之上部38类似的方式构成。
总的来说由320表示的阀部件至少提供了对由延伸部308和外壳304的部分所形成的出口通道324内的加压液体的密封。出口通道324与装置326以流体方式连通,而该装置与人体以流体方式连通。装置326可包括一导管或一I.V.给药系统。如果连接器300用于与I.V.给药系统实现再密封连接,则外壳304最好构造成Y-座的一部分。
阀320包括一个夹钳部分328,该部分夹紧延伸部308而使之变形,从而克服存在于开口通道324内的泄漏压力进行密封。夹钳部分328通过固定夹住位于上外壳件334和下外壳件336之间的周缘330而与外壳304接合,该上外壳件和下外壳件粘接在一起构成外壳。
连接器300还包括一延伸部塌缩部件(collapsing element)338,该部件在阀320密封了延伸部之后以及可能在此密封过程中与延伸部308的一部分接触并且使之部分塌缩。部分塌缩导致液体在阀320密封了延伸部之后从出口通道324内排出。
还参见图5,在优选实施例中,塌缩部件338由于整体形成为阀320的一部分而与之相连。塌缩部件338包括两个与夹钳部分328相连并向下向外延伸的支脚340。支脚340在延伸部338的相对侧延伸并与延伸部接触,使延伸部径向向内变形。当路厄氏尖端18延伸穿过开口316刺穿隔膜302至期望深度D时,尖端与夹钳部分328接触,使夹钳部分向下移动并打开部件,从而使通道66与出口通道324以流体方式连通。支脚340还受径向向外的力作用而贴靠着外壳304,使得延伸部308扩展。当尖端18移去时,阀320的夹钳部分328关闭,开始时密封延伸部308,然后支脚340在夹钳部分之下继续使延伸部308塌缩,迫使一部分液体从出口通道324排出进入装置326中。
为了将夹钳部分328放置于较好位置而与路厄氏尖端18接触并被之驱动,阀320可构形成使中部344偏置于周边330的上部。支脚340与该中部344接合;但支脚可与外壳304的其它部分接合。
为了有利于延伸部308与外壳306的密封接合,下外壳件336形成一径向唇缘346,并且延伸部的下端粘接到靠近该唇缘的外壳305上。为了在路厄氏尖端18迫使隔膜302的中央部分向下移动时防止延伸部308产生弯曲,延伸部在组装时可被拉伸而以拉伸构形连接到外壳上。
主要参见图1和4,与连接器10的方式类似,连接器300的隔膜302可包括环状裙边348和粘接到外壳304上的径向唇缘350。
延伸部308与隔膜302的上部306和外壳304的接合可协助支承上部306以防止因导管314内的加压液体而导致的泄漏。延伸部308在连接器300的使用过程中还防止液体流入伸展部外面的外壳内以及流入难于冲洗的区域。
隔膜302还可包括与下部40(图3)类似的下部(未示出),但最好是阀320提供大部分的密封以防止由于出口通道324内的液压而导致的泄漏。
参见图11和12,总的来说用200表示特别适于在尖端18移去之后使液体流入装置326的连接器的又一备选实施例。还参见图1,连接器200包括可再密封部件201,最好是隔膜202,它具有分别与上部38的结构类似的上部204、与环状裙边52的结构类似的环状裙边206以及与下部40和开口44的结构类似的下部208和开口210。所示的下部208具有V形截面;但其它构形如下部40的构形也可以接受。
隔膜202附着到外壳214的顶端212,以密封由顶端形成的开口216。外壳形成内腔218和径向延伸的阀座220。外壳214的下端224适于形成与装置326的路厄氏连接,而该装置326适于设置成与人体以流体方式连通。
隔膜202还包括向下垂悬的基本上为管状的延伸部228,该延伸部延伸至与阀座220相当靠近的一点处。与延伸部228的下端230密封接合的是径向密封法兰盘234。法兰盘234径向向外延伸,形成与外壳214密封接合的周边236。隔膜202和法兰盘234协同作用,以防止液体流过延伸部228内形成的通道238而进入在延伸部之外且位于法兰盘234和外壳顶端240之间的腔218内。
位于外壳214内并环绕腔218之出口240的是阀248。阀248特别构形成当通道238内为低压液体时液体流动阻力较低,而当通道内为高压液体时液体流动阻力较高。参见图6和图7,阀包括径向密封法兰盘250,该法兰盘具有延伸覆盖阀座220的周边部分254。
阀248包括一组向下垂悬的支脚256,该支脚与外壳214形成的径向台肩258接触。支脚256构形成能支撑法兰盘250,这样周边236与阀座220间隔开。因此液体可从通道238流出而环绕周边254流动,并流出连接器200的出口260。支脚256还构形成当承受一定压力的液体穿过开口210被注入通道238(在图12中具体示出)中时产生弯曲。液体的压力和液体环绕周边部分254的流动使支脚256弯曲,并且法兰盘250向下移动以贴靠着阀座220密封。
阀119还包括最好直径较小且由金属、玻璃或类似材料构成的毛细管262,它向下延伸穿过凸缘250,为少量液流从通道238流入出口260形成通道。管262的尺寸最好使流过通道的液流足以维持KVO或保持静脉开口的液流流向装置326。
此外当路厄氏尖端18插入穿过开口210并且液体被注入延伸部228中时,延伸部在径向方向上弹性扩展而形成储腔268。延伸部228的弹性维持液体在足够大的压力下保持凸缘250密封贴靠着座220,这样液体仅流过毛细管262。当足够多的液体流出储腔268时,延伸部228处于基本上缩瘪状态,通道238内的液压下降至一定水平,这样支脚256伸直,凸缘与阀座220分离,使得更大量液体流入出口260。
因此可以看出,改变构形以及支脚256和延伸部228的材料可使阀248开口处的压力改变。
参见图13,总的来说用400表示无针连接器的又一备选实施例。连接器400包括弹性可再密封的阀402,该阀包括分别与连接器200(图8)的上部38、下部40和环状裙边108的结构类似的上部404、中部406和环状裙边408。另外,阀402包括整个附着在中部406上的圆锥形管状下部410,这样最好为一裂缝的开口414向下延伸穿过上部404和中部406,进入由下部410部分限定的腔416内。
下部410的下边417与连接器400的最好为刚性的外壳418密封啮合。具体地说,外壳418包括与连接器(图8)的上部结构类似的上部420,以提供所期望的抗脱开扭矩。外壳还包括具有一下端426的下部424,该下端构形成与中间装置(未示出)如导管15(图1)进行连接。
下部410的下边缘417环绕向上延伸的接头428并与之接合。由外壳418的下部424形成的轴环430环绕下边缘417延伸,并将下边缘卡向接头428。下部424和上部420最好采用超声焊接或其它类似方式彼此接合。
参见图13和14,连接器400特别适于消除空间并使起始体积最小,因为液流通路处在阀402的下部内,并且液体不能流入阀和上外壳之间的空间内。另外,如果阀402的尺寸合适,则由下部限定的腔416在路厄氏尖端18未插入连接器400中时所限定的体积小于在路厄氏尖端插入时由下部410所限定的腔416’。这样避免了在尖端18移去时液体因虹吸作用而进入腔416内,与之相反的是当尖端18移去时有少量的液体从腔416’中经阀426的下端流出。
参见图15和16,特别适于在路厄氏尖端18移去时防止出现虹吸现象的无针连接器大体上用450表示。最好是连接器450与连接器400(图13)类似,并且对应于连接器400中元件的连接器450的元件以相同的数字标识。
但是连接器450还包括一个塌缩部件452,该塌缩部件452最好是一个位于阀402之下部410和外壳418之上部420之间的空隙456内的裂隙轴环454。塌缩部件452包括位于下部410两相对侧的相对向内的平台458,该平台与下部接合来使下部塌缩,从而减少由下部限定的腔460的容积。平台458由向外成一定角度的支脚464弹性支撑。塌缩部件452可由金属或其它材料制成,使支脚464处具有所期望的弹性。
当路厄氏尖端18插入时,路厄氏尖端18将平台458向外压,使支脚464弯曲,这样支脚变成基本上与平台458大体对齐,并且在尖端18下面的下部410限定腔460’。然后液体可注入连接器中。当移去路厄氏尖端18时,下部410的弹性将导致下部试图呈圆锥形;但是,支脚464将平台458向内压,以进一步使下部塌缩,这样由下部限定的腔460具有比腔460’小的体积。因此避免了在尖端18移去时液体因虹吸现象而进入腔460中,并且在尖端移去时少量的液体经下端426从腔460’中排出。
可以理解,上面描述的本发明实施例用于表明本发明原理的一些应用。本领域技术人员在不脱离本发明精髓和范围的情况下可进行各种修改。
Claims (11)
1.一种与凸形路厄氏尖端建立密封连接的连接器装置,包括:
一个形成有远端开口和中央通道的外壳,其尺寸适于接纳凸形路厄氏尖端,所述通道从所述远端开口沿近端方向延伸;
一个相对于所述外壳被弹性约束的隔膜,所述隔膜包括环绕所述远端开口密封延伸的第一径向部分、和与所述第一径向部分成一整体并在所述通道内从所述径向部分的近端表面开始延伸的第二部分;
在所述隔膜上形成的沿贯穿所述第一径向部分和第二部分的近似方向延伸的一个密封的开口,该第一径向部分和第二部分被构形成使得当所述路厄氏尖端被插入所述通道中时,所述尖端近似地伸入所述第二部分和形成在该第二部分中的开口内,第一径向部分和所述第二部分环绕该路厄氏尖端弹性延伸,由此所述隔膜将所述通道内的液体密封;
其特征在于,所述隔膜还包括一个第三部分,该第三部分的一端与所述第二部分接合并且沿近端方向从所述第二部分向所述外壳延伸,所述第三部分与所述外壳密封连接,以在所述隔膜和所述外壳之间限定一个空间,从所述路厄氏尖端排出的流体流经所述隔膜和所述外壳而不会流入所述空间内。
2.如权利要求1所述的连接器装置,其中所述隔膜具有与所述第一径向部分成一整体的一个环状裙边,所述环状裙边在所述外壳靠近其远端开口处的外表面上延伸并与之接合,从而将所述隔膜相对于所述外壳弹性地加以约束。
3.如权利要求2所述的连接器装置,其中所述隔膜包括一个由所述裙边和所述第一径向部分形成的环形通道,所述外壳的一远端边缘部分被容纳在所述环形通道内。
4.如权利要求3所述的连接器装置,其中所述远端边缘部分形成一个容纳在所述环形通道内的远端平台,所述远端平台的至少一部分与所述隔膜接合。
5.如权利要求4所述的连接器装置,其中所述远端平台的整个长度与所述隔膜接合。
6.如权利要求4所述的连接器装置,其中所述连接器包括将所述外壳靠近其远端开口处的外表面和所述远端平台连接到所述隔膜上的粘接剂。
7.如权利要求6所述的连接器装置,其中所述连接器包括将所述第一径向部分连接到所述外壳上的一定量的所述粘接剂,该粘接剂的量等于或少于当所述外壳的取向为使所述远端边缘部分处于向下方向、所述粘接剂被涂敷到所述外表面上时在所述外壳的远端边缘部分内表面上的粘接剂量。
8.如权利要求1所述的连接器装置,其中所述隔膜的所述第二部分构形成在近端方向上具有矩形的截面。
9.如权利要求1所述的连接器装置,其中所述外壳包括一个其外表面为恒定直径的远端边缘部分、以及从所述远端边缘部分向近端延伸的截头圆锥形的第二部分,所述第二部分具有螺纹,以便与环形凸缘螺纹啮合。
10.如权利要求9所述的连接器装置,其中所述隔膜包括与所述第一径向部分接合的环状裙边,所述环状裙边在所述远端边缘部分的所述外表面上延伸并与之接合。
11.如权利要求1所述的连接器装置,其中当将尖端从所述外壳中取出时,由被密封的第二通道所限定的容积减小。
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-
1998
- 1998-05-20 US US09/081,728 patent/US5957898A/en not_active Expired - Lifetime
-
1999
- 1999-05-20 WO PCT/US1999/011146 patent/WO1999059672A2/en active IP Right Grant
- 1999-05-20 CN CNB998007900A patent/CN1182893C/zh not_active Expired - Fee Related
- 1999-05-20 DE DE69919807T patent/DE69919807T2/de not_active Expired - Lifetime
- 1999-05-20 JP JP2000549334A patent/JP4482230B2/ja not_active Expired - Fee Related
- 1999-05-20 BR BR9906503-7A patent/BR9906503A/pt not_active IP Right Cessation
- 1999-05-20 CA CA002296701A patent/CA2296701C/en not_active Expired - Fee Related
- 1999-05-20 AT AT99933475T patent/ATE274971T1/de not_active IP Right Cessation
- 1999-05-20 ES ES99933475T patent/ES2229735T3/es not_active Expired - Lifetime
- 1999-05-20 AU AU49522/99A patent/AU745426B2/en not_active Ceased
- 1999-05-20 EP EP99933475A patent/EP0998325B1/en not_active Expired - Lifetime
- 1999-08-09 US US09/370,864 patent/US6344033B1/en not_active Ceased
-
2003
- 2003-12-08 US US10/730,772 patent/USRE43142E1/en not_active Expired - Lifetime
-
2008
- 2008-09-02 JP JP2008225307A patent/JP2009006164A/ja active Pending
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2432546A4 (en) * | 2009-05-19 | 2015-05-27 | Nexus Medical Llc | COMPONENT FOR INTRAVASCULAR VALVE WITH IMPROVED POSITIONING OF THE VALVE |
US9352143B2 (en) | 2009-05-19 | 2016-05-31 | Nexus Medical, Llc | Intravascular valve component with improved valve positioning |
Also Published As
Publication number | Publication date |
---|---|
USRE43142E1 (en) | 2012-01-24 |
JP2002515311A (ja) | 2002-05-28 |
AU4952299A (en) | 1999-12-06 |
DE69919807T2 (de) | 2005-09-01 |
CA2296701C (en) | 2008-10-14 |
WO1999059672A3 (en) | 2000-03-02 |
AU745426B2 (en) | 2002-03-21 |
CA2296701A1 (en) | 1999-11-25 |
JP4482230B2 (ja) | 2010-06-16 |
CN1272064A (zh) | 2000-11-01 |
JP2009006164A (ja) | 2009-01-15 |
EP0998325B1 (en) | 2004-09-01 |
US6344033B1 (en) | 2002-02-05 |
BR9906503A (pt) | 2000-09-19 |
US5957898A (en) | 1999-09-28 |
WO1999059672A2 (en) | 1999-11-25 |
ATE274971T1 (de) | 2004-09-15 |
ES2229735T3 (es) | 2005-04-16 |
EP0998325A2 (en) | 2000-05-10 |
DE69919807D1 (de) | 2004-10-07 |
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